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.”

AI in Healthcare: Designed for Progress or Profit?

By Crystal Lindell

As a pain patient, I take a controlled substance medication, which means every single time I need a refill I have to contact my doctor. 

It doesn’t matter that this refill comes every 28 days and that I have been getting it refilled every 28 days for years. It doesn’t matter that my condition has no cure, and that I will most likely need this medication refilled every 28 days for the foreseeable future.

No. I have to make sure to contact my doctor and specifically ask for it, every single time.  

There are ways to automate this process. They could give me a set number of automatic refills and have them sent to the pharmacy every 28 days. If we were even more practical, they could just give me 60 to 90 days worth of pills at a time, and save me from multiple trips to the pharmacy. 

But because of insurance rules, hospital policies and opioid-phobia legislation, all of those options are impossible. In fact, they actively work to make a process that could be automated into something that has to be done manually. 

Which is why I’m so skeptical of Artificial Intelligence (AI) in healthcare. 

The promise of AI is that it can automate away the mundane tasks so many of us hate doing. Many health related tasks could easily be automated. They just purposefully are not. 

The hospital I go to for my medical care, University of Wisconsin-Madison, recently released a report filled with recommendations for how AI should be integrated into healthcare. It was based on a recent roundtable discussion that included healthcare professionals from across the country. 

But while the participant list included doctors, IT staff, policy experts, and academics, there was one very glaring absence – the list of participants included exactly zero patients. 

UW Health was one of the organizers for the panel, along with Epic, a healthcare software developer. Their report includes some seemingly good recommendations. 

They ask that AI be used to supplement the work that doctors, nurses and other healthcare staff perform, as opposed to replacing the staff altogether. They say AI could be a great tool to help reduce staff burnout. 

They also recommend that the technology be set up in such a way that it also helps those living in rural areas, in addition to those in more metropolitan ones. The report also emphasizes that healthcare systems should prioritize “weaving the technology into existing systems rather than using it as a standalone tool.”

Additionally, the report stressed the need for federal regulations to “balance space for innovation with safeguarding patient data and ensuring robust cybersecurity measures.”

I don’t disagree with any of that. But it’s a little frustrating to see those recommendations, when some of those problems could already be solved if we wanted them to be. 

And while the panel’s report is new, UW Health’s use of AI is not. 

In April, UW Health announced that they were participating in a new partnership program with Microsoft and Epic to develop and integrate AI into healthcare. 

At the time they said the innovation would be focused on “delivering a comprehensive array of generative AI- powered solutions… to increase productivity, enhance patient care and improve financial integrity of health systems globally.”

That’s the real motivation to bring AI into healthcare: make more money by improving “financial integrity.” Something tells me that AI won’t be used to lower patient’s bills though. 

UW Health also recently shared that its nurses were using AI to generate responses to patients. Over 75 nurses were using generative AI, which assisted them in creating more than 3,000 messages across more than 30 departments.

“This has been a fascinating process, and one I’ve been glad to be part of,” said Amanda Weber, registered nurse clinic supervisor, UW Health. “I have found having a draft to start from helpful, and I’m glad I could provide feedback on improvements and features to ensure this can be a good tool for nurses and have a positive impact on our patients.”

Before I even knew about this program, I had a feeling that AI was involved. 

Recently, when I messaged my doctor about my upcoming refill, I received an overly-formal, odd response that felt very much like generative AI writing to me. Which is fine. I honestly don’t mind if my doctor saves time by using AI to respond to patient emails. Heck, I myself have used AI to write first drafts of some emails. 

But my doctor and his staff wouldn’t even need to reply to my emails if he was allowed to set up automatic refills of my long-time medication instead. 

There are many ways to improve health care, and tools like generative AI are likely among them. But AI can’t solve problems that exist on purpose. 

Unless patients are at the forefront of the conversations about these tools, I fear they’ll only be used to solve the sole problem hospital administrators actually care about: how to make more money. 

