Merck's Silence Over Parkinson's Drug Shortage Is Unfair and Unacceptable
Merck (MRK)'s mysterious silence over the shortage of its Parkinson's disease drug Sinement has provoked some high-profile critics. A Scottish member of Parliament and a U.K. Parkinson's charity have both turned on the company, demanding an explanation and an end to the Sinemet drought.
The strangest thing, however, is Merck's refusal to tell anyone what is happening with the drug, which is vital for anyone with the disease. It's a position that is unfair to both doctors and patients.
Parkinson's is a progressive and irreversible condition of the nervous system that leads to uncontrollable muscle tremors and difficulty in walking and coordinated motion. Actor Michael J. Fox suffers from it. If PD patients stop taking Sinemet their symptoms return and can worsen. Sinemet is a version of levodopa, also known as L-dopa, a drug that helps limit symptoms of rigidity and slowness.
Parkinson's UK has begun a campaign to end the shortage. "We are yet to receive a full explanation," the nonprofit says. It's asking supporters to flood the email inbox of Merck's medical director with calls for an end to the shortage. Here's what Merck is currently saying about Sinemet.
This temporary shortage is related to a change in the source of supply for the drug and the necessary timelines needed to obtain regulatory approvals for this supply change. It is important to note that this situation is not due to product quality or safety issues, nor is it due to delays on the part of individual regulatory agencies that approve this supply change. To address the expected shortfall, Merck & Co., Inc. (Merck), our parent company, and MSD are taking action to manage available supply of these products through a process that primarily takes into account patient needs, as well as availability of alternative treatments (which exist in most markets), and contractual obligations. In accordance with our analysis, some markets will get their full needs met, many will experience a significant shortfall in their supply, and many will not get any supply of these products.The statement appears to say that the shortage is Merck's own fault. Merck makes clear that it's not a regulatory problem, but says that it is to do with "the necessary timelines needed to obtain regulatory approvals." Those timelines are predictable, so why did Merck fail to work around them? We don't know. Merck has offered no explanation other than "a change in the source of supply," which could mean anything but sounds like Merck is closing one factory and opening another, the type of move that might require a new set of regulatory approvals.
Merck's statement also admits for the first time that some patients -- and some "markets," which is often a drug industry euphemism for "countries" -- will "not get any" Sinemet. That's a worse position than Merck has previously confessed to.
More importantly, Merck hasn't yet felt the need to give patients any details about when and where the shortage of the drug will strike, and what percentage of full capacity the company is supplying, even though the situation is set to last through 2011. The shortage began last year. Parkinson's patients are literally in the dark, hoping for the best. That's just unacceptable.
And this isn't just Merck's fault -- there's no shortage in the U.S. in part because Mylan (MYL) makes a generic version of Sinemet. There's no reason why Mylan can't be asked to supply foreign countries with the drug (I'm sure they'd love the extra business) and yet there's no sign of European authorities requesting that permission from the FDA.
Of course, if that were to happen Merck would lose what market share it has in those countries. Only a cynic would suggest that the two failures are linked ...
Related: