Breast cancer screening cannot be justified, says researcher

'Book argues harm outweighs small number of lives saved, and accuses mammography supporters of misconduct'

Breast cancer screening can no longer be justified, because the harm to many women from needless diagnosis and damaging treatment outweighs the small number of lives saved, according to a book that accuses many in the scientific establishment of misconduct in their efforts to bury the evidence of critics and keep mammography alive.

Peter Gøtzsche, director of the independent Nordic Cochrane Collaboration, has spent more than 10 years investigating and analysing data from the trials of breast screening that were run, mostly in Sweden, before countries such as the UK introduced their national programmes.

Mammography screening: truth, lies and controversy, from Radcliffe Publishing, spells out the findings of the Nordic Cochrane group for laywomen, rather than for scientists.

The data, Gøtzsche has maintained for more than a decade, does not support mass screening as a preventive measure. Screening does not cut breast cancer deaths by 30%, it saves probably one life for every 2,000 women who go for a mammogram. But it harms 10 others. Cancerous cells that will go away again or never progress to disease in the woman's lifetime are excised with surgery and sometimes (six times in 10) she will lose a breast. Treatment with radiotherapy and drugs, as well as the surgery itself, all have a heavy mental and physical cost.

"I believe the time has come to realise that breast cancer screening programmes can no longer be justified," Gøtzsche said. "I recommend women to do nothing apart from attending a doctor if they notice anything themselves."

The book is published as a UK review of the evidence for breast cancer screening, triggered by the Nordic Cochrane group's publications in scientific journals, gets under way. In October, the cancer tsar Sir Mike Richards promised an independent investigation of the data. It will be chaired by Sir Michael Marmot and will include some eminent statisticians, none of whom have been involved in the breast screening controversy before.

Richards has promised to act on its findings. "Should the independent review conclude that the balance of harms outweighs the benefits of breast screening, I will have no hesitation in referring the findings to the UK national screening committee and then ministers," he wrote at the time.

Women in the UK are called for breast screening every three years from the age of 50, and the age range is being extended to encompass all from 47 to 73. The NHS screening programme has consistently disputed the Nordic Cochrane Collaboration's work.

In July last year, in response to a paper that showed no difference in death rates between similar pairs of countries that had introduced or not introduced screening, Professor Julietta Patnick, director of the NHS cancer screening programmes, said: "We can't comment on screening programmes in other countries but here in England we do know that the best evidence available shows that women aged 50-69 who are regularly screened are less likely to die from breast cancer." She cited an estimate from the International Agency for Research on Cancer (IARC) of the World Health Organisation which said mortality was reduced by 35% through screening — a figure Gøtzsche disputes in his book.

Gøtzsche's book tells of personal attacks on him and on other researchers by the pro-screening lobby, some of whom had financial interests in the continuation of screening programmes, he alleges.

He compares screening advocates to religious believers and argues that their hostile attitudes are harmful to scientific progress. A lot of false evidence has been put forward to claim that the screening effect was large, he writes. Those who tried to expose the errors came under personal attack, as if they were blasphemers.

"I cannot help wonder why many people shrug their shoulders when they learn of scientific misconduct and why many scientists don't care that they deceive their readers repeatedly and betray the confidence society has bestowed on them, whether for a political gain, for fame, for money, for getting research funding or for any other reason. People may keep on being dishonest, may get away with it and may publish in the same journals time and again, to the hurrahs of like-minded people who are often editors of the same journals," he writes.

Some of the screening trials were biased or badly done, the book says, for instance by deciding on the cause of death of a woman after researchers knew whether she had been screened for breast cancer or not. The best trials, it says, failed to prove that lives were saved by screening.

Gøtzsche's group also found that one in three cancers detected by screening was misdiagnosed.

Breast cancer deaths have gone down, he says, but better treatment and better-aware women, who go to the doctor as soon as they find a lump, are responsible. Half of all breast cancers are found between screenings, he says.

Gøtzsche and his group have been highly critical of the leaflet sent to women by the NHS screening programme, which, they say, inflates the benefits and discounts the harms. He says he is hopeful that something good will come of the review.

Klim McPherson, professor of public health epidemiology at Oxford University, has been a critic of the information given to women by the NHS and is also hopeful. He gives credit to Gøtzsche for his assiduous work over many years to get to the truth. "His Cochrane reviews of breast cancer screening are of extremely high quality and not to be lightly dismissed," he said.

Gøtzsche says his work is focused on helping women understand the risks and benefits of screening. In the book, he says one of the leaders of the Swedish trials claimed mammography was the best thing that had happened for women during the last 3,000 years and added: "There are still people who don't like mammography. Presumably they don't like women."

Gøtzsche sees it differently. "People who like women, and women themselves, should no longer accept the pervasive misinformation they have consistently been exposed to," he writes. "The collective denial and misrepresentation of facts about overdiagnosis and the little benefit there is of screening, if any, coupled with the disregard of the principles for informed consent and national laws, may be the biggest ethical scandal ever in healthcare.

"Hundreds of millions of women have been seduced into attending screening without knowing it could harm them. This violation of their human rights is the main reason we have done so much research on mammography screening and also why I have written this book." 25.1.12

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'Silent Thalidomide': Thousands of mothers and their daughters at risk of cancer from anti-miscarriage drugs they took decades ago

• Recent study found drug doubled risk of breast cancer in DES daughters aged over 40
• Around 2,000 women have brought cases against drug companies in America after DES exposure

Tens of thousands of woman could suffer a rare cancer caused by a banned drug taken by their mothers or even grandmothers. The drug, Diethylstilboestrol (DES), was freely prescribed to pregnant women in Britain for three decades up to 1973, and was supposed to prevent miscarriages.

But it was belatedly banned in Britain after it was found to increase the risk of miscarriage – and it is now feared that it can lead to a deadly cancer to a second and even third generation. Some 2,000 women have already sought compensation in America, with payouts totalling up to £1bn from the numerous drug companies that sold DES, while scores more are launching more legal action. 

Now fresh compensation cases are set to begin here, with tens of thousands of British women to be asked if they could be potential victims of the drug nicknamed ‘the silent Thalidomide'.

As well as causing a rare cervical and vaginal cancer, and possibly breast cancer, in the daughters, and potentially grandchildren, of the women who took it long ago, DES is also being blamed for causing fertility problems.  The drug, a synthetic copy of the female hormone oestrogen, was created in Britain in 1938, and was soon being prescribed to millions of women around the world.

Doubts about the wisdom of using it surfaced in 1953, when an American study showed it caused more, rather than fewer miscarriages. 

But it was not until 1971 that US authorities told doctors to stop prescribing it - after it was found that one in a thousand of the daughters of women prescribed DES had developed the cervical and vaginal cancer ‘clear cell adenocarcinoma' (CCAC).  And it was only in 1973 that British doctors were advised to stop prescribing the drug.

The Royal College of Obstetrics and Gynaecology has suggested 7,500 British women took DES, but there are other claims that up to 300,000 could be at risk.

Figures suggest that daughters of women who took the drug are made 40 times more likely to develop the cancer CCAC, often when young adults. The cancer is fatal in more than a quarter of cases.

One study suggested that breast cancer risk is also doubled. It will be impossible for many possible victims to find out, of course, whether their mothers or grandmothers used the drug. 

Research on rodents has lent weight to the fear that DES dangerously alters DNA not only in the individual taking the drug, but also that those changes are passed on at least two generations.

Washington DC lawyer Aaron Devine, who is representing the 80 American women currently seeking compensation, is due in Britain in a fortnight to arrange a search for potential victims here.

The first woman in Britain found to have suffered as a result of DES taken by her mother is Heather Justice, 59, of Jarrow in Tyne and Wear.

She was diagnosed with vaginal cancer aged 25, then went through a hysterectomy and other surgery. Records showed her mother had taken DES in the 1950s, but because she did not know which company produced it, has been unable to bring legal action. 

Mrs Justice said: ‘One of the problems is that unlike Thalidomide, where you see the problem the minute the baby was born, women who took DES had healthy babies.

  ‘Problems were hidden until the teens and twenties, by which point we were forgotten about. When I asked my mum what she had taken, she didn't even remember the name of the stuff. It is a complete and utter minefield.'

  Among others who believe they have been afflicted in Britain are Janet Hall, 61, of Bournemouth - whose mother died from lung cancer aged 32 – who had to have much of her cervix removed when she was 20. She suffered a miscarriage, then had two daughters.

One, Hannah, 26, has had pre-cancerous cells found in her cervix, she said.

Mrs Hall said: ‘I feel guilty for my girls. It messes with your mind; it makes you ask why you had to have children.'

A spokesman for the Department of Health spoke of having ‘every sympathy' for self-proclaimed victims, but said: ‘With regard to compensation for people who believe they have been adversely affected by this drug, this is a matter for the manufacturer(s) and/or the UK licensees of the drug.' 23.1.12

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Side effects and effectiveness of 'wonder-drug' Tamiflu under the microscope as Department of Health faces awkward questions over mass prescriptions

Health officials are to face questions about whether they prescribed Tamiflu on a mass scale too quickly in the wake of the 2009 swine flu outbreak.

A two-year review into the widely prescribed drug will reveal findings about the effectiveness and side-effects of the swine flu 'wonder-drug'.

The conclusions made by the Cochrane Collaboration could pose uncomfortable questions for the Department of Health as to whether they rushed into mass prescriptions of Tamiflu when swine flu hit the nation in 2009. Reports at the time of the swine flu outbreak in Britain listed a number of side effects associated with the antiviral, such as nausea, nightmares in children, and other reactions.

As well as questioning issues surrounding Tamiflu, researchers behind the review also claimed the makers of the drug refused to hand over raw data to help them with their appraisal.

Swiss pharmaceutical giant Roche claimed Tamiflu reduced the number of patients who needed to be hospitalised after becoming infected with swine flu.

The comprehensive appraisal by Cochrane, a non-profit group who analyse medical evidence through results from the world's best medical research studies, aims to challenge Roche's claim when its findings are released tomorrow. The Cochrane Collaboration, considered by experts to be the 'gold standard' of medical evidence, also reported problems obtaining data from Roche back in 2009.

Professor Sir Iain Chalmers, a founder of the Cochrane Collaboration, told The Bureau of Investigative Journalism: 'We have invested millions of pounds on stockpiling Tamiflu on the basis of a paper that presented the results of 12 trials, only two of which have been published.

'The investigation... shows Roche refused to provide data to evaluate these trials. 'Investigators got some data through the European Medicines Agency, but this doesn't answer all of the questions they have.' He added: 'It is a disgrace that Roche have not provided this data.'

A teenage girl left disabled by the swine flu treatment Tamiflu did not even have the virus, it was revealed today. Samantha Millard, 19, became critically ill after suffering a severe allergic reaction to the tablets, which she took on the advice of the controversial NHS helpline.

Within 72 hours of taking three pills, doctors put her on life support. Samantha spent a month in hospital after developing the life-threatening Stevens Johnson syndrome, which causes the skin to peel off, and later developed toxic epidermal necrolysis syndrome, which has damaged her sight.

Roche responded by saying it has provided Cochrane with access to 3,200 pages of detailed information as part of their review. The Swiss firm said it made full clinical study data available to health authorities as part of the licensing process.

A spokesperson for Roche said today: 'Roche stands behind the robustness and integrity of our data supporting the efficacy and safety of Tamiflu.'

A Department of Health spokesperson said: 'At the end of last year we published a major review of the scientific evidence base, which showed a clear benefit in offering antivirals to those with severe illness and those with additional risk factors. 'Our priority has always been to minimise the risk of serious illness and death from seasonal flu.' 18.1.12

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Medical journal openly questions science, ethics of HPV vaccinations

On January 12, 2011 the Annals of Medicine published a ground-breaking peer-reviewed paper titled, Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?, 1 written by renowned researchers Lucija Tomljenovic, Ph.D.,and Christopher Shaw, Ph.D., with the Neural Dynamics research Group, University of British Columbia, in Vancouver. 2.

The article points out to the medical community what most consumers now know about the fraudulent global health agency policies in combination with the pharmaceutical companies lack of science based evidence demonstrating the safety and efficacy of Gardasil and Cervarix before they were unleashed on unsuspecting parents of adolescents.

Clinical Trials on Healthy People vs. Mass Vaccination Campaigns
Tomljenovic and Shaw clearly state the obvious in their abstract by stating that vaccines represent 'a special category of drugs generally given to healthy individuals and therefore a small level of risk for adverse reactions is acceptable.'

Merck's clinical trials were flawed because they used an aluminum adjuvant as a 'placebo' and only used saline as a comparative for minor, non-serious adverse reactions. With serious adverse reactions, they pooled the results from the saline group and the aluminum 'placebo' group. By doing this, they concealed the true rate of serious reactions.

If FDA approved drugs and vaccines were as safe and effective as Pharma would like consumers to believe the risk level should be negligible to none. The FDA removal of drugs after they have been on the market and damaged desperate people looking for cures who then have to file lawsuits to recover damages is simply unacceptable.

Medical Ethics Questioned
The authors also point out the myth of informed consent - basically a waiver signed by medical consumers that they have been 'educated' about the risk vs. benefit ratio of the drug about to be administered. Tomljenovic and Shaw open their paper citing that 'medical ethics demand that vaccination be carried out with the participant's full and informed consent' and not just the handing out of the HPV vaccine Patient Product Insert - prepared by none other than the vaccine's manufacturer.

What the authors do not cover in this paper is what happens to informed consent when governments grant children the right to consent to medical procedures, such as California's recent passage of AB 499 - basically granting parental rights of children ages 12 and older to the state for the treatment of STD's. Is it really because the 'state' knows better - or is it because legislatures have been paid off by the pharmaceutical companies?

The authors go on to state:

"What is more disconcerting than the aggressive marketing strategies employed by the vaccine manufacturers is the practice by which the medical profession has presented partial information to the public, namely, in a way that generates fear, thus promoting vaccine uptake.........It thus appears that to this date, medical and regulatory entities worldwide continue to provide inaccurate information regarding cervical cancer risk and the usefulness of HPV vaccines, thereby making informed consent regarding vaccination impossible to achieve."

Money Talks - Nobody Walks - but the Vaccine Injured
According to Maplight California - a web site that reveals money's influence on politics, contributions from interest groups to CA legislators who supported the bill were $2,174,648 - more than 28 times the $76,404 given to interest groups who opposed the bill. It is also interesting to note that republican based groups and pro-life groups were on the dissenting side vs. the overwhelming number of liberal and democratic groups supporting the bill.

Similar bills are now in front of South Carolina and Florida legislatures. We are now personal witnesses to the erosion of medical ethics encouraged by politicians abundantly rewarded with special interest contributions.

Tomljenovic and Shaw continue their message by reminding medical professionals that 'contrary to claims that cervical cancer is the second most common cancer in women worldwide, existing data show that this only applies to developing countries. In the Western world cervical cancer is a rare disease with mortality rates that are several times lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination.'

The author's state - what should become the mantra of all medical practitioners and consumers concerned about vaccine safety and efficacy:

Future vaccination policies should adhere more rigorously to evidence-based medicine and ethical guidelines for informed consent.

Tomljenovic and Shaw cite these key messages:

- To date, the efficacy of HPV vaccines in preventing cervical cancer has not been demonstrated, while vaccine risks remain to be fully evaluated.

- Current worldwide HPV immunization practices with either of the two HPV vaccines appear to be neither justified by long-term health benefits nor economically viable, nor is there any evidence that HPV vaccination (even if proven effective against cervical cancer) would reduce the rate of cervical cancer beyond what Pap screening has already achieved.

- Cumulatively, the list of serious adverse reactions related to HPV vaccination worldwide includes deaths, convulsions, paraesthesia, paralysis, Guillain-Barre Syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and cervical cancers.

- Because the HPV vaccination programme has global coverage, the long-term health of many women may be at risk against still unknown vaccine benefits.

- Physicians should adopt a more rigorous evidence-based medicine approach, in order to provide a balanced and objective evaluation of vaccine risks and benefits to their patients.

- The almost exclusive reliance on manufacturers' sponsored studies, often of questionable quality, as a basis for vaccine policy-making should be discontinued.

- Greater efforts should be made to minimize the undue commercial influences on academic institutions and medical research, as this influence may impede unbiased scientific inquiry into important questions about vaccine science and policies.

- Passive adverse event surveillance should be replaced by active surveillance to better understand the true risks associated with vaccines, particularly new vaccines.

The abstract of Tomljenovic and Shaw's paper, Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds? is posted on the SANE Vax Inc. web site. The entire paper can be accessed via this link on or after January 12. Share the 12-page paper with your medical practitioner, school nurses, and boards of education considering enforcing state legislation, and parents or guardians considering HPV vaccination for their child. Should you have difficulty accessing the entire paper you may contact the corresponding author via email at lucijat77@gmail.com "> lucijat77@gmail.com .

The entire paper can be accessed via this link on or after January 12. Share the 12-page paper with your medical practitioner, school nurses, and boards of education considering enforcing state legislation, and parents or guardians considering HPV vaccination for their child.

Medical consumers need to demand the healthcare industry stop focusing on 'drug policies' and direct efforts toward uncovering science-based evidence to identify those actually at risk for the disease. As Tomljenovic and Shaw readily point in their dissertation on the HPV vaccine, the risk of cervical cancer is relatively small to justify a mandatory mass vaccination program with vaccines of questionable safety.

SaneVax Inc. views the presentation of partial and/or non-factual information regarding cervical cancer risks and the usefulness of HPV vaccines, as cited above, to be neither scientific nor ethical. These practices do not serve public health interests, nor are they likely to reduce the levels of cervical cancer. Independent evaluation of HPV vaccine safety is urgently needed and should be a priority for government-sponsored research programs. 13.1.01 Natural News

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'Worried well' are warned against taking daily aspirin: Pills can cut heart attacks by 10% but raise risk of internal bleeding by nearly a third

Doctors should stop giving aspirin to ward off heart attacks in patients without cardiac disease, claim scientists. British researchers behind the biggest study of its kind warn the tablets can harm the ‘worried well' by raising the risk of stomach bleeding.

At the same time, it has no effect on deaths from heart problems or cancer, they said. But the scientists stress that patients with heart problems must keep taking aspirin as evidence that it prevents further attacks is indisputable.

Thousands of others who have not had a heart attack or stroke are prescribed low-dose aspirin in line with guidelines as they are feared to be at risk of cardiac attack. 

In addition, healthy middle-aged people – the so-called worried well – regularly take aspirin bought over-the-counter at pharmacies in the hope it will benefit them.

Taking daily aspirin is known to cut the risk of repeat heart attacks and stroke by up to a third. But there has been uncertainty over whether it has the same benefit in patients who have never suffered an attack.

The latest study reviewed nine clinical trials involving more than 100,000 people without a history of cardiovascular disease. It found the risk of internal bleeding from aspirin cancels out any benefits to the heart.

Half of the patients took aspirin and half took an inactive substitute for an average of six years. 

Taking aspirin daily, or every other day, cut the risk of heart attacks and strokes by 10 per cent, mainly due to a drop in non-fatal heart attacks. But there were no reductions in deaths from heart attacks or the number of strokes.

However, the benefit to the heart was almost entirely offset by a rise in the risk of internal bleeding affecting the stomach or brain.

Although one heart-related event was averted for every 120 people taking aspirin, one in 73 suffered bleeding during the same period.

Lead author Dr Rao Seshasai said people with a history of heart problems must not stop taking aspirin. He said: ‘However, the benefits in those not known to have these conditions are far more modest than previously believed. In fact, aspirin may potentially result in considerable harm due to major bleeding.' He said doctors should consider aspirin treatment on a ‘case-by-case basis' for low-risk patients.

The study, published online in the Archives of Internal Medicine journal, was carried out by a team from Professor Kausik Ray's group at St George's, University of London. It adds to growing evidence that giving aspirin where patients do not have symptoms of heart  disease is counter-productive. A report in the Drug and Therapeutics Bulletin in 2009 said the practice should be abandoned.

And a UK study also in 2009 found aspirin can double the risk of dangerous internal bleeding in those without a history of heart disease while having no effect on the rate of heart attacks or strokes.

Natasha Stewart, senior cardiac nurse at the British Heart Foundation, said: ‘People who don't have diagnosed heart disease shouldn't take aspirin as the risk of bleeding may outweigh the benefits.'

Nick Henderson, executive director of the Aspirin Foundation, said the study was ‘at odds with so much existing medical opinion'. 10.1.12

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Faulty implants, dodgy drugs and a toothless watchdog that's failing patients

Just over two years ago consultant plastic surgeon Azhar Aslam became deeply worried — he'd had to remove eight silicone breast implants from women within a few months of each other because they had ruptured prematurely. It struck him as highly unusual. ‘If implants do rupture, it is normally after seven to ten years, and it is usually caused by an impact, such as the wearer falling over or having a car accident,' he says.

‘But these implants had failed after only two to three years, and the patients had not been involved in any impact.' All the implants were made by the French firm Poly Implant Prothese (PIP). 

Mr Aslam, previously an adviser to the European Academy for Cosmetic Surgery, sent some of the ruptured implants back to the manufacturer but was not satisfied with their explanation.  So on July 9, 2010, he wrote to Britain's medical safety watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA) which regulates and had approved the use of PIP implants.

He alerted Dr Susanne Ludgate, the medical director of devices, to the problem, offering to supply samples of the faulty implants. Five days later, he received an email saying she'd passed his warning to the agency's Adverse Incident Centre and they would be in touch.  But he heard not a squeak. ‘No one from the Adverse Incident Centre has ever contacted me. Perhaps they were busy or something,' he says. Or perhaps the watchdog was asleep.

For as we now know, more than 40,000 British women have been given these faulty implants.  Behind the furore over whether they should now have their implants removed — and who should pay for it — there is disquiet about the MHRA's role.

Officially the agency is ‘responsible for ensuring that medicines and medical devices work, and are acceptably safe'. It not only approves these devices and drugs, but regulates them. The agency's initial response to fears over the implants was to say the failure rate was only 1 per cent.

Then, last week, the MHRA admitted the safety of breast implants was actually impossible for it to judge, because an accurate record of the number of procedures has not been kept.  Clinics were blamed for this failing, with Health Secretary Andrew Lansley criticising them for providing ‘poor quality' data. 

Mr Aslam lays the blame elsewhere. ‘We rely on the regulatory authorities to ensure our implants are OK,' he says. ‘And when we try to tell them that something is wrong with the safety-approved implants, these authorities do not seem to take any proper notice. It leaves me asking, “Who can I trust?”?'

Sadly, this is not the first time the agency has been criticised for acting slowly and ineffectually. 

In September 2010, for instance, the diabetes drug Avandia was finally banned in Britain after the European Medicines Agency ruled there was a serious risk it could lead to heart attacks or stroke.  Evidence against Avandia had been building since 2007. 

And, while denying it had failed to reveal the risks when they showed up, in July 2010 the drug's maker, GlaxoSmithKline, reportedly paid out £304?million in damages to settle about 10,000 patient lawsuits in the U.S.

However, in the same month an advisory body to the MHRA warned it that the ‘risks (of Avandia) outweigh its benefits, that it no longer has a place on the UK market' and called for prompt action.  The MHRA did not reveal this warning to the public; it simply passed its information on to European authorities.

A few years earlier, media pressure was required to force the MHRA to act over another prescribed-drug danger. Again, it was a GlaxoSmithKline medicine — the antidepressant Seroxat. 

Specialists had been warning for years of the raised risk of suicide in children. But the MHRA, relying on evidence from the manufacturer, issued assurances that there was no suicide link. Then, in 2003, following two BBC Panorama programmes, the drug watchdog mounted its own investigation and discovered the manufacturer had hidden information about the suicide link. 

After this, the MHRA said it wanted to require drug makers to share more information about clinical trials — but admitted that, without stronger legislation in place, there was no chance of prosecuting the company for what it called an ‘ethical lapse'. 

The watchdog was not only asleep, it was toothless.

Similar problems arose with the arthritis painkiller Vioxx. This was withdrawn from the market in the UK four years ago, but only after a 2004 U.S. study found it doubled the risk of heart disease. Leading cardiologists had been flagging up the risks for years.

After Vioxx's withdrawal it emerged that data from clinical trials had been ‘fudged'. 

The MHRA launched an investigation into whether its maker, Merck, had correctly reported the side-effects of Vioxx to the authorities. But government prosecutors decided that there was no realistic prospect of a conviction in this case. The MHRA says the UK laws requiring disclosure of negative drug trial results have since been tightened. No companies have been prosecuted since then.

Yet it's not just the agency's supervision of drugs that raises concerns, but medical devices, too. These include crucial items such as heart pacemakers.  Last May, the British Medical Journal (BMJ) said not enough was being done to check the safety of medical implants. 

It says that in 2009 the MHRA received more than 9,000 reports of ‘adverse incidents' involving medical devices. More than 1,880 of these involved serious injury and 202 resulted in death. In one case, a patient's combined pacemaker/defibrillator misfired more than 30 times in one day, delivering huge jolts of 750 volts direct to his heart. 

The BMJ has said our regulators are not ‘fit for purpose' because of their failure to act in patients' interests.  It is these sorts of problems that have led experts such as Andrew Herxheimer to call for the MHRA to be subjected to ‘root and branch reform'. 

Dr Herxheimer is an emeritus fellow of the UK Cochrane Centre and a world leader in examining clinical trials to see how well therapies work. One problem, says Herxheimer, is that the agency's role is shrouded in confusion. ‘Its job description has not been defined,' he says. 

‘In fact, it seems to be acting as a rather secretive negotiating agency between the government and the pharmaceutical industry. ‘It is certainly too close to the pharmaceutical industry,' adds Herxheimer.  ‘There appears to be a revolving door with people who have previously worked in the pharmaceutical industry coming to work inside the MHRA. '

Accusations have long been made that the watchdog is too close to industrial interests, notably when Ian Hudson, who was worldwide safety director of GlaxoSmithKline until 2001, became director of licensing at the MHRA. Nor have the agency's actions helped assuage these kinds of concerns. 

