FDA Head Tweets New Warning About Kratom

By Pat Anson, Editor

The head of the Food and Drug Administration is warning again about the marketing of kratom and other dietary supplements to treat opioid addiction – calling them “health fraud scams.”

“FDA believes strongly people addicted to opioids should have access to safe and effective, approved treatments for addiction. Unfortunately, unscrupulous vendors are trying to capitalize on opioid epidemic by illegally marketing products for these purposes,” FDA commissioner Scott Gottlieb, MD, warned on Twitter Friday.

Gottlieb was reacting to a story in The New York Times about the marketing of dietary supplements like “Opiate Detox Pro,” a blend of vitamins and amino acids said to have “amazing benefits” in reducing opioid withdrawal symptoms. 

Similar claims are made about kratom by websites such as HowtoQuitHeroin.com, which was founded by Jorge Fernandez, a recovering heroin addict.

“Kratom works. Kratom helps. It can help you to quit heroin. It can help you to quit Suboxone. It can help you to quit Oxycontin. And believe it or not, it can even help you to quit Methadone as well,” Fernandez claims.

Kratom is not approved by the FDA as a treatment for opioid addiction or any other health condition. But because kratom is classified as a dietary supplement, it’s not held up to the same regulatory standards as pharmaceutical drugs -- as long as vendors don’t make any misleading claims about its health benefits. That’s when the FDA can intervene by seizing kratom products or prohibiting their sale.

“They’re marketing products as dietary supplements with unproven claims about ability to treat addiction; or as all-natural alternatives to opioids. Health fraud scams like these can pose serious health risks,” Gottlieb tweeted. “FDA will continue to act when it learns of the deceptive sale or advertising of products that claim to effectively treat opioid use disorder, but which have not been proven safe and effective for these purposes.”

SCOTT GOTTLIEB, MD

Although Gottlieb didn’t specifically name kratom as one of those “health fraud scams,” there’s little doubt that’s one of the supplements he was referring to. Last month the FDA issued a public health advisory about kratom, warning that it was addictive and linked to dozens of overdose deaths.

“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” Gootlieb said at the time.

“I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules. Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In a survey of 6,150 kratom users last year by Pain News Network and the American Kratom Association, most said they used kratom as a treatment for chronic pain, depression or anxiety. But a fair number -- nearly 10 percent -- said the primary reason they used kratom was to treat opioid addiction.

“Kratom is the one thing that has kept me from using opiates and other illegal substances. I've been able to stay clean for 3 years now. It's given me my life back,” one survey respondent wrote.

“Kratom is the only reason I was finally able to end my addiction to hydrocodone. It is nowhere near as potent as hydrocodone, and you can't overdose” said another.

“It has saved my life. I am a mother of four and have anxiety, depression, acute back pain, and I am an opioid addict. It has kept all these at bay for me,” one woman wrote. “I want to be there for my children, but the sad truth is I know I can't live with these conditions and not find something. It's a sad day when I have to turn to the streets again to have any kind of life.”

“I've had several friends who have died from heroin overdose if they knew about kratom they may still be alive today,” wrote another kratom user.

Last year, the Drug Enforcement Administration attempted to list kratom’s two active ingredients as Schedule I controlled substances, which would have made it a felony to possess or sell kratom. The DEA suspended its plan after a public outcry and lobbying campaign by kratom supporters, saying it would wait for a medical evaluation and scheduling recommendation for kratom from the FDA. Although the FDA has warned the public about using kratom, its full report and recommendations have yet to be released.

12 Myths About Opioid Pain Medication

By Ryle Holder, PharmD, Scott Guess, PharmD, and Forest Tennant, MD, Dr. P.H.

Myth #1: Above 100mg of morphine equivalence, opioid pain medications are ineffective. NONSENSE! They have no ceiling in most patients and may remain effective at dosages in the thousands.

Myth #2: All pain patients who take over 100mg of morphine equivalence are diverting or selling part of their prescription allotment. NONSENSE! Most patients who have a bad enough pain problem to need this much opioid don't usually want to part with it.

Myth #3: All patients who use the "Holy Trinity" of an opioid, benzodiazepine, and muscle relaxant are either selling their drugs or will shortly overdose. NONSENSE! The original "Holy Trinity" was a simultaneous ingestion of a combination of the short-acting drugs hydrocodone (Norco), alprazolam (Xanax), and carisoprodol (Soma). A different, long-acting drug from either of these 3 classes (opioid, benzodiazepine, muscle-relaxant) markedly lowers the risk. So does taking the drugs separately.

Many severe, centralized pain patients have to take a drug from the 3 classes and do it safely and effectively. In other words, they take the drugs "as prescribed."

Additionally the “Holy Trinity,” originally called the “Houston Cocktail,” is a term coined by law enforcement. Addicts tend to use monosyllabic terms to refer to their poison of choice; “Holy Trinity” has too many syllables.

Myth #4: Centralized, intractable pain doesn't exist. NONSENSE! Much research documents that pain from an injury or disease may cause glial cell activation and neuroinflammation, which may destroy brain and spinal cord tissue. Multiple, high dose drugs may be needed to prevent tissue damage and control the immense pain that this condition may produce. As inflammation develops, the overall stress on all organ systems increases dramatically, occasionally to a life-threatening level.

Myth #5: The risks of an opioid dosage over 100mg of morphine equivalence are too great to prescribe opioids above this level. NONSENSE! If a severe, chronic pain patient can't find control with opioid dosages below 100mg or with other measures, the benefit of the high dose far outweighs the risks.

Myth #6: Overdoses occur even if opioids and other drugs are taken as prescribed. NONSENSE! If this even happens, it is extremely rare. Overdose victims often take alcohol, marijuana and other drugs in combination, but opioids and the prescribing doctors are always blamed.

Myth #7: There are no "proven" benefits to long-term opioid therapy. NONSENSE! Simply talk to someone who has taken them for 10-20 years. Never has there been, nor will there ever be, a double-blind, placebo-controlled study to provide "evidence." Opioids are a last resort when all else fails. Opioids in doses >100mg have improved quality of life and prevented death in some instances.

Myth #8: Chronic, severe or intractable pain is just a nuisance that doesn't warrant the risk of opioids. NONSENSE! Severe pain has profound detrimental effects on the cardiovascular, immune, endocrine (hormone) and neurologic systems. Pain must be controlled or pain patients may die of stroke, heart attack, adrenal failure or infections due to a suppressed immune system.

Myth #9: Genetics has no effect on the need for a high opioid dosage. NONSENSE! Bigger and heavier people need a higher dose of medications (just add 1 drop of food coloring to a 1 gallon bucket and then a 5 gallon bucket and observe). It is well documented that some genetic variations impede opioid metabolism to the active form of the drug, or increase the speed the body excretes the opioid. Both metabolic variations will require a higher dosage.

Myth #10: All pain patients can get by on standard opioid dosages under 100mg. NONSENSE! There are persons who are outliers with all disease conditions such as heart failure, diabetes and asthma. Same with pain. A few unfortunate individuals will always require high dosages. Remember our friend the bell curve? What if YOU were on the extreme end?

Myth #11: All patients started on opioids some time ago can just suddenly stop opioids. NONSENSE! Once a person is on high dose opioids they don't dare suddenly stop, because sudden withdrawal may cause hypertension, tachycardia, adrenal failure, and sudden heart stoppage. Some patients who have stopped too suddenly have committed suicide because they had no way to control pain. Montana reports that 38% of all suicides in the state are pain patients, many of them undertreated.

