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. 

Feds Found ‘Staggering’ Drug Testing Fraud at Tennessee Pain Clinics

By Fred Schulte, Kaiser Health News

The Justice Department has accused a defunct chain of Tennessee-based pain clinics of cheating Medicare and other taxpayer-funded health insurers out of at least $25 million in needless urine drug tests and genetic testing.

The civil lawsuit names Comprehensive Pain Specialists, also known as Anesthesia Services Associates PLLC; four of its physician owners; and a former top executive. The doctors include Tennessee Republican State Sen. Steven Dickerson and Peter Kroll, both anesthesiologists.

At its peak, CPS ran 60 pain clinics in a dozen states and treated some 48,000 patients per month, according to the suit. It shut down abruptly last summer, leaving many chronic pain patients scrambling to find a new source of narcotic medicines.

The Justice Department fraud case centers largely on the company’s lucrative urine-testing lab in Brentwood, Tenn., which CPS financed with a $1.5 million loan. The suit also alleges overbilling from acupuncture and other services offered to patients.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized Medicare billings for urine drug tests.

Medicare and other federal programs paid over $70 million from 2011 to 2018 for CPS-ordered urine tests, an amount the lawsuit called “staggering.” TennCare, the state’s Medicaid program, paid more than $9 million more during that time.

“For this reason, CPS considered [urine tests] to be ‘liquid gold’ — with revenues of tens of millions of dollars for what was largely unnecessary medical testing,” according to the suit.

The chain’s owners and then-CEO John Davis “viewed every CPS patient as an opportunity to make money, without regard to the individualized need for treatment,” the suit alleges. Davis was convicted last year in Nashville on federal criminal health care fraud charges. He has since filed a motion for a new trial.

Dan Martin, an attorney representing Kroll, said in an emailed statement: “We are aware of the allegations and very familiar with the actual facts. Dr. Kroll did not engage in any wrongdoing whatsoever, and we look forward to correcting the government’s misunderstanding of the facts.”

Dickerson’s attorney, Ed Yarbrough, also issued a statement that read: “Dr. Dickerson is an honest man. We will prove that in court.” 

$8.5 Billion Annually Spent on Drug Tests

In its investigation, KHN, with assistance from researchers at the Mayo Clinic, found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year — more than the entire budget of the Environmental Protection Agency. The federal government paid medical providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.

CPS was among the nation’s most aggressive testers. KHN found that in 2014 five of its medical professionals stood among the nation’s top billers. Anita Bayles, a nurse practitioner working at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billings that year, according to Medicare records analyzed by KHN.

The Justice Department suit says that CPS believed Bayles ordered too many urine tests and overprescribed opioids and in September 2016 decided to fire her. But the decision was reversed by CEO Davis “because of her ability to generate revenues,” according to the suit. Bayles could not be reached for comment.

IMAGE COURTESY OF MARK COLLEN AND PAIN EXHIBIT

Though CPS ran six or more urine tests a year on many patients receiving narcotics, its doctors often did not review the results to make sure patients did not abuse them, according to the suit.

Kroll, who also served as CPS’ medical director, told KHN in 2017 that the high volume of tests was justified to keep patients safe and to reduce chances of black market sales of pills.

Kroll billed Medicare $1.8 million for urine tests in 2015, the KHN analysis of Medicare billing records found.

Kroll said in a 2017 interview that he and Dickerson came up with the idea to open a high-quality pain practice over a cup of coffee at a Nashville Starbucks in 2005.

But the Justice Department alleges that CPS expanded rapidly through bilking the government, conduct that its top executives and founders “failed to take any action to stop,” according to the suit.

In what is called a “particularly egregious example of this fraudulent conduct,” the Justice Department alleged that Kroll caused over 2,500 claims to be submitted to Medicare, for which CPS was paid almost $350,000, during a 10-day period in May 2017 when Kroll was on vacation in Italy.

“Because of these fraudulent claims, Kroll’s billing privileges with Medicare have been revoked,” according to the suit.

The lawsuit states that Medicare officials began investigating overcharging for urine testing at CPS in 2014 and eventually directed the company to repay the government $27.4 million in an extrapolated penalty. But CPS aggressively appealed the decision and managed to get it overturned and stay in business.

Once among the largest pain management groups in the Southeast, CPS crumbled amid financial woes that included nearly a dozen civil suits alleging unpaid debts, as well as the criminal case against Davis. In a court filing in December, the company said that it had terminated all of its employees and that its debts “greatly exceed its assets.”

