Placebo

Placebo

The placebo effect is the measurable, observable, or felt improvement in health not attributable to an actual treatment. The effect is the phenomenon whereby a patient's symptoms can be alleviated by an otherwise ineffective treatment; most likely because the individual 'expects' or 'believes' that the treatment will work. The placebo effect is actually a generic term for various effects that cause people to reinterpret their illness or symptoms.

The placebo effect is a psychological response to treatment. Physical conditions can improve with placebos. Placebos do not cure, as many people mistakenly believe, it is the perceived improvement of symptoms that characterizes the placebo effect.

It is still not fully understood exactly what causes the placebo effect, although the patient's 'beliefs and expectations' may invoke a 'conditioned response' (as in Pavlov's dogs). We are conditioned to 'believe' that medicine makes us better when we're ill, so any treatment that we receive may make us psychologically confirm this belief.

It should be noted that ALL medicines induce the placebo effect. It is only those treatments that have an effect above and beyond that produced by a placebo that are classed as efficacious and now this can be as low as just 5%. However placebo fraud has exposed the very foundations of drug based medicine as most [90%] of the thousands of clinical trials over the last five decades must now be completely thrown out as utterly 'non-scientific' or 'evidence based' rendering the studies 'scientifically invalid' and their drugs as 'unproven'.

A new study in Science Translational Medicine has cast doubt over the scientific validity of nearly all randomized, double-blind placebo controlled studies involving pharmaceuticals used on human beings. It turns out that many pharmaceuticals only work because people expect them to, not because they have any "real" chemical effect on the body. When test subjects were told that they were not receiving painkiller medications -- even though they were -- the medication proved to be completely worthless.

Belief & Expectation
The placebo effect therefore relies on the positive 'belief' or the 'expectation' that the treatment will work and herein lies the problem when applying the placebo effect argument to most non-pharmaceutical treatments. When a patient takes a pill, they 'expect' and 'believe' they will get better [placebo effect] but often they don't. When a patient tries a non-pharmaceutical treatment they are usually 'highly sceptical' [no placebo effect] but often do get better.

Therefore, the placebo effect applies more to medications than it does to non-pharmaceutical therapies.

The idea of the placebo in modern times originated with H. K. Beecher. He evaluated 15 clinical trials concerned with different diseases and found that 35% of 1,082 patients were satisfactorily relieved by a placebo alone (The Powerful Placebo, 1955). Other studies have since calculated the placebo effect as being even greater than Beecher claimed. For example, studies have shown that placebos are effective in 50 or 60 percent of subjects with certain conditions, e.g., 'pain, depression, some heart ailments, gastric ulcers and other stomach complaints'. Therefore any benefit derived from drugs designed to treat these conditions are more likely to come from the placebo effect rather than the drug itself.

If the placebo effect is even higher than 60%, this is very worrying as Dr Allen Roses, worldwide vice-president of genetics at GlaxoSmithKline (GSK), said fewer than half of the patients prescribed some of the most expensive drugs actually derived any benefit from them. "The vast majority of drugs - more than 90 per cent - only work in 30 or 50 per cent of the people," Dr Roses said. "I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 per cent of people. Drugs out there on the market work, but they don't work in everybody." It therefore seems any effect of these drugs has more to do with their placebo effect than actual drug efficacy.

However, In May 2001 The New England Journal of Medicine published an article that called into question the validity of the placebo effect. 'Is the Placebo Powerless? An Analysis of Clinical Trials Comparing Placebo with No Treatment' by Danish researchers Asbjørn Hróbjartsson and Peter C. Götzsche "found little evidence in general that placebos had powerful clinical effects."

Their meta-analysis of 114 studies found that "compared with no treatment, placebo had no significant effect on binary outcomes, regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect, but the effect decreased with increasing sample size, indicating a possible bias related to the effects of small trials." (Most of the studies evaluated by Hróbjartsson and Götzsche were small: for 82 of the studies the median size was 27 and for the other 32 studies the median was 51.)

Clinical Trials not the General Public
Clearly there is a placebo effect which tends to manifest itself more in clinical trials [small groups] rather than in large groups [the general public] who are usually 'sceptical' of non-pharmaceutical therapies mainly due to all the negative coverage instigated by the pharma industry. It is clear the scientific community can not agree amongst themselves with regard to the placebo effect, some claim it is as high as 60% or more while others claims 'placebo's have no significant effect', what is clear, is that the placebo effect applies more to medications than it does to non-pharmaceutical therapies.

Expensive Placebo's
There is some evidence to show that the more expensive a placebo is, the more of a placebo effect it has, this is why branded drugs can appear to ‘work' better than generic drugs and explains why numerous U.S. states have or are in the process of filing lawsuits against drug companies alleging that drug companies had abused the Medicaid system and 24 other states have all been involved in lawsuits against Big Pharma as well. Even the federal government has sued drug companies for reimbursement fraud, the lawsuit alleges that drug companies were marking up these costs as high as 6000% above actual costs.

