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FDA Admits Zelnorm Mistake (Almost)

Posted Oct 28 2008 9:56pm

The FDA partially reversed its decision to yank Zelnorm from the market (for background see FDA Announces Drug Withdrawals ). In a press release earlier today, the FDA announced that “it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol” for the most serious of patients. These are the same patients the FDA refused to acknowledge actually exist back when it removed the drug back on March 30.

The Zelnorm debacle is emblematic of the current situation at the FDA – decisions are being made based on political pressure, not science. There is no longer any consideration given to the risk benefit profile of a product and the potential benefits to patients. The pendulum has swung from one dangerous extreme to the other.

As I mentioned at the time, Novartis’ Zelnorm got yanked because of a minor, and NOT statistically significant, sub-population in an 18,000 person study. 13 people out of 11,614 (or 0.11%) had an increase adverse cardiovascular events. Every one of the patients had pre-existing cardiovascular disease and risk factors (i.e., the doctor never should have put them on the drug in the first place).
I’ll be the first to admit that Zelnorm was personal for me. I have a very close friend who has lived for years with debilitating IBS. Zelnorm was a miracle drug for her and allowed her to live her life…a normal life. She spent four months suffering while the FDA played politics instead of science. I guess she owes a big thank you to Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research for her suffering. Thanks Steven. Good job, you win the gold star.

Let’s make it clear, Zelnorm is only back for the most serious of patients. The FDA has too much at risk politically to admit that the Zelnorm decision was a total farce and allow the product back. Again, it is the FDA putting politics before patients.
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