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In America, a baby is born with opioid withdrawal symptoms every 15 minutes. The focus of this issue of the newsletter are two complementary articles exploring, from different angles, the subject of pregnant mothers with addiction. The first, in the New York Times Magazine, by Pulitzer Prize-winning novelist Jennifer Egan, provides a harrowing but sympathetic view from inside the chemically-hijacked minds of these mothers—who would be considered criminals in some states. The second, by KHN, discusses the conflicting results of research on the impact of opioid withdrawal at birth, or neonatal abstinence syndrome (NAS), on later child development.
In other stories this week, state and federal legislators are pushing to lift bans on off-label marketing by pharmaceutical companies; the federal judge presiding over national opioid litigation ordered the DEA to turn over more data and stayed lawsuits against “key opinion leader” pain doctors while those physicians try to strike a deal with the plaintiffs; the Wall Street Journal explores the disparity between the Congressional responses to the crack and opioid epidemics; and a popular non-opioid painkiller, gabapentin, is increasingly being turned to lethal misuse.
Addiction, Treatment, and NAS
The Times article offers both a searing portrayal of the reality of addiction and a wealth of simple, enlightening facts about the phenomenon of addiction in pregnancy. In the latter category:
- Of the estimated 2.1 million Americans currently addicted to opioids, about 400,000 are adults between 18 and 25 (i.e., prime child-rearing age).
- 90 percent of pregnancies among this group are unintended.
- The standard of care for mothers with addiction is medication-assisted treatment, even though the main medicines—buprenorphine and methadone—are themselves opioids. Thus, the baby will still be at risk for NAS. (Putting the fetus through the trauma of the mother’s detox would be more dangerous.)
- Not all babies of addicted mothers will have NAS; it’s a risk, not a certainty.
- There is no uniform protocol for treating NAS itself. “Morphine, methadone and buprenorphine are all currently given to newborns,” according to Egan, “while some doctors believe that, except in extreme cases, swaddling and skin-to-skin contact with the mother are sufficient.”
Seeking treatment is legally risky for pregnant moms, with minority and low-income women seeming to run statistically greater risk.
- In 24 states and the District of Columbia the use of an illegal substance during pregnancy constitutes child abuse; in three it’s grounds for civil commitment.
- 23 states require doctors to alert child welfare authorities if they suspect a pregnant woman has used an illicit substance.
- In Alabama, between 2006 and 2015, 479 pregnant women were prosecuted, and some imprisoned, under that state’s chemical endangerment law.
- In Chicago in 2016, only 12 percent of children in foster care were white; in NYC, only 6 percent.
Yet it is in Egan’s mini-portraits of the addicted mothers that the article truly excels. She focuses in particular on one mother, addicted to Percocet (oxycodone plus acetaminophen), who sought treatment at a methadone clinic when she got pregnant. Upon noticing that some other pregnant moms there were still abusing on the side, she recounts her surprise that they could still get high despite the methadone. “If I wasn’t pregnant,” she tells Egan, “I would be the first one to say, ‘Hey, let’s see if it still works.’ … I’ve thought about it a million times. It’s scary, because my mind is still being controlled by the pills.”
The KHN story, also carried by NPR, discusses a couple conflicting studies of the impact of NAS on children. One found, a study co-author says, that “the children tended to score within the normal range of the tests that we had.” The second is more concerning. “A number of the children … studied … scored at least one standard deviation below the mean in cognitive, language and motor abilities,” KHN reports. Nevertheless, NAS appears to be less dangerous to infants than fetal alcohol syndrome, which “really affects the brain.”
Regulation and Legislation
Federal and state legislators are pushing to loosen restrictions on off-label marketing by pharmaceutical companies, according to Regulatory Focus, which is, in turn, reporting on an editorial in PLOS Medicine. Traditionally, drug makers have only been permitted to market a drug for the purposes for which the FDA has found it to be safe and effective. Doctors, however, have long been permitted to prescribe FDA-approved medicines for off-label purposes, which is considered within their prerogative as physicians.
In 2012, however, in a case called USA v. Caronia, a 2-1 panel of the US Court of Appeals for the Second Circuit overturned the misdemeanor conviction of a drug company sales rep for off-label marketing. As long as his speech was “truthful,” the court found—for instance, if he acknowledged that the FDA hadn’t approved the drug for the purpose he was promoting—his speech was constitutionally protected. The controversial ruling has not been followed by the FDA outside the Second Circuit (New York, Connecticut, and Vermont).
Bills have been introduced in the US Congress that would, in essence, codify the Caronia court’s view of the law, and bills have actually been passed by state legislatures in Arizona and Tennessee that purport to make it the law in those states. Tennessee’s law takes effect July 1.