Myth #12: There are plenty of alternatives to opioids. NONSENSE! Common pain problems are generally mild to moderate and respond to a variety of non-opioid treatments. Unfortunately, there are some severe, intractable pain patients who can only control their pain with opioids.

Forest Tennant is a pioneer in pain management who operates a pain clinic for intractable pain patients in West Covina, CA. His clinic was recently raided by DEA agents.

Ryle Holder is a Georgia pharmacist and patient of Dr. Tennant. Scott Guess operates an independent pharmacy  and clinic in Atascadero, CA that specializes in pain management.

This column was distributed by Families for Intractable Pain Relief, a project of the Tennant Foundation.

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.

How to Fight Step Therapy

By Barby Ingle, Columnist

With opioid medication becoming harder and harder to obtain, I want to put out some reminders of other access to care issues that we have had for many years. These challenges can’t be overlooked as we combat the fake news media on the opioid crisis and the lack of news coverage of the chronic pain epidemic.

Health insurance companies often find ways to delay or deny pain care, using step therapy, prior authorization, medication claw back, and poorly run clinical trials to keep their own costs down.

Step therapy is a tool that insurers use to control spending by requiring patients to try certain medications first before using more expensive drugs to treat whatever ails them. These “fail first” requirements mostly affect the care of chronically ill patients. Studies show that nearly 60% of commercial insurance companies use some form of step therapy. And three out of four large companies offer employees insurance plans that use step therapy practices.

Requiring patients to try less effective medication delays access to the best treatment and allows some diseases to progress. This lack of proper and timely care denies patients the drugs they need when they need them, and allows insurance companies to practice medicine without a license.

Many patients can’t afford to wait or forgo needed medications. As these patients physically deteriorate, it only adds to future healthcare costs and increases the risk of non-compliance and self-medication.

Currently there are laws protecting patients from step therapy in over a dozen states, including California, Connecticut, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Missouri, Mississippi, New York, Washington and West Virginia. But even in these states, there are often holes in the law that need to be addressed. In California, for example, the law only relates to fail first exceptions and uniform prior authorization forms.

Various groups such as the New Mexico Fail First Awareness Coalition, Minnesota Coalition on Step Therapy, Illinois Pain Alliance, Indiana Pain Alliance, International Pain Foundation, Kansas Affordable Access to Medication Coalition and others are working on pending legislation to stop step therapy practices in Florida, Georgia, Massachusetts, Maine, Minnesota, New Mexico, Ohio, Oregon, Rhode Island, Texas, Utah and Virginia.

There is also a step therapy bill in Congress sponsored by Rep. Brad Wenstrup of Ohio called the “Restoring the Patient’s Voice Act of 2017.” It requires insurers to have a clear and speedy process for patients to request an exception to the step therapy protocol.  In cases where the life and health of a patient are jeopardized by step therapy, the request must be granted no later than 24 hours after it is received.

For all of these state and federal efforts, the pain community needs patients to share their stories of how insurance practices have harmed them or denied them medication that is helpful.

What can you do? If you have already experienced step therapy and found it delayed your care, I suggest you speak out about the impact it has had on you. Talk to your congressional representatives and let them know how it has affected you.

An easy way to do this advocacy work is to call 1-844-872-0234 and wait for the automated message. Press 1 and enter your 5-digit zip-code. This will connect you to the office of a U.S. senator for your state. After the call concludes, it will automatically connect you to your other senator and then your representative in the House. Sometimes a live person will answer or you could be instructed to leave a message.

Craft a personalized message, such as “Good morning. My name is (name), and I am a constituent from (city, state). I am a chronic pain (patient, caregiver, family member or provider). I am asking for your support to help the pain community by supporting step therapy legislation for people in pain living in our state. Thank you.”

It is a simple way to become an advocate and make a difference. I hope that you will find it in you to be a cheerleader of hope, and fight for access to proper and timely care for yourself and others in the pain community.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

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.

Study Advocates Guidelines for Postoperative Pain

By Pat Anson, Editor

Patients recovering from gallbladder surgery need only about a third of the opioid painkillers that are prescribed to them, according to a small new study that could lay the groundwork for new national guidelines on treating postoperative pain.

Researchers at the University of Michigan looked at prescribing data on 170 people who had their gallbladders surgically removed in a laparoscopic cholecystectomy and found that the average patient received an opioid prescription for 250mg morphine equivalent units. That's about 50 pills.

But when the researchers interviewed 100 of those patients, the amount of opioid medication they actually took after their surgeries averaged only 30mg, or about 6 pills. The remaining pills were often left sitting in their medicine cabinets for years.

"For a long time, there has been no rhyme or reason to surgical opioid prescribing, compared with all the other efforts that have been made to improve surgical care," says lead author Ryan Howard, MD, a resident in the U-M Department of Surgery who began the study while attending the medical school.

"We've been overprescribing because no one had ever really asked what's the right amount. We knew we could do better."

When U-M surgical leaders heard about the findings, they gave Howard and his colleagues permission to develop a new prescribing guideline that recommended just 15 opioid pills for gallbladder patients.

Five months later, the average prescription for the first 200 patients treated under the guideline dropped by 66 percent -- to 75mg morphine equivalent units. Requests for opioid refills didn't increase, as some had feared, but the percentage of patients getting a prescription for “safer” non-opioid painkillers such as acetaminophen or ibuprofen more than doubled.

Interviews with 86 of the patients who received the smaller prescriptions showed they had the same level of pain control as those treated before -- even though they took fewer opioid painkillers. A new education guide for patients counseled them to take pain medication only as long as they have pain, and to reserve the opioid pills for pain that's not controlled by ibuprofen or acetaminophen.

"Even though the guidelines were a radical departure from their current practice, attending surgeons and residents really embraced them," said U-M researcher Jay Lee, MD. "It was very rewarding to see how effective these guidelines were in reducing excess opioid prescribing."

Researchers estimate that implementing the new guideline has kept more than 13,000 excess opioid pills out of circulation in the year since the rollout began. Their findings were published in JAMA Surgery.

U-M researchers have expanded on their efforts by developing prescribing guidelines for 11 other common surgeries, including hysterectomies and hernia repair. They believe the guidelines could serve “as a template for statewide practice transformation” and could be adopted nationally as well.   

It’s a common misconception that many patients become addicted to opioid medication after surgery. According to a recent national survey, one in ten patients believe they became addicted or dependent on opioids after they started taking them for post-operative pain. But a recent study in Canada found that long term opioid use after surgery is rare, with less than one percent of older adults still taking opioid pain medication a year after major elective surgery.

Another fallacy is that leftover pain medication is often stolen, sold or given away. The DEA says less than one percent of legally prescribed opioids are diverted.

Many patients are dissatisfied with the quality of pain care in hospitals. In a survey of over 1,200 patients by Pain News Network and the International Pain Foundation, 60 percent said their pain was not adequately controlled in a hospital after a surgery or treatment. And over half rated the quality of their hospital pain care as either poor or very poor.

When Is Pain Not Pain?

By Carol Levy, Columnist

“Pain is not pain.” So says my new pain management doc. And he's right.

My main pain right now, the pain that keeps me disabled with trigeminal neuralgia, is from eye movement. Anything that requires sustained eye usage for more than 15 minutes results in horrific pain.

If I tell myself (what I think most of us tell ourselves when we are doing what we know will hurt later) just five more minutes, just four more emails or just one more chapter; I end up with horrific eye pain and become nauseated.  It is all I can do to walk the 20 steps to my bedroom and lie down.

