FDA Defends Its Handling of Vioxx Safety

[maddezmom]

WASHINGTON - Amid questions about whether the arthritis drug Vioxx was taken off the market soon enough, a key senator suggested Thursday that an independent board of drug safety might be needed to ensure the safety of medications after they're approved for the market.

"Consumers should not have to second-guess the safety of what's in their medicine cabinet," Sen. Charles Grassley (news, bio, voting record), R-Iowa, said as he opened a hearing of the Senate Finance Committee.


Vioxx's maker, Merck & Co. pulled the drug from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.


David Graham, a Food and Drug Administration (news - web sites) reviewer who recommended that the drug be pulled, said told the committee that research indicated that Vioxx caused up to 160,000 heart attacks and strokes.

more: http://story.news.yahoo.com/news?tmpl=story&cid=542&ncid=693&e=6&u=/ap/20041118/ap_on_go_ca_st_pe/vioxx_safety

edited to add this article:
FDA Saw Problems at Vaccine Plant in 2003

WASHINGTON - The Food and Drug Administration (news - web sites) said it was taken by surprise when the U.S. supply of flu vaccine was cut in half in October. Democratic lawmakers said the agency should have seen it coming.

Documents provided by the FDA (news - web sites) to a congressional committee show that inspectors uncovered contamination and unsanitary conditions at a Chiron Corp. flu vaccine manufacturing plant in England in 2003. Yet the agency did not re-inspect the facility until similar problems caused the loss of roughly 50 million flu shots destined for the United States.


Acting FDA Commissioner Lester Crawford said the 2003 problems and those that tainted this year's vaccine were unrelated. "The proof of that is that the 2003 vaccine production was completed on schedule and none of it was condemned," Crawford told the House Government Reform Committee (news - web sites) at a hearing Wednesday.


FDA inspectors who visited the Liverpool plant in June 2003 found records of bacteria concentrations a thousand times the expected level, said a report distributed by committee Democrats.

more: http://story.news.yahoo.com/news?tmpl=story&cid=542&ncid=693&e=9&u=/ap/20041118/ap_on_go_ca_st_pe/flu_vaccine

[idiosyncratic]

1. Idiots!!

The stories I have heard about people who suffered heart attacks because of that drug have been positively heart-breaking. One man buried his 39-year-old, previously-healthy wife the day they pulled Vioxx from the market.

His wife had had a vioxx-induced heart attack.

I hope Merck is bankrupted by all the lawsuits!

[maddezmom]

2. the * misadministration keeping us safer abroad and at home

:puke:

[damntexdem]

3. Maybe we should rename the FDA, but keep the initials:

the Foolish Dubya Abomination.

[JohnOneillsMemory]

4. Merck adverts are now all over National Petroleum Radio.

NPR is where corporateers go to reach white collar workers in between the Heritage Foundation commentators.