What Doctors Really Mean When They Say It’s an ‘Easy Surgery’

By Crystal Lindell

Back in 2009, I had an “easy surgery” to get my gallbladder removed after multiple excruciating gallbladder attacks. Before the operation, my surgeon went on and on about how easy the surgery would be. He emphasized multiple times how simple it was.

I went into that operating room completely underestimating what I would experience when I came out of the anesthesia. 

I woke up from that surgery vomiting so much that the single hour I was scheduled to spend in post-op recovery turned into eight hours. And instead of the three days I was told that I’d need for recovery at home, I spent seven days in excruciating pain, unable to get off the couch without wanting to scream. 

That’s when I realized that a “simple” surgery just means simple for the doctor to perform. It’s also when I started to realize that this logic applies to all the ways doctors explain health issues. 

In fact, when doctors describe any health issues, they aren’t talking about the patient’s experience at all – they are talking about how they themselves experience it. They love to use terms like mild, simple, and easy. But patients should understand that they are not describing the patient experience when they say these things. 

Mild case of the flu? That just means they don’t have to see you in person to treat you. But it could still mean you’re unable to get out of bed for a month. 

Easy surgery? That means it’s easy for them to perform. It has no relation to how difficult recovery will be for you. 

Post-op discomfort? Yeah, it’s super uncomfortable for the doctor to have to see you in so much excruciating pain before they send you home in agony. 

This even applies to the ways doctors often describe medications. They’ll often say a prescription is “a very strong drug” – but only because it’s difficult for them to prescribe because of things like health insurance denials and DEA paperwork. Meanwhile, the side effects from what they call a “common” generic medication could ruin your body and your life. 

This is a lesson that patients often have to learn the hard way. I have. But now, as someone with a chronic illness, I understand. 

While I have only been hospitalized overnight one time since I first got really sick in 2013, doctors would tell you this means I have a “mild” case of intercostal neuralgia and that my Ehlers-Danlos Syndrome is “mild.”

Yet chronic pain and EDS have impacted every single aspect of my life. From my career, to my love life, to how often I’m able to shower. It’s impacted what clothes I can wear because tight shirts are so painful that I can’t leave the house if I try to wear them. I’ve had to quit jobs because I couldn’t work through the pain. And the guy I was dating when I first got sick eventually broke up with me because my health issues were too much for him to handle.

Hearing doctors describe my health issues as “mild” feels both insulting and disorientating. But worse than that, it can also impact how willing doctors are to investigate and treat my health problems. It’s likely why, despite how urgent chronic pain has been for me from the start, it still took doctors five full years to even diagnose me with Ehlers-Danlos Syndrome. As long as I didn’t need emergency medical care, there was no rush on their end. 

I’m not sure it’s worth it for patients to push back on these types of health descriptors. In my experience, it doesn’t usually change how doctors are responding to you. But understanding it yourself – knowing that how a doctor describes your health problem isn’t necessarily indicative of how severe it is to experience it as the patient – can itself be freeing. 

And sometimes, you may even run into a good doctor, who makes this type of thing clear to you as a patient. They are rare, but they do exist. 

You can also take comfort in the fact that if the doctors who don’t make it clear to the patient ever have to endure what you’ve been through, they will come to understand how inaccurate and insulting their descriptors were. Afterall, nothing about something like surgery is ever easy for the patient.

New Non-Opioid Analgesic Gets Priority Review from FDA

By Pat Anson

The Food and Drug Administration could approve an experimental non-opioid analgesic early next year, potentially making it the first new medication for acute pain in over two decades.

Vertex Pharmaceuticals says the FDA has accepted its New Drug Application for suzetrigine, giving the drug a priority review with a target action date of January 30, 2025. Suzetrigine has previously been granted FDA Fast Track and Breakthrough Therapy designations for the treatment of moderate-to-severe acute pain.

“Today’s FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients,” Nia Tatsis, PhD, an Executive Vice President and Chief Regulatory and Quality Officer for Vertex, said in a statement.

“The FDA’s granting of a priority review further reinforces the high unmet need in treating acute pain, and the filing brings us one step closer to our objective of filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.”

