05.14.20

As New Evidence is Revealed, Senator Tammy Baldwin Renews Call for HHS Inspector General Investigation into Trump Administration’s Promotion of Hydroxychloroquine

Baldwin to HHS OIG: “Any objections from public health experts appear to have been cast aside in favor of prioritizing the misguided impulses of the President and White House over science and public health.”

WASHINGTON, D.C. – U.S. Senator Tammy Baldwin today renewed her call for the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) to investigate the Trump administration’s promotion of hydroxychloroquine as a treatment for COVID-19, despite the fact that it is not a Food and Drug Administration (FDA) approved treatment for the coronavirus.

On April 28, Senator Baldwin first requested an HHS OIG investigation into the Trump administration’s promotion of hydroxychloroquine as a treatment for COVID-19. She also raised a number of questions concerning a shipment of hydroxychloroquine by the federal government to Milwaukee, including clarity regarding distribution or final delivery locations of the 335,800 tablets of hydroxychloroquine that were shipped to Milwaukee. On March 19, 2020, President Trump began advertising and promoting hydroxychloroquine as a potential treatment for COVID-19 to the American public. In a tweet from March 21, the President described the combination of hydroxychloroquine and azithromycin, a common antibiotic, as “one of the biggest game changers in the history of medicine,” and on March 23, he noted in a White House press briefing that the federal government was working to obtain large quantities of the drug at his direction. On April 4, the President expressed his support for usage of the drug, adding that individuals had “nothing to lose,” and on April 11, he suggested that he might take it himself. 

Three days after Baldwin’s initial request for an investigation, President Trump announced he was planning to replace HHS Principal Deputy Inspector General Christi Grimm. In a letter to the HHS OIG on Thursday, Senator Baldwin cited a host of new evidence that has emerged in regards to the administration’s promotion of hydroxychloroquine, including new reporting that indicates that the Trump administration’s promotional effort was informed not by experts or scientific evidence, but instead by political advocates with special access to the White House, including a television commentator and “a vitamins executive who occasionally socializes with Trump at his Mar-a-Lago Club in Palm Beach, FL.”

Senator Baldwin also cited a recent whistleblower complaint and writes:

“Any objections from public health experts appear to have been cast aside in favor of prioritizing the misguided impulses of the President and White House over science and public health. New evidence from a recent whistleblower complaint filed by Dr. Rick Bright, who was removed from his position as the director of HHS’ Biomedical Advanced Research and Development Authority (BARDA) and Deputy Assistant Secretary for Preparedness and Response, points to a pattern of Administration officials placing political interests above the needs of patients”

Baldwin noted a Bloomberg News report that FDA had lifted import restrictions on an Indian company that supplies tablets and raw materials for making hydroxychloroquine. The company’s factories had been under an import alert since 2015, after inspectors discovered multiple violations of FDA manufacturing guidelines, including “systemic data manipulation” in tests meant to ensure efficacy and safety. Five days later, on March 28, the FDA issued an Emergency Use Authorization (EUA) allowing hydroxychloroquine and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. 

According to Dr. Bright’s whistleblower complaint, HHS leadership pursued widespread distribution of hydroxychloroquine in an effort to score a “BIG immediate win” and align themselves with the President’s misguided promotional campaign. Officials including Secretary Alex Azar, General Counsel Bob Charrow, and Assistant Secretary for Health Admiral Brett Giroir reportedly went to extreme lengths to promote the drug to the detriment of patient safety, going above and beyond the very FDA guidance that they reportedly sought to influence. At one point, when cautioned that the agency’s EUA limited the use of hydroxychloroquine and chloroquine to the treatment of hospitalized patients, Admiral Giroir responded with the following:

“The EUA matters not…the drug is approved [and] therefore can be prescribed as per doctor’s orders. That is a FINAL ANSWER.”

On May 11, a study published in the Journal of the American Medical Association found that there was no benefit to treating hospitalized COVID-19 patients with hydroxychloroquine. Another recent study published in the New England Journal of Medicine found that hydroxychloroquine did not lower the risk of death among coronavirus patients, with the authors noting that these results “do not support the use of hydroxychloroquine at present.” And, a study from the Department of Veterans Affairs (VA) found that patients with severe cases of COVID-19 treated with hydroxychloroquine alone showed a significantly higher risk of all-cause mortality over either supportive care or a combination of hydroxychloroquine and azithromycin. 

In her call for an HHS OIG investigation, Senator Baldwin writes to Principal Deputy Inspector General Grimm:

“The promotion of hydroxychloroquine demonstrates yet another effort by this White House to accommodate and empower the mistaken whims of the President over science and public health.”

The full letter to the Department of Health and Human Services Office of the Inspector General is available here.