in the public domain; etching by Arnold van Westerhout (1651-1725)

There was an interesting study published in JAMA Internal Medicine noting that doctors who received any opioid-related payments in 2014—even for a single meal—prescribed more opioids in 2015. “One company, INSYS Therapeutics, accounted for 50% of nonresearch payments.” A relatively small number of physicians given nonresearch opioid-related payments (perks), 436 of 25,767 (1.7%), received $1,000 or more in total. The researchers said their findings suggested manufacturers should consider either a voluntary decrease or complete cessation of marketing to physicians for opioids. Federal and state governments were urged to consider legal limits on the number and amount of payments that could be given to doctors.

The research letter by Hadland et al. can be found here. In “More evidence companies pay some doctors to prescribe opioids,” Maggie Fox noted the Hadland study found that one out of every 12 U.S. doctors received something of value (money, lunch, etc.) from companies making opioids. PhRMA (Pharmaceutical Research and Manufacturers of America), the lobby group for pharmaceutical companies, issued a voluntary code of conduct to curb the once-widespread practice of handing out free branded items (mugs, prescription pads and other “swag”).

The three opioid manufacturing companies with the highest payment totals were Insys Therapeutics, Teva Pharmaceuticals USA and Janssen Pharaceuticals. Insys makes Subsys, a spray formulation of fentanyl licensed for extreme pain in cancer patients. “Payments made by Insys topped $4.5 million. Teva and Janssen each spent more than $800,000.”

Former Insys executives were charged with conspiring to “mislead and defraud” health insurance companies. See “Fentanyl: Fraud and Fatality.” Two former Insys executives have pled guilty and are cooperating federal prosecutors. “The company’s billionaire founder, John Kapoor, and other Insys officials and employees are also under indictment.” Insys said a new management team is making efforts to build a company culture of “high ethical standards.”

A company spokesperson wrote: “The company no longer hosts speaker programs for Subsys.” Further, he said there was a decrease of Insys-hosted physician speaker programs by 87% and an 82% drop in the amount in honoraria paid to those physician speakers from 2015 to 2017.  “In reality, according to federal prosecutors, the ‘lectures’ were just booze-fueled social gatherings, and the fees were kickbacks paid to prescribe Subsys.”

In “Opioid-Makers Cut Back On Marketing Payments To Doctors,” Charles Ornstein and Ryann Grochowski Jones wrote how the past two years has been a “time of reckoning” for pharmaceutical manufacturers over their contribution to the opioid epidemic through how they promoted opioid drugs. State and local governments have sued Purdue Pharma, Insys Therapeutics and other drug makers for their allegedly deceptive marketing of opioids. See “Giving an Opioid Devil Its Due” for more on Purdue Pharma and its promotion of OxyContin.

In 2016, drugmakers spent $15.8 million to pay doctors for speaking, consulting, meals and travel related to opioid drugs. That was down 33 percent from $23.7 million in 2015 and is 21 percent less than the $19.9 million spent in 2014. Companies are required to report the payments publicly under the Physician Payment Sunshine Act, a part of the 2010 Affordable Care Act.

The ProPublica Dollars for Docs online tool showed there were $9 billion in promotional payments made to more than 900,000 doctors between 2013 and 2016. The biggest decreases among opioid payments were for Subsys (from more than $6 million in 2015 to less than $2.4 million in 2016); and Hysingla ER, an extended release formula of hydrocodone made by Purdue, which dropped from around $6.3 million in 2015 to $2.2 million in 2016.

Purdue ended its speaker program for OxyContin at the end of 2016 and for Hysingla ER in November 2017. Earlier this year, it ended all direct promotion of its opioids to prescribers and last week [June 20^th], the company laid off its remaining sales representatives.

Michael Barnett, an assistant professor of public health and management at Harvard thought while the decline in opioid marketing is potentially good news, it isn’t clear exactly why it is happening. He said if it is because manufacturers were aware their advocacy and payments to physicians could be seen as pushing opioids in a way that was ethically dubious, that would be a beneficial development. “Given the deluge of media attention with the opioid epidemic, I think we’ve seen the pendulum swing in the opposite direction.” Instead of opioids being seen as a needed and compassionate way to treat pain, they are now “being viewed as pretty toxic and only to be used as a last resort.”

Unfortunately, there has been a slower decrease in the use of prescription opioids than the sharp drop in marketing them noted above. The number of opioid prescriptions in Medicare was 81.7 million in 2014, dropping to 80.2 million in 2015 and then 79.5 million in 2016. Yet the rate of opioid overdoses continues to grow. Of the 42,000 reported overdoses in 2016, 40% involved a prescription opioid.

In a blog post on May 14, 2018, the FDA Commissioner Scott Gottlieb referred to opioid addiction as the biggest public health crisis facing the FDA. He said he regularly hears stories about “the emotional, physical and financial toll this epidemic is taking on Americans.” The FDA is considering guidelines for doctors to encourage the “more rational prescribing” of opioids. One idea is to encourage medical societies to develop evidence-based guidelines on prescribing opioids for acute medical indications.

Having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

While there are many individuals in need of opioids for short and long-term use, a time of reckoning still needs to take place with the opioid manufacturers who exploited this need for their own financial ends. In March of 2018 the CDC released an in-depth analysis of drug overdose data for 2016. From 1999 to 2015, 568,699 persons died from drug overdoses in the U.S. “There were 63,632 drug overdose deaths in 2016; 42,249 (66.4%) involved an opioid.” Increases were noted across demographics, urbanization levels and states. Overdose deaths from prescription opioids increased by 10.6%, from 2015 to 2016. Eight states had significant increases in death rates that included prescription opioids. West Virginia, Maryland and Maine and Utah had the highest rates.