May 23, 2020 Liz Borkowski, MPH 0Comment

A week in mid-May saw two hearings in which federal career scientists from the Department of Health and Human Services (HHS) warned members of Congress that ignoring evidence will lead to far more COVID-19 deaths.

On May 12, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease (NIAID, which is part of the National Institutes of Health, or NIH) was one of four witnesses at the Senate Health, Education, Labor & Pensions Committee hearing “COVID-19: Safely Getting Back to Work and Back to School.”

On May 14, the House Energy & Commerce Committee’s Subcommittee on Health held a hearing on “Protecting Scientific Integrity in the COVID-19 Response” that featured immunologist Dr. Rick Bright, who recently filed a whistleblower complaint after having been transferred from his position as director of HHS’s Biomedical Advanced Research and Development Authority (BARDA) to a more limited position at NIH. Bright’s complaint alleges that he was forced out of his jobs because he resisted efforts to direct contracts to politically connected companies—and the federal office that investigates such complaints determined that there is sufficient evidence to believe that he was the subject of retaliation. Much of the hearing focused on such Bright’s concerns about politics overshadowing science in HHS’s response to the pandemic.

The hearings took place in the context of the Trump administration stifling access to the best available guidance on COVID. Although Fauci testified before the Republican-led Senate, the White House barred him from testifying at a House hearing. The official reason was his busy schedule, but President Trump then stated that it was because the House was full of “Trump haters.” Meanwhile, CDC’s detailed guidance on reopening following stay-at-home orders hadn’t been released, even though many states were moving to lift restrictions. (It has since been released, but in a pared-back form.)


Fauci warns against ignoring checkpoints

Fauci’s prepared opening remarks (longer written version here) focused primarily on NIAID’s work improve diagnostic testing, support vaccine development, and identify therapeutics to treat COVID-19. Many of the Senators’ questions to him requested his expert judgment on the scope and course of the pandemic and on the wisdom of lifting requirements for physical distancing and closures. This exchange with Senator Patty Murray (D-Washington) was particularly striking:

Murray: Dr. Fauci, you have warned of “needless suffering and death” if we push to reopen too soon, but the president has actually been sending the opposite message. I want to ask you today, what is the most important message you have for communities and states that are reopening even as our public health experts make it clear it’s too soon. Tell us what the consequences are.

Fauci: Thank you very much for that question, Senator Murray. As I’ve said many times publicly, what we have worked out is a guideline framework of how you safely open America again. And there are several checkpoints in that, with a gateway first of showing, depending on the dynamics of an outbreak in a particular region, state, city, or area, that would really determine the speed and the pace with which one does re-enter or re-open. So my word has been, and I’ve been very consistent in this, that I get concerned if you have a situation where the dynamics of an outbreak in an area are such that you are not seeing that gradual over 14 day decrease that would allow you to go to Phase One and then if you pass the checkpoints of Phase One, go to Phase Two and Phase Three. What I’ve expressed then, and again, is my concern that if some areas—cities, states, or what have you—jump over those various checkpoints and prematurely open up without having the capability of being able to respond effectively and efficiently, my concern is that we will start to see little spikes that might turn into outbreaks. So therefore I have been being very clear in my message to try to the best extent possible to go by the guidelines, which have been very well thought-out and very well delineated.

The guidelines Fauci refers to are the “Opening Up America Again” guidelines issued by the White House and CDC in mid-April. They provide criteria for states or regions to meet before engaging in phased reopening, and the criteria include a downward trajectory of both “covid-like syndromic cases” and documented COVID cases over a 14-day period (as well as criteria for hospitals and state preparedness responsibilities).

The criteria are indicators that jurisdictions have controlled the spread of the coronavirus, but the hasty reopenings we’ve seen in multiple states suggest that governors, rather than paying attention to the recommended evidence, are basing their decisions on other factors. Fauci is clear that this doesn’t automatically mean disaster, but that he fears it will lead to “little spikes that might turn into outbreaks.” An Associated Press analysis found that several states that had not met the benchmark of a 14-day downward trajectory in new cases or positive test rates but had nonetheless begun the process of opening in early May. It’s possible that enough people in these states will continue with physical distancing measures even if they aren’t required, and that specific local conditions might allow for cases to occur without triggering outbreaks. But, as Fauci explains, these states are increasing the disease risks to their populations.


