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White House sidestepped FDA to distribute hydroxychloroquine to pharmacies, documents show

InternationalOct 31. 2020White House trade adviser Peter Navarro listens as President Trump speaks during a coronavirus briefing Aug. 14 at the White House. MUST CREDIT: Washington Post photo by Jabin Botsford. 

By The Washington Post · Christopher Rowland, Debbie Cenziper, Lisa Rein · NATIONAL, HEALTH, WHITEHOUSE, HEALTH-NEWS

WASHINGTON – The phone call in March from President Donald Trump’s adviser carried an urgent message.

For days Trump had touted the off-label use of the anti-malarial drug hydroxychloroquine as a potential cure for covid-19, despite a lack of scientific evidence it worked and amid mounting concerns about the dangers to patients with underlying medical conditions.

Trump trade adviser Peter Navarro wanted to make sure the administration’s top vaccine expert would be on board with a White House plan to distribute the unproven drug to hard-hit cities.

“The first thing out of his mouth was, ‘I want to know what team you are on,’ ” recalled Rick Bright, who at the time was responsible for stockpiling drugs for medical emergencies as director of the federal Biomedical Advanced Research and Development Authority.

The immunologist, who later filed a whistleblower complaint against the administration, said in an interview with The Washington Post that he told Navarro he was on the side of medical evidence. Navarro, Bright said, replied, “I won’t hold it against you, but we need to move this forward.” Navarro declined to comment on Bright’s account.

The White House decision to set aside the mandatory safety controls put in place by the Food and Drug Administration fueled one of the most disputed initiatives in the administration’s response to the pandemic: the distribution of millions of ineffective, potentially dangerous pills from a federally controlled cache of drugs called the Strategic National Stockpile.

Over a span of four days in early April, the White House ordered the distribution of 23 million hydroxychloroquine tablets from the stockpile to a dozen states, enough pills for 1.4 million covid-19 patients, according to public records obtained by The Post in response to a Freedom of Information Act request.

The Post review found that the process was marked by haphazard planning, little or no communication to local authorities about the flow of pills into their communities, and a lack of public accounting about where they ended up.

The documents also demonstrate the steps the administration took to bypass the FDA’s March 28 authorization for emergency use of the tablets, which limited their use to hospitals and clinical drug trials. According to FDA guidance at the time, state authorities were supposed to request stockpile supplies before they were delivered. But interviews and documents show that procedure was not followed in many cases.

The White House ordered more than a third of the tablets sent to the three major drug distributors in the United States with instructions to deliver them not only to hospitals but also retail pharmacies in five U.S. cities, despite the FDA controls, according to public records.

“At the direction of the White House, SNS did a one-time shipment of hydroxychloroquine to several commercial distributors to support further distribution of hydroxychloroquine directly to hospitals and retail pharmacies in the hard hit areas of NYC, Detroit, Chicago, and New Orleans,” a senior analyst at HHS said in an internal email exchange.

One major wholesaler said it shipped to long-term care facilities, which also were not covered in the FDA’s emergency authorization. All three distributors told The Post they did not ship to retail pharmacies, despite the administration’s request.

The Department of Health and Human Services, which oversees the stockpile, confirmed in an email to The Post that the pills were supposed to go to retail pharmacies but that the agency does not know where the pills ultimately ended up. Through a spokeswoman, the agency said the drugs were supposed to be used for patients with lupus, who encountered shortages early in the pandemic.

The FDA withdrew its emergency authorization in June, after it found hundreds of adverse events linked to the drug’s use in covid-19 patients, including dozens of deaths. In June, two months after the White House’s urgent orders to ship the millions of doses of hydroxychloroquine, health officials told holders of the pills in a general notice they could destroy them.

– – –

The government’s Strategic National Stockpile is maintained for pandemics and biological attacks, with large caches of drugs and medical supplies warehoused around the country for rapid deployment. In his whistleblower complaint, Bright alleged that, from the early days of the pandemic, the White House sought to bypass regular emergency response channels and directly control distribution of hydroxychloroquine. Bright alleged in his complaint, which is still pending, that he was removed from his post in part because of his resistance to the Trump distribution plan.

