In case you missed it, President Trump tweeted this morning to once again apply pressure to the FDA to “act now” on hydroxychloroquine. Below is the release we put out less than two weeks ago on the need for assurances that the vaccine program will be protected from inappropriate pressure from Trump, which includes background on the history of Trump putting inappropriate pressure on the FDA specifically.
June 24, 2020
As Dr. Fauci Expresses Hope for Vaccine By End of Year, Patients Need Assurances That Trump Pressure Won’t Corrupt Development Process
Politico: “White House pressure for a vaccine raises risk the U.S. will approve one that doesn’t work”
Washington Post: “Trump pushing officials to speed up already-ambitious coronavirus vaccine timeline”
Guardian: “Fear mounts Trump may pressure FDA to rush Covid-19 vaccine by election”
NYT: “Could Trump Turn a Vaccine Into a Campaign Stunt?”
CNN: Former Army medical research commander: It would be ‘terrible’ if political pressure rushed Covid-19 vaccine
Washington, DC – Following Dr. Anthony Fauci’s comments yesterday in his testimony to Congress that he is hopeful that a COVID-19 vaccine will be ready by the end of 2020 or beginning of 2021, Patients Over Pharma released the following statement calling for transparency from the Trump Administration’s Operation Warp Speed vaccine and treatment development program to ensure that political pressure isn’t once again impacting the government’s COVID-19 response efforts.“President Trump hasn’t been shy about pressuring government agencies to put his own political interests ahead of science and public health, and there are serious and growing concerns that he’s going to do that again to rush a vaccine through the process so he can announce it before the election,” said Eli Zupnick, spokesman for Patients Over Pharma.
“Operation Warp Speed is spending billions of taxpayer dollars with absolutely no transparency, no indication that they are getting any real assurances from drug companies that vaccines and treatments will be affordable, and all under the direction of a drug company executive who is skirting government ethics rules and refusing to divest from drug companies that stand to benefit from his decisions. People across the country want a vaccine and need to be able to trust that it’s safe and effective when it comes out, so the Trump Administration needs to open up Operation Warp Speed and allow the transparency people need to make sure it’s putting public health and science ahead of Big Pharma and Trump’s political interests.”
Earlier this month, Patients Over Pharma called on Congress to mandate that an independent patient advocate be appointed to audit and provide continued oversight of the Trump Administration’s ‘Operation Warp Speed’ COVID-19 vaccine and treatment development program. This comes after President Trump appointed drug company executive Dr. Moncef Slaoui as chief advisor to the program and exempted him from typical financial disclosure and conflict of interest laws, the removal of a top scientist whistleblower, the replacement of the Inspector General of the Department of Health and Human Services (HHS), and the refusal of HHS to disclose details of the contracts it signed with drug companies.
Last month, following reporting that the HHS refused to confirm whether the Trump Administration secured any assurances regarding vaccine pricing from drug companies receiving the over $2 billion in federal vaccine development investments, Patients Over Pharma filed Freedom Of Information Act (FOIA) requests seeking the details of any vaccine development-related contracts between drug companies and HHS, including the Biomedical Advanced Research and Development Authority (BARDA) and the Assistant Secretary for Preparedness and Response (ASPR).
Background on the Trump Administration’s history of applying pressure to health agencies
Trump Administration Pressured Health Officials Into Clearing Unproven And Potentially Dangerous Hydroxychloroquine
Director Of Key Federal Health Agency Forced Out After Resisting Political Pressure To Direct Funding To Hydroxychloroquine. “The official who led the federal agency involved in developing a coronavirus vaccine said on Wednesday that he was removed from his post after he pressed for rigorous vetting of hydroxychloroquine, an anti-malaria drug embraced by President Trump as a coronavirus treatment, and that the administration had put “politics and cronyism ahead of science.” . . . “I believe this transfer was in response to my insistence that the government invest the billions of dollars allocated by Congress to address the Covid-19 pandemic into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit,” he said in his statement. “I am speaking out because to combat this deadly virus, science — not politics or cronyism — has to lead the way.’” [New York Times, 4/22/20]
Headline: New York Times: “Health Dept. Official Says Doubts on Hydroxychloroquine Led to His Ouster.” [New York Times, 4/22/20]
June 2020: FDA Reversed Emergency Use Authorization For Hydroxychloroquine. “And now, in its most significant walk-back to date, it has pulled that emergency use authorization (EUA) altogether. The decision Monday by the FDA now lends credibility to persistent suspicions that all of this was politicized from the beginning. In its decision, the FDA said, “It is no longer reasonable to believe that oral formulations of [hydroxychloroquine] and [chloroquine] may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.’”
