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: Recent news items about Tylenol and SSRIs in pregnancy can bring up memories of thalidomide and DES scares. Can you offer perspective?

Marc Stone: The thalidomide crisis was horrifying and so graphic, but the drug was never approved in the U.S., and there were only a few cases of people who got the medication from outside the country.

Martha Rosenberg: DES?

Marc Stone: Diethylstilbestrol was supposed to prevent, or at least reduce, the rate of miscarriages. But it then turned out that in the women who were given DES, their children, particularly girls, had abnormalities in their reproductive system, including a form of cancer.

Martha Rosenberg: Some daughters of women given DES even had hysterectomies.

Marc Stone: It’s a tragedy, although again, the numbers involved are not huge like the harm from cigarettes, but it was something that was identifiable. It’s a very important subject, and it’s very important that they do what we call mutagenic studies.

Martha Rosenberg: You have cautioned against over-reaction to breaking health news.

Marc Stone: There is a kind of Puritanism, a feeling that pregnant women shouldn’t take any medication and they should tough it out. There is a great sense of moral superiority, and somebody’s horrified if a pregnant woman has half a glass of wine.

Martha Rosenberg: What about psychoactive drugs in pregnancy?

Marc Stone: Many women who have severe mental health problems like schizophrenia or bipolar disorder cannot be off the drugs. Somebody with schizophrenia and bipolar disorder is at very high risk for suicide, homicide, harming other people, and accidental deaths, not to mention other disruptions in their lives like losing their job.

Certainly, a pregnant woman with a mental disorder like depression should not be treated the same way as a healthy person. The doctor needs to look at what this person’s history of depression is like. Was it very severe? Have they been able to come off drugs in the past? If they take the drug and seem to get better, stop the drug and get worse, they probably need to stay on the drug.

Martha Rosenberg: This brings up ethical and philosophical issues.

Marc Stone: Right, right. Body autonomy and individual rights, and the rights of the fetus versus the mother.

Martha Rosenberg: Where do questions about mother’s milk fit in?

Marc Stone: Again, it’s a trade-off. It’s preferable to use mother’s milk, but formula can be good enough if someone has an offsetting need to be on the medication. You should make sure the doctor understands that you’re pregnant and how that drug might affect the course of the pregnancy or the fetus.

These drugs get studied as to how much gets put into milk, and often there’s very little. The drug labels all have lactation studies in them. It makes sense to be doubly sure. I hesitate to tell people to go look it up themselves because they often don’t understand what they’re reading.

Martha Rosenberg: There used to be a joke about how that is “cyberchondria.” How does Puritanism, or virtue signaling, exist in food choices?

Marc Stone: The idea of what is a healthy diet is something that’s maintained by people who can afford to structure their lives that way, then look down upon people who can’t contain their appetites. There’s certainly a lot of engineering that goes into trying to make food as cheap and attractive as possible and make money off that, but “health food” is just small amounts of luxury goods with huge markups. Moreover, there is danger in mythologizing and exoticizing other people’s diets: if only we ate like the Chinese or the Mediterraneans or the Paleolithic people, our problems would go away.

Martha Rosenberg: You say the weight loss drugs can give rise to virtue signaling.

Marc Stone: Yes. Someone not on GLPs might say, “I earn my fitness and so I deserve it and you don’t,” sort of a reflexive backlash. There’s a whole other thing about junk food and what they call ultra-processed food. What does ultra-processed mean? How is it connected to some physiological process? The term is unscientific; it is in the eye of the beholder. The problem is overconsumption of calories and easy access to these calories.

Martha Rosenberg: That brings us to Serena Williams, a paid spokesperson for the telehealth company Ro and its GLP-1 weight loss drugs.

Marc Stone: She has a huge history of all kinds of injuries, so it’s hard to point to a particular causation.

Martha Rosenberg: In summation, are you suggesting that many or most health items in the news aren’t good science?

Marc Stone: You can’t just do a study unless you control for mental health and social and economic conditions. All these factors can create outcomes, and studies without controls are almost always confounded because things can appear correlated.

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.