Today, Dr. Stephen Hahn defended the FDA’s EUA approval for plasma transfusions to treat COVID-19 infection. Doctor Hahn stated that the Agency fully supported medical and scientific basis for the EUA noting that although there is not definitive data showing this technique works, the safety profile made an EUA appropriate. He also apologized for not handling the rollout of this approval in a better manner as his actions allowed the discourse to become politicized.
I think this raises a number of significant issues for the future of the FDA and creates one major concern.
-While the approval of plasma transfusions may have been warranted as an experimental therapy, much more background should have been given to the debate around its efficacy. People can understand the reasons for an interim approval step when a decision isn’t definitive or final.
-The status of this EUA should be periodically reviewed and the data on this treatment made public in a formal way, not just placed on some website. These communications would allow people to appreciate the development process and not think that any decision came out of the blue or was politically motivated.
-The impact of plasma transfusion as a treatment appears to be of limited use in treating COVID-19 regardless.
– The current discussion has become so politicized I’m afraid it will be hard to get people to enroll in the definitive clinical trials of this therapy to definitively see if it actually works.
All of these issues are minuscule compared with my major concern: If a similar type of chaotic announcement is made around approval of the first COVID-19 vaccines, it will doom acceptance of these products. United States citizens presented with a similar, poorly communicated decision by the FDA will not believe that these vaccines were appropriately vetted and approved solely on their safety and efficacy. In this scenario, their use will be minimal, thus prolonging the pandemic and costing thousands of lives.
Dr. Hahn should understand that this mistake cannot be made.
The FDA should already have in place the means to evaluate and announce the results of the vaccine trials. It also should have an effective way to document the science of the clinical trials that are being conducted on these vaccines and an efficient way to make that information available to the people of the world. Politicians should not get involved in this process as it will only undermine the credibility of the vaccines (and of the politicians themselves).
As we look towards the day that these vaccines become available, a transforming day for the world as it deals with this pandemic, Dr. Hahn cannot allow the message to be misstated, misconstrued, or miscommunicated. We have all worked too hard and made too great an investment of lives and resources to allow this to happen.