Carolyn Dineen King, a senior U.S. Circuit Court judge, resigned from the St. Luke's board on May 30, two weeks after ProPublica and the Houston Chronicle detailed deaths and complications in the famed heart program.
This article first appeared September 04, 2018 on ProPublica.
A prominent federal judge quietly resigned from the board of directors at Baylor St. Luke's Medical Center this year after the Houston Chronicle and ProPublica detailed a high rate of patient deaths and unusual complications following heart transplants at the hospital.
Carolyn Dineen King, a senior U.S. Circuit Court judge, confirmed that she stepped down from the St. Luke's board on May 30, two weeks after the investigation was published. King joined the board in January 2014 and chaired the committee that oversees quality and patient safety at the hospital.
A reporter asked King, 80, if she quit because she hadn't been fully informed by the hospital about problems in the heart transplant program. She responded: "I don't want to talk about it any further than what you just laid out, what you've acquired. I don't really want to get into it."
In a follow-up email, King said it would inappropriate to discuss St. Luke's business since she no longer serves on the board.
On May 16, the Chronicle and ProPublica published the first in a series of stories about the famed heart program. In recent years, the stories revealed, the program performed an outsized number of transplants resulting in deaths or unusual complications while continuing to market itself based on its storied past. Several top physicians left the program after raising concerns, including a couple of cardiologists who started sending some of their patients to other hospitals for transplants.
In a written response, St. Luke's said King was the only board member who resigned this year. Marilyn Gerry, a hospital spokeswoman, said administrators took steps to "correct and improve" the heart transplant program during the past three years and kept board members informed of their progress.
"We shared periodic updates with the board and various committees over this time, and began providing additional updates and further details over the past year as board members wanted more information about our ongoing progress," Gerry wrote.
The hospital also noted that a special committee of the board, appointed after the ProPublica and Chronicle investigation was published, is focused on improving the heart transplant program and "committed to ensuring the high level of excellence that everyone envisions at Baylor St. Luke's."
Marc Shapiro, chairman of the St. Luke's board, praised King in a written statement and said he was pleased that she remains on the board of Baylor College of Medicine, which co-manages St. Luke's as part of a joint venture with the hospital.
"Judge King has made significant contributions to our hospital over many years," Shapiro wrote. "Our entire organization benefited enormously from her wisdom and insight."
Hospital leaders did not address the reasons for King's resignation in its responses to questions.
In the past, boards that govern nonprofit hospitals were primarily concerned with the financial health of their institutions. But increasingly, according to health policy experts, boards are taking a more active role in monitoring and improving the quality of care and patient safety.
Dr. Arnold Epstein, a professor of health policy and management at Harvard University, said it's essential that board members are fully informed about a hospital's performance. Epstein has conducted research that shows hospitals with boards that aggressively monitor outcomes and set goals to improve them score better in health care quality metrics.
"The board should be identifying areas of care in need of improvement and setting annual performance goals," Epstein said. "And, oh by the way, Mr. CEO, your salary is going to be partially dependent on how you perform on this."
King's resignation had not been disclosed publicly, and although many nonprofit hospitals list their board members online, St. Luke's does not. The hospital provided the list on Thursday after reporters asked for comment on King's resignation.
King, appointed to the U.S. Court of Appeals for the 5th Circuit in 1979, is a prominent figure in Houston, where she has volunteered for several educational and health care organizations. She was the first female chief judge of the 5th Circuit and was appointed by the late Chief Justice William Rehnquist to the executive committee of the Judicial Conference of the United States, which oversees the federal court system. She chaired that group from 2002 through 2005.
St. Luke's officials previously have said problems with the heart transplant program were confined to 2015, when seven out of 21 heart recipients died within a year of their transplants. But the program has struggled in other ways since then: Multiple heart transplant recipients have suffered unusual complications, including two who had major veins stitched closed during surgery, according to physicians and other health care professionals who spoke to ProPublica and the Chronicle. Another patient's heart transplant failed this year after operating-room equipment malfunctioned during a key stage of surgery.
On June 1, two days after King's resignation, St. Luke's administrators voluntarily suspended the heart transplant program to study what led to two additional patient deaths in May but then reopened it two weeks later, saying they had made policy and staff changes. Days later, the Centers for Medicare and Medicaid Services announced it would cut off federal funding to the program on Aug. 17 because the hospital failed to demonstrate it had done enough to improve outcomes.
Following the federal termination, St. Luke's is no longer allowed to bill Medicare and Medicaid for heart transplants, a move that could lead private insurance companies to follow suit. The deadline to appeal Medicare's decision is Sept. 14, but hospital administrators have not said if they plan to do so.
The program is continuing to treat patients, hospital officials said. As of Friday, 84 people were listed as awaiting heart transplants at St. Luke's.
The heart transplant program at Baylor St. Luke's Medical Center is set to lose federal funding today, a serious blow to a Houston hospital long regarded as one of the nation's best for cardiac surgery.
By Charles Ornstein, ProPublica, and Mike Hixenbaugh, Houston Chronicle
This article was originally published August 17, 2018, by ProPublica.
The Centers for Medicare and Medicaid Services announced in Junethat it would cut off funding for heart transplants this month after concluding that the hospital had not done enough to correct issues that led to a high rate of patient deaths in recent years. The federal action came weeks after an investigation by ProPublica and the Houston Chronicledetailed the depth of the problems and revealed that several physicians had left the program in recent years after raising concerns.
Barring a last-minute delay by the agency, which would be highly unusual, the hospital will no longer be allowed to bill Medicare and Medicaid for heart transplants, and experts say the termination could affect the hospital in more far-reaching ways.
With the federal sanction looming, some patients awaiting heart transplants at St. Luke's have transferred their care to neighboring Houston Methodist and Memorial Hermann hospitals, officials at both said; at least two patients have already received new hearts since switching to Methodist. Meanwhile, St. Luke's spokeswoman Marilyn Gerry said in an email that the hospital "is continuing to communicate with CMS about possible options" to maintain federal approval.