“The whole thing reeked of political pressure to get that stuff” into state health systems, Bright said in an interview after he departed the federal government this month. “There was no scientific reason or rationale. It was completely political.”

Navarro declined to discuss his role in leading the Trump administration’s push to distribute hydroxychloroquine. Despite the FDA’s revocation of its emergency use order, Navarro continues to insist the drug benefits patients in early stages of infection, both in the hospital and at home as outpatients.

“It is one of the great tragedies of this pandemic that the anti-Trump mainstream media demonized a cheap and effective medicine that could have saved tens of thousands of American lives,” Navarro said in an email to The Post. “How that happened is the only story worth writing about. The rest is just political garbage, and I have no interest in participating further in another hit piece timed around the election cycle.”

Trump said in May he was taking the drug as a preventive measure, but when he contracted the novel coronavirus early this month it was not included in the publicly released list of medications he received.

Navarro was a relentless advocate for hydroxychloroquine in the administration, said Olivia Troye, a former official who served on the staff of Vice President Mike Pence and worked on Trump’s coronavirus task force.

Troye, a public critic of Trump’s pandemic response, said Navarro became visibly irritated at times when other officials would not share his enthusiasm for the drug. He would personally distribute articles and studies around the White House that supported use of hydroxychloroquine to treat covid-19, she said.

“He was really passionate about it,” Troye said. “He was like, ‘Send it out to everyone.’ He was the number one backer of it.”

The anti-malarial drugs in the stockpile were donated by Sandoz, the generic drug division of drug manufacturer Novartis, which dispatched more than 80 million tablets over several months; and Mylan, which is becoming part of Pfizer and donated 10 million.

But even as the manufacturers issued news releases calling attention to their large contributions, they made no claims of their effectiveness to treat covid-19. Medical associations and researchers strongly warned against widespread adoption of the untested pills. Hyroxychloroquine, particularly in combination with the antibiotic azythromycin, a cocktail for covid-19 treatment that a handful of doctors promoted, poses a risk of fatal heart arrhythmia in a small percentage of patients, numerous medical studies have found.

Those concerns were cited in the FDA’s March 28 emergency use authorization, which restricted the Strategic National Stockpile supplies of the drug to hospitalized patients and patients in clinical trials only. The agency wanted to be able to monitor outcomes and track adverse events, according to the EUA.

Despite the EUA’s controls, the administration made plans to ship hydroxychloroquine to pharmacies so patients at home could get the treatment on an outpatient basis. In an exchange of internal HHS emails during the weekend of April 4 and 5 discussing a first shipment of 620,000 pills, top officials outlined a plan to send 220,000 tablets to hospitals and 400,000 to pharmacies in the New York City area, Detroit, Chicago and New Orleans. (The April emails were first reported by Vanity Fair and became public in May when Bright included them in his whistleblower complaint.)

Two of the highest-ranking HHS officials – Adm. Brett Giroir, the assistant secretary of health, and Robert Kadlec, assistant secretary of preparedness and response – agreed that the EUA did not limit the intended distribution.

Under prescribing rules, doctors may prescribe approved drugs for additional “off-label” purposes, meaning for illness other than the approved indications. Hydroxychloroquine has been approved for lupus and rheumatoid arthritis patients for decades.

Giroir, responding to a Strategic National Stockpile official who raised the subject of the EUA limits, was emphatic in an April 5 email that “off-label” outpatient prescribing of hydroxychloroquine was appropriate in the case of covid-19. Giroir is a pediatrician, academic and former hospital administrator appointed by Trump to the rank of four-star admiral in the U.S. Public Health Service.

“NOPE,” Giroir wrote. “Needs to go to pharmacies as well. The EUA matters not – The drug is approved any [sic] therefore can be prescribed as per doctor’s orders That is a FINAL ANSWER.” Giroir added that pharmacies needed the drug for lupus and rheumatoid arthritis as well.

Kadlec answered in a one-word response: “Agree.” Through HHS, he declined to comment.

FDA Commissioner Stephen Hahn, the top drug safety official, also approved sending drugs to pharmacies, despite his agency’s EUA, according to an email in the same chain from Peter Gaynor, the head of the Federal Emergency Management Agency. Gaynor told the other officials on the email chain that he had spoken to Hahn about the issue by phone. FEMA referred questions to HHS.

