The Mayo Clinic is building its future around high-tech approaches to research known as “precision medicine.” This involves gathering huge amounts of information from genetic tests, medical records and other data sources to ferret out unexpected ideas to advance health. But one longtime scientist at the Mayo Clinic isn’t playing along.

Dr. Michael Joyner is a skeptical voice in a sea of eager advocates. Joyner’s lab studies exercise. It is, fittingly enough, in a hospital building founded in the 1880s. While Mayo has built all sorts of new labs at its sprawling campus in Rochester, Minn., Joyner can conduct his work without glitzy DNA sequencers and other high-tech tools of precision medicine.

And it’s not simply that he’s an old-school devotee. He believes that the solution to our most pressing health problems lies in thinking about whole human beings, not breaking everything down to DNA sequences.

“The enthusiasm for this [precision medicine] is occurring in a country where life expectancy is actually falling,” he says as he walks through the old linoleum-tiled halls of St. Mary’s hospital.

That fact alone leads Joyner to ask whether the money being poured into high-tech medical research is really solving the nation’s stark health problems, like obesity, heart disease, high blood pressure, diabetes, Alzheimer’s disease and cancer.

Joyner says there are certainly appropriate places to use this technology, and he doesn’t dispute the individual stories of success his colleagues tout. But he believes the best way to address the health concerns facing the nation is by studying — and treating — whole people, not by breaking the problems down to billions of genetic bits and pieces.

He practices what he preaches in both his personal life — his thorough exercise routine includes commuting by bicycle — and his physiology lab.

On the day I visited at the end of August, volunteer Greg Ruegsegger was outfitted with monitors, a catheter threaded into a vein and a mask to capture his breath. He would exercise to the point of exhaustion while scientists studied him. This is far more informative than any genetic test, Joyner says.

“People have looked at 3,000 elite endurance athletes — these are people who compete in the Tour de France and win Olympic medals in cross-country skiing and distance running — and [scientists] have been unable to find any genetic marker for superior performance.”

And when it comes to the health of ordinary people, Joyner talks about real-world studies, which show that walking or biking to work has four- or fivefold more influence on a person’s body mass index than that person’s genetic profile.

Joyner is focused on how the body’s systems work together during exercise, but the same interconnectedness applies to many diseases. That’s why cancer drugs that target one biological pathway generally don’t last long. Tumor cells simply find workarounds, exploiting the redundancies deeply embedded in biology. And that’s why Joyner has so little faith in science that keeps trying to focus down on smaller and smaller details.

“One of the things we have to ask ourselves when we get these big initiatives is, ‘What’s the definition of success?’ ” he says.

Scientific discoveries alone don’t do it for him. Doctors need to build effective treatments — and patients need to follow along. This is the promise of precision medicine in the long run, but Joyner has published articles (like this one) skeptical of the drive to collect vast piles of information, hoping to make sense of it later.

“Is this just going to be a biological Tower of Babel,” he asks, or will this information also lead to discoveries that translate beyond the laboratory and actually change public health for the better?

He doesn’t doubt that DNA sequencing and other tools of precision medicine are useful in specific instances, such as for diagnosing rare diseases. There are a few uses in cancer treatment, but so far there has been just one randomized study of patients assigned to treatments based on their tumor’s DNA profile, and it showed no advantage over traditional medical judgment.

This isn’t a popular point of view elsewhere at the Mayo Clinic, which is sinking hundreds of millions of dollars a year into precision medicine. The shiny new labs across campus seem a world apart from Joyner’s physiology lab.

After my conversation with Joyner, Mayo public affairs officers eagerly led me to a series of scientists there who disagree with him. One stop was at the Medical Genome Facility.

This room is chock-full of machines that cost many hundreds of thousands of dollars apiece. They can analyze DNA from a person, a tumor or even a single human cell. They can read out an entire genome, or just a subset, which is called the exome.

“I really do believe that understanding our genome is fundamental,” says Julie Cunningham, one of the facility’s three co-directors. Like other scientists at Mayo, she has had swaths of her own exome sequenced.

