After years of Congressional inaction, legislators in both parties want to back efforts by states and hospitals to reduce the U.S. maternal mortality rate, the highest in the developed world.
This article first appeared June 31, 2018 on ProPublica.
Tackling an issue that Congress has largely ignored for decades, the U.S. Senate Appropriations Committee voted Thursday to request $50 million in new funding for programs aimed at reducing the comparatively high U.S. rate of women who die in pregnancy or childbirth.
More than three-quarters of the proposed funding — $38 million — would go to the federal Maternal and Child Health Bureau to expand life-saving, evidence-based programs at hospitals and increase access to the Healthy Start program for new mothers and babies. The remaining $12 million would go to the Centers for Disease Control and Prevention to enhance data collection and research as well as support state boards that count and review maternal deaths.
“I’m kind of blown away,” said Charles Johnson, a maternal health advocate whose wife Kira died from a hemorrhage after giving birth in 2016. Maternal mortality, he added, has come to be seen as “not a black issue, not a white issue, not a liberal issue, not a conservative issue, not even just a woman’s health issue, but what it truly is, which is a human rights issue — that’s the big shift.”
The funding is included in the appropriation committee’s $179.3 billion budget bill for the departments of Labor, Health and Human Services, Education and related agencies, which was approved on a 30-1 vote. On Tuesday, a different Senate panel — the Health, Education, Labor and Pensions committee — unanimously passed the Maternal Health Accountability Act, sponsored by Democrat Heidi Heitkamp of North Dakota and Republican Shelley Moore Capito of West Virginia.
Patty Murray, a Democrat from Washington state who sits on the Senate health and appropriations committees, was instrumental in pushing the two bills forward. “It is absolutely unacceptable that so many mothers in this country are dying in childbirth, and it’s long past time that we address this issue,” Murray said at the Tuesday hearing.
The Heitkamp-Capito legislation would establish a grant program to help states and tribal authorities identify and investigate maternal deaths and translate those lessons into policies that reduce health disparities and save mothers’ lives. The funding would come from the $12 million proposed for the CDC.
“In the 21st century, no mother should have to worry about dying during childbirth, especially in a country as advanced as the United States,” Heitkamp said in a statement. “Rising maternal mortality rates must be urgently addressed, and we need to better understand this crisis so we can more effectively tackle it.”
The Senate actions are the latest by lawmakers across the country in response to the “Lost Mothers” project that ProPublica and NPR launched last year. In recent months, Pennsylvania, Indiana, Oregon and the District of Columbia have established committees to examine maternal deaths, bringing the total number of these state and local maternal mortality review committees to at least 35.
As ProPublica and NPR have reported, more than 700 women die annually in the U.S. from causes related to pregnancy or childbirth, and the rate has increased even as it has fallen in other affluent countries. The rate of near-fatal complications has also soared since the 1990s, endangering more than 50,000 U.S. women a year.
More than 60 percent of pregnancy- and childbirth-related deaths in the U.S. are preventable, a CDC Foundation report indicated this past February. Black and Native American mothers are at the greatest risk of dying and nearly dying.
Spurred by media attention and lobbying by maternal health advocates, a total of 37 senators, including four Republicans, have signed on to the Heitkamp-Capito bill as cosponsors. “Congressional staff are calling us — ‘My boss just read another article about maternal mortality and they want to know what they can do about it,’” said Amy Haddad, director of government and policy affairs for the Association of Maternal & Child Health Programs.
Still, the prospects for passage before the end of the Congressional session are uncertain, especially in the U.S. House of Representatives. Although the House version of the bill has 144 cosponsors, including 34 Republicans, Rep. Michael Burgess — a Texas Republican who chairs the Energy and Commerce committee’s subcommittee on health energy and is himself an obstetrician/gynecologist — has not yet scheduled a hearing. The full Senate must also approve the $50 million in new funds, which would then have to be reconciled with the House budget request — likely to be considerably lower.
As ProPublica updates Dollars for Docs, we found that drugmakers spent less money to market opioids to doctors in 2016 than in prior years. Studies have shown that payments to doctors by opioid makers are linked to more prescribing of the drugs.
This article first appeared June 28, 2018 on ProPublica.
The past two years have been a time of reckoning for pharmaceutical manufacturers over their role in promoting opioid drugs that have fed a national epidemic.
Lawsuits and media reports have accused Purdue Pharma, the maker of OxyContin, of aggressively marketing the powerful narcotic even after it knew the drug was being misused. Prosecutors have charged the founder of Insys Therapeutics and several of the company’s sales representatives and executives for their roles in an alleged conspiracy to bribe doctors to use its fentanyl spray for unapproved uses. State and local governments have sued a host of drugmakers, alleging they deceptively marketed opioids and seeking to recoup what it costs to treat people addicted to the drugs.
But as public attention increases, the marketing tide may finally be retreating, a new ProPublica analysis shows. Pharmaceutical company payments to physicians related to opioid drugs decreased significantly in 2016 from the year before.
In 2016, drug makers spent $15.8 million to pay doctors for speaking, consulting, meals and travel related to opioid drugs. That was down 33 percent from $23.7 million in 2015 and is 21 percent less than the $19.9 million in spent in 2014. Companies are required to report the payments publicly under the Physician Payment Sunshine Act, a part of the 2010 Affordable Care Act.
ProPublica analyzed these payments in conjunction with our update of Dollars for Docs, an online tool that allows users to view and compare promotional payments to doctors from drug and medical device companies. Today, we updated the tool to add payments to doctors for 2016. It now includes more than $9 billion in payments since 2013 to more than 900,000 doctors.
Among opioids, the biggest decreases in spending were for Subsys, the fentanyl spray that has spawned criminal charges against officials and sales representatives at drug maker Insys, and Hysingla ER, an extended-release version of hydrocodone made by Purdue Pharma.
Payments related to Subsys decreased from more than $6 million in 2015 to less than $2.4 million in 2016. Payments for Hysingla dropped from about $6.3 million in 2015 to $2.2 million in 2016.
Dr. Scott Hadland, an assistant professor of pediatrics at Boston University School of Medicine who has studied opioid marketing, said the decreases were “impressive” but not surprising given the growing awareness and concern about pharmaceutical companies’ marketing of opioids.
He said it’s difficult to pinpoint a single reason behind the drop, but “it’s possible that the pharmaceutical companies voluntarily reduced their marketing, realizing that they may have been contributing to overprescribing.”
A number of studies have shown a correlation between marketing of opioids and doctors’ prescribing of the drugs. Hadland and his colleagues reported in May that for every meal a physician received related to an opioid product in 2014, there was an increase in opioid claims by that doctor for Medicare patients the following year. And a report from the New York State Health Foundation published this month found that physicians who received payments from opioid makers prescribed more opioids to Medicare patients than doctors who didn’t receive the payments.
The sharp drop in marketing is more pronounced than the much slower reduction in the use of prescription opioids. The number of opioid prescriptions in Medicare, the public health program for seniors and the disabled, peaked at 81.7 million in 2014, and then dropped to 80.2 million in 2015 and 79.5 million in 2016, according to the Centers for Medicare and Medicaid Services. (Enrollment in Medicare’s prescription drug program continued to grow during that time, so the rate of opioid prescriptions per beneficiary dropped even more.)
Still, the toll of opioid overdoses continues to grow. Some 42,000 people died of opioid overdoses in 2016, the most recent year available, and about 40 percent of those involved a prescription opioid. The epidemic has shifted somewhat away from prescription drugs as more people die of heroin and synthetic opioids like fentanyl.
The public attention has prompted the makers of prescription opioids to revamp their marketing practices.
Purdue Pharma, which has received the most attention because of its one-time blockbuster OxyContin, has ratcheted back its spending on doctors, especially for programs in which doctors talk to their peers over lunch or dinner to help companies market their products. Purdue ended its speaker program for OxyContin at the end of 2016 and for Hysingla ER in November 2017. Earlier this year, it ended all direct promotion of its opioids to prescribers and last week, the company laid off its remaining sales representatives.
Purdue spokesman Robert Josephson said in an email that payments to doctors related to opioids have decreased since 2016 and that there would be very little such spending in 2018.
In 2007, Purdue and three of its executives pleaded guilty to charges of “misbranding” OxyContin and collectively agreed to pay more than $634 million in penalties. In more recent years, though, the company has pushed back against allegations that it has fanned the opioid epidemic, saying it has worked to be part of the solution.
Insys also has been the subject of multiple federal and state investigations related to its marketing of Subsys. The company ended its speaker program for Subsys earlier this year and said it has refocused its sales staff primarily on oncologists who treat patients with severe cancer-related pain, what the drug was initially approved to treat. “Insys is a new company in important aspects, comprised of people who are firmly and sincerely committed to helping patients in need and doing the right things in the right way,” company spokesman Joseph McGrath said in an email.
Insys’ founder John Kapoor has pleaded not guilty to charges of conspiracy to commit racketeering, mail fraud and wire fraud. Some former sales representatives, managers and doctors have pleaded guilty for their roles in the conspiracy detailed by federal prosecutors; others are awaiting trial.
One product that saw increased promotion in 2016 was Opana ER, a pain medication made by Endo Pharmaceuticals. The company pulled the drug from the market in late 2017 at the request of the Food and Drug Administration, after it was linked to a 2015 outbreak of HIV in rural Indiana among intravenous drug users who crushed Opana and injected it with shared needles.
Endo spent about $121,000 on payments to doctors related to Opana in 2015 and $229,000 in 2016.
”Pharmaceutical manufacturers are legally permitted in the U.S. to promote all FDA-approved products to physicians in accordance with the subject product’s label,” Endo said in a statement. “This includes opioid products, which are safely used by millions of Americans to improve their quality of life.”
That said, Endo said it stopped promoting Opana ER in the United States in January 2017 before voluntarily withdrawing the drug in September. “Today, Endo does not promote any opioid products to U.S. physicians,” the company said in a statement.
Some opioids that contain the drug buprenorphine also bucked the downward trend in payments to doctors. Companies spent more than $4.4 million in 2016 promoting the drugs Belbuca, Butrans and buprenorphine, which experts say are less prone to abuse and carry a lower risk of overdose. That was nearly double the amount spent on those drugs in 2015. Almost the entire difference was attributable to Belbuca, which was approved by the FDA in late 2015.
Purdue, which makes Butrans, stopped its speaker program for the drug at the end of 2016. Endo marketed Belbuca until December 2016 and then returned its license to BioDelivery Sciences International Inc., which has marketed the product since then.
Dr. Michael Barnett, an assistant professor of health policy and management at Harvard School of Public Health, said it’s hard to say for certain why marketing has decreased for opioids.