Six years ago it had to apologise for misleading the public over the results of a consultation exercise with the medical royal colleges.  It claimed they were in favour of letting a powerful heart drug be sold by High Street chemists without a prescription. 

In fact, an investigation by medical journal Drugs and Therapeutics Bulletin found the drug, a statin which can help lower cholesterol, had effectively been rejected by two-thirds of the expert bodies consulted because of fears over side-effects.  

The MHRA apologised and said it had made an ‘administrative error'. ‘This has got to be the killer argument for a massive overhaul of the MHRA,' said Dr Ike Iheanacho, the journal's editor. ‘This latest episode totally undermines faith in their decision-making process.'

MPs have also been worried by the agency's behaviour. In 2005, a highly critical report by the Commons health select committee objected to a lack of openness and the MHRA's closeness to the pharmaceutical industry. It warned that scandals on the scale of Vioxx would happen again because the regulators were not sufficiently independent.

In response, the agency said: ‘Since November 2005 all staff and immediate members of their families are not allowed to have any financial or other interests in the pharmaceutical industry.'

But for Paul Flynn, Labour MP for Newport West, this does not go far enough. The problem, he suggests, is that the MHRA is ‘an organisation whose activities are entirely financed by a levy from the pharmaceutical industry'. A key figure on the health select committee, he remains adamant the MHRA must be reformed or replaced with a more robust body.

As the arguments rage over this issue, breast implant surgeons such as Azhar Aslam and their patients are left stuck in the middle — unsure of who to trust for independent advice. ‘I would like to see the regulations tightened up,' he says. ‘Otherwise how can I guarantee to women that the implants I am giving them are safe?' 

The MHRA says it did respond to Mr Aslam. Mr Aslam and his clinic, the Linia Cosmetic Surgery in London, are adamant that they never received any such response. 10.1.12

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Patients at risk after scientists withhold test results from clinical trials of new medicines 

•  Test results are deliberately hidden
•  'These changes have long been called for, and delay has already caused harm', say BMJ authors

Missing data from clinical trials could endanger patients, health experts have warned. The British Medical Journal has raised concern that some   test results go unreported and are deliberately hidden, enabling pharmaceutical firms to make unfounded claims.

Commenting on the findings, Dr Richard Lehman from Oxford University and the journal's Dr Elizabeth Loder stated that more effective regulation is needed to prevent this trend. They called for an end to the 'culture of haphazard publication and incomplete data disclosure'.

The medical publication released several papers looking into the problem of unpublished data, and highlighted that missing data 'distorts the scientific record' and undermines the 'whole endeavour of clinical medicine'.

Dr Lehman and Dr Loder continued: 'Clinical medicine involves making decisions under uncertainty. 'Clinical research aims to reduce this uncertainty, usually by performing experiments on groups of people who consent to run the risks of such trials in the belief that the resulting knowledge will benefit others.

'Most clinicians assume that the complex regulatory systems that govern human research ensure that this knowledge is relevant, reliable and properly disseminated. 'It generally comes as a shock to some clinicians, and certainly to the public, to learn that this is far from the case.'

One U.S. study from Yale University found that fewer than half of the 635 National Institutes of Health funded trials were published in a peer-reviewed, medical journal within 30 months of trial completion.

Lead researcher Joesph Ross said: 'Physicians and policy-makers generally depend on peer-reviewed publications to learn about clinical trial findings.'However, extensive research has shown that the results of studies are often not shared publicly in a timely way.'

More robust regulation and full access to the raw data, is now being called for to ensure greater transparency. BMJ authors stated that those who deliberately hide findings 'have breached their ethical duty to trial participants'.

The pair concluded: 'These changes have long been called for, and delay has already caused harm. 'The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine.'

The BMJ has previously attacked the drug industry for being slow to publish data from trials of drugs in development, and also from trials of medicines already licensed and on the market'. 5.1.12 Corruption in medical science is wide-spread.

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Consequences of ‘stupid medical advice' is bringing ‘rickets back' as cases increase fivefold in 14 years

The number of British children suffering from rickets has increased fivefold since 1997, figures have revealed. More than 760 were admitted to hospital last year with the condition, caused by a shortage of Vitamin D – the vital chemical which is boosted by sunlight.

Better nutrition had all but wiped out rickets, which was common in 19th century Britain , but rates have started to rise in the last decade. It is still a major problem in the third world.

Some experts blame its return on parents' increasing fear of skin cancer, which encourages them to smother their children in sun cream and keep them out of the sun. However the real blame lies with the so-called 'medical experts' who were obsessed with skin cancer and actually 'advised' parents to keep their children out of the sun, forgetting that Vitamin D from sunlight is essential for bone development. Rather than accept responsibility for their 'poor advice' the medical community are now blaming the parents.

Today's children also spend much less time playing outside than previous generations, instead staying indoors to watch television or play on their computers. And fewer youngsters now take cod liver oil capsules, which are rich in vitamin D and, until recently, were given to children to protect against rickets.

Indications that the disease – which causes brittle bones and deformities – is making a return will be greeted with concern among doctors.

Gillian Killiner, of the British Dietetic Association, said: ‘We have taken it for granted that skin cancer is the big one and overlooked the Vitamin D side. ‘Children are covered up with sunblock, t-shirts and hats, and that can be important – but perhaps we've pushed it too far.  ‘We don't have a lot of sun in this country, and in winter you are likely to be lacking in Vitamin D. ‘If you haven't built enough up over summer, that's going to be a certainty.'

She added that children are eating smaller amounts of fish and eggs than in the past, so they get less Vitamin D in their food. ‘It's to do with the way we eat, obesity, and the lack of spending time out and about. In addition, more children are now overweight and that can reduce their ability to absorb Vitamin D,' she said.

She added that black and Asian children were more at risk of rickets because it takes darker skins longer to absorb Vitamin D. ‘This effect can be exacerbated if they have covered up for cultural reasons,' she said.

Figures on the number of patients admitted to hospital with rickets were revealed following a parliamentary question. They showed that in 1997/98, 147 people ended up in hospital  with a primary or secondary diagnosis of rickets. By 2003/04, the total had more than doubled to 329. Within five years, the number had more than doubled again to 723.

Overall, between 1997/98 and 2010/11, the number of rickets sufferers increased more than fivefold from 147 to 762.

While the figures did not specify ages, experts say the vast majority are children, as Vitamin D deficiency manifests itself as rickets in the young and osteoporosis in adults. Rickets is a major problem in third-world countries, where it is caused by a shortage of calcium.  

It became endemic in the growing cities of 19th century Britain , because of a lack of access to sunlight and poor diets, but rates fell during the 20th century. Last year, a group of doctors warned that people were not getting enough Vitamin D due to skin cancer fears.

Dr Barbara Boucher, of Barts and the London School of Medicine and Dentistry, said: ‘Melanoma is a deadly disease. ‘We do worry so much, but it's sensible to be sensible about it. Don't be afraid to have a moderate amount of sunshine.' 10.12.11

Also see: Quarter of toddlers have a vitamin D deficiency

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FDA withdraws approval for breast cancer drug Avastin after declaring it medically useless, but says doctors can still prescribe it

Several years after declaring it to be not only medically useless but also dangerous, the US Food and Drug Administration (FDA) has officially withdrawn approval for the $100,000 breast cancer drug Avastin. In a statement, FDA Commissioner Margaret Hamburg said that Avastin has never been proven to be safe or effective, but also in the same breath noted that doctors can still prescribe the drug if they feel like it.

"FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments," Hamburg is quoted as saying by The Pittsburgh Tribune-Review . "But patients must have confidence that the drugs they take are both safe and effective for their intended use."

After being rapidly approved for use by the FDA back in 2007, Avastin quickly generated more than $1.7 billion for its producer Genentech within the first year. When the FDA finally got around to actually reviewing the drug after approving it, though, the agency discovered that Avastin does not lengthen the lives of breast cancer patients, and that it carries with it severe side effects that include death.

In her 69-page report on Avastin, Hamburg wrote that Avastin's side effects include high blood pressure, bleeding, heart attack or heart failure, and the development of perforations in the nose, stomach and intestines. In at least one case, a patient taking Avastin has died from infection.

But the way the FDA is handling the situation shows how blatantly biased it is towards the drug industry. Avastin was proven dangerous and ineffective several years ago, but the FDA allowed it to remain on the market. Now, it has decided to withdraw approval for Avastin, but is still allowing it to remain on the market.

If Avastin had been a dietary supplement in the same predicament, the agency would have immediately withdrawn its approval (if it would have approved it in the first place), and demanded that it be removed from the market. The agency likely would have also shut down Avastin's manufacturer, as it has done a lot worse to supplement companies that produce safe and effective natural treatments. 27.11.11

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Review site TripAdvisor is useless, damaging and used for blackmail

Hotel guests using threat of poor TripAdvisor reviews to demand free upgrades and refunds. Hotel guests are using the threat of a bad review on Tripadvisor to blackmail owners into paying hundreds of pounds 'compensation' - even when there was nothing wrong with their stay.

Scores of hoteliers say their businesses have been targeted by unscrupulous holidaymakers demanding an upgrade or seeking a refund to prevent them submitting a one-star rating to the travel website.

A bad rating on the site can cost a hotel tens of thousands of pounds in lost bookings.

The Times said it had seen complaints from more than 80 hotel and bed-and-breakfast owners that guests were unjustifiably using Tripadvisor as a 'weapon' against them.

The owner of a hotel in Sussex, which is still involved in legal action, said a guest asked for almost £1,000 claiming he had suffered food poisoning. When the hotel refused to pay - after evidence from other diners showed that the meal he had eaten had not caused the illness - he posted a damning review.

Frequent examples included guests causing extensive damage to rooms - yet when confronted, say they will submit a poor review, forcing owners to back down.

Launched in 2000, Tripadvisor receives 45million unique visitors a month from holidaymakers and business travellers looking for accommodation.

But its business model of using completely anonymous reviews, often without any supporting evidence, has been criticised as unfair to hoteliers.

In other cases, hotels themselves have been accused of posting bogus reviews.

Last month, MailOnline reported that hotel owner Deborah Sinclair was taking legal action after Tripadvisor placed a 'red flag' on the review page of the Riverside hotel which she owns in Evesham, Worcestershire. The message, which was posted on Riverside 's page in August, said TripAdvisor believed the hotel had been posting suspicious reviews.

The business was ranked No 1 in the area, but Mrs Sinclair claims takings have fallen 75 per cent after suffering a 'catastrophic collapse in bookings' since the message appeared in August. Last week, a bus driver who was sacked after a single bad review on Tripadvisor was awarded more than £2,600 by an employment tribunal.

A spokesman for Tripadvisor said:'We take allegations of blackmail or threatening behaviour by guests against property owners very seriously. 'Not only is it strictly against our guidelines, but it may also be illegal.' TripAdvisor has recently launched new customer support phone lines which allow aggrieved hotels to report reviews it believes are untruthful. 22.11.11

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Now barmy EU says you CAN'T claim drinking water stops dehydration

• UKIP MEP Paul Nuttall: ‘I had to read this four or five times before I believed it. This makes the bendy banana law look positively sane'
• Ruling, announced after a conference of 21 EU-appointed scientists, given final approval this week by European Commission President Barroso

Drinking water does not ease dehydration, the European Union has ruled – and anyone who disagrees faces two years in prison.

The decision – after three years of discussions – results from an attempt by two German academics to test EU advertising rules which set down when companies can claim their products reduce the risk of disease. 

The academics asked for a ruling on a convoluted statement which, in short, claimed that water could reduce dehydration. Dehydration is defined as a shortage of water in the body – but the European Food Standards Authority decided the statement could not be allowed.

The ruling, announced after a conference of 21 EU-appointed scientists in Parma and which means that bottled water companies cannot claim their product stops people's bodies drying out, was given final approval this week by European Commission President Jose Manuel Barroso.

Yesterday, Tory MEP Roger Helmer said: ‘This is stupidity writ large. The euro is burning, the EU is falling apart and yet here they are worrying about the obvious qualities of water. If ever there were an episode which demonstrates the folly of the great European project, then this is it.'

Under British law, advertisers who make health claims that breach EU law can be prosecuted and face two years in jail. The decision was being hailed as the daftest Brussels edict since the EU sent down laws on how bendy bananas should be.

UKIP MEP Paul Nuttall said: ‘I had to read this four or five times before I  believed it. ‘It is a perfect example of what Brussels does best. Spend three years, with 20 separate pieces of correspondence before summoning 21 professors to Parma, where they decide with great solemnity that drinking water cannot be sold as a  way to combat dehydration.' 

He added: ‘Then they make this judgment law and make it clear that if  anybody dares sell water claiming that it is effective against dehydration they  could get into serious legal bother. ‘This makes the bendy banana law look positively sane.' 

The statement on which the eminent EU experts ruled claimed that ‘regular consumption of significant amounts of water can reduce the risk of development of dehydration and of concomitant decrease of performance. However the Parma gathering ruled: ‘The panel considers that the proposed claim does not comply with the requirements for a disease risk reduction claim.' 

It declared that shortage of water in the body was just a symptom of  dehydration.

Dr Andreas Hahn and Dr Moritz Hagenmeyer of the Institute for Food Science and Human Nutrition at Hanover Leibniz University said they were unhappy but  not surprised. ‘We fear there is something wrong in the state of Europe,' Professor Hahn  said.

He added that the academics had been trying to test the working of EU food and advertising rules. ‘It was free of charge, there was no apparent red tape attached and it gave food business operators, whom we regularly advise, a chance to advertise their products in a new way,' he added. ‘We thought we should give it a try and see what would happen.  

‘But over almost four years, it became clear that the procedure was anything but straightforward. Any company depending on the claim would long have gone  out of business. What is our reaction to the outcome? Let us put it this way: We are neither surprised nor delighted.' 

He said: ‘The European Commission is wrong; it should have authorised the  claim. That should be more than clear to anyone who has consumed water in the past, and who has not?' 18.11.11

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Fraudsters fleecing NHS of £3bn a year: Bosses 'look the other way' as vast sums are stolen

Fraud is costing the NHS £3billion a year, with millions being paid to doctors and dentists who ‘invent' shifts and treatment. Managers are also using surgery funds to pay their mortgages or buy iPods, digital cameras and computer games.

A report by the think-tank 2020 Health warns that the NHS is ‘looking the other way' as vast amounts of money are lost to fraud. 

Among the cases are:

• A dentist convicted of a £600,000 fraud after he billed the NHS for treating patients who had died;
• A female doctor who conned a hospital trust out of £61,000 by claiming overtime for more than a year after she had stopped working;
• Another dentist jailed for charging the NHS £200,000 for treatment he never performed;
• And a manager at King's College Hospital in London who invented ‘ghost' employees and gave their pay to four of her friends.

Vast amounts of money are also being lost on the treatment of health tourists – overseas patients who are not eligible for NHS care. Critics claim these funds could be used to pay for cancer treatment, extra nurses or even new hospitals.

Although the NHS has been protected from spending cuts, it has been ordered to make efficiencies totalling £20billion by 2014 so the savings can be ploughed back into better treatment and care. Campaigners say that if the NHS did more to prevent fraud it could make fewer efficiency savings.

Julia Manning, of 2020Health, said: ‘Anyone who still claims the NHS does not need to reform should ask themselves whether £3billion a year is an acceptable price to pay for looking the other way.  'Management urgently needs to tackle fraud in an open way that inspires the confidence of the public. The first step to reducing it is to stop being in denial.'

Matthew Sinclair, of the Tax- Payers' Alliance, said: ‘£3billion is enough to pay for over 7,000 nurses for a decade or build five hospitals.'

A spokesman from NHS Protect, its counter-fraud service, said: ‘NHS Protect thoroughly investigates allegations of fraud and presses for the toughest criminal sanctions if necessary. In 2010/11 alone NHS Protect successfully prosecuted over 100 cases.' 14.11.11

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GPs gave 15,000 children as young as five chemical cosh

Soaring numbers of children as young as five are being chemically coshed with antipsychotic drugs, an investigation by Channel 4 News has found. A staggering 15,000 children under the age of 18 were prescribed the medication last year by their GPs – double the number a decade ago.

The drugs, such as Risperdal and Seroquel, are meant for serious mental conditions such as schizophrenia, bipolar disorder and psychosis.

But experts believe they are increasingly used as a chemical cosh to control children's behaviour, for example to calm youngsters with attention deficit hyperactivity disorder or autism. Children can be left on the drugs for years and are not properly monitored, despite side effects such as dramatic weight gain, diabetes, heart disorders and a Parkinson's disease-like tremor that continues even after the medication is stopped.

Worryingly, nobody knows what the long-term side effects are and pharmaceutical companies have blocked all requests for data on trials involving children. Experts are concerned about the effect the drugs have on developing brains.

Guidance provided by professional bodies, such as the Royal College of Psychiatrists, says a child psychiatrist must be involved in the prescription of drugs. But mental health experts believe this is increasingly not happening. Instead, the drugs are needlessly given out by GPs.

Professor Tim Kendall, director of the National Collaborating Centre for Mental Health, said the figures were 'extremely concerning'. ‘As far as I am aware, there is no evidence that there has been a doubling in the rate of psychosis, so if there is a doubling in the rate of children being given antipsychotics, that is a worry,' he added. 'My worry is that these drugs are being used for other purposes.'

Figures released under the Freedom of Information Act show 14,999 children, up to the age of 18, were prescribed antipsychotics in 2010, compared with 7,649 in 2001.  Of these, 253 were aged six or under, 3,205 were seven to 12 and 11,541 were 13 to 18.

The figures are for prescriptions issued by GPs only. No data exists for the number of prescriptions issued in hospitals.

Professor Peter Tyrer of Imperial College London, an antipsychotics expert, said the use of this medication was a 'slow fuse to disaster'.  The drugs affected almost every part of the body, he added.

The figures on antipsychotics follow the recent revelation that 661,500 prescriptions for Ritalin, or similar drugs for ADHD, were issued to children last year. This amounts to more than 12,000 prescriptions a week and an increase of 70 per cent in the past five years. 9.11.11

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More than 200 GPs earn over £250,000 a year while thousands earn more than Prime Minister

• One in 10 GPs earned £150,000 to £200,000 while 40 per cent earned £100,000 to £150,000

More than 200 GPs are earning at least £250,000 a year, official figures reveal. And there are 890 family doctors on  salaries in excess of £200,000. Nearly 4,200 earn more than £150,000 – which is higher than the Prime Minister's £142,500-a-year salary.

However, these figures mask the handful of so-called ‘super GPs' on exceptionally high annual pay packets nearing three quarters of a million pounds. The figures also showed that 210 GPs had an income before tax of at least £250,000 compared to 250 GPs the year before.

Some 680 GPs (2.1 per cent) had an income of £200,000 to £250,000, compared to 700 the year before.

Almost one in 10 GPs earned £150,000 to £200,000 while 40 per cent earned £100,000 to £150,000, both similar to the previous year. Another 40 per cent earned £50,000 to £100,000.

NHS Information Centre chief executive Tim Straughan said: 'Our report shows that, on average, a GP working in the UK earned roughly the same pay before tax in 2009/10 as they did in the previous year. 'If we consider GP earnings over time; the average pay for a contractor GP at present is a decrease on the peak of £110,000 in 2005/06.'

Dr Richard Vautrey, deputy chairman of the British Medical Association's GPs Committee, said: 'The period covered by these figures follows three years of falls in GP income. 'There was also a change to the way GP practices were funded that year, which has helped to make it fairer across all four nations of the UK .

'So what the headline figures don't show is that some GPs saw a decrease in pay while others saw an increase, depending on where their practice was based, with many GPs in England, for example, actually seeing their pay fall yet again.'

A Department of Health spokesman said: 'We are committed to securing the best possible value healthcare from the GP contract so that resources are used to the greatest benefit for patients and the taxpayer. 'The average GP income is now £4,200 (3.7 per cent) lower than in 2005/06.

'In addition, all public sector staff earning more than £21,000 a year, including GPs, are subject to a two-year pay freeze in 2011/12 and 2012/13.

'The GP contract changes recently agreed with the British Medical Association recognises this and demonstrates commitment to delivering improved patient care.' 10.11.11

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Real reason GP's don't want competition in the NHS - rise of the 'Super GP': The family doctor who earns £770,000 a year

•  Shocking salary revealed through Freedom of Information request by the Mail
•  Average GP earns around £105,000

The top-earning GP in the country receives an annual salary of more than £750,000, it emerged yesterday. The astonishing pay packet is his or her pre-tax income even after all outgoings – including the salaries of all locums, nurses and receptionists they employ – have been taken into account.

The unidentified GP from Kent is believed to be reaping the benefits of a new contract that allows doctors to run several surgeries that rake in NHS cash for providing extra treatment, critics said 'this explains why GP's don't want competition in the NHS, they want to provide 'services' themselves at higher prices'. This can include minor operations, tests for diabetes or help for drug addicts.   

The extraordinary salary, revealed through a Freedom of Information request, marks the rise of the ‘Super GP'.  

The request by the Mail was to obtain figures specifically for individual pay of the top-earning GP for every health trust in England.

It uncovered the highest was recorded by NHS Kent and Medway at £770,444. A second doctor in Birmingham has been found to be earning an annual sum of £665,000, while another in Essex was paid £412,400.

The figures have angered patients' groups and other family doctors who say the standard of care provided by these doctors does not match their exceptional pay packets. Their vast salaries, funded by the taxpayer, come at a time of supposed financial austerity and severe cutbacks within the NHS.  

Dr Vijayakar Abrol, a GP in Birmingham, said: ‘These Super GPs are more like businessmen. They employ slaves to run their practices – practice nurses and half a dozen locum doctors. ‘But if you look at all the indicators, they show that the care they are providing is not better, it is worse. 

'The smaller practices are better and patients see a familiar GP, not a locum.'

Family doctors have to provide details of their salaries to their Primary Care Trust every year so the NHS can calculate how much to pay into their pension pots. Earlier this year, it emerged that 950 GPs earned more than £200,000 in the 2008/09 year – up from 910 the year before – despite repeated promises by ministers to get to grips with doctors' pay. 

The average GP earns around £105,000, with many earning between £53,000 and £80,000. But the average figure rose dramatically from about £70,000 in 2004 thanks to a new pay deal negotiated by Labour. 

It enabled doctors to top up their pay by meeting targets for treating a range of conditions as well as allowing them to opt out of working evenings and weekends. But many patients are now finding  it increasingly difficult to see their doctor and in some parts of the country they are forced to wait up to three weeks for an appointment.

As part of the Labour deal, GPs could also choose to become an Alternative Provider of Medical Services – enabling them to run one or more practices that could earn extra NHS cash for providing additional services. This could include minor surgery to remove cysts or ingrowing toenails, treatment for drug addicts or alcoholics or screening for cervical cancer.

Their practices also earn up to £120 a year for every patient on their books – and the largest will have tens of thousands on their lists.

Dr Richard Vautrey, deputy chairman of the GPs Committee of doctors' union, the British Medical Association, said: ‘To earn this amount of money as a GP is unheard of – indeed the 44,000 other GPs in the UK earn absolutely nowhere near this amount. ‘The vast majority of GPs have seen their salary fall in the last few years and most expect that to be the case this year too.'

This week, the Government ordered GPs to take a pay freeze for a second year running as part of a new contract negotiated with the BMA. This actually works out as a pay cut once inflation has been taken into account. 5.11.11

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NHS diet services ‘ineffective', dieters lose twice as many pounds with private slimming clubs than through NHS

Diet programmes such as Weight Watchers, Slimming World and Rosemary Conley are cheaper and far more effective than those run by the NHS, according to new research.

Offering patients one-to-one counselling in diet and fitness via GP surgeries or pharmacies is 'ineffective', as are programmes run by NHS food advisers and dieticians.

Experts from Birmingham University said the money would be better spent on encouraging people to attend classes run by commercial companies.

They said the benefits include cutting the risk of diabetes and boosting life expectancy. They found people who lose just seven pounds in weight could gain an extra year of life, but the weight loss would have to be sustained forever.

The study of 740 British slimmers found that those who went to a commercial slimming group for three months lost twice as much weight as those who were given diet advice by their family doctor. They speculated this could be because group sessions provided a greater morale-boost and that the diet leaders had often gone through weight-loss themselves.

The average weight loss was best for those attending Weight Watchers sessions – who lost almost ten pounds (4.4kg) on average – and worst for those following GP advice, who lost around three pounds (1.4kg).

Study leader Dr Kate Jolly, said commercial sessions, paid for by the NHS, were also significantly cheaper, with a course of 12 one-hour group sessions costing around £55 – just slightly more than one 12-minute GP appointment.

Dr Jolly said the NHS-funded study analysed the effect on life expectancy of weight loss of around seven pounds (3.5kg) in a 14-stone 49-year-old – the average age of people taking part in the study.

She added: ‘It shows that losing a fairly modest amount of weight is worthwhile, although the big challenge is maintaining the weight loss. Many studies show that people tend to put it on again after a short period of time.' 

Almost a third of people allocated to the Weight Watchers group achieved a 5 per cent drop in body weight – the level needed to cut the risk of developing diabetes.

In the study, published in the British Medical Journal, the obese and overweight participants were asked by their GPs to join several commercial weight loss programmes, or have counselling from GPs or pharmacists over 12 weeks. 

Another group was given free vouchers for a local fitness centre. After one year, all those attending commercial sessions had lost significant amounts of weight, while counselling made 'little difference'.  Attendance seemed to be the key factor, with people going more often to commercial sessions.

Dr Jolly said: ‘GPs don't have the tools for helping patients lose weight consistently, but they were the reason these patients were nudged towards losing weight in the first place.' Almost a quarter of adults in England are now classified as obese. 4.11.11

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Serious complaints against doctors for botched care and abusive behaviour soar by 40% in three years

Serious complaints against doctors for failings such as botched surgery and disastrous misdiagnoses have soared by almost 40 per cent in just three years.

