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.
https://www.propublica.org/article/bud-frazier-heart-surgeon-baylor-st-lukes-medical-center-conflicts-of-interest-poor-outcomes
Courtesy of: https://www.medpagetoday.com/publichealthpolicy/ethics/74556
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