Around the world, there’s a cry for help in the Parkinson’s community. Since October 2018, there has been a global shortage of SINEMET®.
This is the brand name version of levodopa-carbidopa, the gold-standard drug used to treat Parkinson’s disease, which Merck packages and sells. It started with a supply shortage, which led to a third-party manufacturer change.
Anytime you change production of pharmaceuticals, the manufacturer has to re-ratify the entire production cycle. Merck now says SINEMET®IR®, Instant Release, will not be available until July 2020 and production has ceased altogether on the continuous release versions including SINEMET®CR 100/25 and 200/50.
In this episode of When Life Gives You Parkinson’s, I talk to folks around the world who were taking SINEMET®to great effect only for it to be unavailable one day and replaced by a less effective, generic version of the drug.
WATCH: (Sept. 12, 2019) When Life Gives You Parkinson’s podcast launches second season
The U.S. Food and Drug Administration first approved SINEMET® in 1975. Nothing in the last 44 years comes as close to normalizing the lives of people with Parkinson’s as it does.
David Ashford Jones was diagnosed with Parkinson’s at 40 years of age after more than a decade in marketing and sales for pharmaceutical companies. He says people with Parkinson’s easily notice the difference between the brand name version of SINEMET® and the generic.
The difference between SINEMET® and the generic versions is not in the active ingredients, but in the absorption rate of the levodopa into the body in order to have an active effect on Parkinson’s symptoms.
Merck has stated that there is not a shortage of levodopa-carbidopa in Canada, because 90 per cent of the people with Parkinson’s are on generic versions. Worldwide, others have estimated 80 per cent of people are on a generic, but Merck did not address the global supply even when requested.
The reality is 10-20 per cent of the people with Parkinson’s who are taking SINEMET® amounts to somewhere between 700,000 and two million people worldwide. After Merck ceased production, it appears the generic drug suppliers could not ramp up production to meet the expanded hole in the market.
Merck agreed to offer written responses to some of the questions from When Life Gives You Parkinson’s,
Based on current demand, depletion of the current inventory of SINEMET®CR 100/25 MG is expected in September 2019. SINEMET®CR 200/50 MG is no longer available.
Despite the availability of generic alternatives in Canada, Merck understands that the situation may be disruptive for patients and is working to identify solutions to ensure a more stable source of supply is available for the SINEMET®IR® formulation. Based on our current information, we are hopeful to be able to rely on a more stable source of supply for the SINEMET®(IR formulation). However, for the time being, the supply disruption for SINEMET®(IR formulation) will continue until mid-2020 in the Canadian market.
Merck is committed to continue to provide regular updates on the situation to Health Canada and Parkinson’s Canada. For the most up to date information regarding SINEMET®supply availability Canadian patients can consult www.drugshortagescanada.ca.
WLGYP: What are the differences differences between SINEMET® and generic forms
WLGYP: What is the timeline for SINEMET®IR to be available in Canada, U.S., U.K, and around the world?
We have been in contact with Parkinson Canada and Health Canada and continue to provide them with frequent updates on the situation as additional information becomes available.
Thank you for listening. Add your voice to the show and leave a message for us here; https://www.speakpipe.com/WhenLifeGivesYouParkinsons
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Twitter: @ParkinsonsPod
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Twitter: @Niki_Reitmayer
Thank you to…
Sandy Jones, Parkinson Canada
Nadia Stewart, Global News – watch her October 2018 report on SINEMET®
David Sangster, person with Parkinson’s, creator of Parkinson’s WorldTV, follow him on twitter @1and20Parkinsons
John Hougan, person with Parkinson’s
Gary Harysom, person with Parkinson’s
Kitty Fitton, person with Parkinson’s, observational comic at https://www.kittyfitton.com, follow her on twitter @kitty_fitton
Rasheda Ali, author, speaker, advocate at http://rashedaali.net/, follow her on twitter @rashedaali
David Ashford Jones, read his blog https://phoenixrisingmyquestforchange.wordpress.com/pharmacology-basics/
Paul Mayhew Archer, author, producer, comedian http://mayhew-archer.com/
Eric Chapman, contributor, in the role of “Mark-Merck”
Rebecca Gifford, my amazing wife.
Merck, Merck.com, follow on twitter @merck, 1-800-444-2080, outside the US & Canada Merck is known as MSD 908-740-4000.
For more info on our presenting partner Parkinson Canada head to http://www.parkinson.ca/
The toll free hotline 1-800-565-3000
Or follow them on Twitter
Parkinson Canada @ParkinsonCanada
Thanks also to our content and promotional partners
Parkinson’s IQ + You– A free, series of Parkinson’s events from the Michael J. Fox Foundation
Spotlight YOPD – The only Parkinson’s organization dedicated to raising awareness for Young Onset Parkinson’s disease and funds for the Cure Parkinson’s Trust.
When Life Gives You Parkinson’s was selected as one of Apple’s best podcasts of 2018.
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