How and Where to Comment on Marijuana Rescheduling

By Pat Anson, PNN Editor

The U.S. public is finally getting a chance to comment on the federal government’s historic decision to reclassify marijuana from a Schedule I substance to a less restrictive Schedule III.

After months of foot dragging, the Justice Department published a notice in the Federal Register today giving the public 60 days to comment on the proposed rescheduling. Written comments must be submitted or postmarked on or before July 22. Online comments can be made here.

Every step in this process has been fraught with delays. And there may be more.

The Food and Drug Administration completed a review last August – nearly a year after it was requested by President Biden -- finding “credible scientific support” for marijuana’s rescheduling. But the FDA report was not made public until January, after a lawsuit was filed by two pro-cannabis lawyers seeking its release when the agency didn’t respond to repeated requests under the Freedom of Information Act (FOIA).

Another five months passed before the Justice Department, which oversees the Drug Enforcement Administration, submitted to the Federal Register a notice about the proposed rescheduling. Since the DEA is charged with enforcing the Controlled Substances Act (CSA) and determines how drugs are scheduled, public notices involving the CSA are almost always signed by the DEA administrator.

This one, however, is signed by Attorney General Merrick Garland, not DEA Administrator Anne Milgram – a sign that her agency is not completely on board with marijuana’s rescheduling.

“DEA has not yet made a determination as to its views of the appropriate schedule for marijuana,” Garland wrote. “The CSA vests the Attorney General with the authority to schedule, reschedule, or decontrol drugs… The Attorney General has delegated that authority to the DEA Administrator, but also retains the authority to schedule drugs under the CSA in the first instance.”

According to an Associated Press report, Milgram told her staff in March that marijuana’s rescheduling “had been taken over” by Garland and the DOJ. The DEA had asked for additional time for studies to determine whether marijuana has an accepted medical use, a request that was rejected.

Former DEA Administrator Tim Shea believes the rescheduling process was hijacked by DOJ for political reasons.

“If she (Milgram) had supported it she would have signed it and sent it in,” Shea told the AP. “DEA was opposed to this and the politics entered and overruled them. It’s demoralizing. Everybody from the agents in the streets to the leadership in DEA knows the dangers this brings.”   

Asked recently during a congressional hearing what her views are on marijuana. Milgram ducked the question.

“Since DEA is ultimately the decider of scheduling and rescheduling, and the DEA administrator is in that role, it would be inappropriate for me to make comments about this process or parts of that process,” Milgram said.

What Will Rescheduling Mean?

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – may be historic, but it’s not the full “legalization” that many cannabis supporters have been calling for.  

Under the CSA, legal access to Schedule III substances requires a prescription from a licensed doctor that is filled at a licensed pharmacy. Any new medical marijuana products would also have to go through a lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would likely only be approved by FDA for certain conditions.  

Garland’s notice in the Federal Register is largely based on the FDA’s 2023 review, which states there is good evidence that marijuana is helpful in treating chronic pain and mixed evidence it could be useful in relieving nausea, anxiety, epilepsy and PTSD.

“FDA’s review of the available information identified mixed findings of effectiveness across indications, ranging from data showing inconclusive findings to considerable evidence in favor of effectiveness, depending on the source. The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain). Numerous systematic reviews concluded that there exists some level of evidence supporting the use of marijuana for chronic pain,” Garland wrote.

As for marijuana’s potential for abuse, Garland cited findings that marijuana poses less of a health risk than most illicit drugs and even some legal medications such as oxycodone and benzodiazepines.

“The rank order of the comparators in terms of greatest adverse consequences typically ranked heroin, benzodiazepines, and cocaine first or in immediately subsequent positions, with marijuana in a lower place in the ranking,” Garland wrote.

“For overdose deaths, marijuana is always in the lowest ranking among comparator drugs. These evaluations demonstrate that there is consistency across databases, across substances, and over time. HHS thus concluded that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The opening of a public comment period does not mark the end of the rescheduling process. The DEA/DOJ will need time to evaluate and review the comments, which will be followed by an administrative hearing and a final ruling that is subject to presidential review. Even then, the final rule has to be published in the Federal Register, followed by a 30 or 60-day wait period before the rule takes effect. 

During that process, and until a final rule is published, marijuana remains a schedule I controlled substance that is illegal under federal law. About three-quarters of states have already legalized marijuana for medical or recreational purposes.

Support for Spouse with Chronic Pain Is Helpful, But Not Always Welcome

By Pat Anson, PNN Editor

Support from a spouse or romantic partner with chronic pain can lead to fewer symptoms of depression and more positive moods, according to new study. But some people in pain have poor psychological health regardless of the support they receive.     

A Penn State research team conducted a series of interviews with 152 long-term couples over the age of 50 in which one of the partners had knee pain from osteoarthritis.

Nearly 40% of middle-aged Americans have knee osteoarthritis, a progressive and painful joint disorder that causes thinning of cartilage and joint damage. The condition is strongly associated with early death, high blood pressure, diabetes and cardiovascular disease, particularly in women.

“Osteoarthritis in the knee can be a challenging condition,” lead author Suyoung Nah, PhD, said in a press release “People with the condition will eventually need support managing their pain. What is more, they are likely to continue needing assistance managing their pain for the rest of their lives.”

Nah and her colleagues asked each couple about the pain management support they received from a spouse or partner, such as assistance in taking pain medication or help standing up.

Most participants who received good support felt loved and grateful, and had fewer depressive symptoms; while those who felt a lack of support had more negative moods and were more likely to be depressed.

A small group of respondents reported feeling angry or resentful — even when they received good support from a partner.

“Almost everyone has times in their life when they do not want to accept help because it makes them feel helpless or because they think they do not need it,” said co-author Lynn Martire, PhD, a Professor of Human Development and Family Studies at Penn State’s Center for Healthy Aging.

Researchers wanted to see if people’s perceptions of the support they receive changed over time, so 18 months later they surveyed the same couples again. Those who felt anger or resentment at the start of the study – regardless of the support they received -- continued having negative moods.

That finding demonstrates the need for good communication between couples when one partner has chronic pain. Providing support – and accepting it -- can be complicated in those relationships.

“Receiving care is not always beneficial to every aspect of a person’s life,” said Nah, who is currently a Postdoctoral Fellow at the Virginia Tech Center for Gerontology. “Additionally, it may be difficult for couples to discuss and negotiate care. As a society, we need to make sure that older people understand their partner’s needs and desires regarding care so that both partners can maximize their physical, emotional and relational quality of life.”

Previous research by Martire found that couples typically don’t have conversations about the type of support that is wanted or needed. Clear communication about expectations and feelings can improve the quality of life for a partner who needs care.

“My main interest is in late-life family relationships — especially couples — navigating chronic illness,” Martire said. “Most older adults have at least two or three chronic illnesses, so helping them find better ways to help each other is really important.”

The study was published in Journal of Aging and Health.

A 2017 study found that criticism from a spouse can make chronic back pain worse. People with back pain who felt they were criticized had more anxiety, anger and sadness, and their pain levels increased for as long as three hours. The study also found that when a partner was supportive – expressing concern about a spouse’s pain or giving “helpful” suggestions – the interaction was still perceived as negative by some pain sufferers.

Millions Lose Medicaid Benefits, Including Disabled

By Daniel Chang, KFF Health News

Jacqueline Saa has a progressive genetic condition called Ehlers-Danlos syndrome that leaves her unable to stand, walk on her own, or hold a job.

Every weekday for four years, Saa, 43, has relied on a home health aide to help her cook, bathe and dress, go to the doctor, pick up medications, and accomplish other daily tasks. She received coverage through Florida’s Medicaid program, until it abruptly stopped at the end of March.

“Every day the anxiety builds,” said Saa, who lost her home health aide for 11 days, starting April 1, despite being eligible.

The state has since restored Saa’s home health aide service, but during the gap she leaned on her mother and her 23- and 15-year-old daughters, while struggling to regain her Medicaid benefits.

“It’s just so much to worry about,” she said. “This is a health care system that’s supposed to help.”

Medicaid’s home and community-based services are designed to help people like Saa, who have disabilities and need help with everyday activities, stay out of a nursing facility

JACQUELINE SAA

But people are losing benefits with little or no notice, getting bad advice when they call for information, and facing major disruptions in care while they wait for the issue to get sorted out, according to attorneys and advocates who are hearing from patients.

