Vioxx pulled from market: But is this reason to celebrate?

The cable news channel I was watching today proclaimed the startling news that Merck had withdrawn its multi-billion-dollar arthritis drug, Vioxx, from shelves worldwide because the medication had been linked to severe and even fatal heart complications. The report advised anyone taking Vioxx to contact their physicians about prescribing alternative medications. The station then broke immediately to a commercial for Celebrex. As a physician who has been cautioning patients about the ills of both medications, I did not feel the urge to dance like the stars of so many commercials for arthritis remedies. Both Celebrex and Vioxx are known as COX-2 inhibitors, a sub-class of non-steroidal anti-inflammatory drugs, or NSAIDS. Older NSAIDS include ibuprofen, naproxen, indomethacin, and many others, including the prototype aspirin. In 1998, fatalities due to NSAIDS among arthritis sufferers rivaled deaths from AIDS.

Ohio October 3, 2004 - by Dr. James D. Chlovechok
Vioxx pulled from market: But is this reason to celebrate?
The cable news channel I was watching today proclaimed the startling news that Merck had withdrawn its multi-billion-dollar arthritis drug, Vioxx, from shelves worldwide because the medication had been linked to severe and even fatal heart complications. The report advised anyone taking Vioxx to contact their physicians about prescribing alternative medications. The station then broke immediately to a commercial for Celebrex.

As a physician who has been cautioning patients about the ills of both medications, I did not feel the urge to dance like the stars of so many commercials for arthritis remedies. Both Celebrex and Vioxx are known as COX-2 inhibitors, a sub-class of non-steroidal anti-inflammatory drugs, or NSAIDS. Older NSAIDS include ibuprofen, naproxen, indomethacin, and many others, including the prototype aspirin.

Facts:
-In 1998, fatalities due to NSAIDS among arthritis sufferers rivaled deaths from AIDS.
-CHF from NSAIDS may have exceeded GI toxicity, which already accounted for 107,000 admissions per year.
-NSAIDS were called a silent epidemic by a prestigious medical journal, and then, incomplete and misleading data published in another leading journal turned newer, but still unimproved, substitutes into a multi-billion-dollar industry.
-NSAIDS inhibit enzymes in the body called cyclooxygenase, of which there are two sub-types: COX-1 and Cox-2. The older NSAIDS block both, while the newer ones target only COX-2. Why is this important?
-According to the New England Journal of Medicine, in 1998 NSAIDS accounted for 16,500 deaths in the U.S. among arthritis sufferers alone, and 107,000 people were hospitalized due to NSAID-related bleeding from the stomach or bowels. The journal editors called this a silent epidemic.
-The deaths among arthritis sufferers due to NSAIDS approached all deaths in this country from AIDS that yearand far exceeded deaths from breast cancer, leukemia, lymphoma, or several other feared killers combined. Worse, the numbers did not include over-the-counter preparations or uses such as headache, backache, dental pain, menstrual or postoperative pain, or many others.
-While retired athletes pitched Advil on television, and physicians wrote thousands upon thousands of new NSAID prescriptions, where were the lapel ribbons, fundraisers, or public awareness campaigns concerning this killer?
-Physicians have been aware of at least one dangerous NSAID complication: GI bleeding. But this was felt to be due to inhibition of the COX-1 enzyme. Hence, the search for selective COX-2 blockers. And in 1999the year after the New England Journal editorialVioxx and Celebrex hit the streets running. Hailed as safer, both were said to lower the incidence of stomach ulcer and bleeding. Physician offices and professional journals were bombarded with this news. Billions of dollars of prescriptions were written. But the whole story had not been told.
-Bleeding is not the only side effect associated with NSAIDS. In March 2000, the Archives of Internal Medicine speculated: The burden of illness from NSAID-related CHF (congestive heart failure) may exceed that resulting from gastrointestinal damage. Other studies indicate half of all hospital admissions for CHF may be due to NSAIDS. And yet this and other potential side effects were ignored by the researchers and marketers hailing Vioxx and Celebrex

Both drugs were denied labeling that would indicate a safety advantage.

The possibility of other side effects did not escape the FDA. Neither did data from the manufacturers own safety studies. Why? For Vioxx, fewer patients suffered GI bleeding compared to an older NSAID, but total serious adverse events were actually higher in subjects taking Vioxx. And the famed Celebrex CLASS study, published in the Journal of the American Medical Association (JAMA), turned out to actually be combined data from three separate studies. And the lower rate of ulcer bleeding was preliminary. Thats right. The studies were not even complete. Celebrex users indeed had fewer ulcers and GI bleeds in the first half of the study, but they had more in the second halfand the numbers balanced out. More shocking, the overall risk of death or adverse effect was higher in those taking Celebrex than in those taking the non-specific NSAID.

So, the miraculous safety advantage of either of these new drugs is a myth. Even before Vioxx was pulled, the FDA had sent warning letters to the both Merck and Pharmacia, maker of Celebrex, regarding deceptive marketing practices. But what about benefit? According to efficacy studies, eight patients would have to take Vioxx for eight weeks to experience a 20% decrease in joint swelling. And studies of Celebrex showed it to be roughly equivalent to naproxen in reducing arthritis joint pain. No NSAID has ever been shown to favorably alter the course of any arthritic condition; in fact, while these drugs may temporarily decrease pain, the studies I have seen demonstrated more rapid destruction of joint tissues with NSAIDS.

In this country, we have come to expect a lot of medical science and our physicians. Unfortunately, most of the science is being financed by those with money riding on experimental results. And these industrial giants answer not to individual patients, but to stockholders. Physicians answer to patients, but receive much of their research information via slanted industrial marketing. And patients are coached through media advertising to ask your physician about this or that drug, or to report symptoms that coincide with a list of indications for prescribing the preferred medication. And this list will have been conveniently dropped off at my office along with some free samples, a few ink pens, and chocolates for my office staff.

I think it is good that Vioxx has been withdrawn. But I am not yet ready to celebrate a healthcare system that puts marketing so far in front of science, or profits ahead of patients interests.

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James D. Chlovechok, M.D., is a former Assistant Medical Director for a major bio-pharmaceutical company and the current Medical Director of the Ohio Sports Medicine Institute. He is working on a book dealing with NSAID risks. Visit him at http://www.doctorjim.org/

Chlovechok is also the author of Game Face, an intense, fast-paced novel that blends mystery and sports, medicine and murdera book that takes you behind the scenes where athletes will do anything to wineven if it kills them.

John Eradi, award-winning sports writer for the Cincinnati Enquirer, calls Game Face right on point; Dean Chance, Major League Baseball Cy Young Award-winning pitcher and current IBA President has this to say: Incredible. Chlovechok knows athletes; and Fritz Hagerman, Exercise Physiologist for the U.S. Olympic Rowing Team and Major League Baseball, NASCAR and NASA consultant calls Game Face Accurate and disturbing.

We hope you will find Dr. James D. Chlovechok and/or Game Face of interest.
For review copies or interview requests, please contact:
Karen Villanueva (505) 764-8323, email: e-mail protected from spam bots
Or Dr. James D. Chlovechok (740) 435-8181, www.doctorjim.org

Dr. James D. Chlovechok, M.D Credentials:
Medical Director - Ohio Sports Medicine Institute, Medical Director - Cambridge Open MRI, Certified American Board of Emergency Medicine, Certified American Board of Independent Medical Examiners, Certified Medical Review Officer Certification Council Member - Ohio BWC Disability Evaluators Panel,
Low Carb Energy Magazine - Expert Panelist