“Given the deluge of media attention with the opioid epidemic, I think we’ve seen the pendulum swing in the opposite direction,” he said, from opioids being seen as a compassionate way to treat pain to “being viewed as pretty toxic and only to be used as a last resort.”
Barnett said if marketing of opioids continues to decline, “it’s potentially good news.”
“If this is actually a result of manufacturers actually saying, ‘Holy crap, people actually care about opioids being used responsibly’ and they’re aware that their advocacy and payments to physicians could be seen as pushing these medications in a way that is ethically dubious, then that’s a beneficial development and something I’d like to see more of.”
As pharma companies underwrite three-fourths of the FDA's budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.
This article first appeared June 26, 2018 on ProPublica.
Nuplazid, a drug for hallucinations and delusions associated with Parkinson's disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment.
Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication.
Nevertheless, the U.S. Food and Drug Administration approved both of these drugs — with a deadly aftermath. Uloric's manufacturer reported last November that patients on the drug were 34 percent more likely to die from heart disease than people taking an alternative gout medication. And since the FDA fast-tracked approval of Nuplazid and it went on the market in 2016 at a price of $24,000 a year, there have been 6,800 reports of adverse events for patients on the drug, including 887 deaths as of this past March 31.
The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world. Between 2011 and 2015, the FDA reviewed new drug applications more than 60 days faster on average than did the European Medicines Agency.
Europe has also rejected drugs for which the FDA accelerated approval, such as Folotyn, which treats a rare form of blood cancer. European authorities cited "insufficient" evidence of health gains from Folotyn, which shrinks some tumors but hasn't been shown to extend lives. It costs more than $92,000 for a seven-week course of treatment, according to research firm SSR Health.
As patients (or their insurers) shell out tens or hundreds of thousands of dollars for unproven drugs, manufacturers reap a windfall. For them, expedited approval can mean not only sped-up sales but also — if the drug is intended to treat a rare disease or serve a neglected population — FDA incentives worth hundreds of millions of dollars.
"Instead of a regulator and a regulated industry, we now have a partnership," said Dr. Michael Carome, director of the health research group for the nonprofit advocacy organization Public Citizen, and a former U.S. Department of Health and Human Services official. "That relationship has tilted the agency away from a public health perspective to an industry friendly perspective."
While the FDA over the past three decades has implemented at least four major routes to faster approvals — the current commissioner, Dr. Scott Gottlieb, is easing even more drugs' path to market. The FDA okayed 46 "novel" drugs — whose chemical structure hadn't been previously approved — in 2017, the most in at least 15 years. At the same time, it's rejecting fewer medications. In 2017, the FDA's Center for Drug Evaluation and Research denied 19.7 percent of all applications for new drugs, biologics, and efficacy supplements, down from a 2010 peak of 59.2 percent, according to agency data.
President Trump has encouraged Gottlieb to give patients faster access to drugs. "You're bringing that down, right?" Trump asked the commissioner at a May 30 event, referring to the time it takes to bring drugs to market. "You have a lot of good things in the wings that, frankly, if you moved them up, a lot of people would have a great shot."
Faster reviews mean that the FDA often approves drugs despite limited information. It channels more and more experimental treatments, including Nuplazid, into expedited reviews that require only one clinical trial to show a benefit to patients, instead of the traditional two.
The FDA also increasingly allows drugmakers to claim success in trials based on proxy measurements — such as shrunken tumors — instead of clinical outcomes like survival rates or cures, which take more time to evaluate. In return for accelerated approval, drug companies commit to researching how well their drugs work after going on the market. But these post-marketing studies can take 10 years or longer to complete, leaving patients and doctors with lingering questions about safety and benefit.
"Clearly, accelerated approval has greater uncertainty," Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said in an interview. When only a single trial is used for approval, "in some cases, there may be more uncertainty about safety findings or with the magnitude of effectiveness."
She attributed the increased use of expedited pathways to more drugmakers developing treatments for rare diseases, "where there's unmet need, and where the patient population and providers are eager to accept more uncertainty."
The FDA's growing emphasis on speed has come at the urging of both patient advocacy groups and industry, which began in 1992 to contribute to the salaries of the agency's drug reviewers in exchange for time limits on reviews. In 2017, pharma paid 75 percent — or $905 million — of the agency's scientific review budgets for branded and generic drugs, compared to 27 percent in 1993.
"The virginity was lost in '92," said Dr. Jerry Avorn, a professor at Harvard Medical School. "Once you have that paying relationship, it creates a dynamic that's not a healthy one."
Industry also sways the FDA through a less direct financial route. Many of the physicians, caregivers, and other witnesses before FDA advisory panels that evaluate drugs receive consulting fees, expense payments, or other remuneration from pharma companies.
"You know who never shows up at the [advisory committee]? The people who died in the trial," lamented one former FDA staffer, who asked not to be named because he still works in the field. "Nobody is talking for them."
The drug industry's lobbying group, Pharmaceutical Research and Manufacturers of America, continues to push for ever-faster approvals. In a policy memo on its website, PhRMA warns of "needless delays in drug review and approval that lead to longer development times, missed opportunities, higher drug development costs and delays in treatments reaching patients."
The agency has internalized decades of criticism that painted it as an obstacle to innovation, said Daniel Carpenter, a professor of government at Harvard and author of a 2010 book on pharmaceutical regulation at the FDA. "They now have a built-in fear of over-regulation that's set in over the last 20 years."
To be sure, nobody wants the FDA to drag out drug reviews unnecessarily, and even critics acknowledge that there's no easy way for the agency to strike the perfect balance between sufficient speed and ample information, particularly when patients have no other treatments available, or are terminally ill.
"I think it's reasonable to move drugs faster particularly in the case where you're dealing with an extremely promising new product which treats a serious or life-threatening disease," said Dr. Aaron Kesselheim, an associate professor at Harvard Medical School. "The key, though, when you do that is that you've got to make sure you closely follow the drug in a thoughtful way and unfortunately, too often we don't do that in the U.S."
Gregg Gonsalves used to be a member of ACT UP, the HIV advocacy group that tried to take over the FDA's headquarters in Rockville, Maryland, in 1988, accusing the agency of holding back cures. While he didn't storm the FDA building, Gonsalves participated in other protests that led the FDA to accelerate approvals. Now an assistant professor of epidemiology at Yale School of Public Health, he said he fears HIV activists "opened a Pandora's box" that the industry and anti-regulation think tanks pounced on.
"We were desperate. We naively had the idea that there were hundreds of drugs behind a velvet curtain at the FDA being held back from us," he said. "Thirty years of our rash thinking has led us to a place where we know less and less about the drugs that we pay more and more for."
After thalidomide, taken by pregnant women to prevent nausea, caused thousands of babies in the early 1960s to be born with stunted limbs, Congress entrusted the FDA with ensuring that drugs going on the market were both safe and effective, based on "substantial evidence" from multiple trials.
Assembling this evidence has traditionally required three stages of clinical trials; the first in a small cohort of healthy volunteers to determine a safe dosage; the second to assess the drug's efficacy and side effects; and then, if results are positive, two larger trials to confirm the benefit and monitor for safety issues. An FDA team of in-house reviewers is then assigned to analyze the results and decide whether the agency should approve the drug. If reviewers want more input, the agency can convene an advisory committee of outside experts.
As the FDA's responsibilities expanded in the 1970s, review times began to lag, reaching more than 35 months on average in 1979. The AIDS crisis followed soon thereafter, prompting complaints from Gonsalves and other activists. Their protests spurred the Prescription Drug User Fee Act in 1992, which established industry fees to fund FDA staff salaries. In return, the FDA promised to review drugs within 12 months for normal applications, and 6 months for priority cases.
The more that the FDA relied on industry fees to pay for drug reviews, the more it showed an inclination towards approval, former employees say.
"You don't survive as a senior official at the FDA unless you're pro-industry," said Dr. Thomas Marciniak. A former FDA medical team leader, and a longtime outspoken critic of how drug companies handle clinical trials, Marciniak retired in 2014. "The FDA has to pay attention to what Congress tells them to do, and the industry will lobby to get somebody else in there if they don't like you."
Staffers know "you don't get promoted unless you're pro-industry," he added.
This tilt is reflected in what senior officials choose to highlight. The agency's Center for Drug Evaluation and Research gives internal awards to review teams each year, according to Marciniak and the former FDA employee who requested anonymity. Both said they had never seen an award granted to a team that rejected a drug application. The FDA did not respond to ProPublica's request for a list of award winners.
Higher-ups would also send congratulatory emails to medical review teams when a drug was approved. "Nobody gets congratulated for turning a drug down, but you get seriously questioned," said the former staffer, adding that the agency's attitude is, "Keep Congress off your back and make your life easier."
Dr. Peter Lurie, a former associate commissioner who left the FDA in 2017, recalled that John Jenkins, director of the agency's Office of New Drugs from 2002 to 2017, gave an annual speech to employees, summing up the year's accomplishments. Jenkins would talk "about how many approvals were done and how fast they were, but there was nothing in there saying, we kept five bad drugs off the market," said Lurie, now president of the nonprofit Center for Science in the Public Interest in Washington, D.C. Jenkins declined to comment.
"I personally have no interest in pressuring people to approve things that shouldn't be approved — the actual person who would be accountable would be me," Woodcock said. She added that the FDA's "accountability to the public far outweighs pressure we might feel otherwise."
Congress has authorized one initiative after another to expedite drug approvals. In 1988, it created "fast track" regulations. In 1992, the user fee law formalized "accelerated approval" and "priority review." When the law was reauthorized in 1997, the goal for review times was lowered from a year to 10 months. In 2012, Congress added the designation, "breakthrough therapy," enabling the FDA to waive normal procedures for drugs that showed substantial improvement over available treatments.
"Those multiple pathways were initially designed to be the exception to the rule, and now the exceptions are swallowing the rule," Kesselheim said.
Sixty-eight percent of novel drugs approved by the FDA between 2014 and 2016 qualified for one or more of these accelerated pathways, Kesselheim and his colleagues have found. Once described by Rachel Sherman, now FDA principal deputy commissioner, as a program for "knock your socks off, home run" treatments, the "breakthrough therapy" label was doled out to 28 percent of drugs approved from 2014 to 2016.
Nuplazid was one of them. It was created in 2001 by a chemist at Acadia Pharmaceuticals, a small biotech firm in San Diego. Eight years later, in the first of two Phase 3 trials, it failed to prove its benefit over a placebo.
The company, which had no approved drugs and hence no revenue stream, halted the second trial, but wasn't ready to give up. Acadia executives told investors that the trials failed because the placebo patients had a larger-than-expected improvement. They asked the FDA for permission to revise the scale used to measure benefit, arguing that the original scale, which was traditionally used for schizophrenia assessments, wasn't appropriate for patients with Parkinson's-related psychosis. The agency agreed to this new scale, which had never been used in a study for drug approval.
