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Perks such as payments, free meals and speaking fees may be strongly influencing some doctors to prescribe opioids, researchers reported Monday.
They found more evidence that a few doctors who prescribe the largest amounts of the painkillers also got the most attention from drug companies.
While saying that the study doesn’t prove that payoffs influence prescribing, the findings strongly suggest that they do, the researchers report in the Journal of the American Medical Association’s JAMA Internal Medicine.
And the company that spent the most money of these perks, Insys Therapeutics, is at the center of a federal investigation into the payoffs.
“Amidst national efforts to curb the overprescribing of opioids, our findings suggest that manufacturers should consider a voluntary decrease or complete cessation of marketing to physicians,” Dr. Scott Hadland of Boston Medical Center and colleagues wrote in their report.
“Federal and state governments should also consider legal limits on the number and amount of payments.”
Opioid abuse is an epidemic across the country.
“The biggest public health crisis facing FDA is opioid addiction,” Food and Drug Administration Commissioner Dr. Scott Gottlieb wrote in a blog post Monday.
Opioids killed more than 42,000 people in 2016, and 40 percent of all opioid overdose deaths involve a prescription opioid, the Centers for Disease Control and Prevention says. It says doctors are definitely helping drive the addiction crisis, prescribing opioids to too many patients, at doses that are often too high and for too long.
At the same time. studies show that pharma companies can and do strongly influence what doctors prescribe, often with simple charm offensives, free lunches and products with name brands emblazoned on them.
One study found that physicians who accepted just one meal sponsored by a drug company were much more likely to prescribe a name-brand drug to patients later.
The Pharmaceutical Research and Manufacturers of America, the lobby group that represents big drugmakers, has issued a voluntary code of conduct to curb the once-widespread practice of handing out free mugs, prescription pads and other swag covered in drug brand names.
Some cities and states especially hard hit by the opioid abuse epidemic have even sued drugmakers, saying their practices have helped fuel the problem.
In 2017, Hadland and colleagues reported that one out of every 12 U.S. doctors gets money, lunch or something else of value from companies that make opioid drugs.
For this study, they looked at Medicare databases as well as the Open Payments database, a federal government tool used for tracking payments made to doctors.
“We studied the extent to which pharmaceutical industry marketing of opioid products to physicians during 2014 was associated with opioid prescribing during 2015,” Hadland’s team wrote.
They found about 370,000 doctors prescribed opioids to Medicare Part D patients. Just under 26,000 of them, or about 7 percent, got some kind of payment not related to research grants, and 436 of them got $1,000 or more.
“The three companies with the highest payment totals were INSYS Therapeutics, Teva Pharmaceuticals USA and Janssen Pharmaceuticals,” they wrote. Insys makes Subsys, a spray formulation of fentanyl made to be squirted under the tongue and licensed for treating extreme pain in cancer patients.
Payments made by Insys topped $4.5 million. Teva and Janssen each spent more than $800,000.
“Marketing included speaking fees and/or honoraria, meals, travel, consulting fees, and education,” they wrote.
“Each meal received in 2014 was associated with an increasing number of opioid claims in 2015.”
It’s possible, Hadland said, that the doctors who prescribe the opioids the most have more expertise and are called on by the drug companies more often.
But last March, federal prosecutors indicted five Manhattan doctors for taking more than $800,000 labeled as "speaker fees" for educational lectures on the drug that the doctors had agreed to give to medical professionals.
In reality, according to federal prosecutors, the "lectures" were just booze-fueled social gatherings, and the fees were kickbacks paid to prescribe Subsys.
Prosecutors have also published the guilty pleas of two former Insys executives, Jonathan Roper and Fernando Serrano, who were charged last year and are now cooperating. The company's billionaire founder, John Kapoor, and other Insys officials and employees are also under indictment.
Insys says things have changed in recent years with a new management team making efforts to build a culture of "high ethical standards".
"The number of Insys-hosted physician speaker programs related to Subsys and the amount in honoraria paid to those physician speakers went down by 87 percent and 82 percent, respectively, in 2017 compared to 2015," a spokesman said by email.
"The company no longer hosts speaker programs for Subsys, which has been on the market for more than six years."
Separately on Monday, FDA announced a public meeting about opioid use and abuse.
The agency is looking for alternatives to opioid use for pain.
“FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies,” Gottlieb wrote.
The agency, he said, is considering guidelines for doctors to encourage “more rational” prescribing.
“For example, one idea the FDA is considering is the development of a strategy for encouraging medical professional societies to develop evidence-based guidelines on appropriate prescribing for different acute medical indications,” Gottlieb said.