The generic in question was manufactured by Mallinckrodt. Unlike Concerta, which uses an osmotic-controlled release oral delivery system (OROS), Mallinckrodt’s version relied on a release profile closer to Ritalin LA. The distinction matters. Concerta’s osmotic pump delivers methylphenidate steadily throughout the day, minimizing peaks and troughs. Mallinckrodt’s round tablet, by contrast, produced bursts of medication followed by crashes. Patients who had relied on Concerta’s smooth arc suddenly found themselves riding waves of energy, focus, and irritability.

Expert consensus on the treatment of preschoolers diagnosed with attention deficit hyperactivity disorder (ADHD) is clear: Try behavioral therapies for six months before prescribing medications. However, a new study found this guideline was followed in only 14.1% of U.S. cases involving children ages 3 to 5. “We found that many young children are being prescribed medications very soon after their diagnosis of ADHD is documented,” said study lead author Dr. Yair Bannett, an assistant professor of pediatrics at Stanford Medicine in California.

A new report from scholars at the Institute for Family Studies demonstrates these findings are more of a trend than unique. Fielding the Women’s Well-Being Survey (WWS) of 3,000 women in the U.S. in early March, these family scholars wanted to understand why married mothers are the happiest among women. The lead researcher is noted scholar, San Diego State University’s Jean W. Twenge. The General Social Survey, the academic gold standard in social science measurements, tells us that among women age 18 to 55 in the United States, 40 percent of those who are married and have children report being “very happy.” Only 25 percent of married childless women report being very happy, while just 22 percent of unmarried childless women do. Unmarried mothers? Only 17 percent report being “very happy.” And during the Covid pandemic, it was those married with kids who were most likely to report being very happy during that very trying time.

One researcher who has followed the saga maintained that a retraction was long overdue. “This article is still being built into guidelines. And most people don’t know its fraudulent,” said David Healy, a former psychiatry professor at Bangor University in Wales, who runs RxISK.org, a website that gathers information about the side effects of medicines. “Editors are the point people in all this. If they don’t respond to physician input, and in this case they didn’t, we have a wild west.” Healy was also a member of a team of researchers who a decade ago reanalyzed the study and found Paxil was not safe or effective in adolescents. Their findings, which were published in The BMJ, broke with scientific custom and signaled a new era in scientific publishing, because different journals published different interpretations of the same study. “This study was fraudulent. It was ghostwritten and was a negative trial spun as safe and effective, which led to thousands of kids put” on the medicine, Healy said. “And the trials in this age group show no benefit with an excess of harms. And the black box [label] warnings [were added] seemingly to no effect. … And all the time, [the journal] may be actively complicit in this, rather than innocents duped by GSK (Glasko-Smith-Kline).” Meanwhile, a 2022 version of the Paxil document that describes the properties and indications of a drug — that GSK released in Canada, noted “controlled clinical studies in depression failed to demonstrate efficacy and do not support the use” in treating children under 18 with depression. It also mentions a higher incidence of adverse events related to emotional changes, “including self-harm.”