WASHINGTON — President Donald Trump has stopped talking about the decades-old antimalarial drug he once touted as a “game changer” for COVID-19, but it won’t be as simple for the rest of the health system to just move on.
When Trump first began touting the drug in mid-March, a frenzy ensued as hospitals, patients and doctors raced to secure supplies. Many believed even if the drug didn’t turn out to be an effective coronavirus treatment, it might be able to ward off infection.
But as quickly as pharmacies were drained of the pills, the tide has now turned against hydroxychloroquine and its chemical cousin, chloroquine. Regulators and scientists have raised concerns about potentially serious side effects, while Gilead Sciences Inc.’s antiviral therapy remdesivir was cleared for U.S. use. Some hospitals, including Mount Sinai Health System in New York, no longer include the antimalarial drug in their treatment regimen for COVID-19.
The surge resulted in shortages that left patients who’d long taken the medication to treat lupus and rheumatoid arthritis hunting for alternatives. To help get more drugs to market, the Food and Drug Administration has allowed overseas manufacturing facilities that were previously sanctioned for quality violations to begin producing it for U.S. patients.
Hydroxychloroquine prescriptions jumped to 298,660 during the week of March 20, more than doubling from a week earlier, according to data compiled by Bloomberg Intelligence. But prescriptions have now plummeted back to nearly normal levels, and there are signs a speed-up in manufacturing is slowing.
Demand for bottles of chemicals made by United States Pharmacopeia that are used as reference standards in pharmaceutical manufacturing skyrocketed 1,733% from mid-March to mid-April compared with the year before, but has since dropped 52% in the week of April 24 to April 30 compared to the week prior, according to USP data.
The swift embrace and rapid abandonment of hydroxychloroquine underlines how publicity of evolving science can have unpredictable consequences on the behavior of physicians and patients. The episode also shows how supply chains and government agencies struggle to keep up with such changes, especially when one perspective is amplified by the president.
“This is the president of the United States with the full force of the task force behind him,” said James Roberts, a marketing professor with expertise in consumer behavior at Baylor University. “He was on TV and at the White House. Whenever someone is facing desperate times, anything that can provide hope, you want to believe.”
Democrats and the media have attacked Trump for what Judd Deere, a White House spokesman, said was discussing “a possible treatment that could save a person’s life.”
“While some are rooting for the drug to fail, President Trump is simply offering a consistent message of hope, comfort, and optimism while telling Americans to consult with their doctor,” Deere said.
Trump’s enthusiasm is still reverberating even as the mania that followed it recedes. The U.S. government has agreed to spend tens of millions of dollars to assess and acquire hydroxychloroquine and chloroquine. And dozens of overlapping clinical trials are looking at the effectiveness of the drugs against COVID-19 at universities and medical centers.
How those dynamics will change now that doctors and health officials are souring on the drug isn’t clear. Results of some of the clinical studies could begin rolling out as soon as later this month. The FDA warned April 24 about potentially deadly heart risks associated with the drugs, but for now the agency isn’t planning to change its emergency-use policy.
Jesse Goodman, a former chief scientist at the FDA who worked under both Democratic and Republican administrations, said the available science didn’t warrant the agency’s blessing.
“The evidence was unusually weak given the potential for widespread use,” he said.
Michael Felberbaum, a spokesman for the FDA, said in an email that the agency can revise or revoke an emergency authorization under certain circumstances, including information related to linked or suspected adverse events, new data, or a change in the agency’s view of a drug’s risks and benefits.
Despite the agency’s efforts to help build up U.S. inventories, the change in sentiment has left medications that were hurriedly added to the emergency supply unused.
The FDA’s emergency authorization allowed 1 million donated doses of chloroquine from Bayer AG to be dispensed from the stockpile because the company’s version isn’t approved in the U.S. But none of Bayer’s drug, sold under the name Resochin, has been requested by the states, a Department of Health and Human Services spokesperson said in an email.
The U.S. government has dispensed numerous contracts tied to hydroxychloroquine. The Department of Health and Human Services awarded Florida-based Alchem Laboratories Corp. $20.7 million to study use of the drug against COVID-19 with famotidine, the main ingredient in the antacid Pepcid, according to a government-contracts database. People have been hoarding famotidine after several studies of the combination piqued interest, and the FDA said Monday the drug is now in short supply.
A research organization set up under the Affordable Care Act awarded Duke University researchers $50 million to study hydroxychloroquine as a preventative measure for U.S. health care workers.
The Department of Veterans Affairs has contracts worth more than $200,000 to acquire the drug. The Department of Justice agreed to pay $60,000 to buy hydroxychloroquine for the prison system, according to the database. HHS also contracted with a research company in North Carolina for $750,000 to collect and analyze the outcomes for patients who use drugs dispensed from the national stockpile, a condition of the FDA’s emergency authorization.
Veterans Affairs has ordered hydroxychloroquine and chloroquine for a number of years for lupus and rheumatoid arthritis patients, and the bulk of its contracts will be used for that, Christina Noel, a spokeswoman for the department, said.
“VA is only using hydroxychloroquine to treat COVID-19 in cases where veteran patients and their providers determine it is medically necessary, and in a manner consistent with current FDA guidance,” Noel said.
The Bureau of Prisons also uses the drugs for patients with autoimmune conditions and the $60,000 contract was to ensure it had enough supply for them and prisoners returning from local hospitals who were prescribed the drugs, said Emery Nelson, a spokesperson for the agency.
The furor over the drugs has been costly for patients with chronic autoimmune diseases. They struggled to get access to treatment as Trump’s daily endorsements caused prescriptions to surge, though some of the strain has shown signs of receding.
“Within the last few days we have seen a drop in calls and emails expressing concern and challenges accessing hydroxychloroquine,” Mike Donnelly, a spokesman for the Lupus Foundation of America, said. “We have also heard that people who had trouble getting their refill at first are now able to.”
Some lupus patients are still struggling to access their medication or are being told they can only get 14-day refills, he said.
The foundation has been talking with the 12 pharmaceutical companies that make the drugs, “and we’ve been in constant contact with federal and state government officials and agency leaders to make sure they’re doing everything possible to address the supply crisis,” Donnelly said.
As regulators try to make it easier for the drug to reach the market, manufacturers that have previously been cited for quality problems are stepping in.
The FDA allowed a drug company in India that the agency previously reprimanded for not meeting U.S. manufacturing standards to help fill in the supply gaps. Mylan NV said it would restart production of hydroxychloroquine in its West Virginia plant. The FDA had warned that facility in November 2018 for ignoring situations in which drugs made there failed to pass routine quality checks.
Mylan didn’t comment on whether those plans are moving forward at expected levels.
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