05.07.20

Murray Digs Into Political Pressure Surrounding Trump Administration Plan to Push Unproven COVID-19 Treatment

Murray demands answers from Sec. Azar regarding political pressure to push untested COVID-19 treatment and retaliation against those who voiced concerns

 

Letter comes as new whistleblower complaint increases scrutiny of Trump Administration efforts to hype hydroxychloroquine and chloroquine as COVID-19 treatments despite lack of evidence

 

Murray: “It has become clear that the process was driven mainly – if not solely – by politics, and may have placed some COVID-19 patients in danger.”

 

Murray: “I am additionally concerned by any efforts to silence or retaliate against individuals who raise concerns about political interference in public health activities.”

 

(Washington, D.C.) – Yesterday, U.S. Senator Patty Murray (D-WA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, wrote to Department of Health and Human Services (HHS) Secretary Alex Azar criticizing the Trump Administration for putting politics ahead of public health and pushing to advance hydroxychloroquine and chloroquine as treatments for COVID-19 despite lacking scientific evidence of safety and effectiveness. She also demanded additional information from Secretary Azar about the Administration’s approach to promoting the drugs, which has resulted in increased risk to patients.

 

“As more information about the risks posed to COVID-19 patients by the use of hydroxychloroquine sulfate (hydroxychloroquine) and chloroquine phosphate (chloroquine) becomes available, I am increasingly concerned about the processes by which the Department of Health and Human Services (HHS) authorized and distributed these drugs across the country.  It has become clear that the process was driven mainly – if not solely – by politics, and may have placed some COVID-19 patients in danger.  It is especially important there be transparency in the public health response during this global pandemic, and I therefore seek additional information about the role of political leadership of HHS agencies in gaining authorization for hydroxychloroquine and chloroquine and for their distribution of the drugs to patients across the country,” wrote Senator Murray.

 

After President Trump pressed health agencies to move fast on promoting hydroxychloroquine and chloroquine as treatments for COVID-19 despite a lack of scientific evidence of their safety and effectiveness, the Food and Drug Administration issued an Emergency Use Authorization for the drugs, the Centers for Disease Control and Prevention (CDC) published guidance for health care professionals listing them as possible therapeutic options for COVID-19 patients, and HHS prepared plans to distribute the drugs nationwide through the Strategic National Stockpile. A new whistleblower report from Dr. Rick Bright, former Director of the Biomedical Advance Research and Development Authority (BARDA), recently shed new light on the Administration’s efforts to push the unproven treatment, and alleges he was removed from his position in retaliation for raising concerns with these efforts.

 

Read the full letter below and HERE.

 

May 06, 2020

 

The Honorable Alex M. Azar II

Secretary

U.S. Department of Health and Human Services

200 Independence Avenue, SW

Washington, DC 20201

 

 

Dear Secretary Azar:

 

As more information about the risks posed to COVID-19 patients by the use of hydroxychloroquine sulfate (hydroxychloroquine) and chloroquine phosphate (chloroquine) becomes available, I am increasingly concerned about the processes by which the Department of Health and Human Services (HHS) authorized and distributed these drugs across the country.  It has become clear that the process was driven mainly – if not solely – by politics, and may have placed some COVID-19 patients in danger.  It is especially important there be transparency in the public health response during this global pandemic, and I therefore seek additional information about the role of political leadership of HHS agencies in gaining authorization for hydroxychloroquine and chloroquine and for their distribution of the drugs to patients across the country.

 

Through March and early April, President Trump and his political leadership pressured public health officials to find a pathway to approve and disseminate hydroxychloroquine and chloroquine as COVID-19 treatments.  On March 19, President Trump first publicly touted the drugs, saying they have shown “very, very encouraging early results” and claiming they had “gone through the [Food and Drug Administration] approval process,” though that was not yet the case.[1]  Just two days later, the Centers for Disease Control and Prevention (CDC) published guidance for health care professionals, listing hydroxychloroquine and chloroquine as possible therapeutic options for COVID-19 patients.[2]  This information is no longer available on CDC’s website.

 

By March 23, an FDA official had directed others within HHS, the National Institutes of Health (NIH), and FDA to have the Biomedical Advance Research and Development Authority (BARDA) sponsor an investigational new drug study as a possible avenue for distributing hydroxychloroquine and chloroquine.[3]  This “complex and unorthodox” approach surprised BARDA staff, where one wrote to another, “We have been hit by a bus. Now we hit back.”[4]  According to press reports and emails, some HHS staff worked to find an alternate solution they deemed safer for patients.