In total, Medicare paid CPS over $150 million from 2011 to 2018, a large part of which was related to urine testing, while TennCare paid CPS over $32.5 million, according to the suit.

The Justice Department complaint consolidates several whistleblower cases filed against the company by doctors and other former employees. Federal whistleblower cases seek recovery of money paid improperly and can include treble damages, or three times the amount of the original overpayment.

One of the whistleblowers said he toured the lab with CPS executives and observed an “overpowering and unpleasant smell of urine.” In response, a CPS executive said, “To me, it smells like money,” according to the whistleblower’s suit.

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.

FDA Warns Curaleaf About Marketing of CBD Products

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning a large cannabis company to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

An FDA warning letter was sent to Curaleaf, a Massachusetts-based company that sells cannabidiol (CBD) products online and in stores, and operates dispensaries in a dozen states. CVS Health responded to the FDA letter by pulling some Curaleaf products off its store shelves.

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” acting FDA Commissioner Ned Sharpless, MD, said in a statement. “Consumers should beware of purchasing or using any such products.”

Curaleaf, which claims to be the largest cannabis operator in the United States, makes an extensive line of CBD lotions, creams, oils and skin patches.

It recently began marketing a line of CBD products for pets to treat pain, spasms, anxiety and inflammation in animals.

The FDA’s warning letter to Curaleaf cited a number of unapproved marketing claims made by the company online and in social media, including:

  • “CBD was effective in killing human breast cancer cells.”

  • “CBD has been linked to the effective treatment of Alzheimer’s disease…”

  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”

  • “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”

The FDA gave Curaleaf 15 working days to respond. Failure to correct the violations could result in legal action, including seizure of the company’s products.

“Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency's letter,” the company said in a statement.

“Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company's cultivation and manufacturing processes.”

CBD Products Loosely Regulated

Unlike prescription drugs approved by the FDA, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects.

Despite the lack of regulatory oversight, there has been explosive growth for CBD companies and their products are starting to appear in mainstream stores. In March, CVS Pharmacy and Walgreens started selling CBD lotions, tinctures, edibles and lozenges — including some made by Curaleaf.

“The only Curaleaf products we are selling are its CBD lotion and CBD transdermal patches,” CVS said in a statement. “Following the FDA’s warning letter to Curaleaf, we will be removing these items from our CBD offering.”  

The FDA sent similar warning letters to three cannabis operators in April. Until now, the enforcement actions have been sporadic and only targeted small companies.

“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, MD.

“We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products.”

The FDA held a public hearing on the issue in May, and opened a docket for public comments to obtain scientific data about the safety, manufacturing, quality, marketing, labeling and sale of CBD products. Nearly 4,500 comments were received. The agency plans to report on its progress this fall.

This week Curaleaf announced it will acquire GR Companies, a large cannabis retailer, in a cash and stock deal valued at $875 million. Curaleaf said the purchase solidifies it’s position as “the world's largest cannabis company by revenue and the largest in the U.S. across key operating metrics.”

Teens Who Abuse Rx Opioids More Likely to Try Heroin

By Roger Chriss, PNN Columnist

A new study from the University of Southern California finds that teens who abuse prescription opioids are more likely to start using heroin by high school graduation.  

Published in JAMA Pediatrics, the study tracked nearly 3,300 students in ten public high schools in the Los Angeles area from 2013-2017. Nearly 600 of those students reported using prescription opioids to get high.

By the end of high school, a total of 70 students had started using heroin, including about 12% of those who abused opioid medication. Only 1.7% of students who did not misuse prescription opioids tried heroin.

The researchers looked closely at not only the nonmedical use of prescription opioids, but also the use of other substances. A family history of smoking, alcohol and drug problems, and interpersonal factors such as impulsiveness, anxiety, depression and delinquent behavior were also assessed.

Among all the different factors, the best predictor of heroin use was the abuse of prescription opioids. This tendency was significantly stronger than the use of alcohol, cannabis, cigarettes or other non-opioid drugs.

"Prescription opioids and heroin activate the brain's pleasure circuit in similar ways," said senior author Adam Leventhal, PhD, director of the USC Institute for Addiction Science. "Teens who enjoy the 'high' from prescription opioids could be more inclined to seek out other drugs that produce euphoria, including heroin.”