The number of patients reporting medics to the General Medical Council, which can strike doctors off the medical register, surged to a record high of more than 7,100 last year. The catalogue of grievances included allegations of medical mistakes, along with claims of sexual misbehaviour and patients being subjected to verbal abuse.

Patients' groups said the figures, contained in an official report, are a ‘devastating insight' into the public's lack of confidence in the NHS and the professionalism of doctors. GPs are among the medical groups most likely to face complaints, along with psychiatrists and surgeons.  

Family doctors have come in for criticism after more than 90 per cent of them opted out of responsibility for out of hours cover, despite pocketing a pay rise in 2004 which saw their average salaries soar by a third to around £105,000.

Analysis has found that patients are more likely to complain against male doctors than female ones, and those over 50 are far more likely to be referred to the medical authorities than younger doctors.

Complaints to the GMC are only the tip of the iceberg. For every referral to the GMC, there are six more to local NHS trusts, with more than 43,000 reports last year. Katherine Murphy, chief executive of the Patients Association, said the problem was that patients believed doctors tend to stick together and cover failings up, rather than admitting they have taken place. She said: ‘I think we have got a huge problem with falling public confidence in the health service. 

These findings are a devastating insight, and they mirror our own experience as a charity, with increasing numbers of people calling us because they do not know where to turn.' 

The report by the GMC also shows the number of doctors being struck off has soared by 18 per cent over the past three years. In 2010, 92 doctors were struck off, while 106 were suspended for up to a year.

Of the 7,100 complaints to the GMC which went on to a full investigation, 60 per cent were about substandard medical care, with allegations about misdiagnoses or poor treatment. Another 26 per cent were about respect and communication with patients, including allegations of verbal abuse, failing to listen to patients and basic rudeness.

Separate figures show that older doctors were more likely to attract complaints. 

Over the past eight years, those above the age of 60 were seven times more likely than those below 40 to be referred to the authorities; while the rate among those in their 50s was four times as high. And male doctors were almost three times as likely to receive complaints.

Niall Dickson, chief executive of the GMC, said that despite a ‘rising tide' of complaints from members of the public, surveys on the NHS suggested overall satisfaction remained high. ‘I don't regard these findings as a cause for despair,' he said. ‘I don't think there is evidence that standards are falling. ‘I think in some ways the system is getting better at identifying problems, and doctors are more willing to identify colleagues who are not performing well.' 24.10.11

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More Fiction & Spin - Number of crack and heroin addicts fall by 10,000 in two years

The number of heroin and crack addicts needing treatment fell by almost 10,000 over the last two years, figures showed today. The National Treatment Agency for Substance Misuse (NTA) said the number of people addicted to class A drugs fell from 62,963 in 2008/09 to 52,933 last year.

The figures also recorded the number of drug users who have been treated successfully and are getting their lives back on track rose by almost a fifth last year. Some 27,969 users were classed as recovering in 2010/11, a rise of 18 per cent on the previous financial year and 150 per cent higher than 11,208 in 2005/06.

There was also a sharp fall in the number of addicts under 30 over the last five years, fuelled by the number of 18 to 24-year-olds seeking treatment for heroin and crack addiction halving from 12,320 in 2005/06 to 6,108 last year. The figures also showed that, of the 255,556 people who entered a drugs treatment programme since April 2005 for the first time, 28 per cent (71,887) successfully completed the course and did not need further treatment.

Paul Hayes, the NTA's chief executive, said the figures, which apply to adults in England only, showed 'recovery is now becoming a reality for more individuals each year'. 'More drug users are recovering from addiction, fewer need treatment, and more are getting over their addiction quickly,' he said.

'The fact that the next generation are getting the message that hard drugs wreak damage to individuals and communities is very positive, for them and the rest of society.'

Speaking during a briefing at the Department of Health in Whitehall, Mr Hayes said that, while the figures 'give cause for optimism', they indicate 'that it's a trend that's moving in the right direction'. 'We're a goal up but it's not half-time yet,' he said.

'I think what it shows is that we've probably passed the high watermark of the impact of epidemic of the late '80s and early '90s and that younger groups of people are reluctant to begin patterns of behaviour - heroin and crack use in this instance - that they've seen cause damage to their older siblings, people in their community, sometimes, sadly their mums and dads. 'They realise the consequences of heroin and crack use and they're turning their backs on that.'

He went on: 'If you see people in your community who actually can't cope because of heroin and crack use, if you also increasingly see heroin and crack dependency concentrated amongst the people in our society who do life least well, as that becomes more apparent, it's difficult to see it as being fashionable or chic.

'If the people who are using heroin are the people who aren't succeeding at school, who aren't working, who don't live in good situations, who aren't attractive to the opposite sex, who are basically in a bit of a state, then that's not much of an attraction if you're 17, 18, 19, to get on that same escalator.'

Mr Hayes added that it was 'unlikely' that heroin and crack addicts were moving to legal highs. Most of those who use heroin and crack are 'concentrated in our poorest, most disadvantaged communities, among people who suffer with many other problems in life: poor education, risks to their mental health, in and out of prison, inadequate parenting when they were younger leading to them being in and out of the care system'.

'Whereas the new drugs coming on to the market tend to be much more part of the recreational pattern of drugs use.'

Mr Hayes said officials were also seeing 'significant declines in purity' which 'suggests that attempts to restrict supply are having an impact'.

'It's extremely likely, from where we sit, that the different aspects of the Government's drugs strategy are coming together to have a positive effect,' he said.

'There is an impact on supply, young people are beginning to turn their backs on the most dangerous drugs and... the success of treatment, those three different strands are coming together to actually improve the situation.'

Mr Hayes also warned that 'the great spike in heroin use arose in the 80s on the back of mass youth unemployment'. 'We've seen much lower levels of youth unemployment during most of the last 20 years,' he said.

'The more young people can actually see opportunities for themselves, hopes and aspirations, then drugs of desperation like heroin will be much less likely to take a hold. 'We need to be vigilant, if youth unemployment does begin to increase, that we don't see a repeat of the 1980s.

'There's no inevitability that we will, not least because help and treatment is now much more readily available than it was in the 80s, and the young people have seen the impact of these drugs. 'So there's absolutely no inevitability that rising unemployment among young people will see a rise to 80s levels of heroin use, but we need to watch that situation very carefully.'

He added that £600 million a year was spent on drugs treatment services in the community, including immediate access, advice and needle exchanges, with a further £200 million going on routing vendors into treatment in prisons and treatment for young people.

A decade ago, just £200 million a year was spent. 'The investment has been enormous and the Government has indicated their commitment to this agenda by maintaining investment in drug treatment,' he said.

Asked about the increasing number of high-profile people who back the decriminalisation of drugs, Mr Hayes said: 'We believe that legalisation would result in increased use; increased use would mean increased risk and increased harm. 'The people who would be most at risk aren't media commentators and academics, it will be the people in our poorest communities.

'If heroin and crack become ever more readily available, because we take the brakes off, then I think more people in those communities will actually begin to use them, become dependent and it will not help them cope with their lives at all. 'Neither will it help the lives of the communities in which they live. We know heroin addiction is a major driver of crime.'

The figures also showed that, of the 255,556 people who entered a drugs treatment programme since April 2005 for the first time, one in three was still in treatment and two in five left without completing their treatment, and did not return within a year.

Simon Antrobus, chief executive of Addaction, said it was "hugely encouraging" that young people were shunning heroin and crack-cocaine. 'What this doesn't mean, however, is that there is less for us to do,' he said.

'The issues underlying young people's drug use still need tackling, and the misuse of all kinds of drugs - including cocaine, mephedrone and cannabis, as well as crack and heroin - is still far too high. We can't let our guard down.' He added: 'While we hope today's figures prove to be a milestone in the tackling of the UK 's drug problems, we certainly cannot be complacent.'

Martin Barnes, chief executive of DrugScope, said: 'For the first time in nearly a generation there is evidence of an overall decline in the number of heroin users in England. 'There can, of course, be absolutely no complacency - there remain around a third of a million heroin and crack cocaine users, many of whose lives are blighted by drug dependency, poor physical and mental health, poverty and exclusion.

'Patterns of drug use and associated harms change and evolve, with the increasing emergence of poly-drug use and substances such as ketamine and mephedrone.'

But critics said the figures were 'fiction and spin' and due to 'creative accounting' by the NTA rather than any real gain in treatment outcomes, which in reality remain largely unchanged'. 7.10.11

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Publish-or-perish: Peer review and the corruption of science

Pressure on scientists to publish has led to a situation where any paper, however bad, can now be printed in a journal that claims to be peer-reviewed.

Peer review is the process that decides whether your work gets published in an academic journal. It doesn't work very well any more, mainly as a result of the enormous number of papers that are being published (an estimated 1.3 million papers in 23,750 journals in 2006 ). There simply aren't enough competent people to do the job. The overwhelming effect of the huge (and unpaid) effort that is put into reviewing papers is to maintain a status hierarchy of journals. Any paper, however bad, can now get published in a journal that claims to be peer-reviewed.

The blame for this sad situation lies with the people who have imposed a publish-or-perish culture, namely research funders and senior people in universities. To have "written" 800 papers is regarded as something to boast about rather than being rather shameful. University PR departments encourage exaggerated claims, and hard-pressed authors go along with them.

Not long ago, Imperial College's medicine department were told that their "productivity" target for publications was to "publish three papers per annum including one in a prestigious journal with an impact factor of at least five.? The effect of instructions like that is to reduce the quality of science and to demoralise the victims of this sort of mismanagement.

The only people who benefit from the intense pressure to publish are those in the publishing industry. Hardly a day passes without a new journal starting. My email inbox is full of invitations to publish in a weird variety of journals. They'll take just about anything. The US National Library of Medicine indexes  39 journals that deal with alternative medicine. They are all "peer-reviewed", but rarely publish anything worth reading. The peer review for a journal on homeopathy is, presumably, done largely by other believers in magic. If that were not the case, these journals would soon vanish.

But it isn't only quack journals that have failures in peer review. In June, the British Journal of General Practice published a paper, " Acupuncture for 'frequent attenders' with medically unexplained symptoms: a randomised controlled trial (CACTUS study) ". It has lots of numbers, but the result is very easy to see. All you have to do is look at their Figure.

It's obvious at a glance that acupuncture has at best a tiny and erratic effect on any of the outcomes that were measured. The results are indeed quite interesting because they show that acupuncture doesn't even have a perceptible placebo effect. But this is not what the authors said. Their conclusion was: "The addition of 12 sessions of five-element acupuncture to usual care resulted in improved health status and wellbeing that was sustained for 12 months."

How on earth did the group, led by Charlotte Paterson at the Peninsula College of Medicine and Dentistry at Exeter University, manage to reach a conclusion like that? Well, perhaps they were people who are committed to acupuncture and it is common enough for advocates of alternative medicine to ignore evidence, even their own . But the real question is how conclusions like these came to be published in a respectable medical journal that is widely read by GPs. To make matters worse, the journal issued a press release that quotes its editor, Professor Roger Jones DM, FRCP, FRCGP, FMedSci.

"Although there are countless reports of the benefits of acupuncture for a range of medical problems, there have been very few well-conducted, randomised controlled trials. Charlotte Paterson's work considerably strengthens the evidence base for using acupuncture to help patients who are troubled by symptoms that we find difficult both to diagnose and to treat."

The tabloid press had a field day on the basis of the press release. The Daily Mail, for example, reported: " Millions of patients with 'unexplained symptoms' could benefit from acupuncture on the NHS, it is claimed ". But there were howls of outrage in the blogosphere, and some choice comments on Twitter. In these days of the citizen journalist, mistakes are soon spotted.

Two months later, the journal published 10 letters that pointed out the problems with the paper . Those problems are so very obvious you'd imagine that the journal would apologise for a failure of the peer review process, and for a press release that misled the public. Anyone can make a mistake, but there was no public apology and no corrected press release.

( Charlotte Paterson and Roger Jones respond to the author's criticisms below .)

So what can be done about scientific publishing? The only service the publishers provide is to arrange for reviews and to print the journals. And for this they charge an exorbitant fee, a racket   George Monbiot rightly calls "pure rentier capitalism" .

There is an alternative: publish your paper yourself on the web and open the comments. This sort of post-publication review would reduce costs enormously, and the results would be open for anyone to read without paying. It would also destroy the hegemony of half a dozen high-status journals. Everyone wants to publish in Nature, because it's seen as a passport to promotion and funding. The Nature Publishing Group has cashed in by starting dozens of other journals with Nature in the title.

There is just one problem with self-publication and post-publication review.   In 2006 Nature magazine tried it   and it wasn't popular. Most people who were asked didn't want to take part, and, more important, most people who were invited to comment declined to do so. The probable reason is the exceedingly competitive nature of research in many fields. A junior person might be terrified to criticise a senior person, and senior researchers might similarly be terrified of criticising each other, in case the person criticised was reviewing their next grant. Nevertheless, I suspect this sort of system has to come and there are things that could be done to ameliorate the problems.

First, it would be essential to allow anonymous comments. Most reviewers are anonymous at present, so why not online? Second, the vast flood of papers that make the present system impossible should be stemmed. I'd suggest scientists should limit themselves to an average of two original papers a year. They should also be limited to holding one research grant at a time. Anyone who thought their work necessitated more than this would have to be scrutinised very carefully. It's well known that small research groups give better value than big ones, so that should be the rule.

With far fewer papers being published, reviewers, grant committees and promotion committees might be able to read the papers, not just count them.   A report of a parliamentary select committee on peer review concluded:

"We therefore have concerns about the use of journal Impact Factor as a proxy measure for the quality of individual articles. While we have been assured by research funders that they do not use this as a proxy measure for the quality of research or of individual articles, representatives of research institutions have suggested that publication in a high-impact journal is still an important consideration when assessing individuals for career progression."

These politicians show more sense than academics and research funders. My own university's promotion form still says "Candidates may wish to provide impact factors, citation rates or other bibliometric information, where appropriate." Most candidates would interpret that as an instruction to do so.

These proposals all depend on research being honest, but cases of outright fraud do happen. In Andrew Wakefield's case, the fraud linked autism with the MMR vaccine, causing the deaths of children from measles, and we owe a lot to Brian Deer, the journalist who exposed it.

Deer has recently backed a proposal from the House of Commons Science and Technology select committee   that an official regulator should be appointed to police science. I don't think this could work. Is the regulator going to repeat experiments, or even check original data, to make sure all is well? In all probability, a regulator would soon degenerate into yet another box-ticking quango, and end up, like the Quality Assurance Agency, doing more harm than good . The way to improve honesty is to remove official incentives to dishonesty.

By and large, the problem does not arise from outright fraud, which is rare. It arises from official pressure to publish when you have nothing to say.

David Colquhoun  is professor of pharmacology at University College London. He blogs at   DC's Improbable Science

Response on behalf of the CACTUS Study research team

Dr Charlotte Paterson, Peninsula College of Medicine & Dentistry, University of Exeter.

Professor Colquhoun uses   the freely available published paper of our CACTUS trial   (Classical Acupuncture for Treating Unexplained Symptoms) as an example of "failures in peer review". His contention, that "it has lots of numbers, but the result is very easy to see. All you have to do is look at their figure" does not correspond with how randomised trials such as this are analysed. In table 3 of the paper we present all the data from the study with the results of the standard statistical tests. It is the results of these tests that determine whether the difference between the groups (those that did receive acupuncture in the first 26 weeks and those that didn't) is statistically significant, ie whether it is most unlikely to have occurred by chance alone.

In our case a statistically significant difference in favour of acupuncture was found for the primary outcome measure – a questionnaire called MYMOP that measures a change in individualised health status – and for the wellbeing questionnaire. Hence our conclusion that the addition of 12 sessions of five-element acupuncture to usual care resulted in an improvement in health status and wellbeing.

The graphs in figure 2 (reproduced in Colquhoun's article) are provided for readers who prefer to see findings depicted in this way. They are, however, only useful when accompanied by the title of the figure: "Outcome data over 52 weeks (acupuncture group received acupuncture weeks 0–26, control group received acupuncture weeks 26–52)". With this information (omitted by Colquhoun), your readers can come to their own conclusions about what appeared to happen to each group during the second six months. This is of interest, but is not the basis for our statistical conclusions, and never would be for any trial.

We discuss the strengths and weaknesses of our study in the paper, including the fact that the average benefit was relatively small, but would refute Colquhoun's unsubstantiated suggestion that we "are people committed to acupuncture". This is simply untrue. As for our response to peer review, this is a process that enabled us to improve the paper, and for our response to the debate in the journal letter pages,   we refer you to the August issue of the British Journal of General Practice where it is published .

Unfortunately, the voice of patients and the public have been largely absent from these debates, although the same issue of the journal includes our paper reporting the results of a study in which some of the trial participants were interviewed. This aspect of the study provided additional in-depth information about the patient experience and the findings support the trial results and provide potential explanations and new insights. For example, in addition to perceiving a range of positive effects, some participants appeared to take on a more active role in consultations and self-care.

We found peer review to be helpful and we believe that the statistical findings of the randomised trial, together with the qualitative analysis of the patients' perspectives, provides doctors and patients with robust and useful information for making decisions about treatment.

Roger Jones, editor of the British Journal of General Practice

David Colquhoun's critique of my journal's peer review and editorial processes is based on a single table lifted from the main research paper, in which the detailed numerical data tell a somewhat different story, rendering his analysis partial and his conclusions specious.

Paterson and colleagues' paper was reviewed on two separate occasions by two expert statisticians, and read by me. The British Journal of General Practice operates an open peer review system, in which the identities of the authors and reviewers are known to each other. The paper was initially rejected, with re-submission offered if the authors could deal with numerous methodological and some presentational issues in their manuscript.

The lack of "attention controls" – which mimic time spent talking and listening to patients – was pointed out, although of course this was a pragmatic, rather than an explanatory randomised controlled trial (RCT). The re-submitted paper was judged to be much improved, although one reviewer still had concerns about the effect size of the intervention (acupuncture). I decided to publish the paper because it reported a well-designed and well conducted RCT in a difficult area of practice: the subjects were patients with unexplained symptoms for which traditional medicine seemed to have little to offer. It was accompanied by a qualitative evaluation of patients' experiences in the same trial, and we also carried an editorial on acupuncture by academic colleagues from Hong Kong.

Publication was rapidly followed by a series of unpleasant and personally vindictive emails and blog comments from Colquhoun, which I was able to discuss at a meeting of the journal's editorial board a couple of weeks later. The board endorsed the working of the peer review process and saw no reason to retract the paper. They were concerned that the results were presented in an overly positive way in the journal, for which I take full responsibility. The next available print issue of the journal contained all the letters we had received about the paper, a note from me about the editorial board meeting and a response from the authors. We later took the unusual step of providing free access to the paper and the associated correspondence for non-subscribers.

Whether or not this episode represents a failure of peer review – and I don't think it does – it has nothing to do with the argument against the principle of peer review. Colquhoun's response, however, represents a failure of post-publication review. It seems to me that his animus derives much more from a profound antipathy towards the subject matter of this research than from a concern about the scientific methods used to investigate it. I find his hectoring communicative style unpersuasive and inappropriate and, if this is a vision of post-publication review in the future, God help us. 5.9.11

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WeightWatchers 'three times better than a GP's advice'

WeightWatchers is up to three times more effective than simply taking diet advice, claim researchers. Those following the points-based slimming programme lost twice as many pounds as those given guidance by GPs, according to an international study.

And they were also three times more likely to lose a tenth of their body weight. This is the proportion deemed necessary to help prevent heart disease and diabetes. Researchers followed more than 770 overweight adults over the course of a year in Britain, Germany and Australia. 

Half were sent to WeightWatchers classes and the remainder were told to visit their family doctor. At the end of the 12 months those following WeightWatchers had lost an average of 6.7kg – just over a stone. Those taking advice from their GP had only managed to shed an average of 3.3kg, or half a stone.

Although the study was funded by WeightWatchers, the researchers insist that it is impartial. They say the slimming programme is so successful that sessions should be widely available on the health service to help tackle the nation's obesity crisis.

Head researcher Dr Susan Jebb from the Medical Research Council's Human Nutrition Research Unit in Cambridge, said: ‘Trials like this are vital to identify effective interventions to tackle obesity and provide the evidence to inform policy decisions.' She added that the similar weight losses achieved in Australia, Germany and the UK implied ‘that this commercial programme, in partnership with primary care providers, is a robust intervention' which could be used in other economically developed countries with a Western lifestyle.

WeightWatchers claims that in the last decade it has helped 10million Britons to slim. Every year 30,000 of the most obese patients are sent to WeightWatchers on the NHS 

But some critics question whether the weekly sessions – which cost £6 a time – should be coming out of the health service's limited budget. The sessions typically begin with the infamous weigh-in when participants find out whether their dieting efforts over the last seven days have been successful.

Members are taught about healthy food and how to follow the points-based system which scores food depending on its calorie content.

Professor Nick Finer, a senior medical consultant on obesity at University College London Hospitals said: ‘This study shows that diets and dietary programmes do work. ‘These important findings show that obesity treatment is effective and structured commercial programmes can enhance outcomes.' The researchers wanted to test whether WeightWatchers was more effective in different countries with slightly varied healthcare systems.

Founded in 1963 in the U.S. by New York homemaker Jean Nidetch, WeightWatchers now operates in about 30 countries around the world. The first UK meeting followed four years later and it is estimated that there are now 6,000 meetings every week in this country. 8.9.11

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Patients sue drugs firm over the diet pills that 'left them suicidal'

Obese patients who took a diet pill to curb their appetites are taking legal action after they claim it led to them becoming depressed and suicidal.

The Government demanded that the drug, Acomplia, be taken off the market two years ago after it was linked to severe psychiatric problems.

At least one person in Britain taking the drug committed suicide and there have been nearly 1,300 reports of other psychiatric side effects, figures from the medicines watchdog show. Many patients who had no previous mental health issues say they were forced to quit their jobs because their depression became so crippling.

Now, some of those most seriously affected are suing drug company Sanofi-Aventis for compensation in a group action which could cost it more than £300,000. It is understood Sanofi-Aventis has refused to enter negotiations to settle out of court.

Former Ministry of Defence civil servant Robert Johnson, 50, said he I considered suicide after being prescribed Acomplia in February 2008 when his weight hit 25 stone. Within two months, he claims he suffered a breakdown in the office. The father of three, from Sevenoaks, Kent, said: ‘I was dominated by thoughts that I would be better off dead.'

Acomplia, introduced in Britain in June 2006, was not approved in the US because it was already known from early clinical trials that it could double the risk of developing depression.

A warning of such a risk was included on the product's packaging in the UK. The European Medicines Agency, which licenses the drug for use in Britain, carried out a review of the drug's side effects in 2008 and decided the risks outweighed the benefits. It found international clinical trials of the medication had recorded five cases of suicide.

The drug was withdrawn in January 2009. It cannot now be prescribed here but is available on the internet. By May 2011, the Medicines and Healthcare Products Regulatory Agency had received 2,885 reports of adverse reactions to the drug. Seven patients taking Acomplia have died. One committed suicide. There is no confirmed evidence linking any of the deaths to the drug.

Bozena Michalowska-Howells, of law firm Leigh Day, which is bringing the action, said: ‘Our clients have suffered extreme depression which has had a great impact on their families and ability to work.'

A spokesman for Sanofi-Aventis said: ‘We will not be providing a comment at this point.' 23.8.11

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Addiction is a 'brain disorder not just a behavioural problem,' say experts  

Addiction is a chronic brain disease and not just a collection of symptoms such as cravings and mood swings, according to a team of more than 80 experts. The American Society of Addiction medicine (ASAM) released the new definition following a four-year consultation process. 'Addiction is about a lot more than people behaving badly,' said study author Dr Michael M. Miller.

They said this was true whether the addiction was drugs and alcohol, gambling or compulsive eating. The specialists added that like other chronic conditions such as heart disease or diabetes, treating addiction and preventing relapse is a long-term endeavor.

Addiction generally is described by its behavioral symptoms: the highs, the cravings, and the things people will do to achieve one and avoid the other.  Two decades of neuroscience have uncovered how addiction hijacks different parts of the brain, to explain what prompts those behaviors and why they can be so hard to overcome. 

The society's policy statement, is part of an effort to translate these findings to doctors and the general public. 'The behavioral problem is a result of brain dysfunction,' said Dr Nora Volkow, director of the National Institute on Drug Abuse. NIDA estimates that 23 million Americans need treatment for substance abuse but only about two million get that help.

Then there is the frustration of relapses, which doctors and families alike need to know are common for a chronic disease, Dr Volkow said.

'You have family members that say, "OK, you've been to a detox program, how come you're taking drugs?" she says.  'The pathology in the brain persists for years after you've stopped taking the drug.'

The team said addiction relied on a complex interplay of emotional, cognitive and behavioral networks. Genetics plays a role, meaning some people are more vulnerable to an addiction if they, say, experiment with drugs as a teenager or wind up on potent prescription painkillers after an injury. Age does, too. The frontal cortex helps put the brakes on unhealthy behaviors, Dr Volkow said.

It is where the brain's reasoning side connects to emotion-related areas. It is among the last neural regions to mature, one reason that it is harder for a teenager to withstand peer pressure to experiment with drugs. Even if a person is not biologically vulnerable to begin with, trying drugs or alcohol can change the brain's reward system.

This is because a chemical named dopamine conditions it to rituals and routines that are linked to getting something you have found pleasurable, whether it is a pack of cigarettes or a few drinks or even overeating.  When someone is truly addicted, that warped system keeps them going back even after the brain gets so accustomed to the high that it is no longer pleasurable.

