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Prasad’s resignation creates new turmoil at FDA
Vinay Prasad is leaving the Food and Drug Administration for the second time under the Trump administration after a tumultuous reign as director of the Center for Biological Evaluation and Research. (He was fired last July and rehired a few weeks later.) STAT’s Lizzie Lawrence has the news of his upcoming departure, and STAT’s Matthew Harper has five key takeaways.
Next, check out Lizzy’s related feature on how the lack of public advisory committee meetings at the FDA is worrying rare disease advocates after a series of shocking drug rejections under the Prasad administration.
Under the Trump administration, the number of drug adcom meetings decreased by 72%. “Advisory committees are expensive,” one senior FDA official told reporters. “The advisory committee moves slowly.”
Analysis shows that generic Ozempic could be manufactured for $28 per year
Prices for weight-loss drugs are coming down, with Novo Nordisk cutting the list price of Ozempic and Wigoby in half to $675 next year. Direct-to-consumer prices are even lower. However, the drug semaglutide remains unaffordable for many people in the United States and other parts of the world.
New analysis suggests generic drugs could become significantly cheaper as patents expire this month in countries including India, China, Canada, Brazil and Turkey. Researchers estimate that the generic drug could be produced for just $28 per person per year, potentially reducing costs for people with conditions such as obesity and type 2 diabetes that currently cannot afford the drug. Read more articles by Ed Silverman.
Why some parents beg for an autism diagnosis
Autism diagnosis rates are rising in the United States, and pediatrician Lawrence Diller says one of the reasons is “following the money.”
Many parents hope that insurance will cover a treatment called applied behavior analysis (ABA). This treatment has been shown to be effective not only for young children with autism, but also for children with conditions such as global developmental delay. But insurance companies are only required to cover services if the child meets criteria for autism, and a year’s worth of treatment can cost families $70,000 out of pocket.
“The only way to stop this desperate search for an autism diagnosis is to provide financial support and services for all conditions affecting infants and preschoolers,” Diller wrote. read more.
Protest against “Corporatization of Healthcare” at Oregon Hospital
Last summer, a first-of-its-kind Oregon law went into effect aimed at reining in the trend of corporate takeovers and private equity in the health care sector. The law is now being tested after hospital operator PeaceHealth ousted a local physician association that had long staffed emergency rooms in favor of Atlanta-based Apollo MD, sparking protests and petitions across the region.
“They expected us to accept a corporate takeover of our jobs,” one local doctor told Tara Banau. To put this trend in context, nationwide, fewer than half of emergency department visits are dominated by physician-owned entities, and only one in three are attended by physicians employed by hospitals. Read more from Tara on how doctors, nurses and community members are fighting back.
Comparisons that help patients make better decisions
Doctors say you have a 6% chance of developing certain types of cancer, but there are medications you can take to reduce your risk. Do you want a pill?
Without context, it can be difficult to make such decisions. For example, knowing that the average person’s risk is 3% may make them more likely to choose that drug.
This is one of the findings reported in a JAMA Insights article last week about how clinicians can use numerical comparisons to help patients assess the risks and benefits of potential courses of action. The authors suggest that providing statistics about alternatives, rather than focusing solely on a patient’s specific situation and the best treatment option, can help patients feel more comfortable following recommendations.
what we are reading
- Can “living medicine” treat autoimmune diseases? New Yorker
- America must not learn to live with 72,000 overdose deaths per year, STAT
- More young women are dying from heart disease — and people are missing these warning signs, Vox
- Urged to avoid controversy, FDA creates new headache with attack on UniQure, STAT
- Emit a harsh alarm sound and emit a quiet alarm sound. New fire department dispatch system aims to reduce stress, Associated Press
