Today, the former head of the agency responsible for rapid development of pandemic responses such as therapies and vaccines announced he would file a whistleblower complaint with the Department of Health and Human Services (HHS). Rick Bright, who had led the Biomedical Advanced Research and Development Authority until this week, says he was transferred to a different position because he insisted on funding scientifically valid vaccine and therapy research over the objections of political appointees at HHS.

The Biomedical Advanced Research and Development Authority (BARDA) has been a relatively obscure agency. It has a broad remit: to enable a rapid response to emerging biomedical threats. Many of its listed threats are focused on terrorism issues, like biological, chemical, and radioactive attacks. But it also handles the related issue of pandemics and emerging diseases, which makes it very relevant at the moment.

The responses BARDA is meant to foster include diagnostics, therapies, and vaccines, and it provides both funding to advance their development as well as technical consulting to help companies overcome bottlenecks in the development process. As such, it has played a key role in determining the government's response to the SARS-CoV-2 pandemic, and it has seen its budget tripled in a recent coronavirus response bill.

Bright has led BARDA since his appointment in 2016, during the prior administration. It was reported yesterday, however, that he has been reassigned in a move the report termed sudden. Bright was being shifted to a public-private effort within HHS meant to expand and coordinate national testing efforts. While this would require a similar set of management skills in coordinating government and private industry, it was clearly a step down from the broad responsibilities of BARDA.

Lawyer up

Today, however, Bright released a statement indicating that he had retained a law firm that specializes in representing whistleblowers and will be asking the Office of Special Counsel to stay his transfer while the causes of it are determined. Bright alleges that they are purely retaliatory and result from his clashes with politically appointed leadership at HHS.

"I believe this transfer was in response to my insistence that the government invest the billions of dollars allocated by Congress to address the COVID-19 pandemic into safe and scientifically vetted solutions," Bright's statement reads, "and not in drugs, vaccines, and other technologies that lack scientific merit." He goes on to be very specific about the ideas that lacked scientific merit: "Specifically, and contrary to misguided directives, I limited the broad use of chloroquine and hydroxychloroquine, promoted by the administration, but which clearly lack scientific merit."

Bright also alleges that he received criticism for acting early to fund the development of a vaccine, as well as for attempting to obtain supplies that could protect people from infections—presumably protective gear like masks and gowns.

Anecdotes

The wide use of chloroquine has been promoted a number of times by President Trump and echoed by media outlets that support his presidency. But its promise as a therapy was based on a small anecdotal study, which is consistent with Bright's use of the terminology "lack scientific merit." More recent studies, while remaining inconclusive, have validated this caution: they show both the dangerous side effects of these drugs and how they have no effect.

According to sources contacted by CNN, however, Bright's issues were primarily with the head of HHS, Secretary Alex Azar.

Regardless of the cause of his transfer, the disruption of work at BARDA does not bode well for the chaotic federal response to the pandemic. In biology, many good ideas often fail for non-obvious reasons, and so pushing multiple avenues of development is critical to ensuring that something useful—be it a diagnostic, therapy, or vaccine—becomes available as soon as possible. While the biotech industry is global, and these efforts are going on around the world, there's little doubt that many of the companies best positioned to develop these technologies are based in the United States. Any sudden changes of strategy or disruptions of funding here could have global implications.