Tuesday, November 23, 2004
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.
....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.
All of the articles are available on the JAMA website for free, although some of the links don't work or are mislabeled. Here's the one that takes Baycol's maker to task. It's authors may have their own conflict of interest. They're expert witnesses for plaintiff's attorneys in Baycol lawsuits. (The Bayer lawyer responds here, and the expert witnesses get the last word here.) The expert witnesses do, however, provide a nice summary of how and when things changed at the FDA:
In the late 1980s and early 1990s, the pressure from companies and patients alike was not for additional safety evaluations but for shorter approval times. In response to the criticism that the FDA approval times were too long, the US Congress introduced user fees in 1992. Pharmaceutical companies that sought drug approvals paid fees that enabled the FDA to hire additional staff, and the FDA was expected to meet new requirements for the timeliness of new drug approvals. During the approved lifetime of cerivastatin, however, the 1992 User Fee Act and its reauthorization in 1997 prohibited the agency from spending users fees "on post-marketing surveillance or other drug-safety programs." The FDA received no additional funds from the US Congress for postmarketing safety despite the fact that many new drugs were first marketed in the United States. In 2001, for instance, the FDA’s Center for Drug Evaluation and Research approved 66 new drugs, 24 of which were new molecular entities never before marketed in the United States. This approach—more and faster new approvals without additional funds for safety surveillance—relied increasingly on the pharmaceutical industry to conduct its own postmarketing safety evaluations.
That would seem to be a problem. Having the industry fund the body that's supposed to be regulating them is an inherently bad idea, and the mandated timelines for drug approvals need to be revisted. It's one thing to work fast to get a potentially life-saving drug to market for a disease that's fatal (such as cancer drugs), but it's quite another to put a rush on these preventive medications of marginal value. As Paul Abramson points out in Overdosed America, 100 people have to take statins for two years to prevent just one heart attack. They deserve a little more scrutiny, especially when it comes to long term side effects.
One of the free JAMA articles looks at the rates of one complication among statins - the break down of muscles, called rhabdomyolysis, and declares the majority of them to be safe (brackets are mine):
The incidence rates for rhabdomyolysis for monotherapy with atorvastatin [Lipitor], pravastatin [Pravachol], or simvastatin [Zocor] remained statistically indistinguishable over time. For therapy intervals of less than 6 months, 6 to 12 months, 13 to 24 months, and more than 24 months, the incidence of rhabdomyolysis per 10,000 person-years was 0.7 (95% CI, 0.3-1.6), 0.2 (95% CI, 0.01-1.2), 0.2 (95% CI, 0.01-1.1), and 0.6 (95% CI, 0.1-2.1), respectively. A similar pattern was observed with cerivastatin [Baycol] and fibrate [Lopid] monotherapy.
But this week's Medical Letter takes a look at the literature and finds a slightly higher incidence of rhabdomyolysis:
Dose-related muscle complaints are the most commonly reported adverse effects of statins. The most serious, myositis with rhabdomyolysis, is rare and often associated with drug interactions; about
1-3 cases have occurred per 10,000 treated patients, with a mortality rate of 8%. The rate of rhabdomyolysis appears to be similar with all currently marketed statins.
posted by Sydney on 11/23/2004 11:01:00 PM 0 comments