Dried psilocybe cubensis psilocybin magic mushrooms inside a plastic prescription medicine bottle isolated on white background.

As Cities Decriminalize Psychedelics, Law Enforcement Should Step Back

By Mason Marks

Amid rising rates of depression, suicide, and substance use disorders, drug makers have scaled back investment in mental health research. Psychedelics may fill the growing need for innovative psychiatric drugs, but federal prohibition prevents people from accessing their benefits. Nevertheless, some cities, dissatisfied with the U.S. war on drugs, are decriminalizing psychedelics.

In 2019, Denver became the first U.S. city to decriminalize mushrooms containing psilocybin, a psychedelic the FDA considers a breakthrough therapy for major depressive disorder (MDD) and treatment-resistant depression.

In a historic vote, Denver residents approved Ordinance 301, which made prosecuting adults who possess psilocybin-containing mushrooms for personal use the city’s “lowest law enforcement priority.” Since then, in Oakland and Santa Cruz, California, voters approved their own decriminalization measures.

As a Schedule I controlled substance, psilocybin remains illegal under federal law, and despite ongoing clinical trials, it is unlikely to become FDA approved for several years. Social distancing requirements due to COVID-19 are disrupting medical research causing further delays. But as the November election approaches, other U.S. cities prepare to vote on psychedelics.

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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from the cost of delayed generic entry in Medicaid, to challenges with false negative tests for SARS-CoV-2 infection, to difficulties in implementing and enforcing state opioid prescribing laws. A full posting of abstracts/summaries of these articles may be found on our website.

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Close up of the Lady of Justice statue

The Privatization of Opioid Litigation

By Dan Aaron

As the opioid litigation continues over the shadow of one of our nation’s most pressing public health crises, some criticism has been levied at private lawyers representing the cities, counties, states, and individuals harmed by the crisis. For example, see the following tweet:

Let’s work out tax and healthcare financing policy county by county, with private lawyers taking a 25% cut every time. Judge Polster seems to like this idea.

The critiques are many, but can be summarized: (1) private lawyers are being enriched; (2) private lawyers are setting opioid policy; (3) private lawyers have misaligned incentives; and (4) private lawyers will not support public health.

Arguably, all these arguments bear some truth. However, do they suggest that the opioid litigation is incorrigibly tainted and tort litigation the improper avenue to address mass torts such as the opioid crisis?

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Pregnant woman sitting across desk from doctor wearing scrubs and holding a pen

Opioid Claims for Fetal Opioid Exposure Alarm Pregnancy Advocates

By Alexa Richardson

Lawyers calling themselves the “Opioid Justice Team” are pushing forward in their mission to certify babies exposed to opioids in utero, as well as “all women in the United States capable of becoming pregnant,” as distinct classes in the multi-district opioid litigation now unfolding in federal court in Ohio. Last week, lawyers filed an amended complaint on behalf of the legal guardians of individuals diagnosed with neonatal abstinence syndrome (NAS), and a list of “experts” with the court. Their claims misrepresent the science regarding fetal exposure to opioids and position fetal rights in opposition to those of pregnant people. National Advocates for Pregnant Women (NAPW) has issued a statement and fact sheet denouncing the claims.

In a series of court filings, sweeping claims about the impact of prescription opioid exposure on fetuses are being made. The lawyers falsely claim “[a]nything a pregnant woman ingests or breathes is transmitted to her baby by the placenta” and that “[i]n-utero opioid exposure leaves most children with physical, social, educational disabilities that require constant and regular interventions. Most of these disabilities are considered permanent.” In actuality, the American College of Obstetricians and Gynecologists states that the available data show “no significant differences” in long-term outcomes for individuals exposed to opioids in utero versus those who are not. The Centers for Disease Control (CDC) finds there may be early childhood impacts on cognitive or developmental abilities from prenatal opioid exposure. However, available studies struggle to separate the physical effects from environmental and social variables. There is not enough data to conclude whether any long-term consequences of fetal opioid exposure exist, the CDC finds.

