In 2012 the National Academy of Medicine estimated the U.S. health care system squandered $765 billion a year. Today hundreds of volunteers collect discarded medical equipment and supplies from a network of hospitals and medical clinics and ship them overseas. From ProPublica.
This article first appeared March 9, 2017 onProPublica.
By Marshall Allen
Just outside Portland, Maine, there's a 15,000-square-foot warehouse that's packed with reasons the U.S. health care system costs so much: Shelves climb floor to ceiling, stacked with tubs overflowing with unopened packages of syringes, diabetes supplies and shiny surgical instruments that run hundreds of dollars apiece. There are boxes of IV fluids and bags of ostomy supplies and kits with everything you'd need to perform an obstetrics surgery.
This, however, isn't a story of about the crippling price of medical supplies. This is about the high cost of medical supplies that hospitals throw away.
On a recent snowy day the warehouse's 65-year-old proprietor, Elizabeth McLellan, gave an indignant accounting: She yanked a urinary catheter out of one bin. It's unopened and has an expiration date of July 2018. "There's no reason to get rid of this." A box of 30 new feeding bags has an August 2019 expiration date. The same type sells on Amazon.com for $129.
That surgical stapler? It's unopened. The same model sells online for $189. And McLellan simply shook her head over a set of a dozen long thin laparoscopic surgery instruments that some hospital discarded. Similar used tools can go for hundreds of dollars.
"There's nothing wrong with these, nothing wrong with any of these," she said.
Ten years ago, McLellan, a registered nurse, shocked to see what hospitals were tossing out, began asking them to give her their castoffs instead. In 2009 she launched Partners for World Health, a nonprofit that now has four warehouses throughout Maine. Today, she and hundreds of volunteers collect medical equipment and supplies from a network of hospitals and medical clinics, sort them and eventually ship containers full of them to countries like Greece, Syria and Uganda.
"This is money." McLellan said, extending her arm to the vast array of supplies. "This is one of the reasons why your health insurance is so expensive."
The vexing riddle of how to make health care more affordable has seldom been more front and center on the national stage. President Trump and Republican lawmakers are wrestling with the future of the Affordable Care Act, which has helped millions of people obtain health insurance. But most Americans would rather their legislators focus on bringing down health care costs, according to a recent survey by the Kaiser Family Foundation. Two-thirds of those surveyed said reducing such costs should be the "top" health care priority for Trump and the Republican-led Congress.
Elizabeth McLellan started Partners for World Health when she worked as a nurse administrator and saw her hospital tossing out useful supplies.
Talk to experts and many agree that waste would be a good place to start. In 2012 the National Academy of Medicine estimated the U.S. health care system squandered $765 billion a year, more than the entire budget of the Defense Department. Dr. Mark Smith, who chaired the committee that authored the report, said the waste is "crowding out" spending on critical infrastructure needs, like better roads and public transportation. The annual waste, the report estimated, could have paid for the insurance coverage of 150 million American workers — both the employer and employee contributions.
"It's unconscionable that we're not only wasting money in health care but in doing so are sacrificing other important social needs," Smith said.
Smith's committee blames the obvious villains — overtreatment, excess administrative costs and high prices — for most of the fat in the system. Left untallied, however, are the discards that arrive in waves into McLellan's warehouses, most of which would otherwise end up in landfills. McLellan estimates the goods her group has right now are worth $20 million. Sure, that's a rounding error in the overall waste tab, but it starts being real money if you add up the discards of all the nation's medical facilities.
Researchers at the University of California, San Francisco Medical Center, for instance, recently estimated that in a single year the hospital wasted $2.9 million in neurosurgery supplies alone. Nearly $3 million. On wasted supplies. In one department.
Last year Partners sent seven containers overseas, each weighing up to 15,000 pounds and with an estimated value of up to $250,000. One is being sent to Syria this week. It includes an ultrasound machine ($25,000), a dozen trocars ($4,400) and an infant warmer ($3,995).
MedShare, a Georgia-based nonprofit more than 10 times the size of Partners, sent 156 containers of discarded medical supplies to developing countries last year, each one worth as much as $175,000. As lawmakers debate, ProPublica is setting off to document the rarely examined — and mind-boggling — ways your health care dollars are frittered away. Our first stop: the world of "medical surplus."
There's a display case in the Partners headquarters that sums up the heedless wealth of American health care. On one side are medical supplies McLellan brought home from Bangladesh: a yellowed plastic respirator mask, dirty tubing and a bloodstained square of gauze that's brown and stiff from being washed and reused over and over again. Above them a sign reads, "Shared By Thousands." On the other side are the same items, sterile and new, the discards of local health care facilities in the U.S.
McLellan once worked as a nurse in Saudi Arabia and her wardrobe reflects her extensive travels in the developing world: velveteen pants from China, a chunky sea rock necklace from Senegal and bangles from Ethiopia. Places that welcome our medical largesse.
At the back of her office, she pushed through a set of swinging double doors that led to her disposable medical supplies warehouse, a room the size of a gymnasium, with 20-foot ceilings and glassy concrete floors.
Donations from throughout Maine, Vermont and Massachusetts come in through a loading dock at the back. McLellan calls it "golden trash" and it generally falls into a handful of categories: equipment discarded for upgraded models, supplies tossed after a hospital changed vendors, or materials donated by the families of patients who have died. Other items are past their expiration dates or were swept out by strict infection control procedures, but remain safely usable.
McLellan grabs a bag from a haphazard, 10-foot mound of boxes and bulging sacks waiting to be sorted. Its contents, she says, came from a single room in a hospital's intensive care unit. She dumps the bag out onto a table like a kid pouring out a pillowcase full of Halloween candy. The stuff rains down into a pile that's three square feet: Handfuls of unopened and unexpired sterile needles, two dozen sterile syringes, packets of alcohol and antiseptic pads, IV tubing; a roll of tape that's never been used, a bag of IV solution that expires in September 2018, 14 saline flushes that expire in 2019, an unopened package of suction catheters and a pulse oximeter adapter.
"This is normal," she said. "This is every hospital."
McLellan started her nonprofit after watching patient rooms being cleaned out at Maine Medical Center, where she was a nurse administrator. When patients were discharged, hospital staff threw out everything, including unopened supplies. McLellan got permission from the hospital's CEO to put out bins to save the discarded items.
A year and a half later, she'd gathered more than 11,000 pounds of supplies and equipment in her house. Today, Partners has three paid employees — McLellan is a volunteer — and an annual budget of $357,000, most of it from individual donations. Hundreds of volunteers pitch in. Similar nonprofits have sprung up around the country.
On a recent afternoon, Donald Madison, 47, Paul Farren, 69, and William Silveira, 85, picked up a used anesthesia machine, an exam table and other items at a Maine Medical Center storage facility and brought them to a different Partners' warehouse stuffed with medical hardware: a sea of new-looking wheelchairs, a shiny mountain of walkers and canes and neat rows of IV pumps. The biomedical equipment room has ultrasound machines, anesthesia machines, laparoscopic surgery towers and more. Biomedical engineers check out each piece before it is sent on to a country in need.
Madison, a supervisor at a retail pharmacy, said it's easy to get disgusted by the waves of wasted medical goods pouring through the warehouse. He grabbed a $30 walker from the pile. "We'll get 400 more of them this year," he said. "Why do we need everyone on Medicare to get a new walker?"
And those pallets of adult diapers stacked high on a shelf? He sells the same type at his pharmacy for $11.99 per package or more. Farren recalled one time they picked up about 100 unopened packages of diapers from the home of a patient who had died. "It was ridiculous," he said.
McLellan is sensitive about the built-in tension of her mission. The hospitals are casting off useful supplies that would otherwise be sent to a landfill. But they are also donating items that are desperately needed in the developing world. "They are trying to be good stewards in our community and in their world," she said.
On the flip side, she can't look past the waste. She said she could fill 15 shipping containers now if she had the $25,000 it cost to send each one overseas.
Hospital officials either declined to comment or, sometimes sheepishly, said some of the waste was unavoidable. Elton Cole, the supply chain manager at Stephens Memorial Hospital in western Maine, said some items, such as a torn exam table, must be replaced to meet infection control guidelines. Same goes for those supplies left in patient rooms. At Stephens, he said, the supplies in the room, such as bandages or gloves, are typically included in the room charge and not billed directly to patients.
Health care finance experts say while patients might not see the cost in their bills, the wasted supplies boost a hospital's overhead, which in turn makes everyone's costs higher.
The waste "contributes a lot to the cost of health care," Cole said. "It's pretty phenomenal the tons of product we're shipping out to Elizabeth's group."
Patricia Fallows, who organizes the University of Vermont Medical Center donations to Partners, sent ProPublica a list of the typical shipment. Among the 100 items are a Medline Skin Staple Remover ($100), a box of Carefusion Blood Sets ($100 for 10) and three cases of unexpired Ethicon sutures ($431 per box). (ProPublica is using the list price of the products online, since the prices hospitals and other medical facilities pay vary widely depending on their individual deals with suppliers.) Officials at the medical center said the waste is a tiny percentage of their budget and some of it is unavoidable.
We called the National Rural Health Association in Leawood, Kansas, to see if they could use anything on this list.
"Oh my gosh!" said Brock Slabach, the vice president for member services. "Some of the equipment I know folks would be interested in."
Slabach said more than 600 rural hospitals are so strapped financially they risk closure and according to the data, some may be uncomfortably similar to facilities in Algeria and Bangladesh. Wealthier hospitals' waste could help them stay afloat.
"Every little bit helps," he said. "None of these things will cure the entire problem altogether. But it would be helpful to meet a need in a community."
Unfortunately, quantifying what's being squandered is difficult. There is scant research, so it's easy for hospitals to say it doesn't add up to much.
Dr. Corinna Zygourakis, the chief neurosurgery resident at UCSF, who has studied operating room waste, said hospitals may not like what they'd find. "It's not nice to say, 'Hey, look at the amount of money we're wasting."
She decided to study waste after a medical mission trip to Mexico in 2015. At UCSF it was common to set out an array of disposable surgical instruments in the sterile field of the operating room just in case a surgeon needed them. Often the surgeon wouldn't even touch the instruments, but they, nevertheless, had to be discarded. In Mexico, they wouldn't have been.
Zygourakis and a team of colleagues tracked 58 neurosurgeries at UCSF and tallied the unused supplies that were discarded. In 26 surgeries, all the blood clotting materials weren't used, for a total of $3,749. In 16, an expensive tissue adhesive wasn't used at a cost of $3,495. Screws were wasted on three cases, totaling $3,144. The items marked as wasted were not billed to patients, and were donated whenever possible, she said.
But the study's findings, published in Journal of Neurosurgery in 2016, were eye-opening: The public hospital wasted an estimated $968 per neurosurgery case, which amounted to about $2.9 million over the course of a year.
UCSF reviewed all the preference cards for each surgeon, which specify how the operating room should be set up before each operation. The hospital now makes sure the set-up doesn't include supplies that aren't actually needed, preventing a significant amount of the waste.
In a separate study in the December edition of JAMA Surgery, Zygourakis and her colleagues showed each UCSF surgeon his or her direct costs per procedure in comparison to other surgeons in the institution. Most doctors were unaware of operating-room costs. Then they gave them an incentive: Their departments would get a bonus if they reduced costs by at least 5 percent.
The median surgical supply costs dropped by 6.5 percent in the group of surgeons who participated — a savings of about $836,000 over one year — while the control group's costs increased by almost 7.5 percent.
"It's really important to make people aware of this," Zygourakis said. "The younger generation of physicians and surgeons do care about these things. We do realize we have limited resources and want to see how we can provide the most and best care to the most number of patients."
Back in Maine, McLellan said she would love for the medical community to put her out of business by cutting the waste and passing the savings on to patients. She's invited hospital CEOs to visit her warehouses, to see the vast display of wasted health care dollars. So far none have come.
"I want to go talk to Trump," McLellan said. "Trump wants to figure out how to do this business in a different way, how to be more cost effective. I'm sure he doesn't understand what the waste is. Not this kind of waste. People don't get it until they see how much is wasted."
A review of federal inspection reports shows that at least 20 rural hospitals around the country have been found in violation of the Emergency Medical Treatment and Labor Act over the last five years.
This article first appeared March 3, 2017 on ProPublica.
ByJulie Lasson
This story was co-published with the Louisville Courier-Journal.
The young woman's water broke late one morning in August 2014, as she stood in the bathroom of her home in rural Kentucky.
Her mother rushed her to the emergency room at Jewish Hospital Shelbyville. She signed a slip at the front desk, listing her chief complaint as "labor."
But Jewish Hospital had closed its obstetrics department eight years earlier. "We don't deliver babies here," the nurse told the woman over the phone, not realizing that she was calling from inside the emergency room, a government inspection found.
With no help offered, the woman and her mother went to a nearby gas station and called 911. An ambulance took her to a hospital 24 miles away, where she delivered a baby girl via C-section.
Under the federal Emergency Medical Treatment and Labor Act, or EMTALA, every U.S. hospital with an emergency room has a duty to treat patients who arrive in labor, caring for them at least until the delivery of the placenta after a baby is born.
But 30 years after EMTALA was passed, hospitals — particularly those in rural areas without obstetrics units — are still turning away women in labor.
A review of federal inspection reports shows that at least 20 rural hospitals around the country have been found in violation of EMTALA over the last five years — including Jewish Hospital Shelbyville. In several cases, women suffered serious complications after being turned away, or were misdiagnosed at facilities that lacked specialists in obstetrics.
A hospital in Willows, California, was cited and fined in October 2013 for not recognizing that 29-year-old Martha Guzman had preeclampsia, a dangerous pregnancy complication. Guzman suffered seizures later that night and was rushed to a different hospital, where she delivered a stillborn boy. She died the next day.
Some ERs not only denied treatment to women in labor, they also would not help them transfer elsewhere, records show. A woman turned away by Monroe County Hospital in Forsyth, Georgia, ended up calling 911 from outside the dialysis center across the street. Another woman, told there were no staff gynecologists at a Hartford, Kentucky hospital, called an ambulance from a grocery store parking lot.
It's unknown how much such lapses contribute to the nation's burgeoning rates of maternal mortality and serious pregnancy-related complications, but inadequate care and misdiagnoses clearly play some role, experts say.
EMTALA was passed primarily to ensure that emergency rooms couldn't refuse patients because they couldn't pay for services. Prompted by a catastrophic case in which a pregnant woman was turned away from two California hospitals that believed she had no insurance, the provisions outlined in EMTALA specific to labor reflected that a growing number of hospitals, especially in rural areas, had begun eliminating obstetrics departments because of high costs and a lack of doctors.
