THE PROGNOSIS

Two months ago, President Trump promised a severe crackdown on vaping. Now the question is whether he’ll follow through in the specific ban he’ll unveil this week.

Anticipation is at a fever pitch as the Food and Drug Administration finalizes the details of a ban expected to restrict sales of flavored e-cigarettes and raise the legal purchasing age for a range of tobacco products from 18 to 21 — a response to the surge in youth vaping and a recent spate of vaping-related lung illnesses.

“We’re going to be coming out with an important position on vaping,” Trump told reporters on the White House lawn on Friday. “We have to take care of our kids, most importantly, so we’re going to have an age limit of 21 or so.”

Hundreds of protesters organized by United Vapers Alliance gathered in front of the White House over the weekend, smoking e-cigarettes and holding signs saying “We Vape We Vote.” Americans for Tax Reform, the American Conservative Union and other conservative groups are pressuring the administration to walk it back. Even as e-cigarette maker Juul and other industry groups say publicly they will support the ban, they’ve spent record sums of money this year lobbying policymakers.

The American Vaping Association:

From attendees:

Amid all this furor, health-care advocates worry the administration might soften the approach Trump outlined back in September. For example, the ban could exempt some flavored e-cigarettes or give broader leeway around who can sell vaping products.

“There has been intense political pressure and lobbying by the e-cigarette industry to gut the administration’s plan,” the Campaign for Tobacco-Free Kids said in a statement released over the weekend. “If the administration caves to these efforts, the e-cigarette industry and the political swamp will win and America’s kids will lose.”

Paul Blair, director of strategic initiatives for Americans for Tax Reform, says the ban could also include an endorsement of legislation being pushed by Senate Majority Leader Mitch McConnell to raise the legal age for buying tobacco to 21, a step the FDA can't take on its own. 

Blair was one of thousands of vaping advocates who participated in the protest on the Ellipse on Saturday:

This much is clear: There are sharp divides inside the administration over how far a ban should go and whether e-cigarettes have any redeeming qualities (such as helping people stop smoking traditional cigarettes). Joe Grogan, the conservative and influential head of the president’s Domestic Policy Council, said last week he still thinks e-cigarettes can still be a good alternative. “We really want to make sure we are data-driven on this and striking the right balance between adult choice and protecting kids,” Grogan told reporters.

Here are questions The Health 202 will be asking when the ban lands:

1. Does it include mint and menthol-flavored e-cigarettes?

The ban will certainly include fruit and candy-flavored e-cigarettes, as those are more commonly used by teenagers. Studies have shown youth perceive sweet flavors as less harmful than tobacco-flavored products. But mint and menthol-flavored e-cigarettes are more of a tossup: They’re also more attractive to kids but are often used by adults to help them stop smoking menthol cigarettes.

Trump said in September he planned to remove all nontobacco-flavored vapes from the market, including menthol. A year ago, then-FDA Commissioner Scott Gottlieb also vowed to issue a formal proposal banning menthol cigarettes, saying they “disproportionately and adversely affect underserved communities.” But now the administration is considering backing away from mint and menthol products, Bloomberg News recently reported.

This might be a hint about what the ban contains: Juul announced last week it is halting sales of its popular mint-flavored e-cigarettes. “Mint accounts for about 70 percent of Juul’s sales in the United States, compared with 20 percent for tobacco-flavored vapes and 10 percent for menthol,” my colleague Laurie McGinley reported. “Juul stopped selling its popular mango, fruit, creme and cucumber liquid-nicotine pods in brick-and-mortar stores last year and online in September.”

“In a statement Thursday, Juul said it made the decision to halt mint sales ‘in light of’ new data released this week showing mint’s popularity among underage vapers,” Laurie notes. “The studies indicated that teens prefer Juul products and that mint is their favorite flavor.”

2. Will the ban exclude adult-only vaping shops?

Opponents of e-cigarette restrictions have argued they could destroy small businesses by forcing thousands of mom-and-pop vape shops to shutter. The result, opponents say, is that people who use e-cigarettes to help them get off traditional cigarettes might either resume their old ways or seek out products on the black market.

