FDA Seeks Shutdown of Stem Cell Clinics

By Pat Anson Editor

The U.S. Food and Drug Administration has stepped up its crackdown on the stem cell industry by filing two complaints in federal court seeking permanent injunctions against stem cell clinics in Florida and California.

US Stem Cell of Sunrise, Florida and California Stem Cell Treatment Center are accused of marketing stem cell products without FDA approval and for “significant deviations” from safety and manufacturing guidelines. Both companies said they would “vigorously defend” themselves and challenge the FDA’s authority to regulate autologous stem cells, which are made from a patient’s own blood or tissue.

The  lawsuits could ultimately decide the fate of hundreds of stem cell clinics that have opened around the country in recent years, offering new therapies for arthritis, neuropathy, degenerative disc disease and other chronic conditions.

“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

In 2015, three elderly women became legally blind after having unapproved stem cell treatments for macular degeneration at US Stem Cell. The clinic was also warned by the FDA last year to stop using adipose tissue (body fat) to make stem cells that were injected into the spinal cords of patients.

The FDA alleges that California Stem Cell Treatment Center – which has clinics in Beverly Hills and Rancho Mirage -- is also using stem cells derived from adipose tissue to treat patients suffering from arthritis, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), diabetes, cancer and other conditions.

“The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors,” the FDA said.

The case against California Stem Cell could have a broad impact because it also targets the Cell Surgical Network Corporation (CSN), which has a chain of about 100 stem cell clinics. At issue in both lawsuits is whether a patient’s own stem cells can be used for therapeutic purposes and are outside the control of federal agencies like the FDA.

“CSN strongly rejects the idea that a person’s own cells should be regulated by FDA as a drug,” Dr. Elliot Lander of CSN and California Stem Cell Treatment Center said in an email to The Niche, a stem cell blog.

“We share FDA’s concern for patient safety, but do not believe that FDA regulation of a surgical procedure that simply harnesses the healing power of a patient’s own cells, without altering the biological characteristics of those cells, is the answer. The decision of whether or not the surgical procedure is performed should be made by the patient and physician – not the FDA or any other arm of the federal government.”

US Stem Cell also released a statement on its website, saying it would “vigorously defend medical freedom of Americans.”

Our Government Is Murdering Its Own Citizens

By Lee Horton, Guest Columnist

I am about to start raising holy hell because I now have nothing to lose. The doctor that has been taking care of me the last 5 years is suddenly scared to death and cutting my pain meds, while my insurance is cutting my benefits and raising my deductible and co-pays.

I live on Social Security disability and a meager pension that leaves me with little extra cash at the end of each month. I can no longer afford to fight both disease, injury and now my government. All of these have become the enemy of good health.

I am no longer "entitled" to my life I guess. Since I'm not a taxpayer thru payroll any longer, they do not see me as having any value to this nation. I have accepted that my only future is to have no future at all.  That's what they have left me with. I'm not good enough, wealthy enough or important enough to save and treat humanely or morally.

I'm being discarded like the trash that my government thinks I am because I have a need for medicines that they are uneducated about and don't understand. 

The whole "Opioid Crisis" is just a massive coverup for our government's inability to stop the flow of illegal drugs that are entering this country by the truckload every stinking day. They are the ones that have failed. They are the people that have gotten us all in trouble. They are the ones that created a "drug problem" in this country.

LEE HORTON

Why is it that almost every other nation on the planet with more liberal drug policies has less of a drug dependence problem?  The answer is quite simple. It is because this country views every problem with a punitive solution. The perspective of our leadership is skewed to make everything appear to be criminal when it’s done by the public, but legitimate when done by the federal government.

We might even be seeing a foreign policy tactic by allowing China to export their drugs for sale in this country. Who the hell knows? Remember the “Fast and Furious” gun scandal, Iran-Contra, Noriega, Afghanistan and the Mujahedin? Point being, this government has done it before.