 

On March 28, at BARDA’s request, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for hydroxychloroquine and chloroquine.[5]  The EUA contained several limitations: (1) it could only be used to treat patients hospitalized for COVID-19, and (2) it only applied to “product supplied from the Strategic National Stockpile (SNS) to public health authorities.”  The EUA also required the SNS to maintain records of distribution for both products.  Even this “safer” option garnered criticism from former FDA officials given the lack of quality evidence supporting the safety and effectiveness of the drugs in treating COVID-19.[6]  I wrote to Commissioner Stephen Hahn seeking assurances the agency’s experts are shielded from political influence and its decisions are driven solely by science, data, and the public health, and expressing concern that if the agency fails to do so, it risks unnecessarily exposing patients to potentially severe adverse health effects and losing the public trust.[7] 

 

On March 29, HHS announced the donation of 30 million doses of hydroxychloroquine and one million doses of chloroquine, by Sandoz and Bayer respectively, for treatment of COVID-19 patients.[8]  The donated products were specifically for use in hospitalized patients or for use in clinical trials.

 

Despite the clear restrictions placed by the EUA and the donation agreements, HHS and FEMA political leadership pushed – at the White House’s request – for dissemination of hydroxychloroquine and chloroquine outside of hospital settings.[9]  On April 4, Assistant Secretary for Health Brett Giroir wrote to Assistant Secretary for Preparedness and Response Robert Kadlec, FEMA Administrator Pete Gaynor, and Supply Chain Task Force lead Rear Admiral John Polowczyk:

 

WH call. Really want to flood Ny and NJ with treatment courses. Hospitals have it. Sick out patients don’t. And can’t get. So go through distribution channels as we discussed. If we have 29 million perhaps send a few million ASAP? WH wants follow up in AM.

 

We can get a lot more of this. Right Bob? Millions per week?[10]

 

Gaynor replied that FDA Commissioner Hahn “asked to distribute to hospitals and the drug stores” and that FEMA was working on additional efforts.  In another email after the issuance of the EUA, Giroir wrote to Gaynor, “Needs to go to pharmacies as well … The EUA matters not. The drug is approved [and] therefore can be prescribed as per doctor’s orders That is a FINAL ANSWER.”

 

Within a few weeks, it became clear that wider use of hydroxychloroquine and chloroquine had resulted in increased risks to patients.  On April 24, FDA issued a Drug Safety Communication warning against use of hydroxychloroquine or chloroquine for COVID-19 outside of a hospital or clinical trial setting, given “reports of serious heart rhythm problems.”[11]  The Safety Communication noted FDA has become aware of use of the drugs in outpatient settings, despite the clear language of the EUA.  The document also made clear that “[h]ydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.”

 

While I understand the need for innovation and expediting delivery of potential treatments to patients in the midst of a global health crisis, such decisions must be driven exclusively by science and public health – and should never be responsive to the unfounded claims of political leaders.  Dr. Rick Bright, who was recently removed as the BARDA Director, detailed many of the events outlined above in his complaint filed with the Office of Special Counsel, and I am additionally concerned by any efforts to silence or retaliate against individuals who raise concerns about political interference in public health activities.[12]  Please respond to the following requests by no later than May 14, 2020:

 

  1. Of the 31 million doses donated to the SNS by Sandoz and Bayer, how many have been distributed?  Does the SNS anticipate receiving additional doses of hydroxychloroquine or chloroquine?

 

  1. Please provide the SNS records from March 28, 2020 to the present for distribution of hydroxychloroquine and chloroquine, including lot numbers, quantity, receiving site, and receipt date.

 

  1. At any time, has hydroxycholorquine or chloroquine been distributed by the SNS for use outside of a hospital or clinical trial setting?  If so, please explain the circumstances under which such distribution occurred and who approved the distribution.

 

  1. Are there any plans to modify the EUA or any practices relating to the distribution of hydroxychloroquine or chloroquine following FDA’s April 24 Safety Communication?

 

  1. Please provide the adverse events reports received by FDA from March 28, 2020 to the present related to use of hydroxychloroquine or chloroquine in COVID-19 patients.

 

Thank you in advance for you attention to this matter.  If you have any questions, or would like to further discuss compliance with this request, please contact Elizabeth Letter with Senator Murray’s HELP Committee Staff at 202-224-0767.

 

Sincerely,

 

PATTY MURRAY
Ranking Member

U.S. Senate Committee on Health, Education, Labor, and Pensions

 

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