CDC Appoints New Opioid Workgroup for Guideline Update

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has named a diverse group of physicians, academics and patients to an “Opioid Workgroup” that will advise the agency as it works on an update and possible expansion of its controversial opioid prescribing guideline. Several advisors on the 23-member workgroup also advised the agency during the 2015-2016 guideline process.

Notably lacking on the new panel are any members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential group of radical anti-opioid activists who played an outsized role in drafting the original guideline.

Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioid prescribing were quickly adopted as policy by other federal agencies, dozens of states, insurers, pharmacies and doctors of all specialties.  As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses, leading to uncontrolled pain, withdrawal and, in some cases, suicide.

Not until last year did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. An update to the guideline is not expected until late 2021, nearly six years after the initial guideline was released. It is expected to include new recommendations for the treatment of acute, short-term pain.  

‘Opioids Gave Me a Life’

There are two pain patients in the workgroup, who have contrasting experiences with opioid medication.

One is Kate Nicholson, a civil rights lawyer and patient advocate who took opioids for several years while disabled with severe back pain. Nicholson declined to talk with this reporter about her appointment to the workgroup, but shared her personal experience with the medical use of opioids in a 2017 PNN guest column.

“As soon as I took opioids, I improved. I wasn’t foggy or especially euphoric. In fact, the opposite happened, space opened in my mind and I could work again.  I also never developed a tolerance, requiring more medication for the same level of pain relief,” Nicholson wrote. “Opioids did not heal me. Integrative treatment over a long period of time did.  But opioids gave me a life until I could find my way to healing. Importantly, they allowed me to continue to work.”  

In a 2019 op/ed in The Los Angeles Times, Nicholson said the CDC guidelines should be revised because they were being treated  as “one-size-fits-all mandates” that were harmful to patients.

“The agency needs to revise its guidelines to recommend that physicians not abandon pain patients or engage in ‘forced tapering.’ The CDC should also study and address any unintended consequences of its 2016 guidelines, as it promised to do,” she wrote.

The other patient on the panel is Travis Rieder, PhD, Director of the Bioethics Masters Program at Johns Hopkins University. Rieder severely injured his foot in a motorcycle accident in 2015 and became dependent on opioids while recovering from surgery.

Rieder has written a book and several articles on his experience with chronic pain and the difficulty he had getting off opioids. He also became frustrated with the healthcare system and how it often abandons patients to pain, addiction or both.

“I represented one of the medical community’s most distressing dilemmas: a patient in obvious severe pain but begging for medication that is killing tens of thousands of people a year. The fact that different doctors, in different moments, treated me in radically different ways is completely unsurprising. Because no amount of public hand-wringing or blunt policy tools is going to make it clear what to do with patients like me. We’re a problem, and there’s no obvious solution,” Rieder wrote in his book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.”

‘Clear Need’ for More Specific Guidelines

The other 18 members of the workgroup bring a mix of mostly academic and medical experience to the table.

At least five members of the panel advised the CDC during the drafting the 2016 guideline. They include the chair of the workgroup, Christina Porucznik, PhD, a professor of public health at the University of Utah, who chaired the opioid workgroup in 2016. Chinazo Cunningham, MD, Anne Burns, RPh, and Mark Wallace, MD, are also returning members of the workgroup. They are joined by Jeanmarie Perrone, MD, was a peer reviewer for the 2016 guideline.

In 2018, Perrone called for even more prescribing guidelines.

“There is a clear need for further impactful guidelines similar to the CDC guidelines that outline more specific opioid and non-opioid prescribing by diagnosis," said Perrone, a professor of Emergency Medicine and director of Medical Toxicology at Penn Medicine.

A new addition to the workgroup is Beth Darnall, PhD, a pain psychologist at Stanford University, who has drawn some controversy in the pain community for her studies about “catastrophizing” — a clinical term used to describe patients who are anxious, angry or feel helpless about their pain. She recently began an effort to find another term for catastrophizing.

Darnall, who has advocated against forced opioid tapering, expressed concern about the misapplication of the CDC guideline in a 2019 op/ed published by The Hill.

“Health-care organizations and states have cited the CDC guideline as a basis for policies and laws that extend well beyond its intended purpose. The guideline has been wrongly cited to substantiate proposed dose-based opioid prescribing policies that fail to account for the medical circumstances of the individual patient,” wrote Darnall. “We need flexible policies that provide meaningful access to comprehensive pain care and do not myopically focus on opioid dose reduction policies.”

‘Vast Improvement’ Over Previous Workgroup

The fact that we even know who is on the new workgroup is a small step forward in transparency for the CDC, which refused to disclose the names of any of its advisors when a draft version of the opioid guideline was released in 2015.

Only when threatened with a lawsuit and a congressional investigation did the CDC make the names public. They included Dr. Jane Ballantyne, President of PROP, along with PROP board members Dr. Gary Franklin and Dr. David Tauben. PROP founder and Executive Director Dr. Andrew Kolodny and PROP member Dr. David Juurlink also participated in a “Stakeholder Review Group” for the CDC.

“This group is a vast improvement over the 2016 Guideline group. There are several people here who I know, and who I trust to act as strong patient advocates,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. “All in all, this is a much better panel, and I'm confident it will produce a much better result for people with pain.”

Twillman cited Burns, Darnall, Wallace and Christine Goertz as workgroup members who would “keep patients in the center of the discussion.”

“The only other member I really know is Jeanmarie Perrone, who, while not a member of PROP, certainly could be. She and I have shared presentation opportunities a couple of times before, and she is very much in the anti-opioid crowd,” said Twillman.

“The new Workgroup constitutes a major improvement over the workgroup involved in drafting the 2016 guideline. That group included a number of well-connected people passionately opposed to the use of opioids in management of chronic pain,” said Stephen Nadeau, MD, a professor of Neurology at the University of Florida College of Medicine.

“Although the new Workgroup membership does not include such people, one could well question the inclusion of several people academically invested in pharmacological or non-pharmacological alternatives to opioid treatment, particularly in the complete absence of comparative effectiveness studies of such treatments.  One could also question the inclusion of surgeons, emergency room physicians, and pharmacists, who do not manage chronic pain.”

More Stakeholders Sought

CDC is seeking additional input from pain patients, caretakers and healthcare providers who will serve as “stakeholders” during the guideline development process. The agency is planning to speak with 100 stakeholders by phone or online for 45-60 minutes “to listen to personal perspectives and experience” related to pain care. The CDC has already obtained written comments from nearly 5,400 people, most of them pain patients.

If you’re interested in being a stakeholder, further information can be found here. The CDC is taking applications until August 21.