It can get so bad that I often end up laying on my bed for 2 to 3 hours; working to not move my eyes and forcing them to stay completely still, an almost impossible task. I wait and wait, and wait some more, for it to calm down.

“Oh my God!” I cry out to my empty apartment. “The pain is so bad. I don't know what to do!”

Sometimes pain meds help by taking the edge off, but the wait for them to kick-in is excruciating. “When will this stop?” I demand to the air. “Why can't someone fix this for me!”

The answer never changes. Total silence.

My new pain management specialist starts appointments with the question we all know only too well: “What does the pain feel like?”

I think about it.  I visualize how my eye feels and what physically happens when it is bad.

“It feels like pulling against the skin and a pushing of the eye against the lids, sometimes burning. Sometimes, it feels like if I could just shut the eye hard enough, which I never can, that would help,” I tell him.

After all those words, I realize there is one word I have not used: Pain!

We all know what pain is. It's the feeling you get when you break a bone, stub your toe, cut yourself, or eat ice cream against a bad tooth. That is what most people think of as pain.

What I feel, what many of us in chronic and intractable pain feel, is not “pain.” Not in any normal or accepted sense of the word.

Why do we not see new pain treatments, outside of the usual drugs and opioids?

It could be because the medical and research community is not studying or addressing our pain.

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.

Former California Lawmaker Charged in Wife’s Suicide

By Pat Anson, Editor

A former California lawmaker has been charged with helping his wife -- who suffered from chronic back pain -- commit suicide last year.

Steven Clute allegedly provided his wife Pamela with a handgun so she could kill herself. He is charged with felony aiding a suicide and will be arraigned tomorrow. Medically assisted suicide is legal in California for terminally ill patients, but suicide by firearm is not permitted.

Pamela Clute was 66 when she killed herself on the morning of August 21, 2016 at the couple’s home in Palm Desert. According to the Desert Sun, her husband found his wife with a gunshot wound and called 911, telling the dispatcher she suffered from severe pain and wanted to end her life.

"Steven said he had given Pamela the revolver as an option to end the pain she was going through based on a previous discussion they had about using the revolver as an option," an arrest declaration released Monday said.

It is not clear what new evidence emerged since the suicide or why the Riverside County District Attorney waited over a year to file charges.

PAMELA CLUTE

Friends and acquaintances of the Clutes said there were rumors of a suicide but didn’t know the cause of Pamela’s death until recently, according to The Press Enterprise. The autopsy report now says she died from a gunshot wound.

steven clute

Pamela Clute was a well-known math professor at the University of California, Riverside. Her husband is a former Navy pilot who served in the California state assembly from 1982 to 1992. The couple had been married for 40 years.

Defense lawyer Virginia Blumenthal told the Associated Press that Clute, who is 69, would plead not guilty at his arraignment.

"You have to understand that everyone around here knows how much in love he was with her," said Blumenthal, who was friends with the Clutes. "They were always together. They were very much in love with each other."

The case is similar to the sad story of Jay Lawrence, a chronic pain sufferer who committed suicide earlier this year with the help of his wife Meredith after his opioid pain medication was cutback.

“I bought the gun that Jay used -- and yes, we talked about the ramifications of that action,” Meredith Lawrence wrote in a PNN guest column. “We went to the park where we had renewed our vows in 2015.  We talked in the car for a while, and then we sat in the same place we had cut our wedding cake.  I was holding his hand when he pulled the trigger.”

Meredith was arrested and charged under Tennessee’s assisted suicide law. She pleaded guilty to a reduced charge of reckless endangerment and is currently on probation.

“I know Jay wanted me to put his story out there.  I know he wanted people to know what it was like to live with the pain he lived with daily. When the doctor took away Jay’s medications, they took away his quality of life. That was what led to his decision,” Meredith wrote.

“Something has to be done to wake up the doctors, insurers and regulators to make them see pain patients as real people. People with husbands, wives and children that love them.”

Can Kellyanne Conway Solve the Opioid Crisis?

By Mark Maginn, Columnist

U.S. Attorney General Jeff Sessions announced last week that White House counselor Kellyanne Conway has been appointed to lead initiatives in the Trump Administration against the opioid crisis currently sweeping the country.

That’s right, President Trump’s former campaign manager and spinner of alternative facts has become the new “opioid czar” – although she is generally thought of inside and outside of the Washington beltway as someone as little acquainted with facts as her employer. 

Appointing a political shill who cares nothing about facts to such a high profile position strains credulity and places millions of pain sufferers and their doctors in jeopardy of more harassment and arrests.

KELLYANNE CONWAY (GAGE SKIDMORE PHOTO)

Ms. Conway is a professional resident of what candidate Trump called the “swamp” he pledged to drain. And now this denizen of the Capital’s reptilian power structure is to be in charge of initiatives alleviating the opioid epidemic. 

This is a position that requires the ability to gather experts together in order to devise wise and humane policies to help those in terrible pain and those who become addicted to opioid drugs such as OxyContin and, of course, heroin.

To add gravitas to the strained credulity of this outrageous appointment, we have none other than “opioid policy expert” and the founder of Physicians for Responsible Opioid Prescribing (PROP) weighing in.

"It is a positive sign. She is a high-profile figure in the administration, showing the administration takes this seriously,” Dr. Andrew Kolodny told BuzzFeed.

It appears that in Kolodny’s brand of myopia, possessing a “high-profile” is evidence of seriousness. Kolodny perpetuates the notion that notoriety equals intellect, organizational ability and tact.

Those who applaud this sad appointment apparently do not take this so-called opioid epidemic with anything approaching the seriousness it requires. Conway’s appointment will likely lead to more of the same stupid drug policy of harassing pain doctors and jailing patients desperate for pain relief. No serious policies can be expected.

For example, after nearly a year in office, the Trump administration has failed to name anyone to head the White House Office of National Drug Control Policy. It also has yet to fund or propose a strategy for the overdose crisis, which President Trump declared a public health emergency in October. Does this look like an administration serious about the causes and treatment of drug addiction and drug overdose deaths?

Conway’s lack of candor and veracity is likely to lead to disastrous policies affecting millions of us. 

She infamously coined the phrase “alternative facts” in defense of then-Press Secretary Sean Spicer’s false statements about the size of the crowd at Trump’s inauguration. Conway later defended the President’s travel ban on mostly Muslim countries by making reference to the “Bowling Green Massacre.” She cited this fictitious terrorist massacre as evidence in support of the president’s travel ban on Muslims. 

The use of lies and half-truths by Conway should have been enough to disqualify her.

Can we believe that Conway will look to the ravages of poverty, the destruction of good middle class jobs, the collapse of education, the increasing wealth gap, and the epidemic of loneliness that I see in my office daily with patients suffering from various forms of depression and despair? No, certainly not. That would require long term financial commitment to jobs, healthcare, education, and housing.

Our current War on Drugs has led to the incarceration of millions of Americans of color. We now have more of our citizens in prison than any other nation. Yet Attorney General Sessions has created a new unit in the DEA that is solely charged with “investigating and prosecuting health care fraud related to prescription opioids.”

This indicates more law enforcement and pressure on doctors prescribing opioids for those of us who depend on these medicines simply to live. That is exactly the wrong policy. 

People of privilege like Ms. Conway and her boss, our President, are not capable of looking beyond their own wealthy horizons and seeing the lonely precincts of a depressed and despairing nation.

We need real, clear-eyed and honest people to bring us real, clear-eyed and honest help.