Blair said he's hopeful the ban will still allow the sale of flavored e-cigarettes in adult-only vape shops. If the White House gives the vape shops some kind of exemption, it would be only a temporary reprieve, Blair said. That’s because makers of flavored eliquids — nicotine-based vaping liquids — have to apply for FDA marketing authorization by May to stay on the market. That requirement would be difficult to meet for many eliquid suppliers, he said.

Trump adviser Kellyanne Conway suggested last week that adult-only vape shops may be exempted, saying the Department of Health and Human Services has jurisdiction over e-cigarettes but not over vape shops. She stressed the new regulations should keep youths away from e-cigarettes without encroaching upon the rights of adults to access the products.

“This is a burgeoning health crisis; the difference is between kids and adults,” Conway said. “So, if we’re talking about e-cigarettes, the president, yes, he’s been discussing this with his team and he will … make an announcement soon.”

The president also hinted at an exemption for vape shops, expressing concern about a regulation that would result in job losses.

“We have a lot of people to look at, including jobs, frankly, because it's become a pretty big industry,” he said.

Laurie McGinley contributed to this report

AHH, OOF and OUCH

AHH: Federal health officials detailed a “breakthrough” in the vaping-related lung injuries and deaths that have been reported across the country: Vitamin E acetate was found in all 29 samples of lung fluid collected from patients who have been sickened or died, our Washington Post colleague Lena H. Sun reports.

“These findings provide direct evidence of vitamin E acetate at the primary site of injury within the lungs,” Anne Schuchat, principal deputy director at the Centers for Disease Control and Prevention, told reporters. The latest data points to growing evidence that the oil is a “a very strong culprit of concern,” Schuchat said.

“The findings announced Friday do not rule out other possible compounds or ingredients that may be causing the lung injuries,” Lena reports. “But Schuchat described the lab results as a ‘breakthrough’ in the investigation. The CDC tested for a wide range of substances that might be found in patients’ lung fluids, including plant oils and petroleum distillates, such as mineral oil.”

The outbreak has sickened more than 2,000 people and killed at least 39. Our colleague adds: “THC, the psychoactive ingredient in marijuana, was also found in 23 patients, including three who said they had not used THC products. Nicotine was detected in 16 of 26 patients. Most patients who have fallen ill in the outbreak have vaped THC, officials have said.”

OOF: Joe Grogan, director of the Whte House Domestic Policy Council, panned House Speaker Nancy Pelosi’s (D-Calif.) drug pricing plan that would enable Medicare to negotiate drug prices.

“Nancy Pelosi’s bill right now is unworkable, it’s impractical, and it’s hyperpartisan,” he said, speaking to reporters on Friday. “And it’s not going to pass in its current form.”

Instead, he endorsed the bipartisan plan from Sens. Charles E. Grassley (R-Iowa) and Ron Wyden (D-Ore.), which would make drug companies pay rebates to Medicare if they raise prices faster than inflation and also caps seniors’ out-of-pocket costs.

“We are very supportive of the Grassley-Wyden compromise. It is the product of a really good, bipartisan, collaborative approach to solving drug pricing,” Grogan added.

“Pelosi and the White House have negotiated on drug pricing legislation since Democrats won back the House last year, but she won’t budge on a provision that would allow Medicare to negotiate drug prices,” the Hill’s Jessie Hellmann reports. “… Grogan expressed frustration with the timeline. The government is quickly approaching another spending bill deadline, and Congress has limited days left in the year to pass legislation.”

OUCH: Doctors and nurses could help curb the number of suicides by asking patients how they’re feeling. But emergency rooms say they don’t have the resources to screen for suicidal thoughts, our Post colleague William Wan reports.

“Universal screening entails asking everyone visiting a primary care clinic or ER whether they are having suicidal thoughts, and if so, following up with brief interventions such as telephone counseling and referrals for additional treatment,” he writes. The idea is backed by the National Institute of Mental Health as well as suicide prevention groups that have been pushing to implement screenings widely. 

