Exclusive: How CDC Will Evaluate the Impact of Its Opioid Guidelines

By Pat Anson

We’ve learned more about a research study the CDC plans to conduct on the impact of its opioid prescribing guideline, which took opioids off the table as a treatment option for millions of Americans suffering from chronic or acute pain. The study was briefly outlined in a public notice published in the Federal Register in October.

It’s been over 8 years since the CDC released its controversial guideline and two years since the agency revised it, after receiving many reports of patient harm, including rapid opioid tapering, withdrawal, poorly treated pain, and suicide.

The agency has released few details on the “mixed-method quasi-experimental design” of the study, the first attempt by the agency to get direct feedback from patients, caregivers and doctors about the guideline’s impact on pain management.

Further details of the study are not coming from the CDC, but from the Office of Management and Budget (OMB), which is evaluating whether the study meets the requirements of the Paperwork Reduction Act, a law that gives OMB broad authority over the collection of data by federal agencies. The CDC’s briefings for the OMB can be found here, here and here.        

“The goal of this research study is to conduct a rigorous, comprehensive evaluation to assess the 2022 CDC Clinical Practice Guideline implementation, uptake, and outcomes. The government will use this information collection to inform CDC efforts and interventions to ensure that Americans have access to safer, effective ways of managing their pain,” the CDC explained.

“We propose conducting an analysis of changes in public and private payers’ policies—e.g., those governing Medicaid, Medicare, private health plans—since late 2022 when the CDC released the Clinical Practice Guideline.”

The study will be conducted over a four-year period and cost nearly $4 million, with much of the work subcontracted to Abt Global, a private research and consulting firm. Abt Global will perform a series of interviews, surveys and focus groups involving patients, caregivers and doctors; as well as dentists, insurers, health system leaders, professional medical associations, and state medical boards.

The DEA and other law enforcement agencies that investigated and prosecuted doctors for “unlawful” opioid prescribing are not included in the study.

The CDC’s previous attempts at evaluating the 2016 and 2022 guidelines relied on data about opioid prescribing rates, not on patient welfare or even whether the guidelines met their primary goal of reducing opioid addiction and overdoses. In that respect, the guidelines have failed. While opioid prescribing has fallen to levels not seen in decades, opioid-related overdoses have nearly doubled since the 2016 guideline’s release.

‘What Has Been Most Effective in Managing Your Pain?’

The CDC is planning an online survey of about 600 doctors (with invitations sent to 3,000) and virtual interviews with 30 of them, asking about their pain management and opioid prescribing practices, as well as any “unintended consequences“ of the agency’s guidelines. Similar questions will be asked of the dentists, insurers, health systems, medical boards, and professional societies.

No interviews or surveys are planned with patients or caregivers. Instead, a series of one-hour focus groups will be conducted involving a total of 135 patients and 90 caregivers, who will receive a $75 gift card as an incentive to participate. The CDC says it will “partner with patient advocacy organizations” to identify participants from their membership lists.

Due to the nature of focus groups, the opinions gathered from patients and caregivers are likely to be viewed as anecdotal or qualitative “perceptions,” not quantitative research.

“We will conduct focus groups with patients to provide an in-depth understanding of a single or small number of cases set in their real-world contexts. Examining the experiences of patients can provide a deeper understanding of real-world behavior within a specific healthcare context to elucidate perceptions of whether and/or how changes occurred in overall treatment and/or pain management, including opioid prescribing,” the CDC said.

The focus groups will be led by Abt Global moderators, who will ask a series of open-ended questions to promote discussion. Notably, there are more questions in the “Patient Focus Group Guide” about non-opioid pain treatments than there are about opioids.

There are also no questions about the CDC’s 2016 guideline. The focus is only on pain management after November 2022, when the revised guideline was released in an attempt to give more flexibility to doctors in using opioids to manage pain.

Focus Group Questions for Patients  

1. What treatments and medications for pain have you tried? What has been most effective in managing your pain?

2. There are a lot of strategies to help with pain. Tell us about your experience with physical therapy or exercise therapy to help with your pain.

3. Counseling or behavioral therapy is often used to help with pain. What has your experience been receiving counseling for pain management?

4. Have you had experience with any other non-medication therapies for pain (e.g., acupuncture)? Can you share your experience with those?

5. Medications other than opioids, such as ibuprofen and acetaminophen, which can be both prescribed or over-the-counter, are also often used for pain management. Tell us your experience with these non-opioid medications to manage your pain.

6. Tell us about your first experience being prescribed opioids for pain. How was your pain after you began taking opioids? What side effects did you experience?

7. When were you initially prescribed opioids for pain? How long were you initially prescribed opioids for? Had you received additional refills for opioids after that first prescription?

8. Have you noticed any changes to how clinicians manage your pain since November 2022? If so, what have you noticed?

9. Give me an example of how the management of your pain has improved since November 2022?

10. Give me an example of how the management of your pain remained the same since November 2022?

11. How has your pain management gotten worse since November 2022?

12. Since November 2022, what other factors may have affected how your pain has been managed, such as a change in primary care clinician or changes in your insurance coverage or changing from a primary care clinician to a pain management specialist?

This kind of detail about the questions, participants and research methods has not been made public before. Only a brief overview of the study was provided in the October 2024 notice in the Federal Register, which the CDC made no effort to publicize to get broad public feedback.

As a result, the notice received only two public comments, one of them a letter from the American Society of Anesthesiologists (ASA). The ASA called the 2022 guideline a “significant improvement” over the 2016 guideline, but added that 40% of its members felt the updated guideline was “ineffective.” There were also criticisms that the guidelines “might lead to reduced access to necessary pain medications.”

The CDC was dismissive of both public comments and said no changes would be made to its study design or methodology.  

“The public comments received did not have specific suggestions that impact any evaluation instruments; therefore, no changes were made to the instruments,” CDC said.      

After Years of Foot Dragging, CDC Plans Review of Opioid Guideline

By Pat Anson

Eight years after releasing its controversial 2016 opioid guideline and two years after revising it, the CDC is finally making plans for a review of the guideline’s impact on patients, caregivers, doctors, and the practice of pain management.

In a notice published in the Federal Register, the CDC said it would open a 30-day public comment period on a “mixed-method quasi-experimental approach” to evaluating the updated 2022 guideline.

In plain English, the CDC plans a web-based survey of about 200 clinicians, and individual interviews with 10 clinicians, 2 dentists, 3 health system leaders, 3 insurers, 3 professional association leaders, and 3 medical board leaders. In addition, CDC will interview up to 15 patients and 15 caregivers in focus groups.

The agency did not indicate how the participants or organizations will be selected, or what questions will be asked.

“CDC is comprehensively evaluating the uptake, implementation, and outcomes of the 2022 CDC Clinical Practice Guideline on evidence-based care for pain management to understand its impact,” the agency said. “The evaluation includes dissemination and impact of the 2022 CDC Clinical Practice Guideline through population-wide changes in prescribing practices for opioids and medications for opioid use disorder.”

This is actually the second time CDC has published a public notice about the guideline review. Only two public comments were received after a similar notice was published in the Federal Register on October 1, which the CDC made no effort to publicize.

‘Timing Is Very Odd’

It’s not clear why a second notice was published during the holiday season and in the final weeks of the Biden administration. CDC did not immediately respond to a request for comment.

“The timing is very odd, and almost everyone missed the opportunity for open comments earlier this year,” said Chad Kollas, MD, a palliative care physician and pain policy expert.

“Few states have backed off from overly restrictive prescribing laws that were created based on the 2016 Guideline. I think that’s the main opportunity here, documenting the failure to implement the revised recommendations in the 2022 guidance. It’s unclear how CDC plans to determine who will get an opportunity to respond in the proposed study, so transparency remains troublesome for them.”

