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FDA Panel Urges Mandatory Opioid Training for Doctors


http://www.wsj.com/articles/fda-panel-urges-mandatory-opioid-training-for-doctors-1462405146
By THOMAS M. BURTON
May 4, 2016 7:39 p.m. ET
39 COMMENTS
WASHINGTON—An advisory panel to the Food and Drug Administration overwhelmingly endorsed mandatory training for doctors who prescribe opioid painkillers, in an effort to stem what has become a national epidemic of deaths and addiction from the drugs.

The recommendation followed a two-day hearing on the medical evidence regarding opioids and ways to improve their safety. Overall, the committee voted unanimously to recommend an overhaul of current federal requirements to train doctors and patients about the risks of overusing the pain drugs.

On the mandatory doctor-training question and some other safety recommendations, the panel’s chairman, Dr. Almut Winterstein of the College of Pharmacy at the University of Florida, said the group had shown “fairly overwhelming agreement.”

“We need to teach people to use these drugs sparingly,” said committee member Jeanmarie Perrone, a professor of emergency medicine and toxicologist at the University of Pennsylvania.

The Centers for Disease Control and Prevention estimates that as many as 19,000 Americans die from narcotic painkillers annually, a number that has been rising for at least the last 15 years. The products involved include medicines that contain hydrocodone, oxycodone, morphine and fentanyl.

They are often given to people with severe postsurgery, cancer and other pain, but many addiction specialists say they are given too often to people with chronic pain.

The FDA often follows the recommendations of its outside panels of medical experts, but it doesn’t have to. Convening the panel is one of several steps taken by the agency on opioids since Dr. Robert Califf became FDA commissioner in February.

The committee acted after hearing extensive public testimony that making opioid training mandatory for doctors was important, and that it shouldn’t be controlled by the drug industry.

Sidney M. Wolfe of the Washington-based consumer group Public Citizen called for “mandatory training and testing to get a narcotics license with as little opioid industry involvement as possible.” Physicians, said Dr. Wolfe, are “too often influenced by opioid industry-funded ‘education’ and promotion.”

Testifying before the panel, Chris Johnson, an emergency medicine doctor in Minneapolis, said: “Every brain is at risk for dependence. As far as the human brain is concerned, all opiates are heroin.” The only way to reduce patient addiction and overdoses, he said, “is to reduce opioid prescribing.”