But the hospital industry, ER doctors and nurses say they don’t have the resources “to deal with suicidal and mentally ill patients they’re already aware of in their facilities — much less additional ones who would be identified by screenings. The American College of Emergency Physicians has come out against the idea, for those same reasons. The Joint Commission — which is in charge of accrediting hospitals and carries enormous influence on their policies — has said that screenings could be helpful but has not made them mandatory.”

“It should be a no-brainer,” Edwin Boudreaux, professor of emergency medicine and psychiatry at the University of Massachusetts Medical School, told William. He is one of numerous suicide prevention researchers pushing for screenings. “You can save hundreds of lives doing this. But the amount of pushback has been frustrating.”

HEALTH ON THE HILL

— It’s been nearly six weeks since Sen. Bernie Sanders (I-Vt.) suffered a heart attack, and there’s been a noticeable change on the campaign trail.

“[T]he famously grumpy U.S. senator from Vermont has reemerged as a more easygoing figure, sprinkling more humor into his policy-centric speeches and opening up about his age, immigrant roots and upbringing — topics he has long resisted emphasizing, despite repeated pleas by his aides,” our Post colleague Sean Sullivan reports.

Off the trail, Sanders has put more faith in his brain trust, campaign officials say.

“The changes underline one of the most remarkable political recoveries of recent years. In the days after his Oct. 1 heart attack, Sanders’s medical status was unclear and his confidants wondered whether his already struggling campaign would continue. Now, he is performing better in the polls than before his health scare,” Sean adds. “…Still, there is no denying the challenges the health scare continues to pose for Sanders, who is the oldest candidate in the race. Polls show Democratic voters are much more concerned about his age and health than they are about his two septuagenarian rivals, Warren, 70, and former vice president Joe Biden, 76.”

REPRODUCTIVE WARS

— There’s a new chain of Christian pregnancy centers in Texas looking to compete for the millions of dollars in federal funds that Planned Parenthood relinquished earlier this year.

Rather than comply with the new Trump administration rules banning Title X clinics from referring patients for abortions, Planned Parenthood announced in August it would forgo $60 million in Title X federal family planning grants.

Now, eight independent pregnancy centers that have merged to form a chain they’re calling the Source, want to vie for the funding, and they plan to offer a “full array of medical services, to include testing for sexually transmitted diseases, first-trimester prenatal care and contraception choices,” our Post colleague Sarah Pulliam Bailey reports.

“The decision to provide contraception is a huge cultural shift for Christian centers that, for religious reasons, do not normally offer birth control,” she writes. “But it represents what some in the antiabortion movement say is a much-needed rebranding for pregnancy centers — away from emphasizing ending abortion and toward placing women’s health care front and center.”

— And here are a few more good reads: 

INDUSTRY RX

As deductibles and co-pays grow, insured patients owe a larger share of their medical bills. More and more are being taken to court.
New York Times

MEDICAL MISSIVES

Health
On Friday, the hospital announced that its own equipment contaminated the milk with bacteria.
Hannah Knowles

STATE SCAN

Five Democratic states are poised to create a pot lovers' paradise, legalizing marijuana from Pennsylvania to Connecticut. But political infighting — especially among Democrats — could conspire to kill it.
Politico

SECOND OPINION

Nothing can prepare you for the immense number of complicated, sometimes life-or-death decisions the disease forces you to make about your own treatment.
Politico

DAYBOOK

Today

  • The Fall 2019 National Association of Medicaid Directors Conference begins.

Coming Up

  • The Senate Health, Education, Labor and Pensions Committee holds a hearing on the response to lung illnesses and the rise in youth e-cigarette use on Wednesday.
  • HHS Secretary Alex Azar, Sen. Ron Wyden (D-Ore.) and Sen. Mike Braun (R-Ind.) will participate in an Axios event “Health Care in 2020” on Wednesday.

SUGAR RUSH