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Friday, September 13, 2002Three days later Stolley and three colleagues sent a 20-page memo to the director of the gastrointestinal division, warning that a "risk management" plan, the option favoured by the company, would not stop the rising toll of "deaths, colectomies, ischemic colitis, and complications of treatment that were never seen previously in the management of irritable bowel syndrome." The memo refuted the company's argument that controlling constipation among patients taking the drug would "manage the risk" of serious adverse events, including ischaemic colitis. On 28th November the company and the regulator met again. Stolley's notes on the meeting record company officials aggressively attacking the 16th November memo as being "crappy" and full of errors, while senior FDA officials sat by and failed to defend their staff. "What message is this sending to young epidemiologists?" he asks. "In my opinion it is sending the message that we don't argue with drug companies; we listen to their distortions and omissions of evidence and we do nothing about it." ...According to Stolley, other staff concerned about the drug's harms were also urged to "help get this drug back on the market," and one of the most senior experts on drug safety was explicitly told not to work on alosetron. Internal emails from the time, published elsewhere, seem to support Stolley's suspicions of an unhealthy closeness between senior officials at the FDA, including Woodcock, and senior officials at the company. Both the company and Woodcock reject that dealings were unhealthy, and both argue they were motivated by a desire to help patients. "The FDA had to work with the company in order to facilitate the drug's availability," said Woodcock. The FDA had to facilitate the drug’s availability? That isn’t the FDA’s job. The FDA’s job is to make sure the drug is safe and effective, and worthy of being brought to market. This doesn’t look good for the FDA. Irritable bowel syndrome is a benign condition. Left to run it's normal course, it can be very inconvenient, but never life threatening. The drug in question, however, is life threatening. It makes no sense to use a drug that does more harm than the condition it's used to treat. The argument that the drug company and irritable bowel activists have used to bring the drug back is that it should be used compassionately for those who are severely inconvenienced by their symptoms. That seemed like a reasonable argument, but after reading the BMJ's account, it seems like a con. The FDA relies on the drug companies to give them extra money so we the taxpayers don’t have to fund all of their activities. This, along with pressure of activist groups (some of whom are also funded by drug companies), is corrupting the system. It would be far better for us if our Congress gave the FDA the money they needed to do their job instead of doling out cash for autism and obesity. posted by Sydney on 9/13/2002 08:25:00 AM 0 comments 0 Comments: |
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