“I learned that by and large I’m really lucky, but I learned that I have two [genetic] variants that affect how I respond to particular drugs that are out there.” She had actually known that before for one of those drugs, “but now I know exactly why I have it and it’s potentially serious. That has to be good. There’s nothing wrong with that.”

Bad drug reactions are a serious medical problem, so in principle, a genome profile should help reduce that risk. The reality, though, is that the vast majority of genomic tests for drug sensitivity give ambiguous answers.

One of the most carefully studied examples involves the blood thinner warfarin. Four separate studies show that people who got genomic testing for this susceptibility did no better — or only marginally better — than patients whose dosages were determined by traditional strategies.

This lack of strong data is a problem for many areas of precision medicine.

“Although we think conceptually this is going to be of high value, and it will ultimately improve health care with better quality and lower cost, we have to prove that,” says Keith Stewart, a hematologist who directs Mayo’s Center for Individualized Medicine. “If it doesn’t all pan out the way we expect that’s OK. But I think there will be plenty of unexpected areas that we haven’t conceptualized yet, so I think it’s a very worthwhile investment on the taxpayers’ point of view.”

Whether precision medicine is going to be a boom or a bust, “right now it’s just speculation on both sides,” he says.

“It is somewhat inevitable that every person in this country will have their genome sequenced.” he adds.

Gianrico Farrugia, a gastroenterologist who is chief executive officer of the Mayo Clinic in Florida, agrees.

“What we’re beginning to see is that technology is invading and replacing traditional testing,” says Farrugia. For example, it is already used to determine treatments for lung cancer and diagnose rare diseases.

And, in any event,he says medicine is already moving aggressively into this new territory and there’s no going back. “That’s not only wrong,” he says, “it’s impossible.”

With the momentum now built up behind this enterprise, precision medicine will be judged like much of modern medicine: in hindsight, after it becomes entrenched in clinical practice.

You can contact Richard Harris via email.

Let’s block ads! (Why?)

Editor’s Note: This story was produced in partnership with WOSU and Side Effects Public Media, a reporting collaborative focused on public health. A web-only version originally ran in Shots in September; listen to the audio above to hear from an Ohio woman, Shani Rucke, who couldn’t get the epidural pain relief she wanted during childbirth because she was 15 years old at the time, and her mom said no.

In 2011, before she became a nurse practitioner, Maureen Sweeney was working as a registered nurse in labor and delivery at a Cleveland-area hospital. She helped hundreds of women deliver their children, many of whom were minors in their early teens.

That’s because, in Ohio, the rate of teenage pregnancy is slightly higher than the national average. This year, about 23 in 1,000 teenage girls will become pregnant.

One patient in particular from those nursing school days sticks out in Sweeney’s mind.

“It was a 15-year-old woman who was coming in, in labor, to the emergency room,” Sweeney remembers.

The teen was scared. She didn’t talk much and didn’t trust any of the doctors. She told Sweeney she had no family and that she was a runaway.

“She was by herself and she was living on the streets or between friends’ houses,” Sweeney says.

In that moment, Sweeney became the young woman’s only support system to help her through the delivery of her baby.

“So as it progressed and it got more and more painful, she did request an epidural,” Sweeney says.

An epidural is a common type of regional anesthesia that eases the pain of labor. As she had done many times before, Sweeney followed hospital protocol and called the anesthesia department. But to her shock, they told her they could not help her young patient.

“They said that without parental consent, … she would not be able to sign for her own epidural,” Sweeney says.

In Ohio, people under 18 who are in labor cannot consent to their own health care. They can receive emergency services, but nothing considered to be elective. For the many Ohio minors who become pregnant, it’s a painful gap in coverage.

It’s also complicated by the fact that in Ohio, there is no legal process for emancipation: A minor’s parents must be deceased, or the minor must be married or enlisted in the armed forces to be granted independent legal status.

Ohio lawmakers are considering legislation that would allow minors to determine their own care during pregnancy. Colorado and North Dakota passed similar laws in recent years.

Abigail English, director of the Center for Adolescent Health and the Law, studies consent laws that govern minors. She says most states do allow pregnant teens to consent to their own care. One by one, it seems holdout states are moving in that direction, too, she says — once someone advocates for the change.

