Christopher Duntsch's surgical outcomes were so outlandishly poor that Texas prosecuted him for harming patients. Why did it take so long for the systems that are supposed to police problem doctors to stop him from operating?
This article first appeared October 02, 2018 on ProPublica.
By Laura Beil
The pain from the pinched nerve in the back of Jeff Glidewell's neck had become unbearable.
Every time he'd turn his head a certain way, or drive over bumps in the road, he felt as if jolts of electricity were running through his body. Glidewell, now 54, had been living on disability because of an accident a decade earlier. As the pain grew worse, it became clear his only choice was neurosurgery. He searched Google to find a doctor near his home in suburban Dallas who would accept his Medicare Advantage insurance.
That's how he came across Dr. Christopher Duntsch in the spring of 2013.
Duntsch seemed impressive, at least on the surface. His CV boasted that he'd earned an M.D. and a Ph.D. from a top spinal surgery program. Glidewell found four- and five-star reviews of Duntsch on Healthgrades and more praise seemingly from patients on Duntsch's Facebook page. On a link for something called "Best Docs Network," Glidewell found a slickly produced video showing Duntsch in his white coat, talking to a happy patient and wearing a surgical mask in an operating room.
There was no way Glidewell could have known from Duntsch's carefully curated internet presence or from any other information then publicly available that to be Duntsch's patient was to be in mortal danger.
In the roughly two years that Duntsch — a blue-eyed, smooth-talking former college football player — had practiced medicine in Dallas, he had operated on 37 patients. Almost all, 33 to be exact, had been injured during or after these procedures, suffering almost unheard-of complications. Some had permanent nerve damage. Several woke up from surgery unable to move from the neck down or feel one side of their bodies. Two died in the hospital, including a 55-year-old schoolteacher undergoing what was supposed to be a straightforward day surgery.
Multiple layers of safeguards are supposed to protect patients from doctors who are incompetent or dangerous, or to provide them with redress if they are harmed. Duntsch illustrates how easily these defenses can fail, even in egregious cases.
Neurosurgeons are worth millions in revenue for hospitals, so Duntsch was able to get operating privileges at a string of Dallas-area institutions. Once his ineptitude became clear, most chose to spare themselves the hassle and legal exposure of firing him outright and instead let him resign, reputation intact.
At least two facilities that quietly dumped Duntsch failed to report him to a database run by the U.S. Department of Health and Human Services that's supposed to act as a clearinghouse for information on problem practitioners, warning potential employers about their histories.
"It seems to be the custom and practice," said Kay Van Wey, a Dallas plaintiff's attorney who came to represent 14 of Duntsch's patients. "Kick the can down the road and protect yourself first, and protect the doctor second and make it be somebody else's problem."
It took more than six months and multiple catastrophic surgeries before anyone reported Duntsch to the state medical board, which can suspend or revoke a doctor's license. Then it took almost another year for the board to investigate, with Duntsch operating all the while.
When Duntsch's patients tried to sue him for malpractice, many found it almost impossible to find attorneys. Since Texas enacted tort reform in 2003, reducing the amount of damages plaintiffs could win, the number of malpractice payouts per year has dropped by more than half.
Duntsch's attorney did not allow him to be interviewed for this story. Representatives from one hospital where he worked also would not respond to questions. Two more facilities said they could not comment on Duntsch because their management has changed since he was there, and a fourth has closed.
In the end, it fell to the criminal justice system, not the medical system, to wring out a measure of accountability for Duntsch's malpractice.
The case was covered intensely by local and state media outlets. D Magazine, Dallas' monthly glossy, published a cover story in 2016 with the headline "Dr. Death"; the nickname stuck.
Last year, Duntsch was convicted and sentenced to life in prison, becoming the first doctor in the nation to meet such a fate for his practice of medicine.
"The medical community system has a problem," Assistant District Attorney Stephanie Martin said in a press conference after the verdict. "But we were able to solve it in the criminal courthouse."
Glidewell was the last patient Duntsch operated on before being stripped of his license to practice medicine.
According to doctors who reviewed the case, Duntsch mistook part of his neck muscle for a tumor and abandoned the operation midway through — after cutting into Glidewell's vocal cords, puncturing an artery, slicing a hole in his esophagus, stuffing a sponge into the wound and then sewing Glidewell up, sponge and all.
Glidewell spent four days in intensive care and endured months of rehabilitation for the wound to his esophagus. To this day, he can only eat food in small bites and has nerve damage. "He still has numbness in his hand and in his arm," said his wife, Robin. "He basically can't really feel things when he's holding them in his fingers."
Neither Glidewell, nor the prosecutors, nor even Duntsch's own attorneys said they thought his outlandish case had been a wake-up call for the system that polices doctors, however.
"Nothing has changed from when I picked Duntsch to do my surgery," Glidewell said. "The public is still limited to the research they can do on a doctor."
For Duntsch, the path into medicine was unconventional and, perhaps, a reflection of his tendency to fixate on unlikely goals.
The first of these had been college football. Duntsch's father had been a gridiron standout in Montana and Duntsch, though not a particularly talented athlete, was determined to follow in those footsteps. He trained hour after hour on his own and played linebacker on his high school team in Memphis, Tennessee. Classmates remember him as a turbine of sheer determination.
"He had his goal, his sight on a goal and whatever it took to get there," said one classmate, who did not want to be named. "He wanted to go to college and play, and I can recall he was like 180 pounds and said, 'I need to get to 220' in order to be a linebacker at Colorado or Colorado State."
He did get a football scholarship, but it was to Millsaps College in Mississippi. He yearned to transfer and play linebacker for a Division I team. He set his sights on the Colorado State Rams his sophomore year and made it as one of the few walk-on players. Chris Dozois, a fellow linebacker with the Rams, recalled Duntsch struggling, even with basic drills, but begging to run them over and over.
"He'd be, 'Coach, I promise I can get this, let me do it again.' He'd go through; he'd screw it up again," Dozois said. "I gathered very quickly that everything that he had accomplished in sports had come with the sweat equity. When people said, 'You weren't going to be good enough,' he outworked that and he made it happen."
Homesick, Duntsch left Colorado after a year and transferred again to what was then Memphis State University, now the University of Memphis. He had hoped to play football, but he tearfully told Dozois his multiple transfers had taken away his eligibility.
It was then, Dozois recalled, that Duntsch set his sights on his next goal: to be a doctor. And not just any doctor — a neurosurgeon, operating on injured backs and necks.
After getting his undergraduate degree in 1995, Duntsch enrolled at the University of Tennessee at Memphis College of Medicine, in an ambitious program to earn both an M.D. and a Ph.D.
As part of the program, he worked in a research lab, studying the origins of brain cancer and the various uses of stem cells. For a time, after he earned his dual degrees in 2001 and 2002, it seemed he might make a career in biotechnology rather than treating patients.
As he did his surgical residency, Duntsch teamed up with two Russian scientists, recruited by the University of Tennessee, to explore the commercial potential of stem cells to revitalize ailing backs. They patented technology to obtain and grow disk stem cells, and in 2008, they launched a company, DiscGenics, to develop and sell such products. Two of Duntsch's supervisors from the university were among the first investors.
While Duntsch appeared to be thriving during these years, more unsavory aspects of his life simmered below the surface.
In sworn testimony from 2014, an ex-girlfriend of one of his closest friends described a drug-fueled, all-night birthday celebration for Duntsch about midway through his residency. Revelers drank and used cocaine and pills, she said. At dawn, Duntsch slipped on his white coat and headed for rounds at the hospital.
"Most people, when they go binge all night long, they don't function the next day to go to work," she said in her deposition. "After you've spent a night using cocaine, most people become paranoid and want to stay in the house. He was totally fine going to work."
One of the early investors in DiscGenics, Rand Page, said he was initially impressed with how Duntsch presented himself and the company, but as time passed, Page became wary of his new business partner.
"We would meet in the mornings, and he would be mixing a vodka orange juice to start off the day," Page said. Once, he stopped by Duntsch's house to pick up some paperwork. He opened a desk drawer to find a mirror with cocaine and a rolled-up dollar bill sitting on top of it.
Ultimately, Duntsch was forced out of DiscGenics and his partners and investors sued him over money and stock. (Representatives of DiscGenics declined to be interviewed for this story.)
The University of Tennessee said it could not comment on Duntsch, citing the confidentiality and privacy of medical students' records, but Dr. Frederick Boop, chief of neurosurgery at the hospital where Duntsch did his residency, appears to have known about Duntsch's substance abuse.
In a 2012 phone call recorded by a Texas doctor who contacted Boop because he was alarmed by Duntsch's surgical errors, Boop acknowledged that an anonymous woman had filed a complaint against Duntsch, saying he was using drugs before seeing patients.
In the phone conversation, Boop said university officials had asked Duntsch to take a drug test, but he had avoided it, disappearing for several days. When he returned, he was sent to a program for impaired physicians and closely supervised for the remainder of his surgical training, Boop told the Texas doctor. (An attorney for the University of Tennessee said Boop would not respond to questions for this story.)
It's not clear how much training Duntsch actually received, however.
After his arrest, the Dallas district attorney's office subpoenaed every hospital on Duntsch's CV for records of his surgeries, including those during his residency and subsequent one-year fellowship.
According to the Accreditation Council for Graduate Medical Education, a neurosurgery resident does about 1,000 operations during training. But according to records gathered by the DA, by the time Duntsch finished his residency and fellowship, he had operated fewer than 100 times.
Despite what Duntsch had told friends when he headed off to medical school, Page said Duntsch had staked his fortune on being a businessman, not a doctor.
"I don't think his plan was ever to become a surgeon," he said. When Duntsch was kicked out of DiscGenics, "I think the decision was made for him that he was going to have to enter into the medical community to support himself."
Duntsch's first job as a practicing physician was at the Minimally Invasive Spine Institute in the affluent Dallas suburb of Plano, which hired him in the summer of 2011, when he also received privileges to operate at Baylor Regional Medical Center.
The hospital welcomed Duntsch with a $600,000 advance. While no one from the practice agreed to be interviewed, they sent an email describing the recommendations they had gotten from Duntsch's supervisors at the University of Tennessee medical school in Memphis.
"We were told Duntsch was one of the best and smartest neurosurgeons they ever trained, as they went on at length about his strengths," they said in the email. "When asked about Dr. Duntsch's weaknesses or areas for improvement, the supervising physician communicated that the only weakness Duntsch had was that he took on too many tasks for one person."
In 2010, Boop faxed a recommendation for Duntsch to Baylor-Plano, checking off "good" or "excellent" in boxes asking about his skills and noting, "Chris is extremely bright and possibly the hardest working person I have ever met." Another supervisor, Dr. Jon Robertson, who was an old family friend of the Duntsches and an investor in DiscGenics, noted on his recommendation that Duntsch had an "excellent work ethic." (A University of Tennessee attorney said Robertson could not respond to questions.)
A vascular surgeon who operated at Baylor-Plano, Dr. Randall Kirby, said he met Duntsch soon after he started and found him to be an arrogant know-it-all.
"I would see him maybe once a week at the scrub sinks or in the doctor's lounge," Kirby said. "He is among giants up there, and he was trying to tell me over and over again how most of the spine surgery here in Dallas was being done inappropriately and that he was going to clean this town up."
Duntsch lasted only a few months at the spine institute, not because his patients had complications, but because of a falling out with the other doctors over whether he was fulfilling his obligations.
One weekend in September 2011, Kirby said, Duntsch was supposed to be taking care of a patient. He went to Las Vegas instead. One of the partners, Dr. Michael Rimlawi, "was notified by the administration that the patient wasn't getting rounded on, and Dr. Rimlawi then dismissed Dr. Duntsch after that," Kirby said. (Rimlawi declined to comment for this story.)
Nonetheless, Duntsch still had privileges at Baylor-Plano, and on Dec. 30, 2011, he operated on a man named Lee Passmore.
At the time, Passmore was an investigator in the Collin County Medical Examiner's office, just north of Dallas. He had undergone successful back surgery once before, but the pain had returned. Passmore's pain specialist told him he didn't have a back surgeon to whom he routinely referred patients, but that he'd gone to lunch recently with one who "seemed like a guy that knew what he was talking about," Passmore recalled in court testimony.
Vascular surgeon Mark Hoyle assisted with the operation. In later testimony, he said he watched in alarm as Duntsch began to cut out a ligament around the spinal cord not typically disturbed in such procedures. Passmore started bleeding profusely, so much so that the operating field was submerged in a lake of red. Duntsch not only misplaced hardware in Passmore's spine, but he stripped the screw so it could not be moved, Hoyle testified. At one point, Hoyle said, he either grabbed Duntsch's scalpel or blocked the incision — he could not remember which — to keep Duntsch from continuing the procedure. Then Hoyle said he left the operating room and vowed never to work with Duntsch again. (In response to a request for comment, Hoyle sent a note saying he was through talking about Duntsch.)
Passmore did not respond to requests for comment for this story. Passmore has testified that he lives with chronic pain and has trouble walking as a result of Duntsch's errors.
The next patient Duntsch operated on was Barry Morguloff.
Morguloff ran a pool service company. He had worn out his back working in his father's import business, helping to unload trucks. "It took a toll on my back even with back supports and exercise and a strong core," Morguloff said. His pain returned after an earlier back surgery, but the surgeon recommended exercise and weight loss, not another procedure.
A pain specialist gave Morguloff Duntsch's card.
"Everything that I read when we first got his card — outstanding reviews, people loved him. I read everything I could about this guy," Morguloff said. He set up an appointment and found himself impressed by Duntsch's easy confidence.
"Phenomenal, great guy, loved him," Morguloff recalled. Most importantly, he added, "I was in pain and somebody, a neurosurgeon, said, 'I can fix you.'"
His surgery, an anterior lumbar spinal fusion, took place on Jan. 11, 2012. At the request of a head-and-neck surgeon also on the case, the vascular surgeon assisting Duntsch was Kirby. Kirby said it should have been a routine case.
"In the spectrum of what a neurosurgeon does for a living, doing an anterior lumbar fusion procedure's probably the easiest thing that they do on a daily basis," he said.
But Duntsch quickly got into trouble. Instead of using a scalpel, he tried to pull Morguloff's problem disk out with a grabbing instrument that could damage the spine. Kirby said he argued with Duntsch, even offering to take over, but Duntsch insisted he knew what he was doing. Kirby left the room.
Morguloff awoke in excruciating pain.
His previous surgeon testified at Duntsch's trial that the procedure had left bone fragments in Morguloff's spinal canal. The surgeon said he repaired what damage he could, but Morguloff still walks with a cane. As scar tissue builds up, his pain will worsen and his range of motion will decrease. One day, he will likely be in a wheelchair.
