Rejecting Purdue Pharma’s Bankruptcy Plan Harms Pain Patients, Again

By Crystal Lindell

Turns out the family behind Purdue Pharma wasn’t always acting on the up and up when it came to their money — a revelation that surprises almost no one. But a recent Supreme Court decision punishing them for that has the potential to prolong — and even cause — more suffering for millions of pain patients.

In short, last week the Supreme Court ruled 5-4 that it was wrong for the Sackler family, which owns Purdue, to essentially try to shield some of their money through bankruptcy proceedings. Under a proposed bankruptcy plan, Purdue agreed to settle a massive lawsuit over the fraudulent marketing of the opioid medication OxyContin, which they claimed was less addictive than other opioids.

Specifically, according to an NPR article about the decision, "The ruling upended a carefully-crafted settlement worth roughly $8 billion… (for) all the individuals, states and local governments that had sued over harms from the opioid epidemic.”

The high court’s ruling means the Sackler family is now open to more lawsuits against it, and that some of the previously decided opioid cases could now be re-opened. That’s not just bad for those slated to receive money from those lawsuits, it’s also bad for pain patients. Continuing the opioid lawsuits will only perpetuate the anti-opioid zealotry that’s infiltrated the medical community.

To be honest, on a broad level, I kind of agree with the Supreme Court. If you lose or settle a lawsuit, you should not be able to move your money around by filing for bankruptcy to shield it. The problem I have with the ruling is that it is only going to serve to prolong the failed and harmful strategy of trying to solve opioid-related problems with lawsuits.

The lawsuits are especially damaging because they perpetuate the myth that the biggest sin Purdue committed in regard to OxyContin was claiming the medication wasn’t as addictive as other opioids.

That myth is even referenced on in the Supreme Court opinion:

“Because of the addictive quality of opioids, doctors had traditionally reserved their use for cancer patients and those ‘with chronic diseases.’ But OxyContin, Purdue claimed, had a novel ‘time-release’ formula that greatly diminished the threat of addiction. On that basis, Purdue marketed OxyContin for use in ‘a much broader range’ of applications, including as a ‘first-line therapy for the treatment of arthritis.’”

However, as a pain patient myself, and also as a former OxyContin user, I am here to tell you the truth: Purdue’s biggest sin wasn’t lying about how addictive OxyContin was. No, Purdue’s biggest sin was that they claimed that OxyContin time-released pills lasted 12 hours. In reality they only last about 4-6 hours.

Don’t take my word for it though. The Los Angeles Times reported the same thing in 2016.

“The drugmaker Purdue Pharma launched OxyContin two decades ago with a bold marketing claim: One dose relieves pain for 12 hours, more than twice as long as generic medications… [But] the drug wears off hours early in many people,” the Times said.

Purdue’s lie meant that thousands of patients were not prescribed enough pills to get through the day or the month, leading to two likely outcomes.

In one scenario, patients took an OxyContin when their last one wore off, and then ran out of their medication days or even weeks before their next refill date. They then faced the impossible choice of debilitating withdrawal or seeking medication on the black market.

The second scenario is that they took the medication as prescribed, only every 12 hours, and that meant they went through daily cycles of short bursts of pain relief followed by hours of pain while they wait for their next dose.

The Times also reported that Purdue was very aware of these possible problems, but wanted to maintain the lie that OxyContin lasted 12 hours to make it stand apart from less expensive opioids.  Purdue told doctors to stick to the 12-hour dosing schedule and to prescribe stronger doses if patients complained.  

Here’s the thing, the way to fix the real lie -- about how long the pills last -- is to give patients more opioids, not fewer. So instead of prescribing two 10mg OxyContin per day, the doctor should prescribe four to six 10mg OxyContin per day.

Unfortunately, that is not the lesson doctors learned from OxyContin and the opioid lawsuits. Instead, doctors decided the best solution was to minimize prescribing any opioids to any patient.  As long as these lawsuits continue, medical professionals and law enforcement will be flooded with even more propaganda about how the best way to save lives is to limit opioids.

Maybe one day, we will finally realize just how damaging it has been to make people suffer needlessly by limiting opioid prescriptions. But I fear that as long as the opioid lawsuits continue, that day will be pushed further and further out into the future.

Patients know firsthand that these lawsuits have made many doctors and pharmacists scared of prescribing opioids, even for post-op pain. But opioids are still the only effective treatment for many painful conditions. This leaves patients to languish in suffering or resort to the black market for needed relief.

We could do better than that though. We could actually help people.

How Stress, Burnout and Labor Shortages Affect Anesthesia Care

By Pat Anson, PNN Editor

Growing demand for surgical procedures to treat chronic pain and other medical conditions is contributing to shortages of anesthesia care providers, according to an op/ed in Anesthesiology, the journal of the American Society of Anesthesiologists.