The CDC was slow to acknowledge the harm caused by the 2016 guideline. Although voluntary, the agency’s recommendations were widely implemented as mandatory by states and law enforcement agencies, resulting in patients having their opioid medication reduced or cutoff, and doctors being prosecuted for exceeding the guideline’s dosage recommendations.

To address those issues, CDC issued a revised guideline in 2022. But many of the problems caused by the original guideline linger.

“The 2016 guidelines led to a variety of restrictive policies, including limitations on opioid dosages. These measures created significant barriers for patients trying to access pain care and made it more challenging for physicians to prescribe necessary medications,” Donald Arnold, MD, President of the American Society of Anesthesiologists (ASA) wrote in a letter to the CDC, one of the two public comments made in response to the October 1 public notice.

The ASA surveyed its members on the impact of the 2022 revised guideline. Over half (56%) thought it was “somewhat effective” in reversing the harm caused by the 2016 guideline, while 40% thought it was ineffective.

A PNN survey of over 2,500 patients, providers and caregivers also found mixed reviews of the 2022 guideline. Only 39% of respondents thought it was “improved” or “much improved” over the original guideline.  Most respondents said it was about the same or even worse.

‘Same Problems Still Exist’

The CDC never conducted a comprehensive review on the impact of the 2016 guideline, but it did hire a consulting firm to improve its image after the agency was widely criticized for its secrecy and lack of transparency during the guideline’s development process.

A former CDC epidemiologist was so dismayed by the agency’s lack of accountability that he wrote a book about it, “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids.” Dr. Charles LeBaron says CDC leadership was blinded by its own hubris.

“The problem was not looking at the (guideline) sufficiently quantitatively and then not checking the consequences, or at least responding to the consequences when they're brought to your attention,” LeBaron told PNN. “Many of the same problems continue to exist, even though the personalities are completely different, and there are still significant restrictions on people in chronic pain for no apparent benefit.”

The personalities will change yet again when the Trump administration takes office on January 20. Conservative activists have made clear they want a major restructuring of the CDC, returning the agency to its core mission of collecting and disseminating data on communicable diseases. They want the CDC to stop telling people what to do, and to leave medical guidelines to professional societies and state medical boards.

Women, Elderly and Rural Americans More Likely to Have Chronic Pain

By Crystal Lindell

American women are more likely than men to experience chronic pain and high-impact pain severe enough to disrupt their lives. Americans of both sexes are also more likely to have pain if they live in rural areas, are over age 65, and of American Indian or Alaska Native descent. 

Those are the findings in a new report from the Centers for Disease Control and Prevention, which found that 24.3% of U.S. adults (60 million people) experienced chronic pain in 2023, while 8.5% (21 million) experienced high-impact pain that limited their daily life and work activities. 

What the report doesn’t tell you is that pain rates have risen dramatically since 2016, the year the CDC introduced its controversial opioid prescribing guideline, which drastically reduced patient access to opioids. Not only has the guideline failed to reduce overdoses, it appears to have worsened pain care for millions of Americans.

In 2016, the National Health Interview Survey estimated that 20.4% (50.0 million) of U.S. adults had chronic pain, while 8% (19.6 million) had high-impact chronic pain. What that essentially means is that 10 million more Americans have chronic pain today than in 2016, and 1.4 million more people have debilitating pain.

The CDC report does not speculate about why pain rates have increased, but a recent study that looked at the same survey data offers some insight, suggesting the increase is due to a number of factors, such as long Covid, more sedentary lifestyles, more anxiety and stress, and reduced access to healthcare.

“The widely-cited 20% prevalence of CP (chronic pain) in the adult US population appears obsolete,” wrote co-authors Anna Zajacova, PhD, and Hanna Grol-Prokopczyk, PhD, in medRxiv. “Our findings indicated that chronic pain, already a widespread issue, has reached new heights in the post-pandemic era, necessitating urgent attention and intervention strategies to address and alleviate this growing health crisis.”

While the CDC report neglects to cover the causes of pain, it does provide a detailed look at chronic pain rates by sex, race, age, and location.  For example, researchers found that people aged 65 and older are three times more likely to have chronic pain than young adults, while Whites are more likely to have pain than Blacks, Hispanics and Asians.

Chronic and High-Impact Pain by Sex:

• Women: 25.4% and 9.6%

• Men: 23.2% and 7.3%

Chronic and High-Impact Pain by Age:

• Ages 18–29: 12.3% and 3.0%

• Ages 30–44: 18.3% and 4.9%

• Ages 45–64: 28.7% and 11.3%

• Ages 65 and older: 36% and 13.5%

Chronic and High-Impact Pain by Race: 

• American Indian and Alaska Native: 30.7% and 12.7%

• White: 28% and 9.5%

• Black: 21.7% and 8.7%

• Hispanic: 17.1% and 6.5%

• Asian: 11.8% and 2.6%

Whether you live in a city, suburb or rural area also affects pain rates, with rural Americans significantly more likely to have chronic pain than those who live in cities. In the CDC study, large metropolitan areas of one million or more people are categorized as “central” or “fringe” counties. Medium and small metropolitan areas are counties with 250,000–999,999 people or less than 250,000 people, respectively. Non-metropolitan areas are rural counties with significantly fewer people.

Chronic Pain by Urban Area:

• Large central metropolitan area: 20.5% 

• Large fringe metropolitan area: 22.5%

• Medium and small metropolitan area: 26.4% 

• Non-metropolitan area: 31.4%

The CDC does not address the impact of chronic pain in its bare-bones report. But independent researchers Anna Zajacova and Hanna Grol-Prokopczyk do in their analysis, pointing out that pain “profoundly impacts” physical, mental and cognitive health, as well as employment, relationships, sexual function and sleep. It all adds up to an economic impact of $560-$635 billion annually — more than any other health condition.

“The findings are a call to action for public health professionals, policymakers, and researchers to further investigate the root causes of this increase. Addressing the rise in chronic pain is critical, as pain serves as a sensitive barometer of population health and has profound economic, social, and health consequences,” they wrote.

CDC Is Worried About Shortages of ADHD Stimulants. What About Rx Opioids?

By Pat Anson

The Centers for Disease Control and Prevention is worried that shortages of stimulant medication used to treat attention-deficit hyperactivity disorder (ADHD) may be forcing some patients to turn to street drugs or even suicide.

In a new report, the CDC estimates that 15.5 million U.S. adults have ADHD¸ a condition that causes inattention, impulsiveness and hyperactivity. About a third of those patients were prescribed a stimulant, but 71.5% of them had difficulty getting their prescription filled because of shortages.

“Shortages of stimulant medications in the United States have affected many persons with ADHD who rely on pharmacotherapy to appropriately treat their ADHD,” wrote lead author Brooke Staley, PhD, an epidemiologist at the CDC’s National Center on Birth Defects and Developmental Disabilities.

“Patients experiencing these difficulties might seek medication outside the regulated health care system, increasing their risk for overdose because of the prevalence of counterfeit pills in the illegal drug market, which might contain unexpected substances such as fentanyl.”

This is the second CDC report in recent months to warn about stimulant shortages. In a CDC Health Advisory released in June, the agency said ADHD patients who are unable to obtain Adderall and other stimulants are at risk of “social and emotional impairment, increased risk of drug or alcohol use disorder, unintentional injuries, such as motor vehicle crashes, and suicide.”

The CDC’s concern about ADHD patients is in marked contrast to its ongoing neglect of pain patients, who face similar shortages of opioid medication.

In a recent PNN survey, 90% of pain patients said they experienced delays or problems getting their opioid prescriptions filled at a pharmacy. Desperate for relief, some bought counterfeit medication or other illicit drugs; obtained opioids prescribed to another person; or used alcohol, cannabis and other substances to ease their pain. Nearly a third said they considered suicide because their pain was so severe.

In short, the very same risky behavior that concerns the CDC about ADHD patients.   

We asked the CDC if it was studying the impact of opioid shortages on pain patients and instead got a defense of the ADHD study.

