Dr. Raeford Brown
The Food and Drug Administration approved a powerful new painkiller Friday over the objections of a Kentucky doctor who co-chairs its advisory committee on such matters, and other physicians.
Dr. Raeford Brown of the University of Kentucky and others argue that sufentanil, 10 times more powerful than fentanyl, “would inevitably be diverted to illicit use and cause more overdose deaths,” reports Lenny Bernstein of The Washington Post.
Brown, a professor of anesthesiology and pediatrics, is the longtime chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. The panel voted 10-3 on Oct. 12 to support approval of the drug, which was developed with millions of dollars from the Pentagon, which wants an easier-to-use painkiller for the battlefield.
“Clearly, the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown said. “I will continue to hold the agency accountable for their response to the worst public-health problem since the 1918 influenza epidemic.”
Dr. Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University and is executive director of Physicians for Responsible Opioid Prescribing, an education and advocacy group, told Stat, “There is absolutely no need for this product. Claiming we need it on the market to help soldiers on the battlefield is ridiculous,” because fentanyl administered under the tongue is available for battlefield use.
The Post reports, “The FDA says that controls on drugs inside medical facilities are tight and the greatest risk of diversion is among medical personnel themselves. A 2016 survey conducted by the federal Substance Abuse and Mental Health Services Administration shows that narcotics are rarely stolen from doctor’s offices, clinics, hospitals or pharmacies. Fewer than 1 percent of people said they acquired opioids that way.”
The rate of overdose deaths among health care workers is relatively high, however, according to an August study by the Centers for Disease Control and Prevention, with 876 succumbing to prescription opioids between 2007 and 2012.
Sufentanil is “commonly used after surgery and in emergency rooms,” the Post notes. The Dsuvia pills “would not be available in retail pharmacies” and would carry a wholesale price of $50 to $60 per dose. “A spokeswoman said the company is not providing information on expected sales.”