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News Roundup: May 18, 2018: ONDCP Is A No-Show
By ROGER PARLOFF|May 18, 2018
Jacob Creswick Unsplash
Quick Takeaway
  • Administration declines to send any ONDCP representative to a Congressional hearing.
  • Are "opioid contracts"—required by doctors of their pain patients—fair?
  • Justice Department joins whistleblowers suits against Insys Therapeutics.

At one level, the federal government is working with unprecedented dedication to curb the opioid crisis. The House Energy and Commerce Committee has now advanced 57 opioid-related bills (expected to reach the full House in June) while at least two Senate committees are marking up successor legislation to the Comprehensive Addiction and Recovery Act of 2016. Yet yesterday, at a House hearing to reauthorize the Office of National Drug Control Policy, the Trump Administration declined an invitation (see 35:45) to send the acting director (or any other representative) to participate. A National Drug Control Strategy, due in February, has not yet been submitted. One member of theWhite House Commission on Combating Opioid Drug Addiction and the Opioid Crisis has, in retrospect, denounced its work as a “sham.” Appropriations remains insufficient to meet demands, and the future shape of Medicaid—which undergirds addiction treatment—remains a question mark. Meanwhile, Sen. Lindsay Graham (R-SC), The Hill reports, is working on another repeal-and-replace bill for the Affordable Care Act.

Politics aside, this week saw a spray of significant developments across a broad range of fronts. Issues raised by chronic pain patients were at the top of the agenda, with FDA Commissioner Scott Gottlieb scheduling a public meeting to hear from patients and advocates on July 9. In other news, a JAMA study suggested that opioid manufacturers’ payments to physicians do bear dividends; the Department of Justice reached a record opioid diversion settlement with a hospital system; there were enlightening stories about Medicaid, including the positive role it can play in facilitating treatment; the FDA approved a drug that helps people endure withdrawal on the way to longer term, naltrexone-assisted treatment; the Washington Post reported that sponsors of the infamous 2016 law that weakened the DEA’s enforcement power over opioid distributors now face rocky primary and general election battles; the Center for Safe Internet Pharmacies and Partnership for Drug-Free Kids announced a partnership; and a mother penned a wrenching account of how she was unable to surmount bureaucratic hurdles to getting her son buprenorphine in time, and he died.

News Roundup: June 8, 2018: Pain Refugees

Chronic Pain

  • Late last week, family physician Kenneth Lin, MD, wrote in Medscape of the high-dose opioid, pain refugees who have come to him because their original doctors, for various reasons, won’t prescribe opioids anymore or, at least, not at those doses. Lin declines to taper the patients down against their will, and he’s now having trouble filling their prescriptions, due to resistant pharmacies and insurers. “I fear that recent ‘pill limit’ policies … will lead to a great deal of unintended and unnecessary suffering.”
  • In Lin’s post, he cites a NEJM commentary, from February, which has some similarities to his own, and yet some nuances of difference, too. Those writers, who are pain specialists in New Mexico, also describe a “flood” of stranded high-dose opioid patients coming to their clinic. These doctors sound torn, however. They believe that “every effort must be made to reduce [the patients’] … dose … to the safest dose achievable.” On the other hand, they acknowledge that “many [patients] cannot achieve adequate pain control without their current doses.” At a pragmatic level, the authors recommend at least switching the patients from their existing prescriptions, like oxycodone, to buprenorphine due to the latters’s “excellent pain-relieving properties and … much safer overdose profile.” (Doctors do not need special certification, they note, to prescribe buprenorphine for pain. That’s only needed to prescribe it as an addiction treatment.)
  • “Opioid contracts” were also in the news this week. These are documents in which doctors require patients “to agree to random urine drug screens, opioid pill counts, and other conditions,” according to Fox News, on pain of “no longer being prescribed opioids by that medical professional.” Pain patients and advocates, like Boston Marathon bombing survivor Lynn Julian Crisci, protest that these agreements are “coercive” and “damage the doctor-patient relationship.” The American Academy of Pain Management endorses them, on the other hand, and one pain specialist defends them for creating clarity between doctor and patient and establishing “an understanding of treatment guidelines and expectations.” (On a flip-side tangent, two Tampa anesthesiologists applaud the four states that have enacted laws giving surgery patients the right to execute “non-opioid directives”—demands that no opioids be administered to them—and urge anesthesiologists to learn how to comply.)
  • In calling for a public meeting July 9 with chronic pain patients, FDA Commissioner Scott Gilbert said, “We’re focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines. His statement was circumspect, however, and the only specific examples he gave of conditions where opioids might be “the only drugs that work” were “metastatic cancer or severe adhesive arachnoiditis”—an excruciating inflammation near the spinal cord.

Insurance/Medicaid

  • Virginia appears to have successfully expanded access to medication-assisted addiction treatment by boosting Medicaid reimbursement rates for those services. Doing so, writes Vox’s German Lopez, encourages existing facilities to accept Medicaid, and also attracts new providers. The early data suggest that the number of Virginians with opioid use disorder receiving treatment has gone up 29 percent, while overdose-related ER visits have dropped 31 percent. (Alas, the state’s overdose death rates are still on track to rise 14 percent.)
  • Congress still can’t figure out how to reform the so-called IMD exclusion, an outmoded law that, everyone agrees, is inadvertently hampering reimbursement for addiction treatment. Modern Healthcare explains the vexing reasons why. (The old law bars reimbursement of services in “institutions for medical disease” with more than 16 beds.)
  • Some states want to make Medicaid applicants who are suspected of substance use disorders submit to drug tests. In an interview with the Washington Post, it sounds like CMS Administrator Seema Verma thinks that’s reasonable, as a way to link those individuals “to the services that are going to be most appropriate.”