In Colorado, Texas, and Washington, D.C., the National Health Law Program, a nonprofit that advocates for low-income and underserved people, has filed civil rights complaints with two federal agencies alleging discrimination against people with disabilities. The group has not filed a lawsuit in Florida, though its attorneys say they’ve heard of many of the same problems there.

Attorneys nationwide say the special needs of disabled people were not prioritized as states began to review eligibility for Medicaid enrollees after a pandemic-era mandate for coverage expired in March 2023.

“Instead of monitoring and ensuring that people with disabilities could make their way through the process, they sort of treated them like everyone else with Medicaid,” said Elizabeth Edwards, a senior attorney for the National Health Law Program. Federal law puts an “obligation on states to make sure people with disabilities don’t get missed.”

At least 21 million people nationwide have been disenrolled from Medicaid since states began eligibility redeterminations in spring 2023, according to a KFF analysis.

The unwinding, as it’s known, is an immense undertaking, Edwards said, and some states did not take extra steps to set up a special telephone line for those with disabilities, for example, so people could renew their coverage or contact a case manager.

As states prepared for the unwinding, the Centers for Medicare & Medicaid Services, the federal agency that regulates Medicaid, advised states that they must give people with disabilities the help they need to benefit from the program, including specialized communications for people who are deaf or blind.

The Florida Department of Children and Families, which verifies eligibility for the state’s Medicaid program, has a specialized team that processes applications for home health services, said Mallory McManus, the department’s communications director.

People with disabilities disenrolled from Medicaid services were “properly noticed and either did not respond timely or no longer met financial eligibility requirements,” McManus said, noting that people “would have been contacted by us up to 13 times via phone, mail, email, and text before processing their disenrollment.”

Benefits Cut Without a Call

Allison Pellegrin of Ormond Beach, Florida, who lives with her sister Rhea Whitaker, who is blind and cognitively disabled, said that never happened for her family.

“They just cut off the benefits without a call, without a letter or anything stating that the benefits would be terminating,” Pellegrin said.

Her sister’s home health aide, whom she had used every day for nearly eight years, stopped service for 12 days.

“If I’m getting everything else in the mail,” she said, “it seems weird that after 13 times I wouldn’t have received one of them.”

Pellegrin, 58, a sales manager who gets health insurance through her employer, took time off from work to care for Whitaker, 56, who was disabled by a severe brain injury in 2006.

Medicaid reviews have been complicated, in part, by the fact that eligibility works differently for home health services than for general coverage, based on federal regulations that give states more flexibility to determine financial eligibility. Income limits for home health services are higher, for instance, and assets are counted differently.

RHEA WHITAKER

In Texas, a parent in a household of three would be limited to earning no more than $344 a month to qualify for Medicaid. And most adults with a disability can qualify without a dependent child and be eligible for Medicaid home health services with an income of up to $2,800 a month.

The state was not taking that into consideration, said Terry Anstee, a supervising attorney for community integration at Disability Rights Texas, a nonprofit advocacy group.

Even a brief lapse in Medicaid home health services can fracture relationships that took years to build.

“It may be very difficult for that person who lost that attendant to find another attendant,” Anstee said, because of workforce shortages for attendants and nurses and high demand.

Nearly all states have a waiting list for home health services. About 700,000 people were on waiting lists in 2023, most of them with intellectual and developmental disabilities, according to KFF data.

Daniel Tsai, a deputy administrator at CMS, said the agency is committed to ensuring that people with disabilities receiving home health services “can renew their Medicaid coverage with as little red tape as possible.”

CMS finalized a rule this year for states to monitor Medicaid home health services. For example, CMS will now track how long it takes for people who need home health care to receive the services and will require states to track how long people are on waitlists.

Staff turnover and vacancies at local Medicaid agencies have contributed to backlogs, according to complaints filed with two federal agencies focused on civil rights.

The District of Columbia’s Medicaid agency requires that case managers help people with disabilities complete renewals. However, a complaint says, case managers are the only ones who can help enrollees complete eligibility reviews and, sometimes, they don’t do their jobs.

Advocates for Medicaid enrollees have also complained to the Federal Trade Commission about faulty eligibility systems developed by Deloitte, a global consulting firm that contracts with about two dozen states to design, implement, or operate automated benefits systems.

KFF Health News found that multiple audits of Colorado’s eligibility system, managed by Deloitte, uncovered errors in notices sent to enrollees. A 2023 review by the Colorado Office of the State Auditor found that 90% of sampled notices contained problems, some of which violate the state’s Medicaid rules. The audit blamed “flaws in system design” for populating notices with incorrect dates.

Deloitte declined to comment on specific state issues.

In March, Colorado officials paused disenrollment for people on Medicaid who received home health services, which includes people with disabilities, after a “system update” led to wrongful terminations in February.

Another common problem is people being told to reapply, which immediately cuts off their benefits, instead of appealing the cancellation, which would ensure their coverage while the claim is investigated, said attorney Miriam Harmatz, founder of the Florida Health Justice Project.

“What they’re being advised to do is not appropriate. The best way to protect their legal rights,” Harmatz said, “is to file an appeal.”

‘So Many People Are Calling’

But some disabled people are worried about having to repay the cost of their care. Saa, who lives in Davie, Florida, received a letter shortly before her benefits were cut that said she “may be responsible to repay any benefits” if she lost her appeal.

The state should presume such people are still eligible and preserve their coverage, Harmatz said, because income and assets for most beneficiaries are not going to increase significantly and their conditions are not likely to improve.

The Florida Department of Children and Families would not say how many people with disabilities had lost Medicaid home health services.

But in Miami-Dade, Florida’s most populous county, the Alliance for Aging, a nonprofit that helps older and disabled people apply for Medicaid, saw requests for help jump from 58 in March to 146 in April, said Lisa Mele, the organization’s director of its Aging and Disability Resources Center.

“So many people are calling us,” she said.

States are not tracking the numbers, so “the impact is not clear,” Edwards said. “It’s a really complicated struggle.”

Saa filed an appeal March 29 after learning from her social worker that her benefits would expire at the end of the month. She went to the agency but couldn’t stand in a line that was 100 people deep. Calls to the state’s Medicaid eligibility review agency were fruitless, she said.

“When they finally connected me to a customer service representative, she was literally just reading the same explanation letter that I’ve read,” Saa said. “I did everything in my power.”

Saa canceled her home health aide. She lives on limited Social Security disability income and said she could not afford to pay for the care.

On April 10, she received a letter from the state saying her Medicaid had been reinstated, but she later learned that her plan did not cover home health care.

The following day, Saa said, advocates put her in touch with a point person at Florida’s Medicaid agency who restored her benefits. A home health aide showed up April 12. Saa said she’s thankful but feels anxious about the future.

“The toughest part of that period is knowing that that can happen at any time,” she said, “and not because of anything I did wrong.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Non-Opioid Analgesic Gets Another Poor Grade for Pain Relief

By Pat Anson, PNN Editor

An expensive analgesic drug that’s often touted as a safer alternative to opioids is not reliable or effective as a pain reliever, according to a new study.

Exparel is an injectable form of liposomal bupivacaine, a non-opioid local anesthetic used for post-operative pain and as a nerve block to numb parts of the body during surgery.

Because Exparel is a proprietary formulation of bupivacaine, Pacira BioSciences has priced it 10 times higher than generic bupivacaine. A 20 milliliter vial of Exparel costs about $376, compared to $38 for a same size vial of bupivacaine.

Some anesthesiologists have questioned whether Exparel is actually worth the higher cost, saying its effectiveness in relieving post-operative pain is “clinically unimportant” and no different than other local anesthetics.  

To see if they might be right, researchers at the Medical University of Vienna recruited 25 healthy volunteers for a blinded clinical study in which participants received two nerve blocks about a month apart, one with plain bupivacaine for pain control and the other with liposomal bupivacaine (Exparel).

"Since the combination of both forms of bupivacaine is recommended, little was known about the effectiveness of the use of liposomal bupivacaine alone in pain therapy during and immediately after surgery," wrote lead author Peter Marhofer, MD, a Professor of Anesthesia and Intensive Care Medicine at MedUni Vienna.

The study findings, recently published in the journal Anesthesiology, show that Exparel alone blocked pain in less than a third of the volunteers, compared to everyone who received plain bupivacaine.

