Health

BIO chaos, Ozempic, MDMA therapy, Guardant

Published

1 month ago

May 25, 2024

BIO chaos, Ozempic, MDMA therapy, Guardant

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Morning! Today, we’re seeing some gaps in the data on MDMA-assisted therapy, and we’re thinking about how this could impact the FDA’s upcoming decision on its approval. Also, the agency’s advisers are debating Guardant’s liquid biopsy test for colon cancer, and we’re seeing new data showing Ozempic’s effectiveness in preventing death in diabetes and chronic kidney disease patients.

One programming note: This newsletter is taking a holiday on Monday in honor of Memorial Day. Enjoy a fantastic long weekend. Do not work too hard.

MDMA studies do not take into account patients with negative experiences

MDMA-assisted therapy is on the verge of possible FDA approval. But while one small study cited an 83% response rate, that doesn’t apply to everyone. One patient reported that she seriously considered suicide while on the phone with her study therapists. “For the first time in a long time, I said, ‘I’m done,’” she said. “The only thing running through my head is: ‘Why am I not the 83%?’”

Such incidents are not reflected in the trial’s published data, STAT’s Olivia Goldhill writes. But critics say there are inconsistencies and flaws in the data that could compromise the integrity of the clinical trials under review by the FDA.

All studies tracked suicidal ideation, a spokesperson for Lykos Therapeutics – the study’s sponsor – told STAT. But it was not considered a side effect unless the recorded levels of suicidal ideation after the trial were higher than before.

Ozempic reduces the risk of death in type 2 diabetes and chronic kidney disease

Ozempic has scored another clinical trial win: its Novo Nordisk blockbuster reduced the risk of death in patients with type 2 diabetes and chronic kidney disease by 20%. It reduced cardiovascular deaths by 29% and lowered the risk of serious heart complications by 18%. These data suggest that these GLP-1 drugs could provide benefits to patients over other classes of drugs, writes STAT’s Elaine Chen.

Novo plans to seek FDA approval to expand the use of Ozempic to treat chronic kidney disease. Wegovy, Novo’s obesity-targeted GLP-1 counterpart, recently received approval for cardiovascular risk reduction. Novo is testing Wegovy for heart failure, MASH and Alzheimer’s disease.

Even more commotion at BIO

How does a pharmaceutical industry lobby group move forward after years of turmoil, including having four CEOs in four years?

This week, STAT’s Washington chief correspondent Rachel Cohrs Zhang joins us on “The Readout LOUD” to discuss the layoffs at trade group BIO and how things could change. We also invite STAT reporter Eric Boodman to talk about his new series of investigations examining how Black women with sickle cell disease were forced to undergo sterilization.

Listen.

FDA advisors recommend Guardant’s blood-based colon cancer test

An FDA advisory committee yesterday recommended that the agency approve a blood-based detection test for colon cancer conducted by Guardant Health. Of the nine voting members, eight thought it was safe, six thought it was effective, and seven believed its benefits outweighed its risks.

If regulators approve the diagnosis, it would pave the way for possible coverage by CMS.

In 2021, CMS declined to provide coverage for Epi proColon, an FDA-approved blood-based colon cancer test made by Epigenomics, write STAT’s Angus Chen and Jonathon Wosen. Shortly after the CMS denial, the company said it would stop marketing the test, and last year Epigenomics announced restructuring and layoffs.

But Shield, Guardant’s test, may be just enough accurate that both the FDA and CMS will approve it.