| | | |   | Happy Tuesday, D.C. Diagnosis readers! I hope to see you in Boston this week for the STAT Summit, where both your DCD writers will be moderating panels. Say hi or send news and tips to sarah.owermohle@statnews.com. | | | Inside STAT’s illegal shopping spree  Reporter Nick Florko, holding the illegal products he purchased within just a few miles of the FDA's headquarters (Alex Hogan/STAT) Let’s face it: The FDA might be tasked with policing the foods, drugs, and tobacco products sold in the United States, but illegal products are all over the place – including in the agency’s own backyard. We know, we bought them. STAT’s Nicholas Florko spent a day on a shopping spree around the FDA’s suburban Maryland campus buying everything from cannabis chocolates to dangerous skin cream — and STAT’s Alex Hogan was there to document it all.
While people have been trying to thwart regulators since the FDA was formed over a century ago, Nick writes that the problem appears to be getting worse. After all, in recent years the CBD, vaping, and kratom industries have all made a killing, despite the FDA’s missives against selling these products. Just take the kratom we bought 3.5 miles from the FDA’s campus: The FDA says it’s cracking down on these products, but the company marketing the big bag of kratom we bought brags on its website that it supplies products to “more than 15,000 stores nationwide.”
If you’ve ever walked into a convenience store and thought “how the hell is that legal?” This video is for you. Check it out here. | Indian biotech tweaked Covid trials amid ‘political’ pressure When pressure mounted in Bharat Biotech’s race to develop India’s home-grown Covid-19 vaccine, the company made some questionable changes to the trial protocols for the Covaxin vaccine, according to a review of internal documents from STAT’s Ed Silverman.
The number of people enrolled in the Phase 1 portion of the trial differed from what was later published in a medical journal, for example. The protocol for Phase 3 was also approved while Phase 2 was still underway, and the final vaccine candidate was selected without Phase 2 data, Ed reports.
Bharat executives told Ed their decisions reflected the unusual challenges of working amid the pandemic and argued they faced “political” pressure to get a vaccine out of the laboratory door as quickly as possible — but denied taking any shortcuts. They also insisted the steps taken to speed the trial were vetted during discussions with regulators.
But outside experts say the quiet changes could tear down already fragile public confidence in vaccine makers and government health organizations.
Read more about the internal documents from Ed. | Research fueled by a shared mission to eliminate cancer STAT Wunderkinds have made discoveries that will have lasting impacts on health and medicine. Similarly, MD Anderson researchers are committed to advancing breakthroughs that will bring them closer to their goal to end cancer. These breakthroughs are made possible by MD Anderson’s unique research enterprise, which fuels an ongoing cycle of innovation and translation. This brings insights from the lab to the clinic and back again, leading to practice-changing discoveries at unparalleled speed. The institution is seeking talented scientists to join its mission. Learn more here. | Democrats’ Senate majority puts some health priorities at ease With Democrats projected to protect their narrow Senate majority, the Biden administration can breathe a sigh of relief over health and science goals like installing Senate-confirmed agency directors and curbing Republican probes of top officials including soon-to-be-retired NIAID Director Anthony Fauci.
The House remains uncalled, though polls tip towards Republicans winning a small majority that could launch its own investigations, stall coronavirus funding and launch new legislation. But without a GOP Senate — let alone the White House — the party’s most ambitious goals are stymied, for now.
For example: Democrats’ Senate majority will figuratively declaw Sen. Rand Paul, a Kentucky Republican who had been chomping at the bit to gain control of the Senate health committee and use it to press Fauci for information about the coronavirus pandemic, my colleague Rachel Cohrs writes. Without committee leadership, Paul won’t have subpoena power.
That said, things won’t be simple for Democrats either. With a split Congress they won’t easily be able to pass new Covid-19 funding or advance ambitious health care reforms that need approval from both chambers. Ultimately, the answer these next two years will be bipartisan legislation.
House Republicans have set out a few goals, like lowering hospital prices, investigating pharmacy benefit managers and building onshore manufacturing that they feel will garner bipartisan support, aides and lobbyists told STAT earlier this month.
Read more from Rachel on Democrats holding the Senate. | What to read around the web today - White House to seek more covid funding in lame-duck session, The Washington Post
- She was a celebrated oncologist. Why did she hide her breast cancer until it was too late? The Boston Globe
- Investigating private equity’s stealthy takeover of health care across cities and specialties, Kaiser Health News
- Opinion: Better access to amyloid-PET scans won’t reduce racial inequities in Alzheimer’s disease, STAT
| | | Thanks for reading! More on Thursday,  | |
No comments