Since there were no treatments approved for Parkinson's-related psychosis, the FDA also granted Acadia's request for the breakthrough therapy designation, and agreed that Nuplazid needed only one positive Phase 3 trial, instead of two, for approval.
In 2012, Acadia finally got the positive trial results it had hoped for. In a study of 199 patients, Nuplazid showed a small but statistically significant advantage over a placebo.
FDA medical reviewer Dr. Paul Andreason was skeptical. Analyzing all of Nuplazid's trial results, he found that you would need to treat 91 patients for seven to receive the full benefit. Five of the 91 would suffer "serious adverse events," including one death. He recommended against approval, citing "an unacceptably increased, drug-related, safety risk of mortality and serious morbidity."
The FDA convened an advisory committee to help it decide. Fifteen members of the public testified at its hearing. Three were physicians who were paid consultants for Acadia. Four worked with Parkinson's advocacy organizations funded by Acadia. The company paid for the travel of three other witnesses who were relatives of Parkinson's patients, and made videos shown to the committee of two other caregivers. Two speakers, the daughter and grand-daughter of a woman who suffered from Parkinson's, said they had no financial relationship with Acadia. However, the granddaughter is now a paid "brand ambassador" for Nuplazid. All begged the FDA to approve Nuplazid.
"Acadia or its consultants interacted with some of the potential speakers to facilitate logistics and reimburse for travel, as is common practice," Acadia spokeswoman Elena Ridloff said in an email. "…All speakers presented their own experience in their own words."
The only speaker who urged the FDA to reject the drug was a scientist at the National Center for Health Research who has never had any financial relationship with Acadia.
The witnesses' pleas affected the panel members, who voted 12-2 to recommend accelerated approval. "If there were a safe and effective alternative on the market, I would not have voted yes," said Almut Winterstein, a professor of pharmaceutical outcomes and policy at the University of Florida. "But I think that, in particular, the public hearing today was very compelling. There clearly is a need."
Dr. Mitchell Mathis, director of the FDA's division of psychiatry products, sided with the advisory panel, overruling Andreason. "Even this small mean improvement in a disabling condition without an approved treatment is meaningful," Mathis wrote, adding that its safety profile was no worse than other antipsychotics on the market. Like other antipsychotics, Nuplazid carries a warning on the label of increased deaths in elderly patients with dementia-related psychosis. Since Nuplazid's approval in 2016, Acadia has raised its price twice, and it now costs more than $33,000 a year.
As Nuplazid began to reach patients, reports of adverse events poured in. While it's impossible to ascertain whether the treatment was responsible for them, the sheer numbers, including the 887 deaths, are "mind boggling," said Diana Zuckerman, president of the National Center for Health Research.
In more than 400 instances, Nuplazid was associated with worsening hallucinations — one of the very symptoms it was supposed to treat.
That's what happened to Terrence Miller, a former Hewlett Packard and Sun Microsystems employee who was diagnosed with Parkinson's in the early 1990s. About five years ago, Miller began to experience mild hallucinations, such as seeing cats and dogs in his home in Menlo Park, California. At the time, he realized that the animals weren't real, and the visions didn't bother him, so he didn't take any medication for them. But two years later, after surgery for a hip injury, the hallucinations worsened.
"He was convinced that he hadn't had the surgery yet and people were going to harvest his organs," recalled his wife, Denise Sullivan. "He'd see spaceships outside the window and they had to call security to help restrain him."
In 2016, Dr. Salima Brillman prescribed Nuplazid. Miller tried Nuplazid twice, for a few months each time. His hallucinations became darker. "I'd say, ‘Who are you talking to?' and he said, ‘They're telling me to do bad stuff,'" Sullivan said. Afraid "he might hurt me because of what his evil ‘friends' were telling him," Sullivan, who was paying more than $1,000 a month for the drug out of her own pocket, then stopped the treatment.
What Sullivan and Miller didn't know is that Brillman earned $14,497 in consulting fees from Acadia in 2016, ranking as the company's seventh highest paid doctor, government records show. The top five prescribers of Nuplazid in Medicare, the government's health program for the elderly, all received payments from Acadia. Dr. David Kreitzman of Commack, New York, prescribed the most: $123,294 worth of Nuplazid for 18 patients in 2016, according to data company CareSet. He was paid $14,203 in consulting fees.
Brillman and Kreitzman didn't respond to multiple requests for comment.
Miller's new doctor switched him onto Seroquel, an old drug long used off-label for Parkinson's-related psychosis. With it, he's sleeping better and the hallucinations, while remaining, have become more benign again, Sullivan said. Patients like Miller, whose hallucinations worsen, may not have been on Nuplazid for long enough, said Ridloff, the Acadia spokeswoman.
The 887 reported deaths of Nuplazid patients may be an undercount. A nurse in Kansas, who specializes in dementia care, said a resident in one of the facilities she worked at had no history of cardiac issues, yet died from congestive heart failure within a month of starting on Nuplazid. The nurse requested anonymity because she continues to work in nursing care facilities.
"We questioned the ordering physician whether this should be reported to the FDA in relation to Nuplazid and he said, ‘Oh no, the drug rep said this couldn't have happened because of Nuplazid,' and it was never reported," she said.
Acadia's Ridloff said such behavior by a sales representative would be "absolutely not consistent with our protocols, policies and procedures."
She said that deaths are to be expected among patients who are elderly and in an advanced stage of Parkinson's, and that Nuplazid does not increase the risk of mortality.
"Acadia's top priority has been, and continues to be, patient safety," she said. "We carefully monitor and analyze safety reports from clinical studies and post-marketing reporting to ensure the ongoing safety of Nuplazid. Based on the totality of available information, Acadia is confident in Nuplazid's efficacy and safety profile."
After a CNN report in April about adverse events related to Nuplazid prompted lawmakers to question the FDA, Gottlieb said he would "take another look at the drug." Agency spokeswoman Sandy Walsh confirmed that that an evaluation is ongoing, and the FDA "may issue additional communications as appropriate."
Nuplazid isn't the only drug approved by an FDA senior official against the advice of lower-level staffers. In 2016, internal reviewers and an advisory committee called for rejecting a drug for a rare muscular disease called Duchenne muscular dystrophy. Only 12 patients participated in the single trial that compared the drug, Exondys 51, with a placebo. Trial results showed that Exondys 51 produced a small amount of dystrophin, a protein Duchenne patients lack. But the company didn't show that the protein increase translated into clinical benefits, like helping patients walk.
Woodcock approved the drug. Internal FDA documents later revealed that she was concerned about the solvency of the drugmaker, Sarepta Therapeutics in Cambridge, Massachusetts. A memo by the FDA's acting chief scientist recounted Woodcock saying that Sarepta "needed to be capitalized" and might go under if Exondys 51 were rejected. Exondys 51 went on the market with a price tag of $300,000 a year.
"We don't look at a company and say they'll have a lower standard because they're poor, but we're trying to recognize that, small or large, companies will never work on developing a drug if they won't make a profit," said Woodcock. "Our job is to work with the field, and with the firms to try and find a path forward," especially on rare diseases where a large trial is impractical, she said.
Last month, the European Medicines Agency's advisory committee recommended rejection of Exondys 51's application, saying "further data were needed to show … lasting benefits relevant to the patient."
Sarepta is asking the committee to reconsider, the company said in a June press release.
The debate over Exondys 51 centered on the value of a so-called surrogate endpoint, a biological or chemical measure that serves as a proxy for whether the drug actually treats or cures the disease. Surrogate measures speed drug development because they're easier and quicker to measure than patient outcomes.
Some surrogate measures are well-established. Lowering cholesterol has been proven repeatedly to help reduce heart attacks and strokes. But others aren't, like how much dystrophin needs to be produced to help Duchenne patients, raising concerns that drugs may be approved despite uncertain benefits.
The jury is still out on two other drugs, Folotyn and Sirturo, which received expedited approval based on surrogate measurements. There's no proof that Folotyn helps patients with a rare cancer — peripheral T-cell lymphoma — live longer, while Sirturo, an antibiotic for multi-drug-resistant tuberculosis, has potentially fatal side-effects. Yet since both drugs were aimed at small or under-served populations, the FDA rewarded their manufacturers with valuable perquisites.
In a clinical trial, Folotyn reduced tumors in 29 of 107 patients, but the shrinkage lasted longer than 14 weeks in only 13 people. Since everyone in the study got Folotyn, it wasn't apparent whether the drug would help patients do better than a placebo or another drug. Meanwhile, 44 percent of participants in the trial suffered serious side effects, including sores in mucous membranes, including in the mouth, lips and digestive tract, and low levels of blood cells that help with clotting. One patient died after being hospitalized with sores and low white blood-cell counts.
While tumor shrinkage is a commonly used surrogate measurement in cancer trials, it often has a low correlation with longer life expectancy, according to a 2015 study. "I would say to a patient, this drug may be more likely to shrink a tumor either partially or even completely, but that may in fact be a pyrrhic victory if it doesn't help you live better or longer," said Mikkael Sekeres, director of the leukemia program at the Cleveland Clinic Cancer Center, who voted against approving Folotyn at the FDA's advisory panel discussion in 2009. He was out-voted 10 to four. Three years later, the European Medicines Agency rejected the drug.
Because peripheral T-cell lymphoma only affects about 9,000 Americans each year, the FDA designated Folotyn as an "orphan" drug, giving its manufacturer, Allos Therapeutics, tax incentives and at least two extra years of patent exclusivity. Nevada-based Spectrum Pharmaceuticals acquired Allos in 2012. At more than $92,000 per course of treatment, Folotyn is Spectrum's top-selling product, earning $43 million in 2017.
Dr. Eric Jacobsen, clinical director of the adult lymphoma program at Dana-Farber Cancer Institute in Boston, has become disillusioned with Folotyn since he helped Allos run the original trial. "Enthusiasm for the drug has waned," he said. "It's been on the market for a long time, and there's no additional data suggesting benefit." He now prescribes other options first, particularly because of the mouth sores Folotyn can cause, which make it painful to eat or drink.
The FDA approved Sirturo in 2012 without requiring Johnson & Johnson, the manufacturer, to demonstrate that patients on the drug were cured of tuberculosis. Instead, Johnson & Johnson only had to show that the treatment, when added to a traditional drug regimen, killed bacteria in the sputum faster than did the regimen alone. Sirturo was successful by that measure, but 10 patients who took it died, five times as many as the two in the group on placebo.
Dean Follmann, a biostatistics expert at the National Institutes of Health, voted as an FDA advisory committee member to approve Sirturo but wrestled with how to read the sputum data in light of the higher death rate: "The drug could be so toxic that it kills bacteria faster, but it also kills people faster."