“Given complete sensory blockade in merely 32% of cases, as compared to 100% with plain bupivacaine, liposomal bupivacaine does not emerge from our study as a suitable ‘sole’ local anesthetic for intraoperative regional anesthesia,” said Marhofer.

Those who did get pain relief from Exparel say it reduced their post-operative pain for up to 3.5 days. But because its effects varied widely from subject to subject, researchers don’t consider it a reliable analgesic when used alone.

"Our study showed unpredictable effects of liposomal bupivacaine in terms of nerve block and associated pain relief. Based on our findings, the substance cannot currently be recommended for use in pain therapy during and after surgery," said co-author Markus Zeitlinger, MD, an Associate Professor of Clinical Pharmacology at MedUni Vienna.

Pacira did not respond to a request from PNN for comment on the study. In the past, the company has aggressively promoted Exparel and used hardball tactics to silence critics.

In 2021, Pacira filed a lawsuit against the American Society of Anesthesiologists for publishing “false and misleading conclusions” in the journal Anesthesiology that said Exparel worked no better than other bupivacaine products. The lawsuit was later dropped.

In 2014, Pacira took the unusual step of filing a lawsuit against the FDA, after the agency sent a warning letter to Pacira for off-label marketing of Exparel. Pacira won that case in an out-of-court settlement when the FDA withdrew its warning letter and approved the use of Exparel for more types of post-operative pain.

Over the years, Pacira has paid nearly $34 million to doctors to help promote Exparel, according to Open Payments. That strategy backfired In 2020, when Pacira paid $3.5 million to settle allegations that it gave kickbacks to doctors in the form of fake research grants.

Pacira has also been active politically, spending over $3 million on lobbying and campaign donations since 2018, according to OpenSecrets. In 2019, the company hired former New Jersey governor Chris Christie as a consultant for $800,000 and lucrative stock options. Christie had recently chaired President Trump’s opioid commission, which issued a report recommending that hospitals use more non-opioid pain relievers.

Pacira is also bankrolling Voices for Non-Opioid Choices, an advocacy group that is lobbying the Biden administration for early implementation of the NOPAIN Act. Passed by Congress in late 2022, the law requires Medicare and Medicaid to pay for Exparel and other non-opioid treatments in outpatient surgical settings, starting in 2025. Supporters of the bill want the timetable moved up to 2024, which would generate millions of dollars in additional revenue for Pacira. 

Fatal Overdoses Show First Decline in 5 Years

By Pat Anson, PNN Editor

There’s good and bad news in the latest report on the overdose crisis in the United States.

Preliminary data released by the CDC show that there were an estimated 107,543 drug deaths in 2023, a 3.1% decline from 2022 and the first annual drop since 2018. The rate of confirmed overdoses fell even more -- by 5.1 percent – a number subject to change as lagging data and toxicology reports come in.

“We are encouraged to see the preliminary data that shows a decrease in the overdose death rate for the first time in five years, especially following the period of rapid double-digit increases from 2019-2021,” said White House Drug Control Policy director Dr. Rahul Gupta, in a statement.

That’s the good news.

The bad news is that drug deaths kept rising in several western states, with Alaska (+44%), Nevada (+29%), Oregon (+30%) and Washington (+28%) showing substantial increases.

In contrast, overdoses declined in the East and Midwest, with significant decreases in Nebraska (-25%), Indiana (-18%), Kansas (-16%) and Maine (-16%).

The report did not offer any explanation for the wide variation between states and regions.

Percent Change in Drug Overdose Deaths 2022-2023

SOURCE: nchs

The National Center for Health Statistics (NCHS) said over 74,000 deaths last year involved fentanyl – most of it illicit – and more than 36,000 deaths were attributed to methamphetamine.

Most overdose deaths involve multiple drugs, according to the NCHS, so “a single death might be included in more than one category” and be counted multiple times.

Although the numbers remain somewhat unreliable, this report and others suggest that fentanyl and other illicit drugs play a far greater role in the nation’s drug crisis than prescription opioids.

A study published this week in the International Journal of Drug Policy reported that law enforcement seized a record 115 million counterfeit pills containing fentanyl last year. That compares to only 4 million prescription opioid pills that were reported lost or stolen by the DEA in 2023.   

Fake Pills Containing Fentanyl Seized by Law Enforcement

International Journal of Drug Policy

“Availability of illicit fentanyl is continuing to skyrocket in the U.S., and the influx of fentanyl-containing pills is particularly alarming,” wrote lead author Joseph Palamar, PhD, an Associate Professor in the Department of Population Health at the NYU Grossman School of Medicine.

“Both the number and size of drug seizures containing fentanyl have increased in the US between 2017 and 2023, with the majority of seizures –– particularly in pill form –– occurring in the West.”

Prescription opioids are mentioned only a handful of times in the DEA’s recent National Drug Threat Assessment, mainly within the context of their theft and diversion falling to the lowest levels in 12 years. That report also warns that counterfeit pills are increasingly being found with xylazine, a potent animal tranquilizer, and nitazenes, a synthetic opioid that is 40 times stronger than fentanyl  

CDC Could Be ‘Dismantled’ in Second Trump Term

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention is “the most incompetent and arrogant agency in the federal government,” not qualified to offer medical advice to patients, and its ability to set public health policy should be “severely confined.”  

Those are some of recommendations being made by The Heritage Foundation, a conservative think tank that seeks a major overhaul of the federal government if a Republican president – presumably Donald Trump – is sworn into office next year.

The agenda for Project 2025 is outlined in “Mandate for Leadership” – an 887-page book that advocates for many traditional conservative goals: smaller government, lower taxes, restrictive abortion laws, and an end to federal policies that promote equality and diversity.

We’re not going to get into those hot button issues, but will focus on how Mandate for Leadership would “dismantle the administration state” that governs healthcare in America.

That section of the book is written by Roger Severino, the former director of the Office for Civil Rights at the Department of Health and Human Services (HHS) during the first Trump administration.   

To begin, it’s pretty clear that the CDC has a target on its back, largely due to how the agency responded to the COVID-19 pandemic by shutting down much of the country in a bid to control the virus.    

“COVID-19 exposed the Centers for Disease Control and Prevention (CDC) as perhaps the most incompetent and arrogant agency in the federal government. CDC continually misjudged COVID-19, from its lethality, transmissibility, and origins to treatments,” wrote Severino.

“Unaccountable bureaucrats like Anthony Fauci should never again have such broad, unchecked power to issue health ‘guidelines’ that will certainly be the basis for federal and state mandates. Never again should public health bureaucrats be allowed to hide information, ignore information, or mislead the public concerning the efficacy or dangers associated with any recommended health interventions.”

Substitute “Tom Frieden” for “Anthony Fauci” and that paragraph would nicely sum up how many pain patients and doctors feel about the former CDC director and the 2016 CDC opioid guideline. Drafted in secret under Frieden’s leadership, the agency’s guideline development process likely violated federal open meeting and conflict-of-interest laws, while hiding behind an almost comical “Cone of Silence.”

Although its recommendations are voluntary, the opioid guideline was quickly adopted as a mandatory policy by many states, regulators and law enforcement – resulting in hundreds of doctors losing their medical licenses or going to prison for “overprescribing” opioids.

Severino, an attorney who seems well-positioned for another key healthcare job if Trump is elected to a second term, says the CDC went far beyond its authority when it created medical guidelines.  

“Most problematically, the CDC presented itself as a kind of ‘super-doctor’ for the entire nation. The CDC is a public health institution, not a medical institution,” he wrote. “It is not qualified to offer professional medical opinions applicable to specific patients. We have learned that when CDC says what people ‘should’ do, it readily becomes a ‘must’ backed by severe punishments, including criminal penalties.

“CDC guidelines are analogous to guidelines from other public health associations or medical societies: They are informative, not prescriptive. By statute or regulation, CDC guidance must be prohibited from taking on a prescriptive character.”

Split in Two

How can the CDC be reined in? The answer, according to Severino, is to cut the CDC in half and slash much of its funding.

“The CDC should be split into two separate entities housing its two distinct functions,” he wrote. “These distinct functions should be separated into two entirely separate agencies with a firewall between them. We need a national epidemiological agency responsible only for publishing data and required by law to publish all of the data gathered from states and other sources. A separate agency should be responsible for public health with a severely confined ability to make policy recommendations.”

