In the summer of 1997, I was months away from launching the first consumer magazine about mental illness. My company had acquired a state and federal trademark for the title, Mental Fitness (The Science of Mental Wellness). I had done a long interview with the veteran 60 Minutes journalist, Mike Wallace and his wife, Mary, about how he had survived major depressive disorder.  My photographers had even re-arranged the Wallace’s living room furniture to take cover photos of the couple for the premier magazine. As far as advertisers go, many of the existing advertisers for our medical journals were working on consumer ads for Mental Fitness. As one pharmaceutical executive told me, “we can’t afford not to advertise if this gets in the hands of patients.” It was as true then as it is now that physicians are the most important component of a drug’s success or failure. But patient compliance was always the big issue for doctors. The assumption quickly took hold in the medical community that if a patient “requested” a drug — and assuming the doctor was in agreement that the drug could help — patients had a much higher compliance rate. In other words, if they requested the drug, they most likely took the drug as scheduled.

The first issue of Mental Fitness went to press in the Autumn of 1997.  In addition to a long feature about Mike Wallace, we had developed columns and features to discuss topics such as New Agents for Manic Depressive Illness, Hollywood’s Take on Psychiatry, and even The New Trend in Health Food Stores: Feeding the Mind. Then I was completely blindsided for the first in my career as a publisher. Literally overnight, the FDA lifted the ban on medical consumer advertising. Overnight, television and consumer magazines of every kind were filled with medical advertising for drugs and hospitals. Later, medical ads would dominate the web as well. In short, Mental Fitness had become an overnight anachronism. Lesson learned.

Almost 20-years later, as health care industry ad spending tops $14 billion, the FDA is re-visiting its 1997 decision. The New York Times yesterday reported that as the volume and spending on advertising increases, health economists and doctors are raising concerns about the trend, which they say increases prices and encourages patients to seek out more expensive and, often, inappropriate treatment. According to Elizabeth Rosenthal, writing for The Times, “The United State and New Zealand are the only two countries that allow consumer advertising for drugs. The American Medical Association recommended a ban last year on advertising for drugs and medical devices directed toward consumers.” The group was concerned “about the negative impact of commercially driven promotions” on health care and costs, said Dr. Patrice A. Harris, the chairwoman-elect of the association, in issuing the decision. “Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”

Hospital ads are coming under similar scrutiny. When Dr. Yael Schenker, a physician at the University of Pittsburgh who specializes in end-of-life care, studied advertisements for cancer centers, she found that “there was not much actual information, and what there was focused much more on benefits than on risks.” Her research, published in the Annals of Internal Medicine in 2014, “debunks the notion that advertising empowers patients to make better choices,” she said.

According to Rosenthal, “During the 1980s and ’90s, the Food and Drug Administration set some rules for medical advertising — then in its infancy — to ensure that patients got accurate, balanced information. Current regulations mandate that manufacturers advertise their drugs only for the disease for which they received federal approval, and that they list all potential side effects and risks.”

Yet clever marketing departments have danced around those limits. “Worried patients are, of course, a great captive audience. Television coverage during the debates and primaries has featured many commercials for new drugs to treat Type 2 diabetes, a condition that is often associated with the overweight and is most common in middle age and beyond. Ads for the condition have increased 200 percent in the last three years, Nielsen found. Even though older, cheaper drugs for Type 2 diabetes are effective for most people — and, doctors say, should generally be the first line of treatment — the ads have promoted an array of new injections and pills,” costing over $500 per month. No doubt this will become a big election-year topic which will, almost certainly, not go well for Big Pharma. Lesson learned.