The FDA referred a question about Hahn’s actions to a blog post published on the FDA website in May. In that post, Hahn explained that outpatient prescribing was justified despite the EUA limits because donation agreements with Sandoz and Mylan for hydroxychloroquine “allowed for it to be distributed for clinical trials and to the commercial market for use in the outpatient setting, if appropriate.”

Hahn also said in the blog that part of the need for outpatient supplies was to relieve shortages of the drugs for lupus and rheumatoid arthritis patients.

On the Monday after that weekend of emails, an order for more than 9 million pills went from the White House to the stockpile, according to a spreadsheet of hydroxychloroquine distributions provided to The Post in response to a Freedom of Information Act records request.

The April 6 order, relayed via email by a White House aide who worked with Navarro’s staff, resulted in 3 million pills sent to each of the three major wholesale distributors of prescription drugs, McKesson, Cardinal Health and AmerisourceBergen.

A former pharmaceutical executive with one of the three distributors, who is familiar with discussions around hydroxychloroquine distribution and spoke on the condition of anonymity to discuss internal deliberations, said Navarro had been in direct phone conversations with the executive’s company.

The message from Navarro was very clear, the former executive said: “You take it, you send it, you manage the distribution.”

In response to detailed written questions from The Post, each of the wholesalers declined to provide data on how many of the government-supplied free drugs they distributed, where they went, and how many they had left by the time the EUA was revoked in June.

A spokesman for Cardinal Health said the drug was sent to hospitals and long-term care facilities but would not provide numbers or elaborate. McKesson said it limited shipments to hospitals and one small order for a hospital-affiliated long-term care facility that it did not name. AmerisourceBergen said it limited shipments to hospitals.

Of the large retail pharmacy chains, CVS and Walgreens said they did not receive or distribute shipments of hydroxychloroquine from the national stockpile. Rite Aid did not response to requests for comment.

– – –

Next, the White House ordered another shipment of 10.1 million pills on April 8. In a spreadsheet supplied to The Post, the government redacted information about the destination of those drugs or who was responsible for distributing them, citing an exemption from public disclosure for stockpile supplies. The White House ordered another 4 million drugs shipped on April 9. Again, the government would not disclose where the drugs were sent.

FEMA told news outlets at the time that the drugs were being sent to cities across the country, starting with New York, Chicago, Detroit and New Orleans, followed by D.C., Baltimore, Miami, Philadelphia, Pittsburgh, Baton Rouge, St. Louis, Indianapolis, Milwaukee and Houston.

ASPR, the section of the Department of Health and Human Services that oversees the stockpile, does not have an accounting of where all the drugs were sent once they went to wholesalers, an HHS spokeswoman said in an email.

“The SNS does not maintain visibility on where product was distributed once it left federal custody and has not received such a list,” the spokeswoman said.

State and local officials contacted by The Post said they were unaware whether drugs went to retail pharmacies in their states.

Officials in Michigan, Illinois, New York and Louisiana said they either were not told by the Trump administration of its plans to distribute large quantities of hydroxychloroquine to hospitals and retail pharmacies in their states – or were aware of the plan but did not participate in decision-making.

“The State was not made aware of the SNS distribution to the health systems until after it was completed,” Lynn Sutfin, the spokeswoman for Michigan’s health and human services department, said in an email.

Garth Reynolds, executive director of the Illinois Pharmacists Association, said he and other officials were unaware of any delivery of hydroxychloroquine from the national stockpile.

“It kind of surprises me that it was given to any pharmacy outside of a health system,” Reynolds said in an interview, “because there would be no rationale for a community pharmacy to be giving it out.”

Sen. Tammy Baldwin, D-Wis., demanded an investigation last spring of a shipment of 335,000 pills that FEMA told her office it shipped to Milwaukee. A top state regulator, Philip Trapskin, chairman of the state Pharmacy Examining Board, told The Post he could find no evidence the drugs ever made it to the state’s hospitals.

“I have been asking around to health systems all over Wisconsin. I have not found anyone who received hydroxychloroquine from FEMA,” Trapskin said.

