Merck Explains Parkinson's Drug Shortage -- Nearly a Year Later
Almost a year into a shortage of the Parkinson's Disease drug Sinemet, Merck (MRK) has finally answered some detailed questions about why it happened and what it's doing about it. The tone of the company's communications has also changed -- management appears to have figured out that their lack of elaboration was doing more harm than good.
According to a chart Merck sent to the Parkinson's Action Network, Sinemet is only fully "available" in 15 of the 35 countries in which Merck markets a version of the drug. In the other 20 countries there is some restriction in supply. Merck chief medical officer Dr. Michael Rosenblatt told PAN:
I would like to personally express our sincere apology for this supply interruption.And Merck medical director Dr. Paul Robinson also answered specific questions from Parkinson's patients here.
However, the one question Merck has declined to answer is what caused the shortage in the first place. Merck has said only that the shortage was caused by a change in suppliers, and that it was not the result of regulatory delays. The company has also declined to explain why such a shortage was not anticipated prior to the supply change. Robinson told patients:
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.Merck does admit that the shortage was caused by one of its suppliers:
... MSD [Merck] changed the manufacturing supply source as a result of a decision by our supplier about their business. As you can appreciate, because MSD is bound by a confidentiality clause with its supplier, we are not able to provide further details of our contractual arrangements.Merck then attempted -- but apparently failed -- to build up a supply to bridge the gap as it switched suppliers:
We did build supply inventory from our original supplier and we are manufacturing using supply from our new supplier. However, the process of identifying, qualifying, and obtaining necessary regulatory approvals that are required to establish a new supply source for an active ingredient is complex and takes time.Lastly, Merck admitted that it had not done enough to warn patients that they may have difficulty getting their drugs:
I can assure you that the company has been actively communicating since the issue arose at the end of 2009, however, as I have already mentioned, it is clear that our messages were not being cascaded to all patients.It's good that Merck is finally opening up about this issue and moving to repair some of the damage to its reputation that it created with its own patients since the shortage began.
Nonetheless, it's surprising that the mainstream press has mostly failed to cover this issue. Clearly, there's more here than meets the eye. Merck has not revealed the name of the supplier who made the "decision" that triggered the switch. It's astonishing that healthcare providers, doctors and regulatory authorities have shown such little curiosity as to how this happened.
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