EMTALA has not reversed this trend. "The availability of OB services in rural areas has steadily declined since the beginning of EMTALA in 1985," notes Dr. Todd Taylor, a longtime emergency room physician and EMTALA compliance consultant.
A study by The Walsh Center for Rural Health Analysis shows the portion of non-metropolitan counties without hospital-based obstetric services grew from 24 percent in 1985 to 44 percent in 2002, pointing to EMTALA as one reason why. Another study by the University of Minnesota Rural Health Research Center found that 7 percent of hospitals in nine states with large rural populations closed their obstetrics units between 2010 and 2014.
An official at the Centers for Medicare and Medicaid Services said that the agency does not track whether hospitals drop obstetric services or if the number of EMTALA violations at hospitals without such services has grown.
The EMTALA violation at Jewish Hospital Shelbyville prompted CMS to cite the hospital for placing patients in "immediate jeopardy," warning that if it did not swiftly fix the problems in its emergency room, it could lose Medicare funding.
"This was an existential threat," said Dr. Peter Hasselbacher, who conducts research and writes about state health policy for his web site, the Kentucky Health Policy Institute. Government health programs cover over 75 percent of Jewish Hospital's patients, he added.
The hospital, which is part of KentuckyOne Health, the state's largest health system, says it has made the required changes.
"We are fully capable of dealing with obstetric emergencies at Jewish Hospital Shelbyville Emergency Department," said Barbara Mackovic, Jewish Hospital Shelbyville's senior manager of media relations. She said the hospital has the equipment and the board-certified personnel it needs to handle such cases and educates its employees on the law.
The hospital's commitment to handling emergency deliveries hasn't been tested, however. Since the case in August 2014, it has not delivered a baby, Mackovic said.
Dealing with emergency deliveries tests rural hospitals in several ways, experts say. These cases create tough decisions for all practitioners, but especially those who see a lower volume of patients and have less experience.
Active labor can be hard to diagnose unless it is obvious, and the process can take hours, said Dr. Shailey Prasad, an associate professor at the Department of Family Medicine and Community Health at the University of Minnesota. Doctors in rural communities who perform few deliveries should use simulations to maintain their skills so they're ready when emergencies arise, he said.
Jennifer Boomer Trammell lives in remote Alpine, Texas (population 6,000). Last year, when she was pregnant with her second child, she saw the first obstetrician/gynecologist to come to town, but also traveled eight hours to Dallas for prenatal examinations starting at the 30-week mark of her pregnancy. She had complications so severe during the delivery of her first child, now three and a half years old, that she had to be medevaced to a hospital with a neonatal intensive care unit.
"It opened my eyes to how naive I was to give birth in a place like this," she said. "I'm hyper-aware of how dangerous it could be."
She stayed in Dallas three weeks before the birth of her second child and six weeks afterwards. "I just don't want to take that risk," she said back in July, when she was making arrangements.
Some rural hospitals singled out for EMTALA violations have since made concerted efforts to change their approach. Harlan County Health in Alma, Nebraska, was cited for an incident in 2011 when an emergency department staffer told the boyfriend of a woman in labor that the hospital didn't do deliveries and didn't have a maternity ward, prompting the couple to leave.
The hospital itself reported the problem and, in response to the citation, hired a consultant to update its policies, gave the staff a half day of training on EMTALA, and purchased new equipment to be more prepared for emergencies, said Manuela Wolf, now Harlan's CEO. The hospital also has a telemedicine system that allows practitioners elsewhere to guide hospital staff members through deliveries via live stream. Harlan has delivered four babies since the incident.
But not all facilities have followed suit, even if staffers are well aware of EMTALA's requirements.
Government inspectors cited East Texas Medical Center Carthage in Carthage, Texas, for a July 2012 incident in which a staffer told a woman in labor that the hospital didn't have obstetric services or an obstetrician, and didn't know where ambulances were stationed to transfer her elsewhere. She and her husband tried to drive themselves to another hospital, but their car broke down, the inspection report said. An ambulance took them to the facility, where she delivered by C-section, but the baby died shortly thereafter.
As part of their investigation, inspectors turned up an email from one Carthage staff member to another, noting this was not the first time the medical center had turned away an emergency delivery.
"That very scenario is why we have the EMTALA law, and this," the staff member wrote, referring to the July 2012 case, "was an EMTALA violation."
Officials at East Texas Medical Center Carthage did not respond to questions about these incidents.
Experts say hospitals need to do a better job of upholding their obligations to women in labor, even if they've closed their obstetric units.
"It is hard to understand the legal requirements in an emergency room and many physicians have a mental block when it comes to the law," said Dr. Larry Weiss, a physician, lawyer and University of Maryland professor of emergency medicine. "But ignorance of the law is no excuse."
To persuade payers to cover the costs of new cures for the hepatitis C virus, drug makers have deployed a potent new ally, a company whose marquee figures are leading economists and healthcare experts at the nation's top universities.
This article first appeared February 23, 2017 onProPublica. This story was co-published with Consumer Reports.
Over the last three years, pharmaceutical companies have mounted a public relations blitz to tout new cures for the hepatitis C virus and persuade insurers, including government programs such as Medicare and Medicaid, to cover the costs.
That isn't an easy sell, because the price of the treatments ranges from $40,000 to $94,000—or, because the treatments take three months, as much as $1,000 per day.
To persuade payers and the public, the industry has deployed a potent new ally, a company whose marquee figures are leading economists and health care experts at the nation's top universities. The company, Precision Health Economics, consults for three leading makers of new hepatitis C treatments: Gilead, Bristol-Myers Squibb, and AbbVie.
When AbbVie funded a special issue of the American Journal of Managed Care on hepatitis C research, current or former associates of Precision Health Economics wrote half of the issue. A Stanford professor who had previously consulted for the firm served as guest editor-in-chief.
At a congressional briefing last May on hepatitis C, three of the four panelists were current or former Precision Health Economics consultants. One was the firm's co-founder, Darius Lakdawalla, a University of Southern California professor.
"The returns to society actually exist even at the high prices," Lakdawalla assured the audience of congressional staffers and health policymakers. "Some people who are just looking at the problem as a pure cost-effectiveness problem said some of these prices in some ways are too low."
Even as drug prices have come under fierce attack by everyone from consumer advocates to President Donald Trump, insurers and public health programs have kept right on shelling out billions for the new hepatitis C treatments, just as Precision Health Economics' experts have urged them.
With a battle looming between the industry and Trump, who has accused manufacturers of "getting away with murder" and vowed to "bring down" prices, the prestige and credibility of the distinguished academics who moonlight for Precision Health Economics could play a crucial role in the industry's multipronged push to sway public and congressional opinion.
While collaboration between higher education and industry is hardly unusual, the professors at Precision Health Economics have taken it to the next level, sharpening the conflicts between their scholarly and commercial roles, which they don't always disclose. Their activities illustrate the growing influence of academics-for-hire in shaping the national debate on issues from climate change to antitrust policy, which ultimately affect the quality of life and the household budgets of ordinary Americans — including what they pay for critical medications.
The pharmaceutical industry is digging in, with one of its trade groups raising an additional $100 million for its war chest. For years, it has spent millions of dollars lobbying politicians, hoping to enlist their support on a wide range of legislation. It has similarly wooed doctors, seeking to influence what they research, teach and prescribe. Now, it's courting health economists.
"This is just an extension of the way that the drug industry has been involved in every phase of medical education and medical research," said Harvard Medical School professor Eric G. Campbell, who studies medical conflicts of interest. "They are using this group of economists it appears to provide data in high-profile journals to have a positive impact on policy."
The firm participates in many aspects of a drug's launch, both advising on "pricing strategies" and then demonstrating the value of a drug once it comes on the market, according to its brochure."Led by professors at elite research universities," the group boasts of a range of valuable services it has delivered to clients, including generating "academic publications in the world's leading research journals" and helping to lead "formal public debates in prestigious, closely watched forums."
Precision Health Economics may be well-positioned to influence the Trump administration. Tomas Philipson, an economist at the University of Chicago and the third co-founder of Precision Health Economics, reportedly served briefly as a senior healthcare adviser for the Trump transition team. He did not respond to requests for comment. Dr. Scott Gottlieb, reported to be a candidate for commissioner of the Food and Drug Administration, is a clinical assistant professor at New York University School of Medicine and a former "academic affiliate" of Precision Health Economics, according to its website.
Although it's hard to gauge the firm's precise impact, associates of Precision Health Economics have often waded into the political fray. Last fall, big pharma spent more than $100 million successfully defeating a California referendum that would have controlled the prices of both generic and name-brand drugs. Testifying in September at a state Senate hearing on a generic drug, co-founder Goldman steered the discussion to name-brand drugs, such as the hepatitis C treatments, arguing that their prices should not be regulated.
"We have to ensure access to future innovation, and that's going to require some recognition that if someone develops an innovative drug, they're going to charge a lot for it," Goldman said.
Prescription drugs on average cost more than twice as much in the U.S. as in other developed nations. That's mostly due to name-brand drugs. They represent 10% of all prescriptions but account for almost three-quarters of the total amount spent on drugs in the U.S. Their prices have doubled in the past five years.
The U.S. grants drugmakers several years of market exclusivity for their products and remains one of the only industrialized countries that allows them to set their own prices. These protections have allowed the pharmaceutical industry to become one of the economy's most profitable sectors, with margins double those of the auto and petroleum industries.
To justify the value of expensive drugs, the professors affiliated with Precision Health Economics rely on complicated economic models that purport to quantify the net social benefits that the drugs will create.
For one industry-funded hepatitis C study, Lakdawalla and nine co-authors, including three pharmaceutical company researchers, subtracted the costs of the treatment from the estimated dollar value of testing all patients and saving all livers and lives. By testing and treating all patients now, they concluded, society would gain $824 billion over 20 years.
Critics have at times questioned the assumptions underlying the consultants' economic models, such as the choice of patient populations, and suggested that some of their findings tilt toward their industry clients. For example, some have tried and failed to reproduce their results justifying the value of cancer treatments.
Precision Health Economics allows drugmakers to review articles by its academics prior to publication in academic journals, said a former business development manager of the consulting group. Such prior review is controversial in higher education because it can be seen as impinging on academic freedom.
"Like other standard consulting projects, you can't publish unless you get permission from the company," the former employee said. Carolyn Harley, senior vice president and general manager of the firm, said that pre-publication review was not company policy, but "in some cases, client contracts provide them the opportunity for review and comment before submission."
"I have never published anything that I am not comfortable with or prepared to defend, nor have I ever been asked to," said Lakdawalla about his firm's research.
Goldman says the firm's research is independent, and its clients don't influence its findings. "From my perspective it's very clear: I say things that piss off my sponsors, I say things that piss off the detractors," he told ProPublica. "People are coming to us because they have an interest in sponsoring the research that's generated. These are our ideas. This is how you get your ideas recognized."
He said his consulting work does not involve setting prices of specific drugs, and his academic research focuses only on categories of drugs, rather than on particular brands.
The professors' disclosure of their ties to the firm and to the pharmaceutical industry in scholarly articles is inconsistent: sometimes extensive, sometimes scanty. Members of Precision Health tend to reveal less about their paid work in blogs, public forums like conferences, and legislative testimony. At the Capitol Hill briefing last May on hepatitis C drugs, Lakdawalla didn't mention his affiliation with Precision Health Economics, although it was listed in the journal issue, which was provided to attendees.
"Conflicts are always a concern, which is why it is important to be transparent about study methods—that way they can be scrutinized and debated in the academic literature," said Lakdawalla, adding that he has disclosed his ties to the firm in at least 33 publications over the past three years.
Goldman said he and other academics at Precision Health Economics disclose their ties whenever appropriate, but typically journal editors and conference sponsors decide how to make that information available. "I wear two hats," Goldman said in an interview. "And I try to reveal what that might mean in terms of perceived conflict of interest."
The issues at stake aren't just academic. Goldman says that pharmaceutical companies need to reap financial rewards from the enormous time and expense they invest in developing better medical treatments. Yet the high prices of some drugs have left government health programs strapped, or forced them to limit coverage. For example, one promising hepatitis C treatment is so expensive that some state Medicaid programs have chosen to cover its cost for only the sickest patients.
"Triage, triage, triage," said Emily Scott, a Tennessee factory worker with hepatitis C who was denied coverage for the new treatment. "They set their price so high that we poor folks can't afford it."
Despite such cases, four researchers from Precision Health Economics warned in an articlelast month that any government controls on drug prices could actually shorten the average American's life by two years by discouraging development of new drugs.
"As the pace of innovation slows, future generations of older Americans will have lower life expectancy relative to the status quo," they wrote. The article, funded by the pharmaceutical trade group PhRMA, was published in Forum for Health Economics & Policy, of which Goldman is the editor-in-chiefand co-founder. More than half of the editors listed on its masthead are current or former consultants at the firm.
Just after Precision Health Economics co-founder Dana Goldman completed his PhD in economics at Stanford, in 1994, he was diagnosed with type 1 diabetes. He was 29 years old. With a pump he wears every day, he takes insulin to treat the disease.
"I would pay hundreds of thousands of dollars if I could take one pill that would make me better," Goldman said.
His desire for a cure led to a new scholarly interest: the economics of medical innovation. Because there were few government funders for research in the field, he turned to industry. In 2005, Goldman established the firm with Lakdawalla and Philipson.
The headquarters of Precision Health Economics sits in a West Los Angeles office building flanked by palm trees, about 10 miles from Goldman's academic center at USC. Goldman's assistant at USC is also an executive assistant at the consulting firm. Daniel Shapiro, director of research compliance at USC, said that both Goldman and Lakdawalla were in compliance with the university's standards on consulting.
Precision Health Economics has counted at least 25 pharmaceutical and biotech companies and trade groups as clients. The roster includes Abbott Nutrition, AbbVie, Amgen, Biogen, Bristol-Myers Squibb, Celgene, Gilead, Intuitive Surgical, Janssen, Merck, the National Pharmaceutical Council, Novartis, Otsuka, Pfizer, PhRMA, rEVO Biologics, Shire and Takeda. The firm has 85 staff members in nine locations.
Over the years, the founders recruited an impressive cadre of high-profile academics to consult for these clients. Early in 2016, the firm boasted more than two dozen academic advisers and consultants from top universities on its website. (The site later stopped identifying professors by their university affiliations.) The list of associates has also included some policy heavyweights who recently left the government, including a top official from the Congressional Budget Office, a senior economist from the White House's Council of Economic Advisors, and an FDA commissioner. About 75% of publications by the firm's employees in the past three years have either been funded by the pharmaceutical industry or have been done in collaboration with drug companies, a ProPublica review found.
Some academics worry that a tight relationship with industry might suggest bias. "I personally find, when your enterprise relies so substantially on a particular source of funds, you will tend to favor that source," said Princeton economist Uwe Reinhardt.
