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BMS Settles On Vanlev
Pharmaceutical firm Bristol-Myers Squibb (www.bms.com) issued a press release last week announcing it had reserved $185 million as payment to settle a class action lawsuit brought on behalf of investors. The settlement, which includes financial terms which have been agreed to in principle and non-financial terms which are being finalized, should resolve the nearly six-year old dispute surrounding Vanlev, a compound BMS was developing for the treatment of high blood pressure. Development and marketing were halted in 2000 when the U.S. Food and Drug Administration informed BMS that it was concerned about side effects of the drug.
According to Labaton Sucharow, the law firm representing the class of investors bringing the suit, the settlement is significant because of BMS' agreement to report publicly on the clinical trials of its products. Not only will information about what clinical trials have been conducted be available, but the results of the research will be presented in on-line databases established specifically to serve as information resources to physicians and patients about BMS drugs.
Is this something new? To a large extent it is. While drug manufacturers have always had to present results of the clinical trials they sponsor to the FDA when they applied for approval of a drug, the availability of that information tended to be somewhat restricted. Research participants and consumers were usually provided with only aggregated data -- that is, the overall results of data after they had been analyzed. And if clinical trials did not demonstrate a drug to be effective, then the results never needed to be made public, or even submitted to the FDA, if the manufacturer decided against marketing the drug.
This settlement is an example of how the game is changing. More and more, results of clinical trials are being made available to physicians, medical researchers, consumers, and, most importantly, research participants. Of course, this also means that competing companies will know more about one another's results. That should be interesting.
In the meantime, I am curious to see how and when BMS will announce the details of the data sharing terms of its settlement. When I checked today, its web site database of clinical trial results did not include information on Vanlev.
-Joe
Related Topics: Sorting Through the Latest Drug Studies, Warning for Blood Drug Hydroxyurea
Technorati Tags: bristolmyerssquib, vanlev
According to Labaton Sucharow, the law firm representing the class of investors bringing the suit, the settlement is significant because of BMS' agreement to report publicly on the clinical trials of its products. Not only will information about what clinical trials have been conducted be available, but the results of the research will be presented in on-line databases established specifically to serve as information resources to physicians and patients about BMS drugs.
Is this something new? To a large extent it is. While drug manufacturers have always had to present results of the clinical trials they sponsor to the FDA when they applied for approval of a drug, the availability of that information tended to be somewhat restricted. Research participants and consumers were usually provided with only aggregated data -- that is, the overall results of data after they had been analyzed. And if clinical trials did not demonstrate a drug to be effective, then the results never needed to be made public, or even submitted to the FDA, if the manufacturer decided against marketing the drug.
This settlement is an example of how the game is changing. More and more, results of clinical trials are being made available to physicians, medical researchers, consumers, and, most importantly, research participants. Of course, this also means that competing companies will know more about one another's results. That should be interesting.
In the meantime, I am curious to see how and when BMS will announce the details of the data sharing terms of its settlement. When I checked today, its web site database of clinical trial results did not include information on Vanlev.
-Joe
Related Topics: Sorting Through the Latest Drug Studies, Warning for Blood Drug Hydroxyurea
Technorati Tags: bristolmyerssquib, vanlev