Mark Maginn lives with chronic back pain. He is a licensed mental health and social worker who spent 18 months working in New York City with survivors of the 9/11 terrorist attacks. Mark now has a private practice in psychotherapy in Chicago, where he specializes in working with people in intractable pain. 

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.

Medical Marijuana Will Not Cure the Opioid Crisis

By Roger Chriss, Columnist

There is a strong push underway to utilize medical marijuana as an alternative to opioid pain medications.

“There’s a large group of patients who have chronic pain who rely on opioids,” Dr. Charles Bush-Joseph recently told the Chicago Tribune. “Those are the patients who would benefit from medical cannabis.”

Indeed, medical marijuana and synthetic forms of cannabis are showing promise in treating chronic pain and related disorders. Recent research has shown that the marijuana-based medication dronabinol is effective in the management of neuropathy in multiple sclerosis. Similarly, another novel cannabidiol made by GW Pharmaceuticals has been found to help manage treatment-resistant epilepsy.

But while medical marijuana is showing potential in treating many medical problems -- including chronic pain conditions -- it will not have a significant impact on the rate of opioid addiction or overdoses.  

Media reports from outlets like Big Think erroneously associate the opioid crisis with chronic pain management and misinterpret recent studies on opioid overdose rates in states with legal medical cannabis.

In fact, chronic pain management is not a significant causal factor in the opioid crisis. The National Institute on Drug Abuse estimates that between 8 and 12 percent of people on long-term opioid therapy develop some form of opioid use disorder.  A Cochrane review put the number even lower – with less than 1% of chronic pain patients becoming addicted.

In other words, people who need opioid pain medication are rarely the ones who become addicted and reports of doctor-shopping pain patients are greatly exaggerated.  It is also clear from recent reports by the CDC that the prescribing of opioid pain medication has been dropping steadily since 2010 and that the main drivers of the opioid crisis are now heroin and illicit fentanyl.

Moreover, research only shows an association, not a causal relation, between legal medical cannabis and opioid overdose rates. A recent study from the University of New Mexico showed that people with chronic musculoskeletal pain preferentially used medical cannabis over opioid analgesics. But this result is only preliminary and small-scale, and is unrelated to opioid addiction or overdose.

A 2014 study in JAMA also found an association between medical marijuana laws and a decline in opioid overdose mortality rates. But the authors of the study were careful to note that “our findings apply to states that passed medical cannabis laws during the study period and the association between future laws and opioid analgesic overdose mortality may differ.”

Recent data from Colorado, which legalized medical cannabis in 2000, shows the number of newborns in the state addicted to opioids jumped 83 percent from 2010 to 2015, a result that suggests rising levels of opioid use. Similarly, significant increases in fatal overdoses involving opioids are emerging in Washington state, where medical marijuana has been legal since 1998.

Opioid overdoses are also increasing in other states that recently legalized cannabis, although the increase is most likely caused by heroin and illicit fentanyl, not opioid pain medication.

Medical cannabis has been mentioned as potentially helpful in treating opioid addiction. But a small new observational study from Washington State University concludes that cannabis use by patients in an addiction treatment program may actually strengthen the relationship between pain, depression and anxiety.

"For people who are using cannabis the most, they have a very strong relationship between pain and mood symptoms, and that's not necessarily the pattern you'd want to see," said lead researcher Marian Wilson, PhD, of the Washington State University College of Nursing. "You would hope, if cannabis is helpful, the more they use it the fewer symptoms they'd see."

About two-thirds of the 150 patients surveyed by Wilson said they had used marijuana in the past month.

"Some are admitting they use it just for recreation purposes, but a large number are saying they use it to help with pain, sleep, and their mood," Wilson said. "We don't have evidence with this study that cannabis is helping with those issues."

None of this is meant to downplay the potential of cannabis in pain management or other areas of medicine. Medical cannabis has long been recognized for its use in treating chemotherapy-induced nausea, in loss of appetite due to end-stage cancer, and in treating pain in disorders like multiple sclerosis. More research will help clarify what else medical cannabis may be able to do.

But the legalization of medical cannabis is not going to cure the opioid crisis. Instead, the excessive and uncritical enthusiasm for it in some recent media reports and research publications is creating unrealistic expectations. These expectations could be used to justify reductions in pain medications that are working, complicating the lives of people with intractable pain disorders for no good reason.

If medical cannabis works, let's use it. But let’s make sure we’re using it for the right reasons.

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.

Canada’s ‘Deeply Flawed’ Opioid Guideline

By Pat Anson, Editor

Just six months after adopting an opioid prescribing guideline modeled after the CDC's guideline in the United States, they’re already having second thoughts in Canada.

An editorial published in the Canadian Medical Association Journal says the guideline is “deeply flawed,” may have contributed to several deaths, and has created “a climate of fear” among doctors and patients.

Like the opioid guideline released by the Centers for Disease Control and Prevention in 2016, the Canadian version strongly recommends that patients not receive opioid doses in excess of 90mg morphine equivalents daily (MED), and that patients receiving a higher dose by tapered to the “lowest effective dose” or stop getting opioids altogether.

“The Guideline neglects to warn physicians that tapering can put patients at high risk for overdose, because patients will lose tolerance, experience distressing withdrawal symptoms, and turn to other sources for their opioid,” warns lead author Meldon Kahan, MD,  director of addiction treatment at Women’s College Hospital in Toronto.

Kahan helped write Canada’s 2010 opioid guideline, which recommended a much higher ceiling of 200mg MED.  He says the current guideline fails to address addiction or how to treat opioid use disorder with medications such as buprenorphine and methadone.

“By not discussing these treatments, the Guideline encourages physicians to manage opioid addiction through tapering, which is usually ineffective and sometimes dangerous,” wrote Kahan.

“The Guideline is contributing to a climate of fear around opioid prescribing. We are aware of several instances of death following rapid tapering or abrupt discontinuation. The Guideline needs extensive revision to ensure patient safety; until this is done, the medical community and medical regulators must not use the Guideline as the standard for opioid prescribing.”

Over 50 clinicians, academics, patients and “safety advocates” helped draft the Canadian guideline. Among them were three board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played a key role in drafting the CDC guidelines: PROP Vice-President Gary Franklin, MD, Mark Sullivan, MD, and David Juurlink, MD.

One major difference between the Canadian guideline and the CDC’s is that the latter is only intended for primary care physicians, while Canada’s guideline applies to all prescribers, including family physicians, pain specialists and nurse practitioners.

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the highest rate of opioid prescribing outside the United States. Opioid prescribing peaked in the U.S. in 2010, but prescriptions are still trending upward in Canada. A report released last week by the Canadian Institute for Health Information shows that the total number of opioid prescriptions rose by nearly seven percent between 2012 and 2016, although fewer pills are being prescribed.

Opioid overdoses are soaring in Canada, as they are in the United States, but increasingly the deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

Minnesota’s Tough New Guideline

Canada may be having second thoughts about its guideline, but Minnesota appears close to adopting even tougher rules for prescribers – which would arguably be the most draconian anywhere in the United States.

The draft guidelines released last week by the Minnesota Opioid Prescribing Work Group (MOPWG) would limit new opioid prescriptions for acute, short-term pain to just three days’ supply and a total of no more than 100mg MED – meaning the average daily dose would be less than 34mg MED.

Treatment for acute pain that lasts longer – for up to 45 days – would be limited to a total of 200mg MED every 7 days. Prescriptions would also have to be obtained weekly.

Daily doses for chronic pain lasting longer than 45 days would be limited to 90mg MED – if a patient is able to get them at all. The guideline specifically discourages doctors from prescribing opioids for fibromyalgia, migraine, “uncomplicated” back pain, and just about every other chronic pain condition. It also strongly recommends that  doctors discuss tapering with patients on long term opioid therapy, "regardless of their risk of harm."