Researchers also found that students who initiated heroin use were more likely to be male, have less parental monitoring, more delinquent behavior, and impulsive personalities.

The USC study adds to previous research on the complex drug use trajectories that culminate with heroin. It has long been known that nonmedical prescription opioid use is associated with later heroin use, with some anti-opioid activists claiming that 80% of heroin addicts begin by abusing prescription opioids. That is a misleading statistic, as I discussed in a previous column.

There clearly is an association between the misuse of prescription opioids and heroin use, but as the USC researchers found, many other factors are also involved and more research is needed. Their study, for example, did not look at how teens who misused prescription opioids obtained them.  Most likely, they were obtained from friends or family members.

The USC study findings not only advance our understanding of heroin initiation, but also signal the importance of developing better policies to prevent nonmedical opioid use.

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.

FDA Approves First Generics for Lyrica

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first generic versions of Lyrica (pregabalin), a medication widely prescribed for the treatment of fibromyalgia, diabetic neuropathy and other types of chronic pain.

Lyrica has been a blockbuster drug for Pfizer since its approval in 2004, generating revenue of $4.6 billion annually. The recent expiration of Pfizer’s patent on Lyrica opened the door to much cheaper generic competitors.

A one year supply of Lyrica currently costs about $2,800 in the United States, according to Healthcare Bluebook, while a similar dose of pregabalin under the UK’s National Health Service costs about $74.

“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

The FDA granted approvals for generic pregabalin to 9 drug makers: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

Pfizer’s patent for Lyrica CR — an extended released version of Lyrica — remains in effect until April, 2021.

Side Effects

The most common side effects for Lyrica are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and difficulty concentrating. Lyrica’s warning label also cautions users that the drug may cause suicidal thoughts in about 1 in 500 people.

Pregabalin is classified as Schedule V controlled substance in the U.S., which means it has a low potential for abuse. In recent years, however, there is growing concern that pregabalin and its sister drug gabapentin (Neurontin) are being abused and overprescribed. The drugs were recently classified as controlled substances in the UK.

Pregabalin and gabapentin were originally developed to prevent epileptic seizures, but their use has tripled over the past 15 years as more doctors prescribed them off-label as “safer” alternatives to opioids.

A recent study in the British Medical Journal found the drugs increase the risk of suicide, overdose and traffic accidents in younger people. The risks were strongest for those taking pregabalin and were most pronounced among adolescents and young adults aged 15 to 24. Patients aged 55 and older taking gabapentinoids were not at greater risk.



Common Meds Can Cause Cognition Problems in Seniors

By Judith Graham, Kaiser Health News

By all accounts the woman, in her late 60s, appeared to have severe dementia. She was largely incoherent. Her short-term memory was terrible. She couldn’t focus on questions that medical professionals asked her.

But Dr. Malaz Boustani, a professor of aging research at Indiana University School of Medicine, suspected something else might be going on. The patient was taking Benadryl for seasonal allergies, another antihistamine for itching, Seroquel (an antipsychotic medication) for mood fluctuations, as well as medications for urinary incontinence and gastrointestinal upset.

To various degrees, each of these drugs blocks an important chemical messenger in the brain, acetylcholine. Boustani thought the cumulative impact might be causing the woman’s cognitive difficulties.

He was right. Over six months, Boustani and a pharmacist took the patient off those medications and substituted alternative treatments. Miraculously, she appeared to recover completely. Her initial score on the Mini-Mental State Exam had been 11 of 30 — signifying severe dementia — and it shot up to 28, in the normal range.

An estimated 1 in 4 older adults take anticholinergic drugs — a wide-ranging class of medications used to treat allergies, insomnia, leaky bladders, diarrhea, dizziness, motion sickness, asthma, Parkinson’s disease, chronic obstructive pulmonary disease and various psychiatric disorders.

Older adults are highly susceptible to negative responses to these medications. Since 2012, anticholinergics have been featured prominently on the American Geriatrics Society Beers Criteria list of medications that are potentially inappropriate for seniors.

“The drugs that I’m most worried about in my clinic, when I need to think about what might be contributing to older patients’ memory loss or cognitive changes, are the anticholinergics,” said Dr. Rosemary Laird, a geriatrician and medical director of the Maturing Minds Clinic at AdventHealth in Winter Park, Fla.

