More coverage of Tysabri from the WSJ. The FDA has come under 'scrutiny' in the same way that the 2000 U.S. presidential elections in Florida came under scrutiny (all smoke and no fire).
WSJ.com - A Death Prompts Withdrawal Of Promising MS Drug:
Shares of Elan declined $18.90 to $8 as of 4 p.m. in New York Stock Exchange trading. Biogen Idec shares were down $28.63, to $38.65, as of 4 p.m. in Nasdaq stock-market trading.
The decision to halt sales of Tysabri comes amid wider controversy about the safety of other drugs approved by the FDA, particularly whether regulators have been correctly balancing the risks of new drugs with their benefits. The FDA has come under scrutiny in recent months over the safety of widely used painkillers, following the voluntary decision by Merck & Co. to pull its best-selling painkiller Vioxx last September after a trial tied it to higher rates of heart attacks and strokes.
Many analysts expected Tysabri to quickly become a blockbuster with annual sales of over $2 billion within a couple of years. The one-year results showed the drug was about twice as good as existing drugs in reducing flare-ups of symptoms in MS patients, such as tingling, double vision and muscle weakness.
Still, the experience with Vioxx offers some hope for Biogen and Elan. An FDA panel last month narrowly voted in favor of allowing the painkiller back on the market, but also called for strong restrictions including an end to consumer promotion of the drug and tough warnings that would sharply limit its use.
