Donald Trump's aides on the front lines of the White House coronavirus response launched a huge behind-the-scenes effort to push antim...
Donald Trump's aides on the front lines of the White House coronavirus response launched a huge behind-the-scenes effort to push antimalarial drug hydroxychloroquine as a treatment for the new virus.
Brett Giroir, the assistant secretary for health at the Department of Health and Human Services, sent a group email in early April outlining the White House's effort to push the drug, according to a Friday report from Vanity Fair.
'WH call. Really want to flood Ny and NJ with treatment courses,' Grior said in the email to FEMA administrator Pete Gaynor, HHS Assistant Secretary for Preparedness and Response Robert Kadlec and Navy Rear Admiral John Polowczyk, who leads a supply-chain task force at FEMA.
New York and New Jersey remain the two state most hard-hit by COVID-19, with nearly 21,000 combined deaths and are approaching a combined 360,000 confirmed cases.
'Hospitals have it,' Grior said of hydroxychloroquine in the April 4 email. '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,' he continued. 'We can get a lot more of this. Right Bob? Millions per week?'
Grior was not satisfied with restrictions only allowing hydroxychloroquine use in hospitals, and pushed against it in the emails chain.
Revelations of this internal push came just before the Food and Drug Administration warned Friday morning against using hydroxychloroquine to treat coronavirus patients outside of hospital settings or in clinical trials.
'The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin,' the FDA wrote in a statement issued Friday.
'We are also aware of increased use of these medicines through outpatient prescriptions. Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine,' it continued.
White House aides are behind a serious effort to push hydroxychloroquine to treat coronavirus and ramp up production and distribution of the Malaria drug
Admiral Brett Giroir, the assistant secretary at HHS, sent an email April 4 pushing for government officials 'to flood Ny and NJ with treatment courses'
Donald Trump often touts the use of hydroxychloroquine to treat coronavirus, despite experts pushing back that the effectiveness in COVID-19 patients is still unproven and could pose more risk than benefit
The emails between White House officials and members of the coronavirus response team show that the administration's top officials were closely involved in the effort to push Americans to use the drug and make it widely available.
The Food and Drug Administration rolled out an emergency rule limiting distribution of hydroxychloroquine to patients hospitalized with coronavirus.
Just one hour after the initial email, however, Gaynor replied to Kadlec, Giroir, and Polowczyk and suggested that FDA Commissioner Stephen Hagn was on board with expanding patient access to the drug.
'Hahn asked to distribute to hospitals and the drug stores,' the FEMA administrator said.
Gaynor then said in a second email sent that night that he was working closely with Rear Admiral Polowczyk on the initiative.
'Me and Adm P are on it. More to follow in the am,' Gaynor wrote.
President Trump has been touting hydroxychloroquine for weeks at his nearly-daily press briefings as an effective treatment for coronavirus, often calling the drug a 'game changer' in the midst of the coronavirus pandemic.
The email from Grior followed the April 4 press briefing where Trump claimed the U.S. has millions of doses, as governors across the country pleaded for the federal government to help them acquire more tests, ventilators and personal protective equipment (PPE) for health care workers.
'We have millions and millions of doses of it—29 million to be exact,' the president said of the Malaria drug. 'We're just hearing really positive stories, and we're continuing to collect the data.'
A federal official with knowledge of the deliberations surrounding the drug told Vanity Fair that the federal government's top interagency working group of clinicians and scientists tried to stop White House conversations about its use to treat coronavirus on March 24.
The White House push for using the drug that attacks blood parasites for COVID-19, which is thought to be a respiratory disease, has sparked worldwide shortage of the drug. It also prompted the start of U.S. negotiations with Indian Prime Minister Narendra Modi to lift export restrictions on its active ingredient.
These officials were not satisfied with only allowing hospitals to obtain and give out hydroxychloroquine, and pushed for it to also be available at drug stores
A medical countermeasures group within HHS recommended the proposed treatment only be studied in controlled trials, Vanity Fair revealed in document reviews.
The safety and efficacy, the HHS group claimed, was 'not supported by data from reliable clinical trials or from non-human primates' and carried 'potential risks.'
Hydroxychloroquine is used to treat malaria as well as autoimmune conditions like lupus, and can have serious side effects, including heart arrhythmias.
A FEMA spokesperson asserted to Vanity Fair that the administration 'does not maintain stocks of medicine,' despite Gaynor's apparent involvement in the White House effort to get more stock of the drug.
'Given increased demand, Dr. Hahn considered whether the donated drugs could be distributed in the commercial market to ensure a stable supply for malaria, lupus, and rheumatoid arthritis patients,' the spokesperson said.
While there has been a push for hydroxychloroquine use by some in the White House, there are others who are starkly against urging coronavirus patients to use the drug.
An HHS official who was the administration's top coronavirus vaccine developer, Rick Bright, was pushed out of his position April 21 - and he claims he was ousted because he resisted efforts 'to fund potentially dangerous drugs promoted by those with political connections.'
Bright was the head of the Biomedical Advanced Research and Development Authority (BARDA), which partners with private ventures to develop vaccines, drugs and diagnostics.
'I rightly resisted efforts to provide an unproven drug on demand to the American public,' Bright said in a statement reported by The New York Times. 'I insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician.'
Top officials, however, were not pleased with the restrictive approach and pushed for widespread distribution of hydroxychloroquine.
Grior sent an email to Gaynor arguing against limiting the drugs to use only at hospitals.
'NOPE. Needs to go to pharmacies as well,' he wrote in the email. 'The EUA matters not. The drug is approved [and] therefore can be prescribed as per doctor's orders That is a FINAL ANSWER.'
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