"The labor supply-demand imbalance for anesthesia clinicians has reached critical levels, with major implications for safe and effective patient care," says lead author Amr Abouleish, MD, an anesthesiologist and professor at the University of Texas Medical Branch, Galveston.

Many outpatient and elective surgical procedures that were postponed during the Covid-19 pandemic have been rescheduled, leading to a surge in demand that has exacerbated shortages of anesthesia staff. Before the pandemic, about 35% of hospitals and surgical centers reported an anesthesia staffing shortage. Two years after the pandemic, the staffing shortage doubled to 78%.

“But these shortages aren't unique to just anesthesia,” Abouleish told PNN. “We're short nurses, technicians, pharmacists, even aides. And we see that in all our facilities now nationwide.”

Tired of the stress, burnout and workload demands, some providers left healthcare to pursue other professions or retired early. That has contributed to a “dangerous spiral” that has compromised healthcare access and the quality of care. Instead of using general or full anesthesia in an operating room, many outpatient procedures are now performed using partial anesthesia or a local anesthetic, which are cheaper and require less staff.

Abouleish, who specializes in pediatric care, says the staffing shortages haven’t affected patient safety in his practice. But he often finds himself working with someone on a surgery team for the first time.

“The first time we meet the nurse anesthetists is literally the day I’m working with them,” he explained. “When I work with somebody I've worked with for 10 years, we have a rapport. We've developed trust and we understand each other's limits. And that's clearly more effective, better for the team, and better for patients. As long as there is a constant change in staff, I think that's worrisome for patient safety. The surgeons will tell you the same thing.”

Abouleish says the opioid crisis has led to a more multimodal approach to treating chronic pain, which has resulted in more fusions, nerve blocks, spinal injections and other procedures that require some level of anesthesia.

“It's gone from what I saw maybe 10 years ago, before the opioid crisis, where you had physicians or clinics where the only pain management was to hand out opioids. Now it's a multimodal, multidisciplinary approach,” he said.

“There are some patients who do well with a low dose opioid, there's no question about that. But it's also important to have that multi-disciplinary approach to chronic pain. The goal oftentimes is not to take the pain away, it's just to make your everyday life more livable.”

The Center for Anesthesia Workforce Studies estimates that nearly 4,800 anesthesia professionals in the U.S. left the workforce in 2022. The following year, about 5,200 anesthesia professionals entered the workforce from training programs. Although the anesthesia workforce is growing, it’s not growing fast enough to keep pace with demand or attrition. About 57% of anesthesiologists are 55 or older and nearing retirement.

To ease workforce shortages, Abouleish and his co-authors say the number of anesthesiologist residency positions should be increased. Steps should also be taken to improve staff retention by addressing burnout and other workplace issues through more flexible scheduling and part-time work. They also say Medicare payments for anesthesiology services need to increase to keep pace with inflation and higher healthcare costs. 

‘Misplaced and Dangerous’ Opioid Study Debunked by Critics

By Pat Anson, PNN Editor

Nearly a year after publishing a controversial study that questioned the effectiveness of opioid pain medication, The Lancet medical journal has published two rebuttal letters that challenge the study’s design and conclusions.

The blinded, placebo-controlled clinical trial – known as the OPAL study -- found that a 6-week course of low-dose oxycodone worked no better than a placebo in treating patients with recent mild-to-moderate back and neck pain. Based on that finding, Australian researchers recommended that opioids should not be used to treat acute back and neck pain, and that medical guidelines should be changed to reflect that view.

“Opioids should not be recommended for acute back and neck pain, full stop,” said lead investigator Christine Lin, PhD, a professor in the School of Public Health at University of Sydney.

“This recommendation is an extraordinary, misplaced, and dangerous conclusion, considering the authors studied the effects of only one type of slow-release opioid not indicated for acute pain and that guidelines should not be changed on the basis of a single randomized trial,” said Asaf Weisman, Dr. Youssef Masharawi and Dr. James Eubanks in their rebuttal letter. 

Weisman is a physiotherapist and spine researcher at Tel Aviv University, Masharawi is a professor of physical therapy at Tel Aviv University, and Eubanks is an assistant professor at the Medical University of South Carolina.    

“Relief of pain is one of the obligations of medical doctors. Despite the documented risks, which cannot be understated, opioids are indispensable for pain management, particularly in cases in which other forms of treatment are ineffective or inadequate,” they wrote. 

The second rebuttal letter noted that the OPAL study had an “extremely high” dropout rate and nearly a quarter of patients in the placebo group were taking opioids when the study began – two factors that confound and weaken the study’s findings. 

“We should be careful when drawing decisive conclusions based on this trial,” wrote Dr. Yu Toda, a palliative care specialist at Japan’s National Cancer Center Hospital. 

In reply to the letters, Lin and her co-authors defended the design of the OPAL study, but agreed the conclusions may have been too broad.

“We agree that we cannot generalize our results to all opioids. There are different opioid classes with different pharmacological profiles,” said Lin. “We agree that the OPAL results might not be generalizable to all patients with acute low back and neck pain, including those experiencing hyperacute pain requiring immediate pain relief in the emergency department.” 