The imbalance in deaths during the trial "was a safety signal" that led the FDA to require "its most serious warning in product labeling," known as a boxed warning, said agency spokeswoman Walsh. The packaging, she added, specified that Sirturo "should only be used for patients for whom an effective TB regimen cannot otherwise be provided. Thus, current labeling provides for a safe and effective use."
Under a 2007 provision in the user-fee law, aimed at spurring treatments for developing nations, Sirturo's approval qualified Johnson & Johnson for a voucher given to manufacturers who successfully get a tropical disease drug to market. The voucher can be used in the future, for any drug, to claim priority review - within six months instead of the usual 10. Time is money in the drug industry, and beating your competitor to market can be worth hundreds of millions of dollars. Vouchers may also be sold to other drugmakers, and have garnered up to $350 million. Sarepta received a voucher under a similar program for pediatric rare diseases when the FDA approved Exondys 51.
In South Africa, where Sirturo is mainly used, the drug is seen as a helpful option for highly drug-resistant patients. A study at one South African hospital by Dr. Keertan Dheda found that 45 out of 68 patients who took Sirturo were cured, as against 27 out of 204 before the drug was available. That doesn't rule out the possibility that Sirturo may be killing a small subset of patients, said Dheda, but the risk is "very minor compared to the disease itself."
Adrian Thomas, Johnson & Johnson's vice president of global public health, said in an interview that observational results since the drug went on the market make him "much more confident that there is no more unexplained imbalance in mortality" and that the "benefit/risk in drug-resistant tuberculosis is incredibly reasonable when you don't have other treatment choices."
Still, the World Health Organization said in a 2016 report that the "quality of evidence remains very low" regarding Sirturo. "There is still some residual uncertainty for mortality," the group said, and "specific harms" to the respiratory system "continue to be observed."
While the FDA expedites drug approvals, it's content to wait a decade or more for the post-marketing studies that manufacturers agree to do. Definitive answers about Sirturo are likely to be lacking until 2022, when Johnson & Johnson is expected to finish its study, a full decade after the drug was approved. Studies of Nuplazid and Folotyn aren't expected until 2021. Spectrum has missed two FDA deadlines for post-marketing studies on Folotyn. Spectrum spokeswoman Ashley Winters declined comment.
Post-marketing studies often take far longer to complete than pre-approval trials, in part because it's harder to recruit patients to risk being given a placebo when the drug is readily available on the market. Plus, since the drug is already on the market, the manufacturer no longer has a financial incentive to study its impact— and stands to lose money if the results are negative. Of post-marketing studies agreed to by manufacturers in 2009 and 2010, 20 percent had not started five years later, and another 25 percent were still ongoing.
And, despite taking so long, most post-marketing studies of drugs approved on the basis of surrogate measures rely on proxy criteria again rather than examining clinical effects on patients' health or lifespans. In fact, Folotyn's post-marketing trials will measure what's known as "progression-free survival," or the time it takes before tumors start growing again, but not whether patients live longer.
Proving that a drug extends survival is especially hard in cancer trials because patients don't want to stay in a trial if their disease gets worse, or may want to add another experimental treatment. "In cancer, we're probably not going to get a clean answer," Woodcock said. Instead, the best evidence that cancer drugs are effective would be an increase in national survival rates over time, she said.
By law, the FDA has the authority to issue fines or even pull a drug off the market if a drugmaker doesn't meet its post-marketing requirements. Yet the agency has never fined a company for missing a deadline, according to Woodcock.
"We would consider fines if we thought companies were simply dragging their feet, but we would have the burden to show they really weren't trying, and it'd be an administrative thing that companies could contest," said Woodcock.
Even when post-marketing studies belatedly confirm that drugs are dangerous, the agency doesn't always pull them off the market. Consider Uloric, the gout treatment. Even though it consistently lowered uric acid blood levels, the FDA rejected it in 2005 and again in 2006, because trials linked it to cardiovascular problems. But a third study by the manufacturer, Takeda Pharmaceutical of Osaka, Japan, didn't raise the same alarms. So the agency decided in 2009 to let the drug on the market, while asking Takeda for a post-marketing study of 6,000 patients to clarify the drug's cardiovascular effects.
Takeda took more than eight years to complete the study. It found that patients on Uloric had a 22 percent higher risk of death from any cause and a 34 percent higher risk of heart-related deaths than patients taking allopurinol, a generic alternative. The FDA issued a public alert in November 2017, sharing the results of the trial, but left Uloric on the market.
Public Citizen has warned patients to stop taking Uloric. "There is no justification for using it," said Carome. "If the results of the most recent study had been available prior to FDA approval, the FDA likely would have rejected the drug."
FDA spokeswoman Walsh said it is "conducting a comprehensive evaluation of this safety issue and will update the public when we have new information."
Takeda is working with the FDA to "conduct a comprehensive review," spokeswoman Kara Hoeger said in an email. The company wants to ensure that "physicians have comprehensive and accurate information to make educated treatment decisions." Thomas Moore, senior scientist of drug safety and policy at the Institute for Safe Medication Practices, warned that future post-marketing findings on Nuplazid could be similarly bleak. Uloric "is the story of [Nuplazid] but a few years down the pike," he said.
Nevertheless, FDA Commissioner Gottlieb is forging ahead with more shortcuts. In May, he announced plans to approve gene therapies for hemophilia based on whether they increased the level of clotting proteins, without waiting for evidence of reduced bleeding.
Two years ago, a prescient Dr. Ellis Unger, FDA's Director of the Office of Drug Evaluation, had warned against precisely this initiative. After Woodcock approved Exondys 51 in 2016, Unger wrote, "A gene therapy designed to produce a missing clotting factor could receive accelerated approval on the basis of a tiny yet inconsequential change in levels of the factor…The precedent set here could lead to the approval of drugs for rare diseases without substantial evidence of effectiveness."
Gottlieb seems less worried than Unger.
"For some of these products, there's going to be some uncertainty, even at the time of approval," Gottlieb said when announcing the plan. "These products are initially being aimed at devastating diseases, many of which are fatal and lack available therapy. In these settings, we've traditionally been willing to accept more uncertainty to facilitate timely access to promising therapies."
His decision pleased investors. That day, while biotechnology stocks overall fell, shares of hemophilia gene therapy manufacturers rose.
Federal health officials say the hospital hasn't done enough to improve care after a string of patient deaths. The decision comes a month after ProPublica and the Houston Chronicle found serious problems with the program.
This article first appeared June 22, 2018 on ProPublica.
The federal Medicare program informed Baylor St. Luke's Medical Center on Friday that it would cut off funding to its heart transplant program in August, saying the Houston hospital has not done enough to fix shortcomings that endanger patients.
The decision by the Centers for Medicare and Medicaid Services is a devastating blow to what was once one of the nation's most renowned heart transplant programs. Losing Medicare's seal of approval on Aug. 17 would threaten its viability, experts say, depriving it of an essential source of funding. The termination could trigger private insurance companies to follow suit and force all 88 patients on the program's waiting list to either pay out of pocket or, more likely, transfer to another hospital.
Losing Medicare funding is not unprecedented, but it is rare. St. Luke's can appeal the termination, but that will not freeze the process, according to Medicare rules.
CMS's decision comes just weeks after an investigation by ProPublica and the Houston Chroniclefound that the program performed an outsized number of transplants resulting in deaths and has lost several top physicians in recent years. Multiple St. Luke's doctors raised concerns about errors during operations and serious surgical complications after Dr. Jeffrey Morgan took over as the program's top surgeon in 2016, and a few cardiologists began referring some of their patients to other hospitals for transplants.
Following the report, St. Luke's temporarily suspended the heart transplant program in order to review the cases of two patients who died in May after receiving transplants earlier in the year. All told, three of the nine patients who received new hearts this year have died; nationally more than 90 percent of heart transplant recipients survive at least a year.
A week ago, St. Luke's said it was reopening the program after finding no "systemic issues related to the quality of the program." Nonetheless, it said it was reorganizing its transplant surgery team, refining the criteria for which patients it would accept for heart transplants, and making other improvements to strengthen the program.
Medicare officials, however, wrote that they are not satisfied that the program has taken steps to ensure the safety of its patients.
In a statement, St. Luke's said it looks forward to discussing CMS' concerns with agency officials. The hospital said it believes it is eligible to take further corrective steps, including a systems improvement agreement, "which would provide a long-term path forward for our program."
"Our unwavering focus is always to ensure our patients receive the best possible medical care, and in ways that reflect our core values of reverence, integrity, compassion, and excellence," the hospital said.
Systems improvement agreements, when they occur, are usually first offered by CMS, rather than requested by a hospital. No such agreement was offered in the CMS letter.
Alexander Aussi, a San Antonio-based consultant who specializes in helping transplant programs satisfy regulatory requirements, said he and other transplant experts were surprised when St. Luke's announced it was reactivating the heart program after only two weeks. Given its struggles in recent years, he believes leaders should have taken more time to make changes.
"They could have dealt with this better in my opinion," Aussi said. "They should have acknowledged their problems more fully, kept the program inactive longer and fixed it all before restarting. Now it seems they are paying the price for that decision."
Nelly Reed, whose husband, Daniel, is waiting for a heart at St. Luke's, was relieved last week when a hospital staffer contacted the family to let them know the program was being reactivated. Daniel Reed, 47, is on Medicare by virtue of his disability.
"Oh God," Nelly Reed said upon learning about Medicare's decision from a reporter. "Here comes that black cloud again."
The Reeds traveled to Houston earlier this month from their home, six hours away in the Rio Grande Valley, to search for a short-term apartment where Nelly can stay once Daniel receives a new heart. Now, she said, they will ask a doctor about transferring to one of the two other Houston hospitals with heart transplant programs.
CMS first cited the heart transplant program in January for its significantly worse-than-expected outcomes and threatened to cut off Medicare funds. St. Luke's responded, saying the problems had been fixed and asking for reconsideration based on mitigating factors.
But in a letter sent Friday, Medicare rejected that request.
"It could not be confirmed, from the documentation submitted, that the program implemented improvements in surgical processes or implemented procedures to minimize" the amount of time patients spent on heart-lung bypass machines during transplant operations, wrote David Wright, director of the CMS Quality and Safety Oversight Group. "There was no documentation of program oversight to ensure that any improvements were implemented and sustained."
Wright's letter details, for the first time publicly, what the hospital said was wrong with its program, resulting in twice as many deaths as expected within a year of transplants performed from January 2014 to June 2016. The hospital cited three root causes, including intraoperative surgical processes, essentially what happens during surgery.