"We have taken steps to make sure all of the critically ill patients in our heart transplant program continue to receive the care they need," Gerry wrote. "We have advised all of our Medicare and Medicaid patients on the heart transplant wait list of their options. Many of them have chosen to continue their care at Baylor St. Luke's with the physicians and staff they have come to know."
Gerry downplayed the impact of federal termination, saying that it "only affects how Medicare pays for heart transplant costs" and that it won't affect patients in need of lung, liver or kidney transplants.
But experts say once Medicare refuses to cover heart transplants at a hospital, private insurance companies often follow suit. If that happens, most of the 87 patients on the program's heart waiting list would have to either pay out of pocket for their surgeries, transfer to another hospital or hope that St. Luke's is willing to perform the procedure at no cost.
The transplant program has remained open since Medicare announced its intentions, but it performed no heart transplants in June or July, an unusual gap for a program that historically has done about 40 each year. St. Luke's administrators suspended the program for two weeks in June to study what led to two patient deaths in May but then reopened it after saying they had made policy and staff changes.
St. Luke's officials declined to say if the program has performed any heart transplants in August.
Hospital leaders also would not say if they intend to formally appeal the termination or whether they will seek recertification from Medicare, a costly process that can sometimes take several months or years. The deadline to appeal to an administrative law judge is Sept. 14.
The federal termination could affect St. Luke's in a number of ways beyond heart transplants. For example, federal rules require hospitals to have a written agreement with a Medicare-approved heart transplant program before implanting mechanical heart pumps in Medicare patients who would eventually require a new heart — a common treatment known as "bridge-to-transplant." Without such an agreement, St. Luke's much-celebrated left ventricular assist device program could suffer.
In addition, private cardiologists might hesitate to send some advanced heart failure patients to a hospital that lacks a Medicare-approved transplant program. And St. Luke's, along with its academic partner Baylor College of Medicine, could have a more difficult time recruiting top physicians, fellows or residents to staff its heart failure program.
"This has far-reaching ramifications beyond just the heart transplant program," said Alexander Aussi, a San Antonio-based transplant consultant who has closely followed the situation at St. Luke's.
Losing Medicare is not unprecedented, but rarely has such a severe sanction been levied against a transplant program of St. Luke's prominence. Some of the world's first heart transplants were performed at the hospital in the 1960s and '70s. Since the heart transplant program was formally established in 1982, only a handful of hospitals in the nation have performed more. And, along with its research affiliate, the Texas Heart Institute, St. Luke's has been credited with numerous advancements in the development of mechanical heart pumps now routinely used to keep patients alive until they can receive a transplant.
"I hope they recover from this," Aussi said. "This is one of those marquee programs that's going to remain in the history books when it comes to innovation. ... We all have a vested interest in it succeeding."
Medicare first raised concerns about the heart transplant program during an inspection in December. At the time, an unidentified St. Luke's transplant physician told a CMS inspector that the hospital had hired a consultant to determine what led to poor outcomes in 2015. The physician "explained that issues were identified with the major issue being surgical technique with one of the heart transplant surgeons, who was no longer practicing," inspectors wrote.
St. Luke's officials have declined to say which surgeon was being blamed for poor outcomes.
In a more detailed written response to regulators a few weeks later, the hospital's CEO, Gay Nord, detailed actions the hospital was taking to improve outcomes. In 2015, Nord wrote, the hospital hired "an international leader in heart transplantation" as the heart program's new surgical director. The new surgeon, she wrote, had "led another renowned heart transplant program to national prominence."
The physician St. Luke's had hired, Dr. Jeffrey Morgan, came from Henry Ford Hospital in Detroit, whose heart program was smaller than St. Luke's. Morgan was not its director and had only been the lead surgeon on 18 heart transplants in the previous five years.
St. Luke's officials say the heart transplant program's one-year survival rate improved in 2016 and 2017 under Morgan's leadership. But multiple heart transplant recipients have suffered unusual complications since 2016, the ProPublica and Chronicle investigation found, 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.
Once Medicare cuts off funding, the program could face an uphill fight if the hospital wishes to regain federal approval, said Laura Aguiar, an Arizona-based transplant consultant who has spent years helping programs navigate regulations.
In most cases, Aguiar said, a program seeking Medicare approval must perform 10 transplants and follow those patients for a year to demonstrate it has the proper medical and administrative infrastructure in place to support a safe transplant program.
"The challenge is going to be finding 10 patients they can transplant who have coverage," Aguiar said, noting that Medicaid and most private insurance companies won't pay for heart transplants at programs that don't have Medicare approval. "Otherwise, the hospital will have to make a decision to absorb those costs."
From the Mayo Clinic to Harvard, sources don't always get the facts right about preeclampsia. Reached by ProPublica, some are making needed corrections.
This article first appeared August 14, 2018 on ProPublica.
Preeclampsia, a dangerous form of hypertension that can develop during pregnancy or in the days and weeks after childbirth, is one of the most common causes of maternal death and severe complications in the U.S. The large majority of deaths occur after delivery, often from strokes.
But you'd never know it from the incomplete, imprecise, outdated and sometimes misleading information published by some of the most trusted consumer health sites in the country.
Instead, you might come away with the impression that, as Harvard Health Publishing says, preeclampsia "occurs only during pregnancy."
From an article on the government-affiliated site MedlinePlus, you might conclude that the "cure" for preeclampsia is delivering the baby. Until this weekend, the Mayo Clinic's site said the same thing. In reality, said Eleni Tsigas, executive director of the Preeclampsia Foundation, even after delivery, "it can still take a while for the mother to get better, and some mothers get worse before they get better." If treatment is delayed because people believe the danger is in the past, mothers can die.
Preeclampsia has been back in the news, thanks to Beyoncé's Vogue interview discussing her recent experience with the condition. That's led to a spike in Google searches of symptoms, preventive measures and treatments. Many of those readers are going to health websites that regularly make Top 10 lists for trustworthiness, and journalists are linking to the same highly regarded sites in their stories. Yet the information on some of those sites — especially about the risks of preeclampsia in the postpartum period — has been "bad or misleading," Tsigas said, something she called "really disturbing."