Frieden calls that proposal “very dangerous and very wrong.”

“We don’t split up the military because it’s too big. We don’t split up corporations because they’re too big,” Frieden told Politico. “Big organization needs a big management structure and also flexibility.”

Severino says the CDC Foundation, a not-for-profit organization that works closely with the agency in promoting health policy, should be prohibited from accepting contributions from the pharmaceutical industry. The foundation received nearly $275 million in donations last year, much of it coming from Pfizer, Biogen, Merck and other healthcare companies.  

“This practice presents a stark conflict of interest that should be banned,” wrote Severino. “The CDC and NIH Foundations, whose boards are populated with pharmaceutical company executives, need to be decommissioned. Private donations to these foundations — a majority of them from pharmaceutical companies— should not be permitted to influence government decisions about research funding or public health policy.”

Severino also wants stronger transparency and conflict of interest policies, not just at the CDC, but at HHS and all federal agencies involved in healthcare. He thinks a lengthy “cooling off period” should be adopted to prevent federal regulators from going into industries they helped regulate once their government jobs end. A 15-year cooling off period “would not be too long,” according to Severino.

To be clear, Mandate for Leadership is more of a wish list than anything else. It all hinges on the outcome of the 2024 presidential election. If it does become a playbook for a second Trump administration, some of its recommendations could be imposed by executive order, but many will require congressional approval. CDC directors, once directly appointed by the president, will need Senate confirmation next year under a new law, just as other cabinet members do.      

Whatever happens, it’s clear that conservative advocates are gunning for the CDC.

“The federal government’s public health apparatus has lost the public’s trust. Before the next national public health emergency, this apparatus must be fundamentally restructured,” Severino wrote.

Regulations Should Be Eased for Cannabis and Psilocybin

By Dr. Kevin Boehnke  

The U.S. Drug Enforcement Agency announced in late April 2024 that it plans to ease federal restrictions on cannabis, reclassifying it from a Schedule I drug to the less restricted Schedule III, which includes drugs such as Tylenol with codeine, testosterone and other anabolic steroids. This historic shift signals an acknowledgment of the promising medicinal value of cannabis.

The move comes in tandem with growing interest in the use of psilocybin, the active component in magic mushrooms, for treatment of depression, chronic pain and other conditions. In 2018 and 2019, the U.S. Food and Drug Administration granted a breakthrough therapy designation to psilocybin, meant to expedite drug development given that preliminary studies suggest it may have substantial therapeutic value over currently available therapies for treatment-resistant depression and major depressive disorder.

Both of these developments represent a dramatic change from long-standing federal policy around these substances that has historically criminalized their use and blocked or delayed research efforts into their therapeutic potential.

As an assistant professor of anesthesiology and a pain researcher, I study alternative pain management options, including cannabis and psychedelics.

I also have a personal stake in improving chronic pain treatment: In early 2009 I was diagnosed with fibromyalgia, a condition characterized by widespread pain throughout the body, sleep disturbances and generalized sensory sensitivity.

I have seen and experienced firsthand the ways that clinicians and patients talk about chronic pain medications, and find them to generally be disempowering to the patient, clinician, and drugs themselves. My goal in this article is to help provide a new and more useful lens to think about medications, especially given the poor treatment outcomes for people with chronic pain, the frustration providers express about treating these ‘challenging patients,’ and the ongoing opioid overdose crisis.

I see cannabis and psilocybin as promising therapies that can contribute to bridging that need. Given that an estimated 50 million Americans have chronic pain – meaning pain that persists for three months or more – I want to help understand how to effectively use cannabis and psilocybin as potential tools for pain management.

Cannabis History

Cannabis, also known as marijuana, is an ancient medicinal plant. Cannabis-based medicines have been used for at least 5,000 years for applications such as arthritis and pain control during and after surgery.

This use extended through antiquity to modern times, with contemporary cannabis-based medications for treating certain seizure disorders, promoting weight gain for HIV/AIDS-related anorexia and treating nausea during chemotherapy.

As with anything you put in your body, cannabis does have health risks: Driving while high may increase risk of accidents. Some people develop cyclical vomiting, while others develop motivation or dependence problems, especially with heavy use at younger ages.

That said, lethal overdoses from cannabis are almost unheard of. This is remarkable considering that nearly 50 million Americans use it each year.

In contrast, opioids, which are often prescribed for chronic pain, have contributed to hundreds of thousands of overdose deaths over the past few decades. Even common pain medications like nonsteroidal anti-inflammatory drugs, such as ibuprofen, cause tens of thousands of hospitalizations and thousands of deaths each year from gastrointestinal damage.

Furthermore, both opioids and nonopioid pain medications have limited effectiveness for treating chronic pain. Medications used for chronic pain can provide small to moderate pain relief in some people, but many ultimately cause side effects that outweigh any gains.

These safety issues and limited benefit have led many people with chronic pain to try cannabis as a chronic pain treatment alternative. Indeed, in survey studies, my colleagues and I show that people substituted cannabis for pain medications often because cannabis had fewer negative side effects.

However, more rigorous research on cannabis for chronic pain is needed. So far, clinical trials – considered the gold standard – have been short in length and focused on small numbers of people. What’s more, my colleagues and I have shown that these studies employ medications and dosing regimes that are far different from how consumers actually use products from state-licensed cannabis dispensaries. Cannabis also causes recognizable effects such as euphoria, altered perceptions and thinking differently, so it is difficult to conduct double-blind studies.

Despite these challenges, a group of cannabis and pain specialists published a proposed guideline for clinical practice in early 2024 to synthesize existing evidence and help guide clinical practice. This guideline recommended that cannabis products be used when pain is coupled with sleep problems, muscle spasticity and anxiety. These multiple benefits mean that cannabis could potentially help people avoid taking a separate medication for each symptom.

Since the Controlled Substance Act was passed in 1970, the federal government has designated cannabis as a Schedule I substance, along with other drugs such as heroin and LSD. Possession of these drugs is criminalized, and under the federal definition they have “no currently accepted medical use, with a high potential for abuse.” Because of this designation and the limits placed on drug manufacturing, cannabis is very difficult to study.

State and federal regulatory barriers also delay or prevent studies from being approved and conducted. For example, I can purchase cannabis from state-licensed dispensaries in my hometown of Ann Arbor, Michigan. As a scientist, however, it is very challenging to legally test whether these products help pain.

Reclassifying cannabis as a Schedule III drug has the potential to substantially open up this research landscape and help overcome these barriers.

Emerging Role of Psychedelics

Psychedelics, such as psilocybin-containing mushrooms, occupy an eerily similar scientific and political landscape as cannabis. Used for thousands of years for ceremonial and healing purposes, psilocybin is also classified as a Schedule I drug. It can cause substantial changes in sensory perception, mood and sense of self that can lead to therapeutic benefits. And, like cannabis, psilocybin has minimal risk of lethal overdose.

Clinical trials combining psilocybin with psychotherapy in the weeks before and after taking the drug report substantial improvements in symptoms of psychiatric conditions such as treatment-resistant depression and alcohol use disorder.

Risks are typically psychological. A small number of people report suicidal thoughts or self-harm behaviors after taking psilocybin. Some also experience heightened openness and vulnerability, which can be exploited by therapists and lead to abuse.

There are few published clinical trials of psilocybin therapy for chronic pain, although many are ongoing, including a pilot study for fibromyalgia conducted by our team at the University of Michigan. This treatment may help people develop a healthier relationship with their pain by eliciting greater acceptance of it and decreasing rumination often related to negative thoughts and feelings around pain.

As with cannabis, some states, such as Colorado and Oregon, have decriminalized psilocybin and are building infrastructure to increase accessibility to psilocybin-assisted therapy. One recent analysis suggests that if psychedelics follow a similar legalization pattern to cannabis, the majority of states will legalize psychedelics between 2034 and 2037.

Challenges Ahead

These ancient yet relatively “new” treatments offer a unique glimpse into the messy intersection of drugs, medicine and society. The justifiable excitement about cannabis and psilocybin has led to state policies that have increased access for some people, yet federal criminalization and substantial barriers to scientific investigation remain. In the years ahead, I hope to contribute toward pragmatic studies that work within these difficult parameters.

For example, our team developed a coaching intervention to help veterans use commercially available cannabis products to more effectively treat their pain. Coaches emphasize how judicious use can minimize side effects while maximizing benefits. Should our approach work, health care providers and cannabis dispensaries everywhere could use this treatment to help clients in chronic pain.