“Opioid analgesics should not be used to manage chronic pain. There is very limited shorter-term evidence on the efficacy of opioids for chronic pain management and a growing body of evidence of significant harm associated with use,” the MOPWG said in a statement.

The MOPWG was chaired by Chris Johnson, MD, an outspoken critic of opioid prescribing who is a board member of PROP, as well as the Steve Rummler Hope Foundation.

“If pain doctors still think these medicines are effective, then they have a lot of explaining to do and their competence and professionalism deserve to be challenged,” Johnson said a few months ago.

If opioids are prescribed long term, Minnesota's guidelines recommend that doctors evaluate a patient’s mental health, as well as any history of physical or emotional trauma. The guidelines claim that patients with a history of trauma are more likely to develop chronic pain.

“Patients with chronic pain tend to report higher rates of having experienced traumatic events in their past, compared to people without chronic pain. A traumatic event is an event (or series of events) in which an individual has been personally or indirectly exposed to actual or threatened death, serious injury or sexual violence,” the guideline states.  

“Traumatic events illicit a number of predictable responses, including anxiety, physiological arousal and avoidance behaviors. A growing body of evidence finds that individuals who have experienced trauma may develop a persistently aroused or reactive nervous system. When confronted with an acute injury or pain following a surgical procedure, people whose nervous systems are already in a state of persistent reactivity due to a past trauma may be more likely to transition for acute to chronic pain.”

If adopted, Minnesota’s draft guideline would only apply to patients covered by the state’s Medicaid programs. However, they are expected to influence all prescribers, as well as insurance company policies and state regulatory boards. The guideline is available for public review and comment for the next 30 days.

Are My Good Years Over?

By Louis Ogden, Guest Columnist

My story is a follow-up to the guest column by Kimberley Comfort that was recently published here in Pain News Network.

I am also a patient of Dr. Forest Tennant and, after reading Kimberley’s heart-felt story, I immediately felt compelled to write mine.  I am currently 67 years old and, much like Kimberley, my problems with pain started during childhood.

kristen and louis ogden

The pain waxed and waned until I was in my mid-20’s, when it became a daily part of my life.  I tried very hard to ignore the pain and remained in denial until many years later. I did not even tell my wife at the time. I did realize that I was consuming way too much Excedrin and was aware of the dangers posed by taking too many NSAIDs. 

I went to several doctors seeking help in the 1980s, but none of them could find anything wrong with me.  I worked through the pain until it became impossible for me to continue doing the physical work required of an electrician. The pain was body-wide, but the worst pain of all was constant, crushing headaches that were absolutely paralyzing. 

Deciding that I must change careers, I returned to college.  I was accepted at James Madison University and enjoyed college life so much that after graduation I decided to stay in academia and teach.  I received an academic scholarship to Syracuse University, but was not able to finish my Master’s thesis due to the excruciating pain, an inability to concentrate, and the severe chronic fatigue that often accompanies extreme pain.

Then I started searching again for a doctor that could help me.  My initial diagnosis was fibromyalgia.  I asked that doctor if there were anything he could give me for the pain and his exact words were, “Yes, I could, but you would be a junkie within two weeks.”  He offered no medication or treatment of any kind. 

I kept trying doctor after doctor, and almost every therapy and medication known to science. Nothing helped.

My search finally took me to Dr. Tennant in 2010.  He is considered one of our country’s foremost experts on pain and the prescribing of opioids, having operated a pain clinic in West Covina, CA since 1975.  He is also the Editor Emeritus of Practical Pain Management, a monthly medical journal about pain.  His current research interests are inflammatory markers and the role of hormones in pain care.   He is a frequent speaker at major pain conferences. 

How could I possibly go wrong by having this expert in pain as my doctor? 

When I first saw Dr. Tennant in 2010, he was very blunt with me and told me that I might not live much longer.  By then my severe chronic pain had given me high blood pressure, which can cause heart failure or stroke.  In addition, my lab results were not good.  Dr. Tennant told me that my pain had “centralized” -- meaning that I had suffered the pain so long that it had become my normal state.  Pain that has not centralized will be sporadic, while centralized pain is constant.

DR. FOREST TENNANT

I suffer from a post-viral autoimmune illness that first presented years ago with symptoms similar to fibromyalgia, arthritis, and myalgic encephalomyelitis.  Dr. Tennant began treating me with opioid medication and titrated me to a higher dose to effectively manage my pain.  I had been on a standard dose, but Dr. Tennant found through genetic testing that I have a genetic anomaly that makes me a poor metabolizer of many medications.  This is why I required a high-dose therapy. 

Here is where I differ from Kimberley Comfort.  She metabolizes her medications so rapidly, that she could not reach a level of comfort on a standard dose.  My problem is the opposite – I am a very poor metabolizer -- but the outcome is the same.  We both require high doses to properly treat our pain. 

After years of debilitating constant pain, I began feeling much better.  Opioid medication not only did a good job of relieving the pain, but along with hormone supplements and anti-inflammatory drugs, they also improved my quality of life, allowing me to do things now that I could not do before.  It may sound trite, but this man “gave me my life back.”

In late 2015, I was diagnosed with cancer, the onset of which may have been facilitated by my overall disease state.  More recently, imaging has shown that I have abnormalities of the cervical spine that likely contribute to my continuing complex array of symptoms.  Like most of Dr. Tennant’s patients, I am an outlier – a patient whose complex disease state places me far outside the usual patient, in terms of severity and resulting disability and pain.  I believe that I would probably not be alive today without the thorough assessment, evaluation, diagnosis and treatments provided by Dr. Tennant. 

Now, the DEA has raided his office and seized all of his patients’ records.  I have read the search warrant and was very surprised to find that a family practice physician (not a pain specialist) had advised the DEA. Dr. Timothy Munzing suggests in the warrant that any patient from out of state receiving high-dose prescriptions for opioids must be selling their medications because they could not take those doses and survive.  That is absolutely not true. I’ve been taking these high doses for seven years and have had the best seven years of my adult life. 

Dr. Tennant’s practice is in California and I live in Virginia, so imagine how I feel now. I am quite frankly scared to death of having my door kicked in, my medications seized, and then going into serious withdrawal.  At my age and my level of pain, I could die along with many other patients of Dr. Tennant.  How can the DEA practice medicine?  They have no medical license.  These decisions should be made by the doctor and the patient. 

Dr. Tennant recently received a Lifetime Achievement Award for Pain Medicine from his colleagues at PainWeek.  In making the presentation, Dr. Kevin Zacharoff described Dr. Tennant as “the kind of doctor that listens, digests, and most importantly, invests in every patient, the patient's problems, and those of society."  Zacharoff describes him as “the true doctor's doctor," a term used in years past to mean the kind of physician other physicians would want to seek out for their own medical care.  

Why doesn’t the DEA understand what pain physicians and patients understand about Dr. Forest Tennant?

Louis Ogden and his wife Kristen live in Virginia. Kristen volunteers in Dr. Tennant’s pain clinic and recently wrote a column about why it is such a “special place” for patients and their families.

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.

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

The Tyranny and Tragedy of Pain Scales

Bu Janice Reynolds, Columnist

When the Joint Commission issued its first pain standards, they recommended that pain should be assessed on a regular basis and encouraged providers to ask patients a simple question: “Are you in pain?”

