Policy News Roundup: December 19, 2024

Overdose deaths continue record decline

The stats: Provisional data from the Centers for Disease Control and Prevention (CDC) estimates there were 94,112 overdose deaths in the year ending July 2024, a 16.9% decrease from the prior year.

• All states except Washington, Oregon, Nevada, Utah, Montana and Alaska saw decreases.

What’s being said:

• Senior Biden administration officials credited a combination of policies such as higher investment in preventing drug use among young people, making naloxone more accessible, getting more people into treatment early and disrupting the supply of illicit drugs and precursor chemicals.

The details: It is possible the government’s efforts to disrupt drug trafficking and provide improved prevention, harm reduction and treatment services are beginning to achieve their desired effect.

• The White House’s efforts to distribute naloxone have helped reverse 500,000 overdoses.
• The administration has been historically supportive of harm reduction, providing support for syringe exchange and drug checking equipment and looking the other way on supervised consumption sites.
• It has overhauled methadone regulations, eliminated the buprenorphine waiver requirement and expanded access to treatment via telehealth.

But:

• Other potential reasons for the decline include a change in the drug supply and a shift toward more cautious drug use behavior based on years of experience with fentanyl.
• Progress could be threatened by the reemergence of carfentanil, which is 100 times more powerful than fentanyl. A CDC study found that overdose deaths with carfentanil remain rare but increased approximately 7-fold from January-June 2023 to January-June 2024.

The larger context: The decrease is the largest in history, but the death toll remains high and disparities persist.

• The ~94,000 deaths is nearly 40% more than when deaths began rising in Jan. 2019 and about the same as it was in Jan. 2021, when Biden took office.

Source: White House takes credit for a big drop in fatal overdoses (Politico); Biden officials take credit for ‘largest drop’ in overdose deaths. Experts are more cautious (STAT); Future Threats (Politico)

President Biden is commuting the sentences of roughly 1,500 people who were released from prison and placed on home confinement during COVID and is pardoning 39 Americans convicted of nonviolent crimes.

Why it’s important: It is the largest single-day act of clemency in modern history. Those pardoned had been convicted of nonviolent crimes including drug offenses.

• Some likely would have received shorter sentences if they had been sentenced under current law and sentencing practices.
• Some of the individuals have gone on to work as addiction counselors, peer support specialists, recovery coaches and youth mentors, in the health care field and with youth, veterans, individuals experiencing homelessness, etc.
• Federal convictions make it difficult to secure housing, jobs, educational opportunities, benefits and health care.

Biden said: “As president, I have the great privilege of extending mercy to people who have demonstrated remorse and rehabilitation, restoring opportunity for Americans to participate in daily life and contribute to their communities, and taking steps to remove sentencing disparities for non-violent offenders, especially those convicted of drug offenses.”

Reminder: Biden had previously issued 122 commutations and 21 other pardons. He has also broadly pardoned those convicted (at the federal level) of use and simple possession of marijuana.

What’s coming: Biden said he would be taking more steps in the weeks ahead and would continue to review clemency petitions.

Source: Biden commutes roughly 1,500 sentences and pardons 39 people in biggest single-day act of clemency (Associated Press)

McKinsey has agreed to pay $650 million to resolve charges from the Department of Justice over advice it provided to Purdue on how to “turbocharge” sales of OxyContin.

The details: This resolves both civil and criminal charges, including conspiring to misbrand a drug and obstruction of justice.

• To resolve the criminal charges: McKinsey has agreed to pay a penalty of over $231 million, a forfeiture of over $93 million (reflecting all money it was paid by Purdue 2004-2019) and a payment of $2 million to the Virginia Medicaid Fraud Control Unit.
• Civil settlement agreement: McKinsey will pay over $323 million to resolve liability under the False Claims Act. The company provided advice to Purdue that caused the submission of false and fraudulent claims to federal health care programs for medically unnecessary prescriptions for OxyContin. It also failed to disclose to the Food and Drug Administration (FDA) conflicts of interest arising from its concurrent work for Purdue and the FDA.
• A former senior McKinsey partner, Martin Elling, agreed to plead guilty to obstructing justice by destroying records concerning McKinsey’s work for Purdue. He faces up to a year in prison.

What’s coming:

• McKinsey has agreed to implement a compliance program, including a system of policies and procedures to identify and assess high-risk client engagements. This will include new document retention procedures and training for all partners, officers and employees who provide advice to clients.
• Under a deferred prosecution agreement, unless the company commits additional wrongdoing linked to opioids, the other executives who led McKinsey during the years it helped drug companies boost opioid sales will not face criminal charges or trial.

What McKinsey is saying: McKinsey said in a statement that it was “deeply sorry” and that its work for opioid manufacturers “will always be a source of profound regret for our firm.” It said, “We should have appreciated the harm opioids were causing in our society and we should not have undertaken sales and marketing work for Purdue Pharma.”

Why it’s important:

• The case is the latest in a series aiming to hold companies accountable for their role in contributing to the opioid crisis by pushing addictive prescription opioids.
• The case marks the first time a management consulting firm has been held criminally responsible for advice it had given that resulted in a client committing a crime.

Reminder: McKinsey previously reached agreements totaling nearly $1 billion to settle state/local opioid lawsuits.

Source: Justice Department Announces Resolution of Criminal and Civil Investigations into McKinsey & Company’s Work with Purdue Pharma L.P.; Former McKinsey Senior Partner Charged with Obstruction of Justice (Department of Justice); Consulting firm McKinsey to pay $650 million to resolve US opioid charges (Reuters); McKinsey & Company to pay $650 million for role in opioid crisis (NPR)

The Food and Drug Administration (FDA) submitted a proposed rule to limit the amount of nicotine in cigarettes to the Office of Management and Budget (OMB) this week.