Headline: Washington Post: “FDA’s hydroxychloroquine reversal raises even bigger questions about Trump’s role in pushing for the drug.” [Washington Post, 6/15/20]
Headline: New York Times: “A Mad Scramble to Stock Millions of Malaria Pills, Likely for Nothing.” [New York Times, 6/16/20]
FDA Granted Orphan Drug Status To Gilead’s Coronavirus Treatment Remdesivir
FDA Initially Granted Orphan Drug Status For Coronavirus Treatment Drug Remdesivir. “The Food and Drug Administration gave an experimental medicine called remdesivir to treat COVID-19 what’s called orphan drug status on Monday. To qualify for an orphan designation, drug companies must show that their product will treat a population of fewer than 200,000 patients or that it would be unprofitable.” [NPR, 3/24/20]
Orphan Drug Status Intended For Medicines Treating Conditions Afflicting Fewer Than 200,000 People; Afforded Companies Government Incentives Including Exclusive Rights To Distribution. “”Orphan” drug status is a designation for medicines that treat conditions that would otherwise be unprofitable for companies to invest research and development resources in. The status provides certain government benefits, including exclusive rights to distribution, that ostensibly incentivize companies to address lesser-known diseases. The FDA will provide orphan status to any medication that treats a disease that afflicts fewer than 200,000 people in the United States.” [USA Today, 3/27/20]
Following Public Outcry, Gilead – Not FDA – Requested Orphan Status Rescinded. “On Wednesday, Gilead issued another statement,saying that it had withdrawn its request for orphan status for remdesivir. “Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” it read.” [USA Today, 3/27/20]
Key White House Adviser Joe Grogan Joined Administration After Years As Top Lobbyist For Gilead. “The White House official who will shape a large part of the administration’s drug price plan worked on many of the same issues as an industry lobbyist, raising questions about whether he violated President Donald Trump’s ethics rules. . . . Grogan worked as the top lobbyist for Gilead Sciences until he arrived at OMB last March, dealing with issues including how much federal health programs would pay for its medicines.” [Politico, 5/27/18]
White House Ordered Halt To NIH Study Of Coronavirus Transmission Via Bats
White House Ordered NIH To Halt Funding For Study Of Coronavirus Transmission From Bats After Project Was Linked To Wuhan Lab Subject To Unproven Conspiracy Theories About Pandemic Origin. “Top infectious disease doctor Anthony Fauci told POLITICO that the White House ordered the National Institutes of Health to pull funding for a project showing how coronaviruses spread from bats to people, POLITICO’s David Lim and Brianna Ehley report. That decision came shortly after the project, run by nonprofit EcoHealth Alliance, was linked to the Wuhan Institute of Virology — a facility that’s been subject to unproven conspiracy theories about the pandemic’s origins. — The White House immediately shifted responsibility for the cancellation, saying that while it encouraged the decision, it was HHS that made the final call. An HHS spokesperson in turn said the research grant for the project was not in compliance with the NIH’s policies.” [Politico Pulse, 6/24/20]
Trump Official Directed Hundreds Of Millions In Funding For Coronavirus Response To Former Client
Headline: Roll Call: “Trump health official’s approach to contracts faces scrutiny.” [Roll Call, 6/10/20]
Kadlec’s Former Client, Emergent Biosolutions, Awarded $628 Million HHS Contract For Coronavirus Response. “A company that won a $628 million contract from the Department of Health and Human Services last week is one Robert Kadlec, the official who leads the agency’s pandemic response, knows well. Kadlec, the assistant secretary for preparedness and response, served as a consultant to Emergent Biosolutions until 2015, according to a company spokeswoman. Since Kadlec’s 2017 confirmation, the biodefense company has received more than $1.2 billion from the division Kadlec oversees, including a part of HHS known as the Biomedical Advanced Research and Development Authority, federal records and company news releases show. Emergent Biosolutions is scheduled to get more.” [Roll Call, 6/10/20]