You Make the Call

For three days last week, the Gaithersburg Maryland Hilton was scene to an FDA advisory panel debating the safety and medical worth of COX-2 inhibitors. And it was a scene. Reflecting the nationwide import of the Vioxx withdrawal, the conference room was packed with doctors, clinical researchers, pharmaceutical representatives, government officials and reporters. Overflow rooms with their own closed circuit televisions were needed, the attendance was so great.

After occasionally sharp debate, the panel recommended what was recently unthinkable; by a 17-15 vote, the panel suggested that, noted heart risk notwithstanding, Bextra, Celebrex, and Vioxx should be available for the right patient. The recommendation for all three was wrapped in caution and qualification but the panel did go so far as to say Celebrex was less hazardous than the other two medications. Additionally, the panel urged prominent "black-box" labeling to explain the potential heart risk and severe limitationsÑif not an outright banÑon direct-to-consumer advertising.

This may not be the drama's final act. However strongly worded, the panel's recommendations are solely recommendations. Though the FDA usually follows the suggestions of such panels, it can still choose to keep Vioxx off the market just as it can ignore the call to strengthen laws against direct-to-consumer advertising. The FDA is expected to act on the panel's recommendations within the next several weeks.

Beyond the FDA's own actions, it is unclear what will happen to the approximate 600 Vioxx lawsuits brewing nationwide. After all, it is estimated some 20 millions Americans took Vioxx between its release in 1998 and its withdrawal in 2004. If the FDA sanctions Vioxx's risks, does that mean Merck is now safe from legal liability, which has been estimated at 4 to 20 billion dollars? Though some Wall Street analysts and lawyers would agree, Daniel Becnel, a Louisiana attorney with at least 100 Vioxx cases filed had this to say: "I don't think too many doctors will prescribe it and the doctor that will is playing Russian roulette with his malpractice insurance." So, like much in this story, the matter of legal liabilities remains unclear right now.

Should Vioxx come back, the doctor-patient consultation will be imperative. Specifically, high blood pressure, a stressful lifestyle and old age will definitely weigh on any decision to take Vioxx. These factors may exclude older arthritis patientsÑwho commonly have high blood pressureÑfrom taking Vioxx (or Bextra and Celebrex for that matter). And once a COX-2 Inhibitor is deemed appropriate for the patient, it will most probably be fore a short time only and at lower doses than before.

Amidst the uncertainty of legal liabilities and patient treatment, at least one lesson is learned: Medical innovations like COX-2 Inhibitors can expand a doctor's options when treating a patient, but these innovations will never be a cure all for all patients. In other words, the panel's recommendation to reintroduce Vioxx is a sobering reminder of the necessary risk-benefit calculus that goes into medical treatment. Said Dr. Raymond Gaeta, an anesthesiologist directing Stanford University's pain management clinic, "All of us have been reacting to the news as it comes forward, as to whether some of our tools will be taken off the market. This is good news for patients over all. Clearly there are side effects with every medication but it's really important to weigh the potential side effects versus the benefits for an individual patient."

Article References
Ron Winslow, Heather Won Tesoriero, Anna Wilde Mathews, "Where Finding on Painkillers Leave Patients" Wall Street Journal, D1 2/22/05

Barbara Martinez, "A Vioxx Comeback Could Tilt Balance in Merck Legislation" Wall Street Journal, B1 2/22/05

Barnaby Feder, "Federal Panel Consolidates Vioxx Suits" New York Times, C1, 2/17/05

Mary Duenwald, "For Pain Management, Doctors Prescribe Caution." New York Times, A1 2/20/05.