Goldman says his industry connection has helped him ask better questions.
"The right way to do these things is not to push away the private sector, but to engage them," he told ProPublica. "If we end up with a world where everyone who has a voice in a debate must be free of perceived bias, we lose the importance of the diversity of ideas." In a later interview, he added, "You have to separate the appearance of the bias with actual bias."
These ideas were recently echoed in an op-ed that he wrote with Lakdawalla in the online publication The Conversation.
"To be sure, collaboration with industry supplements our income through consulting fees. But no matter who funds our research—foundations, government, or companies—we apply the same template to our work," wrote Goldman and Lakdawalla. "The ivory tower is not always the best place to understand the social benefits of treatments, the incentives for medical innovation, and how aligning prices with value can aid consumers."
Engaging the private sector has indeed boosted Goldman's income. According to federal conflict of interest forms filed last year, when he served on an advisory panel to the Congressional Budget Office, Goldman earned consulting income from the firm in the range of $25,000 to $200,000, on top of his income as a USC professor. He also has more than $500,000 in equity in the firm. Precision's Harley says Goldman and Lakdawalla each have equity stakes of less than 1%, indicating that the firm is worth at least $50 million. Lakdawalla and Philipson have not publicly disclosed their consulting incomes.
In April 2015, Precision Health Economics was acquired by a privately held biotech company, Precision for Value. Terms weren't disclosed.
Precision Health Economics raised its profile in 2013 when the president's annual economic report cited a cancer study by several of the firm's principals and consultants. To some critics, though, the study showed how industry funding can taint academic research.
As the study acknowledged, it was funded by Bristol-Myers Squibb, a company that at the time was developing a much-anticipated cancer treatment. It was priced at more than $150,000 per year when it eventually came on the market. All three founders of Precision Health Economics were listed as authors of the Health Affairs article, alongside one of their employees, yet none of the founders disclosed their ties to their consulting firm in the published study. In an interview, Goldman said this might have been an "oversight."
Goldman later emailed ProPublica to clarify that the journal was aware that the study was a Precision Health Economics publication and that Goldman and his co-founders were affiliated with the firm. Goldman has published more than 25 articles and letters to the editor in Health Affairs since co-founding Precision Health Economics, and only five have listed the connection.
"This affiliation is clearly not a secret and I include it where relevant," Goldman wrote in the email. "The bottom line is that disclosure policies vary across journals, journal editors, and over time. Definitions of what is 'relevant' are also subject to their own judgments."
Donald Metz, executive editor of Health Affairs, said the journal followed its policy of leaving disclosure to the "authors' discretion." Its editorial staff did not exclude any information on conflicts or affiliations that the authors provided alongside their draft, he said.
As the cancer study gained national recognition, its methodology and findings came under fire. Researchers from Dartmouth College tried and failed to reproduce the results. Cancer care in the U.S., their research found, may actually provide less value than cancer care in Europe, considering cost.
"We know that [the U.S. health care system] is more disorganized and disorganization is more expensive, so it's surprising to believe that the U.S. would perform better in a cost-effectiveness sense," said Samir Soneji, one of the authors of the counter-study and an assistant professor of health policy at Dartmouth. The science in the original study, Soneji says, was "questionable."
Soneji was not alone in his criticism. Aaron Carroll, a pediatrics professor at the Indiana University School of Medicine, reviewed the methodology and concluded that the Precision Health Economics researchers had used a measure that can frequently be misinterpreted. Instead of relying on mortality rates, which factor in a patient's age of death, the study employed survival rates, looking at how long people live after diagnosis. Cancer screening, which can increase survival rates, is more frequent for some cancers in the U.S. than in other countries, Carroll says.
"When they wrote that paper using survival rates, they were clearly cherry picking," Carroll told ProPublica. "If the arguments are flawed and people keep using them, I would be concerned that they have some other motive."
The founders of Precision Health Economics defended their use of survival rates in a published response to the Dartmouth study, writing that they "welcome robust scientific debate that moves forward our understanding of the world" but that the research by their critics had "moved the debate backward."
Precision Health Economics has become a prominent booster of a new way of setting drug prices—based on their overall value to society. Value is determined by comparing the drugs' cost with their effectiveness in saving lives and preventing future health expenses.
Pharmaceutical companies have traditionally justified their prices by citing the cost of research and development, but recent research on drug pricing has challenged this argument. Many of the largest drug companies spend moreonsales and marketingthan on developing their drugs. And notably, one researcher has found that about 75% of new molecular entities, which are considered the most innovative drugs, trace their initial research funding back to the government.
"There is substantial evidence that the sources of transformative drug innovation arise from publicly funded research in government and academic labs," said Dr. Aaron Kesselheim, an associate professor at Harvard Medical School whose research looks at the cost of pharmaceuticals. Pharmaceutical pricing, he says, is primarily based on what the market can bear.
Many early proponents of value pricing, including American health insurers, saw it as a way to rein in drug prices. Some nations, particularly those with national health systems, like the U.K., rely on official cost-effectiveness analyses to decide which drugs to pay for. Overpriced drugs are sometimes denied coverage. This powerful negotiating tool has helped keep drug prices down abroad.
Efforts to establish similar practices in the U.S., however, have been stymied by lobbying from patient groups, many of them funded by the pharmaceutical industry, contending that value pricing could lead to rationing of health care. More recently, though, the industry has used academic consultants to help it redefine the concept of "value" to justify its pricing.
At the congressional briefing on the new hepatitis C drugs, Harvard Medical School associate professor Anupam Jena, a Precision Health Economics consultant, suggested that part of a drug's value is earning enough profit that pharmaceutical companies are enticed to develop treatments for other diseases. Otherwise, Jena said, "you don't incentivize innovations that actually deliver value, and so the next cure … may not be developed."
Princeton's Reinhardt said pricing drugs based on this notion of value could give the industry carte blanche to charge whatever it wants. "If you did value pricing and say it's OK for the drug companies to charge up to what the patient values his or her life to be, you are basically saying that the pharmaceutical companies can take your savings," he said. "American society will not stand for that."
Not long after the controversy over its cancer research, Precision Health Economics became embroiled in another academic spat related to a client's product. This time, it was over a breakthrough treatment that, injected one to two times per month, could help millions of Americans with high cholesterol. At the $14,000-per-year price set by one of its makers, Amgen, the PCSK9 inhibitor could also hike the nation's annual prescription drug costs by an unprecedented $125 billion, or 38%. Its price in the U.S. is twice as much as in the U.K.
The U.S. price of the drug has come under vigorous attack from the nonprofit Institute for Clinical and Economic Review. ICER, which began as a small research project at Harvard Medical School, studies the cost-effectiveness of drugs, balancing their value to patients against the impact of their cost on society. The Centers for Medicare and Medicaid Services proposed a new rule in March 2016 that includes the use of value-based pricing studies, specifically citing the work of ICER.
The industry has attacked many of the institute's studies, particularly those that find a treatment is overpriced. Some patient groups have contended that ICER emphasizes cost savings because it receives funding from health insurers. However, foundations are ICER's biggest source of funding, and it is also supported by the pharmaceutical industry and government grants. The pharmaceutical lobby has similarly attacked the Drug Effectiveness Review Project, a coalition of state Medicaid agencies and other payers, accusing it of using its studies to justify "rationing."
ICER concluded in 2015 that the new cholesterol treatment, the PCSK9 inhibitor, should cost about one-fifth what Amgen is charging. A few months later, Philipson, the Precision Health Economics co-founder, and Jena wrote an op-ed in Forbes, citing the institute's research and deriding its approach to value pricing as "pseudo-science and voodoo economics." Only Philipson disclosed his ties to Precision Health Economics, and neither academic disclosed that Amgen was a client of the firm.
After being asked by ProPublica about the lack of transparency, Forbes added a disclosure statement to the op-ed. "Manufacturers of PCSK-9 inhibitors and novel treatments for hepatitis C, such as Amgen, Gilead, and Abbvie, are clients of Mr. Philipson's consulting firm, Precision Health Economics, for which Dr. Jena also works," the publication noted. "In general, the pharmaceutical and biotechnology companies which retain Precision Health Economics benefit from higher drug prices."
Goldman, along with Precision Health Economics employees and two Harvard professors, including Jena, published their own study on the cholesterol drug in the American Journal of Managed Care, where Goldman serves on the editorial board. They found that the new cholesterol drugs were indeed cost-effective at the listed prices. The article disclosed the authors' ties to Precision Health Economics and the source of funding: Amgen.
The drug is "not cheap, but it's a good deal" for patients who need it, Goldman said, after his team's economic models calculated its net value between $3.4 trillion and $5.1 trillion over 20 years.
ICER's finding that the PCSK9 inhibitor was overpriced was later affirmed in a related study published in the peer-reviewed Journal of the American Medical Association. Associates of Precision Health Economics again rushed to Amgen's defense. Philipson and an Amgen executive wrote a letter to the editor of JAMA to dispute the study's conclusion that the price should be about $4,500 per month, less than a third of the drug's average price.
The two studies made different assumptions that shaped their conclusions. Dr. Dhruv Kazi, one of the authors of the JAMA study and an associate professor at the University of California San Francisco, said that the Precision Health Economics study assumed that there were fewer eligible patients who would take the drug, lowering the cost to society. It also posited that they had a higher risk of cardiac events, like heart attacks, boosting the drug's value as measured in lives saved.
"This is an example where you would end up assuming that the population is at higher risk than is true for the real world population and that would make your drug look better," Kazi said. "It's not a wild idea to think that a cost-effectiveness study funded by industry would look more favorable" to the industry's viewpoint, he said. "If that weren't the case, they wouldn't fund it."
Jena said the patient population for the Precision Health Economics study more accurately reflected the real world. One should not automatically assert that a study is "invalid or flawed" because of industry funding, he added.
The JAMA study "over-exaggerated the cost" of the drug and "unnecessarily rang 'alarm bells,'" said Amgen spokeswoman Kristen Neese.
Amgen has ties to all three founders of Precision Health Economics. Working for other firms, Philipson has twicetestified as an expert witness for Amgen, defending the company's rights to drug patents, according to his curriculum vitae. The other two founders, Goldman and Lakdawalla, are principals at the Leonard D. Schaeffer Center for Health Policy and Economics at USC, which received $500,000 in late 2016 from Amgen for an "innovation initiative," according to public disclosures. Goldman said the funds were unrestricted and could be used at the center's discretion. Richard Bradway, the CEO and chair of Amgen, is on the advisory board of the university center, and Leonard Schaeffer, a professor at USC and the namesake of the center, sat on Amgen's board of directors for nearly a decade.
With funding from Amgen, the Schaeffer Center hosted a forum in Washington, D.C., in October 2015 on the affordability of specialty drugs. Before a panel focused on the new cholesterol treatment, Goldman cautioned against lowering drug prices.
"We know that the pricing of these treatments is often controversial," he told the crowd of policymakers, which included Sen. Bill Cassidy, R-La., a physician who sits on the Health, Education, Labor and Pensions Committee. "If we dropped all the prices today, in the long run, we wouldn't have any innovation."
The PCSK9 inhibitor's price inhibits access for some patients who need it. Scott Annese, a 50-year-old computer technician from South Daytona, Florida, has diabetes and a total blood cholesterol level topping 260. After he suffered a heart attack and had two stents inserted in his left coronary artery, his doctor prescribed a statin, a low-cost drug to lower cholesterol. However, the statin combined with his diabetes to cause painful side effects, including muscle aches, cramping, and soreness in his legs that incapacitated him, he said. Amgen's drug, his doctor told him, was the only other option.
But Annese, who makes $13.50 an hour, couldn't afford the new drug. He doesn't have health coverage through his job and says Obamacare, especially with its rising premiums, is too expensive for him. He tried to get insurance through Medicaid, but he earns too much to qualify. His last option, he said, is Amgen's patient assistance program, which he has applied for. His application is pending.
"If you're in the industry to help people, you're not helping them if you raise the drugs to the point that they can't afford it," said Annese. "The drug companies are hurting the people who need it most."
Gilead Sciences' $84,000 list price for its highly effective treatment for the hepatitis C virus prompted dozens of state Medicaid programs and prison systems to restrict treatment to only the sickest patients. A congressional investigation in 2015 found that Gilead, which purchased the drug from a smaller pharmaceutical company, had set the price of the treatment at the peak it thought the market could bear, more than double what the drug's original developers had suggested.
"Gilead pursued a calculated scheme for pricing and marketing its hepatitis C drug based on one primary goal, maximizing revenue, regardless of the human consequences," said Sen. Ron Wyden, D-Ore., when he presented the findings of the congressional investigation.
While Precision Health Economics often portrays itself as an advocate for wider access to vital medications such as the hepatitis C drugs, the high price of those drugs forces some payers, such as the Medicaid programs, to ration them. As a result, the professors may influence who ultimately gets the drug and who doesn't. The impact is reverberating in the rugged hills of eastern Tennessee, where hepatitis C is spreading due to the opioid epidemic. Because the virus can be asymptomatic for years, only a fraction of those infected know they are carriers, leading many to spread the potentially fatal liver disease unknowingly, mostly by sharing needles.
Over the past seven years, the number of acute cases of hepatitis C in Tennessee has tripled. The state has estimated that more than 100,000 residents are likely to have a chronic version of the disease without realizing it. Just last year, the state issued a public-health advisory addressing the crisis, but the rates of infection continue to rise.
It took years for Emily Scott, the factory worker from the Cumberland Gap region of eastern Tennessee, to find out she had the virus. After donating blood in January 2016, she received a certified letter from the blood bank informing her that her blood could not be accepted because it had tested positive for hepatitis C.
She didn't believe the letter at first, hoping they had mistaken her blood with that of another donor. After all, she had never experienced any symptoms. But a local doctor reran her blood work and her diagnosis was confirmed.
Like many in her community, Scott had battled an addiction to drugs, mostly painkillers, and she had used syringes in the past for her highs. She'd been clean for the past four years but believes that she contracted the disease through her drug use.
"I made some mistakes," said the 26-year-old Scott. "But I didn't ask to be sick."
Shortly after her diagnosis, Scott learned from a television advertisement that the new drugs had a cure rate of 90%. But getting the treatments would prove elusive.
Raising her two sons on her own, Scott barely supports the family with her weekly income of about $350 from sewing shirts at an apparel factory. She is one of more than 11,000 Tennesseans on Medicaid who have been diagnosed with hepatitis C, according to the most recent state data. If all of them received the new medication, the state estimated that it would cost over $1.6 billion, more than double what Tennessee's Medicaid program spends on drugs in a year.
"There isn't an endless bank account," said Darin Gordon, Tennessee's former Medicaid director, who was in charge when the hepatitis C cure was launched. "States have to balance budgets, and this came in and hijacked our budget."
