And here's another mentioning more than Cox 2 drugs, especially Crestor.
US scientist casts doubt on AstraZeneca's Crestor
By Katherine Griffiths in New York
19 November 2004
AstraZeneca was dealt a blow yesterday when an official from the US's drugs watchdog questioned whether one of its key products ought to be sold in the world's largest pharmaceuticals market.
David Graham, a scientist who reviews medicines for the Food and Drug Administration, said AstraZeneca's cholesterol-lowering drug, Crestor, was one of five drugs "on the market today that I think need to be looked at quite seriously to see if they belong there".
Mr Graham added that GlaxoSmithKline's asthma drug, Serevent, and several other treatments from Pfizer, Roche and Abbott Laboratories ought to be assessed more closely.
He issued the warning at a senate hearing to look at the sudden removal of the arthritis drug, Vioxx, by America's Merck in September.
The withdrawal of Vioxx was the biggest ever, and has heightened concerns about whether drugs are being properly monitored by the FDA.
The increased risk of heart attack caused by Vioxx, which is used by 20 million Americans, was a "tragedy", Mr Graham said. His comments came as politicians criticised the FDA for not being quick enough to crack down on pharmaceuticals companies when their drugs showed worrying signs in trials.
Charles Grassley, a Republican senator from Iowa, said the FDA's relationship with drug makers was "too cosy".
Merck is under fire over allegations it knew about the risks of taking Vioxx, but did not act quickly to withdraw the drug, which it introduced in 1999 and generated $2.5bn (£1.3bn) in sales annually.
Raymond Gilmartin, the chief executive, gave evidence at the Senate hearing, denying that Merck dragged its heels in establishing the side-effects of Vioxx and scrapping the drug.
Mr Graham, a critic of Vioxx, has linked the drug to 27,785 heart attacks and deaths. Yesterday, he toldCapitol Hill the number of people adversely affected was more likely between 88,000 and 139,000.
Merck has lost 40 per cent of its value and its triple-A credit rating since the Vioxx recall. It confirmed last week that the US Justice Department and Securities and Exchange Commission have begun investigations.
AstraZeneca has been the subject of a campaign against Crestor, which was billed as one of its most exciting new drugs. The pressure group Public Citizen is calling for the FDA to withdraw the drug on the basis that it allegedly causesrhabdomyolysis, a muscle-destroying condition.
|
