Thursday, March 03, 2005

US FDA official promises early drug risk warnings

My questions about the article below are these:

1. Exactly what "improvements in health and information technology" is Dr. Woodcock referring to? I'm not aware of any recent advancements in information technology that would "address recent concerns over drug side effects." The world of clinical IT issues a lot of press, but not enough substance - and that's in the delivery sector. Pharma seems a decade behind the healthcare delivery sector in my interactions with multiple companies, being firmly stuck in the data processing mentality of yesteryear as opposed to the clinical informatics mentality of the 21st century. An example: pharma computing leadership with management information systems (business computing) skills but no clinical or scientific credentials whatsoever .

2. On the issue of "considering whether longer pre-marketing trials are needed to catch problems earlier," my question is, what, exactly, needs to be considered? If longer (and/or larger) pre-marketing trials are not needed, then how, exactly, would the COX-2, Fen-Phen and pediatric antidepressant suicide problems have been avoided?

3. Regarding Woodcock's "declining to endorse proposals circulating in Congress," and her defense of the FDA's current system for detecting drug risks, how can one be considering changing a system while defending the current system at the same time? This strongly sounds like bureaucratic doubletalk.

There is so much money at stake in this issue, I expect true change to proceed even more slowly than in the provider sector. Much more slowly.

-- SS

US FDA official promises early drug risk warnings
Thu Mar 3, 2005 03:15 PM ET

By Lisa Richwine

WASHINGTON, March 3 (Reuters) - U.S. regulators are moving to get drug safety warnings to patients and physicians earlier, which should limit prescribing and cut the number of dangerous side effects, a top U.S. Food and Drug Administration official told Congress on Thursday. FDA acting deputy commissioner for operations, Dr. Janet Woodcock, said those efforts,
plus improvements in health and information technology, would address recent concerns over drug side effects.

Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) withdrawal of arthritis drug Vioxx in September prompted criticism that the FDA was lax in its oversight.

"We are now ... planning to put information out directly to the public on emerging safety issues" even before the FDA and a manufacturer agree to change the drug label, Woodcock told the Senate Health, Education, Labor and Pensions Committee.

Vioxx was widely prescribed because doctors were unaware of a 2000 study called Vigor that linked the drug to cardiovascular problems, Woodcock told the committee.

"Communications about the findings of the Vigor trial were not effective in reaching prescribers and patients, despite a (2002) label change that was made. Most prescribers really did not know about that finding," Woodcock said.

Merck withdrew Vioxx from the market last year after another study showed the drug increased the chances of heart attacks and strokes.

Pain relieving medicines such as Vioxx are approved after relatively short studies of three to six months of use.

FDA officials are considering whether longer pre-market trials are needed to catch problems earlier, Woodcock said. "It's something we are going to have to wrestle with," she told reporters.

Lawmakers are considering whether to give the FDA new authority or funding, or to change the agency's structure to improve the monitoring of medicines already on the market. The FDA has proposed a new drug safety board, but some lawmakers want a panel completely independent of the agency.

Woodcock declined to endorse any proposals circulating in Congress, and she defended the FDA's current system for detecting drug risks.

"It is really a continuum between pre-market and post-market (reviews).
It is by no means 'we simply forget this drug' after it's been approved," she said.

Sen. Mike Enzi, the health committee's chairman, said he had not decided what type of legislative fix to pursue. But the Wyoming Republican said "doing nothing to address the current controversies is not an option."

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