Tennessee quickly limited the treatments to the sickest patients. After reviewing the scientific literature, Gordon's medical team determined that it was only medically necessary to treat patients whose livers had begun to show scarring, a sign that the disease had progressed beyond the initial latent stage. Even if patients' conditions stabilize while they await the treatment, they are still contagious. Once the treatment is finished, they no longer can spread the virus.
Under this policy, less than 10% of diagnosed Medicaid patients have been treated, still costing the program more than $100 million in the past two years. Patients like Scott, whose liver has no significant scarring, were forced to wait for the disease to progress before being prescribed any of the new drugs.
The state denied Scott's request for the cure in March 2016. But she wouldn't let that stop her. She appealed and was granted a hearing in Knoxville, which she had to attend by phone because it was two and a half hours' drive from her home. She explained to the judge that she was a single mother of two young boys and could not risk her health declining. A few days later, she received a court order in the mail, denying her access to the treatment.
By forcing Tennessee Medicaid and other public payers to delay coverage, the high price of the hepatitis C drugs incurs a social cost. While waiting to become sick enough for treatment, patients may transmit the disease. Some, including Scott, begin to feel symptoms like fatigue and muscle pains, which may hinder their ability to work.
"The drug companies do not have people's interest in mind, they have money in mind," Scott said. "It's not fair that they are playing with people's lives."
Since the firm's sale in 2015, Precision Health Economics' three founders have taken roles in its parent company. Goldman is an executive economist at Precision for Value and chairs an advisory board focused on "value and evidence." Lakdawalla is the chief scientific officer, and Philipson is listed as chief economist and the chair of the strategy and innovation board.
On its website, Precision for Value lays out how it can help biotech companies with "preliminary pricing, access, and evidence strategy" and "launch price strategy." The company says that it can "pressure test" a company's proposed messaging strategy on value with key stakeholders and determine how willing the market might be to pay future drug prices.
Under its new ownership, Precision Health Economics recently launched a group focused explicitly on assessing the value of innovative drugs. The firm's three founders are involved with this Innovation and Value Initiative, which bills itself as an "unparalleled convergence of academic leaders and scientific experts." Lakdawalla serves as executive director of the initiative. On the initiative's health advisory panel, which is supposed to steer the research agenda, Goldman and Philipson sit alongside mostly executives from pharmaceutical companies and trade groups.
The initiative also has a scientific advisory group for internal peer review. All of its members are current or former Precision Health Economics consultants or staffers. Lakdawalla said in an email that all of its projects "either undergo academic peer review at a journal, or include an external peer reviewer outside [the firm]."
To promote the new initiative, Precision Health Economics has launched an extensive advertising campaign, sponsoring content in Health Affairs, writing op-eds in The Washington Post and Forbes, and even buying ads on Google.
In a phone conversation, Goldman was asked whether the stratospheric drug prices bolstered by the professors at Precision Health Economics deprive low-income patients, like Emily Scott, of vital treatments. He responded that it's important to take a longer-term view.
"You worry about access for the people for whom there is a treatment," he said. "I'm worried also for the access for people for whom there isn't a treatment."
Years after research contradicts common practices, patients continue to demand them and doctors continue to deliver. The result is an epidemic of unnecessary and unhelpful treatment.
This article first appeared February 22, 2017 onProPublica. This story was co-published withThe Atlantic.
First, listen to the story with the happy ending: At 61, the executive was in excellent health. His blood pressure was a bit high, but everything else looked good, and he exercised regularly. Then he had a scare. He went for a brisk post-lunch walk on a cool winter day, and his chest began to hurt. Back inside his office, he sat down, and the pain disappeared as quickly as it had come.
That night, he thought more about it: middle-aged man, high blood pressure, stressful job, chest discomfort. The next day, he went to a local emergency department. Doctors determined that the man had not suffered a heart attack and that the electrical activity of his heart was completely normal. All signs suggested that the executive had stable angina—chest pain that occurs when the heart muscle is getting less blood-borne oxygen than it needs, often because an artery is partially blocked.
A cardiologist recommended that the man immediately have a coronary angiogram, in which a catheter is threaded into an artery to the heart and injects a dye that then shows up on special x-rays that look for blockages. If the test found a blockage, the cardiologist advised, the executive should get a stent, a metal tube that slips into the artery and forces it open.
While he was waiting in the emergency department, the executive took out his phone and searched "treatment of coronary artery disease." He immediately found information from medical journals that said medications, like aspirin and blood-pressure-lowering drugs, should be the first line of treatment. The man was an unusually self-possessed patient, so he asked the cardiologist about what he had found. The cardiologist was dismissive and told the man to "do more research." Unsatisfied, the man declined to have the angiogram and consulted his primary-care doctor.
The primary-care physician suggested a different kind of angiogram, one that did not require a catheter but instead used multiple x-rays to image arteries. That test revealed an artery that was partially blocked by plaque, and though the man's heart was pumping blood normally, the test was incapable of determining whether the blockage was dangerous. Still, his primary-care doctor, like the cardiologist at the emergency room, suggested that the executive have an angiogram with a catheter, likely followed by a procedure to implant a stent. The man set up an appointment with the cardiologist he was referred to for the catheterization, but when he tried to contact that doctor directly ahead of time, he was told the doctor wouldn't be available prior to the procedure. And so the executive sought yet another opinion. That's when he found Dr. David L. Brown, a professor in the cardiovascular division of the Washington University School of Medicine in St. Louis. The executive told Brown that he'd felt pressured by the previous doctors and wanted more information. He was willing to try all manner of noninvasive treatments—from a strict diet to retiring from his stressful job—before having a stent implanted.
The executive had been very smart to seek more information, and now, by coming to Brown, he was very lucky, too. Brown is part of the RightCare Alliance, a collaboration between health-care professionals and community groups that seeks to counter a trend: increasing medical costs without increasing patient benefits. As Brown put it, RightCare is "bringing medicine back into balance, where everybody gets the treatment they need, and nobody gets the treatment they don't need." And the stent procedure was a classic example of the latter. In 2012, Brown had coauthored a paper that examined every randomized clinical trial that compared stent implantation with more conservative forms of treatment, and he found that stents for stable patients prevent zero heart attacks and extend the lives of patients a grand total of not at all. In general, Brown says, "nobody that's not having a heart attack needs a stent." (Brown added that stents may improve chest pain in some patients, albeit fleetingly.) Nonetheless, hundreds of thousands of stable patients receive stents annually, and one in 50 will suffer a serious complication or die as a result of the implantation procedure.
Brown explained to the executive that his blockage was one part of a broader, more diffuse condition that would be unaffected by opening a single pipe. The cardiovascular system, it turns out, is more complicated than a kitchen sink. The executive started medication and improved his diet. Three months later, his cholesterol had improved markedly, he had lost 15 pounds, and the chest pain never returned.
Now, listen to the story with the sad ending: Not long after helping the executive, Brown and his colleagues were asked to consult on the case of a 51-year-old man from a tiny Missouri town. This man had successfully recovered from Hodgkin's lymphoma, but radiation and six cycles of chemotherapy had left him with progressive scarring creeping over his lungs. He was suffocating inside his own body. The man was transferred to Barnes Jewish Hospital, where Brown works, for a life-saving lung transplant. But when the man arrived in St. Louis, the lung-transplant team could not operate on him.
Four months earlier, the man had been admitted to another hospital because he was having trouble breathing. There, despite the man's history of lymphoma treatment, which can cause scarring, a cardiologist wondered whether the shortness of breath might be due to a blocked artery. As with the executive, the cardiologist recommended a catheter. Unlike the executive, however, this man, like most patients, agreed to the procedure. It revealed a partial blockage of one coronary artery. So, doctors implanted a stent, even though there was no clear evidence that the blockage was responsible for the man's shortness of breath—which was, in fact, caused by the lung scarring. Finally, the man was put on standard post-implantation medications to make sure he would not develop a blood clot at the site of the stent. But those medications made surgery potentially lethal, putting the man at an extremely high risk of bleeding to death during the transplant. The operation had to be delayed.
Meanwhile, the man's lung tissue continued to harden and scar, like molten lava that cools and hardens into gray stone. Until one day, he couldn't suck in another breath. The man had survived advanced-stage lymphoma only to die in the hospital, waiting until he could go off needed medication for an unneeded stent.
What the patients in both stories had in common was that neither needed a stent. By dint of an inquiring mind and a smartphone, one escaped with his life intact. The greater concern is: How can a procedure so contraindicated by research be so common?
When you visit a doctor, you probably assume the treatment you receive is backed by evidence from medical research. Surely, the drug you're prescribed or the surgery you'll undergo wouldn't be so common if it didn't work, right?
For all the truly wondrous developments of modern medicine—imaging technologies that enable precision surgery, routine organ transplants, care that transforms premature infants into perfectly healthy kids, and remarkable chemotherapy treatments, to name a few—it is distressingly ordinary for patients to get treatments that research has shown are ineffective or even dangerous. Sometimes doctors simply haven't kept up with the science. Other times doctors know the state of play perfectly well but continue to deliver these treatments because it's profitable—or even because they're popular and patients demand them. Some procedures are implemented based on studies that did not prove whether they really worked in the first place. Others were initially supported by evidence but then were contradicted by better evidence, and yet these procedures have remained the standards of care for years, or decades.
Even if a drug you take was studied in thousands of people and shown truly to save lives, chances areit won't do that for you. The good news is, it probably won't harm you, either. Some of the most widely prescribed medications do little of anything meaningful, good or bad, for most people who take them.
In a 2013 study, a dozen doctors from around the country examined all 363 articles published in The New England Journal of Medicine over a decade—2001 through 2010—that tested a current clinical practice, from the use of antibiotics to treat people with persistent Lyme disease symptoms (didn't help) to the use of specialized sponges for preventing infections in patients having colorectal surgery (caused more infections).
Their results, published in the Mayo Clinic Proceedings, found 146 studies that proved or strongly suggested that a current standard practice either had no benefit at all or was inferior to the practice it replaced; 138 articles supported the efficacy of an existing practice, and the remaining 79 were deemed inconclusive. (There was, naturally, plenty of disagreement with the authors' conclusions.) Some of the contradicted practices possibly affect millions of people daily: Intensive medication to keep blood pressure very low in diabetic patients caused more side effects and was no better at preventing heart attacks or death than more mild treatments that allowed for a somewhat higher blood pressure. Other practices challenged by the study are less common—like the use of a genetic test to determine if a popular blood thinner is right for a particular patient—but gaining in popularity despite mounting contrary evidence. Some examples defy intuition: CPR is no more effective with rescue breathing than if chest compressions are used alone; and breast-cancer survivors who are told not to lift weights with swollen limbs actually should lift weights, because it improves their symptoms.
A separate but similarly themed study in 2012 funded by the Australian Department of Health and Ageing, which sought to reduce spending on needless procedures, looked across the same decade and identified 156 active medical practices that are probably unsafe or ineffective. The list goes on: A brand new review of 48 separate studies—comprising more than 13,000 clinicians—looked at how doctors perceive disease-screening tests and found that they tend to underestimate the potential harms of screening and overestimate the potential benefits; an editorial in American Family Physician, co-written by one of the journal's editors, noted that a "striking feature" of recent research is how much of it contradicts traditional medical opinion.
That isn't likely to change any time soon. The 21st Century Cures Act—a rare bipartisan bill, pushed by more than 1,400 lobbyists and signed into law in December—lowers evidentiary standards for new uses of drugs and for marketing and approval of some medical devices. Furthermore, last month President Donald Trump scolded the FDA for what he characterized as withholding drugs from dying patients. He promised to slash regulations "big league. … It could even be up to 80 percent" of current FDA regulations, he said. To that end, one of the president's top candidates to head the FDA, tech investor Jim O'Neill, has openly advocated for drugs to be approved before they're shown to work. "Let people start using them at their own risk," O'Neill has argued.
So, while Americans can expect to see more drugs and devices sped to those who need them, they should also expect the problem of therapies based on flimsy evidence to accelerate. In a recent Stat op-ed, two Johns Hopkins University physician-researchers wrote that the new 21st Century Cures Act will turn the label "FDA approved" into "a shadow of its former self." In 1962, Congress famously raised the evidentiary bar for drug approvals after thousands of babies were born with malformed limbs to mothers who had taken the sleep aid thalidomide. Steven Galson, a retired rear admiral and former acting surgeon general under both President George W. Bush and President Barack Obama, has called the strengthened approval process created in 1962 the FDA's "biggest contribution to health." Before that, he said, "many marketed drugs were ineffective for their labeled uses."
Striking the right balance between innovation and regulation is incredibly difficult, but once remedies are in use—even in the face of contrary evidence—they tend to persist. A 2007 Journal of the American Medical Association paper coauthored by John Ioannidis—a Stanford University medical researcher and statistician who rose to prominence exposing poor-quality medical science—found that it took 10 years for large swaths of the medical community to stop referencing popular practices after their efficacy was unequivocally vanquished by science.
According to Vinay Prasad, an oncologist and one of the authors of the Mayo Clinic Proceedings paper, medicine is quick to adopt practices based on shaky evidence but slow to drop them once they've been blown up by solid proof. As a young doctor, Prasad had an experience that left him determined to banish ineffective procedures. He was the medical resident on a team caring for a middle-aged woman with stable chest pain. She underwent a stent procedure and suffered a stroke, resulting in brain damage. Prasad, now at the Oregon Health and Sciences University, still winces slightly when he talks about it.
University of Chicago professor and physician Adam Cifu had a similar experience. Cifu had spent several years convincing newly postmenopausal patients to go on hormone therapy for heart health—a treatment that at the millennium accounted for 90 million annual prescriptions—only to then see a well-designed trial show no heart benefit and perhaps even a risk of harm. "I had to basically run back all those decisions with women," he says. "And, boy, that really sticks with you, when you have patients saying, ‘But I thought you said this was the right thing.'" So he and Prasad coauthored a 2015 book, "Ending Medical Reversal," a call to raise the evidence bar for adopting new medical standards. "We have a culture where we reward discovery; we don't reward replication," Prasad says, referring to the process of retesting initial scientific findings to make sure they're valid.
Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, says the situation with stents, at least, is improving. As a previous president of the American College of Cardiology, he helped create guidelines for determining when a stable patient might be a reasonable candidate for a stent. (Both Nissen and David Holmes, a Mayo Clinic cardiologist and also a former ACC president, said that in cases in which patients have had bad responses to medication and persistent, life-altering chest pain, even a short-term reduction of symptoms may justify a stent.) Thanks to such guidelines, the frequency of clearly inappropriate stent placement declined significantly between 2010 and 2014. Still, the latest assessment in more than 1,600 hospitals across the country concluded that about half of all stent placements in stable patients were either definitely or possibly inappropriate. "Things have gotten better," Nissen says, "but they're not where they need to be." Nissen thinks removing financial incentives can also help change behavior. "I have a dozen or so cardiologists, and they get the exact same salary whether they put in a stent or don't," Nissen says, "and I think that's made a difference and kept our rates of unnecessary procedures low."