The CDC has also funded a series of new studies on opioid and non-opioid treatments for chronic pain. The report on opioids was released in April by the Agency for Healthcare Research and Quality. It concluded that opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose. At least three PROP members served as experts and peer reviewers during the drafting of that report.

U.S. Pain Foundation Pockets $210,000 from Insys Therapeutics

By Pat Anson, PNN Editor

The U.S. Pain Foundation has decided to keep over $210,000 leftover from a controversial co-pay prescription drug program funded by Insys Therapeutics, a disgraced Arizona drug maker blamed for the overdose deaths of hundreds of pain patients.

The funds have been designated as “unrestricted grant revenue” by the Connecticut based-charity, which at one time claimed to be the nation’s largest non-profit advocacy group for pain patients. The decision to keep the money, which was being held in an escrow account, reverses a previous pledge by U.S. Pain in 2018 that it “will not accept funding from Insys going forward.”

“It has been determined that the funds may be used for charitable purposes consistent with the tax-exempt purpose of USPF in assisting people living with chronic pain. Going forward these funds will be allocated for such purposes,” U.S. Pain disclosed in a recent audit statement. “The escrow reserve of $210,974 was reversed in 2019 and the unrestricted funds were recorded as unrestricted grant revenue.”

Insys and U.S. Pain launched the “Gain Against Pain” program in 2016 with $2.5 million donated by the company. The stated goal of the co-pay program, which was administered by NeedyMeds, was to help patients obtain medication for breakthrough cancer pain.

But the program was apparently only used to generate prescriptions for Subsys, an expensive and potent fentanyl spray that was Insys’ flagship product. A four-day supply of Subsys can cost nearly $24,000.

The Gain Against Pain program was shut down in 2018 after Insys executives were charged with racketeering, fraud, bribery and other criminal charges over their marketing of Subsys. Insys filed for bankruptcy in 2019 and its founder sentenced to 66 months in prison.

Controversy over the co-pay program and other financial irregularities also led to the resignation of Paul Gileno, the founder and CEO of U.S. Pain. Gileno later pleaded guilty to charges of fraud and tax evasion, and served a few months in federal prison.

“We now know that Insys Therapeutics advanced this program using predatory practices and were assisted in doing so by U.S. Pain Foundation via access to the vulnerable populations served by that organization,” said Stefanie Lee Berardi, a patient advocate and grant writer who worked in nonprofit management.

“Nonprofits receiving large charitable donations have a duty to ensure the source of those funds is both legal and ethical before those funds are accepted. Once the funds are accepted, it is very difficult to give those funds back.”

The $210,000 in leftover co-pay funds would be a significant amount of money for most charities. U.S. Pain had over $1.4 million in revenue according to its 2019 tax return, about 30% less than the year before. The charity also disclosed in its audit statement that it received $92,805 this year from the federal government’s Payroll Protection Loan Program.

Questionable Spending

Under Gileno’s leadership, there was virtually no oversight of spending at U.S. Pain, which used donated funds to pay for highly questionable purposes, such as operating a money-losing bakery, loans to Gileno’s brothers and a family vacation to Universal Studios in Florida. The charity now has a chief financial officer and a new board of directors, and says it has other safeguards in place to prevent further fraud.

U.S. Pain CEO Nicole Hemmenway, who was vice-president and board chair under Gileno, did not respond to a request for comment for this story.

The charity’s audit statement indicates the $210,974 was received in two checks from NeedyMeds and had not been spent or earmarked for any program. Classifying the funds as unrestricted grant revenue means they can be used for any purpose – not just helping cancer patients.

“What I am really not understanding is why U.S. Pain chose to accept these as unrestricted funds, rather than to a restricted fund that would help individuals and families who were harmed by Insys’ co-pay program,” Berardi said in an email.

“Given that they haven’t yet done so, it is now imperative that they clearly define how those monies will be used. It is still possible for them to do the right thing. Should they choose to, they may find that they can mitigate the reputational harm sustained as a result of unethical and illegal business practices for which their CEO went to prison and an irresponsible board of directors who failed to meet their duty of care.”

Another critic believes U.S. Pain should donate the money to another charity.

“Given what has come out about both Insys and the U.S. Pain Foundation, the ethical thing to do would have been to give the money to a nonprofit organization that provides treatment for opioid use disorder,” said Adriane Fugh-Berman, MD, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive marketing in the healthcare industry.

Co-pay prescription drug programs – also known as co-pay charities – are ostensibly designed to help needy patients pay for prescription drugs. But in recent years, several major pharmaceutical companies have paid heavy fines to settle fraud allegations that they used co-pay programs to steer Medicare patients to their high-priced drugs.

The assistance programs typically pay only a small amount for the prescriptions, with the rest of the cost picked up by Medicare. Federal anti-kickback laws prohibit drug companies from making any kind of payment to induce Medicare patients to purchase their drugs.

The High Cost of California's Death Certificate Project

By Dr. Denise Phan, Guest Columnist

Even as the Covid-19 pandemic occupies the nation’s attention, most of my work as a primary care doctor still revolves around other chronic diseases.  

Every day, people are still giving birth, still getting sick, still dying from terminal diseases, still getting hurt and still having pain. Yet more and more, physicians’ hands are tied when it comes to prescribing opiate medication to reduce their patients’ pain and suffering, especially now that surgeries, physical therapy and injections are discouraged due to social distancing guidelines.

Last year, a patient came to me with a letter from her previous doctor explaining that he is no longer able to prescribe any opiates. The local pain specialists he recommended in his letter were either not taking new patients on opiates or would not prescribe the dosage of oxycodone needed to control her pain.

Several months ago, another patient came in complaining that his pain specialist had cut his dosage down so quickly that he now resorts to street heroin to control the pain and withdrawal.

Yet another patient asked me a few months ago to stop the chemotherapy for his lung cancer and put him in hospice care so he can get adequate pain control.

And just last month, a patient told me she can no longer bear to attend her online fibromyalgia support group because five people in the group had killed themselves in the past few years.

Recently, a frustrated nurse in the oncology/orthopedic ward asked me, “What is it with you doctors? Are you all going to let people scream themselves to death from pain? "

DR. DENISE PHAN

A cardiologist friend of mine remarked, “Ten years ago you could get sued for not prescribing pain meds to patients, now you can get sued just for writing one."

Project Targets ‘Inappropriate’ Prescribing

One of the causes for this sad state of affairs in California is the state medical board’s “Death Certificate Project.” The board investigated the overdose deaths of 450 patients who may have received “inappropriate” opioid prescriptions and sent warning letters to their physicians. Disciplinary action was taken against dozens of them.

The Death Certificate Project sounds like a well-meaning idea, but in practice it has decimated the field of pain management and brought tremendous suffering to patients living with real legitimate pain.