Other critics found additional flaws in the OPAL study, pointing out that the daily dose of oxycodone was relatively low – ranging from 15 to 30 MME (morphine milligram equivalents) -- and that the oxycodone was combined with naloxone, a medication that blocks the effects of opioids. In clinical practice, a slow-release formulation of oxycodone is usually not prescribed for short-term pain and is never combined with naloxone,

Publishing rebuttal letters is a common practice for medical journals, but – until now -- The Lancet has not shared with its readers any counterpoints to the OPAL study

“The Lancet received submitted replies criticizing the OPAL Trial’s authors’ over-generalized conclusion within a month of the study’s online publication. Given evidence for patient harms from excessively rapid dose reductions or discontinuation of opioid therapy, waiting almost a year to publish these criticisms seems recklessly irresponsible,” said Dr. Chad Kollas, a palliative care physician and pain policy expert, whose rebuttal letter was rejected several months ago by The Lancet’s editors.

‘Many Patients Have Been Hurt’

The OPAL study received a fair amount of media attention when it came out and was even hailed as a “Landmark Trial” by some news outlets. But like many news stories dealing with opioids, they conveyed the simplistic message that all opioids are risky and ineffective, regardless of a patient’s condition, pain level or need.

“The Great Opioid Lie: Addictive painkillers do NOT reduce lower back or neck pain,” was the headline used by the Daily Mail. “Opioids might actually worsen pain in the long-run while increasing the odds of becoming addicted.”  

The OPAL study was even cited by U.S. Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) in a letter to the FDA urging the agency not to conduct studies on the efficacy of opioids. Further studies are not needed, they claimed, and would only lead to the approval of new opioid medication.

“A recent randomized placebo-controlled study found that prolonged opioid use was ineffective for acute back and neck pain,” Sens. Markey and Manchin wrote. “For too long, drug manufacturers have been given the benefit of the doubt in developing and marketing a drug that unleashed a widespread, decades-long epidemic. Using a study model that risks continued bias in favor of approval is unacceptable.”

Weisman and his two colleagues say “opioid phobia” in the U.S. has led to pain patients around the world being denied appropriate treatment, causing unnecessary suffering.  

“Unfortunately, the opioid epidemic in the USA has led to many countries adopting strict umbrella policies and led to so-called opioid phobia among clinicians, and many patients worldwide have been hurt due to these processes,” they wrote.

Illegal Online Pharmacies Still Advertise on Facebook

By Pat Anson, PNN Editor

At least two illegal online pharmacies are advertising on Facebook, offering to sell opioids and other controlled substances to people without a prescription and without visiting a doctor. The ads appear to be a direct violation of Facebook’s own policies and may be illegal.

“29 common medications, delivered fast and privately. No prescription required,” says one ad displaying an image of Adderall and Xanax tablets.

“Don’t leave your home, stay safe with us,” says another ad offering to sell Xanax. “Get our delivery services and we will have everything you need.”  

Of course, there’s nothing “safe” about the sale of medication – real or counterfeit -- by sketchy companies over the internet.

In addition to Adderall and Xanax, Canadian Online Pharmacy and BestPharm also offer home delivery of opioids, muscle relaxers, weight loss, anti-anxiety, and erectile dysfunction drugs – many of them brand name medications sold at inflated prices.  

I was surprised to see the ads in my Facebook feed. I’ve been covering pain management for over a decade and frequently interact with PNN readers over Facebook, so it’s likely the ads are using Facebook algorithms and user history to selectively target me and my readers – many of them chronically ill -- even though Facebook and its parent company Meta have strict policies about pharmaceutical advertising.

“Promoting prescription drugs is not allowed without prior written permission from Meta,” Facebook states on its website, directing advertisers to an online application form that requires they first be registered and certified by LegitScript. Facebook and other e-commerce platforms use LegitScript to make sure they’re doing business with reputable companies that can pay them for advertising.

However, unlike other internet companies, Facebook does not use LegitScript to proactively monitor and screen ads to make sure they don’t promote questionable products or engage in illicit activity.

If they did, they would quickly learn that LegitScript classifies Canadian Online Pharmacy as a “rogue” pharmacy that uses fraudulent or deceptive business practices.  

“LegitScript has reviewed this Internet pharmacy and determined that it does not meet LegitScript Internet pharmacy verification standards,” LegitScript states on a webpage that anyone can use to check the URLs of online pharmacies to see if they are legitimate.  

“Additionally, LegitScript has determined that this pharmacy website meets our definition of a Rogue Internet Pharmacy.”

BESTPHARM FACEBOOK AD

BestPharm isn’t even listed in LegitScript’s database, which means Facebook shouldn’t be running their ads, according to its own policies.

Facebook and Meta did not respond to requests from PNN for comment on this story.