Here’s what older adults should know about these drugs:

The Basics

Anticholinergic medications target acetylcholine, an important chemical messenger in the parasympathetic nervous system that dilates blood vessels and regulates muscle contractions, bodily secretions and heart rate, among other functions. In the brain, acetylcholine plays a key role in attention, concentration, and memory formation and consolidation.

Some medications have strong anticholinergic properties, others less so. Among prescription medicines with strong effects are antidepressants such as imipramine (brand name Trofanil), antihistamines such as hydroxyzine (Vistaril and Atarax), antipsychotics such as clozapine (Clozaril and FazaClo), antispasmodics such as dicyclomine (Bentyl) and drugs for urinary incontinence such as tolterodine (Detrol).

In addition to prescription medications, many common over-the-counter drugs have anticholinergic properties, including antihistamines such as Benadryl and Chlor-Trimeton and sleep aids such as Tylenol PM, Aleve PM and Nytol.

Common side effects include dizziness, confusion, drowsiness, disorientation, agitation, blurry vision, dry mouth, constipation, difficulty urinating and delirium, a sudden and acute change in consciousness.

Unfortunately, “physicians often attribute anticholinergic symptoms in elderly people to aging or age-related illness rather than the effects of drugs,” according to a research review by physicians at the Medical University of South Carolina and in Britain.

Seniors are more susceptible to adverse effects from these medications for several reasons: Their brains process acetylcholine less efficiently. The medications are more likely to cross the blood-brain barrier. And their bodies take longer to break down these drugs.

Long-Term Effects

In the late 1970s, researchers discovered that deficits in an enzyme that synthesizes acetylcholine were present in the brains of people with Alzheimer’s disease. “That put geriatricians and neurologists on alert, and the word went out: Don’t put older adults, especially those with cognitive dysfunction, on drugs with acetylcholine-blocking effects,” said Dr. Steven DeKosky, deputy director of the McKnight Brain Institute at the University of Florida.

Still, experts thought that the effects of anticholinergics were short-term and that if older patients stopped taking them, “that’s it — everything goes back to normal,” Boustani said.

Concerns mounted in the mid-2000s when researchers picked up signals that anticholinergic drugs could have a long-term effect, possibly leading to the death of brain neurons and the accumulation of plaques and tangles associated with neurodegeneration.

Since then several studies have noted an association between anticholinergics and a heightened risk of dementia. In late June, this risk was highlighted in a new report in JAMA Internal Medicine that examined more than 284,000 adults age 55 and older in Britain between 2004 and 2016.

The study found that more than half of these subjects had been prescribed at least one of 56 anticholinergic drugs. (Multiple prescriptions of these drugs were common as well.) People who took a daily dose of a strong anticholinergic for three years had a 49% increased risk of dementia. Effects were most pronounced for people who took anticholinergic antidepressants, antipsychotics, antiepileptic drugs and bladder control medications.

These findings don’t constitute proof that anticholinergic drugs cause dementia; they show only an association. But based on this study and earlier research, Boustani said, it now appears older adults who take strong anticholinergic medications for one to three years are vulnerable to long-term side effects.

Preventing Harm

Attention is now turning to how best to wean older adults off anticholinergics, and whether doing so might improve cognition or prevent dementia.

Researchers at Indiana University’s School of Medicine hope to answer these questions in two new studies, starting this fall, supported by $6.8 million in funding from the National Institute on Aging.

One will enroll 344 older adults who are taking anticholinergics and whose cognition is mildly impaired. A pharmacist will work with these patients and their physicians to take them off the medications, and patients’ cognition will be assessed every six months for two years.

The goal is to see whether patients’ brains “get better,” said Noll Campbell, a research scientist at Indiana University’s Regenstrief Institute and an assistant professor at Purdue University’s College of Pharmacy. If so, that would constitute evidence that anticholinergic drugs cause cognitive decline.

The second trial, involving 700 older adults, will examine whether an app that educates seniors about potential harms associated with anticholinergic medications and assigns a personalized risk score for dementia induces people to initiate conversations with physicians about getting off these drugs.

Moving patients off anticholinergic drugs requires “slow tapering down of medications” over three to six months, at a minimum, according to Nagham Ailabouni, a geriatric pharmacist at the University of Washington School of Pharmacy. In most cases, good treatment alternatives are available.

Advice for Older Adults

Seniors concerned about taking anticholinergic drugs “need to approach their primary care physician and talk about the risks versus the benefits of taking these medications,” said Shellina Scheiner, an assistant professor and clinical geriatric pharmacist at the University of Minnesota.

