This article was produced in collaboration with the Houston Chronicle.
Update, July 20, 2018: This story has been updated to reflect two corrections that have been added to the original story on Dr. O.H. “Bud” Frazier.
During the past month, nearly 50 physicians, researchers, patients and community leaders have authored letters criticizing an investigation by the Houston Chronicle and ProPublica that revealed allegations of serious research violations and ethical breaches by famed Houston heart surgeon O.H. “Bud” Frazier.
Several of the letters supporting Frazier were published in the Houston Chronicle’s opinion pages; others have been shared directly with reporters or compiled on a website that was launched following publication of the article.
Many of the writers lavished praise on Frazier, who helped pioneer mechanical heart pumps and is working to develop an artificial heart. Indeed, the news organizations’ reporting described in detail Frazier’s contributions to his field and included supportive comments from a fellow surgeon and a former patient.
Some letter writers went further, however, saying the story was inaccurate; one called it a “biased smear attempt.” Linda Gale White, the widow of former Texas governor Mark White and a friend of Frazier’s, called it “fake news.”
We stand by our reporting and have corrected two errors.
The story, which revealed that Frazier has been accused of violating federal research rules and skirting ethical guidelines at St. Luke’s Episcopal Hospital (now Baylor St. Luke’s Medical Center) and its research arm, the Texas Heart Institute, was based on internal hospital records, court filings, official reports to federal regulators and interviews with medical professionals. Reporters posted several source documents with the online version of the story.
Frazier had an opportunity to respond to every finding from our reporting before the story was published. We sent extensive and detailed questions to Frazier and a lawyer representing him and repeatedly extended the deadline for them to respond. We took their responses seriously and included them in our story.
Below are specific criticisms of the reporting and our responses:
Claims’ of Research Violations
“We were taken aback by claims that Dr. Frazier violated clinical research protocols and good research practice by implanting left ventricular assist devices (LVADs) in patients ineligible for the studies. … Neither Mr. Hixenbaugh nor Mr. Ornstein had access to the case report forms or requested information from the sponsor of the trial or the physician primary investigators making the source of their allegations pertaining to research misconduct unclear and raising the possibility that other ‘facts’ are inaccurate.” — Dr. Robert L. Kormos, Dr. Joseph G. Rogers, Dr. Mark S. Slaughter, in a letter to reporters
The authors of the letter — three of the primary researchers in the HeartMate II clinical trial — and others characterized the story’s findings as “claims” or “allegations” made by reporters. Texas Heart Institute, St. Luke’s research partner, made a similar statement in a letter to donors this month. These characterizations are incorrect. The findings of research violations in Frazier’s LVAD program reported in our story stemmed from an internal review by top officials at his hospital.
None of the letters written in support of Frazier acknowledge that.
In the 2008 internal report, St. Luke’s concluded that Frazier and his team implanted experimental heart pumps in patients who did not meet medical criteria to be included in clinical trials. St. Luke’s and Texas Heart together reported the violations that year to the federal Office for Human Research Protections and pledged a host of research reforms. (Read the letter they sent to federal officials and other correspondence.)
Despite having self-reported these research violations a decade ago, Texas Heart’s letter in response to our story said the institute had assisted with a review that found no evidence to support the “assertions” made by ProPublica. In fact, Dr. James Willerson, then-president of Texas Heart, co-signed the 2008 letter reporting the research violations in Frazier’s program to the government. In subsequent correspondence with regulators, Texas Heart and St. Luke’s reported auditing all of the studies led by Frazier to find and correct any similar violations.
Our story included, in detail, Frazier’s contention that the hospital’s findings of research violations were incorrect. The story also quoted David Pate, the CEO of St. Luke’s at the time, who said he stood behind the decision to report the research violations and repay millions of dollars to Medicare based on findings of problems in Frazier’s research program.
The letter from the researchers said that we did not request information from the sponsor of the trial or the physician primary investigators. That is not correct. A statement from the trial’s sponsor was included in the story, and prior to publication, reporters sent two emails seeking comment from Slaughter, one of the primary investigators, but he did not respond.
The New England Journal of Medicine, which published studies based in part on Frazier’s research, initially told reporters that it was not aware of any concerns prior to our reporting. In an email this month, a journal spokeswoman wrote that editors subsequently received information about patients enrolled in the trial.