Two years ago, a trio of Bloomberg journalists reported that Mount Sinai Hospital in New York City was scheduling "emergencies-by-appointment" for patients to get stents, because, the report said, insurance is more likely to cover the procedure in an emergency situation. (For a patient who is having a heart attack, a stent can be life-saving.) Mount Sinai's catheter lab features annual reports that boast of how many stents are implanted, alongside patient testimonials, like one from 77-year-old Nelly Rodriguez, who notes that her doctor "reassures me that as long as I follow his instructions, eat healthy, and remain smoke-free, the stents he has put into my arteries over the years should last and I will feel well." In most cases, every word of that sentence between "smoke-free" and "I will feel well" could be deleted and it would be just as true.
It is, of course, hard to get people in any profession to do the right thing when they're paid to do the wrong thing. But there's more to this than market perversion. On a recent snowy St. Louis morning, Brown gave a grand-rounds lecture to about 80 doctors at Barnes Jewish Hospital. Early in the talk, he showed results from medical tests on the executive he treated, the one who avoided a stent. He then presented data from thousands of patients in randomized controlled trials of stents versus noninvasive treatments, and it showed that stents yielded no benefit for stable patients. He asked the doctors in the room to raise their hands if they would still send a patient with the same diagnostic findings as the executive for a catheterization, which would almost surely lead to a stent. At least half of the hands in the room went up, some of them sheepishly. Brown expressed surprise at the honesty in the room. "Well," one of the attendees told him, "we know what we do." But why?
In 2007, after a seminal study, the COURAGE trial, showed that stents did not prevent heart attacks or death in stable patients, a trio of doctors at the University of California, San Francisco, conducted 90-minute focus groups with cardiologists to answer that question. They presented the cardiologists with fictional scenarios of patients who had at least one narrowed artery but no symptoms and asked them if they would recommend a stent.
Almost to a person, the cardiologists, including those whose incomes were not tied to tests and procedures, gave the same answers: They said that they were aware of the data but would still send the patient for a stent. The rationalizations in each focus group followed four themes: (1) Cardiologists recalled stories of people dying suddenly—including the highly publicized case of jogging guru Jim Fixx—and feared they would regret it if a patient did not get a stent and then dropped dead. The study authors concluded that cardiologists were being influenced by the "availability heuristic," a term coined by Nobel laureate psychologists Amos Tversky and Daniel Kahneman for the human instinct to base an important decision on an easily recalled, dramatic example, even if that example is irrelevant or incredibly rare. (2) Cardiologists believed that a stent would relieve patient anxiety. (3) Cardiologists felt they could better defend themselves in a lawsuit if a patient did get a stent and then died, rather than if they didn't get a stent and died. "In California," one said, "if this person had an event within two years, the doctor who didn't intervene would be successfully sued." And there was one more powerful and ubiquitous reason: (4) Despite the data, cardiologists couldn't believe that stents did not help: Stenting just made so much sense. A patient has chest pain, a doctor sees a blockage, how can opening the blockage not make a difference?
In the late 1980s, with evidence already mounting that forcing open blood vessels was less effective and more dangerous than noninvasive treatments, cardiologist Eric Topol coined the term, "oculostenotic reflex." Oculo, from the Latin for "eye," and stenotic, from the Greek for "narrow," as in a narrowed artery. The meaning: If you see a blockage, you'll reflexively fix a blockage. Topol described "what appears to be an irresistible temptation among some invasive cardiologists" to place a stent any time they see a narrowed artery, evidence from thousands of patients in randomized trials be damned. Stenting is what scientists call "bio-plausible"—intuition suggests it should work. It's just that the human body is a little more Book of Job and a little less household plumbing: Humans didn't invent it, it's really complicated, and people often have remarkably little insight into cause and effect.
Chances are, you or someone in your family has taken medication or undergone a procedure that is bio-plausible but does not work.
According to the Centers for Disease Control and Prevention, about one in three American adults have high blood pressure. Blood pressure is a measure of how hard your blood is pushing on the sides of vessels as it moves through your body; the harder the pushing, the more strain on your heart. People with high blood pressure are at enormously increased risk for heart disease (the nation's No. 1 killer) and stroke (No. 3).
So it's not hard to understand why Sir James Black won a Nobel Prize largely for his 1960s discovery of beta-blockers, which slow the heart rate and reduce blood pressure. The Nobel committee lauded the discovery as the "greatest breakthrough when it comes to pharmaceuticals against heart illness since the discovery of digitalis 200 years ago." In 1981, the FDA approved one of the first beta-blockers, atenolol, after it was shown to dramatically lower blood pressure. Atenolol became such a standard treatment that it was used as a reference drug for comparison with other blood-pressure drugs.
In 1997, a Swedish hospital began a trial of more than 9,000 patients with high blood pressure who were randomly assigned to take either atenolol or a competitor drug that was designed to lower blood pressure for at least four years. The competitor-drug group had fewer deaths (204) than the atenolol group (234) and fewer strokes (232 compared with 309). But the study also found that both drugs lowered blood pressure by the exact same amount, so why wasn't the vaunted atenolol saving more people? That odd result prompted a subsequent study, which compared atenolol with sugar pills. It found that atenolol didn't prevent heart attacks or extend life at all; it just lowered blood pressure. A 2004 analysis of clinical trials—including eight randomized controlled trials comprising more than 24,000 patients—concluded that atenolol did not reduce heart attacks or deaths compared with using no treatment whatsoever; patients on atenolol just had better blood-pressure numbers when they died.
"Yes, we can move a number, but that doesn't necessarily translate to better outcomes," says John Mandrola, a cardiac electrophysiologist in Louisville who advocates for healthy lifestyle changes. It's tough, he says, "when patients take a pill, see their numbers improve, and think their health is improved."
The overall picture of beta-blockers is complex. For example, some beta-blockers have been shown clearly to reduce the chance of a stroke or heart attack in patients with heart failure. But the latest review of beta-blockers from the Cochrane Collaboration—an independent, international group of researchers that attempts to synthesize the best available research—reported that they "are not recommended as first line treatment for hypertension as compared to placebo due to their modest effect on stroke and no significant reduction in mortality or coronary heart disease."
Researchers writing in Lancet questioned the use of atenolol as a comparison standard for other drugs and added that "stroke was also more frequent with atenolol treatment" compared with other therapies. Still, according to a 2012 study in the Journal of the American Medical Association, more than 33.8 million prescriptions of atenolol were written at a retail cost of more than $260 million. There is some evidence that atenolol might reduce the risk of stroke in young patients, but there is also evidence that it increases the risk of stroke in older patients—and it is older patients who are getting it en masse. According to ProPublica's Medicare prescription database, in 2014, atenolol was prescribed to more than 2.6 million Medicare beneficiaries, ranking it the 31st most prescribed drug out of 3,362 drugs. One doctor, Chinh Huynh, a family practitioner in Westminster, California, wrote more than 1,100 atenolol prescriptions in 2014 for patients over 65, making him one of the most prolific prescribers in the country. Reached at his office, Huynh said atenolol is "very common for hypertension; it's not just me." When asked why he continues to prescribe atenolol so frequently in light of the randomized, controlled trials that showed its ineffectiveness, Huynh said, "I read a lot of medical magazines, but I didn't see that." Huynh added that his "patients are doing fine with it" and asked that any relevant journal articles be faxed to him.
Brown, the Washington University cardiologist, says that once doctors get out of training, "it's a job, and they're trying to earn money, and they don't necessarily keep up. So really major changes have to be generational."
Data compiled by QuintilesIMS, which provides information and technology services to the health-care industry, show that atenolol prescriptions consistently fell by 3 million per year over a recent five-year period. If that rate holds, atenolol will stop being prescribed in just under two decades since high-quality trials showed that it simply does not work.
Just as the cardiovascular system is not a kitchen sink, the musculoskeletal system is not an erector set. Cause and effect is frequently elusive.
Consider the knee, that most bedeviling of joints. A procedure known as arthroscopic partial meniscectomy, or APM, accounts for roughly a half-million procedures per year at a cost of around $4 billion. A meniscus is a crescent-shaped piece of fibrous cartilage that helps stabilize and provide cushioning for the knee joint. As people age, they often suffer tears in the meniscus that are not from any acute injury. APM is meant to relieve knee pain by cleaning out damaged pieces of a meniscus and shaving the cartilage back to crescent form. This is not a fringe surgery; in recent years, it has been one of the most popular surgical procedures in the hemisphere. And a burgeoning body of evidence says that it does not work for the most common varieties of knee pain.
Something like the knee version of the oculostenotic reflex takes hold: A patient comes in with knee pain, and an MRI shows a torn meniscus; naturally, the patient wants it fixed, and the surgeon wants to fix it and send the patient for physical therapy. And patients do get better, just not necessarily from the surgery.
A 2013 study of patients over 45 conducted in seven hospitals in the United States found that APM followed by physical therapy produced the same results as physical therapy alone for most patients. Another study at two public hospitals and two physical-therapy clinics found the same result two years after treatment.
A unique study at five orthopedic clinics in Finland compared APM with "sham surgery." That is, surgeons took patients with knee pain to operating rooms, made incisions, faked surgeries, and then sewed them back up. Neither the patients nor the doctors evaluating them knew who had received real surgeries and who was sporting a souvenir scar. A year later, there was nothing to tell them apart. The sham surgery performed just as well as real surgery. Except that, in the long run, the real surgery may increase the risk of knee osteoarthritis. Also, it's expensive, and, while APM is exceedingly safe, surgery plus physical therapy has a greater risk of side effects than just physical therapy.
At least one-third of adults over 50 will show meniscal tears if they get an MRI. But two-thirds of those will have no symptoms whatsoever. (For those who do have pain, it may be from osteoarthritis, not the meniscus tear.) They would never know they had a tear if not for medical imaging, but once they have the imaging, they may well end up having surgery that doesn't work for a problem they don't have.
For obvious reasons, placebo-controlled trials of surgeries are difficult to execute. The most important question then is: Why, when the highest level of evidence available contradicts a common practice, does little change?
For one, the results of these studies do not prove that the surgery is useless, but rather that it is performed on a huge number of people who are unlikely to get any benefit. Meniscal tears are as diverse as the human beings they belong to, and even large studies will never capture all the variation that surgeons see; there are compelling real-world results that show the surgery helps certain patients. "I think it's an extremely helpful intervention in cases where a patient does not suffer from the constant ache of arthritis, but has sharp, intermittent pain and a blockage of motion," says John Christoforetti, a prominent orthopedic surgeon in Pittsburgh. "But when you're talking about the average inactive American, who suffers gradual onset knee pain and has full motion, many of them have a meniscal tear on MRI and they should not have surgery as initial treatment."
Still, the surgery—like some others meant for narrower uses—is common even for patients who don't need it. And patients themselves are part of the problem. According to interviews with surgeons, many patients they see want, or even demand, to be operated upon and will simply shop around until they find a willing doctor. Christoforetti recalls one patient who traveled a long way to see him but was "absolutely not a candidate for an operation." Despite the financial incentive to operate, he explained to the patient and her husband that the surgery would not help. "She left with a smile on her face," Christoforetti says, "but literally as they're checking out, we got a ding that someone had rated us [on a website], and it's her husband. He's been typing on his phone during the visit, and it's a one-star rating that I'm this insensitive guy he wouldn't let operate on his dog. They'd been online, and they firmly believed she needed this one operation and I was the guy to do it."
So, what do surgeons do? "Most of my colleagues," Christoforetti says, "will say: ‘Look, save yourself the headache, just do the surgery. None of us are going to be upset with you for doing the surgery. Your bank account's not going to be upset with you for doing the surgery. Just do the surgery.'"
Randomized, placebo-controlled trials are the gold standard of medical evidence. But not all RCTs, as they are known, are created equal. Even within the gold standard, well-intentioned practices can muddle a study. That is particularly true with "crossover" trials, which have become popular for cancer-drug investigations.
In cancer research, a crossover trial often means that patients in the control group, who start on a placebo, are actually given the experimental drug during the study if their disease progresses. Thus, they are no longer a true control group. The benefit of a crossover trial is that it allows more people with severe disease to try an experimental drug; the disadvantage is the possibility that the study is altered in a manner that obscures the efficacy of the drug being tested.
In 2010, on the strength of a crossover trial, Provenge became the firstcancer vaccine approved by the FDA. A cancer vaccine is a form of immunotherapy, in which a patient's own immune system is spurred by a drug to attack cancer cells. Given the extraordinary difficulty of treating metastatic cancer, and high expectations following the abject failure of other cancer vaccines, the approval of Provenge was greeted with ecstatic enthusiasm. One scientific paper heralded it as "the gateway to an exciting new paradigm." Except, Provenge did not hinder tumor growth at all, and it's hard to know if it really works.
Provenge was approved based on the "IMPACT study," a randomized, placebo-controlled trial initially meant to see whether Provenge could stop prostate cancer from progressing. It didn't. Three-and-a-half months into the study, the cancers of patients who had received Provenge and those who had received a placebo had advanced similarly. Nonetheless, patients who received Provenge ultimately had a median survival time of about four months longer than those who received the placebo. Due to the way in which the IMPACT trial unfolded, however, it's hard to tell if Provenge was truly responsible for the life extension.
Because Provenge did not halt tumor growth, many of the patients who began the study on it also started to receive docetaxel, a chemotherapy drug that is well established to treat advanced prostate cancer. The cancers of the patients on a placebo were also progressing, so they were "crossed over" and given Provenge after a delay. Their cancer continued progressing, and after another delay, many of them also got docetaxel. In the end, fewer patients in the group that started on a placebo received docetaxel, and, when they did, they got it later in the study. So Provenge may have worked, but it's impossible to tell for sure: Was the slightly longer survival of one group because they got Provenge earlier or because the other group got docetaxel later?
The year after Provenge was approved, the federal government's Agency for Healthcare Research and Quality issued a "technology assessment" report examining all of the evidence regarding Provenge efficacy. The report says there is "moderate" evidence that Provenge effectively treats cancer, but it also highlighted the fact that more patients who got Provenge at the beginning of the seminal trial also received more and earlier chemotherapy. The report concludes that the effect of Provenge is apparent "only in the context of a substantial amount of eventual chemotherapeutic treatment." In other words, it is unclear which effects in the trial were due to Provenge and which were due to chemotherapy.