Don’t try stopping cold turkey or on your own. “People can become dependent on these drugs and experience withdrawal side effects such as agitation, dizziness, confusion and jitteriness,” Ailabouni said. “This can be managed, but you need to work with a medical provider.”

Also, “don’t make the assumption that if [a] drug is available over the counter that it’s automatically safe for your brain,” Boustani said. In general, he advises older adults to ask physicians about how all the medications they’re taking could affect their brain.

Finally, doctors should “not give anticholinergic medications to people with any type of dementia,” DeKosky said. “This will not only interfere with their memory but is likely to make them confused and interfere with their functioning.”

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.

Task Force: Canada's Chronic Pain Patients ‘Simply Deserve Better’

By Pat Anson, PNN Editor

In March, Health Canada created a new national task force to study how to prevent and treat chronic pain and remove barriers to pain treatment. Health Minister Ginette Petitpas Taylor called it “the first step in addressing the issue of chronic pain in this country.”

One in five Canadians lives with chronic pain and -- like their counterparts in the United States -- many have trouble just finding a doctor willing to treat them. Some patient advocates were skeptical of Health Canada’s task force and its plan to release an initial report this summer, followed by two more reports in 2020 and 2021. It sounded like bureaucratic foot dragging.

“We are happy they are actually acknowledging chronic pain is an issue. However, the time frame is wrong and a little bit too late,” said Barry Ulmer of the Chronic Pain Association of Canada (CPAC).

Four months later, that initial report from the task force has now been released. It calls pain a “significant public health issue” in Canada and admits the nation’s healthcare system often fails to treat pain patients. Efforts to rein in opioid prescribing — such as Canada’s opioid guideline — have made a bad situation worse.

“Some Canadians have been unable to access opioid medications when needed for pain and function. Others have faced undue barriers to obtaining or filling their opioid prescriptions, and some have had their opioid dose abruptly lowered or discontinued. This has resulted in unnecessary pain and suffering, and has led some Canadians to obtain illegal drugs to treat their pain,” the task force found.

“People living with pain have limited access to the services they require and often face stigma and undue suffering as a result of their condition. This stigma often intersects with other forms of discrimination related to poverty, housing and employment instability, mental illness, race and ethnicity, and other factors further complicating the challenge of living with pain. Canadians living with pain and their loved ones simply deserve better.”

Patients Not Believed

In its short history, the task force completed an ambitious review of pain care in Canada; holding public workshops, meeting with federal and local governments, and consulting with healthcare providers and researchers. Importantly, the panel also reached out to the pain community and invited 12 Canadians living with chronic pain to share their experiences. Many said they had poor access to pain care or were not believed by healthcare providers.

“I was bounced between various outpatient clinics and utilizing the ER multiple times a month and making no progress,” one patent said. “I was consistently questioned whether or not I was making up the pain for attention, or if the pain was due to a mental health condition.” 

“While I am fortunate to be seen periodically by a pain specialist, I do not have access to a multidisciplinary pain clinic where key services, such as physiotherapy and psychology are provided. Many patients in my community have even less (or no) access to a pain specialist and are unduly suffering as a result. They do not know where to turn,” another patient said.

“I found the transition from the pediatric pain clinic to the adult pain clinic very difficult. At the pediatric pain clinic they have a multi-disciplinary team, which include a psychologist, a physiotherapist, a nurse, and a pain specialist. At the adult pain clinic they only have a physician who is amazing but is overstretched, sometimes I can only get an appointment every 6 months,” another patient told the task force. 

Pain Education Lacking

Improving pain education in Canada’s medical schools was one of the first goals identified by the task force. In a review of 10 Canadian universities, the panel found that 68% of the medical programs were not providing any designated hours for pain education.  Incredibly, veterinary students receive 2 to 5 times more pain education than that of health science students.

The panel also found that pain care in Canada is largely dependent on where people live and what type of insurance they have; that pain patients need better access to psychological support, physical therapies and other healthcare services; and that more research and better evidence is needed to help providers make informed decisions on pain care.

“This report makes Health Canada aware of what Canadians with pain have known for too long: that pain care is largely not accessible, many health care providers lack the knowledge and skills to manage pain and breakthroughs in research are hampered by lack of funding,” said Maria Hudspith, co-chair of the task force and Executive Director of Pain BC, a patient advocacy group in British Columbia.

