- Associated Press - Monday, September 17, 2018

Minneapolis Star Tribune, Sept. 14

Tough action must follow ultimatum on e-cigarettes and young users

New FDA initiative provides timely warning to manufacturers.

Bravo to FDA Commissioner Dr. Scott Gottlieb for giving a timely ultimatum to e-cigarette makers last week: These firms can either crack down on underage use of their harmful products or face serious consequences for their bottom lines.

The challenge now for Gottlieb is to back up that tough rhetoric with action, particularly if e-cigarette firms respond with vague assurances or by targeting Gottlieb himself. The Food and Drug Administration commissioner is a Trump appointee and serves in an administration that has elevated regulatory rollback as a priority.

The fast-growing industry, which has one firm valued at $15 billion, may well mount a lobbying campaign to cow Gottlieb. He should stay the course and ensure that protecting new generations from nicotine addiction remains a top agency priority. While Gottlieb is well-regarded, a previous decision that gave the e-cigarette industry a regulatory reprieve raises troubling questions about his resolve.

The ultimatum from the FDA came on Sept. 12 as part of a “series of critical and historic enforcement actions” to stem e-cigarette use in kids. Juul, the leading manufacturer by far, and four other firms have been given 60 days to prove they can keep these products out of underage hands. If they can’t, they could face severe consequences, including a move that could cripple their business - market removal of the sweet-flavored nicotine products very young users find so appealing.

The bold action is merited. Gottlieb has rightly called e-cigarette use by teenagers an “epidemic.” Use by high-school students rose from 1.5 percent in 2011 to nearly 12 percent in 2017, according to a national youth tobacco survey by the U.S. Centers for Disease Control and Prevention (CDC). A Minnesota breakout of the survey showed that 19.2 percent of high school students here have used or tried e-cigarettes in the past 30 days, up 49 percent from 2014.

It’s easy to see how e-cigarettes’ design attracts young users. The sleek Juul device looks like a flash drive to store computer data. It’s also easy to hide in a classroom or in a home. Videos on YouTube and photos posted by users of other social media underscore how these products, which deliver a nicotine vapor, have been embraced by a young crowd. In Minnesota, consumers generally must be 18 to buy, though some cities have moved to raise the age to 21.

Concrete steps and hard deadlines are critical in the plans Juul and other firms provide to Gottlieb before the end of the year. Sensible remedies already outlined by 11 public health-minded U.S. senators in an April 18 letter should form the framework of the response. These include strengthening age verification for direct sales on the company websites and strategies to do the same on eBay and other third-party online sellers.

Another step is aggressively protecting the companies’ trademarked names and logos, and preventing them from appearing on T-shirts, hoodies and other products. FDA rules already prevent traditional cigarette brand names from being used this way. The industry should voluntarily end this type of marketing rather than wait for the FDA to step in.

A myth about e-cigarettes needs to be clearly understood. They appear to be less harmful than traditional cigarettes, though long-term research is lacking. But less harmful is still not good. Nicotine can “harm adolescent brain development,” and the vapor may contain other cancer-causing chemicals, according to the CDC.

Critics of Gottlieb’s initiative may contend that it will simply result in young people smoking regular cigarettes. That’s a false “either-or” claim. The crackdown will help ensure that fewer young people get addicted to nicotine. More must be done to prevent all types of cigarette use, but the FDA initiative is a logical step - if Gottlieb carries it through.

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The Free Press of Mankato, Sept. 13

Health insurance: State should take action on uninsured rate

Why it matters: A growing number of people without insurance will push costs up for everyone.

The number of people without health insurance rose in Minnesota last year, and that threatens to increase costs for medical providers and insurance companies who will be forced to pass on those costs to all Minnesotans who have health insurance.

But the state government, providers and consumers can play a role in mitigating the risk of those cost increases.