"It can mean the difference between life and death," she added.
Preeclampsia affects 3 to 5 percent of expectant and new mothers in the U.S., up to 200,000 women a year, and it is responsible for 15 percent of premature births. No one knows what causes it, although the placenta is believed to play a role. As in Beyoncé's case, the risk factors include having twins, being black and being over 35. But it can strike any woman, usually after the 20th week of pregnancy, and it can quickly become a crisis. Around the world, preeclampsia kills about five women every hour. At least 60 percent of preeclampsia deaths are preventable, and patient education is an important part of the solution, experts say.
In affluent countries, the condition is highly treatable. Yet in the U.S., preeclampsia accounts for 7.4 percent of maternal deaths, according to the Centers for Disease Control and Prevention, killing more than 50 mothers a year — one reason the U.S. has the highest maternal mortality rate in the industrialized world. One of those women was Lauren Bloomstein, a neonatal intensive care nurse in New Jersey, whose 2011 death some 20 hours after giving birth was chronicled by ProPublica and NPR as part of our Lost Mothers project.
The greatest risk is to black mothers, who are more likely to enter pregnancy with chronic high blood pressure and to develop preeclampsia. They are more than twice as likely to die from the condition than white women, the CDC Foundation reported this year. Preeclampsia-related complications are the third-leading cause of maternal deaths among African-American women.
Leading Underlying Causes of Pregnancy-Related Deaths, by Race-Ethnicity
After reading reports about Beyoncé, ProPublica took a look at how top health sites discuss preeclampsia. We sent screenshots and links to Tsigas, one of the leading experts on the condition in the U.S., for review last week.
Virtually every site we asked her to look at contained some problematic language, Tsigas noted in her written comments. Her biggest area of concern: A number of sites flubbed how they explained postpartum preeclampsia — sometimes mentioning it only in passing, or sometimes failing to mention it entirely. In the case of the Mayo Clinic, the main overview article that had long been on the site had "no mention of postpartum anywhere," Tsigas wrote. The Mayo Clinic site did discuss post-birth preeclampsia in a separate article, but it didn't link to that information in its main overview, so it was easy to overlook.
Postpartum preeclampsia can be especially dangerous because the symptoms, including swelling, gastric problems and headaches, often mirror the discomforts of normal birth. Meanwhile, new moms are often too tired and overwhelmed to go to the doctor or the emergency room unless they are sure something is wrong. Accurate information about post-birth complications is essential, said Cynthia Gyamfi-Bannerman, a maternal-fetal medicine specialist and co-director of the Columbia University Preterm Birth Prevention Center in New York, "because in that period, women might not have access to a provider, and they will look up their symptoms online."
Tsigas also took issue with sites, including MedlinePlus and (until this weekend) the Mayo Clinic, for using a variation of this language: "The only cure for preeclampsia is delivery of your baby." This idea that the condition goes away after delivery is long-outdated, but — as ProPublica and NPR's reporting has shown — it continues to be all-too-prevalent among providers, including ER staff. The language may also reflect the concern among some medical professionals that if women don't believe their condition is serious, they will resist delivering before their due date or by cesarean section — and put themselves and their babies at risk.
"There's no question that delivery is often indicated, and sometimes quite urgently, to save the life of mother and/or baby," Tsigas wrote. But, she added, "No provider should tell a patient that ‘the cure for preeclampsia is delivery.''' Instead, she said, delivery should be seen as a "critical treatment" along with other measures, such as medication to reduce blood pressure and magnesium sulfate to prevent seizures and strokes. Describing delivery as a cure "lets everybody off the hook. Moms, their partners and even the providers all stop paying attention to mom's health concerns after she delivers her baby. … We need to continue to monitor mom until her blood pressure and other vital signs return to normal."
The Mayo Clinic updated its language over the weekend, saying it had "self-identified the need to refine its preeclampsia content" before ProPublica reached out last Thursday. "All content is reviewed by Mayo Clinic's subject matter experts for medical accuracy, relevance and to ensure a Mayo Clinic-wide interpretation of the best-available evidence from sources such as U.S. federal agencies and guidelines," Dr. Sandhya Pruthi, the Mayo Clinic website's chief medical editor, wrote to us on Friday. "All health information is reviewed on a scheduled, rolling basis, and any critical developments (e.g., FDA pulls drug from market) are processed swiftly to ensure that the content is accurate and relevant."
Before and After: Old Mayo Clinic Language
Left untreated, preeclampsia can lead to serious — even fatal — complications for both you and your baby. If you have preeclampsia, the only cure is delivery of your baby.
Updated Mayo Clinic Language
If you have preeclampsia, the only cure is delivery of your baby. Even after delivering the baby, it can still take a while for you to get better … Rarely, preeclampsia develops after delivery of a baby, a condition known as postpartum preeclampsia.
The Mayo Clinic also updated its language to note that black women have a higher risk of developing the condition. Two other respected sites, of the Cleveland Clinic and MedlinePlus, continue to omit this important fact. That doesn't surprise Monica McLemore, an assistant professor of nursing at the University of California, San Francisco, who studies racial disparities in infant and maternal outcomes. "A lot of the sites are designed by people who don't understand the importance of informing a variety of women about what their risks are," she said.
Victoria Vinci, a Cleveland Clinic spokesperson, said its site would add the risk for black mothers in the next regular update. "Our standard for updating our page articles is every three to four years. This one is coming up on that mark."
Incorrect information on MedlinePlus, which is published by the U.S. National Library of Medicine, is especially problematic because it carries the government's seal of approval. "Medline should be the gold standard," McLemore said.
Yet the site's main preeclampsia article "does not reflect the latest information," Tsigas wrote. In addition to the already-noted problems, she cited the article's suggestion that protein must be present in the urine for a preeclampsia diagnosis to be made. One of the mistakes providers often make is discounting spiking blood pressure and other symptoms because a protein test is inconclusive.