Understanding some of the brain reactions at the root of the problem will 'hopefully reduce some of the shame about some of these issues, hopefully reduce stigma,' Dr Miller said.

Meanwhile, Dr Volkow said research is under way to use those brain findings to develop better treatments, not just to block an addict's high temporarily but also to strengthen the underlying brain circuitry to fend off relapse.

Critics said 'the research was 'flawed' as most people grow out of addiction problems with very few older addicts. In addition the ASAM is working from a vested interested to develop more drugs so are trying to make the problem seem more complex than it actually is, they are clearly perpetuating the addiction myth'. 15.8.11

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Academics who lend their names to Big Pharma ghostwriting schemes should be charged with fraud, say university professors

A college student who pays his friend to write a paper for him is guilty of plagiarism -- and if he is caught, he could receive a failing grade or even be expelled from school. But when drug companies secretly pay doctors or academics to pretend as though they wrote journal-published studies actually written by Big Pharma ghostwriters, it is considered a mere "marketing strategy." But two university professors are working to change this injustice by pushing for such cheats to be prosecuted for fraud.

"It's a prostitution of their academic standing, and it undermines the integrity of the entire academic publication system" said Professor Trudo Lemmens, a Faculty of Law professor at the University of Toronto (UT). He and Professor Simon Stern, also from UT, rightly believe that taking credit for a journal article written by someone else constitutes criminal activity, and should be considered fraud under the Racketeer Influenced and Corrupt Organizations Act (RICO).

"Guest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability," said the two in a recent article published in the journal PLoS Medicine . "Pharmaceutical sponsors borrow the names of academic experts precisely because of the value and prestige attached to the presumed integrity and independence of academic researchers."

Back in 2008, for instance, it was revealed that Wyeth Pharmaceuticals (now part of Pfizer) paid ghostwriters to compose articles hyping the supposed benefits of its hormone replacement therapy (HRT) drug Prempro, and solicited academics to then stamp their names on them claiming authorship. The forged articles then appeared in prestigious journals where thousands of doctors ended up reading and absorbing the information as if it was independent, evidence-based medicine.

If academics who participate in ghostwriting fraud were held accountable in the way Lemmens and Stern are suggesting, it would have the potential to revolutionize the way drugs are approved, as well as the way drug litigation is handled in court. No longer would drug companies be able to use fraudulent medical research to convince the US Food and Drug Administration (FDA) to approve a drug, and Big Pharma lawyers would no longer be able to use ghostwritten studies as court evidence to defend the safety of harmful drugs.

"[Ghostwritten studies] are often used in litigation to support the manufacturer's arguments about a drug's efficacy and safety, or to establish a record of scientific acceptance for Daubert purposes, or to credentialize an expert witness," added Lemmens and Stern. "Each of those uses, if attempted by a party that had helped to create the article, could risk sanction." Natural News 23.8.11
Sources for this story include: http://www.rawstory.com/rs/2011/08/...

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Major drug research company faked thousands of documents to get drugs approved, FDA says no big deal

It is truly astounding to witness the utter corruption that takes place -- and practically in plain sight -- within the pharmaceutical drug industry. The US Food and Drug Administration (FDA) has announced that drug firm Cetero Research, for many years knowingly forged thousands of clinical trial documents for drug companies in order for them to gain drug approval. The FDA's response to this, though is that this massive corruption is basically no big deal.

It is no secret, of course, that the FDA routinely works in illicit tandem with drug companies to get dangerous drugs on the market in exchange for cash. One example of this includes the Lexapro scandal in which the FDA approved this dangerous antidepressant drug for children at the same time as federal and state governments were suing Forest Laboratories, maker of the drug, for pushing it on children.

The FDA's own scientists have even publicly indicted the agency for censoring truthful scientific data, intimidating and unfairly targeting supplement companies, and using the drug approval system to extort cash from drug companies in exchange for its rubber stamp of approval.

The entire racket between the FDA and Big Pharma is mind-bogglingly extensive, and it is even seen in the FDA's recent announcement "against" Cetero. While it initially appears that the FDA is upset at Cetero for lying via its clinical trial documents, the agency's solution is to tell the drug companies to go back and redo them themselves .

FDA not interested in truly regulating drug industry, tells it to go regulate itself

In the FDA's recent announcement concerning Cetero, the agency declared that both an internal company investigation and a third-party audit revealed "significant instances of misconduct and violations" in conducting clinical trials. Between April 2005 and June 2009, there were at least 1,900 instances of fraud and falsified studies, and each one of these instances was falsely used to prove that a drug was safe before it went on the market.

"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," said the FDA, noting that drug companies may have to go back and perform new safety studies.

But the real kicker is that the FDA also stated that this is not really that big of a deal. Millions of people's lives are on the line as potentially fatal drugs were approved with false data -- but according to the FDA, nobody should be concerned. In fact, the FDA has known for years that Cetero has been falsifying data, and the agency has done absolutely nothing about it.

FDA does not even know which companies used Cetero's corrupt services

One would assume that the nation's food and drug regulatory agency would at least have saved records of which drug companies used Cetero for their early clinical trials. Such information is standard on any drug application, right? Apparently not. The FDA actually has no idea which drug companies used Cetero's services , and it is now asking drug companies to search their records and determine whether or not they contracted with Cetero.

Even a cursory analysis of this whole approach shows how utterly foolish it actually is. Does the FDA really think the drug companies that used Cetero, are going to willingly participate in this? Of course not. It would mean the companies would have to go back and redo their clinical trials if they fess up.

These are important questions that should be asked:

- Why does the FDA itself not have records of the research companies used for the drugs that it approves?

- Why is the FDA apparently unconcerned about the safety of these drugs, considering they were approved using falsified data?

- Why is the FDA not attempting to hold Cetero accountable for its actions, other than to make an announcement about them?

Despite the nonchalant way in which the mainstream media is reporting on this issue, what Cetero has done is nothing short of high-profile crime. By falsifying drug trial data, Cetero has willingly put millions of people's lives at risk. The only right thing to do is immediately shut down the company and order a full investigation. All parties involved must be held accountable, including those at the FDA that may have been complicit as well.

However, in the real world, the FDA's solution is to tell the fox to go back and guard the hen house a little bit better, while simultaneously reassuring the world that the fox itself is safe and would never hurt anybody. In fact, the agency is actually alleging that all approved drugs -- even those that were approved with falsified Cetero data -- are perfectly safe and "unlikely to be affected" by this massive criminal cover up.

So there you have it. While it is absolutely insane to make such a claim, the FDA has done just that, and it expects the world to take it seriously. The FDA's logic is essentially no different than, say, an amusement park claiming that all of its roller coasters are safe, even after it was determined by multiple investigations that the manufacturer of the coasters had lied about the quality of the materials used, and that the pieces may not actually hold together.

The question remains, would you ride those roller coasters, or have the nerve to tell other people to ride those roller coasters? The FDA did. Natural News 6.8.11 Sources for this story include: http://www.reuters.com/article/2011...

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Law experts speak out - academics who "guest author" medical journal articles guilty of fraud

Back in 2008, Mike Adams sounded an alarm about something the mainstream media seemed to know little about -- Big Pharma companies had long been paying in-house writers to ghostwrite scientific research articles then paying (Adams called it "bribing") doctors and high-level academics to pretend they were the authors.

Unfortunately, the use of ghostwriters and guest authored journal papers hasn't gone away. But here's good news: two prominent attorneys are speaking out that the practice is not just a sham but constitutes legal fraud .

So why be concerned about ghostwriting in the medical profession? It turns out that Big Pharma and other medical industry sponsored research has been published with the names of academic "guest authors" tacked on -- although these highly degreed "authors" may have made slim to no contributions to the so-called research.

Yet these very articles have been published in leading medical journals and through the years have helped hype hormone replacement therapy, numerous anti-depressants and other potentially dangerous drugs including Vioxx, Neurontin and Fen-Phen. In turn, these articles are often cited by their drug company sponsors to promote off-label use of their products and bring in more millions to the prescription pharmaceutical industry.

The ghostwriting and guest authoring of industry-controlled studies clearly raise what the law experts call "serious ethical and legal concerns, bearing on integrity of medical research and scientific evidence used in legal disputes."

It is such a breach of ethics that Professors Simon Stern and Trudo Lemmens of the University of Toronto law faculty have flat out called for "guest" authors of medical and scientific articles to be charged with professional and academic misconduct and fraud, even if the articles attributed to the "ghost" or "guest" writers contain factually correct information. The law experts compare the academic "ghostwriting" and tacked on bogus academic authorships to racketeering and even the world's oldest profession.

In a media release about their article (which was just published in the journal PLoS Medicine ), the law professors stated: "Guest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability. The false respectability afforded to claims of safety and effectiveness through the use of academic investigators risks undermining the integrity of biomedical research and patient care."

Lemmens, who is also a member of the University of Toronto's school of medicine faculty, had particularly hard hitting words for academics who participate in guest authorship which involves "lending" their names and receiving substantial credit where little or none is due. "It's a prostitution of their academic standing," said Lemmens. "And it undermines the integrity of the entire academic publication system."

In their article, entitled "Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles," Stern and Lemmens argue that because medical journals, academic institutions, and professional disciplinary bodies have done little if anything to enforce effective sanctions against this practice of bogus authorship of research papers, a more successful effective approach would be to take legal action. Imposing liability on the guest authors "..may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO)."

"The same fraud could support claims of fraud on the court against a pharmaceutical company that has used ghostwritten articles in litigation," the law professors added. Moreover, that kind of claim could prevent the Big Pharma sponsor of "ghosted" and "guest authored" articles from presenting them as evidence in court, and could result in sanctions against attorneys who try to use any of these articles as legally valid evidence in a malpractice, drug injury or other case. Natural News 3.8.11

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NHS Personal health budgets

Supporters of personal health budgets point to the benefits of allowing patients with long-term conditions to choose activities that help improve their quality of life. But some doctors think the scheme is bureaucratic, potentially wasteful and unfair. Mike Foster reports 

Singing classes, Wii games and a trolley to carry a watering can are not normally associated with healthcare. 

But PHBs (personal health budgets) being piloted across England are allowing patients with long-term conditions and care plans to identify — and fund — new approaches to improve their health outcomes.

Extensive in-depth piloting of PHBs is taking place in 20 former PCT areas and a third interim evaluation report was published by the Department of Health last month. The Cost of Implementing Personal Health Budgets examines the costs associated with setting up PHBs. 

A key finding was that most PCTs involved believed it would take two years to successfully implement PHBs at an average total cost of around £146,000. The report concludes that the start-up costs should reduce as PHBs become more mainstream.

The question for the Westminster government is not whether to offer patients PHBs, but how. In its response to the NHS Future Forum recommendations for amendments to the Health and Social Care Bill, the government states that a mandate to the NHS Commissioning Board will ‘make it a priority to extend [PHBs], including integrated budgets, across health and social care'.

It points out that this will be subject to evidence from the pilots but adds: ‘Our ambition is to use the powers in the bill to introduce over time a right to a PHB for patients who would benefit from one.'

A further consultation will take place on the details, but the NHS Future Forum's report concludes that PHBs ‘can help improve outcomes and join up services for users, especially when they are offered an integrated way across health and social care'.

Evaluation crucial
In May, leading policy makers from local and national government, doctors, representatives of charity groups and project managers leading PHB pilots gathered at a WHF (Westminster Health Forum) seminar entitled Personal Health Budgets: Pilots, Personalisation and Empowerment.

The event, held in London, offered some insight into early findings from pilots, which began in April 2010, and raised some emerging issues.

DH head of the PHB team Alison Austin told the event: ‘[PHBs] are here to stay but the evaluation is very important.' She added that the evaluation, which will run for another two years, will examine the cost-effectiveness of PHBs, but the thinking was that these will be cost-neutral overall. She said there were some examples in continuing healthcare where there had been savings of 10 to 20 per cent. 

As for what a PHB can fund, it is nearly anything that would benefit the patient and could be agreed in a care plan that was acceptable to the NHS — that means no alcohol, tobacco, gambling or debt repayment, she said.

Azra Iqbal, project manager for the PHB pilot at the BHWP (Birmingham Health and Wellbeing Partnership), related the good news from four programmes for patients with COPD, diabetes, multiple sclerosis and mental health: ‘Patients are loving it.'

Weight loss success
However, she added that there was a downside — a lot of bureaucracy. It took a year to work through systems and processes, including legality issues surrounding giving people equipment, and the need for CRB (Criminal Records Bureau) checks for workers hired via PHBs.

Ms Iqbal said there was also resistance from healthcare professionals and management staff, who said the care-planning process with individual patients was going to take up too much time.

However, the scheme run by the BHWP, which comprises Birmingham East and North, South Birmingham and Heart of Birmingham PCTs and Birmingham City Council, has yielded some positive results, she said.

The game Wii Fit was used to encourage housebound patients — one of whom had not even been moving out of their chair — to begin some gentle exercise, she said. And, in one case, an older woman used a PHB to purchase a trolley to carry her watering can, so that she could get outside and pursue her passion for gardening.

Meanwhile, one multiple sclerosis patient lost 18kg (40lbs) in six months after using a PHB to get a personal trainer to help her exercise in her home, Ms Iqbal said. Also, four patients with diabetes had lost more than 6kg (13lbs) each in six months after using PHBs to pay for gym use, and there were also reduced glucose levels and increased mobility among patients, she said.

Other items funded via PHBs include massages, anxiety management sessions, cooking classes for people with diabetes, seasonal affective disorder lamps, wheelchairs and mobility scooters.

The BMA, in its response to the DH consultation Direct Payments for Healthcare last year, set out its concerns about NHS funds being spent on non-evidence-based treatments, the administrative burden of setting and monitoring care plans, and the potential for unfairness if only certain patients receive extras on the NHS.

Types of budget
Doctors leaders also highlighted how decisions about healthcare are far more complex than interactions in social care and argued that serious consideration should be given to making sure that funds can be used only on services and treatments currently prescribed by GPs. The BMA has also been wary of dipping into NHS budgets to cover costs traditionally associated with social care.

There are three types of PHBs:

• Notional, where the budget is held by the commissioner but the patient is aware of the amount

• Third-party brokerage budgets, where cash is held by a GP, care manager or advocate

• Direct payments, a cash entitlement that patients could use to buy the services and treatments that they thought best suited their needs

The WHF event also heard from Karen Jones, a research fellow who is leading the University of Kent's Personal Social Services Research Unit independent evaluation commissioned by the DH. Ms Jones also said the evaluation would be used to guide the roll-out of PHBs after 2012.

The evaluation, as of May, had recruited around 1,500 people — 876 with PHBs and 651 in a comparison group —and 122 completed support plans had been received. It aims to recruit more than 2,000 patients with diabetes, mental health problems, COPD, stroke, long-term neurological conditions and those receiving NHS continuing healthcare. It will also explore whether PHBs have an impact on maternity care and end-of-life care. Half will have PHBs and half will be a control group with patients receiving conventional NHS services, she said.

Culture change required
The evaluation, which is being run by a partnership of research teams, will measure participants' psychological well-being and perception of quality of life. It will examine whether the PHB has had an impact on health outcomes, the services that are being purchased, whether these are outside the mainstream and the costs of implementation.

Last November, the evaluation published its Experiences of Implementing PHBs: 2nd Interim Report, which is based on interviews with 43 operational staff, health professionals, commissioning managers and third-party budget holders.

It concluded that there was an overwhelming view that PHBs would have a positive impact by giving patients more choice and control over their care, boosting self-confidence and self-esteem, spurring flexible and creative services, and improving relationships between nurses and doctors and patients.

However, it also cited delays in some pilot sites caused by the ‘degree of culture change required' which was made worse by NHS reform proposals, the clustering of PCTs and the focus on cost savings. The report states that there have been ‘difficulties maintaining the momentum' for PHBs.

Some staff leading PHB programmes also did not have the right training to guide budget holders and there was ‘little guidance being offered to frontline staff, which was leaving them confused as to the process,' it states.


Ms Jones told the WHF event that there was also a lack of choice of services as the market has not developed to cater to those with PHBs, and there was a lack of appropriate systems that can facilitate integration between health and social care.

Meanwhile, some delegates, such as Laurence Mynors-Wallis, Royal College of Psychiatrists registrar and Dorset Healthcare University NHS foundation trust medical director, raised concerns about the use of PHBs. 

Dr Mynors-Wallis, picking up on Ms Iqbal's description of two patients who had successfully used hypnotherapy to quit smoking, said if there was clear evidence that this worked it would be used by trusts up and down the country. 

He said there was ‘a tension between choice and effectiveness', adding: ‘This is completely opening the door for a whole range of treatments … I have an anxiety that there is going to be a roll-out before the evidence is there. The research that you are running with a control group is all very well, but wouldn't we all feel better if we were given hundreds of pounds to spend on food, gym membership [and] driving lessons?'

Who is responsible?
Royal College of Physicians of London patient and carer network chair Suzie Hughes also raised some interesting points, such as asking ‘who the ring-holder is'.

For example, if a patient with COPD decides to go for singing lessons, what happens if their condition does not get better? Who is responsible? Health outcome measures are also ‘very surgery orientated', she pointed out. Ms Hughes also asked why PHBs were needed to spur new ways of working and whether ill patients really wanted to be talking about budgets. 

Ms Austin said the issue was about helping patients with long-term conditions to get the most out of their life and knowing the cost of their care was ‘empowering'.

‘It empowers them to say, if I have x amount of money I would rather do a, b and c,' she said.

Self-directed support
Health lead of the charity In Control Rita Brewis said PHBs were ‘not just about giving people money to buy different things', nor were they just about choice. She described them as ‘a lever or tool to support a change in the relationship between people and the NHS … a shift in how people see and deal with each other.'

Ms Brewis, who has been leading the charity's Staying in Control programme, which has been developing a model for self-directed support and personal budgets in healthcare, said PHBs were not meant to be an ‘either-or' choice but rather a ‘both-and' with regular NHS services.

Ms Brewis said PHBs aimed to combine professional clinical expertise and knowledge with people's personal experience of their illness. She recognised a range of issues need to be resolved, including:

• How to make sure that everyone who wants a PHB can get one

• How to provide sufficient information and support

• Alternative ways to hold the money so that people who lack capacity or are ‘just plain scared' of managing money can still have control

• How decisions are made about who can have what within limited resources, particularly in light of shortfalls in funding and tensions between health and social care

• Which commissioner has the final say.

Legal concerns
Meanwhile, Hempsons law firm partner Christian Dingwall asked the rhetorical question of whether legal issues would ‘act as a brake' on PHBs.

Mr Dingwall said there was a contradiction inherent in the policy: as more control is passed to the patient, there will need to be more regulation about how that control is overseen, he said. Commissioners, whether they be PCTs or in future clinical commissioning groups, will ultimately remain responsible for the care of patients and ‘the buck will continue to stop with them,' he said.

He added the patient with a PHB who hires people in to care for them will be an employer from a legal standpoint. He said: ‘If there is an employment relationship breakdown there will be the ordinary risks of employment liabilities, for example, relating to unfair dismissal.'

In spite of all the legal issues that need to be resolved, Mr Dingwall said he hoped this would not be used ‘as an excuse for not allowing PHBs to happen'.

Fringe therapies
Meanwhile, the BMA continues to be wary of the drive towards PHBs. Delegates at the 2011 BMA annual representative meeting in Cardiff in June backed a statement deploring the proposals.

Buckinghamshire trauma and orthopaedics consultant Gordon Matthews argued that PHBs were ‘fundamentally flawed' and ‘against the fundamental principle of the NHS to provide care to all when and where it is needed.' He raised fears that PHBs could be used to fund homeopathy, for example.

Dr Matthews told delegates: ‘Under the (PHB) system it would be easier for uninformed patients to waste their funds on unproven fringe therapies.'

However, BMA committee on community care chair Helena McKeown tried to convince doctors to vote against the statement, arguing that it would send ‘a paternalistic message'.

The CCC, working with patient groups such as Asthma UK, Diabetes UK and Rethink, was aware that patients with long-term conditions liked the idea of PHBs, she said, adding that the CCC was also watching their development ‘extremely carefully'.

Patients as ‘commodities'
Meanwhile, Buckinghamshire GP Gill Beck said PHBs ‘package patients like commodities, who are ready to be cherry-picked by commercial organisations, only too happy to help patients spend and manage their account'.

Dr Beck, in response to the argument that patients liked PHBs, said: ‘I have quite a few patients who like heroin — they don't get it either.'

Dr McKeown tells BMA News that the pilots suggest that PHBs could be ‘hugely demanding of resources' and that this is a concern at a time when huge savings are required in the NHS.

She says: ‘For patients and their carers to be able to exert choice in the healthcare they receive from their budgets they will need a variable amount of support, depending on their knowledge of their illness, its treatments and the relative value of various management (methods) available to them. This, inevitably, is going to be very demanding for some people and will not be for everyone.'

And the challenges don't stop there. Although the pilots may have found that patients love PHBs Dr McKeown says the BMA has longer term concerns that they could become rationing tools, and lead to greater private sector involvement.

She says: ‘What happens when an individual's PHB is exhausted and [there is] the potential for the private sector to profit by offering more insurance and the use of top-up payments?' 

 

NHS bosses warned over anti-competitive behaviour

NHS bosses are pursuing anti-competitive practices often for no valid reason, an official review says. The investigation by the independent Co-operation and Competition Panel for the government highlighted a range of tactics it had concerns about.

These included block contracts and restrictions which often favour local hospitals ahead of the private sector and other parts of the NHS. It comes as the government is extending the role of competition in health.

Earlier this month ministers said community services, including podiatry and counselling, should be opened up to greater competition so that patients could choose between NHS, private and voluntary sector providers.

'Blocking choice'
This was done for non-emergency hospital operations, such as knee and hip surgery, five years ago. About 200,000 of the five million procedures done each year are now performed by private hospitals approved to do NHS work.

Patients have also used choice to opt to be treated in hospitals outside their local areas. This is sometimes done so they can be close to family members while being treated or because they believe they can get better care elsewhere.

The Co-operation and Competition Panel (CCP) has been looking at this area of the health service.

They received evidence that nearly half of the 151 local management bodies known as primary care trusts (PCTs) were blocking choice.

In particular, they highlighted a series of measures which were being taken:

•  Block contracts -  These guarantee certain hospitals a set number of patients, leaving the private sector and other providers only what is left over.

•  Management referral centres  - These vet GP referrals, allowing patients to be channelled to favoured providers.

•  Minimum waiting times  - Insisting patients wait a certain length of time before treatment. Private firms say this is about lowering the bar so that they cannot use the pulling power of quicker care.

•  Activity caps  - Limits on the number of patients that can be referred to certain providers.

•  Fewer options  - Reducing the range of treatments a provider can offer patients. Hospitals whether in the private sector or NHS only get paid if a PCT will release the funds.

PCTs had argued they needed to do this for a combination of reasons, including balancing the budget and protecting the future of their local hospitals. But the report rejected this, saying in many cases there was unlikely to be valid reasons for such moves.

It also accused managers of a lack of transparency about the decisions and warned them they were leaving themselves open to formal challenge.

However, the panel did not go as far as to suggest there should be a complete ban on the practices. CCP director Andrew Taylor said: "We strongly recommend that commissioners review their policies and take steps to bring themselves into compliance with their obligations around patient choice."

The Department of Health said it would be studying the findings "carefully". 1.8.11

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NHS competition saves lives

LSE research quoted by David Cameron suggests link between greater choice and death rates - but critics claim study is flawed which is the usual rebuttal of evidence they dislike.

Almost 1,000 lives were saved because the NHS was subject to competition, a study by London School of Economics has found – sparking a war of words in the academic community over claims the research was "extremely flawed".

The paper, which was written by Dr Zack Cooper of the LSE and which was quoted by the prime minister last month, showed that where patients had more choice of hospitals they had lower death rates.

By comparing more and less competitive hospital markets before and after competition was introduced in 2006 under Labour, Cooper and his colleagues found that mortality rates of patients with heart disease fell more quickly in the more "competitive areas of England". Thus the academics estimate that the reforms led to approximately a 7% relative reduction in heart attack deaths in the NHS in England between 2006 and 2008 – around 900 fewer deaths.

The coalition has been keen to highlight the benefits of competition and choice in the NHS and has seized on research to bolster its pro-market reforms. Many academics who have been critical of this approach say that Cooper's work is "flawed".

Allyson Pollock, professor of public health research and policy at Queen Mary, University of London, said that "acute myocardial infarction (heart attacks) are not a measure of hospital performance". She said that many of the better outcomes for patients are due to better screening by GPs and a new non-surgical procedure that had been developed to open blocked heart arteries. "This study is extremely flawed," said Pollock.

However, Cooper points out that heart attack patients were considered because hospitals improved all their services – and that his work had been peer-reviewed and published in the prestigious Economic Journal.

"Incentives cannot be a dirty word in the NHS. Creating financial incentives can save the NHS money and improve clinical quality," he said. "We find that competition between hospitals in a market with fixed prices led to very strong improvements in patient outcomes. Going forward, if the NHS is going to be successful, it can't shy away from competition."

The Co-operation and Competition Panel (CCP), the government body that investigates competition issues in the NHS, has found that patients are losing out as a result of restrictions on their choice of provider of NHS care.

An investigation found that nearly half the NHS primary care trusts were blocking competition by guaranteeing NHS providers set amounts of work before patients can be sent to the private sector, or restricting the number of services that private hospitals can offer at all.

The panel said that the expected benefits of patient choice – both to patients and taxpayers – will not be realised to their full potential and recommended that commissioners such as GPs would in the future have to explain why patients were not being offered alternatives to the NHS.