"As time goes on, the scar tissue and everything builds up, and I lose more and more function of that left side," he said. "I do my best to stay active. But some days I just can't get moving. The pain is continuous."
Soon after the Morguloff surgery, Duntsch took on a patient who was also an old friend.
Jerry Summers had played football with Duntsch in high school and helped with logistics at the research lab during his residency. When Duntsch took the job in Dallas, he asked Summers to move with him and help set up his practice. They lived in a downtown luxury high-rise while Duntsch shopped for a house.
In a deposition he gave later to the district attorney, Summers said he asked Duntsch to operate on him because he had chronic pain from a high school football injury that had gotten worse after a car accident. After the February 2012 surgery, however, Summers couldn't move from the neck down.
According to doctors who later reviewed the case, Duntsch had damaged Summers' vertebral artery, causing it to bleed almost uncontrollably. To stop the bleeding, Duntsch packed the space with so much anticoagulant that it squeezed Summers' spine.
For days after the operation, Summers lay in the ICU, descending into a deep depression. "Jerry was calm with Chris," said Jennifer Miller, then Summers' girlfriend, "but all Jerry would say to me is: 'I want to die. Kill me. Kill me. I want to die.'"
One morning, Summers began screaming and told several nurses that he and Duntsch had stayed up the night before the surgery doing eight-balls of cocaine. In truth, the night before the surgery Summers and Miller had dinner at a local restaurant and watched the University of Memphis basketball team play Southern Mississippi on the bar TV.
In his 2017 deposition, Summers acknowledged he made up the pre-surgery cocaine binge because he felt Duntsch had abandoned him, as both his surgeon and his friend.
"I was just really mad and hollering and wanting him to be there," Summers said. "And so I made a statement that was not something that was necessarily true. … The statement was only made so that he might hear it and go, 'Let me get my ass down there.'"
Baylor officials took Summers' accusation seriously and ordered Duntsch to take a drug test. As at the University of Tennessee, he stalled at first, telling administrators he got lost on the way to the lab. He passed a separate psychological evaluation and, after three weeks, was allowed to operate again, but he was told to stick to relatively minor procedures.
His first patient after his return was elementary school teacher Kellie Martin, who had a compressed nerve from falling off a ladder as she fetched Christmas decorations from her attic. During the surgery, records show, Martin's blood pressure inexplicably plummeted.
As she regained consciousness after the surgery, the nurses tending to Martin testified that she began to slap and claw at her legs, which had turned a splotchy, mottled color. She became so agitated the staff had to sedate her. She never reawakened. An autopsy would later find that Duntsch had cut a major vessel in her spinal cord, and within hours, Martin bled to death.
Baylor-Plano again ordered Duntsch to take a drug test. The first screening came back diluted with tap water, but a second, taken a few days later, came up clean. Hospital administrators also organized a comprehensive review of Duntsch's cases, after which they determined that his days at the facility were over.
But — importantly — they did not fire him outright. Instead, he resigned, leaving on April 20, 2012, with a lawyer-negotiated letter saying, "All areas of concern with regard to Christopher D. Duntsch have been closed. As of this date, there have been no summary or administrative restrictions or suspension of Duntsch's medical staff membership or clinical privileges during the time he has practiced at Baylor Regional Medical Center at Plano."
Since Duntsch's departure was technically voluntary and his leave had been for less than 31 days, Baylor-Plano was under no obligation to report him to the National Practitioner Data Bank.
The databank, which was established in 1990, tracks malpractice payouts and adverse actions taken against doctors, such as being fired, barred from Medicare, handed a long suspension, or having a license suspended or revoked.
The information isn't available to the public or other doctors, but hospital administrators have access to the databank and are supposed to use it to make sure problem doctors can't shed their pasts by moving from state to state or hospital to hospital. Robert Oshel, a patient safety advocate and former associate director of the databank, says that hospitals are required to check all applicants for clinical privileges and once every two years for everyone who has clinical privileges.
Many hospitals, however, hesitate to submit reports to the databank, worrying that doing so may hurt doctors' job prospects or even prompt lawsuits.
"What happens sometimes is that doctors are allowed to resign in lieu of discipline so that the hospital can protect its perceived legal liability from the doctor," said Van Wey, the Dallas trial lawyer. "If Dr. Duntsch was unable to get privileges at other hospitals, theoretically Dr. Duntsch could have sued Baylor and said: 'Look, I could be making $2 million a year here. … You owe me $2 million for the rest of my life.'"
According to a report by Public Citizen, a consumer watchdog group, about half the hospitals in the country had never reported a doctor to the databank by 2009. A more recent analysis didn't find much change, said Dr. Sid Wolfe, a founder of Public Citizen's Health Research Group.
Despite his string of problems at Baylor-Plano, Duntsch also wasn't reported to the Texas Medical Board, the state's main purveyor of doctor discipline. Such boards often move slowly, but if hospital officials submit material they've gathered to justify letting a doctor go, boards can act to protect patients from imminent harm.
"Had Baylor's action been reported appropriately, I would anticipate the board would have met within days to have an immediate suspension," said Dr. Allan Shulkin, a Dallas pulmonologist who was on the medical board in 2012.
The board would still have conducted an investigation, but Duntsch would not have been allowed to operate while it was going on, Shulkin said. He was visibly angered by Baylor-Plano's failure to report. "What's the worst that can happen, a lawsuit?" he said. "Come on. These are people dying, and we're stopping because you're afraid of a lawsuit?"
Two years after Duntsch left Baylor-Plano, the hospital's decision not to report its review of his work or its results prompted an investigation by state health authorities. The hospital was hit with a violation and fined $100,000 in December 2014, but a year later, the citation and penalty were withdrawn. The Texas Health and Human Services Commission would not explain why, saying the records were confidential.
Hospital officials declined to be interviewed for this story, submitting a written statement instead.
"Our primary concern, as always, is with patients," it said. "Out of respect for the patients and families involved, and the privileged nature of a number of details, we must continue to limit our comments. There is nothing more important to us than serving our community through high-quality, trusted healthcare."
Duntsch's next stop was Dallas Medical Center, which sits outside Dallas' northern edge in the city of Farmers Branch. Baylor-Plano officials might have thought any future employer would contact them before hiring him and they could share information confidentially, but Dallas Medical Center granted Duntsch temporary privileges while its reference checks were still going on.
On July 24, 2012, Duntsch operated on Floella Brown, 64, a banker about to retire after a long career. She had come to Duntsch for cervical spine surgery to ease her worsening neck and shoulder pain.
About a half hour into Brown's surgery, Duntsch started to complain that he was having trouble seeing her spine.
"He was saying: 'There's so much blood I can't see. I can't see this,'" said Kyle Kissinger, an operating room nurse. He kept telling the scrub tech "'suck more, suck more. Get that blood out of there. I can't see.' That's really concerning to me because, not only that he can't do it correctly when he can't see that but, why is it still bleeding?"
Brown bled so much that blood was saturating the blue draping around her body and dripping onto the floor. The nursing staff put down towels to soak it up.
After the operation, Brown woke up and seemed fine, but early the next morning she lost consciousness. Pressure was building inside her brain for reasons that were unclear at the time.
That same morning — with Brown still in the ICU — Duntsch took another patient into surgery.
The patient's name was Mary Efurd. She was an active 71-year-old who'd sought Duntsch's help because back pain was keeping her off her treadmill.
Duntsch arrived at the hospital about 45 minutes after Efurd's surgery had been set to start, Kissinger said. He spotted a hole in Duntsch's scrubs. "It's on the butt cheek of his scrubs. He didn't wear underwear. That's why it really shined down to me," Kissinger said. The nurse realized he'd seen that hole for three straight days — Duntsch apparently hadn't changed his scrubs all week. Kissinger also noticed that Duntsch had pinpoint pupils and hardly seemed to blink.
When Duntsch arrived, the staff told him that Brown, his patient from the day before, was in critical condition.
Soon after beginning Efurd's surgery, Duntsch turned to Kissinger and told him to let the front desk know he would be performing a procedure on Brown called a craniotomy, cutting a hole in her skull to relieve the pressure in her brain. Problem was, Dallas Medical Center did not perform those, or even have the proper equipment to do them.
As he operated on Efurd, Duntsch quarreled first with Kissinger and later with his supervisors, insisting on a craniotomy for Brown, according to court testimony. All the while, the operating room staff questioned whether Duntsch was putting hardware into Efurd in the right places and noticed he kept drilling and removing screws.
In the end, Duntsch did not perform a craniotomy on Brown. She was moved to another hospital but never regained consciousness. In court, her family said they withdrew life support a few days later. A neurosurgeon hired to review her case would later determine that Duntsch had both pierced and blocked her vertebral artery with a misplaced screw. The review also found that Duntsch misdiagnosed the source of her pain and was operating in the wrong place.
The day after her surgery, Efurd awoke in agony. She couldn't turn over or wiggle her toes. Hospital administrators called Dr. Robert Henderson, a Dallas spine surgeon, to try to repair the damage.
Shortly after he arrived at the hospital, Henderson pulled up Efurd's post-operative X-rays. When he saw them, he said, "I'm really thinking that some kind of travesty occurred." That impression only grew when Henderson reopened Efurd's freshly made incisions the next day. "It was as if he knew everything to do," Henderson said of Duntsch, "and then he'd done virtually everything wrong."
There were three holes poked into Efurd's spinal column where Duntsch had tried and failed to insert screws. One screw was jabbed directly into her spinal canal. That same screw had also skewered the nerves that control one leg and the bladder. Henderson cleaned out bone fragments. Then he discovered that one of Efurd's nerve roots — the bundle of nerves coming out of the spine — was completely gone. For some inexplicable reason, Duntsch had amputated it.
The operation was so botched, Henderson recalled thinking Duntsch had to be an impostor passing himself off as a surgeon. Even after Henderson's repairs, Efurd never regained her mobility and now uses a wheelchair. (In an email, Efurd said that discussing what happened to her again would take a toll on her health.)
By the end of the week, hospitals administrators told Duntsch he would no longer operate at Dallas Medical Center. But, as had happened at Baylor-Plano, Duntsch was allowed to resign and the hospital didn't notify the National Practitioner Data Bank. Dallas Medical Center officials said the hospital had different managers when Duntsch worked there and that current administrators could not comment on his work or the circumstances under which he left.
Duntsch would continue to operate. In fact, his career in Dallas was only about half over.
After Duntsch's disastrous run at Dallas Medical Center, he was finally reported to the state medical board. The first report came from Shulkin, the Dallas physician who served on the board, who had been told of the surgeries on Efurd and Brown. Other doctors started complaining, too.
"Once I heard about those cases, I called the medical board," said Kirby, the vascular surgeon who had been present for Morguloff's surgery. "I said: 'Listen, we've had egregious results at Baylor-Plano. He was not reported to the databank. We've had egregious results at Dallas Medical Center. He's got to be stopped.'"
After being called in to help Efurd, Henderson, too, made it his personal mission to stop Duntsch from operating. He called Boop at the University of Tennessee to ask about Duntsch's training and spoke to officials at Baylor-Plano hospital. He also called the state medical board.
When a couple of months passed and they didn't hear about more bad outcomes, Henderson and Kirby said they assumed perhaps Duntsch's mistakes had finally caught up with him.
Then, in December 2012, Kirby was asked to help Jacqueline Troy, a patient suffering from a severe infection. (The Troy family would not comment for this story.) Troy was being transferred to a Dallas hospital from a surgery center in the suburb of Frisco. She'd had neck surgery, but the surgeon had cut her vocal cords and one of her arteries. When Kirby learned the details, he asked the doctor who referred the case to him about the surgeon: "Is it a guy named Christopher Duntsch?"
It was.
Duntsch had managed to get a job at Legacy Surgery Center, an outpatient clinic. (The ownership of the clinic has changed and the new owners declined to comment for this story.)
Soon after Troy's surgery, Duntsch was finally reported to the National Practitioner Data Bank, though not by any of his previous employers. A report dated Jan. 15, 2013, obtained by an attorney representing one of Duntsch's patients, shows that Methodist Hospital in the Dallas suburb of McKinney had reported Duntsch after denying him privileges six months earlier. Their rejection was based on Duntsch's "substandard or inadequate care" at Baylor-Plano. (Methodist McKinney declined to comment for this story.)
But even after the report to the databank, Kirby was stunned to discover another hospital had given privileges to Duntsch. In May 2013, he was invited to a "Meet Our New Specialist" dinner thrown by University General hospital at a Dallas restaurant. The event was to celebrate the arrival of a new neurosurgeon: Christopher Duntsch.
"I called down there and raised holy hell," Kirby said.
University General, formerly known as South Hampton Community Hospital, had a troubled history: two bankruptcies and a former CEO sentenced to prison for health care fraud. Purchased for $30 million in 2012 by a Houston-based company, University General was one of only three hospitals serving Dallas' southern half, an area that spans 200 square miles and includes more than 560,000 people. The surrounding community was hoping for a turnaround.
The hospital is now closed, and its administrators from that time did not respond to questions about why they hired Duntsch.
It likely came down to simple economics. According to the health care analysis firm Merritt Hawkins, the average neurosurgeon is worth $2.4 million a year in revenue to a hospital.
"That's a dream for a hospital administrator," Kirby said.
It's also a virtual employment guarantee for a doctor with Duntsch's credentials, Dallas neurosurgeon Dr. Martin Lazar said.
"I don't think it's because of our charm," Lazar added dryly. "We are like a cash cow."
It was at University General that Glidewell had his neck surgery, knowing none of Duntsch's by then two-year history of botching operations.
Glidewell's back problems had begun almost a decade earlier, in 2004, when he broke his back in two places in a motorcycle accident. After a year of rehab, he tried to go back to his job working on air conditioning systems but lasted only months before the pain stopped him. He left his first meeting with Duntsch elated and filled with hope.
"I was actually so happy with the way it went that I called my wife and my mother and said, 'I think I found somebody on my insurance that's gonna fix my neck,'" he said.
The day of the surgery began ominously. That morning, "We pulled out of the driveway, and soon as we started going forward down the street, a black cat ran across the front of the car," Glidewell said. "I said, 'Oh, Lord, this is not good.' We turned the corner, and when we got on the first county road, and another one. Turning into the hospital, another one."
Three black cats on the way to the hospital. "I said, 'We need to just turn around and go home.'"
Once at the hospital, Glidewell and his wife waited. And waited. Three hours late, they said, Duntsch finally arrived in a cab. "He had on jeans that were frayed at the bottom," Glidewell said. "He didn't look like he was ready for a surgery."
Reluctantly, Glidewell went ahead. But hours later, Duntsch came out and told Glidewell's wife that he had found a tumor in Glidewell's neck and aborted the procedure.
