Living Well with Parkinsons Disease

Dancing in the Rain: Lessons Learned on my Personal Journey with PD (more at www.PDPlan4Life.com) Copyright 2013-18 Sheryl Jedlinski

Still no end in sight for Sinemet shortage

By Sheryl Jedlinski

“Those who fail to learn from history are doomed to repeat it,” said Winston Churchill. No one group knows this better, I suspect, than people with Parkinson’s (PWP) disease who depend on ready access to the drug, Sinemet, to keep moving, but silently endure repeated shortages of this “gold standard” treatment. The  current shortage of pharmaceutical giant Merck’s brand name immediate release Sinemet began months ago, and still there is no word as to when production may begin again.  A similar scenario played out in 2011 when Merck transitioned the making of Sinemet to Mylan Pharmaceuticals. During this period, patients could not obtain Sinemet in any formulation or dosage. This past fall, Merck permanently stopped making Sinemet CR (controlled release) due to its inability to secure a “reliable and stable supply” of this off-patent drug, which at the time Merck said accounted for less than one percent of the U.S. market share having been chewed up by generic competitors.

The National Parkinson Foundation’s report, Lessons from the 2011 Sinemet Shortage, concluded: “… with all the stakeholders working more closely together with good information, we sincerely hope we could avoid (drug shortages) in the future.”

Well, the future is here and the past is repeating itself. In the interim, drug shortages have grown increasingly commonplace across a wide variety of medical conditions. Last March, Teva made a “business decision” to stop making a widely used pediatric chemotherapy drug, leaving the only other manufacturer of this drug  in the United States to pick up the slack. Doctors warned they may need to resort to rationing to make the current supply last, ultimately putting children’s lives at risk as no other known drug available is as effective. And yet Teva walked away and never looked back, knowing that no one, not even the government, can compel a company to manufacture a drug it no longer wants to make.

Unless and until we legislate real change, big pharma will continue business as usual, exercising free rein over everything from prescription drug pricing to creating artificial drug shortages to suit their own needs. Answering first and foremost to their stockholders, pharma puts profit margins ahead of patients’ best interests; and discontinues older drugs to replace them with newer, more profitable ones. The concern is that if pharmaceutical companies are required to jump through too many hoops and the process isn’t lucrative enough for their desire, they will opt out of high risk drug research and put their money to work elsewhere. This won’t happen, however, if the rules are consistent for all companies across all illnesses and conditions.

Drug shortages have reawakened debate about the increasing reliance on generic drugs across the board, and what consumers sacrifice to obtain lower priced drugs. .In each instance of Sinemet shortage, consumers reported the generic substitutes wore off sooner, took longer to kick in, and failed to achieve as great a maximum effect as the brand name drug, despite attempts to work with their doctors to optimally titrate it.  The bottom line, according to a report by the National Parkinson’s Foundation, is that the FDA’s bioequivalency standard for generic drugs “is not sufficiently rigorous to ensure equal efficacy in anti-parkinson medications.”

While generic drugs must have the same active ingredients in the same amount as the original brand name drug, the inactive ingredients (dyes, flavoring agents, and binding materials) can be different, affecting how quickly the medication gets absorbed in the bloodstream, and accounting for variations in therapeutic efficacy, overall patient tolerance, side effects, and allergic reactions.  Still, pharmacists routinely swap brand name drugs for generics or one generic for another, and dispense differing generic formulations at each refill without necessarily letting patients know. They justify this behavior by arguing that most patients tolerate generic substitution with little or no problem. Why then are many doctors recommending that generic substitution be treated as a medication change, and be managed by a patient’s physician.

Prescribing physicians may request a specific generic or name brand drug if a patient reports better results with that formulation, but the pharmacy may not stock it, in which case patients may ask their pharmacist to check other pharmacies in their network. Be aware that pharmacies will try to sell the medicines lining their shelves before ordering something new. Do not leave the pharmacy without checking the label on the medicine you are picking up. In many states, by law, once medicine leaves the store, it cannot be returned for a refund, even if it is not what your doctor prescribed.

The bottom line is that we need to bring new more effective treatments to pharmacy shelves quicker and at a lower cost. Even clinical trials that “fail” reveal important information that helps propel us toward better therapies. Prescription drugs have made our lives better, but are only as good as they are affordable and available. Let these current drug shortages be a wake-up call for the need to revamp our system, putting patients’ needs first. Reach out to the national Parkinson’s disease organizations and offer to work with them to convince legislators and policymakers to push for policies favorable to Parkinson’s research and care.

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This entry was posted on November 19, 2019 by in Advocacy, Drugs, FDA, Treatments.

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