The public-private partnership that has now been in preparation for almost a year, in which NIH and FDA, on the one hand, will work with the pharmaceutical industry, on the other, to expedite and approve new opioid treatments and nonaddictive painkillers, has spawned a series of questions about ethics, transparency, and logistics. They are one focus of this edition.
Otherwise, recent news has been dominated by a flurry of governmental activity, which continues this week with the twin, upcoming hearings on Thursday, by the key US House and Senate committees involved, on major, multifaceted, opioid-related bills.
We also highlight an HHS study on the impact of the opioid epidemic on foster care; a Kaiser Family Foundation report on the crisis’ cost to employers’ insurance plans; and an AP-NORC Center for Public Affairs poll on Americans’ paradoxical attitude toward drug addiction. (Most consider it a “disease,” yet most also favor a “crackdown” on those who suffer from it.) Finally, we draw attention to a Harpers story on “pain refugees” in Montana.
News Roundup: June 8, 2018: Pain Refugees
Regulation, Legislation and Politics
Far too much has been happening in this realm to cope with it in any other fashion than bullet points.
- A few days after FDA Commissioner Scott Gottlieb called out Internet providers (like Twitter, Facebook and Google) for failing to police their websites for illicit opioid sales, (see, e.g., STAT), Instagram (owned by Facebook) shut down some hashtags being used for such commerce, per CBSNews. But Gottlieb actually needs to share the credit with a woman named Eileen Carey, according to Wired. Carey has been complaining about Instagram accounts selling opioids for three years, and recently started shaming the company on Twitter.
- Surgeon General Jerome Adams issued a public health advisory—the office’s first in 13 years—calling on friends and family of addicts to carry and learn to use naloxone (e.g., AP). A couple days later The Hill reported that CVS had started offering a discount on Narcan (the nasal spray version of the overdose-reversal medication) to the uninsured. (Incidentally, like nearly every major retail pharmacy chain, CVS has been named as a defendant in a number of the more than 500 cases filed by municipalities against opioid manufacturers and distributors. The most conspicuous defendant in the litigation, OxyContin manufacturer Purdue Pharma, has also made Narcan-related donations—to first-responders, in Purdue’s case. Meanwhile, lead distributor defendant McKesson set up a $100 million foundation last month to donate to various anti-epidemic causes. Wal-Mart, a peripheral defendant, has started giving out a free DisposeRx product, which enables customers to destroy left-over opioid pills, according to Fortune.)
- The Senate Health, Education, Labor and Pensions Committee will hold a hearing at 10:00am on Wednesday, April 11, (with live video) on its draft Opioid Crisis Response Act of 2018. The Hill has a good overview of the bill, which impacts NIH, FDA, SAMHSA, CDC, DEA, and CBP (Customs and Border Patrol), and would also rejigger formulas for state block grants to give more money to hard-hit states and Indian tribes. (It would also extend the availability of opioid treatment medication via telemedicine, the importance of which we’ve written about here.)
- The House Energy & Commerce Committee will also hold a hearing on opioid-related bills on Wednesday, April 11. Its will be at 2:15pm, also with live video. This is the last of three scheduled hearings, and will focus on more than 30 bills related to Medicaid and Medicare issues. One important issue is whether to lift the longstanding, so-called IMD (institutes of mental disease) exclusion. Current law generally bars the use of federal Medicaid funds to reimburse otherwise eligible services in an inpatient facility treating mental disease if the facility has more than 16 beds. Though there is generally bipartisan support for the lifting the ban, a simple repeal would be expensive: $60 billion over ten years. Supporters of reform say they can make it cost less by limiting it to substance abuse treatment and by capping stays at 90 days.
- Sen. Elizabeth Warren (D-Mass.) and Rep. Elijah Cummings (D-Md.) are urging a major opioid treatment bill, modeled on the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act of 1990, according to WBUR and Modern Healthcare. It would cost $100 billion over 10 years, according to WBUR.
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Conflicts, Transparency, and the Private-Public Partnership
- As NIH and the FDA prepare to work with industry to develop new treatments and nonaddictive painkillers, an advisory working group has been preparing a report on ethical considerations.
