The ongoing multi-state measles outbreak that is particularly severe in Texas reminds us of what happens when confidence in well-established science underlying public health and well-being is undermined. Measles, which killed more than 100,000 unvaccinated children last year in Africa and Asia owing to pneumonitis and encephalitis caused by the virus, had been eliminated from our shores. The two-dosemeasles, mumps, rubella vaccine regimen (MMR) using over the past decades has a remarkablyfavorable benefit-risk profile. The MMR vaccine is 97% or more effective in preventing measles followingthe two-dose series, and its safety has been remarkably well studied. Though rarely followed by a single fever-related seizure, or very rarely by allergic reactions or blood clotting disorders, the vaccine very simply does not cause autism, nor is it associated with encephalitis or death. It does, however, protect against a potential devastating consequence of prior measles infection, subacute sclerosing panencephalitis (SSPE), which is an untreatable, relentlessly progressive neurologic disorder leading to death in about 1 in 10,000 individuals infected with measles. Undermining confidence in well-established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security.
In the years following the pandemic, at the Center for Biologics Evaluation and Research we have applied the same unwavering commitment to public health priorities to the development of cell andgene therapies to address both hereditary and acquired rare diseases. During my tenure as Center Director we have approved 22 gene therapies, including the first gene therapy ever to be approved in the United States. However, we know that we must do better to expedite the development of treatments for those individual suffering from any one of the thousands of diseases potentially addressable by the advances in molecular medicine over the past decades. Drawing from learnings of the pandemic, the staff at the Center for Biologics Evaluation and Research are implementing best practices learned during the pandemic such as increased communication with product developers to further expedite bringing needed treatments to those in need. They have also been exploring the dramatic transformation of our regulatory approach to expedite the delivery of directly administered genome editing products. If thoughtfully approached and further developed and refined, these treatments have the potential to transform human health over the coming years.
Over the past 13 years I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health. As you are aware, I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine.
However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.
My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science. Though I will regret not being able to bepart of future work at the FDA, I am truly grateful to have had the opportunity to work with such aremarkable group of individuals as the staff at FDA and will do my best to continue to advance public health in the future