Suzetrigine is designed to block pain in the peripheral nervous system, rather than the brain. That means it won’t have the “liking” effects of opioids or be as addictive.  

In Phase 3 clinical studies, suzetrigine was more effective in reducing post-operative pain than a placebo after minimally invasive surgeries.  Over 80% of patients rated suzetrigine as good or excellent in treating acute pain, but it was not more effective than a combination of the opioid hydrocodone and acetaminophen, more commonly known as Vicodin.

Vertex hopes suzetrigine will eventually be approved for a variety of pain conditions, not just post-operative pain.  The company has been studying the drug as a treatment for pain caused by diabetic peripheral neuropathy.

“In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain. Too many people today are either undertreated, dealing with negative side effects of currently available therapies or foregoing pain medications altogether for fear of becoming dependent on opioids,” said Scott Weiner, MD, a Vertex consultant and Associate Professor of Emergency Medicine at Harvard Medical School.

The Biden Administration has been under pressure from lobbyists, politicians and anti-opioid activists to have the FDA approve more non-opioid medications like suzetrigine. The new analgesics are expected to be far more expensive than opioids and other older pain relievers.

If the FDA approves suzetrigine in January, it will coincide with implementation of the NOPAIN Act, which will expand access to non-opioid analgesics in outpatient surgical settings by making them eligible for higher Medicare reimbursement rates.

AARP Should Stop Blaming Pain Patients for the Opioid Crisis

By Carol Levy

Toast and jam. Cake and coffee. Peanut butter and jelly. Pain patients and the opioid crisis.

One of these things is not like the others. But to most people, they all go together. Even when research shows little correlation between opioid prescriptions and overdose deaths.

We’ve been hearing that same old tired narrative for years, often from “experts” who speak with absolute certainty.

“Two major facts can no longer be questioned. First, opioid analgesics are widely diverted and improperly used, and the widespread use of the drugs has resulted in a national epidemic of opioid overdose deaths and addictions,” Nora Volkow, MD, Director of the National Institute on Drug Abuse, and Thomas McLellan, PhD, founder of the Treatment Research Institute and a scientific advisor to Shatterproof, wrote in a joint op/ed in The New England Journal of Medicine in 2016.

“Second, the major source of diverted opioids is physician prescriptions. For these reasons, physicians and medical associations have begun questioning prescribing practices for opioids, particularly as they relate to the management of chronic pain.”

We now know that prescription opioids play a minor role in the overdose crisis and that only about three-tenths of 1% are actually diverted. Illicit fentanyl and other street drugs are responsible for the vast majority of overdose deaths, not pain medication.

But the same tired and misinformed narrative continues, with patients who need opioids paying the price when their doses are reduced or taken away.

Recently, the American Association of Retired Persons released an AARP bulletin, with the main headline being “The War on Chronic Pain.” Wow!  I was excited. Maybe some new information that I can use?

My heart sank as I read the article and quickly came upon these words: “Our attempts to treat chronic pain with medication have led to an opioid abuse epidemic so severe that overdoses are now among the leading causes of death for adults ages 50 to 70. “

The stereotype wins again. Prescription opioids caused the crisis.

I was curious to see what else AARP had to say about pain management and found several articles over the years with a glaringly obvious bias against opioids.

“Americans over 50 are using narcotic pain pills in surprisingly high numbers, and many are becoming addicted,” a 2017 AARP article warned. “A well-meant treatment for knee surgery or chronic back troubles is often the path to a deadly outcome.”

The article went on to claim that older Americans had become “new opioid dealers” who fueled the opioid crisis by “selling their prescription painkillers to drug pushers.”

A 2019 AARP article took a more nuanced approach to pain, claiming that “science was homing in on better ways to treat it,” such as non-opioid drugs, exercise and cognitive therapy.

“If the opioid crisis has provided an excellent example of how not to treat chronic pain, advances in brain science are leading to a fuller understanding of how to more safely find solutions,” AARP said.

Five years later, science has brought us no real solutions. Opioids are still the most potent and reliable medications for pain. For patients in severe pain, they are often the only treatment that works.