Litigation

  • As of Tuesday, there were 718 lawsuits consolidated in federal court in Cleveland against opioid manufacturers or distributors. They have been filed mainly by municipalities, Indian tribes, and self-insured unions.
  • Six more states sued those defendants this week: Florida, Nevada, North Carolina, North Dakota, Tennessee, and Texas. That makes at least 22 states, by my count.
  • A court document filed this week revealed that, as the Wall Street Journal reports, the Department of Justicehas intervened in five consolidated whistleblower suits against Insys Therapeutics in federal court in Los Angeles. They stem from the same allegations that led to the criminal racketeering indictment against Insys’s founder and six top executives: alleged bribery of physicians, through sham speaking fees, to prescribe the company’s fentanyl mouth spray to inappropriate patients, and lying to insurance companies to get them to pay for the prescriptions. (Insys says it has “completely transformed” its culture since it learned of the federal criminal probe five years ago. The criminal defendants have pleaded not guilty.)
  • The U.S. Attorney for the Southern District of Georgia secured what it calls the “largest hospital drug diversion civil penalty settlement in U.S. history.” Springfield, Ga.-based Effingham Health System agreed to pay $4.1 million, without admitting wrongdoing. The government says that over a four-year period tens of thousands of oxycodone pills went unaccounted for at the hospital, and are believed to have been diverted.

Regulations

  • The FDA approved lofexidine, marketed by Kentucky-based US WorldMeds as Lucemyra, to relieve the symptoms of withdrawal. (Reported by, among others, STAT.) The main use of lofexidine, a nonopioid, is expected to be as a bridge for those who want to use naltrexone (Vivitrol), also a nonopioid, as a long-term medication for treating their addiction. Unlike the other two long-term addiction treatment medications, buprenorphine and methadone (which are opioids), naltrexone cannot be used until the patient is completely detoxed and, therefore, has gone through the misery of withdrawal.
  • The FDA has discovered a more than 20 percent discrepancy between the amount of prescription fentanyl sold in the US over the last five years and the amount reported by IQVIA, a private company that tracks prescription drug data and provides it to the FDA (among others). Finding anomalies in the oxycodone figures, too, the FDA expressed “serious concerns about systemic issues.” IQVIA characterized the problem as a “measurement conversion issue,” and said it was working with the FDA to resolve it.

Research

  • Opioid manufacturers’ payments to physicians—for speaking fees, consulting, meals, etc.—do bear fruit, according to a JAMA Internal Medicine study. Researchers compared payments made to opioid prescribers in 2014 to the number of prescriptions those doctors wrote for Medicare patients the following year. Unpaid doctors wrote fewer opioid prescriptions in 2015 than in 2014, while paid physicians wrote more—about 9.3 percent more than the unpaid physicians. About half of all the money paid by opioid manufacturers to opioid-prescribing physicians in 2015 was paid by Insys Therapeutics (i.e., about $4.5 million out of $9 million spent).
  • PDMPs were not associated with lower overdose death rates in the states where they were implemented, according to a review in the Annals of Internal Medicine. “Some evidence showed unintended consequences,” i.e., an increase in heroin deaths after implementation. “Research is needed to identify a set of ‘best practices’ and complementary initiatives to address these consequences.”

Fentanyl

  • Illicit fentanyl is being mixed with cocaine, crack cocaine, benzodiazepines (like Xanax), methamphetamines, and more, according to the Atlantic and the Los Angeles Times, causing unaccustomed overdose deaths in all those categories.
  • The DEA made three arrests of Bronx men charged with conspiracy to distribute 100 grams of carfentanil (in addition to heroin), and issued a public health warning. Carfentanil is 100 times more powerful than fentanyl—i.e., 5,000 times more powerful than heroin. Twenty micrograms, or 0.00002 grams, could be a lethal dose.

Addiction and Families

  • Center for Safe Internet Pharmacies and Partnership for Drug-Free Kids announced last week a national  coalition to curb the epidemic last week.  The new group is called MedicineSafe, and is supported by a number of national and state organizations as well.  The MedicineSafesite provides a range of free resources, including information about safely storing and disposing of medication; talking with your kids; recognizing signs of medicine abuse; treatment options; a free, downloadable book explaining medication-assisted treatment; how to use naloxone; and immediate help via phone, chat, text, or email.
  • Jesse Dunleavy, a retired school administrator in Annapolis, wrote a commentary in her city’s paper, the Capital Gazette, entitled, “My Child Died Because He Couldn’t Get Medication-Assisted Treatment.” Her son’s inpatient treatment ended prematurely, she writes, because of “insurance and other bureaucratic snafus.” He asked her to find him Suboxone [buprenorphine] while he returned to work. She ran up against restrictions “brought on by availability or insurance,” she writes. “In one call, I was lectured on the pitfalls of ‘substituting one opioid for another’ and was told I was prolonging the problem. Tragically, my son died within a few days. … A safe and controllable level of medication … would not have prolonged the problem. It would have prolonged his life. But street drugs were easier to get.”
Filed under: Legislation/ News Roundup