It’s not-so-great timing for the White House to be waffling on President Trump’s promised vaping ban: the retreat is taking place as the president is trying to institute a new leader of the agency that regulates vapes.
A vote on radiation oncologist Stephen Hahn to lead the Food and Drug Administration is planned for a week from today in the Senate Health, Education, Labor and Pensions Committee. GOP leaders aim to Hahn confirmed by the full Senate by the end of the year, but Democrats — and some Republicans — have made clear they’re not pleased with how Trump is contemplating significantly weakening a proposal for the FDA to more heavily regulate vaping.
It’s still unclear exactly where the administration will land — Trump is reportedly meeting today with aides about the matter after extensive meetings with stakeholders last Friday. But an eventual ban may now exclude mint and menthol flavors and independent vape shops, as Trump worries that job losses in the vaping industry and upset vapers could harm his reelection chances.
But health advocates and stakeholders say there may be no final word until the Hahn confirmation process is further along. The whole issue is causing consternation among members of Congress and health-care advocates who had lauded Trump’s promises earlier this fall to crack down on youth vaping.
Members of the HELP panel made their opposition clear last Wednesday at a confirmation hearing.
“Anger about the delay in implementing the flavor ban came from both parties during the Hahn hearing,” my colleague Laurie McGinley reported. “Sen. Mitt Romney (R-Utah) called youth vaping ‘the canary in the coal mine, or better, the child in the vaping room,’ and asked Hahn whether the FDA could take action to protect teens if the White House were opposed.”
And at Friday’s meeting, supporters and opponents of vaping debated strenuously before Trump in what Laurie and colleague William Wan described as “a public policy version of ‘The Apprentice’ that featured combatants trying to score points with a demanding host who also happens to be the president.”
“At the end, no one was fired, and it seemed as though the contest — which involved a major public health issue — was far from over,” Laurie and William write.
Here’s another twist: It’s now clear that vaping-related illnesses, which Trump cited as his original impetus for a ban, are about THC oil and not about vaping itself. That’s something more than 100 scientists at the Centers for Disease Control and Prevention in Atlanta discovered after working around the clock for three months, my colleague Lena H. Sun reports in this fascinating play-by-play of the investigation.
The team is “scrambling to create new investigative tools and techniques as they seek to prevent additional injuries and deaths from the vaping-related illness,” which were “reported for the first time this summer among previously healthy young people,” Lena writes.
“ … Over the past three months, teams of scientists working to solve the mystery developed extensive lab tests and built a new data-collection system on the fly. They even relied on 3-D printers to manufacture custom parts so vaping devices could be fit into CDC’s special smoking machines, enabling them to ‘puff’ on the devices to test the aerosols that are released.”
The investigation was particularly difficult because no one had any idea what might be sickening so many people. And health officials were dealing with a huge number of possible suspects, including several hundred e-cigarette or vaping devices and thousands of e-liquids containing many different ingredients. Complicating matters further, supply chains for vaping products vary by state.
“The level of difficulty on this one is probably a 9 out of 10,” Jim Pirkle, director of the laboratory science division at the CDC’s National Center for Environmental Health, told Lena.
Pirkle could name only two other investigations he participated in during his nearly four decades at CDC that were harder.
“One involved a mysterious syndrome in the 1980s involving contaminated oil fraudulently sold as olive oil in Spain that killed hundreds and sickened thousands,” Lena writes. “That took several years to solve, he said. The other involved developing a way to measure levels of the toxin dioxin in Vietnam War veterans who had been exposed to Agent Orange.”
What first alerted scientists to vitamin E acetate in THC — the ingredient in marijuana that produces a high — was their analysis of lung fluid from sick patients. This vitamin E oil is often added to black-market vape cartridges to dilute typically expensive THC. It doesn’t cause harm when swallowed as a supplement, but it can cling to the inner linings of the lung when inhaled.
“By early November — more than three months after the first cases had been reported in Wisconsin — a team of 25 scientists had found vitamin E acetate in lung fluid from 19 patients,” Lena reports. “That in itself was remarkable. … More remarkable, the scientists found no evidence of other chemicals or compounds on the list of possible suspects.”
Vaping opponents acknowledge the lung illnesses may not provide the most persuasive arguments for a ban. But to them, that’s irrelevant because they say measures to dissuade kids from vaping are long overdue.
Keysha Brooks-Coley, vice president of federal advocacy for the American Cancer Society Cancer Action Network, told me that it’s “not dependent on the fact of the illnesses or other things that have happened over the past few weeks.”
“This is something that should have been addressed a long time ago,” she said.
AHH, OOF and OUCH
AHH: U.S. Customs and Border Protection rejected a recommendation from the Centers for Disease Control and Prevention last winter to vaccinate migrants at detention facilities against the flu.
The recommendation was revealed in a newly released letter from the CDC to Rep. Rosa L. DeLauro (D-Conn.) this month in response to questions about flu outbreaks at detention facilities, Robert Moore reports for The Post.
“An 8-year-old Guatemalan boy died of the flu while being detained near El Paso in December, a month before CDC’s vaccination recommendation. In the months after CBP rejected the recommendation, at least two children — one in El Paso and one in Weslaco, Tex. — died after being diagnosed with the flu in Border Patrol custody, autopsy reports showed,” Robert writes.
“CDC’s recommendations are clear: flu vaccines should be administered to people as soon as possible to prevent the spread of this deadly disease,” wrote DeLauro, who chairs the House Appropriations subcommittee that oversees funding for the Department of Health and Human Services.