The most egregious of the project's many faults is the decision to pull death certificates from 2012-2013, and then use the state’s prescription drug database to identify "overprescribers." The deaths occurred years before the medical board adopted tougher guidelines on the prescribing of opiates in 2015 and the CDC released its opioid guideline in 2016. 

By this irrational act, the project targeted hundreds of primary care doctors and pain management specialists who were caring for the high-risk populations of chronic pain patients, and were following previous California guidelines to treat pain aggressively and with opiate medications if necessary.  

To date, the board has filed accusations of negligent prescribing against 66 physicians. Forty-eight of them have faced discipline such as license surrender, public reprimands and probation. Some were forced into early retirement. Eighteen doctors are still awaiting hearings or trials. The vast majority of them are responsible physicians who have had no other complaints lodged against them. 

Throughout the Covid-19 pandemic, standards of care and public policies have been rapidly evolving, even flip-flopping from week to week, some causing and some preventing thousands of deaths along the way. It is incredibly irrational to retroactively penalize doctors for following the previous standards of care during a epidemic. Yet this is precisely what the Death Certificate Project is doing by focusing on overdoses in 2012-2013, when the opioid epidemic had not even been recognized or publicized by the medical board itself. 

Imagine going to work every day on the frontline of an epidemic, knowing that the state or federal government can change their policies at any time; and that they can go back and prosecute you for the deaths that resulted from their previous policies.  As we watched our colleagues in the field falling like dominoes one by one, can you blame the doctors for running scared?

The primary result of the Death Certificate Project has been the effective removal of dozens of frontline doctors amid a decades-long shortage of primary care physicians and on the eve of a pandemic. The secondary result of this program is the refusal of terrorized remaining physicians to prescribe any pain medications at all or to drastically reduced the dosages. This has caused a marked increase in pain, suffering and suicide rates in the legitimate pain and addiction patient populations, as well as the subsequent rise in the use of street opioids and thus opioid deaths overall.

The data on California and national overdose deaths shows that prescription opioid overdoses have declined since 2014. Overall drug deaths spiked up sharply in 2017-2018 – but this was mainly due to street heroin and illicit fentanyl. This shows how sadly unnecessary and harmful the project is.

Beside the human and societal costs listed above, this project is costing California millions of dollars annually in funding for administrative, consulting and legal fees. This is not counting the immeasurable cost to the medical system from the loss of physician resources during the biggest pandemic of our time. 

When a medication or treatment does not work as intended and causes many harmful side effects, we need to stop it. If you are a resident of California, please join me in a letter writing campaign to end this irrational, unnecessary, harmful and costly Death Certificate Project at the Action Network website

Dr. Denise Phan is an Internal Medicine physician in Los Angeles. She works in private practice in the San Fernando Valley and is on staff at Valley Presbyterian Hospital. Dr. Phan is active in the annual missions of the mobile health units of the Social Assistance Program for Vietnam and the International Humanitarian Mission. 

Gabapentinoids Involved in a Third of Overdoses in Scotland

By Pat Anson, PNN Editor

A new study in Scotland is shining more light on the risks of overprescribing gabapentin (Neurontin) and pregabalin (Lyrica). The two drugs belong to a class of nerve medication called gabapentinoids, which are increasingly prescribed in Western nations to treat chronic pain.

In 2018, there were 1,187 accidental drug-related deaths (DRDs) in Scotland – the highest overdose rate in the European Union — and gabapentinoids were involved in about a third of them.

According to research published in the British Journal of Anaesthesia, gabapentin was implicated in 15.2% of fatal overdoses in Scotland, while pregabalin was linked to 16.5% of drug deaths. That’s up from 3% and 1% of fatal overdoses, respectively, in 2012.

Researchers say deaths involving gabapentinoids are rising because they are frequently co-prescribed with opioids and other medications that depress the central nervous system and raise the risk of overdose. Drug diversion also plays a role.

“Gabapentinoid prescribing has increased dramatically since 2006, as have dangerous co-prescribing and death. Older people, women, and those living in deprived areas were particularly likely to receive prescriptions. Their contribution to DRDs may be more related to illegal use with diversion of prescribed medication,” wrote lead author Nicola Torrance, PhD, Senior Research Fellow at the School of Nursing & Midwifery, Robert Gordon University, in Aberdeen, Scotland.

From 2006 to 2016, the number of pregabalin prescriptions in Scotland rose by an astounding 1,600 percent, while prescriptions for gabapentin quadrupled. About 60% of the time, gabapentin was co-prescribed with an opioid, benzodiazepines or both.  

Gabapentinoids are also showing up in Scotland’s illicit drug supply. Drug users have found they can heighten the effects of heroin, marijuana, cocaine and other substances. In the Scottish region of Tayside, gabapentinoids were involved in 39% of drug deaths. About three out of four of those overdose victims did not have a prescription for the drug.

In addition to overdoses, gabapentinoids have also been associated with increased risk of suicidal behavior, accidental injuries, traffic accidents and violent crime. UK health officials were so alarmed by misuse of the drugs and the rising number of deaths that gabapentin and pregabalin were reclassified as controlled substances in 2019.

Gabapentin is not currently scheduled as a federally controlled substance in the United States, but pregabalin is classified as a Schedule V controlled substance, meaning it has low potential for addiction and abuse.  

A 2019 clinical review found little evidence that gabapentinoids should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The U.S. Food and Drug Administration also recently warned that serious breathing problems can occur in patients who take gabapentin or pregabalin with opioids or other drugs that depress the central nervous system.

The CDC, Opioids and Cancer Pain

By Roger Chriss, PNN Columnist

In 2016, the Centers for Disease Control and Prevention issued its controversial opioid prescribing guideline. Insurers, states and other federal agencies soon followed with mandatory policies and regulations to reduce the use of opioid pain medication. All this was supposed to exclude cancer-related pain care, but in practice that’s not what happened.

Dr. Judith Paice, director of the Cancer Pain Program at Northwestern University’s Feinberg School of Medicine, told the National Cancer Institute in 2018 that the opioid crisis “has enhanced fear — fear of addiction in particular” among both patients and doctors.

“Many primary care doctors no longer prescribe opioids. Oncologists are still prescribing these medications, but in many cases they’re somewhat anxious about doing so. That has led some patients to have trouble even obtaining a prescription for pain medication,” Paice said.

In 2019, the Cancer Action Network said there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.” One out of four said a pharmacy had refused to fill their opioid prescription and nearly a third reported their insurance refused to pay for their opioid medication.

That same year, CDC issued a long-awaited clarification noting the “misapplication” of the guideline to patients it was never intended for, including “patients with pain associated with cancer.”  

