Isotretinoin prescriptions face an uncertain future in a post-Roe world
Patients with acne may have to decide between less effective treatment or complete sexual abstinence (1,264 words, 6 minutes)
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Stateside patients and practitioners are concerned that the overturn of the Roe v. Wade ruling could have severe implications for U.S. patients on an isotretinoin regimen. On June 24, the U.S. Supreme Court released its decision ending the federally protected right to abortion.
Roe v. Wade is the 1973 ruling that declared abortion a constitutional right in the U.S. Now, the power to establish abortion laws has returned to individual states, and many states immediately outlawed the practice.
Approved in 1982, more than a decade after Roe v. Wade was established, isotretinoin is an oral retinoid prescription medication used to treat severe acne that has not responded to other treatments. In addition to common side effects such as joint pain and skin irritation, taking isotretinoin while pregnant can result in miscarriage or severe congenital disabilities.
When prescribed isotretinoin, sexually active patients are counselled to practice regular birth control and take monthly pregnancy tests—with these protections in place, patients are unlikely to become pregnant. According to Dr. Michele Farber, a dermatologist practising in Philadelphia in an article on the Refinery29 website: “If [a patient is] careful and taking two forms of birth control, pregnancy on [isotretinoin] is very rare because there is a system in place. With that said, it's not impossible.”
In states where abortion is entirely outlawed or less accessible, dermatologists have spoken out about how medical practices may have to change. “In those states where abortion is not an option, if a young girl on isotretinoin for acne gets pregnant, she will not have a local option for an abortion to terminate her pregnancy,” Dr. Jane M. Grant-Kels said in an article on the Healio website. She is a professor of dermatology, pathology, and pediatrics at the University of Connecticut.
“This is going to alter in certain states the medications we choose to use or not use. It also takes autonomy, or the right to have control over your own healthcare, away from these women,” she said.
Isotretinoin is typically only prescribed to those who have exhausted all other therapeutic options for acne, so patients and prescribers now have a difficult choice. According to Dr. Grant-Kels: “If you take isotretinoin out of my toolbox, there are women who are going to walk around with permanent scars from acne for the rest of their lives. And if you have a child with fetal abnormalities, it can mean financial and emotional turmoil for a family.”
As for the future of isotretinoin in a post-Roe world, fewer prescriptions might mean dire consequences for the product.
With abortion bans creating new barriers, the pharma world might see the reduction or disappearance of isotretinoin as a prescription drug. According to Dr. Grant-Kels, many dermatologists may choose not to prescribe isotretinoin if abortion access is limited, meaning patients will have to rely on other less effective medications or treatments.
THIS WEEK 08/23/22
The U.S. FDA has approved betibeglogene autotemcel (Zynteglo), a one-time gene therapy for the treatment of the underlying genetic cause of beta‑thalassemia in patients who require regular red blood cell transfusions. The therapy was developed by Somerville, Mass.-based bluebird bio, Inc.
Joysbio, a lateral flow rapid test kit manufacturer based in China, announced the development of two Monkeypox tests reported to deliver results in under 15 minutes. These recently launched tests are a Monkeypox Antigen Rapid test and a Monkeypox IgM/IgG Antibody Rapid test. Both are already CE-IVD marked.
The European Medicines Agency (EMA) has validated the Menarini Group’s Marketing Authorization Application (MAA) for elacestrant, a selective estrogen receptor degrader (SERD), for the treatment of ER+/HER2- advanced or metastatic breast cancer.
Kyowa Kirin, the Japanese pharmaceutical group, announced the European Commission (EC) approved burosumab (Crysvita) for the treatment of FGF23-related hypophosphatemia in patients with Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localized.
LISTEN NOW
In season seven of the NPC Podcast, Michael Stone, General Manager for Canada of Mallinckrodt Pharmaceuticals, talks about taking on a leadership role during the pandemic, attracting younger, tech-savvy talent and the relevance of an education degree in pharma. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea and Mark McElwain.
CANADIAN HEALTHCARE MARKETING HALL OF FAME
The Canadian Healthcare Marketing Hall of Fame awards were established in 2002 to honour healthcare marketers who have contributed to our vocation and inspire others.
More than 100 honourees have been selected during the past 18 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge one past Hall of Fame Honoree each week.
2004 Inductee
Dave Rimell
Ottawa
Editor’s note: Dave Rimell died in April 2021.
Mention the name Dave Rimell and heads nod in recognition. Always a fixture on the healthcare scene, his boundless energy and unique talents as an innovator and a mentor made him something of an icon over his 30-year career. “I didn’t really choose healthcare as a career, I guess it chose me,” says Rimell, reflecting on his early success at Maclean Hunter where he earned the President’s Trophy for top salesman in 1967. The year after that, Rimell found himself at MD Magazine for a two-year stint, but a brainstorming session with the dean of the parliamentary press corps and the ex-general secretary of the Canadian Medical Association would send him down a new and exciting career path. That meeting sparked the birth of Medifacts, the first company in Canada to pioneer the electronic medium as a vehicle for continuing medical education.
“When I think about my greatest challenges, there are almost too many,” says Rimell, whose biggest task was to gain credibility for the concept among industry marketers as an effective means of communicating commercial messages to physicians. Rimell would also need to overcome the hurdle of convincing physicians to try a new learning experience, as well as ensure a pipeline of cassette players for physicians who didn't yet have one. He went on to establish the company as the largest annual non-entertainment producer of audio cassettes in Canada, following that with a symposium and a seminar business and his own video production studio and computer software services.
But Rimell maintains that the highlight of his career was when the College of Family Physicians of Canada adopted the Medifacts continuing ed program as part of their curriculum for independent studies. “I’ll never forget the day that Dr. Don Rice, then executive director of the College, came to Ottawa and said ‘We are so concerned that companies are producing material for our membership and we have no control over it. What do you say we form an editorial advisory board of the College for Medifacts?’ I almost fell off my chair."
Despite his professional successes, Rimell says his proudest moments occurred outside the healthcare industry in a volunteer capacity doing what he loves most: mentoring young people. A dedicated boys’ baseball coach for years while in Montreal, a move to Ottawa (where Medifacts was located) left him without a charitable cause. But then a radio advertisement for the Big Brothers Association caught his attention, and he remembers thinking, “that seems to be my ticket.” After an interview, Rimell was matched up with his little brother, a nine-year-old boy named Scott. Over a period of 33 years, Rimell devoted far more than the requisite four hours per week to his little brother, taking him to the family cottage on weekends and offering him a place to stay when his birth mother passed away.
“He has fond memories of those days,” says Rimell, who notes that Scott, now 42, is all grown up with a wife and son of his own. Theirs continues to be an enduring relationship. “I think joining the Big Brothers was one of the most important things I’ve ever done,” he adds.
Register now for the NPC End-of-Summer Webinar on Sept. 7 at 11:00 a.m
As we wrap up the summer of 2022 and new challenges emerge, the National Pharmaceutical Congress invites you to our End-of-Summer webinar on Sept. 7: "With Covid in the Rear-View: The Way We Live Now." Speakers will include Eileen McMahon of Torys LLP, Mark Smithyes, MBA, and other Life Sci leaders. Ben Parry of The Pangaea Group and Mitch Shannon of Chronicle Companies will share moderating duties.
The event will also provide a preview of the 16th annual NPC, which will be live on Nov. 2 at the Mississauga Convention Centre.
The last NPC webinar was attended by more than 250 pharma industry delegates, so register today before all spaces are filled. The event is free. See you in September. Register at this link: https://lnkd.in/g5pPFTYg
NEXT WEEK
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