Approaches like these can supplement more traditional clinical trials to help researchers determine whether these drug classes offer benefit and whether they have comparable or less harm than current treatments. As our society connects to the rich history of healing using these ancient drugs, these proposed changes may offer safer and substantive options for the 50 million Americans living with chronic pain.

Kevin F. Boehnke, PhD, is an Assistant Professor in the Department of Anesthesiology and the Chronic Pain and Fatigue Research Center at the University of Michigan.  He receives funding from the National Institutes of Health, the State of Michigan Veteran Marijuana Research Program, and has received grants from Tryp Therapeutics and Journey Biosciences.

This article originally appeared in The Conversation and is republished with permission.

DEA Report Downplays Role of Prescription Opioids in Drug Crisis

By Pat Anson, PNN Editor

After a three-year absence, the DEA’s National Drug Threat Assessment (NDTA) has returned, with a tacit admission by the agency that prescription opioids don’t play much of a role anymore in the nation’s drug crisis.

Prescription opioids are mentioned only a handful of times in the 57-page report, mainly within the context of their theft and diversion declining to levels not seen in over a decade.

“The DEA Theft/Loss Reporting Database reveals that the number of unaccounted-for narcotic prescription drugs (opioids) in 2022 was at its lowest level in 12 years and continued to decline into the first nine months of 2023,” the NDTA report states.

The DEA said the number of unaccounted-for opioids fell from 19.5 million pills/units in 2011 to just 4 million in 2023, an 80% decline.

Most of the focus in the 2024 NDTA is on illicit fentanyl, methamphetamine, and counterfeit medications that have become increasingly more toxic and deadly.

Nearly 108,000 fatal overdoses were reported in 2022, with fentanyl and other synthetic opioids – most of them illicit -- involved in 68% of drug deaths. The remaining overdoses were linked primarily to cocaine, methamphetamine and other synthetic stimulants.

“The shift from plant-based drugs, like heroin and cocaine, to synthetic, chemical-based drugs, like fentanyl and methamphetamine, has resulted in the most dangerous and deadly drug crisis the United States has ever faced,” DEA Administrator Anne Milgram said in a press release.

“At the heart of the synthetic drug crisis are the Sinaloa and Jalisco cartels and their associates, who DEA is tracking world-wide. The suppliers, manufacturers, distributors, and money launderers all play a role in the web of deliberate and calculated treachery orchestrated by these cartels.”

Most counterfeit medications in the U.S. are spiked with illicit fentanyl, a synthetic opioid 50 times more potent than heroin and 100 times stronger than morphine. In 2023, a DEA laboratory analysis found that about 70% of counterfeit pills contain at least 2 milligrams of fentanyl, a potentially deadly dose.

Fake pills are also increasingly being found with xylazine, a potent animal tranquilizer, and nitazenes, a synthetic opioid chemically unrelated to fentanyl. According to some estimates, nitazenes are 40 times more potent than fentanyl and 1,000 times more potent than morphine. Nitazenes have never been approved for medical use in the United States.  

Although Milgram called the NDTA “a critical tool for informing and educating the public about the current drug threats,” the DEA’s annual report literally disappeared from public view three years ago. The last NDTA was released in 2021.

The DEA did not respond to a request for comment from PNN on why a NDTA was not published for three straight years or why one was finally released this week.

The DEA has been under growing criticism for its failure to stop fentanyl trafficking and for imposing steep cuts in production quotas on drug manufacturers, which has contributed to record shortages of opioids, ADHD stimulants and other essential drugs.  

Sometimes, what is not disclosed in the DEA’s report can be just as revealing as what is. For example, while the DEA officially lists kratom as a “drug of concern” and even tried to ban the herbal supplement, the agency has never said a word about kratom in a NDTA report. Not in 2021. And not in 2024.

Are Rx Drug Databases ‘Trojan Horses’ for Law Enforcement?

By Pat Anson, PNN Editor

Prescription drug monitoring programs (PDMPs) were widely adopted in the U.S. over a decade ago to help identify patients who might be abusing opioid medication or other controlled substances. All 50 states now have databases that physicians and pharmacists can use to monitor a patient’s prescription drug history and look for possible signs of abuse.

Although widely billed as a way to improve patient safety and prevent diversion, critics say PDMP’s quickly became a surveillance tool for local and federal law enforcement --- in effect, ‘Trojan Horse’ technologies that turned pharmacists into undercover cops.

“Equipped with PDMPs, pharmacists readily police patients. Pharmacists use this surveillance tool to interrogate patients about their drug use, document interactions defensively, and let patients know they are being watched,” said Elizabeth Chiarello, PhD, an Associate Professor of Sociology at Saint Louis University.

“PDMPs are surveillance technologies, not healthcare tools, so they do not offer pharmacists new ways to deal with patients’ pain or substance use disorders, they simply empower pharmacists to view patients with suspicion and refuse to treat them.”

Chiarello conducted 118 interviews with pharmacists in six states, asking how PDMP’s have affected their work and relationships with patients. Her findings, recently published in American Sociological Review, suggest that many pharmacists now feel pressured to work with law enforcement to identify suspicious prescriptions.   

A pharmacist in Mississippi said she was approached by a DEA agent, who gave her his card and said, “Call me anytime you need me.”

“From then on, she called the DEA when she spotted a fake prescription and worked with them to arrest the patient,” wrote Chiarello. “Pharmacists have become more comfortable deciding which patients deserve opioids and turning away those deemed undeserving. PDMP use has also strengthened communication with law enforcement, so pharmacists now contact them about troubling patients.”

A pharmacist in Missouri told Chiarello that he and his colleagues “work pretty well” with local law enforcement:

“We get calls all the time from the police that say ‘Hey, can you find out if they’re actually on this?’… I’ll call the police if I ever need any help, especially with someone who is jumping from pharmacy to pharmacy or doing something that’s illegal. But they’ll come back to me as well saying, ‘Hey, can you check the fill dates for this guy or can you check where he’s been filling for me?’ And so they kind of use me as a PDMP resource as well.”

Congressional investigators recently reported that three pharmacy chains -- CVS, Kroger and Rite Aid – faced “extreme pressure” from law enforcement to immediately respond to requests for patient information, even without a warrant. In most cases, patients are not informed that their medical records have been shared with law enforcement or why they were being sought.

Only three states – Louisiana, Montana and Pennsylvania – have laws that require a warrant or subpoena before medical data is disclosed.  

‘We Don’t Go Fishing’

In a recent webinar with medical providers, a DEA investigator denied that the agency uses PDMPs to troll for suspicious patients and providers.

“This comes up sometimes, so I'll just address the elephant in the room. We don't go fishing in the (PDMP) data. Okay? Why do people think we have this open access to driving records and that we pull whatever we want? No. We have to have a case and we have to have a subpoena. We just don't go trolling through the records,” said Jed Nitzberg, a DEA Supervisory Diversion Investigator.

The DEA has long been interested in prescription drug records. In 2020, the agency solicited bids from contractors to create and operate a surveillance program that would identify patients, prescribers and pharmacies that may be involved in the diversion or abuse of drugs.

Under the proposed program, the DEA would have “unlimited access” to prescription data, including the names of prescribers and pharmacists. The names of patients would be redacted, but if investigators suspect a drug was being abused or diverted, they could get a subpoena to identify them. No contract was awarded by DEA and it’s unclear if the surveillance program was ever initiated.

Even without prompting from law enforcement, pharmacists are under enormous pressure to be alert to suspicious behavior by patients and physicians. Under the national opioid settlement, if a pharmacy has too much “Red Flag activity” such as patients paying for drugs in cash or a prescription written by a doctor in another zip code, it risks being terminated from receiving any more shipments of opioids and other controlled substances.

Ironically, the theft, loss and diversion of prescription opioids is at its lowest level in over a decade. In the DEA’s latest National Drug Threat Assessment, the agency said the number of “unaccounted-for” opioids had fallen by 80 percent, from 19.5 million pills/units in 2011 to just 4 million in 2023.

A Pained Life: Stop the Denial

By Carol Levy, PNN Columnist

For many of us, pain is sporadic. Sometimes we know exactly when it will be start or what will set it off. Other times, it may hit spontaneously.

