[olsen]

Uproar Over Shortage Of Merck Parkinson’s Drug

http://www.pharmalot.com/2010/07/upr...28Pharmalot%29


Posted: 06 Jul 2010 05:47 AM PDT

Patient groups and politicians are demanding that Merck move faster to end an ongoing shortage of Sinemet, a widely used Parkinson’s treatment that the drugmaker says may not become available again until sometime in 2011...,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 ... “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: “...“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 ...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... 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