Medicine in the Gray Zone

To the Editors:

I was delighted to see that The New York Review and none other than the supremely talented Dr. Jerome Groopman took the time to review my book Ticker: The Quest to Create an Artificial Heart [NYR, November 22, 2018]. But I’d like to respond to several points in the review that draw heavily on “A Pioneering Heart Surgeon’s Secret History of Research Violations, Conflicts of Interest and Poor Outcomes,” a May 2018 article by Charles Ornstein of ProPublica and Mike Hixenbaugh of the Houston Chronicle.

Dr. Groopman notes that Dr. Bud Frazier has denied the allegations in Ornstein and Hixenbaugh’s article. Indeed he has, with a libel suit filed last July that in December was allowed to go forward in court in Harris County. The judge in the case cited five false impressions and ten false statements in the article.

Just as the article is available with a Google search, so, too, is the lawsuit, though the latter has been cited on the rarest occasions while the former has been recycled over and over again. For instance, Dr. Groopman accepts Ornstein and Hixenbaugh’s assertion that Dr. Frazier broke the rules for purposes of experimentation. In fact, Dr. Frazier followed the FDA protocols for exemptions during his decades as a medical researcher. Their article, however, did not mention his use of them.

Dr. Groopman also repeats the accusations of Dr. Frank Smart, who claimed he had to “hide” patients “by moving them to other parts of the hospital” to keep them safe from Dr. Frazier’s ambitions. Dr. Smart has retracted and disputed that claim in a letter included in the lawsuit (“I will say I thought the influence of one of the cardiologists had more to do with premature implants than Bud”). Further, such high-risk experimental surgery cannot go forward without permissions from the hospital’s institutional review board (IRB) and the device maker—surely if the surgery considered was improper, one or both of these entities would have supported the decision of the patient’s primary doctor to bypass a surgical solution. Dr. Frazier, in fact, got those permissions and was allowed to go forward. None of this information appeared in the Houston Chronicle/ProPublica article.

Dr. Groopman also cited the article’s claim that Frazier’s surgical outcomes were among the worst in the country. Depending on which statistics are chosen for review, yes, they were: he took the sickest patients referred from some of the best heart hospitals in the United States, including the Cleveland Clinic, the country’s leader in heart surgery. These were not patients shipped to Houston against their will; their doctors gave them the option of a last-ditch effort with Dr. Frazier, the surgeon most experienced with the use of heart assist devices. This information was also missing from the article.

A reasonable refutation of every claim made in the article and repeated by Dr. Groopman can be found in the lawsuit. Medical reporting is difficult; there are layers beneath layers that are traps for even the best reporters. Medical breakthroughs are decried until they become mundane. People die in clinical trials, yet they clamor desperately to be included. We have all become suspicious of the medical profession, either because of legitimate personal experience or because of accurate stories reporting abuses. But the repetition ad infinitum of information that is, at best, debatable serves no one, especially at a time when legitimate journalism is under attack from so many malevolent forces.

Mimi Swartz
Executive Editor, Texas Monthly
Houston, Texas

Jerome Groopman replies:

The accomplished writer and editor Mimi Swartz believes that I relied too heavily on the investigative reporting in the Houston Chronicle about Dr. Frazier. Careful reading of my review readily addresses several criticisms outlined by Ms. Swartz. I did more than merely state that Dr. Frazier rebutted his critics; I gave two examples of his specific rebuttals that challenged some of the ProPublica and Houston Chronicle reporting. Furthermore, I highlighted the assertion by his defenders that many patients would not be alive today without his willingness to take on the most difficult cases. I also wrote that the FDA approved Dr. Frazier’s heart device in 2010, which could be taken as a vindication of his clinical experimentation. As to Ms. Swartz’s recommendation that I should have done a Google search to read rebuttals, I provided readers in footnote 2 the source for the reporters’ responses to those rebuttals.

Ms. Swartz contends that Dr. Frazier’s research conduct was endorsed by the hospital’s IRB and the experimental device maker, so any deviations from the protocol for implanting the devices were appropriate and properly monitored. But she fails to mention that an internal investigation commissioned by the hospital led it to communicate with the federal Office for Human Research Protections about federally insured patients who had been “enrolled in the studies in violation of the entry criteria” and to repay millions of dollars to Medicare. Ms. Swartz further states that inclusion of very sick patients skewed the assessment of Dr. Frazier’s operative outcomes. But the reporters’ conclusion that Dr. Frazier’s outcomes were poor was specifically based on an analysis of his Medicare patients compared to national averages on the same category of patients, i.e., those on Medicare. The reporters provided details of their analysis to justify their conclusion, and their methodology (which Dr. Frazier’s lawyers contest) is readily found using a Google search.

Ms. Swartz is wrong in writing that Dr. Frank Smart retracted his statements about hiding patients from Dr. Frazier. Nowhere in Dr. Frazier’s lawsuit does Dr. Smart retract his on-the-record quotes and deny this practice. Patients aren’t, of course, physically hidden by physicians to shield them from misguided advice and treatments. Rather, they are purposely transferred to different clinical services (e.g., from the heart failure service to a general medical ward or rehabilitation setting), and/or their physician purposely does not request a consultation from a specialist whose judgment is not trusted. Ms. Swartz’s citation of Dr. Smart’s words (taken not from a letter but from an e-mail replying to Dr. Frazier’s wife included in the lawsuit) omits the crucial text in which Dr. Smart explains the reason for his eschewing Dr. Frazier’s intervention: “Yes there were patients that I thought got a VAD [i.e., were taken to surgery by Dr. Frazier for implantation of the experimental devices] before they had been given an adequate chance on heart failure medications. He [Dr. Frazier] and I frequently discussed this as well.”^* ProPublica and the Houston Chronicle cite two unnamed St. Luke’s staffers confirming the practice of hiding patients from Dr. Frazier.

Ms. Swartz refers to the decision of Judge Wesley Ward that there is sufficient cause for the defamation case brought by Dr. Frazier against ProPublica and the Houston Chronicle to proceed to trial. The judge’s decision came down on December 18, 2018. My review appeared in the November 22 issue of The New York Review. In March, ProPublica and the Houston Chronicle’s ongoing exposé, “Heart Failure,” was named a finalist for the National Institute for Health Care Management Foundation’s Health Care Print Journalism Award.

I agree with Ms. Swartz from firsthand experience that there is a considerable gray zone around decisions to treat desperately ill patients with experimental therapies. I called these decisions “agonizing” in my review.

The controversy around Dr. Frazier’s work occurred after the two books under review were written. I felt it a service to readers to include the claims and rebuttals as a coda to both authors’ illuminating insights into the contentious history of the artificial heart. Ms. Swartz’s conclusion that “every claim” in the news articles has been annulled by the “reasonable refutations” in Dr. Frazier’s lawsuit is premature. The truth of those claims and refutations will be further sought in the courtroom.