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Medical studies are commonly sponsored by private industries such as drug companies. Ideally, the sponsor is just that, a silent partner meant to pay for and back the study while keeping their hands clean of the study itself. However, in a recent survey of 108 U.S. medical schools, it was found that many contracts between the schools and their industry sponsors were not adequately safeguarded, which leaves sponsors free to get their hands dirty.
Guidelines, provided by the International Committee of Medical Journal Editors, meant to protect the independence of researchers from their sponsors were revised last year due to concern over the issue. They call for adherence to a range of provisions-from ensuring that independent investigators participate in designing the study to allowing them access to all trial data and giving them control over whether the study is published.
According to the survey, however, these guidelines are often not followed, or are completely missing, from medical-study contracts. It is not uncommon for studies to be conducted without an independent member to monitor a financial sponsor's role, and it is not a requirement that the study be published. This means that valuable information, including negative results that could potentially harm a sponsor, may never be reported.
The survey points out an urgent need to revamp the process of contracting in medical research studies.
The New England Journal of Medicine October 24, 2002; 347:1335-1341
| DR. MERCOLA'S COMMENT: |
Nice to acknowledge that there are major flaws in the system, but acknowledging them really doesn't fix them, does it?
Two years ago the editor of JAMA had similar comments on this issue.
The system is rotten at the core. Two years ago USA Today exposed that the very system that is used to approve drugs is corrupted. More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions.
Also, two years ago, NEJM posted an article that most of the media coverage of the drugs was corrupted by highly conflicted drug company interests.
It's clear that a change needs to be made to protect the integrity of medical studies, but whether the apparent need will be addressed remains to be seen.
Related Articles:
USA Today Exposes Conflicts of Interest in FDA Drug Approvals
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