Nor, Tsigas said, is the information about treatment in line with current recommendations from the American College of Obstetricians and Gynecologists and other leading maternal health organizations. "The recommendations for bedrest and salt reduction aren't really evidence-based," Tsigas pointed out.
Medline Plus' Language
Treatment
The only way to cure preeclampsia is to deliver the baby.
Most often, at 37 weeks, your baby is developed enough to be healthy outside the womb.
As a result your provider may want your baby to be delivered so the preeclampsia does not get worse. You may get medicines to help trigger labor, or you may need a C-section.
If your baby is not fully developed and you have mild preeclampsia, the disease can often be managed at home until your baby has matured. The provider will recommend:
Bed rest, and lying on your left side most or all of the time
Drinking plenty of water
Eating less salt
Frequent doctor visits to make sure you and your baby are doing well
Medicines to lower your blood pressure (sometimes)
Medline's article comes from a company called A.D.A.M., part of the Georgia-based health care services conglomerate Ebix Inc., which also provides content to other health sites. "You raise some important points, in particular about postpartum preeclampsia," A.D.A.M.'s editorial director, Brenda Conaway, wrote in an email on Monday. "As it happens, this article" — last reviewed in May 2016 — "is currently in review as part of our editorial review process. I will be talking with the senior medical editor and our medical director about the article today, and we will update it to reflect any needed changes."
When reached by ProPublica, Harvard Health Publishing also agreed to make revisions. The problems with its preeclampsia write-up extend beyond the initial assertion that preeclampsia only occurs in pregnancy, Tsigas said. By focusing on eclampsia — seizures — as the main danger to mothers, it ignores the immediate risk of strokes caused by high blood pressure. Women with preeclampsia also have a much higher risk of heart attacks and strokes later in life.
The site's chief medical editor, Dr. Howard LeWine, said the current language that the condition "occurs only during pregnancy" would be quickly revised. He said the wording is "technically correct" — preeclampsia only occurs in women who've recently been pregnant, and even postpartum preeclampsia is believed to originate during pregnancy. But, he acknowledged, "it gives the wrong impression. It's misguiding people and will get changed."
Democratic lawmakers said they will investigate how three outsiders have been shaping policy and personnel at the Department of Veterans Affairs. A ProPublica investigation Tuesday revealed the vast influence of the trio, who often meet at President Donald Trump's Mar-a-Lago club.
Tim Walz, the ranking Democrat on the House Veterans' Affairs Committee, sent a letter to the agency's new secretary demanding that the VA hand over all records of contacts between agency officials and the three men, who are sometimes referred to as the "Mar-a-Lago Crowd."
"This situation reeks of corruption and cronyism," Walz (D-Minn.) said in a statement. "If these revelations prove true, and VA is being secretly run from the shadows of Mar-a-Lago by individuals with no accountability to taxpayers and who have never served in the United States military or government, then that would amount to an unprecedented, disturbing, and profoundly unacceptable betrayal of our nation's veterans."
The troika is led by Ike Perlmutter, the chairman of Marvel Entertainment who has long known Trump. Another is Bruce Moskowitz, a Palm Beach doctor who caters to the ultra-wealthy. The third is Marc Sherman, a lawyer who serves as an expert witness in white collar trials. While they lack relevant experience to veterans' health care, what they do have is the president's ear.
ProPublica's investigation, based on interviews with former officials and hundreds of documents obtained through the Freedom of Information Act, revealed that VA officials treated their directives as orders. Officials who didn't get along with the Mar-a-Lago Crowd were sidelined or removed.
The top Democrat on the Senate veterans committee, Jon Tester of Montana, also chimed in saying the VA should be listening to veterans, not politics insiders. "Any influence and supervision of taxpayer-funded VA personnel and programs by unelected, unaccountable and politically-motivated advisors is deeply concerning," Tester said in a statement.
Another member of the committee called for a hearing. "It is just astounding to me that this group of totally unaccountable, unelected and behind-the-scenes people can exert this kind of influence," said Sen. Mazie Hirono (D-Hawaii), in an interview on CNN.
The scrutiny comes at a sensitive time at the VA, where Robert Wilkie is serving his first full week as the new secretary. Wilkie has already run into resistance from the Mar-a-Lago Crowd's allies in the agency, according to people familiar with the situation.
Other Democrats voiced their outrage on Twitter:
This is a huge corruption scandal.
Trump gave power to make decisions at the VA - affecting every US veteran - to three men who are neither government officials nor vets.
Their only qualification: membership at Mar-A-Lago, for which they pay Trump.https://t.co/PQvOYRiuTE
Veterans deserve accountability and transparency in how decisions at the VA are being made. Decisions that will impact the care and resources they've earned. https://t.co/q5JgxxVPVD
The White House said the trio do not exercise any direct authority over the VA. In a statement, Perlmutter, Moskowitz and Sherman said their advice was always optional.
In his letter to Wilkie requesting documents, Rep. Walz raised particular concern about the instances in ProPublica's story where the Mar-a-Lago Crowd "may have used their influence for personal gain." He asked for records about former secretary David Shulkin's appearance at the New York Stock Exchange with Perlmutter's company, Marvel, and about Moskowitz's involving his son in an effort to get the VA and Apple to build an app.
The American Legion, the largest veterans service organization, also responded to the article by questioning the Mar-a-Lago Crowd's qualifications to advice Trump on veterans policies.
"We are not about to tell President Trump who he can or cannot take advice from, but we hope that he carefully considers the qualifications and motivations of those offering that advice when it comes to the treatment and wellbeing of America's veterans," National Commander Denise Rohan said in a statement on Twitter.
Last February, shortly after Peter O'Rourke became chief of staff for the Department of Veterans Affairs, he received an email from Bruce Moskowitz with his input on a new mental health initiative for the VA. "Received," O'Rourke replied. "I will begin a project plan and develop a timeline for action."
O'Rourke treated the email as an order, but Moskowitz is not his boss. In fact, he is not even a government official. Moskowitz is a Palm Beach doctor who helps wealthy people obtain high-service "concierge" medical care.