A Department of Health spokesman said: "This report highlights why we need to modernise the NHS, protect patients' rights to choice and increase transparency. Patients' rights to choice are enshrined within the NHS constitution. Under our plans to modernise the NHS we are extending choice for patients, giving them a louder voice, and making sure they are at the heart of our health system. We are also giving doctors and nurses the freedom to better tailor care for patients. The Department will consider the CCP's specific recommendations carefully to ensure that the benefits to patients of greater choice in their healthcare are realised." 29.7.11

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The waste of the Labour years: £3.75bn cut from Whitehall budget in just ten months

Bloated Whitehall budgets have been cut by £3.75billion in less than a year, the Government will announce today. Francis Maude, the Cabinet Office Minister, will reveal that spending had spiralled to such an extent under Labour that the Coalition had managed to save the equivalent of 200,000 junior nurses' salaries with relative ease.

He said this was only ‘scratching the surface' of attempts to restore sanity to public spending by reducing outlay on external consultants, marketing, agency staff and IT schemes and negotiating more effectively with suppliers.

Last May, the Government promised to cut £3.2billion of wasteful spending in government departments as part of £6.2billion of in-year cuts. This target has been beaten by more than £500million.

The savings enabled the Treasury to prevent part of Labour's planned National Insurance increase – a levy on employers that business leaders described as a ‘tax on jobs' which could have killed the recovery.

Mr Maude said ahead of the announcement that the figures ‘show that our ambitious targets to cut waste and save money have paid off'. 

He continued: ‘To put £3.75billion into context, it's equivalent to the salaries of 200,000 junior nurses; or 150,000 secondary school teachers; it could pay for several Whitehall departments; and it's about the same as the revenue derived from one penny of the basic rate of income tax.  

Labour told us to carry on wasting money and slap a tax on jobs that business said would endanger the recovery. It's that kind of thinking that got us into this mess.

‘It is these savings, which have been achieved in just ten months, that have allowed departments to protect essential front-line services and jobs... but this is just scratching the surface of what we have planned for the coming months and years.' 

Independently audited figures show that £870million has already been saved by cutting spending on consultants, and nearly £500million by reducing the outlay on temporary agency staff. 

Some £400million has been cut from marketing budgets and £360million saved by centralising spending on common goods and services, while renegotiating deals with some of the Government's largest suppliers has saved £800million.

There has been a £90million reduction in the cost of Whitehall's property estate by exerting better control over lease renewals, and the equivalent of £300million has been cut from salary costs by reducing the size of the civil service by more than 17,000 workers.

Another £150million has been saved by halting or cutting back on major IT projects, with £300million cut from the budgets of smaller schemes. 

Mr Maude added: ‘These savings prompt me to ask what on earth my predecessors in this office, such as Ed Miliband, were doing. 

‘We have just got started on this. This is the low-hanging fruit, but there is a lot more to come.' 1.8.11

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How Whitehall pays £3,500 for a £250 computer in 'obscene' waste of public money

Whitehall is wasting an ‘obscene' amount of public money on IT systems and other items, a report by MPs admits. The report cites some Whitehall departments who blow an average of £3,500 on a desktop computer, while they can be bought for as little as £250 on the High Street, 14 times cheaper.

Ministers have created a ‘recipe for rip-offs' by buying from a cartel of suppliers at massively inflated prices, it says.

The Public Administration Select Committee described the Government's overall record in developing and implementing IT systems as ‘appalling'.

According to the most recent figures, those for 2009, an estimated £16billion of public money was spent on IT in a single year. But over the past 20 years, a number of high-profile government computer projects have run late, over budget, underperformed or failed. 

The latest shocking example of Government profligacy comes at a time when ministers are making savage cuts across Whitehall in a bid to reduce Britain's largest peace-time deficit.

Billionaire retail magnate Sir Philip Green last year produced a report which catalogued staggering examples of Whitehall waste.  Claiming his Topshop business would ‘go bust' if it was run like the Government, he told ministers they could slash £20billion a year from public spending without sacking a single civil servant. 

Examples of extraordinary waste have included officials paying £73 for a box of copier paper that can be bought in bulk for just £8 and an NHS Trust spending £47 on a bag of gluten-free pasta that costs just £2.

Calling for the Coalition to widen its IT supplier base to smaller firms, the MPs' report said: ‘The lack of IT skills in Government and over-reliance on contracting out is a fundamental problem which has been described as a “recipe for rip-offs”. ‘IT procurement has too often resulted in late, over-budget IT systems that are not fit for purpose. Given the cuts that they are having to make in response to the fiscal deficit it is ridiculous that some departments spend an average of £3,500 on a desktop PC.' 

The MPs went on to criticise the Government's reliance on a ‘cartel' of suppliers who regularly charge between seven and ten times more than the standard rate.

Tory MP Bernard Jenkin, chairman of the PASC, said: ‘The Government has said that it is overly reliant on an “oligopoly” of suppliers; some witnesses went further and described the situation as a “cartel”. ‘Whatever we call the situation it has led to an inexcusable situation that sees governments waste an obscene amount of public money.'

The report pointed to a number of disastrous IT initiatives including the trouble-prone Child Support Agency's computer system.

In March this year, the CSA computers malfunctioned, leaving staff having to sort out 100,000 maintenance claims by hand. Previous failures by the system mean that nearly £3.7billion is still owed by absent parents to their children.

Tony Blair's former IT chief Ian Watmore has blamed ministers in the previous Labour government for ordering expensive computer projects as an afterthought or in an effort to make their policies ‘sound sexy'. The Coalition has already called a halt to big IT projects, vowing no scheme will cost over £100million. 

It has also promised to open up the procurement process to smaller companies. The current process can take up to 77 weeks, which puts off smaller firms, who often cannot afford to have staff working for so long on a bid they may not win. Tory MP Nadhim Zadawi said: ‘A “recipe for rip-offs” could sum up Labour's entire tenure in government. And yet Ed Miliband and Ed Balls would not do anything differently. The Labour Party just does not seem to appreciate that the amount of money they have wasted is unacceptable.' 

Emma Boon, from the TaxPayers' Alliance, said: ‘It smacks of incompetence that the Government has been paying way over the odds for IT, and means that millions of pounds of taxpayers' money has been wasted.  ‘It is simply unacceptable for departments to be haemorrhaging cash because there is a lack of  skills and too much reliance on contracting out.' 28.7.11

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Nation of pill poppers: NHS prescriptions have soared 70% in the past decade

•  927 million prescriptions given out last year alone

•  Average 17.8 prescriptions for every person in England 

•  Cost to NHS estimated at £9 BILLION every 12 months

More prescription drugs than ever are being given out, with the annual bill soaring to nearly £9 billion.

The amount of medicine dispensed has jumped almost 70 per cent over the last decade. Last night fears were expressed that doctors were taking the easy way out when reaching for the prescription pad instead of considering other treatments. There were also concerns about the huge amount of medicine which is simply wasted by patients.

But experts denied that Britain is over-dependent on drugs, saying an ageing population and more emphasis on preventing disease inevitably pushes up prescribing rates. Acording to the figures from the NHS Information Centre, diabetes is the most costly condition, accounting for £713million in England last year.

There has been a surge of 75 per cent in four years in type 2 diabetes, which is caused by obesity and lack of exercise. Doctors prescribe insulin to treat it, but recent research has suggested that the disease can go into remission with exercise and dieting.

The highest number of drugs  dispensed last year was for heart conditions, closely followed by painkillers and cholesterol-busting drugs including statins. More than 7 million in Britain currently rely on statins, a 350 per cent increase on the 2million users a mere four years ago. It means one in three over-45s take the cholesterol-lowering drugs. Antidepressants are also on the rise, despite efforts to prescribe talking therapies rather than drugs.

Last year the NHS wrote 41million prescriptions for anti-depressants, almost 23million of which were for drugs such as Prozac and Seroxat – a 43 per cent jump in four years – while there were only 600,000 referrals for therapy.

Katherine Murphy of the Patients Association said doctors may be issuing too many prescriptions. She said: ‘If patients are getting access to more of the medicines they need, in particular more specifically tailored medicines, we would welcome this trend. ‘However, we are concerned that with consultation times being so short, rather than being able to tackle the problems patients have, doctors may be simply prescribing medicines.

‘More appropriate treatments may be available, such as physiotherapy or counselling, and doctors should only prescribe medicines when they are needed.' Mike Holden, chief executive of the National Pharmacy Association, said that too often drugs were not actually helping patients. ‘There is a huge amount of waste,' he said. ‘Up to half of all medicines for long-term conditions are not taken as intended by the prescriber.

‘There is no doubt that much more value for patients and the taxpayer could be extracted from this massive investment by supporting more effective medicines use. ‘After all, the least cost-effective medicine is one that is used improperly or not at all.'

The NHS figures relate to prescriptions made up by community pharmacists and not in hospitals.

In 2010, 927million prescription items were dispensed in England, up 4.6 per cent on 2009 and 68 per cent on 2000. For every person in England, an average of 17.8 prescription items were dispensed in the year, compared with 17.1 in 2009 and 11.2 in 2000.

The average cost per head was £169 in 2010, compared with £165 in 2009 and £113 in 2000.

A spokesman for the Association of the British Pharmaceutical Industry said the data showed NHS medicines now provided better value for money and had improved patients' lives. He said: ‘The rise in prescriptions dispensed in the community in recent years is the result of an ageing population that require more medicines. ‘Older people already account for around two-thirds of the treatments prescribed. ‘A population that is living longer will mean a disproportionate increase in the demand for medicines.

‘Prescription medicines for older people in the community have made a huge impact on quality of life and have made treatment at home, rather than in hospital, much more common, which is a better outcome for the patient and presents savings to the NHS.'

Simon O'Neill of Diabetes UK said: ‘The long-term costs of poor diabetes management, namely caring for someone who's had a heart attack or stroke, lost their sight or lower limb, far outweigh those of the drugs which help prevent such devastating complications.'

Care Services Minister Paul Burstow said: ‘The big rise in prescribing largely reflects the impact of a growing and ageing population, as well as an increase in the prescribing of preventive medicines, such as low-cost statins. ‘We are increasing investment in the NHS by £12.5billion, but it needs to be smarter with its resources. That is why we are continuing to encourage the prescribing of preventive medicine. 28.7.11

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80% of GPs prescribe drugs to patients they believe are addicted

80% of  GPs routinely prescribe drugs to patients they believe are addicted to them, research shows. Half of family doctors surveyed are worried about prescription drug abuse in their area and are aware of situations where prescriptions may have been sold on.  Drugs most typically abused are sleeping pills, anti-depressants and painkillers.

The survey was carried out by the Family Doctor Association, which called for more research into the problem of prescription drug addiction. 
Dr Peter Swinyard, chairman of the FDA which represents about 1,000 practices, said: ‘Our simple concern is the patient – nothing else matters.  ‘But sometimes, somewhat misguidedly, we don’t do the right thing.  ‘We need the research to back up and to prove to GPs as well that there’s a problem here we need to address.’ 

The survey of 197 GPs found 80 per cent were aware of prescribing to people who may be addicted. Almost 53 per cent were quite or very worried about prescription drug abuse in their area. And half said they were aware of situations where prescriptions may have been sold on and think more research is needed on the issue.

More than 40 per cent of the practices have minimal or no support from addiction services in their area.

Others said the addiction may be well established over many years and it is hard to stop patients having treatment if they still have symptoms.
A research paper published earlier this year by the National Treatment Agency for Substance Abuse said there were ‘conflicting messages’ about where the responsibility for the problem lay and what should be done about it.

Dr Swinyard said proposed changes to practice boundaries allowing patients to sign on at different GP practices may make it easier to shop around for prescription drugs.

Official statistics show 1.5million Britons are addicted to prescribed sedatives, known as benzodiazepines. This comes at a high cost to the NHS, which spends £3billion a year on tranquillisers and anti-depressants.

A report from the Health Research Board last year found that the numbers being treated for ‘problem use’ of benzodiazepines between 2003 and 2008 rose 63 per cent.

It also found the number of deaths caused by them rose 35 per cent from 65 in 1998 to 88 in 2007. Twice as many men as women died.
Many addicts are the elderly, who in most cases were prescribed the drugs decades ago. Some continue to suffer debilitating side effects, including paranoia and memory issues.

Withdrawal effects are severe. But unlike addictions to heroin and cocaine, there is almost no specialist help to quit. In 1988 the drug watchdog first warned this medication should not be prescribed for more than a few weeks. 26.7.11

BBC: Almost 80% of GPs routinely prescribe drugs to which they believe the patient may be addicted, a survey suggests.

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Charles? He's just a snake-oil salesman: Bitter Professor attacks prince on ‘dodgy' alternative remedies

Prince Charles has been branded a ‘snake-oil salesman' by Britain's first professor of complementary medicine for supporting ‘dodgy' alternative therapies. Professor Edzard Ernst claimed yesterday that the prince's backing for ‘unproven and disproven' remedies was an attempt to smuggle them into the NHS despite scientific evidence showing they could be dangerous.

Prof Ernst, who set up Exeter University's Centre for Complementary Medicine in 1993, left his post last month after claiming that a row with a senior aide to the prince had led to the withdrawal of support from university managers and the drying up of research funds.

He has carried out a series of scientific investigations into complementary medicine such as homeopathy and herbal remedies over the past decade but critics said his research was 'flawed'.

Yesterday Prof Ernst told a conference in London that he found evidence that around 20 therapies were useful for various conditions, ranging from Co-enzyme Q10 supplements for high blood pressure to St John's wort herbal pills for depression.

But the evidence was lacking for alternative therapies such as chiropractic, detox, herbal slimming aids, cancer cures, and homeopathy – which has long been championed by the prince and other members of the Royal Family.

In a bitter attack over losing his job he said such remedies were being peddled by ‘snake-oil salesmen and pseudo science' and were dangerous to the public, who might be put directly at risk or as a result of rejecting conventional medicine in favour of ‘dodgy' remedies. Critics said 'Professor Ernst is clearly upset at losing his funding and job but there have been concerns over his research for some time'.

Asked whether he classified the prince as a snake-oil salesman, Prof Ernst replied: ‘Yes.'

In a comment for the Journal of Internal Medicine, the professor, who has been nicknamed the Quackbuster for his efforts to root out alternative remedies for which he can find no evidence, criticised the concept of integrated, or integrative, medicine. This advocates treating the patient with conventional and complementary approaches and is backed by the prince.

Prof Ernst said it covered a ‘wide range of unproven and disproven' therapies, and was ‘nothing other than a cloak of respectability disguising alternative medicine'. He wrote: ‘At best, integrative medicine is well meaning but naive, at worst it represents muddled or even fraudulent concepts with little potential to serve the needs of patients.'

He said he suspected that Prince Charles wanted to get the NHS to supply more alternative therapies despite the lack of scientific evidence for many of them. The prince's complementary health charity, the Foundation for Integrated Health, closed last year amid a criminal investigation into fraud and money-laundering.

Prof Ernst has clashed with the prince before. He accused him of ‘exploiting a gullible public' by putting his name to a detox treatment in his Duchy Originals brand.

The £10 Duchy Herbals Detox Tincture relied on ‘superstition and quackery' rather than science and the range should be re-named ‘Dodgy Originals', he said.

Prof Ernst, 63, has also blamed a row with the prince's office five years ago for forcing his early retirement from Exeter's complementary medicines unit in June – two years early. He attacked a report advocating complementary medicine, commissioned by the prince, as ‘outrageous and deeply flawed'.

This prompted a formal complaint from Sir Michael Peat, the prince's private secretary. Prof Ernst said he had been cleared after a long investigation but blamed lack of support from the university coupled with lack of research funding for a closure threat to the unit.

He claimed he had offered to go if it would save the unit, and his offer was accepted by Professor Steve Thornton, the new dean of the university's Peninsula Medical School, who agreed to fund the appointment of a successor. A university spokesman said: ‘We are looking to replace Professor Ernst on his retirement with another specialist in complementary medicine. 'We will support that person to raise funds to enable research to continue, but have earmarked £234,000 to support the centre over the next 12 months.'

One expert said 'Professor Ernst is clearly upset at losing his job and launched this attack to undermine CAM therapies but the evidence is there for its use, he just ignored it'. Last night Clarence House declined to comment. 26.7.11

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GPs told to stop 'chemical cosh' for dementia victims which cause hundreds of deaths

Doctors will be told not to prescribe needless ‘chemical cosh' drugs to dementia sufferers amid concerns that the medicines  are causing hundreds of deaths a year.

Around 180,000 elderly patients with Alzheimer's and similar memory-loss illnesses are taking some form of antipsychotic medication. But the drugs, dubbed ‘chemical cosh' due to their dangerous side-effects, have been blamed for causing 1,800 deaths a year. They are also known to worsen symptoms of confusion, dizziness and unsteadiness and often  lead to falls.

Ministers are concerned that many GPs hand out the drugs ‘inappropriately' without considering other forms of care and treatment. Under new guidelines, family doctors are being told to review every single patient taking one of these drugs to consider whether it is necessary. There are concerns the drugs are being prescribed simply to sedate patients to make their carers' jobs easier. 

Campaigners, including the Alzheimer's Society charity, claim there are far more effective and less harmful treatments. This week scientists demonstrated that simple painkillers including antipsychotics were just as effective – and far less harmful. The researchers working at Kings College London pointed out that patients were often aggressive because they were  in pain.

Other forms of therapy such as crosswords, singing and problem-solving exercises to keep patients' minds active are also thought to be effective.

Nearly a quarter of the 750,000 people in Britain with some form of dementia are prescribed an antipsychotic drug. Numerous studies have shown  that patients who take them over a long period are twice as likely to die early as those who do not. 
Antipsychotics can increase symptoms of dementia.

According to the Alzheimer's Society, five people die every day as a result of these drugs and another four come to some form of harm. The guidelines also urge  doctors to refer patients for memory tests if they show early signs of dementia – such as confusion, repeating things or forgetfulness.

Care Services Minister Paul Burstow said: ‘With early diagnosis and good care, people with dementia can continue to live well for many years. 

‘But for this to happen, it is vital that services are designed and delivered to meet the needs of individuals and their local communities.

‘This is why we want to devolve power to clinicians and patients but we also recognise that local commissioners need to be supported with expert tools and advice.' 25.7.11

NHS spending on 'chemical cosh' child-calming drugs soars by 60% to £31m  Chemical cosh drugs to be cut by two thirds

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NHS services to be opened up to competition

More than £1bn of NHS services are to be opened to competition from private companies and charities, including wheelchair services for children

The government will open up more than £1bn of NHS services to competition from private companies and charities, the health secretary announced on Tuesday, raising fears it will lead to the privatisation of the health service.

In the first wave, beginning in April, eight NHS areas – including musculoskeletal services for back pain, adult hearing services in the community, wheelchair services for children, and primary care psychological therapies for adults – will be open for "competition on quality not price". If successful, the "any qualified provider" policy would from 2013 see non-NHS bodies allowed to deliver more complicated clinical services in maternity and "home chemotherapy".

Andrew Lansley – admitting that the government's initial plans for competition in the NHS were too ambitious, and stung by criticism from Steve Field, the senior doctor called in by David Cameron to review the reforms, that the proposals were "unworkable" – has slowed down the rollout of competition. The health secretary said his plans would now "enable patients to choose [providers] … where this will lead to better care".

Labour questioned the policy, which the shadow health secretary, John Healey, said was "not about giving more control to patients, but setting up a full-scale market".

His colleague Emily Thornberry, the party's health spokeswoman, added that "today is a good day to announce the policy because everyone is preoccupied with telephone hacking. [They] hope no one will notice it."

This theme was picked up on Twitter with a stream of comments about it "being a good day to bury bad news".

Critics warned of "huge dangers lurking in the plans".

The trade union Unison said: "Patients will be little more than consumers, as the NHS becomes a market-driven service, with profits first and patients second. And they could be left without the services they need as forward planning in the NHS becomes impossible."

A spokesman for the British Medical Association questioned "the assumption that increasing competition will always mean improving choice.

"The ultimate consequence of market failure in the NHS is the closure of services, restricting the choice of patients who would have wished to use them." The Department of Health dismissed these charges and argued the policy would benefit patients by bringing many services out of hospitals, which would make it easier to access healthcare.

As an example, the policy could lead to patients being able to walk into a retailer on the high street or a local GP's surgery for a blood test rather than being forced to go to hospital.

One of the new policy's aims is to promote innovation, highlighting the "Tony Blair example". Abnormal heart rhythms, such as those suffered by Tony Blair, no longer need the immediate attention of a cardiologist.

Instead, a concerned patient could be treated by using the telephone to measure the heart beats and give an instant diagnosis, followed by a call from a nurse advising on whether the patient needed to go to hospital or not.

There were also major savings that could be made, the department said. It cited the example of chronic leg wounds, where the NHS pays out £18,000 per patient over four years, often without curing them. One not-for-profit company – Wound Healing Centre in Sussex – treats patients successfully for £720.

Lansley's commissioning tsar, Dame Barbara Hakin, said the NHS must push ahead with the agenda to offer patients more choice despite financial challenges and a period of "significant transition".

The NHS must save £20bn over the next four years in efficiencies.

Labour disputed the gains, saying the policy was just a step towards privatisation.

Healey said: "The Tory-led government is pushing ahead with its wasteful and unnecessary NHS reorganisation, rather than focusing on improving patient care."

Care options
From April 2012 patients receiving one of eight types of community and mental health services in England will be able to be choose to access their care or support from a private health provider or voluntary or charitable organisation, not just the NHS.

• Services for back and neck pain.

• Adult hearing services in the community.

• Continence services (adults and children).

• Diagnostic tests closer to home.

• Wheelchair services (children).

• Podiatry (feet) services.

• Leg ulcer and wound healing.

• Talking Therapies (primary care psychological therapies, adults).

These represent about £1bn of the NHS's £110bn a year activity. 20.7.11

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America conned: Psycho pharma drug pushing empire under fire

Is America truly stricken with widespread mental illness? Do tens of millions need mind-altering drugs? A recent flurry of media articles lead readers to a realization that Big Pharma and the "mental health" industry have deceived Americans on a grand scale.

The "New York Review of Books" two-part article by Dr. Marcia Angell, Senior Lecturer at Harvard Medical School and former Editor in Chief of The New England Journal of Medicine, summarizes it extremely well. She analyzes three books by authors Irving Kirsch, Robert Whitaker, and Daniel Carlat. Each deconstructs the apparent mental illness epidemic and theory that mental disorders stem from brain chemical imbalances which can be corrected by drugs.

Dr. Angell's review has sparked a host of other journalists to applaud her and fuel the fire. An article in Forbes even concludes, "psychopharma is looking like an idea whose time has passed."

As an overview:

Ten percent of Americans over age six take antidepressants. Antipsychotic drugs, once reserved for schizophrenics, have become the top-selling class of drugs in the US, with over $14 billion in sales in 2009. ADHD, bipolar and autism diagnoses have exploded in the past two decades with at least 5 million US kids now on psychiatric drugs. Ten percent of boys take drugs for ADHD. Half a million kids take antipsychotics, including preschoolers.

The chemical imbalance theory rose to fame when Prozac hit the market in 1987, accompanied by massive hype that it corrected a chemical deficiency in the brain. In the years that followed, the number of people prescribed drugs for mental illness skyrocketed. Today, "treatment" for mental disorders is synonymous with psychoactive (mind-altering) drugs.

Tracing the origin of this theory shows it wasn't that chemical imbalances were discovered in the mentally ill and then drugs were devised to correct the imbalance. Instead, drugs created for other purposes were incidentally found to also affect brain chemicals and blunt mental symptoms. Drug companies, hungry for new markets, and psychiatry, eager to build stature in the medical arena, leapt on this. They conducted a vast campaign to popularize chemical imbalances as the cause of mental disturbance and push drugs as the answer.

As Dr. Angell writes, "instead of developing a drug to treat an abnormality, an abnormality was postulated to fit a drug." "Or similarly," she says, "one could argue that fevers are caused by too little aspirin."

Many scientific studies disprove the chemical imbalance theory. After fifteen years of research, Irving Kirsch - psychologist and author of "The Emperor's New Drugs" - concludes, "It now seems beyond question that the traditional account of depression as a chemical imbalance in the brain is simply wrong." Research studies show psychoactive medications actually disrupt brain chemistry and causes the brain to function abnormally. This year prominent neuroscientist, Dr. Nancy Andreason, announced proof that antipsychotics shrink the brain.

Studies also demonstrate that long-term recovery rates are higher for nonmedicated patients. For instance, the World Health Organization conducted an investigation in fifteen cities around the world and out of 740 depressed individuals studied, those that weren't on psychiatric drugs had the best long term outcomes.

In the pre-medication era, it was known that with time, people usually recovered from depression. If kids had tantrums, were unruly or shy, they were apt to outgrow it. Today, individuals branded with disorders are likely to receive long-lasting diagnoses, endless prescriptions and the poorer ones tend to remain on disability for life.

Big Pharma manipulation
Dr. Marcia Angell says the author of each of the three books agrees on "the disturbing extent to which the companies that sell psychoactive drugs - through various forms of marketing, both legal and illegal, and what many people would describe as bribery - have come to determine what constitutes a mental illness and how the disorders should be diagnosed and treated."

According to IMS Health, an information and consulting company, pharmaceutical companies spent $6.1 billion in 2010 in marketing to US doctors. Another $4 billion was spent on direct-to-patient advertising.

Drug trials, used to bring a drug to market, are funded by drug companies, heavily biased and misleading. Companies may sponsor as many trials as they like until they have just two positive ones to submit to the FDA. Great care is taken to hide negative trials. The highly positive results of placebo trials are downplayed: a high percentage of patients recover on a fake drug (like a sugar pill) - proving that the more a person believes he will benefit from a treatment, the more likely he will experience a benefit.

In regards the Diagnostic and Statistical Manual - the psychiatric bible of mental disorders, used in prescribing drugs - Dr. Angell points out "in all of its editions, it has simply reflected the opinions of its writers." The majority of the psychiatrists involved in creating the current edition had financial ties to drug companies.

Author Daniel Carlat points out that "psychiatrists consistently lead the pack of specialties when it comes to taking money from drug companies."

