Government scientist felt pressured to approve contract for work on drug Trump touted

The federal scientist recently ousted from a senior position overseeing research on coronavirus vaccines felt pressured by Trump administration officials to award a $21-million contract to a Florida laboratory to study an anti-malaria drug touted by the president as a COVID-19 treatment, according to a person familiar with the incident.

Rick Bright, who was abruptly removed this week from his senior post at the Department of Health and Human Services, was told by officials to approve the contract for a clinical trial of hydroxychloroquine to Alchem Laboratories, a small drug-development firm, the person said.

“He was very concerned and was ordered to do it,” said the person.

The contract with the laboratory introduces a new element to an episode that burst into public view this week. The controversy began when Bright said he had been demoted because he resisted pressure from administration officials to provide widespread access to hydroxychloroquine, an anti-malaria drug that President Trump repeatedly has touted as a potential cure for COVID-19, the illness caused by the coronavirus.

The government awarded the contract to Alchem on April 14, a week before Bright was moved out of his job running the Biomedical Advanced Research and Development Authority, a research agency within the Health and Human Services Department that, among other duties, was overseeing research on coronavirus vaccines.

The internal fight over the study was part of a weeks-long clash pitting Bright and his team of immunologists against senior administration officials who, he says, were seeking regulatory approval for nationwide, unsupervised use of hydroxychloroquine to treat COVID-19 patients.

Bright had been pushing for a controlled study of the drug before it was put into widespread use. The study proposed by Alchem and backed by senior officials at the department called for combining hydroxychloroquine with intravenous doses of famotidine, an anti-heartburn drug known by the brand name Pepcid.

The design of the planned study appears to have been a key concern to Bright, according to the person familiar with the case. It’s unclear what possible role famotidine may have in the treatment of COVID-19.

Bright’s lawyers said Thursday they were planning to file a federal whistleblower complaint, alleging he was reassigned to a lesser job in his department because he questioned Trump’s promotion of hydroxychloroquine.

“In our filing we will make clear that Dr. Bright was sidelined for one reason only — because he resisted efforts to provide unfettered access to potentially dangerous drugs, including chloroquine, a drug promoted by the administration as a panacea, but which is untested and possibly deadly when used improperly,” Bright’s lawyers, Debra Katz and Lisa J. Banks, said in a statement.

They accused the adminstration of “making demonstrably false statements about Dr. Bright, one of the nation’s leading vaccine, drug and diagnostic experts, to deflect attention from its retaliatory removal of him as the director” of the research agency.

A spokeswoman for the Department of Health and Human Services did not immediately answer questions about possible links between the contract and Bright’s dismissal.

Administration officials have denied that Bright, who has a PhD in immunology, was removed over a dispute about hydroxychloroquine, saying instead that he had requested that the Food and Drug Administration grant special permission for Health and Human Services to acquire stocks of the drug.

“It was Dr. Bright who requested an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for donations of chloroquine that Bayer and Sandoz recently made to the Strategic National Stockpile for use on COVID-19 patients,” the Department of Health and Human Services said in a statement.

But the person familiar with Bright’s role said he had agreed to seek the emergency-use authorization as “a compromise” with senior officials pressing for wider use of the drug, including by patients not being treated in hospitals for COVID-19.

On Wednesday, Bright said in a statement that he was reassigned for insisting that “the billions of dollars allocated by Congress to address the COVID-19 pandemic” be invested “into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit.”

“Rushing blindly towards unproven drugs can be disastrous and result in countless more deaths,” he added. The statement was first reported by the New York Times.

As the number of coronavirus cases rose in February and March, Trump touted hydroxychloroquine and its close relative chloroquine repeatedly, at one point calling them potentially “the biggest game-changers in the history of medicine.”

In recent days, as more negative results about hydroxychloroquine have become public, Trump has toned down his promotion of it.

Researchers from the Columbia VA Health Care System in South Carolina and the University of Virginia School of Medicine reported earlier this week that in 368 hospitalized COVID-19 patients treated with a range of medicines, hydroxychloroquine failed to reduce patients’ need for mechanical ventilation to assist with breathing.

They also found that in some cases, the drug was linked to higher rates of death, especially when administered without the antibiotic azithromycin, according to a copy of the study posted Thursday to the research site MedRxiv.

Of the 368 patients, all of them male, the 97 who got hydroxychloroquine alone were almost 2½ times more likely to die than those who got neither drug. The 113 who got hydroxychloroquine and azithromycin were roughly twice as likely to die as the 158 patients who got neither drug.

The “retrospective analysis” of COVID-19 patients treated within the VA system was hastily conducted after the Food and Drug Administration waived its usual evaluation process and allowed the drug’s use as treatment for a disease without first evaluating its safety and effectiveness. It was only the second time in its history that the agency has done so.

Alchem Laboratories, the firm conducting the study funded by the Department of Health and Human Services, is located in the north-central Florida city of Alachua, near Gainesville.

The firm appears to have gotten into the hydroxychloroquine business in January 2018, when the Army Medical Research Acquisition Activity awarded it a contract “to procure, synthesize, or purify potential antimalarial drug candidates” for the Walter Reed Army Institute of Research.

The contract was just one of $10.6 million in federal contracts that Alchem won in early 2018, mainly with the Department of Health and Human Services and the National Institutes of Health.

The company described itself at that time as a “contract manufacturing organization” and appeared largely to manufacture “experimental therapeutics” for use in clinical trials.

Later in 2018, the firm appears to have moved aggressively into doing more clinical trials.

The current agreement between the firm and the government calls for it to “rapidly implement a multi-site, randomized, double-blind, multi-arm historical control, comparative trial of the safety and efficacy of Hydroxychloroquine and the combination of Hydroxychloroquine and Famotidine for the treatment of moderate to severe COVID-19 disease in hospitalized adults.”

James D. Talton, the company’s president and chief executive officer, hung up abruptly when contacted Thursday by The Times. “I cannot speak to you, I’m sorry,” he said.

Cloud reported from Washington and Healy from New York. Times staff writer Noam Levey in Washington contributed to this report.