Arcoxia debate important to psoriasis community

Last week, an advisory committee to the U.S. Food and Drug Administration (FDA) voted 20-1 to recommend that the FDA not approve a cox-2 inhibitor called Arcoxia (a non-steroidal anti-inflammatory drug, or NSAID, that relieves pain). This Merck drug (also known as etoricoxib), which is already approved in more than 60 other countries, is seen by the company as a successor to Vioxx, which was pulled from the market in 2004 because it has been linked to increased risk of heart attacks.

While Arcoxia might help some patients with psoriatic arthritis (and is probably already being used by some such patients living outside the U.S.), the broader debate that is occurring about Arcoxia and the FDA committee's reasoning could impact everyone with psoriasis and psoriatic arthritis for years to come.

Among the reasons cited for rejecting Arcoxia were claims that it poses an unsafe risk of heart attack and that the data from clinical trials conducted so far is insufficient. We have no opinion on those claims at this time.

But what should be of interest and perhaps concern to the psoriasis community is some of the other reasoning behind the committee's decision. For example, as a critic of the FDA committee's decision noted in the Wall St. Journal:

Asked about Arcoxia, one of FDA's senior officials said "simply having another drug on the market . . . didn't seem to be sufficient reason" for approval. But the fact remains that all drugs that are tweaks on other medicines have different profiles. Sometimes small changes can dramatically impact how a new drug performs. But more often the therapeutic differences are subtler, mattering only for subsets of patients who only respond well to one particular version of a molecule. This is why doctors sometimes cycle a patient through multiple drugs in a "class" of medicines before finding one that works well for that person.

What's more:

Earlier this week, the FDA staff had concluded that if safer alternatives were available, U.S. regulators should not approve new painkillers in the same class as Vioxx.

While that sounds reasonable, it is not necessarily realistic. What is safer for you may not be what is safer for your neighbor. The millions of permutations of individual health histories and genetic backgrounds is why we have physicians and patients deciding together what makes sense for a particular patient at a particular time. We are wary of any suggestion that FDA officials know today what will be best for millions of psoriasis patients at some future date.

We hear frequently from psoriatic arthritis patients who find pain relief from one drug but not another, and psoriasis patients know all too well that a treatment that works for some may not work at all for them. That is why Psoriasis Cure Now consistently argues for additional treatment options. What some deride as "me-too" treatments that seem too much like existing treatments to us offers hope to patients who have not yet found the treatment that will work for them.

Again, we are not taking a position on Arcoxia--even the Journal commentator wrote that Merck did a poor job defending its drug. But all of us with psoriasis and psoriatic arthritis need to decide if we will really be better off if the FDA continues to block additional treatment options with arguments that patients have plenty of options already.

This is one reason we spoke at the FDA advisory committee that considered Vioxx back in 2005. We feared an overreaction by FDA that would cost the psoriasis community additional treatment choices. Our fears may be coming true. (You can read more here about our FDA testimony at the Vioxx hearing.)

We'll give the final word on this to Dr. Scott Gottlieb, the Journal essayist (and former FDA official) quoted above:

Patients need new drug choices, such as Arcoxia, even when the new drugs reveal the same side effects as the old drugs. Equally important to surfacing side effects is revealing the science that explains why only certain patients will suffer them. The science to do these things is at hand. ...

Given the sheer size of trials Merck ran, few pain pills in Arcoxia's class will be as closely examined and clearly understood. Yet in today's political environment, precautionary principles will keep the FDA from letting patients choose if this pill is right for them. All drugs have risks that patients must weigh against the benefits. Limiting choices patients can make in seeking relief won't change that. But patients would be better off if the FDA focused on unearthing information to help doctors determine which pills will perform the best for each individual patient.