Tuesday, December 14, 2010

Back to—and from—the books

Some of you might have been wondering about my uncharacteristic silence since the 2nd edition of my book was born. No—it’s not from post-partum depression. From June until Thanksgiving I have either been working caring for patients or been immersed in the ritual hazing known as preparing for the “Boards.” I am now coming back to my usual self and a more normal life. I have just taken the ABIM’s Infectious Diseases computer-graded subspecialty examination, yet won’t know the results for months. While recovering from this miserable rite of passage, I thought I would get back to commenting on recent notable events.

Two of my favorite pharma scandals to follow have been intermittently in the news. First is the ongoing saga of Pfizer’s Trovan trials, now of Wikileaks fame. Guess apologies are due for my previous guarded defense of Pfizer. Sorry…

Genzyme is often in my thoughts. Perhaps their story reminds me of karma. They were one of the darlings of biotechs. First, they had great respect, having developed life-saving drugs for orphan diseases, Gaucher’s, Fabry’s, and Pompe’s disease, each caused by in-born errors in metabolism.

Then the company’s avarice caught up with them, and they exploited their position as the sole provider of treatment, as I’ve written about here, both in the US and in Latin America, where courts have upheld the constitutional right of access to medication, regardless of the cost.

Last spring, Genzyme’s products were found to have viral contaminants and even bits of trash, prompting a shutdown of its plant and rationing of the life-saving drugs. This has led to the FDA’s issuing a costly consent decree and fast-tracking a rival’s drug. The rationing has gone on for 18 months (for Fabrazyme) and no end is in sight.

Genzyme has also been the target of a takeover bid from Sanofi Aventis in recent months.

So, patients petitioned the NIH and DHHS to override Genzyme’s patent exclusivity, given that the NIH funded the research at Mt. Sinai, which then licensed Fabrazyme only to Genzyme. Last week, NIH turned down this appeal for licensing rights.

Given that patients have no other source of vitally needed medicines, that the drug development was funded by the public, and that Genzyme has not been a good steward of its patent monopoly, do you think pro-business laws like the Bayh-Dole act should be reconsidered? Should NIH now reject patent exclusivity in favor of patient access? What do you think?