A Pained Life: We Need More Than Opioids

By Carol Levy, PNN Columnist

There is no question we need to be active and stay on top of what the CDC and other federal agencies are doing that impedes our ability to get opioid medication.  For many chronic pain patients, opioids are the only effective pain reliever.

I wonder though: In focusing almost all of our energies on the issue of opioids, are we ignoring another front that needs to be addressed?

Cancer seems like the best analogy to me, maybe the only one. There are many forms of cancer but at the end of the day they all involve the excessive growth of cells that spread into surrounding tissue. All cancers, to my knowledge, start from that one errant misfire.

In recent years we have seen cancer treatments change and become more specific -- this combination of chemotherapy for lung cancer, a different type of chemo for sarcoma or leukemia, and so on. But ultimately, they are all some form of chemotherapy.

Unlike cancer, we can’t put all of our eggs into one basket. There is no universal type of “chronic pain.” We need to have different treatments and regimens for each pain disorder.

Trigeminal neuralgia and other cranial neuropathies have a different cause and mechanism than rheumatoid arthritis and other autoimmune diseases. So do multiple sclerosis and arachnoiditis.  Conditions like fibromyalgia and Chronic Regional Pain Syndrome (CRPS) are still poorly understood and difficult to treat.

Unlike cancer, we need to have multiple approaches to chronic pain syndromes. No one has come up with anything better than opioids for pain control and relief – at least not yet -- so this choice must remain accessible. But we must also not lose sight of the need for better treatments and possibly even cures for every pain condition.

We have to let it be known that we need opioids, not because they make us high, but because there is nothing else out there to take their place.  It is well past time for the government to understand, if they want to end the use of opioids, they must first ensure that there are other viable options out there.

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.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CDC: Still Not Enough Naloxone

By Pat Anson, PNN Editor

The Trump Administration is stepping up efforts to increase prescribing of naloxone, an overdose recovery drug credited with saving thousands of lives.

Although naloxone prescriptions have increased dramatically, a new CDC Vital Signs report estimates that nearly 9 million additional prescriptions could have been dispensed last year if every patient with a high-dose opioid prescription was offered naloxone.  Patients are considered “high risk” if they take an opioid dose of 50 morphine milligram equivalent (MME) or more per day.

Naloxone has been used for years by first responders and emergency medical providers to revive overdose victims. Current efforts are focused on expanding access to the drug by prescribing it directly to patients considered at risk of an overdose.

In 2018, CDC researchers say only one naloxone prescription was dispensed for every 70 high-dose opioid prescriptions nationwide. Naloxone “under-prescribing” was even more acute in rural counties, which are nearly three times more likely to be ranked low in naloxone dispensing than metropolitan counties.

“It is clear from the data that there is still much needed education around the important role naloxone plays in reducing overdose deaths. The time is now to ensure all individuals who are prescribed high-dose opioids also receive naloxone as a potential life-saving intervention,” CDC Director Robert Redfield, MD, said in a statement.

Ironically, federal policies contribute to the under-prescribing. In 2018, most (71%) Medicare prescriptions for naloxone required a copay, compared to 42% for commercial insurance.

In January, the Food and Drug Administration encouraged drug makers to make naloxone available over-the-counter without a prescription. The FDA even developed an OTC label for Narcan, a naloxone nasal spray that sells for about $135. Seven months later, the FDA could not confirm to PNN that any company had submitted an application for an OTC version of naloxone.

Last year the Department of Health and Human Services released guidance urging doctors to “strongly consider” prescribing naloxone to patients on any dose of opioids when they also have respiratory conditions or obstructive sleep apnea, are co-prescribed benzodiazepines, have a mental health or substance abuse disorder, or a history of illegal drug use or prescription opioid misuse.

Many states are also taking steps to increase naloxone prescribing. California now requires doctors to “offer” naloxone prescriptions to pain patients deemed at high risk of an overdose. State law does not make the prescriptions mandatory, yet some patients say they were “blackmailed” by pharmacists who refused to fill their opioid scripts unless naloxone was also purchased. Patients around the country report similar experiences.   

Unintended Consequences

The drumbeat for naloxone comes at a time when sales are already booming. There were 556,000 naloxone prescriptions in 2018, twice as many as in 2017.

There’s no doubt naloxone saves lives, but some researchers say the drug has had little effect on the overdose crisis and may in fact be making it worse. In a recent study published by SSRN, two economics professors warned of “unintended consequences” if naloxone becomes more widely available.

“We expect these unintended consequences to occur through two channels. First, the reduced risk of death makes opioid abuse more appealing, leading some to increase their opioid use — or use more potent forms of the drug — when they have naloxone as a safety net. Some of those abusers may become criminally active to fund their increased drug use,” wrote Jennifer Doleac, PhD, Texas A&M University, and co-author Anita Mukherjee, PhD, University of Wisconsin.

“Furthermore, expanding naloxone access might not in fact reduce mortality. Though the risk of death per opioid use falls, an increase in the number or potency of uses means the expected effect on mortality is ambiguous.”

The researchers said there were anecdotal reports of “naloxone parties” where attendees used heroin and prescription opioids to get high knowing they could be revived. News reports have also quoted first responders who are frustrated that the same opioid abusers “are saved again and again by naloxone without getting treatment.”

Co-Pay Assistance Programs Fail to Help Uninsured Patients

By Pat Anson, PNN Editor

Co-pay assistance programs – also known as co-pay charities – are ostensibly designed to help needy patients pay for prescription drugs. But a new study by researchers at the Johns Hopkins Bloomberg School of Public Health found that nearly all co-pay programs fail to cover uninsured patients who need financial help the most.

The researchers also found that co-pay programs were more likely to cover high-cost, brand-name prescription drugs, despite the availability of lower-priced generic medications. The findings are published online in JAMA.

“Independent patient assistance programs favor higher-priced drugs, and the higher the drug price, the higher the likelihood of it being covered,” says co-author Gerard Anderson, PhD, professor in the Bloomberg School’s Department of Health Policy and Management. “Unfortunately patients with the greatest financial needs -- people without health insurance -- do not qualify for these programs.”

Anderson and his colleagues looked at the six largest charity organizations, which ran 274 different patient assistance programs in 2018.

Most of the programs only covered drugs for cancer-related conditions or genetic and rare diseases. None offered free drugs and typically they only covered the most expensive medications.

“Only covering insured patients may help these programs cover more patients with their limited funds,” said lead author So-Yeon Kang, MPH, a research assistant in the Bloomberg School’s Department of Health Policy and Management. “But leaving out the uninsured diminishes the charitable aspects of these organizations supported by tax-exempted donations.”

Misconduct Widespread

Patient assistance programs run by independent charities are usually funded by pharmaceutical companies. Federal investigations into several co-pay assistance programs led to multimillion-dollar settlements with drug companies for allegedly steering patients to their higher-priced drugs.

Over the past year, Pfizer, Amgen, Jazz Pharmaceuticals, Astellas Pharma, Lundbeck and Alexion have all paid heavy fines to settle allegations that they used co-pay programs to defraud Medicare. Federal anti-kickback laws prohibit pharmaceutical companies from making any kind of payment to induce Medicare patients to purchase their drugs. The prohibition includes co-pays.