More to the point, he is one-third of an informal council that is exerting sweeping influence on the VA from Mar-a-Lago, President Donald Trump's private club in Palm Beach, Florida. The troika is led by Ike Perlmutter, the reclusive chairman of Marvel Entertainment, who is a longtime acquaintance of President Trump's. The third member is a lawyer named Marc Sherman. None of them has ever served in the U.S. military or government.
Yet from a thousand miles away, they have leaned on VA officials and steered policies affecting millions of Americans. They have remained hidden except to a few VA insiders, who have come to call them "the Mar-a-Lago Crowd."
Perlmutter, Moskowitz and Sherman declined to be interviewed and fielded questions through a crisis-communications consultant. In a statement, they downplayed their influence, insisting that nobody is obligated to act on their counsel. "At all times, we offered our help and advice on a voluntary basis, seeking nothing at all in return," they said. "While we were always willing to share our thoughts, we did not make or implement any type of policy, possess any authority over agency decisions, or direct government officials to take any actions… To the extent anyone thought our role was anything other than that, we don't believe it was the result of anything we said or did."
VA spokesman Curt Cashour did not answer specific questions but said a "broad range of input from individuals both inside and outside VA has helped us immensely over the last year and a half." White House spokeswoman Lindsay Walters also did not answer specific questions and said Perlmutter, Sherman and Moskowitz "have no direct influence over the Department of Veterans Affairs."
But hundreds of documents obtained through the Freedom of Information Act and interviews with former administration officials tell a different story — of a previously unknown triumvirate that hovered over public servants without any transparency, accountability or oversight. The Mar-a-Lago Crowd spoke with VA officials daily, the documents show, reviewing all manner of policy and personnel decisions. They prodded the VA to start new programs, and officials travelled to Mar-a-Lago at taxpayer expense to hear their views. "Everyone has to go down and kiss the ring," a former administration official said.
If the bureaucracy resists the trio's wishes, Perlmutter has a powerful ally: The President of the United States. Trump and Perlmutter regularly talk on the phone and dine together when the president visits Mar-a-Lago. "On any veterans issue, the first person the president calls is Ike," another former official said. Former administration officials say that VA leaders who were at odds with the Mar-A-Lago Crowd were pushed out or passed over. Included, those officials say, were the secretary (whose ethical lapses also played a role), deputy secretary, chief of staff, acting under secretary for health, deputy under secretary for health, chief information officer, and the director of electronic health records modernization.
At times, Perlmutter, Moskowitz and Sherman have created headaches for VA officials because of their failure to follow government rules and processes. In other cases, they used their influence in ways that could benefit their private interests. They say they never sought or received any financial gain for their advice to the VA.
The arrangement is without parallel in modern presidential history. The Federal Advisory Committee Act of 1972 provides a mechanism for agencies to consult panels of outside advisers, but such committees are subject to cost controls, public disclosure and government oversight. Other presidents have relied on unofficial "kitchen cabinets," but never before have outside advisers been so specifically assigned to one agency. During the transition, Trump handed out advisory roles to severalrichassociates, but they've all since faded away. The Mar-a-Lago Crowd, however, has deepened its involvement in the VA.
"On any veterans issue, the first person the president calls is Ike"
—former administration official
Perlmutter, 75, is painstakingly private — he reportedly wore a glasses-and-mustache disguise to the 2008 premiere of "Iron Man." One of the few public photographs of him was snapped on Dec. 28, 2016, through a window at Mar-a-Lago. Trump glares warily at the camera. Behind him, Perlmutter smiles knowingly, wearing sunglasses at night.
When Trump asked him for help putting a government together, Perlmutter offered to be an outside adviser, according to people familiar with the matter. Having fought for his native Israel in the 1967 war before he moved to the U.S. and became a citizen, Perlmutter chose veterans as his focus.
Perlmutter enlisted the assistance of his friends Sherman and Moskowitz. Moskowitz, 70, specializes in knowing the world's top medical expert for any ailment and arranging appointments for clients. He has connections at the country's top medical centers. Sherman, 63, has houses in West Palm Beach and suburban Baltimore and an office in Washington with the consulting firm Alvarez & Marsal. His legal work focuses on financial fraud, white collar investigations and damages disputes. His professional biography lists experience in eight industries, none of them related to health care or veterans.
Moskowitz and Sherman helped Perlmutter convene a council of health care executives on the day of the Trump-Perlmutter photograph, Dec. 28, 2016. Offering more private healthcare to vets was a signature promise of Trump's campaign, but at that point he hadn't decided who should lead an effort that would reverse the VA's longstanding practices.
A new name surfaced in that meeting: David Shulkin, who'd led the VA's health care division since 2015. Perlmutter then recommended Shulkin to Trump, according to a person familiar with his thinking. (Shulkin did not respond to requests for comment.)
Once nominated, Shulkin flew to Mar-a-Lago in early February 2017 to meet with Perlmutter, Sherman and Moskowitz. In a follow-up email a few days later, Moskowitz elaborated on the terms of their relationship. "We do not need to meet in person monthly, but meet face to face only when necessary," he wrote. "We will set up phone conference calls at a convenient time."
Shulkin responded diplomatically. "I know how busy all of you are and having you be there in person, and so present, was truly a gift," he wrote. "I found the time we spent, the focus that came out of our discussions, and the time we had with the President very meaningful."
It wasn't long before the Mar-a-Lago Crowd wore out their welcome with Shulkin. They advised him on how to do his job even though they sometimes seemed to lack a basic understanding of it. Just after their first meeting, Moskowitz emailed Shulkin again to say, "Congratulations i[t] was unanimous." Shulkin corrected him: "Bruce- this was not the confirmation vote- it was a committee vote- we still need a floor vote."
Perlmutter, Moskowitz and Sherman acted like board members pounding a CEO to turn around a struggling company, a former administration official said. In email after email, officials sought approval from the trio: for an agenda Shulkin was about to present to Trump for a research effort on suicide prevention and for a plan to recruit experts from academic medical centers. "Everything needs to be run by them," the first former official said, recalling the process. "They view themselves as making the decisions."