The sad part is, if AARP had simply asked the American Medical Association, they would have found that prescription opioids are not the main cause of overdoses and deaths.

In 2021, the AMA reported that opioid prescriptions had fallen by over 44%, yet drug overdoses and deaths were still rising. “The nation’s drug overdose and death epidemic has never just been about prescription opioids,” said then-AMA President Gerald Harmon, MD.

In a 2023 report, the AMA warned again that “reductions in opioid prescribing have not led to reductions in drug-related mortality.”

Why is that not worth including in AARP’s latest sensational reporting on the opioid crisis?

I read this line the other day: “There is no word for infinite pain.” That rings very true for me, probably for many of us. Chronic pain often does not end. We may have a diagnosis, some condition or disorder that causes pain, but there is no good word for pain that is unending and unrelenting.

AARP’s continuing portrayal of many seniors as addicts or drug dealers pushing “narcotic pain pills” is not helpful. Repeatedly labeling us like that has had devastating consequences on pain patients around the country. 

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

Genes May Explain Why Gabapentin Works for Some Pain Patients

By Pat Anson

Over the years, gabapentin (Neurontin) has been prescribed for dozens of health conditions, from epilepsy and fibromyalgia to depression and post-operative pain. It’s even been used to treat bipolar disorder. Gabapentin has been marketed for so many different conditions – at times illegally -- that a pharmaceutical company executive infamously referred to the drug as “snake oil.”

Even though it’s been approved for medical use for over 30 years, the UK’s National Health Service admits it’s still “not clear exactly how gabapentin works.”

A new study may finally help explain why gabapentin is an effective pain medication for some patients and an addictive drug with unwelcome side effects for many others.

It could be all in the genes.

Researchers at the University of Edinburgh took another look at a previous study of women with chronic pelvic pain to see why gabapentin worked no better than a placebo for most, but was a moderately effective pain reliever for about 40% of them.

Researchers took saliva samples from 71 women who participated in the study -- 29 who responded to gabapentin and 42 who had no improvement -- and found that the responders were more likely to have a variation of the gene Neuregulin 3 (NRG3). The gene is primarily expressed in the brain, spinal cord and central nervous system, and helps regulate pain sensation and transmission.

The findings, recently published in the journal iScience, may explain why gabapentin works for some women with chronic pelvic pain.

"A genetic factor that can predict how well gabapentin will work in patients offers the prospect of tailored treatment, and provides invaluable insights into understanding chronic pain. We hope eventually to use this genetic marker to optimize personalized treatment decisions and minimize adverse effects for women with chronic pelvic pain," wrote lead author Scott Mackenzie, MD, from the University of Edinburgh's Centre for Reproductive Health.

The study also has implications for other chronic pain conditions. Further research is needed to confirm the findings, but researchers say a genetic test for NRG3 could help limit the use of gabapentin to people who actually benefit from the drug.

"Isolating this single genetic marker is an important discovery that could ultimately help refine treatments for millions of women worldwide who suffer from chronic pelvic pain, as well as increasing our understanding of its role in other pain conditions. We believe this is an exciting opportunity for collaboration with a commercial partner who can help translate the research into a clinical setting," said Susan Bodie, PhD, Head of Business Development for the College of Medicine and Veterinary Medicine at the University of Edinburgh.

Gabapentin and other nerve drugs like pregabalin (Lyrica) have come under increased scrutiny in the UK because they are increasingly involved in overdose deaths.  

A recent analysis of drug tests suggests that gabapentin is also being misused in the U.S. Gabapentin was found in in over 13% of urine samples that tested positive for fentanyl -- about twice the number of drug tests in which prescription opioids were found.

Despite the risks of side effects and addiction, gabapentin is increasingly prescribed “off-label” for conditions it is not approved to treat, such as dental pain. A 2019 study found little evidence that gabapentin and pregabalin should be used for pain and said their effectiveness was often exaggerated by prescribing guidelines.