“There has been limited information about (ADHD) diagnosis and treatment in adults and this analysis aimed to fill that information gap – providing the first national estimates on prevalence of adult ADHD in more than a decade. It is also the first national estimates to describe age at diagnosis and treatment, including telehealth and difficulty filling stimulant prescriptions,” a spokesperson said in an email.

It would not be unreasonable to say that the CDC shares some of the blame for chronic shortages of hydrocodone, oxycodone and other prescription opioids. The agency’s controversial 2016 opioid guideline paved the way for steep cuts in opioid prescribing, resulting in “serious harm” to patients who were rapidly tapered and left in uncontrolled pain. Some committed suicide.

The CDC guideline also greased the skids of opioid litigation by exaggerating the risk of opioid addiction and overdose. Faced with a tsunami of lawsuits, drug distributors and pharmacy chains agreed to ration the supply of opioids at individual pharmacies, and drug makers cut back on the production of opioids to avoid further liability. As recently as last month, Teva Pharmaceuticals stopped production of immediate-release fentanyl medicines, potent pain relievers that were relied on by dying cancer patients.

The CDC has been silent about opioid shortages – so have the FDA and DEA.

“We don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a 2023 interview. 

Faced with complaints about shortages of ADHD medication, the DEA recently said it would raise the supply of stimulants that drug makers are allowed to produce in 2025, but would continue with its decade-long campaign to reduce the supply of opioids.

That discrepancy hasn’t been lost on pain sufferers.

“You’ve corrected course for ADHD drugs, now do the same for opioid pain analgesics,” one patient posted in a comment on the DEA’s plan. “Do not cut opioids production in 2025. The shortages across the country will be worse, with a corresponding increase in suffering and deaths among chronic pain patients.”

“These proposals will only further the pain and harm on a community of disabled individuals that did not ask to be disabled,” wrote Rebecca Meadows. “Would you want your mother, brother, sister, child or yourself to suffer unnecessarily due to unwarranted cutbacks in pain medications being made? The amount of people who suffer now is ridiculous but it’s only going to get worse if we continue on this path.”

A former CDC epidemiologist wrote a book about how the CDC’s “Disastrous War on Opioids” made the overdose crisis worse. Opioid overdoses have nearly doubled since the 2016 guideline was released.

“There are still significant restrictions on people in chronic pain for no apparent benefit. There continues to be very high rate of overdoses,” said author Charles LeBaron, MD. “I'm kind of a diehard public health guy. I want to see whether anything good happens. Nothing good happened. Time to reconsider.”

Should CDC Be Involved in Cannabis Regulation?

By Pat Anson

If you think the Centers for Disease Control and Prevention bungled its handling of COVID-19 tests and misled the public about the risks of opioid pain medication – then you’re probably not going like a new recommendation from a federal advisory panel.     

The National Academies of Sciences, Engineering, and Medicine (NASEM) wants the CDC to play a much larger role in setting federal policy on cannabis, such as expanding its surveillance of cannabis use and establishing “best practices” for states to follow in cannabis regulation.

In other words, a CDC cannabis guideline that would be used as a model for state laws and regulations, much like the agency’s opioid prescribing guideline was. Only this guideline would go much further.

“The best practices should encompass marketing restrictions, age restrictions, physical retail and retail operating restrictions, taxation, price restrictions, product design, and measures to limit youth access,” NASEM said in a 312-page report released this week. “Once the Centers for Disease Control and Prevention’s best practices have been developed, they should be incorporated into the model legislation.”

Cannabis is currently illegal under federal law, but 38 states and the District of Columbia allow its medical and/or recreational use. At the urging of the Biden Administration, the DEA is considering a proposal to reclassify cannabis as a Schedule III controlled substance, which would allow for some medical use of cannabis under federal law. A final decision is not likely until sometime next year.    

But with a major change in federal policy on the horizon and a hodgepodge of state regulations already in place, NASEM wants federal agencies and Congress to get more involved in setting policy for legalized cannabis.

“There is an urgent need for a coordinated public health approach to cannabis policy in the U.S.,” said Steven Teutsch, a senior fellow at the University of Southern California and chair of the committee that wrote the NASEM report. “Our report shows that cannabis policy often focuses on regulating sales and revenue first, and protecting public health second. Now is the time for the federal government to create guidance for states that have legalized cannabis in the interest of protecting the public’s health.”

The first recommendation from NASEM is for Congress to overhaul the regulation of hemp, which was legalized under the 2018 Farm Bill.  That opened the door for cannabis companies to tweak the chemical composition of hemp-derived Delta-8 THC to make it more potent. Intoxicating edibles containing Delta-8 THC are now widely sold as candy, cookies, gummies and beverages – even in states where medical and recreational cannabis are illegal.

NASEM wants Congress to close that loophole by changing the definition of hemp so that Delta-8 THC is regulated the same way as other cannabis products.

Public Health Campaigns

The report also calls for the CDC to develop “targeted public health campaigns” to warn about the risks of cannabis use by children, pregnant women and older adults.  

The latter is one of the fastest growing segments of the population using cannabis, according to a recent survey that found 12% of Americans over 50 had consumed a THC-containing product in the past year. Only 3% were using cannabis in 2006. Ironically, many older adults use cannabis to manage chronic pain because they are no longer able to obtain opioids after the widespread misapplication of the CDC’s opioid guideline.

The NASEM report also warns about the lobbying influence of the cannabis industry, which it blames for the weakening of cannabis regulations in Colorado and Washington, as well as conflicts of interest and “financial entanglements” that some state regulators have with the industry.

“The influence of the burgeoning legal cannabis industry on policy development raises concern about potential bias. Lobbying efforts by the industry have demonstrably impacted regulation,” the report states.

That’s pretty rich when you consider the many biases and conflicts the CDC had when it secretly developed the opioid guideline, and how CDC insiders hijacked a public hearing to silence anyone who might oppose it. Some CDC consultants were later paid millions of dollars testifying as expert witnesses in opioid litigation.

Conservative critics of the CDC are unlikely to support any effort to get the agency involved in cannabis regulation.  The Heritage Foundation’s Project 2025 calls for the CDC’s budget to be slashed and its ability to set healthy policies severely restricted.

“COVID-19 exposed the Centers for Disease Control and Prevention as perhaps the most incompetent and arrogant agency in the federal government,” wrote Roger Severino, former director of the Office for Civil Rights at the Department of Health and Human Services during the Trump administration.

“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.”

A CDC spokesperson told the Associated Press the agency would study NASEM’s recommendations, but more money would be needed to implement them.

Are U.S. Overdose Deaths Really Declining?

By Pat Anson

Preliminary data from the CDC suggest that U.S. overdose deaths have declined significantly, falling by 10% in the last year alone. If confirmed, the double-digit drop would mean there were 11,247 fewer drug deaths in the 12-month period ending in April 2024.

The decline, first reported by NPR, was hailed by addiction and public health experts as a hopeful sign that progress is finally being made in reducing the number of drug deaths, which have doubled in the past decade to over 100,000 a year.

“This is exciting," said Dr. Nora Volkow, director of the National Institute on Drug Abuse. "This looks real. This looks very, very real."

Good news, if it’s true. But caution is warranted about how “real” the decline is, because preliminary death data often changes as more information comes in.

Overdose data is fragmented in both quality and quantity, as it comes from 50 different sources. The data is collected by each state and then submitted to the CDC to decipher for its monthly Provisional Drug Overdose Death Count.

Some states still do not use toxicology tests to confirm whether a death is drug-related – leaving it up to medical examiners and coroners to decide which drugs, if any, may have played a role in someone dying. Some elected coroners, particularly in rural counties, have no medical training or expertise in drug death investigations. And in many cases, autopsies are not performed.

In addition to the wide variability in expertise and data collection, overdoses are typically not reported to the CDC until four months after the date of the death, sometimes longer. In its most recent provisional count, the CDC acknowledged that its overdose data may underestimate the actual number of deaths.