The Veterans Administration then had the bright idea to use a numerical pain scale to assess pain, as well as making pain the “5th Vital Sign.”  Other organizations followed like lemmings and eventually it was felt by most to be mandatory.  This was very wrong and damaged people in pain immensely.

Pain scales were never meant for this purpose. They originated and were validated in research projects, but wound up being incorporated into the assessment of pain.

Assessment requires many other questions besides the simple “Are you in pain?”

How does your pain feel now? What word would describe your pain? How long does it last? When does it occur? What makes it feel better or worse? And so on. 

The original question was supposed to lead to an actual assessment of pain and whether a person was having any. Then it was intended that the pain be addressed.  Pain scales are based on the premise that “pain is what the person says it is, existing when they say it does.”

Pain is subjective, it can never be objective.  The best use of a pain scale is before and after an intervention to ascertain whether the intervention was effective.

There are many different pain scales. The visual analog scale is a line where a patient selects a point on the line to represents where their pain is. Numerical rating scales typically rate pain on a scale of 1 to 10, while a vertical scale uses a 1 to 10 “thermometer” that has been shown to work best with older adults.

There are also face scales and behavioral scales -- like the one below -- which are used for young children or when adults are unable to communicate.

With the current madness over pain medication, an attempt is being made to make the scales more objective, so we have physicians and even patients designing their own scales. One very scary one designed by a woman with fibromyalgia (and of course loved by some providers) actually says “10 – Unspeakable pain. Bedridden and possibly delirious. Very few people will ever experience this level of pain.”

As a pain management nurse and someone living with pain, I emphatically call these made up scales quackery.

Unfortunately, pain is not always quantifiable, especially persistent pain.  Even a functional scale (based on how well you are able to function and do activities of daily living) is not always useful or believed. I remember telling a surgeon a patient rated her pain a 10 on a scale of 1 to 10.  His parting comment was, “If her pain was really 10/10, she would be dead.”

One of the results of using numerical rating scales is a further lack of response in acknowledging pain and treating it.  It has become a routine to ask if you are having pain and to put a number on it, but rarely does it result in further assessment, diagnostic tests, or actually doing something about the pain, even if you rated your pain a 10. 

The people asking the questions often have little idea about how to use a rating scale and become frustrated. I remember a nurse telling a developmentally challenged woman who could not use a scale that she needed to learn how. 

The last time I saw my neurologist, a nurse asked me to rate my pain. So I said, “Are you asking about my skull, my foot, or my hip?”  This of course flustered the nurse, who replied, “Which ever one the doctor is treating you for.” I told her, “He doesn’t treat any of my pain, I am seeing him for a seizure.” 

I eventually took mercy on her and gave her a “number” for my skull pain. But, like 99% of numbers reported in a screening, it was useless.

Pain terrorists (a phrase I use to describe opioiphobics and people biased against pain sufferers) are claiming pain scales have contributed to or even caused the “opioid addiction crisis.” I have also heard claims the scales were created by pharmaceutical companies to increase their sale of opioids and that they have allowed false claims of pain to proliferate.

When a group of U.S. senators submitted a letter to have questions about pain removed from Medicare quality of care surveys, they claimed too many doctors were prescribing opioids so that their hospitals would get good ratings. Sen. Susan Collins was quoted as saying “there is no objective diagnostic method that can validate or quantify pain” and that patients were not the best judge of how good their pain management is. This essentially denies that pain exists when a person says it does.

The bottom line is the use of pain scales to identify pain has been both a tyranny and a tragedy.  

It's a tyranny because it forces people to use a scale that was never designed for that purpose, which blames them for problems associated with using them, and allows pain terrorists even more ammunition for fear-mongering.

It’s a tragedy because it has contributed to the erosion of the art and science of pain management, and increased the damage to people suffering in pain.

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on pain management and has co-authored several articles in peer reviewed medical journals.  Janice has lived with persistent post craniotomy pain since 2009. 

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.

Chronic Pain and Depression Common in Overdoses

By Pat Anson, Editor

People who die from opioid overdoses are significantly more likely to suffer from chronic pain and depression, according to a new study that highlights the risk of combining opioid pain relievers with benzodiazepines, a class of anti-anxiety medication.

Researchers at Columbia University Medical Center analyzed over 13,000 overdose deaths among Medicaid patients and found that over 61 percent had been diagnosed with back pain, headaches or some other chronic pain condition. Many also suffered from depression, anxiety, bipolar disorder, schizophrenia and other mental health problems.

Significantly, nearly half of those with chronic pain (49%) filled a prescription for opioid pain medication during the last 30 days of their lives, and just over half (52%) filled a prescription for benzodiazepines. Prescriptions for anti-depressants, anti-psychotics and mood stabilizers were also common.

“This medication combination is known to increase the risk of respiratory depression, which is the unusually slow and shallow breathing that is the primary cause of death in most fatal opioid overdoses," said Mark Olfson, MD, a professor of psychiatry at Columbia and lead investigator of the study.

“Most persons with opioid-related fatalities were diagnosed with one or more chronic pain condition in the last year of life. As compared to people with opioid-related deaths without diagnosed chronic pain conditions, the decedents with chronic pain diagnoses were more likely to have also received substance use and other mental health disorder diagnoses. They were also more likely to have filled prescriptions for opioids, benzodiazepines, and other psychotropic medications and to have had a nonfatal drug overdose.”

The Columbia study included opioid overdoses linked to both pain medication and illegal opioids such as heroin, but was limited to Medicaid patients who died between 2001 and 2007. Since that time, opioid prescribing has declined, while illegal opioids and counterfeit medication have become increasingly available on the black market.

Public health officials have only recently started warning about the risks of combining opioids with benzodiazepines, and some insurers now refuse to pay for the medications when they are prescribed jointly.

A recent study of overdose deaths in Florida found that benzodiazepines such as Xanax and Valium killed nearly twice as many Floridians in 2016 as oxycodone. Another study in Pennsylvania also found that overdose deaths involving benzodiazepines exceeded those from opioid painkillers.

The Columbia study was published online in the American Journal of Psychiatry. The study was funded by the Agency for Healthcare Research and Quality, the National Institute on Drug Abuse, and the New York Psychiatric Institute.

GAO Seeks Expanded Tracking of Medicare Rx Opioids

By Pat Anson, Editor

A new report to Congress by the Government Accountability Office (GAO) recommends that the federal government greatly expand the monitoring of Medicare patients who receive high doses of opioid pain medication, as well as the doctors who write their prescriptions.

If adopted, an estimated 727,000 Medicare beneficiaries who receive opioids in excess of 90mg morphine equivalent doses (MED) would have their prescriptions tracked by private insurers and reported to the Centers for Medicare & Medicaid Services (CMS). Critics say such a policy would have a chilling effect on doctors, who increasingly fear government sanctions for prescribing opioids.

In 2016, over 14 million elderly and disabled Medicare patients received an opioid prescription, and CMS spent over $4 billion paying for their opioid medication.

“A large number of Medicare Part D beneficiaries use prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” the GAO report says.

“Despite working to identify and decrease egregious opioid use behavior — such as doctor shopping — among beneficiaries in Medicare Part D, CMS lacks the necessary information to effectively determine the full number of beneficiaries at risk of opioid harm.”

Under current CMS policy, patients are only considered “at risk” if they receive high dose opioid prescriptions from four or more providers and have them filled at four or more pharmacies. Last year, 11,594 Medicare beneficiaries met that criteria, a tiny fraction of those who receive opioids.