The Mar-a-Lago Crowd bombarded VA officials with demands, many of them inapt or unhelpful. On phone calls with VA officials, Perlmutter would bark at them to move faster, having no patience for bureaucratic explanations about why something has to be done a certain way or take a certain amount of time, former officials said. He issued orders in a thick, Israeli-accented English that can be hard to understand.
In one instance, Perlmutter alerted Shulkin to what he called "another real-life example of the issues our great veterans are suffering with when trying to work with the VA." The example came from Karen Donnelly, a real estate agent in Palm Beach who manages the tennis courts in the luxury community where Perlmutter lives. Donnelly's son was having trouble accessing his military medical records. After a month of dead ends, Donnelly said she saw Perlmutter on the tennis court and, knowing his connection to Trump, asked him for help. Perlmutter told her to email him the story because he's "trying to straighten things out" at the VA, she recalled. (Donnelly separately touched off a nasty legal dispute between Perlmutter and a neighbor, Canadian businessman Harold Peerenboom, who objected to her management of the tennis courts. In a lawsuit, Peerenboom accused Perlmutter of mounting a vicious hate mail campaign against him, which Perlmutter's lawyer denied.)
Perlmutter forwarded Donnelly's email to Shulkin, Moskowitz and Sherman. "I know we are making very good progress, but this is an excellent reminder that we are also still very far away from achieving our goals," Perlmutter wrote.
Shulkin had to explain that they were looking in the wrong place: Since the problem was with military service records, it lay with the Defense Department, not the VA.
Perlmutter, Moskowitz and Sherman defended their intervention, saying, "These were the types of stories of agency dysfunction and individual suffering that drove us to offer our volunteer experience in the first place — veterans who had been left behind by their government. These individual cases helped raise broader issues for government officials in a position to make changes, sometimes leading to assistance for one veteran, sometimes to broader reforms within the system."
Right after meeting Shulkin, Moskowitz connected him with his friend Michael Zinner, director of the Miami Cancer Institute and a member of the American College of Surgeons' board of regents. (Zinner declined to comment.) The conversation led to a plan for the American College of Surgeons to evaluate the surgery programs at several VA hospitals. The plan came very close to a formal announcement and contract, internal emails show, but stalled after Shulkin was fired, according to the organization's director, David Hoyt.
Besides advocating for friends' interests, some of the Mar-a-Lago Crowd's interventions served their own purposes. Starting in February 2017, Perlmutter convened a series of conference calls with executives at Johnson & Johnson, leading to the development of a public awareness campaign about veteran suicide. They planned to promote the campaign by ringing the closing bell at the New York Stock Exchange around the time of Veterans Day.
The event also turned into a promotional opportunity for Perlmutter's company. Executives from Marvel and its parent company, Disney, joined Johnson & Johnson as sponsors of the Veterans Day event at the stock exchange. Shulkin rang the closing bell standing near a preening and flexing Captain America, with Spider-Man waving from the trading pit, and Marvel swag distributed to some of the attendees. "Generally the VA secretary or defense secretary don't shill for companies," the leader of a veterans advocacy group said.
The VA was aware of the ethical questions this event raised because of Shulkin's relationship with Perlmutter. An aide to Shulkin sought ethics advice from the agency's lawyers about the appearance. In an email, the aide noted, "the Secretary is friends with the President of Marvel Comics, Mr. Ike Perlmutter, but he will not be in attendance." The VA redacted the lawyer's answer, and the agency's spokesman would not say whether the ethics official approved Shulkin's participation in the event.
Perlmutter did not answer specific questions about this episode. His joint statement with Moskowitz and Sherman said, "None of us has gained any financial benefit from this volunteer effort, nor was that ever a consideration for us."
Perlmutter also facilitated a series of conference calls with senior executives from Apple. VA officials were excited about working with the company, but it wasn't immediately obvious what they had to collaborate on.
As it turned out, Moskowitz wanted Apple and the VA to develop an app for veterans to find nearby medical services. Who did he bring in to advise them on the project? His son, Aaron, who had built a similar app. The proposal made Apple and VA officials uncomfortable, according to two people familiar with the matter, but Moskowitz's clout kept it alive for months. The VA finally killed the project because Moskowitz was the only one who supported it.
Moskowitz, in the joint statement, defended his son's involvement, calling him a "technical expert" who participated in a single phone call alongside others. "Any development efforts, had they occurred, would not have involved Aaron or any of us. There was no product of Dr. Moskowitz's or Aaron's that was promoted or recommended in any way during the call," the trio said. "Again, none of us, including Aaron, stood to receive any financial benefit from the matters discussed during the conversation — and any claims to the contrary are factually incorrect."
Moskowitz had more success pushing a different pet cause. He has spent years trying to start a national registry for medical devices, allowing patients to be notified of product recalls. Moskowitz set up the Biomedical Research and Education Foundation to encourage medical institutions to keep track of devices for their patients to address what he views as a dangerous hole in oversight across the medical profession. At one point, the foundation built a registry to collect data from doctors and patients. Moskowitz chaired the board, and Perlmutter's wife was also a member. Moskowitz's son earned $60,000 a year as the executive director, according to tax disclosures.
Moskowitz pushed the VA to pick up where he left off. He joined officials on weekly 7:30 a.m. conference calls in which officals discussed organizing a summit of experts on device registries and making a public commitment to creating one at the VA. In an email to Shulkin, the VA official in charge of the project referred to it as the "Bruce Moskowitz efforts."
When the summit arrived, on June 4, Moskowitz and his son did not attend. It's not clear what role they will have in setting up the VA's registry going forward — their foundation has shut down, according to its website, and Moskowitz's son said he's no longer involved. But in his opening remarks at the summit, Peter O'Rourke, then the acting secretary, offered a special thanks to "Dr. Bruce Moskowitz and Aaron Moskowitz of the Biomedical Research and Education Foundation" as "driving forces" behind it.
Over the course of 2017, there was growing tension within the Trump administration about how much the VA should rely on private medical care. During the campaign, Trump championed letting veterans see any doctor they choose, inside or outside the VA system. But Shulkin warned that such an approach was likely to result in poorer care at a higher cost. His preferred solution was integrating government-run VA care with a network of private providers.