“Some states may have longer than usual delays in submitting drug overdose deaths. In particular, North Carolina is experiencing substantial delays in the resolution of pending records by the medical examiner’s office. Recent trends may underestimate the death count in affected states and this potential impact should be considered when comparing results for states to previous months,” the CDC said.

Percent Change in Drug Overdose Deaths (April 2023 to April 2024)

SOURCE: CDC

Reported vs Predicted

Because the provisional counts are often incomplete and the causes of many deaths are “pending investigation,” the CDC maintains two different data sets. One is the number of “reported” cases, and the other is the “predicted” number of deaths. The latter is where the 10% decline comes from.

The number of reported drug deaths is even lower than the predicted ones, suggesting there has been a 12.2% decline in overdoses nationwide. But that number is also misleading because it is based on incomplete data.

Take North Carolina, for example. For the most recent 12-month period ending in April, North Carolina reported 2,512 drug deaths, compared to 4,317 overdoses from the year before. That’s a whopping decrease of nearly 42 percent!

No one believes that number is real and will hold up over time. Not even Nora Volkow.

North Carolina is not an outlier. Reported drug deaths in Nebraska are down nearly 30 percent, but the data from there is considered “underreported due to incomplete data.” The same is true for Ohio, Pennsylvania and Michigan, where reported drug deaths are down about 20 percent. Big states like that can sway nationwide estimates.

Meanwhile, reported drug deaths are up in several western states: +42% in Alaska, +15% in Oregon, +13% in Nevada, +10% in Washington and +7% in Utah. It’s hard to square those numbers with any national trend.

“Utah’s trends haven’t aligned with national trends for some time. We plateaued while overdoses increased significantly at the national level, especially during the pandemic,” Megan Broekemeier, an overdose research coordinator for the Utah Department of Health and Human Services, told the Deseret News. “We haven’t seen statistically significant changes in the rate yet.”

‘The Dip in Overdoses Is Real’

To be fair, some of the overdose-related data is encouraging and suggest that drug deaths are in fact declining.

In a blog that tracks health data trends, Nabarun Dasgupta, PhD, a drug researcher and scientist at the University of North Carolina, reported a nationwide drop in ER visits and EMS calls (ambulance runs) involving overdoses. He estimates that non-fatal overdoses have fallen -15% to -20% nationwide

“A 15-20% decrease in non-fatal overdose and a 10% decrease in fatal overdose is a major impact. There is barely any public health intervention that has credibly achieved this magnitude of decrease,” wrote Dasgupta. “Our conclusion is that the dip in overdoses is real, and not a data artifact. It remains to be seen how long it will be sustained.”

Dasgupta attributes the decline to several possible factors, such as wider access to the overdose recovery drug naloxone and increased law enforcement seizures of illicit fentanyl.

He does not think the decline in opioid prescribing has anything to do with the drop in overdoses. Deaths linked to opioid pain medication have remained flat for nearly a decade, even as prescribing levels fell to 20-year lows.

“Let's put one hypothesis to rest: Reductions in opioid analgesic prescribing is not driving the changes in overdose rates. We've studied it, and that's not what is driving current fentanyl overdoses,” says Dasgupta.    

The CDC has a checkered history when it comes to tracking overdose deaths. When the agency released its controversial 2016 opioid guideline, it laid the blame for rising overdose deaths squarely on opioid analgesics.

“Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug overdose epidemic,” said then-CDC director Dr. Thomas Frieden, a claim based on weak evidence and false assumptions.

Two years later, after millions of pain patients had their opioid doses reduced or cutoff, the CDC admitted that illicit fentanyl was driving the overdose crisis and that it mistakenly classified many fentanyl deaths as overdoses caused by prescription opioids.The death toll from prescription opioids in 2016 was nearly cut in half — from 32,445 down to 17,087 — when the deaths were reclassified as fentanyl-related.

The CDC says its data collection and analysis have improved in recent years, but they still come with a disclaimer that the monthly provisional counts “may not include all deaths that occurred” and are “subject to change.”

"I think we have to be careful when we get optimistic and see a slight drop in overdose deaths," said Dan Salter, Director of the North Carolina Office of National Drug Control Policy, told NPR. "The last thing we want to do is spike the ball."

An Insider’s Perspective on CDC’s ‘Disastrous War on Opioids’

By Pat Anson

Dr. Charles LeBaron is a medical epidemiologist who worked for 28 years at the Centers for Disease Control and Prevention. LeBaron was not directly involved in developing the CDC’s 2016 opioid guideline, but knew colleagues who did and largely supported their efforts to rein in opioid prescribing.

Then LeBaron developed crippling pain from a meningitis infection and learned firsthand how the CDC guideline was harming patients. While hospitalized, he screamed into his pillow at night because a nurse -- following the CDC’s recommendations -- gave him inadequate doses of oxycodone. The pain relief only lasted a couple of hours, and then he had to wait in misery for the next dose.

“I hadn't experienced the pain that so many patients feel, so I hadn't had the level of sensitivity to the issue that would have benefited me. It took full personal experience to straighten me out,” said LeBaron. “You'd rather be dead than in pain. In that bubble of pain, it really is life changing.

“Once you experience that, you tend to view things very differently through a very different lens. At least that was my experience. There was nothing like being in acute pain.”

LeBaron eventually recovered from the infection and no longer needed oxycodone. He also didn’t become addicted. That lived experience made him wonder if the CDC -- his longtime employer – made mistakes in developing the guideline. He came to recognize that the CDC’s push to limit opioid doses was based on weak evidence and the false presumption that many patients quickly become addicted.

Most of all, he was shocked at how quickly the CDC guideline was adopted throughout the healthcare system. He’d never seen anything like it, in all his years at the agency.

“Most of the recommendations we come out with, that people should eat right, exercise or whatever, no one ever bothers doing. We have a tough time getting people to do things. This recommendation? They just had remarkably fast implementation,” LeBaron told PNN.

“I've never seen a recommendation that got implemented that fast and that hard by so many actors. Normally, it’s like herding cats in public health, trying to get everybody involved. And for prescription medications, there are a million cats. There are pharmacies, benefit managers, physicians, insurance and so forth. This thing just took off.”

Now retired, LeBaron decided to write a book about his personal experience with pain, along with a critique of the CDC guideline. “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids” gives a rare insider’s look into how the agency works and thinks.

The word “greed” may suggest there were financial motives behind the CDC guideline, but LeBaron says it’s more a matter of pride and hubris that borders on institutionalized arrogance.

The agency was so caught up in its reputation as the “world’s premier public health agency” -- one that defeated polio, smallpox, HIV and other infectious disease outbreaks -- that it developed an outsized belief that it could do no wrong.

According to LeBaron, that was the mindset that Dr. Tom Frieden had when he was named CDC Director during the Obama administration. While serving as New York City’s health commissioner, Frieden led ambitious campaigns to stamp out tuberculosis, ban smoking in public places, and limit unhealthy trans fats served in the city’s restaurants.  

At CDC, LeBaron says Frieden became “the driving force” behind a campaign to limit opioid prescriptions as a way to reduce rising rates of opioid overdoses.

“I would not attribute vicious and evil impulses to the people who were involved,” says LeBaron. “I think they were gravely mistaken, but not driven by the desire to harm. They conceived of themselves as wanting to do good in a very emphatic fashion.

“The problem here was not the motivation, the notion that if you can kind of reduce prescription opioids, maybe you'll reduce subsequent addiction. The problem was not looking at the thing sufficiently quantitatively and then not checking the consequences, or at least responding to the consequences when they're brought to your attention.”

People working in public health are normally careful about tracking the outcomes of their policies. But before and after the CDC guideline, the agency turned a deaf ear to a chorus of complaints that it was forcing millions of patients on long-term opioids into rapid tapers that resulted in uncontrolled pain, withdrawal and even suicide.    

