FDA Vinay Prasad, Ozempic, autism diagnosis: Morning Rounds

Fresh turmoil at the FDA with Prasad’s exit

Vinay Prasad, who served as the head of the Center for Biological Evaluation and Research at the Food and Drug Administration, is facing fresh turmoil with his upcoming departure from the agency. This marks the second time Prasad has exited the FDA during the Trump administration, following a tumultuous tenure that included being fired in July of last year, only to be re-hired a few weeks later. STAT’s Lizzy Lawrence covers the news of his impending departure, while STAT’s Matthew Herper highlights five key takeaways from Prasad’s time at the FDA.

Additionally, a related feature by Lizzy delves into the concerns raised by rare disease advocates over the lack of public advisory committee meetings at the FDA. This issue has become more pronounced following a series of surprising drug rejections under Prasad’s leadership. Notably, the number of advisory committee meetings on drugs has declined by 72% under the Trump administration, with one senior FDA official citing cost and speed as reasons for reducing these meetings.

Generic Ozempic could be made for $28 a year, says analysis

There is good news on the horizon for individuals seeking weight loss medications, as Novo Nordisk plans to slash the list prices of Ozempic and Wegovy to $675 next year, representing a 50% reduction from their current costs. Even lower prices are expected for direct-to-consumer sales. However, despite these price reductions, the semaglutide drugs may still be unaffordable for many individuals in the U.S. and other countries.

An analysis has suggested that generic versions of these drugs could be significantly cheaper as patents expire, starting in countries like India, China, Canada, Brazil, and Turkey. Researchers estimate that generic versions could be produced for as little as $28 per person per year, offering hope for individuals with conditions such as obesity and type 2 diabetes who currently find the brand-name drugs financially out of reach.

Why some parents beg for an autism diagnosis

The rising rates of autism diagnoses in the U.S. have sparked discussions around the motivations behind seeking such a diagnosis. Pediatrician Lawrence Diller suggests that one factor driving this trend is the financial considerations associated with insurance coverage for a treatment known as applied behavioral analysis (ABA). This treatment has shown benefits not only for children with autism but also for those with conditions like global developmental delays.

However, insurance companies often only cover ABA services for children who meet autism criteria, leaving families facing substantial out-of-pocket costs. Diller emphasizes the need for broader financial support and services for all conditions affecting toddlers and preschoolers to address the desperation some parents feel in seeking an autism diagnosis.

The outcry over ‘corporatization of health care’ at Oregon hospitals

The corporate takeover of health care is a growing concern, as highlighted by a recent conflict at Oregon hospitals. A new state law aimed at curbing corporate influence is being tested as hospital operator PeaceHealth replaces a local physicians group with the Atlanta-based ApolloMD in staffing emergency rooms. This decision has sparked protests and petitions from the community, with healthcare professionals and residents expressing opposition to the shift towards corporate-driven healthcare.

Nationally, the trend of corporate ownership in healthcare is on the rise, with a decreasing number of emergency room visits being handled by majority physician-owned groups. The resistance in Oregon reflects a broader pushback against the corporatization of healthcare and the impact it has on patient care and community relationships.

Comparisons that help patients make better decisions

Effective communication in healthcare involves providing patients with context and information to make informed decisions about their treatment options. A recent article in JAMA Insights emphasizes the importance of using numerical comparisons to help patients understand the risks and benefits of different courses of action.

By offering statistics about alternatives and presenting information in a clear and accessible manner, clinicians can empower patients to make decisions that align with their preferences and values. Providing context and comparisons can enhance patient understanding and confidence in following recommended treatment plans.

What we’re reading

• Can a ‘living drug’ cure autoimmune diseases? The New Yorker
• America must not learn to live with 72,000 overdose deaths a year, STAT
• More young women are dying from heart disease — and people are missing these warning signs, Vox
• The FDA, urged to avoid controversy, creates a new headache with attacks against UniQure, STAT
• Jarring alarms out, quieter alerts in. New firehouse dispatch systems aim to ease stress, AP