“We are committed to ensuring that pharmaceutical companies do not use third-party foundations to pay kickbacks masking the high prices those companies charge for their drugs,”  U.S. Attorney Andrew Lelling said in a statement. “This misconduct is widespread, and enforcement will continue until pharmaceutical companies stop circumventing the anti-kickback laws to artificially bolster high drug prices, all at the expense of American taxpayers.”

Similar allegations were made against Insys Therapeutics and the “Gain Against Pain” co-pay program run by the U.S. Pain Foundation. Insys donated over $3.1 million to U.S. Pain, with most of the money going to its co-pay program to help patients pay for Subsys, an expensive fentanyl spray made by Insys. A four-day supply of Subsys can cost nearly $24,000.

The founder of Insys and four former executives were recently found guilty of racketeering charges unrelated to the co-pay program. The company also agreed to pay $225 million in fines and penalties to settle criminal and civil investigations. U.S. Pain ended the “Gain Against Pain” program in 2018 and said it would no longer accept funding from Insys.

In an editorial, Katherine Kraschel, a lecturer at Yale Law School, and Gregory Curfman, MD, deputy editor of JAMA, called for more oversight of co-pay programs to make sure they help patients who truly need it.

“Although patient assistance programs may provide important financial relief for patients, the current patient assistance program structure largely neglects uninsured individuals,” they wrote.  “Absent other regulatory interventions, the Department of Justice needs to continue to scrutinize patient assistance program practices, and the Internal Revenue Service and state attorneys general should examine the tax-exempt status of patient assistance programs.”

Professional Athletes Get Stem Cell Therapy, But Should You?

By Liz Szabo, Kaiser Health News

Baseball superstar Max Scherzer — whose back injury has prevented him from pitching for the Washington Nationals since he last played on July 25 — is the latest in a long list of professional athletes to embrace stem cell injections in an attempt to accelerate their recovery.

But many doctors and ethicists worry that pro athletes — who have played a key role in popularizing stem cells — are misleading the public into thinking that the costly, controversial shots are an accepted, approved treatment.

“It sends a signal to all the fans out there that stem cells have more value than they really do,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It’s extremely good PR for the people selling this kind of thing. But there’s no question that this is an unproven treatment.”

Stem cells and related therapies, such as platelet injections, have been used for the past decade by top athletes: golfer Tiger Woods, tennis pro Rafael Nadal, hockey legend Gordie Howe, basketball player Kobe Bryant and NFL quarterback Peyton Manning. Stem cells are offered at roughly 1,000 clinics nationwide, as well as at some of the country’s most respected hospitals.

Depending on the treatment, the cost can range from hundreds to thousands of dollars. Insurance does not cover the treatments in most cases, so patients pay out of pocket.

Yet for all the hype, there’s no proof it works, said Paul Knoepfler, a professor in the department of cell biology and human anatomy at the University of California at Davis.

By Arturo Pardavila III from Hoboken, NJ, USA

Referring to Scherzer, Knoepfler said, “There’s really not much evidence that it’s going to help him, other than as a psychological boost or as a placebo effect.”

Scherzer, 35, said he received a stem cell shot Friday for a mild strain in his upper back and shoulder. According to a news story on the Major League Baseball website, Scherzer also previously had a stem cell injection to treat a thumb injury.

If the diagnosis of Scherzer’s mild muscle strain is correct, it should completely heal itself with 10 days of rest, Rickert said, so Scherzer would probably feel ready to play by Monday even without the stem cells. But Rickert said he worries about other athletes who are tempted to return to the field too soon.

“The risk from the stem cell procedure is that it could give someone a false sense of confidence, and they could go back to play too early” and reinjure themselves, he said.

A spokeswoman for the Washington Nationals declined to provide information about Scherzer’s treatment, such as the type of stem cells used or the name of the clinician who administered them.

Clinics that offer stem cell treatments prepare injections by withdrawing a person’s fat or bone marrow, then processing the cells and injecting them back into aching joints, tendons or muscles.

Another popular treatment involves concentrating platelets — the cells that help blood clot. Many people confuse platelet injections with stem cell injections, perhaps because the shots are promoted as treatments for similar conditions, said Dr. Kelly Scollon-Grieve, a physical medicine and rehabilitation specialist at Premier Orthopaedics in Havertown, Pa.

Placebo Effect on Pain

When it comes to pain, injections can act as powerful placebos, partly because suffering patients put so much faith in treatment, said Dr. Nicholas DiNubile, an orthopedic surgeon and former consultant for the Philadelphia 76ers.

In a recent analysis, more than 80% of patients with knee arthritis perceived a noticeable improvement in pain after receiving a placebo of simple saline shots.

Team doctors often treat athletes with a variety of therapies, in the hope of getting them quickly back on the field, said Arthur Caplan, director of the division of medical ethics at New York University School of Medicine. Athletes may assume that stem cells are responsible for their recovery, when the real credit should go to other remedies, such as ice, heat, nonsteroidal anti-inflammatory medications, cortisone shots, massage, physical therapy or simple rest.

“These are the richest, most highly paid athletes around,” Caplan said. (Scherzer and the Nats agreed to a $210 million, seven-year contract in 2015.) “So anything you can think of, they’re getting. But I wouldn’t use them as a role model for how to treat injuries.”

While athletes often talk about their stem cell treatments, Caplan said he wonders, “Would the inflammation or problem have just gone away on its own?”

Sports fans shouldn’t expect to have the same reaction to stem cells — or any medical intervention — as a professional athlete, DiNubile said.

In general, athletes recover far more rapidly than other people, just because they’re so young and fit, DiNubile said. The genes and training that propelled them to the major leagues may also aid in their recovery. “They have access to the best care, night and day,” DiNubile said.

Whenever a top athlete is treated with stem cells, word spreads quickly on social media. Fans often end up doing the stem cell industry’s marketing for them: A 2015 analysis found that 72% of tweets about Gordie Howe’s stem cell treatments were positive. Of 2,783 tweets studied, only one mentioned that Howe’s treatment, delivered in Mexico after Howe’s stroke, was unproved and not approved by the U.S. Food and Drug Administration. Howe died in 2016.

The Mexican stem cell clinic provided Howe’s treatment at no charge. Clinics use such donations as a form of marketing, because they generate priceless publicity, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published articles describing the size and dynamics of the stem cell market.

“Clinics provide free stem cell treatments or offer procedures at a discounted rate, and in return they can generate YouTube testimonials, press releases and positive media coverage,” Turner said. “It’s also a good way to build relationships with wealthy individuals and get them to refer friends and family members for stem cell procedures.”

Stem cell clinics often feature athletes and other celebrities on their websites and in marketing materials.

In a 2018 column, Los Angeles Times writer Michael Hiltzik noted that stem cell treatment has failed three baseball players with the Los Angeles Angels. Players Shohei Ohtani, Andrew Heaney and Garrett Richards, who is no longer with the Angels, tried stem cells in the past three years in an effort to avoid surgery. All ended up needing surgery anyway.

As DiNubile said, “the marketing is clearly ahead of the science, no question.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Would Decriminalization Solve the Overdose Crisis?