Delivery room doctors and nurses are often the ones pushing for that change.

When the hospital wouldn’t authorize an epidural for the 15-year-old Sweeney was caring for in 2011, Sweeney called the office of Cuyahoga County Children and Family Services; oftentimes an agent from children’s services can sign for medical consent in these cases. But it was 3 a.m. The young woman was in active labor and an agent couldn’t make it to the hospital until 9 a.m.

Sweeney remembers how hard to was to tell her patient the news.

“I had to go in, sit down with her and talk about the fact that she wasn’t going to be able to get an epidural, and she was going to have to do this naturally,” Sweeney says.

That’s when the young woman broke down, Sweeney says, and folded in on herself in tears.

Throughout the U.S., minors are generally required to have permission from their parents or legal guardian before they can receive most medical treatment that’s not considered emergency care. However, each state has established a number of exceptions.

According to the Guttmacher Institute, 26 states allow minors 12 and older to get prescription methods of contraception without a parent’s or guardian’s consent, and just two allow minors to consent, on their own, to an abortion. Ohio is one of more than a dozen states with no explicit policy allowing a minor to consent to prenatal and pregnancy-related care.

Diana Thu-Thao Rhodes directs public policy for Advocates for Youth, an advocacy organization that focuses on, among other things, the rights of minors to get access to health care. She says in the last few years, minor-consent laws in some places around the country have become increasingly restrictive.

“We can legislate minors’ decision-making much easier because of the fact that they are minors,” says Thu-Thao Rhodes.

Dr. Michael Cackovic, an obstetrician at The Ohio State University Wexner Medical Center, says every couple of months he sees a teenage mom who, under Ohio law, is unable to receive elective treatment, like an epidural. He says it’s frustrating to see patients in unnecessary pain.

“First of all, from a labor and delivery standpoint, you don’t like to see anybody uncomfortable,” Cackovic says.

Both Cackovic and Sweeney report that, just as frequently, they’ve had cases where the mothers intentionally denied their teenage daughters an epidural – as a sort of punishment for getting pregnant.

All Cackovic can do is try to talk them out of it.

“To take the mom aside,” he says, “and say, ‘You know, this isn’t some life lesson here. This is basically pain — and there’s no reason for somebody to go through that.’ “

This gap in Ohio law bars a young mother from choosing a C-section. And she can’t consent for a procedure to test for chromosomal abnormalities in the fetus.

Cackovic says he thinks that’s pretty backward: After she gives birth, the teenage mother can consent to the care of her baby, but she can’t consent to the prenatal procedure that would help pinpoint a diagnosis.

There is no way to know for sure how many teens across the country are denied these elective procedures. Thu-Thao Rhodes says in states like Ohio these young patients have been overlooked by lawmakers because they’re not in a position to advocate for themselves.

“The priority for a lot of these young people is to just get the basic health care and services they need,” Thu-Thao Rhodes says, “not spending unnecessary, and often unavailable, time and resources navigating complicated healthcare and legal systems.”

Let’s block ads! (Why?)

Dr. Howard Bennett creates elaborate Lego sculptures, juggles squishy balls during office visits and transforms exam gloves into water balloons, but it’s his booger and fart jokes that crack up even his grumpiest pediatric patients.

“Kids of any age are curious about their bodies,” the pediatrician writes in his latest book, The Fantastic Body: What Makes You Tick & How You Get Sick, “especially if what they’re learning about is gross! That’s why kids laugh hysterically if someone tells a booger joke or lets out a big, juicy fart in class.”

Bennett, who practices in Washington, D.C., has been writing about children’s health for years, in books and in a column for The Washington Post. The Fantastic Body includes fun facts about lice, pimples, warts and other nasty stuff, but he also explains to children how muscles work, how you digest food, what’s going on inside your brain and heart, how to treat common ailments and how to avoid getting sick in the first place. This interview has been edited for length and clarity.

How did you discover that telling gross jokes could help children feel more comfortable?