“Facebook has a role to play in enforcing their advertising policy and, in this case, their policy is not meeting their own expectations,” says Libby Baney, senior advisor to the Alliance for Safe Online Pharmacies, a trade group that estimates there are 35,000 active online pharmacies worldwide, about 95% of them operating illegally or engaged in fraud.     

“A number of years ago, the social media platforms were admonished by the FDA to try to do more to prevent this type of advertising or content to consumers. And many, including Facebook, made commitments or pledges to government and public health officials to do more to screen their ads for this type of content,” Baney told PNN.

“I was quite surprised actually to see how blatant the advertisements were that you found and I don't have a real explanation for it, other than they’re falling through the cracks of the advertising policy standards that many of these companies, including Facebook, have in place.”

‘How Can This Be Legal?’

Fortunately, many Facebook users who saw the same ads I did questioned whether the pharmacies are legitimate. They showed their skepticism in the comment section of the ads.

“Xanax being promoted on Facebook? Profits must be low,” wrote one poster who saw an ad that featured a hand holding about 20 Xanax tablets.

“Wow, that’s enough to sedate an entire neighborhood. Way to make yourselves look legit, LOL!” said another poster.

“Your Prices are INSANE.......... cheaper to buy from the dude slinging drugs on the corner,” wrote another Facebook poster.

“How can this be legal?” asked another.

Remember, these ads are deliberately targeting people with chronic pain and other illnesses, who often have trouble getting their medications. There are currently record shortages of prescription drugs and many pharmacies are out of stock or rationing medications in short supply.

CANADIAN ONLINE PHARMACY FACEBOOK AD

In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled.

Desperate people do desperate things. We’ll never know many Facebook users clicked the button to “Learn more,” which takes them directly to the advertiser’s website where they can place an order for drugs.

“It could be a total scam, meaning your credit card and personal information are stolen. Or it could be a partial scam that could endanger your health, which is you get something dangerous laced with fentanyl,” says Baney. “You're putting your life in the hands of some anonymous advertiser on the internet.”

‘No Prescriptions Needed’ 

A close look at an online pharmacy’s website may provide a clue to their legitimacy. Canadian Online Pharmacy, for example, bills itself as an “international” pharmacy that ships medications around the world.

“Your Global Source for Quality Medicines! No prescriptions needed, no awkward doctor visits! Enjoy convenience, privacy, and savings on top-notch medications, all delivered to your doorstep,” the website claims.

Where is the Canadian Online Pharmacy based? The company lists an address in Wheeling, West Virginia that is shared with dozens of other online companies, selling everything from pillows and audio equipment to cameras and pizza. The telephone that’s listed has a Washington DC area code.

BestPharm doesn’t provide a physical address or telephone number, but does share the names and pictures of several people who supposedly run the company in its “About Us” section. Their names and images appear to be fictitious or stolen off the internet.

The picture for Chief Operating Officer Jessica Pearson, for example, is the same one used by over a dozen other women online, only their names are Emma, Emily and Ella.

Emma is particularly notable. Her Linkedin page claims she works for Google on special projects involving artificial intelligence, and that she’s a graduate of the Massachusetts Institute of Technology, where she studied “the toggled self-assembly of colloidal suspensions in binary systems.”

BESTPHARM

LINKEDIN

All of this might be funny, if it wasn’t for the fact that people are getting ripped off and risking their lives by buying drugs from fake pharmacies.

“I hear about these types of incidents or patient experiences from parents who've lost loved ones, who have purchased counterfeit products online after seeing ads that are clearly in violation of U.S. law,” Baney said.

According to The Wall Street Journal, Meta is under investigation by federal prosecutors for its role in the illicit sale of drugs online. A grand jury has been convened to look into whether the company’s social-media platforms are facilitating and profiting from illicit drug sales. No criminal charges have been filed.

“The sale of illicit drugs is against our policies and we work to find and remove this content from our services,” a spokesman for Meta said in a statement to the newspaper.

‘When Are You Going to Take Down These Posts?’

In 2018, Meta CEO Mark Zuckerberg was grilled during a congressional hearing about Facebook publishing posts and ads for illegal online pharmacies.

“Your platform is still being used to circumvent the law, and allow people to buy highly addictive drugs without a prescription,” said Rep. David McKinley (R-WV). “When are you going to take down these posts that are done with illegal, digital pharmacies?”

“Right now when people report the posts to us, we will take them down and have people review,” Zuckerberg replied. “I agree that this is a terrible issue, and respectfully, when there are tens of billion pieces of content that are shared every day, even 20,000 people reviewing it can’t look at everything.” 

Six years have passed and illegal online pharmacies are still advertising on Facebook. The company heavily relies on artificial intelligence (AI) to screen the millions of advertisements it runs every year.

But clever advertisers find ways to outsmart AI. There’s even a tutorial on YouTube to help cannabis companies get around Facebook restrictions on cannabis advertising. The key is to avoid using certain keywords like “THC” or getting “high,” which could get an ad rejected by AI. It’s better to use emojis, images and vague terms to get your point across.