- With ethics issues in the air, STAT puts Addiction Policy Forum CEO Jessica Hulsey Nickel back under the microscope. In February the New York Times reported that her patient advocacy group, APF, was receiving “tens of millions” of dollars from PhRMA in a multiyear deal. This week STAT reports that until last Fall Nickel was working for APF at the same time she was serving a lobbyist for Alkermes, the maker of Vivitrol, a form of injectable naltrexone, used to stanch opioid cravings. Other sponsors of APF include Indivior, maker of Suboxone(buprenorphine plus naloxone) and Sublocade (an injectable form of buprenorphine), and Braeburn Pharmaceuticals, which is seeking FDA approval for an injectable buprenorphine product. Nickel tells STAT that the publication’s questions betray “an old way of thinking.”
- Coincidentally or not, KHN just launched a database to “expose Pharma’s ties to patient groups,” called Pre$cription for Power. An accompanying story reports that 14 companies gave $116 million to patient groups in 2015, which was more than those companies spent on lobbying.
- Seven NIDA and the FDA officials, led by NIDA director Nora Volkow and FDA CDER director Janet Woodcock, have an article in Science Translational Medicine, about the challenges of approving new opioid treatment medications, now that the public health community has recognized that abstinence is no longer necessarily the goal. Abstinence was easy to measure, while reduced opioid use and improved functionality are harder to assess—especially since self-reported surveys aren’t always reliable.
- On average in this country, every 10 percent rise in a county’s drug overdose deaths is associated with a 4.4 percent rise in the rate at which that county’s children enter the foster care system, a new HHS study finds. We have a story about that study and related evidence of the heavy toll the epidemic is exacting on children.
- Sandy Santana, the executive director of Children’s Rights, discusses related issues in a USA Today editorial.
Harpers has a well-written article this month on the subject of “pain refugees.” It relates the story of a chronic pain patient whose doctor was abruptly fired by his pain management clinic in Montana and who was then told by a nurse practitioner, according to the article, that he had to reduce his opioid dose 80% without tapering. Stefan Kertesz, associate professor at the University of Alabama at Birmingham, tells Harpers that states and insurers are “weaponizing” the 2016 CDC guidelines by adopting, in effect, rigid dosage limits, with cruel consequences. (The clinic denies, Harpers reports, enforcing any upper limit on dosage.) The story also discusses the predicament of pain patients with “medically unexplained symptoms.”
In a different vein, NPR carries a story about a chronic pain patient who, after two unhappy years on opioids, successfully transitions to physical therapy and other nonopioid means of pain reduction. “The gold standard of treatment” for chronic back pain, says the article, paraphrasing Erin Krebs of the Minneapolis VA Healthcare System, “is a combination of things like exercise, rehabilitation therapies, and cognitive behavioral therapies.”
Also Of Note
- The Kaiser Family Foundation released this week a study finding that employers spent $2.6 billion in 2016 for opioid addiction treatment—eight times more than they spent in 2004, per the AP.
- An Associated Press-NORC Center for Public Affairs poll finds that 53% of Americans think addiction is a disease, yet 55% favor a “crackdown” on those who “misuse” drugs, per the Washington Post. “Most would not welcome those suffering from the problem into their neighborhoods, workplaces, or families,” the paper writes.
- Bloomberg writes this week about two Chicago men, with a company called Novum Pharma, who are, the magazine asserts, behind several jaw-dropping pharmaceutical price hikes. They allegedly counsel companies on how to use data analytics and specialty pharmacies to pull off such hikes. One of the drugs whose price they helped jack up, according to the story, is Kaleo’s Evzio product—the auto-injector version of naloxone—which skyrocketed from $575 per two-injector packet in 2014 to about $3750 today (as STAT reported earlier this month).
- WBUR has a short profile of Mary Daly, a 13-year federal prosecutor who has now been named the US Department of Justice’s new “opioid coordinator.” She is the daughter of William Barr, the US Attorney General under President George H.W. Bush.