Adults are typically scared about what’s wrong with them. Children are scared about what you’re gonna do to them, but in both cases, patients need to know that you’re interested in why they’re there, interested in them as people, that you care about them. There’s lots of different ways to do that. You don’t have to talk about pee and poop. You can talk about the weather, politics, and you can be kind and very serious and still get it across.

It just so happens that part of me never grew up, so pee and poop and that kind of stuff, my patients’ parents see that their kids like this, and so they let me go with it because they realize it makes the kids feel more comfortable.

In the adult world, research has shown that if you come into my office, and I spend just a minute talking to you about something unrelated to why you’re there, you’ll be more satisfied with the visit, and you’ll be more likely to do what I’m suggesting you do, so it improves patient compliance. It’s not just touchy-feely stuff. It actually has an impact on health care.

Do your strategies work even with very sick kids?

One time when I was in the ER, this child was very scared, and somebody called me over to see if I could do something ’cause I guess I had a little bit of a reputation for being childlike, if not childish. He was in his bed wearing Ernie pajamas and Ernie slippers, and I pulled out my Ernie puppet. I swear I could have put a tube in the child’s throat, and he would have said ‘Thank you.’ He was mesmerized. By taking out Ernie, I showed him that I liked kids, and I liked toys, and if I liked toys, maybe I’m not a jerk.

Do your jokes ever backfire?

At one visit, I was ranting about potty humor, and the mom said, “Dr. Bennett, we don’t use potty humor in our house.” For the next 20 years, I never used potty jokes with them. Another mom wrote me a letter explaining that my humor is inappropriate and offered to take me out to lunch to teach me how to interact with children. I declined.

I went into the room once with this girl who got hit on the head with a lacrosse ball, and the first thing she said is, “My head really hurts; I don’t want any jokes,” so I didn’t do any. You get a feel for it, but still, anybody can mess up. If people know that your intentions are good, I think it’s OK.

When did you start writing books, and how did you decide to write The Fantastic Body?

The first book I did was The Best of Medical Humor in 1991. Then I did Waking Up Dry: A Guide to Help Children Overcome Bedwetting in 2005, and I saw there was a perfect way to put together my writing for kids and my working with kids. You know that standard line about write what you know? It finally sort of came together. The Fantastic Body grew out of my KidsPost columns. There are a lot of gross books out there, but this was the first time anybody put the body, physiology, medical facts and gross stuff all together.

What’s your favorite gross fact in the new book?

One of my favorites is a sidebar in the skeleton chapter. When lobsters molt, and they’re just these things crawling around with no shell, people in the lobster industry refer to them as turds, so this is perfect. I’ve got a medical fact, and I’ve got a gross fact all wrapped into one.

Lauren Kafka is a freelance writer, editor and English tutor and founder of Kafka Consulting in Bethesda, Md. Her twins have been Dr. Bennett’s patients for 19 years. She’s on Twitter: @LaurenKafka

Let’s block ads! (Why?)

It may sound like the plot of a movie: police find a young man dead with stab wounds. Tests quickly show he’d had Ebola.

Officials realize the suspects in the case, men in a local gang, may have picked up and spread Ebola across the slum. These men are reluctant to quarantine themselves and some – including a man nicknamed “Time Bomb” – cannot even be found.

This scenario actually unfolded in the West African country of Liberia in 2015. And what followed was a truly unconventional effort by epidemiologists to stop a new Ebola outbreak.

On today’s Radio Replay, we hear how those epidemiologists built trust to prevent an epidemic. Then, we talk with author Tim Harford about the surprising benefits of messiness and chaos in our everyday lives.

Hidden Brain is hosted by Shankar Vedantam and produced by Maggie Penman, Jennifer Schmidt, Rhaina Cohen, Parth Shah and Renee Klahr. Our supervising producer is Tara Boyle. You can also follow us on Twitter @hiddenbrain, and listen for Hidden Brain stories each week on your local public radio station.

Let’s block ads! (Why?)

Earlier this year, the Gallup organization set out to identify the top concerns everyday Americans have about money. Researchers asked more than a thousand people across the country, “What is the most important financial problem facing your family today?” Their top answer: the cost of health care.