Although those problems were known in 2016, Medicare said as recently as this year, "the program continued to identify the need to improve intraoperative surgical methods" and reduce the amount of time patients spend on the heart-lung bypass machine, which increases the risk of complications such as bleeding.
Medicare's conclusion mirrors findings reported by ProPublica and the Chronicle. Multiple heart transplant recipients have suffered unusual complications since 2016, including two who had major veins stitched closed during surgery, according to numerous sources. Another patient's heart transplant failed this year after operating-room equipment malfunctioned during a key stage of surgery.
St. Luke's told Medicare that it had improved its process for selecting patients for its transplant waiting list and donor hearts. The documentation it provided, however, "did not explain how the program implemented improvements in this area and how these improvements led to improved outcomes," Wright wrote.
For weeks, officials at St. Luke's and its affiliated Baylor College of Medicine have defended the program, saying they had made improvements following a string of patient deaths in 2015. Officials said the program's one-year survival rate after heart transplants had reached 94 percent in 2016 and 2017 under Morgan's leadership.
Even after reactivating the program, St. Luke's was continuing its efforts to fill several key positions related to heart transplants, including a vice president to oversee all of the hospital's transplant operations. The hospital also has posted openings for several nursing positions in the heart program, and it recently hired a new administrator to oversee heart and lung transplants.
Officials said they found no “systemic issues” in the care of two patients who died last month, but that they are making staffing and policy changes to improve the program.
This article first appeared June 15, 2018 on ProPublica.
Baylor St. Luke’s Medical Center said Friday it has reopened its storied heart transplant program, two weeks after suspending it to conduct an internal review of two recent deaths.
In a written statement, the hospital said its review “did not identify systemic issues related to the quality of the program” but that it had nonetheless reorganized its transplant surgery team, refined the criteria for which patients it would accept for heart transplants, and made other improvements to strengthen the program.
Among the changes: The hospital’s top lung transplant surgeon, Dr. Gabriel Loor, will now perform or participate in every heart transplant going forward, working alongside the heart program’s surgical director, Dr. Jeffrey Morgan.
Loor, a 42-year-old cardiothoracic surgeon who was recruited to St. Luke’s last year based on his experience with lung surgery, has performed what the hospital described as “more than 20” heart transplants in his career. The heart program is also recruiting two additional cardiac surgeons.
“After reviewing two recent cases and taking steps to strengthen the heart transplant team, we are confident that the program is ready to move forward and serve the critically ill patients and their families who have placed their trust in us,” Doug Lawson, CEO of Catholic Health Initiatives Texas Division, which owns St. Luke’s, said in the statement. “Our unwavering focus is always to ensure our patients receive the best possible medical care, and in ways that reflect our core values of reverence, integrity, compassion, and excellence.”
The decision to temporarily halt the program came after an investigation by ProPublica and the Houston Chronicle found that it had performed an outsized number of transplants resulting in deaths and had lost several top physicians in recent years.
Friday’s decision means that the program will once again be in a position to accept hearts donated for the 88 patients on its waiting list. As of Thursday, a half dozen were listed as Status 1A, meaning they were in urgent need of a new organ and could receive an offer any day. Twenty-five of the patients on the list are currently inactive, meaning that they are not eligible to receive donor hearts due to illness or other factors.
Although the program is reopening, St. Luke’s is continuing its efforts to fill several key positions related to the heart transplant program, including a vice president to oversee all of the hospital’s transplant operations. The hospital has posted openings for several nursing positions in the heart program. In recent weeks, the hospital has hired an administrator to oversee heart and lung transplants.
The hospital also has changed some aspects of its patient care. It added new “parameters and benchmarks” by which it will select patients to add to its heart transplant waiting list, and it “streamlined” its daily rounds in which physicians, nurses and other health professionals assess patients’ progress and develop care plans for each, the hospital said in a written response to questions.
Finally, a special committee of the hospital’s board of directors is exploring “additional processes and changes that could further improve the heart transplant program,” the hospital said in its statement. The panel’s work is expected to continue into next year.
In the meantime, Loor’s role will expand as co-chief of adult cardiac surgery. The hospital said Morgan, who started in 2016 as surgical director of its heart transplant and mechanical heart pump program, will remain in his position. Although Loor has performed a relatively small number of heart transplants, he has performed more than 1,000 adult cardiac operations and inserted 30 mechanical heart pumps in his career, the hospital noted.
The investigation by ProPublica and the Chronicle revealed that multiple St. Luke’s physicians raised concerns about errors during operations and serious surgical complications after Morgan’s arrival, and a few cardiologists began referring some of their patients to other hospitals for transplants.
Initially, Morgan performed both heart and lung transplants, but he stopped performing lung transplants not long after his arrival after some of his initial patients experienced complications. Earlier this year, Morgan said in response to written questions that “it is rare for a surgeon to focus on both heart and lung transplants.” Under the hospital’s current plan, Loor will have a central role in both.
In response to a question, the hospital said: “Dr. Loor is experienced in both heart and lung transplants. In fact, we are interviewing candidates with dual credentials in heart and lung transplant, which is not uncommon.”
Morgan has defended his performance and that of the program under his leadership. He did not reply to a message seeking comment after the hospital released its plan to restart the program.
Dr. Paul Klotman, president and CEO of Baylor College of Medicine, said in a written statement that the effort to improve the program won’t stop with its reactivation.
“Baylor St. Luke’s believes strongly that improvement is a never-ending process,” Klotman said. “Although this voluntary pause in the program is complete, we will continue to recruit additional surgical and clinical expertise, refine procedures and practices, and implement improvements as soon as we identify opportunities.”
Alexander Aussi, a San Antonio-based transplant consultant, had predicted the program would extend its deactivation beyond 14 days and make sweeping changes to improve care. Based on his past experience helping programs meet regulatory requirements, he believes St. Luke’s has more work to do.
“I still believe they have an organic issue that is multifactorial,” Aussi said. “It’s not one surgeon or one physician. It’s multiple issues that stemmed from a myriad of problems that culminated in these outcomes we’ve seen at St. Luke’s.”
In 2015, St. Luke’s had some of the worst survival rates in the country for patients in the first year after heart transplants. Six of the 21 patients who received heart transplants that year died. In the following two years, the hospital says it rebounded with a one-year survival rate of 94 percent among patients who received new hearts in 2016 and 2017.
The program ran into more trouble this year: The pace of transplants slowed dramatically starting in January, and three of nine patients to receive a heart this year have died, prompting the voluntary suspension two weeks ago.
The family of Guadalupe Cantu, the most recent patient to die, said they did not know about the program’s recent track record until they read media reports.
Cantu, a 69-year-old retired oilfield worker from the Rio Grande Valley, received a heart transplant on March 15. He died on May 18, two days after ProPublica and the Chronicle published their findings on the program.
Right after the transplant, doctors told his family that there had been complications with his lungs and he was on a life-support machine for his heart and lungs, said Monica Aleman, his daughter. Cantu began to improve, communicating with his family and participating in physical therapy.
But then, a few weeks after the transplant, he was diagnosed with pneumonia and influenza, she said. “They took him into critical care and a day later, everything started going downhill.” He was reconnected to the life-support machine and it was never removed. “He lasted about two months, more or less, until he passed,” she said.
During that time, he suffered from edema, a swelling caused by excess fluid in the body’s tissues, and his skin began to fall off. “All this time my mom was told that he was going to be fine, to have faith, you know stuff like that, but we started seeing everything get worse and worse and worse and worse,” Aleman said. “It was just horrible.”
Two other patients who had heart transplants this year had died before Cantu.
James “Lee” Lewis, a 52-year-old pipefitter from Bay City, Texas, received a transplant on Jan. 2. Operating room equipment malfunctioned during a key stage of the surgery, and the donor heart failed. Lewis died nearly three months later, on March 23, after undergoing more than a dozen operations and suffering numerous complications, including strokes, serious infections and organ failure. His wife, Jennifer, chronicled her husband’s transplant and drawn-out death on Facebook and shared it with reporters.
Another patient, a 67-year-old bankruptcy lawyer named Robert Barron, received a heart transplant on February 27, said his son, Craig Barron. The transplant seemed to go well, Craig Barron said, but a couple of days later, the donor heart stopped twice, requiring emergency follow-up surgeries and leaving Robert Barron in critical condition. Barron spent weeks connected to life-support machines and seemed to be recovering gradually, before suffering from serious infections and other complications. He died on May 5.
If St. Luke’s had decided to keep its transplant program closed beyond 14 days, it would have had to meet additional regulatory requirements before it could reopen. That process, intended to protect patients and ensure the most efficient use of limited donor organs, can sometimes take several months, according to experts.
Cardiologists and transplant surgeons across the country have paid close attention to the situation at St. Luke’s, given its legacy as a leader in heart surgery in collaboration with its research partner, the Texas Heart Institute. It was at St. Luke’s that famed surgeon Denton Cooley performed some of the world’s first heart transplants back in the 1960s, and where his protégé, Dr. O.H. “Bud” Frazier, has pursued a lifelong quest to develop a complete mechanical replacement for the human heart.
Aleman said it was traumatic for her family to learn about the program’s problems from news reports after her dad died.
“It was a shock hearing the stories of the other people and how apparently the surgery had gone not right and all of the sudden they started having complications,” she said. “That’s exactly what happened to my dad, too,”
Earlier this month, when Baylor St. Luke’s Medical Center in Houston announced it was temporarily suspending its renowned heart transplant program, it threw the care of dozens of patients into limbo, including some who have yet to hear directly from the hospital.
This article first appeared June 31, 2018 on ProPublica.
By Charles Ornstein, ProPublica, and Mike Hixenbaugh, Houston Chronicle
Earlier this month, when Baylor St. Luke’s Medical Center in Houston announced it was temporarily suspending its renowned heart transplant program, it threw the care of dozens of patients into limbo, including some who have yet to hear directly from the hospital.
Now those patients are left waiting to learn if the troubled program will restart Friday, at the end of a two-week internal review, or if it is in store for a much longer overhaul.
Daniel Reed is among them. He and his wife, Nelly, traveled to Houston last weekend from their home, six hours away in the Rio Grande Valley, to search for a short-term apartment where she can stay after he receives a new heart. They were surprised to learn from a reporter that the hospital had put the transplant program on hold after three of the nine patients to receive a heart transplant in 2018 died.
“I sort of feel like we’ve been left in the dark,” Nelly Reed said.
The voluntary suspension, announced on June 1, came after an investigation by ProPublica and the Houston Chronicle revealed persistent problems with the program, which in recent years has experienced an exodus of top doctors and a higher-than-expected death rate among patients within a year of transplants.
