Merck Misses Deadline to Explain Parkinson's Drug Shortage and Conspiracy Theories Flourish
Merck (MRK) missed a July 19 deadline to explain why it stopped making Sinemet, the drug which staves off the symptoms of Parkinson's disease, a debilitating nerve disorder. Merck's silence is a classic example of how companies that decline to be transparent about their operations generate a vacuum that's quickly filled with negative speculation and conspiracy theories.
Merck had been urged by Parkinson's UK, a patients' charity, and a Scottish member of parliament to give details on why the company suddenly stopped making Sinemet last year. Merck has said nothing about the Sinemet crisis other than it has something to do with regulatory approval for a "supply change." Merck has said the shortage will last until 2011.
Parkinson's is a progressive, irreversible condition of the nervous system that leads to uncontrollable muscle tremors. Actor Michael J. Fox suffers from it. If PD patients stop taking Sinemet their symptoms return and can worsen.
Parkinson's UK had gathered a list of representative questions for Merck from its membership. The charity said Merck agreed to answer the questions "as fully as they can" during the week of 19 July 2010. But no answers have appeared on the charity's web site.
UPDATE: Merck told BNET:
Merck is doing its best to restore supplies as soon as possible and sincerely regrets any inconvenience or distress this interruption has caused to the people who rely on SINEMET. As previously communicated, the extent of the supply shortage is related to a change in the source of supply and the necessary time needed to obtain regulatory approvals for the change -- this varies from country to country. In the meantime, Merck is managing available supply of SINEMET through an allocation system to optimize use of available stock. In most markets, alternative products are available to treat Parkison's disease. We encourage all patients and caregivers who have questions about their treatment options to speak to their healthcare provider.One Parkinson's patient, Bob Dawson, got hold of the email address of Merck medical director Paul Robinson, and engaged him in a brief exchange about the shortage. Robinson didn't say much more about what's going on except that the shortage is "due to a change in the source of supply of a raw ingredient" (full text after the jump) He also said:In regards to the Parkinson's UK organization, we are in the process of responding to their questions. See link that refers to such: http://www.parkinsons.org.uk/default.aspx?page=11157
Please let me reassure you that your conspiracy theories are not true.That conspiracy theory revolves around the fact that Apotex also stopped making Sinemet in Canada at about the same time. A shortage of cheap generic Sinemet likely benefits Boehringer Ingelheim's more expensive drug, Mirapex.
I'll keep you posted as soon as a full explanation emerges from Merck.
Related:
From: Robinson, Paul [mailto:[redacted]@merck.com] Sent: July-16-10 8:10 AM To: Bob Dawson Subject: RE: Sinemet Well I, for one, joined the pharma industry to develop new medicines, and make them available. I shall continue to do my best, because one day, I shall be a patient I'm sure. I wish you well. From: Bob Dawson [mailto:[redacted]@gmail.com] Sent: 15 July 2010 23:16 To: Robinson, Paul Subject: RE: Sinemet Oh Paul, we've read the same press release a hundred times. At first we did think it looked awfully like an organised shut down But the more we see of it the more we know it is too bizarre to be a conspiracy The fear is not that it is a conspiracy The fear is that it is all a Monty Python skit, and none of you have any idea what you are doing. Paul? Amgen Monkeys in the Middle, world-wide shortage of drugs, Mirapex lawsuits, unexplained disruptions in supply, no new treatment in 50 years---- and often no provision to take care of the terminal--.. Paul? SOMETHING IS WRONG. From down here, having PD, there is way too much nonsense going on. 31% falsified research (Lancet). The PD system, the industry that grew up around our illness, is the text-book case of putting together a contraption that is almost sure to fail. And so we ask questions and we get Monty-Python answers. From: Robinson, Paul [mailto:[redacted]@merck.com] Sent: July-15-10 4:30 PM To: [redacted]@gmail.com Subject: Sinemet Mr Dawson, Thank you for your email. I cannot comment on the availability of Sinemet in Canada - I do not have access to your local data, nor am I aware of the Apotex situation. Please let me reassure you that your conspiracy theories are not true. The manufacturing difficulties affecting the UK are due to a change in the source of supply of a raw ingredient, and the time it takes to ensure that new product meets the required specifications, and then apply for and obtain approval in each country to use product made from the new supplier. We will resume manufacturing as soon as we can, but there will be continued disruption whist we re-stock the supply chain in all countries. If you would like me to put you in contact with the Canadian Medical Director, I can do so. Yours sincerely Dr Paul Robinson. ______________________________ E-mail received states; "I am a person with Parkinson's in Canada, and it was remarkable that Canada's only maker of sinemet - Apotex - shut down production four months AFTER Merck announced a world-wide shortage of the drug. Added to the mystery shutdown at Merck, it certainly appears to be a synchronized shut-down of production by multiple companies in multiple markets. We asked questions, and could find out nothing - information about what the problem is cannot be told, because it is "proprietary". What caused the "world-wide shortage of sinemet", if indeed there is a legitimate shortage, and not just a game? How did it some about that a drug that has been routinely cranked out for half a century, with cosmetic variations, suddenly becomes impossible to produce for 1 8 months to 2 years? Was this a lack of planning, or a criminal act? Was it caused by incompetence and negligence, or was it caused by viciousness and greed? It's a crime in progress, and Parkinson's people should require their governments to investigate and press charges. The lambs have been silent for too long. Yours sincerely Mr bob dawson [redacted] havelock, quebec CANADA