"I was devastated, crying," Robin Glidewell recalled. She went to see her husband in the recovery room. "Immediately, Jeff was: 'Where is the doctor? I can't move my arm or my leg.' He was having trouble even talking and said, 'Something's wrong, something's wrong.'"
There was no tumor, but Duntsch had made a series of errors after mistaking a portion of Glidewell's neck muscle for a growth, according to a review of the case.
The owner of University General heard about what happened to Glidewell and called Kirby to try to mitigate the damage.
"I, with reluctance, went down there and met the Glidewell family and took care of him," Kirby said. Glidewell was spiking fevers and was transferred to another hospital for care. He would remain there for months.
"This was not an operation that was performed," Kirby said. "This was attempted murder."
By the time Duntsch operated on Glidewell, the state medical board had been investigating him for about 10 months.
Frustrated by the board's inaction, Henderson had called the lead investigator six months earlier to beg for faster intervention. In a recording Henderson made of the call, he says, "This is a bad, bad guy, and he needs to be put on the fast track if there's such a thing." She tells him she wishes they could suspend his license while they investigate, but the board's attorneys wouldn't go for that.
Kirby sent the board a five-page letter on June 23, 2013, spurred by what had happened to Glidewell. "Let me be blunt," it said. "Christopher Duntsch, Texas Medical Board license number N8183, is an impaired physician, a sociopath, and must be stopped from practicing medicine." Robin Glidewell also sent a letter, describing what happened to her husband.
By then, Brett Shipp, a reporter from Dallas' ABC affiliate, had gotten tips about the board's slow-moving investigation of Duntsch from a friend of one of Duntsch's patients and a plaintiff's attorney. "Very shortly after I contacted them," Shipp said, "they suspended his license."
On June 26, Duntsch was ordered to stop operating. The head of the medical board at the time, San Angelo family physician Dr. Irvin Zeitler, said the investigation took a while because "it's not uncommon for there to be complications in neurosurgery."
It also struck the board as highly improbable that a surgeon fresh out of training could be so lacking in surgical skill.
"So none of us rushed to judgment," Zeitler said. "That's not fair, and in the long run, it can come back to be incorrect. To suspend a physician's license, there has to be a pattern of patient injury. So that was, ultimately that's what happened. But it took until June of 2013 to get that established."
Even after the board acted, those most involved in trying to keep Duntsch from operating were afraid it would not be the end of his career.
"I was terrified of that term, 'suspended,'" Henderson said. "I mean, that indicates that he might get it back at some point in time, and I was already aware of the fact of how glib Dr. Duntsch was, and how disarming he was, and how friendly and intelligent he appeared whenever he introduced himself to people that he wanted to impress. I was concerned that he would do the same thing in getting his license back whether it was six months later, a year later, two years later."
Kirby, Henderson and another doctor decided to contact the district attorney, convinced that Duntsch's malpractice was so egregious it was criminal. They met with an assistant DA but got little traction.
On Dec. 6, 2013, the medical board permanently revoked Duntsch's license.
He left Texas, moving in with his parents in Colorado and filing for bankruptcy, claiming debts of around $1 million. His life seemed to go into a free fall. In January 2014, he was pulled over by police in southern Denver around 3:30 a.m. Officers said he was driving on the left side of the road with two flat tires. When he opened the window, they smelled the sour tang of alcohol and spotted an empty bottle of Mike's Hard Lemonade on the floor of the car. A full one was sitting in the console. After a breath test, Duntsch was arrested for DUI and sent to a detox facility.
Even though he was living in Colorado, he continued to return to Dallas to see his two sons. His older son had been born back when he at Baylor-Plano. His girlfriend, Wendy Young, had a second son in September of 2014.
The following spring, in March, police were called to a bank in Northeast Dallas after passers-by noticed a man with blood on his hands and face beating on the doors. It was Duntsch, babbling about his family being in danger. He was wearing the shirt of his black scrubs. It was covered in blood. Officers took him to a nearby psychiatric hospital.
In April, Duntsch went to a Dallas Walmart because his father had wired him money. According to a police report, he filled a shopping cart with $887 worth of merchandise, including watches, sunglasses, silk neckties, computer equipment, a walkie-talkie and bottle of Drakkar Noir cologne. He put them in bags he swiped from a register. He then then picked out a pair of trousers and put them on in a dressing room. He put his own pants into the cart and rolled the cart out the front door without paying for the pants he was wearing. Moments later, he was arrested for shoplifting.
By then, reporters were following every twist in the Duntsch saga. In May 2015, the Texas Observer published an article with the headline, "'Sociopath' Surgeon Duntsch Arrested for Shoplifting Pants." In the comment section underneath the article, Duntsch responded with a series of diatribes against everyone he thought had conspired against him. His cybermanifesto ran to more than 80 pages when printed out.
In one comment directed at Kirby, he wrote, "You use the word without explanation impaired physician and sociopath. Since I am going to sue you or [sic] libel and slander of a criminal nature, this might be a good point to defend this comment." He called Morguloff's surgery "a perfect success."
Kirby took the comments to the district attorney's office. By then, a judge who knew Glidewell had also brought the case to the DA's attention.
Prosecutors began discussing the case anew and one assistant district attorney, Michelle Shughart, found it particularly interesting. In 13 years with the Dallas DA's office, she'd prosecuted drug dealers, robbers, but never a doctor. "I went and started doing my own research," she said. "I just ended up taking over the case."
One of the biggest challenges was that there hadn't been a case like it before.
"We did a lot of research to see if we found find anyone else who had done any cases like this, any other doctors who had been prosecuted for what they had actually done during the surgery," Shughart said. "We couldn't find anyone."
As she and other prosecutors contacted every person Duntsch had ever operated on or their survivors, they struggled to figure what crimes he could be charged with. They settled on five counts of aggravated assault arising from his treatment of four patients, including Brown and Glidewell, and one count of injury to an elderly person, because Efurd was over 65.
In Texas, this charge carried a potential life sentence, but prosecutors had to race to file the case.
"We had about four months left before we were going to run out on the statute of limitations" on Efurd's case, Shughart said. "I spent those four months just digging as hard as I possibly could, trying to gather as much information as I could. And by the time we got down to that July, I had overwhelming evidence to indict him."
Duntsch was taken into custody on July 21, 2015.
For some of his patients, the criminal case offered a last chance at justice they couldn't get through the civil courts.
Since Texas capped damages in medical malpractice lawsuits, limiting the amount plaintiffs can be awarded for pain and suffering in most cases to $250,000, the number of suits filed and amounts paid out have plummeted.
The suits that go forward often ride on economic damages, such as lost earning power, which the law does not limit in non-death cases. But many of Duntsch's patients were disabled when they came to him, or older, or had lower incomes. Some had pain that was hard to economically quantify. Despite having clear-cut claims and serious, irreversible injuries, three patients I talked to said me they had trouble finding attorneys to take their cases.
"It is not worth an attorney's time and energy to take on a malpractice case in the state of Texas," Morguloff said.
Ultimately, at least 19 of Duntsch's patients or their survivors obtained settlements, but 14 of them were represented by Van Wey, who said she's taken them on more out of a sense of outrage than out of any financial upside.
Morguloff was told no so often, he was surprised when attorney Mike Lyons finally took his case. He received a confidential settlement but said, "It wasn't much." He took more solace from the criminal case.
"To get this guy off the streets so nobody else got hurt again was important," he said. "The public needed to know that there was a monster out there."
Duntsch's trial began on Feb. 2, 2017, and focused on the charge related to Efurd, injuring an elderly person.
She testified, but first, to show that her botched surgery was part of pattern, prosecutors — over objections from Duntsch's attorneys — put a long line of his other patients and their relatives on the stand.
"You had people in walkers. You had people on crutches. You had people that could barely move. You had people that had lost loved ones," Robbie McClung, Duntsch's lead defense attorney, said. "You had all sorts of things that had gone wrong. Before we even get to Mary Efurd, you can see that it's just ... it's going downhill. I mean, it's going downhill fast."
Duntsch held up remarkably well, seeming calm in the certainty that he really was a good surgeon.
"I always thought when I looked at him, even when he was in his jail clothes, he exuded a confidence," Richard Franklin, another member of the defense team, said. "And I could certainly understand why patients would trust him."
Then Lazar and other experts walked the jury through a litany of Duntsch's surgical missteps. Duntsch's attorneys noticed a change come over him. He deflated before their eyes.
"I think that he thought he was doing pretty good," Franklin said. "Really and truly, in his own mind. Until he actually heard from those experts up there."
A key prosecution witness was Kimberly Morgan, who had been Duntsch's surgical assistant from August 2011 through March 2012 and was also his ex-girlfriend. Morgan described Duntsch's mercurial nature, vacillating from being kind and caring to patients to being angry and confrontational behind closed doors.
The prosecutors had Morgan read parts of an email Duntsch had sent to her in the early morning hours of Dec. 11, 2011, three weeks before he operated on Passmore at Baylor-Plano, the first of his surgical disasters.
The subject line of the email was "Occam's Razor." Occam's razor is the idea that the simplest explanation for anything is most likely the right one. The email rambled on for five profanity-laced pages, but Morgan delivered the most startling passage.
"Unfortunately, you cannot understand that I am building an empire and I am so far outside the box that the Earth is small and the sun is bright," Duntsch had written. "I am ready to leave the love and kindness and goodness and patience that I mix with everything else that I am and become a cold blooded killer."
It took the jurors just hours to find Duntsch guilty of knowingly injuring Efurd. He was sentenced to life in prison. He's currently incarcerated in Huntsville, about an hour outside Houston. On Sept. 18, his attorney filed an appeal in a Dallas court, arguing that the testimony on cases other than Efurd's and the email read by Morgan unfairly influenced the jury.
In February, I visited Summers, Duntsch's old football buddy-turned-patient, in his small apartment in downtown Memphis.
He remains in much the same condition as he awoke in after Duntsch operated on him, unable to move from the neck down. He requires 24-hour caregivers and sat, tipped back, in his power wheelchair, as I talked to him about Duntsch.
Summers seemed resigned to his injuries, to his friend's role in them and to the systemic weaknesses that allow problem doctors to keep practicing. He said he tries not to think about Dallas anymore.
I asked him why he'd trusted Duntsch to be his doctor. He couldn't say. He looked out the window.
He knew his friend could barely drive a car without getting lost, he said. He just assumed he had been better trained for neurosurgery.
The executive told Memorial Sloan Kettering staff that the hospital did not do enough to limit the industry conflicts of its chief medical officer, who has resigned.
This article first appeared October 01, 2018 on ProPublica.
The chairman of the board of Memorial Sloan Kettering Cancer Center bluntly disparaged the hospital's former chief medical officer on Monday, telling the hospital staff that he "crossed lines" and went "off the reservation" in his outside dealings with health and drug companies.
The remarks by Douglas A. Warner III, the chairman of the center's board of managers and overseers, as well as Dr. Craig B. Thompson, the chief executive, went beyond previous hospital statements about the former chief medical officer, Dr. José Baselga. Until Monday, the hospital had said he followed internal policies and had mainly just failed to disclose his industry affiliations in some medical journal articles.
"I have to say, while we pushed back on a lot and discussed a lot, we were not as effective as we should have been," Warner said, according to a preliminary transcript of a meeting with the hospital staff that was inadvertently emailed by the hospital to a reporter for The New York Times. "He crossed lines that we should have done more to stop."
Baselga did not respond to phone calls or an email message requesting comment.
Monday's meeting between hospital executives and its employees is the latest in a series held by the cancer center as it conducts a broad review of policies about the nonprofit institution's ties to outside industries. Memorial Sloan Kettering has been forced to re-examine its rules governing board memberships and compensation in the wake of articles by The Times and ProPublica that revealed insider deals with startups that were poised to reap millions of dollars for breakthroughs in cancer treatments and biotech advances.
The hospital's highest executives have come under scrutiny in recent weeks, leading Warner to question on Monday whether Thompson would be permitted to continue sitting on the board of Merck, which makes the blockbuster cancer drug Keytruda. In addition to Merck, Thompson is also a director of Charles River Laboratories, a publicly traded company that assists research in early drug development.
Thompson received $300,000 in compensation from Merck in 2017, according to company financial filings. He was paid $70,000 in cash from Charles River in 2017, plus $215,050 in stock. The compensation for the two corporate boards was in addition to what he was paid as chief executive at Memorial Sloan Kettering. In 2016, he earned $6.7 million in total compensation from the cancer center and related organizations, according to the most recent Internal Revenue Service filings.
"Should Craig continue to sit on the Merck board? We have no policy on that," Warner said during the meeting, explaining that he had discussed the board membership with Thompson when he joined the hospital in 2010. And while it was viewed as a "good thing," Warner added that "we need to step back from that now and ask ourselves whether that continues to be appropriate, whether it's appropriate in the future."
In a memo late last week and again at Monday's meeting, the New York-based cancer center emphasized the need to overhaul its policies, which had failed to address some of the potential conflicts made public recently at a time when investors are tossing vast amounts of money at startups developing promising treatments.
Thompson said Monday that working with for-profit companies remained a priority. "We cannot be shy about the importance of investments in bringing forward these advances," he said.
Neither his resignation letter nor the hospital's statement about it suggested that he was fired. But in his remarks, Warner indicated that Baselga was forced out. "I have to say it's a tragedy. I liked José. I like José a lot," he said. "But unfortunately, José left us no choice."
Baselga, one of the world's leading breast cancer researchers, has also resigned from the boards of the drugmaker Bristol-Myers Squibb and Varian Medical Systems, a maker of radiation equipment.
Christine Hickey, a hospital spokeswoman, said: "Dr. Baselga resigned, he was not fired. Mr. Warner was making the point that we had no choice but to accept his resignation."
She also said Warner and Thompson were referring not to his ties to outside companies but to a "conflict of commitment."
"Dr. Baselga wanted to take on more, join more boards, be involved in more outside efforts," she said. "He was overextended."
On Monday, Rep. Debbie Dingell, Democrat of Michigan, sent a letter to Thompson seeking answers to a series of questions about the deal with the company, Paige.AI, giving it the right to access images of 25 million tissue slides analyzed over decades. Her letter questioned how the hospital planned to ensure patient privacy, among other issues, many of which had been raised by hospital doctors at the internal meetings once the deal became public.
Also on Monday, The New England Journal of Medicine published a correction on two of Baselga's articles. The correction lists Baselga's relationships with 15 companies. An editor's note appended to the correction states: "Dr. Baselga failed to disclose in these articles his multiple, substantial financial associations, which are now apparent in the updated disclosure forms. When we learned of this breach of trust, we conveyed our concern to Dr. Baselga's institution, Memorial Sloan Kettering Cancer Center."