Long Term Use of Opioids Uncommon

Cancer pain management in the U.S. has been severely impacted by the CDC guideline, even though rates of long-term or “persistent” opioid use are relatively low and stable:

• A major review of over 100,000 military veterans who survived cancer found that only 8.3% were persistent opioid users. Less than 3% showed signs of opioid abuse or dependence.

• A study of older women with breast cancer who were prescribed opioids found that only 2.8% were persistent opioid users.  

• A study of 276 patients with head or neck cancer found that only 20 used opioids long-term – a rate of 7.2 percent.

• And a study of nearly 23,500 women with early-stage breast cancer who had a mastectomy or mastectomy found that 18% of them were using opioids 90 to 180 days after surgery, while 9% were still filling opioid prescriptions 181 to 365 days later.

While any sign of opioid abuse or addiction is concerning, these studies show that long-term use of opioid medication is relatively uncommon among cancer survivors. The American Cancer Society says opioids are “often a necessary part of a pain relief plan for cancer patients” and “can be safely prescribed and used” for cancer pain.

Cancer patients and their doctors have been successfully managing opioid risks long before the CDC guideline or associated state laws and regulations. Perhaps it is time for lawmakers, regulators, insurers and pharmacies to learn from the cancer community rather than getting in the way of clinical best practices.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

Researchers Developing Safer Version of Acetaminophen

By Pat Anson, PNN Editor

Researchers at Louisiana State University have created a new type of analgesic that is similar to acetaminophen but can relieve pain and reduce fever without the risk of liver or kidney damage.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. Over 50 million Americans take acetaminophen each week, many unaware that excessive use can cause liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Researchers at LSU Health New Orleans created 21 chemical compounds that are structurally similar to acetaminophen, but did not cause liver or kidney toxicity in tests on laboratory rodents. Their findings are published online in the European Journal of Medicinal Chemistry.

"The new chemical entities reduced pain in two in models without the liver and kidney toxicity associated with current over-the-counter analgesics that are commonly used to treat pain -- acetaminophen and NSAIDs. They also reduced fever in a pyretic model,” said senior author Nicolas Bazan, MD, Director of the LSU Health New Orleans Neuroscience Center of Excellence.   

The intellectual property behind the acetaminophen analogs has been licensed to South Rampart Pharma. The company expects to file an investigational new drug application with the Food and Drug Administration in the third quarter 2020, which would pave the way for clinical studies.

"Our primary goal is to develop and commercialize new alternative pain medications that lack abuse potential and have fewer associated safety concerns than current treatment options,” said Bazan. "Given the widespread use of acetaminophen, the risk of hepatotoxicity with overuse, and the ongoing opioid epidemic, these new chemical entities represent novel, non-narcotic analgesics that exclude hepatotoxicity, for which development may lead to safer treatment of acute and chronic pain and fever.”

Bazan said the development of safer pain relievers and fever reducers is particularly important because of the COVID-19 pandemic. Current treatments have led to kidney and liver disease in critically ill SARS-CoV-2 patients.

Acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus. It’s also used in opioid pain medications such as Vicodin. Nearly two-thirds of the world’s supply of acetaminophen comes from China.

Gabapentinoids Ineffective for Pain Relief After Surgery

By Pat Anson, PNN Editor

Would you want to take Lyrica (pregabalin) or Neurontin (gabapentin) for pain relief after a major surgery? Both drugs belong to a class of nerve medication called gabapentinoids that are increasingly being prescribed to patients perioperatively (after surgery) as an alternative to opioid medication.

But gabapentinoids also have risks and there is little evidence to support their use for postoperative pain relief, according to a large new study by a team of Canadian researchers.  

“No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events. These results do not support the routine use of pregabalin or gabapentin for the management of postoperative pain in adult patients,” wrote lead author Michael Verret, MD, a resident at Laval University in Quebec City.  

Verret and his colleagues conducted a meta-analysis of 281 clinical trials involving nearly 25,000 patients undergoing a wide range of surgeries, including orthopedic, spinal and abdominal operations.

Their findings, recently published in the journal Anesthesiology, indicate that the analgesic benefits of pregabalin and gabapentin after surgery are negligible, regardless of the dose or type of operation. Gabapentinoids were also ineffective in preventing chronic pain from developing after surgery, one of the primary justifications for using the drugs postoperatively.

“Gabapentinoids were also associated with a greater incidence of adverse events, namely dizziness and visual disturbance, while other major adverse events such as respiratory depression and addiction are not reported or are underreported,” said Verret.

The findings contradict guidelines published by the American Pain Society (APS) in 2016,  which advocate “around the clock” use of gabapentin, pregabalin and other nonopioid drugs both before and after surgery.

“The panel recommends use of gabapentin or pregabalin as part of a multimodal regimen in patients who undergo surgery. Both medications are associated with reduced opioid requirements after major or minor surgical procedures, and some studies reported lower postoperative pain scores,” the APS guideline states.

“The panel suggests that clinicians consider a preoperative dose of gabapentin or pregabalin, particularly in patients who undergo major surgery or other surgeries associated with substantial pain, or as part of multimodal therapy for highly opioid-tolerant patients.”

‘Evidence of Harm’

Although opioid addiction is relatively rare after surgery, dozens of U.S. hospitals followed the lead of the APS and other medical guidelines by stopping the use of opioids for certain surgeries.

Cleveland Clinic Akron General Hospital, for example, adopted a policy of only using gabapentin and other non-opioid analgesics for colorectal operations.

“It is now clear that over the past two decades, evidence of benefit from routine perioperative administration of gabapentinoids has diminished, while evidence of harm has increased.”

— Dr. Evan Kharasch

Critics say gabapentinoids have become a trendy alternative for post-surgical pain relief, even though evidence supporting their use is minimal.

“It is now clear that over the past two decades, evidence of benefit from routine perioperative administration of gabapentinoids has diminished, while evidence of harm has increased. If any potential benefits exist in ‘special populations,’ published reports have yet to identify the benefits or the populations,” lead author Evan Kharasch, MD, Editor-in-Chief of Anesthesiology, wrote in an editorial.

“The good intentions that led to routine gabapentinoid use should be redirected to lead the way out. The French Society of Anesthesia and Intensive Care Medicine now states that gabapentinoids should not be used systematically or in outpatient surgery. Other societies should follow. As the weight of evidence has shifted and the risk–benefit balance tilted away from benefit, evidence-based practice impels revising if not eliminating the routine use of perioperative gabapentinoids in adults.”

It's too late for the APS to change its guideline. The organization filed for bankruptcy in 2019, ironically because of the high cost of legal fees in defending itself against opioid litigation.

