PResident Biden’s appointment of Robert Califf as head of the Food and Drug Administration is in the political crosshairs. Oddly enough, the attacks did not come from the usual suspects. Instead, it’s friendly fire from an unlikely trio of Democrats: Senators Bernie Sanders, Elizabeth Warren and Joe Manchin, who are concerned about Califf’s past involvement in the pharmaceutical industry.
These concerns are unwarranted and show a disturbing lack of understanding and superficial knowledge of the experience needed in drug development and clinical research to run the nation’s leading regulatory agency for therapeutics.
Califf is a clinical cardiologist who was the founding director of the Duke University Clinical Research Institute (the country’s first and largest academic clinical research organization). Throughout his career, Califf has strived to improve the way new drugs and devices are tested by developing innovative clinical trial designs. His productivity, innovation and vision have taken him to the pinnacle of academic medicine.
His job also required him to interact extensively with the pharmaceutical industry, not in a way that required him to carry his water, but in a way that gave him direct and in-depth experience in the development of new treatments as well as government and regulatory approval. to treat.
I say this not as a casual observer but as someone with personal knowledge and professional experience with Califf. I was a faculty member at the University of North Carolina School of Medicine in 1999 when I received the largest grant ever from the National Institute of Mental Health: to complete the Clinical Antipsychotic study Trials of Intervention Effectiveness (CATIE). I was aware of Califf’s groundbreaking cardiovascular disease research, in which he conducted innovative but tightly-controlled clinical trials that produced results generalizable to real-world practice – no small feat in the field. medical research – and I thought the CATIE trial might benefit from his knowledge.
So I drove the eight miles on the “tobacco road” between the UNC and Duke campuses to seek his advice. Aside from the intense basketball rivalry between the two schools, Califf generously advised me on how to approach study design issues such as sample selection, outcome measures, and statistical methods of analysis. Datas. Six years later, the results of the CATIE study were published in the New England Journal of Medicine. It remains one of the most cited scientific reports on the treatment of mental illness.
A decade later, as commissioner of the FDA under the Obama administration, Califf invited me (in my role as president of the American Psychiatric Association) to a one-day meeting he called with key mental health organizations to listen to their concerns about the lack of innovation in psychotropic drugs. drugs, too many “me too” drugs, excessive prices and access restrictions, and share his vision and his projects. His administrative and political capacities to manage the formidable challenges of leading this critical and complex body of the federal government were fully demonstrated. But more importantly, it has demonstrated its ability to connect with the different leaders of important but often overlooked mental health actors – mental health care providers, patients, families, advocacy groups, researchers, and more. He was able to hear their concerns, answer their questions and give them hope.
Manchin’s assertion that “Dr. Califf’s appointment and his important connection to the pharmaceutical industry sets us back, not forward” is absurd. And adding that his appointment “is an insult to the many families and individuals whose lives have been forever changed as a result of [opioid] addiction, ”Manchin reflects a complete lack of understanding of the opioid epidemic, the candidate’s record and the history of the FDA.
Califf had no direct involvement with an opioid maker or connection to the crisis other than being one of the nine Commissioners of the FDA who chaired the FDA during the 30-year period to the during which drug approvals and marketing practices resulted in the opioid epidemic. In addition, his 10-month tenure as head of the agency at the end of the Obama administration was the shortest of any commissioner during that time. Viewing the Manchin Duck as a valid basis for rejecting Califf is doomed to failure and reflects the flippant and irresponsible nature of his opposition.
As severe as the opioid epidemic is, killing thousands of people a year in the United States, there are other ethical and regulatory breaches of concern on the part of the FDA. The crisis of the moment is clearly the mismanagement by the federal government – mainly the FDA and the Centers for Disease Control and Prevention – of the Covid-19 pandemic, starting with the lack of laboratory tests, followed by the unavailability of test kits and supplies. , and finally confusion over communication, distribution, prioritization of eligible recipients and implementation of vaccines, which has reduced the meteoric success of their development by the pharmaceutical industry.
In addition, old issues like high drug costs and price controls persist and new ones have arisen: the controversy over the FDA approval of Biogen’s drug Aduhelm for Alzheimer’s disease, with its dubious efficiency and exorbitant price; the impending tsunami of technology-assisted health care; telemedecine; new forms of brain stimulation; and the growing interest in the use of psychedelic drugs as treatments. The FDA also faces the challenge of how to best harness the power and harness the benefits of the life science industry juggernaut, which develops technologies such as CRISPR, robotics, artificial intelligence, nanomedicine. , medical imaging, digital healthcare applications and telemedicine, as well as new forms of therapy. To accelerate their development but also to protect the public interest and ensure the safety of people, the FDA must have competent leadership that guarantees a reliable and efficient regulatory process.
These questions, rather than being reasons to question Califf’s competence, bolster his candidacy. His qualifications make him the best person to lead the FDA today and perhaps the best qualified candidate in the agency’s history. If Congress fails to confirm Califf, it will rob the FDA and the country of the best fit at a most critical time.
Leading the FDA is a tall order. The agency’s mission to approve safe and effective drugs – along with foods, vitamins, nutritional supplements, nutraceuticals and health products – is hampered by archaic legislation annotated by a patchwork of amendments. In addition, the agency is underfunded and understaffed.
The next FDA commissioner should be selected on the basis of his qualifications and expertise, not on distorted perceptions or as a reward for patronage and political contributions, as if it were an ambassadorial post. prized or other honorary appointment. Too much is at stake.
Jeffrey A. Lieberman is a psychiatrist, president of psychiatry at Columbia University Vagelos College of Physicians and Surgeons, past president of the American Psychiatric Association, and author of “Shrinks: The Untold Story of Psychiatry” (Little, Brown and Company, 2015).