-Caveat Lector- body snatchers bust prompts reforms --shm.com.au Stricter rules governing drug trialling are promised. But they shouldn't be necessary if doctors stick to their guidelines. Gerard Ryle reports. Embarrassment has done its work. Those who run the system always knew. Now that the public knows, they've promised reforms. That anyone was surprised by the news this week that doctors were getting paid by global pharmaceutical firms to do drug trials on their patients might be considered an extraordinary oversight for a profession that likes to stand on a platform of ethics. The response from authorities was immediate. The State Health Minister, Craig Knowles, announced two inquiries into the matter, one by his department and one by the NSW Medical Board. He also set about creating Australia's first publicly accessible register of clinical trials by ordering that all hospitals list all such trials - and moneys received from pharmaceutical firms - in their annual reports. The chief medical officer of Australia, Professor Richard Smallwood, said that an even more comprehensive register of clinical trials should be compiled at a national level. Meanwhile, the leader of the Australian Democrats, Meg Lees, said her party would ensure that laws were changed so that doctors would have to tell patients who volunteered for trials of financial arrangements the doctors had with pharmaceutical firms. But in view of doctors' own self-imposed rules, such legal reform should not be necessary. At least two medical codes of conduct in Australia refer to the commercial relationships between the pharmaceutical industry and the medical profession. The guidelines attempt to moderate between the ever increasing needs of big business and the delicate patient-doctor relationship. The latest code of ethics issued by the Royal Australasian College of Physicians couldn't spell it out more clearly: "The nature of the compensation to be paid to the investigators or the institution should be declared to, and approved by, the ethics committee and this fact should be noted in the explanatory statement provided to potential volunteers." The fact is, this hasn't always happened. More ... THE EXPOSE Australians used as guinea pigs for global drug market Thousands of Australian patients are being used as guinea pigs in drug trials for global pharmaceutical companies without explicit laws to adequately protect their rights. Full report Australians used as guinea pigs for global drug market A HERALD INVESTIGATION By Gerard Ryle Thousands of Australian patients are being used as guineapigs in drug trials for global pharmaceutical companies without explicit laws to adequately protect their rights. Intellectually disabled men and women, incapable of giving consent on their own behalf, are being included in the trials, which are largely aimed at getting new drugs to the United States and European markets. Pharmaceutical companies are paying private doctors up to $6,000 for every patient they recruit but the patients do not have to be told of the financial arrangement. The money covers trial expenses and allows a profit for the doctors. Drug trials are vital in bringing life-saving medicines to market but the number being conducted in Australia has risen 20-fold since 1990 and many never result in approval for the drug. Some trials are abandoned after reports of side-effects and deaths, either here or overseas, or because the drug simply does not work. The chairman of the Australian Drug Evaluation Committee, Professor Martin Tattersall, who is at the forefront of medical research in Australia, believes the protection of patients' rights in drug trials needs a major overhaul. "Basically most patients do what their doctors say," he said. "They do that because they want to trust their doctors. Some patients taking part in clinical trials don't appreciate that they are in a clinical trial." A Herald investigation has found that: Patients are being bought and sold like commodities by doctors and pharmaceutical companies but are not being told that money changes hands when they volunteer for new treatments. The Therapeutic Goods Administration, the main responsible Federal Government authority, was obliged to directly review only two of the 1,712 clinical trials done in Australia last year. Patients are not always given copies of the consent forms they sign and are often not in a position to question their doctor's suggestion that they join a trial. Nearly one in six of the 210 medical bodies which approve trials - known as ethics committees - are being run out of private organisations. One Sydney doctor who conducted trials on his patients got approval from an ethics committee that included, among others, his former lawyer, his former patient, his rabbi and his sister. Global pharmaceutical companies have rushed to Australia at a time when debates have arisen over similar trials in Europe and the US, and because of the relative cheapness and ease of getting approval here. Australian trials include experiments on dementia patients, the testing of hormone creams on menopausal women, and new vaccines in children. One experiment, approved by the NSW Guardianship Tribunal, involved putting intellectually disabled people on an anti-epileptic drug which never succeeded in being registered anywhere in the world. Professor Tattersall said many trials which harmed patients may be hidden from public view because pharmaceutical companies controlled the data. "One of the main flaws in the process of [drug] registration is that you only know the studies which are shown to you," he said. "You don't know the studies that were done and weren't shown to you. "Clearly there is an opportunity for a company which is sponsoring a study to hide the dirty washing. "I think the other thing that is true is that while the barriers for buying doctors have gone up quite a lot in North America and increasingly in Europe, they haven't gone up here yet." Professor John Simes, director of the National Health and Medical Research Council's clinical trial centre, said the lack of a publicly accessible central trials register in Australia meant there was no accurate way of knowing what trials were being done, and by whom. Associate Professor Paul Komesaroff, chairman of the ethics committee of the Royal Australasian College of Physicians, said industry funded research was easier to obtain and much more lucrative than government-funded research. "In many cases the industry sponsored trial doesn't have a valid scientific intention. It is eroding research that is truly innovative in favour of research that satisfies commercial purposes." TOMORROW: How Sydney public hospitals earn cash trialling drugs on their patients For The Rest of the "News" Visit The Mother Of All Newshounds to see What Has Been Dug Up www.geocities/peatluke/watchdog.html ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ To Join the Daily WatchDog Ezine Mailing List Info: For more information: http://groups.yahoo.com/group/DailyWatchdog ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ <A HREF="http://www.ctrl.org/">www.ctrl.org</A> DECLARATION & DISCLAIMER ========== CTRL is a discussion & informational exchange list. Proselytizing propagandic screeds are unwelcomed. Substance—not soap-boxing—please! 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