By Pat Anson, PNN Editor

Vancouver, British Columbia was the first major North American city to be hit by the overdose crisis. In 2016, after a wave of overdose deaths involving illicit fentanyl and even more deadly synthetic opioids like carfentanil, the western Canadian province declared a public health emergency.

Despite efforts to decrease the supply of prescription opioids in BC, over 3,600 more people have overdosed since the emergency was declared, with fentanyl detected in 87% of the deaths last year.

So when BC’s largest healthcare system recommends some radical solutions to the overdose crisis, it’s worth noting. Vancouver Coastal Health (VCH) released a report last month recommending that illegal drugs be decriminalized and that drug users be given access to prescription opioids as an alternative to the black market.

"Legalization and regulation of all psychoactive substances would reduce people's dependence on the toxic illegal supply, criminal drug trafficking and illegal activities that people with addictions must engage in to finance their drug use," said Dr. Patricia Daly, VCH’s chief medical health officer.  

Some Canadian drug policy experts think the idea makes sense.

"The illegal market is an absolute toxic mess right now," Donald MacPherson, executive director of the Canadian Drug Policy Coalition, told the CBC. "It's really in line with consumer protection strategy ... just like we do with every other substance that we ingest, whether it be food or drugs."

Also notable about the VCH report is that – unlike most regulators and politicians in Canada and the U.S. – prescription opioids are not singled out as the root cause of the overdose crisis. Instead, opioid medication is seen as part of the solution.

The report recommends pilot programs to see if prescription fentanyl and other opioid medications made available at supervised consumption sites could help high-risk illicit drug users “transition” to legal opioids.

“Piloting legal access to opioids is different from OAT (opioid agonist therapy) as treatment and would be low-barrier and flexible. Initial pilots would include observation of consumption, followed by pilots allowing distribution of opioids for people to take away for later consumption,” the report recommends.

The idea is controversial, but some doctors are warming up to it. A pilot program recently began at a Vancouver clinic, where hydromorphone tablets are given to about 50 patients who ingest them on site under staff supervision. In Ontario, over 400 healthcare providers and researchers recently signed an open letter asking that high dose injectable hydromorphone be made widely available to illicit drug users.

Substance Abuse and Socioeconomic Problems

The primary cause of the opioid crisis, according to the VCH report, is a “complex interaction” of socioeconomic problems, such as unemployment and homelessness, combined with substance abuse and an increasingly dangerous black market supply.

VCH analyzed the deaths of 424 overdose victims from 2017 and found that less than half (45%) even sought treatment for acute or chronic pain. They were far more likely to be unemployed (72%) and have a substance abuse problem (84%). About four out of ten overdose victims used opioids, alcohol or stimulants daily.

“Most of those who died used multiple substances including opioids, alcohol and stimulants such as cocaine and crystal meth. A significant percentage of those who died of opioid overdoses had primary alcohol use disorder and/or stimulant use disorder,” the report found.

Importantly, most of those who died were no strangers to the healthcare system. The vast majority (77%) had seen a healthcare provider in the year before they overdosed and one out of five (21%) had seen a provider a week before their death. Six out of ten (59%) had received Suboxone or methadone to treat opioid addiction, but the medications were either not effective or they dropped out of treatment.

In addition to decriminalization, the VCH report recommends improving access to addiction treatment, better substance abuse training of healthcare providers, and increased access to the overdose reversal drug naloxone.

Empathy Must Be Included in Pain Management Education

By Dr. Lynn Webster, PNN Columnist

The National Institutes for Health (NIH) is seeking input on how to improve medical education in the fields of pain management and the treatment of opioid use disorder.

Although the NIH is primarily asking healthcare professionals and researchers to weigh in, comments from the general public are also welcome. The information will be used to update the NIH’s Centers for Excellence in Pain Education, which is developing pain management curriculum for medical, dental, nursing and pharmacy schools to improve how students are taught about pain and its treatment.

If you are a person in pain, or love someone who is, your input is what all healthcare providers should hear. You can see the Request for Information (RFI) by clicking here. The link includes an email address to use to contribute your thoughts.

This is an opportunity to tell the NIH what you would like to see included in pain education, or what needs to be taught regarding opioid misuse or abuse. People often want to be heard. This is the time to let the NIH know what you believe is important to teach all healthcare providers.

Potential educational topics could include:

• What should be the primary goal of pain treatment

• The role of empathy, rather than animus, in treating people with pain

• The power of trust, rather than suspicion and disbelief, in the therapeutic relationship

• Techniques to reduce the stigma of pain, disability and opioid use disorder

Therapies of the Heart

My comments to the NIH will include some of my strongly-held beliefs, including:

Pain therapy must include compassion. A therapeutic relationship may not be considered mainstream medical treatment, but it is crucial to pain management. It includes acceptance, compassion, listening, respect, encouragement, trust, kindness, patience, and being fully present.

I call these the therapies of the heart. They are simple, yet vital, components of a broad-based approach to treating the whole person.

Too often, people in pain are abandoned by health care professionals, family members, and friends. They need to be supported by all the key people in their lives and treated by medical professionals who are adequately trained.

Education should convey that pain isn't just biological. It is psychological, social, and spiritual. A healthcare professional who treats pain must internalize this concept to provide the most humanistic treatment possible.

The fact that withdrawal does not mean addiction is a concept too few people in healthcare understand. Any education that discusses opioids must make clear the differences between addiction and withdrawal. Providers also must learn that a person who experiences withdrawal is not necessarily addicted.

I will recommend to the NIH that their program require all participants watch Travis Rieder’s TED Talk on opioid withdrawal:

I will also ask that pain management curriculum make it clear that babies cannot be born addicted. The fact that the media commonly uses the phrase "addicted babies" in place of "babies with neonatal abstinence syndrome" only reinforces the misunderstanding of what clinical withdrawal means.

Additionally, education should address misconceptions about people in pain, and how chronic pain affects families and other relationships. Educational content should include a discussion of the losses that accompany chronic pain -- to the person in pain and also to their family members.

Providers need to be trained to understand that pain is personal and individualized; therefore, treatment must be individualized, too. What works for one person may not work for another.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth” and co-producer of the documentary, “It Hurts Until You Die.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Lessons from the Opioid Database

By Roger Chriss, PNN Columnist

Last month The Washington Post made public for the first time a DEA database of opioid prescribing that shows “the path of every single pain pill” sold in the United States from 2006 to 2012.

The Post’s analysis showed that 76 billion pills flowed through the country and nearly 100,000 fatal overdoses occurred over a seven-year period.

Biospace explained that opioid manufacturers, distributors and retailers “allowed the drugs to reach the streets of communities large and small, despite persistent red flags that those pills were being sold in apparent violation of federal law and diverted to the black market.”

The first lesson from the database seems obvious. Too many pills were prescribed, with opioid manufacturers, distributors and retailers failing to report suspicious orders and government agencies failing to oversee the prescription opioid supply.

“If you don’t start millions of opioid-naive people on opioids they don’t need, it translates … in the longer term into fewer overdoses,” Stanford psychiatry professor Keith Humphreys told the Post.

