Two pain management physicians are criticizing plans by the Food and Drug Administration for a voluntary educational campaign for doctors on the risks and benefits of prescribing opioid painkillers. The FDA’s risk evaluation and mitigation strategy (REMS) calls on 20 drug makers to fund training courses for doctors and to create non-promotional medical guides for patients on extended release opioids.
“The propriety of having the pharmaceutical industry develop unbiased education for prescribers and patients is debatable,” wrote Lewis Nelson, MD, and Jeanmarie Perrone, MD, in an opinion column published in the Journal of the American Medical Association. “Although such education for prescribers will be offered through ostensibly independent continuing medical education providers, the expectation of the FDA that this will be funded by the pharmaceutical industry raises several concerns, including financial motivations and creative risk/benefit messaging.”
Dr. Perrone is an associate professor of emergency medicine at the Hospital of the Universityof Pennsylvania. Dr. Nelson is an emergency physician and medical toxicologist at New YorkUniversity’s LangoneMedicalCenter. Nelson is one of 37 physicians who recently signed a petition calling on the FDA to change labeling guidelines so that opioids are no longer indicated for moderate pain.
“Although it appears logical to prescribe potent analgesics to patients with chronic noncancer pain, the data to support the effectiveness of opioids for this indication are limited,” Nelson and Perrone wrote. “Even used as prescribed, opioids are associated with significant morbidity and mortality.”
Over 14,000 people died in 2008 from overdoses of prescription drugs, most of which were narcotic painkillers, according to the Centers for Disease Control and Prevention.
Doctor Training to be Voluntary
The doctors also questioned why the training courses for doctors on extended release opioids would be voluntary, when the FDA mandated training for health care providers and patients about the use of fentanyl, another type of painkiller.
An FDA advisory committee had recommended mandatory training for opioids, expressing concern that not enough doctors would volunteer their time. However, the agency overruled the advisory board, saying mandatory training would be “potentially burdensome.” The FDA’s goal under the voluntary program is to have 60 percent of the nation’s doctors who prescribe opioids take the courses within three years.
Due to a lack of pain curriculum in medical schools, several non-profit medical organizations – such as the American Pain Society – have been offering educational seminars on pain management. Courses provided by those organizations are expected to play a key role in the FDA’s training program for physicians.
Questions have been raised, however, about the financial ties between pharmaceutical companies and the non-profit pain organizations. The U.S. Senate Finance Committee has asked three drug makers for a detailed accounting of their donations to the organizations. Senators Max Baucus (D-Montana) and Chuck Grassley (R-Iowa) claim there is evidence that some companies funded the pain organizations to spread “misleading information about the drugs’ safety and effectiveness.”
“The American Pain Society has put together an outstanding educational program that industry has no control over whatsoever,” said Roger B. Fillingim, PhD, president of the American Pain Society, in a recent interview with American News Report. “And thus far we’ve trained over a thousand providers in this program. That’s an example of the kind of work that we like to do. And we’re happy to take donations from people if they want to support that work, but thus far it’s been supported by industry and it’s been very effective for us and that kind of educational program is broadly needed as I think the national community is recognizing now.”
One pharmaceutical company has already established an online training course for physicians under REMS. Purdue Pharma’s training program for doctors covers safe prescribing methods for OxyContin, its widely prescribed and abused painkiller. The program ends with a short quiz, but physicians are not graded on their answers and are not required to demonstrate competency before being certified that they took the program.
The website notes that “completion of the questions does not affect your ability to prescribe OxyContin.”