“The goal is not to try to break the rules, but to see where you can bend the rules. Be a little bit creative,” says Aaron Nosbisch, CEO and Founder of Brez, a cannabis-infused drink.

“My ads are saying you’ll experience euphoria, feelings of relief, and be a great alternative to alcohol. Promote the ideas of what the products do for people (without mentioning) THC and CBD. People are looking to feel good. People are looking to have a good night and have a good time. Sell that.”

What can Facebook do to stop advertisers from exploiting cracks in its screening system?

“Enforce their own policy,” says Baney. “We look forward to Facebook addressing these issues that they've committed to in public forums with government officials.”

Little Evidence That Antidepressants Work for Chronic Pain

By Drs. Hollie Birkinshaw and Tamar Pincus

About one in five people globally live with chronic pain, and it is a common reason for seeing a doctor, accounting for one in five GP appointments in the UK.

With growing caution around prescribing opioids – given their potential for addiction – many doctors are looking to prescribe other drugs, “off-label”, to treat long-term pain. A popular option is antidepressants.

In the UK, doctors can prescribe the following antidepressants for “chronic primary pain” (pain without a known underlying cause): amitriptyline, citalopram, duloxetine, fluoxetine, paroxetine and sertraline. Amitriptyline and duloxetine are also recommended for nerve pain, such as sciatica.

However, our review of studies investigating the effectiveness of antidepressants at treating chronic pain found that there is only evidence for one of these drugs: duloxetine.

We found 178 relevant studies with a total of 28,664 participants. It is the largest-ever review of antidepressants for chronic pain and the first to include all antidepressants for all types of chronic pain.

Forty-three of the studies (11,608 people) investigated duloxetine (Cymbalta). We found that it moderately reduces pain and improves mobility. It is the only antidepressant that we are certain has an effect. We also found that a 60mg dose of duloxetine was equally effective in providing pain relief as a 120mg dose.

In comparison, while 43 studies also investigated amitriptyline (Elavil), the total number of participants was only 3,372, indicating that most of these studies are very small and susceptible to biased results.

The number of studies and participants for the other antidepressants are:

• Citalopram (Celexa): five studies with 209 participants

• Fluoxetine (Prozac): 11 studies with 622 participants

• Paroxetine (Paxil): nine studies with 960 participants

• Sertraline (Zoloft): three studies with 210 participants.

The evidence for amitriptyline, citalopram, fluoxetine, paroxetine and sertraline was very poor, and no conclusions could be drawn about their ability to relieve pain.

This is particularly important as UK prescribing data shows 15,784,225 prescriptions of amitriptyline in the last year. It is reasonable to assume that a large proportion of these may be for pain relief because amitriptyline is no longer recommended for treating depression.

This suggests that millions of people may be taking an antidepressant to treat pain even though there is no evidence for its usefulness. In comparison, 3,973,129 duloxetine prescriptions were issued during the same period, for a mixture of depression and pain.

In light of our findings, which were published in May 2023, the UK’s National Institute for Health and Care Excellence (Nice) recently updated its advice to doctors on how to treat chronic pain.

The updated Nice guidance now suggests 60mg of duloxetine to treat [chronic primary pain] and the same drug and dose to treat nerve pain.

Limited Treatments Options

GPs often report frustration at the limited options available to them to treat patients experiencing chronic pain. Amitriptyline is cheap to prescribe – only 66p per pack (US 82.5 cents) – which may explain the high number of prescriptions for this drug.

This is an example of how the gap between evidence and clinical practice could harm patients. Although our review was unable to establish the long-term safety of antidepressant use, previous research has highlighted the high rates of side-effects for amitriptyline, including dizziness, nausea, headaches and constipation.

It’s important to bear in mind, though, that pain is a very individual experience, and the evidence in our review is based on groups of people. We acknowledge that certain drugs may work for people even when the research evidence is inconclusive or unavailable. If you have any concerns about your pain medication, you should discuss this with your doctor.

Hollie Birkinshaw, PhD, is a Research Fellow at University of Southampton. She specializes in research involving chronic musculoskeletal pain, and the integration of psychology in pain and health services. Birkinshaw receives funding from the UK’s National Institute for Health and Care Research (NIHR).

Tamar Pincus, PhD, is a Professor of Health Psychology at University of Southampton. Her research focuses on the psychological aspects of chronic pain. Pincus receives funding from NIHR, Medical Research Council and Versus Arthritis.  

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

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.

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.

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.  

Patients Blame DEA for Drug Shortages, Not Monopolies or Middlemen

By Pat Anson, PNN Editor

Two federal agencies are getting more than they bargained for when they asked the public to comment on record shortages of prescription drugs.

In February, the Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) made a joint Request for Information in the Federal Register, asking how wholesalers and other “middlemen” in the drug supply chain were contributing to persistent shortages.

