Episode Details

(featured photo shows David, his wife Yvonne, and son, Joey, when young)

Today we continue our conversation with my dear friend and esteemed colleague, Dr. David Antonuccio, a true scholar, clinician, researcher, musician, and champion of scientific transparency.

The Nicotine Patch Study

David revisited his landmark research on the nicotine patch, a costly trial involving roughly 600 participants who were randomly assigned to receive either a real nicotine patch or a sham patch. The goals were to assess safety and efficacy.

The safety data looked reassuring. However, the efficacy findings were unexpected: the placebo patch worked just as well as the active nicotine patch in reducing smoking. The sponsoring company published the safety data but refused to publish—and refused David access to—the efficacy findings, which showed no advantage for the nicotine patch. You can check the link to the NEJM article here.

David writes: "Notice the 48 week follow-up data were excluded in this paper despite the fact that they were available. That really annoyed me. I also now believe that the original version of the paper was ghostwritten and ghost analyzed by the industry folks.in other words. I'm not sure that the authors ever had access to the "raw" data before they were analyzed."

This was important because there was a decrease in smoking DURING the study among those wearing the patch, and getting their "fix" of nicotine that way. . . but what happened AFTER the study?

David writes: "Here is the link to the follow up paper that emphasized efficacy and included the 48 week follow-up data."

Notice that this paper was not published until three years later, when the Nicotine Patch had already been heavily advertised and sold on the market. This early experience in his career revealed the tension between marketing interests which focus on sales, and scientific interests which focus on truth and transparency—a daunting and frustrating pattern that would emerge again and again in his career.

Expert Testimony in a Tragic Criminal Case

David then described expert testimony he provided in a deeply troubling legal case. A 72-year-old woman, happily married for 50 years and a respected kindergarten teacher, had recently been prescribed Paxil, along with Ambien and Ativan.

She abruptly, and without memory, woke up in the middle of the night and stabbed her husband 200 times and was subsequently arrested for homicide.

There was no jury trial; instead, a plea bargain was used to determine sentencing. Dr. David Antonuccio was called as an expert witness in her defense. He described Dr. David Healy's research documenting a significant increase in both suicidal and violent urges among some patients taking SSRIs, especially Paxil. He argued that this woman's bizarre behavior was consistent with a drug-induced dissociative or fugue state.

Based in part on David's testimony, the charge was reduced to manslaughter, and the judge sentenced her to time served, allowing her to return home to her children.

For more on this topic:

• David Healy's Research on SSRIs and Homicidal Urge
• SSRIs Called on Carpet Over Violence Claims

Black Box Warnings and Patient Rights

David also emphasized the urgent need to revise Black Box warnings to reflect the full range of possible toxic or dissociative effects of psychiatric medications—not ju