In his own comments to the staff, Thompson apologized for what he described as his poor handling of the recent crisis and said Baselga had not acted appropriately.
"José reported to me, and I wish I had done more to keep him away from the line," Thompson said, according to the partial transcript of Monday's meeting. "While Dr. Baselga has acknowledged his mistakes and resigned, this has not brought closure to MSK. It has led to discussions of whether we still know where the right side of the line is."
Warner, a former chairman of JPMorgan Chase & Company, acknowledged "widespread anger" among staff members and that the hospital's reputation had been harmed.
"The question that you're asking quite properly is: Where the hell was management and the board in all of this, you should have protected this institution," Mr. Warner said. "The fact that you're angry is all about the passion that you feel for this place, that love that you have for this place, that commitment that you have to this place, and I wouldn't have it any other way."
A vice president at Memorial Sloan Kettering received a stake of nearly $1.4 million in a biotech company for representing the hospital on its board. He will give back his stake as the cancer center grapples with questions about conflicts of interest.
This article first appeared September 29, 2018 on ProPublica.
A vice president of Memorial Sloan Kettering Cancer Center has to turn over to the hospital nearly $1.4 million of a windfall stake in a biotech company, in light of a series of for-profit deals and industry conflicts at the cancer center that has forced it to re-examine its corporate relationships.
The vice president, Dr. Gregory Raskin, oversees hospital ventures with for-profit companies. As compensation for representing the hospital on the biotech company's board, Raskin received stock options whose value soared when the startup went public a little over a week ago.
The move to hand over his stake is one of several steps now underway as the cancer center tries to contain a crisis that has already led to the resignation of its chief medical officer and a review of its conflict-of-interest policies. Several board members and some executives of the nonprofit institution have maintained close ties to the health and drug industries at a time when stunning cancer breakthroughs are generating excitement among investors and spawning a flurry of biotech startups.
At other cancer centers and research institutions, employees are barred from accepting personal compensation when they represent their institution on corporate boards. But Memorial Sloan Kettering had no such prohibition until now.
Raskin has been involved with the startup, Y-mAbs Therapeutics, since 2015 when he signed off on the deal with Memorial Sloan Kettering, where the company's experimental treatments for children with cancer have been developed. His vested stock options are worth about $675,000, at least on paper. Stock options that will vest in the future are worth about $616,000 more. In addition, shares he had personally purchased earlier at a discounted price are now worth about $106,000 more than he paid for them.
After ProPublica and The New York Times asked about Raskin's compensation, Memorial Sloan Kettering said it would change its policy so that he and other employees in similar roles would not profit personally from such arrangements, and that all proceeds would revert to the hospital and its research.
On Friday, the hospital issued a memo to thousands of employees, announcing that it would restrict some interactions with for-profit companies. It said it was imposing a moratorium on board members investing in or holding board positions in startups that originated with Memorial Sloan Kettering.
For now, the moratorium on board investments only applies to new deals, the hospital said. It would not affect the exclusive deal the hospital made with an artificial intelligence company, Paige.AI, to license digital images of 25 million tissue slides. Three insiders, including a member of Memorial Sloan Kettering's executive board, were company co-founders, and three other board members were investors. Staff turmoil over the deal caused Dr. David Klimstra, the chairman of the pathology department, to announce that he would divest his equity stake in Paige.AI.
Memorial Sloan Kettering said in the memo, "We have determined that when profits emerge through the monetization of our research, financial payments to MSK-designated board members should be used for the benefit of the institution."
The proposed policies stopped short of barring hospital executives from receiving compensation for their work on outside boards, although officials have said that is a move they are considering. Dr. Craig B. Thompson, the cancer center's chief executive, sits on the board of the drugmaker Merck. Dr. José Baselga, the chief medical officer who resigned under fire this month after an article in The Times and ProPublica about his undisclosed industry ties, sat on the board of the drugmaker Bristol-Myers Squibb and Varian Medical Systems, a manufacturer of radiation equipment. He resigned both positions after he stepped down from his role at the hospital.
In an email, Raskin said that all of his compensation for work with Y-mAbs "is being committed to Memorial Sloan Kettering and the amazing work we do." He said he "couldn't be prouder of the work we've accomplished at Y-mAbs in extending children's lives. I am grateful that I have the opportunity to lend my expertise in biotech business development and licensing intellectual property to bring MSK's unique and critical discoveries to cancer patients."
Christine Hickey, a spokeswoman for Memorial Sloan Kettering, said Raskin brought the matter to hospital leadership on Sept. 21, the same day that Y-mAbs began trading publicly and a day after the article about Paige.AI was published online. She said he had fully disclosed his ties to the company, as required by the hospital.
Before joining Memorial Sloan Kettering in 2012, Raskin was vice president of the venture capital arm of AllianceBernstein, focusing on biotechnology. He now leads the cancer center's Office of Technology Development.
Hospitals and universities have long assisted researchers with tasks like registering patents, but Raskin's field --- known as technology transfer --- has expanded in recent years. Technology transfer offices have become increasingly involved in helping to set up companies, said Stephen Susalka, the chief executive of the Association of University Technology Managers. More than 1,000 startups originated at universities, hospitals or research institutions in 2017, according to his group, up from about 550 in 2007.
Research institutions have varying policies when it comes to allowing employees to represent them on the boards of companies. Some, like the Cleveland Clinic and the University of Texas MD Anderson Cancer Center, permit employees to represent the hospital on company boards, while others, like the University of Utah, do not.
The Cleveland Clinic said it prohibits employees from personally profiting when they are representing the interests of the institution. A spokeswoman for MD Anderson said that its head of technology transfer serves on one corporate board as a hospital representative, but that position is uncompensated.
Karin Immergluck, the executive director of the Office of Technology Licensing at Stanford University, said she would not serve on a company board in her position overseeing the commercialization of research discoveries at Stanford.
"It looks very conflicted, and I would think people from the outside might ask who you are representing," the nonprofit institution or the for-profit company, she said.
Y-mAbs, based in New York, was formed around immunotherapy treatments developed by the lab of Dr. Nai-Kong V. Cheung, a pediatric oncologist at Memorial Sloan Kettering. As part of a commercialization agreement, he received a stake worth $64.5 million on Friday. Researchers whose discoveries lead to new drugs are not covered by the new policy.
With help from those promising therapies, the company's market value has skyrocketed to nearly $867 million.
"Memorial Sloan Kettering couldn't be prouder of the work of our colleagues --- who persisted over a 20-year period --- to develop antibodies against different forms of advanced neuroblastoma; they are literally saving children's lives," Hickey said.
Y-mAbs is hoping to win approval for its two lead products, naxitamab and omburtamab, to treat neuroblastoma and other cancers. Both drugs were given a breakthrough designation by the Food and Drug Administration, which means the agency will give them an expedited review because there is evidence they could be a substantial improvement over existing treatments.
In August 2015, Raskin signed off on the licensing deal between Memorial Sloan Kettering and Y-mAbs. Within weeks, he had taken a seat on the Y-mAbs board. After that, he had to recuse himself from hospital decisions about the company and was not allowed to sign agreements between Memorial Sloan Kettering and the company, officials said.
The company said Raskin received the same package of compensation as others on the nine-member board who are not company executives.
Between 2015 and 2017, Raskin also served on the board of another company, Sellas Life Sciences Group, that was created to commercialize a cancer vaccine developed at the hospital. Memorial Sloan Kettering said he was not serving as the hospital's official designee, and Raskin received $30,000 for his service in 2017, according to financial filings. He will now give that to the hospital to benefit research, Memorial Sloan Kettering said.
Memorial Sloan Kettering Cancer Center has abruptly changed the focus of an annual fundraising campaign amid a widening crisis that has already led to the resignation of its chief medical officer and a sweeping re-examination of its policies.
The campaign, initially titled "Harnessing Big Data," was to have focused on the cancer center's research into the use of artificial intelligence in cancer treatment, according to a brochure on Memorial Sloan Kettering's website.
Pathologists at the hospital complained that their work was being commercialized for private gain and that patients were not being informed that images of their tissue slides were being shared with an outside company. The hospital and its officials said they did nothing wrong, but acknowledged that they could have communicated better.
Kenneth Manotti, the cancer center's senior vice president and chief development officer, made a reference to the article in an email sent Friday to board members of the Society of MSK, the hospital's volunteer fundraising arm, and an affiliated committee. It said the fundraising effort, which would have accelerated the center's research on artificial intelligence, would be postponed "under the current circumstances, as we navigate through the issues at hand."
A spokeswoman for Memorial Sloan Kettering said Tuesday that the Society of MSK would instead focus on patient care and would proceed. The society's annual campaign typically raises funds ranging from roughly $800,000 to $1 million for the hospital, she said. Over all, the society raised more than $20 million a year for Memorial Sloan Kettering, according to its annual reports.
The change highlights the fundraising challenges faced by Memorial Sloan Kettering, which is one of the nation's most prestigious cancer centers and recently completed a $3.5 billion multiyear fundraising drive. Earlier this month, the hospital's chief medical officer, Dr. José Baselga, resigned under fire after an article by ProPublica and the Times revealed that he had failed to disclose his extensive industry ties in dozens of medical journal articles in recent years.
At meetings and in online forums, patients and staff members have expressed concern about the institution and the way in which it interacts with the health and pharmaceutical industries. The hospital has announced a task force to study its conflict-of-interest policies and said Tuesday in a note to the staff that it would hire an outside law firm to conduct a "focused review" of unspecified concerns that had been raised internally. The leaders said they believed the concerns were without merit.
That uneasiness was reflected at a staff meeting on Thursday, when a pediatric neurologist told the leaders that she was a little embarrassed about the institution even though she is a spokeswoman for Cycle for Survival, a Memorial Sloan Kettering charity that raises money for research. She asked for advice on how to move on, according to several attendees.
Dr. Craig B. Thompson, the hospital's chief executive, responded that it was important to focus on the cancer center's dedication to treating cancer, including the rare cancers that are the focus of Cycle for Survival, according to the attendees. Cycle for Survival raised $39 million this year. The hospital spokeswoman, Christine Hickey, said the 2019 Cycle for Survival event was already planned and would proceed.
The fallout has led medical and academic experts to call for tighter disclosure rules on potential conflicts of interest in the cancer research fields and among major nonprofit organizations. Thompson and Dr. Lisa DeAngelis, acting physician-in-chief, acknowledged the issue of low morale in an email to the staff on Monday.
"We and our board are very aware of the disappointment and distress that many of you are experiencing after recent events at our center," they said in the memo, which was obtained from hospital staff members. "We share these concerns and are deeply sorry that you feel let down. As your leaders, we recognize that nothing is more important than maintaining the integrity and reputation of MSK and its staff."
Fundraising can quickly dampen when charities sustain a reputational hit, said Sophia Shaw, the co-founder and managing partner of Acorn Advisors, which advises nonprofits. "They're exactly like investors in a for-profit company," Shaw said of donors. But rather than expecting a return on investment, donors are expecting a return on the charity's mission. "If the donor doesn't feel that their money is furthering that mission, then they could be reluctant to give it away at that time."
Consultants for nonprofits said major donors were unlikely to be easily rattled by news reports, but that could change depending on what happens next and how the hospital responds.
"Individual funders — and also foundations and corporations — don't like bad news," said Richard Mittenthal, president and chief executive of the TCC Group, which advises nonprofits. "And when there's bad news, there's always a question of — is there any more bad news?"
A ProPublica analysis found that black people and Native Americans are under-represented in clinical trials of new drugs, even when the treatment is aimed at a type of cancer that disproportionately affects them.
This article first appeared September 19, 2018 on ProPublica.
It's a promising new drug for multiple myeloma, one of the most savage blood cancers. Called Ninlaro, it can be taken as a pill, sparing patients painful injections or cumbersome IV treatments. In a video sponsored by the manufacturer, Takeda Pharmaceutical Co., one patient even hailed Ninlaro as "my savior."
The U.S. Food and Drug Administration approved it in 2015 after patients in a clinical trial gained an average of six months without their cancer spreading. That trial, though, had a major shortcoming: its racial composition. One out of five people diagnosed with multiple myeloma in the U.S. is black, and African Americans are more than twice as likely as white Americans to be diagnosed with the blood cancer.
Yet of the 722 participants in the trial, only 13 — or 1.8 percent — were black.
The scarcity of black patients in Ninlaro's testing left unanswered the vital question of whether the drug would work equally well for them. "Meaningful differences may exist" in how multiple myeloma affects black patients, what symptoms they experience and how they respond to medications, FDA scientists wrote in a 2017 journal article.
The racial disparity in the Ninlaro study isn't unusual. Reflecting the reluctance of the FDA to force drugmakers to enroll more minority patients, and the failure of most manufacturers to do so voluntarily, stark under-representation of African Americans is widespread in clinical trials for cancer drugs, even when the type of cancer disproportionately affects them. A ProPublica analysis of data recently made public by the FDA found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5 percent of the patients were black. African-Americans make up 13.4 percent of the U.S. population.
Source: U.S. Food and Drug Administration; National Cancer Institute (Riley Wong for ProPublica)
As a result, desperately ill black patients who have exhausted other treatment options aren't getting early access to experimental drugs that could extend their life spans or improve their quality of life. While unapproved treatments also carry a risk of setbacks or side effects, new cancer drugs have dramatically shifted outcomes for some patients.
Recently approved lung cancer treatments are "revolutionary," said Dr. Karen Kelly, associate director for research at UC Davis Comprehensive Cancer Center. Even in the first phase of clinical testing, which is aimed at making sure a drug is safe, 20 percent of cancer patients now see their tumors shrink or disappear, up from 5 percent in the early 1990s, Kelly said.
Dr. Kashif Ali, research head at Maryland Oncology Hematology, has spent seven years recruiting patients for about 30 cancer and blood disease trials a year. He said he's often seen minorities, including African Americans, miss out on trials because of financial hurdles, logistical challenges and their lingering distrust of the medical community due to a history of being victimized by medical experimentation.
"They're potentially losing out on life-extending opportunities because it's one more option they no longer have," Ali said. "Especially when patients are in advanced stages of cancer, treatments are like stepping stones: When one stops working, you move on to the next."
Not joining a trial can mean "you've lost life expectancy," he said.
Pat Conley, a 72-year-old retired business analyst whose multiple myeloma relapsed last year, has never participated in a clinical trial. She was interested several times and didn't meet the criteria. Now she's eligible for one, but worries about the burden of regular hourlong trips from her Fayetteville, Georgia, home to the trial site in Atlanta, as well as the copays for medical tests. "They'll want a new biopsy and Lordy, biopsies are not cheap," she said.
