Drug Safety, the Sequel: This Time It's Specialist Products
The withdrawal of Biogen Idec Inc. and Elan Corp.'s natalizumab (Tysabri) multiple sclerosis treatment just weeks after its introduction showed that specialist products aren't immune from serious safety issues. Sales and clinical trials of the drug were suspended with the cooperation of the FDA after two patients in the companies' clinical study of Tysabri in combination with Avonex developed the rare and often fatal demyelinating disorder PML.
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FDA's senior management is worried that it may have created a political Frankenstein when it called for an outside review of the agency's role in drug safety decisions by the Institute of Medicine. The agency asked for the study to take the heat out of Congressional efforts to split up safety and efficacy reviews. The committee has shown interest in the arguments to create new publicly-funded centers for post-market trials.
The Vioxx withdrawal is one of those seminal events that, because of the players involved--the industry's largest companies, some of their most valuable drugs, both the European and American regulatory structures--holds up a mirror to an entire industry. Given the record breaking valuation slides, the market is taking a very critical look at the industry's strategies; so should the people who run it.
The dynamics of specialty chronic care markets suggest that Biogen Idec and Elan's highly anticipated Antegren may have trouble turning the scrappy $3.5 billion MS market on its head, at least right away.