But this misses a key lesson. Although no drug should ever be used when it is not needed, this leaves open the obvious and essential question: How do we reduce risks in people who do need opioids?

We cannot ban opioids completely without returning to pre-Civil War medicine. But each year we have millions of car crashes, severe battlefield and workplace injuries, new cases of cancer, major surgeries and devastating long-term illness.

In the many commentaries on the opioid database, little has been said about improving prescribing safety. We need better ways to use opioids safely because sometimes we just don’t have any other option.

If it is true, as Julie Croft, an Oklahoma addiction treatment provider wrote, “We are all just one accident away from becoming addicted to painkillers” -- then we had better rapidly improve how we use opioids or come up with better alternatives since we have millions of accidents annually.

To this end, Yale and the Mayo Clinic were recently awarded a $5.3 million FDA grant to study patients with acute pain and their use of opioids.

Reduced Prescribing May Not Be Enough

The next lesson in the database is vulnerability to substance abuse. Dennis Scanlon, PhD, and Christopher S. Hollenbeak, PhD, note in the American Journal of Managed Care, that “although using government or regulatory mechanisms to prevent or significantly curb the supply of addictive narcotics is certainly valuable, there is also value in preventing or reducing addiction at its core.”

In other words, policies that reduce opioid prescribing may be helpful, but they may also not be enough. We need better tools and greater understanding of opioid prescribing. The National Institute of Drug Abuse currently estimates that 8% of people on long-term opioid therapy develop some form of opioid use disorder, while The BMJ estimates that less than 1% of surgical patients receiving opioids face a similar fate. These numbers may seem low, but every effort should be made to reduce them.

As bioethicist Travis Reider states in his book “In Pain” about his personal struggle with opioids: “The bottom line is that we are not, by and large, acting decisively in an evidence-based way to tackle the myriad problems raised by opioids. Although we don’t know everything about how to turn the corner on this crisis, we know a lot, and we’re simply not doing it.”

The last essential lesson from the opioid database is that opioid abuse and addiction came long before the crisis. The clichéd response that we “cannot arrest our way” out of the crisis needs to be extended to we “cannot simply restrict our way out” either. We need better prevention and early intervention for opioid use disorder, and improved management of the opioid supply chain so as to prevent theft and diversion.

The crisis is a fast-moving target, with prescription opioid levels having dropped significantly since 2012. Overdoses involving prescription opioids have also fallen, while deaths linked to illicit opioids like fentanyl, cocaine and methamphetamine are rising sharply. We will need far more than a prescribing database to guide policy moving forward.

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.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Marijuana Use May Affect Patient Anesthesia

By Kata Ruder, Kaiser Health News

When Colorado legalized marijuana, it became a pioneer in creating new policies to deal with the drug.

Now the state’s surgeons, nurses and anesthesiologists are becoming pioneers of a different sort in understanding what weed may do to patients who go under the knife.

Their observations and initial research show that marijuana use may affect patients’ responses to anesthesia on the operating table — and, depending on the patient’s history of using the drug, either help or hinder their symptoms afterward in the recovery room.

Colorado makes for an interesting laboratory. Since the state legalized marijuana for medicine in 2000 and allowed for its recreational sale in 2014, more Coloradans are using it — and they may also be more willing to tell their doctors about it.

Roughly 17% of Coloradans said they used marijuana in the previous 30 days in 2017, according to the National Survey on Drug Use and Health, more than double the 8% who reported doing so in 2006. By comparison, just 9% of U.S. residents said they used marijuana in 2017.

“It has been destigmatized here in Colorado,” said Dr. Andrew Monte, an associate professor of emergency medicine and medical toxicology at the University of Colorado School of Medicine and UCHealth. “We’re ahead of the game in terms of our ability to talk to patients about it. We’re also ahead of the game in identifying complications associated with use.”

One small study of Colorado patients published in May found marijuana users required more than triple the amount of one common sedation medicine, propofol, as did nonusers.

Those findings and anecdotal reports are prompting additional questions from the study’s author, Dr. Mark Twardowski, and others in the state’s medical field: If pot users indeed need more anesthesia, are there increased risks for breathing problems during minor procedures?

Are there higher costs with the use of more medication, if a second or third bottle of anesthesia must be routinely opened? And what does regular cannabis use mean for recovery post-surgery?

But much is still unknown about marijuana’s impact on patients because it remains illegal on the federal level, making studies difficult to fund or undertake.

It’s even difficult to quantify how many of the estimated 800,000 to 1 million anesthesia procedures that are performed in Colorado each year involve marijuana users, according to Dr. Joy Hawkins, a professor of anesthesiology at the University of Colorado School of Medicine and president of the Colorado Society of Anesthesiologists. The Colorado Hospital Association said it doesn’t track anesthesia needs or costs specific to marijuana users.

As more states legalize cannabis to varying degrees, discussions about the drug are happening elsewhere, too. On a national level, the American Association of Nurse Anesthetists recently updated its clinical guidelines to highlight potential risks for and needs of marijuana users. American Society of Anesthesiologists spokeswoman Theresa Hill said that the use of marijuana in managing pain is a topic under discussion but that more research is needed. This year, it endorsed a federal bill calling for fewer regulatory barriers on marijuana research.

Should Patients Disclose Marijuana Use? 

No matter where patients live, though, many nurses and doctors from around the country agree: Patients should disclose marijuana use before any surgery or procedure. Linda Stone, a certified registered nurse anesthetist in Raleigh, N.C., acknowledged that patients in states where marijuana is illegal might be more hesitant.

“We really don’t want patients to feel like there’s stigma. They really do need to divulge that information,” Stone said. “We are just trying to make sure that we provide the safest care.”

In Colorado, Hawkins said, anesthesiologists have noticed that patients who use marijuana are more tolerant of some common anesthesia drugs, such as propofol, which helps people fall asleep during general anesthesia or stay relaxed during conscious “twilight” sedation. But higher doses can increase potentially serious side effects such as low blood pressure and depressed heart function.

Limited airway flow is another issue for people who smoke marijuana. “It acts very much like cigarettes, so it makes your airway irritated,” she said.

To be sure, anesthesia must be adjusted to accommodate patients of all sorts, apart from cannabis use. Anesthesiologists are prepared to adapt and make procedures safe for all patients, Hawkins said. And in some emergency surgeries, patients might not be in a position to disclose their cannabis use ahead of time.

Even when they do, a big challenge for medical professionals is gauging the amounts of marijuana consumed, as the potency varies widely from one joint to the next or when ingested through marijuana edibles. And levels of THC, the chemical with psychoactive effects in marijuana, have been increasing in the past few decades.

“For marijuana, it’s a bit of the Wild West,” Hawkins said. “We just don’t know what’s in these products that they’re using.”

Marijuana’s Effects On Pain After Surgery

Colorado health providers are also observing how marijuana changes patients’ symptoms after they leave the operating suite — particularly relevant amid the ongoing opioid epidemic.

“We’ve been hearing reports about patients using cannabis, instead of opioids, to treat their postoperative pain,” said Dr. Mark Steven Wallace, chair of the pain medicine division in the anesthesiology department at the University of California-San Diego, in a state that also has legalized marijuana. “I have a lot of patients who say they prefer it.”