In September 2017, the Mar-a-Lago Crowd weighed in on the side of expanding the use of the private sector. "We think that some of the VA hospitals are delivering some specialty healthcare when they shouldn't and when referrals to private facilities or other VA centers would be a better option," Perlmutter wrote in an email to Shulkin and other officials. "Our solution is to make use of academic medical centers and medical trade groups, both of whom have offered to send review teams to the VA hospitals to help this effort."
In other words, they proposed inviting private health care executives to tell the VA which services they should outsource to private providers like themselves. It was precisely the kind of fox-in-the-henhouse scenario that the VA's defenders had warned against for years. Shulkin delicately tried to hold off Perlmutter's proposal, saying the VA was already developing an in-house method of comparing its services to the private sector.
Shulkin also clashed with the Mar-a-Lago Crowd over how to improve the VA's electronic record-keeping software (the one episode involving the trio that has previously surfaced, in a report by Politico). The contract, with a company called Cerner, would cost more than $10 billion and take a decade to implement. But Moskowitz had used a different Cerner product and didn't like it. He complained that the software didn't offer voice recognition, even though newer versions of Cerner's product do. For months, the Mar-a-Lago Crowd pressured Shulkin to put the contract through additional vetting.
On Feb. 27, 2018, Shulkin flew to Mar-a-Lago — not to see Trump, who was back in Washington, but to meet with Perlmutter, Moskowitz and Sherman. The trip was supposed to close the deal on the Cerner contract, according to two people familiar with the meeting. By then, Shulkin's stature had been badly diminished by an ethics scandal, and he expected he didn't have much longer in the job, but he wanted to finish the Cerner deal first.
Shulkin brought O'Rourke, an ex-Trump campaign aide who stepped in as chief of staff after the ethics scandal led to the departure of Shulkin's top aide. O'Rourke took the opportunity to ally himself with the Mar-a-Lago Crowd. "It was an honor to meet you all yesterday," he wrote in a follow-up email. "I want to ensure that you have my VA and personal contact information." He then provided his personal cell phone number and email address. (Using personal email to conduct government business can flout federal records laws, as President Trump and his allies relentlessly noted in their attacks on Hillary Clinton during the 2016 campaign.) "Thank you for your support of the President, the VA, and me," O'Rourke wrote. (O'Rourke didn't answer requests for comment.)
Perlmutter welcomed the overture. "I feel confident that you will be a terrific asset moving forward to get things accomplished," he replied.
The Mar-a-Lago Crowd grew frustrated with Shulkin, feeling like he wasn't listening to them, and Perlmutter came to regret recommending Shulkin to Trump in the first place, according to people familiar with his thinking. That aligned them with political appointees in the VA and the White House who started to view Shulkin as out of step with the president's agenda.
One of these officials, senior adviser Camilo Sandoval, presented himself as Perlmutter's eyes and ears within the agency, two former officials said. For instance, in an email obtained by ProPublica, Sandoval kept tabs on the Apple project and reported back to Moskowitz and Sherman. "I will update the tracker, and please do let me know if this helps answers [sic] questions around Apple's efforts or if additional clarification is required," he wrote. Sandoval, who didn't answer requests for comment, knew Perlmutter because he worked on the campaign with Trump's son-in-law, Jared Kushner, who is also close with Perlmutter.
In December, White House adviser Jake Leinenkugel sent Sandoval a memo outlining a plan to upend the department's leadership. Leinenkugel would not say who asked him to write the memo. But it was clearly not intended for Sandoval alone, since it refers to him in the third person. Three people familiar with the situation said the memo was sent to Sandoval as a channel to Perlmutter. The spokeswoman for Perlmutter, Sherman and Moskowitz said they didn't know about the memo.
The memo recommended easing Shulkin out and relying on Perlmutter for help replacing him. "Put [Shulkin] on notice to exit after major legislation and key POTUS VA initiatives in place," the memo said. "Utilize outside team (Ike)." Although several factors contributed to Shulkin's downfall, including the ethics scandal and differences with the White House over legislation on buying private health care, three former officials said it was his friction with the Mar-a-Lago Crowd over the Cerner contract that ultimately did him in.
Perlmutter, Moskowitz and Sherman dispute that contention. "Any decisions of the agency or the president," they noted in their statement, "as well as the timing of any agency decisions, were independent of our contacts with the VA."
But it wasn't just Shulkin — all the officials that the Leinenkugel memo singled out for removal are now gone, replaced with allies of Perlmutter, Sherman and Moskowitz. The memo suggested that Sandoval take charge of the Office of Information and Technology, overseeing the implementation of the Cerner contract; he got the job in April. The memo proposed removing Deputy Secretary Tom Bowman; he left in June, and the post hasn't been filled. The memo floated Richard Stone for under secretary for health; he got the job on an acting basis in July. Leinenkugel himself took charge of a commission on mental health (the same topic Moskowitz had emailed O'Rourke about). O'Rourke, having hit it off with the Mar-a-Lago Crowd, became acting secretary in May.
Wilkie, who was sworn in on July 30, now faces a choice between asserting his own authority over the VA or taking cues from the Mar-a-Lago Crowd.
Trump initially nominated White House doctor Ronny Jackson to replace Shulkin, with Pentagon official Robert Wilkie filling in on a temporary basis. On Wilkie's first day at the VA, Sherman was waiting for him in his office, according to a calendar record.
Within a few weeks, Wilkie made a pilgrimage to Mar-a-Lago. He tacked it onto a trip to his native North Carolina, and O'Rourke caught up with him in Palm Beach. They visited a VA hospital and rehab facility, then headed to Mar-a-Lago to meet with Perlmutter, Moskowitz and Sherman, according to agency records.
The Mar-a-Lago Crowd gave Wilkie and O'Rourke rave reviews. "I am sure that I speak for the group, that both you and Peter astounded all of us on how quickly and accurately you assessed the key problems and more importantly the solutions that will be needed to finally move the VA in the right direction," Moskowitz told Wilkie in a follow-up email.