When my trigeminal neuralgia pain started in 1976, it was constant, triggered and spontaneous. Now it can be triggered by any touch to the affected area. Or it can come out of the blue.

When I don’t have pain, it often lulls me into denial. I’ll think, “Hey, I'm okay!” Denial is one of my defense mechanisms. I don't have the pain right now, so I won't have it. 

And then, like a freight train bearing down on me, the pain hits. That's when the denial ends. Sometimes it takes only a few minutes to recover, sometimes much longer.

Denial of pain also comes from friends, colleagues or family. It often results in an argument or anger. Does that change their denial? Not often.

Is it worth the hurt and emotional pain when we try to change their minds, when we try to convince them of the reality of our pain? Again, not often.

Many of us have had medical professionals refuse to accept our pain. Years ago, I found this note in my neurologist's chart: “There are days like today when I believe in her pain.”

It wasn't his to believe in or not. If he chose not to believe me, then the remedy was simple. Fire me as a patient. It is not worth debating with a doctor about the existence of our pain.  

A big pain trigger for me is eye movement. Any eye usage causes pain. I can read, sometimes for as long as 20 minutes, before the pain starts yelling at me and I am forced to put the book away.  

Too many times I don't want to give in to the pain. Just one more paragraph, I’ll think, or at least a sentence. If I try to deny the pain and continue to read, it grows stronger, bigger, a green hulk of pain.  

Then I have no choice. I fling the book away and wait, sometimes for hours, for the pain to subside to a tolerable level. I could have stopped the pain. I could have taken control over it. All I had to do was accept that I can't read for as long as I want. But, like a food addict, the pleasure I get from reading overwhelms my common sense.

For those of us struggling to stop denying the pain when we know we should, the denial only adds to our battle. We call ourselves “survivors” or “victims.” Those are words of war.

For me, the war isn’t over. If and when I win, I'll stop the denial. 

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

Seniors Often Left Stranded in Emergency Rooms

By Judith Graham, KFF Health News

Every day, the scene plays out in hospitals across America: Older men and women lie on gurneys in emergency room corridors moaning or suffering silently as harried medical staff attend to crises.

Even when physicians determine these patients need to be admitted to the hospital, they often wait for hours — sometimes more than a day — in the ER in pain and discomfort, not getting enough food or water, not moving around, not being helped to the bathroom, and not getting the kind of care doctors deem necessary.

“You walk through ER hallways, and they’re lined from end to end with patients on stretchers in various states of distress calling out for help, including a number of older patients,” said Hashem Zikry, an emergency medicine physician at UCLA Health.

Physicians who staff emergency rooms say this problem, known as ER boarding, is as bad as it’s ever been — even worse than during the first years of the covid-19 pandemic, when hospitals filled with desperately ill patients.

While boarding can happen to all ER patients, adults 65 and older, who account for nearly 20% of ER visits, are especially vulnerable during long waits for care. Also, seniors may encounter boarding more often than other patients.

The best estimates I could find, published in 2019, before the covid-19 pandemic, suggest that 10% of patients were boarded in ERs before receiving hospital care. About 30% to 50% of these patients were older adults.

“It’s a public health crisis,” said Aisha Terry, an associate professor of emergency medicine at George Washington University School of Medicine and Health Sciences and the president of the board of the American College of Emergency Physicians, which sponsored a summit on boarding in September.

What’s going on? I spoke to almost a dozen doctors and researchers who described the chaotic situation in ERs. They told me staff shortages in hospitals, which affect the number of beds available, are contributing to the crisis. Also, they explained, hospital administrators are setting aside more beds for patients undergoing lucrative surgeries and other procedures, contributing to bottlenecks in ERs and leaving more patients in limbo.

Then, there’s high demand for hospital services, fueled in part by the aging of the U.S. population, and backlogs in discharging patients because of growing problems securing home health care and nursing home care, according to Arjun Venkatesh, chair of emergency medicine at the Yale School of Medicine.

Long Waits Risky for Seniors

The impact of long ER waits on seniors who are frail, with multiple medical issues, is especially serious. Confined to stretchers, gurneys, or even hard chairs, often without dependable aid from nurses, they’re at risk of losing strength, forgoing essential medications, and experiencing complications such as delirium, according to Saket Saxena, a co-director of the geriatric emergency department at the Cleveland Clinic.

When these patients finally secure a hospital bed, their stays are longer and medical complications more common. And new research finds that the risk of dying in the hospital is significantly higher for older adults when they stay in ERs overnight, as is the risk of adverse events such as falls, infections, bleeding, heart attacks, strokes, and bedsores.

Ellen Danto-Nocton, a geriatrician in Milwaukee, was deeply concerned when an 88-year-old relative with “strokelike symptoms” spent two days in the ER a few years ago. Delirious, immobile, and unable to sleep as alarms outside his bed rang nonstop, the older man spiraled downward before he was moved to a hospital room. “He really needed to be in a less chaotic environment,” Danto-Nocton said.

Several weeks ago, Zikry of UCLA Health helped care for a 70-year-old woman who’d fallen and broken her hip while attending a basketball game.

“She was in a corner of our ER for about 16 hours in an immense amount of pain that was very difficult to treat adequately,” he said. ERs are designed to handle crises and stabilize patients, not to “take care of patients who we’ve already decided need to be admitted to the hospital,” he said.

How common is ER boarding and where is it most acute? No one knows, because hospitals aren’t required to report data about boarding publicly. The Centers for Medicare & Medicaid Services retired a measure of boarding in 2021. New national measures of emergency care capacity have been proposed but not yet approved.

“It’s not just the extent of ED boarding that we need to understand. It’s the extent of acute hospital capacity in our communities,” said Venkatesh of Yale, who helped draft the new measures.

In the meantime, some hospital systems are publicizing their plight by highlighting capacity constraints and the need for more hospital beds. Among them is Massachusetts General Hospital in Boston, which announced in January that ER boarding had risen 32% from October 2022 to September 2023. At the end of that period, patients admitted to the hospital spent a median of 14 hours in the ER and 26% spent more than 24 hours.

Maura Kennedy, Mass General’s chief of geriatric emergency medicine, described an 80-something woman with a respiratory infection who languished in the ER for more than 24 hours after physicians decided she needed inpatient hospital care.

“She wasn’t mobilized, she had nothing to cognitively engage her, she hadn’t eaten, and she became increasingly agitated, trying to get off the stretcher and arguing with staff,” Kennedy told me. “After a prolonged hospital stay, she left the hospital more disabled than she was when she came in.”

What Seniors Can Do

When I asked ER doctors what older adults could do about these problems, they said boarding is a health system issue that needs health system and policy changes. Still, they had several suggestions.

“Have another person there with you to advocate on your behalf,” said Jesse Pines, chief of clinical innovation at US Acute Care Solutions, the nation’s largest physician-owned emergency medicine practice. And have that person speak up if they feel you’re getting worse or if staffers are missing problems.

Alexander Janke, a clinical instructor of emergency medicine at the University of Michigan, advises people, “Be prepared to wait when you come to an ER” and “bring a medication list and your medications, if you can.”

To stay oriented and reduce the possibility of delirium, “make sure you have your hearing aids and eyeglasses with you,” said Michael Malone, medical director of senior services for Advocate Aurora Health, a 20-hospital system in Wisconsin and northern Illinois. “Whenever possible, try to get up and move around.”

Friends or family caregivers who accompany older adults to the ER should ask to be at their bedside, when possible, and “try to make sure they eat, drink, get to the bathroom, and take routine medications for underlying medical conditions,” Malone said.

Older adults or caregivers who are helping them should try to bring “things that would engage you cognitively: magazines, books … music, anything that you might focus on in a hallway where there isn’t a TV to entertain you,” Kennedy said.

“Experienced patients often show up with eye masks and ear plugs” to help them rest in ERs with nonstop stimulation, said Zikry of UCLA. “Also, bring something to eat and drink in case you can’t get to the cafeteria or it’s a while before staffers bring these to you.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

You Have the Right to Lose Your Rights

By Mia Maysack, PNN Columnist

After experiencing medical injustice and malpractice multiple times, I began advocating for myself and others who live in similarly painful ways.

It didn't take long to realize that the concept of "pain" is universal, but different for each of us. We all experience pain to varying degrees, but our perspectives differ. Each individual possesses an existence that is unique to them alone.