CBP says it has “significantly expanded medical support efforts" but said it has never provided immunizations for detained migrants and has no plans to start doing so. “To try and layer a comprehensive vaccinations system on to that would be logistically very challenging for a number of reasons,” said agency spokeswoman Kelly Cahalan. “The system and process for implementing vaccines — for supply chains, for quality control, for documentation, for informed consent, for adverse reactions — is complex, and those programs are already in place at other steps in the immigration process as appropriate.”
OOF: A massive lobbying effort in Washington has been working to defeat Medicare-for-all, or any other incremental expansion of health care, Politico’s Adam Cancryn reports in this deep dive.
What began as a few calls in response to Sen. Bernie Sanders’s 2017 speech introducing the Vermont independent’s Medicare-for-all plan ballooned into an all-out operation. It began with Chip Kahn, president and CEO of the Federation of American Hospitals.
“Those calls would lead to a series of secretive meetings in downtown D.C. where officials from every part of the health care industry — from insurance companies to hospital giants, drugmakers and even, for a time, doctors — would forge an alliance united to ensure that Sanders’ promises never became reality,” Adam writes. “Out of their pact grew an influence operation known today as the Partnership for America’s Health Care Future, a multimillion-dollar cooperative designed to overwhelm not just the swelling Medicare for All movement, but every single Democratic proposal that would significantly expand the government’s role in health care.”
“The reason for the invention of the Partnership was that the Democratic Party was forgetting what it had done and, in our view, going off on a tangent that would shake everything up if they ever really got power,” Kahn told Politico. “In this country, incremental change, and pragmatic change, has always been the style.”
OUCH: The Justice Department has been in talks with Teva Pharmaceutical and other generic drug manufacturers in an ongoing investigation of alleged price-fixing, Bloomberg News’s Riley Griffin, Emma Court and David McLaughlin report.
The discussions have been ongoing for months. Federal prosecutors are looking into numerous possibilities, including deferring prosecution agreements, which would require the drug companies to admit to certain allegations, cooperate with the probe and pay fines in order to avoid indictment.
“Prosecutors have been investigating allegations that generic drugmakers conspired to prop up the prices of certain widely used medications for more than five years, and have hinted several times this year that charges could be imminent,” Riley, Emma and David report. “Nine of every 10 prescription drugs dispensed in the U.S. are generics, and lawmakers say the alleged illegal coordination on pricing has cost federal health programs billions of dollars.”
“We continue to cooperate with the DOJ’s investigation,” Teva spokeswoman Kelley Dougherty told Bloomberg. “As with any government investigation or litigation, we are willing to entertain possible resolution but only if it makes sense for the company, our shareholders and the patients that we serve. We will continue to defend ourselves vigorously in these matters.”
HEALTH ON THE HILL
The plan includes filling treatment bed shortages in states including Iowa, Nevada, South Carolina, and Michigan and also includes doubling research funding from the Defense and Veterans Affairs departments to address veterans’ mental health concerns such as PTSD, military sexual trauma, and traumatic brain injury. The plan also focuses on services for the severely mentally ill.
“Probably one of the biggest public policy failures of America is the failure to address mental health and put the resources into it as a priority. The result of that is that people are silently suffering who should never suffer,” Harris said at a campaign event in South Carolina, the Post and Courier’s Jamie Lovegrove writes.
The proposal doesn’t specify how Harris would fund the mental health plan, but notes she would expand coverage through her Medicare-for-all plan.
My mental health plan will:— Kamala Harris (@KamalaHarris) November 25, 2019
→Cover mental health care on demand
→End the mental illness to jail pipeline
→Double DoD and VA research dollars to help our veterans after they come home
— More veterans seem to be using telemedicine services, according to recent data from the Veterans Affairs Department. The agency said more than 900,000 veterans used VA telemedicine resources in the 2019 fiscal year, a 17 percent increase from the year before, Modern Healthcare’s Jessica Kim Cohen reports.
“The VA in 2017 began rolling out a telemedicine app called VA Video Connect, through which veterans can schedule video appointments with their providers. That's on top of telemedicine services that veterans can access online through a desktop website and at VA facilities,” Jessica writes. “More than 99,000 veterans used the VA Video Connect app in fiscal 2019 to complete roughly 294,000 video sessions, more than two-thirds of which were for mental healthcare.”
— The trade group representing the country’s top drug companies is reportedly slashing its funding for a nonprofit that funds addiction treatment.
The Pharmaceutical Research and Manufacturers of America, known as PhRMA, has already decreased its donation to the Addiction Policy Forum this year from $8.1 million to $6 million. After providing the nonprofit with nearly all of its funding, it will end all funding in 2020, Politico’s Sarah Owermohle reports.
Numerous former and current employees told Sarah the forum’s chief executive, Jessica Hulsey Nickel, “had poorly managed some of the millions the forum spent on a K Street office, a now empty, million-dollar high-tech Chicago call center, annual meetings and other projects. Nickel — a lobbyist who has described growing up in foster care as her parents struggled with heroin addiction — denies the accusations of poor management, saying the digital health software and telecommunications infrastructure the forum bought for more than $1 million is still in use.”
“Nickel told POLITICO that the end of PhRMA funding was the natural conclusion of a three-year grant period and said the forum would continue its work through 2023 with ‘a diverse array of funding sources,’ ” Sarah adds. “A spokesperson for PhRMA told POLITICO that while it was cutting funding, ‘we are confident that the organization will remain at the forefront of efforts to save lives.’ ”
— And here are a few more good reads:
- HHS's Office of Women's Health holds a workshop on Women's Mental Health from a Life Course Perspective on Dec. 2.