Bright emphasizes the need to listen to scientists

In the House hearing, Bright told the subcommittee that HHS leadership ignored repeated warnings in late January that we lacked enough personal protective equipment for an infectious disease crisis. “I pushed that forward to the highest levels I could in HHS and got no response,” he said. “From that moment I knew that we were going to have a crisis for our health care workers because we were not taking action.” His anguish at what this inadequate preparation meant for healthcare workers was evident, and he also emphasized that the toll could grow substantially worse. Without better planning, he told the committee, 2020 could be “the darkest winter in modern history.”

A theme in Bright’s testimony was the need for strong leadership with a prominent role for science. “We need to install and empower leadership, and we need to unleash the voices of the scientists in our public health system in the United States,” Bright urged. “Their guidances need to be listened to, and we need to convey that information to the American public so they have the truth about the real risk and dire consequences of this virus.” Associated Press reporters Ricardo Alonso-Zaldivar and Richard Lardner quote Bright giving more specifics about necessary steps:

“We need still a comprehensive plan, and everyone across the government and everyone in America needs to know what that plan is, and what role they play,” he told the House Energy and Commerce Committee. “There are critical steps that we need to do to prepare … we do not still have enough personal protective equipment to manage our health care workers … we still do not have the supply chains ramped up for the drugs and vaccines, and we still don’t have plans in place for how we distribute those drugs and vaccines. We still do not have a comprehensive testing strategy.”

In a statement made shortly after his removal from the helm of BARDA, Bright said he believes his transfer was in response to his insistence that the government invest its COVID response funds in “safe and scientifically vetted solutions” rather than in drugs and vaccines that “lack scientific merit.” He then stated that “contrary to misguided directives, I limited the broad use of chloroquine and hydroxychloroquine … I rightly resisted efforts to provide an unproven drug on demand to the American public. I insisted that these drugs be provided only to hospitalized patients with confirmed COVID-19 while under the supervision of a physician.”

At the hearing, several Republican members focused their statements and questions on hydroxychloroquine. Representative Michael Burgess (R-Virginia) said he was hearing from a lot of doctors who report significant benefit from using the drug early in the course of the disease; Representative Morgan Griffith (R-Virginia) asked “why not at least let doctors try?”; and Representative Larry Bucshon (R-Indiana) said that if doctors hear anecdotes about a drug working, they won’t wait for government approval and will go ahead and use it off-label. Bright repeatedly had to explain the value of conducting clinical trials and point out that hydroxychloroquine can have serious, potentially fatal, side effects.

Questions from Democratic committee members sought Bright’s information on several different aspects of preparedness, including personal protective equipment, testing supplies, and vaccines. The two exchanges from Democratic members on hydroxychloroquine highlighted larger issues with how the Trump administration is handling the pandemic.

Representative Doris Matsui (D-California) noted that in Bright’s whistleblower complaint it appears that the administration prioritized political interests when it came to hydroxychloroquine. Bright explained that BARDA has a very rigorous scientific review process for the investments it makes, and attempts to bypass that rigorous vetting process caused him concern. Without scientific vetting, he pointed out, there’s an increased risk of supporting a drug that has safety concerns.

Representative Ben Ray Luján (D-New Mexico) asked whether the president’s obsession with hydroxychloroquine distracted from other crucial work. “The order was extremely distracting to dozens of federal scientists who were focused on the coronavirus outbreak,” Bright responded, explaining that it drew attention from efforts in developing other vaccines and drugs.

Many of us have grown so accustomed to Trump’s narcissistic behaviors and misdirections that it’s easy to forget that they have consequences. In this case, insisting on promotion of a risky and unproven drug caused a distraction that could further delay a more effective response to COVID, and thereby cost many more lives.


Congressional responses

An important bit of good news followed these two distressing hearings: The Heroes Act passed by the House of Representatives contains the Scientific Integrity Act, which Representative Paul Tonko (D-New York) introduced and garnered bipartisan support for. The Act would prohibit federal agency personnel from misrepresenting or suppressing scientific findings and codify agency scientists’ rights to publish their work and review agency statements about their work before such statements are made public. Although abuses of scientific integrity have occurred in several past administrations, the consequences of suppressing and misrepresenting scientists’ work are particularly stark and visible during the COVID pandemic.

In addition to protecting scientific integrity, we need stronger protections for whistleblowers so that government employees involved with COVID-19 science can bring these kinds of matters to the attention of those who can address them.

As the push to “reopen” gains steam, I expect to see further moves to distort and downplay evidence that coronavirus transmission isn’t under control in counties, states, or the nation as a whole. We need strong legal and institutional safeguards to ensure that elected leaders and the public have access to the best available evidence in order to make consequential decisions. As Fauci and Bright made clear, ignoring evidence on COVID can be deadly.

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