Some 243,000 Minnesotans went without health insurance last year, an increase of 18,000 people compared to 2016, according to a report by the Census Bureau. Minnesota still has one of the lowest rates of uninsured in the country at 4.5 percent. The national level is 8.8 percent.

The Minnesota Department of Health put the uninsured rate at 6.5 percent using somewhat different methods, according to a report in the Star Tribune. That would a more significant increase from a rate of 4.3 percent uninsured from 2015.

Health care economists told the Star Tribune the rate of increase is troubling particularly because it came at a time of fairly robust economic growth and low unemployment rates. Other experts noted that the upward trend is troubling because there is no real safety net for those who have enough income to make them ineligible for government programs, but not enough to afford good insurance.

But there are solutions. The state estimates that about half of the people without insurance could qualify for government Medicaid programs or for help paying premiums. The first and easiest solution would be to make a robust effort to publicize the help programs to the uninsured population.

Experts also note the cost of health care puts pressure on premiums, making them less affordable. The state has programs that offer incentives for providers who become more efficient and coordinate care. Those programs should be expanded.

And third, consumers, even those with robust insurance policies, should evaluate their need for costly care. Those decisions are made easier by price transparency. If consumers know how much a procedure costs their insurance company and can compare those costs with other providers, they can make good choices on care.

Minnesota has just scratched the surface on providing price transparency. Several proposals in the Legislature for requiring transparency have been introduced but not gotten very far. There are public reports that also show average prices at different providers, but they are sometimes not complete or user friendly for intensive price scrutiny.

The health care cost and affordability dilemma will not go away on its own. It requires focused and urgent action by the state, providers and consumers.

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Post Bulletin, Sept. 12

Ken Burns film illuminates Rochester-Mayo values

Ken Burns’ Mayo Clinic documentary, which had its world premiere Monday night at Mayo Civic Center, resulted in a variety of reactions from the audience. There were tears, laughter, applause and knowing nods as stories and faces, familiar and new, appeared on the screen.

Overall, though, it was impossible to suppress a sense of hometown pride. “Mayo Clinic: Faith-Hope-Science,” traces the history of the clinic and rightly emphasizes the close connection between the Mayos, the Sisters of St. Francis, and the community of Rochester.

“It feels like we’re back home,” Burns said as he introduced the film. Burns and his crew spent three years working on the film, exploring Mayo and Rochester, digging through the archives, observing surgery, going on hospital rounds with doctors, interviewing patients, talking to locals. “What transpires in this town,” Burns said, “is nothing short of a miracle.”

Rochester and Mayo are intertwined. As the film shows, the city and the clinic grew side by side. When patients began arriving at Mayo in their hundreds of thousands, the community built lodgings to house them, restaurants to feed them, and eventually an international airport to transport them.

The relationship has been testy at times. Growing pains, the changing nature of medical care, the need for affordable housing - we could go on and on - have all helped create stress and pressure. Generally, Rochester and Mayo have learned to navigate these challenges.

If Mayo does well, Rochester will prosper. But Mayo can’t do well if Rochester doesn’t prosper. It’s a truism both Mayo and city officials will need to keep in mind as we face an even more challenging future.

“We’re not perfect,” Dr. John Noseworthy, Mayo president and CEO, said in a discussion after the screening of the film. “We don’t always do things right.”

After all, the clinic is made up of imperfect humans. Has it become more imperfect as it grows? Has the drive for economies made the clinic’s mission more problematical? Has Rochester bit off more than it can chew with the Destination Medical Center project? The answers to those questions won’t be found in Burns’ film.

Yes, Mayo Clinic has changed, as has Rochester. We are, after all, tied to each other.

Most importantly, though, both Mayo and Rochester are dedicated to service to humanity. “This is a film mostly about values,” Burns said of his documentary.

Those values are what ultimately connect Rochester and Mayo Clinic. It’s something of which all of us who live and work in this region can be proud.

As Burns said Monday, “It could only take place here.”

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