All that is to say that my advocacy efforts shifted away from "my" cause and instead became “ours.” It has continued evolving to the point where it is no longer solely fixated on healthcare, but instead acknowledges all systems (political, economic, social, cultural, etc.) and how they tie together and influence each other.

That's why I no longer identify specifically as a "patient advocate."  I lost patience with all the sh*t!  Now I'm just someone who believes in rights and liberation for all, understanding there are different ingredients in that recipe for each person.

The following is a recent example of a situation I experienced that connected different systems together – and not in a good way. There are far too many examples of things like it leading to a person's harm, hurt or worse. My aim is to make an illustration of the hypocrisy behind it and the hurdles it creates.

‘We Don’t Make the Laws’

On some days, I just cannot get outta bed. Other days, I may be able to take a little trip somewhere.  Why not enjoy different scenery, apart from the four walls that seem to close in on me?

While taking a drive, I passed police officers on two separate occasions. Although I thought nothing of it either time because I had no reason to, they pulled me over. When they approached the vehicle to request my license, I respectfully asked why this was happening. 

Their reply was: “Your tints."

As someone disabled by a neurological disorder that makes me very sensitive to light, tinted windows assist in making moments of normalcy possible for me. This amenity even has the approval of a world-renowned neurology department in one of the top teaching hospitals in the country, which happens to be located in my state. I provided the proof of that claim to the officers, and what happened next is where the system fails.

Although it was acknowledged that my tints are for a health issue, it was also explained to me that even with proper documentation, I'm still not legally allowed to have tinted windows on my car. I've had them for years and driven endless places without an issue, but now I was being told that I can’t have them, because dark windows can be a safety issue.  

“Driving isn't something I'm always able to do,” I protested. “The law is prohibiting a tool that I need and helps keep myself and others safe."

"We don't make the laws," the officers said.

I understand that. But I also took the opportunity to explain that people in positions of authority -- whether a cop, doctor or elected official -- are public service workers. That means they exist to aid, assist, support and contribute to the betterment of those they are in the position to serve: Us.

Tints are a petty example in the grand scheme of things, but they speak to a deeper issue of policies and regulations being put in place that do not benefit each individual on a case-by-case basis.

Simply put, the law does not get to dictate what’s best for our health. This is an issue I’ll continue addressing, perhaps even in court, because it’s difficult enough to survive without having your liberties threatened. 

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is a healthcare reform advocate and founder of Keepin’ Our Heads Up, a support network; Peace & Love, a life coaching practice; and Still We Rise, an organization that seeks to alleviate pain of all kinds.

Will Bird Flu Be the Next Pandemic?

By Amy Maxmen, KFF Health News

Headlines are flying after the Department of Agriculture confirmed that the H5N1 bird flu virus has infected dairy cows around the country. Tests have detected the virus among cattle in nine states, mainly in Texas and New Mexico, and most recently in Colorado, said Nirav Shah, principal deputy director at the Centers for Disease Control and Prevention, at a May 1 event held by the Council on Foreign Relations.

A menagerie of other animals have been infected by H5N1, and at least one person in Texas. But what scientists fear most is if the virus were to spread efficiently from person to person. That hasn’t happened and might not. Shah said the CDC considers the H5N1 outbreak “a low risk to the general public at this time.”

Viruses evolve and outbreaks can shift quickly. “As with any major outbreak, this is moving at the speed of a bullet train,” Shah said. “What we’ll be talking about is a snapshot of that fast-moving train.” What he means is that what’s known about the H5N1 bird flu today will undoubtedly change.

With that in mind, KFF Health News explains what you need to know now.

Q: Who gets the bird flu?

Mainly birds. Over the past few years, however, the H5N1 bird flu virus has increasingly jumped from birds into mammals around the world. The growing list of more than 50 species includes seals, goats, skunks, cats, and wild bush dogs at a zoo in the United Kingdom. At least 24,000 sea lions died in outbreaks of H5N1 bird flu in South America last year.

What makes the current outbreak in cattle unusual is that it’s spreading rapidly from cow to cow, whereas the other cases — except for the sea lion infections — appear limited. Researchers know this because genetic sequences of the H5N1 viruses drawn from cattle this year were nearly identical to one another.

The cattle outbreak is also concerning because the country has been caught off guard. Researchers examining the virus’s genomes suggest it originally spilled over from birds into cows late last year in Texas, and has since spread among many more cows than have been tested. “Our analyses show this has been circulating in cows for four months or so, under our noses,” said Michael Worobey, an evolutionary biologist at the University of Arizona in Tucson.

Q: Is this the start of the next pandemic?

Not yet. But it’s a thought worth considering because a bird flu pandemic would be a nightmare. More than half of people infected by older strains of H5N1 bird flu viruses from 2003 to 2016 died. Even if death rates turn out to be less severe for the H5N1 strain currently circulating in cattle, repercussions could involve loads of sick people and hospitals too overwhelmed to handle other medical emergencies.

Although at least one person has been infected with H5N1 this year, the virus can’t lead to a pandemic in its current state. To achieve that horrible status, a pathogen needs to sicken many people on multiple continents. And to do that, the H5N1 virus would need to infect a ton of people. That won’t happen through occasional spillovers of the virus from farm animals into people. Rather, the virus must acquire mutations for it to spread from person to person, like the seasonal flu, as a respiratory infection transmitted largely through the air as people cough, sneeze, and breathe. As we learned in the depths of covid-19, airborne viruses are hard to stop.

That hasn’t happened yet. However, H5N1 viruses now have plenty of chances to evolve as they replicate within thousands of cows. Like all viruses, they mutate as they replicate, and mutations that improve the virus’s survival are passed to the next generation. And because cows are mammals, the viruses could be getting better at thriving within cells that are closer to ours than birds’.

The evolution of a pandemic-ready bird flu virus could be aided by a sort of superpower possessed by many viruses. Namely, they sometimes swap their genes with other strains in a process called reassortment. In a study published in 2009, Worobey and other researchers traced the origin of the H1N1 “swine flu” pandemic to events in which different viruses causing the swine flu, bird flu, and human flu mixed and matched their genes within pigs that they were simultaneously infecting. Pigs need not be involved this time around, Worobey warned.

Q: Can I get sick from contaminated milk?

Cow’s milk, as well as powdered milk and infant formula, sold in stores is considered safe because the law requires all milk sold commercially to be pasteurized. That process of heating milk at high temperatures kills bacteria, viruses, and other teeny organisms. Tests have identified fragments of H5N1 viruses in milk from grocery stores but confirm that the virus bits are dead and, therefore, harmless.

Unpasteurized “raw” milk, however, has been shown to contain living H5N1 viruses, which is why the FDA and other health authorities strongly advise people not to drink it. Doing so could cause a person to become seriously ill or worse. But even then, a pandemic is unlikely to be sparked because the virus — in its current form — does not spread efficiently from person to person, as the seasonal flu does.

Q: What should be done?

A lot! Because of a lack of surveillance, the U.S. Department of Agriculture and other agencies have allowed the H5N1 bird flu to spread under the radar in cattle. To get a handle on the situation, the USDA recently ordered all lactating dairy cattle to be tested before farmers move them to other states, and the outcomes of the tests to be reported.

But just as restricting covid tests to international travelers in early 2020 allowed the coronavirus to spread undetected, testing only cows that move across state lines would miss plenty of cases.

Such limited testing won’t reveal how the virus is spreading among cattle — information desperately needed so farmers can stop it. A leading hypothesis is that viruses are being transferred from one cow to the next through the machines used to milk them.

To boost testing, Fred Gingrich, executive director of a nonprofit organization for farm veterinarians, the American Association of Bovine Practitioners, said the government should offer funds to cattle farmers who report cases so that they have an incentive to test. Barring that, he said, reporting just adds reputational damage atop financial loss.

“These outbreaks have a significant economic impact,” Gingrich said. “Farmers lose about 20% of their milk production in an outbreak because animals quit eating, produce less milk, and some of that milk is abnormal and then can’t be sold.”

The government has made the H5N1 tests free for farmers, Gingrich added, but they haven’t budgeted money for veterinarians who must sample the cows, transport samples, and file paperwork. “Tests are the least expensive part,” he said.