“We hope this report lays the foundation for a national pain strategy that will improve the lives of Canadians who live with pain.”

Not everyone is happy with the direction the task force is taking. CPAC called it a “knee jerk” reaction to the pain crisis that continues to spread stigma about pain patients and their use of opioid medication.

“You see it again in this report,” CPAC’s Ulmer said in a statement. “Pain patients are supposedly often mentally ill—somehow, the need for relief has been recast as mental illness, though it seems pretty sane to me. And patients are repeatedly said to be at high risk of addiction.”

Last month, a federal task force in the U.S. released a final report on recommended best practices for pain management. It found nearly identical problems as the panel in Canada — and called for a balanced approach to pain treatment that focuses on individualized patient care, not rigid prescribing guidelines that have triggered a pain crisis for millions of Americans.

 

Finding Safe Shores From Suicidal Thoughts

By Mia Maysack, PNN columnist

When you have lost or almost lost loved ones to suicide, it changes you.  

My first experience with this happened at a young age and I took it very personally, even though it was an intimate, personal decision that didn't involve me. I guess that is one of the things that hurt most about it.  

Time passed, life was experienced and as my health conditions worsened, I found myself on the stone-cold ground of rock bottom -- which granted me a bittersweet comprehension of the temptations to end never-ending pain.

Years later, someone I cared for took her own life, after secretly enduring the late stages of terminal cancer. I’d witnessed that kind of suffering before during my days working in hospice care. This further reshaped my mind around the concept.

Of course, none of us want to lose anyone, especially in a way such as this, but the question does remain.  Which could be considered more “selfish” -- someone eliminating their life or someone else not wanting them to?

“I want to leave this earth because I feel as though I just can't do it anymore. It truly has nothing to do with anyone else. I am solely human and have reached my absolute breaking point.  Ultimately, I make my own decisions -- though it’s impossible to comprehend the ripple effect my actions will have on others.”

“I don't want you to leave this earth because I care so much about you. I know you feel as though you cannot do this anymore, but I am here for you and have a difficult time understanding why that isn't enough. I would do anything to ease your suffering. There are others who care and need you, so stick around for their sake.”   

The dialogue may as well be night and day, two entirely different realities.  Both lack consideration for the other on either end of the spectrum.  

Some pain sufferers may not have even one support person in their lives who they can turn to when the going gets tough, yet many seem to think the best way to deal with suicide is by not talking about it. They fear that by discussing it and making it real, somehow that will trigger chaos and we'll begin dropping like flies once the seed has been planted. 

The intent of this article is the exact opposite.

Recently I took part in a class where this topic was discussed in a small group session. To my left was a person who had been in pain their entire life. They were over it, pun fully intended, literally in the process of orchestrating a move to someplace where assisted suicide is legal. 

To my right was someone also in pain, who was squeamish about the subject and could not begin to relate to it.

Then there was me, a splash of irony right there in the middle.

Not too long ago, I took a mental health day at a local beach along Lake Michigan. When I am able to swim, my skills are strong. But as I approached my targeted distance, weather conditions shifted and I was both pulled under and pushed back. It was as though I'd been swept into a riptide and under current at the same time.  

At this point, I was exhausted and in low temperature water far longer than anticipated. Swirling thoughts crashed into my mind, much like the waves that had begun to cover my face. If I'm not able to move into shore I will die.

I've made it through worse, and there's no way this is how it's going to end-- not without a fight. So I powered through the water at full force until I felt as I could no longer – which is when the tip of my toes could finally touch the sand bar.  With a touch of hypothermia and major shock to the system, I made it.     

This is everyday life with chronic pain and illness. The emotions can submerge and escort us to the very edge of sanity, a tsunami that can swallow us whole and leave us fighting for every breath. Sometimes these ailments are much like anchors on our feet, shackling us to inevitable trenches of darkness and gloom.    

Many who can relate to these experiences are traumatized by judgmental stigma, so it's important that we acknowledge it is not only understandable but also normal to feel defeated. 

Observing these feelings as opposed to just absorbing them is a way of co-existence. The relationship with oneself is critical. At some of our lowest points, it is within us to choose the direction of our sails and head to safer shores.   

When navigating the treachery of these waters, our pursuit of quality of life against all odds presents itself as proof that we can make it through this and that we're in it together. We just gotta Keep Our Heads Up!  

If you or someone you know is contemplating suicide, PLEASE REACH OUT 

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.