Crime against humanity
And where has the "mental health" industry and "drug therapy" brought our nation?

As Americans line up at their local pharmacy, documented side effects are legion: weight gain, deadened emotions, diabetes, heart problems, liver damage, stunted growth in kids, shortened life spans and on and on. Those prescribed one psychoactive drug are commonly prescribed another to address side-effects, with many on daily cocktails of meds.

An estimated 2.2 million Americans are hospitalized each year for adverse drug reactions. Over 100,000 die from them.

Instead of decreasing, the number of adults on disability pay for mental illness has soared 250% since 1987 and for kids it's a 35X increase.

The greatest crime to humanity is the mass drugging of children. Yet it's perpetrated within schools, doctor offices, foster homes and juvenile facilities daily.

There is good news. In the past few years, drug companies have faced a rise of multi-billion dollar class action suits. The key popularizer of childhood bipolar and antipsychotics for kids, Dr. Joseph Biederman, was publicly sanctioned by Harvard Medical School for failing to report $1.6 million he pocketed from drug companies. Some drugmakers are steering away from pursuing new psychoactive drugs.

Nazi chief propagandist Joseph Goebbels once said, "If you tell a lie big enough and keep repeating it, people will eventually come to believe it."

This chemical-imbalance/drug therapy lie has been told big enough and repeated enough, that much of America believes it. Isn't it time we all put a stop to it? Natural News 26.7.11

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Ex pharma sales rep Gwen Olsen says Big Pharma only interested in profits, not health

Gwen Olsen, an ex-pharmaceutical sales representative, is using her personal experience and insider knowledge to turn the tables on Big Pharma and tell people the disturbing and disheartening truth about the highly corrupt industry: it's only after the money, not the health of its patients.

Gwen, a 2007 Human Rights Award recipient, is a dedicated mental health activist, public speaker, and writer committed to child and mental health advocacy; her specialties include promoting the cessation of America's over medication of its children and teens. It's hard to imagine that this same woman was once a successful pharmaceutical sales rep for more than 15 years, working for many of the industry's big name manufacturers. "We (were) being trained to misinform people," said Gwen.

Now on a personal, passionate quest to wake up as many people as possible to the deception of the pharmaceutical industry, Gwen's research emphasizes her concerns about the increasingly prevalent use of prescription drugs and the deadly effects that these drugs can have. "There is no such thing as a safe drug," said Gwen in a video interview.

Gwen's astounding admissions in another video interview on Natural News ( http://naturalnews.tv/v.asp?v=29359... ) dispels the myth that Big Pharma is in the business of healing or helping cure disease -- instead, the industry is out to regulate illness, manage symptoms, and keep people trapped in a lethal cycle of chemical dependency, says Gwen.

In the video, Gwen explains that drugs -- psychiatric drugs in particular -- are meant to encourage people to remain customers of the pharmaceutical industry. After all, if Big Pharma intended to help cure disease, they would be putting themselves out of business.

"I don't want people thinking that I am a conspiracy theorist, because in fact, there is no theory behind what I'm telling you, it's all provable... what I'm saying is provable is, the pharmaceutical industry doesn't want to cure people," said Gwen in the video.

The confessions of a Pharma veteran
The Rx Reformer recently released a book, Confessions of an Rx Drug Pusher ( http://www.amazon.com/Confessions-D... ), which provides considerable insider knowledge of the serious dangers that lie within the game of the pharmaceutical industry and the disinformation that has jeopardized lives. Her book presents many admissions, some deeply personal, of what she discovered and observed throughout her career with Big Pharma, during which she was encouraged to minimize the side effects of the drugs she was selling when speaking to doctors.

Confessions of an Rx Drug Pusher is a strikingly candid and much-needed wake-up call about the flawed U.S. health care system, which is -- with good reason -- currently ranked last among 19 industrialized nations worldwide. You can read more about the book on Gwen's site: http://www.gwenolsen.com

As Gwen's book reveals to readers, more than 180,000 people die annually from the effects of legal drugs. "By the time a drug is approved and it hits the general population, we don't even know 50% of the side effects involved," said Gwen. In the same interview, Gwen explains that there is no medical evidence required for psychiatrists who wish to prescribe their patients drugs. This broadens the potential patient population considerably, allowing Big Pharma a lucrative advantage over an increasingly diseased and medicated public.

How the Rx Reformer came into existence
Gwen's self-proclaimed calling as the "Rx Reformer" evolved not only from extensive personal experiences obtained during the years she spent working for major drug companies, but a shocking event that occurred within her own family.

The health of Gwen's niece, Megan Blanchard, a bright pre-med student, quickly deteriorated through the onset of drug-induced addiction, withdrawal, mental illness, and depression. This painful suffering resulted in Meg's unfortunate and tragic suicide, and Gwen quickly realized that her niece was not the first to painfully suffer from the consequences of doctor prescribed pharmaceuticals, nor would she be the last. In her book, Gwen writes: "Compassion is what Meg really needed, not more drugs."

"There are thousands and thousands of people like that out there -- and they need a voice," said Gwen. "I serve as that voice."

Gwen's disillusionment with the industry -- her anger at the immense deceit and misinformation she witnessed taking place within the profitable alliance between medical doctors and Big Pharma -- led her to get out of pharmaceutical sales and pursue a new vocation: spreading truth.

"I had been used in the game, I literally was the one at the front lines, harming people -- unintentionally -- but I was responsible, and I carry a burden for that now," said Gwen.

Gwen has now made it her moral obligation, or what she has labeled her "spiritual calling," to educate others on what she learned the hard way about the abundance of harmful drugs being given to a credulous population. Natural News 12.6.11

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The anti-depressants epidemic: One in three women take pills to relieve despair during their life

One in three women have taken anti-depressants at some point in their lives, researchers say. The study by women's campaign group Platform 51 found that 48 per cent of women currently using the drugs have taken them for at least five years, while 24 per cent have taken them for 10 years or more.

Meanwhile, 24 per cent of women on anti-depressants have waited a year or more for a review, the research found.

The charity, which commissioned a survey of more than 2,000 adults in England and Wales, said the figures pose 'worrying questions' about the appropriateness of prescriptions.

Platform 51's director of policy, campaigns and communications Rebecca Gill, said: 'These shocking figures reveal an escalating crisis in women's use of anti-depressants. 'We know from working with women and girls in our centres that anti-depressants have a role to play but they are too readily prescribed as the first and only remedy.

'Three in five women are offered no alternative to drugs at their reviews and one in four currently on anti-depressants have waited more than a year for review. ‘Our research suggests that there is still a huge stigma attached to poor mental health. With so many women not telling their families, it is clear that women fear they will be judged on the state of their mental health.

'The current NICE guidelines are not being followed: women want more checks to make sure the medication use is right for them and they want more choice when it comes to receiving treatment.'

Platform 51 is calling on health authorities to launch a review into the guidelines for anti-depressant use and prescription.

The charity's research found 57 per cent of women who have taken anti-depressants were not offered any alternatives to drugs when they were prescribed. It also found 18 per cent kept their prescription a secret from their family and one in 10 did not tell their partner.

People with depression have a chemical imbalance in the brain [this is utter rubbish, no test for a chemical imbalance]. Anti-depressants work by increasing the levels of chemicals called neurotransmitters, such as serotonin and dopamine. As it takes time to increase the levels the full effects are usually not felt until after two to four weeks.

While anti-depressants may relieve some of the physical feelings of the condition, they won't tackle what may have caused the depression in the first place. Therefore experts advise doctors to prescribe the drug in combination with therapy. 5.7.11

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Statin prescriptions soar to a million a week despite side effects

Prescriptions for statins have reached record levels, with the number soaring over the last 30 years. Around one million prescriptions for the cholesterol-lowering drugs are written each week, compared with a few thousand in 1981 which is good news for pharma profits.

Despite side effects ranging from memory loss to muscle pains, nerve damaage, liver failure and a host of other complaints, statins have become a mainstay for doctors treating heart attack and stroke survivors. They make up nearly a fifth of all medicines prescribed for heart and circulatory disease, according to the British Heart Foundation. 

There are more than 52??million prescriptions for lipid-lowering drugs – the majority of which are statins – in England each year. The drugs are effective in lowering levels of cholesterol, the fatty substance in the blood that clogs up arteries. The BHF says prescriptions related to heart and circulatory disease total about 266million annually.

In 1981, lipid-lowering drugs only accounted for 295,000 – not even one per cent of a total 46million prescriptions for cardiovascular medicines. 

Professor Peter Weissberg, Medical Director at the British Heart Foundation, said ‘When the BHF was founded in 1961, statins weren't even available to doctors but now they help many millions of people across the UK.  'They've undoubtedly changed the face of heart disease treatment for the better and prevented many heart attacks and strokes.

‘As with any other medicine, some people do experience side effects from statins but these are rarely life threatening and the benefits of statins far outweigh any disadvantages. 'They continue to make a major contribution to the nation's heart health.' About 7million patients in the UK are taking statins, many of whom have survived a first heart attack. 

But the Cochrane Library recently said there was little evidence of protection unless a person's risk of a heart attack was already high. Warnings about side effects such as memory loss, fatigue, muscle pain and weakness, continue to emerge, with estimates ranging from one to 20 per cent of patients affected.

The Medicines and Healthcare Products Regulatory Agency recently warned about additional risks including sleep disturbances, sexual dysfunction and depression.  Research last month found high dose statins increase the risk of type 2 diabetes by 12 per cent compared with moderate doses.

But the BHF said the drugs were safe.

Cambridge GP and Associate Medical Director at the BHF, Dr Mike Knapton, said ‘Statins are among the safest and most studied drugs available to me for the benefit of patients. 'Over the course of my 30-year career in medicine, I've seen lots of people debilitated by heart attacks and strokes and I try very hard to prevent them happening – statins help me to do that. ‘But these drugs aren't the only development we've seen in the field of cardiovascular care. 

'The last 50 years have seen huge advances, including heart failure drugs and heart transplants, and most children born with a heart defect now survive thanks to life-saving surgery. 'Combined with statins, these breakthroughs have undoubtedly improved people's health and saved lives.'

Statins: The side effects 'are worse than feared'

The other side of statins: doctors now fear for some, the side effects could be devastating

Statins are the new NHS wonder but do they have sinister side-effects?

Can it really be true that statins are a waste of time and won't stop heart attacks?

Why taking statins might be pointless - and even bad for you

5.7.11

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Drug firms 'too heavily reliant on ageing sales portfolios'

Pharmaceutical companies are trialling fewer new medicines and relying heavily on sales from an ageing portfolio of products, casting into doubt their ability to replace revenues lost to cheaper generic products.

The latest Pharmaceutical Research and Development (R&D) Factbook, compiled by CMR International, a Thomson Reuters business, paints a gloomy picture of drug makers' attempts to shore up their pipelines against the "patent cliff".

According to CMR, over the next three years, more than 110 products – including 14 blockbusters – will lose patent exclusivity in America. But, data shows that pharmaceutical companies are still relying heavily on revenue from established products and are struggling to develop successful new medicines.

Last year, drug sales were at an all-time high of $856bn (£535bn), but only 5pc of those sales were driven by products launched within the last five years. The struggle companies face in reinvigorating their portfolios was illustrated by the number of "new molecular entities" launched last year dropping to 21, down from 26 in 2009.

Meanwhile, the number of potential new drugs entering Phase I and II trials fell by 47pc and 53pc respectively, compared to 2007.

CMR said the number of drugs failing at the latter stages of trials should be "of particular concern to the industry", with 55 Phase III proj-ects being terminated in 2007-09 and 2008-10, more than double the number terminated in 2005-07.

Hans Poulsen, head of life sciences consulting at Thomson Reuters, said: "The industry is continuing to struggle with being able to progress new medicines through the development cycle, so there are more failures at Phase II and III. What it means is there may be a delay in replacing the revenue the industry is losing to generics."

Drug makers have tried to bolster their pipelines by in-licensing products and companies have taken steps to be more focused in their R&D. But Mr Poulsen said: "What we need to understand is [whether the fall in compounds entering trials] is just because they make better decisions earlier on or just that there's not enough innovation at the early-stage pipeline." 29.6.11

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Drug R&D spending fell in 2010, and heading lower

R&D spending $68 bln in 2010 vs $70 bln in 2009

* First ever decline follows poor returns

* Trend set to continue as Pfizer, others cut more

The global drug industry cut its research spending for the first time ever in 2010, after decades of relentless increases, and the pace of decline looks set to quicken this year. Overall expenditure on discovering and developing new medicines amounted to an estimated $68 billion last year, down nearly 3 percent on the $70 billion spent in both 2008 and 2009, according to Thomson Reuters data released on Monday.

The fall reflects a growing disillusionment with poor returns on pharmaceutical R&D. Disappointing research productivity is arguably the biggest single factor behind the declining valuations of the sector over the past decade.

"For the first time, drug companies are reducing costs in their R&D organisations and I believe we will see that trend continue," said Hans Poulsen, head of life sciences consulting at Thomson Reuters.

Traditionally, R&D laboratories have been largely immune to cost cutting but that has changed in the past year or so, and in recent months the pace of cutbacks has increased.

Pfizer , the world's biggest drugmaker, has taken the most dramatic steps under new Chief Executive Ian Read, with plans to slash around a quarter of its R&D budget over the next two years. Other companies have also made smaller cuts.

The winding back of research budgets represents a major change for an industry that has ploughed billions of dollars into the hunt for new drugs, often with little to show for it.

Since 2000, research investment by drug companies accounting for 80 percent of the industry's total R&D has increased by more 50 percent -- but output of new medicines has actually gone down.

Last year, 21 new molecular entities were launched on the global market, down from 26 in 2009, and only a third of those were from major drugmakers with annual research budgets of at least $2 billion, according to the 2011 Pharmaceutical R&D Factbook compiled by Thomson Reuters unit CMR International.

Between 2008 and 2010 there were 55 terminations of projects that had already reached the final Phase III stage of clinical testing, more than double the level of 2005-07, reflecting the growing difficulty of developing new drugs that are better than existing ones.

IN-LICENSING DILEMMA
Faced with the loss of exclusivity on more than 110 products in the key U.S. market between 2012 and 2014, the industry has stepped up its drive to buy in promising experimental medicines from small biotech companies.

But this in-licensing strategy, too, is facing difficulty, as drugs that originate inside Big Pharma companies actually have a 20 percent higher chance of making it to market, according to CMR figures.

Recently, some experts have suggested that productivity in drug research may be improving, as evidenced by progress with breakthrough medicines like GlaxoSmithKline's new drug Benlysta for lupus and Bristol-Myers Squibb's melanoma treatment Yervoy. Poulsen, however, believes it is too early to judge. "We could see an improvement but it may take four to six years before we can really say the trend has been reversed," he said.  28.6.11

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GP bonuses 'lead to poor patient care' as financial incentives boost some treatments... but caused a decline in others

Bonus payments for GPs mean some patients are missing out on improved care, say researchers. The financial incentives have led to better measuring of high blood pressure and cholesterol levels, a study shows.

But in other areas of patient care which are not in the scheme improvements were ‘significantly below' what was expected. These included measurements involving people suffering from arthritis, dementia and back pain.

Pay-for-performance targets were introduced in 2004 as part of a new contract for GPs to reward them for taking better care of patients. The scheme had an annual price tag of £1.8billion at the time and is now worth around £1billion.

Around a quarter of GPs' average income – currently £105,000 a year – is linked to achieving the targets. But the study says there may be ‘unintended consequences' to the scheme, which is known as the Quality and Outcomes Framework. The study, published last night in the British Medical Journal, looked at data from 500 UK general practices and trends in quality of care for 42 activities.

Of these, 23 measurements or treatments attracted a bonus payment including measuring blood pressure and smoking habits. A further 19 activities did not lead to extra money, including measurement of thyroid function or blood sugar levels in certain categories of patients.

For all activities, there was a general improvement in quality before incentives were introduced. When bonuses were attached to some measurements, there was a significant increase in quality during the first year after the scheme came in.

This levelled off after three years to a 4 per cent rise above what would have been expected without incentives. 

For measurements that did not attract extra money, quality was ‘significantly worse' after three years, with a 5 per cent drop compared with the improvement that would have been expected  without incentives. Dr Tim Doran, who led the research team, said financial incentives resulted in a quicker rate of improvement in some activities.

But it was questionable whether this lasted, and whether patients whose conditions did not attract bonuses were being neglected. 

Dr Doran, a clinical research fellow at Manchester University, said: ‘It's not possible to incentivise everything. It does improve quality in the short to medium term but it has a small detrimental effect on activities that do not attract financial targets.  ‘In the medium term these may have been slightly neglected.'

Dr Doran said there were limitations to ‘bonus' schemes because they set priorities for care that might result in other areas such as depression receiving less attention, partly because it was harder to measure improvements. Earlier this year research found that targets set to improve high blood pressure and cut heart attacks and strokes ‘had no impact'.

Researchers, led by Dr Brian Serumaga, a Harvard Medical School fellow working at Nottingham University, investigated 470,000 patients with high blood pressure. They found ‘little evidence' of effectiveness of pay for performance targets.

The Government has pledged to reform the way GPs are paid for targets in the face of criticism.  The British Medical Association says the Quality and Outcomes Framework was designed to ensure that patients received uniform high-quality care no matter where they lived in the country, and, by doing that, to improve public health over the long term. 

A Department of Health spokesman said: ‘The Quality and Outcomes Framework and other incentives for GPs are insufficiently focused on outcomes, including patient experience.  ‘We therefore intend to reform the payment system so that GPs are rewarded appropriately for improving patient outcomes.' 29.6.11

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Busted! Big Pharma epilepsy study rigged to push drug Gabapentin

If you think being concerned over natural health issues means you automatically dismiss everything that mainstream medicine has to say - think again. Not only are many mainstream researchers coming up with evidence that nutrition and other natural therapies really are effective but now comes a report published in none other than Archives of Internal Medicine , a Journal of the American Medical Association (JAMA), that blows the lid off an unethical Big Pharma practice.

Specifically, the article shows how drug pushing - not science - appears to have been the motivation behind a study that supposedly was testing the drug Neurontin (gabapentin), currently widely used to treat nerve pain. The test was allegedly designed to document how various doses could treat epilepsy. But it turns out the trial was set up to "seed" the results in order to sell the drug, much like a card shark might stack a deck of cards in order to cheat at a game of poker.

According to the just published article, when researchers are involved in so-called seeding research, they are conducting clinical trials primarily as marketing tools so the drug can be promoted and sales pushed by doctors. Bottom line: these are promotional trials used for selling drugs and research subjects and physicians may not be told the true purpose of the studies.

Surely, promoting a study as true scientific research when it is really a ploy used to market drugs must be illegal, right? According to the new report, Big Pharma is allowed to get away with seeding studies under the current law. However, the authors (Samuel D. Krumholz, B.A., David S. Egilman, M.D., M.P.H., and Joseph S. Ross, M.D., M.H.S., who are consultants at the request of plaintiffs currently suing Pfizer Inc. over the gabapentin seeding study in the U.S.), report the practice is clearly unethical.

To prepare their report, entitled "Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS)", the researchers investigated whether the study was a seeding trial by looking into documents related to the marketing, sales practices, and product liability litigation of Neurontin (gabapentin), prescribed for epilepsy. Because the authors were consultants to the plaintiffs in a lawsuit involving the drug, they had access to depositions and the document database. And that meant they were able to get their hands on damning correspondence, clinical research reports and market research analyses for a look inside the workings of Big Pharma's pushing of the drug.

What did they discover? Although the trial's supposed purpose was to study dose-titration of gabapentin among 2,759 patients enrolled by 772 investigators, the study was uncontrolled and unblended. In other words, it didn't meet the basic criteria for a sound drug study.

However, articles based on the results of this anything-but-gold-standard-science study managed to be published in two journals - even though the sloppy study design was questioned by two outside sources and that "data quality during the study was often compromised."

But here's even more compelling evidence something was not on the up and up: the authors cite documents that strongly suggest drug company marketing personnel were involved in collecting the trial data. What's more, the Big Pharma marketing heads viewed the trial (and not only its results) as a way to push sales of gabapentin.

This involvement of the marketing team and the failure to disclose the study's real purpose from both research subjects and collaborators are the "smoking guns" that mark the STEPS study as a seeding trial, according to the authors. They are calling for institutional review boards (IRBs) to finally take a strong stance in discouraging these types of marketing-over-science trials. "Reform of the current IRB system," they wrote, "as well as promoting better clinical trial practice in the human subjects research community, are necessary to prevent continued conduct of seeding trials by the pharmaceutical industry."

In an accompanying commentary to the study, G. Caleb Alexander, M.D., of the University of Chicago, noted that seeding trials negatively affect scientific knowledge and clinical care. "The biomedical enterprise depends on good science for its foundation, and good science requires transparency of methods and integrity of purpose," he wrote.

He pointed out the evidence presented by Krumholz and colleagues "strongly supports the conclusion that STEPS meets key criteria of seeding trials." Dr. Alexander also stated that these unethical seeding trials can detract from the legitimate value of well-designed and well-conducted phase 4 studies of pharmaceutical drugs.

"Although the road is long and the hill steep, these and other changes offer the promise of incrementally improving and safeguarding the integrity of the biomedical enterprise. One can only hope that the report by Krumholz et al will contribute to this evolution," he concluded.

Let's be blunt here: the new report in the Archives of Internal Medicine shows that Big Pharma's research results cannot always be trusted and may place more importance of skewing data to promote and push drugs on the public than in coming up with true scientifically sound data. 28.6.11

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MPs demand NHS complaints shake-up as it is too complicated for patients

The NHS complaints process needs a 'complete overhaul' as it is simply too difficult for patients to understand, MPs said last night. They called on ministers to carry out an immediate review of the way trusts handle complaints from patients.

The current structure is not working and urgent measures are required to encourage a 'more open culture' when dealing with complaints and admitting mistakes, members of the cross-party Commons health select committee said.

Last year, the Mail launched a campaign for a better complaints procedure in the Health Service following complaints from patients organisations that people face having to complain to those guilty of making the mistake before they can go to an independent investigator.

The select committee called on ministers to make it easier for patients to have an independent investigation. The number of complaints about the NHS is rising and tops one million a year. 

Experts believe a mixture of factors is to blame, including worsening care, increased demand for healthcare and better awareness of the complaints process. The report calls for a review of the system 'without delay', suggesting ministers consider whether two systems should be created, one dealing with complaints about customer care and a second examining more serious complaints about clinical issues.

They said there was unacceptable variation across the country, and that 'NHS culture is too often defensive and the service remains to be persuaded to adopt a more open culture'. 'In particular we are concerned about the number of individual cases where complainants did not feel the NHS was sufficiently responsive to their concerns.'

The report said the role of the independent Health Service Ombudsman should also be expanded to allow more claims to be examined as part of an appeals process when patients are unhappy.

At present, patients complain first to the NHS trust in charge of their treatment. If they are not satisfied, they can ask the Ombudsman to review the case.

But MPs said the Ombudsman's remit is much narrower than patients think. Only about 3 per cent of the complaints received by the Ombudsman are accepted for formal investigation or intervention, although many more are examined unofficially.

Tory MP Stephen Dorrell, chairman of the committee, said: 'The legal and operational framework of the Health Service Ombudsman should be widened so that she can independently review any complaint which is referred to her following rejection by a service provider.' 

Katherine Murphy, of the Patients Association, said the system was failing patients. 'How can a system hope to be fair and impartial when it relies on the trust investigating itself,' she added.

Ambulance-chasing 'claims farmers' who encourage people to sue the NHS are undermining doctors and costing taxpayers a fortune, MPs said.

The select committee said claims management companies are largely responsible for a 25 per cent rise in NHS litigation costs between 2007/08 and 2009/10 to £787million.

The firms collect claims, assess their value and then sell them on to personal injury lawyers or legal firms. Claims are sometimes sold to the highest bidder. 28.6.11

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Taxpayers will no longer 'bail out' failing NHS hospitals

Failing hospitals will no longer be secretly “bailed out” using taxpayers' money, the Government has claimed in the latest details of its controversial NHS reforms.

The Department of Health said “poor quality” organisations would not be “propped up with subsidies” any more, as it highlighted the importance of competition and choice to improving public services. Ministers have scrapped plans to protect certain health services deemed essential from going bust in advance, raising the prospect that some hospitals or units may be allowed to go to the wall.

It comes as growing numbers of health experts and members of the medical profession start to discuss the idea, which politicians rarely admit in public, that in some cases hospitals closing may actually benefit patients if they can receive higher-quality and lower-cost treatment elsewhere.

Currently, if NHS hospital trusts get into financial difficulties they can be bailed out with public money, with recent figures suggesting almost £1billion has been spent on emergency loans from Whitehall and support from local health bodies in recent years.

When individual hospitals or units do close, it is usually as part of planned regional “service reconfigurations” rather than them being declared insolvent.

Under the original Health and Social Care Bill, ministers intended to “designate” particular services that were only available from one source in a particular locality, such as an A&E department in a rural area, with the intention that they would be subsidised even if they treated few patients or failed to balance their books.

But in the Department of Health's detailed response to last week's NHS Future Forum report on improvements to the unpopular legislation , a tougher line is taken. It states that the “failure regime” should be focused on “protecting patients' access to essential services – irrespective of the type of provider – and avoiding bail-outs for poor services at the taxpayer's expense”.

The document goes on: “Managers and clinicians expect to be held accountable for the outcomes they achieve and for the system to reward success. This won't work if we penalise successful organisations and simply ‘bail-out' overspending.

“We will have an effective failure regime that ends the culture and practice of hidden bailouts and gets the right incentives into the NHS, whilst protecting essential services.” The document admits there were “concerns” about how practical it would be to designate protected services in advance, and so the proposal will be scrapped.

Under the revised failure regime, it is expected that ministers will be given more power to make “ad hoc” decisions on which services to save based on public reaction and the likely consequences of failure.