Worst of all, the number of fatal opioid overdoses doubled to over 80,000 annually after the guideline’s release, an outcome that demonstrated CDC had gone after the wrong target at the wrong time and with the wrong solution.

“The typical person who's having an overdose is a 30-year-old male taking illicit medication. The most typical person who's getting chronic opioids for pain would be a 60-year-old woman with a variety of rheumatological conditions. So you're aiming at a completely off-center target,” LeBaron explained.

“Then subsequently the data started coming in that, in effect, you are worsening the situation. If you take people who really need pain control off their meds, in a sense, it normalizes illegal acquisition.

“If somebody is really in terrible pain, needs opioid medication and can't get it through the legal system, pain is a remarkable motivator. Very few motivators are as strong as pain. And ultimately, somebody will come up to you and say, ‘I know a guy.’ And sure enough, then you end up with completely uncontrolled, unregulated stuff.”

Not until 2022 did the CDC revise its original guideline and give doctors more flexibility in prescribing opioids. By then, its 2016 recommendations were so ingrained in the U.S. healthcare system that the revisions had little, if any, impact.

Frieden left the CDC in 2017. LeBaron says Frieden’s two immediate successors did little to address the overdose crisis and the harms created by the guideline. But he does have hope for the agency’s current director, Dr. Mandy Cohen, because she has experience in public health and a better understanding of the primary role played by illicit fentanyl and other street drugs in the overdose crisis.

Asked if the CDC guideline should be scrapped or withdrawn completely, LeBaron is circumspect. He thinks a review of the guideline is in order, as well as a return to public health policies that are checked and double-checked to make sure they have outcomes that actually work.

“The difficulty here, in my opinion, is many of the same problems continue to exist, even though the personalities are completely different, and there are still significant restrictions on people in chronic pain for no apparent benefit. There continues to be very high rate of overdoses,” LeBaron said.

“I'm kind of a diehard public health guy. I want to see whether anything good happens. Nothing good happened. Time to reconsider.”

Long COVID Risk Declining, Mostly Due to Vaccinations

By Crystal Lindell

Rates of Long Covid appear to have declined over the course of the pandemic, according to new research from the Washington University School of Medicine. One reason is that people who are vaccinated against COVID-19 and its variants have about half the risk of developing Long Covid than those who are unvaccinated.

Long Covid refers to a wide range of symptoms that some people experience four or more weeks after an initial infection with COVID-19. Symptoms such as fatigue, body pain and shortness of breath may last for weeks, months or years, and can be mild or severe.  

While the new research only looked at COVID cases through 2022 – making it unclear how newer COVID strains and vaccines in 2023 and 2024 may be impacting Long COVID cases  – it does provide a ray of hope.

Specifically, researchers attributed about 70% of the risk reduction to vaccination against COVID-19 and 30% to changes over time, such as the evolving characteristics of SARS-CoV-2 and improved detection and management of COVID-19. The research was published in The New England Journal of Medicine.

“The research on declining rates of long COVID marks the rare occasion when I have good news to report regarding this virus,” said the study’s senior author, Ziyad Al-Aly, MD, a Washington University clinical epidemiologist and global leader in COVID-19 research. “The findings also show the positive effects of getting vaccinated.”

Although the latest findings sound more reassuring than previous studies, Al-Aly tempered the good news. 

“Long COVID is not over,” said the nephrologist, who treats patients at the John J. Cochran Veterans Hospital in St. Louis. “We cannot let our guard down. This includes getting annual COVID vaccinations, because they are the key to suppressing long COVID risk. If we abandon vaccinations, the risk is likely to increase.”

For the research, Al-Aly and his team analyzed millions of de-identified medical records in a database maintained by the Department of Veterans Affairs, the nation’s largest integrated health-care system. 

The study included over 440,000 veterans with SARS-CoV-2 infections and more than 4.7 million uninfected veterans. Patients included those who were infected by the original strain, as well as those infected by the delta and omicron variants. Some were vaccinated, while others were unvaccinated. 

The Long COVID rate was highest among those with the original strain, about one in every ten (10.4%). No vaccines existed while the original strain circulated.

The rate declined to 9.5% among those in the unvaccinated groups during the delta era and 7.7% during omicron. Among the vaccinated, the rate of Long COVID during delta was 5.3% and 3.5% during omicron.

“You can see a clear and significant difference in risk during the delta and omicron eras between the vaccinated and unvaccinated,” said Al-Aly. “So, if people think COVID is no big deal and decide to forgo vaccinations, they’re essentially doubling their risk of developing long COVID.”

Al-Aly also emphasized that even with the overall decline, the lowest rate — 3.5% — remains a substantial risk. 

“That’s three to four vaccinated individuals out of 100 getting long COVID,” he said. “Multiplied by the large numbers of people who continue to get infected and reinfected, it’s a lot of people. This remaining risk is not trivial. It will continue to add to an already staggering health problem facing people across the world.”

The World Health Organization has documented more than 775 million cases of COVID-19.

Disabled at Higher Risk of Long COVID  

The CDC recently found that Long COVID symptoms were more prevalent among people with disabilities (10.8%) than among those without disabilities (6.6%).

The new data was released as part of the CDC’s annual update to its Disability and Health Data System, which provides quick and easy online access to state-level health data on adults with disabilities.

The report found data that over 70 million adults in the U.S. reported having a disability in 2022.

Older adults reported a higher disability rate (43.9% for those aged 65 and older) compared to younger age groups. The race/ethnic groups with the highest rate of disability, regardless of age, identified as American Indian or Alaska Natives.

The CDC has fact sheets that provide an overview of disability in each state, including the percentages and characteristics of adults with and without disabilities. Click on any state listed here to view that state’s profile.

The findings underscore the fact that people with disabilities are a large part of every community and population.

FDA and CDC Face Flood of Litigation After Supreme Court Ruling

By Stephanie Armour, KFF Health News

A landmark Supreme Court decision that reins in federal agencies’ authority is expected to hold dramatic consequences for the nation’s health care system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care.

The June 28 decision overturns a 1984 precedent that said courts should give deference to federal agencies in legal challenges over their regulatory or scientific decisions. Instead of giving priority to agencies, courts will now exercise their own independent judgment about what Congress intended when drafting a particular law.

The ruling will likely have seismic ramifications for health policy. A flood of litigation — with plaintiffs like small businesses, drugmakers, and hospitals challenging regulations they say aren’t specified in the law — could leave the country with a patchwork of disparate health regulations varying by location.

Agencies such as the FDA are likely to be far more cautious in drafting regulations, Congress is expected to take more time fleshing out legislation to avoid legal challenges, and judges will be more apt to overrule current and future regulations.

Health policy leaders say patients, providers, and health systems should brace for more uncertainty and less stability in the health care system. Even routine government functions such as deciding the rate to pay doctors for treating Medicare beneficiaries could become embroiled in long legal battles that disrupt patient care or strain providers to adapt.

Groups that oppose a regulation could search for and secure partisan judges to roll back agency decision-making, said Andrew Twinamatsiko, director of the Health Policy and the Law Initiative at Georgetown University’s O’Neill Institute. One example could be challenges to the FDA’s approval of a medication used in abortions, which survived a Supreme Court challenge this term on a technicality.

“Judges will be more emboldened to second-guess agencies,” he said. “It’s going to open agencies up to attacks.”

Regulations are effectively the technical instructions for laws written by Congress. Federal agency staffers with knowledge related to a law — say, in drugs that treat rare diseases or health care for seniors — decide how to translate Congress’ words into action with input from industry, advocates, and the public.

Fragmented Health Policy

Up until now, when agencies issued a regulation, a single rule typically applied nationwide. Following the high court ruling, however, lawsuits filed in more than one jurisdiction could result in contradictory rulings and regulatory requirements — meaning health care policies for patients, providers, or insurers could differ greatly from one area to another.

One circuit may uphold a regulation from the Centers for Disease Control and Prevention, for example, while other circuits may take different views.