Still, two drug regimens haven't halted her cancer and she wants something positive to come from her illness. "If they don't have African Americans to test it on, how will they know it's going to work?" she asked. "If it doesn't help me, it'll help my children, it'll help somebody else."
Pharmaceutical companies contacted by ProPublica all said diversity in clinical trials is important to ensure that drugs meet patients' needs. The issue "is not elevated high enough in the discussion on clinical studies," said John Maraganore, chair of the industry group Biotechnology Innovation Organization. But he added that enrolling minorities is challenging, often for reasons beyond the manufacturer's control, and that it would require a "public-private partnership, working with the FDA and NIH [National Institutes of Health]."
Black participation reached 10 percent in trials for only two of the 31 cancer drugs: the multiple myeloma drug Darzalex, where the figure was exactly 10 percent, and Yondelis, which treats two types of soft tissue cancer. Twelve percent of patients in the Yondelis trial were black, the highest proportion in the ProPublica study. Both drugs are made by Johnson & Johnson, which said it has an internal working group on trial diversity. The working group trains site leaders in best practices for diverse recruitment and seeks minority physicians to help run trials, since some patients prefer being treated by doctors of their own race.
Not enrolling in clinical trials is just one of many ways that African Americans trail white Americans in the quality of their health care. From diagnosis to death, they often experience inferior care and worse outcomes. Because some black Americans can't afford the health insurance mandated under the Affordable Care Act, they remain less likely to have coverage than non-Hispanic white Americans. African Americans are 30 percent more likely than white Americans to die from heart disease. Black mothers are three to four times as likely as white mothers to die in pregnancy or childbirth, and black children are diagnosed with autism later than white children.
While the scarcity of African Americans stands out in ProPublica's analysis, there appear to be gaps in participation of other minority groups as well. Asians were well represented in trials held in some foreign countries, but they made up only 1.7 percent of patients for drugs for which at least 70 percent of trials were conducted within the U.S. By comparison, about 6 percent of the U.S. population identifies as Asian. Almost two-thirds of the trials didn't report any Native Americans or Alaska Natives, who together make up about 2 percent of the U.S. population. ProPublica's analysis excluded Hispanics, because the FDA reports did not have a separate category for them until 2017 and do not distinguish between white and non-white Hispanics.
The very relationship of race to drug development is fraught with controversy. Race is primarily seen as a social concept, rather than as a product of measurable biological traits. Yet there's growing evidence that, whether for environmental or genetic reasons, drugs may have different effects on different populations.
In 2014, the state of Hawaii sued Bristol-Myers Squibb Co. and Sanofi, the manufacturers of the blood thinner Plavix, accusing them of deceptive marketing for failing to disclose that the drug was less effective for some patients of East Asian or Pacific Islander descent. The drugmakers have denied allegations of misconduct and argue that genetic traits have not been proven to affect how well Plavix works. The case is pending. In the meantime, the FDA has added a warning to the label saying that Chinese patients are more likely to have a gene variation that renders the drug ineffective. Researchers at the University of California, San Francisco have found that a commonly used asthma medication, albuterol, doesn't work as well for African-American and Puerto Rican children as it does for European American or Mexican children.
Inadequate minority representation in drug trials means that "we aren't doing good science," said Dr. Jonathan Jackson, founding director of the Community Access, Recruitment and Engagement Research Center at Massachusetts General Hospital in Boston. "If we aren't doing good science and releasing these drugs out into the public, then we are at best being inefficient, at worst being irresponsible."
The National Black Church Initiative, a coalition of 34,000 U.S. churches, urged the FDA in 2017 to mandate diversity in all clinical trials before approving a drug or device. "Simply put, the pharmaceutical community is not going to improve minority participation in clinical trials until the FDA compels them to do so via regulations," it wrote to Commissioner Scott Gottlieb.
The FDA hasn't done so. Although it noted in a 2013 report that a lack of diversity betrays a key ethical principle of medical research — equal justice for all — the agency has shied away from setting quotas or numerical guidelines for participation by race.
Instead, it has relied on persuasion. In its 2014 Action Plan, it said it aims to "share best practices," to "support" industry efforts at improving diversity in clinical trials, and to "encourage" patients to participate in trials via social media, emails and blog posts.
"The FDA believes that enrollment should reflect the patients most likely to use a medical product," spokeswoman Gloria Sanchez-Contreras said. The FDA "does not have the regulatory authority to require specific levels of minority representation in clinical trials," although it may ask drugmakers for additional data, she said.
Dr. Rachel Sherman, the FDA's principal deputy commissioner, said that she's "not entirely satisfied" with minority enrollment but that clinical trials have become more diverse in other ways. Two decades ago, women and children were rarely included in drug studies. Now those groups are better represented and the FDA is working on including more minorities, she said.
Sherman added that the agency has to balance how much information it demands from drugmakers against the need to get a drug onto the market, where it will be broadly available for all patients.
"When it comes to clinical research in this country, there's a credit card, and there's a limit on the credit card," she said. "If we spend on one thing, it won't get spent on another. We have to be judicious in what we require and what we demand and what we encourage."
Diversity has its trade-offs. Clinical trials already cost hundreds of millions of dollars, and drugmakers say that requiring participants to be racially representative would likely add more time and expense.
"If you have a significant delay in enrollment, that would delay the medication advancing to the whole patient population, hurting everybody including the black population," said Maraganore, who is also CEO of drugmaker Alnylam Pharmaceuticals Inc.
To offset costs caused by these delays, manufacturers might reduce the number of drugs in development, depriving some patients of experimental treatments, or raise prices, which would translate into higher insurance premiums and make new drugs even less affordable for the uninsured. Maraganore favors improving diversity through patient education — "a carrot-based approach" — rather than government regulation.
Despite these short-term expenses, eliminating racial disparities in clinical trials would ultimately save costs through disease prevention and improved treatment, according to a 2015 analysis by researchers at the University of California, San Francisco. Without FDA pressure, though, manufacturers may be unlikely to increase efforts to recruit African Americans, especially if their sights are set on a worldwide market. They can use the same clinical trial data to gain approval in the European Union, or Japan.
Takeda, which is based in Tokyo, Japan, tested Ninlaro in the U.S., Japan and 24 other countries, including Australia, Austria, Denmark, New Zealand, Sweden and others with small black populations. "Clinical trials are reflective of the ethnicity distribution in the population where the study takes place," Phil Rowlands, head of Takeda's oncology unit, said in an email. "While we cannot control enrollment eligibility based on the strict clinical criteria, our recruitment efforts extend to diverse patient populations, including minorities."
Asked why Takeda didn't pick sites with higher black populations, Rowlands said that Takeda does not "select sites with ethnicity as an eligibility criteria unless specific risk factors require that."
Income is another reason for sparse African-American representation. Clinical trials are largely a middle-class option. A 2015 study found that patients with an annual household income below $50,000 had 32 percent lower odds of participating in a trial than patients with income above that threshold. The median household income of African Americans in 2016 was $39,490, compared to $65,041 for non-Hispanic white Americans.
Patients who can't afford to travel long distances to a trial, take time off work or find child care are at a disadvantage. They are usually reimbursed for travel and food costs, but drugmakers are careful not to pay too much because they do not want to appear to be enticing patients to join when it isn't in their medical interests, said Laurie Halloran, founder and CEO of a consulting firm for the drug industry.
While the experimental drug used in a study is free, any approved treatments that are part of the trial typically need to be covered by a patient's own insurance, according to Ali, the research director at Maryland Hematology Oncology.
He recalled one black patient who was eligible for a study that entailed taking an already approved drug in combination with a new treatment. The approved drug cost $10,000 a month and the patient's insurance charged 20 percent as his copayment, Ali recalled. The patient decided that joining the trial would be too expensive. He instead underwent chemotherapy, which was cheaper, but he didn't tolerate it well. The patient is now considering hospice, Ali said.
Criteria for admission to clinical trials have become more stringent over the years, Mass. General's Jackson said, and patients of color are increasingly excluded. They are more likely than white people to have other conditions such as stroke, hypertension and diabetes, which could complicate research results. Trials often want to enroll "the healthiest sick people they can find" and preclude patients with other conditions. "The wall basically gets taller and taller," he said.
Aredia Taylor didn't qualify on other grounds. A former U.S. Department of Agriculture supervisor for food safety inspections, she was diagnosed with multiple myeloma in 2014 and has undergone a gamut of treatment including various chemotherapy drugs and a stem cell transplant.
While the transplant drove her cancer into remission, there is no cure for multiple myeloma, and she needs to take Revlimid — a standard treatment — daily to keep the cancer at bay. The drug has given her side effects that she describes as devastating to her daily life, including diarrhea, muscle spasms and an inability to concentrate. She said she wants to stop taking Revlimid and would be willing to try an experimental treatment.
Taylor, 58, said she saw pamphlets at her doctor's office encouraging patients to ask about clinical trials, so she asked her oncologist, Dr. Larry Anderson at the University of Texas Southwestern Medical Center in Dallas, whether she should join a study. He told her that she "wasn't a fit," she said. Anderson told ProPublica that most trials are seeking patients with either newly diagnosed or relapsed multiple myeloma, and since Taylor is currently in remission, she wouldn't be accepted.
Taylor was disappointed. Knowing that African Americans like herself are especially susceptible to multiple myeloma, she'd like to be a part of developing more effective treatments.
"I want to pay it forward and be a blessing to somebody else," she said. "I want to be one of the people that they try to do a clinical trial for, so they find a way to a cure."
Spurred by Congress, the FDA began in January 2015 to regularly publish a "Drug Trials Snapshot" for every new drug approved, delineating the demographic breakdown for clinical trial participants by sex, race and age subgroups. ProPublica's analysis focused on participants in trials for the 31 cancer drugs approved since then, comparing their demographics with data from the National Cancer Institute on the incidence of various cancers by race.
Eighteen of those drugs targeted cancers that are at least as likely to afflict black Americans as white Americans. On average, only 4.1 percent of patients in those trials were black. Trials for four multiple myeloma drugs, including Ninlaro, averaged 5 percent black participation.
Source: U.S. Food and Drug Administration; National Cancer Institute (Riley Wong for ProPublica)
An FDA study over a longer time period corroborated ProPublica's findings. In a 2017 article in the journal Blood co-authored by Richard Pazdur, the FDA's cancer chief, the agency reported that black patients on average made up 4.5 percent of participants in trials for multiple myeloma drugs since 2003. Higher enrollment of minorities in myeloma trials would have "multiple benefits," the FDA scientists noted. Not only would "underserved populations" gain access to new therapies, but additional data could help researchers identify subtypes of the blood cancer and develop targeted treatments.
A similar pattern emerges for treatments of non-small cell lung cancer. It occurs in 56 out of 100,000 black Americans, versus 49 out of 100,000 white Americans. Yet ProPublica found that in trials for two recently approved drugs for a type of non-small cell lung cancer driven by a mutation in what is known as the ALK gene, less than 2 percent of participants were black.
Those drugs, Takeda's Alunbrig and Genentech's Alecensa, are approved for patients whose lung cancer has spread to other parts of the body. In trials, both drugs were able to shrink tumors, including lesions in the brain. Patients taking Alecensa lived without the disease progressing for an average of 25.7 months, more than double the 10.4 months for patients on another treatment.
"We believe that we must consider differences across all populations to deliver on the promise of personalized health care," said Meghan Cox, a Genentech spokeswoman, adding that the drugmaker is "continuing to study patient response to Alecensa across populations in the post-marketing setting."
Source: U.S. Food and Drug Administration; National Cancer Institute (Riley Wong for ProPublica)
Similarly, prostate cancer affects 178 out of every 100,000 African Americans, more than for any other race in the U.S., compared to 106 out of every 100,000 white Americans. Black Americans are twice as likely as white Americans to die from prostate cancer.
Yet from 2009 to 2015, in seven trials conducted for five new prostate cancer therapies, only 3 percent of participants were black, according to a study conducted by Dr. Daniel Spratt, vice chair of research for the department of radiation oncology at the University of Michigan. More recently, 11 times as many white as black participants — or 66 percent compared to 6 percent — joined trials for Johnson & Johnson's new prostate cancer treatment, Erleada.
The FDA approved Erleada in February after trials showed patients on the drug lived an average of two years longer without their cancer spreading into other organs than if they were taking a placebo. In a J&J press release, physicians hailed Erleada's "impressive clinical benefits" for prostate cancer patients.
J&J is "confident in the efficacy and safety data that have supported the approval" of Erleada, J&J spokeswoman Satu Glawe said.
Source: U.S. Food and Drug Administration; National Cancer Institute (Riley Wong for ProPublica)
Like Genentech, J&J and Takeda said they track drugs after approval to see if any racial differences emerge. For example, after another J&J drug for prostate cancer, Zytiga, went on the market in 2011, the company ran a new study of 100 patients, 50 black and 50 white.
"We were aware of the low number of African American men" in the pre-approval drug studies of Zytiga, Glawe said. The post-marketing study was intended "to ensure the medication was also providing clinical benefit to these patients." In fact, it showed that black men responded better than white men to the drug.
The FDA is able to look for signs that an approved drug isn't helping a specific population through a surveillance system launched in 2016, called Sentinel, which provides access to medical claims and other data on 200 million Americans obtained from insurers and other health providers, Sherman, the FDA's principal deputy commissioner, said.
Still, post-marketing surveillance doesn't compensate for lack of diversity in clinical trials. Minorities still miss out on experimental treatments — and, if they take a drug once it's approved, may suffer unanticipated side effects.
Leaving analysis of a drug's effect on minorities until it's already on the market is "a hubristic assumption, unnecessarily arrogant," Jackson said. Drugs should "work for the individuals who are the most vulnerable," he said. "That necessarily includes racial and ethnic minorities."
Like African Americans, Native Americans rarely enroll in clinical trials. Among the drug trials analyzed by ProPublica, 64.5 percent did not report any Native American participants, even for types of cancer that Native Americans get at similar rates as other races. (It's possible that some Native Americans were enrolled but lumped into a generic "other" category.)
Native Americans are at higher risk of colorectal cancer than white or Asian Americans. Yet the drugmaker Taiho Oncology didn't report a single Native American among the 800 participants in its trials for the colorectal cancer treatment Lonsurf. Taiho didn't respond to requests for comment.
To understand how a small minority group responds to a drug, researchers might have to enroll more patients than what would be a nationally representative sample. In a trial of 100 people, two Native American or Alaska Native patients would reflect those groups' proportion of the U.S. population, but wouldn't give doctors enough information about race-related impacts.
Dr. Linda Burhansstipanov, founder of the Native American Cancer Research Corporation, estimated that 85 percent of Native Americans want to participate in clinical trials when informed of the opportunity. She knows several Native American patients who drove three hours each way to participate in a trial, despite losing an entire day of work.