The NHS Confederation, which represents trust managers, said health service reforms combined with the need to make £20billion of efficiency savings by 2015 would “inevitably” mean changes to where care is delivered.

Mike Farrar, its chief executive, said: “This may include a positive move from hospital services to community and primary care. “All of us have to do better in explaining the rationale for these changes if we are to do the best for patients. This will require more courage on the part NHS managers, politicians and clinicians.”

Elsewhere, the Government's response confirms an idea set out in last year's Coalition Agreement that hospitals must admit mistakes to patients under a new “duty of candour”. Patients must also be informed of their rights to receive treatment promptly and from a range of providers, and will be better represented on the boards of several bodies in the reformed NHS.

The Government also sets out safeguards against the backdoor privatisation of the NHS and “cherry-picking” of simple procedures and healthier patients by the independent sector. A bonus scheme for the new GP-led Clinical Commissioning Groups, which will buy treatment instead of managers, will also be changed amid fears it was “unethical” and would lead to conflicts of interest.

However the document insists that the “core tenet” of the legislation is that competition, when properly regulated and used appropriately, can improve public services.

Some Liberal Democrats, whose objections led to the Bill being “paused” earlier this year, have said they are still not satisfied with the latest changes. Andrew George MP, who sits on the Health Select Committee, said: “If the Government had been listening it would have scrapped the Bill. Instead it looks as if they've just massaged and tweaked it a bit.” 21.6.11

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Government has lost its way on reforms, says CBI

The deputy director general of the CBI has accused the Government of "losing momentum" over its public sector reforms, which he said had been "derailed" and had turned into a "debacle".

Neil Bentley, of the CBI, said the coalition had given the impression of "having lost its way", saying ministers were uneasy about how to present reforms and unsure how to convey them to the public. Mr Bentley also praised the government's progress in some areas, saying it had hit targets for efficiency savings, improved government procurement and given a greater role to private firms in its welfare-to-work programmes.

Speaking at the CBI 's south east annual dinner in Epsom, Surrey, he questioned the Government's commitment to reform and warned that failure to embrace competition could lead to deficit-reduction plans faltering.

"In most areas, we're seeing public services cling on to existing ways of doing things, with vested interests fighting modernisation at every turn and campaigning against change". "Just this week, we have seen the forces of inertia in the NHS unions triumph on health reform. This is a missed opportunity for the Government and it will have profound consequences.

"Patient services will only be improved if the NHS is opened up to far greater competition and dependence on hospital care is reduced.

"Without reform, the £20bn savings needed to help balance the NHS books will surely hit services.

"Health's not alone. In local government, policing, probation and elsewhere, reforms are losing momentum.

"The coalition gives the impression of having lost its way, uneasy about reforms and unsure how to present them." 17.6.11

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Safety alert over diabetes drug Actos linked to bladder cancer after it is suspended in France and Germany

A popular diabetes drug used by almost a quarter of a million Britons has been suspended by French and German safety chiefs. The move comes after concerns that Actos, and a similar drug called Competact, raise the risk of bladder cancer.

The UK watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), is due to assess the drug later this week as part of a European-wide review. It has been notified of two patients taking Actos who developed bladder cancer, but stressed this did not mean the drug caused the disease.

It advised patients not to stop taking the drug but ensure they attend appointments for monitoring their condition with healthcare staff.

Actos (pioglitazone), which was licensed in 2000, belongs to a class of drugs called thiazolidinediones which are widely used for the treatment of type 2 diabetes.  They help to control blood sugar levels, but are know to cause side effects including weight gain, fluid retention and heart failure.

There have been persistent reports that Actos, which was prescribed for 233,000 Britons last year, increases the risk of bladder cancer.

As a result the U.S. Drug and Food Administration started a review of the drug last September. The European Medicines Agency initiated its own review in March which is due to report next week. But last week the drug safety body in France announced the suspension of the use of drugs containing the active ingredient pioglitazone, including Actos, in response to a French study showing a heightened risk.

Germany has since taken the same action.

In the UK, a total of 573 reports of suspected adverse reactions associated with pioglitazone have been made to the MHRA, describing a total of 1,140 adverse reactions. Two of reports were for ‘bladder cancer' and ‘bladder transitional cell carcinoma'.

A spokesman for the MHRA said 'It is important to note that a report of a suspected adverse drug reaction does not necessarily mean that it was caused by the drug. 'Other factors such as the underlying disease or other medicines may contribute to suspected adverse reactions.'

However, the active ingredient in the drug was linked to promotion of bladder cancer growth in animal research. The MHRA said patients should not stop treatment while the EU review is taking place. She said 'We are aware of the French medicines regulator's decision to suspend the use of pioglitazone-containing medicines in France. 

'This is based on the results from an observational study carried out in France which have just become available. 'The EMA is currently reviewing all relevant information, including the results from the French study,  and will discuss the issue at its meeting later this month, following which a recommendation for the EU will be made.

'The MHRA is contributing to the current  EU assessment. 'While the review is ongoing no change is recommended to the use of pioglitazone-containing medicines. 'Patients are reminded of the importance of attending their routine appointments to monitor their diabetic care.' 15.6.11

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National Cancer Institute and American Cancer Society skewered in new book by leading cancer expert

A new book by leading cancer expert, Dr. Samuel S. Epstein, skewers the National Cancer Institute and American Cancer Society and blames the organizations for America losing the war against cancer.

In the book, "National Cancer Institute and American Cancer Society: Criminal Indifference to Cancer Prevention and Conflicts of Interest," Epstein argues that the NCI and ACS have spent tens of billions of taxpayer and charity dollars focusing on treatment to the exclusion of prevention, which has allowed cancer rates to skyrocket, with the disease now affecting nearly one in two men and more than one in three women. Furthermore, the author claims that not only do numerous conflicts of interest exist within the NCI and ACS, but the NCI and ACS are also withholding a mass of information on avoidable causes of cancer.

Epstein, who has served as a consultant for the U.S. Senate Committee on Public Works, is an internationally recognized authority on avoidable causes of cancer, particularly carcinogen exposure through conduits such as food, air, wate, household products, cosmetics, prescription drugs or industrial carcinogens in the workplace.

Epstein is professor emeritus of Environmental and Occupational Medicine at the University of Illinois School of Public Health and chairman of the Cancer Prevention Coalition. He has published more than 270-peer reviewed articles and 20 books, including the prize-winning 1978 The Politics of Cancer , and has appeared on national media, including NPR, 60 Minutes, Face the Nation, Meet the Press, The McNeil/Lehrer News Hour, Good Morning America and The Today Show. He was a key expert in the banning of hazardous products including DDT, chlordane and aldrin. In his new book, he is now the leading critic of the cancer establishment for its indifference to prevention of the disease, which, for the ACS , he claims, borders on hostility.

Cancer funding skyrockets along with cancer rates, followed by exaggerated claims of progress

The cancer industry has made a series of misleading claims about the advances in the war against cancer over the past three decades, wrote Epstein.

Some of the false claims, according to Epstein, include the industry's 1984 announcement by the NCI that cancer mortality would be halved by 2000, the 1998 NCI and ACS Report Card announcement of a reversal in the almost twenty-year trend of increasing cancer incidence and death , and the 2003 pledge by NCI Director and former ACS president-elect Andrew von Eschenbach to "eliminate suffering and death from cancer by 2015."

The NCI, ACS and the Centers for Disease Control and Prevention also claimed that "considerable progress has been made in reducing the [number of people with cancer] in the U.S. population" in its 2003 "Annual Report to the Nation on the Status of Cancer, 1975-2000."

The claim, however, is not consistent with NCI's own data, Epstein said, which shows the overall number of people with cancer and incidence rates actually increased by 18 percent. The data also shows a dramatic increase in nonsmoking-related cancers, according to Epstein, including a 104 percent increase in liver cancer, an 88 percent increase in prostate cancer, a 54 percent increase in thyroid and testicular cancer, a 29 percent increase in breast cancer and a 14 percent increase in brain cancer. Epstein also notes the overall cancer mortality rates have remained unchanged and have increase by 6 percent for blacks.

It seems that the more we spend on cancer, the more cancer we get, Epstein said, because while the number of people with cancer goes up, so does the NCI budget paid for by tax payers and charity. The NCI budget has increased 25-fold, from $220 million to $4.6 billion, between 1971 and 2000.

Prevention is the key
The fixation on "damage control" instead of prevention is the root cause of the booming cancer rates in the face of billions of dollars aimed at elimination of the disease, according to Epstein.

He claims the NCI priorities are all wrong. The opening statement of the NCI's 2001 Cancer Facts report says that " cancer prevention is a major component and current priority -- to reduce suffering and death from cancer." Meanwhile the report claimed that only 12 percent of the NCI's then $3.75 billion budget was allocated to prevention.

Epstein shows that the actual attention to prevention is probably even less, by citing an analysis of a 1992 NCI budget showing that less than 2.5 percent of its then $2 billion budget was spent on prevention.

Epstein further crucifies NCI stating that prevention tactics defined by NCI only covered the value of avoiding smoking and a bad diet, while wholly ignoring the myriad of environmental and occupational carcinogens.

NCI & ACS withholding a mass of cancer prevention information
The NCI has failed to inform the public of published scientific information on a wide range of avoidable causes of multiple cancers, Epstein said.

According to Epstein, there are three major categories of avoidable causes including:

1. Environmental contaminants in air, water, soil, the workplace, and food ;

2. Carcinogenic ingredients in consumer products, particularly pesticides;

3. Carcinogenic prescription drugs and high-dose diagnostic radiation, particularly pediatric CAT scans.

Epstein wrote, "NCI's silence on cancer prevention is in flagrant violation of the 1971 National Cancer Act's specific charge to disseminate cancer information to the public. This silence is in further violation of the 1988 Amendments to the National Cancer Program, which called for an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens."

Epstein blamed this NCI failure to inform Congress and regulatory agencies of avoidable carcinogens for encouraging petrochemical and other industries to continue manufacturing products containing carcinogens and encouraging corporate polluters to continue polluting.

NCI's aversion to publicizing avoidable carcinogens has even gone as far as suppression and denial, Epstein said, quoting the following examples:

"In 1983, the Department of Health and Human Services directed NCI to investigate the risks of thyroid cancer from I-131 radioactive fallout following atom bomb tests in Nevada in the late 1950s and early 1960s."

"NCI released its report in 1997, based on data which had been available for over fourteen years, predicting up to 210,000 thyroid cancers from radioactive fallout. These cancers, whose incidence has almost doubled since 1973, could have been readily prevented had the NCI warned the public in time and advised them to take thyroid medication."

"At a September 1999 hearing by the Senate Subcommittee of the Committee on Government Affairs, former Senator John Glenn (D-OH) charged that the NCI investigation was plagued by lack of public participation and openness. Senator Tom Harkin (D-IA) charged that NCI's conduct was a travesty."

[Just] as serious is NCI's frank suppression of information. At a 1996 San Francisco Town Hall Meeting on breast cancer, chaired by Congresswoman Nancy Pelosi (D-CA), former NCI director Richard Klausner insisted that "low level diagnostic radiation does not demonstrate an increased risk ." However, this was contrary to long-term studies on patients with spinal curvature (scoliosis), which showed that such radiation was responsible for 70% excess breast cancer mortality.

ACS has just as abysmal a track record on prevention as NCI, according to Epstein, and it has been and remains the target of periodic attacks by leading scientists and public interest groups.

One attack in a 1994 press release by the Center for Science in the Public Interest stated, "A group of 24 scientists charged that the ACS was doing little to protect the public from cancer-causing chemicals in the environment and workplace. The scientists urged ACS to revamp its policies and to emphasize prevention in its lobbying and educational campaigns."

The scientists criticized ACS for requiring human evidence of carcinogenic effects before implementing regulation, saying that they had an unrealistically high action threshold. The scientists included: Harvard University Nobel Laureates Matthew Meselson and George Wald; former Occupational Safety and Health Director Eula Bingham; and past president of the Public Health Association, Anthony Robbins.

One major instance of ACS ignoring the science, according to Epstein, was in 1993 when they came out in support of the pesticide industry just before the airing of the PBS Frontline special, "In Our Children's Food." ACS released a memorandum in which it trivialized pesticides as a cause of childhood cancers, and reassured the public that pesticide residues were safe, even for infants.

Possibly most shocking is the failure of the NCI and ACS to inform the public of the increasing incidence of childhood cancers, which has escalated to alarming rates, according to Epstein. The Cancer Prevention Coalition's 2003 report said that childhood cancers have increased by 32 percent between 1975 and 2000 and that cancer is one of the leading causes of death in children, second only to accidents.

Even more shocking, the NCI claims that "the causes of childhood cancer are largely unknown." This is diametrically opposed to substantial scientific evidence, according to Epstein, which shows that children are exposed to numerous avoidable carcinogens, including everything from X-rays, prescription drugs, pesticides and contaminants in beauty products to petrochemical and industrial pollutants , radioactive pollutants in the air and drinking water, and pollutants from hazardous waste sites.

In 2000, the industry publication Cancer Letter had a commentary on ACS' behind-the-scenes creation of a legislative committee to gain major control of national cancer policy, according to Epstein. In the commentary, former executive president of the American Society of Clinical Oncologists Dr. John Durant shared his assessment of ACS behavior.

"It has always seemed to me that was an issue of control by the ACS over the cancer agenda," Durant said. "They are protecting their own fundraising capacity [from competition by survivor groups.]"

Conflicts of Interest
But emphasis on treatment looks likely to remain if, as Epstein shows, the ACS and NCI are in bed with those who profit from a treatment focus.

Approximately half of the members of the ACS board are doctors and scientists with close ties to the NCI, Epstein said. Many of the board members and their colleagues obtain funding from both the ACS and NCI, he said. Frank conflicts of interest are evident in many ACS priorities, according to Epstein, including the two major examples of mammography and cancer drugs.

"The ACS has close connections to the mammography industry," Epstein writes. "Five radiologists have served as ACS presidents, and in its every move, the ACS reflects the interests of the major manufacturers of mammogram machines and films ... In fact, if every woman followed the ACS and NCI mammography guidelines, the annual revenue to health care facilities would be a staggering $5 billion.

ACS promotion continues to lure women of all ages into mammography centers, leading them to believe that mammography is their best hope against breast cancer. A leading Massachusetts newspaper featured a photograph of two women in their twenties in an ACS advertisement that promised early detection results in a cure "nearly 100 percent of the time."

An ACS communications director responded .... "The ad isn't based on a study. When you make an advertisement, you just say what you can to get women in the door. You exaggerate a point. Mammography today is a lucrative [and] highly competitive business."

"The ACS exposes premenopausal women to radiation hazards from mammography with little or no evidence of benefits," Epstein said. "The ACS also fails to tell them that their breasts will change so much over time that the 'baseline' images have little or no future relevance."

The cancer drug industry is even more lucrative than mammography with annual sales over $12 billion. The intimate association between ACS and the pharmaceutical industry is illustrated, Epstein said, by the unbridled aggression which ACS directs at its critics.

"ACS maintains a Committee on Unproven Methods of Cancer Management, which periodically reviews unorthodox or alternative therapies," Epstein wrote. "This committee is comprised of volunteer health care professionals, carefully selected proponents of orthodox, expensive, and usually toxic drugs patented by major pharmaceutical companies, and opponents of alternative or unproven therapies that are generally cheap, and minimally toxic."

Periodically, the committee updates its statements on unproven methods, which are then widely disseminated to clinicians, cheerleader science writers, and the public. Once a clinician or oncologist becomes associated with unproven methods, he or she is blackmailed by the cancer establishment. Funding for the accused quack becomes inaccessible, followed by systematic harassment.

"The highly biased ACS witch-hunts against alternative practitioners are in striking contrast to its extravagant and uncritical endorsement of conventional toxic chemotherapy. This despite the absence of any objective evidence of improved survival rates or reduced mortality following chemotherapy for all but some relatively rare cancers."

The cancer industry's favor of pharmaceutical products is evidenced, Epstein said, "by the fact that the U.S. Food and Drug Administration has approved approximately 40 patented drugs for cancer treatment, while it has yet to approve a single nonpatented alternative drug."

According to Epstein, "Dr. Samuel Broder, NCI director from 1989 to 1995, frankly admitted, in a 1998 Washington Post interview, that 'the NCI has become what amounts to a government pharmaceutical company.' Taxpayers have funded R & D and expensive clinical trials for over two-thirds of cancer drugs on the market. These drugs are given, with exclusive rights, to the industry, which sells them at inflated prices."

Epstein calls for change
NCI reform is two decades overdue, Epstein wrote, based in part on "The Stop Cancer Before it Starts Campaign: How to win the Losing War against Cancer," which is a 2003 report sponsored by eight leading cancer prevention experts and endorsed by over one hundred activists and citizen groups.

Numerous NCI reforms were proposed in 1992 at a Cancer Prevention Coalition press conference, a group of 68 leading cancer prevention and public health experts, past directors of federal agencies, and citizen activists across the nation. But prophetically, the press release concluded, "There is no likelihood that such reforms will be implemented without legislative action."

And the ACS has done no better, according to Epstein.

"The verdict is unassailable," Epstein said. "The ACS bears a major decades-long responsibility for losing the winnable war against cancer. Reforming the ACS is, in principle, relatively easy and directly achievable. Boycott the ACS. Instead, give your charitable contributions to public interest and environmental groups involved in cancer prevention. Such a boycott is well overdue and will send the only message this charity can no longer ignore." Natural News 14.6.11

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The gold-tipped laser that zaps varicose veins in minutes - so why are NHS patients still being given a painful procedure that costs the same?

Caroline Gard was on a walking holiday in New Zealand when she noticed the front of her right shin had suddenly become very red and inflamed. The redness died down after a couple of days, and she put it down to the heat. But when she returned home a month later, she noticed she'd developed a knobbly varicose vein running down the inside of her right calf. 

Over the next few years, the vein continued to flare up if she stood or walked for long periods. 

Then, two years ago, the vein became more of a problem. ‘It started flaring up every month or so and would really ache and throb,' says Caroline, 57, a retired teacher from Frinton-on-Sea, Essex. 

‘I had to cover it up with trousers because it looked so angry. Sometimes I even had to miss a day's walking because I couldn't face aggravating it.'

When Caroline saw her GP, he confirmed that she had varicose veins.  Doctors don't fully understand what causes them, although there is known to be a family link. The condition is caused by faulty valves in the calf veins. The valves are meant to ensure blood reaches the heart, by preventing it falling back down the leg.

If the valves fail, blood starts to pool in the veins, causing inflammation. This can lead to complications such as ‘varicose' eczema and even ulcers.

Caroline was told she also had phlebitis, another common complication of varicose veins. Here, the pressure of the pooling blood causes the small, superficial veins in the legs also to become inflamed, making the leg even more tender. Blood can leak into the skin, causing the characteristic unsightly red and brown patches. Phlebitis, which usually lasts two or three weeks but can take longer to clear up, is extremely painful.

Initially, Caroline was given stockings to wear and a cream for the itchiness. But to prevent the problem recurring, the varicose vein must be tackled. 

Her GP explained that the standard NHS treatment was vein stripping, where the faulty vein is pulled out through an incision in the groin and knee.  ‘I had a friend who'd had vein stripping and I knew it was really painful and you're laid up for six weeks to recover,' says Caroline. ‘I just couldn't face anything that would stop me being active.'

Another option is a laser treatment — there are several different techniques, but essentially heat is used to cause the vein to collapse so it can't fill with blood again. 

Caroline had heard about this from friends, but knew she'd have to pay for it privately — and with a starting cost of around £1,000, this was too much. However, over the following years, her varicose vein and episodes of phlebitis got worse. 

Every time she played golf, or went for a long walk, the pain and inflammation would flare up again, lasting for up to a week. The skin around her shin was also becoming unbearably itchy and starting to flake away.

Last October, a year after her diagnosis, Caroline saw another GP, who referred her to Chris Backhouse, consultant vascular surgeon at Colchester Hospital University NHS Foundation Trust. He told her about a virtually pain-free laser treatment being trialled on the NHS.

‘Usually in laser treatment, a fibre which emits a very hot laser beam is drawn through the vein,' explains Mr Backhouse. ‘But because the laser is emitted in a fan-like beam, it can also hit the lining of the vein. This can become damaged and even perforated and cause painful bruising.'

Instead, he uses the NeverTouch laser. It has a gold, tube-shaped shield around the top, so the beam shines straight out and doesn't damage the vein wall.

Although this laser beam is less powerful than with other techniques, it has longer wavelengths, which means it is more readily absorbed, causing less damage. In April, Caroline became one of the first Britons to have this treatment on the NHS.

First, Mr Backhouse made a 3?mm incision below her knee and fed the 1.5?mm laser through the vein, firing it continuously so it shrivelled the vein in three minutes.

‘It was great — I went home that lunchtime, and was walking to the local shop by 3pm,' says Caroline. ‘For two weeks I wore support stockings, and while there was a bit of an ache on day three, I didn't even need painkillers.'

Tens of thousands of patients are treated for varicose veins every year on the NHS. But although laser treatment has been available since 2000, 67??per cent of NHS patients are still treated with vein stripping, which means a general anaesthetic and up to six weeks' painful recovery.

Minimally invasive techniques are often done under local anaesthetic.  These cost around £1,000 a leg privately and a similar cost to the NHS, comparable to what some health authorities for vein stripping. 

‘But the alternative procedures are not widely available on the NHS — in too many areas, patients have to go private, partly because some NHS trusts are not willing to make the capital outlay on the equipment,' says Mr Backhouse. 

Indeed, although it's a widespread problem, the number of varicose vein treatments on the NHS is declining, from 45,000 in 2000-01 to fewer than 35,000 in 2008-09, says Eddie Chaloner, consultant vascular surgeon at BMI The Blackheath Hospital in London and University Hospital Lewisham. 

Local health authorities are refusing to pay, often claiming that varicose veins are a cosmetic problem, or that in too many cases veins recur (in 30 per cent of cases, the condition returns within 20 years of treatment). 

‘They say it's a matter of prioritisation,' says Mr Chaloner. ‘But at least 40 per cent of patients with varicose veins get significant discomfort, especially people who walk a lot — teachers, hairdressers, police officers. Their legs ache and throb. 

‘Trusts say these problems can be controlled by compression stockings, and to an extent they can, but no one wears them all day, every day because they are tight and uncomfortable.' Varicose vein treatment on the NHS is largely confined to patients with significant complications, including phlebitis and ulcers.

Even in these cases, minimally invasive treatments would be a better option than vein stripping, says Mr Chaloner.  ‘There is no doubt about this — minimally invasive treatments are far better because they can be done under local anaesthetic and mean a shorter recovery time and lower risk of infection, as well as less scarring,' he says. 

In 25 per cent of cases, open surgery can damage nerves, he says, causing pain and loss of sensation — laser treatment carries a risk of nerve damage of under 2.4 per cent. Mr Backhouse adds: ‘I believe elderly patients should be considered for more minimally invasive techniques, because they won't need a general anaesthetic with associated risks.'

The figures speak for themselves; while nearly 70 per cent of NHS patients have vein stripping, private companies use laser techniques on 90 per cent of patients. ‘It's ironic that although better treatments are available, all too often we can't offer them on the NHS,' says Mr Chaloner.

Caroline, meanwhile, is delighted with her treatment. ‘Now I can play golf and walk as much as I want, without having to worry about that unsightly vein,' she says. 14.6.11.

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Labour spending: Gordon Brown and Ed Balls ignored warnings and wasted billions

Gordon Brown and Ed Balls ignored warnings over the profligacy of their spending plans and the damaging impact of key tax policies, leaked documents disclose.

A confidential document presented to the Cabinet in January 2006 asks: "We've spent all this money, but what have we got for it?"
It warns that the efficiency of the public sector needed to improve rapidly and insisted that "spending growth will slow". The document drafted by civil servants also says that "ineffective spending" must be "closed down".

However, Gordon Brown discarded the advice and embarked on a £90 billion increase in spending when he became prime minister. The expenditure meant that the economy was left facing a record deficit as the effects of the recession were felt. The document is among 19 papers disclosed today by The Daily Telegraph that were obtained from the personal files of Mr Balls, the shadow Chancellor. They follow the divulgence yesterday of dozens of documents detailing Mr Balls's central role in a plot to topple Tony Blair.

Today, the Ed Balls files make public the warnings of officials and others over Labour's tax and spending plans. The document is the first official evidence that shows the scale of concern over the activities of Mr Brown and those around him in his time as chancellor. In an analysis of spending plans drawn up in January 2006 for the following year's Comprehensive Spending Review, the document states that any increase in taxpayer expenditure should only be in line with inflation. It sets out detailed plans for cutting spending in more than 12 areas to reduce spending by billions of pounds.

However, Mr Brown neglected the advice and increased spending by twice as much as recommended. He only cut the wasteful spending in four of the areas identified.

At the time that the Treasury document was produced, Mr Balls was still a backbench MP and would not have been on the official circulation list.
However, other files show he was playing an important role in drawing up Mr Brown's policies. Before the October 2007 spending review he was made a Treasury minister then given a Cabinet seat as Secretary for Children, Schools and Families.

The Coalition seized on the disclosures as evidence that Mr Brown's "reckless" decisions over public spending left the country in a vulnerable position when the economic downturn hit Britain. A Conservative source said: "This document shows the reckless approach of Brown and Balls which left Britain dangerously exposed to the economic crisis."

Michael Fallon, the deputy chairman of the Conservative Party, said: "As recently as last year, Ed Balls and Ed Miliband were denying something we now know to be true. While Britain's debt doubled, welfare spending spiralled out of control and education standards fell, they were obsessing about getting rid of the elected prime minister and putting Gordon Brown into the position."Instead of owning up to their role in a dysfunctional government and coming up with a credible plan to deal with the problems facing Britain, they are starting to plot against each other. They can never be trusted with government again."

