— Virginia hospital took issue with article co-authored by Paul Marik, MD

by Jennifer Henderson

On the same day that one of his papers was retracted, a physician who has been a vocal proponent of ivermectin filed suit against his hospital.

Paul Marik, MD, a founding member of the Front Line COVID-19 Critical Care (FLCCC) Alliance, filed a complaint against Sentara Healthcare in Virginia on November 9 over its ban of certain treatments for COVID-19.

That same day, the Journal of Intensive Care Medicine (JICMretracted an article that Marik co-authored on his MATH+ Hospital Treatment Protocol for COVID-19, which includes ivermectin.

The retraction notice cites a communication it had received from Sentara Norfolk General Hospital “raising concerns about the accuracy of COVID-19 hospital mortality data reported in the article pertaining to Sentara.”

Marik is chief of pulmonary and critical care medicine at Eastern Virginia Medical School, and he practices at Sentara Norfolk General. According to an announcement from the FLCCC Alliance, Marik alleged that the health system banned the use of certain therapies against COVID, violating the rights of patients.

Marik’s complaint also stated that the MATH+ protocol is being used by physicians all over the world to treat COVID-19, and that “data indicate that it is saving lives.”

Fred Taylor, JD, a partner at the Virginia law firm Bush & Taylor who is representing Marik in the lawsuit, told MedPage Today in an email that the suit is “not about a journal article.”

“This case is about whether a hospital administration can legally prohibit critically ill COVID patients from receiving information — and treatment, if they so decide it is medically appropriate for them — about safe, FDA-approved, and potentially life-saving medicines as determined by their attending physician,” Taylor said.

A spokesperson for Sentara said in an email that the health system could not comment on pending litigation, but did provide additional information about its treatment guidelines and communication with JICM prior to the journal’s retraction notice.

The spokesperson said in a statement that the CDC, NIH, and FDA “currently do not recommend the use of ivermectin as a treatment for COVID-19 due to a lack of evidence regarding its safety and efficacy.”

“Sentara generates treatment guidelines by engaging multi-disciplinary groups of clinicians to review literature, care standards and provide expert advice,” the statement continued. “In most situations, physicians are able to deviate from guidelines to individualize care for patients. However, in some scenarios, treatments that may potentially harm patients or that are widely considered to be outside the standard of care may be limited.”

Regarding the article retraction, the spokesperson said, “Of note, on Tuesday, November 9, prior to when we were informed about Dr. Marik’s lawsuit, the Journal of Intensive Care Medicine‘s … editorial board retracted a recent article that Dr. Marik co-authored on the MATH+ protocol, in which ivermectin is used.”

“Sentara Healthcare felt obligated to reach out to JICM with our concerns about Sentara Norfolk General Hospital data that the authors used to make conclusions, and provide accurate data to the journal. After thorough review by JICM‘s editorial board, the article was retracted. The journal followed their retraction guidelines and procedures.”

Sentara did not seek the retraction, the spokesperson said.

In its retraction notice, JICM included several statements from Sentara’s communication to the journal.

“We have conducted a careful review of our data for patients with COVID-19 from March 22, 2020 to July 20, 2020, which shows that among the 191 patients referenced in Table 2 that the mortality rate was 10.5%, rather than 6.1%,” Sentara’s communication to the journal stated. “In addition, of those 191 patients, only 73 patients (38.2%) received at least 1 of the 4 MATH+ therapies, and their mortality rate was 24.7%. Only 25 of 191 patients (13.1%) received all 4 MATH+ therapies, and their mortality rate was 28%.”

“Apparently … census and mortality counts from hospital reports [were used] to calculate a mortality rate, but in so doing counted some patients in the denominator but not in the numerator because they died after July 20, 2020, the reported end date of the study. This would be an incorrect calculation of a hospital mortality rate, but might explain the incorrect number of 6.1% in Table 2. Using this incorrect mortality rate to compare with the published reports and claim a ‘75% absolute risk reduction’ is thus an incorrect conclusion regardless of which mortality rate is used,” Sentara’s communication noted.

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