Matthew Sheahan, 25, of Denver, said he used marijuana to relieve pain after the removal of his wisdom teeth four years ago. After surgery, he smoked marijuana rather than using the ibuprofen prescribed but didn’t disclose this to his doctor because pot was illegal in Ohio, where he had the procedure. He said his doctor told him his swelling was greatly reduced. “I didn’t experience the pain that I thought I would,” Sheahan said.

In a study underway, Wallace is working with patients who’ve recently had surgery for joint replacement to see whether marijuana can be used to treat pain and reduce the need for opioids.

But this may be a Catch-22 for regular marijuana users. They reported feeling greater pain and consumed more opioids in the hospital after vehicle crash injuries compared with nonusers, according to a study published last year in the journal Patient Safety in Surgery.

“The hypothesis is that chronic marijuana users develop a tolerance to pain medications, and since they do not receive marijuana while in the hospital, they require a higher replacement dose of opioids,” said Dr. David Bar-Or, who directs trauma research at Swedish Medical Center in Englewood, Colo., and several other hospitals in Colorado, Texas, Missouri and Kansas. He is studying a synthetic form of THC called dronabinol as a potential substitute for opioids in the hospital.

Again, much more research is needed.

“We know very little about marijuana because we’ve not been allowed to study it in the way we study any other drug,” Hawkins said. “We’re all wishing we had a little more data to rely on.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Feds Warn of Counterfeit Oxycodone Deaths

By Pat Anson, PNN Editor

In the wake of four fentanyl overdoses in southern California, federal authorities have issued a public safety alert warning drug users about a lethal strain of counterfeit medication designed to look like 30mg oxycodone tablets.

The blue bills have the letter “M” in a box on one side and the number “30” with a line down the center on the other. On the street they are referred to as blues, M-30s or Mexican Oxy.

The pills were found at the scene of four fatal overdoses in San Diego County last week. The deaths in Poway, Santee, Lakeside and Valley Center were all reported within 24 hours.

Although tests on the pills are ongoing, authorities suspect they are laced with illicit fentanyl or carfentanil, which can be fatal in tiny doses.

SAN DIEGO SHERIFF’S DEPT. IMAGE

“That heroin, that meth, that coke, that oxy you think you are taking? Well, it just might have fentanyl in it, and it just might be the last thing you ever do,” U.S. Attorney Robert Brewer said in a statement. “I cannot be more clear than this: Fentanyl may be the costliest drug you ever do, because you may pay with your life, and you won’t even know you took it.”

Brewer said border seizures, prosecutions and overdoses are on pace to hit all-time highs in San Diego County by the end of 2019. The Medical Examiner’s Office has confirmed 50 fentanyl-related overdose deaths so far this year, plus another 28 suspected but yet-to-be confirmed cases.

If the trend continues, the death toll could potentially reach 130, which would amount to a 47 percent increase over last year’s total of 90 deaths. The victims are overwhelmingly male, with the average age about 36.

“Just when we think it can’t get any worse, the latest numbers prove us wrong,” Brewer said.  “I am alarmed by the dramatic surge in trafficking activity and deaths, particularly of young people. San Diego is the fentanyl gateway to the rest of the country, and we are working hard to close that gate with interdiction, prosecution and education.”

Federal authorities have confiscated 1,175 pounds of illicit fentanyl – more than half a ton -- at or near the international border so far this year. In addition, there has been a record number of seizures involving counterfeit blue pills labeled M-30 that contain fentanyl. The pills sell on the street for $9 to $30 each and are appearing around the country.

Ports of entry near San Diego are major transit points for illicit fentanyl smuggled in from Mexico. The fentanyl is usually transported in vehicles, often by legal U.S. residents acting as couriers.

A recent report from the Wilson Center found that Mexican cartels are playing an increased role in the fentanyl trade.

“San Diego is the fentanyl gateway to the rest of the country.”

— U.S. Attorney Robert Brewer

“Chinese companies produce the vast majority of fentanyl, fentanyl analogues, and fentanyl precursors, but Mexico is becoming a major transit and production point for the drug and its analogues as well, and Mexican traffickers appear to be playing a role in its distribution in the United States,” the report found.

“Both large and small organizations appear to be taking advantage of the surge in popularity of the drug, which is increasingly laced into other substances such as cocaine, methamphetamine, and marijuana—very often without the end-user knowing it. To be sure, rising seizures of counterfeit oxycodone pills laced with fentanyl illustrate that the market is maturing in other ways as well.”

Last week a former Mexican police officer was indicted for fentanyl trafficking by a federal grand jury in Texas. Assmir Contreras-Martinez, 30, was pulled over by a Texas trooper on Interstate 40 in Amarillo in May. About 73 pounds of illicit fentanyl powder was found inside his 2007 Ford Explorer, enough to kill 10 million people, according to DEA experts. 

Contreras-Martinez admitted he was paid $6,000 to transport the fentanyl from California to Florida and that it was his second such trip. Before his unlawful immigration to the United States nine months ago, Contreras-Martinez had been employed for eight years as a municipal police officer in Cananea, Sonora, Mexico.

Pain Is Not a Competition

By Mia Maysack, PNN Columnist

Recently I chose to step away from one of the last support group forums I belonged to because it continually felt less than supportive.  

“Pain is pain” may be the motto of our community, yet there are persistent comparisons that consistently belittle someone’s reality in some shape or form.  It’s like a competition to see who has the most pain.

To serve as one example, “cluster migraine” is not a scientific term, though it is a phrase I use to convey the type of pain that I feel -- an inclusion of multiple beasts (chronic migraine, cluster headache and fibromyalgia) that are not to be confused as the same or even similar, but co-exist within me nonetheless.

There's no doubt that cluster headache is one of the most excruciating conditions known to humankind. If you haven’t gone through it -- there is no possible way to fully comprehend it.  This does not mean that migraine is any less valid or any less painful.

We all seek validation in having our perception understood and it is frustrating that we consistently battle general stigma and then turn around and cast the same judgment onto each other. Cluster or migraine aside, it’s like a whole new attack.   

One person could say migraine is worse because it can literally be never-ending, whereas cluster headache episodes are considerably shorter in length. 

The next person states that it doesn't get any more terrible than cluster headache as they're called suicide headaches for good reason. 

Then someone else shares they have lost someone to migraine as well. Point is, there's a spectrum.  

By eliminating the unnecessary tone of competition (that no one should want to “win” anyway), we make room for discovering the similarities we all share. One being that whichever way this sh*t pie gets sliced, it stinks!

Nobody wants or deserves to be shunned just because their truth is different. And no one gets to degrade how someone else views the world. Whether or not we agree, there should be a sense of camaraderie throughout our planet that is severely lacking. It most certainly shouldn't be among us Spoonies.  

Fixating on how an individual thinks does not benefit our cause. That same focused energy on the bigger picture could create lasting change -- like how the word “headache” isn't an accurate depiction of any brain disease or disorder to begin with. And if it were, aspirin would have cured it long ago, right? 

It’s imperative we avoid contributing to the very issue we want to solve by joining forces and declaring that we are more than just suffering patients. We are actual people living with the disability inflicted by these conditions.

