This Friday I’ve decided to recognize an individual who is not a household name and has not continually put himself in the press. Regardless, he will likely be the most important individual in determining whether any of the COVID-19 vaccines in development will be approved for use in humans.
Peter Marks, M.D., Ph.D. is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.
Dr. Marks received his graduate degree in cell and molecular biology and his medical degree at New York University. Following this, he completed an Internal Medicine residency and Hematology/Medical Oncology fellowship at Brigham and Women’s Hospital in Boston, where he subsequently joined the attending staff as a clinician-scientist and eventually served as Clinical Director of Hematology.
He then worked for several years in the pharmaceutical industry prior to returning to academic medicine at Yale University where he led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. After joining the FDA in 2012 as Deputy Center Director for CBER, he became Center Director in 2016. Dr. Marks is board certified in internal medicine, hematology, and medical oncology, and is a Fellow of the American College of Physicians.
I’m well aware of Dr. Marks in part because I’m an allergist and he oversees allergenic products. I have always felt that he takes an entirely scientific and medical view of the medications he is evaluating. Many of the products under review at CBER are unique and new, such as gene therapies. Most of them are the first time a therapeutic has attempted to treat a disease. This means there is no track record and no prior therapy for comparison. It makes the review very difficult in sorting out the risk to the patient versus any potential benefit in treating their disease.
The decisions made by CBER are therefore challenging and sometimes controversial. Often, patients clamor for a therapy even if it shows little benefit and may be toxic. Under Dr. Marks, CBER has handled these challenges remarkably well and has always come down on the side of whether the data supports the benefit of a therapy. Just this week CBER delayed approval of a gene therapy because there was not enough evidence of long-term benefit. This is a drug that could benefit hemophilia patients and had strong enthusiasm in the patient community. Despite this, CBER held to their scientific standards.
This past week Dr. Marks stated he would resign if any vaccine for COVID-19 were approved before it was shown to be both safe and effective. He said this in no small part to reassure people that he would not allow anything other than the data from the clinical trials to decide the value of a vaccine. He alluded to the fact that if he were to resign, Americans could conclude it would be because there was “something wrong” in the process. He didn’t seek to publicize these remarks or draw attention to himself (they were made in a private call with vaccine developers), but did confirm them when the comments were leaked. He subsequently described this decision as a “red line” he would not cross.
Having worked in government myself, I can tell you that one of the most difficult jobs is being in Administration at the FDA. Every decision has billion-dollar implications, and the only time you get recognized is when something goes wrong. We should all be thankful that there are individuals like Dr. Marks who are willing to assume these important positions at this difficult time.