Doctors want new agency to monitor drug safety

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Doctors want new agency to monitor drug safety

Reports question whether Baycol was pulled quickly enough

http://www.cnn.com/2004/HEALTH/11/22/risky.drugs.ap/index.html

 

 

 

 

Monday, November 22, 2004 Posted: 9:29 AM EST (1429 GMT)

 

 

 

(AP)

-- New reports accuse another drug company of being too slow to pull a

dangerous medication from the market and question the ability of the

federal Food and Drug Administration to protect the public from such

risks.

This time it's Baycol, a cholesterol-lowering statin

that Bayer AG withdrew in 2001 after some who took it developed a

severe and sometimes fatal muscle disorder. A new study found that the

risks were far greater than had been believed.

The study

concludes that today's top-selling statins are very safe, but could be

risky when taken with other drugs called fibrates by older people with

diabetes.

It also reveals that fibrates alone can be dangerous. These drugs

lower triglycerides and often are taken by diabetics.

Six

papers on the issue were to be released Monday and will be published

Dec. 1 in the Journal of the American Medical Association. Its editors

called for a new, independent office separate from the FDA to monitor

drugs after they're on the market.

"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," they write.

Merck & Co. and

the FDA have been accused of moving too slowly to stop sales of the

arthritis drug Vioxx, which Merck withdrew in September after revealing

it raised the risk of heart attacks and strokes. Some scientists claim

that pain killers similar to Vioxx, especially Pfizer Inc.'s Bextra,

also carry risks.

On Thursday, Dr. David Graham, associate

director of science in the FDA's Office of Drug Safety, told a Senate

panel that the FDA was incapable of protecting the public, and that

dangerous drugs are being sold now. Bextra and AstraZeneca PLC's

statin, Crestor, were among the five he named.

Crestor wasn't

part of the new study that Graham and nine other government and private

scientists published Monday because the drug was only approved in

August 2003 and their study started in 2001, just after Bayer withdrew

Baycol.

They checked records from 11 large health insurance

companies on more than 250,000 statin-users from 1998 to 2001. Statins

lower LDL or "bad" cholesterol, and fibrates lower a different kind of

fat in the blood, triglycerides. People often are prescribed both.

Those

taking the top-selling statins Lipitor, Pravachol and Zocor had an

extremely low risk of the muscle disorder. But it was five times more

common in people taking a fibrate, and an additional two-fold greater

in people taking both types of drugs.

The risk with Baycol was 10

times higher than for other statins, and astronomical when it was

combined with a fibrate: one out of 10 patients taking these for a year

would have developed the dangerous side effect.

"I can't think of another drug safety combination where the level of

risk is this high," Graham said.

Some

popular brand names of fibrates are Abitrate, Atromid, Lopid and

TriCor. As for Crestor, the newest statin on the market, its label

already warns that people over 65 and those with diabetes or kidney

problems are at greater risk of the muscle disorder.

 

Bayer said it disclosed risks properly

Bayer

added a similar warning to Baycol's label but not for more than a year

and a half after it had evidence of the risk, Dr. Bruce Psaty of the

University of Washington in Seattle and three other drug safety experts

write in another article in the medical journal.

As proof, they

cited published studies on Baycol and internal company documents that

have become public as part of a lawsuit in Texas against Bayer over the

drug.

There is a "striking asymmetry" between what the company

knew within three months of putting Baycol on the market and what it

told the public and physicians, they write. Companies have financial

motives to keep such damaging information quiet, and should not be in

charge of monitoring the safety of their own drugs -- an independent

group needs to do this, they write.

A lawyer for Bayer, Joseph

Piorkowski, wrote a response noting that Psaty and another author have

been experts for people who unsuccessfully sued Bayer over Baycol. He

also defended the company's actions, saying it labeled and disclosed

risks appropriately.

In a separate article, Dr. Brian Strom of

the University of Pennsylvania acknowledged the conflict of interest in

allowing drug companies to monitor their own products, but said the

solution is more support for the FDA and its work -- not another

oversight agency.

Graham, the FDA whistleblower, said people

taking statins or fibrates should watch for signs of the

life-threatening muscle disorder, which can be treated if caught early.

Patients should immediately tell doctors of any muscle pain, weakness,

fever, dark urine, nausea or vomiting.