Hospitals were also sometimes surprised by shipments of hydroxychloroquine showing up at their doors without warning, according to the American Society of Health-System Pharmacists, which represents pharmacists in hospitals.

By late April, the dangers of the drug came into greater focus.

The FDA issued a special caution on April 24 noting hydroxychloroquine can lead to arrhythmia and sudden cardiac death in a small percentage of patients. With millions of doses being sent across the nation, health experts warned that the potential for hundreds of needless deaths was real.

But Trump and the White House continued to tout the drug. On May 18, Trump declared that he was taking hydroxychloroquine as a prophylactic to prevent contracting the virus and said he was receiving “so many letters” from constituents who said the drug was great.

“I want the people of this nation to feel good,” Trump said.

The very next day, inside the FDA, drug safety scientists completed a detailed analysis based on reporting by doctors and hospitals in the United States and abroad, that found nearly 400 adverse health events, including 87 deaths, linked to the use of hydroxychloroquine and a similar anti-malarial drug, chloroquine, in coronavirus patients. The report was not posted on the FDA website until July 1.

In the White House, the scientific data detailed in the memo set off conflict, said Troye, the former senior adviser on Trump’s coronavirus task force.

“I remember Dr. Hahn saying they were going to have the revoke the EUA because of it,” Troye told The Post. “It sent Navarro spinning.”

She said Navarro was particularly heated in a Situation Room meeting in May when Hahn said the evidence of harm was clear.

“He was really angry and saying, ‘You can’t do this, taking away a potential therapeutic.’ They had been acquiring this in large amounts,” she said.

Navarro declined to discuss what information the White House has gathered about where the drugs were shipped, and how much of the drugs shipped to states remains unused. Trump dispatched 2 million pills to Brazil as a gesture of goodwill.

Hospitals also had excess, unused supply. Out of 204 hospitals responding to a questionnaire by the American Society of Health-System Pharmacists, half said they wanted to return excess amounts of the drug to wholesalers.

“In this case, it wasn’t something that the wholesalers would accept back,” said Michael Gaino, the society’s director of pharmacy practice and quality. In June, federal officials said that “holders of the product may choose to destroy the product.”

Sandoz said in response to questions that it is prepared to take back nearly 50 million tablets that remain in the stockpile and were not distributed, but litigation has delayed the return. Sandoz did not identify the litigation.

Some physicians who are continuing to push its continued use have gone to federal court in Michigan against the HHS. A group of physicians called the Association of American Physicians and Surgeons sought a preliminary injunction demanding release of all of the stockpile’s hydroxychloroquine supplies. The group lost an initial request and is appealing.

Jane Orient, a Tucson physician and the group’s executive director, said patients are demanding the drug. She said she knows of one Arizona coronavirus patient who drove all the way to Dallas to find a doctor willing to prescribe a hydroxychloroquine prescription. She accused the government of “hoarding” millions of pills.

“It’s probably just sitting there waiting to expire in the government warehouses, instead of giving it to pharmacies,” she said.

In the meantime, normal commercial supplies of the drug – outside of the emergency stockpile – have bounced back after March and April shortages. Doctors who still believe in its benefits for treatment of covid-19 wrote about 100,000 more prescriptions per month in each of May, June, July and August compared to those months in 2019, according to monthly figures provided to The Post by IQVIA, which tracks drug industry data.

“If we want we want to use it off label, we can use it off label,” said Brian Tyson, a primary care doctor who runs an urgent care clinic in a small strip mall in El Centro, Calif. Tyson joined other activist doctors in demonstrating on the Supreme Court steps this monthto demand greater access to hydroxychloroquine. He said he has treated 1,700 patients with the drug and that no one has suffered an adverse event or been hospitalized with symptoms of the coronavirus.

He said he was warned by administrators of a Medicare-managed care plan that his hydroxychloroquine prescribing was above average but said he is not concerned about repercussions from bureaucrats or medical licensing boards.

“If something happens and they want to sue me, that’s fine,” Tyson said. “I’m not going to listen to nonmedical people tell me how to practice medicine.”

