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Merck Knew of Parkinson's Drug Shortage in 2009, but Only Now Blames the FDA

By Jim Edwards

Updated on: February 22, 2011 / 2:23 PM EST / MoneyWatch

A worldwide shortage of Sinemet, a Parkinson's Disease drug, entered its third calendar year without Merck (MRK) explaining why its supply of the drug was been disrupted. The company did, however, blame the FDA in addition to its own suppliers for the Sinemet drought, which reached the U.S. in January. Today, the company reported to the FDA it had resolved the shortage without explaining what caused it.

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 Parkinson's 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.

The shortage began in late 2009, and patients in Australia, Spain and Canada began hoarding the drug. At the time, Merck released a contradictory statement that said the problem was due to the time it takes to get regulatory approvals although the regulators themselves were not to blame:

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.

The only way that statement made sense was if Merck, knowing how long it takes to get approvals, failed to plan ahead.

Merck agreed to answer questions from British Parkinson's patients in July 2010, but missed a deadline for doing so. In August that year it gave its first full answers, but said the real reason for the shortage was a secret:

We understand your frustrations but I must also ask that you appreciate that we cannot provide some information, such as the details of our contractual arrangements with our suppliers, as we are bound by a confidentiality clause, and therefore are not able to provide any further details.

The shortage reaches America
In December 2010, Merck told the U.S. Parkinson's Action Network to brace for the shortage. It gave a little more detail:

Currently, Merck manufactures SINEMET for supply in the U.S. and globally, and Bristol-Myers Squibb distributes the product in the U.S. At the end of this year, Merck will regain the marketing and distribution rights to SINEMET in the U.S. Concurrently, Merck has filed an application with the FDA to change the manufacturing supply source of SINEMET from Merck to a new source, a process that requires regulatory approval. As a result of these two events, a potential temporary supply shortage may occur in early 2011 across some of the dosages.

The changeover in distribution from BMS to Merck is irrelevant, as Merck has always been the original manufacturer. It doesn't matter whose trucks deliver the drug. The use of the word "concurrently" suggests that Merck's application to the FDA was made at the same time as Merck regained the U.S. distribution rights -- if that's true, it seems unfair of Merck to blame the FDA for the delay because the company has known about this issue, and the BMS switch, since 2009.

The switch in Merck's Sinemet "supply source" is the same reason it has offered since 2009. Merck has never explained who that source is, what exactly is being supplied, or why it needs a third party supplier when Merck itself claims to be the manufacturer. Nor has it explained why it could not continue using the old supply source while it waited for regulatory approval of a new one.

The shortage was not expected to be a problem in the U.S., as Mylan (MYL) among other companies makes a generic version. Merck told pharmacists to encourage U.S. patients to use generics, but has not explained why those companies were not encouraged to ship their product internationally. Patients, however, don't like the generic versions as they are slightly different than Merck's and thus doses need to be tweaked up and down to get them right.

Today an entry in the FDA's "Resolved Drug Shortages" database said only:

Merck has changed its manufacturing supply source of Sinemet and Sinemet CR and is releasing product.

Until Merck gives a full account of how it has screwed up its Sinemet franchise only one thing is clear: By Merck's own words, sometime in 2009 the company made a disastrous decision that left thousands of Parkinson's patients with a shaky supply of the drug they depend on for more than two years.

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