Restoring Credibility of Medical/Scientific studies- REAL or PUBLIC RELATIONS??

[Guest guest]

The numerous instances of Drug Company influence on Medica/Scientific studies supporting drig approval has finally been recognized as a PROBLEM. The FDA has had to withdraw more drugs from the market than they ever had to before. The studies approving them were cutting corners and the "advisory panels" they set up to recommend FDA action are so heavily biased by known "conflict of interest" that they have had to give "waivers" to almost 60% of the members they chose to be on these panels. The Real problem is that the prestige and influence that comes from being on the panels, can easily be withdrawn to ever so gently contribute to an environment that rewards only people who consent to front for the Drug Companies who control those who give out the academic and professional perks they all need.

Now Even the major journals are in a defensive position. If their Editorial stance about INDEPENDENCE is to have meaning they must also become less dependent on drug company advertising in their journals-how can it be independence without that? We have had Public Relations from them and FDA for years covering this corrupting relationship over.

Arnold Gore

Article: Medical Journals take a Stand Plan to counter drug companiesí influence on studies Aug. 5 ó Editors at the worldís most prominent medical journals, alarmed that drug companies are exercising too much control over research results, have agreed to adopt a uniform policy that reserves the right to refuse to publish drug company-sponsored studies unless the researchers involved are guaranteed scientific independence. THE NEW ENGLAND Journal of Medicine, the Lancet, the ls of Internal Medicine and the Journal of the American Medical Association (JAMA) are among the journals that have agreed to publish a joint editorial in mid-September outlining the new policy, which was drafted by a committee of editors over the last several months. The unprecedented move could have a significant impact on how medical research is conducted and reported by giving researchers more leverage in their dealings with the pharmaceutical industry. Companies are eager to publish studies in these prestigious journals because doctors view them as credible sources of information to help them decide which drugs to prescribe to patients. Editors said the new policy is a response to companiesí increasingly tight hold over how research is done ó and, in many cases, over whether and how the results are made public. In recent years, drug companies have become the dominant funder of biomedical research, especially of large studies of medicinesí safety and effectiveness. The authors who receive top billing on drug studies published in respected, peer-reviewed journals are usually medical school professors who are experts in their fields, but much of the research is paid for, and in large measure carried out, by companies with an enormous financial stake in the outcome. Company employees usually collect and analyze the data, and they often decide how it should be presented and write the reports. CONCERNS OVER RESULTS The journal editors decided to act after several recent cases involving charges that drug companies tried to withhold research results or present them in the most favorable way, several said during interviews last week. ìItís become a huge problem,î said off, who as editor of the ls of Internal Medicine was among those who decided to take a stand on the issue at an international meeting of medical journal editors in May in Philadelphia. D. DeAngelis, the editor of JAMA, said her journal already has a policy of demanding that study authors vouch for the integrity of their data. ìThe goal would be that all of the major journals would adopt similar . . . principles,î she said. M. Drazen, editor in chief of the New England Journal of Medicine, confirmed that the editorial is to be published in mid-September but declined to discuss its content other than to say ìitís an important issue.î The decision was praised by several observers of biomedical studies who have become alarmed about the influence of the drug industry on the integrity of medical research. In large, company-sponsored drug trials involving multiple hospitals, all of the information collected is typically held by the company, said Marcia Angell, former editor in chief of the New England Journal of Medicine. ìNot even the principal author sees all the data,î she said. As editor of the journal, Angell recalled, she sometimes received manuscripts from company-sponsored studies that had the ìmethodsî section ó the explanation of how the study was carried out ó left blank. ìTheyíd say, ëThis is proprietary,í î she said. Surveys of the medical literature have shown that studies paid for by drug companies are more likely than those with other sponsors to show results favorable to the product tested, said Bero, a professor of clinical pharmacy and health policy at the University of California at San Francisco. Many medical schools include clauses in grant agreements with companies stating that researchers will be free to publish even if the results are negative. ìBut even if you have one of those, you can still get hassled, still get pressure put on you for fear that you wonít get any future funding,î Bero said.