March 3, 2024: Bariatric surgery compared to medication treatment study; heart device malfunctions; hearing aids; dry mouth side effects; FDA weighs in on yogurt and diabetes prevention claims
New Drug Approvals
Gilead’s Covid-19 drug Veklury (remdesivir) has been approved to treat children younger than 12 (from birth on up) weighing at least 1.5 kg. who are either hospitalized or are at high risk for progression to severe Covid-19.
https://www.empr.com/home/news/pediatric-approval-of-veklury-for-covid-19-treatment-further-expanded/
J&J's Rybrevant (amivantamab-vmjw) received traditional approval for certain types of metastatic non-small cell lung cancer (NSCLC), based on its post-accelerated-approval clinical trials results. Its continued approval had been contingent on follow-up verification of clinical benefits in confirmatory trials.
https://www.empr.com/home/news/rybrevant-combo-approved-as-first-line-tx-for-nsclc-with-egfr-exon-20-insertion-mutations/
Alvotech's Simlandi received FDA approval as a biosimilar (generic) to Humira, the popular tumor necrosis factor (TNF) blocker often used to treat rheumatoid arthritis. As an "interchangeable" biosimilar, Simlandi can be substituted for Humira directly at the pharmacy without prescriber approval. Like Humira, Simlandi treats adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. Since Humira went off patent, 10 biosimilar products have entered the market. The first one was AMJEVITA, which was approved in 2016 but did not become available until January 2023.
https://www.fiercepharma.com/pharma/after-long-road-approval-teva-and-alvotech-believe-their-new-humira-biosimilar-simlandi-may
Weight Loss Research
A potential competitor to Eli Lilly's weight loss drug Zepbound has shown promising results in a 13-week Phase 2 clinical trial. The trial, which included 176 adults who are obese (BMI ≥30 kg/m2), or adults who are overweight (BMI ≥27 kg/m2) with at least one weight-related comorbid condition, demonstrated statistically significant reductions in body weight at all doses as compared to placebo. Viking Therapeutic's product, known now as VK2735, is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), similar to the ingredients used in Ozempic and Zepbound.
https://www.prnewswire.com/news-releases/viking-therapeutics-announces-positive-top-line-results-from-phase-2-venture-trial-of-dual-glp-1gip-receptor-agonist-vk2735-in-patients-with-obesity-302072459.html
Research by Cleveland Clinic and three other U.S. medical centers has found that bariatric surgery provides better long-term control of blood glucose levels in patients with obesity and Type 2 diabetes, compared with medication treatments. Study participants who had bariatric surgery also experienced higher rates of complete diabetes remission up to 12 years after their surgical procedure.
For the trial, 262 eligible participants were enrolled between 2007 and 2013 and followed until 2022. The medical group included 96 participants and the surgical groups had 166 participants. Patients in the medical group received a variety of medications for the treatment of Type 2 diabetes, including FDA-approved incretin/GLP-1 agonists. The study was published in JAMA.
Medical Devices
Hearing loss raises the risk of cognitive decline, dementia, falls, depression, and social isolation. KFF Health News' Judith Graham investigated hearing aid use by older adults, and finds that although hearing problems become pervasive with advancing age, exceeding 90% in people 85 and older and 53% of 71- to 74-year-olds, only 29% of those with hearing loss use hearing aids. Barriers are often related to ease of use, design, and cost. Graham presents some tips from audiologists on choosing the right hearing aid.
https://kffhealthnews.org/news/article/hearing-aids-frustrating-to-use-but-necessary-older-adults/
Sid Covington, of Austin, Texas, had a mechanical pump implanted in his heart in January 2022 due to advanced heart failure. Covington says the device, Thoratec's HeartMate 3, has helped him keep an active lifestyle but that it also requires close attention and care. For other patients, the HeartMate3 has malfunctioned and led to death a short time after implantation. Reports in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database describe fatal incidents due to complications not mentioned in the manufacturer’s instructions, such as the locking mechanism malfunction.
KFF Health News' year-long investigation "When Medical Devices Malfunction" revealed that a series of FDA-cleared products, both implanted in the human body and used to treat chronic diseases, have been suspected of contributing to thousands of injuries and patient deaths.
https://kffhealthnews.org/news/article/medical-device-heart-lvad-fda-database-abbott-thoratec/
The MAUDE (Manufacturer and User Device Experience) database is similar to the FAERS (Adverse Event Reporting System) database for adverse effects of prescription drugs reports. It contains ten years' worth of individual medical device incident reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) along with voluntary reports from health care professionals, patients and consumers that are submitted through the MedWatch program. Searchable by brand name, manufacturer, date, and more. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/textSearch.cfm
The FDA issued a statement announcing an alarming trend in premarket medical device submissions to the FDA. An increasing number of testing labs, many in China and India, that contract with device firms are generating false testing data, or data that is duplicated from other device submissions, or otherwise unreliable. The FDA reminded sponsors of device studies and manufacturers of devices (“device firms”) to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA. It is the responsibility of device firms to ensure that all information submitted to the FDA is truthful and accurate.