Perlmutter was similarly thrilled with the new regime. "For the first time in 1½ years we feel everyone is on the same page. Everybody 'gets it,'" he said in an email. "Again, please know we are available and want to help any possible way 24/7."
Wilkie replied that the honor was his. "Thank you again for taking time to see me," he wrote.
Soon after, Jackson's nomination imploded over allegations of misconduct as White House physician. (Jackson denied the allegations, and they're still being investigated.) At that point, Perlmutter's endorsement cleared the way for Trump to nominate Wilkie.
Wilkie, who was sworn in on July 30, now faces a choice between asserting his own authority over the VA or taking cues from the Mar-a-Lago Crowd. Wilkie reportedly wants to sideline O'Rourke and Sandoval and restock the agency leadership with his own people. But people familiar with the situation said the Mar-a-Lago Crowd's allies are pushing back on Wilkie's efforts to rein them in. As his predecessor learned the hard way, anyone who crosses the Mar-a-Lago Crowd does so at his own risk.
A Central Brooklyn hospital featured in ProPublica and NPR's "Lost Mothers" series for its high hemorrhage rate will serve as a pilot for quality reforms.
This article first appeared July 30, 2018 on ProPublica.
In response to alarming racial disparities, New York City announced a new initiative last week to reduce maternal deaths and complications among women of color. Under the new plan, the city will improve the data collection on maternal deaths and complications, fund implicit bias training for medical staff at private and public hospitals, and launch a public awareness campaign.
Over the next three years, the city will spend $12.8 million on the initiative, with the goal of eliminating the black-white racial disparity in deaths related to pregnancy and childbirth and cutting the number of complications in half within five years.
"We recognize these are ambitious goals, but they are not unrealistic," said Dr. Herminia Palacio, New York City's deputy mayor for health and human services. "It's an explicit recognition of the urgency of this issue and puts the goal posts in front of us."
The city's health department is targeting nearly two dozen public and private hospitals over four years, focusing on neighborhoods with the highest complication rates, including the South Bronx, North and Central Brooklyn, and East and Central Harlem. Hospital officials will study data from cases that led to bad outcomes, and staff will participate in drills aimed at helping them recognize and treat those complications.
Health department officials approached SUNY Downstate Medical Center in May to serve as a pilot site for many of the new measures.
The Central Brooklyn hospital was featured in the "Lost Mothers" series published by ProPublica and NPR last year as one of the starkest examples of racial disparities among hospitals in three states, according to our analysis of over 1 million births in Florida, Illinois and New York. In the second half of last year, two women, both black, died shortly after delivering at SUNY Downstate from causes that experts have said are preventable. The public, state-run hospital has one of the highest complication rates for hemorrhage in the city.
"We look forward to working with all of our partners to provide quality maternal health care for expectant mothers," said hospital spokesperson Dawn Skeete-Walker.
"SUNY Downstate serves a unique and diverse population in Brooklyn where many of our expectant mothers are from a variety of different backgrounds, beliefs, and cultures."
The city will also specifically target its own public hospitals, which are run by NYC Health + Hospitals, training staff on how to better identify and treat hemorrhage and blood clots, two leading causes of maternal death.
The initiative is "aimed at using an approach that encourages folks to have a sense of accountability without finger pointing or blame, and that encourages hospitals to be active participants to identify practices that would benefit from improvement," said Palacio.
In addition to training, the city's public hospitals will hire maternal care coordinators who will assist high-risk pregnant women with their appointments, prescriptions and public health benefits. Public hospitals will also work to strengthen prenatal and postpartum care, including conducting hemorrhage assessments, establishing care plans, and providing contraceptive counselling, breastfeeding support and screening for maternal depression.
Starting in 2019, the health department plans to launch a maternal safety public awareness campaign in partnership with grassroots organizations.
"This is a positive first step in really being able to address the concerns of women of color and pregnant women," said Chanel Porchia-Albert, founder and executive director of Ancient Song Doula Services, which is based in New York City. "There need to be accountability measures that are put in place that stress the community as an active participant and stakeholder."
The city's initiative is the latest in a wave of maternal health reforms following the "Lost Mothers" series. Over the past few months, the U.S. Senate has proposed $50 million in funding to reduce maternal deaths, and several states have launched review committees to examine birth outcomes.
As ProPublica and NPR reported, between 700 and 900 women die from causes related to pregnancy and childbirth in the United States every year, and tens of thousands more experience severe complications. The rate of maternal death is substantially higher in the United States than in other affluent nations, and has climbed over the past decade, mostly driven by the outcomes of women of color.
While poverty and inadequate access to health care explain part of the racial disparity in maternal deaths, research has shown that the quality of care at hospitals where black women deliver plays a significant role as well. ProPublica added to research that has found that women who deliver at disproportionately "black-serving" hospitals are more likely to experience serious complications — from emergency hysterectomies to birth-related blood clots — than mothers who deliver at institutions that serve fewer black women.
In New York City, the racial disparity in maternal outcomes is among the largest in the nation, and it's growing. According to a recent report from New York City's Department of Health and Mental Hygiene, even as the overall maternal mortality rate across the city has decreased, the gap between black and white mothers has widened.
Regardless of their education, obesity or poverty level, black mothers in New York City are at a higher risk of harm than their white counterparts. Black mothers with a college education fare worse than women of all other races who dropped out of high school. Black women of normal weight have higher rates of harm than obese women of all other races. And black women who reside in the wealthiest neighborhoods have worse outcomes than white, Asian and Hispanic mothers in the poorest ones.
"If you are a poor black woman, you don't have access to quality OBGYN care, and if you are a wealthy black women, like Serena Williams, you get providers who don't listen to you when you say you can't breathe," said Patricia Loftman, a member of the American College of Nurse Midwives Board of Directors who worked for 30 years as a certified nurse-midwife in Harlem. "The components of this initiative are very aggressive and laudable to the extent that they are forcing hospital departments to talk about implicit bias."
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.