While the CDC’s controversial opioid guideline does not advocate using gabapentinoids for post-surgical pain, it does recommend their use in treating chronic pain -- with little to no mention of their side effects.

One of the co-authors of the CDC guideline, Dr. Roger Chou, also played a significant role in drafting the APS guideline. Chou is currently heading much of the research being conducted by the CDC as it prepares to update and possibly expand its 2016 guideline.

Long-Term Use of Muscle Relaxants Has Tripled

By Pat Anson, PNN Editor

Long-term use of muscle relaxants has nearly tripled in the U.S. since 2005, according to a new study by researchers at the University of Pennsylvania, who say the drugs are often prescribed inappropriately for chronic pain and to older adults.

Skeletal muscle relaxants (SMRs) like carisoprodol (Soma) and metaxalone (Skelaxin) were approved years ago for short-term treatment of muscle spasms and back pain. Researchers believe many doctors are now prescribing the drugs as an alternative to opioids for long-term pain management.

"There are few studies on the short-term efficacy and safety of skeletal muscle relaxants, and almost no data on their long-term effects, so it is very concerning that patients, and particularly older adults, are using these drugs for an extended period of time," said Charles Leonard, PharmD, an assistant professor of Epidemiology at Perelman School of Medicine. "Providers seem to be reaching for them despite incomplete information on their potential benefits and risks."

Medical guidelines generally recommend limiting the use of muscle relaxants to three weeks because they have not been shown to work for muscle spasms beyond that duration. The drugs can also have side effects such as falls, fractures, vehicle crashes, abuse and dependence. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

To measure national trends in muscle relaxant prescribing, researchers analyzed the number of office visits that resulted in muscle relaxant prescriptions from 2015 to 2016. They found the number of new prescriptions remained stable at about 6 million per year. But office visits for renewals of muscle relaxant prescriptions tripled -- from 8.5 million in 2005 to 24.7 million in 2016.

Over two-thirds (67%) of the patients getting renewals for muscle relaxants in 2016 were also taking opioid medication, despite an FDA warning that co-prescribing the drugs could lead to respiratory depression and overdose. Older adults accounted for about one in four (22%) office visits for muscle relaxants.

"For older adults, I think the message should be to avoid using muscle relaxants, especially when we consider the side effects and increased risk of falls and fractures, and to find alternatives for pain management," said first author Samantha Soprano, MPH, a research coordinator and student in Penn's Master of Behavioral and Decision Sciences program.

In addition to potential side effects, researchers say muscle relaxants may not be any more effective in managing pain than medications like Tylenol or Advil.

"Muscle relaxants' place in therapy is really limited. Based on most guidelines, they're normally reserved as second- or third-line therapies," Leonard said. "Our findings suggest that prescribers may be reaching for these drugs sooner than that."

The findings are published in JAMA Network Open.

Overdose Deaths Are Rising Again and the Pandemic Is Making It Worse

By Roger Chriss, PNN Columnist

The nation’s overdose crisis seemed to ease a bit in 2018, when fatal drug overdoses dropped 4.1% compared to 2017. This was heralded as a turning point in the crisis, a possible light at the end of the tunnel of overdoses that rose annually for nearly three decades.

But new data from the CDC shows that 2019 saw increases that almost wiped out the drop in 2018. Although provisional, the data shows a 3% increase in overdose deaths between November 2018 and November 2019.

Overdoses are rising but the drugs are largely the same: Illicit fentanyl is involved in the vast majority of deaths, with an uptick in overdoses involving cocaine and other psychostimulants, too. Deaths involving prescription opioids and heroin both fell a little. Overdoses rose in the West, Midwest and South, while declining in New England and Mid-Atlantic states.

SOURCE: cdc

The early data for 2020 is mixed. Rhode Island’s preliminary data show a 22% increase in drug overdose deaths in the first quarter compared to the same period in 2018. Other states were doing better, at least until March.

Then came the coronavirus pandemic. State-mandated lockdowns, combined with reduced access to addiction treatment and talk therapy, along with loss of work and social support, were quickly seen as a perfect storm of risk factors for substance use problems, relapse and overdose, accidental or otherwise.

And that’s what is happening. Psych Congress reports that drug overdoses are up 16.5% nationwide from January to April 2020. Fatal overdoses rose by 11.4% during that period and nonfatal overdoses by 18.6%. This trend continued in early May, too.

The risks of the pandemic were recognized early. In March, Buzzfeed predicted that fatal overdoses were likely to increase during the pandemic because of disruption to recovery routines and access to treatment.

“The people who were getting help aren’t really getting any help right now at all,” said Danny Pont, who is part of an opioid treatment program in Rhode Island. “I suspect there will be a lot of relapses — and with a lot of relapses, there’s going to be an uptick in overdoses.”

National Public Radio also reported that treatment options are even more scarce during the pandemic, with inpatient and outpatient programs ill-equipped to operate under physical distancing rules.

All of this and more is now happening. The Well Being Trust has forecast an additional 75,000 deaths from overdose, alcohol abuse and suicide resulting from the socioeconomic stress of the pandemic, so-called deaths of despair.

The American Medical Association is trying to “reignite the fight” against the opioid crisis amid Covid-19. The AMA is calling on states to adopt new federal rules for telemedicine prescribing; removing prior authorizations or step therapy for treating opioid use disorder; removing arbitrary barriers on dose, quantity, and refill requirements; and allowing harm reduction strategies.

But the federal and state response to Covid-19 is a fragmented patchwork of policies, according to The Atlantic. The country cannot even agree on whether or not the pandemic exists, let alone if people should wear masks in public or engage in social distancing. And the rapidly shifting outbreaks, hotspots and epicenters of the pandemic make what little agreement there is transitory at best.

Sadly, the American response to the pandemic echoes the response to the overdose crisis. Too little science and too much ideology muddies what should be a clearly focused public health effort. As a result, 2020 may become the worst year for the opioid overdose crisis.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

CDC Study Finds ‘No Significant Change’ in Use of Rx Opioids

By Pat Anson, PNN Editor

A new study by CDC researchers has a surprise finding, concluding that there has been “no significant change in the use of prescription opioids” over the past decade by U.S. adults.

The study is based on the National Health and Nutrition Examination Survey, in which a nationally representative sample of nearly 20,000 adults is asked every two years about their healthcare and nutrition.

Although the number of opioid prescriptions in the U.S. has dropped 43% since their peak in 2011, the survey found that the use of opioid medication hasn’t changed much at all.  

In 2017–2018, the survey found that 5.7% of U.S. adults used one or more prescription opioids in the past 30 days, compared to 6.2% of adults a decade earlier.

