After all, it was the FDA that protected Americans from the heartbreak of thalidomide. But the COVID-19 pandemic of 2020 has made us rethink our confidence in this agency, as well as other health related government entities such as the Centers for Disease Control and Prevention.
Emergency use authorizations and new drug approvals must be based on expert scientific evidence and not by politics underlined by wishful thinking or pharmaceutical company press releases.
While all of us desire effective therapies and vaccines for COVID-19, we must remember that Fantasyland is part of Disney World, and is not the 51st state.
An emergency use authorization for a drug is not an actual drug approval. Instead it is useful for accessing a medication that might save lives during a national health emergency prior to drug approval, when there is preliminary evidence of efficacy and safety.
Our question now is, how does an unproven vaccine fit into this definition? Particularly when vaccines are useful for disease prevention but not acute treatment of illness, how would a vaccine fit into an emergency use authorization? With short and long term effects yet to be identified, how can it be granted? Will it be enough if the FDA says there is plenty of proof, but that proof has not yet been evaluated by an independent advisory panel and published in a peer-reviewed journal?
Prescribing health care professionals must have data to make appropriate decisions. Health care professionals must feel confident in the information that has been made available through well researched clinical trials establishing specific guardrails for clinical prevention and management of illness.
When politics weakens and destroys those guardrails, the ability to protect patients is damaged.
On a recent visit to our primary care clinician, we were saddened to find the physician struggling with how she would manage the tough discussions in the weeks ahead. As patients seek her advice about how she should provide care for them, our physician may be asked to make decisions that are life giving as well as life taking, just in deciding whether or not a therapy or vaccine, yet inadequately proven, should be administered. We share her concerns about the overwhelmingly difficult decisions we as providers might be asked to make.
Credit: Glen
Credit: Glen
Clinicians should not have to balance politics and science in medical decision making.
The FDA and the CDC have been internationally respected leaders in the evaluation of drug safety, efficacy and global health.
When practitioners and international medical organizations lose faith in the professionalism of these revered agencies, our entire planet suffers.
It’s a small world after all.
Cynthia Sheppard Solomon is a clinical assistant professor in the Department of Internal Medicine and Neurology at Wright State University-Boonshoft School of Medicine. Glen D. Solomon is a professor and chairman of Internal Medicine and Neurology at the school of medicine. Guest columns are submitted or requested fact-based opinion pieces typically of 300 to 450 words.
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