Increases in medical costs have substantially outpaced economic growth for decades. In recent months, ProPublica has shown that it doesn’t have to be this way. It’s been estimated that the U.S. health care system wastes about $765 billion a year — about a quarter of what’s spent. We’ve identified ways that tens of billions of dollars are being wasted, some of them overlooked even by many experts and academics studying this problem.

It’s possible to reduce or eliminate some of the waste, but there are also formidable forces that benefit from it. Excess spending generates revenue and profit for what some have called the “medical industrial complex,” said Dr. H. Gilbert Welch, professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice. “There are a number of people who can imagine ways to solve things,” Welch said of the wasted spending. “But the political will and the forces at work can stop them pretty easily.”

Still, wasting fewer health care dollars could drive down insurance premiums and out-of-pocket costs and maybe even free up resources for education, retirement and wage increases, among other things.

Here are the ways ProPublica found the medical industry is needlessly gobbling up money, along with steps health care leaders or policymakers say we could take right now to reduce the waste.

What Hospitals Waste: The nation’s health care tab is sky-high. We’re tracking down the reasons. First stop: A look at all the perfectly good stuff hospitals throw away.

What ProPublica found: Hospitals routinely toss out brand-new supplies and gently used equipment. Most of it goes to the dump, but some gets picked up by nonprofit organizations that ship the goods to the developing world.

How much money is wasted: No one tracks the total, but one charity in Maine had about $20 million worth of discarded goods filling its warehouses. Similar nonprofits operate around the country. The University of California, San Francisco Medical Center studied how much it wasted during neurosurgery operations in one year. The discarded supplies were worth $2.9 million.

How to stop the squandering: UCSF reduced waste by reviewing the lists of supplies each surgeon wanted prepped for an operation. Many items could be taken off the lists. That reduced the number of supplies opened to set up each procedure, said Dr. R. Adams Dudley, director of the UCSF Center for Healthcare Value.

Hospitals could reduce wasted supplies by tracking everything thrown away, said Dr. Robert Pearl, former CEO of The Permanente Medical Group, the country’s largest medical group and author of the book Mistreated. The amount of waste could be reported when each patient is discharged, he said. Seeing the waste quantified would motivate people to prevent it, he said.

Several experts said paying hospitals a lump sum for everything involved in a particular procedure , instead of a la carte for each item, would mean they make more profit by cutting the amount of wasted supplies and equipment.

America’s Other Drug Problem: Every year nursing homes nationwide flush, burn or throw out tons of valuable prescription drugs. Iowa collects them and gives them to needy patients for free. Most other states don’t.

What ProPublica found: Nursing home patients typically have their drugs dispensed a month at a time. So whenever a drug gets discontinued – if a patient dies, or moves out, or has a reaction – there’s excess. Most nursing homes throw away the leftover drugs. They flush them down the toilet, put them in the trash or pay to have them incinerated. Iowa started a nonprofit organization to recover the excess drugs, inspect them and dispense them for free to patients.

How much money is wasted: It’s estimated that hundreds of millions of dollars a year are wasted by throwing out nursing home medications. The CEO of a long-term care pharmacy in Florida said his company incinerates about $2.5 million in valuable medication every year. He estimated the total is $50 million statewide. Colorado officials said the state’s long-term care facilities toss out 17.5 tons of potentially reusable drugs each year, worth about $10 million. Iowa is on pace to recover $6 million in drugs from nursing homes this year.

Other harm to the public: Flushing drugs down the toilet contaminates the water supply. Trace levels of pharmaceuticals have been detected in water throughout the country.

How to stop the squandering: Many states have laws that allow drug donation, but they have not invested in a program to help the process. ProPublica’s story prompted lawmakers in Florida and New Hampshire to introduce legislation to create a program like Iowa’s. Leaders in the Vermont medical community have also shown interest in starting a drug donation program.

How Two Common Medications Became One $455 Million Specialty Pill: After I was prescribed a brand-name drug I didn’t need and given a coupon to cover the out-of-pocket costs, I discovered another reason Americans pay too much for health care.