The GAO wants to change the criteria so that everyone prescribed a high dose would be monitored, regardless of how many doctors or pharmacies they use.  The principal author of the report said the recommendation is not aimed at taking patients off opioids or lowering their dose, but to improve the data on high dose prescribing.

“We are suggesting that CMS take a close look and monitor and track the numbers of people at risk of harm,” Elizabeth Curda, Director of GAO Health Care, told PNN. “We’re not suggesting CMS investigate 700,000 people who get more than 90mg per day. We want them to focus on how many people are getting these doses and what’s happening to that number. Is it going down? Is it going up?  We have this strategy to reduce harm, so we want to see it coming down.”

“Frankly this is unbelievable.  It is very hard for me to understand how reducing the amount of opioids to people in pain is going to help reduce the amount of smuggled heroin and fentanyl into the United States,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.  “We need to remember 3 out of 4 drug overdoses do not involve a prescription opioid.  And most of the overdose deaths involving prescription opioids are not in people prescribed the medications.”

Webster is also concerned about a GAO recommendation that Medicare insurers be required to identify and report to CMS all high-dose opioid prescribers. Currently, there’s only a voluntary reporting system when doctors are investigated for fraud, waste or abuse.

“Investigating doctors who prescribe high dose opioids will have a chilling effect.  It will deter all providers from treating people with pain at any dose.  People will suffer.  There will be more suicides because of inadequately treated pain. This is not hyperbole,” said Webster. 

“The whole notion that reducing dose will solve the opioid crisis is misguided.  People who benefit from the high doses will be denied pain relief and those who use any dose for non-medical purposes will just seek illicit and more lethal drugs.”

Patients and Prescribers Ignored

Critics of the GAO report are also disturbed that the agency did not consult with any pain sufferers, patient advocacy organizations or professional medical organizations that represent prescribers. Instead, the GAO met primarily with insurance companies, regulators and addiction treatment specialists.

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group," the GAO report says in a footnote.

"We also interviewed 12 stakeholders that represent a range of perspectives on opioid use and prescribing patterns in Medicare: AARP, American Health Insurance Plans, American Society of Interventional Pain Physicians, Brandeis Prescription Drug Monitoring Program Training and Technical Assistance Center, Federation of State Medical Boards, National Association of Drug Diversion Investigators, National Association of Medicaid Directors, National Healthcare Antifraud Association, Pew Charitable Trust, Pharmaceutical Care Management Association, Physicians for Responsible Opioid Prescribing (PROP), and one expert on opioid abuse."

The GAO would not identify any of the individuals it met with, saying the interviews were conducted on a “not for attribution” basis to encourage frank discussion. However, it seems likely that Andrew Kolodny, MD, was interviewed, as he is the founder and Executive Director of PROP, works at Brandeis University, and is considered by some to be an expert on opioid abuse.

Kolodny, who is the former chief medical officer of the addiction treatment chain Phoenix House, did not respond to a request for comment. Pain News Network is filing a request under the Freedom of Information Act with the GAO to disclose who they talked to.

ANDREW KOLODNY, MD

“I find it very disturbing that federal agencies continue to ignore pain care providers and advocacy groups for people with pain when they formulate policies that very clearly will impact those parties. Again and again, they consult with parties that have a vested interest in reducing opioid prescribing regardless of the impact on people with pain," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“They even go so far as to invite one solo participant who is an ‘expert on opioid abuse.’ It’s as if they were asking representatives from the sugar industry to help develop guidelines on when artificial sweeteners should be used. Clearly, this speaks to a policy that is concerned with driving down opioid prescribing across the board, without considering the needs of the people with pain who actually benefit from opioid analgesics. It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

“It appears the GAO did not include patients, professional pain organizations and the American Medical Association in their deliberations. I would like to know how they feel their process can be justified,” added Webster. “They only invited groups to comment that appear to benefit financially from reduced prescribing or are opposed philosophically to opioids for non-cancer pain treatment.”

The only professional medical organization the GAO did consult with, the American Society of Interventional Pain Physicians, represents doctors who typically specialize in spinal injections and surgery.

The GAO’s Elizabeth Curda downplayed the role of people who were interviewed, telling PNN they were “not a major part of our methodology” in preparing the report.

Pain patients and pain management experts are often excluded or ignored when federal decisions are made about pain care.

The Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians while drafting its 2016 opioid prescribing guideline and secretly holding many of its deliberations.  The CDC also ignored a warning from its own consultant that some doctors stopped prescribing opioids after the guideline was issued.

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in "special session" last year to discuss Medicare's opioid prescribing policies. As PNN reported, major insurers like Aetna, Anthem, Cigna and Humana were invited to attend, but no other stakeholders in pain care were asked to appear or to share their insights.

More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

DEA Tactics Questioned in Tennant Raid

By Roger Chriss, Columnist

Agents with the Drug Enforcement Administration recently raided the offices and home of Dr. Forest Tennant, a prominent pain physician in California. According to an affidavit the DEA filed in support of a search warrant, Dr. Tennant is “profiting from the illicit diversion of controlled substances” and is part of a drug trafficking organization that has “submitted millions of dollars in fraudulent Medicare prescription drug claims.”

Dr. Tennant, who was recently honored with a lifetime achievement award,  has not be charged with a crime and denies doing anything wrong.  He says the DEA is out to smear his reputation and those of other doctors who prescribe opioid pain medication.

The DEA’s mandate includes protecting the public from inappropriate distribution of drugs, including opioids, and securing the supply of all controlled substances. But the DEA’s methods have long been scrutinized and found wanting.

A study from 2008 identified 725 doctors who were charged with offenses involving opioid medication. Of those, about 40 percent were general or family practice physicians, and only 3.5% were board-certified pain specialists.

A 2016 study attempted to quantify the nature of these investigations. Researchers analyzed 100 cases of allegedly improper opioid prescribing and found that most of the physicians were male (88%); over 40 years of age (90%); non-board certified (63%); and nearly all were in small private practices (97%). A little over half of the doctors (54%) were said to have “self-centered personality traits.”

A thorough review of the legal issues involved in improper opioid prescribing came to several important conclusions. First, that the “information available about physician misprescribing is in small supply.” This alone is surprising, since the DEA, as well as the FDA, state medical boards and pharmacies would seem well-equipped to have very granular data about opioid prescribing practices.

Next is the “4D Model” of investigations, which typically group “misprescribers” into four categories: dated, duped, disabled or dishonest. The model emerged in the late 1970s from work by addiction medicine experts, but has been shown to be dysfunctional at best, and arguably even damaging to both pain medicine specialists and chronic pain patients.

In particular, the 4D Model cannot readily be applied to misprescribing because “dishonest” is too vague and narrow. As a result, “for liability to attach to physicians, they must prescribe controlled substances knowingly; without a legitimate medical purpose; and outside the course of professional practice.” As the raid on Dr. Tennant suggests, these criteria are not always satisfied, as his very sick patients will attest.

But the DEA is empowered to investigate as it sees fit. The DEA says the “types of cases in which physicians have been found to have dispensed controlled substances improperly under federal law generally involve facts where the physician’s conduct is not merely of questionable legality, but instead is a glaring example of illegal activity.”

Prosecution of Doctors Increasing

Since 2008 the DEA has been adding agents and resources to its ranks. From the review article, “the squads increased investigations, inspections, and administrative actions significantly” and “the number of criminal malpractice prosecutions in this area has also risen.”

That is having a substantial impact on the world of pain management. Although investigations are certainly warranted in cases like pill mills, rogue doctors, and illegal online pharmacies, most DEA investigations do not result in criminal charges. But even a warning letter from the DEA to one physician at a healthcare facility can have a chilling effect on prescribing practices in the entire facility. Thus, the DEA’s actions can ripple out to chronic pain patients far removed from the target of an investigation.

