Henry Ford: Probe found star doc did nothing wrong in pressing hydroxychloroquine approval

Henry Ford Health told the Free Press its investigation found no wrongdoing more than a year after documents revealed one of the health system's star cardiologists collaborated with senior Trump administration officials in pressuring federal regulators to allow the use of hydroxychloroquine to treat COVID-19 after the drug was found to be ineffective and could cause dangerous heart arrhythmias.

The documents, made public in an August 2022 report from the House Select Subcommittee on the Coronavirus Crisis, show that Dr. William O'Neill, medical director of Henry Ford's Center for Structural Heart Disease, worked with White House senior advisers Peter Navarro and Dr. Steven Hatfill in the summer of 2020 in a failed attempt to push the U.S. Food and Drug Administration to reauthorize hydroxychloroquine as a treatment for COVID-19.

After the FDA revoked the authorization of hydroxychloroquine — used to treat malaria and certain autoimmune diseases — the documents suggest O'Neill continued to prescribe it off-label to COVID-19 patients. In an email message to his White House contacts, he urged them to help doctors and researchers who "need cover" as they continued to prescribe it.

The special subcommittee’s report included emails that suggested O’Neill also tried to secure millions of dollars in federal funding through Trump administration allies to help pay for a Henry Ford research study on hydroxychloroquine.

Navarro — who was convicted Thursday on two counts of criminal contempt in a separate congressional investigation into the Jan. 6, 2021, insurrection at the U.S. Capitol, according to the Associated Press — and Hatfill sent nearly three dozen messages from private email accounts in an effort to obscure White House involvement in their communications, according to the report. In one of those messages, Hatfill told O’Neill not to disclose his ties to the Trump administration, admonishing him to “NEVER mention the White House together with my name[.]"

O'Neill responded: "It’s a mistake, you have sensitized me and I won't EVER use your name or the WH again in texts or emails.”

Henry Ford in investigation: 'No wrongdoing'

Detroit-based Henry Ford Health told the Free Press in August 2022 that it would review the findings of the subcommittee's report and would "take appropriate action."

"Like other health systems, we participated in a number of studies and clinical trials, including for hydroxychloroquine, during a time when there were no known treatments for COVID-19. When our own studies determined that hydroxychloroquine was not an effective treatment, we suspended the study and any use of the drug," the health system said at the time.

More: Henry Ford doctor, Trump White House tried to pressure FDA into hydroxychloroquine use

Earlier this month, Henry Ford said its investigation of the findings in the congressional report found no misconduct. The health system, however, refused to provide the Free Press with details of its investigation and also declined an interview.

Instead, it issued the following statement:

“As soon as we reviewed the congressional report, we launched an independent third-party investigation. That weeks-long investigation revealed no wrongdoing," the statement said. "This is in addition to robust oversight that had already occurred during the initial hydroxychloroquine trials and studies. As in all the studies and trials in which we participate, decisions are made by teams, not by just one person, and there are stringent policies and procedures in place the teams follow along every step of the way.

"We can confidently say the processes we used to assess the study conduct were heavily scrutinized, abided by the strict scientific standards, followed every safeguard we have in place and, as always, were in the best interest of the patients we serve.”

Henry Ford did not answer questions about who conducted the third-party investigation, nor would it disclose the "strict scientific standards" used to assess its hydroxychloroquine studies or the “robust oversight” that was implemented.

Hydroxychloroquine study considered outlier

O'Neill was among the first doctors in the U.S. to use angioplasty to treat heart attacks and is credited with performing the nation’s first minimally invasive aortic valve replacement through a catheter when he worked for Beaumont Health in 2003. In 1998, he operated on then-Red Wings coach Scotty Bowman's heart.

He also was among the authors of a Henry Ford study published in the summer of 2020 in the International Journal of Infectious Diseases that claimed that early treatment with hydroxychloroquine cut in half the death rate in patients hospitalized with COVID-19.

More: Trump tweets support of Henry Ford study, doctors warn against politicizing medicine

The study, however, was considered an outlier by many in the medical community because it contradicted other research and was observational, retrospective and not randomized or controlled. Some saw evidence of bias in the study design.

Additionally, many of the patients who were treated with hydroxychloroquine in the Henry Ford study also got corticosteroids, which have been shown to improve outcomes for people with COVID-19.

But after the Henry Ford study was published, then-President Donald Trump — an early proponent of hydroxychloroquine, saying it could be a pandemic "game changer" — took to Twitter (now known as X) to praise the Henry Ford study.

He wrote: "The Henry Ford Health System just reported, based on a large sampling, that HYDROXYCHLOROQUINE cut the death rate in certain sick patients very significantly. The Dems disparaged it for political reasons (me!). Disgraceful. Act now @US_FDA"

Medicine and politics mix

Days after Trump's social media post, Dr. Steven Kalkanis, executive vice president and CEO of Henry Ford Hospital, told the Free Press that medicine shouldn't be political.

"We're scientists, not politicians," Kalkanis said. "We've never had a preconceived agenda with this study or any study regarding hydroxychloroquine. We simply wanted to use the resources and the opportunity of COVID, given that Detroit was such a hard-hit region, to find out which treatments worked and which treatment didn't.

"So early on, we embarked on several different studies, and we wanted to let the data lead us to what is appropriate for patients. We stand behind the results of our study."

Ultimately, the FDA denied Henry Ford's request to continue treating COVID-19 patients with hydroxychloroquine.

Henry Ford Health leaders announced in an open letter that they would no longer publicly discuss the use of hydroxychloroquine to treat COVID-19, saying: "the political climate that has persisted has made any objective discussion about this drug impossible."

Since 2019, O'Neill has donated more than $30,000 to Republican candidates and political action committees, including the Republican National Committee, Donald J. Trump for President, Inc., along with such candidates for the U.S. House and Senate as John James of Michigan, Tim Scott of South Carolina, Marco Rubio of Florida, Cicely Davis of Minnesota, and Martha McSally of Arizona, campaign finance reports show.

Contact Kristen Jordan Shamus: kshamus@freepress.com. Subscribe to the Free Press. 

This article originally appeared on Detroit Free Press: Henry Ford: No wrongdoing in hydroxychloroquine COVID-19 investigation