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Bright shines harsh light on America’s COVID-19 preparedness, FDA’s independence

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Cronyism has crippled America’s pandemic response, enriching undeserving entrepreneurs and politically potent consultants who siphoned funds that could and should have been used to mount a defense against COVID-19, according to a whistleblower complaint filed by Rick Bright, the former director of the Biomedical Advanced Research and Development Authority and HHS deputy assistant secretary for preparedness and response.

While Bright’s allegations of cronyism are attracting a great deal of attention, in the long run the light he has shed on FDA’s decision-making during this era may be more important.

“The allegations, including political pressure brought to bear to issue an EUA for the antimalarial drugs, as well as to then promote their access even outside of the EUA conditions, document a serious threat to science-based decision-making and FDA’s scientific integrity and independence,” Jesse Goodman, former director of FDA’s Center for Biologics Research and Evaluation and former FDA chief scientist, told BioCentury.

“The integrity of the agency in making its decisions is essential, and any threats to it also threaten public confidence in judgments the agency will need to make in coming months about COVID-19 vaccines,” said Goodman, who is a Georgetown University professor. “Ensuring sound decisions and public confidence will be essential in controlling the pandemic and saving lives.”

“I wonder why the EUA is still out there.”

Jesse Goodman, Georgetown University

Bright, who was fired in April by HHS Secretary Alex Azar, detailed his assertions in a complaint against his immediate supervisor, Robert Kadlec, HHS assistant secretary for preparedness and response (ASPR) that was made public May 5.

The complaint adds weight to fears that FDA has reached an inflection point at which bending to political winds and shaky leadership imperils confidence that its decisions are based on science and the best interests of the public.

Before Bright made his concerns public, FDA’s decision to grant an EUA for chloroquine and hydroxychloroquine had already raised these concerns.

In March a BioCentury Editor’s Commentary called the EUA “unnecessary and unwise” and warned that it put patients at risk and eroded FDA’s reputation for independence (see “FDA’s Authorization of Malaria Drugs for COVID-19 Looks Like Political Science”).

The whistleblower complaint reinforces those concerns, and raises questions about FDA Commissioner Stephen Hahn’s ability to insulate the agency from political pressure.

While political attacks on FDA’s independence, and more subtle attempts to influence its decisions are common, traditionally the Commissioner has served as a buffer, protecting the agency’s staff and the institution’s reputation.

“An incredibly important role for the FDA commissioner is to protect the integrity of the FDA and its decision-making processes,” Goodman told BioCentury. The EUA and Bright’s allegations “raise concerns about that. More broadly, part of the problem with the whole federal response is from the very highest level this started out with wishful thinking.”

Goodman expressed concern that the controversy over Bright’s allegations could play into fears about vaccines. “As we get new therapies and particularly vaccines coming online, and there are efforts to sow distrust in vaccines, it will be important that government and FDA make the best possible decisions. We can speed things up, but we need to do things in an environment where decisions aren’t made under intense political pressure or fear for jobs.”

Agreeing to an EUA to avoid expanded access

In addition to asserting that Kadlec improperly steered contracts to specific biopharmaceutical companies, Bright alleges that political considerations shaped FDA’s decision to grant Emergency Use Authorization (EUA) to chloroquine and hydroxychloroquine for COVID-19.

“In an apparent effort to score a short-term political victory for the Administration during the escalating health crisis, the Office of the ASPR pressured BARDA to promote the malaria drug chloroquine as a therapeutic for COVID-19, despite a clear lack of scientific support,” Bright alleges.

He charges that fealty to President Donald Trump led HHS to pressure FDA to authorize use of unproven therapies and to stymie Bright’s efforts to purchase personal protective equipment including N95 masks for the national stockpile.

The complaint states that starting in 2018 Bright resisted Kadlec’s attempts to steer funds to companies that had hired consultants with close ties to Jared Kushner. The document, which refers to Bright in the third person, states that the tension increased when BARDA’s attention focused on the COVID-19 pandemic. “Dr. Bright became even more alarmed about the pressure that Dr. Kadlec and other government officials were exerting on BARDA to invest in drugs, vaccines, and other technologies without proper scientific vetting or that lacked scientific merit.”

HHS, which portrayed Bright’s firing as a promotion, declined to respond to his specific allegations. “Dr. Bright was transferred to NIH to work on diagnostics testing -- critical to combating COVID-19 -- where he has been entrusted to spend upwards of $1 billion to advance that effort,” HHS spokesperson Caitlin Oakley told BioCentury. “We are deeply disappointed that he has not shown up to work on behalf of the American people and lead on this critical endeavor.”

“Americans should be able to trust that ASPR’s decisions are guided by the best science and the public’s interest in mind.”

Luciana Borio

Former senior government officials expressed support for Bright and alarm at his allegations.

“In the aftermath of hurricane Katrina, Congress, the Pandemic and All Hazards Preparedness Act established the position of the assistant secretary for preparedness and response to clearly answer the question of who is in charge during a public health emergency,” Luciana Borio, former director for medical and biodefense preparedness policy at the National Security Council, told BioCentury.

Borio, who served with Bright, added: “Americans should be able to trust that ASPR’s decisions are guided by the best science and the public’s interest in mind. As BARDA director, Dr. Bright’s work has been guided by these values.”

Bright’s allegations that political considerations, including the White House’s predilection for assuming a best-case scenario, suggest that time that could have been used to procure and develop countermeasures such as diagnostics and masks were squandered, said Goodman. “There were many missed opportunities and we are paying the price now.”

