Assessing the performance of additional government leaders of the COVID-19 response.

Tonight we undertake the second part of our analysis of the government’s coronavirus leadership and how it should change going forward.

While last night’s individuals were officials who clearly should leave their position in government, tonight’s leaders are more difficult to evaluate. These individuals have accomplished some useful activities, but have issues that seem to have interfered with their performance. As such, I will weigh the positives and negatives in trying to come up with an assessment of whether or not they should stay or leave their positions.

Deborah Birx, MD, coronavirus response coordinator.

Dr. Birx has made a reasonable effort to manage the government’s response to the coronavirus pandemic. She has also tried to coalesce the varying opinions in the government towards a coherent policy. Dr. Birx also aggressively (maybe too aggressively) tried to coordinate the efforts of different government organizations such as the CDC and FDA.

Despite this, Dr. Birx has been ineffective and disconcertingly inconsistent. She disappeared for long stretches only to come back and almost incidentally mentioned that things were “bad and people need to get more aggressive about the pandemic.” She also announced COVID-19 outbreaks in different areas of the country that had not occurred, and at times seemed at odds even with agreed upon statements about what precautions were appropriate.

A recent article in Science magazine also outlined failings in her managerial style in running roughshod over the FDA. This was accompanied by significant technical missteps because of her lack of familiarity with respiratory virus containment as compared to her strong background in HIV.

It would seem to be in everyone’s best interest if Dr. Birx returned to her role at the State Department where she manages the international effort on HIV. This is where her true expertise lies.

Moncef Slaoui, PhD. Lead, Operation Warp Speed. 

Dr. Slaoui has a remarkable background in vaccine development that makes him an excellent person to run “Operation Warp Speed.” He has overseen the organization’s selection process that has advanced many of the most promising vaccines into clinic trials. He also appears to have a good working relationship with the FDA which oversees these clinical trials. He has kept a low profile and has the confidence of those around him especially other scientists and members of the vaccine industry.

Despite his expertise and success, Dr. Slaoui has one huge problem. He has millions of dollars in personal funds tied to companies in the program that he oversees. Because he was not formally hired as a government employee he was not required to divest of these holdings. While he sold his Moderna stock after a multimillion dollar windfall due to their potential as a COVID vaccine developer, the agreements surrounding his tens of millions of dollars of GSK stock does not meet the expectations for someone in his position. While I believe he should continue in his job, I think he needs to resolve his conflict of interest entirely before moving forward.

Stephen Hahn, MD. Head of the FDA.

Dr. Hahn has had a rocky start to his tenure as head of the FDA. He arrived with the emerging pandemic and had little time to steady himself. He’s made unfortunate and incorrect statements, including those related to the use of convalescent plasma therapy as a treatment for COVID-19. He embarrassingly had to retract those comments and this undermined the agency’s integrity since the statements seemed to be coming from a political appointee who was appointed FDA spokesperson.

Despite this Dr. Hahn has shown independence in reasserting control over the vaccine approval process. He appears to work well with many of the key people at the FDA including Dr. Steven Marks who will be the individual primarily responsible for the review of the COVID-19 vaccines. He certainly has an excellent background in clinical research and developing therapeutics in cancer and appears to be finally gaining control over the agency and its public face.

I believe Dr. Hahn should stay in his position especially since the next few months will be so crucial to evaluating the COVID-19 vaccines. To replace him at this time would only further undermine the agency’s credibility and make it more difficult for the public to accept the approved vaccines.

The COVID-19 response is at a crucial point, with vaccines approaching regulatory review. Significant progress has been made that has improved treatments and saved lives. Moving forward, whether there is a vaccine or not, more decisiveness and consistency in the government’s response is necessary. Changes with the individuals identified last night and tonight could help that process.