Still, trial protocols are rarely designed with minority communities in mind, Burhansstipanov said. It has long been rumored among Native Americans, she said, that a clinical trial in the 1990s required patients to take a medication upon rising in the morning. In many Native American tribes, the first thing people do when they wake up is greet the sun with morning prayers. For some tribes, prayers can take more than half an hour. Because of the delay, the tale goes, Native American patients were kicked out of the clinical trial for violating the protocol. "The story spread and became a barrier for people to take part in clinical trials," she said.
In addition, the history of unscrupulous medical experimentation on minorities feeds wariness of clinical trials. Angela Marshall, an internal medicine doctor and board member of Black Women's Health Imperative, said she sees a "lack of excitement among minority communities for clinical trials, coming from a mistrust of the medical community."
Her black patients often cite the infamous Tuskegee study, conducted from 1932 to 1972 by the U.S. Public Health Service, in which researchers knowingly withheld treatment from African American sharecroppers with syphilis in order to study the progression of the disease. Some Native Americans are similarly suspicious of the medical community, Burhansstipanov said, because the Indian Health Service (a unit of the U.S. Department of Health and Human Services) sterilized thousands of Native American women in the 1970s without their consent.
"The medical community has to engage in some serious trust-building initiatives," Marshall said.
That trust is what has helped to keep Thomas Goode alive. An African American diagnosed with multiple myeloma in 2005 when he was 34, Goode has endured three stem cell transplants. In between each transplant, he participated in clinical trials, where he gained access to drug cocktails that helped bridge him to the next procedure. He counted himself lucky that he lived close to Durham, North Carolina, which is a research hub, so he was able to see specialists and take part in trials.
"I never knew anything about clinical trials, but a lot of my trust and faith was in the doctor," he said. "I said, 'I trust you, doctor, whatever you say.'"
Now, Goode has gone six years without a relapse. "I'm in a good place right now," he said, "But if I didn't try a trial, who's to say I would still be here?"
For years, North Carolina has bet against a storm like Hurricane Florence.
Even as nationally known insurance companies pulled out of the state's coastal communities, development boomed along the shore, despite the threat from a megastorm like Harvey or Maria.
In the face of warnings that climate change was making such storms more common, the state-created "insurer of last resort" has written policies for thousands of coastal properties worth tens of billions of dollars.
With Hurricane Florence headed straight for North Carolina, the state faces not only a natural disaster but a financial reckoning.
According to the most recent totals available, from 2017, the state-created insurance plan had access to about $3 billion in reserves, reinsurance, and contributions from insurance companies to repair and rebuild damaged homes and properties. It could need a lot more than that if it were to be hit by a storm comparable to Harvey, which devastated Houston last year. Insurers estimate that the total payout from claims related to Harvey will reach $19.4 billion, according to the Texas Department of Insurance.
"I hate to say it, but all of us who want to live on the coast, we are living on borrowed time," said David Redwine, a vice president of Coastal Insurance in Shallotte, North Carolina, and a former state representative. "We've been lucky, but will we be lucky in the future? There's no guarantee of that."
Today, the Coastal Property Insurance Pool, which was created by North Carolina legislators and is run by a nonprofit association of commercial insurers, insures more than three-quarters of all coastal property. As of June, the beach plan, as it's called, had 198,039 coastal policies representing roughly $74 billion in potential liability. Over the last 12 years, the plan has taken on an additional $20 billion in exposure.
There are safeguards: Private insurers promise to pay a portion, and the plan has a reserve fund and buys an insurance policy of its own. But if a large enough coastal disaster strikes, every person who insures property in North Carolina, from tobacco farmers hundreds of miles from the coast to the wealthy second-home owners who chose to build stilted cottages dipping into ocean waves, will also have to help foot the bill.
North Carolina officials say that is unlikely to happen. They say the plan is prepared to handle billions of dollars in losses, and they also point to historical trends that show the worst storms have occurred inland, and not on the coast. The North Carolina Insurance Underwriting Association, which administers the coastal insurance pool, said it "believes that it is prepared" for a major storm or series of storms. Alvin Ashworth, the association's assistant general manager, said via email that based on analysis of multiple weather models, the organization had concluded that the likelihood of a storm disaster big enough to trigger the statewide surcharge was "nearly de minimis," or so low that it that it hardly merited consideration.
But climate change has made those patterns less reliable predictors of future weather. Scientists and experts who work with data to predict storm patterns for the insurance industry all say future storms will be stronger and develop faster. Recent research even suggests a "Category 6" may be in the making — the strongest hurricanes are currently rated as Category 5.
Hurricane Harvey, which deluged Houston and the Texas coast, is ample evidence of the limits of traditional storm prediction. The storm and the ensuing floods — which had less than a 0.2 percent chance of occurring in a given year and had no historical precedent — caused around $125 billion in damage, including the $19.4 billion in insured losses. While much of the destruction was caused by flooding, which is covered by a federal insurance program, the scale of the storm was enough to make any state reconsider even the best-funded plans.
Harvey's insured losses were more than five times more than what North Carolina's coastal plan is currently financially prepared to handle. So if a storm with comparable consequences struck North Carolina, tens of billions of dollars in costs could be spread among every insurance customer in the state for years.
"States aren't intending to mislead people about the risk," said Cynthia McHale, director of insurance at Ceres, a sustainability advocacy group. "[But] it does mask the fact that the risks are increasing. The consequence is that action is delayed, people aren't getting the signal."
Florence, the first hurricane to hit North Carolina this season, is massive. The eye of the storm was 28 miles wide as Florence made landfall as a Category 1 hurricane Friday morning. Up to a million people had evacuated from the path of the storm, officials said, and more than 120 shelters were providing refuge for at least 12,000 people across the state. More than 320,000 people were already without power, as weather officials issued dozens of flash flood warnings Thursday evening. The National Hurricane Center, for days, forecasted that Florence would bring "life-threatening" storm surges and "catastrophic" floods.
"Today, the threat becomes a reality," Gov. Roy Cooper said during a press conference Thursday. "We cannot underestimate this storm."
North Carolina is a prime example of how states are pushing aside the difficult task of dealing with climate change by subsidizing insurance and blunting free-market signals that might discourage building new properties along the coast's most vulnerable areas.
Traditionally, residents and businesses would turn to the private market to buy property insurance. But where the market won't go, state legislatures can step in to fill in the gaps.
Fair Access to Insurance Requirements, or FAIR, plans were created as part of a congressional push in the late 1960s to inoculate cities from blight caused by race riots and allow people living in those areas to obtain reasonably priced insurance. Around the same time, several states along the Atlantic and Gulf coasts created plans to provide windstorm coverage for residents.
In 1990, these "markets of last resort" held just $54.7 billion in exposure. By 2011, that jumped to nearly $1 trillion, tracking development and the rise in tax base along with it.
Insurers considered shifting their business away from coastal areas after a series of intense storms battered the Atlantic and Gulf coasts in the early 2000s. There seemed to be no way to predict which storms would become "mega-hurricanes," insurers said, and that rattled an industry that is all about predictability. From Hurricanes Charley, Frances and Ivan to Katrina in New Orleans, insurers said their risk projections far exceeded what they were permitted to charge in premiums.
"People who live on the coasts oftentimes believe they should not be subjected to premiums that fully reflect their risk," said Robert Hartwig, former president of the Insurance Information Institute, an industry association. "They believe they should be entitled to some form of subsidy."
Even as insurers pulled back from vulnerable coastlines, states continued to see those same regions as prime real estate. Whether those states had climate change policies in place or not, many of them accepted the increased risk as they reaped the benefits of more development. In Florida, the financial strain of this arrangement has become a subject of considerable public concern.
If officials bend to pressure from real estate developers who want to build in coastal areas, "you end up with states suppressing rates so you can expand swampland or coastal development," said Robert Gordon, senior vice president of policy research at the Property Casualty Insurers Association of America, a lobbying group.
States all along the coast insure property some private companies wouldn't touch.
In Florida, a perennial target of hurricanes, Citizens Property Insurance Corp. — the state's insurance pool — saw its insurance liabilities balloon alongside investment in South Beach. By 2012, Citizens insured much of Florida's coastline, with exposure of $500 billion.
Florida has since taken steps to shift more policies to private insurance companies, but in other states, the plans still shoulder an enormous financial liability. In 2011, this exposure peaked at nearly $1 trillion, according to the Insurance Information Institute.
The federal National Flood Insurance Program, which allows property owners in flood-prone areas to insure their properties, is the best known government-backed disaster insurance program. Experts said the program, by insuring homes in flood plains, counters the market forces that would otherwise make such policies prohibitively expensive for most homeowners. State-backed coastal insurance plans do the same thing for people living in coastal areas, said Professor Kyle Logue of the University of Michigan Law School, who wrote a paper on state insurance plans and said he is concerned by the effects of such policies.
"The hope is that the private market would dominate, but … that's not how it's worked out," he said. "The government insurer winds up providing the only policies that people actually buy."
Beyond the market, what truly kept coastal states like North Carolina from financial disaster was an unusual calm in the Atlantic hurricane patterns in recent years.
"We are just at the front end of discovering what the impacts are when these risks come home to roost," said Rachel Cleetus, lead economist and policy director at the Union of Concerned Scientists.
Coastal North Carolina's vulnerability to hurricanes has long made it an expensive bet for insurers. But as concerns grew about climate change in the early 2000s, the industry sought to self-correct.
Allstate and North Carolina Farm Bureau Mutual Insurance shrunk the number of policies they wrote covering wind damage in 2005; State Farm stopped writing new homeowner policies for houses within a mile of the ocean in 2006. By the end of 2008, Farmers Insurance and Encompass Insurance announced they, too, were backing away from the coast. The companies continued to write policies in the state's interior.
Companies blamed the state coastal insurance plan — and the potential uncapped liabilities they faced after a disaster — as reason enough to flee the area.
In 2008, an actuarial firm commissioned by an insurer trade group found that the coastal insurance plan was not financially prepared to weather a catastrophic storm. The plan already insured some $70 billion worth of property, and was adding about $1 billion in exposure every month, according to reports, yet it had no more than $1.5 billion in cash on hand to pay for claims.
That meant if a storm hit, private insurers could be forced to make up the difference.
"When we added it up, our executives saw our liability — that we'd be paying double what we collect," a Farmers Insurance spokesman said at the time.
In an effort to keep the companies writing policies, North Carolina went to great lengths to insulate insurance companies from the risks.
In 2009, the legislature put a $1 billion cap on the assessments the plan could collect from its members, and it directed profits from premiums to the plan's cash reserve to pay for losses, operating expenses and reinsurance. But legislators also created a mechanism to pass along big bills to the public; property insurance policyholders statewide could be assessed up to 10 percent of their annual premium each year until the claims were settled.
The plan bought $1 billion in reinsurance to bolster its finances, and in total, these measures provided nearly $3 billion in financial protection. Insurers and other experts agree that the changes strengthened the beach plan's finances.
"It didn't remove the bomb," Wayne Goodwin, former North Carolina insurance commissioner, said. "But it did extend the fuse quite a bit. It bought us some time."
Though some smaller insurers moved into North Carolina, the bigger insurance companies, by and large, have never returned to the coast.
Meanwhile, building in coastal North Carolina only accelerated.
Developers flocked to the area, constructing 113,231 new homes between 2000 and 2014, according to Zillow data. Taxable property values — including real estate, vehicles and other personal property — in the 18 coastal counties grew by $479.6 billion between 2004 and 2016.
The worst storm to hit North Carolina in recent memory was in 2016.
Hurricane Matthew made landfall at the South Carolina border and brought heavy rains and flooding to southeastern North Carolina. It dropped nearly 19 inches of rain in some communities, inundating homes and roads. The state emergency management agency found that Hurricane Matthew caused an estimated $4.8 billion in damage to property, roads, public facilities and agriculture.
Climate scientists, however, say Matthew isn't representative of North Carolina's risk. It had weakened considerably by the time it approached the state, and the storm's eye skirted the Outer Banks. Instead, experts point to two smaller storms — Bertha and Fran — in 1996, which delivered successive blows to the state's vulnerable coast.
Bertha hit the state that July as a Category 2 hurricane, but it quickly lost steam as it crossed the state. Still, the storm brought heavy rains, gusting winds and 10-foot storm surges that eroded beaches along Cape Fear and Cape Lookout. A main road in North Topsail Beach collapsed, and a quarter of the town's homes lost their roofs. Statewide, more than 400,000 people were left without power. Surveys found the storm destroyed more than 1,100 homes and damaged an additional 4,000. The losses totaled $1.2 billion in North Carolina.
Then, just two months later, as the state was still recovering, Fran hit.
At the time, local news reports compared Fran to Hurricane Hazel, the Category 4 storm that struck on the border of the Carolinas in 1954. South Carolina officials told tourists and residents to evacuate for Fran; those who refused "were asked to disclose their next of kin."
Fran crossed over Bald Head Island, North Carolina, as a Category 3 hurricane and then meandered north, taking 90 minutes to carve a 35-mile path of destruction from Cape Fear to Wilmington. Fran's top wind speed whipped at 124 miles per hour. With the storm came a 12-foot storm surge and overwash that destroyed dunes and drowned beaches from Carolina Beach to Wrightsville Beach and Topsail Island in up to 8 feet of water. In North Topsail Beach, a double-wide trailer doubling as police headquarters was lost.
"Everything that Bertha didn't get, Fran got from a different direction," the mayor of North Topsail Beach at the time, Marty Bostic, told the Charlotte Observer.
The twin impact of Bertha and Fran caused more than $10 billion in damage to North Carolina alone. That matches what both climate scientists and the insurance industry's modelers say is far more likely in the future as storms become more frequent, and more intense.
Dr. José Baselga, the hospital's chief medical officer, stepped down days after a report by ProPublica and the New York Times that he failed to disclose millions of dollars in payments from the health care and drug industry in research articles.
This article first appeared September 13, 2018 on ProPublica.
Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles.
The revelations about Baselga's disclosure lapses, reported by The New York Times and ProPublica last weekend, have rocked Memorial Sloan Kettering, one of the nation's leading cancer centers, in recent days. Its top executives scrambled to contain the fallout, including urgent meetings of physician leaders and the executive committee of its board of directors.
In his resignation letter released Thursday, Baselga, who also served as the physician-in-chief, said he feared that the matter would be a distraction from his role overseeing clinical care and that he had been "extremely proud" to work at Memorial Sloan Kettering.
"It is my hope that this situation will inspire a doubling down on transparency in our field," he said, adding that he hoped the medical community would work together to develop a more standardized system for reporting industry ties.