“Between 2009–2010 and 2017–2018, no significant trend in the use of prescription opioids was observed; however, an increasing trend in the use of nonopioid prescription pain medications without prescription opioids was seen,” researchers found.

USE OF PRESCRIPTION PAIN MEDICATIONS BY U.S. ADULTS

SOURCE: CDC

In 2017-2018, women (6.4%) were more likely to be prescribed opioids than men (4.9%). The use of opioids increased with age, from 2.8% among young adults aged 20–39 to 8.2% for those aged 60 and over.

The use of opioid prescriptions was highest among whites (6.4%), followed by blacks (5.2%), Hispanics (3.4%) and Asian adults (1.4%).

The survey did not ask respondents about the dose of opioids they were prescribed, which may account for the discrepancy with other prescription drug databases.    

A 2018 study by the health analytics firm IQVIA found a significant decline in the number of high dose opioid prescriptions of 90 MME (morphine milligram equivalent) or more. But low dose prescriptions of 20 MME or less remained relatively stable.

While the percentage of Americans using opioid prescriptions has remained relatively flat over the past decade, according to the survey, there was a notable increase in the use of non-opioid prescription pain relievers, which rose from 4.3% in 2009-2010 to 5.7% in 2017-2018.

Migraine drugs, COX-2 inhibitors, and non-steroidal anti-inflammatory drugs (NSAIDs) were classified in the survey as non-opioid prescription pain relievers, but anti-depressants and anti-convulsants were not – even though they are increasingly used to treat pain. The IQVIA study found 67 million prescriptions for the anti-convulsant medication gabapentin (Neurontin) in 2018 — a fact that is not reflected in the CDC findings.

The CDC is currently preparing an update of its controversial 2016 opioid guideline, which has been widely adopted as policy by other federal agencies, states, insurers, pharmacies and many doctors — who have used it as an excuse to take people off opioids or greatly reduce their doses.

The updated guideline – which is expected in late 2021 -- is likely to expand the CDC’s recommendations to include the use of opioids for treating short-term acute pain.

AMA: ‘CDC Guideline Has Harmed Many Patients’

By Pat Anson, PNN Editor

The American Medical Association is urging the Centers for Disease Control and Prevention to make significant changes to its 2016 opioid prescribing guideline to protect pain patients from arbitrary limits and other restrictions on opioid medication.

“It is clear that the CDC Guideline has harmed many patients,” the AMA said in a 17-page letter to the CDC.

The letter was in response to the CDC’s request for public comment as it considers an update and expansion of its controversial guideline. The guideline was only intended for primary care physicians treating chronic pain, but the CDC’s voluntary limits on opioid prescribing have been widely adopted as strict policy by federal agencies, states, insurers, pharmacies and doctors of all specialties.

The guideline has also failed to end the so-called opioid epidemic, which is now largely fueled by illicit fentanyl and other street drugs.  

“The nation no longer has a prescription opioid-driven epidemic. However, we are now facing an unprecedented, multi-factorial and much more dangerous overdose and drug epidemic driven by heroin and illicitly manufactured fentanyl, fentanyl analogs, and stimulants. We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens,” wrote AMA Executive Vice President and CEO James Madara, MD. 

“The nation’s opioid epidemic has never been just about prescription opioids, and we encourage CDC to take a broader view of how to help ensure patients have access to evidence-based comprehensive care that includes multidisciplinary, multimodal pain care options as well as efforts to remove the stigma that patients with pain experience on a regular basis.”

Over 5,300 public comments were submitted to the CDC, most of them from patients who blame the agency for their untreated and poorly treat pain. Tuesday was the deadline for comments to be submitted.

One-Size-Fits-All Restrictions

The AMA’s letter points out that opioid prescriptions were declining long before the CDC guideline was released, falling 33% from 2013 to 2018.  

Many patients cutoff from opioids have had no effective alternatives for pain relief. Some non-opioid therapies recommended by the CDC – such as massage and meditation – are still not fully covered by insurance.    

“In many cases, health insurance plans and pharmacy benefit managers have used the 2016 CDC Guidelines to justify inappropriate one-size-fits-all restrictions on opioid analgesics while also maintaining restricted access to other therapies for pain,” Madara wrote. 

The CDC plans to update and expand its guideline to include recommendations for treating short-term acute pain and tapering patients safely off opioid medication.

Madara said the agency should start by recognizing that pain patients need individualized care, not “one-size-fits-all algorithms and policies that do not take individual patient’s needs into account.”   

“Some patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than guidelines or thresholds put forward by federal agencies, health insurance plans, pharmacy chains, pharmacy benefit management companies, and other advisory or regulatory bodies,” Madara said. 

The AMA said the CDC Guideline could be substantially improved in three ways:  

1. Acknowledge that many patients experience pain that is not well controlled, impairs their quality of life, and could be managed with more compassionate patient care.  

2. Make the guideline part of a coordinated federal strategy to ensure patients receive comprehensive pain care delivered in a patient-centered approach.  

3. Urge states, insurers, pharmacies and other stakeholders to immediately suspend use of the CDC Guideline as an arbitrary policy to limit, discontinue or taper a patient’s opioid therapy. 

The CDC has been slow to respond to criticism of its 2016 guideline. The agency ignored an early warning from a consulting firm that many patients are “left with little to no pain management options” because “doctors are following these guidelines as strict law rather than recommendation.” The warning came in August 2016, five months after the CDC released its guideline.

It took the agency another three years to publicly admit that many patients were being tapered off opioids inappropriately, putting them at risk of uncontrolled pain, withdrawal and suicide. The agency’s long awaited “clarification” in 2019 had little impact on the problem, because many insurers, pharmacies and doctors still adhere to strict dosing policies. 

Even now, the agency appears to be dragging its feet on making revisions to the guideline, which seem more focused on expanding the recommendations rather than fixing them. The CDC does not anticipate the updated guideline to be ready until late 2021.   

‘You Ruined My Life’: Patients Blame CDC for Poor Pain Care

By Pat Anson, PNN Editor

Nearly 5,400 people have left comments in the Federal Register sharing their experiences and concerns about the quality of pain care in the United States. Tuesday was the final day for people to make public comments, which the Centers for Disease Control and Prevention will consider as it updates and possibly expands its controversial opioid prescribing guideline.

Most of the respondents are patients who blame the CDC for their poorly treated or untreated pain. Although the 2016 guideline was only intended for primary care physicians treating chronic pain, the CDC’s recommended limits on opioid prescribing have been widely adopted as policy by federal agencies, states, insurers, pharmacies and many doctors — who use the guideline as excuse to take people off opioids or greatly reduce their doses.  

