As the House Energy & Commerce Committee prepares to mark up about 60 individual, opioid-related bills, and the Senate Health Committee continues to craft and tweak a massive, comprehensive bill, one provision is conspicuous by its absence from all of the above. Neither chamber is contemplating repeal of the 2016 law that weakened the DEA’s powers to stop suspicious opioid sales—the one that became the subject of a blockbuster Washington Post/60 Minutes exposé last October and led to Rep. Tom Marino (R-Pa.) withdrawing his name as a nominee to become President Trump’s drug czar. We’ll discuss.
Also topping the news, once again, are conflict-of-interest issues, as the NIH abruptly drops a plan to accept money from drug-makers for its long-planned public-private partnership to fight the opioid crisis. In addition, Politico puts Patrick Kennedy under the conflicts microscope, much as STAT and the New York Times each recently did to Jessica Hulsey Nickel of the Addiction Policy Forum. Politico focuses on Kennedy’s compensation and directors fees from drug-makers and other companies and nonprofits that stand to benefit from increased spending to fight the epidemic. In other important developments, the AMA and American Society of Addiction Medicine propose an important plan for how insurers should pay for medication-assisted treatment; a Johns Hopkins study finds that newly abundant, “increased-risk” transplant organs, received from overdose victims, actually carry little increased risk; and—in rare, unambiguously good news—the number of opioid prescriptions continued to drop during 2017, while the number of patients initiating medication-assisted treatment each month nearly doubled.
The Hill carries the intriguing sequel—a mystery, of sorts—to the Washington Post/60 Minutes exposé. Though Sen. Claire McCaskill would like to introduce a measure to repeal the provision that curbed the DEA’s power, she can’t find a Republican co-sponsor. Some speculate that Republicans sense that McCaskill is vulnerable in an upcoming election, or that they want to protect Rep. Marino, who sponsored the 2016 law, and is still in the House. Others posit that PhRMA is blocking repeal, but PhRMA claims it never backed the 2016 law in the first place and has no problem with repeal. It seems like the only person willing to admit openly his support for the law as it stands is Sen. Orrin Hatch (R-Utah), who says he shares the concerns of patient advocates and manufacturers who fear that the DEA may otherwise cut off pain patients’ access to opioids they legitimately need. (Hatch’s state is home to two leading pain management authorities—Lynn Webster and Perry Fine—who have been identified as “key opinion leaders” in hundreds of lawsuits filed by municipalities against opioid manufacturers. The plaintiffs allege that these famous and widely quoted doctors underestimated the risks of opioids, and that manufacturers knowingly exploited their mistaken views. In at least 80 lawsuits in federal court, those doctors have been named as co-defendants as well.)
Meanwhile, the DEA, which sets production caps on controlled substances after receiving estimates of demand from manufacturers, announced a beefed up policy regarding what opioid manufacturers will have to demonstrate in the future to get approvals. As the Wall Street Journal notes, DEA had been sued by the West Virginia attorney general for alleged lax oversight.
As an aside, I’d note that the DEA’s role in the epidemic is an ambiguous one—or at least that seems to be the view of US District Judge Dan Polster, who is handling the roughly 600 cases consolidated before him in Cleveland. When Polster ruled against the DEA last week, ordering it to disclose a vast storehouse of opioid distribution data to the plaintiffs lawyers, he concluded: “There is overwhelming need for the Plaintiffs … to learn the truth surrounding marketing and distribution of opioids, including what the manufacturers, distributors, retailers, and DEA knew and when they knew it; what, if anything, was kept, intentionally or unintentionally, away from the DEA and the public by defendants; and what, if anything, the DEA kept, intentionally or unintentionally, from the States, counties, and cities that have filed the [consolidated] lawsuits.” (Italics added.)
In other Congressional news, Sen. Bernie Sanders (I-Vt.) is pushing a bill that would subject the executives of opioid manufacturers to mandatory minimum 10-year prison terms and massive fines (equal to all their compensation plus $7.8 billion) if their companies are shown to have contributed to the epidemic through misleading marketing. From the stories in STAT and The Hill, I can’t tell if the bill purports to impose retroactive liability—in which case it is unconstitutional under the ex post facto clause—or merely prospective, in which case it would very ostentatiously close a barn door years after all the animals have fled.
At the same time, Sen. Elizabeth Warren (D-Mass.) and Rep. Elijah Cummings (D-Md.) continue to advocate for a 10-year, $100 billion reform bill modeled upon the 1990 Ryan White legislation to fight AIDS, according to, among others, The Hill.
NIH has suddenly backed away, STAT reports, from accepting cash from industry players for the public-private partnership it has long been working on to develop new nonaddictive painkillers and opioid recovery and treatment therapies. Director Francis Collins took the advice of a special ethics working group, whose recommendations are laid out here. It will still accept in-kind contributions—industry will set up a clinical trial network, for instance—and the partnership’s scientific goals remain the same. The article explains that NIH has accepted industry cash in partnerships in the past (for instance, to develop cancer immunotherapy), but the fact that some of the drug makers in the partnership are currently being sued by states and municipalities for allegedly helping cause the epidemic changed the calculus in this instance. Finally, the story notes in passing that an official at the Foundation for NIH (FNIH)—an external organization that acts as a go-between between NIH and industry in such partnerships—has also recused herself. The official is one Jillian Sackler, the third wife and widow of Arthur Sackler, who, according to Barry Meier’s book, Pain Killer, lent money to his two brothers to acquire Purdue Pharma’s parent in 1952, and secretly held a one-third interest in the company until his death in 1987. There is a dispute over whether Jillian ever benefited from OxyContin, which wasn’t introduced until 1996.
Also this week, Politico shined a harsh light on mental health advocate and former Congressman Patrick Kennedy’s financial arrangements. The article describes him as “the go-to player for companies seeking to benefit from the Trump Administration’s multibillion-dollar response to the opioid crisis.” Kennedy, 50, is a long-time mental health advocate who has personally struggled with addiction, and who sat on President’s Trump’s opioid commission. He is CEO of the nonprofit Kennedy Forum, for which he received $1.1 million over three years, and receives directors fees for serving on the boards of such groups as CleanSlate Centers, which provides medication-assisted treatment; Axial Healthcare, which sells “pain and opioid management products”; and Braeburn Pharmaceuticals, which is seeking FDA approval for an injectable, long-acting buprenorphine product, something like Indivior’s Sublocade. The Kennedy Forum discloses sponsorships by PhRMA, Eli Lilly (which is developing a nonopioid pain drug), and Janssen (which makes the Duragesic fentanyl patch), and has nondisclosed sponsors as well. “Ultimately, I want to build a movement,” Kennedy tells Politico, “and we’ve got to get money behind it. I’m not running away from it. I’m fine with it.”
Patrice Harris, who chairs the AMA’s opioid task force, spoke to Steven Ross Johnson of Modern Healthcare this week about an important plan that the AMA and American Society of Addiction Medicine are jointly urging to improve reimbursement of medication-assisted treatment. “Under the model endorsed by the AMA and ASAM,” Johnson writes, “patients would receive outpatient treatment using either buprenorphine or naltrexone. They would also have to receive psychological or counseling therapy services as well as care coordination to provide social support or other medical services as needed. A physician would only qualify to receive payment under the payment model if they were part of an opioid addiction treatment team where they would be contracted to deliver all three types of services.”