Can We Reimport These?

Hyper-regulatory Europe speeds in front of the United States again. Dr. Gilbert Ross writes in TCS Daily.

There are two new COX-2 inhibitors on the market in Europe and many other regions, offering possible help against both arthritis and cancer but not in the United States: Novartis' Prexige and Merck's Arcoxia. Will our drug agency fairly evaluate them on the standard benefits and risks scale?

Not only can a firm open its shares to public purchase without premeasuring its officers for prison garb, but a person with arthritis can fill a prescription for the newest COX2 inhibitors.

Now Merck is testing the COX-2 waters again. Its Arcoxia has been available worldwide for some time, but the application it first submitted to the FDA in 2003 has been on hold ever since. A newly released study shows that the drug is relatively safe for the stomach and has no excess cardiovascular risk. These data came from a study involving over 34,000 patients and were reported by researchers from the Harvard Medical School. Merck expects the FDA to have its re-evaluation completed by April 2007.

The Swiss company Novartis recently received EU approval to market Prexige. A new study showed that this drug was associated with far fewer gastrointestinal side effects than two older NSAIDs, ibuprofen and naproxen. And, as with Arcoxia, there was no increase in cardiovascular adverse effects. The FDA will also get to consider Prexige early in 2007, according to Novartis.

Doctors and patients will be keeping close track of the FDA deliberations on these drugs. Will the new members of the suspect COX-2 class get a fair hearing from the chronically risk-averse FDA? Experience has shown that the FDA is not immune to unscientific pressures. In the case of the COX-2 drugs, trying to avoid all risk is, in fact, a bigger risk than allowing them on the market. The newer COX-2's have been shown to be as effective as, and safer than, the older arthritis drugs. The scientists at the FDA know that all drugs have risks. As a former practicing rheumatologist, I can bear witness to the suffering caused by arthritis, and I hope the regulators see fit to allow patients access to new treatment options and do not hesitate because of baggage from "the Vioxx taint."

Too much government power has been given to the FDA. People and their doctors should be able to choose these medicines where they're appropriate.

Pharmaceuticals Posted by jk at December 11, 2006 7:26 PM