Reed is among 89 people awaiting a heart transplant at St. Luke’s, though only a half dozen are high on the waiting list and at risk of missing opportunities for a new heart during the two-week suspension. But if the program doesn’t reopen by Friday, that will trigger additional regulatory requirements that could force it to remain suspended for weeks or months longer, potentially affecting the fate of every patient awaiting a heart at St. Luke’s.
In a written response to questions, a St. Luke’s spokeswoman said the hospital directly contacted the most critically ill patients on its waiting list “and others as available” to make them aware of the suspension. Meanwhile, she said, the hospital is continuing its internal review and “will determine next steps for the program at the end of the 14-day period this Friday.”
The investigation last month by ProPublica and the Chronicle revealed that multiple heart transplant recipients have suffered unusual complications since 2016, including two who had major veins stitched closed during surgery, according to numerous sources. Another patient’s heart transplant failed this year after operating-room equipment malfunctioned during a key stage of surgery.
The problems led a few St. Luke’s cardiologists, starting two years ago, to begin referring some of their sickest patients to other hospitals, and in January, the Centers for Medicare and Medicaid Services cited the program for its poor outcomes.
In response to the news reports, the hospital launched a marketing website, HeartTransplantFacts.org, boasting above-average outcomes following one bad year, 2015. Two weeks later, on June 1, the site was stripped of most of its promotional content and replaced with a video of a St. Luke’s official announcing the decision to suspend the program for 14 days following the two most recent patient deaths.
Given the scope of the problems, some experts question whether St. Luke’s can make all the necessary changes so quickly.
“I seriously doubt, being in transplantation the last 25 years, they are going to be able to do it in 14 days,” said Alexander Aussi, a San Antonio-based consultant who specializes in helping transplant programs satisfy regulatory requirements.
A decade ago, Aussi was a top administrator over a California heart transplant program that suspended operations for more than three years in order to make improvements. He noted that St. Luke’s has recently advertised openings in severalkeypositions related to the heart transplant program, including for a surgeon to replace one who left last month, an administrator to direct heart and lung transplantation and a vice president to oversee all of the hospital’s transplant operations. The hospital also has posted openings for several nursing positions in the heart program.
The wave of openings leads Aussi to believe that St. Luke’s is heading for a major overhaul.
“That’s why I think they are going to extend that inactivation period,” said Aussi, now the chief operating officer of the consulting firm Guidry & East. “Because what they have is symptomatic of a much larger problem that is multifactorial and systemic in nature. It’s not one thing.”
When a transplant program is inactivated for more than two weeks, the United Network for Organ Sharing — or UNOS, the federal contractor that oversees the nation’s organ wait list — imposes additional requirements before allowing a program to restart. That regulatory process, intended to protect patients and ensure the most efficient use of limited donor organs, can sometimes take several months, according to experts.
A program that is inactive for more than 14 days is also required to send written notice to every patient on its waiting list and to assist those who wish to transfer to other programs. In Houston, two other hospitals perform heart transplants. Houston Methodist and Memorial Hermann are each a short walk from St. Luke’s and have posted better patient survival rates in recent years.
As patients await word on the transplant program’s future, St. Luke’s has warned staff members against posting on social media or talking to reporters. Last week, St. Luke’s CEO Gay Nord sent a note to all staff members reminding them not to release “ANY information whatsoever to members of the news media regarding patient care or business operations” without permission from the hospital’s marketing staff, lest they run afoul of patient privacy laws and risk losing their jobs. A staff member promptly forwarded the memo to reporters.
A hospital spokeswoman said the note from Nord came in response to “complaints we received from patients and concerns that personal information was being disclosed inappropriately.”
After the ProPublica and Chronicle reports last month, the hospital released a statement characterizing the news organizations’ findings as “inaccurate” and “incomplete,” although it has cited no errors.
St. Luke’s “Heart Transplant Facts” website touted better-than-expected outcomes in 2016 and 2017, but at least two — and perhaps all three — of the patient deaths this year occurred before the website was launched. A hospital spokeswoman said the website did not include 2018 outcomes because “we do not yet have year-end figures for this year.”
St. Luke’s legacy as a leader in heart care has drawn patients from across Texas and around the country. Famed surgeon Denton Cooley performed some of the world’s first heart transplants at St. Luke’s five decades ago, and the program has performed more than 1,400 since then, among the most in the nation.
That history gave Reed, 47, and his wife confidence after he suffered a major heart attack three years ago, and it is why they have continued to travel more than 300 miles to the hospital from their home in Harlingen, near the U.S.-Mexico border. In 2015, a St. Luke’s surgeon implanted a left ventricular assist device in Reed to keep his weakened heart going long enough for a transplant.
He’s worked to lose weight, exercise and stay healthy since then, hoping to make himself a stronger candidate for a new heart. Nelly Reed quit her job to help take care of her husband and, in anticipation of his transplant, has been trying to find a job near the hospital so she can earn money while he recovers from the surgery.
When the Reeds visited St. Luke’s for their monthly appointment only days before the hospital announced it was halting heart transplant operations, nobody mentioned any of the recent problems. The visit filled them with hope: Five of the six patients in the clinic that day had already received transplants and were thriving — one for 25 years, another for a decade.
“I was really optimistic and really in awe,” Nelly Reed said. “I was under the assumption that they were the best. The treatment there has always been wonderful.”
The couple connected 20 years ago in an online chatroom and, soon after meeting in person, fell in love. Daniel’s heart troubles have been stressful, but Nelly said she has tried to allow him to focus on his health. She handles all of the medical and insurance paperwork and stays on top of his appointments.
“I tell him don’t worry,” she said. “Don’t worry.”
They spent Saturday and Sunday in Houston, filling out applications for work and short-term apartments. It’s hard to be so far from home, Nelly Reed said, but it’s worth it if it means her husband receives the best care possible.
Now, after learning about the program’s voluntary suspension, she’s not sure what to think.
“Do we need to change providers? Doctors?” she said. “I don’t know where to go.”
After surgery last spring, Kristen Davis suffered adverse reactions to a steroid used during general anesthesia, including steroid-induced mania and hormones elevated ten times above normal levels. “It was a living hell,” said Davis, who also experienced iatrogenic PTSD from the ordeal.
This article first appeared June 10, 2018 on ProPublica.
After surgery last spring, Kristen Davis suffered adverse reactions to a steroid used during general anesthesia, including steroid-induced mania and hormones elevated ten times above normal levels. “It was a living hell,” said Davis, who also experienced iatrogenic PTSD from the ordeal. Worse, she discovered, the drug was unnecessary for her procedure, and no one had spoken with her about its use before the surgery.
Davis tried talking to her surgeon and anesthesiologist, but they dismissed her concern. Even medical professionals in her family failed to listen. She was overreacting, they said, and should have asked more questions upfront; her doctor was just doing his job. The reactions only served to rewound her.
“I wanted somebody to be held accountable,” said Davis, who lives in Salt Lake City, Utah. “But I didn’t know how to do that. I didn’t know what the government agencies were; I didn’t know who to complain to.”
This is what Davis was looking for when she stumbled upon ProPublica reporter Marshall Allen’s 2012–2016 investigation into patient safety, which covered the prevalence of medical error in the U.S. health care system and provided resources for patients. There she not only learned where to formally voice her complaints; she discovered the ProPublica Patient Safety Community, a public Facebook group where those who have experienced medical harm can share information and connect with others. Launched in 2012, the active community has more than 5,500 members and is still moderated by Allen to this day.
“The group has helped me feel less isolated,” said Davis, who remains a dedicated member a year later. “It’s like a little online support group. I feel heard and validated. Members have given me valuable resources for getting what I need out of medical care, and I’ve also been able to give advice to others who are going through the same thing, from recommending PTSD therapies to how to get informed consent from anesthesiologists.”
Davis’ participation in the ProPublica Patient Safety Community also triggered her decision to increase her advocacy efforts. She is currently studying to receive her patient advocacy certification. “After this incident, it’s pretty obvious to me that we all have to be our own advocates,” she said. “I want to also be able to do that for my friends and family, so they have somewhere they can turn.”
Baylor St. Luke’s Medical Center in Houston temporarily suspended its renowned heart transplant program on Friday following two deaths in recent weeks, saying it needs to reassess what went wrong and determine the path forward.
This article first appeared June 01, 2017 on ProPublica.
By Charles Ornstein, ProPublica, and Mike Hixenbaugh, Houston Chronicle
Baylor St. Luke’s Medical Center in Houston temporarily suspended its renowned heart transplant program on Friday following two deaths in recent weeks, saying it needs to reassess what went wrong and determine the path forward.
The decision to put the program on a 14-day inactive status — meaning it will turn away all donor hearts during that time — came about two weeks after ProPublica and the Houston Chronicle reported that in recent years the program has performed an outsized number of transplants resulting in deaths and lost several top physicians.
Colleagues had raised concerns to hospital leaders about the program’s direction under Dr. Jeffrey Morgan, its surgical director since 2016. A second surgeon, Dr. Masahiro Ono, left for another job this week. Neither Morgan nor Ono responded to requests for comment.
“We greatly respect and value the trust patients and their families have placed in us over the years, and believe this temporary pause will serve their best interests,” Doug Lawson, CEO of Catholic Health Initiatives Texas Division, which owns St. Luke’s, said in a written statement Friday afternoon. “Although extensive reviews are conducted on each unsuccessful transplant, the recent patient outcomes deserve an in-depth review before we move forward with the program. Our prayers are with the families, as well as all those on the waiting list.”
For weeks, officials at St. Luke’s and its affiliated Baylor College of Medicine have defended the program, saying they had made improvements after a string of patient deaths in 2015. Officials said the program’s one-year survival rate after heart transplants had reached 94 percent in 2016 and 2017 under Morgan’s leadership.
But of nine patients who received heart transplants at St. Luke’s since the start of 2018, at least three have died, according to interviews with patients’ family members, information provided by the hospital and data from the United Network for Organ Sharing.
James “Lee” Lewis, a 52-year-old pipefitter from Bay City, Texas, received a transplant on Jan. 2, and he never recovered. Operating room equipment malfunctioned during a key stage of the surgery, and the donor heart failed.
Lewis died nearly three months later, on March 23, after undergoing more than a dozen operations and suffering numerous complications, including strokes, serious infections and organ failure. His wife, Jennifer, chronicled her husband’s transplant and drawn-out death on Facebook and shared it with reporters for a story published last week.
“I’m glad they are doing something,” Jennifer Lewis said upon learning of the program’s suspension Friday. “That was my hope in speaking out and telling Lee’s story.”
Another patient, a 67-year-old bankruptcy lawyer named Robert Barron, received a heart transplant on February 27, his son, Craig Barron, told a reporter this week. The transplant seemed to go well, Craig Barron said, but a couple of days later, the donor heart stopped twice, requiring emergency follow-up surgeries and leaving Robert Barron in critical condition.