The CDC’s revised opioid guideline says gabapentin and pregabalin can have “small to moderate improvements” on pain, but with a moderate risk of side effects.

Rite Aid Settles Opioid Dispensing Case

By Pat Anson

Embattled pharmacy chain Rite Aid has agreed to a settlement with the federal government over the illegal dispensing of opioid pain medication, removing one of the last legal hurdles in the company’s bankruptcy case. Details of the settlement, which includes an explicit offer to cooperate with DEA investigations, were made public this week.

Rite Aid agreed last month to a bankruptcy restructuring plan that eliminates $2 billion in debt, while giving the company access to another $2.5 billion in loans to finance a turnaround plan. The pharmacy chain has already closed over 520 stores, about a quarter of the 2,100 pharmacies it operated prior to filing for Chapter 11 bankruptcy.

Rite Aid allegedly violated the Controlled Substances and False Claims Acts by dispensing hundreds of thousands of prescriptions for opioids and other controlled substances that lacked a “legitimate medical purpose.” The government said the prescriptions were filled by Rite Aid pharmacists from 2014 to 2019, despite “red flags” that they were suspicious or illegal.

“Pharmacies and pharmacists have an affirmative legal duty to ensure that the prescriptions they fill are legitimate,” Rebecca Lutzko, U.S. Attorney for the Northern District of Ohio, said in a statement. “When they disregard this responsibility and instead ignore red flags indicating that prescriptions for addictive painkillers are invalid, they violate the public’s trust and harm the community they are supposed to serve — all to make a buck.”

The Justice Department may have squeezed all it can get out of Rite Aid. Under the settlement, the company agreed to pay the government $7.5 million, along with an “allowed, unsubordinated, general unsecured claim” of nearly $402 million in the bankruptcy case.

An unsecured claim means the government is not entitled to any liens on liquidated Rite Aid property and has to stand in line behind other secured creditors. The $7.5 million payment may be the only one the government receives.

Rite Aid and other pharmacy chains have faced “extreme pressure” from regulators and law enforcement to rein in their opioid prescribing. According to congressional investigators, Rite Aid, CVS and Kroger allow their pharmacy staff to routinely hand over prescription records to law enforcement without a warrant. In most cases, patients are never informed that their medical records were provided to law enforcement or why they were being sought.   

That cooperative relationship with law enforcement is being codified under Rite Aid’s settlement with the government. The company and the DEA have signed a memorandum of agreement “to increase communication between the company, its retailers and DEA.” The agreement requires Rite Aid to keep records relevant to DEA investigations for a minimum of five years and to give employees additional training to help them identify suspicious prescriptions.

Law enforcement agencies are not covered by the Health Insurance Portability and Accountability Act (HIPAA), which protects patient privacy.

Rite Aid also agreed to a corporate integrity agreement, which requires the company to submit data on prescriptions for controlled substances to an Independent Review Organization to determine whether the drugs are properly prescribed, dispensed and billed.

‘They Give Me the Runaround’

It’s already quite common for a pharmacist to refuse to fill an opioid prescription, regardless of a patient’s condition or need.

In 2019, a California woman with late-stage breast cancer posted a tearful video online, after a Rite Aid pharmacist said he would not refill her prescription for Norco, an opioid medication she took for cancer pain. Doyle said the pharmacist told her he was worried about being fined or losing his job if he filled her prescription, even though cancer pain is exempt from opioid prescribing guidelines. 

“I have to take 20 pills a day just to stay alive,” Doyle said. “Every time I take my pain pill prescription there, they give me the runaround.”

Rite Aid eventually apologized to Doyle and offered to fill her prescriptions, but she refused to go back to the Rite Aid pharmacy where she shopped for 20 years.  She died of cancer in 2020, leaving behind a 9-year-old son.

April Doyle’s case is not unique. A recent PNN survey of nearly 3,000 pain patients found that over 90% with an opioid prescription experienced delays or problems getting their medication. Nearly 20% couldn’t to get their prescription filled, in part because opioids such as hydrocodone and oxycodone are in short supply.