What ProPublica found: A drug company combined two over-the-counter drugs, naproxen, which goes by the brand name Aleve, and esomeprazole magnesium, also known as Nexium, to create a new pill called Vimovo. My doctor prescribed it to me. The company that makes it, Horizon Pharma, marketed the single pill as an innovation because it was easier to take one pill than two. A month’s supply of the two inexpensive drugs costs about $40. The company billed insurance $3,252 for the Vimovo.

How much money is wasted: My insurance company rejected the bill, but Vimovo has net sales of more than $455 million since 2014. Horizon brought in $465 million more in net sales from a similar drug, Duexis, which combines ibuprofen and famotidine, aka Advil and Pepcid.

How to stop the squandering: Spurred by ProPublica’s story, Connecticut now requires doctors to get prior authorization to prescribe Horizon’s drugs to the 200,000 public employees, retirees and their dependents covered by a state insurance plan. The Connecticut comptroller also urged the attorney general’s office to investigate Horizon’s relationship with pharmacies and physicians. Other insurers have removed the drugs from their formularies.

Welch, the Dartmouth doctor, suggested tongue-in-cheek “warning labels” on drugs that aren’t actually big innovations. In the case of Vimovo, the warning could say that the “specialty” pill is actually just a combination of two cheaper ingredients. “There may need to be public service advertisements that counter the advertising that says everything is the best thing since sliced bread,” he said.

In cases where there are dramatic price increases, state lawmakers could require pharmaceutical companies to justify the higher costs, said Dr. Steven Pearson, president of the Institute for Clinical and Economic Review.

Secret deals and rebates currently cloak the actual price of drugs. Drug companies should have to publish the real prices of their products, said Linda Cahn, an attorney who advises corporations, unions and other payers on how to reduce their costs. Cahn recently proposed in an op-ed in The Hill what she calls a “bid day,” where any drug company that wants to sell its products to Medicare beneficiaries would be required to submit the net cost of each medication. All the companies would be required to submit their price at the same time, say twice a year, and then stick with the price, which Medicare would make public for all to see. The bidding would inform consumers and force competition, she said. The same process could be used for all insurance plans, she said.

The Myth of Drug Expiration Dates: Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. Meanwhile the FDA has long known that many remain safe and potent for years longer.

What ProPublica found: The term “expiration date” is a misnomer. The dates on drug labels are the point up to which pharmaceutical companies guarantee their effectiveness. But that does not mean the drugs are ineffective or dangerous the moment after they “expire.” The Food and Drug Administration and Defense Department created the Shelf Life Extension Program to test the stability of drugs in the federal government’s stockpiles and then extend their expiration dates, when possible. A 2006 study of 122 drugs tested by the program showed that two-thirds of them were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years. But the same type of drugs in hospitals or pharmacies get thrown away when they “expire.”

How much money is wasted: The total is unknown, but one mid-size hospital in Boston had to destroy about $200,000 in expired drugs in 2016. If hospitals nationwide throw out similar amounts of drugs annually, the total would be about $800 million trashed each year by hospital pharmacies alone.

Other harm to the public: Some expired drugs are in short supply and difficult to replace. On occasion, a pharmaceutical company will extend the expiration date of drugs for which there are shortages, but they are not required to do so.

How to stop the squandering: Drug companies could be required to do studies to determine how long their products actually last, and report the information, said Lee Cantrell, a pharmacist who helps run the California Poison Control System. Also, the government could publish data from the Shelf Life Extension Program, which is funded by taxpayers. The information would help people see “many types of medications are safe and effective much longer than their original expiration dates,” Cantrell said.

Drug Companies Make Eyedrops Too Big – And You Pay for the Waste: The makers of cancer drugs also make vials with too much medication for many patients. The excess drugs are tossed in the trash — another reason health care costs are so high.

What ProPublica found: Drug companies make eyedrops much larger than what the eye can hold. That means patients pay for the excess from each drop, which runs down their cheeks. Vials of cancer drugs are also larger than necessary. The leftover cancer medication is billed to the patient – and thrown in the trash can.

