Yet another drug has been withdrawn from the U.S. market. Vioxx, which boasted 2003 sales of $1,800,000,000 – the actual number appears more impressive than simply saying $1.8 billion – was withdrawn by its manufacturer, Merck Pharmaceuticals, after a study designed to prove the drug’s effectiveness in preventing colon polyps backfired by revealing a higher death rate from heart disease in subjects taking the drug.

As is almost always the case, Vioxx was withdrawn not because it increased the risk of death from heart disease, but because it did so more frequently than its competitors. Baycol, a cholesterol-lowering drug, was withdrawn several years ago not because it increased the risk of fatal complications when combined with another drug, gemfibrosil, but because it did so more frequently than competing brands. Severe, life-threatening muscle breakdown, called rhabdomyolysis, can be triggered by any drug in the class known as “statins”. This condition occurs more frequently when these drugs are combined with a second drug called Lopid (gemfibrozil).

Rhabdomyolysis occurred at a rate of 4.24/100,000 prescriptions when Baycol, a “statin” drug, was combined with gemfibrozil. When other statin drugs are combined with gemfibrozil, rhabdomyolysis occurs at a rate of approximately 1/100,000 prescriptions. Since this incidence is considered “rare” Baycol’s cousins not only remain on the market but are being prescribed in combination with gemfibrozil with increasing frequency. Unfortunately, if you are the 1 in 100,000 people who develops rhabdomyolysis the incidence in your case is not rare; it is 100 %.

Vioxx was a member of the “cox-2 inhibitor” class of drugs. Others include Celebrex and Bextra, which are available in the United States, Prexige, which is currently approved for use in 16 countries, and Arcoxia, which is currently approved for use in 38 countries, including Canada.

Merck, the manufacturer of Vioxx, filed an application for approval of Arcoxia with the FDA in December, 2003, but withdrew the application in March, 2004. While Merck maintains that it withdrew the application to allow time to gather more data to support its use in chronic pain, it is quite likely that questions regarding its safety were also involved. It is significant that this was the first new drug application withdrawn by Merck in over ten years.

An application for approval of Plexige is currently pending. Its manufacturer, Novartis, is touting the drug as safer than other cox-2 inhibitors, but the study upon which this claim is based specifically excluded individuals at risk for cardiovascular disease from participation. In addition, the drug has a tendency to cause liver toxicity and appears to be more likely to adversely affect the liver than existing drugs of its class.

While I hesitate to do so perhaps saying, “I told you so!” will encourage people to take other recommendations more seriously and thus save their lives. I warned patients of the risks of taking Phen-Fen for weight control years before the combination was taken off the market due to an excessive number of deaths related to its use. I warned of the dangers of using ephedra (ma huang) for years before its dangers finally caused it to be removed from the U.S. marketplace. I wrote of the dangers of Vioxx and its cousins and the dangers of statin drugs the June issue of Health By Design and recommended alternative approaches to the challenges for which they are prescribed.

I am currently fighting an uphill battle in my campaign to educate people about the true causes of atherosclerosis, heart attacks, and strokes. The actual causes of cardiovascular disease are damage to LDL cholesterol by free radicals and damage to arterial walls by homocysteine - not elevated cholesterol levels and aspirin deficiencies. Despite overwhelming evidence that this is true, most individuals continue to obsessively lower their cholesterol levels and take an aspirin a day, ignoring the known risks of doing so. The reasoning I am most often given is, “All of the people warning about the dangers of cholesterol can’t be wrong. Besides, I don’t want to make my doctor unhappy with me.”

History has repeatedly demonstrated that popular conceptions are frequently wrong. The prevailing view of 15^th century Europeans was that the earth was flat. Galileo was declared a heretic for suggesting that the earth revolves around the sun. As late as the nineteenth century, hand washing was held in disdain by physicians. The hospital death rate from childbirth fever was 25 per cent in Europe and the United States. In the late 1840's, Dr. Ignaz Semmelweis ordered doctors and medical students on his ward to wash their hands before examining a woman in labor. Even though the incidence of childbearing fever dropped to less than 1 per cent he was greeted with hostility by his peers and forced to resign his position. Dr. Oliver Wendell Holmes met with ridicule when he endorsed the practice of hand washing in the United States.

Twenty years after cholesterol reduction was first heralded as the answer to preventing heart attacks, 500,000 people die from them each year in the United States. Perhaps it is time to consider the possibility that those who continue to promote cox-2 inhibitors like Vioxx and statin drugs like Baycol are not taking a logical approach to the health challenges confronting people in the twenty-first century.