“Based on this information, which is confidential, we are satisfied that the published data are accurate and that the trial is appropriately described. For these reasons, we do not consider it necessary to take further action. The internal Texas Heart Institute review you provided to us focused on the clinical trials of two different devices: the HeartMate II device and the Jarvik 2000 device. NEJM did not publish any data from the Jarvik 2000 study, so we cannot evaluate the veracity of reports from that trial.”
“(Frazier) sacrificed a large financial gain, yet the Chronicle has falsely accused Dr. Frazier of being unethical in his financial dealings.” — Dr. Joe N. Kidd, cardiovascular surgeon
Several letter writers criticized reporters for focusing on Frazier’s financial relationships with device makers, which he often did not disclose in medical journal articles. They maintained that Frazier could have gotten rich off his work developing heart pumps but did not. Frazier made a similar point, which was included in the story.
Regardless of how much Frazier could have earned, he did receive payments from companies that make devices he tested, but he did not fully report these potential conflicts of interest in medical journals. ProPublica and the Chronicle reviewed the past 100 papers on which Frazier was listed as an author, dating to 2010. Frazier disclosed conflicts of interest in less than 10 percent, and those disclosures often were inconsistent and incomplete.
For instance, Frazier received stock options from HeartWare International, which made a continuous flow pump that he helped develop and tested in patients at St. Luke’s. In the midst of working on the device’s clinical trials, Frazier gave those options to his son, who earned $130,813 by exercising them, none of which was disclosed in Frazier’s journal articles.
Most medical journals require such disclosure so that other scientists and the public can judge whether personal interests may have influenced research findings.
As a result of our reporting, the New England Journal of Medicine said Frazier had agreed to submit corrected disclosure forms, according to a journal spokeswoman.
LVAD Mortality Rates
“I am not the least convinced by using the newspaper’s quotes of Medicare mortality figures as a reliable tool to compare surgical outcomes since they are NOT risk-adjusted. Furthermore, these numbers do not take account of how many patients have died while waiting for a heart transplant that never became available. Indeed a surgeon who selects the better risk patients would obviously have better survival at one year, than somebody like yourself who will accept the neediest and sickest patients, without concern about how the publicly available statistics would look down the road.” — Dr. Kamal G. Khalil, adjunct professor of cardiothoracic surgery at UTHealth’s McGovern Medical School, in a letter to Frazier
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. We published an article explaining how we conducted the analysis.
It is correct that the mortality figures were not risk adjusted. That said, the differences between Frazier and other surgeons nationally and at his own hospital were profound. His Medicare outcomes ranked among the worst in the country.
We included in the story that Frazier took issue with ProPublica’s analysis, saying it was “grossly unfair” to focus only on Medicare patients rather than the larger pool of patients the hospital treats, though he did not provide data showing his overall outcomes.
Frazier also said he was rarely the lead surgeon during his final five years operating, from 2010-15, but when asked about this contention, St. Luke’s said it stood behind the accuracy of the numbers it submitted to Medicare.
The Unlicensed Physician
“The Chronicle report on Dr. Branislav Radovancevic is totally a hospital issue. The hospital should have removed him immediately if he didn’t have the correct credentials. Dr. Frazier was never censored (sic) or warned of any wrong-doing. These events occurred over 20 years ago and aren’t relevant at this time. The Chronicle’s attempt to make Dr. Frazier look as bad as it can in the public’s view is unfounded.” — Dr. Joe N. Kidd, cardiovascular surgeon
As reported in the story, Radovancevic completed a fellowship at Texas Heart in the late 1980s but subsequently failed his medical licensing exams and could not practice as a doctor in Texas. Nonetheless, according to a federal lawsuit filed by a former St. Luke’s nurse, Radovancevic continued treating patients, with the knowledge of hospital officials and Frazier.
The lawsuit also alleged that Frazier, Radovancevic and others at the hospital “participated in a scheme” to unnecessarily admit patients to an intensive care unit in order to move them higher on the organ waiting list and increase their odds of receiving a transplant.
Frazier was named as a defendant in the lawsuit and was specifically accused of allowing Radovancevic to treat patients. In some instances, according to documents filed with the court, Frazier’s signature was stamped onto medical orders made by Radovancevic. Frazier testified in a deposition as part of the lawsuit and he was named as a party to a settlement.
We included Frazier’s response, in which he defended Radovancevic as a brilliant researcher who merely offered advice on patient care, and we linked to documents that Frazier’s lawyer said vindicate his position.