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Doctors Sue HHS for Removing Patient Safety Papers

Physicians from Harvard Medical School whose papers were removed from a government patient safety website have filed a lawsuit against federal agencies to have their work republished.

In their complaint, Gordon Schiff, MD, and Celeste Royce, MD, allege that the respective papers they co-authored on suicide risk and endometriosis were removed from the Patient Safety Network site, part of the Agency for Healthcare Research and Quality (AHRQ), in violation of the First Amendment and without a reasoned basis.

The American Civil Liberties Union (ACLU), the ACLU of Massachusetts, and the Media Freedom and Information Access Clinic at Yale Law School are representing Royce and Schiff in their suit.

Last month, MedPage Today reported on the removal of papers by Schiff, Royce, and additional authors from the Patient Safety Network site in the wake of a Trump administration Office of Personnel Management (OPM) memorandum, "Initial Guidance Regarding President Trump's Executive Order Defending Women."

Each of the removed papers had a term, such as "transgender," "gender identity," "non-gender-conforming," or "LGBTQ" that violated OPM guidance.

Now, OPM, AHRQ, its parent agency HHS, and their respective leaders have been named as defendants in the complaint filed by Schiff and Royce.

"I think a lot of people in medicine feel very threatened, right now, and very apprehensive about what the future holds," Royce told MedPage Today. "But I think we really need to put our values into action. And if we're really here to serve patients and to advocate for patients, then we need to push back in whatever ways that we can, and for me, this is my way of pushing back."

The federal government is "targeting these papers because [they contain] a certain message that the government doesn't like," Scarlet Kim, JD, senior staff attorney at the ACLU, who is representing the plaintiffs in the lawsuit, further told MedPage Today. "And in doing so, it's endangering patient safety and public health."

"That's the core underlying purpose for the website, and it's the core underlying purpose for these papers," she said. "And when these papers come down, that information is no longer available to doctors and other medical professionals."

"I think it strikes a real blow at the driving mission of the website, to take down this research solely because the government doesn't like certain terms that are contained in the papers," she continued. "And we think that's unconstitutional, unlawful, and also fundamentally subverts the very purpose of PSNet."

The defendants argue in their complaint that the censorship of their papers violates the First Amendment "by imposing a viewpoint-based and unreasonable restriction on plaintiffs' speech and violates the Administrative Procedure Act (APA) because it is arbitrary and capricious."

The complaint further argues that the OPM guidance that prompted the removal of the papers violates the APA because it exceeds the office's statutory authority.

For Schiff and Royce, each of their papers included a single line that proved problematic under the OPM guidance, as MedPage Today previously reported.

"I think as a matter of principle, it's not a good idea to give into this," Schiff told MedPage Today in an interview last month.

In Schiff's 2022 paper on suicide risk assessment, there was a line noting several groups at high risk of suicide, including the LGBTQ community. And Royce's 2020 paper on endometriosis as a commonly missed diagnosis had a final bullet point stating that, "it is important to note that endometriosis can occur in trans and non-gender-conforming people and lack of understanding this fact could make diagnosis in these populations even more challenging."

In speaking with MedPage Today regarding the lawsuit, Royce raised concern about recent attempts to "prohibit or limit" physicians' ability to care for patients and to "think about their care or about their diagnosis in an informed way."

She also stressed the importance of being able to "provide appropriate training" to peers, trainees, and students.

"I think we have to stand up for our rights whenever we can," Royce said.

Ultimately, the lawsuit is aimed at having the plaintiffs' papers republished on the Patient Safety Network site, and having the court prevent federal agencies from removing other papers in the future.

The claims in the suit are similar to those levied by Doctors for America against OPM, CDC, FDA, and HHS last month over the removal of a "broad range of health-related data and other information used every day" by health professionals and researchers.

Federal health agencies restored several pages and datasets following a federal judge's order in the case.

As for papers removed from the Patient Safety Network site, they extend beyond those authored by Schiff and Royce.

Last month, Patrick Romano, MD, MPH, of the University of California Davis, who is co-editor-in-chief of the Patient Safety Network, told MedPage Today that five full-length, peer-reviewed cases and commentaries, at least one perspective interview, and about 15 short summaries of other published papers had been removed from the site.

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Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.

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