There is disturbing evidence that some drug companies manipulate their research studies to punch up marketing hype while avoiding important questions about the safety and effectiveness of their drugs.
One solution is to create a mandatory registry that makes public the full list of clinical trials and their results. There is such widespread support -- even from within the pharmaceutical industry -- that there is no excuse not to act. Washington must enact the toughest possible version of the registry measure introduced as part of the effort to beef up the Food and Drug Administration.
The New Jersey Public Interest Research Group says the blockbuster painkiller Vioxx provides a good example of why research needs more exposure to public light.
Merck eventually pulled Vioxx from the market because of a link to cardiovascular risks. Merck, however, never did a clinical test designed to look specifically for cardiac problems, even though some scientists called for such a study. Since recalling Vioxx, Merck has been accused of suppressing data that pointed early on to such a risk. The cornerstone of its legal defense against thousands of Vioxx suits has been the lack of clinical studies showing a risk except after long-term use. There is no evidence because Merck never did a clinical trial to look for evidence -- and the FDA did not make it.
Instead Merck studied whether Vioxx was gentler on the stomach than the competition -- which fit advertising plans.
Has objective science been subverted for marketing and perhaps legal reasons? If the design of clinical trials and the results can be examined and analyzed by independent scientists, the public might have to worry less about that question -- or get the answer sooner. A good drug registry would be translated into plain English so consumers could look for information about their own conditions and for clinical trials they might want to join. A clinical trial can provide cutting-edge treatment.
Individual companies and PhRMA, the industry's trade association, have created limited, voluntary databases, but they are not enough. Tired of waiting for Washington to act, NJPIRG and other organizations are asking states to create their own mandatory registries and prohibit the sale of drugs that are not submitted to such review.
The theory is that in the age of the Internet, if any entity re quires the reporting and makes it public, everyone will have access and benefit from it. That's true, and if Congress does not act or tries to water down the registry effort, the drug industry may have to suffer the chaos of different states demanding different things.
One mandatory federal registry -- coupled with an FDA that is given the authority to impose serious consequences for noncompliance -- is what the country needs.
© 2007 The Star Ledger
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