“When you’re prescribed an important medication by your doctor, and you learn the drug is out of stock, your heart sinks,” HHS Secretary Xavier Becerra said in a press release. “This devastating reality is the case for too many Americans who need generic drugs for ADHD, cancer, and other conditions. (This) announcement is part of the Biden-Harris Administration’s work to tackle healthcare monopolies and lessen the impact on vulnerable patients who bear the brunt of this lack of competition.”

Nearly 10,000 comments have been received so far, with many blaming the federal government for the drug shortages -- not monopolies, middlemen or lack of competition. Drawing the most criticism is the Drug Enforcement Administration (DEA), which sets annual production quotas for opioids, stimulants and other controlled substances. The CDC and FDA also came under fire from frustrated patients.

“The heavy-handed failure of the FDA/DEA to properly and ethically manage the uptick in ADHD prescriptions is creating a crisis on par with their equally underhanded failure in managing the opioid crisis,” wrote Matti Dupre. “Hardworking Americans are left looking at the individuals leading these organizations as a source of pain rather than as a means of support.”

“Millions of people are having a hard time getting their prescription opioid medications filled at pharmacies now. Why? Because the DEA have cut production down so low, pharmacies can't get what they need to fill our prescriptions,” said Candi P. “Wake up! Stop playing with our lives!”

“The government has gone way too far, with their guidelines and regulations regarding opioids,” wrote Julie Anuskewic, who has a painful immune system disorder. “My pain is not controlled because the CDC has scared all doctors into not prescribing. It’s bad enough that they have destroyed the doctor-patient relationship. Now they are destroying the patient-pharmacist relationship.” 

Notably lacking in the FTC and HHS statement about drug shortages is any mention of the National Opioid Settlement, which has forced major drug wholesalers and big chain pharmacies to ration opioids and other controlled substances or risk losing their DEA licenses. Some manufacturers are also cutting back on production of generic opioids because the profit margins are low and the risk of further litigation is high.

A recent PNN survey found that 90% of patients with opioid prescriptions had trouble getting them filled, with one in five unable to get their pain medication even after contacting multiple pharmacies.  

“The FTC is looking in the wrong places for reasons for drug shortages, at least as far as opioids and stimulants are concerned,” wrote Andrea MacNary. “In those cases, the shortages are a direct result of the DEA's policies – with input from the FDA – that have seen annual reductions in the amount of drugs that manufacturers are allowed to produce.

”This results in patients being unable to obtain their legally prescribed medications in a timely manner. Because pharmacies have shortages, patients are then forced to call around to different pharmacies looking for their meds. This is extremely difficult, because not only do pharmacies not want to disclose whether they have the drugs in stock, but if the patient does find them, they must obtain a new prescription from their doctor.”

‘Broken Quota System’

One critic sees the public outreach by the FTC and HHS as a ham-handed attempt to coverup the DEA’s “crude and inadequate system” for regulating controlled substances   

“I believe the FTC is only trying to find cover for the Drug Enforcement Administration.The DEA is the only governmental agency that sets production and distribution quotas for every drug company manufacturing controlled medication,” William Dodson, MD, wrote in a recent op/ed in ADDitude. “This problem traces its roots and long tendrils back to the DEA alone. No other agency has the authority to create and prolong it. 

“The time has long since passed for the DEA to admit its fault and fix its broken quota system. There has already been too much needless suffering by innocent people who did nothing to cause the DEA’s restrictions.”

That’s not how the DEA sees it. This month a top DEA official compared the growing demand for Adderall and other ADHD stimulants to the early stages of the opioid crisis. Matthew Strait claimed the problem isn’t tight supplies, but excessive prescribing of stimulants.

“I’m not trying to be a doomsday-er here,” said Strait, deputy assistant administrator in the DEA’s diversion control division. “It makes me feel like we’re at the precipice of our next drug crisis in the United States.”

If you’d like to make a comment in the Federal Register on the FTC and HHS Request for Information, click here. Comments will be accepted until May 30. 

Pain Patients Challenge DEA’s ‘Bogus Judicial System’

By Pat Anson, PNN Editor

Patients of a California doctor whose license to prescribe opioids and other controlled substances was suspended by the DEA have launched another long shot legal bid to get his license reinstated.

DEA administrator Anne Milgram suspended the license of Dr. David Bockoff in 2022, largely based on allegations that five of his pain patients were receiving dangerously high doses of opioids. Bockoff’s abrupt suspension left 240 patients – including many who suffer from severe and incurable pain conditions -- scrambling to find new providers and pain medication.

At least three of those patients have since died, including one who committed suicide with his wife and another who died after buying opioid medication in Mexico.

“Every time you take away a doctor's license without giving them any opportunity to fight it, you put a patient on the street who's a chronic pain patient and they've just been abandoned. No explanation or anything,” says attorney John Flannery. “And the government doesn't give a damn. They don't care at all.”

