Hello, I’m Arthur Allen. I write about the drug industry and related topics for KFF Health News. If you know of a neglected story in this area, send me a nudge at aallen@kff.org.
Today’s edition: The White House is urging Congress to crack down on fentanyl traffickers. The Centers for Disease Control and Prevention is launching a fall vaccination push for livestock workers. But first …
Compounding pharmacies’ big stake in anti-obesity drugs
As many as 1 in 8 American adults has tried one of the GLP-1 anti-obesity drugs, but a surprising number aren’t getting their supplies from pharma giants Novo Nordisk or Eli Lilly. Up to 30 percent of the market, by some estimates, is made up of copycat versions from compounding pharmacies.
Compounding is legal, though the resulting products sometimes fall into a gray area because they’re copies of drugs under patent and are not approved by the Food and Drug Administration.
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Mark Mikhael, CEO of Orlando-based Olympia Pharmaceuticals, estimates that his and other large compounders provision up to 2 million Americans each month with semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.
Many of the compounded drugs are produced for and sold by online pharmacies like Hims & Hers Health, Henry Meds and Ro. Others come from smaller compounding companies.
Novo Nordisk and Lilly fiercely oppose these sales and lump the compounders together with unregulated medical spas peddling bogus semaglutide. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them.
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When there’s a drug shortage — the FDA has put semaglutide and tirzepatide on shortage lists since 2022 — the agency allows compounders to make it. The compounding companies get raw material for the drugs from mostly Chinese businesses that are registered and, at least in theory, inspected by the FDA.
Because the drugs are not strictly FDA-approved, those who make, prescribe or take them should exercise “an increased level of responsibility or awareness,” FDA spokesperson Amanda Hils said.
But she distinguished the compounded drugs from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit. The agency recently warned about patients taking the wrong doses of the compounds, but it hasn’t received a disproportionate number of side effect reports linked to these drugs.
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Semaglutide and tirzepatide have registered unprecedented success in weight loss. They are also showing promise against heart, kidney and liver diseases, and are being tested to treat or prevent Alzheimer’s disease and drug addiction. It’s no wonder they are in shortage.
While most compounded drugs are copies of old, cheap generics, semaglutide and tirzepatide are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Compounded forms are cheaper, particularly for patients whose insurers won’t cover the branded drugs.
While the pharmaceutical giants can’t keep up with demand, they dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”
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Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — regulated directly by the FDA. Smaller 503A pharmacies are largely overseen by state boards of pharmacy.
The compounders are defiant, calling the diabetes and diet drugs essential products.
“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — an independent source of health policy research, polling and journalism.
White House prescriptions
Biden urges Congress to get tougher on fentanyl traffickers
New this a.m.: The White House is endorsing proposals to stiffen penalties on synthetic drug traffickers, monitor machines used to make fentanyl pills and close a loophole that allows criminal groups to easily ship drugs in packages, The Post’s David Ovalle reports.
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President Biden is calling on Congress this morning to greenlight a bipartisan border security bill that passed the Senate but died in the GOP-controlled House. “These are the key investments needed to stop fentanyl from reaching our communities,” he said in a statement.
Biden is also issuing a national security memo calling on federal agencies “to do even more” to stop fentanyl trafficking.
The bigger picture: Biden announced the initiatives as state and federal officials grapple with how to curb a drug epidemic that has killed more than 300,000 people during his administration alone. Border security has proved to be a political flash point, with Republicans hammering the White House about the failure to stop fentanyl from entering the country.
Agency alert
CDC announces $5 million effort to vaccinate livestock workers
The CDC is launching a $5 million initiative to provide seasonal flu shots this fall to about 200,000 livestock workers in states hit hardest by the bird flu outbreak, The Post’s Lena H. Sun reports.
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The agency will buy the seasonal flu shots and states can order them as needed. The CDC is also awarding $5 million to community organizations for outreach and education efforts.
Why it matters: Workers at poultry, dairy and pig farms are at greatest risk of being simultaneously exposed to seasonal flu and the H5N1 bird flu. Duel exposure raises the rare but serious possibility of the viruses exchanging genetic material, potentially creating a new influenza strain that could be more transmissible and severe, according to Nirav Shah, CDC’s principal deputy director. He said widespread seasonal flu vaccination would reduce that risk.
