Slave to the Pill | 2

Around the world there continues to be a worldwide 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 lead 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 the podcast, 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. 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.  He offers this advice to other people with Parkinson’s, “If you can get a consistent version (of a generic), that minimizes the potential for that swapping of levels.” The goal for maximum effectiveness of any form of levodopa-carbidopa is to keep the gaps between peaks and valleys of levodopa in your body to a minimum. Merck has stated that there is not a shortage of levodopa-carbidopa in Canada, because 90% of the people with Parkinson’s are on generic versions. Worldwide, others have estimated 80% of people are on a generic, but Merck did not address the global supply even when requested. The reality is 10-20% of the people with Parkinson is 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, WLGYP: Why is there a shortage [of SINEMET®]? Why couldn’t it be anticipated? MERCK: (...) It is important to note that there are no current shortages of either formulations of carbidopa-levodopa in Canada as various generic manufacturers have made them available to Canadian patients. Currently, approximately 90% of the market of levodopa-carbidopa in Canada is supplied by generic formulations. (Source: IQVIA: CompuScript June DM, 2019) 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 MERCK: As defined by Health Authorities, a generic drug is a copy of a brand name drug. The generic drug is pharmaceutically equivalent to the brand name drug: it contains the identical medicinal ingredients, in the same amounts and in a similar dosage form. Generic medications may have different non-medicinal ingredients than the brand name drug, but the company must show that these do not affect the safety, efficacy, or quality of the drug compared to the brand name drug.[i] Currently, approximately 90% of the market of levodopa-carbidopa in Canada is supplied by generic formulations. (Source: IQVIA: CompuScript June DM, 2019) WLGYP: What is the timeline for SINEMET®IR to be available in Canada, U.S., U.K, and around the world? MERCK: We expect that the supply disruption for SINEMET®IR will continue until mid-2020 in the Canadian market. Merck Canada Inc. remains committed to finding solutions to provide this product to Canadian patients as quickly as possible. The most up to date information regarding SINEMET®supply availability is regularly updated on www.drugshortagescanada.ca. It is important to note that currently, approximately 90% of the market of levodopa-carbidopa in Canada is supplied by generic formulations. (Source: IQVIA: CompuScript June DM, 2019) 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 Follow me, Larry Gifford  Twitter: @ParkinsonsPod Facebook: Facebook.com/ParkinsonsPod Instagram: @parkinsonspod Follow Co-host and Producer Niki Reitmeyer 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.  Learn more about your ad choices. Visit megaphone.fm/adchoices