Although most U.S. drug overdoses involve illicit fentanyl and other street drugs, federal prosecutors and law enforcement continue to blame doctors, pharmacies, drug wholesalers and opioid manufacturers for the nation’s overdose crisis.  

“America continues to live through the worst opioid epidemic we have ever seen. Rite Aid contributed to this crisis by ignoring obvious red flags and dispensing hundreds of thousands of unnecessary opioids,” said DEA Administrator Anne Milgram. “DEA will continue to do everything in our power to protect the health and safety of Americans and to end the opioid epidemic.”

Many Doctors Hesitant to Accept Patients Using Opioids or Cannabis

By Crystal Lindell

Chronic pain patients who use either opioids or cannabis are still finding it hard to find new primary care physicians, according to new research at the University of Michigan.

Lead author Mark Bicket, MD, and his colleagues surveyed more than 1,000 U.S. primary care physicians about whether they were accepting new patients with chronic non-cancer pain. The physicians were all based in states with medical cannabis programs.

Of the 852 physicians who said they were taking new patients, 20% said they would not accept patients taking prescription opioids. Nearly a third (32%) said they would not accept a patient using opioids daily.

In contrast, only 18% of doctors said they would not take a pain patient using medical cannabis. And 40% said they would not accept a patient using cannabis “obtained from other sources” — meaning the cannabis probably came from the black market.

Primary Care Doctors Willing to Take New Patients Using Opioids or Cannabis

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“There’s a group of legacy patients with chronic pain who have been on long-term opioids for some time, and they may have to find a doctor, maybe because they’ve moved or their doctor has retired,” said Bicket, who is an anesthesiologist and pain researcher at Michigan Medicine. “For those patients in particular, finding someone else to help with their care is challenging.”

Making matters worse, pain patients are at higher risk of having a substance problem if they don’t have access to pain medication.

“This lack of access could inadvertently encourage patients to seek nonmedical treatments for their chronic pain, given that relief of pain is the most commonly reported reason for misuse of controlled substances,” Bicket wrote. “I empathize a lot with the patients, as well as the prescribers out there, trying to treat people in pain because we’re trying to do the right thing, and yet, we’re flying in the dark when it comes to having access to high quality evidence to guide next steps for cannabis and opioids.”

While the study didn't assess the reasons for physician reluctance, it adds to a growing body of evidence that patients using cannabis or opioids have less access to care. 

In a 2019 PNN survey of nearly 6,000 chronic pain patients, almost three out of four (72%) said it was hard to find a doctor willing to treat their pain. More than a third of patients (34%) said they’ve been abandoned by a doctor and 15 percent said they haven’t been able to find a doctor at all.

That same year, another survey by researchers at the University of Michigan found that only 40% of primary care practices would take a new patient on opioids. That survey used a "secret shopper" method, with researchers posing as the adult children of patients taking the opioid Percocet calling primary care clinics in Michigan to see if they could schedule an appointment for their parent.

Less than half of the clinics (41%) were willing to schedule an initial appointment and 17 percent said they needed more information before making a decision.

Drug Prohibition Is Making the Overdose Crisis Worse

By Drs. Kora DeBeck and Perry Kendall

Should heroin and cocaine be legally available to people who need and want them? If we are serious about stopping the crisis of drug overdose deaths, that is exactly the kind of profound change we need. Yes, extensive regulations would be necessary. In fact, the whole point of regulating drug production and sales is that we can better control what is being sold and to whom.

After British Columbia’s Provincial Health Officer Dr. Bonnie Henry testified to the all-party health committee in Ottawa in May that regulating these controlled drugs would minimize harms, B.C. Premier David Eby said he disagreed. He is quoted saying “in a reality-based, real-world level, (it) doesn’t make any sense.” But does our current approach of drug prohibition “make sense?”

Since the overdose crisis was declared in 2016, illicit drug toxicity deaths have become the leading cause of unnatural death in B.C. and the leading cause of death from all causes for those aged 10 to 59. More than 44,000 people have died from drug poisoning in Canada since 2016, and more than one-third of those were in B.C. An average of 22 people are dying every day in Canada because the illicit supply of drugs is toxic.

