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Medical Forum / Diseases and Disorders / Arthritis / December 2004New Doubts About Celebrex
New York Times December 18, 2004 EDITORIAL New Doubts About Celebrex Let's hope that Pfizer isn't falling into the same mind-set that Merck demonstrated when it stonewalled for years over the safety of its popular arthritis drug, Vioxx, only to yank it from the market when a convincing study found it raised the risk of cardiovascular problems. Yesterday Pfizer announced the results of a government-sponsored clinical trial, which showed that its own best-selling arthritis drug, Celebrex, more than doubled or tripled the risk of heart attacks, strokes and cardiovascular deaths, depending on the dosage. The company found all sorts of ways to express uncertainty over the meaning of these findings, calling them "unexpected" and inconsistent with its own similar trial and other data. It pledged immediate steps to "fully understand" the results. Yet even before any more data comes in, it seems clear that patients and doctors must confront the possibility that this overhyped class of drugs, known as COX-2 inhibitors, may raise the risk of heart problems while offering at best only limited benefits for some patients. The Food and Drug Administration, notoriously weak in policing drugs already on the market, must step in to reduce the dangers. Vioxx and Celebrex became blockbusters thanks to heavy promotional campaigns that propelled sales far beyond reason. The ads typically implied that the drugs provided exceptional pain relief, but in truth careful clinical trials showed that they were no better in that regard than such common pain relievers as Advil, Motrin and Aleve. The presumed advantage of COX-2 inhibitors was that they might cut the rate of gastrointestinal side effects like ulcers and bleeding. But the evidence of any benefit is skimpy and seems to be offset by the heart risks that have driven Vioxx from the market. Those risks have also led to required new label warnings about Bextra, Pfizer's other entry in the class, and left Celebrex under a cloud. This is a bizarre turn of events for drugs taken by millions of Americans in the belief that they were safer and more effective than older painkillers. Pfizer said it would not pull Celebrex off the shelves, a stance that is not surprising given the profits generated by the drug, and the widespread belief in the industry that Merck only compounded its legal and financial problems by withdrawing Vioxx. But if Vioxx was risky enough for Merck to remove from the market, one wonders why Celebrex should not be yanked as well. The best hope for an honest assessment of the risks of Celebrex lies with the F.D.A. and its expert advisory committees. The agency has been sharply criticized of late for failing to protect the public adequately against unsafe drugs, especially after the drugs are already on the market. Its own reputation will be on the line as it ponders how tough to get about Celebrex in coming days. All statins had deaths from Rhabdomyolysis. Bayer pulled Baycol voluntarily. Pfizer continued marketing Lipitor and increased the dosages recommended and the target populations, as did the other statin manufacturers. People continue to die from rhabdomyolysis, and continue to be disabled from myopathy, neuropathy, cognitive damage, memory loss and amnesia. There have been absolutely no industry studies on a treatment for these disabled people, nor any studies on how to screen out those who will be harmed. Why is anyone surprised that Pfizer, after admitting its other blockbuster drug, Celebrex, kills and harms some people, will 1) continue to market; 2) refuse to investigate any treatment to correct the harm done to those who survive; and 3) refuse to determine the characteristics of those at risk for death or disability and then screen them out of the potential customer population? Is it any wonder that 2/3 of the doctors working for the FDA reported to a survey that they do not believe the FDA is effectively monitoring drugs for safety? The days are past when the Lipitor disabled could be accused of bias in stating this same belief. The FDA doctors now publicly agree! The only fix for this situation is for the Congress to revise the way the FDA is funded. Since Congress made FDA rely nearly entirely on "user fees" (i.e., a % of the sales of approved drugs), the FDA is in the position of cutting its own budget if it takes a drug off the market. Conversely, the only way the FDA can increase its budget is by approving more drugs, or increasing the markets that can buy the drug. An example of this in action is the decision by the FDA to increase the Statin market to Diabetics, immediately after 3 studies by Dr. Gaist were published showing that statins CAUSE neuropathy. Diabetics have a particular succeptibility to neuropathy, but a diabetic population consuming statins meant a larger 'take' for the FDA in user fees. Congress holds the abilty to put this right. As it is now, both the FDA and the Drug Cos are playing by the rules, as set by Congress. > New York Times > December 18, 2004 [quoted text clipped - 50 lines] > already on the market. Its own reputation will be on the line as it > ponders how tough to get about Celebrex in coming days. > All statins had deaths from Rhabdomyolysis. Bayer pulled Baycol > voluntarily. Pfizer continued marketing Lipitor and increased the [quoted text clipped - 4 lines] > studies on a treatment for these disabled people, nor any studies on > how to screen out those who will be harmed. To put this in some perspective: Deaths reported in Statin-Associated Rhabdomyolysis (October 1997 through December 2000) without concurrent Fibrates and taking more than one statin: 51 (see: http://www.citizen.org/publications/release.cfm?ID=7051) From October 1997 to January 2001, nearly 300 million prescriptions were written for statins. That works out to less than 1 chance in 750,000 of getting rhabdomyolysis and 1 in 5,747,000, or 0.000017 percent, of dying from it. The odds of a serious bleed from aspirin can be 1 in 50,000. L. (snipped) > The only fix for this situation is for the Congress to revise the way the > FDA is funded. Since Congress made FDA rely nearly entirely on "user > fees" (i.e., a % of the sales of approved drugs), ... It's not a percentage of sales. User fees are a flat rate. > the FDA is in the position of cutting its own budget if it takes a drug > off the market. True, if the NDA is withdrawn therefor no user fees would be paid for that drug. > An example of this in action is the decision by the FDA to increase the > Statin market to Diabetics, immediately after 3 studies by Dr. Gaist were > published showing that statins CAUSE neuropathy. Diabetics have a > particular succeptibility to neuropathy, but a diabetic population > consuming statins meant a larger 'take' for the FDA in user fees. Only if it's a new drug or a new formulation of an existing drug. If it's merely an additional indication for an existing product, there would be no increase in user fees other than the initial application fee for the supplement. Frightening irony in this scenario: People at risk for heart attack are prescribed Pfizer drug Lipitor. Pfizer drug Lipitor causes myopathy and mitochondrial damage (visible on muscle biopsy), resulting in apoptosis, resulting in high levels of uric acid (body's way of halting cell death), resulting in gout (arthritis). People with arthritis are prescribed Pfizer drug Celebrex. Pfizer drug Celebrex causes increased risk for heart attack. People at risk for heart attack are prescribed Pfizer drug Lipitor... In software engineering, they call this an endless loop. > New York Times > December 18, 2004 [quoted text clipped - 50 lines] > already on the market. Its own reputation will be on the line as it > ponders how tough to get about Celebrex in coming days. Sharon. There is a pattern emerging with {our} posts... Zee (aka mfg) http://tinyurl.com/4knnr ~~~~~~~~~~~~~~~~~ > Frightening irony in this scenario: > [quoted text clipped - 66 lines] > > already on the market. Its own reputation will be on the line as it > > ponders how tough to get about Celebrex in coming days. |
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