Watchdog or Lap Dog?
Sick people, beware: Food and Drug Administration officials have been working behind the scenes with a pharmaceutical company to put back on the market a drug removed only last year, after the deaths of five users. It may turn out there is good reason for a limited reintroduction of the drug Lotronex, a treatment for a common digestive disorder called irritable bowel syndrome--but such a move should be made only with proper oversight by an FDA that is subject to public scrutiny.
As Times staff writer David Willman reported Monday, FDA officials have not indicated any plans to limit Lotronex to people who could conceivably use it safely. Instead, Dr. Janet Woodcock, director of the FDA’s drug evaluation center, has privately voiced support for the drug to GlaxoSmithKline, the manufacturer. She has conferred with Glaxo on how to stage a public advisory committee meeting to minimize criticism, assured Glaxo executives that “we can manage the media” and declined Willman’s requests for an interview in which she would have had the chance to explain her reasoning to the public.
For the record:
12:00 a.m. June 8, 2001 For The Record
Los Angeles Times Friday June 8, 2001 Home Edition California Part B Page 16 Metro Desk 1 inches; 28 words Type of Material: Correction; Editorial
FDA reference--An editorial in May 31 editions, “Watchdog or Lapdog?”, gave the wrong date for a Times story it referenced. ‘FDA Moving to Revive Deadly Drug,’ by David Willman, appeared on May 30.
It’s disturbing that the FDA seems to be turning a blind eye to science: New evidence makes it clear that the drug could cause life-threatening complications. Even worse is what the Lotronex matter reveals about the way federal officials apparently colluded with the industry they oversee to increase the market share of a product that last year generated sales topping $50 million.
Earlier this month, the British medical journal the Lancet editorialized that Lotronex’s story “reveals not only dangerous failings in a single drug’s approval and review process but also the extent to which the FDA, [and] its Center for Drug Evaluation and Research in particular, has become the servant of industry... it defies belief that this drug should be allowed back on the market now.”
It is fine for Woodcock to maintain a collegial relationship with the pharmaceutical industry. The industry is not the FDA’s enemy, and getting helpful drugs on the market quickly is in everyone’s best interests. But taxpayers pay Woodcock to protect sick people from dubious drugs, not to help companies market them.