“You could have eight or nine of 11 different views of the courts,” said William Buzbee, a professor at Georgetown Law.

A court in one circuit could issue a nationwide injunction to enforce its interpretation while another circuit disagrees, said Maura Monaghan, a partner at Debevoise & Plimpton. Few cases are taken up by the U.S. Supreme Court, which could leave clashing directives in place for many years.

In the immediate future, health policy leaders say agencies should brace for more litigation over controversial initiatives. A requirement that most Affordable Care Act health plans cover preventive services, for example, is already being litigated. Multiple challenges to the mandate could mean different coverage requirements for preventive care depending on where a consumer lives.

Drugmakers have sued to try to stop the Biden administration from implementing a federal law that forces makers of the most expensive drugs to negotiate prices with Medicare — a key cog in President Joe Biden’s effort to lower drug prices and control health care costs.

Parts of the health care industry may take on reimbursement rates for doctors that are set by the Centers for Medicare & Medicaid Services because those specific rates aren’t written into law. The agency issues rules updating payment rates in Medicare, a health insurance program for people 65 or older and younger people with disabilities. Groups representing doctors and hospitals regularly flock to Washington, D.C., to lobby against trims to their payment rates.

And providers, including those backed by deep-pocketed investors, have sued to block federal surprise-billing legislation. The No Surprises Act, which passed in 2020 and took effect for most people in 2022, aims to protect patients from unexpected, out-of-network medical bills, especially in emergencies. The high court’s ruling is expected to spur more litigation over its implementation.

“This really is going to create a tectonic change in the administrative regulatory landscape,” Twinamatsiko said. “The approach since 1984 has created stability. When the FDA or CDC adopt regulations, they know those regulations will be respected. That has been taken back.”

Industry groups, including the American Hospital Association and AHIP, an insurers’ trade group, declined to comment.

Agencies such as the FDA that take advantage of their regulatory authority to make specific decisions, such as the granting of exclusive marketing rights upon approval of a drug, will be vulnerable. The reason: Many of their decisions require discretion as opposed to being explicitly defined by federal law, said Joseph Ross, a professor of medicine and public health at Yale School of Medicine.

“The legislation that guides much of the work in the health space, such as FDA and CMS, is not prescriptive,” he said.

In fact, FDA Commissioner Robert Califf said in an episode of the “Healthcare Unfiltered” podcast last year that he was “very worried” about the disruption from judges overruling his agency’s scientific decisions.

The high court’s ruling will be especially significant for the nation’s federal health agencies because their regulations are often complex, creating the opportunity for more pitched legal battles.

Challenges that may not have succeeded in courts because of the deference to agencies could now find more favorable outcomes.

“A whole host of existing regulations could be vulnerable,” said Larry Levitt, executive vice president for health policy at KFF.

Other consequences are possible. Congress may attempt to flesh out more details when drafting legislation to avoid challenges — an approach that may increase partisan standoffs and slow down an already glacial pace in passing legislation, Levitt said.

Agencies are expected to be far more cautious in writing regulations to be sure they don’t go beyond the contours of the law.

The Supreme Court’s 6-3 decision overturned Chevron U.S.A. v. Natural Resources Defense Council, which held that courts should generally back a federal agency’s statutory interpretation as long as it was reasonable. Republicans have largely praised the new ruling as necessary for ensuring agencies don’t overstep their authority, while Democrats said in the aftermath of the decision that it amounts to a judicial power grab.

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

‘We’re Flying Blind’: Response to Bird Flu Outbreak Mirrors Covid Errors

By Amy Maxmen, KFF Health News

It’s been nearly three months since the U.S. government announced an outbreak of the bird flu virus on dairy farms. The World Health Organization considers the virus a public health concern because of its potential to cause a pandemic, yet the U.S. has tested only about 45 people across the country.

“We’re flying blind,” said Jennifer Nuzzo, director of the Pandemic Center at the Brown University School of Public Health. With so few tests run, she said, it’s impossible to know how many farmworkers have been infected, or how serious the disease is. A lack of testing means the country might not notice if the virus begins to spread between people — the gateway to another pandemic.

“We’d like to be doing more testing. There’s no doubt about that,” said Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention. The CDC’s bird flu test is the only one the Food and Drug Administration has authorized for use right now. Shah said the agency has distributed these tests to about 100 public health labs in states.

“We’ve got roughly a million available now,” he said, “and expect 1.2 million more in the next two months.”

But Nuzzo and other researchers are concerned because the CDC and public health labs aren’t generally where doctors order tests from. That job tends to be done by major clinical laboratories run by companies and universities, which lack authorization for bird flu testing.

As the outbreak grows — with at least 114 herds infected in 12 states as of June 18 — researchers said the CDC and FDA are not moving fast enough to remove barriers that block clinical labs from testing. In one case, the diagnostics company Neelyx Labs was on hold with a query for more than a month.

“Clinical labs are part of the nation’s public health system,” said Alex Greninger, assistant director of the University of Washington Medicine Clinical Virology Laboratory. “Pull us into the game. We’re stuck on the bench.”

The CDC recognized the need for clinical labs in a June 10 memo. It calls on industry to develop tests for the H5 strain of bird flu virus, the one circulating among dairy cattle.

“The limited availability and accessibility of diagnostic tests for Influenza A(H5) poses several pain points,” the CDC wrote. The points include a shortage of tests if demand spikes.

Testing Failures Made Pandemic Worse

Researchers, including former CDC director Tom Frieden and Anthony Fauci, who led the nation’s response to covid, cite testing failures as a key reason the U.S. fared so poorly with covid. Had covid tests been widely available in early 2020, they say, the U.S. could have detected many cases before they turned into outbreaks that prompted business shutdowns and cost lives.

In an article published this month, Nuzzo and a group of colleagues noted that the problem wasn’t testing capability but a failure to deploy that capability swiftly. The U.S. reported excess mortality eight times as high as other countries with advanced labs and other technological advantages.

A covid test vetted by the WHO was available by mid-January 2020. Rather than use it, the United States stuck to its own multistage process, which took several months. Namely, the CDC develops its own test then sends it to local public health labs. Eventually, the FDA authorizes tests from clinical diagnostic labs that serve hospital systems, which must then scale up their operations. That took time, and people died amid outbreaks at nursing homes and prisons, waiting on test results.

In contrast, South Korea immediately rolled out testing through private sector laboratories, allowing it to keep schools and businesses open. “They said, ‘Gear up, guys; we’re going to need a ton of tests,’” said Frieden, now president of the public health organization Resolve to Save Lives. “You need to get commercials in the game.” 

Nuzzo and her colleagues describe a step-by-step strategy for rolling out testing in health emergencies, in response to mistakes made obvious by covid. But in this bird flu outbreak, the U.S. is weeks behind that playbook.

Ample testing is critical for two reasons. First, people need to know if they’re infected so that they can be quickly treated, Nuzzo said. Over the past two decades, roughly half of about 900 people around the globe known to have gotten the bird flu died from it.

Although the three farmworkers diagnosed with the disease this year in the United States had only mild symptoms, like a runny nose and inflamed eyes, others may not be so lucky. The flu treatment Tamiflu works only when given soon after symptoms start.

The CDC and local health departments have tried to boost bird flu testing among farmworkers, asking them to be tested if they feel sick. Farmworker advocates list several reasons why their outreach efforts are failing. The outreach might not be in the languages the farmworkers speak, for example, or address such concerns as a loss of employment.

If people who live and work around farms simply see a doctor when they or their children fall ill, those cases could be missed if the doctors send samples to their usual clinical laboratories. The CDC has asked doctors to send samples from people with flu symptoms who have exposure to livestock or poultry to public health labs.

“If you work on a farm with an outbreak and you’re worried about your welfare, you can get tested,” Shah said.

But sending samples to public health departments requires knowledge, time, and effort.

“I really worry about a testing scheme in which busy clinicians need to figure this out,” Nuzzo said.