If testing on farms remains elusive, evolutionary virologists can still learn a lot by analyzing genomic sequences from H5N1 viruses sampled from cattle. The differences between sequences tell a story about where and when the current outbreak began, the path it travels, and whether the viruses are acquiring mutations that pose a threat to people. Yet this vital research has been hampered by the USDA’s slow and incomplete posting of genetic data, Worobey said.

The government should also help poultry farmers prevent H5N1 outbreaks since those kill many birds and pose a constant threat of spillover, said Maurice Pitesky, an avian disease specialist at the University of California-Davis.

Waterfowl like ducks and geese are the usual sources of outbreaks on poultry farms, and researchers can detect their proximity using remote sensing and other technologies. By zeroing in on zones of potential spillover, farmers can target their attention. That can mean routine surveillance to detect early signs of infections in poultry, using water cannons to shoo away migrating flocks, relocating farm animals, or temporarily ushering them into barns. “We should be spending on prevention,” Pitesky said.

Q: What could happen to people who get the H5N1 bird flu?

No one really knows. Only one person in Texas has been diagnosed with the disease this year, in April. This person worked closely with dairy cows, and had a mild case with an eye infection. The CDC found out about them because of its surveillance process. Clinics are supposed to alert state health departments when they diagnose farmworkers with the flu, using tests that detect influenza viruses, broadly. State health departments then confirm the test, and if it’s positive, they send a person’s sample to a CDC laboratory, where it is checked for the H5N1 virus, specifically. “Thus far we have received 23,” Shah said. “All but one of those was negative.”

State health department officials are also monitoring around 150 people, he said, who have spent time around cattle. They’re checking in with these farmworkers via phone calls, text messages, or in-person visits to see if they develop symptoms. And if that happens, they’ll be tested.

Another way to assess farmworkers would be to check their blood for antibodies against the H5N1 bird flu virus; a positive result would indicate they might have been unknowingly infected. But Shah said health officials are not yet doing this work.

“The fact that we’re four months in and haven’t done this isn’t a good sign,” Worobey said. “I’m not super worried about a pandemic at the moment, but we should start acting like we don’t want it to happen.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

Wild Orangutan Used Plant as Pain Reliever

By Pat Anson, PNN Editor

Humans have used natural remedies like cannabis, kratom and willow trees for thousands of years for pain relief. But other primates may have beaten us to the punch when it comes to using plants as medicine.

That’s one of the theories emerging after a wild orangutan in Indonesia was observed using a plant to help heal a facial wound. The orangutan, named Rakus by scientists, lost a chunk of flesh below his right eye, apparently during a fight with another male orangutan.

A wound like that could easily become infected in the damp rain forests of Sumatra, but Rakus had other ideas.

Scientists observed Rakus rubbing sap from a flowering vine called liana (Fibraurea tinctoria) directly on the wound and then chewing on its leaves to create a paste that he applied over the wound as a poultice.

Scientists say the wound never became infected and within a few days was completely healed.

Since liana leaves are not typically eaten by orangutans as food, it’s believed to be the first time that a big ape was observed self-medicating.

“The behavior of Rakus appeared to be intentional as he selectively treated his facial wound on his right flange, and no other body parts, with the plant juice. The behavior was also repeated several times, not only with the plant juice but also later with more solid plant material until the wound was fully covered. The entire process took a considerable amount of time,” says Isabelle Laumer, PhD, a researcher at the Max Planck Institute of Animal Behavior in Germany.

“Interestingly, Rakus also rested more than usual when being wounded. Sleep positively affects wound healing as growth hormone release, protein synthesis and cell division are increased during sleep.”

Rakus’ behavior raises several intriguing questions. Did he discover the healing powers of lianas on his own? Or was it something he learned from other orangutans and was passed down, from one big ape to another, over generations?

Indigenous people in Southeast Asia also use lianas as medicine. Are the plant’s medicinal properties something they learned while watching orangutans?

“This and related liana species that can be found in tropical forests of Southeast Asia are known for their analgesic and antipyretic (fever reducing) effects and are used in traditional medicine to treat various diseases, such as malaria,” said Laumer, who reported her findings in the journal Scientific Reports.

Like kratom, the pain-relieving effects of lianas comes from chemical compounds called alkaloids, which act on opioid receptors in the brain. The alkaloids in lianas also have antibacterial, anti-inflammatory, anti-fungal, and antioxidant properties that promote wound healing. In Borneo, native people have even used Fibraurea tinctoria to treat diabetes.

“It shows that orangutans and humans share knowledge. Since they live in the same habitat, I would say that’s quite obvious, but still intriguing to realize,” said co-author Caroline Schuppli, PhD, a primatologist at the Max Planck Institute.

“As forms of active wound treatment are not just human, but can also be found in both African and Asian great apes, it is possible that there exists a common underlying mechanism for the recognition and application of substances with medical or functional properties to wounds and that our last common ancestor already showed similar forms of ointment behavior.”

We only know about Rakus because he lives in an animal sanctuary where orangutans are closely monitored. In 21 years of observation, scientists there have not seen any other orangutans treat their wounds with lianas, although that may be due to the fact that they are solitary animals who spend most of their lives in trees and injured ones are rarely seen.    

Schuppli says Rakus may have learned how to treat his wound from his mother, by observing other orangutans, or through “individual innovation.” Orangutans eat hundreds of different fruits and plants, and it’s possible Rakus just stumbled onto the right one at the right time.

“As Fibraurea tinctoria has potent analgesic effects, individuals may feel an immediate pain release, causing them to repeat the behavior several times,” she said.   

Work Comp Claims for Opioids Down Significantly

By Pat Anson, PNN Editor

Workers’ compensation claims in the U.S. for opioids and other pain relievers fell significantly in 2023, one of the largest drops the work comp industry has seen in years, according to a new report.

San Diego-based Enlyte analyzes drug utilization and spending trends annually for property and casualty insurers. The company’s Drug Trends Report for 2023 estimates that overall opioid use per claim fell by 9.7 percent, with the use of sustained-release opioids such as oxycodone down more than 10 percent.

Surprisingly, work comp claims for non-opioid pain relievers also fell, even though they are increasingly prescribed as alternatives to opioids. Claims for non-steroidal anti-inflammatory drugs (NSAIDs) fell by 3% last year, with anticonvulsants like gabapentin down 7.4% and antidepressants such as duloxetine falling 6.1%. 

"This, by far, marks one of the largest drops in opioid utilization we've seen in years," Nikki Wilson, PharmD, senior director of clinical pharmacy solutions at Enlyte, said in a press release. "In addition, opioid alternatives commonly prescribed to manage acute and chronic pain also experienced decreases in utilization per claim, although to a lesser degree than opioids."

Enlyte said the decline in opioid use was “supported by prescribing guidelines,” noting that claims for high-dose opioid prescriptions have fallen for nine consecutive years. The 2016 CDC opioid guideline urged doctors not to prescribe doses higher than 90 morphine milligram equivalents (MME) per day. Although that recommendation is voluntary, it has taken root in many laws, regulations and insurance policies governing the use of opioids.

As a result, non-opioid analgesics and muscle relaxants are used more often than opioids for pain management during the first two years of a work comp claim. Only afterwards are sustained-release opioids used more frequently for chronic pain caused by job-related injuries.

Even though opioid use has fallen dramatically in recent years, opioids remain the top therapeutic class for claims, followed by NSAIDs, anticonvulsants, muscle relaxants, antidepressants and topical medications. Those six therapeutic classes represent over two-thirds of the prescription drug claims in 2023.

Respiratory and Migraine Drugs  

While the overall cost of prescription drugs fell slightly (down 0.2%) in 2023, the price of respiratory and migraine medications rose significantly, up 14.7% and 10.2%, respectively.

Newer migraine drugs that block calcitonin gene-related peptides (CGRPs) are some of the most expensive medications, with the average wholesale price of a Nurtec prescription reaching $1,916 and $1,654 for a Ubrelvy prescription.      

"Basically, what's driving these trends are the costs of the top three medications in their respective classes," Wilson said. "For instance, for migraine medications, Nurtec ODT is prescribed about 15% of the time yet makes up more than 31% of the total drug spend in this category. Similarly, respiratory medication like Trelegy Ellipta is prescribed about 10%, but accounts for nearly 19% of all respiratory medication total costs."

Enlyte reported the number of retail and mail order prescription drug claims is trending downward due to an “evolving work environment.” More people are working from home and as independent contractors, reducing the number of on-site job injuries and employee compensation claims.