"The people who went on docetaxel went on it because their disease was progressing, so you've already broken the randomization," says Elise Berliner, director of AHRQ's Technology Assessment Program. Prasad, the oncologist who advocates for higher standards of preapproval evidence, is less diplomatic: "If the treatment were Pixy Stix, you'd have a similar effect. One group gets Pixy Stix, and when their cancer progresses, they get a real treatment."
The larger issue has nothing to do with Provenge specifically but about the way it gained FDA approval. Therapies are frequently approved for use based on clinical trials that can't actually prove whether they work. "Clinical trials almost all have issues like this one," Berliner says, "and it's very hard to do randomized controlled trials after drugs are approved." According to a new paper in the Journal of the American Medical Association Oncology, even when cancer drugs clearly do work in trials, they often don't work or work substantially less well in the real world, perhaps because subjects in trials are not representative of typical patients. Berliner is hoping to expand and improve registries that track large numbers of real-world patients as an additional source of information. "I've been here for 15 years producing these reports," she says, "and I'm getting frustrated."
"Just do the surgery. None of us are going to be upset with you for doing the surgery. Your bank account's not going to be upset with you for doing the surgery. Just do the surgery."
Ideally, findings that suggest a therapy works and those that suggest it does not would receive attention commensurate with their scientific rigor, even in the earliest stages of exploration. But academic journals, scientists, and the media all tend to prefer research that concludes that some exciting new treatment does indeed work.
In 2012, a team of scientists from UCLA published an article in the prominent New England Journal of Medicine, the most cited medical journal in the world, showing that deep brain stimulation—delivered via electrodes implanted in the brains of Parkinson's patients—improved spatial memory, a lot. The study was understandably small—just seven subjects—as there are only so many people with electrodes already implanted in their brains. It was covered in outlets like The New York Times ("Study Explores Electrical Stimulation as An Aid to Memory"), The Wall Street Journal ("Memory Gets Jolt in Brain Research"), and LiveScience ("Where Did I Park? Brain Treatment May Enhance Spatial Memory"). The NEJM itself published an editorial in the same issue noting that the study was "preliminary, is based on small samples, and requires replication" but was worth following up with "well-designed studies."
Given the potential impact, an international team led by Joshua Jacobs, a biomedical-engineering professor at Columbia University, set out to replicate the initial finding with a larger sample. "If it did indeed work, it would be a very important approach that could help people," Jacobs says. The team took several years and tested 49 subjects, so that their study would give more statistically reliable results. The scientists were rather stunned to find that deep brain stimulation actually impaired spatial memory in their study. It was a disappointing result, but they were encouraged to show that brain stimulation could affect memory at all—a step toward figuring out how to wield such technology—and they felt an obligation to submit it to the NEJM. That is how science is supposed to work, after all, because failing to publish negative results is recognized to be a massive source of scientific misinformation.
Replication of results in science was a cause-célèbre last year, due to the growing realization that researchers have been unable to duplicate a lot of high-profile results. A decade ago, Stanford's Ioannidis published a paper warning the scientific community that "Most Published Research Findings Are False." (In 2012, he coauthored a paper showing that pretty much everything in your fridge has been found to both cause and prevent cancer—except bacon, which apparently only causes cancer.) Ioannidis's prescience led his paper to be cited in other scientific articles more than 800 times in 2016 alone. Point being, sensitivity in the scientific community to replication problems is at an all-time high. So Jacobs and his coauthors were bemused when the NEJM rejected their paper.
One of the reviewers (peer reviewers are anonymous) who rejected the paper gave this feedback: "Much more interesting would have been to find a set of stimulation parameters that would enhance memory." In other words: The paper would be better if, like the original study, it had found a positive rather than a negative result. (Last spring, ProPublica wrote about heavy criticism of the NEJM's reluctance to publish research that questioned earlier findings.) Another reviewer noted that electrodes were placed on most of the subjects differently in the replication study compared with those in the original study. So Jacobs and his coauthors analyzed results only from patients with the exact same electrode placement as the original study, and the findings were the same. Three of the authors wrote back to the NEJM, pointing out errors in the reviewer comments; they received a short note back saying that the paper rejection "was not based on the specific comments of the reviewers you discuss in your response letter" and that the journal gets many more papers than it can print. That is, of course, very true, particularly for important journals. Neuron, one of the most prominent neuroscience-specific journals, quickly accepted the paper and published it last month. (It did not receive the media fanfare of the original paper—or almost any at all—although The Wall Street Journal did cover it.)
The same week the paper appeared in Neuron, Columbia University held a daylong symposium to discuss the replication problem in science. The president of the National Academy of Sciences and the director of the U.S. Office of Research Integrity spoke—so too did Jeffrey Drazen, editor-in-chief of the NEJM. Jacobs was in the audience.
In the final Q&A, Jacobs stepped up to one of the audience microphones and asked Drazen if journals had an obligation to publish high-quality replication attempts of prominent studies, and he disclosed that his team's had been rejected by the NEJM. Drazen declined to discuss Jacobs's paper, but he said that "as editors, we're powerless," and the onus should be on the replication researchers, or "the complainant," as he put it, "and the original paper author to work together toward the truth. We're not trying to say who's right and who's wrong; we're trying to find out what we need to know. Veritas, to advance human health, it's that simple."
Jacobs did not find the answer that simple. He found it strange. On a panel about transparency and replication, Drazen seemed to be saying that journals, the main method of information dissemination and the primary forum for replication in science, could do little and that "complainants" need to sort it out with de facto defendants. Many doctors, scientists, patient advocates, and science writers keep track of new developments through premier publications like the NEJM. The less publicly a shaky scientific finding is challenged, the more likely it becomes entrenched common knowledge.
Of course, myriad medical innovations improve and save lives, but even as scientists push the cutting edge (and expense) of medicine, the National Center for Health Statistics reported last month that American life expectancy dropped, slightly. There is, though, something that does powerfully and assuredly bolster life expectancy: sustained public-health initiatives.
Medicine can be like wine: Expense is sometimes a false signal of quality. On an epochal scale, even the greatest triumphs of modern medicine, like the polio vaccine, had a small impact on human health compared with the impact of better techniques for sanitation and food preservation. Due to smoking and poor lifestyle habits, lung cancer—which killed almost no Americans in the early 20th century—is today by far the biggest killer among cancers. Thankfully, public pressure to curb smoking has put lung-cancer deaths in rapid decline since a peak in the 1990s. Deaths from lung cancer should continue to diminish, as they are tightly correlated to smoking rates—but with a 20-year lag; that is, lung cancer deaths will decline 20 years after smoking rates decline.
The health problems that most commonly afflict the American public are largely driven by lifestyle habits—smoking, poor nutrition, and lack of physical activity, among others. In November, a team led by researchers at Massachusetts General Hospital pooled data from tens of thousands of people in four separate health studies from 1987 to 2008. They found that simple, moderate lifestyle changes dramatically reduced the risk of heart disease, the most prolific killer in the country, responsible for one in every four deaths. People deemed at high familial risk of heart disease cut their risk in half if they satisfied three of the following four criteria: didn't smoke (even if they smoked in the past); weren't obese (although they could be overweight); exercised once a week; ate more real food and less processed food. Fitting even two of those categories still substantially decreased risk. In August, a report issued by the International Agency for Research on Cancer concluded that obesity is now linked to an extraordinary variety of cancers, from thyroids and ovaries to livers and colons.
At the same time, patients and even doctors themselves are sometimes unsure of just how effective common treatments are, or how to appropriately measure and express such things. Graham Walker, an emergency physician in San Francisco, co-runs a website staffed by doctor volunteers called the NNT that helps doctors and patients understand how impactful drugs are—and often are not. "NNT" is an abbreviation for "number needed to treat," as in: How many patients need to be treated with a drug or procedure for one patient to get the hoped-for benefit? In almost all popular media, the effects of a drug are reported by relative risk reduction. To use a fictional illness, for example, say you hear on the radio that a drug reduces your risk of dying from Hogwart's disease by 20 percent, which sounds pretty good. Except, that means if 10 in 1,000 people who get Hogwart's disease normally die from it, and every single patient goes on the drug, eight in 1,000 will die from Hogwart's disease. So, for every 500 patients who get the drug, one will be spared death by Hogwart's disease. Hence, the NNT is 500. That might sound fine, but if the drug's "NNH"—"number needed to harm"—is, say, 20 and the unwanted side effect is severe, then 25 patients suffer serious harm for each one who is saved. Suddenly, the trade-off looks grim.
Now, consider a real and familiar drug: aspirin. For elderly women who take it daily for a year to prevent a first heart attack, aspirin has an estimated NNT of 872 and an NNH of 436. That means if 1,000 elderly women take aspirin daily for a decade, 11 of them will avoid a heart attack; meanwhile, twice that many will suffer a major gastrointestinal bleeding event that would not have occurred if they hadn't been taking aspirin. As with most drugs, though, aspirin will not cause anything particularly good or bad for the vast majority of people who take it. That is the theme of the medicine in your cabinet: It likely isn't significantly harming or helping you. "Most people struggle with the idea that medicine is all about probability," says Aron Sousa, an internist and senior associate dean at Michigan State University's medical school. As to the more common metric, relative risk, "it's horrible," Sousa says. "It's not just drug companies that use it; physicians use it, too. They want their work to look more useful, and they genuinely think patients need to take this [drug], and relative risk is more compelling than NNT. Relative risk is just another way of lying."
Even remedies that work extraordinarily well can be less impressive when viewed via NNT. Antibiotics for a sinus infection will resolve symptoms faster in one of 15 people who get them, while one in eight will experience side effects. A meta-analysis of sleep-aid drugs in older adults found that for every 13 people who took a sedative, like Ambien, one had improved sleep—about 25 minutes per night on average—while one in six experienced a negative side effect, with the most serious being increased risk for car accidents.
"There's this cognitive dissonance, or almost professional depression," Walker says. "You think, ‘Oh my gosh, I'm a doctor, I'm going to give all these drugs because they help people.' But I've almost become more fatalistic, especially in emergency medicine." If we really wanted to make a big impact on a large number of people, Walker says, "we'd be doing a lot more diet and exercise and lifestyle stuff. That was by far the hardest thing for me to conceptually appreciate before I really started looking at studies critically."
Historians of public health know that most of the life-expectancy improvements in the last two centuries stem from innovations in sanitation, food storage, quarantines, and so on. The so-called "First Public Health Revolution"—from 1880 to 1920—saw the biggest lifespan increase, predating antibiotics or modern surgery.
In the 1990s, the American Cancer Society's board of directors put out a national challenge to cut cancer rates from a peak in 1990. Encouragingly, deaths in the United States from all types of cancer since then have been falling. Still, American men have a ways to go to return to 1930s levels. Medical innovation has certainly helped; it's just that public health has more often been the society-wide game changer. Most people just don't believe it.
In 2014, two researchers at Brigham Young University surveyed Americans and found that typical adults attributed about 80 percent of the increase in life expectancy since the mid-1800s to modern medicine. "The public grossly overestimates how much of our increased life expectancy should be attributed to medical care," they wrote, "and is largely unaware of the critical role played by public health and improved social conditions determinants." This perception, they continued, might hinder funding for public health, and it "may also contribute to overfunding the medical sector of the economy and impede efforts to contain health care costs."
It is a loaded claim. But consider the $6.3 billion 21st Century Cures Act, which recently passed Congress to widespread acclaim. Who can argue with a law created in part to bolster cancer research? Among others, the heads of the American Academy of Family Physicians and the American Public Health Association. They argue against the new law because it will take $3.5 billion away from public-health efforts in order to fund research on new medical technology and drugs, including former Vice President Joe Biden's "cancer moonshot." The new law takes money from programs—like vaccination and smoking-cessation efforts—that are known to prevent disease and moves it to work that might, eventually, treat disease. The bill will also allow the FDA to approve new uses for drugs based on observational studies or even "summary-level reviews" of data submitted by pharmaceutical companies. Prasad has been a particularly trenchant and public critic, tweeting that "the only people who don't like the bill are people who study drug approval, safety, and who aren't paid by Pharma."
Perhaps that's social-media hyperbole. Medical research is, by nature, an incremental quest for knowledge; initially exploring avenues that quickly become dead ends are a feature, not a bug, in the process. Hopefully the new law will in fact help speed into existence cures that are effective and long-lived. But one lesson of modern medicine should by now be clear: Ineffective cures can be long-lived, too.
The government is still covering prescriptions written by doctors who have been kicked out of Medicare and even some who have pleaded guilty to crimes.
This article first appeared February 10, 2017 onProPublica.
This story was co-published with NPR's Shots blog.
Back in 2014, federal officials settled on what they thought would be a straightforward fix to curb abusive pill pushing: Require doctors and other health providers to register with the Medicare program in order to prescribe medications for beneficiaries.
That way, the government could screen them and take action if their prescribing habits were deemed improper. Officials figured the modest change would barely ruffle the medical community: Doctors already had to fill out an application, have their credentials verified and enroll to get paid by Medicare for seeing patients, after all.
But this fix, which followed a 2013 ProPublica investigation into questionable prescribing in Medicare, has yet to be implemented. The government now says it needs until 2019 to put it in place — 3 1/2 years longer than initially expected.
"It has definitely been much more challenging" than anticipated, said Jonathan Morse, acting director of the Center for Program Integrity within the Centers for Medicare and Medicaid Services, the federal agency that runs Medicare.
As a result, the government is still covering prescriptions written by doctors who have been kicked out of Medicare and even some who have pleaded guilty to crimes. Three New Jersey doctors who pleaded guilty in July 2013 to charges related to a bribery scheme continued prescribing drugs to Medicare patients the following year, a ProPublica review found.
One of those doctors, Franklin Dana Fortunato, told ProPublica that he was advised that he could continue treating patients between his guilty plea and his sentencing in May 2015.
In addition, at least 40 doctors kicked out of Medicare before 2014 had their prescriptions covered by Medicare's prescription drug program, known as Part D, that year, a ProPublica analysis shows.
Much of the reason for the delay rests with dentists. Medicare, which provides health care to seniors and the disabled, doesn't typically cover dental services, but the Part D program pays for drugs, such as antibiotics or painkillers, that dentists order for beneficiaries.
"Since Medicare covers very few dental item and services, many (perhaps most) dentists have little incentive to enroll in Medicare" outside of this requirement, the American Dental Association wrote to CMS in September 2016. The dental group also said the enrollment process is too complex and that CMS already has the information it needs to address fraud and abuse concerns.
ProPublica analyzed all providers who wrote at least 50 prescriptions for at least one drug in Part D in 2014. All told, more than 92 percent of the 428,000 providers were enrolled in Medicare. But among 18,500 dentists, almost the exact opposite was true: More than 82 percent weren't enrolled.
