Senior Dem concerned about political influence at FDA: Letter

FDA granted emergency authorization to anti-malaria drug promoted by Trump.

April 17, 2020, 3:08 PM

A senior Senate Democrat voiced concern Friday that politics may be inappropriately influencing the Food and Drug Administration’s decision-making in the chaos surrounding the fight against the coronavirus.

In a new letter to FDA Commissioner Stephen Hahn, Sen. Patty Murray, D-Wash., a member of Democratic leadership and the top Democrat on the Senate panel with jurisdiction over public health and medical research, raised questions about the agency’s emergency authorization of malaria drugs to treat COVID-19 before adequately testing and review of their efficacy.

“Now more than ever, it is critical that FDA shield its experts from political influence,” Murray wrote. “If the agency fails to do so, it risks unnecessarily exposing patients to potentially severe adverse health effects and losing the public trust in the tests, drugs, and vaccines that are -- and will be -- critical for addressing the COVID-19 pandemic.”

President Trump has been vocal in his hopes for the drug chloroquine and its medical relatives, describing them last month as a “gamechanger” against the coronavirus, and asking the FDA to study their use. By the end of the month, the FDA gave emergency authorization the use of chloroquine phosphate and hydroxychloroquine sulfate for coronavirus patients.

Trump continued to tout the drug this week in a White House meeting Tuesday, telling coronavirus survivors, “I haven’t heard a bad story” about the use of the anti-malaria drug.

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PHOTO: Sen. Patty Murray speaks with reporters after a news conference in the Capitol, March 3, 2020.
Sen. Patty Murray speaks with reporters after a news conference in the Capitol, March 3, 2020.
Caroline Brehman/CQ-Roll Call via Getty Images, FILE

Hydroxychloroquine is officially approved for treating malaria, rheumatoid arthritis and lupus, but a recent scientific review of the available data suggests that it’s still too early to tell if the drug -- or any other -- is an effective treatment for COVID-19. It’s been used by doctors in the U.S. and other countries searching for a treatment for ill patients.

“Although there are no currently approved treatments for COVID-19, both drugs have shown activity in laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19),” the Department of Health and Human Services said in a March 29 release after the agency accepted donations of the medicine from the national stockpile as possible COVID-19 treatments. “Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. Clinical trials are needed to provide scientific evidence that these treatments are effective.”

In a statement, the FDA said the authorization for the malaria medication was "prepared by expert FDA career staff and reflects extensive discussions with experts" at several government health agencies "who are involved in pandemic response."

"During the evaluation of the criteria under which to issue an EUA, it was determined, based on the scientific evidence available, that it is reasonable to believe that the specific drugs may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus outweigh the known and potential risks when used under the conditions described in the EUA," the statement said.

And Trump is not alone in his optimism. Following the FDA’s authorization, some states have ramped up trials of the drug, including New York and South Dakota, and have touted its potential benefits based on the anecdotal evidence.

“Hospital administrators, doctors want to have a significant data set before they give a formal opinion. Anecdotally, you’ll get suggestions that it has been effective. But we don’t have any official data yet from a hospital or a quote-unquote study, which will take weeks if not months,” New York Gov. Andrew Cuomo said in a briefing last week.

And in Michigan, a Democratic state representative has claimed the anti-malarial drug saved her life when she contracted COVID-19.

Still, Murray asked the FDA to brief her staff on the steps being taken to insulate the agency and decision-making from political pressure, the emergency use authorization review process, and on any guidance from the agency to administration officials about public comments on "unapproved and unauthorized uses of medical products for the diagnosis, cure, mitigation and treatment" of COVID-19.

In her letter, Murray also raised concerns about reported shortages of the drug to treat patients with other conditions, and said the agency’s review of products “must be based solely on science, data, and the best interests of the public health, and not on political pressure from President Trump or other officials in the Administration.”

Michael Felberbaum, a spokesperson for the FDA, said the administration would "respond directly to the Senator." A spokesperson for the White House did not immediately respond to a request for comment for this report.

PHOTO: This Monday, April 6, 2020, photo shows an arrangement of hydroxychloroquine pills in Las Vegas.
This Monday, April 6, 2020, photo shows an arrangement of hydroxychloroquine pills in Las Vegas.
John Locher/AP, FILE

Beyond Trump’s repeated efforts to promote the malaria drugs as treatment for COVID-19, Murray also cited a report from Politico that the White House had encouraged the FDA to approve a Japanese flu drug for use as a coronavirus treatment, despite limited evidence of its benefits.

Several former FDA leaders have raised similar concerns about the emergency authorization of the antimalarial drugs.

Margaret Hamburg, who served as FDA commissioner in the Obama administration, told Science Magazine she was “surprised and perturbed” by the announcement from the typically apolitical agency.

“I understand the desire to find hope, but we need more evidence than is currently available before we encourage widespread use,” she said.

Outside the actions of the FDA during the coronavirus crisis, Democrats are also concerned that members of the president’s inner circle could stand to profit from some of the administration’s actions in the coronavirus response.

In a letter to the White House counsel’s office earlier this week, Sens. Elizabeth Warren, D-Mass., Richard Blumenthal, D-Conn., and Tom Carper, D-Del., said reports about Trump being informally advised by individuals with financial interests in the anti-malaria drug “raise significant ethics and conflict of interest concerns.”

According to The New York Times, Ken Fisher, a major GOP donor, runs an investment company with a large stake in Sanofi, a French pharmaceutical company that makes a brand-name version of hydroxychloroquine. Chirag Patel, a member of Trump National Gold Course in Bedminster, New Jersey who has reportedly golfed with the president, co-founded Amneal Pharmaceuticals, a generic drug-maker that produces the anti-malaria drug, according to the Times.

The company recently donated 40,000 hydroxychloroquine tablets to Louisiana for clinical trials for COVID-19 patients, according to ABC affiliate WBRZ.

Trump, according to the Times, had reported limited investments in a mutual fund with a large holding in Sanofi.

The senators, in their letter to the White House, asked for details of any steps that have been taken to address concerns about potential conflicts of interest.

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