Barron spent weeks connected to life-support machines and seemed to be recovering gradually, his son said. But then in April, Barron began to suffer from serious infections and other complications. A lack of blood flow to his father’s intestines had left them “dead,” Craig Barron recalled doctors saying. Later, physicians informed the family they would need to amputate his father’s leg at the hip to try to prevent infection from spreading.
With no hope of recovery, the family made the decision to withdraw care on May 5, more than two months after the transplant. Four days after his father’s funeral, Craig Barron was stunned to read the ProPublica and Chronicle story about problems in the program.
“It seemed like nobody could tell us what went wrong,” Craig Barron said.
At least one other patient has died in recent weeks, hospital officials confirmed, though the person’s identity was not released.
Prior to Friday, St. Luke’s gave no indication of continued problems with the program. The day ProPublica and the Chronicle published their investigation, hospital CEO Gay Nord sent a message to employees: ”We continue to express strong confidence in our internationally recognized heart-transplant program, despite this morning’s media criticism that we believe … in some cases is inaccurate, incomplete and does not represent our quality of care or our expertise in this specialized field of heart transplant,” Nord wrote in the email, obtained by reporters. Neither Nord nor the hospital have contacted the news organizations seeking a correction.
St. Luke’s also launched a website, HeartTransplantFacts.org, to counter the story’s findings. On Friday, the site was replaced with a notice about the program’s inactive status.
The decision punctuates a dramatic fall for one of the nation’s most respected heart transplant programs. It was at St. Luke’s that famed surgeon Denton Cooley performed some of the world’s first heart transplants back in the 1960s, and where his protégé, Dr. O.H. “Bud” Frazier, has pursued a lifelong quest to develop a complete mechanical replacement for the human heart.
The hospital says it made changes when outcomes began to decline three years ago. After a string of transplant patient deaths in 2015, the program hired Morgan as its surgical director and became more conservative, removing some higher-risk patients from its waiting list. It is also more selective than its peers in its acceptance of donor hearts. Since then, program leaders said, the survival rate had improved.
But by at least some measures, the program continued to struggle.
In one of Morgan’s first transplant surgeries at St. Luke’s, in early 2016, he sewed shut one of two major veins that carry blood back to the heart, and the patient died a few weeks later, according to six medical professionals familiar with the case. Morgan declined to comment on the case, citing patient privacy.
In another patient’s transplant a year later, Morgan stitched through the other major vein, according to the patient’s cardiologist, though Morgan said the man’s previous cancer treatments complicated the case. After the initial surgery, the blocked vein caused blood to pool in the patient’s head, leading to an emergency repair, weeks of follow-up operations, a three-month hospital stay and ongoing health struggles, including kidney failure.
Some St. Luke’s cardiologists grew so troubled by the program’s direction in 2016 that they began referring some of their patients to other hospitals for transplants. One of those was Dr. Deborah Meyers, the medical director of the heart failure program at St. Luke’s until early 2017, who said she raised concerns both before and after Morgan arrived, but believed she was ignored.
Last month, Meyers wrote a letter to Nord, the CEO, defending Frazier, who created the transplant program in 1982 and was the subject of another story by ProPublica and the Chronicle last week. In her letter, she was harshly critical of what the transplant program had become since CHI purchased the hospital in 2013.
“In my opinion, the shocking story of the Baylor St Luke’s CHI transplant program is one of greed, careerism, corporate takeovers, appalling administrative oversight, failure of leadership, poor hiring practices, completely avoidable lawsuits, and the inevitable public distortions of their underlying mission, all of which have occurred as medicine has become perverted into ‘big business,’” she wrote to Nord, indicating that she intended to share the letter with a ProPublica reporter.
Nord, in her reply, implored Meyers not to send the letter to the reporter.
Told Friday that the transplant program had been suspended, Meyers replied, “Finally, finally.”
“The only ethical thing to do is stop the program right now,” she said.
Across the country, other hospitals have suspended their heart transplant programs in order to make changes and then reopened them. Thomas Jefferson University Hospital suspended its heart transplant program for several months in 2016 while it recruited new surgeons and cardiologists. The Medical University of South Carolina suspended its program in 2014 after a patient died and other transplant recipients had weak hearts; it resumed the following year. St. Thomas Health in Nashville suspended its heart transplant program in 2011 when key staff left. It took five years to restart it.
During the suspension at St. Luke’s, officials said they will continue recruiting surgeons “to strengthen the program.” A newly created special committee of the hospital’s board of directors will also conduct a comprehensive review. The move will not affect other heart-failure procedures, such as heart-pump implants, or any other transplant programs across the hospital.
Judy Kveton said she was happy to learn St. Luke’s was pausing to make changes. Her husband, David Kveton, died in February 2017 a week after receiving a heart transplant at St. Luke’s. Two months later, she received an anonymous letter outlining problems at St. Luke’s and indicating her husband didn’t receive the care he deserved.
“I hope that they can clean up those problems within 14 days,” Judy Kveton said of the program suspension. “However, I think they are so massive, it probably will take longer. It should take longer.”
Since ProPublica launched Lost Mothers, we’ve covered many facets of the U.S. maternal mortality crisis. Despite spending more per capita on health care than any other country, the U.S. has the highest rate of deaths related to pregnancy and childbirth in the industrialized world.
This article first appeared May 29, 2017 on ProPublica.
Since ProPublica launched Lost Mothers, we’ve covered many facets of the U.S. maternal mortality crisis. Despite spending more per capita on health care than any other country, the U.S. has the highest rate of deaths related to pregnancy and childbirth in the industrialized world.
But what makes maternal health care in other affluent countries look so different than the U.S.? Among other things, midwives. Midwives in the U.S. participate in less than 10 percent of births. But in Sweden, Denmark and France, they lead around three-quarters of deliveries. In Great Britain, they deliver half of all babies, including all three of Kate Middleton’s. So if the midwifery model works for royal babies, why not our own?
Check out the video above to find out how midwives have been at the center of a culture war that’s deeply rooted in race and class in America.
Today we see vestiges of that history in states with restrictive midwifery laws and barriers to entry for midwives. Earlier this year, one study was the first systematic look at how and where they practice, offering new evidence that empowering them could significantly boost maternal and infant health. Many of the states with poor health outcomes and hostility to midwives also have large black populations. And with black mothers three to four times more likely to die in pregnancy or childbirth, the study raises the possibility that greater use of midwives could reduce racial disparities in maternal health.
This story makes up the eighth installment in Vox’s collaboration with ProPublica. You can find this video and all of Vox’s videos on YouTube. Subscribe and stay tuned for more from our partnership.
Patients may think their insurers are fighting on their behalf for the best prices. But saving patients money is often not their top priority. Just ask Michael Frank.
This article first appeared May 25, 2017 on ProPublica.
Michael Frank ran his finger down his medical bill, studying the charges and pausing in disbelief. The numbers didn’t make sense.
His recovery from a partial hip replacement had been difficult. He’d iced and elevated his leg for weeks. He’d pushed his 49-year-old body, limping and wincing, through more than a dozen physical therapy sessions.
The last thing he needed was a botched bill.
His December 2015 surgery to replace the ball in his left hip joint at NYU Langone Medical Center in New York City had been routine. One night in the hospital and no complications.
He was even supposed to get a deal on the cost. His insurance company, Aetna, had negotiated an in-network “member rate” for him. That’s the discounted price insured patients get in return for paying their premiums every month.
But Frank was startled to see that Aetna had agreed to pay NYU Langone $70,000. That’s more than three times the Medicare rate for the surgery and more than double the estimate of what other insurance companies would pay for such a procedure, according to a nonprofit that tracks prices.
Fuming, Frank reached for the phone. He couldn’t see how NYU Langone could justify these fees. And what was Aetna doing? As his insurer, wasn’t its duty to represent him, its “member”? So why had it agreed to pay a grossly inflated rate, one that stuck him with a $7,088 bill for his portion?
Frank wouldn’t be the first to wonder. The United States spends more per person on health care than any other country. A lot more. As a country, by many measures, we are not getting our money’s worth. Tens of millions remain uninsured. And millions are in financial peril: About 1 in 5 is currently being pursued by a collection agency over medical debt. Health care costs repeatedly top the list of consumers’ financial concerns.
Experts frequently blame this on the high prices charged by doctors and hospitals. But less scrutinized is the role insurance companies — the middlemen between patients and those providers — play in boosting our health care tab. Widely perceived as fierce guardians of health care dollars, insurers, in many cases, aren’t. In fact, they often agree to pay high prices, then, one way or another, pass those high prices on to patients — all while raking in healthy profits.
ProPublica is examining the bewildering, sometimes enraging ways the health insurance industry works, by taking an inside look at the games, deals and incentives that often result in higher costs, delays in care or denials of treatment. The misunderstood relationship between insurers and hospitals is a good place to start.
Today, about half of Americans get their health care benefits through their employers, who rely on insurance companies to manage the plans, restrain costs and get them fair deals.
But as Frank eventually discovered, once he’d signed on for surgery, a secretive system of pre-cut deals came into play that had little to do with charging him a reasonable fee.
After Aetna approved the in-network payment of $70,882 (not including the fees of the surgeon and anesthesiologist), Frank’s coinsurance required him to pay the hospital 10 percent of the total.
When Frank called NYU Langone to question the charges, the hospital punted him to Aetna, which told him it paid the bill according to its negotiated rates. Neither Aetna nor the hospital would answer questions about the charges.
Frank found himself in a standoff familiar to many patients. The hospital and insurance company had agreed on a price and he was required to help pay it. It’s a three-party transaction in which only two of the parties know how the totals are tallied.
Frank could have paid the bill and gotten on with his life. But he was outraged by what his insurance company agreed to pay. “As bad as NYU is,” Frank said, “Aetna is equally culpable because Aetna’s job was to be the checks and balances and to be my advocate.”
And he also knew that Aetna and NYU Langone hadn’t double-teamed an ordinary patient. In fact, if you imagined the perfect person to take on insurance companies and hospitals, it might be Frank.
For three decades, Frank has worked for insurance companies like Aetna, helping to assess how much people should pay in monthly premiums. He is a former president of the Actuarial Society of Greater New York and has taught actuarial science at Columbia University. He teaches courses for insurance regulators and has even served as an expert witness for insurance companies.
The hospital and insurance company may have expected him to shut up and pay. But Frank wasn’t going away.
Patients fund the entire health care industry through taxes, insurance premiums and cash payments. Even the portion paid by employers comes out of an employee’s compensation. Yet when the health care industry refers to “payers,” it means insurance companies or government programs like Medicare.