An open letter from 20 consultants and a patient group published on bmj.com, calls on the Prime Minister to take action over a legal loophole that allows drug companies to make massive profits by re-licensing existing treatments for rare or orphan diseases to take full advantage of the placebo effect for these new uses. Examples quoted are a drug to treat two rare muscle diseases costs £800 to £1,000 per patient per year but costs the NHS £40,000 to £70,000 per patient per year a 50-fold to 70-fold increase and oral ibuprofen for analgesia that costs £0.08 per gram but is later resold to the NHS for £6,575 per gram.

There is no doubt the placebo effect exists, it's effects vary and are more prominent in small groups [clinical trials] rather than when used by the general public, so the claim any benefit derived from any non-pharmaceutical therapy is due to the placebo effect is clearly wrong, so why do the scientific community make such claims?

False Claims
They make these false claims to attack and undermine any non-pharmaceutical treatment as they are paid to do so. Directly or indirectly the scientific community is reliant on the pharmaceutical industry for funding, wages, research grants or employment and so toe the 'party-line'. They are therefore bias towards the pharmaceutical industry and are not independent, to suggest any benefit derived from any non-pharmaceutical therapy is solely due to the placebo effect is an example of their bias and prejudice and lets not forget that 'two in every three conclusions published in medical journals are later found to be wrong or fraudulent.

The Placebo Problem
Placebos in drug trials are getting more effective and drug makers are desperate to know why. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time. It turns out drug companies are finding it harder to find people who aren't influenced by all their claims and advertising. The fact that an increasing number of medications are unable to beat supposedly inert pills has thrown the industry into crisis. After decades in the jungles of fringe science, the placebo effect has become the elephant in the boardroom.

When a pharmaceutical company tests a product in a placebo-controlled trial, where do you suppose they get placebo pills? Do they place an order with a placebo pill manufacturer?

The fact is, drug companies make their own placebo pills for research purposes, and for each individual study they create a unique placebo formula - sometimes including ingredients that match ingredients in the drugs being tested which creates a second class of 'placebo fraud'. But the contents of placebos are never revealed.

Does that sound inert or inactive to you? Suddenly the idea of a sugar pill doesnt seem so innocent anymore.

Before conducting human trials for drugs, pharmaceutical companies are often fully aware of many of the side effects of the products they're testing. So, for instance, if a drug is known to cause dizziness and nausea, the drug company running the test may want the placebo to have the same side effects. And they have an explanation for this. They say the placebo should mimic the drug being tested so that the control group of the experiment will have side effects similar to the placebo group. Without that, they claim, the results of a blind study would be compromised!

Dr. Beatrice Golomb, PhD, is an assistant professor of medicine at the University of California in the US , and has been actively fighting the research establishments claim that placebos are inactive substances. Dr. Golomb wants scientists to provide a list of placebo ingredients so trial results can be properly evaluated.

To level the playing field, Dr. Golomb suggests that drug companies start divulging all placebo ingredients. She also recommends that standardised placebos should be developed so that side effects will be uniform and predictable. This would go a long way toward eliminating the pharmaceutical industrys cynical manipulation of test data.

As you might suspect, the drug companies are not very receptive to Dr. Golombs idea of letting go of this aspect of product testing that they have full control over but clearly they are no longer testing against neutral pills, they are either constructed to make the control group feel worse or to mirror the same side-effects as the drug being tested, either way its fraud.

Victims of Their Own Lies
The irony is, the pharmaceutical industry has helped prove how effective complementary treatments really are. After decades of telling everyone their products are 'superior' and 'scientifically proven' while complementary treatment are bogus, don't work and should not be trusted, they are now finding it difficult to find test subjects for clinical trials who aren't influenced by all their misleading claims. Their drugs are struggling to out perform the placebos!. At the same time people using complementary treatment do not expect or believe they will work [no placebo effect] but are pleasantly surprised by their results.

In her new book, The Truth About Drug Companies: How They Deceive Us and What to Do About It the former editor of the New England Journal of Medicine contends that the industry has become a marketing machine that produces few innovative drugs and is dependent on monopoly rights and public-sponsored research.

Angell disputes the industry's reputation as an “engine of innovation,” arguing that the top U.S. drug makers spend 2.5 times as much on marketing and administration as they do on research. At least a third of the drugs marketed by industry leaders were discovered by universities or small biotech companies, writes Angell, but they're sold to the public at inflated prices. She cites Taxol, the cancer drug discovered by the National Institutes of Health, but sold by Bristol-Myers Squibb for $20,000 a year, reportedly 20 times the manufacturing cost. The company agreed to pay the NIH only 0.5 percent in royalties for the drug.

The majority of the new products the industry puts out, says Angell, are “me-too” drugs, which are almost identical to current treatments but “no better than drugs already on the market to treat the same condition.” Around 75 percent of new drugs approved by the FDA are me-too drugs. They can be less effective than current drugs, but as long as they're more effective than a 'placebo', they can get the regulatory green light.

It's not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late '90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them.

Random factors can sway drug trials one way or the other, yet drug companies aren't required to submit for regulatory review all of the tests they run on a particular drug. They can submit just the ones they do well in and keep the ones that they fail to themselves, even if the factors for "doing well" are as esoteric (and non-scientific) as the color of the pill given, the branding of the pill, the price of the pill, or which country the trial was held.

So beware anyone who mentions the placebo effect as a way to discredit CAM treatments, as it is clearly a ploy.