Yes, but: Despite having a stockpile of 4.8 million doses of the H5N1 bird flu vaccine, the federal government isn’t currently recommending its use in farmworkers. The rationale? The 13 infections reported in humans so far have had mild symptoms, and the virus isn’t spreading between people or asymptomatically. However, Shah noted that discussions on the matter are ongoing.
Data point
Study: Suicide among preteens is rising
New federal data shows that the suicide rate for U.S. preteens has steadily climbed over the past decade and a half, especially among young girls, our colleague Sabrina Malhi reports.
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By the numbers: Between 2001 and 2022, a total of 2,241 children ages 8 to 12 years old died by suicide. After a period of decline until 2007, rates increased by about 8 percent annually from 2008 to 2022, according to a report from the National Institute of Mental Health.
Boys continue to have a higher suicide rate overall, but girls have experienced a disproportionate increase over the past 15 years. Suicide was the fifth leading cause of death among girls ages 8 to 12 between 2008 and 2022, moving up from being the 11th leading cause between 2001 and 2007.
The bigger picture: The study’s authors blamed no single reason for the increase, but outside experts say the problem is multifaceted, citing technology, social media and guns as the main culprits. The coronavirus pandemic also led to increases in anxiety, depression and other mental health issues nationwide.
On the Hill
Senate plows ahead on bipartisan health-care bills
On tap today: The Senate, Health, Education, Labor and Pensions Committee set to mark up three bipartisan health-care measures.
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One key bill up for consideration would reauthorize the Older Americans Act, which supports home and community-based services for seniors and is set to expire at the end of September. It proposes more than $2.7 billion in funding for fiscal 2025, with annual 4.6 percent increases over the next five years.
The committee will also vote on legislation to bolster programs and research related to autism spectrum disorder, as well as a measure to reauthorize prevention, surveillance and programs related to traumatic brain injury.
In other news from Capitol Hill …
The Senate passed a pair of bills to enhance online privacy and safety protections for children, handing a win for parents and youth activists who argue tech companies endanger children’s well-being, The Post’s Cristiano Lima-Strong reports.
The legislation, approved 91-3, would force digital platforms to take “reasonable” steps to protect children and extend existing federal privacy protections to include those 16 years and younger. Sens. Ron Wyden (D-Ore.), Rand Paul (R-Ky.) and Mike Lee (R-Utah) voted against the bills.
Next steps: Supporters hope Senate approval will pressure the House to take up the package, which has bipartisan backing but faced setbacks last month due to infighting among House Republican leaders.
In other health news
- Medicare payments to hospice providers will increase by 2.9 percent — or $790 million — in 2025, according to a final rule from the Centers for Medicare and Medicaid Services that also enacts new quality reporting measures.
- Nearly 32 percent of adolescents ages 12 to 17, or about 8.3 million people, received mental health treatment in the past year, an increase of more than 500,000 from 2022, according to new data from the Substance Abuse and Mental Health Services Administration.
- Wells Fargo was hit with a lawsuit yesterday alleging that the banking giant violated federal law by mismanaging its employee health plan, leading tens of thousands of workers to overpay for prescription drugs, Daniel Wiessner reports for Reuters.
Health reads
When private equity buys a hospital, assets shrink, new research finds (By Peter Whoriskey | The Washington Post)
Woman sues Kansas hospital over alleged denial of emergency abortion (By Nadine El-Bawab | ABC News)
Sugar rush
@washingtonpost NEW Alzheimer's test 90% accurate A new study shows that a simple blood test can outperform traditional exams when it comes to determining whether Alzheimer’s is responsible for memory problems, accurately diagnosing the disease about 90 percent of the time. Compare that with dementia specialists who successfully identified Alzheimer’s 73 percent of the time, while primary care doctors did so with a 61 percent rate, according to the study of 1,213 patients in Sweden that was published Sunday on JAMA, the journal published by the American Medical Association, and presented at the Alzheimer’s Association International Conference on the same day in Philadelphia. The encouraging findings come amid larger efforts to develop a cheap, simple blood test that can quickly diagnose patients with Alzheimer’s without forcing people to undergo more expensive and invasive exams, such as spinal taps. Although blood tests are already used in clinics, they are often not covered by insurance, costing hundreds of dollars or more.
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