Yesterday, in a public relations email full of misplaced platitudes, Sanofi Pasteur informed urologists that they had given up making BCG. I would cite a website or newswire but that (surprise!) does not exist. BCG is the principal and most effective drug used to combat and prevent bladder cancer. It is instilled in the bladder to reduce the likelihood of recurrences. It is the mainstay drug in bladder cancer therapeutics for local disease.
With little fanfare, bladder cancer patients and treating urologists are–yet again–faced with the prospect of a severe shortage of the drug.
Some background: when the FDA inspected the Toronto-based vaccine laboratory of Sanofi Pasteur in the fall of 2011 they came across 58 different mold infractions. Since Sanofi was not making a blue cheese version of a Stilton BCG–the drug was at severe risk of contamination. The FDA quickly shut the lab down. With Sanofi on the sidelines the only other manufacturer of BCG became and still is Merck. Merck was ill prepared to handle the demand in 2012 and shortages started immediately. Then, remarkably enough, Merck was unable to make the drug at all for a few months (“an unfortunate batch contamination,” I was told). Many patients either missed their doses or received inferior drugs in place of the BCG. My article outlining this debacle here.
Two years later and Sanofi has the BCG Toronto laboratory cleared to make the drug. Now they have decided to exit, most likely because the profit did not follow the fix. So what has been the response? Urologists and patients are profoundly scared. We already know Merck has a poor track record of keeping up with demand. Shortages will begin appearing in weeks after the Sanofi drug stops shipping in 2017. Patients will suffer irreparable harm once more.
Guesstimates on how and why the biologic cancer drug market got to this point are hard to pinpoint. Attempts at getting a meaningful or timely response from Sanofi, Merck or the FDA have been met with a dim thud. Sanofi sent me a recapitulation of the original letter and told me “no executive is available.” Merck and the FDA said nothing in response to my inquiries.
It is hard not to wander into a profound depression over it all. Is this the state of our byzantine drug maze? Do we not have institutions looking out, preventing and planning for shortages of life-giving drugs? The Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144) specifically called for pharmaceuticals to report to the FDA every six months prior to any anticipated shortages (posted to websites). Sanofi has reported to the website–and that is all we have, really: a pretty little website. Feckless government stopgap legislation has done absolutely nothing to help cancer drug shortages.
Nobody, particularly in this new off-kilter Trumpian political environment, wants to push new government interventions. In my view, this is exactly what needs to happen. Cancer drugs–and, for that matter, a host of other essential drugs of little profit–should be produced or supported by the government (perhaps with vaccine production as our guide). It is not an ideal solution, but if there is a constant truism in the omnipresent drug shortage debacle is that drug markets are not looking out for the citizens of this country; it’s time our government did.