Tagged Medical Devices

Podcast: KHN’s ‘What The Health?’ New Year, New Health Proposals

The new Democratic majority in the House of Representatives took its first steps on health care — voting to intervene in the appeal of a Texas-led lawsuit that found the Affordable Care Act unconstitutional in December. And around the country, Democratic governors and mayors unveiled new initiatives aimed at making health care cheaper and more accessible.

In Washington, the partial shutdown of the government has left most health agencies untouched but shuttered major parts of the Food and Drug Administration and the Indian Health Service.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Anna Edney of Bloomberg News and Rebecca Adams of CQ Roll Call.

Among the takeaways from this week’s podcast:

  • Much of the attention on the impact of the federal judge’s decision in Texas to invalidate the ACA has centered on how it affects people with preexisting medical conditions. But the ruling is much more far-reaching and could affect broad swaths of health care in the country.
  • The partial government shutdown has had only a small impact on the Department of Health and Human Services, which already received its funding. But the FDA, which is funded through the Agriculture Department’s appropriations bill, is affected. Officials there say they are trying to keep up with high-risk food inspections and may bring some employees back to work.
  • The FDA receives a substantial part of its budget through the fees paid by pharmaceutical companies for review of their products. But during the shutdown, the agency is not allowed to accept more fees, so it will run out of money for drug application reviews in about a month, officials said.
  • Recent efforts by some Democratic state and local officials highlight the intraparty debate over health care. New California Gov. Gavin Newsom has proposed expanding insurance premium subsidies to people making up to 600 percent of the federal poverty level (about $72,800 for an individual) — up from the law’s current 400 percent (about $48,500) — while Washington Gov. Jay Inslee wants to set up a government-run plan that would be an option for people buying their own insurance. And in New York City, Mayor Bill de Blasio wants to offer coverage to people who are in the country illegally.
  • The latest government enrollment figures show that more than 11 million people signed up for coverage offered in the ACA marketplaces. That is down a bit from prior years, but still more than industry watchers predicted given the tax penalty for not having coverage expired this year.
  • The small slippage in enrollment in the past two years, following changes made by the Trump administration and a Republican-led Congress, may signal challenges in the future, especially in small markets where getting competition has been tough.

Also this week, Julie Rovner interviews KHN senior correspondent Jordan Rau, who investigated and wrote the latest “Bill of the Month” feature for Kaiser Health News and NPR. It’s about a skiing accident that required repeat surgeries — and bills for the patient, although she did nothing wrong. You can read the story here, and its update here.

If you have a medical bill you would like NPR and KHN to investigate, you can submit it here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:

Julie Rovner: Rewire.News’ “There’s Almost No Data About What Happens When Catholic Hospitals Deny Reproductive Care,” by Amy Littlefield

Rebecca Adams: The Washington Post Magazine’s “Life, Death and Insulin,” by Tiffany Stanley

Margot Sanger-Katz: Vox.com’s “A $20,243 Bike Crash: Zuckerberg Hospital’s Aggressive Tactics Leave Patients With Big Bills,” by Sarah Kliff

Anna Edney: The Washington Post’s “The FDA Is Still Letting Doctors Implant Untested Devices Into Our Bodies,” by Jeanne Lenzer and Shannon Brownlee

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

When Doctors Have Conflicts of Interest

My mother-in-law is an impressive woman.

At the age of 77, she still maintains a garden the size of my entire backyard, on the three acres of land she and my father-in-law, now 81, share in rural western Pennsylvania.

She does not tolerate stasis, and anytime my father-in-law collapses into his plaid armchair in front of the television, she appears on the scene within a minute or two, barks at him that there will be plenty of time to rest when they’re in the old age home, grabs the remote control, and turns the television off while simultaneously giving him another task to perform.

Photo

Mikkael Sekeres, M.D.

Mikkael Sekeres, M.D.Credit

She has kept old age at bay through constant activity, sheer strength of will, and a splash of denial.

Her hip must have been bothering her for some time, then, before she let me and my wife in on her problem. At our insistence, she told one of her doctors, who sent her for X-rays and reviewed them with her, in his office, with my wife at her side.

“Ouch,” her doctor said, pointing at the image of her hip where her femur was scraping against the acetabulum of her pelvis, bone-on-bone. “That looks like it hurts.”

“Well, I do a few chores around the house in the morning and rest on the couch with a heating pad, and then I’m all right,” she told him.

My wife interjected. “Just so you understand, by ‘a few chores,’ she means that she plants five flats of flowers.”

Her doctor’s eyes widened. Recognizing that she is the type of person who would have to decide for herself when she was ready for surgery, he recommended she let the rest of us know when that time occurred. Earlier this summer, she decided it was time.

She met with the orthopedist who would perform her surgery, and the two quickly bonded. As it turned out, his wife is also a gardener, and like my father-in-law, he collects classic cars. He discussed the surgery he intended to perform, her likely recovery period, and then paused.

“Now, I have to tell you that the artificial hip I’m going to use is one that I had a hand in inventing, and although I will receive no royalties for implanting this hip in you, I do have a conflict of interest, and want to make sure you’re O.K. with that.”

I sit on our institution’s conflict of interest committee and this scenario, while not falling into the majority of doctor-patient interactions, is becoming increasingly common.

There are a number of different types of potential conflicts that can arise.

Like my mother-in-law’s surgeon, a doctor may invent a technology, or develop a drug, and receive payments every time that technology or drug is used – though, as my mother-in-law’s doctor told her, no royalties are received if the device is used at our institution. Still, you might wonder if his using that artificial hip influences other doctors who want to emulate him to use the same device, from which he would receive royalties.

Or, a doctor may provide advice to a company, for which she receives an honorarium, and conducts research (such as being an investigator on a clinical trial) using that company’s product. Will the payment she received influence her interpretation of the clinical trial results, in favor of the investigational drug? Or did she make the trial better because of the advice she provided?

What if, instead, the drug for which she provided advice is already commercially available. How much is her likelihood of prescribing this medication – what we call a conflict of commitment – influenced by her having been given an honorarium by the manufacturer for her advice about this or another drug made by the same company?

We know already that doctors are influenced in their prescribing patterns even by tchotchkes like pens or free lunches. One recent study of almost 280,000 physicians who received over 63,000 payments, most of which were in the form of free meals worth under $20, showed that these doctors were more likely to prescribe the blood pressure, cholesterol or antidepressant medication promoted as part of that meal than other medications in the same class of drugs. Are these incentives really enough to encroach on our sworn obligation to do what’s best for our patients, irrespective of outside influences? Perhaps, and that’s the reason many hospitals ban them.

In both scenarios the doctor should, at the very least, have to disclose the conflict to patients, either on a website, where patients could easily view it, or by informing them directly, as my mother-in-law’s doctor did to her.

More importantly, what do patients think of these conflicts? Back in the comfort of our family room, following her appointment, I asked my mother-in-law that very question.

“Oh, I was glad he told me.” I prodded her to go on, as she shifted in her chair, trying to get comfortable. “It made me trust him more. He must be an expert if he helped invent the hip. And of course I want him using the one he invented, he knows it better than anyone!”

It turns out, she’s not alone. In a study of over 600 surgical patients, about 80 percent felt it was both ethical and either did not influence, or actually benefited their health care, if their surgeons were consultants for surgical device companies.

It’s complicated. Certainly, the relationships doctors have with drug or device manufacturers drive innovation, and help make those products better for patients. But can we ever be sure these relationships aren’t influencing the purity of our practice of medicine, even a little?

Dr. Mikkael Sekeres is director of the leukemia program at the Cleveland Clinic. Follow him on Twitter @MikkaelSekeres.