How much money is wasted: It’s unknown how much it costs to waste a portion of each eyedrop, but the industry is huge. Last year, drug companies brought in about $3.4 billion in the U.S. alone for dry eyes and glaucoma drops, according to the research firm Market Scope. A 2016 study estimated that, of the top 20 cancer drugs packaged in single-use vials, 10 percent of the medication is wasted, at a cost of $1.8 billion a year.

How to stop the squandering: Citing ProPublica’s story, two U.S. senators introduced legislation that would require federal agencies to stop the waste associated with eyedrops and single-use cancer drug vials. Drugmakers could reduce the waste of cancer medication by making vials in varying sizes, so that less would be left over from each patient, said Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York. Bach led a team that estimated the waste associated with vials of cancer drugs.

A Hospital Charged $1,877 to Pierce a 5-year-old’s Ears. This is Why Health Care Costs So Much: An epidemic of unnecessary treatment is wasting billions of health care dollars a year. Patients and taxpayers are paying for it.

What ProPublica found: It’s common for medical providers to deliver care that’s not needed, or that costs more than necessary, and patients get stuck with the bills. In one case, a Colorado mom said her surgeon offered to pierce her daughter’s ears as an add-on to a different operation. The mom agreed, assuming it would be free. But the hospital stuck her with a bill for $1,877 for “operating room services.” ProPublica also highlighted unnecessary imaging tests, like extra mammograms and ultrasounds, and found it’s common for hospital intensive care to be delivered to patients who are too sick or too healthy to benefit.

How much money is wasted: Unnecessary or needlessly expensive care wastes about $210 billion a year, according to the National Academy of Medicine. The cost of false-positive tests and overdiagnosed breast cancer is $4 billion a year, according to a 2015 Health Affairs study. Unnecessary intensive care costs about $137 million a year for about 100 hospitals in two states, one study estimated. That would put the tab of non-beneficial intensive care in the billions nationwide.

How to stop the squandering: Medicare has a fee schedule that sets prices and makes them public, said Welch, the Dartmouth physician who advocates against overtreatment. States could pass laws that establish similar fee schedules, he said, or insurance companies could implement them. Establishing set prices would reduce administrative overhead, he said, and allow patients to shop for the best deals.

Several experts said policymakers need to move medical providers from payment based on volume of services to payment based on value. Right now “fee for service” payment is common, so providers get a fee for everything they do. This gives them the incentive to do more, sometimes more than is necessary, or to provide care that’s more expensive than it has to be. If providers were paid a lump sum to care for individuals or a group of patients, and the outcomes of their performance were measured to ensure quality didn’t suffer, they would cut the waste. “You want to empower organizations to be responsible for improving patient health and reducing costs,” said Dr. Elliott Fisher, director of The Dartmouth Institute for Health Policy and Clinical Practice.

ProPublica is a nonprofit newsroom based in New York. You can follow Marshall Allen on Twitter:@marshall_allen. Have you seen examples of wasted health care spending? Share them with Marshall here.

Let’s block ads! (Why?)

Updated at 4:17 p.m. ET to include comment from homeopathic pharmacists.

The Food and Drug Administration said it plans to crack down on the sale of some homeopathic products.

The agency unveiled a new, risk-based approach to regulating homeopathic treatments Monday that aims to protect the public from dangerous products.

“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” FDA Commissioner Scott Gottlieb said in a statement announcing the new policy.

“In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse — that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” Gottlieb says.

Homeopathy is an ancient practice based on the idea that small traces of substances that cause diseases can actually be used to treat illness. But critics have long charged that there is no scientific evidence to support homeopathy and that some homeopathic products could be dangerous.

Critics have been especially concerned about products being contaminated with dangerous substances, or sold for serious conditions for which other, proven treatments work.

The FDA has issued warnings about specific products in the past, and the Federal Trade Commission has required better labeling of homeopathic products.

But over the past decade, the homeopathic drug market has grown “exponentially,” according to the FDA, becoming a nearly $3 billion industry in the United States.

The FDA has seen a “corresponding increase in safety concerns, including serious adverse events” resulting from homeopathic products, the FDA says.

In response to the growth and continuing concerns, the FDA convened a public hearing to revisit a 1988 decision not to regulate homeopathic products like standard medical treatments.