"From their perspective, they're basically saying to us, what incentive do they have to enroll," said Morse, the head of program integrity for CMS.
Part D, which began in 2006, has received high marks from patients. It now covers more than 42 million people. But experts have long complained that the program places a higher priority on getting prescriptions into patients' hands than on targeting problem prescribers. The Department of Health and Human Services' inspector general has repeatedly called for tighter controls.
Medicare's response, finalized in May 2014, gave officials the power to kick health providers out of the program if their prescribing is abusive, a threat to public safety or in violation of Medicare rules. CMS said it would use prescribing data, disciplinary actions, malpractice lawsuits and more to identify problem providers.
To date, officials said, Medicare has only done so once.
But the plan to require that providers enroll in Medicare has been met by delay after delay after delay.
At first, CMS gave providers until June 1, 2015, to either enroll in Medicare or formally opt out. Either way, the government would have additional information about them. If they neither enrolled nor formally opted out, Medicare said it would no longer cover drugs they ordered for beneficiaries.
Finally, in October 2016, CMS pushed it off until January 2019. Beginning this spring, it said it will block prescriptions from doctors who have been barred from participating in federal health programs, those ousted from the Medicare program for other reasons, and those convicted of a felony in the past 10 years.
The delays have enabled troubled doctors to continue prescribing—while still having their prescriptions paid for by Medicare.
A family practice doctor in Michigan, for example, was charged in December 2012 with conspiracy to commit fraud and illegally distributing a controlled substance. But he wrote 7,864 prescriptions in Part D in 2014. In fact, 41 percent of his Part D patients received at least one prescription for a narcotic painkiller that year. He pleaded guilty in 2015 and was sentenced to seven years in prison.
And in Georgia, a nursing home doctor kicked out of Medicare in February 2014 for "abuse of billing privileges" nonetheless wrote nearly 45,000 prescriptions covered by the program that year.
While CMS has delayed its enrollment requirement, it has begun to review the reams of data it collects to identify doctors with aberrant prescribing patterns. It sent a round of letters to doctors, alerting them to how they compared to peers, but a study in the journal Health Affairs last year found that the letters were ineffective at changing behaviors.
A second round of letters, which contained stronger warnings, has led to a small change in prescribing practices, Morse said.
"Rather than saying, 'Hey we've noticed that you have this odd or higher than average prescribing behavior,' now it's much more 'We plan to take action if your behavior does not fall into line with that of your peers,'" he said. "It has become more effective because the letter is more strongly worded."
Suha Abushamma, MD, a Cleveland Clinic medical resident, chose on Jan. 28 to withdraw her visa rather than to be deported and does not have a valid document with which to re-enter the U.S.
This article first appeared February 6, 2017 onProPublica.
Joyous homecomings and family reunions broke out at airports across the country after a federal judge in Washington state blocked the implementation of President Donald Trump's order barring visitors from seven predominantly Muslim countries.
But Dr. Suha Abushamma, a Cleveland Clinic medical resident, is still abroad and it's not clear she's going to be allowed home anytime soon.
A first-year resident at the Cleveland Clinic, she was forced to leave the U.S. hours after landing at New York's John F. Kennedy International Airport on Saturday, Jan. 28. Abushamma, a Sudanese citizen, was given the choice of withdrawing her visa application "voluntarily" or being forcibly deported and not allowed back to the U.S. for at least five years. She chose to withdraw her visa, meaning she does not currently have a valid document with which to enter the U.S.
Her plane took off around the same time as a federal district judge in Brooklyn issued a temporary stay blocking the government from removing people like her. Abushamma said she asked an officer and supervisor with Customs and Border Protection to allow her to wait for the results of the hearing, but her request was denied.
"My heart sank when she told me she was on that plane," David Leopold, a lawyer who was working with Abushamma, previously told ProPublica. "It was one of the hardest moments I've ever had being a lawyer."
Lawyers are suing on Abushamma's behalf, seeking an order that would allow her to come back to the U.S. The lawsuit contends that Abushamma was denied access to legal advice and was unlawfully removed. Abushamma is currently in Saudi Arabia, where her family lives. A hearing in her case is set for Feb. 15.
If Abushamma loses her suit, she'll have to reapply for a visa, which can be a lengthy process.
The government has not yet filed its response to Abushamma's lawsuit. In a series of tweets over the weekend, Trump criticized U.S. District Judge James Robart, who ruled against his executive order.
"The judge opens up our country to potential terrorists and others that do not have our best interests at heart. Bad people are very happy!" Trump wrote in one tweet.
For some of those whose disrupted lives ProPublica detailed, the judge's decision opened the doors to the country again.
Dr. Kamal Fadlalla, a second-year resident in internal medicine at Interfaith Medical Center in Brooklyn, had been stuck in Sudan where he had been visiting his family. When Fadlalla arrived at New York's John F. Kennedy International Airport yesterday, he was greeted by elected officials and colleagues from the Committee of Interns and Residents/SEIU Healthcare.
Dr. Abubaker Hassan also was reunited with his wife, Sara Hamad, and his infant daughter Alma, who had been stuck overseas after visiting relatives in Qatar. Hassan is in his second year of an internal medicine residency program at Detroit Medical Center, a hospital that serves a low-income and minority community. Although their daughter is a U.S. citizen, his wife holds a visa and was blocked by the travel ban. They flew into Philadelphia yesterday.
And Batoul Elamin, a neonatologist in Virginia, was finally able to see her mother. Her mother, a Sudanese citizen, flew in yesterday from Saudi Arabia, where she had been waiting while the travel ban was in effect.
As recently as Friday, Dr. Majid Rouhbakhshzaeri, a pediatric eye doctor in Chicago, had been thinking about abandoning the life he had built life in the U.S. to go back to his native Iran.
Rouhbakhshzaeri, a permanent resident with a green card, had been working for three years to bring his family to Illinois. His wife, Nasim Nami, and his two young children, Adrian and Ryan, received their visas at the end of last year and they were planning to move here this month.
They arrived yesterday in Boston. Rouhbakhshzaeri flew there to greet them. "I'm so happy, excited and worried," he texted as his family was in transit.
"My younger kid does not know me because when he was two or three months, I moved here, and my older kid was like 1-year-old," Rouhbakhshzaeri said on Friday. "I miss them a lot. They also miss me — and the burden is on my wife and her family."
Doctors say the federal travel ban has sown widespread fear. The Medical Colleges Association estimates that about 18,000 current medical residents are not U.S. citizens. Other foreign doctors are practicing on non-immigrant visas.
This article first appeared February 2, 2017 onProPublica.
Get sick in Toledo, Ohio, and chances are good you'll be treated by a doctor born in another country. If you have allergies, stomach issues or neurological problems, the chances are even better. At least half of those doctors are foreign-born, Ohio Medical Board data shows — some from the seven countries listed on President Trump's travel ban.
Allergist Syed Rehman, for instance, was born in Iraq, attended medical school in Pakistan and came to the United States for his specialty training in 1984. Neurologist Mouhammad Jumaa was born in Syria, went to medical school in Damascus, then did eight years of training in Pittsburgh. And Dr. Imran Ali, a professor of neurology at the University of Toledo Medical School, left Pakistan to complete his training in North Carolina.
For decades, foreign-born doctors like Rehman, Jumaa and Ali have played a vital role in shoring up American's health care system. The doctors come to the United States for residency, drawn by cutting edge medical training and American ideals, then stay to fill the country's growing need for doctors. But Trump's executive order this week — and worries it may expand to other countries, such as Pakistan — has touched off a wave of anxiety, anger and dire predictions that immigrant doctors, faced with hostility or uncertainty, may go somewhere else. The news made the front pages of media outlets across Pakistan and India.
"Overall the thing that attracts people to America is the society, the people, the freedom to pursue your dreams," said Ali, who has raised three kids in Toledo. "If that paradigm changes then what's the reason to come?"
And that, Ali and other physicians said, should worry everyone.
Foreign-born doctors often are willing to work in the isolated rural areas, small towns and blighted urban centers that many American-born doctors shun. It's estimated that about 10,000 foreign-born doctors have served such stints. There are about 926,000 active doctors in the United States, according to the Kaiser Family Foundation. As of 2013, about 45,000 of them came from India, 11,000 from Pakistan and 10,000 from the Philippines, according to data gathered by the American Medical Association. Another 3,800 came from Syria and 3,900 from Iran, which are included in Trump's ban, the data showed.
The need for foreign doctors is likely to grow. A 2016 report by the Association of American Medical Colleges projected a shortage of between 62,000 and 95,000 primary care and specialty physicians over the next decade as the population grows and ages. Monday, the association, which represents medical schools and teaching hospitals, said Trump's 90-day ban on visitors from seven predominantly Muslim countries could cause long-term damage to patients and health care in the United States.
The significant role of foreign-born doctors in many communities can be seen in Toledo, a Rust Belt city of about 285,000 residents. Some foreign-born doctors there estimate that as many as 40 percent of their peers were born outside the U.S., although there's been no official count. Eight of the 14 specialists in the University of Toledo neurology department come from other countries. "I can't even imagine what medicine would look like without foreign-born doctors," said Dr. Gretchen Tietjen, an American-born neurologist who is chair of the department.
Trump's temporary ban is limited to Iran, Iraq, Libya, Somalia, Sudan, Syria and Yemen. It's unknown whether it will be extended or applied to other countries, though such possibilities have been mentioned. Its chaotic implementation caused high-profile examples of doctors being stranded or detained en route to the U.S.
Doctors say the ban has sown widespread fear, even among practitioners from countries it doesn't include. The Medical Colleges Association estimates that about 18,000 current medical residents are not U.S. citizens. Other foreign doctors are practicing on non-immigrant visas. As a result, in Toledo some doctors say colleagues have decided not to go home to Pakistan, or bring loved ones from abroad, because they're afraid of getting caught up in a travel ban.
The ban could also create bias in the process of matching residents to programs in teaching hospitals throughout the country. The Medical Colleges Association estimates that about 1,000 foreign medical school graduates from the seven banned countries have applied for American residency and fellowship programs this year. Many other applicants could be affected if the ban is expanded to other countries.
On Tuesday, the American Medical Association sent a letter to the Department of Homeland Security voicing concern that residencies may go unfilled and urging it to "provide details and mitigate any negative impact on our nation's health care system," the letter said.
It's resulted in an uncomfortable quandary for Tietjen, who is currently deciding how to rank applicants for four coveted neurology residency positions. Residents are a crucial part of the workforce, she said, helping staff about 1,000 beds at multiple hospitals. Of the 40 applicants who made it to the interview phase, five come from countries under the ban, she said. Now, for the first time, she can't simply judge their skills and potential, she must also look at their nationality and their chances of getting through immigration. Five of the 16 current residents are from Pakistan, and one is from Iran.
"It just feels morally wrong not to look at people by their qualifications rather than where they came from," she said. "I feel empathy for people who don't get a spot because of this ban."
The White House press office did not respond to an email and phone call.
In interviews, Toledo doctors from countries such as Syria and Iraq said Trump's ban is likely to discourage others like them from coming to the United States for residency. The physicians are taking a risk and cannot afford to have their time wasted, said Rehman, the allergy specialist, who's affiliated with multiple hospitals in Toledo. "It will hurt us in the near future," he said.
Egyptian radiologist Haitham Elsamaloty came to the United States in 1994 and is the interim chairman of the radiology department at the University of Toledo. He worries his home country may soon be added to Trump's ban and wonders whether others may choose not to follow his path.
"This ban is going to limit students who are very good and have all the drive and motivation to be the scientists of the future," Elsamaloty said. "They will look to Canada. Canada has open arms. Or Germany, France or the U.K. They are all open societies and don't have a ban."
Jumaa, the stroke specialist from Syria, said the U.S. will always be attractive to foreign doctors because it has the best medical education in the world. But it's a high-risk, once-in-a-lifetime investment to apply for residency in the U.S., he said. Will potential residents from the seven countries still want to come if their families can't visit, or their travel might be restricted?
"I would tell them not to go through the uncertainty and to pursue medical education in another country," he said.
A Cleveland Clinic doctor barred from entering the United States over the weekend by President Donald Trump’s travel ban is suing the president and his administration, seeking a writ of habeas corpus and an order that would allow her to come back.
This article first appeared February 1, 2017 onProPublica.
The president's executive order barred visitors from seven predominantly Muslim countries from entering the U.S. for at least 90 days while the government comes up with methods to more thoroughly screen them. The order, however, has ensnared doctors like Suha Abushamma, a first-year internal medicine resident, who already had been working in this country and were abroad when it was signed.
Abushamma, a Sudanese citizen, was visiting family in Saudi Arabia when friends encouraged her to come back quickly because of rumors about a Trump travel ban. Abushamma landed in the U.S. at 11 a.m. Saturday and was held for about nine hours before being forced to leave the country. Her plane took off around the same time as a federal district judge in Brooklyn issued a temporary stay blocking the government from removing people like her.
ProPublica interviewed her while she was flying back to Saudi Arabia and published a story before she landed.
Abushamma's situation has attracted attention from the leadership of the Cleveland Clinic, as well as Ohio's two senators. Lawyers for the firm Cleary Gottlieb Steen & Hamilton, working pro bono on Abushamma's behalf, filed an amended petition Tuesday in U.S. District Court in Brooklyn asking the judge to let her come back into the country. During a hectic stretch on Saturday, lawyers had filed an emergency application to prevent her from being kicked out, but the petition was not acted upon before she left.
The lawsuit contends that Abushamma was denied access to a lawyer and was unlawfully removed. It says she was told that she either had to voluntarily withdraw her visa application and leave the country or be deported, which would have prevented her from returning for five years. Abushamma asked an officer and supervisor with Customs and Border Protection to allow her to wait for the results of the legal hearing, but her request was denied.
In their legal pleadings filed Tuesday, Abushamma's lawyers note that the federal district judge in Brooklyn, Ann Donnelly, told the government's lawyers on Saturday night, "I'm going to direct you, if there's somebody right now who is in danger of being removed, I am going to direct you to communicate that I have imposed a stay. Nobody is to be removed in this class, okay?"
According to a timeline assembled by the lawyers, Donnelly's instruction appear to have come after Abushamma boarded her flight and after it pushed back from the gate, but before it took off just before 9 p.m. Dozens of other lawsuits have been filed across the country by people affected by Trump's order.
Dr. Abby Spencer, program director for the Cleveland Clinic's internal medicine residency program, said in a court filing that Abushamma graduated from medical school in Sudan at the top of her class and had received the "Best Overall Performance" award.
"Since matriculating to the program in July, she has been a stand-out physician and colleague," Spencer wrote. "She has repeatedly and consistently demonstrated the utmost ethical standards and continued to prioritize patient needs."
