How the treatment of genital warts impacted AF therapy…

I know the title sounds crazy, but this isn’t just a headline grabber. It is real.

Here’s the story:

Tambocor is the brand name version of the helpful AF drug, flecainide. “Flec,” as we call it, helps control AF episodes in patients with atrial fibrillation (AF) AND a structurally normal heart.

Its patent long expired; most AF patients take and get along fine on generic flecainide. A handful of patients, however, have seemed to do better with Tambocor. It’s hard to explain because the drugs appear equivalent on paper. But it’s also well established that medicines impact people differently. Call this a rule of medicine.

Recently, it has been brought to my attention that brand-name Tambocor is no longer available. Poof, it’s gone. A patient tells me that Walgreens wiped it from its list.

Why would this be? And how do genital warts and bankruptcy figure in the story?

The old doctor in me said, “Okay, Tambocor is no longer around, let’s get on with other plans: tolerate generics, change meds or reassess the need for medicine.” The blogger in me wanted to understand why a useful drug just went poof.

In a couple of hours, with the help of an enterprising associate, Google and a link that a patient emailed to me, I found some leads.

My memory had Tambocor being made by 3M pharmaceuticals. This was true, until 2006, when Graceway Pharmaceuticals bought the 3M Co’s pharmaceutical division. In this venture, Graceway wasn’t interested in an AF drug that had a preferred lower-priced generic. They were after 3M’s gems: dermatology creams used in the treatment of HPV-related genital warts and inhaled meds for asthma.

This strategy worked well until the skin creams lost patent protection, which helped pushed Graceway into bankruptcy. Enter yet another pharma company. Arizona-based Medicis Pharmaceutical Corporation quietly bought struggling Graceway in September 2011.

And it looks like Medicis’ plans for Tambocor are murky. From an associate looking into the matter at my request:

I called and spoke with a Medicis representative who said that they are waiting on information from the FDA and do not have a release date for Tambocor at this time.

So that’s it. No profits, no medicines.

Herein lies a familiar story. Shortages of older and less profitable drugs can be life threatening. My friend DoctorWes first reported on shortages of mexiletine, a heart drug used to quell life-threatening rhythm problems. NPR has chronicled the plight of cancer patients forced to take lesser drugs.

Pretty serious issues here.

Reminds of the jingle in the Big Yellow Taxi tune:

Don’t it always seem to go,
That you don’t know what you’ve got
Til its gone

JMM

P.S. For the AF readers affected: My experience with the Tambocor v. flecainide issue is that the great majority of patients do fine with generic flecainide. When I needed chemical cardioversion of AF, I took flecainide. It worked. I know of no studies suggesting Tambocor performs better than generic flecainide. All I have are rare anecdotes in selected patients. That’s not much of an evidence base.