Drug Shortage Has Parkinson's Patients in a Panic -- and No One Can Explain It
Parkinson's patients in the U.S., however, are so far unaffected.
Parkinson's disease 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. Sinemet is a version of levodopa, also known as L-dopa, a drug that helps limit symptoms of rigidity and slowness.
An impending shortage was announced last year by Merck (MRK) in the United Kingdom:
Starting in late 2009 and continuing into 2011 MSD will experience a significant global supply shortage of SINEMET and SINEMET CR. 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.Merck did not explain what the specific problem with the supply was. On Monday, Merck told BNET that the shortage "affects most markets," but did not elaborate on why it is taking two years to change the supply source. A spokesperson said supply issues were proprietory and that the company expected regulatory approvals to be received by sometime in 2011.
"Merck is taking action to manage available product supply through a process that primarily takes into account patient needs, as well as the availability of alternative treatments and contractual obligations," the company said, adding:
In most markets, alternative products are available to treat Parkinson's disease. The company expects to be able to supply full global needs of these products sometime in 2011; but some countries are expected to return to regular supply earlier than this date.Since 2009, drug shortages have been announced in Australia, Spain and Canada. Patients have also been confused by a lack of information about what is going on with the drug, which is generic and can presumably be supplied by any company that wants to steal Merck's market share.
As a result, PD sufferers have taken to hoarding the drug or going to unusual lengths to get it, according to this PD community bulletin board. Some have taken less than they need in hopes that other sufferers without the drug can get a few pills. Bob Dawson, a PD blogger, tells BNET:
Parkies are hoarding the drug. They're buying on the black market. People have been down to 2 day supply and spend those 2 days going from pharmacy to pharmacy.You can see more fear and confusion on PD bulletin boards here and here.
A Merck spokesperson in the U.K. confirmed that there "certainly is a shortage at the moment" but declined to comment further until Merck executives in the U.S. were available.*
The U.S. appears not to be affected by the shortage as generics maker Mylan received approval to market the product late last year. It is not clear why Mylan's supply of the product cannot be shipped internationally.
*UPDATE: This story was updated with a statement from Merck, above.