Uproar Over Shortage Of Merck Parkinson’s Drug
6 CommentsBy Ed Silverman // July 6th, 2010 // 7:47 am
Patient groups and politicians in the UK are demanding that Merck move faster to end an ongoing global shortage of Sinemet, a widely used Parkinson’s treatment that the drugmaker says may not become available again until sometime in 2011. For the past few months, Merck has issued a statement blaming the problem on a change in the supply source and the time needed to obtain regulatory approvals, but not safety or quality issues (see a statement given to the Association of British Neurologists).
The Parkinson’s UK group, however, is no longer willing to accept this excuse and has begun an online campaign to prompt Merck officials to do a better job of communicating the details and more effectively manage the ongoing problem (see here). “Waiting until 2011 is simply not good enough,” says Parkinson’s UK chief executive on the group’s web site. “This shortage should end now.”
And Margo MacDonald, a member of the Scottish Parliament and a Parkinson’s sufferer, tells The Herald: “This news really does horrify me. This drug is supplied by NHS doctors so therefore I assume that there has to be some arrangement between the Health Department and the drug’s suppliers. “I think there might be room for some political questioning as to why this has been allowed to come about.”
Other formulations of the active ingredient are available, but the issue, for some patients, is that simply switching to another medication is a difficult adjustment due to differences in other substances - although, not the active ingredient - used to make those pills.
There has been speculation on the NeuroTalk forum that warnings about compulsive behavior, which have plagued another Parkinson’s drug, Boehringer Ingelheim’s Mirapex, appeared on the Sinemet labeling (see page 6) just as the shortage began, although this logic would suggest Merck yanked the drug to avoid the sort of lawsuits that have plagued Mirapex (see this). Sinemet sales are not disclosed in the last Merck filing with the Securities and Exchange Commission (see page 5), suggesting it is not a big seller.
UPDATE: A spokeswoman for Bristol-Myers Squibb, which distributes the same product in the US, tells us the drugmaker is not having the same supply issue and so US patients are unaffected. And a Merck spokesman sends us a statement reiterating earlier remarks, while adding that supplies of “full global needs” should begin “sometime in 2011; but some countries are expected to return to regular supply earlier than this date.”
bmartinmd
Confusing story as written. It’s not clear if the reported Sinemet shortage affects only the UK or other parts of the world. A reponse from BMS (which markets and distributes the drug in the United States) indicates that American patients aren’t affected.
Ed Silverman
Hi Barbara,
Thanks for the note and sorry for any confusion. In hopes of clarifying, I’ve added a few words in bold near the top.. “in the UK” and “global.” And the jump includes an update about Bristol-Myers and US distribution as well.
I hope that helps,
Ed
Paul
I am puzzled. This product went generic years and years ago. Where’s the responsibility of all those generic companies?
The model may be broken if they are just interested in copying products while they are big and growing and are willing to walk away when they are small and lose share to newer products. Why is the original manufacturer of ions ago still on the hook? Shouldn’t generic authorizations come with certain responsibilities?
Josh
Paul,
Happens to generics as well. The brand will disappear and leave the generic company with the sole responsibility of manufacturing the product. A lot of these products are difficult to make and may cause the company to lose money on it. I am beginning to think that the innovator sometimes hopes someone will make a generic so they can get out of it.
bmartinmd
In the United States, generic carbidopa/levodopa (standard release) has been around for several years, and many American PD patients use the generic combo pill. To my knowledge, there is no current or anticipated shortage of carbidopa/levodopa–in either branded or generic form.
From a global perspective (at least by my reading), the Sinemet shortage appears to affect most acutely supplies of the controlled-release (CR) form–a generic version of which is not universally available (depending on the country). In the United States, a generic CR version of carbidopa/levodopa (Mylan) was approved by the FDA last year.
mike
Its possible that the reason there is no shortage in the US because the US FDA approved the change in the manufacture whereas the EU hasnt approved the change. According to merck, there was a raw material change in the manufacturing process that required the regulators to approve, looks like some countries have approved in but some others havent done so yet, they generally do but the time involved varies and maybe the EU has asked for further info before approving.