In the News

FDA Post-Approval Studies Lack Transparency, Consistent Enforcement, According to Researchers – Healio

Read article – Quotes Steven Woloshin, professor of medicine, community and family medicine, and of the Dartmouth Institute for Health Policy and Clinical Practice, about a study he conducted that found more than half of the post-approval studies required by the FDA in 2009 and 2010 were either delayed or had not yet started as of 2015. “Unfortunately, we do not have any example of where the FDA has actually imposed a fine or rescinded approval,” says Woloshin. “We know that there have been a few warning letters written to companies that haven’t fulfilled their requirements, but the FDA, as far as we can tell, has never actually imposed a fine or revoked approval for a drug because the post-marketing studies have not been completed.”

How Kentucky Is Leading the Way in Addiction Care for Pregnant Women – Pacific Standard

Read article – Quotes Alison Holmes, professor of pediatrics, community and family medicine, and of the Dartmouth Institute for Health Policy and Clinical Practice, about the positive impact of PATHways—an innovative, new program housed in a small University of Kentucky HealthCare clinic that provides both prenatal and addiction care to mothers with substance use disorders.

Biological Clock Discoveries By 3 Americans Earn Nobel Prize – U.S. News & World Report via Associated Press

Read article – Cites comments by Jay Dunlap, chair and professor of molecular and systems biology, and professor of biochemistry and cell biology, about the recent news that three Americans won a Nobel Prize for discovering key genetic “gears” of the body’s 24-hour biological clock. Dunlap, who studies biological clocks in bread mold, said the Nobel-winning work helped expose the molecular details behind daily rhythms and that such knowledge can be important in telling when to deliver drugs for maximum effect, and perhaps for developing new ones. (Additional coverage: The New York Times, The Washington Post, The Wall Street Journal, and more)

After 15 Years in Vegetative State, Man Responds to Nerve Stimulation – CNN

Read article – Quotes James Bernat, the Louis and Ruth Frank Professor of Neuroscience and emeritus professor of neurology and medicine, about how French researchers say a man in a 15-year vegetative state is showing signs of consciousness following vagus nerve stimulation. The study results challenge ideas that consciousness disorders lasting longer than 12 months are irreversible, the researchers believe. Bernat, who was not involved in the study, referred to the new case report as “provocative” and “exciting,” and praised the researchers for their choice of patient: someone in a long-term vegetative state. Additional coverage: Washington Post, U.S. News & World Report.

Many Drug Companies Fail to Conduct Timely Safety Checks on Medicines After FDA Approval – Reuters Health

Read article – Features research led by Steven Woloshin, professor of medicine, community and family medicine, and of the Dartmouth Institute for Health Policy and Clinical Practice, that found that drug companies aren’t meeting the Food and Drug Administration’s requirement to study possible side effects and alternative doses for medicines once they hit the broader market. Woloshin and his colleagues looked at federal records and found that among the 614 studies mandated in 2009 and 2010, 20 percent were never started and 9 percent have been delayed.

Special Series: ‘Alternatives’ – N.H. Gets Creative to Curb Ongoing Opioid Crisis – NHPR

Read article – Louisa Chen, Geisel ’20, and Nasim Azizgolshani, Geisel ’20, are featured in a series called “Alternatives,” which examines some of the less traditional approaches in curbing New Hampshire’s opioid epidemic. Chen and Azizgolshani are two of five Geisel medical students who are running a needle exchange at the Claremont Soup Kitchen. This kind of program is common in many other states but it’s the first of its kind in New Hampshire.

Building Physician Resilience a Top Priority for AAFP President-Elect – MedPage Today

Read article – Features an interview with John Cullen, clinical assistant professor of community and family medicine and president elect for the American Academy of Family Physicians. In the interview, Cullen discusses his plans for his term as president-elect and how preventing physician burnout and helping practices get up to speed on payment reform are among his top priorities. (Subscription may be required.)