Direct-to-consumer drug ads deserve a closer look

Says Mr. Pharmalot, aka my STAT colleague Ed Silverman.

"After nearly 30 years in which prescription drug ads have become a fixture on television, the Trump administration is attempting a crafty maneuver to largely rid the airwaves of these promotions. To what extent the gambit will work is uncertain. But the effort revives an important debate that I think is worth having," Silverman writes in an opinion piece published today.

Health secretary Robert F. Kennedy Jr., a frequent critic of the pharma industry, wants to eliminate a provision in the law that he says allows drug makers to avoid sufficiently disclosing the risks of medicines in their ads. Eliminating this loophole could make marketing drugs to consumers too expensive, while skirting challenges based on First Amendment grounds.

With that said, drug ads can benefit consumers in some circumstances, Silverman writes. If the administration is confident of its position, then it should somehow prove that its forthcoming rule would prevent harm to consumers as a basis for tackling free speech concerns.

liquid biopsy

Exact Sciences launches $689 multi-cancer blood test

Exact Sciences has debuted Cancerguard, a $689 liquid biopsy test that promises to detect signals from 50 cancers using DNA and protein markers. But experts are urging caution: While the company touts overall sensitivity of 64% and high specificity (97.5%), the test's performance for early-stage cancers drops to 39%, which raises questions about how useful it might be in the real world, STAT's Angus Chen writes. The data come from a case-controlled study, not a prospective trial, which fuels skepticism among oncologists and biostatisticians who warn of false positives, costly follow-ups, and incidental findings.

"It is premature to be releasing these tests to the public," one biostatistician at the Fred Hutch Cancer Center told STAT. "It's challenging not just to understand their performance, but to get a sense of their impact on health systems and on patients for better or for worse."

Still, Exact's chief medical officer Tom Beer argues the unmet need justifies release, pointing to deadly cancers lacking screening tools and backing a $6,000 imaging reimbursement guarantee for patients whose insurers balk. Meanwhile, the company has a 25,000-person prospective trial called FALCON underway.

awards

Scientists win Lasker for cystic fibrosis breakthrough

Three scientists — Vertex's Paul Negulescu, former Vertex researcher Jesús González, and University of Iowa's Michael Welsh — have won the $250,000 Lasker Award for their roles in developing Trikafta, a triple-drug therapy that transformed cystic fibrosis from a childhood death sentence into a manageable condition.

Approved in 2019, the Vertex drug can extend life expectancy for CF patients into their 80s if started in adolescence, benefiting more than 90% of people with the disease. Although it changed the paradigm for cystic fibrosis treatment, however, Trikafta's $300,000 annual price tag leaves many patients in low- and middle-income countries without access. To address this, Vertex has launched a donation program in 14 nations.

podcast

Trump, Chinese biotech, and an industry career reshaped by illness

On this week's episode of "The Readout LOUD": a drug-industry career reshaped by illness, and the potential for political blowback against Chinese biotech.

Listeners of this podcast probably know pharma consultant Mike Rea for his annual ranking of drug company R&D productivity. But this week, he wrote a poignant personal essay explaining how some medical setbacks have impacted his professional life. He joins us to discuss.

But first, President Trump is considering a significant crackdown on drugs invented in China, according to a recent report in the New York Times. Industry support for the possible measures are mixed, however. While strengthening the U.S. biopharma industry garners wide support, so too does the freedom to source innovative drugs from Chinese biotechs.

Listen here.

fda

Vinay Prasad is back in the C-suite...of the FDA

Vinay Prasad, who briefly exited the FDA in July under scrutiny for his handling of Sarepta's Elevidys safety concerns, is back again in two corporate-seeming roles at the federal agency. Prasad, first appointed in May as director of Center for Biologics Evaluation and Research, now also holds the title of chief medical and scientific officer at the FDA, an update to its website shows.

The oncologist — who now oversees vaccine policy for the U.S. — was a vocal critic of Covid-19 vaccine and mandates while at his former post at UCSF.

"As Chief Medical and Scientific Officer, Dr. Prasad advises the FDA Commissioner and other senior officials on cross-cutting and emerging medical and scientific issues impacting regulatory science and public health," his FDA biography now reads.

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