A mysterious vaping-related lung illness has now afflicted more than 1,000 people and killed at least 21 — and America's patchwork approach to marijuana law is probably part of the problem, Axios' Dan Primack and I report.

The big picture: Most of these lung illness cases involve people who vaped THC, the primary psychoactive ingredient in marijuana, and many of those pods are believed to have come from the black market. A more cohesive regulatory scheme could help consumers know what to trust.

Health officials don't know yet whether the culprit is the liquids being vaped, their interaction with the vape pen materials, or a combination of the two. But legal, regulated products used as directed don't seem to be the primary cause.

• Juul neither makes THC vape pods nor intends for them to be used in their devices.

Where it stands: THC is a Schedule 1 drug under federal law, severely restricting scientists' and regulators' ability to study its effects.

• But THC is legal in more than a dozen states. Few of those states, though, require stringent oversight of THC-specific products such as vape pods.
• "State laws that have loosened access to cannabinoids have come at a public health cost," said former Food and Drug Administration commissioner Scott Gottlieb, adding that "ultimately, a federal regime could make it easier to access cannabis for conducting proper studies."

Yes, but: At least a few patients afflicted by the lung illness claim to have only vaped nicotine.

• And research this week from New York University found that vaping nicotine caused lung cancer in mice, per CNBC. The researchers said vaping is likely "very harmful" to humans as well.

The bottom line: Traditional vaping deserves political attention. But so does an inconsistent regulatory framework that is contributing to serious, immediate dangers.

The Institute for Clinical and Economic Review and the pharmaceutical industry
don’t even agree on what should be considered relevant evidence when deciding if a drug is safe and effective, Axios' Bob Herman reports.

Why it matters: "This debate on what constitutes high-quality, 'real-world' evidence is not going away," said Walid Gellad, a pharmaceutical expert at the University of Pittsburgh.

Driving the news: Pharmaceutical companies that were singled out in ICER’s report yesterday on "unjustified" price hikes sent along hundreds of studies for ICER to consider in its analysis. ICER rejected almost all of them.

• Many of the drug company studies were observational and funded by the companies, and ICER made it clear from the outset that it would only consider observational studies "that were high quality and comparative."

What we're watching: The FDA wants to use more simple trials and observational data in drug evaluations, similar to what drug companies submitted to ICER. 

• But as Joseph Ross, a professor of medicine at Yale, wrote several years ago, it’s important to assess "the methodological rigor of observational studies before interpreting real-world effects."

Our thought bubble, via Bob: ICER's report is transparent, telling readers that none of the funding for its report came from any part of the industry and outlining clearly what it considered to be acceptable research.

• Pharmaceutical companies, meanwhile, have every financial incentive to try to dress up the data around those drugs.

Medical bills have created financial hardship for most Americans within the last 5 years, including most people with high credit scores, according to a new survey by Elevate's Center for the New Middle Class.

• The survey divided respondents into "prime" and "non-prime" categories based on their credit score, with "prime" responders having a score of 700 or above.

Even worse, 43% of those surveyed said that they've had catastrophic hardship because of medical expenses over the past 5 years, including 31% of prime respondents and 59% of non-prime.

By the numbers: More than half said someone in their household had visited an emergency room in the past 5 years.

• 65% of prime respondents said the visit was at least a little financially disruptive, while 72% of non-prime respondents said it was. And 17% of people in each category said it was very disruptive.
• Non-prime respondents who have used the ER were nearly 3 times more likely to report that they haven't yet paid off their bills.
• Emergency rooms are often the source of surprise medical bills. Even so, respondents reported that inpatient hospital visits were the source of the most disruptive expenses.

Why it matters: Health care costs are increasingly unaffordable not just to low-income or financially illiterate people, but also to those who are comfortably middle class with a proven track record of money management.

More doctors are linking up with companies that allow them to treat patients via text or online chat, AP reports.

Why it matters: Texting provides a convenience even video chats can't provide, but there are limits to how much a doctor can help without seeing a patient at all, Axios' Marisa Fernandez writes.

The state of play: For millions of Americans, chats have a chance to limit expensive emergency room visits, improve care access and encourage more patients to keep tabs on their health.

• Health Affairs published a survey in 2018 from the American Medical Association that found a small number of physicians (about 15%) have used telemedicine.
• Still, the companies that primarily provide the services, CirrusMD, 98point6 and K Health, are increasingly going mainstream.
• Walmart's Sam's Club, for instance, announced in September that 98point6 visits are included in a care program it's testing, per AP.

Go deeper: Telemedicine has enabled new forms of Medicaid fraud

A majority — 65% — of pregnant women in the U.S. said they were unvaccinated for influenza and whooping cough, according to a Vital Signs report released on Tuesday by the Centers for Disease Control and Prevention.

Why it matters: Only 9% of women in the U.S. ages 15–44 become pregnant each year. But pregnant women accounted for at least 34% of influenza-related hospitalizations each season between 2010 and 2018, Marisa writes.

• Newborns who contract influenza or whooping cough are at a high risk of hospitalization and death, as they are too young to be vaccinated.

For both vaccines, lack of vaccination coverage affected women with lower socioeconomic status, black women, those who were publicly insured or who lived in the South.