It is also important to note that DEA investigations and resulting charges are often dismissed. In a blog post  in support of Dr. Tennant, pain management expert Dr. Lynn Webster recounts his own experience with a DEA investigation that was dropped four years after it began.

“The DEA wanted information, but even more, they wanted to exhibit a show of force to intimidate my patients, employees, and me,” said Webster.

In Florida, Dr. Debra Roggow was caught up in a pill mill investigation, mostly based on the amount of opioids she prescribed. Roggow was ultimately acquitted of all charges, but not until her reputation and practice were ruined.

"This has been a horrifying, humbling experience," she said. "I was worried, of course. I knew of my innocence, but innocent people do go to jail."

There is a vast gulf between a legitimate pain specialist like Dr. Tennant and a pill mill.

As Sam Quinones describes in his book Dreamland, “If you see lines of people standing around outside, smoking, people getting pizza delivered, fistfights, and traffic jams—if you see people in pajamas who don’t care what they look like in public, that’s a pill mill.”

Misprescribing opioids is not a well-studied or well-understood problem. This is peculiar, given that it is now 20 years since the start of the opioid crisis. The current 4D Model is flawed, and given the influx of heroin and illicit fentanyl into the country, the DEA does not seem to be fulfilling its mission statement of “reducing the availability of illicit controlled substances on the domestic and international markets.”

The raid on Dr. Tennant’s practice may be part of a legitimate operation, such as the investigation of Insys Therapeutics and its fentanyl product Subsys. But if so, that arguably could have been accomplished without the drama of DEA agents swarming into a small medical practice or breaking into the home of a respected 76-year physician while he and his wife were out of town.

A spirit of cooperation between physicians and law enforcement would go a long way to help pain management specialists and their patients in 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.

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

Can Kratom Be Patented?

By Jane Babin, Guest Columnist

Discussions surrounding kratom are heating up following the Food and Drug Administration’s public health advisory, and questions have appeared about whether kratom and its constituents are patented or could be. 

The short answer is no.

Patents are important tools for protecting investment in innovation.  Without patent protection, far fewer new drugs would be developed.  An alternative is to keep details of an invention secret to ensure that no one will be able to copy it.  However, this approach isn’t possible in the pharmaceutical industry, where regulations require extensive public disclosure. 

To encourage inventors to share details about their inventions, the U.S. grants a patent right to prevent other people from making the same invention for a limited time, in exchange for publicly disclosing the details about the invention.  The public can read patents and apply their disclosures to other situations, which immediately advances science and technology.  After a patent expires, the invention itself can be made by anyone.

Patents Granted for a Limited Time

U.S. Patents 3,256,149 (“Compositions Compromising an Alkaloid of Mitragyna Speciosa and Methods of Using Same”) and 3,324,111 (“Speciofoline, an Alkaloid from Mitragyna Speciosa”), were both granted to Smith Kline & French Laboratories.

FDA Commissioner Scott Gottlieb has ties to GlaxoSmithKline (the successor to Smith Kline & French) and some have suggested a conflict of interest motivated his warning about kratom.

If there is a conflict, it isn't over these patents, which were issued in the 1960's and have long since expired.  Patents are granted for a limited time.  Currently, patents expire 20 years after filing.  Prior to 1995, a patent term was 17 years from the date of issuance.

Products of Nature are Not Patentable

Prior to their expiration, the two patents gave Smith Kline & French the right to prevent others from making, using, selling, and importing certain alkaloids isolated from kratom, but not the whole plant or leaf. 

Plants themselves and other substances found in nature have never been patentable, unless they are changed substantially by an inventor.  In the 1960s, isolating a substance from a plant was considered a substantial change to the substance. Today it isn’t. 

Courts have held that substances found in nature, even in impure form, cannot be patented whether they are isolated from a natural source or synthesized in a lab.  If a chemical has the same structure as a natural substance, it is not patentable.

Derivatives are Patentable

Derivatives of natural chemicals can be patented, however.  As good as a natural chemical may be, changing it slightly may make it even better -- or worse.  Scientists tweak a compound's structure to alter its properties, repurpose it, investigate interactions with other molecules, and design around compounds that are unpatentable. 

Patents have been granted for derivatives of kratom alkaloids, particularly derivatives of mitragynine and 7-hydroxymitragynine (e.g. U.S. Patent Nos. 8,247,428 & 8,648,090), which potentially may become new drugs that are improved over natural alkaloids. 

Even if they are never commercialized, studying how structural changes affect biological activity can lead scientists to modify other compounds to impart similar properties.  For example, making non-addictive kratom derivatives may show scientists ways opioids could be made non-addictive. 

U.S. patent law recognizes the importance of such inquiry and includes an exception under 35 USC §371(e), allowing scientists to use patented inventions in certain types of research.  Unlike scheduling under the Controlled Substances Act, no permission or pre-approval is needed to take advantage of this exception.

Distinguishing a Patent from a Published Application

Another misconception about patents is that every document that looks like a patent is one.  To obtain a patent, an inventor must first file an application, which doesn't become a patent until the Patent Office is satisfied that it meets all legal requirements. Whether granted or not, the application is usually published, and it looks very much like a granted patent. 

There are two ways to distinguish a U.S. patent from an application:

1. U.S. Patents have the words "US Patent" at the top of the first page, while applications have "US Patent Application Publication."
2. Current patents are identified by a 7 digit number.  Published applications numbers have eleven digits beginning with a 4 digit year. For example, 9,458,426 is a US patent, while 2014/0186948 is a published application.

Foreign countries also issue patents and an inventor must obtain a patent in each country where he or she wants to enforce patent rights.  Thus, there may be multiple patents covering the same invention in different countries.  Each country has its own numbering system and may or may not publish applications prior to granting them.  Instead of immediately filing multiple applications in foreign countries, inventors can initially file a single international application with the World International Patent Organization (WIPO) under the Patent Cooperation Treaty (PCT), which can be used as the first step toward patents in many countries.  

Requirements for a Patent and Examination

Applications don't automatically become patents.  They are first examined to see if a patentable invention that meets certain legal criteria is described and claimed.  In addition to claiming patentable subject matter, an invention must be novel, non-obvious, and the application must disclose sufficient description that someone in the field would be able to make and use the invention. 

Examination involves a dialogue between applicant and a patent examiner, often resulting in changes to the claims (the legally enforceable part of a patent).  Some applications are never granted.

US 2010/0209542 is a kratom-related application that is frequently discussed.  It claims a method for treating withdrawal from an addictive substance using a kratom extract.  When this application was first examined, it was rejected because existing literature described kratom itself as being addictive.  The applicant might have overcome this rejection by arguing that kratom is non-addictive or that other addictive substances are used to treat withdrawal.  However, the inventors faced bigger challenges because they didn't actually treat anyone for withdrawal with a kratom extract and described no studies of their own showing the method actually worked. 

Self-treatment using kratom had been reported, but that didn’t help the application because it meant that the applicant was not the first to "invent" the method and the invention was not novel.  Facing an uphill battle, the application was abandoned and never matured into an enforceable patent.

There may be many obstacles on the path to general acceptance of kratom as a beneficial herbal supplement.  Fortunately, patents are not one of them.

Jane Babin, PhD, is a molecular biologist and a biotechnology patent attorney in southern California. Jane has worked as a consultant for the American Kratom Association, a pro-kratom consumer group.

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.