Toxic Drug Supply

Why is the drug supply so toxic? Because we are letting organized crime manufacture drugs instead of regulated licensed industries that are required to follow health and safety standards.

In the context of drug prohibition, organized crime and drug cartels are incentivized to make highly potent products because it is cheaper and hence more profitable. This is what happened during alcohol prohibition in the 1920s. Organized crime ran rampant, and people were poisoned because there were no health and safety standards for production.

The failure of alcohol prohibition in meeting its key objectives of eliminating the supply and demand of alcohol are the same failures of drug prohibition. Illegal drugs are easy to find regardless of their illegal status. Reliable estimates are that 225,000 people are using illegal substances in B.C.

What is the way out? Our knowledge of research evidence and decades of collective experience — including as a researcher (Kora DeBeck), a B.C. provincial health officer (Perry Kendall) and chief coroner (Lisa Lapointe) during the overdose crisis — brings us to drug regulation. When we regulate a substance, we have the most control over its production, distribution and consumption.

Lessons From Tobacco

Some may argue that regulating drugs sends the “wrong message” and will encourage drug use, most concerningly among young people. However, if we look to lessons from tobacco regulation, we can see that public health-based regulations can actually be strong and effective substance-use deterrents.

By strictly controlling tobacco marketing, packaging, purchase price, purchase age and consumption locations alongside educating people about the health risks, tobacco consumption and associated health harms have been significantly reduced without all the additional risks of banning tobacco products (for example, criminal black markets controlling production and sales).

The same kinds of regulatory tools would be available to control the use of currently illegal drugs if we moved from prohibition to regulation.

Addiction Treatment Not Enough

But what about addiction treatment? Isn’t that what we really need? While it’s true that eliminating wait times and increasing access to effective, evidence-based treatment are critically important and much needed, the reality is that many people who use drugs don’t have an addiction and many others are not currently seeking treatment. Yet all people who use drugs face the deadly consequences of an unregulated toxic drug supply.

It is also important to remember that addiction recovery is complex and relapse is common in the recovery journey. In today’s toxic drug environment, people who relapse after a period of abstinence face a significantly higher risk of death due to their reduced tolerance. We also know that substance treatment is not regulated or standardized, and treatment outcomes are not reported.

While supporting people to recovery is important and can be lifesaving, addiction treatment is not the straightforward solution many believe it should be. Thousands of lives remain at risk every day.

A Regulated Drug Supply

Taking the production and sale of currently illegal drugs away from organized crime and drug cartels is the most promising way to keep our kids and communities safe. With strict health and safety standards for the production of these drugs and stringent public health-based regulations on their distribution and sale, we have the best shot at reversing the carnage of overdose fatalities and managing drug-related harms.

Regulating drugs may seem to some like a radical proposition but governments regulate the production and distribution of potentially dangerous goods all the time. The regulation of firearms in Canada includes licensing that requires passing a firearms safety course. Mandatory ingredient lists that disclose the amount of sugar, sodium and fat in the foods we eat is another example of a government regulation that is designed to protect the public and provide information that may shape consumption patterns and reduce health risks.

Implementing an effective regulatory framework for currently illegal drugs will be a complex undertaking requiring close monitoring and evaluation and inevitably corrections and revisions along the way. While the task may appear daunting, allowing overdose deaths to continue at the current rate is unconscionable.

Transformational and life-saving drug regulation is urgently required because, borrowing terminology from Premier Eby, at the “reality-based, real-world level,” our current approach is a catastrophic failure.

Kora DeBeck, PhD, is a Distinguished Associate Professor in the School of Public Policy at Simon Fraser University and a Research Scientist at the BC Centre on Substance Use.

Perry Kendall is a Clinical Professor in the Faculty of Medicine, School of Population and Public Health at the University of British Columbia. He is also a former Provincial Health Officer for BC

This article was also co-authored by Lisa Lapointe, who was BC’s Chief Coroner from 2011 to 2024.

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

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.