Chloroquine and hydroxychloroquine

The allegations in Bright’s complaint contribute to the weight of evidence suggesting that FDA should rescind the Emergency Use Authorization (EUA) for chloroquine and hydroxychloroquine to treat COVID-19, Goodman told Biocentury. “I wonder why the EUA is still out there. There is insufficient evidence to support the EUA.”

To dramatically increase access to chloroquine and hydroxychloroquine for COVID-19, Azar and White House officials decided in March that they needed FDA authorization, and that BARDA should apply for an expanded access IND.

Rather than an endorsement of the drugs, requesting the EUA was a compromise crafted in consultation with Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, Bright alleges.

According to Bright, on March 23, he “received an urgent directive from HHS General Counsel Bob Charrow, passed down from the White House, to drop everything and make the chloroquine donated by Bayer widely available to the American public. Mr. Charrow told Dr. Bright that Secretary Azar was directing BARDA to establish a Nationwide Expanded Access Investigational New Drug (“IND”) protocol for chloroquine, which would provide significantly greater access to the drug than would an EUA.”

Bright states that FDA Chief Counsel Stacy Amin and other HHS officials urged him to proceed with the expanded access request, but on March 24, Woodcock “called Dr. Bright and strongly recommended that BARDA submit an application for an EUA instead of an Expanded Access IND protocol.”

The EUA, according to Bright, “was a compromise position, to rein in HHS leadership’s initial campaign to make the drugs available to the public outside of a hospital setting and without physician supervision.”

FDA’s response

In a statement provided to BioCentury, FDA acknowledged that it had considered and rejected a proposal to provide chloroquine and hydroxychloroquine via expanded access and use technology from Oracle Corp. (NYSE:ORCL) to track outcomes.

“The variety of therapeutic areas being evaluated include existing therapies such as chloroquine and hydroxychloroquine, which are approved for other conditions. As part of efforts to collect data on how these drugs are being used and the treatment outcomes for patients, various ways to collect information to complement traditional clinical studies, such as the Oracle project, were discussed and explored,” the agency stated.

“From an FDA perspective, this project was not intended as a mechanism to distribute drugs and ultimately the agency did not support a nationwide expanded access investigational new drug application (IND) for this effort.”

FDA added that it “has not waived any regulatory requirements and never sought any use of the drugs that wouldn’t be under physician supervision in connection with this or other related efforts. The FDA’s clinical trial regulations and guidances outline the physician supervision that is part of an IND.”

In addition, FDA stated that it has taken steps to ensure a stable supply of the two drugs for patients who need them to treat lupus and rheumatoid arthritis. These steps included “examining whether drugs that were being offered for donation could be distributed in the commercial market to ease pressure of product that was already in shortage as reflected in the FDA shortages database.”

FDA said it considered options for making donated drugs available, “determined an IND was not feasible,” and instead issued an EUA.

“This decision was based on evaluation of the EUA criteria and the scientific evidence available and reflected extensive discussions with career experts at the FDA, including Dr. Woodcock, and others at CDC, NIH, and BARDA who are involved in pandemic response.”

The agency noted that donations include chloroquine product not currently approved for any use in the U.S. “As per FDA’s standard practice when a drug is in shortage, the agency tested the unapproved product to evaluate acceptability for importation and determined product met USP standards. Given that the hydroxychloroquine products are already FDA-approved, the drug was also provided to wholesale distributors to further supply hospitals as well as retail pharmacies that were experiencing product shortages for people who use the drug for the maintenance of chronic conditions such as rheumatoid arthritis and lupus.”

Allegations of contracting impropriety

Bright alleges that Kadlec improperly intervened in BARDA’s contracting procedures to force the agency to award contracts for drugs and vaccines to companies that had hired John Clerici as a consultant.

Starting in 2017 and continuing until he was removed as BARDA director, Bright’s complaint alleges that “HHS leadership pressured Dr. Bright and BARDA to ignore expert recommendations and instead to award lucrative contracts based on political connections and cronyism.”

Bright said he “repeatedly clashed with Dr. Kadlec and other HHS leaders about the outsized role played by John Clerici, an industry consultant to pharmaceutical companies with a longstanding connection to Dr. Kadlec, in the award of government contracts.”

“Dr. Bright was transferred to NIH to work on diagnostics testing -- critical to combatting COVID-19.”

Caitlin Oakley, HHS

Clerici, a principal at consulting firm Tiber Creek Partners and at law firm Dentons LLP, denied Bright’s allegations in a statement emailed to BioCentury. “I unequivocally deny all of the allegations lodged by Dr. Bright and his lawyers. It’s sad that during this crisis Dr. Bright and his team have chosen to launch politically motivated allegations against me and other people. The record is clear that his allegations are false and will be proven so.”

Clerici’s influence led Kadlec to overrule objections from BARDA staff and to grant hundreds of millions of dollars to drug companies to provide generic and new drugs to the strategic national stockpile, according to Bright.

Bright alleges that Kadlec involved Clerici, who is not a government employee, in discussions about BARDA contracting, including in 2017 when Bright declined to extend a contract to Aeolus Pharmaceuticals Inc. (OTCQX:AOLS). “In attempting to justify the extension of this failed contract, Mr. Clerici emphasized that Aeolus’s Chief Executive Officer was a ‘wildcard’ and a friend of Jared Kushner, President Trump’s son-in-law and a Senior Advisor to the President.”

Aeolus could not be reached for comment.

Bright made similar allegations that Clerici and Kadlec intervened to overrule objections from BARDA professional staff about other drug contracts.

Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus

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