And since we’re already in the fight for our lives, let's make sure it’s together and not against one another.

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Kratom Advocates Call for End to ‘Leafer Madness’

By Pat Anson, PNN Editor

If you are curious about the herbal supplement kratom and did some research online to learn more about it, chances are you’ve come across some of the scary headlines:

“Warnings Issued on Kratom Use”

“The Herbal Supplement That Could Poison You”

“Kratom Is Unsafe for People’s Health”

“Kratom: Deadly Supplement or Supplementing Death?”

With news coverage like that, you might wonder why anyone would try kratom. But according to the American Kratom Association, there are 16 million kratom users in the United States, most taking it to treat chronic pain, addiction, withdrawal or anxiety.

Why is a popular supplement being demonized in the media? Kratom advocacy groups say many news organizations in the U.S. have succumbed to a collective case of ‘Leafer Madness’ – similar to the ‘Reefer Madness’ over marijuana.

In a media analysis released in May, the industry-funded Kratom Information and Resource Center (KIRC) concluded there was a “tsunami of unfair and unbalanced” reports on kratom.

Ninety-two percent of the nearly 2,500 media stories analyzed by KIRC were found to be negative or unbalanced. Most of the negative coverage was by local media, which was heavily influenced by FDA and CDC reports linking kratom to overdose deaths or comparing kratom to opioids. Those reports were rarely questioned by reporters who didn’t seek another opinion.

This week KIRC followed up on its media analysis by sending a petition to nine media trade organizations asking that kratom be covered more fairly.

“You are in a position to encourage your members to start reporting on the coffee-like herb kratom in a fair and balanced way. Please urge them to tell both sides of the story, seek out the reputable scientists who dispute claims made against kratom, and stop depicting kratom consumers as unsavory characters.

“To date, most ‘reporting’ about the kratom consumed today by millions of American adults without ill effect has been sensationalistic and one-sided, the modern-day equivalent of the irresponsible and inaccurate ‘Reefer Madness’ media depictions that once were used to justify keeping in place restrictions on marijuana and to stigmatize those choosing to consume it.”

The nine media trade groups receiving the KIRC petition are: The American Society of News Editors, National Association of Science Writers, Association of Health Care Journalists, News Media Alliance, Investigative Reporters and Editors, National Newspaper Association, The Association of Magazine Media, Society of Professional Journalists and The National Association of Broadcasters.

“Stop treating kratom like some kind of pinata that you can whack away at as though the rules of journalism don’t apply,” KIRC spokesperson Max Karlin said in a statement.

“Our message to the media is very simple: Get your facts straight about kratom and listen to all voices, not just those with the biggest megaphones. There is a great deal of scientific disagreement about kratom when it comes to such issues as pain management and dependency. All experts should be heard, not just a cherry-picked few who have been lined up by proponents of prohibition.”

The “scientific disagreement” over kratom stems from the fact that so little is known about it – even though it’s been used for centuries in southeast Asia as a natural pain reliever and stimulant.  There have been few clinical studies of kratom to document its risks and benefits — leaving mostly anecdotal reports to rely on.

Still Interested in Learning About Kratom?  

One can find a lengthy and balanced review of kratom that was recently published in the journal Substance Abuse and Rehabilitation.  The authors — two pharmacy professors at the University of Florida and Midwestern University in Arizona — question the claims about kratom causing overdoses, because “causality could not be established in almost all cases because of poly-drug exposures.”

And while reports of kratom addiction “are of serious concern” given the opioid crisis, Oliver Grundmann, PhD, and Charles Veltri, PhD, found no solid evidence that kratom causes dependency.

At the same time, however, they urge kratom consumers to be cautious about be exposed to kratom products that could interact with medications they are already taking.

“The labeling of Kratom products available to consumers needs to follow appropriate regulatory standards as well as quality good manufacturing practices to ensure that consumers who seek out Kratom are not exposed to adulterated or contaminated products,” Grundmann and Veltri wrote. “Health care providers should be trained on the science of Kratom and its clinical implications to assist consumers in making the right choice and avoid herb–drug interactions.”

Medical Cannabis Won’t Solve the Opioid Crisis

By Roger Chriss, PNN Columnist

Medical cannabis legalization isn’t helping reduce opioid overdoses. Two major studies have closely examined over a decade’s worth of data, finding no support for the idea that legalizing medical cannabis reduces prescription opioid use, overdose or mortality.

In June, Stanford researchers led by Chelsea Shover, PhD, published a study in PNAS using the same methodology as a 2014 JAMA study that found a positive association between cannabis legalization and lower opioid mortality from 1999 to 2010. But Shover and colleagues included more recent data and states with legalized medical cannabis.

“Our expanded analysis does not support the interpretation that broader access to cannabis is associated with lower opioid overdose mortality,” they concluded.

The 2014 study was very cautious in its findings, but cannabis advocates and industry representatives used it to support legalization efforts.

“It’s become such a pervasive idea,” Shover told STAT News. “It would be amazing if it was this simple, but the evidence is telling us now that it’s not.”

Early this month, Columbia University’s Mailman School of Public Health published a new study in JAMA Network Open that looked at whether people use cannabis in place of prescription opioids.  Researchers looked at data from 627,000 people aged 12 years and older who took the National Survey on Drug Use and Health from 2004 to 2014.

The results showed that enactment of medical marijuana laws was not associated with a reduction in prescription opioid abuse, contradicting the hypothesis that people would substitute marijuana for prescription opioids.

“We tested this relationship and found no evidence that the passage of medical marijuana laws — even in states with dispensaries — was associated with a decrease in individual opioid use of prescription opioids for nonmedical purposes," said senior author Silvia Martins, MD, PhD, an associate professor of epidemiology at Columbia.

The Shover-PNAS study also made the important point that medical cannabis users comprise only about 2.5% of the U.S. population. The vast majority of cannabis use is recreational. The Washington State Liquor Control and Cannabis Board estimates that only about 20% of so-called medical users are really using cannabis for medical reasons.

In other words, there aren’t enough medical cannabis users to impact nationwide overdose trends. And in state-level analysis, there is no evidence of any substantial effect, positive or negative, from medical cannabis legalization.

There are concerns that cannabis could actually make the opioid crisis worse. A 2018 study published in the American Journal of Psychiatry found that “cannabis use appears to increase rather than decrease the risk of developing nonmedical prescription opioid use and opioid use disorder.”

“Scientific evidence does not support claims that marijuana helps people kick opioids.”

— Dr. Nora Volkow, NIDA Director

"My main concern is by basically misinforming potential patients about the supposedly beneficial effects of cannabis, they may forgo a treatment that is lifesaving," NIDA director Nora Volkow, MD, told USA Today. “Scientific evidence does not support claims that marijuana helps people kick opioids.”

The FDA is taking note, warning a large cannabis operator last week to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

Medical cannabis has uses, of course, but taking it for conditions it is not proven to help may lead to harms. Perhaps a way can be found to incorporate cannabis in addiction treatment, but that is quite different from expecting medical cannabis legalization to be an exit ramp for the opioid 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.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Addiction and the 2020 Presidential Race

By Dr. Lynn Webster, PNN Columnist

I found the recent story about Hunter Biden's drug and alcohol problems disturbing, not because he has an addiction — there's no shame in that — but because of the way the media tiptoes around the problem.