In an email sent to the staff Thursday evening, Dr. Craig B. Thompson, the hospital's chief executive, said that Baselga had made "numerous" contributions to Memorial Sloan Kettering, patients and cancer treatment. Dr. Lisa DeAngelis, the chairwoman of neurology, will take over as acting physician-in-chief until Baselga's successor is hired.
The resignation was effective immediately, and he will have no continuing role at the cancer center, although he will stay for two weeks to ease the transition, said Christine Hickey, a spokeswoman for the cancer center.
Thompson echoed comments he made to the hospital staff on Sunday, saying that the cancer center had "robust programs" in place to manage employees' relationships to outside companies, but that "we will remain diligent." He added, "There will be continued discussion and review of these matters in the coming weeks."
Baselga, a prominent figure in the world of cancer research, omitted his financial ties to companies like the Swiss drugmaker Roche and several small biotech start-ups in prestigious medical publications like the New England Journal of Medicine and the Lancet. He also failed to disclose any company affiliations in articles he published in the journal Cancer Discovery, for which he serves as one of two editors in chief.
All told, ProPublica and The Times found that Baselga had failed to report any industry ties in 60 percent of the nearly 180 papers he had published since 2013. That figure increased each year — he did not disclose any relationships in 87 percent of the journal articles that he co-wrote last year.
In an interview and later statement, Baselga said he planned to correct his conflict-of-interest disclosures in 17 journal articles, including in the New England Journal and the Lancet. But he contended that in dozens of other cases, no disclosure was required because the topics of the articles had little financial implication. He also said his failed disclosures were unintentional and should not reflect on the value of the research he conducted.
Baselga and Memorial Sloan Kettering said that he had disclosed his industry relationships to the cancer center.
The New England Journal and the Lancet, as well as professional societies like the American Society of Clinical Oncology and the American Association for Cancer Research, said they were conducting reviews of Baselga's disclosure practices after inquiries from The Times and ProPublica. Baselga was president of the AACR in 2015 and 2016 and appears to have violated disclosure rules for reporting conflicts of interest during that period.
In his statement Thursday, Baselga said that he took full responsibility for his disclosures and that he had already submitted updates to medical journals "and will continue to do so until the record is complete."
A spokeswoman for the New England Journal, Jennifer Zeis, said in an email Thursday that Baselga had submitted changes to his disclosures but that editors had questions for him before the articles could be corrected. A spokeswoman for the AACR said that organization was continuing to review Baselga's disclosures.
Baselga, 59, is an expert in breast cancer research and played a key role in the development of Herceptin, which was developed by Genentech, a subsidiary of Roche. He came to Memorial Sloan Kettering in 2013 after serving as chief of hematology and oncology at Massachusetts General Hospital in Boston. Before that he was a leader at the Vall d'Hebron Institute of Oncology in Barcelona, Spain.
Medical journals and professional societies have imposed stricter rules about reporting relationships to industry after a series of scandals a decade ago in which prominent physicians failed to disclose payments from drug companies. But medical journals have said they don't routinely fact-check authors' disclosures, and much is left to the honor system.
Ethicists say that outside relationships with companies can shape the way studies are designed and medications are prescribed to patients, allowing bias to influence medical practice. Reporting those ties allows the public, other scientists and doctors to evaluate the research and weigh potential conflicts.
Jeffrey S. Flier, who was dean of the Harvard Medical School from 2007 to 2016, said medical leaders should be held to a higher standard.
"The higher you are in the organizational structure, the more important it is that you fulfill those obligations," he said. "You're not just another faculty, you're also a faculty to whom other people look up and your reputation is tied to the institution's reputation."
That said, he added, relationships between academic faculty members and the health care industry are essential to developing new drugs.
Baselga has extensive ties to a range of companies, including sitting on the board of the large pharmaceutical company Bristol-Myers Squibb and serving as a director of Varian Medical Systems, which sells radiation equipment and for whom Memorial Sloan Kettering is a client.
Baselga has served on the boards of at least four other companies since 2013, and the positions required him to assume a fiduciary responsibility to protect the interests of those companies, even as he oversaw the cancer center's medical operations. Baselga and Memorial Sloan Kettering have said the cancer center has put firewalls in place to prevent any conflicts.
Baselga received nearly $3.5 million in payments from drug, medical equipment and diagnostic companies from August 2013 through 2017, according to Open Payments, a federal database that tracks payments to physicians from health care companies. Most of that amount, about $3 million, involved a payment from Genentech for Baselga's ownership interest in a company it acquired, Seragon Pharmaceuticals, in 2014.
But the $3.5 million in the Open Payments database does not include payments from companies that don't have products approved by the Food and Drug Administration. Such companies are not required to report their payments under federal law.
For instance, Infinity Pharmaceuticals, a start-up with no approved drug, paid Baselga nearly $250,000 in cash and stock options for serving on its board from 2015 to 2017. He declined to disclose how much he received from such companies.
Baselga was one of the highest-paid staff members at Memorial Sloan Kettering, earning more than $1.5 million in 2016, the most recent year for which the nonprofit's financial filings are available.
The move comes after ProPublica and The New York Times reported that one of its top executives failed to report payments from drug and health care companies in dozens of medical journal articles.
This article first appeared September 31, 2018 on ProPublica.
By Charles Ornstein, ProPublica, and Katie Thomas, The New York Times
The chief executive of Memorial Sloan Kettering Cancer Center sent an email to all staff members on Sunday saying that the institution and its faculty "need to do a better job" of disclosing their relationships with the drug and health care industries.
"The matter of disclosure is serious," wrote the executive, Dr. Craig B. Thompson, along with Kathryn Martin, the chief operating officer.
The email, which was labeled an "important message," referred directly to an article published this weekend by ProPublica and The New York Times about the failure of Dr. José Baselga, the cancer center's chief medical officer, to disclose his extensive industry relationships in dozens of research articles since 2013.
The Times and ProPublica found that Baselga had received millions of dollars in consulting fees and in ownership interests in health care companies, but had often failed to disclose those ties in appearances at scientific conferences and in journal articles. His reporting failures included articles in prestigious publications like the New England Journal of Medicine and the Lancet as well as in Cancer Discovery, a journal for which he serves as one of two editors in chief.
Baselga acknowledged that he had frequently failed to disclose industry connections, and said he planned to correct the record in 17 recent articles. But he disputed whether he should have disclosed his ties in dozens of other cases, saying that the articles involved early-stage research for which there was little financial implication for companies.
Several institutions, including the New England Journal of Medicine and the American Society of Clinical Oncology, have said they are looking into his disclosures. The American Association for Cancer Research said it had also begun a review of Baselga's reporting practices. Baselga appears to have violated disclosure rules while he was president of that organization in 2015 and 2016. The AACR also publishes Cancer Discovery.
In the email, Thompson and Martin described the guidelines for reporting industry relationships as "nebulous," adding that "we need to work with journal publishers and professional societies to standardize the reporting process." They said they had been discussing the issue with ASCO, the cancer group, which has pushed for more standardized disclosure.
A decade ago, a series of scandals relating to hidden payments by drug companies to prominent physicians prompted medical journals and professional societies to beef up their reporting requirements. But as Baselga's case and others demonstrate, much is still left to the honor system. Medical journals have said they don't routinely fact-check authors' disclosures.
In comments to The Times and ProPublica, the New England Journal of Medicine acknowledged that the problem of failed disclosures is "widespread" and said it was putting in place a better system to track authors' disclosures. Two of the articles that Baselga said he planned to correct were published in that journal.
Baselga has served since March on the board of Bristol-Myers Squibb, a major manufacturer of cancer drugs, and since 2017 on the board of Varian Medical Systems, which sells radiation equipment to cancer centers, including to Memorial Sloan Kettering.
Baselga received nearly $3.5 million in payments from drug, medical equipment and diagnostic companies from August 2013 through 2017, according to Open Payments, a federal database that tracks payments to physicians from health care companies. The bulk of that amount, about $3 million, involved a payment from Genentech, a subsidiary of the Swiss pharmaceutical giant Roche, for Baselga's ownership interest in a company it acquired, Seragon Pharmaceuticals, in 2014.
But that total amount does not include many companies with which Baselga has ties that do not report physician payments to the federal database because they are biotech start-ups without any products approved by the Food and Drug Administration. Baselga declined to provide a tally of the money he has received from such companies.
Memorial Sloan Kettering employs about 17,000 people and conducts hundreds of clinical trials.
In the email to staff, Thompson and Martin closed by affirming the value of working with the health care industry.
"Collaboration with industry leaders, from early stage start-ups to large corporations, is necessary to focus on bringing better treatments to patients," they said.
Christine Hickey, a spokeswoman for Memorial Sloan Kettering, said the cancer center had no further comment.
The CMS inspector's notes suggest a tense and dysfunctional transition more than two years ago as the heart transplant program, long known as one of the best in the nation, made staffing changes aimed at improving care.
This article first appeared September 31, 2018 on ProPublica.
For months, officials at Baylor St. Luke's Medical Center have declined to specify the factors behind a rash of patient deaths in the hospital's heart transplant program three years ago.
But a newly released federal document describes program leaders as more blunt in their assessment when regulators questioned them privately in December.
In an interview with the Centers for Medicare and Medicaid Services, one of the hospital's top heart transplant physicians blamed the program's struggles, at least in part, on "a retiring surgeon" — a "legend" — who "wouldn't stop performing transplants," according to typed notes prepared for CMS.
The notes, obtained by ProPublica and the Houston Chronicle under the Freedom of Information Act, do not identify anyone by name, but the descriptions make clear that the physician being interviewed could only be Dr. Andrew Civitello, the program's top cardiologist. And there was only one retirement-age transplant surgeon at St. Luke's in 2015 who could be described as a legend in the field of heart surgery: Dr. O.H. "Bud" Frazier, who is one of the world's most prolific heart transplant surgeons.
Civitello acknowledged through a hospital spokeswoman that he spoke with CMS about changes in staffing at the transplant program but said the notes did not accurately reflect his remarks. Frazier did not respond to messages seeking comment for this story.
A spokesman for CMS said the agency stands behind the findings documented in its inspection reports and the notes that support them.
The inspector's notes shed new light on how doctors at the hospital accounted for poor transplant outcomes that triggered federal scrutiny and led to the loss of Medicare funding. Combined with other details made public in recent months, the notes suggest a tense and dysfunctional transition more than two years ago as the heart transplant program, long known as one of the best in the nation, made staffing changes aimed at improving care.
Additional records reviewed by ProPublica and the Chronicle reveal this was not the first time the renowned transplant program has had an unusually high rate of patient deaths and considered changes.
According to the CMS inspector's notes, the unnamed physician whose job description matches that of Civitello explained that a "very good" surgeon was hired to replace an aging surgeon, but the replacement "eventually left in frustration." Dr. Hari Mallidi joined St. Luke's as a top transplant surgeon in 2012 and left in mid-2015 for a job at a Harvard-affiliated teaching hospital.
"That left the program with an old surgeon and an inexperienced surgeon. Had many deaths in a short period of time," the notes said of Civitello's commentary, apparently referring to Frazier, 78, and Dr. Steve Singh, a junior surgeon at the program until 2016 and the only St. Luke's physician from that time who matches that description. Singh did not respond to requests for comment.
In a statement provided by St. Luke's, Civitello said: "The notes you provided are not my words and do not accurately reflect my comments. My conversation with the surveyor focused on the new policies and procedures we put in place to strengthen the heart transplant program, including the addition of intensivists in the ICU, internal lab analysis for consistency, and other measures."
In response to questions for this story, CMS said inspectors take handwritten notes during hospital visits and that it has the "highest confidence" that they accurately reflect what they see and hear.
In 2015, seven out of 21 heart transplant recipients at St. Luke's died within a year of their surgeries, significantly more than would have been expected. During a meeting with reporters in January about what led to the deaths, hospital leaders said only that the program slowed down that year and identified subtle ways to improve care. At the start of 2016, the hospital brought in a new surgeon, Dr. Jeffrey Morgan, to lead the program.
The CMS notes were written in December when at least one inspector visited the hospital to evaluate its poor transplant outcomes. The resulting report, obtained early this year by ProPublica and the Chronicle, referred to a St. Luke's physician who "explained that issues were identified with the major issue being surgical technique with one of the heart transplant surgeons, who was no longer practicing." The document did not provide any additional details, but the newly released notes suggest that the statement referred to Frazier.
In April, a St. Luke's spokeswoman told reporters that "we did not discuss the technique of any individual surgeon with CMS" and that it would be "presumptuous to infer that the surgeon CMS referenced is Dr. Frazier."
Civitello was not the only St. Luke's physician interviewed by CMS in December who discussed the program's surgical staffing.
The inspector also interviewed a St. Luke's heart transplant surgeon, according to the newly released notes, who "explained that one surgeon had bad outcomes" in 2015 and that the deaths that year were due in part to the way in which the hospital was selecting patients eligible for transplants as well as the donor hearts it accepted for them. The unnamed doctor told the inspector that he was hired after the rash of poor outcomes in 2015 and that he reviews all organ offers; only Morgan matches that description.
It is not clear, based on the details provided, which surgeon Morgan was blaming for the poor outcomes that occurred prior to his arrival at the program. Morgan did not respond to a request for comment and the hospital did not provide one on his behalf.
In the January interview, Morgan, 44, spoke glowingly of his predecessor, saying that it had been "very, very special" to work with him and learn from him on a daily basis. During that same interview, Civitello told reporters that Frazier "is the heart and the soul of our organization."
In the written statement this week, Civitello said, "We are grateful for Dr. Frazier's decades of service, innovation and sacrifice to our patients, our community and the advancement of treatments for those who are critically ill facing heart failure."
Frazier, who started the heart transplant program in 1982, stopped operating as its lead surgeon sometime in 2015. In a previous interview, Frazier said that he merely consulted on heart transplants during the period in question and that he personally made the decision to stop operating that year because of his age.
"I told them I was getting tired of being up all night," Frazier said in April of his exit from the operating room three years ago. "I was 75, and I just told them I wasn't going to do that anymore."
ProPublica and the Chronicle sent the hospital and its affiliated Baylor College of Medicine a list of questions about its interactions with Frazier and his outcomes, but the hospital declined to answer them "given the pending litigation between Dr. Frazier and the two of you, the Houston Chronicle, and ProPublica." Frazer is suing the news organizations and its reporters following an article published about him in May.
That article detailed, among other things, below-average one-year survival among Medicare patients who received an implantable heart pump from Frazier between 2010 to 2015, his final years operating. ProPublica and the Chronicle did not assess Frazier's transplant outcomes.
