Wednesday, August 15, 2018

Transparency 2

There’s a story Bud Frazier tells often. It was around 1966, and Frazier, now one of the world’s most celebrated heart surgeons, was a medical student at Baylor College of Medicine.

An Italian teenager had come to Houston for an aortic valve replacement, but at some point during or after the surgery, the teen’s heart stopped. Doctors told Frazier to reach in and start pumping the failed organ by hand.

As he did so, the teen lifted a hand to Frazier’s face, and in that moment, just before the patient died, he says he realized his life’s calling.

“As long as I was massaging that kid’s heart, he would wake up,” Frazier, now 78, said last year. “I thought then, and I’ve often returned to this: If my hand can keep this kid alive, why couldn’t we make a device to do the same?”

In the five decades since, Dr. O.H. “Bud” Frazier has obsessively pursued that goal, contributing to many breakthroughs in the long and unfinished effort to develop a permanent mechanical replacement for the human heart. Today, devices he tested at Baylor St. Luke’s Medical Center and its research partner, the Texas Heart Institute, are credited with extending the lives of thousands of people worldwide each year.

But out of public view, Frazier has been accused of violating federal research rules and skirting ethical guidelines, putting his quest to make medical history ahead of the needs of some patients, an investigation by ProPublica and the Houston Chronicle has found. Reporters reviewed internal hospital reports, federal court filings, financial disclosures and government documents. The records and interviews with former St. Luke’s physicians show:

Frazier and his team implanted experimental heart pumps in patients who did not meet medical criteria to be included in clinical trials, according to a hospital investigation a decade ago. The findings, which have never been disclosed publicly, prompted St. Luke’s to report serious research violations to the federal government and repay millions of dollars to Medicare.

A former top St. Luke’s cardiologist said he believes that Frazier favored experimental heart pumps over more proven treatments and that Frazier was reluctant to acknowledge when the devices led to serious complications. Two other doctors made similar observations. In one instance, one of them said Frazier discouraged publication of research that found a high rate of strokes in the first group of patients implanted with a pump he championed.

Frazier has often failed to publicly disclose consulting fees and research grants — and in one case, stock options he received and later transferred to his son — from companies that made the pumps he tested. Most medical journals require such disclosure so that other scientists and the public can judge whether personal interests may have influenced research findings.

And a former St. Luke’s nurse alleged that Frazier allowed a researcher who was not licensed to practice medicine in Texas to treat heart failure patients in his program. Her 1994 lawsuit, which was backed by patient records, testimony and secret recordings of hospital employees, revealed that Frazier’s signature stamp was sometimes used to authorize the researcher’s improper medical orders.
Over time, several St. Luke’s and Texas Heart executives were made aware of many of these allegations. But for years, they took little or no action to rein in a doctor whose work continues to earn the hospital international acclaim, according to records and interviews.

Frazier continued to operate on patients well into his 70s, and during those latter years, his Medicare outcomes ranked among the worst in the country. From 2010-15, about half of the traditional Medicare patients who received an implantable heart assist device from Frazier died within a year, nearly double the national mortality rate for such patients, according to a ProPublica analysis of federal data.

In a phone interview in April and subsequent written responses to questions, Frazier denied any wrongdoing and said his patients were sicker and higher risk than those treated at other hospitals…

Supporters defend his actions, arguing that he followed the example of Michael DeBakey and Denton Cooley, the pioneering cardiac surgeons under whom he trained. Both tried untested techniques when the field of heart surgery was in its infancy; Cooley famously obtained an artificial heart from DeBakey’s lab without his approval and implanted it in a patient, becoming the first in the world to do so.

Like his mentors, Frazier was willing to try promising but unproven medical devices to help desperate patients, his allies say. If he broke rules, they say it was to give dying people a shot at survival, a mission that consumed his life. Frazier was so committed to the work, he was known to roam the hospital late into the night checking on patients and often slept on a leather sofa in his office.

Dr. Billy Cohn, a longtime Texas Heart surgeon who has worked closely with Frazier since 2004, defended Frazier’s approach to clinical research: “He had a different view of the world. If he had had the modern view, this field wouldn’t exist, and tens of thousands of patients wouldn’t be alive.”

Dr. Frank Smart, Texas Heart’s top transplant cardiologist between 2003 and 2006, sees it differently. Smart said he admired Frazier’s commitment to developing lifesaving heart pumps, but he believed it led him to surgically implant the devices into some patients who were not yet sick enough to justify what was, at the time, an experimental treatment.

Frazier’s drive likely moved the field forward, Smart said, but he and others worried that it sometimes came at the expense of individual patients.

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