In other legislative news:
- Top current or former executives of the nation’s five largest drug distributors were raked over the coals by a House Energy and Commerce subcommittee. Joseph Mastandrea, chairman of Miami-Luken, distinguished himself. He was the only one who admitted when asked that, “yes,” his company had “contributed to the crisis.” See, for example, STAT or the Washington Post. STAT notes that the compensation of McKesson CEO John Hammergren also came up at the hearing. He was paid $600 million over a 10-year span.
- The House E&C Committee advanced 25 opioid-related bills to the full House of Representatives.
- Sen. Claire McCaskill (D-Missouri) issued a report asserting that US ports of entry—airports, seaports, border crossings—where most illicit fentanyl enters the country, are undermanned by about 4,000 officers, per The Hill. The report, by the minority staff of the Senate Committee on Homeland Security and Government Affairs, is here. (The enormous significance of fentanyl and other illicit synthetic opioids to the future of the epidemic is discussed by veteran drug policy expert and first NIDA director Robert DuPont, MD—who has been fighting against opioid addiction for 50 years—in an interview with Opioid Watch here.)
There are now roughly 650 lawsuits consolidated before US District Judge Dan Polster in Cleveland, in which municipalities around the country have sued opioid manufacturers and distributors for allegedly misrepresenting the addictive properties of prescription opioids and failing to police suspicious sales. This week, Judge Polster took several significant actions:
- He held another closed-door settlement conference, and scheduled the next one for July. While pushing several “model” cases forward toward trial, he is also seeking a global resolution of all the litigation.
- On Tuesday he expanded an earlier ruling, requiring the DEA to disclose to the litigants much more data from its confidential ARCOS tracking system. The system “shows the precise number of opioid pills delivered to each city and county in America, partitioned by manufacturer and distributor and pharmacy,” as he notes. He thinks the information will, among other things, promote settlement by better showing how to allocate responsibility. He also says that the ARCOS data disclosed so far is already “providing invaluable, highly-specific information regarding historic patterns of opioid sales, which are proving very interesting to [state and local] law enforcement.”
- On May 9 Polster stayed scores of cases that name as defendants four “key opinion leader” doctors: Russell Portenoy, Lynn Webster, Perry Fine, and Scott Fishman. The order indicates that these doctors are in discussions with the municipalities about a “potential resolution” and want to “preserve their limited resources” while discussions continue. Municipalities have filed at least 80 cases in federal court against Webster, Fine and Fishman, and 19 against Portenoy, and Opioid Watch has explained what they’re about here.
Also of Note
- Stefan Kertesz, MD, has an editorial in The Hill urging caution as we cut back opioid prescribing. He asserts that chronic pain patients are being subjected to drastic and arbitrary cuts in their opioid dosages, which are proving disastrous to their health. A physician of internal and addiction medicine at the University of Alabama in Birmingham Medical School, Kertesz has emerged as a key spokesperson for chronic pain patients resisting efforts to cut back on opioid prescribing.
- Jose A. Del Real, a New York Times journalist who has been writing remarkable stories about the epidemic from across the country, has another one this week from Eureka, California, “long celebrated as a gateway to the scenic Redwood Empire.” Heroin has joined methamphetamine as a scourge there in rural Humboldt County, where opioid overdoses are about five times the state average. The one good piece of news is that illicit fentanyl isn’t as common on the West Coast, and doesn’t mix well with the black tar heroin, which is prevalent there.
- The Wall Street Journal considers whether differences between Congress’ response to the opioid crisis (treating it primarily as a public health issue) and its response to the crack epidemic of the late 1980s and 1990s (treating primarily as a crime problem) was race-based. “In 2016, white victims made up almost 80 percent of the deaths from opioid overdoses,” the paper notes, “while in 2000, 84% of crack cocaine offenders were black.”
- USA Today has an editorial arguing that AG Jeff Sessions’ anti-medical marijuana stance appears to be backfiring.
- Gabapentin, a non-opioid, and one of the most commonly prescribed medications, is suddenly being misused in significant numbers, according to both the AP and Stateline, a news service of the Pew Charitable Trusts. It was involved in one third of Kentucky’s overdose deaths this year, according to Stateline. When used with heroin, it increases the risk of death, according to a study performed in England and Wales. Gabapentin is sold as Neurontin by Pfizer, and is related pregabalin, sold as Lyrica, also by Pfizer.
- Wal-Mart said it would limit initial opioid prescriptions for acute pain to seven days. Patrice Harris, who chairs the AMA’s opioids task force, has previously said she has she has “grave concerns” about any limits on dosage, according to The Hill.
- Despite the opioid crisis, Louisiana—facing a $648 million budget shortfall—may wipe out opioid addiction treatment programs affecting about 4,600 people, according to the Times-Picayune. A larger cut, that could eliminate all support for opioid addiction treatment, is also on the table.