Another leaked memorandum warns Mr Brown and Mr Balls that plans to scrap the 10p tax rate would hit millions of poorer Britons and pensioners - but the change was still introduced.

Mr Brown later denied that there would be any losers from the tax changes – before being forced to announce an emergency compensation plan.
The Daily Telegraph also publishes documents today revealing how Mr Brown's major policy idea to be introduced when he was Prime Minister was a new British constitution. Detailed plans for the bill of rights were prepared, including possible new regulations for the media, but the proposal was quietly dropped after he moved into Number 10.

The disclosure of the economic documents in the Ed Balls files comes as the shadow chancellor demands that the Coalition abandons its public spending cuts. Mr Balls has said that the pace and scale of cuts is unacceptable. Last week, Mr Balls demanded that George Osborne, the Chancellor, draw up a "plan B" for public spending if the economy deteriorates.

But, Ed Miliband, the Labour leader, is understood to privately believe that some of the cutbacks should be accepted – threatening a repeat of the divide between Mr Blair and Mr Brown over public spending plans.

Yesterday, Alistair Darling, the former Chancellor, gave an interview in which he dismissed the wisdom of Mr Ball's "plan B" concept. Mr Darling is currently finalising his memoirs which are also expected to criticise Mr Balls' influence over economic policy under Mr Brown's premiership.
Yesterday, in the wake of The Daily Telegraph's disclosures over his role in plotting to replace Mr Blair with Mr Brown, the shadow Chancellor denied he had acted improperly.

Mr Balls also effectively accused Mr Blair of lying to the electorate in 2005 about his intention to serve a full third term as prime minister.
Labour began discussing the "transition" from Mr Blair to Mr Brown even before the 2005 general election, Mr Balls claimed. Mr Blair fought and won the 2005 election on a promise to serve a full third term in office. In 2004, he declared: "If I'm elected I would serve a third term. I want to see it through."

But, in a radio interview, Mr Balls alleged that talks between Mr Brown and Mr Blair about a transfer of power began before the election. "The discussions about how to make that transition work began before the 2005 general election," he said. He was asked: "Even though publicly Mr Blair had said he would serve a full third term, he wasn't saying that privately?" Mr Balls replied: "Yes."

The claim was last night disputed by friends of Mr Blair. One said: "Ed is basically saying Tony deceived the British public at the 2005 election. That is not true."

Mr Balls has previously denied any involvement in any plot – which this newspaper disclosed was codenamed "Project Volvo" because of Mr Brown's reliable but dull image - to force Mr Blair from office. Yesterday, he said he had taken part in "difficult discussions" about Mr Blair's position. "There was not a plot but there was genuine and open and sometimes difficult discussion," he said. "There were tensions, there were arguments."

Mr Balls said he and Alistair Campbell, Mr Blair's aide, had tried to calm those tensions. He said: "Should Tony Blair and Gordon Brown have done things better in that period? Probably. Were people like me and Alistair Campbell and others trying to hold things together? Absolutely."
Mr Campbell later appeared to raise doubts about Mr Balls' role in relations between the two camps.

Mr Campbell said yesterday: "It is right, as Ed Balls says today, that he and I worked together at times to try to keep TB-GB in a better place, but I think Ed would have to admit he was doing so very much from a GB perspective, whereas I always sought to see things from a team perspective too."

Mr Miliband, the new Labour leader, said he was focussed on the future and described the revelations as "ancient history". However, he side-stepped questions over his role in the plot and declined to defend the secret talks as Mr Balls had done. The Cabinet Office announced it was launching an investigation into the source of the leak of the Ed Balls files, which yesterday gripped Westminster.

Volvo, the car company, also attempted to distance itself from being linked to Mr Brown's image. Peter Rask, Regional President of Volvo Car UK, Ireland and Iceland, said: "If only the Labour party had been like today's Volvos - dynamic, agile and innovative - perhaps the UK economy would have been in a better place than it finds itself today!" with a credible plan to deal with the problems facing Britain, they are starting to plot against each other. They can never be trusted with government again.”

Another leaked memorandum warns Mr Brown and Mr Balls that plans to scrap the 10p tax rate would hit millions of poorer Britons and pensioners, but the change was still introduced. Mr Brown later denied that there would be any losers from the tax changes, before being forced to announce an emergency compensation plan.

The Daily Telegraph also publishes documents today revealing how Mr Brown wanted to create a British constitution. Detailed plans for a Bill of Rights were prepared, including possible regulations for the media, but the proposal was quietly dropped after he moved into No 10.
The disclosure of the economic documents in the Ed Balls files follows demands from the shadow chancellor that the Coalition abandons its public spending cuts. Last week, Mr Balls demanded that George Osborne, the Chancellor, draw up a “plan B” for spending if the economy deteriorates.
Ed Miliband, the Labour leader, is understood to privately believe that some of the cuts should be accepted, threatening a repeat of the divide between Mr Blair and Mr Brown over spending plans.

Alistair Darling, the former chancellor, gave an interview yesterday in which he dismissed the wisdom of Mr Balls’s “plan B” concept.
In the wake of the disclosures over his role in plotting to oust Mr Blair, Mr Balls denied he had acted improperly.He also effectively accused Mr Blair of lying to the electorate in 2005 about his intention to serve a full third term as prime minister.

Labour began discussing the “transition” from Mr Blair to Mr Brown even before the 2005 general election, Mr Balls claimed.
Mr Blair fought and won the 2005 election on a promise to serve a full third term in office. In 2004, he declared: “If I’m elected I would serve a third term. I want to see it through.”

But, in a radio interview, Mr Balls alleged that talks between Mr Brown and Mr Blair about a transfer of power began before the election.
“The discussions about how to make that transition work began before the 2005 general election,” he said.
He was asked: “Even though publicly Mr Blair had said he would serve a full third term, he wasn’t saying that privately?”
Mr Balls replied: “Yes.”

The claim was last night disputed by friends of Mr Blair. One said: “Ed is basically saying Tony deceived the British public at the 2005 election. That is not true.”Mr Balls has previously denied any involvement in any plot – which this newspaper disclosed was codenamed “Project Volvo” because of Mr Brown’s reliable but dull image - to force Mr Blair from office.

Yesterday, he said he had taken part in “difficult discussions” about Mr Blair’s position.“There was not a plot but there was genuine and open and sometimes difficult discussion,” he said. “There were tensions, there were arguments.” Mr Balls said he and Alistair Campbell, Mr Blair’s aide, had tried to calm those tensions. He said: “Should Tony Blair and Gordon Brown have done things better in that period? Probably. Were people like me and Alistair Campbell and others trying to hold things together? Absolutely.”

Mr Campbell later appeared to raise doubts about Mr Balls’ role in relations between the two camps. Mr Campbell said yesterday: “It is right, as Ed Balls says today, that he and I worked together at times to try to keep TB-GB in a better place, but I think Ed would have to admit he was doing so very much from a GB perspective, whereas I always sought to see things from a team perspective too.”

Mr Miliband, the Labour leader, described the revelations as “ancient history”, but side-stepped questions over his role in the plot. The Cabinet Office announced an investigation into the source of the leak of the files. 10.6.11

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The government's failure to justify NHS reform has left the public short of options

Huge strides have been taken to offer NHS patients a choice of different providers, but there is now a real chance of a backwards step under the coalition government, says management consultant Paul Corrigan.

I have always understood why parts of the NHS resist competition. If you are in a monopoly position it means that you can look inwards and feel in charge of the world that you see. No-one can come up with an important innovation from outside that will turn your cosy world upside down. You are in charge of your own pace of change.

Successful competition brings innovation and change that is beyond the control of those who prefer their monopoly world.

Occasionally, this opposition to competition looks a bit strange. There are conservative individuals in the British Medical Association arguing against the very competitive processes that have developed the consumer goods market that has created their lifestyle. Opponents of capitalism who drive Porsches have never been very persuasive.

This eccentricity reached its apogee just a few weeks ago here in HSJ when BMA consultants committee chair Mark Porter said:   “The BMA is not opposed to capitalism” . Weird times indeed when the BMA has to clarify its position on models of economic organisation in this way.

A lot of this debate was thrashed out during the ‘noughties'. The challenge that the Labour government from Alan Milburn onwards laid down to opponents of competition was: why do you want to restrict patient choice?

Of course, unions such as the BMA were against competition because it makes those members who are in monopoly positions feel uneasy.

But by the time of the last election that was not a raging issue with the public. Most people accepted that providing a choice of provider added to the experience of the NHS. Then it followed that if a patient was allowed to choose, the money would follow their choice. And if patients had the possibility to choose, then surely it would be a good idea to have different organisations for them to choose between.

So much, so normal for our society.

Up in arms
But here we are 13 months after the election, with a Conservative-led government, and parts of the country are anxious that the Tories are going to privatise the NHS. So they are up in arms against competition.

Everyone – including the government itself – is now saying that the problem is the coalition failed to provide a compelling vision for why it is carrying out the reforms.

Given that they won't tell us, this left people to find their own explanation for the upheaval.

In January, after a few weeks of the public scratching their heads as to why a government would change something without reason, an explanation emerged that the public took hold of and developed – the government is selling the NHS.

The public think that no government would be daft enough to start this scale of change without a good reason, and since privatisation is the sort of thing Tories do, that must be it.

After a few ritual denials that no, no, they are in love with the NHS, the government has recognised it is in a fix. The four words of Tory, NHS, cuts and privatisation have been formed into a sentence in the public's mind, and taken root.

Everything the government now does will be scrutinised against the charge of privatisation. The secret rationale will be uncovered in the smallest of actions.

This leaves the government with no choice – it now has to spend every day proving that it is not privatising the NHS. As it will find, proving a negative is hard.

One example is its attempt to say that it will stop price competition. This is the measure of the chaos. We have a Conservative led government trying to put through legislation that will ban the variation of prices. 

How will it achieve this? Will there be a hundred NHS Commissioning Board price police combing through all the commissioning invoices searching for an illegal bargain? How many NHS bosses (so loved by Andrew Lansley) will it take to stop a price market?

If you are in the third sector organisation, thinking of developing some services for the NHS, this all makes an uninviting sight.

On the one hand you are encouraged to develop value for money to help save the NHS; on the other you are told that value for money is not welcome here.

Those of us who believe that choice for NHS patients is an important way of proving that socialised medicine can provide the same offer as private medicine will have to recognise the government will not be capable of making that case. Patient groups will have to find ways of making that case against the monopolists who want to deny NHS patients the rights that private money can buy. 10.6.11

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The right prescription: a call to action on the use of antipsychotic drugs for people with dementia

The Dementia Action Alliance has launched a call to action on the use of antipsychotic drugs for people with dementia.

The aim of this call to action is that:

•  All people with dementia who are receiving  antipsychotic drugs should receive a clinical review from their doctor to ensure that their care is compliant with current best practice and guidelines and that alternatives to medication have been considered by 31 March 2012.

Antipsychotics  are drugs designed to treat conditions like schizophrenia, however they are often inappropriately prescribed to people with dementia as a first response to behavioural and psychological symptoms of dementia like distress or agitation.

In some cases the use of  antipsychotic drugs  is the right treatment option, but it is estimated that around two thirds of the use of antipsychotics in people with dementia is inappropriate. The use of antipsychotic drugs is linked to serious side effects for people with dementia, creating mobility problems, sedation and sometimes death, particularly when used for longer than 12 weeks.

To achieve a reduction in the use of these drugs, eight groups, including people with dementia and carers, GPs, leaders in care homes and pharmacists, are being asked to sign up to commitments outlining how they can play their part in ensuring reviews take place.

To support progress towards achieving this call to action, the Dementia Action Alliance has produced best practice guidance for people with dementia and carers and health and social care professionals on the use of antipsychotics.

For copies of these resources and for more information on antipsychotics, please visit  alzheimers.org.uk/antipsychotics

For information on how to get involved with this call to action, please visit the  NHS Institute for Innovation and Improvement's website 9.6.11

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Magnets could prevent heart attacks by thinning the blood as effectively as aspirin

People at risk of heart attacks are often prescribed aspirin to thin the blood, but now scientists believe that MAGNETS could one day be used instead. Scientists at Temple University in Michigan found that a device that uses a magnetic field to thin fuel, can have the same effect on human blood.

Professor Rongjia Tao pioneered the use of electric or magnetic fields to decrease the viscosity of oil in engines in 2008. He realised that this could work on our own circulation system in a similar way. Because red blood cells contain iron, Tao has been able to reduce a person's blood viscosity (resistance to flow) by 20-30 per cent by subjecting it to a magnetic field for about one minute. The field measured 1.3 Telsa which is about the same as an MRI machine.

After testing numerous blood samples in a laboratory, Tao found that the magnetic field polarises the red blood cells causing them to link together in short chains, streamlining the movement of the blood.  

As these chains are larger than the single blood cells, they flow down the centre, reducing the friction against the walls of the blood vessels. The combined effects reduce the viscosity of the blood, helping it to flow more freely.

When the magnetic field was taken away, the blood's original viscosity state slowly returned over a period of several hours.

'By selecting a suitable magnetic field strength and pulse duration, we will be able to control the size of the aggregated red-cell chains, hence to control the blood's viscosity,' said Tao.  

Currently, the only method for thinning blood is through drugs such as aspirin; however, these drugs often produce unwanted side effects.

Tao said that the magnetic field method is not only safer, it is repeatable. The magnetic fields may be reapplied and the viscosity reduced again. He also added that the viscosity reduction does not affect the red blood cells' normal function.

Tao said that further studies are needed and that he hopes to ultimately develop this technology into an acceptable therapy to prevent heart disease. Tao and his former graduate student, Ke 'Colin' Huang are publishing their findings in the journal, Physical Review E. 9.6.11

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WHO Recognition for Homeopathy

Deviating from the trend of rejecting homeopathy treatment and medicine as mere placebos, the World Health Organisation (WHO) has declared that homeopathy is the second-most used medical system internationally.

"Clinical trials have proved that this method of treatment has been successful if the practitioners have taken into account the individual holistic nature of the patient before opting for homeopathy," says Dr T N Sreedhara Kurup, Assistant Director In-Charge of the Central Research Institute for Homeopathy.

Different patients will receive different treatments for the same disease making it difficult to conduct randomised control trials, he said. " Homeopathy is that stream of medicine, which prescribes medicines suitable to the individual and the cost of treatment is affordable when compared to Allopathy. Besides, it is claimed that homeopathic medicines are devoid of any harmful side-effects," says Dr Ravi M Nair, a homeopathy specialist.

About 500 million people rely on homeopathy treatment in the world. As a system of medicine, it draws support from hundreds of thousands of doctors, teaching institutions and universities where homeopathy is taught.

Research centres and manufacturing units with focus on developing newer drugs for treatment of diseases provide ample proof that homeopathic medicines are not mere placebos, Nair said. Modern medicine and research too have arrived at a premise that many diseases have their origin in genes. It was 200 years ago that Samuel Hahnemann started working on this concept to evolve a mode of treatment based on the individual requirements called homeopathy, he said.

Newindpress, India - 24 Dec 2005 WHO report pulled in 22.02.07

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Homoeopathy's benefit questioned despite WHO report

A leading medical journal has made a damning attack on homoeopathy, saying it is no better than dummy drugs. The Lancet says the time for more studies is over and doctors should be bold and honest with patients about homoeopathy's "lack of benefit".

A Swiss-UK review of 110 trials found no convincing evidence the treatment worked any better than a placebo. Advocates of homoeopathy maintained the therapy, which works on the principle of treating like with like, does work.

Continuing dispute
Someone with an allergy, for example, who was using homoeopathic medicines would attempt to beat it with an ultra-diluted dose of an agent that would cause the same symptoms.

The row over homeopathy has been raging for years.

In 2002, American illusionist James Randi offered $1m to anyone able to prove, under observed conditions in a laboratory, that homeopathic remedies can really cure people. To date, no-one has passed the preliminary tests.

In the UK, homoeopathy is available on the NHS. Some argue that it should be more widely available, while others believe it should not be offered at all. In 2000, the UK Parliamentary Select Committee on Science and Technology issued a report on complementary and alternative medicine.

It reported that "any therapy that makes specific claims for being able to treat specific conditions should have evidence of being able to do this above and beyond the placebo effect".

According to Professor Matthias Egger, from the University of Berne, and Swiss colleagues from Zurich University and a UK team at the University of Bristol, homoeopathy has no such evidence.

They compared 110 trials that looked at the effects of homoeopathy versus placebo with 110 trials of conventional medicines for the same medical disorders or diseases.

This included trials for the treatment of asthma, allergies and muscular problems, some large and some small.

For both homeopathy and conventional medicines, the smaller trials of lower quality showed more beneficial treatment effects than the larger trials. However, when they looked at only the larger, high-quality trials, they found no convincing evidence that homeopathy worked any better than placebo.

Professor Egger said: "We acknowledge to prove a negative is impossible. "But good large studies of homeopathy do not show a difference between the placebo and the homoeopathic remedy, whereas in the case of conventional medicines you still see an effect."

He said some people do report feeling better after having homoeopathy. He believes this is down to the whole experience of the therapy, with the homeopath spending a lot of time and attention on the individual. "It has nothing to do with what is in the little white pill," he said.

'Research bias'
However, the Lancet also reports that a draft report on homoeopathy by the World Health Organization says the majority of peer-reviewed scientific papers published over the past 40 years have demonstrated that homeopathy is superior to placebo in placebo-controlled trials.

Furthermore, it says that homoeopathy is equivalent to conventional medicines in the treatment of illnesses, both in humans and animals.

Professor Edzard Ernst, professor of complementary medicine at the Peninsula Medical School in Exeter, said the draft WHO report seemed overtly biased and that all of the trials cited happened to be positive. "They are not the most rigorous ones, not the most recent," he said.

A spokeswoman from the Society of Homoeopaths said: "Many previous studies have demonstrated that homeopathy has an effect over and above placebo.

"It has been established beyond doubt and accepted by many researchers, that the placebo-controlled randomised controlled trial is not a fitting research tool with which to test homeopathy."   26.8.05 http://news.bbc.co.uk/1/hi/health/4183916.stm

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Reform or die, Cameron warns NHS as he makes five personal guarantees on Health Bill

• Most people now recognise that change is needed, says Cameron
• New private providers will be allowed in NHS but there will be 'no U.S-style insurance system'
• Hospital doctors and nurses to join GPs in commissioning care services
• NHS will be 'overwhelmed' unless we reform today, P.M warns 

David Cameron today warned that the NHS's ‘precious principle' of care for all, free at the point of use, is under threat.

The Prime Minister used a speech this afternoon to claim the founding cornerstone of the Health Service will be eroded unless the Government pushes ahead with plans to put GPs in charge of commissioning care.

However, he said hospital doctors and nurses would now be involved in clinical commissioning and 'clinical senates' would be set up to oversee the boards.

He added that patients for the first time would be able to decide on what treatments they had. Mr Cameron said: 'You will be able to decide what is the best treatment for you as long as it complies with NHS standards. It will be "no decision about me without me."'

Putting his reputation on the line, he outlined his 'vision' for the NHS, making five pledges to preserve what matters most to the public in an address to NHS staff in central London.

The Prime Minister is due to unveil changes to the Coalition's health plans next week after halting the passage of legislation to consult doctors.

But today he insisted a radical overhaul is needed to prevent the NHS going bust in the future. ‘We have to change the NHS to avoid a crisis tomorrow,' he said, warning that failure to act will lead to 'overstretch' and ‘the NHS buckling under the pressure of an ageing population and the rising cost of treatments'.

In his starkest warning yet about the consequences of inaction, he said ‘the principle we all hold dear, and we all want to keep, of free healthcare when they need it – for all who need it, that precious principle [is] coming under threat'. The Prime Minister said there needs to be an overhaul of the way the NHS works because ‘we're wasting too much money on empty bureaucracy when it could be spent on the frontline'.

However, he said: 'We recognise many people have had concerns with what we have been doing.'

Mr Cameron reassured his audience that he would stick to five principles throughout the reforms. He said: ‘We will not endanger universal coverage – we will make sure it remains a ‘national' Health Service.

‘We will not break up or hinder efficient and integrated care – we will improve it.

‘We will not lose control of waiting times – we will ensure they are kept low.

‘We will not cut spending on the NHS – we will increase it.

'The Prime Minister concluded: ‘If you're worried that we are going to sell-off the NHS and create some American-style private system – we will not.'  But he admitted he would not stop new private providers being allowed in to the system, saying competition was a way of raising standards and value for money.

Mr Cameron will have his work cut out to win over patients, with a poll today showing most voters believe the Tories want to privatise the NHS.

PoliticsHome found seven out of 10 voters agree with the Prime Minister that ‘the way in which the NHS spends its money needs to be reformed', but the same proportion said the reforms had been ‘rushed'. A total of 59 per cent of voters agree that ‘deep down, the Conservatives want to fully privatise the NHS', while 45 per cent think any reforms to the Health Service made by the Tories are designed to ‘help business, not patients'.

The Prime Minister's five pledges are designed to assuage these fears, but leave the door open to changes. He vowed that waiting times would not go out of control – a tacit admission that they are rising and will continue to do so. He added that there is too much difference in quality of care in different regions.

Critics will also point out that the notion of a ‘national' Health Service is likely to be watered down when GP commissioning gets under way, as it is likely to lead to a postcode lottery with different health outcomes in different parts of the country. 

Mr Cameron's speech is part of a month-long PR campaign designed to salvage reforms drawn up by the embattled Health Secretary Andrew Lansley, which have faced massive opposition from the general public, health professionals and Liberal Democrat MPs.

Today, the Prime Minister said his campaign is beginning to bear fruit. ‘A whole range of people are changing their view,' he will say.

‘Before the pause, many were claiming the NHS is fine, and telling us not to touch it. Now, whatever their views about how to do it, most agree change is needed. ‘What's more, a significant number are now more clearly on board with the thrust of what we are proposing.'

The Prime Minister said that GPs representing 1,100 practices across England have expressed support ‘for the basis of our plans', along with the Association of Surgeons of Great Britain and Ireland and the Royal College of Surgeons. He added that patients' groups such as Saga and Age UK have also ‘backed key parts of our plans'.

However, Labour Party leader Ed Miliband, poured scorn on the Prime Minister's five pledges. Speaking to the press at the Royal Festival Hall this morning, he said: 'He (Cameron) has already broken at least two of these pledges: on maximum waiting times and on protecting the NHS budget.

'Hundreds of millions of pounds, which should be being used for patient care, is being wasted on handing out redundancy notices to staff from primary care trusts who may well have to be re-hired. 'David Cameron has spent a year mismanaging the NHS and the consequence is chaos, confusion and damaged patient care.' 7.6.11

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MPs condemn NHS for ignoring official guidance on IVF provision

More than 70% of NHS trusts and care providers are ignoring official guidance on offering infertile couples three chances at IVF, according to a report by an all-party group of MPs. Some primary care trusts have stopped offering IVF altogether. Others are placing tough restrictions on who can qualify.

The MPs say the result is a postcode lottery of care and are calling on trusts to implement the official guidelines properly.

In 2004 the National Institute for Health and Clinical Excellence (NICE) said couples, where the woman is aged 23 to 39, should be given up to three cycles of IVF on the NHS.In the UK's devolved healthcare system this guidance applies to England and Wales, but will also be taken into account in Scotland and Northern Ireland.

"It's clear that many PCTs are not giving IVF the priority they should. There are instances where it is being lumped in with tattoo removals.” Gareth Johnson MP All Party Parliamentary Group on Infertility

The All Party Parliamentary Group on Infertility sent freedom of information requests to primary care trusts (PCTs) in England, health boards in Scotland and Wales, and health and social care trusts in Northern Ireland.

Their answers revealed 70% of the authorities contacted were ignoring the NICE guidance and putting in place strict limits on who can get the treatment.

Restrictions on smokers
For example, Bury PCT only allows women to be treated between the ages of 39 and 40, with a similar picture in many Welsh Health Boards.

Others have restrictions on access for smokers, those who are overweight or if one of the couple already has a child - even if that child does not live with them. At the time of the survey, five PCTs - Warrington, Stockport, North Yorkshire and York, North Staffordshire and West Sussex - offered no IVF at all.

A spokeswoman at NHS West Sussex said: "In line with NHS trusts across the country, we did have to face some tough decisions last year to ensure that we met our legal duty to break even financially.

"Now we are in the new financial year, the decision we made last year on fertility treatment has been reviewed and funding has been reinstated for all eligible cases."

Too young
In 2006, Clare Dando went to her PCT in Hampshire after realising that she would need IVF.

But she was told that at the age of 33 she was too young, as the local policy was to restrict NHS treatment to those over 36 - even though her chances of success would reduce the older she got.

Sher said: "Eventually we realised that time was ticking away so we re-mortgaged our house to raise £15,000. We had to pay for three IVF cycles ourselves and the last one in September 2007 worked. "Our little boy Alex will be three next week."

The Hampshire guidelines have now changed, so now one IVF cycle is funded for women aged between 30 to 35.

Gareth Johnson, the Conservative MP for Dartford, is the chairman of the All Party Parliamentary Group on Infertility. He said: "It's clear that many PCTs are not giving IVF the priority they should. There are instances where it is being lumped in with tattoo removals. "There is always going to be a limit to what you can provide but the guidance from NICE says three cycles.

"That's a fair balance between the needs of the patient and the burden placed on the taxpayer."

Postcodes
Infertility Network UK has campaigned for more equal access to IVF treatments and says providers must follow the guidance from NICE.

In a foreword to the report, Health Minister Anne Milton said many PCTs had made good progress towards implementing the Nice recommendations. "I am aware, however, that a small number of PCTs with historical funding problems have temporarily suspended provision of IVF services. "I have already expressed my concerns about this approach and would encourage all PCTs to have regard to the current Nice guidance."

NICE is currently reviewing its guidance and will publish a report in 2012. 7.6.11

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