Why it’s important: The goal is to slash the nicotine to a level that would make cigarettes undesirable, helping people to quit smoking and reducing the number of young people becoming addicted.

But: OMB’s review of agency proposals can take months, suggesting it cannot get approved before the end of the administration.

The details: The draft proposal elicited more than 7,700 comments from the public, including industry, and the FDA has since refined the plan. But it remains unclear whether the proposal would also affect nicotine levels in cigars, hookahs or e-cigarettes.

What’s coming: Even if the FDA does receive clearance to advance the proposal, whether it can survive once president-elect Donald Trump takes office is unclear given the sustained opposition from the industry.

• The tobacco lobby was a significant donor to Trump’s campaign.
• Trump is known to personally oppose cigarette smoking but has not weighed in recently on agency issues like nicotine levels in cigarettes.

Source: F.D.A. Tries Last-Ditch Move to Slash Nicotine Levels in Cigarettes (The New York Times)

A New York Times investigation found that Acadia, the country’s largest chain of methadone clinics, has built its business in part through fraud and deception, failing to provide required services.

The details:

• Regulations require the clinics to provide counseling and other services, like drug testing, in addition to methadone. But Acadia often fails to provide that counseling. Instead, employees at times falsify the medical records that Acadia uses to bill insurers.
• Acadia’s business is built on volume. Its counselors carry caseloads that are sometimes more than double the limit set by state regulators.
• Clinic directors can get bonuses when their patient enrollment goes up. This has created an incentive to treat people who do not have opioid use disorder, even though regulations require patients to meet medical criteria for opioid addiction to be eligible for treatment at a methadone clinic.

The larger context: Acadia’s methadone clinics have come under investigation for other issues, including overbilling Medicaid for urine tests and hiring counselors without proper credentials.

• The company also runs psychiatric hospitals, which have been found to be holding patients against their will to maximize insurance payments.

Why it’s important:

• People with opioid use disorder need access to quality treatment. Insufficient or low-quality treatment can be deadly with a potent drug supply.
• Congress is considering a bill that would allow patients to access methadone at pharmacies, which would greatly expand access to care. But Acadia is fighting the legislation, arguing that providing methadone without counseling could lead to more overdose deaths, even as it fails to provide those counseling services.

What’s coming: Sen. Markey (D-MA) wrote a letter to Acadia Healthcare, raising concerns regarding the company’s profit motivations and the impact on the quality and safety of, and access to, behavioral health care.

Source: Fraud and Fakery at the Country’s Largest Chain of Methadone Clinics (The New York Times)

According to a STAT examination of Robert F. Kennedy Jr.’s past statements on drug use and his own recovery, a documentary he made on addiction (“Recovery America”) and interviews with advocates he spent time with during filming, his philosophy toward addiction policy is ideologically flexible.

Why it’s important:

• As nominee to lead the Department of Health and Human Services (HHS), Kennedy’s beliefs carry immense implications for the response to the overdose crisis. HHS controls key funding streams for addiction treatment and prevention and oversees key sub-agencies focused on addiction, like the Substance Abuse and Mental Health Services Administration (SAMHSA) and the National Institute on Drug Abuse (NIDA).
• Appointing an individual with a known history of addiction to a cabinet post is a powerful symbol of inclusion (he would be one of the highest-ranking officials in history openly in long-term recovery), but personal experience can be a “double-edged sword,” bringing compassion and empathy but also policy based on personal experience at the expense of science/evidence.

Kennedy’s ideology:

• As a presidential candidate, Kennedy cast the addiction and opioid crisis as a symbol of the nation’s broader ills.
• Kennedy has said that what America is doing has not worked. He has expressed open-mindedness about which policies might be most effective at reducing overdose rates, but his main wish is for government to take a back seat.
• Kennedy notes that not every approach will work for every person, and those who have spoken with Kennedy credit him with being driven largely by what is most effective.

But: He has pitched a nationwide system of “healing farms,” espoused the virtues of 12-step recovery like Alcoholics Anonymous and advocated “tough love” for people battling addiction.

The details:

• Harm Reduction: This is likely to be a central debate, given the Biden administration’s historic support for harm reduction. Kennedy has indicated he is less likely to support it, noting we need “common sense solutions not ‘harm reduction.’” Kennedy has expressed admiration for Amsterdam’s drug crisis response decades ago, which included prescription heroin, and at one point suggested he was open to supervised consumption. But he has effectively argued for the opposite approach, advocating for allowing people to “hit bottom.” Some in Kennedy’s orbit warn harm reduction can go too far.
• Law Enforcement: To the extent government is involved, Kennedy believes police must play a larger role in the response and intends to use law enforcement and the threat of incarceration as a cudgel to force people into treatment.
• Treatment: Since his own recovery began, Kennedy has espoused the virtues of 12-step recovery, and he believes people are best positioned for recovery if they undergo “profound spiritual realignment.” The biggest unknown is Kennedy’s view on medications for opioid use disorder, which remain highly stigmatized, particularly in 12-step recovery circles.
• Healing Farms: This could become Kennedy’s marquee proposal, despite evidence demonstrating such programs are ineffective. He has proposed building hundreds of “wellness farms” where people with addiction could go to “reconnect to America’s soil,” “learn the discipline of hard work,” and receive job/technical training. He has proposed funding them via a tax on legalized marijuana. The proposal reflects Kennedy’s broader view that addiction is at least as much spiritual as physiological.
• Marijuana/Psychedelics: Kennedy’s support for proposals to legalize and tax marijuana and to use psychedelics for therapeutic purposes is unprecedented for a health secretary in a Republican administration.

Source: ‘Tough love’: How RFK Jr.’s views on addiction could bring a new era of U.S. drug policy (STAT)