Flannery represents nine Bockoff patients who have tried repeatedly to gain legal standing as interested parties in the DEA case against the Beverly Hills doctor. Their efforts so far have failed. An Administrative Law Judge would not let them attend DEA hearings on the case, and a federal judge refused to grant a temporary restraining order that would have restored Bockoff’s license while he appeals his suspension.

Recently, a three-judge panel on the District of Columbia’s U.S. Court of Appeals declined to intervene in the case, saying the patients provided the court with “no credible factual submissions” that document how they were harmed by Bockoff’s suspension. The judges’ order makes no mention of the patients who died.

‘We Were Entirely Hamstrung’

Part of the problem is the closed administrative system that the DEA uses to discipline doctors, in which the agency essentially serves as the prosecutor, judge and executioner. Flannery calls it a “bogus judicial system” that the DEA created for itself. Even the rulings of a supposedly independent Administrative Law Judge (ALJ) can be rejected by the DEA Administrator.

“There is much talk about how the government is ‘open’ and transparent, but DEA’s proceedings are entirely opaque to patients and the public,” Flannery wrote in his latest appeal, in which he asks the full DC Court of Appeals for an en banc review of the case.

“We were entirely hamstrung to proceed to seek review in any DEA proceedings as we had no right to review any pleadings, to attend any hearings, to monitor the proceedings, to review any of the ‘evidence,’ to hear the arguments, and the only decision made available to us by the ALJ related to the (unsuccessful) motion to intervene.”

Flannery says federal law allows any “interested persons” or “person aggrieved” by the DEA to have a legal standing in its administrative hearings. If the Appeals Court accepts that argument, it would set a major precedent that would affect all future DEA cases against doctors by giving their patients a seat at the table.

Flannery says the DEA’s disciplinary actions against Bockoff and other doctors interfere with the practice of medicine.

“I hate to say it’s a witch hunt, but I think we found a witch and the witch is the present DEA administrator,” Flannery told PNN. “She's part of a machine that just keeps chugging along, hurting and hurting and hurting. How does one go into government to do that? Who do they think they're saving? They found five patients that they claim were harmed, and so the other 235 patients, they have no idea about them, and they just cut them off. How do you justify that?”

Flannery’s appeal also cites the DEA’s “flimsy evidence” against Bockoff, most notably the agency’s expert witness, Dr. Timothy Munzing, a family practice physician who has launched a lucrative second career for himself as a government witness against doctors accused of overprescribing opioids. Munzing has made over $3.4 million testifying for the federal government in dozens of cases against doctors. In an Ohio case, a judge declared a mistrial after Munzing contradicted himself during testimony.

“The DEA’s expert, Dr. Timothy Munzing, was, by any fair review, ‘damaged goods’ by DEA’s overuse of his ‘skills,’” Flannery wrote. “On information and belief, this impeachment material involving Dr. Munzing, the DEA’s sole expert witness, was withheld from Dr. Bockoff in the DEA Administrative proceeding.”

A protracted legal challenge of this kind is expensive and a GoFundMe campaign has been created by the nine Bockoff patients to help support it. Over $10,000 has been raised so far.

“Please know that we'll be working as hard as we can to keep this fundraiser and our effort going,” said Kristen Ogden, the wife of one of the patients. “Our donors are helping so much in this effort to make a difference for chronic pain patients and doctors. As John (Flannery) says, we are doing something that hasn't been done before... seeking to intervene so that patients can have a voice.”

U.S. Drug Shortages Reach Record Levels

By Pat Anson, PNN Editor

Shortages of opioids and other medications reached a record level in the U.S. during the first quarter of 2024, according to the American Society of Health-System Pharmacists (ASHP). The 323 medications listed in short supply are the highest number since the ASHP began tracking drug shortages in 2001.

Some of the most acute shortages are for basic, life-saving injectable drugs used in hospitals for pain control, sedation and chemotherapy.

Most of the drug manufacturers contacted by the ASHP did not provide a reason for the shortages, but some blamed supply/demand issues (14%), manufacturing problems (12%), business decisions (12%) and raw material issues (2%).

The ASHP also cited reduced DEA production quotas and the fallout from opioid litigation settlements, which have curtailed the supply of opioid medication at many pharmacies.

“New DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances,” the ASHP said in its latest report.

The Drug Enforcement Administration has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. The DEA says it acts on the advice of the Food and Drug Administration, which projected a 7.9% decline in the “medical need” for opioids in 2024, months before the new year even began.

Many pain patients question whether the demand for opioids is really going down. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy. Nearly 20% were unable to get their pain medication, even after contacting multiple pharmacies.

“The pharmacist said they could not get my medication because the supplier informed them that they had reached their yearly max and the DEA would not let them supply anymore medication,” one patient told us.

“I am terrified of the cuts being pushed by the DEA,” said another patient. “Several times I have had to wait over a week until my local CVS got my medication back in stock. Honestly, I have such intolerable pain I had no choice but to turn to illicit street drugs to fill in the gaps.”

