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   FDA Reviewer Says 5 Drugs Need Closer Scrutiny (including Crestor) (High Cholesterol board)

22nd November 2004
Quote from LV40:
WASHINGTON - Twenty-nine patients who took AstraZeneca's cholesterol drug Crestor have developed kidney damage, a consumer group said on Friday as it called again for a ban on the medicine.

The rate of reported kidney problems is about 75 times higher with Crestor than with all other drugs in the same class combined, consumer group Public Citizen said. According to its analysis, there have been 6.4 reports of acute kidney failure or kidney damage for every 1 million Crestor prescriptions filled.

“It becomes clearer by the day that this drug is uniquely toxic without offering any unique benefit, and that it must be removed from the market,” Dr. Sidney Wolfe, head of Public Citizen’s Health Research Group, wrote in a letter to the Food and Drug Administration.


Rahod, did you know that Dr. Sidney Wolfe, and the Public Citizen’s Health Research Group, was responsible for leading the effort to remove Baycol from the market?
23rd November 2004
The following link >>> http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/11/23/MNGSPA04NI1.DTL&type=printable

states the following in part relating to this topic:

The Journal of the American Medical Association, citing the slow pace of drug recalls after evidence turns up lethal side effects, called Monday for the creation of an independent agency to monitor the safety of pharmaceuticals once they come to market.

The call for more nimble "post-marketing" surveillance was prompted by a spate of recent drug failures such as the arthritis pill Vioxx and cholesterol- lowering Baycol, both of which were pulled off the market long after studies showed they could be dangerous.

In a sternly worded editorial released in advance of its Dec. 1 publication, the prestigious medical journal suggested that inherent conflicts of interest among industry researchers had led to suppression of study findings that were unfavorable to the companies for whom they worked.

The editors also faulted the U.S. Food and Drug Administration for lackluster response to reports of adverse side effects in newly approved medications and concluded that only a separate agency could be trusted to monitor safety once drugs cleared the FDA.

"It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong,'' the editorial declared.

It was signed by the Journal's editor in chief, Dr. Catherine DeAngelis, and by deputy editors Drs. Drummond Rennie and Phil Fontanarosa.

A professor of medicine at UCSF, Rennie said in an interview that the FDA itself has become a tool of the pharmaceutical industry it is supposed to regulate. "There is no question that the senior folk at the FDA are behaving as if their primary client was the drug companies and not the public,'' he said.
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