January 21, 2024: New drugs roundup; obesity drugs trends; Eli Lilly's new telehealth and Rx service; Netflix-style health & drug delivery; BetterHelp secret shopper story; Drugs & insulin resistance
Welcome to the Ask a Patient® biweekly roundup of consumer-friendly pharma-focused treatment news & stories.
Dear Readers, a post sent separately from this news roundup today contains a special feature on acupuncture treatment. Keep an eye out for it and learn (among other things) how acupuncture helped a pug with paralysis after a car accident. Read the indepth Q & A with an acupuncture practioner to find out if such a treatment might be right for you. You may also read it here.
Drug Approvals
The U.S. FDA (Food & Drug Administration) published its annual report on new drug approvals. For 2023, of the 55 new drugs, 65% of them (36 drugs) gained approval using on one or more of the FDA’s expedited review pathways. The 33-page booklet is available for download.
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-202
The FDA approved Vertex’s Casgevy, a cell-based gene therapy for patients age 12 and over with transfusion-dependent beta-thalassemia, an inherited disorder characterized by life-long anemia requiring frequent blood transfusions. To produce Casgevy, patients’ own stem cells are modified by genome editing utilizing CRISPR/Cas9 technology. Casgevy was also recently approved for the treatment of sickle cell disease in patients 12 years and older.
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-vertexcrispr-gene-therapy-an-inherited-blood-disorder-2024-01-16/
The FDA approved Merck’s Keytruda (pembrolizumab) for yet another indication, this time as a treatment for patients with stage III-IVA cervical cancer. The drug label was also updated to include geriatric use information from clinical trials.
https://www.curetoday.com/view/keytruda-plus-crt-offers-better-chance-of-cure-in-advanced-cervical-cancer
Zydus’ pimavanserin, a generic for Nuplazid, was granted tentative approval (due to patent disputes) to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214493
The FDA extended the shelf life of the life-saving drug for opioid overdoses, nalaxone from three years to four years. This shelf-life extension applies only to Narcan (4 mg) nasal spray products produced after January 2024.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-shelf-life-extension-naloxon
Drug Safety Labeling
For drug safety labeling updates and other FDA safety communications highlights, check out our new section. This update includes Prolia, Dupixent, GLP-1 (weight loss and diabetes) drugs. A commonly used CPap device mask is under recall.
Obesity Drugs: Where the Patients Live
PurpleLab HealthNexus released data based on 1.9 billion claims from private insurers and Medicare and Medicaid that reveal where new GLP-1 weight loss drugs are being prescribed in the U.S. Not surprisingly, the data show that areas of the country with the most obesity also have higher rates of weight loss drug prescriptions. For every 1,000 Kentuckians, roughly 21 were prescribed drugs like Ozempic and Wegovy. That was followed by West Virginia with 19 prescriptions per 1,000, and Alaska in third with about 18 prescriptions per 1,000. Rhode Island had the least prescriptions rate with just 3.7 per 1,000. Check out this New York Post article for a variety of maps based on the data.
https://www.yahoo.com/news/states-most-people-weight-loss-150954065.html
Eli Lilly Launches Telehealth and Drug Delivery Service
Eli Lilly launched a new website called Lilly Direct that will allow patients to get a weight loss (Zepbound), migraine (Emgality), or diabetes drug (Humalog insulin) prescriptions through its telehealth provider partners. (Check out this complete Medications List) The company says this will improve access to the "extremely popular and effective" drugs, including its recently approved weight loss drug Zepbound. LillyDirect joins a growing list of platforms like WeightWatchers and Ro offering weight loss drugs through telehealth, but is the first of its kind from a pharmaceutical company. Includes video interview with Eli Lilly CEO David Ricks.
https://www.nbcnews.com/health/health-news/weight-loss-drug-online-website-eli-lilly-rcna131597
Not everyone is happy with the idea of a pharma-sponsored telehealth business model. "The idea that you have pharmacists and doctors who are devoted, in effect, to Lilly products does not seem in the best interest of patients," said Dr. Peter Lurie, president and executive director of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA.
https://www.cnn.com/2024/01/04/health/eli-lilly-medication-service/index.html
Subscription-Based Health Care and Prescription Refills
Associated Press Health and Science Department investigated the growing phenomenon of online subscription services for health care. They say that companies including Hims & Hers, Ro and Lemonaid Health now provide quick access to specialists and regular prescription deliveries for a growing list of health issues. Hims recently launched a weight-loss program starting at $79 a month without insurance. Lemonaid began treating seasonal affective disorder last winter for $95 a month. Ro still provides birth control, but it also connects patients trying to have children with regular deliveries of ovulation tests or prenatal vitamins. This Netflix-like approach promises help for two common difficulties in the U.S.: access to health care and prescription refills. But it also stirs concerns about quality of care. The A.P. Health and Science Department received support from the Howard Hughes Medical Institute’s Science and Educational Media Group for the investigation.
https://apnews.com/article/hims-ro-lemonaid-subscription-health-care-6bbd960335fd8a7cc71563858e1a441a
Licensed Psychologist Secret Shops at Mental Health Subscription Service BetterHelp
Robert Cohen, Ph.D, a practicing clinical psychologist, decided to evaluate first-hand the prominent online mental health treatment platform BetterHelp as both a patient seeking psychotherapy and as a therapist seeking to be hired by the company. His experience revealed "concerns about BetterHelp’s ability to provide quality, secure treatment—and the unresolved tensions in the science of psychotherapy that services like BetterHelp exploit." As a subscriber, he asked for help with genuine problems: overeating in the evenings after dinner and procrastination in completing paperwork and writing projects. While acknowledging that he worked as a therapist, he did not reveal that he was also gathering information to write about the platform.
Cohen also applied to be a BetterHelp therapist, where he learned that it was easy to get hired, pay was low, and hourly rates were tied to the number of hours worked. Cohen is on the faculty of the University of Michigan department of psychiatry and at the Michigan Psychoanalytic Institute. Read about his experience as a patient seeking help from three separate therapists and his experience as an independent contractor therapist at BetterHelp.
https://www.madinamerica.com/2024/01/therapy-app-clinical-psychologist-betterhelp/
Drugs and Insulin Resistance
Even if you are not obese, you still might have "insulin resistance," which is when your body doesn't respond to insulin properly, resulting in high levels of blood sugar, a precursor symptom of diabetes. In fact, MedShadow Foundation reports that 44% of adults in the U.S. have insulin resistance, but only half of them also have obesity. Drugs that can cause insulin resistance include HIV drugs, corticosteroids, anti-seizure meds, and statins (like rosuvastatin/Crestor). Even endocrine-disrupting chemicals found in our everyday environment may contribute to insulin resistance. Read more about the condition and what you can do about it:
https://medshadow.org/what-to-know-about-insulin-resistance
Have you used any of the drugs mentioned in this newsletter? Our website is very much in need of NEW drug ratings and reviews!
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