Under the new policy, the FDA will more carefully scrutinize these products, especially those sold to treat infants and children, those containing ingredients with significant safety concerns, such as belladonna, and those sold for serious conditions such as opioid addiction, heart disease and cancer.

“We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm,” Gottlieb says.

Mark Land, president of the American Association of Homeopathic Pharmacists, said in an email that the group “shares the FDA’s commitment to protecting public health,” and noted the action “would not materially affect the vast majority of homeopathic drug products available in the United States.”

“As always, AAHP is committed to ensuring that consumers have access to natural, safe, homeopathic medicines in the United States and throughout the world,” Land said.

During a briefing for reporters about the proposed new policy, FDA officials stressed that the agency had no intention of requiring most homeopathic products that are on the market to undergo formal FDA review, however, or to remove most homeopathic products. So people who believe such products help them will still have access to many of them, the officials said.

The proposed policy will be open for public comment for 90 days. The agency will review the comments before making the policy final.

The agency’s move was praised by long-term critics of the industry.

“I think that it’s about time that these snake oil salesmen were held accountable for what they’re selling,” says Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia. “The consumer will clearly benefit.”

Let’s block ads! (Why?)

The average American reads at an 8th-grade level, but the patient information that doctors and hospitals provide often presumes that people have much more advanced reading skills.

So some researchers decided to see what happens when 9-year-olds write the patient guides.

Dr. Catrin Wigley at University Hospitals Coventry and Warwickshire NHS Trust and colleagues analyzed six National Health Service patient information leaflets from across England for total hip replacement and found that the average readability level was age 17, even though the average Brit reads at a 4th-grade level. You’d have to have the reading comprehension of a high school senior to understand from these brochures what a hip replacement is, why you need it and what complications might occur.

The researchers recruited 57 nearby elementary school children ages 8 to 10 to help revise the content.

After a lesson about hip replacement, the children were asked to write their own leaflet and draw an image to illustrate it. They were given four headings: indications for surgery, complications of surgery, before the procedure, and the procedure.

What the children came up with was clear, concise and without sugarcoating.

“Your hip is old and rotten,” says Mohammed.

“It is past its sell-by date,” adds Jaime.

What is not allowed before surgery? Coca Cola, fries, and chocolate, according to Lilly.

Of course, no one is suggesting we actually let children write the guides, but maybe we can learn something from their approach.

The authors write: “What better way to write a new leaflet than by engaging with 9-year-old children, so that we can begin to appreciate the disparity in the language we use to convey information through formal patient information leaflets.”

It’s a novel experiment, but can’t really work in practice, according to Cynthia Baur, director of the Horowitz Center for Health Literacy at the University of Maryland’s Public School of Health.

“While children may be able to say things simply, they don’t have the context and experience to recognize aspects of topics that might need more in-depth information or explanation, and they can’t anticipate adult concerns,” Baur says.

But it may shed fresh light on a problem that has been percolating for decades.

Low health literacy leads to poor outcomes for patients and millions of dollars in unnecessary health costs. Countless commissions and organizations have developed plans for improvement. In 2010, the U.S. Department of Health and Human Services published a 73-page action plan to improve health literacy and called for making it a public health priority.

The proliferation of computer-generated patient leaflets was supposed to help. Yet measurement tools with great names like Simple Measure of Gobbledygook (SMOG) and Gunning Fog (GFI) show that these patient education materials are often too complex for the average person.

“I definitely think patient materials have improved, but they are still far from where they need to be,” says Baur, who edited the HHS action plan and created the Centers for Disease Control and Prevention’s health literacy site prior to her appointment at Maryland. “These tools, along with audience testing, of the materials will make health materials much better much faster.”

So can we learn something from the experiment? Maybe simplicity. “Let’s take our cue from the children and begin speaking honestly and to the point with our patients in a language they understand,” Wigley and her colleagues write in their analysis.

What works, says Bauer, is involving the intended recipients. “Health care organizations that truly care about excellent patient experiences and well-being will find ways to involve patients, caregivers and others in the routine development of all types of health communication, even forms and facility signs,” she says.

Let’s block ads! (Why?)