| |   | Hey everyone, it’s Lev Facher, filling in for Rachel. I have some exciting news: As of this month, I’m STAT’s new addiction reporter! My goal in the new beat is to ask and answer big questions about why our country’s system for preventing and treating addiction is failing so dramatically. I’d love your help: If you have tips or ideas, I’m reachable at lev.facher@statnews.com. And a reminder: In keeping with August recess, after today, this newsletter is on hiatus until Sept. 6. | | | Methadone saves lives. So why is the government limiting access? When it comes to treating opioid addiction, there’s no tool as effective as methadone. Despite the medication’s lifesaving properties, however, it’s still incredibly difficult to access. It’s not like most drugs, which you can pick up at a pharmacy if you have a prescription. Instead, people taking methadone need to show up every day, sometimes at the crack of dawn, at a specialized facility just to obtain a single dose.
In a new story for STAT, I untangle the thick web of rules and regulations that make methadone inaccessible to thousands of Americans, and the recent effort to expand access to the medication amid skyrocketing overdose deaths. Here’s one bit I, personally, found shocking: When methadone is prescribed to treat pain, it’s treated as any other opioid — and available at the pharmacy counter. But when it’s prescribed to treat addiction, it’s subject to a whole raft of restrictions!
Now, though, policy experts and treatment advocates are pushing to regulate methadone more like any other drug — and they say key federal agencies have the authority to act now, without waiting for Congress. Read more here. | How pharma could argue the new drug pricing law is unconstitutional Drug makers have been making veiled threats for weeks that they’re going to sue to block Democrats’ new drug pricing reform law. But could it actually work? In a new story for STAT, my colleague Rachel Cohrs explores the legal arguments that the industry might use.
Rachel talked to legal experts and dug through an old Congressional Research Service report (which our colleague Nick Florko scooped back in the day) to identify some of the legal arguments the industry is likely to use.
There are two primary parts of the Constitution that could potentially be implicated: One prohibits the government from seizing private property, and another protects individuals from excessive fines. Read the full rundown here. | Federal watchdog slams NIH for not enforcing transparency rules The NIH isn’t doing a good enough job making sure the results of clinical trials it funds get reported publicly, according to a new government review. And even though the NIH recently finalized rules that are much more strict when it comes to reporting trial results, the agency still got dinged by the HHS Office of the Inspector General for doing such a poor job in years past.
It’s a long-running problem for the nation’s $43 billion biomedical research agency, which funded 72 trials in 2019 and 2020 — conducted both by its own researchers and by scientists at NIH-funded institutions across the country.
Fewer than half of those trials reported results to ClinicalTrials.gov, a centralized government website. Deborah Zarin, the website’s former director, told STAT’s Ed Silverman that she finds the NIH’s track record “disappointing and indeed shocking.” Read more from Ed here. | This fall, join STAT live in DC Learn from the researchers, patient advocates, and lawmakers driving the next breakthroughs in rare disease research this September 15. Stay once the conversation is complete for a networking and cocktail hour. Purchase your ticket now (or unlock a free pass as a STAT+ subscriber). | A look at the CDC’s ‘ambitious’ overhaul plans The CDC’s reputation has taken a beating since the onset of the Covid-19 pandemic, thanks to an embarrassing testing snafu in early 2020 and a long series of messaging gaffes since then. When it comes to the monkeypox crisis, things don’t seem to be going much better.
Now the agency is looking to remake itself, STAT’s Helen Branswell reports — and it all starts with an “ambitious” overhaul being led by the agency’s director, Rochelle Walensky. So far, she’s not sugarcoating the situation.
“For 75 years, CDC and public health have been preparing for Covid-19, and in our big moment, our performance did not reliably meet expectations,” Walensky told agency employees in an email. Read more here. | What we’re reading - Health agencies use Covid lessons to tackle addiction, guns, STDs, Kaiser Health News
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Hospital mergers that dodge antitrust scrutiny lead to higher prices, STAT -
CVS, Walgreens, and Walmart must pay $650.5 million in opioids case, The New York Times -
A venture capital firm co-founded by former Google CEO Eric Schmidt is bringing in a Theranos researcher to help expand its biotech investing, STAT | Thanks for reading! More after Labor Day,  | | | |
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