The Strategic National Stockpile has shipped 28 million tablets of a malaria drug that President Donald Trump touted as a potential treatment for COVID-19 to states since April 1. States received millions more from donations or taxpayer-funded purchases.
But after doubts arose about whether the drug, hydroxychloroquine sulfate, is safe and effective for the coronavirus-based disease, states are donating supplies to patients who need them for other reasons, seeking refunds or weighing what to do with them.
As Trump encourages some states to lift shelter-at-home orders, states report that hydroxychloroquine, a linchpin of Trump’s response to the COVID-19 pandemic, won't be used to prevent any resulting surge of illnesses and deaths because the drug may not work and has dangerous side effects.
Meanwhile, a whistleblower complaint that was filed Tuesday by former Biomedical Advanced Research and Development Authority Director Rick Bright raises other safety concerns about the stockpile’s hydroxychloroquine and chloroquine tablets.
Bright and other officials were “concerned about the quality and potential toxicity of chloroquine supplies produced and shipped in from facilities in India and Pakistan that were not approved by the FDA, and were therefore not approved to be used in the U.S. marketplace,” the complaint to the Office of Special Counsel alleges.
States like Texas report that the drug no longer plays a role in their emergency response plans. In one week stretching from late March into early April, dozens of Texas hospitals across the state requested 467 bottles of hydroxychloroquine from the state’s emergency supply.
By the week of April 20, as new evidence emerged about the drug’s sometimes deadly side effects, requests fell to a trickle. Ten bottles were requested between April 20 and April 24, data supplied by the Texas Department of State Health Services show. Over the last two weeks, following a Food and Drug Administration warning, no bottles were requested.
About 9,200 bottles of hydroxychloroquine, or 920,000 pills, remain sitting in the Texas stockpile.
North Carolina, which acquired 1.5 million tablets from donations and the national stockpile, also saw a drop-off in requests, according to the state’s Department of Health and Human Services.
Questions remain about how many states and hospitals obtained hydroxychloroquine and how they plan to use it. A spokesperson for the national stockpile would not specify which states and hospitals requested supplies, and said stockpile officials are not aware of which hospitals and long-term care facilities received it.
Amneal Pharmaceuticals, which donated supplies directly to several states in early April, did not respond to a request for comment.
The hydroxychloroquine boom may have burned up valuable time and resources.
Michael Carome, director of the health research group at Public Citizen, said the use of hydroxychloroquine before FDA approval for COVID-19 may have diverted people from participating in clinical trials to study it and other nascent therapies. It may have also led to deaths.
“Some patients who were given the drug were probably harmed and some may have died,” he said.
Trump began championing the drug as a “game changer” with “very, very encouraging early results” on March 19. The FDA issued an emergency use authorization for hydroxychloroquine sulfate and a related drug, chloroquine phosphate, on March 28, based on anecdotal evidence rather than clinical data.
A small pilot study supporting its efficacy in mild cases, which was touted on Fox News, was determined to not meet the “expected standard” of the International Society of Antimicrobial Chemotherapy, whose medical journal published it.
More evidence emerged throughout April that hydroxychloroquine may not be the effective treatment the president claimed.
A study of COVID-19 patients at Veterans Affairs facilities treated with hydroxychloroquine alone or in combination with another drug, azithromycin, found no evidence that the drug prevented COVID-19 respiratory problems. The study found patients taking hydroxychloroquine alone actually had a higher mortality rate than patients who did not.
The study, funded by the National Institutes of Health, has not yet been vetted by experts through peer review or published in a journal.
By April 24, the FDA issued its warning that hydroxychloroquine should not be prescribed off-label, and should only be used in a hospital or a clinical trial because of heart rhythm risks.
The Infectious Diseases Society of America recommends the drug only be used for COVID-19 in a clinical trial.
Some of the 28 million tablets shipped by the national stockpile will be used to fuel these clinical trials.
In hard-hit New York, the Mount Sinai Health System recommends that its physicians not use the drug to treat patients with COVID-19 because of the potential for harm, including the arrhythmias and the blood disorder methemoglobinemia.
New York Gov. Andrew Cuomo, a Democrat, worked with the Trump administration in March to get hydroxychloroquine. The New York Department of Health did not respond to a request for comment.
The Philadelphia Department of Health specified that though some hospitals independently acquired hydroxychloroquine, the city had not acquired the drug and would not direct its use for COVID-19.
Georgia GOP Rep. Doug Collins said on April 7 a donation of hydroxychloroquine from drugmaker Amneal “could potentially save thousands of lives across our state.” Collins thanked the Georgia Department of Public Health for helping secure the donation.
The Georgia Department of Public Health referred questions to the governor’s office, which did not respond.
Use for other conditions
Interest in the drug as a COVID-19 therapy led to shortages for patients with the autoimmune conditions hydroxychloroquine was approved by the FDA to treat. State boards of pharmacy and patient advocates have sounded the alarm about these shortages.
Some of the supply from the national stockpile will be directed to the lupus and rheumatoid arthritis patients who faced problems because the drug was in short supply, a Health and Human Services spokesperson said.
Public health departments in Oregon and Connecticut report they may use their donated supplies in part to alleviate the artificial shortages. Oregon has not decided exactly how it will use its hydroxychloroquine, said Jake Sunderland, spokesman for the state’s COVID-19 emergency response team.
“The research about the use of hydroxychloroquine is in the preliminary stages. There are potentially severe cardiac side effects to taking hydroxychloroquine and the data are insufficient to recommend it generally, and it has not been approved by the FDA for use in treatment of COVID-19,” Sunderland said in a statement.
“However, the limited supply of this drug has impacted patient access to the medication for those who need it for FDA indicated and approved uses, for example lupus and rheumatoid arthritis. This supply could assist those who are having trouble accessing the medication for these types of uses.”
In Connecticut, a donated supply of hydroxychloroquine was shipped to hospitals according to bed capacity. But hospitals are not required to use it for COVID-19.
“The ultimate decision about whether or not to use it lies with the individual doctors based on their patient need,” said state spokesperson Lora Rae Anderson.
While many states obtained hydroxychloroquine through donations, some purchased it. Utah GOP Gov. Gary Herbet received a refund last week for the $800,000 his office paid to a pharmacy called Meds in Motion for a supply of hydroxychloroquine.
A left-leaning good government group seeking more information about the purchase filed a price-gouging complaint, but the Utah Department of Commerce closed the case without conducting an investigation. The agency said it only has jurisdiction over retail purchases, not public purchases.
The state of Oklahoma sent $2 million to a company called FFF Enterprises for the drug. The state “stepped in as a back stop of hydroxychloroquine supplies for Oklahoma’s medical community,” Shelley Zumwalt, chief innovation officer at the State Department of Health, said in a statement.
“As soon as the FDA approved Hydroxychloroquine to treat COVID-19 more than five weeks ago, medical professionals across Oklahoma asked for support to ensure the State had adequate access to this critical drug,” Zumwalt said.
The state’s attorney general has called for an audit of the department’s COVID-19 pandemic purchases.