In previous interviews, as well as in the legal complaint, Frazier has emphasized his willingness to operate on "mortally ill" patients who have been turned away by other surgeons and are often at a higher risk of dying after surgery.
Frazier has remained active in the heart program after 2015, conducting research and sometimes advising surgeons during complex operations.
A newly published book, "Ticker," which details Frazier's decades-long quest to develop an artificial heart, touches on the hospital's concerns about his surgical outcomes prior to Morgan's arrival.
"Depending on who you ask," the book's author, Mimi Swartz, wrote, "Bud either asked to operate less because of his back or his knees, or the hospital tried to ease him out of the operating room. Baylor brought in a much younger man from the Northeast who was supposed to take control; at least now he had most of the titles Bud had always been so proud of."
Swartz, who reported spending many hours interviewing Frazier for the book over the course of several years, describes the relationship between Frazier and Morgan.
"(He) was exceedingly deferential to Bud, treading lightly, as if he were almost embarrassed to be nearby," Swartz wrote, without identifying Morgan by name. "It was like sending in the waterboy to give instructions to the star quarterback."
St. Luke's leaders say the hospital's heart transplant survival rate improved significantly after Morgan took over, though some of his colleagues raised concerns about his surgical performance.
In an interview in April, Frazier made clear that he was not asked to play a role in selecting his replacement: "I didn't hire Jeff. He was hired by the people at Baylor without even consulting me. And the people that hired him never did a transplant. … But he's, you know, he's a hard worker academically."
Some St. Luke's physicians have blamed the heart transplant program's issues in recent years on administrative changes that came after the hospital was purchased by Catholic Health Initiatives in 2013 and, a year later, entered into a joint-operating agreement with Baylor College of Medicine.
But documents reviewed by ProPublica and the Chronicle show that St. Luke's has had poor heart transplant outcomes in the past.
Between 2000and2003, when the hospital was known as St. Luke's Episcopal and the heart transplant program was still run by Frazier, only about 77 percent of the hospital's heart transplant recipients survived at least a year, according to reports published in 2003, 2004 and 2005. Based on an analysis by the Scientific Registry of Transplant Recipients that took into account the severity of patient conditions and the quality of donor organs, about 86 percent of St. Luke's heart recipients should have survived at least a year over that period.
St. Luke's was one of a small number of hospitals nationally to be singled out for statistically worse-than-expected heart transplant outcomes at that time — the same finding that landed the program in trouble with regulators this year. But that was a couple of years before the Centers for Medicare and Medicaid Services began taking punitive action against centers based on their performance, and the hospital faced no public consequences.
The hospital did not respond to questions about its performance in those years, citing Frazier's lawsuit against the news organizations.
In 2007, Dr. James Young, a prominent Cleveland Clinic cardiologist, was hired to review the hospital's heart transplant and mechanical heart pump program. Young's report, which primarily focused on compliance with federal research protocols, concluded that the transplant and mechanical pump program "was rather autocratic with a leader who is opinionated and commanding in authority, but also an incredibly skilled surgeon and driving force." Those issues, along with a willingness to operate on "futile patients," likely contributed to "less than stellar" outcomes after heart transplantation, Young wrote.
Young's confidential report was made public in July when it was filed in Harris County District Court as part of the lawsuit against ProPublica and the Chronicle.
"These issues seem related to an appearance of 'chaos and confusion' that emerged," Young wrote in his 2007 report. "Though leadership of the effort has been well meaning, with the interests of saving the lives of horribly ill patients, the program is in a vulnerable position."
Young identified problems with research practices and documentation, but said "it does not appear that any egregious professional misconduct has occurred."
It's not clear what changes were made at that time.
Mallidi — referred to in the CMS inspector notes as the "replacement surgeon" — was hired five years later, in 2012, around the same time the program's longtime No. 2 surgeon, Igor Gregoric, left St. Luke's to start a heart transplant program at neighboring Memorial Hermann hospital. Frazier continued to serve as the surgical director of heart transplants at St. Luke's, and Mallidi was put in charge of lung transplants.
Mallidi said recently that his relationship with Frazier did not factor in his decision to leave in 2015.
Morgan joined the hospital six months later, in January 2016, and Frazier formally transitioned to a non-surgical leadership post focused on research.
In their communication with federal regulators since then, St. Luke's leaders have said the heart transplant program's outcomes improved in 2016 and 2017, posting one-year survival rates at or above 94 percent, better than the national average.
As a result, St. Luke's can no longer bill Medicare or Medicaid for heart transplants, a move that could lead private insurance companies to follow suit. Experts say the losses could threaten the program's long-term viability and force the hospital to restart the historic program from the ground up.
Administrators say the program remains open and continues to treat the 83 patients on its heart waiting list, but the program — which historically has performed about 45 heart transplants each year — did not perform any in June or July, the latest months for which public data is available.
Hospital officials did not answer Thursday when asked if the program had performed any heart transplants since then.
Memorial Sloan Kettering Cancer Center CMO José Baselga has received millions of dollars in payments from companies that are involved in medical research. His omissions expose how weakly conflict-of-interest rules are enforced by journals.
This article first appeared September 08, 2018 on ProPublica.
One of the world's top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and the Lancet.
The researcher, Dr. José Baselga, a towering figure in the cancer world, is the chief medical officer at Memorial Sloan Kettering Cancer Center in New York. He has held board memberships or advisory roles with Roche and Bristol-Myers Squibb, among other corporations; has had a stake in start-ups testing cancer therapies; and played a key role in the development of breakthrough drugs that have revolutionized treatments for breast cancer.
According to an analysis by ProPublica and The New York Times, Baselga did not follow financial disclosure rules set by the American Association for Cancer Research when he was president of the group. He also left out payments he received from companies connected to cancer research in his articles published in the group's journal, Cancer Discovery. At the same time, he has been one of the journal's two editors in chief.
At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.
Baselga did not dispute his relationships with at least a dozen companies. In an interview, he said the disclosure lapses were unintentional.
He stressed that much of his industry work was publicly known although he declined to provide payment figures from his involvement with some biotech startups. "I acknowledge that there have been inconsistencies, but that's what it is," he said. "It's not that I do not appreciate the importance."
Baselga's extensive corporate relationships — and his frequent failure to disclose them — illustrate how permeable the boundaries remain between academic research and industry, and how weakly reporting requirements are enforced by the medical journals and professional societies charged with policing them.
A decade ago, a series of scandals involving the secret influence of the pharmaceutical industry on drug research prompted the medical community to beef up its conflict-of-interest disclosure requirements. Ethicists worry that outside entanglements can shape the way studies are designed and medications are prescribed to patients, allowing bias to influence medical practice. Disclosing those connections allows the public, other scientists and doctors to evaluate the research and weigh potential conflicts.
"If leaders don't follow the rules, then we don't really have rules," said Dr. Walid Gellad, an associate professor of medicine at the University of Pittsburgh and director of its Center for Pharmaceutical Policy and Prescribing. "It says that the rules don't matter."
The penalties for such ethical lapses are not severe. The cancer research group, the AACR, warns authors who fill out disclosure forms for its journals that they face a three-year ban on publishing if they are found to have financial relationships that they did not disclose. But the ban is not included in the conflict-of-interest policy posted on its website, and the group said no author had ever been barred.
Many journals and professional societies do not check conflicts and simply require authors to correct the record.
Officials at the AACR, the American Society of Clinical Oncology and The New England Journal of Medicine said they were looking into Baselga's omissions after inquiries from The Times and ProPublica. The Lancet declined to say whether it would look into the matter.
Christine Hickey, a spokeswoman for Memorial Sloan Kettering, said that Baselga had properly informed the hospital of his outside industry work and that it was Baselga's responsibility to disclose such relationships to entities like medical journals. The cancer center, she said, "has a rigorous and comprehensive compliance program in place to promote honesty and objectivity in scientific research."
Asked if he planned to correct his disclosures, Baselga asked reporters what they would recommend. In a statement several days later, he said he would correct his conflict-of-interest reporting for 17 articles, including in The New England Journal of Medicine, the Lancet and the publication he edits, Cancer Discovery. He said that he did not believe disclosure was required for dozens of other articles detailing early stages of research.
"I have spent my career caring for cancer patients and bringing new therapies to the clinic with the goal of extending and saving lives," Baselga said in the statement. "While I have been inconsistent with disclosures and acknowledge that fact, that is a far cry from compromising my responsibilities as a physician, as a scientist and as a clinical leader."
The Corporate Imprint on Cancer Research
Baselga, 59, supervises clinical operations at Memorial Sloan Kettering, one of the nation's top cancer centers, and wields influence over the lives of patients and companies wishing to conduct trials there. He was paid more than $1.5 million in compensation by the cancer center in 2016, according to the hospital's latest available tax disclosures, but that does not include his consulting or board fees from outside companies.
Many top medical researchers have ties to the for-profit health care industry, and some overlap is seen as a good thing — after all, these are the companies charged with developing the drugs, medical devices and diagnostic tests of the future.
Baselga's relationship to industry is extensive. In addition to sitting on the board of Bristol-Myers Squibb, he is a director of Varian Medical Systems, which sells radiation equipment and for whom Memorial Sloan Kettering is a client.
In all, Baselga has served on the boards of at least six companies since 2013, positions that have required him to assume a fiduciary responsibility to protect the interests of those companies, even as he oversees the cancer center's medical operations.
The hospital and Baselga said steps had been taken to prevent him from having a say in any business between the cancer center and the companies on whose boards he sits.
The chief executive of Memorial Sloan Kettering, Dr. Craig B. Thompson, settled lawsuits several years ago that were filed by the University of Pennsylvania and an affiliated research center. They contended that he hid research conducted while he was at Penn to start a new company, Agios Pharmaceuticals, and did not share the earnings. Thompson disputed the allegations. He now sits on the board of Merck, which manufactures Keytruda, a blockbuster cancer therapy.
Hickey said the cancer center cannot fulfill its charitable mission without working with industry. "We encourage collaboration and are proud that our work has led to the approval of novel, life-saving cancer treatments for patients around the world," she said.
Some Disclosures Are Required; Others Aren't
After the scandals a decade ago over lack of disclosure, the federal government began requiring drug and device manufacturers to publicly disclose payments to doctors in 2013.
From August 2013 through 2017, Baselga received nearly $3.5 million from nine companies, according to the federal Open Payments database, which compiles disclosures filed by drug and device companies.
Baselga has disclosed in other forums investments and advisory roles in biotech start-ups, but he declined to provide a tally of financial interests in those firms. Companies that have not received approval from the Food and Drug Administration for their products — projects still in the testing phases — do not have to report payments they make to doctors.
Serving on boards can be lucrative. In 2017, Baselga received $260,000 in cash and stock awards to sit on Varian's board of directors, according to the company's corporate filings.
ProPublica and The Times analyzed Baselga's publications in medical journals since 2013, the year he joined Memorial Sloan Kettering. He failed to disclose any industry relationships in more than 100, or about 60 percent of the time, a figure that has increased with each passing year. Last year, he did not list any potential conflicts in 87 percent of the articles that he wrote or co-wrote.
Baselga compiled a color-coded list of his articles and offered a different interpretation. Sixty-two of the papers for which he did not disclose any potential conflict represented "conceptual, basic laboratory or translational work," and did not require one, he said. Questions could be raised about others, he said, but he added that most "had no clinical nor financial implications." That left the 17 papers he plans to correct.
Early-stage research often carries financial weight because it helps companies decide whether to move ahead with a product. In about two-thirds of Balsega's articles that lacked details of his industry ties, one or more of his co-authors listed theirs.
Baselga defended the articles, saying that "these are high-quality manuscripts reporting on important clinical trials that led to a better understanding of cancer treatments."
The guidelines enacted by most major medical journals and professional societies ask authors and presenters to list recent financial relationships that could pose a conflict.
But much of this reporting still relies on the honor system. A study in August in the journal JAMA Oncology found that one-third of authors in a sample of cancer trials did not report all payments from the studies' sponsors.
"We don't routinely check because we don't have those kind of resources," said Dr. Rita F. Redberg, the editor of JAMA Internal Medicine, who has been critical of the influence of industry on medical practice. "We rely on trust and integrity. It's kind of an assumed part of the professional relationship."
Jennifer Zeis, a spokeswoman for The New England Journal of Medicine, said in an email that it had now asked Baselga to amend his disclosures. She said the journal planned to overhaul its tracking of industry relationships.
The American Association for Cancer Research said it had begun an "extensive review" of the disclosure forms submitted by Baselga.
It said that it had never barred an author from publishing, and that "such an action would be necessary only in cases of egregious, consistent violations of the rules."
Among the most prominent relationships that Baselga has often failed to disclose is with the Swiss pharmaceutical giant Roche and its United States subsidiary Genentech.
In June 2017, at the annual meeting of the American Society of Clinical Oncology in Chicago, Baselga spoke at a Roche-sponsored investor event about study results that the company had been counting on to persuade oncologists to move patients from Herceptin — which was facing competition from cheaper alternatives — to a combination treatment involving Herceptin and a newer, more expensive drug, Perjeta.
The results were so underwhelming that Roche's stock fell 5 percent on the news. One analyst described the results as a "lead balloon," and an editorial in The New England Journal called it a "disappointment."
Baselga, however, told analysts that critiques were "weird" and "strange."
This June, at the same cancer conference, Baselga struck an upbeat note about the results of a Roche trial of the drug taselisib, saying in a blog post published on the cancer center website that the results were "incredibly exciting" while conceding the side effects from the drug were high.
That same day, Roche announced it was scrapping plans to develop the drug. The news was another disappointment involving the class of drugs called PI3K inhibitors, which is a major focus of Baselga's current research.
In neither case did Baselga reveal that his ties to Roche and Genentech went beyond serving as a trial investigator. In 2014, Roche acquired Seragon, a cancer research company in which Baselga had an ownership stake, for $725 million. Baselga received more than $3 million in 2014 and 2015 for his stake in the company, according to the federal Open Payments database.
From 2013 to 2017, Roche also paid Baselga more than $50,000 in consulting fees, according to the database.
These details were not includedin the conflict-of-interest statements that are required of all presenters at the American Society of Clinical Oncology conference, although he did disclose ownership interests and consulting relationships with several other companies in the prior two years.
ASCO said it would conduct an internal review of Baselga's disclosures and would refer the findings to a panel.
Baselga said that he played no role in the Seragon acquisition, and that he had cut ties with Roche since joining the board of a competitor, Bristol-Myers, in March. As for his presentations at the ASCO meetings in the last two years, he said he had also noted shortcomings in the studies.
The combination of Perjeta with Herceptin was later approved by the FDA for certain high-risk patients. As for taselisib, Baselga stands by his belief that the PI3K class of drugs will be an important target for fighting cancer.