There seems be some reluctance to discuss Hunter's problem because of the way it may affect his father – former Vice President Joe Biden – and Biden’s bid for the presidency in 2020. To me, this illustrates a serious barrier to addressing the terrible disease of addiction.

Drugs, Politicians and Their Families

Marijuana is not considered a hard drug today, but it was considered a serious drug of abuse 27 years ago, when President Bill Clinton admitted he had used it. The stigma attached to using marijuana at the time was such that he disingenuously claimed he didn't inhale.

Of course, Clinton wasn't the only president who used or abused chemicals. Nor was he the only president whose reputation took a hit when his drug use was exposed to the public:

President Richard Nixon was reported to have an alcohol problem that worsened as his presidency neared its end.

President George W. Bush reportedly used cocaine in his youth and admitted “drinking too much.” ABC News even polled voters to find out whether his cocaine use might affect their willingness to vote for him.

President Barack Obama admitted that he used marijuana and cocaine. He was also a cigarette smoker with a nicotine addiction, and dealt with media inquiries about his attempts to quit throughout his presidency.

Hunter Biden is not the only family member of a presidential candidate with addiction.

Jeb Bush's daughter, Noelle Bush, had a drug problem. New York City Mayor Bill de Blasio’s daughter, Chiara de Blasio, abused alcohol and drugs while dealing with depression. Sen. Amy Klobuchar's father has struggled with alcohol his whole life. And President Trump’s brother, Fred Trump, Jr., died of complications related to alcoholism, which contributes to an estimated 88,000 deaths per year.

What Do Candidates Know?

Clearly, the endemic nature of addiction in our culture means that we should be interested in how the candidates deal with the presence of drugs in their lives. Are they able to talk openly about drug use instead of letting it remain a dark and shameful secret? Are they compassionate and supportive of family members who struggle?

To what extent do they personally use drugs and alcohol in daily life? And by extension, how well do they cope with stress? These are relevant, appropriate questions for candidates auditioning for a job that impacts the entire world.

It would be inappropriate to vote for a candidate solely on the basis of whether or not their loved ones struggle with addiction. But one criteria we can use for voting is a candidate’s positions on the critical issue of addiction in America. Here is how I would evaluate a candidate:

1) How much awareness do they demonstrate on the basic issues, including:

• Do they know the difference in the prevalence of prescription opioid vs. illicit opioid abuse?

• Do they know that addiction is not determined by the drug, but by genetic and environmental factors?

• Do they know that the volume of pills prescribed to people in various parts of the country does not determine the number of overdose deaths?

• Do they know that the prevalence of overdose deaths correlates with the loss of jobs and lack of income opportunity?

2) Will they de-stigmatize the disease of addiction by:

• Decriminalizing the use of drugs?

• Acknowledging addiction is a disease?

• Understanding that babies cannot be born addicted?

• Educating people that physical dependence and withdrawal can occur without addiction?

3) Do they favor access to substance abuse treatment in a timely fashion for everyone who needs it, regardless of their ability to pay?

4) Will they advocate for people in pain to receive opioid therapy when appropriate at the dose determined by their provider, rather than by the government?

5) Will they acknowledge the unintended consequences of the CDC opioid prescribing guideline?

Shining a Light on Addiction

The ideal candidate should recognize the tragedies associated with all addictions, not just with prescription opioids. He or she must recognize that addiction is part of being human, and that some people are more vulnerable to addiction than others, just as some people are more vulnerable to developing cancer or heart disease.

Whoever becomes or remains our president must shine the light of information on addiction, rather than hide it in the darkness of misinformation, shame and denial. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth” and co-producer of the documentary, “It Hurts Until You Die.”

You can find him on Twitter: @LynnRWebsterMD.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

‘Opioid of the Future’ Postponed

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is tapping the brakes on NKTR-181, an experimental opioid pain medication that has less abuse potential than traditional opioids like oxycodone or hydrocodone.

In an SEC filing, Nektar Therapeutics said it received a letter from the FDA on July 23 saying the agency was postponing all advisory committee meetings for opioid analgesics, including one scheduled for August 21 to discus Nektar’s new drug application for NKTR-181.

The FDA was due to make a final decision on NKTR-181 eight days later, but that too is apparently being postponed while the agency considers “a number of scientific and policy issues relating to this class of drugs.”

Nektar called NKTR-181 the “opioid of the future” because it is the first full mu-opioid agonist that can provide pain relief without the euphoria or “high” that can lead to abuse and addiction.

The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier, which slows its rate of entry into the brain.

In a Phase III clinical study, patients with chronic back pain reported that their pain scores dropped an average of 65% when taking NKTR-181 twice daily. Safety studies also found that recreational drug users had significantly less “drug liking” of NKTR-181 when compared to oxycodone.

NEKTAR IMAGE

The research was so promising the FDA gave NKTR-181 “fast track” designation to speed its development. Nektar executives told PNN two years ago they were hopeful the drug would be approved in late 2018, with a commercial launch early this year.

Obviously that didn’t happen. And the FDA’s fast track has turned into a slow walk.

Two FDA advisory committees met last month and decided “much better-quality data” was needed before approving any new opioids — even ones with low risk of abuse.  

The agency has been under growing public and political pressure to tighten its regulation of opioids. In February, a 60 Minutes report claimed the FDA “opened the floodgates” to the opioid epidemic by approving the use of OxyContin for chronic pain. The following month, the agency received a petition from Public Citizen calling for a moratorium on new opioid approvals because the agency “can no longer be trusted” due to its “poor record” of regulating opioids.

On July 25, Howard Robin, Nektar’s President and CEO, sold 100,000 shares of Nektar for $3.1 million. A spokesman said the sale was previously scheduled due to expiring options. The company’s chief financial officer and a director also sold shares this month. Nektar shares (NASDAQ: NKTR) lost about 10% of their value after the SEC filing was made public.

Lawyer Calls for DOJ to End ‘Indiscriminate Raids’ on Doctors

By Pat Anson, PNN Editor

In recent years, hundreds of physicians, pharmacists and addiction treatment doctors have had their offices raided and searched by DEA agents.

Many of the raids were orchestrated by the Justice Department’s Opioid Fraud and Abuse Detection Unit, a special team of investigators created in 2017 to mine opioid prescribing data to identify suspicious orders and practices. The investigations have resulted in the high-profile arrests of healthcare providers for fraud and risky opioid prescribing.

"If you're a doctor and you want to act like a drug dealer, we're going to treat you like one. And sometimes the only difference between a doctor and a drug dealer is a white coat," U.S. Attorney Jay Town said about a federal takedown in April that resulted in charges against 60 practitioners in seven states.

Rarely publicized are the cases where criminal charges are never filed because the evidence against doctors is weak or non-existent.

“It’s quite frustrating to see how their careers were ruined even though they never faced criminal charges. That’s because the government was incapable of bringing credible charges against them,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. “When I read a criminal complaint, what I would see as ‘best practices’ is construed as criminal exploitative behavior on the part of the prosecutors.

