To paraphrase an old song, “What the World Needs Now Is …” a vaccine and/or treatment for COVID-19. We are all so ready to get back to living pre-pandemic lives.
While multiple COVID-19 research facilities previously indicated that one or more vaccines could be available by the end of 2020 or in early 2021, recent announcements by the White House said that such vaccines could be available just before the election. That would be fantastic, but the most important aspect of any new vaccine is its safety and efficacy, not political credit. If it takes more time to make sure the vaccines are absolutely safe, we’ll wait. Americans should insist that the Food and Drug Administration (FDA) follows Dr. Frances Kelsey’s model.
Many people are not familiar with my personal hero, Dr. Kelsey, who died in 2015 at age 101. I am indebted to her for ensuring my family’s healthy happy life. Let me explain.
Dr. Kelsey, Ph.D., M.D., went to work at the FDA in 1960. Her job was to review new drug applications and certify their safety. A Cincinnati company manufactured the drug Thalidomide and was anxious to get it approved in the U.S. It was being used in more than a dozen countries for insomnia, anxiety and especially “morning sickness” in pregnancy.
For a year and half, Dr. Kelsey demanded specific information from the manufacturer to evaluate Thalidomide; she wanted only “scientifically reliable evidence.” The company, anxious to increase sales, put pressure on the FDA and called Dr. Kelsey “a bureaucratic nitpicker” because she would not approve the drug rapidly enough to suit their business plans.
Thalidomide would have hit the U.S. market about 1962, at which time I was pregnant with our first child. My “morning sickness” was extreme, lasting 24/7. Never had food looked, smelled or tasted so bad. Had a pill for morning sickness been available in this country in 1962, it likely would have been prescribed for me. Thanks to Dr. Kelsey, it was never approved.
Our son was born healthy with perfect arms and legs. But thousands of women around the world who took Thalidomide weren’t so fortunate. Their newborns were missing parts of and sometimes their whole arms and legs because Thalidomide interfered with the development of those appendages in utero.
As someone who grew up in the days of polio epidemics, mumps, measles and chickenpox, I truly appreciate safe effective vaccines. Flu, pneumonia and shingles vaccines also have done wonders for our nation’s health. But some vaccines when rushed out, such as the one for the 1976 swine flu, cause problems.
It is the FDA’s job to make sure that medicines and medical treatments offered to the American public are safe and appropriate for the disease. The world desperately needs a safe, effective COVID-19 vaccine. Yet, it even more desperately needs an FDA with Dr. Kelsey’s ethics and courage to make sure that no politician, entrepreneur or investor calls the shots.