‘Get Prepared Before Things Get Crazy’

The other reason to involve clinical laboratories is so the nation can ramp up testing if the bird flu is suddenly detected among people who didn’t catch it from cattle. There’s no evidence the virus has started to spread among people, but that could change in coming months as it evolves.

The fastest way to get clinical labs involved, Greninger said, is to allow them to use a test the FDA has already authorized: the CDC’s bird flu test. On April 16 the CDC opened up that possibility by offering royalty-free licenses for components of its bird flu tests to accredited labs.

Several commercial labs asked for licenses. “We want to get prepared before things get crazy,” said Shyam Saladi, chief executive officer of the diagnostics company Neelyx Labs, which offered covid and mpox tests during shortages in those outbreaks. His experience over the past two months reveals the types of barriers that prevent labs from moving swiftly.

In email exchanges with the CDC, shared with KFF Health News, Saladi specifies the labs’ desire for licenses relevant to the CDC’s test, as well as a “right to reference” the CDC’s data in its application for FDA authorization.

That “right to reference” makes it easier for one company to use a test developed by another. It allows the new group to skip certain analyses conducted by the original maker, by telling the FDA to look at data in the original FDA application. This was commonplace with covid tests at the peak of the pandemic.

At first, the CDC appeared eager to cooperate. “A right of reference to the data should be available,” Jonathan Motley, a patent specialist at the CDC, wrote in an email to Saladi on April 24. Over the next few weeks, the CDC sent him information about transferring its licenses to the company, and about the test, which prompted Neelyx’s researchers to buy testing components and try out the CDC’s process on their equipment.

But Saladi grew increasingly anxious about the ability to reference the CDC’s data in the company’s FDA application. “Do you have an update with respect to the right of reference?” he asked the CDC on May 13. “If there are any potential sticking points with respect to this, would you mind letting us know please?”

He asked several more times in the following weeks, as the number of herds infected with the bird flu ticked upward and more cases among farmworkers were announced. “Given that it is May 24 and the outbreak has only expanded, can CDC provide a date by which it plans to respond?” Saladi wrote.

The CDC eventually signed a licensing agreement with Neelyx but informed Saladi that it would not, in fact, provide the reference. Without that, Saladi said, he could not move forward with the CDC’s test — at least not without more material from the agency. “It’s really frustrating,” he said. “We thought they really intended to support the development of these tests in case they are needed.”

Shah, from the CDC, said test manufacturers should generate their own data to prove that they’re using the CDC’s test correctly. “We don’t have a shortage such that we need to cut corners,” he said. “Quality reigns supreme.”

The CDC has given seven companies, including Neelyx, licenses for its tests — although none have been cleared to use them by the FDA. Only one of those companies asked for the right of reference, Shah said. The labs may be assisted by additional material that the agency is developing now, to allow them to complete the analyses — even without the reference.

“This should have happened sooner,” Saladi told KFF Health News when he was told about the CDC’s pending additional material. “There’s been no communication about this.”

Greninger said the delays and confusion are reminiscent of the early months of covid, when federal agencies prioritized caution over speed. Test accuracy is important, he said, but excessive vetting can cause harm in a fast-moving outbreak like this one. “The CDC should be trying to open this up to labs with national reach and a good reputation,” he said. “I fall on the side of allowing labs to get ready — that’s a no-brainer.”

Clinical laboratories have also begun to develop their own tests from scratch. But researchers said they’re moving cautiously because of a recent FDA rule that gives the agency more oversight of lab-developed tests, lengthening the pathway to approval. In an email to KFF Health News, FDA press officer Janell Goodwin said the rule’s enforcement will occur gradually.

However, Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include the nation’s largest commercial diagnostic labs, said companies need more clarity: “It’s slowing things down because it’s adding to the confusion about what is allowable.”

Creating tests for the bird flu is already a risky bet, because demand is uncertain. It’s not clear whether this outbreak in cattle will trigger an epidemic or fizzle out. In addition to issues with the CDC and FDA, clinical laboratories are trying to figure out whether health insurers or the government will pay for bird flu tests.

These wrinkles will be smoothed eventually. Until then, the vanishingly slim numbers of people tested, along with the lack of testing in cattle, may draw criticism from other parts of the world.

“Think about our judgment of China’s transparency at the start of covid,” Nuzzo said. “The current situation undermines America’s standing in the world.”

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

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.

Oregon Medical Board Has ‘No Limits’ on Prescription Opioids

By Pat Anson, PNN Editor

The Oregon Medical Board has come full circle in its regulation and enforcement of pain management guidelines. After years of taking disciplinary action against doctors for prescribing high dose opioids without a “legitimate medical purpose,” the board has acknowledged that its policies had a chilling effect on doctors who no longer felt safe treating chronic pain with opioids.

“The Board is well aware some number of clinicians have shied away from long-term pain management in part or in whole for fear of Board sanctions. We wish it weren’t so, and the Board is hopeful the realignment in prescribing guidance will provide reassurance to those licensees caring for patients with long-term pain,” David Farris, MD, Medical Director of the Oregon Medical Board (OMB), recently wrote in the board’s newsletter.

The board’s “realignment” came a year after the Centers for Disease Control and Prevention revised its own opioid guideline to give doctors more flexibility in treating pain patients.

In 2016, the CDC initially recommended that daily opioid dosages not exceed 90 MME (morphine milligram equivalents), which was widely seen as a mandatory dose limit.

But after numerous reports of patients being rapidly tapered, going into withdrawal and dying by suicide, the CDC guidance was revised in 2022 to eliminate any dose thresholds. Physicians were instead urged to prescribe opioids cautiously at the “lowest possible effective dose.”   

“There are no set regulatory limits on the daily dosage of opioids that can be prescribed in Oregon. There is also not a requirement to rapidly taper or discontinue opioids for patients.”

— Oregon Medical Board

In a “Statement of Philosophy” adopted in January, the OMB urged doctors to read the CDC guideline and heed its advice about treating patients individually and to allow “shared decision making” about their treatment.

“In alignment with this statement and CDC guidelines, there are no set regulatory limits on the daily dosage of opioids that can be prescribed in Oregon. There is also not a requirement to rapidly taper or discontinue opioids for patients on existing opioid doses. The Board wants to ensure licensees accepting new patients on existing chronic opioid therapy do not feel pressured to rapidly change a patient’s current opioid dose,” the OMB said.

‘More Harm Than Good’

Opioids have been a contentious issue in Oregon for several years. In 2018, the state considered rule changes to its Medicaid program that would have limited coverage of opioids to just 90 days for patients with neck or back pain. The proposal, which would have forcibly tapered thousands of patients on long-term opioid therapy, was supported by Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.     

The plan was scrapped after pain management experts signed a joint letter warning that Oregon’s tapering plan was unsupported by treatment guidelines and would do “substantially more harm than good.”

The Medical Board’s decision to give more leeway to doctors reflects a growing awareness that the crackdown on opioids is harming pain patients and may be worsening the drug crisis.    

“The Board wishes to reassure and encourage licensees to assume the prescribing responsibilities for such patients, regardless of MME level, at least temporarily, in order to avoid patients going into withdrawal or turning to illicit sources,” Farris wrote.

“It is gratifying to see the OMB finally recognize that their arbitrary opioid dosing policies harmed people with chronic pain and the providers caring for them. It seems as though the Board may have been adversely affected by advice received from home state clinicians aligned with PROP, and, inevitably, the chickens have come home to roost in that regard,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management, who signed the 2018 joint letter.

“I hope this change in stated policy will be reflected in changes to Board investigations and to the state-developed CME (Continuing Medical Education) program on pain management that is mandated for all prescribers in the state. It's going to take years to repair the damage done so far, but I'm hoping the pendulum can finally come to rest somewhere near the midpoint of the extremes we've seen over the last 30 years.”