“There’s a heavy bias against medications to treat pain and opioid use disorder that is driving some of the aggressive enforcement actions. Also, an overzealousness combined with a lack of understanding of the practice of medicine.”

Barnes recently wrote an op/ed, published online by American University’s Washington College of Law, calling for an end to the DOJ’s “indiscriminate raids” on doctors.

“DOJ raids and searches of professionals’ homes and medical clinics interrupt the delivery of health care, put patients’ lives at risk, and unjustly destroy careers and livelihoods. They also create confusion and fear,” wrote Barnes. “Not all health care professionals subject to the DOJ’s searches and seizures are ‘dirty docs.’ In fact, some of them are nationally recognized leaders not just in pain management, but also in addiction medicine.” 

Barnes cites the case of Dr. Stuart Gitlow, an addiction psychiatrist whose Rhode Island home and office were raided by FBI agents in March 2018. Sixteen months later, the reasons for the raid remain unclear and Gitlow, the former president of the American Society of Addiction Medicine, has not been charged with a crime.  

MICHAEL BARNES

Neither has Dr. Forest Tennant. In November 2017, DEA agents raided the office and home of Tennant, a prominent California pain physician who was flagged for “very suspicious prescribing patterns.” In a search warrant, the 76-year old Tennant was depicted as the kingpin of a drug trafficking organization that spanned several states.

“I know based on my training and experience that patients traveling long distances to obtain controlled substance prescriptions is another ‘red flag’ of drug abuse and addiction,” wrote DEA investigator Stephanie Kolb, who led a two-year investigation of Tennant.

But Kolb, who was self-employed as a dog walker and pet groomer before she started working for the DEA in 2012, failed to note that Tennant only treated intractable pain patients, many from out-of-state, and often prescribed high doses of opioids because of their chronically poor health. Some patients were in palliative care and near death, and one committed suicide after learning of the raid, fearing she would lose access to opioid medication.

Tennant denies any wrongdoing and was never formally charged, but retired from clinical practice a few months after the raid.

“It’s hard to continue operating when they never closed my case, and so I’m going to retire and move on,” Tennant told PNN at the time. “That’s on the advice of both my lawyers and my doctors."

(Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.)  

Biased Investigations

Barnes says the biases of some prosecutors extends to the expert witnesses they hire to help build their cases. The role of these witnesses is important because they help DOJ persuade judges to sign off on search warrants that are key to gathering evidence. It’s a lucrative sideline for some paid witnesses, who charge the government hundreds of dollars an hour for their time and expertise.

“Expert witnesses are eager to give DOJ business to get the expert witness fees, and they of course will help to spin the facts in a way that is prejudicial to the defendant,” Barnes said. “What we’re seeing here is people who are really not qualified to be making assessments of other practices serving as experts for the government.” 

Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has worked as a medical consultant for the DEA, FBI and DOJ on over 100 investigations, most of which involve prescriptions for opioids and other controlled substances.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1 million in DOJ contracts since 2017 and is currently working on nearly two dozen DEA investigations, mostly reviewing patient files and data from prescription drug monitoring programs.

It would be unusual for a family practice physician to treat an intractable pain patient without making a referral to a pain or palliative care specialist. But Munzing was one of the expert witnesses hired by the DEA to analyze Tennant’s prescribing.

“I find to a high level of certainty that after review of the medical records… that Dr. Tennant failed to meet the requirements in prescribing these dangerous medications,” Munzing wrote in an affidavit. “These prescribing patterns are highly suspicious for medication abuse/and or diversion. If the patients are actually using all the medications prescribed, they are at high risk for addiction, overdose, and death.”  

Munzing’s affidavit and the DEA search warrant identified no patients who were actually harmed while under Tennant’s care. As PNN reported, some patients found the allegation that they were selling their medication and funneling the profits back to Tennant laughable.      

“It’s like everything else they do. They don’t talk to any patients. They don’t talk to any doctors. They just go and throw all this stuff out there and making all these incriminations against people. They don’t have any evidence that I’ve sold anything. It’s just ludicrous,” said Ryle Holder, a Tennant patient who lives in Georgia.  

Barnes says the bias against opioid prescribing “is inherent in the work of many of the investigators and prosecutors.”

“Then there is the incompetence as it relates to many of the law enforcement officers not having the medical expertise to make judgements of a medical nature. And then, when they do consult with the experts, those experts are typically trying to please their clients and getting repeat business as a result,” he told PNN. 

State Medical Boards

To bring more expertise into investigations of healthcare providers, Barnes is proposing that state medical boards play a more prominent role. He wants Congress to amend federal law to require DOJ investigators and prosecutors to get a referral from a state licensing board before investigating a practitioner for misconduct. Similar laws at the state level would also need to be changed to require state and local law enforcement to get a referral from a medical licensing board.

To make sure complaints are handled in a timely manner, Barnes says federal funds should be used to bolster the budgets of state licensing boards so they can investigate allegations of misconduct.  

“There are some detractors who say medical boards didn’t do an adequate job leading up to the overdose crisis. But the reality is neither did law enforcement,” Barnes says. “The medical boards could get up to speed and make these assessments on medical needs and patient care to make sure that healthcare providers can be assessed with medical expertise, rather than law enforcement trying to guess about standard of care and best practices.”

“Making it more difficult for law enforcement to investigate potential diversion of dangerous and addictive controlled substances, including powerful painkillers, is probably not going to happen right now,” says DEA spokesman Rusty Payne.

“This idea that people need to worry about the DEA hiding in the bushes if they write an oxycodone prescription is ridiculous.”

— Rusty Payne, DEA spokesman

Payne points out the DEA is both a law enforcement and regulatory agency, one that oversees 1.3 million practitioners licensed to prescribe controlled substances. He says enforcement actions are relatively rare and not “indiscriminate” as Barnes suggests.

“The numbers are incredibly low. It is a very, very, very small number.  So this idea that people need to worry about the DEA hiding in the bushes if they write an oxycodone prescription is ridiculous,” he told PNN. “We don’t have the resources. We don’t track individual prescriptions. We look for patterns and large-scale significant diversion.”  

Getting state medical boards involved, according to Payne, is not a good idea.

“I don’t think making it harder for us to scrutinize those that are acting outside the law is in anyone’s best interest,” he said.

But Barnes’ proposal makes sense, according to Dr. Lynn Webster, a PNN columnist and former president of the American Academy of Pain Medicine. 

“Barnes makes a sensible recommendation. If the law enforcement suspects a provider is not complying with the law, then the first step should be a referral to the medical board where the provider can be evaluated by their peers,” Webster said. “If a doctor goes to trial, they will not be evaluated by their peers. That is not the way the justice system is supposed to work.” 

Webster was once the target of a federal investigation of his opioid prescribing practices and DEA agents raided his Utah pain clinic in 2010. Four years later, the DOJ said it would not prosecute Webster, who said his “reputation was tarnished forever.”  

“DEA investigations are often designed to entrap a provider on technicalities.  Even if an investigation never leads to any charges the doctor's reputation is damaged.  In the court of public opinion an investigation must mean something was wrong,” Webster said.