Marc Stone, MD served as deputy director for safety in the FDA Center for Drug Evaluation and Research’s Division of Psychiatry until 2024.
Martha Rosenberg: Recently, in the Cato Institute journal Regulation you and co-authors Andrew Mosholder, MD and Tarek Hammad, MD wrote that the FDA’s antidepressant warning did not kill American children through discouraging prescriptions as alleged in an earlier story. What did yours and Dr. Hammad’s earlier research on the topic suggest?
Marc Stone: Our study in the BMJ in 2009 (“Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration”) analyzed hundreds of trials and 100,000 patients and found suicide linked to the drugs was elevated in younger people. Suicide risk was actually a little bit lower [overall, in the data], but then we broke it down by age and found in younger people and younger adults it was elevated.
Martha Rosenberg: Since you found the risk was not elevated in middle-aged and older adults, what could explain this finding?
Real physician voices, twice a week
Free, and one click to unsubscribe.
Marc Stone: The [antidepressant] drugs can make people agitated (akathisia) and since children have less impulse control, they’re more likely to do something drastic. Younger nervous systems are also likely to be more sensitive. There’s also a difference between middle-aged and elderly adults. The risk for suicidal behavior in the elderly is less with drug than with placebo; for the middle-aged it’s about equal. That’s not because the drugs are more effective in the elderly; they tend to be a little less effective. The difference is explained by middle-aged people having some of the same sensitivity we see in younger people. It’s less common, which is why the net effect is canceled out by other people becoming less suicidal due to drug treatment.
Martha Rosenberg: You have incurred criticism from both sides of the antidepressant debate for daring to say that the meds sometimes work and sometimes carry risks.
Marc Stone: Yes. So the problem isn’t that the drugs aren’t any good or just have minimal effects. The problem is that we can’t identify the patients who really benefit.
Martha Rosenberg: Some are suggesting that AI could clarify these issues. What do you think?
Marc Stone: You have to be careful about that. AI is looking for so many things, and it may find some interesting connection, but is that just chance, or is that some real mechanism going on? In the absence of a control, which you can’t do fundamentally, you need a treated group and a control group.
Martha Rosenberg: You have training in economics and have criticized the current U.S. medical model of service delivery.
Marc Stone: Currently, doctors work under organizations that lack governance structures, reasonable feedback and accountability, and they nonetheless see a maximum number of patients who they try to placate. If doctors became part of an integrated health care delivery system this would change.
Martha Rosenberg: You have suggested there are religious overtones to the medical profession.
Marc Stone: Yes. You go in to the hospital and there’s this oracular machine and these people in white coats dance around you [it’s like a] ritual, relying on the power of the image, and hospitals are like cathedrals. It’s not exactly cult like but there’s some of those elements: exercise and diet which are “mortification” of the flesh and “fasting.” Doctors also get good results from “confession,” listening to their patients. That’s why before having a patient undress and sit on the table [we should] start talking to them, like, “What’s going on?” instead of just running through this ritual that we’re trained in.
Martha Rosenberg: How has our health care delivery system changed, for the worst according to many?
Marc Stone: Once you got a bill from the doctor [which you paid] and you were reimbursed by the insurance company. That was pretty inefficient, and so they started setting up systems, so that the insurer would pay the doctor directly. The politicians wanted to make it easier for people and so they said, “The doctor should send the bill to Medicare and Medicare can pay them directly.” The term “reimbursement” was retained; doctors and other providers say they are being “reimbursed,” which isn’t accurate. They are being paid just like any other seller of goods and services; they just like to pretend they are above any financial motivation.
Health care is very important and a basic need, but it’s also a consumption good, and so much of American health care is really conspicuous consumption. Doctors basically push the idea that they have all these great things for you to offer, and, of course, the fact that you don’t have to pay for it directly, that there’s an insurance company that’ll pick up the bill, was a huge conflict of interest. I think there is a great tendency to medicalize almost everything, a huge number of problems in society.
Martha Rosenberg: Your medical career brought you to Ukraine as a USAID contractor, work at Medicare, the Institute of Medicine, Harlem Hospital in New York and Cook County Hospital in Chicago and finally to the FDA.
Marc Stone: Yes, in Ukraine I helped design a post-Soviet health care reform program. At Medicare I first worked to simplify a payment system for physicians to be able to judge how much services should be worth, later returning for other projects. At the Institute of Medicine I was a study director for a report on Medicare coverage of thyroid screening.
At FDA, I worked in safety issues for psychiatry and neurology drugs. I became the deputy director for safety for the division of psychiatry from which I retired in 2024. I am continuing to work in drug safety after leaving the agency.
Martha Rosenberg is an investigative reporter whose work has appeared in the British Medical Journal (BMJ), Consumer Reports, Public Citizen, the Center for Health Journalism at USC Annenberg, the Nieman Foundation for Journalism at Harvard University, and other outlets. She studied at Rush Medical School and writes on health care, food, medicine, and public policy.
Rosenberg’s reporting has been cited by Memorial Sloan Kettering Cancer Center, Mayo Clinic Proceedings, Public Library of Science Biology, ScienceDirect, the Journal of Pain & Palliative Care Pharmacotherapy, the Journal of Trauma & Dissociation, Britannica, National Geographic, Hastings Law Journal, and Wikipedia. She is the author of several books, including Multidisciplinary Management of Chronic Pain: A Practical Guide for Clinicians, Born With a Junk Food Deficiency, Big Food, Big Pharma, Big Lies, and Food, Clothes, Men, Gas and Other Problems. She publishes on Substack, OpEdNews, and her Amazon author page.