Opioid prescribing in Oregon has been falling for nearly a decade – as it has nationwide – but overdose deaths in the state keep rising. According to CDC data, Oregon has one of the lowest rates of fatal overdoses involving prescription opioids in the country. Deaths linked to illicit fentanyl, stimulants, methamphetamine and heroin are far more common in Oregon.  

A Pain Patient's Perspective on Opioid Prescribing

By Barby Ingle, PNN Columnist

It is essential to prescribe pain treatments that are appropriate and effective for each patient. I say that based on my own experiences as a patient, as well as thousands of others I have spoken with over the years as a friend and advocate.

Patients who need opioids, benzodiazepines, antidepressants and other medications should have access to them -- just as a heart patient has access to medication that keeps their heart functioning or a diabetic needs access to insulin.

People living with pain should also be offered individualized treatment. That could be anything from physical therapy and analgesics to surgical procedures and alternative therapies like acupuncture. I have tried over 100 different types of pain treatment; some have worked and others have not. It often made me feel like a guinea pig. Unnecessary surgery hurt me most in the end.

There are many public education campaigns underway to prevent addiction and overdoses by reducing the use of prescription opioids. These campaigns are repeated in the media, but the information does not always include facts or is presented in a misleading way.

For example, there is the DEA’s “One Pill Can Kill” campaign, which is aimed at raising awareness about a surge in counterfeit pills made with illicit fentanyl and other street drugs. Another is the CDC’s “Rx Awareness” campaign, which shares the stories of people whose lives were impacted by prescription opioids. The overall theme is that opioids are “addictive and dangerous.”  

Although well-intentioned, these campaigns have a tendency to demonize FDA-approved medications that have a lot of science and research behind them. Most people are unaware that fentanyl has been used safely and effectively for decades to treat severe pain and as an analgesic in millions of surgeries. Saying “one pill can kill” to a pain patient who has improved their life with a legally prescribed medication is disheartening.

I have seen this misinformation firsthand over the years and how it has put a damper on opioid prescribing. Physicians should prescribe opioids for pain when appropriate, but many are afraid to do so because of potential sanctions and legal threats. As a result, many providers won’t prescribe opioids or will only do so minimally and as a last resort.

Individualized Treatment

I believe each patient is different and should be treated as such. We need providers to operate on the assumption that each individual is unique and requires something different, even when they have the same disease or injury as someone else.

Physicians today can use pharmacogenomics to see if a patient’s DNA can affect how they respond to a treatment or what is chemically right for them. The dosage, brand, procedure and frequency will vary depending on each patient. I often bring my pharmacogenomics information to communicate more effectively with my providers, which benefits us both.

I also know that doing what is least invasive first and then progressing to other options is essential. Sometimes, surgery is the best option. Sometimes, opioids or other pain medications should be used first. Every medical provider should work at finding the treatment that most effectively suits the patient.

It is a considered best practice to prescribe opioids to someone in severe pain from sickle cell disease. Yet, when many sickle cell patients go to the ER or are admitted to a hospital, they are denied opioids because of hospital policy. What is the point of having a trained medical providers on staff if you won’t let them treat a patient the way they should be?

Denying pain relief is not only cruel, it can be the worst practice for everyone involved. For example, a man in severe chronic pain committed suicide after a doctor at a Kentucky pain clinic cut his opioid dose in half. The man’s family filed a lawsuit and won a $7 million judgement against the doctor and clinic.  

Ultimately, it should be the patient's responsibility to weigh the risks and benefits of any treatment, after getting input from their provider and conducting due diligence. Unfortunately, there are many obstacles standing in the way of that. One of the biggest is finding a doctor willing to prescribe pain medication. In addition, there are insurance restrictions, the cost of medication, and other logistical issues such as transportation to appointments.

Here in Arizona, patients must see their provider every month to renew a prescription for a controlled substance. Policies like that were put in place to “protect” pain patients, but only added extra costs, burdens and stigmas to them.

Patient-Physician Communication

How can we change the narrative about opioid prescribing? We can start by emphasizing the importance of effective communication between physicians and patients, even those as young as elementary school. Early education on how to talk to medical professionals and advocate for yourself is vital. I see this as one of the most critical things for patients to do.

Communication and trust are essential. Patients need to know when to take medication, how much to take, and what the potential side effects are. They also need to be able to express how the medication is working and what their symptoms are. Patients should feel comfortable asking questions and discussing their pain management plan. Physicians need to listen, provide feedback and give advice when needed.

Individualized treatment plans should be tailored to the patient’s age, gender, medical history, lifestyle and other factors.  That will help ensure that the treatment is effective and also reduce the risk of adverse reactions and potential complications. Collaborative decision-making makes patients feel more comfortable, confident in their treatment plan, and more likely to follow it.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

Stimulants Involved in Growing Number of Fentanyl Overdoses

By Pat Anson, PNN Editor

The number of drug deaths involving both fentanyl and stimulants has soared in recent years, according to a new UCLA study that highlights the complex and changing nature of the U.S. overdose crisis.

Stimulants such as cocaine and methamphetamine are now involved in nearly a third of fentanyl-related overdoses, the most of any other drug class. Fentanyl is a synthetic opioid up to 100 times more potent than morphine and 50 times as potent as heroin.

In 2010, researchers say there were only 235 fatal overdoses in the U.S. involving illicit fentanyl and stimulants. In 2021, there were 34,429 drug deaths linked to fentanyl and stimulants, a 14,550% increase in a little over a decade.

"We're now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the US overdose crisis," said lead author Joseph Friedman, PhD, an addiction researcher at the David Geffen School of Medicine at UCLA. "Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances. This poses many health risks and new challenges for health care providers.

“We have data and medical expertise about treating opioid use disorders, but comparatively little experience with the combination of opioids and stimulants together, or opioids mixed with other drugs. This makes it hard to stabilize people medically who are withdrawing from polysubstance use."

People who overdose on stimulants and other non-opioid substances mixed with fentanyl may not be as responsive to naloxone, which only works as an antidote to opioids.

The study findings, published in the journal Addiction, highlight the four “waves” of the overdose crisis, which began with an increase in deaths from prescription opioids (Wave 1) in the early 2000s, followed by a rise in heroin deaths (Wave 2) in 2010, and fentanyl-related overdoses in 2013 (Wave 3). The fourth wave — overdoses from fentanyl and stimulants — began in 2015 and continues to escalate.

The Four Waves of Overdose Crisis

SOURCE: ADDICTION

Since cocaine, methamphetamine and other stimulants are not opioids, the findings undercut the long-held theory that the overdose crisis started with prescription opioids and is still being fueled by people addicted to them. Deaths involving prescription opioids and heroin have been in decline for several years.

Researchers found that fentanyl/stimulant deaths disproportionately affect African Americans and Native Americans. There are also geographical patterns to fentanyl/stimulant use. In the northeast US, fentanyl is usually combined with cocaine, while in the south and western US, fentanyl is most commonly found with methamphetamine.

"We suspect this pattern reflects the rising availability of, and preference for, low-cost, high-purity methamphetamine throughout the US, and the fact that the Northeast has a well-entrenched pattern of illicit cocaine use that has so far resisted the complete takeover by methamphetamine seen elsewhere in the country," Friedman said.

In addition to its low cost, drug users say methamphetamine helps prolong fentanyl’s “high” and delays the onset of withdrawal symptoms.  

Counterfeit pills laced with fentanyl – which are frequently made to look like oxycodone or alprazolam (Xanax) – represent about a quarter of all illicit fentanyl seizures. Researchers say it is difficult to track deaths involving counterfeit pills because they are often mistaken for legitimate medication, so the data is not completely reliable.

In its most recent update on the overdose crisis, the CDC estimates there were a record 111,355 drug deaths in the 12-month period ending April 2023 -- about a thousand more deaths than the year before. Fentanyl and its analogues were involved in nearly 70% of the overdoses, stimulants were linked to about a third of them, and cocaine was involved in about a quarter of the drug deaths.