https://www.fda.gov/medical-devices/industry-medical-devices/fraudulent-and-unreliable-laboratory-testing-data-premarket-submissions-fda-reminds-medical-device
Assessing Risky Treatments – Things to Consider
It's difficult for a patient to make medical decisions when faced with differing recommendations on the best course of treatment. MedShadow Foundation talked to Terry and Joe Graedon, producers and co-hosts of the People’s Pharmacy about how the medical community develops a consensus and how you can make medical decisions for yourself. Especially useful is an explanation of what the phrase "risk reduction" really means. They explain the difference between relative risk reduction and absolute risk reduction for a statin drug study example.
https://medshadow.org/how-to-make-medical-decisions-when-experts-disagree-on-whats-best/
John Mandrola, a heart doctor and writer/podcaster for Medscape and Stop and Think, gives three examples of previously beneficial treatments that he argues need to be retested because clinical situations have changed over time. For example, the implantable cardioverter defibrillator (ICD) has provided a benefit for patients with heart failure who might die from a sudden arrhythmia. ICDs prevent this kind of death by delivering a shock to stop cardiac arrest. ICDs, rightly, became a standard preventive procedure. But now, Mandrola says things have changed: heart failure medical therapy has improved greatly and so maybe ICD is not always the right treatment.
Stop and Think: “Trials and Expiration Dates”
Medication Availability
A ransomware cyberattack on UnitedHealthcare Group’s health technology provider Change Healthcare is wreaking havoc nationwide, as some hospitals and pharmacies cannot get paid, and many patients are unable to get prescriptions. In a federal filing this week, UnitedHealth said that Change Healthcare first discovered the hack on Feb. 21, disconnecting impacted systems "immediately." According to the Washington Post, the outage has been especially hard on independent pharmacies, because they can only see prescriptions that a patient filled at their own pharmacy and so can’t check for information about drug interactions or a patient’s history of controlled substances (like opioids) refills.
https://www.cbsnews.com/news/unitedhealth-cyberattack-change-healthcare-prescription-access-still-impacted/
Two of Bayer's brand name drugs will soon be available at Mark Cuban's Cost Plus discount pharmacy: Yaz (oral contraceptive) and Climara (estradiol – a hormone replacement therapy). While generic oral contraceptives no longer require a copay, for those who want the brand name, the prices offered at Cost Plus will be a bargain compared with prices offered from PBM-mediated pharmacies.
https://health.wusf.usf.edu/npr-health/2024-02-19/bayer-makes-a-deal-on-popular-contraceptive-with-mark-cubans-online-pharmacy
CVS and Walgreens announced they will begin filling prescriptions (issued by certified prescribers) for abortion drug mifepristone in their pharmacies in certain states, beginning with Massachusetts and Rhode Island. Pharmacies must comply with RISK EVALUATION AND MITIGATION STRATEGY (REMS) program for each prescription dispensed. Until recently, the drug was only dispensed in a clinical setting.
https://www.npr.org/2024/03/01/1235265078/abortion-pill-cvs-walgreens-mifepristone
Medication Tips and Side Effects
Taking Eli Lilly's Mounjaro for Type 2 diabetes or Zepbound for weight loss? The Checkup reports that people with pancreatitis, thyroid cancer, gastroparesis, or diabetic retinopathy may experience severe interactions if taking Mounjaro. Also, because Mounjaro causes delayed gastric emptying, the drug may lessen the effectiveness of oral hormonal contraceptives. Check out more potential drug interactions with Mounjaro.
https://www.singlecare.com/blog/mounjaro-interactions/
Mounjaro reviews at Ask a Patient
Some blood pressure drugs (such as thiazide diuretics and beta blockers) increase the risk of erectile dysfunction, while others may alleviate the problem by helping to lower blood pressure by reducing stress on the blood vessels and allowing more normal blood flow.
https://www.singlecare.com/blog/best-blood-pressure-medication-for-erectile-dysfunction/
Vitamin C, including citrus fruit and ascorbic acid, may lessen the effectiveness of ADHD drug Adderall.
https://www.singlecare.com/blog/vitamin-c-and-adderall/
Some drugs may cause dry mouth, which sometimes leads to bad breath. The Checkup lists medications causing dry mouth, which include antidepressants, ADHD drugs and others. They also provide suggestions for reducing the dry mouth side effect.
https://www.singlecare.com/blog/medications-that-cause-dry-mouth/
Bupropion, used in antidepressants and stop-smoking meds like Zyban, is associated with numerous reports of dry mouth on AskaPatient:
Wellbutrin and dry mouth
Wellbutrin XL and dry mouth
Zyban and dry mouth
Here are some examples of ADHD meds with patient reports of dry mouth:
Vyvanse and dry mouth
Adderall and dry mouth
Concerta and dry mouth
Food as Medicine: Yogurt to help avoid diabetes?
The U.S. Food and Drug Administration announced that there is some evidence, but not significant scientific agreement, that eating at least 2 cups of yogurt per week may reduce the chance of developing Type 2 diabetes, a disease that affects about 36 million Americans. This is considered a "qualified" health claim — a claim that lacks full scientific support but is allowed as long as there are disclaimers to keep from misleading consumers. Qualified health claims have been allowed for dietary supplements since 2000 and foods since 2002.
Expect to see these "health claims" on future yogurt commercials and on product packaging. The FDA's announcement was made as a response to a "qualified health claim petition" submitted by Danone North America, maker of Activia and other yogurt brands.
https://www.yahoo.com/news/yogurts-limited-claim-reducing-risk-195628749.html
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