A Painful Decision

A Food and Drug Administration panel voted overwhelmingly not to approve the Merck painkiller Arcoxia last week. This is bad news for consumers for many reasons.

The 20 of 21 panel members who recommended against approval, presumably, reasoned that this Cox-2 inhibitor, like its relative Vioxx, came with heart risks without offering improved pain relief beyond what is currently available.

First and foremost, consumers do need more choices in available medicines. Anti-pharmaceutical demagogues will tell you that we don't need more "me too" drugs, as Dr. Marica Angell calls them. But in fact, some patients respond better to different drugs in the same class. That is why, for instance, if one statin doesn't lower a patient's cholesterol enough, a physician may switch to different "me too" statins until they get the expected outcome. Similarly, side effects can be reduced or eliminated by trying different medications within a class. Yet these important subtleties held no sway over the panel.

One panel member, Dr. P. Jay Pasricha (University of Texas at Galveston) got it right, voting to approve the drug, "with the additional labeling that it be used for patients who can't tolerate existing traditional nonsteroidals and who are at low risk for cardiovascular events." What a sensible approach.

In fact, physicians in 63 other countries already have Arcoxia in their approved pain-treating arsenal. This drug, like all others, does have risks. That is why it shouldn't be approved for over the counter use and it should come with a black box warning label, just like the one on Celebrex, the only other Cox-2 still on the American market.

The physician, together with the patient, should weigh the risks and the benefits of prescribing Arcoxia, Celebrex, and any other drug versus the risks and benefits of other treatment options. Such decisions should be made based on the patient's individual risk profile. For instance, a patient with severe arthritis, no cardiovascular risk factors, and a sensitive stomach (which would make the older painkilling NSAIDs riskier) might find that Celebrex or Arcoxia may be good choices, at least for short-term relief.

But the panel's decision is not a rational cost-benefit conclusion. It is a signal to drug companies that they shouldn't invest in developing new drugs unless they offer a completely new way of treating a disease. But this policy runs counter to the science. As former FDA deputy commissioner Dr. Scott Gottleib wrote in the Wall Street Journal, "Science is leading us toward matching specific drugs to specific patients, a therapeutic process that requires more drug variety, not less."

Yet if the FDA and future panels follow the lead of the Arcoxia panel, one drug of its type will be all we get.

Finally, Cox-2 inihibitors like Arcoxia may be powerful cancer-fighting tools.

There are data to show that this class of drugs may be effective against prostate and colon cancer. Yet research in these promising areas has predictably slowed with the end of Vioxx and thus income from sales of Vioxx and similar drugs. The FDA panel's vote against Arcoxia will surely serve to further discourage this cancer-fighting research.

There is some hope. FDA Commissioner Dr. Andrew von Eschenbach told Reuters on Tuesday that the FDA would "be open to any new products coming forward, including Cox-2 inhibitors," so long as safety issues were taken into account, as the sole dissenting panel member advised.

The FDA could send a loud message in favor of innovation by taking the almost unprecedented step of overruling its own panel and approving Arcoxia now. That loud noise you'll hear would be cheering from arthritis patients.