“The day the CDC guidelines came out, I was taking 400mg oxycodone and leading a productive life. Then I was taken completely off all my medication. I went through hell and wanted to kill myself,” wrote Wren Lum. “I lost my job because I couldn't work anymore. I could no longer get out of bed. Lost my house because I could no longer pay the mortgage. CDC, you ruined my life.”

“I am not being prescribed the right dose of pain medication and it’s all because of the CDC guidelines. I used to be on three times the amount of oxycodone that I am now on and it’s taken away my ability to walk. I’m only 34 years old. This is devastating to me and my family, and now have such a lack of quality of life,” wrote Holly Letendre.

“I was given opioid medicine for 8 years. I could work, volunteer, socialize, care for my children, my husband, my home, and importantly, myself. I now shower every 10-14 days, it's too painful. When I do, I am curled up in horrendous pain for hours afterwards,” said Donna Johnson. “This is due to the CDC’s guidelines. It was then that doctors became afraid to prescribe, even to compliant patients living happy lives. I want my life back.”

The CDC is planning to update or expand the guideline to include recommendations for treating short-term acute pain and tapering patients safely off opioid medication. It took the agency three years to acknowledge that some patients were being taken off opioids too rapidly, putting them at risk of withdrawal, uncontrolled pain and suicide.

“My life has become miserable. I suffer every day after my doctor cut my dosage by almost 90 percent. Ninety percent! My blood pressure meds have had to be tripled. I have gained weight since I am now for all intents and purposes nearly bedridden,” said Kendal Rice in her comment to the CDC. “You people are just monsters. Every one of you. You certainly are not healers.”

PROP ‘Urgent Action Request’

Thousands of people – mostly pain patients and their loved ones – left comments critical of the CDC guideline. That prompted anti-opioid activists to launch their own campaign in support of the agency.

Dr. Andrew Kolodny, founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), emailed an “urgent action request” to supporters last night, urging them to leave their own comments. He claimed without any evidence that the backlash against the CDC was bankrolled by drug companies.

“The CDC has been receiving pressure to weaken the recommendations in its 2016 CDC Guideline,” wrote Kolodny. “Not surprisingly, much of this pressure is coming from pain organizations funded by drug companies and from opioid-dependent pain patients. Many of these patients are fearful and angry because they're having a harder time finding clinicians willing to prescribe opioids aggressively.” 

In a joint letter to CDC Director Dr. Robert Redfield, Kolodny and several PROP members said the guideline was “tremendously helpful” to primary care physicians and has led to “downward trends in inappropriate prescribing.” The letter also claimed that long term use of opioids often makes pain worse and leads to “intolerable negative mood changes” in patients. 

“We know from clinical experience and from controlled studies that opioids are rarely beneficial for chronic pain,” Kolodny wrote. “Now is not the time to reverse the gains of the 2016 guideline. The focus now should be twofold: to find better ways to help people already on opioids and improve access to better means than opioids to treat chronic pain.” 

Alternative Treatments

Many patients say they’ve already tried non-opioid treatments and found them ineffective for severe pain. 

“The majority of antidepressant and anti-seizure medications available today pose just as much a risk for dependency, withdrawal and death as opioids, if not more. Yet these medications are prescribed 1,000 times more and have much more severe side effects and withdrawal effects,” wrote Lois Luesing, who says her 36-year old son is housebound and unable to work because of chronic pain.

“He’s tried numerous available Rx meds, creams, alternative treatments, supplements, patches, etc. and nothing works. The only medication that will work to relieve his pain and give him his life back are opioids, yet we can’t find a doctor to prescribe this life-saving medication for him. It’s not his fault that’s the only thing that works. There are millions of others that this is the same for.”

Some patients have found alternatives that do work.  Although the herbal supplement kratom isn’t even mentioned in the CDC guideline, hundreds of kratom users left comments in the Federal Register asking the CDC not to regulate kratom.  

“Kratom is a life saver for me. I was being personally prescribed opiates for almost 20 years due to chronic pain. Although I always took as directed and never let them ruin my life, there's a very fine line to not go over the edge with them. They are so addictive and pretty dangerous for that matter. Since finding kratom this past year, I've been able to stop taking the opiates,” wrote Michael B. “Please don’t take this wonderful plant away from us. I assure you it will end up destroying many people's lives.” 

An update to the CDC guideline is not expected until late 2021, nearly six years after the initial guideline was released.  The agency has funded a series of new studies on opioid and non-opioid treatments for chronic pain.

The report on opioids was released in April. It concluded that opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose.

FDA Targets Websites Selling Illicit Opioids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is trying to put more teeth into efforts to stop the sale of unapproved or misbranded opioid medications online.

The FDA has launched a pilot program with the National Telecommunications and Information Administration (NTIA) that could result in online pharmacies being blocked or having their domain names suspended for selling illicit opioids. The NTIA is a branch of the U.S. Commerce Department that is responsible for telecommunications and information policy issues.

Under the pilot program, the FDA will notify three internet registries – Neustar, Verisign and Public Interest Registry – when the agency sends a warning letter to a website operator for selling opioids illicitly and the operator does not respond adequately within the required time frame. The internet registries could then voluntarily block or suspend the website domains, which would effectively take them offline.

“Stopping abuse of illegal opioids, including those sold online, has been one of President Trump’s top health priorities. The men and women of FDA have worked tirelessly over the years with the private sector and federal partners, like NTIA, to fight illegal online opioid sales,” Health and Human Services Secretary Alex Azar said in a statement.

For now, according to an FDA spokesperson, the pilot program will not target websites selling kratom, an herbal supplement that the agency considers an opioid.

“Websites selling kratom are not being included in this pilot at this time,” the spokesperson said in an email to PNN. “FDA continues to express concerns about kratom, which affects the same opioid brain receptors as morphine and appears to have properties that expose users to the risks of addiction, abuse, and dependence.”

In recent years, the FDA has sent hundreds of warning letters to rogue online pharmacies that sell counterfeit drugs or illegal medication. When they are caught, the websites often reappear under new domain names or move offshore.

‘Our Best Selling Product’

Sometimes the letters are simply ignored. For example, in September 2019, the FDA sent a warning letter to Euphoria Healthcare, which operates an online pharmacy called “Generic Wellness.” The letter warned Euphoria about selling the opioid tapentadol under the name “Aspadol” – a generic version of Nucynta. The FDA considers Aspadol to be an unapproved and misbranded drug, and gave Euphoria 15 days to respond to the letter or face possible civil or criminal charges.

Nine months later, Generic Wellness not only continues marketing Aspadol, it calls the drug “our best selling product” and claims the company is a “well known online pharmacy for selling FDA approved high quality generic medicines.”