The lawyers also included a declaration from an Ohio lawyer, David Leopold, who said that he tried to help Abushamma on Saturday but that the Customs and Border Protection officer would not talk to him. He shared text messages that Abushamma sent him, desperate for help.
On Monday, then-Acting Attorney General Sally Yates said the Justice Department would not defend Trump's order in court. Shortly thereafter, Trump fired her and replaced her with an appointee who said he would defend the action.
"It is time to get serious about protecting our country," Trump said in a statement on Monday night. "Calling for tougher vetting for individuals travelling from seven dangerous places is not extreme. It is reasonable and necessary to protect our country."
In a statement Sunday, the Cleveland Clinic said it is "fully committed" to the safe return of its employees affected by the action. The Cleveland Clinic's CEO, Dr. Toby Cosgrove, is an adviser to Trump and withdrew his name from consideration to be secretary of the Department of Veterans Affairs.
The clinic is planning a fundraiser next month at Trump's Mar-a-Lago club in Florida. A group of medical students and others have drafted a letter asking the clinic to reconsider and cancel the event in solidarity with Abushamma.
After a task force of experts said evidence didn't support some cancer screenings, it became the target of lawmakers, including Price and others with health industry ties.
This article first appeared February 3, 2017 onProPublica.
This story was co-published with NPR's Shots blog.
If the last few years are any guide, one group that may find itself in the crosshairs of Rep. Tom Price, President Trump's pick to lead the Department of Health and Human Services, is an influential panel of medical experts.
The U.S. Preventative Services Task Force, a group of mostly physician and academics from top universities, reviews medical practices to see whether they are supported by research and evidence.
Under the Affordable Care Act, the group's recommendations have been used to guide private insurers. If the group gives a test high marks, insurers are required to cover it. If it doesn't, they are free not to.
But letters reviewed by ProPublica show that Price twice pushed HHS to quash the task force's recommendations to limit widely used cancer screenings. The panel said that the screenings too often led to unnecessary biopsies and other harmful treatment.
Democrats on the Senate Finance Committee boycotted a Tuesday vote on Price's nomination, citing unanswered ethics questions.
In 2011, Price and other lawmakers signed a letter asking the head of HHS to "push for the withdrawal" of the panel's draft prostate screening recommendations. The panel was made up of "bureaucrats," the letter said, and decisions about prostate testing were best left to doctors and their patients. "This recommendation jeopardizes the health of countless American men," the letter said.
The task force went ahead and in 2012 recommended that men of all ages forgo using blood tests to search for prostate cancer. The recommendation didn't apply to men with a history of prostate cancer.
Three years later, Price signed two letters protesting the task force's proposed recommendations that mammograms be given every two years for healthy and risk-free women between the ages of 50 and 74, and by individual choice for women between 40 and 49. Other groups, including the American College of Radiology, recommend starting mammograms at 40 and having them every year or two.
In May 2015, Price and other lawmakers wrote that the task force recommendations "would jeopardize access to screenings." In June, a second letter signed by Price and others with the GOP Doctors Caucus, went further, urging the head of HHS to ensure the recommendations weren't finalized. The recommendations, the letter said, could "result in thousands of additional breast cancer deaths."
Despite the complaints, the mammogram recommendations were issued in 2016. Proponents praised them as the fruit of the task force's independent and evidence-based approach. But the guidelines raised the ire of a much more powerful constituency: the urologists and radiologists who made billions of dollars off the testing and related procedures.
The dirty underbelly of screening is that it's a great way to get more patients," said Dr. Gilbert Welch, professor of medicine at the Dartmouth Institute for Health Policy & Clinical Practice and a close observer of the task force's work. "The financial underpinnings are huge."
The health-care industry spends more money lobbying Congress than almost any other sector, according to the tracking site OpenSecrets.org. Price, an orthopedic surgeon, took in $479,000 in health professional donations in the 2016 campaign cycle, one of the largest sums to any member of Congress.
To be sure, the industry has a host of more pressing concerns, from the ACA and Medicare and Medicaid to the cost of drugs. But the task force's recommendations have continued to draw complaints by lawmakers who received financial support from the industry.
In November, lawmakers bashed its screening recommendations during a hearing of the health subcommittee of the House Committee on Energy and Commerce. The task force "can deprive patients of lifesaving services," said Rep. Michael Burgess, a Republican from Texas who received nearly $611,000 from health professionals in the 2016 campaign cycle.
His colleague, Rep. Marsha Blackburn, a Tennessee Republican who received $259,000 in donations from health professionals in the 2016 campaign cycle, predicted equally dire outcomes. The task force, she said, "turned its back on over 20 million women by finalizing erroneous guidelines that would limit access to mammograms."
Earlier this month, Blackburn re-introduced legislation that would, among other things, add specialists to the panel. The group currently consults with specialists in the areas they are reviewing. Critics of the proposed bill say specialists are not ideal to perform the task force's broad array of evidence reviews, and adding them could create conflicts of interest. "There is considerable support for 'draining the swamp' in Washington," Welch wrote in testimony he submitted for the hearing. "But there is no swamp currently in the task force. Please don't create one."
Questions sent to Price's office were answered by Ryan Murphy, who is currently an HHS adviser. Murphy was most recently communications director for the House Budget Committee, of which Price is chairman.
"Dr. Price's concerns — shared by others as you noted — were with specific recommendations made by the task force," Murphy said. "As a physician, Dr. Price knows firsthand the value of scientific research as well as how important it is to ensure patients and their doctors are able to make choices regarding treatments that they agree are in the best interest of the individual patient."
Price has embraced task force findings that recommend more treatment. In 2014, for example, he co-signed a letter to the HHS secretary and the Medicare administrator asking that Medicare expand its coverage for lung cancer screenings for smokers based on task force recommendations.
With the shifts in power both in Congress and under the Trump administration, proponents of the task force fear setbacks in the decades-long push for evidence-based medicine. The task force has 96 current recommendations, which it routinely updates. Its $11.6 million budget is funded through HHS's Agency for Healthcare Research and Quality, which has been on the lawmakers' chopping block in the past. If confirmed, Price or congressional Republicans could reduce the task force's influence or independence, or cut its funding.
"Science is really under attack," said Fran Visco, president of the National Breast Cancer Coalition. "We've spent decades building a scientific and research infrastructure and community all in order to produce the evidence that will save lives. Sometimes the science doesn't give us the answer we would like, but it actually gives us the facts and the evidence."
While some disagree with the task force's recommendations, its work is in line with a global push toward evidence-based medicine and with the guidelines of some other groups. The International Agency for Research on Cancer says there isn't enough evidence to recommend for or against mammograms for women between 40 and 49. Like the task force, the American College of Physicians says mammograms should be an individual decision for women between the ages of 40 and 49 and be provided every other year at the patient's request.
The task force and others found widespread screening often led to false positives, painful biopsies and life-altering operations for patients who were not actually at risk of cancer. Unnecessary screening also contributes to an overtreatment epidemic that the Institute of Medicine has estimated costs $210 billion a year.
Dr. Kirsten Bibbins-Domingo, chairwoman of the task force, is a internist and epidemiologist at the University of California, San Francisco. She said the attacks by Blackburn and others risk misleading patients about the effectiveness of screening for patients who are not at risk and are free of symptoms. "Patients and clinicians need to understand the benefits and the harms so they are empowered to make the best decisions for themselves," Bibbins-Domingo said.
Regardless of what happens politically, she said, patients and doctors will still need evidence-based recommendations to make informed decisions.
The evidence-based work of the task force could be "endangered" because the panel is caught up in the political fight around the ACA, said Dr. Sheldon Greenfield executive co-director of the Health Policy Research Institute at the University of California, Irvine. "It wouldn't surprise me if it does become a casualty."
The worst outcome, he said, would be for health care in the United States to revert to the way it used to be. The old joke is that doctors ignore science and say, "I know best," Greenfield said, trumping evidence-based medicine with "eminence-based" medicine.
Marshall Allen is examining how waste and overtreatment are affecting patients and raising the cost of care. If you have evidence of wasted health-care dollars, please email him at marshall.allen@propublica.org.
Hours after landing in New York on Saturday, a doctor at the prestigious Cleveland Clinic was forced to leave the country based on an executive order issued by President Donald Trump that bans visitors from seven predominantly Muslim countries for 90 days.
This article first appeared January 29, 2017 onProPublica.
By Charles Ornstein
Hours after landing in New York on Saturday, a doctor at the prestigious Cleveland Clinic was forced to leave the country based on an executive order issued by President Donald Trump that bans visitors from seven predominantly Muslim countries for 90 days.
Her flight to Saudi Arabia took off minutes before a federal judge in New York put a temporary stay on turning back people in such situations.
Suha Abushamma, 26, is in the first year of an Internal Medicine residency program at the clinic and held an H-1B visa for workers in "specialty occupations." Born and raised in Saudi Arabia, she holds a passport from Sudan, one of the seven countries from which Trump barred visitors.
On Saturday evening, Abushamma was forced to make a choice by Customs and Border Protection agents: She could leave the country voluntarily and withdraw her visa — or she could be forcibly deported, which would have prevented her from coming back to the United States for at least five years. The latter also would have resulted in a permanent black mark on her immigration record.
She asked for a delay but was refused, she said in a FaceTime interview with ProPublica while she was flying over the Atlantic on her way back to Saudi Arabia. Saudi Arabia is not one of the countries on Trump's list, but because Abushamma's passport is from Sudan, she was told she is covered by the executive order.
"I'm only in this country to be a doctor, to work and to help people — that's it," she said. "There's no other reason."
David Leopold, a prominent immigration attorney and former president of the American Immigration Lawyers Assocation, had been in contact with Abushamma for hours and was trying to help her stay. He said at one point he told her to give the phone to a Customs and Border Protection agent so he could argue her case.
The agent refused to allow her to delay her flight while the hearing in the Brooklyn federal courthouse was proceeding. On Saturday night, District Court Judge Ann M. Donnelly put a stay on deporting people who hand landed in the U.S. and were covered by the executive order.
"My heart sank when she told me she was on that plane," Leopold said of Abushamma. "It was one of the hardest moments I've ever had being a lawyer."
Abushamma had left the U.S. Monday to visit family in Saudi Arabia and then travel to Sudan. Friends alerted her on Wednesday about the possibility that Trump would sign an executive order that could make it difficult for her to return. Though she had planned to be out of the country for two more weeks, she moved quickly to change her plans, obtain a new visa and come back to the U.S. early.
"She picked up her passport from the U.S. embassy, changed her flight and came as quickly as she could but she wasn't able to make the stroke of the pen," said her friend, Faris El-Khider, who is a gastroenterology fellow at the Cleveland Clinic and is from Sudan. "She was basically racing against Trump."
A spokesperson for the Cleveland Clinic said the institution was still gathering details about the situation, but ProPublica was able to verify Abushamma's residency at the clinic through online records.
Abushamma said she landed in New York a little after 11 a.m. Saturday, hoping that she would be let in. At first, her experience with Customs and Border Protection agents seemed normal, until she was directed into a holding area at Terminal One at John F. Kennedy Airport, where she saw another doctor from Iran who works at the Cleveland Clinic. That doctor and her husband both have green cards (making them permanent U.S. residents) and, after a few hours, they were allowed into the country.
Abushamma said she watched as others were questioned—she said there were 30 or more people in the room. Those with green cards, including her colleague, were eventually allowed entry to the country. Those with visas were not.
She texted with her friend El-Khider, who desperately sought legal help for her and advised her to try to stay as long as she could while the matter headed to court.
She said she knew she was in trouble when a representative for Saudi Airlines approached her and told her she would have to book a flight home. Then an officer, whose name she wrote down as T. Lam, told her her choices: "Either to withdraw my visa … so it wouldn't leave a negative mark on my profile … or the second option was to refuse to withdraw" and be banned from the U.S. for five years. "I told them at that point I already had lawyers working on my case. I just need a few more hours … They absolutely refused. I even talked to the supervisor."
According to FlightAware, a flight tracking website, the plane pushed back from the gate at 8:29 p.m. and took off at 8:53 p.m. The earliest reports of the judge's stay of deportations under the executive order came at around 9 p.m.
"I'm happy for the people that are held," she said. "I met a really bright young female from Iran who's studying at NYU. Her flight was at 11. I'm happy for her that she at least gets to go in. I'm frustrated, but it's the way it is."
Abushamma said she couldn't believe it when she was offered an interview with the Cleveland Clinic, let alone the residency. "My parents are both doctors. They know the Cleveland Clinic. They know all the big names in the U.S. so they were even more excited than I was."
Abushamma had to select when to take her vacation last spring, two months before she began working at the clinic. Because there are dozens of residents in the program, creating a calendar takes advanced planning. She decided to go home in late January because she'd had visits from her parents earlier in 2016. "I thought it would be a good time for me to see my family."
When she departed the U.S. last Monday, she said, "there was no talk at that point" about Trump's executive order.
Two days later, as word began to leak about the president's plans, Abushamma said she rushed to come back. She had a visa interview on Wednesday and the officer at the U.S. consulate was "super helpful," telling her about the rumored executive order and advising her to go back as soon as possible. The consulate worker even issued her a visa in one day when it usually takes three business days. "Exactly what she said was 'I don't want your patients not to have you.'"
Abushamma received her passport back with the newly issued visa on Friday and booked the first flight out Saturday morning, leaving at 6 a.m. Saudi time. "I knew he signed something. I didn't know the exact details of it," she said. "I thought there might be some changes to it that didn't affect me. I just went with great hopes that I would go in."
Asked what she would do when she landed back in Saudi Arabia, Abushamma said she would try to see if she could get a waiver for the 90-day period in which no visitors from the seven countries are allowed.
Abushamma's friend El-Khider said he might have found himself in her situation. Though he is a green card holder, he was planning to leave the country last Wednesday to visit Sudan. At the airport, he heard about Trump's order and decided not to leave. "By the time I got to the airport, I thought wait a minute. I canceled my flight and my friend drove me back to my house."
Leopold, the immigration lawyer, said now that Abushamma has left the U.S. and "voluntarily" canceled her visa, she may not be able to return anytime soon.
"She's not going to be able to get a visa for at least 90 days," he said. "She's already been removed, so I think it's over. This is heartbreaking."
Update, Jan. 29: In a statement released this morning, the Cleveland Clinic did not refer to Abushamma directly but said the recent immigration action "has caused a great deal of uncertainty and has impacted some of our employees who are traveling overseas. We are fully committed and actively working toward the safe return of any of our employees who have been affected by this action.' The clinic's CEO, Dr. Toby Cosgrove, was considered by President Donald Trump for Secretary of Veterans Affairs but withdrew from consideration. He is a member of a new panel of 16 business leaders advising Trump on the way in which the government affects economic growth.