Shortages of stimulants used to treat attention-deficit/hyperactivity disorder (ADHD) get far more attention than shortages of opioids, which the FDA and DEA have largely ignored. The DEA modestly raised production quotas for ADHD drugs in 2024, but they remain in short supply.

About 12% of the 323 drugs currently listed in shortage by the ASHP are controlled substances regulated by the DEA because they are potentially addictive.

University of Utah Drug Information Service

“I can’t say for sure that every single controlled substance shortage is due to quota issues, but it’s a contributing factor for some,” says Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP. “DEA changed their quota process to try to help with ADHD drug shortages, but didn’t take into account how their change affects injectable manufacturers.”

Fox shared a recent letter sent by Pfizer to U.S. hospitals warning of “additional supply interruptions and potential stock outs” due to DEA quota changes. The letter warns of limited supplies of several injectable medicines made by Pfizer, including meperidine (Demerol), hydromorphone and morphine.  

“I understand that DEA is working to prevent drug diversion and was under fire for the ADHD medication shortages, but injectable manufacturing is very different than oral products and DEA did not take into account all of the special processes that are required for injectables,” Fox said in an email to PNN.

Nearly half of the drugs on the ASHP’s shortage list are injectables. Opioids, stimulants and other drugs that affect the central nervous system are the leading class of medication in short supply, followed by antibiotics, hormonal agents, and chemotherapy drugs.

The FDA, which uses a different system to track drug shortages, currently lists only 153 medications in short supply, less than half the number listed by the ASHP.

A Third of Independent Pharmacies May Close

By Pat Anson, PNN Editor

These are tough times for many retail pharmacies and their customers. Big chain pharmacies like CVS, Walgreens and Rite Aid are closing over 1,500 stores, as they grapple with declining sales, higher debt, drug shortages, fallout from opioid litigation, and an overworked, demoralized workforce.

For many patients who had trouble getting their prescriptions filled for opioids and other controlled substances, small independent pharmacies became a welcome refuge from the big chains.

“I'm fortunate to have a compassionate, independent pharmacy that bends over backwards to ensure I have the meds my doctor prescribes. If I was stuck with a chain pharmacy like Walgreens or CVS, my experience would be completely different. Those pharmacies treat pain patients like criminals,” one patient told us.

But now even the independent pharmacies are threatened. About a third of them could close in 2024, according to a dire prediction from the National Community Pharmacists Association (NCPA), a trade group that represents nearly 20,000 independent pharmacy owners in the U.S.

“Nearly a third of independent pharmacy owners may close their stores this year under pressure from plunging prescription reimbursements by big insurance plans and their pharmacy benefit managers,” says B. Douglas Hoey, RPh, NCPA’s CEO.

At issue is a new rule by the Centers for Medicare & Medicaid Services (CMS) that requires insurers and pharmacy benefit managers (PBMs) to implement discounts and price concessions at the point of sale, where a drug is dispensed. The rule is intended to make pricing more transparent for patients, but it’s hurting the bottom line of pharmacies who say the discounts are being unfairly forced on them by insurers.

Part D Prescriptions at Risk

In a recent survey of NCPA members, 32% said they may have to close by the end of the year due to the CMS rule and 93% said they’d consider dropping out of Medicare’s Part D prescription drug program. Most say they are losing money on Part D prescriptions, which don’t compensate the pharmacies for rent, taxes, payroll and other costs of doing business.

“Cash flow for many pharmacies remains in a precarious state, leading to dire concerns for beneficiary access. Our members continue to experience significant harm from egregious Medicare Part D PBM practices,” Hoey wrote in a letter to CMS, which faulted the agency for doing little to stop the PBMs.

Asked which PBMs are causing the most financial stress in the Part D program, almost half the NCPA members identified Express Scripts, with CVS/Caremark coming in at 35 percent.

Hoey says CMS already has the legal authority to change reimbursement practices, but wants Congress to intervene if CMS doesn’t act soon.

“This is an emergency. And if Congress fails to act again, thousands of local pharmacies could be closed within months and millions of patients could be stranded without a pharmacy,” Hoey said in a statement.

NCPA says there are about 2,200 fewer retail pharmacies today than there were four years ago. This has created hundreds of pharmacy “deserts,” primarily in low-income rural and urban areas, where access to a pharmacy is limited or non-existent. Alabama alone has lost 300 pharmacies in recent years.

“With every closure, 5,000 Alabamians are left without a critically important health care provider. This is a major issue for every community in our state, but rural Alabama is hit the hardest. In many cases, that local pharmacy is the only healthcare provider in that rural community,” Alabama State Rep. Phillip Rigsby, a pharmacist, wrote in an op/ed published in AL.com.

“In other businesses, if an operating cost increases, the company’s prices increase to compensate. In pharmacy, that just is not possible. A pharmacy cannot pass on that cost to a patient because the contract doesn’t allow for that.”