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Death toll rises in powerful Aegean earthquake as Turkish rescuers race to find survivors

InternationalOct 31. 2020

By The Washington Post · Kareem Fahim, Zeynep Karatas · WORLD, EUROPE, MIDDLE-EAST

ISTANBUL – The death toll from a powerful earthquake in the Aegean Sea rose to 28 Saturday as rescue workers in the Turkish city of Izmir raced to save more dozens of people thought to be trapped under the rubble of at least eight collapsed buildings, Turkish officials said.

Related story:

Powerful Aegean earthquake kills at least 14 people in Turkey and Greece, injures hundreds

The earthquake, which struck Friday afternoon just north of the Greek island of Samos, caused deaths in both Turkey and Greece, flooded coastal areas and flattened residential buildings. Twenty-six people were killed in Turkey and more than 800 people were injured, Turkey’s health minister and the country’s disaster management agency said Saturday. Two teenagers were killed on Samos after they were crushed by a collapsing wall.

Nine boats sank and more than 20 ran aground, Turkish authorities said.

The earthquake was the second large tremor to strike Turkey this year and came as the government was struggling to contain multiple crises, including a rise in coronavirus cases and a sharp economic downturn. The U.S. Geological Survey said it was a 7.0 magnitude earthquake, while Turkey’s disaster management agency recorded its magnitude as 6.6.

Tremors were felt hundreds of miles from the epicenter, in Athens and Istanbul. More than 500 aftershocks followed, the disaster agency said.

Izmir Mayor Tunc Soyer told Fox News Saturday that rescue teams were still trying to reach 180 people trapped under the rubble. Turkish media showed footage of orange and red-clad rescue workers slowly removing debris from a completely collapsed structure in Bornova, in the northwest corner of Izmir and one of the city’s hardest hit neighborhoods.

More than five thousand rescue personnel and 20 sniffer dogs were deployed to find survivors, the disaster management agency said. The state run Anadolu news agency said 100 people had already been pulled alive from buildings, including an elderly woman who was freed from a pancaked structure on Saturday morning.

Zahide Kucukbozdol, 38, who was at home with her husband two children when the earthquake struck in Bayrakli, another badly-hit district in Izmir, described the panicked rush to find safety.

“First my husband felt it. I took my son in my arms. The earthquake was so strong, and it was very long,” she said in a telephone interview Saturday. When the shaking stopped, plumes of smoke were rising outside her window. “I grabbed my two children in my arms, one is one-and-a-half and the other is four. I felt so strong in that moment and without thinking of what I was wearing or doing, I went out the door. My husband took other essential things like phones, wallets and a baby carriage.”

Outside, “buildings were collapsing around us. It was like the movies. It is depressing and scary when you experience for yourself the things that happen in movies.”

In Greece, there was extensive damage as well to the aging, one-story houses on Samos, where many residents spent Friday night sleeping outdoors or in cars, local media reported. Nine people were injured, including a teenager who was airlifted to Athens in serious condition, the authorities said.

The earthquake provided a temporary respite from an acrimonious feud between the governments of Turkey and Greece over a large range of issues, including contested sovereignty in the Aegean. Greek Prime Minister Kyriakos Mitsotakis and Turkish President Recep Tayyip Erdogan – NATO allies who have engaged in a bitter war of words in recent months – spoke by telephone Friday and then posted conciliatory messages on Twitter.

“Turkey counts many victims and great damage. I have already contacted President Erdogan stressing that beyond difficulties in our relations in times like these the priority is the unity of our people,” Mitsotakis said in a televised address Saturday. “For us the importance of human life overcomes borders and differences. Ι thank him for his positive response to my phone call.”

The leaders’ gestures raised faint hopes that the tragedy might quiet their broader arguments. And indeed, there was a precedent for greater cooperation between Turkey and Greece following earthquakes: In 1999, when powerful tremors occurred within weeks of each other in both countries, one about 50 miles from Istanbul and the other in Athens. Each government sent rescue teams to aid the other, contributing to an outpouring of popular goodwill.

After Friday’s earthquake, Morgan Ortagus, the U.S. State Department spokeswoman, said the United States was “heartened by” and supported the cooperation between the two governments.