Patients who want to know what they’ll be paying — let alone shop around for the best deal — usually don’t have a chance. Before Frank’s hip operation he asked NYU Langone for an estimate. It told him to call Aetna, which referred him back to the hospital. He never did get a price.
Imagine if other industries treated customers this way. The price of a flight from New York to Los Angeles would be a mystery until after the trip. Or, while digesting a burger, you’d learn it cost 50 bucks.
A decade ago, the opacity of prices was perhaps less pressing because medical expenses were more manageable. But now patients pay more and more for monthly premiums, and then, when they use services, they pay higher co-pays, deductibles and coinsurance rates.
Employers are equally captive to the rising prices. They fund benefits for more than 150 million Americans and see health care expenses eating up more and more of their budgets.
Richard Master, the founder and CEO of MCS Industries Inc. in Easton, Pennsylvania, offered to share his numbers. By most measures MCS is doing well. Its picture frames and decorative mirrors are sold at Walmart, Target and other stores and, Master said, the company brings in more than $200 million a year.
But the cost of health care is a growing burden for MCS and its 170 employees. A decade ago, Master said, an MCS family policy cost $1,000 a month with no deductible. Now it’s more than $2,000 a month with a $6,000 deductible. MCS covers 75 percent of the premium and the entire deductible. Those rising costs eat into every employee’s take-home pay.
Economist Priyanka Anand of George Mason University said employers nationwide are passing rising health care costs on to their workers by asking them to absorb a larger share of higher premiums. Anand studied Bureau of Labor Statistics data and found that every time health care costs rose by a dollar, an employee’s overall compensation got cut by 52 cents.
Master said his company hops between insurance providers every few years to find the best benefits at the lowest cost. But he still can’t get a breakdown to understand what he’s actually paying for.
“You pay for everything, but you can’t see what you pay for,” he said.
Master is a CEO. If he can’t get answers from the insurance industry, what chance did Frank have?
Frank’s hospital bill and Aetna’s “explanation of benefits” arrived at his home in Port Chester, New York, about a month after his operation. Loaded with an off-putting array of jargon and numbers, the documents were a natural playing field for an actuary like Frank.
Under the words, “DETAIL BILL,” Frank saw that NYU Langone’s total charges were more than $117,000, but that was the sticker price, and those are notoriously inflated. Insurance companies negotiate an in-network rate for their members. But in Frank’s case at least, the “deal” still cost $70,882.
With a practiced eye, Frank scanned the billing codes hospitals use to get paid and immediately saw red flags: There were charges for physical therapy sessions that never took place, and drugs he never received. One line stood out — the cost of the implant and related supplies. Aetna said NYU Langone paid a “member rate” of $26,068 for “supply/implants.” But Frank didn’t see how that could be accurate. He called and emailed Smith & Nephew, the maker of his implant, until a representative told him the hospital would have paid about $1,500. His NYU Langone surgeon confirmed the amount, Frank said. The device company and surgeon did not respond to ProPublica’s requests for comment.
Frank then called and wrote Aetna multiple times, sure it would want to know about the problems. “I believe that I am a victim of excessive billing,” he wrote. He asked Aetna for copies of what NYU Langone submitted so he could review it for accuracy, stressing he wanted “to understand all costs.”
Aetna reviewed the charges and payments twice — both times standing by its decision to pay the bills. The payment was appropriate based on the details of the insurance plan, Aetna wrote.
Frank also repeatedly called and wrote NYU Langone to contest the bill. In its written reply, the hospital didn’t explain the charges. It simply noted that they “are consistent with the hospital’s pricing methodology.”
Increasingly frustrated, Frank drew on his decades of experience to essentially serve as an expert witness on his own case. He gathered every piece of relevant information to understand what happened, documenting what Medicare, the government’s insurance program for the disabled and people over age 65, would have paid for a partial hip replacement at NYU Langone — about $20,491 — and what FAIR Health, a New York nonprofit that publishes pricing benchmarks, estimated as the in-network price of the entire surgery, including the surgeon fees — $29,162.
He guesses he spent about 300 hours meticulously detailing his battle plan in two inches-thick binders with bills, medical records and correspondence.
ProPublica sent the Medicare and FAIR Health estimates to Aetna and asked why they had paid so much more. The insurance company declined an interview and said in an emailed statement that it works with hospitals, including NYU Langone, to negotiate the “best rates” for members. Frank’s claims were correct given his coverage, the billed services and the Aetna contract with NYU Langone, it wrote.
NYU Langone also declined ProPublica’s interview request. The hospital said in an emailed statement it billed Frank according to the contract Aetna had negotiated on his behalf. Aetna, it wrote, confirmed the bills were correct.
After seven months, NYU Langone turned Frank’s $7,088 bill over to a debt collector, putting his credit rating at risk. “They upped the ante,” he said.
Frank sent a new flurry of letters to Aetna and to the debt collector and complained to the New York State Department of Financial Services, the insurance regulator, and to the New York State Office of the Attorney General. He even posted his story on LinkedIn.
But no one came to the rescue. A year after he got the first bills, NYU Langone sued him for the unpaid sum. He would have to argue his case before a judge.
You’d think that health insurers would make money, in part, by reducing how much they spend.
Turns out, insurers don’t have to decrease spending to make money. They just have to accurately predict how much the people they insure will cost. That way they can set premiums to cover those costs — adding about 20 percent to for their administration and profit. If they’re right, they make money. If they’re wrong, they lose money. But, they aren’t too worried if they guess wrong. They can usually cover losses by raising rates the following year.
Frank suspects he got dinged for costing Aetna too much with his surgery. The company raised the rates on his small group policy — the plan just includes him and his partner — by 18.75 percent the following year.
The Affordable Care Act kept profit margins in check by requiring companies to use at least 80 percent of the premiums for medical care. That’s good in theory but it actually contributes to rising health care costs. If the insurance company has accurately built high costs into the premium, it can make more money. Here’s how: Let’s say administrative expenses eat up about 17 percent of each premium dollar and around 3 percent is profit. Making a 3 percent profit is better if the company spends more.
It’s like if a mom said told her son he could have 3 percent of a bowl of ice cream. A clever child would say, “Make it a bigger bowl.”
Wonks call this a “perverse incentive.”
“These insurers and providers have a symbiotic relationship,” said Wendell Potter, who left a career as a public relations executive in the insurance industry to become an author and patient advocate. “There’s not a great deal of incentive on the part of any players to bring the costs down.”
Insurance companies may also accept high prices because often they aren’t always the ones footing the bill. Nowadays about 60 percent of the employer benefits are “self-funded.” That means the employer pays the bills. The insurers simply manage the benefits, processing claims and giving employers access to their provider networks. These management deals are often a large, and lucrative, part of a company’s business. Aetna, for example, insured 8 million people in 2017, but provided administrative services only to considerably more — 14 million.
To woo the self-funded plans, insurers need a strong network of medical providers. A brand-name system like NYU Langone can demand — and get — the highest payments, said Manuel Jimenez, a longtime negotiator for insurers including Aetna. “They tend to be very aggressive in their negotiations.”
On the flip side, insurers can dictate the terms to the smaller hospitals, Jimenez said. The little guys, “get the short end of the stick,” he said. That’s why they often merge with the bigger hospital chains, he said, so they can also increase their rates.
Other types of horse-trading can also come into play, experts say. Insurance companies may agree to pay higher prices for some services in exchange for lower rates on others.
Patients, of course, don’t know how the behind-the-scenes haggling affects what they pay. By keeping costs and deals secret, hospitals and insurers dodge questions about their profits, said Dr. John Freedman, a Massachusetts health care consultant. Cases like Frank’s “happen every day in every town across America. Only a few of them come up for scrutiny.”
In response, a Tennessee company is trying to expose the prices and steer patients to the best deals. Healthcare Bluebook aims to save money for both employers who self-pay, and their workers. Bluebook used payment information from self-funded employers to build a searchable online pricing database that shows the low-, medium- and high-priced facilities for certain common procedures, like MRIs. The company, which launched in 2008, now has more than 4,500 companies paying for its services. Patients can get a $50 bonus for choosing the best deal.
Bluebook doesn’t have price information for Frank’s operation — a partial hip replacement. But its price range in the New York City area for a full hip replacement is from $28,000 to $77,000, including doctor fees. Its “fair price” for these services tops out at about two-thirds of what Aetna agreed to pay on Frank’s behalf.
Frank, who worked with mainstream insurers, didn’t know about Bluebook. If he had used its data, he would have seen that there were facilities that were both high quality and offered a fair price near his home, including Holy Name Medical Center in Teaneck, New Jersey, and Greenwich Hospital in Connecticut. NYU Langone is one of Bluebook’s highest-priced, high-quality hospitals in the area for hip replacements. Others on Bluebook’s pricey list include Montefiore New Rochelle Hospital in New Rochelle, New York, and Hospital for Special Surgery in Manhattan.
ProPublica contacted Hospital for Special Surgery to see if it would provide a price for a partial hip replacement for a patient with an Aetna small-group plan like Frank’s. The hospital declined, citing its confidentiality agreements with insurance companies.
Frank arrived at the Manhattan courthouse on April 2 wearing a suit and fidgeted in his seat while he waited for his hearing to begin. He had never been sued for anything, he said. He and his attorney, Gabriel Nugent, made quiet conversation while they waited for the judge.
In the back of the courtroom, NYU Langone’s attorney, Anton Mikofsky, agreed to talk about the lawsuit. The case is simple, he said. “The guy doesn’t understand how to read a bill.”
The high price of the operation made sense because NYU Langone has to pay its staff, Mikofsky said. It also must battle with insurance companies who are trying to keep costs down, he said. “Hospitals all over the country are struggling,” he said.
“Aetna reviewed it twice,” Mikofsky added. “Didn’t the operation go well? He should feel blessed.”
When the hearing started, the judge gave each side about a minute to make its case, then pushed them to settle.
Mikofsky told the judge Aetna found nothing wrong with the billing and had already taken care of most of the charges. The hospital’s position was clear. Frank owed $7,088.
Nugent argued that the charges had not been justified and Frank felt he owed about $1,500.
The lawyers eventually agreed that Frank would pay $4,000 to settle the case.
Frank said later that he felt compelled to settle because going to trial and losing carried too many risks. He could have been hit with legal fees and interest. It would have also hurt his credit at a time he needs to take out college loans for his kids.
After the hearing, Nugent said a technicality might have doomed their case. New York defendants routinely lose in court if they have not contested a bill in writing within 30 days, he said. Frank had contested the bill over the phone with NYU Langone, and in writing within 30 days with Aetna. But he did not dispute it in writing to the hospital within 30 days.
Frank paid the $4,000, but held on to his outrage. “The system,” he said, “is stacked against the consumer.”