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What’s New
Mainstream medical opinion is rapidly coalescing in support of clinical trial registries and results databases, which make it impossible for the drug marketers to hide or misrepresent negative clinical trial data.
The American Medical Association, the National Academy of Science’s Institute of Medicine, and the World Health Organization have all endorsed the concept. While none of these groups takes identical positions on the details of the registries, the consensus in favor of full and accurate disclosure is overwhelming.
Individual pharmaceutical companies have embraced the concept as well, and the pharmaceutical industry trade groups have endorsed the concept and created their own version. Unfortunately, these industry registries are inadequate, because they are not comprehensive, do not disclose enough, and are voluntary. Nonetheless the industry’s support for the concept is important.
NJPIRG is working to pass a strong, comprehensive clinical trial registry and results database bill, A2951/S2307. Passing this bill would solve the problem for everyone in the country, because the information would be available on the internet.
How You Can Help
Ask Asm. Conaway, Chairman of the Health and Senior Services committee and sponsor of A2951, to have the bill considered at the next committee meeting.
Background
The Problem: Deceptive Drug Marketing Endangers Patients
Drug marketers’ main concern is selling drugs, not your health. Sales are hurt if doctors perceive a drug as dangerous or of limited value. Thus drug marketers have a strong incentive to present their drugs as safer or more effective than they really are.
Our report, “Turning Medicine into Snake Oil, How Drug Marketers Put Patients at Risk” documents the problem in detail. From 2001-2005 the FDA sent 85 different drug companies at least 170 letters to drug marketers telling them their advertising was false or misleading. Those letters, which we analyze in the report, are available by clicking here. Our report found that over 2/3 of the deceptive messages aimed at doctors misrepresented risks or promoted unproven uses. Because both of these types of messages distort the risk/benefit analysis, they put our lives at risk.
Deceptive Drug Marketing Corrupts the Science of Pharmaceutical Medicine
In addition to the FDA letters, our report surveyed the existing literature to identify deceptive marketing problems that were largely outside the scope of the FDA letters. One of the most disturbing types of deceptive marketing that largely escapes FDA notice is the suppression and misrepresentation of clinical trial data, the fundamental science that underpins pharmaceutical medicine. In addition to outright data suppression, drug marketers influence clinical trial design to ensure the only the “right” questions are asked, and employ PR firms to write the first drafts of clinical trial reports and thereby control their spin. The PR firms’ ghostwriting is not acknowledged in the final reports. By distorting the underlying scientific data set, drug marketers put our lives at risk. Read our report.
The Solution
Reining in the drug marketers will require multiple changes to current law. Our first focus is ending the scientific misconduct of suppressing and distorting clinical trial data. To end that problem, New Jersey must create a comprehensive database of clinical trial data for all drugs sold in New Jersey, called a clinical trial registry and results database. Bills A2951/S2307, sponsored by Assemblyman Dr. Conaway and Senator Buono, would do just that. The registry would be hosted on the internet and would be publicly accessible. Key data about each study, ranging from its design to its results to the financial relationships among the researchers and drug marketers, would be included.
Passing these bills would restore the fundamental integrity of the science of prescription drug medicine. However, eventually more must be done.