This article was produced in collaboration with the Houston Chronicle.
When Houston surgeon O.H. “Bud” Frazier co-authored a research paper about mechanical heart pumps in the New England Journal of Medicine last year, he reported that his only potential conflict of interest was a fellowship in his name established by the maker of one of the devices tested in the study.
“Dr. Frazier does not receive any financial gain from this,” his disclosure said of the fellowship.
In June, Frazier submitted an updated disclosure listing more potential conflicts, including lecture fees and travel reimbursements he received from three medical device makers; one of those was from HeartWare, the company that established the fellowship in his name. The updated disclosure also included travel expenses from a fourth company and a patent granted in 2012 for a pulseless artificial heart system.
The updated disclosures followed an investigation in May by ProPublica and the Houston Chronicle that found, among other things, that Frazier had often failed to fully report potential conflicts of interest related to his research in the field of mechanical heart pumps. Most medical journals require such disclosure so that other scientists and the public can judge whether personal interests may have influenced research findings.
Over the years, the ProPublica and Chronicle investigation found, companies have reimbursed Frazier for travel and paid him consulting and lecture fees; others supported his research with grants. One device maker rewarded him with stock options, corporate filings show, which he later gave to his son.
ProPublica and the Chronicle reviewed the past 100 papers on which Frazier was listed as an author, dating to 2010, and found that he disclosed industry relationships in less than 10 percent. Those disclosures often were inconsistent and incomplete.
Before the story was published, reporters asked the New England Journal about Frazier’s omissions in two specific studies — one from 2009 and one from 2017 — as well as a 2014 letter about a mechanical heart pump. In response to reporters’ questions, editors at the Journal contacted Frazier, and Journal spokeswoman Jennifer Zeis said that Frazier agreed to submit revised disclosure forms.
After the ProPublica and Chronicle story ran, Frazier formally submitted the updated conflict disclosures for both studies and for the 2014 letter. Two of the amended disclosures were posted online last week; the other was posted this week.
For the 2009 article, a clinical trial of the HeartMate II left ventricular assist device, Frazier initially only disclosed reimbursements for travel expenses from Thoratec, the maker of the device. His updated disclosure now also lists consulting and lecture fees from Thoratec and from device companies Terumo Heart and Jarvik Heart, as well as serving on an advisory board for HeartWare and receiving stock options from HeartWare that he subsequently gave to his son.
Frazier also disclosed the patent for a pulseless artificial heart system, which he initially filed in 2008 with another surgeon, Dr. Billy Cohn.
In the case of the 2017 study, Frazier initially reported the fellowship in his name established by HeartWare, the maker of one of the pumps being studied. His updated disclosure form said he had also received lecture fees and travel expenses from HeartWare. In addition, he reported receiving lecture fees and travel expenses from Thoratec and St. Jude, makers of other cardiac devices, and travel expenses from Syncardia, maker of an artificial heart. He also disclosed the patent.
In the letter published in 2014 about his experience with the HeartMate II device, Frazier originally noted that he had no potential conflict of interest relevant to the letter. In the new disclosure, he reported that he had received “consulting fees, lecture fees, and travel support from Thoratec, lecture fees and travel support from HeartWare, and grant support from Thoratec and HeartWare.” He also reported his patent and being a member of the medical advisory board for HeartWare.
Frazier, 78, has received international acclaim for his work developing mechanical heart pumps during the past four decades. Devices he tested over the years 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.
In response to questions from reporters in May, prior to publication of the ProPublica/Chronicle investigation, Frazier said he never made money from his work on behalf of device makers.
“My efforts have never been for personal financial gain,” Frazier wrote in response to written questions, adding that he “freely shared the mechanics of my heart flow pump with all comers, including two companies that later sold for billions of dollars.”
Frazier also said he didn’t know which companies paid him consulting fees or reimbursed him for his travel.
“I have personally never sent a bill,” he wrote, “and don’t know what is charged for anything I do.”
A representative for Frazier did not answer questions about Frazier’s decision to update his disclosure forms, but rather referred reporters to a deputy editor of the New England Journal of Medicine. In an email to reporters, the Journal said the updated disclosures were prompted by the ProPublica reporting. Asked why Frazier had not disclosed the relationships when he initially submitted the papers for publication, the journal wrote, “We do not know; this answer must come from Dr. Frazier.”
Frazier is suing ProPublica and the Chronicle, as well as the authors of this article, in Harris County District Court for libel. Among other things, the lawsuit accuses the publications of misleading readers regarding the nature of Frazier’s relationships with device makers. The lawsuit alleges that reporters tried to create the impression that “Dr. Frazier could be bought off” by device makers.
The suit says that “industry standards for reporting conflicts of interest in medical journals vary; some journals do not even publish conflict of interest statements.”
The lawsuit also notes that Frazier was only listed as the first author of five of the 100 papers reviewed by ProPublica and the Chronicle. “The rest were drafted by other authors who were responsible for obtaining conflicts of interest from the coauthors.” The suit also said that many of the 100 articles were about general heart surgery, transplants and devices other than HeartWare, “none of which would even require a statement of conflict of interest.”
According to guidelines set by the International Committee of Medical Journal Editors, all study authors, not just the first author, should broadly report all industry relationships, financial or otherwise, that might be perceived as a conflict of interest.
Mike Hixenbaugh is an investigative reporter at the Houston Chronicle. Email him at [email protected] and follow him on Twitter at @Mike_Hixenbaugh.
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