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Disclosure of clinical trials for popular medicines

        U.S. Cardiologists were complaining this week about the refusal of drug manufacturers to disclose the results of clinical trials on cholesterol-lowering drugs Zetia and Vytorin.  Despite the fact that they are prescribed to almost 800,000 Americans every week, at a total cost of $4 billion dollars, the manufacturers have consistently refused to provide prescribing physicians, consumers, or insurance payors with the results of clinical trials investigating [or documenting] their effectiveness.  We wonder why the physicians continue to prescribe these drugs if the manufacturers are unwilling to document that they are actually effective and continue to refuse and delay release of their test data?  The reason for this delay and obfuscation seems patently obvious.

        Despite heavy pressure from cardiologists, manufacturers Merck and Schering-Plough have refused to provide any results thus far, and have only promised to provide partial results in March of 2008.  Further, they announced that they were changing the "endpoint" of the study, thus re-designing the goal of the study mid-stream:  that is considered to be inappropriate in clinical research.

        These medications reduce cholesterol in a manner that is different than "statin" drugs such as Lipitor.  Unlike statins, these particular medications have never been shown to be effective in protecting patients from coronary artery disease.  The manufacturer originally claimed that this study would document that effectiveness, however, it is now suggesting that such documentation will have to be delayed until 2010 or later (while billions of dollars of revenue are generated annually).  The manufacturers' decision not to release their data must also be considered in the context of their 2005 agreement to "promptly" furnish drug effectiveness data.  The results of this particular study have been promised to cardiologists several times in the past and were originally to be produced by March of 2007.

        All-in-all, it is patently clear that the public has a significant interest in the data collected on patients included in these studies and that the FDA should be empowered to exercise greater control over this industry.  With medical expenses, and pharmacological expenses in particular, draining an ever-greater share of the gross domestic product and influencing the lives of more and more Americans, it is inappropriate and absurd to leave the regulation of safety in this area to manufacturers who have billions of dollars in annual sales at risk.  If, for example, these medications are not protecting patients against a future heart attack as well as a statin would, they and there doctors should be provided with the raw data that would allow them to make an informed decision about which medication to prescribe and purchase.

Thompson O’Neil, P.C.
309 East Front Street
Traverse City, Michigan 49684
Toll Free: 1-800-678-1307
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