There seems to be a never-ending battle regarding the cardiovascular safety of cox-2 inhibitors such as Vioxx, Bextra and Celebrex. These medications have been known to cause:
Ironically, despite health concerns, direct-to-consumer marketing for these potentially harmful drugs has appeared in advertisements everywhere.
Should marketing these drugs be permitted?
This is a question prominent cardiologist Dr. Eric J. Topol is more than prepared to tackle. Topol explains that action must be taken in order to reevaluate the government's policy of allowing such advertising to persist. He also stated, "The combination of mass promotion of a medicine with an unknown and suspect safety profile cannot be tolerated in the future."
Further, Topol refers to the hazardous drug class as a "house of cards," in that they seemed destined for failure from the start. Such medicines were marketed to consumers with unrealistic expectations concerning:
The problem? Instead of waiting an adequate amount of time to fully ensure the safety of these drugs after they were approved by the Food and Drug Administration, the medicines were immediately sent off for public use, worsening the public health problem. Thus, it has been suggested that all new drugs be subject to a sufficient trial period before being offered to consumers.
Journal of the American Medical Association January 2005;293 Free Full-Text Pre-Publication Article
The last time I had TV in my home was when the Bulls finished their string of six world championships with Michael Jordan nearly 10 years ago. At that time it was illegal for any drug company to have direct-to-consumer ads on television. But that has long since changed.
I really haven't had the chance to view any of these ads, but I know they are being broadcast. The drug companies are spending over $3 billion every year in this area, and it has been very effective in helping them sell their products.
Fortunately, even leading conventional medicine experts are questioning this policy.
Vioxx, Bextra and Celebrex, taken by millions of patients worldwide, were heavily advertised on television and in magazines and were considered blockbuster successes for their manufacturers. But though Vioxx had fewer side effects on the stomach than earlier generations of arthritis medicines, none of the three drugs was proven to be markedly better at reducing pain.
FDA officials have not publicly addressed the issue of whether high-powered advertising campaigns for newly approved drugs are in the best interest of public health.
"The heart attack risks of arthritis painkillers Vioxx, Bextra and Celebrex have exposed a regulatory 'house of cards' at the Food and Drug Administration," wrote Dr. Eric J. Topol, the chairman of cardiovascular medicine at the Cleveland Clinic. Dr. Topol has been an outspoken critic of the drug companies in the Vioxx catastrophe. JAMA has released this editorial he wrote and allowed the public free access to it.
In the article, Dr. Topol continues to state:
"These drugs were mass-marketed from the moment they were commercially available in the new world of direct-to-consumer advertising, with unrealistic expectations about pain relief, marked gastrointestinal protection and safety. One has to question the wisdom of allowing direct-to-consumer advertising for lifestyle medications that have no capability of preserving life or preventing major events such as heart attack or stroke."
Folks, I think it is high time the Federal Trade Commission (FTC) reevaluates their policy of allowing drugs to be advertised on TV. However, since pharmaceutical companies have spent more money lobbying Congress than other health care organizations, we may never see the FTC reverse its policy unless the public cries loud enough or 50,000 more people are killed.
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