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Ohio state flags waving in front of the Ohio State House

Ohio’s Efforts to Centralize Control Over Opioid Claims

By Daniel Aaron

On October 21, two Ohio counties are slated to present their opioid claims in a federal trial. However, last week, 13 states and the District of Columbia signed onto a brief requesting that the 6th Circuit Court of Appeals stay the upcoming trials. Their reasoning? States should control lawsuits for harms within the state; cities and counties do not have authority to sue on their own. While it makes sense that Ohio’s attorney general, spearheading this effort, would want more power and control over opioid claims, the move has the potential to harm public health by disempowering local governments from addressing public health crises. Ohio’s three main arguments will be discussed in turn.

Argument 1: Violation of State Sovereignty

First, Ohio argues that the county lawsuits violate state sovereignty and disrupt the “federal dual-sovereign structure” of the United States:

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swarm of media and tv cameras

The Hidden Cost of Misinformation: Harms from Opioid Hysteria Extend Beyond Overdose Deaths

Fentanyl is a potent opioid analgesic and has been the center of the opioid and overdose epidemic. As an illicit agent, fentanyl is often in the form of a powder, which is then either insufflated (the fancy medical term for snorting) or dissolved in water and injected intravenously. It is fifty to one-hundred times more potent than heroin, the drug it replaced as the illicit opioid of choice. It can cause significant euphoria and analgesia, which is why it is so widely used. It can also cause respiratory depression or complete respiratory arrest, the reason it can be so deadly. It is readily absorbed when insufflated or injected and the actions are almost immediate. These are the facts.

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Close up on a pile of yellow pain pills

Addressing the Opioid Epidemic Starts with How We Treat Pain

As a nurse practitioner in a busy suburban emergency department, pain is my job. Pain is one of the most common reasons people come to an emergency department (ED). It could be abdominal pain, chest pain, back pain or even emotional pain, including depression or suicidal ideations. Pain is a driver for people seeking medical care. We have made pain into a vital sign, and we ask, “How would you rate your pain on a scale of 1 to 10?” a mandatory question for any patient who steps through our door.

This whole concept evolved circa 1987 when the Institute of Medicine urged healthcare providers to use a quantified measure for pain. It gained even more traction in 1990 when then president of the American Pain Society, Dr. Mitchell Max, called for improved means to assess and treat pain. The term “oligoanalgesia” gained popularity in the published literature, meaning that we weren’t giving enough pain medication to patients in the ED, in clinics or in any other healthcare setting. Healthcare providers responded. We asked about and we thought, more effectively treated pain to address this issue.

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Medical team in an emergency room

The Emergency Department is The “New” Frontier of Public Health

I had always considered my field of expertise to be emergency medicine. I worked through the ranks as an emergency medical technician, then onward as a paramedic, which included a nine-year stint on a busy medical helicopter. I worked in disaster medicine, and was the associate director of a Harvard-affiliated disaster medicine fellowship in Boston. My current practice is as a nurse practitioner in a busy suburban emergency department (ED) and I am still active in emergency medical services as a SWAT medic and as an educator.

The emergency part of what I do is the exciting part —the part that stimulates the excitatory neurotransmitters that flood the brain, preparing it to act quickly and concisely.

We are selling ourselves short, however, when we label this role as “emergency” providers. Instead, “public health provider” is a much more appropriate term to use, because emergency departments and those who provide care there are really public health workers.

All of us who practice in emergency medicine know that real emergencies are few and far between. Our day-to-day is much more mundane. We deal with many urgent issues as well as some less urgent, primary care problems. We may even spend time filling printer paper or bringing a patient their lunch. We may help to find someone a homeless shelter, send a family home with warm coats for the kids, or pack up a bag with food and toiletries for a young girl we feel is being trafficked.

In light of all this, the purpose and the policies of the emergency department need to be redefined. Read More

person wearing gloves holding HIV test

Southern Indiana’s HIV Outbreak: A Lesson on the Importance of Incentivizing HIV Testing

By 2015, major news outlets were reporting on what the CDC was calling “one of the worst documented outbreaks of HIV among IV users in the past two decades.” Between 2011 and 2015 over 200 people in southern Indiana’s Scott County acquired HIV. The primary source of the spread was the sharing of needles to inject opioid drugs. While the outbreak has now been contained, there linger many lessons to be learned from the tragedy that struck this small rural county in southeast Indiana.

Some of those lessons are about the havoc being wreaked on much of rural America by opioid abuse. But the lessons I’m focusing on here are the dangers of disincentivizing HIV testing, especially among high-risk populations like injection drug users. Read More