SHOW ARCHIVE |
09 February 2010 |
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PATRICK HOLFORD - November 3, 2009
Emperor’s new drugs
One is often led to believe that the major drugs are well researched and well proven but a new book by Dr Irving Kirsh, called the Emperor’s New Drugs shows how false this assumption is in relation to anti-depressants, one of the biggest money spinners. Kirsh’s analysis shows how most people on these trials guess they are on anti-depressants due to side-effects, that the more side-effects the better their improvement, and that placebos that induce side-effects enhance response. The small difference between anti-depressant response and placebo is simply explained by an enhanced placebo response. In trials where placebo that also induce side-effects are given there’s no difference! There’s also no evidence that increasing the dose works, which it what most doctors do, although with more side-effects there may be a further enhanced placebo effect. Also, most reported benefit occurs in the first two weeks so the often used explanation that you just haven’t taken them for long enough is not true. The crazy thing is that, until recently a drug company could run a dozen trials, many that may prove the drug to be ineffective, but only had to submit two that show an effect to get a licence. Thanks to continued pressure all trials must now be registered and it’s by obtaining this data through the Freedom of Information Act that Kirsh was able to find out about the negative trials that never got published. As Kirsh points out, as long as the regulator, the MHRA in Britain, is paid for by the pharmaceutical industry we are not going to see fair play. But it gets worse. You might have wondered whether any of these trial results get fudged. A recent review [www.plosone.org] set out to explore this. In surveys that asked about the behaviour of research colleagues 14% knew someone who had fabricated, falsified or altered data, and up to 72% knew someone who had committed other questionable research practices. Misconduct was reported most frequently by medical and pharmacological researchers. The British Medical Journal carried a good editorial recently about the dangers of medicine only taking into account placebo controlled trial results. The trouble with these trials is that they only really work for testing pills, thus playing into the hand of the pharmaceutical industry. They also cost, on average, about £5 million. Lifestyle factors such as exercise and nutrition aren’t amenable to this kind of research and, anyway, there’s not that kind of money floating around for non-patentable treatments. These kind of trials are often called the ‘gold standard’ but most people don’t realise that they are so-called, not because it is necessarily the best way of doing research, but because the advocate of this approach was Harry Gold from Cornell University. But it’s not just the science that gets distorted. Earlier this year Pfizer got the biggest ever parking ticket, $2.3 billion dollar fine, plead guilty to one felony count to settle federal criminal and civil charges that it illegally promoted its Bextra pain-killer and other drugs. The net result of all this jiggery pokery is we end up with a type of medicine that is completely dependent on drugs. The recent debacle over the cervical cancer vaccine shows just how far medicine has drifted away from the principle of ‘first do no harm’. Some experts estimate that the vaccine may be 20% effective, rather than the 70% quoted by manufacturers and health authorities. Already, side effects have been reported by 2,000 of the girls given the cervical cancer vaccine — some serious. What incenses me is the huge profits organisations like Merck, which produces anti-cervical cancer vaccine Gardasil, make when there are so many unanswered questions. How about first proving a vaccine is safe before young girls are pressured into having it?
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