The FDA had better luck with a March 2019 warning letter to the online pharmacy “The Don Rx” for selling misbranded versions of the opioid tramadol. That website has apparently been blocked or is no longer operating.  

The FDA’s new pilot program is apparently the result of meetings the agency had with internet stakeholders and registries to discuss ways to collaboratively stop sales of illicit opioids online. As a result of those meetings, Google began to de-index websites named in FDA warning letters, and social media platforms like Facebook and Instagram redirected users looking to buy opioids to a government run help line.

How Poppy Seed Muffins Could Get You Flagged by a Drug Test

By Pat Anson, PNN Editor

If you’re a patient who is prescribed opioid pain medication, you may have been warned not to eat poppy seed muffins or bagels before a drug test.

The tiny black seeds may contain trace amounts of morphine and codeine, which can be detected in a drug screen and wreak havoc with your medical care. A positive test could result in your doctor taking you off opioid medication or even dropping you as a patient.

Is the poppy seed warning accurate or just an urban myth? A group of researchers wanted to find out, so they ran a series of tests to measure opiate levels in commercially available poppy seeds. They washed, steamed and heated the seeds to see how that changed concentrations of three opium alkaloids: morphine, codeine and thebaine.

Washing or soaking the poppy seeds in water significantly reduced the presence of all three opium alkaloids. So did heating the seeds at a temperature of 392 F for at least 40 minutes.

However, baking the seeds in a muffin for 16 minutes at 392 F didn't significantly change the opium alkaloids, possibly because the internal and external temperatures of the muffins reached only 211 F and 277 F, respectively.

“Baking had no significant effect on concentrations of opium alkaloids. Overall, these results indicate that opium alkaloids may not be significantly affected by baking or steam application and that poppy seeds may require water washing or extended thermal treatment to promote reduction of these compounds,” said lead author Benjamin Redan, PhD, a research chemist who works in the FDA’s Institute for Food Safety and Health.

Redan says poppy seed muffins would have to be baked for at least two hours just to reduce morphine and codeine levels by 50 percent – which is not a recipe for passing a drug test or for baking tasty muffins.

The findings were recently published in the American Chemical Society’s Journal of Agricultural and Food Chemistry.

Poppy Seed Tea

Researchers and law enforcement agencies have been paying more attention to the lowly poppy seed because of anecdotal reports of people using the seeds to brew a potent tea that can be used for pain relief or to get high.

Late last year, Drug Enforcement Administration classified unwashed poppy seeds as a Schedule II controlled substance. While the poppy plant has long been classified as an illegal substance, the unwashed seeds were exempt because they were not perceived as a problem until recently.

“Individuals wishing to extract the opium alkaloid content from unwashed poppy seeds, use the seeds to create a tea, which contains sufficient amounts of alkaloids to produce psychoactive effects,” the DEA said. “Unwashed poppy seeds are a danger to the user and their abuse may result in unpredictable outcomes including death.”

The Internet is filled with stories about people experimenting with poppy seed tea. One alternative health website even has a recipe for making poppy seed tea that comes with a stark warning.

“Unfortunately, the abuse of or having insufficient knowledge about this tea has led to a few fatal incidences,” the recipe warns.

Prescriptions for Hydroxychloroquine Surge, But Drop for Hydrocodone

By Pat Anson, PNN Editor

Prescriptions for the antimalarial drugs hydroxychloroquine and chloroquine surged dramatically over the last few months, likely due to their off-label use for treating COVID-19, according to a new analysis published in JAMA. The study also found a significant decline in prescriptions for the opioid painkiller Vicodin and other hydrocodone/acetaminophen combinations.  

Researchers at Brigham and Women's Hospital studied prescription drug data from over 58,000 chain, independent and mail-order pharmacies in the U.S. from February 16 to April 25, and compared them to prescriptions over the same period in 2019.

Prescriptions for hydroxychloroquine and chloroquine spiked in mid-March – rising over 2,000 percent in one week -- soon after President Trump began touting the drugs as a possible treatment for the coronavirus. Brigham researchers estimate there were close to half a million additional prescriptions filled for hydroxychloroquine/chloroquine in 2020 compared to the year before.

SOURCE: JAMA

Hydroxychloroquine is only approved by the Food and Drug Administration to treat autoimmune diseases such as lupus and rheumatoid arthritis. Increased demand for the drug and government stockpiling soon led to spot shortages of hydroxychloroquine.

"There have been indications that hydroxychloroquine (HCQ) prescribing had increased and shortages had been reported, but this study puts a spotlight on the extent to which excess hydroxychloroquine/chloroquine prescriptions were filled nationally," said corresponding author Haider Warraich, MD, an associate physician in the Division of Cardiovascular Medicine at the Brigham.

"This analysis doesn't include patients who were prescribed HCQ in a hospital setting -- this means that patients could have been taking the drugs at home, without supervision or monitoring for side effects."

Last month President Trump took hydroxychloroquine for about two weeks with a doctor’s permission, even though the FDA warned that hydroxychloroquine should not be used as a treatment for COVID-19 outside of a hospital or clinical study because it could aggravate heart problems. The drug has been linked to at least 48 deaths in the U.S. so far this year, according to an FDA database.

On Sunday, the White House announced the U.S. supplied Brazil with 2 million doses of hydroxychloroquine. Brazil reported a record 33,274 new cases of the coronavirus over the weekend. Its death toll now ranks only below the United States, Britain and Italy.

Other Drugs Impacted by Pandemic

Brigham researchers say prescriptions for hydrocodone/acetaminophen fell by nearly 22 percent over the study period. There were also notable declines in prescriptions for the antibiotics amoxicillin and azithromycin, the blood pressure drug lisinopril, and the nerve drug gabapentin. Researchers said there are a variety of reasons why the drugs are being prescribed less often.

“The modest decline for most common long-term therapies after peak could represent reduced contact with prescribing clinicians, restricted access to pharmacies, pharmacist rationing, loss of insurance from unemployment, or replete supplies from early stockpiling,” researchers said. “Steep declines for amoxicillin and azithromycin appeared out of proportion to expected seasonal declines and could represent fewer outpatient prescriptions for upper respiratory tract infection symptoms.”

The pandemic appears to be taking a toll on the nation’s mental health. In the early stages of the outbreak, pharmacy benefit manager Express Scripts reported a surge in prescriptions for anti-anxiety medications such as Xanax and Valium, as well as antidepressants and anti-insomnia drugs.

A recent survey by the Kaiser Family Foundation found that nearly half of Americans said that they or a family member had cancelled or postponed medical care because of the pandemic. About one in every ten said the person’s medical condition worsened as a result of the delayed care.