What I do know is that I'm done. I'll no longer be quiet, and I won't let them get away with murder. That's exactly what they are doing, our government is murdering its own citizens by putting us in the position of either suffering every day of our lives or ending our lives.

And we send these callous, heartless and unimaginative politicians to Washington DC so they can lie and hide the truth from their constituents. If any of those people in DC truly believed that the source of the opiate epidemic was the pharmacy, they would be educating themselves on these drugs and how they also benefit more people than they harm.

But we don't see anyone doing that, do we? We see politicians, department managers, and the heads of the FDA, DEA and other agencies all looking for someone to catch and blame so they can score some points with Congress and get a bigger budget next year.

A good general or military planner always looks for the potential "collateral damage" when putting together a battle plan. The FDA, DEA and Congress have not done that, or they would not have been painting with such a broad brush.

Patients Need to ‘Rise Up’

I'm done with all that BS. I probably only have a few years left, so if I am to have any chance at making any difference and helping anyone that suffers in chronic pain, I must start now.

I have spoken to my doctor about this and he agrees that the patients need to "rise up" and start making noise, and the public needs to be educated and told the truth about the overdose stats the government and media keep listing. The vast majority of opiate-related deaths and overdoses come from heroin, illicit fentanyl, and other illegal street drugs, not the prescription pain meds that they are using as a scapegoat.

This is as good a place as any to start my war on stupidity and ignorance.  I want others to hear why I need these medications that the public is being taught to blame the ills of society on. I have yet to steal a car stereo or rob a liquor store to support my “habit.”  THAT is what the government and the media want the public to imagine when they hear of someone taking opioids.

This is about the health and well being of American citizens that they are placing at risk. It's easy for them to live with collateral damage when it's in Syria or Afghanistan, when they don't have to see the faces and know who and how many they hurt. Let's see if they are still so eager to cause suffering when it's their own people.

All the work and risk by colonists to discover America and build a nation, free from persecution and suppression by a corrupt government -- out the window.  We’re right back where they started. Literally out of the 16th century frying pan and into the 21st century fire.

Is this proof that liberty, freedom and independence are not yet possible for the human race? Are humans insufficiently evolved? When I see deliberate, intentional cruelty and the persecution of anyone, it makes me stop and wonder.

Lee Horton lives in Texas. He has osteoarthritis, neuropathy, stenosis, Ankylosing Spondylitis, fibromyalgia and numerous broken bones due to workplace injuries and accidents. Before he was disabled, Lee worked for 40 years as an operating engineer in heavy construction.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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.

Critics Say DEA Plan Could Worsen Opioid Shortages

By Pat Anson, Editor

Pain sufferers and patient advocates are overwhelming opposed to plans by the U.S. Drug Enforcement Administration to further restrict the supply of opioid medication to punish drug makers that allow too many of their painkillers to be diverted and abused. Health organizations also caution that the proposal could worsen an acute shortage of pain medication in the nation’s hospitals.

Over 1,500 people left public comments in the Federal Register on the DEA’s plan to change the rules governing opioid production quotas. Under the proposal, the DEA could arbitrarily reduce the amount of opioids a company can make -- even if it has no direct role in the diversion or abuse.

"It’s a common sense idea: the more a drug is diverted, the more its production should be limited," said Attorney General Jeff Sessions. 

But critics say the plan will not prevent opioid abuse and will likely harm patients.

“The DEA has no business deciding how much valid medicine can be produced. The doctors prescribing the medicine should dictate the amount. The DEA is going to cause a crisis,” wrote Tina Liles.

“Reducing opiate medication has done nothing to help the rate of overdose deaths in this country because opioid prescriptions are not the issue in this country it is illicit fentanyl and heroin,” said Nicole Garage.

“Limiting access to the only medication that helps to control severe, intractable pain will not stop the crisis; those who abuse or sell drugs illegally have not stopped due to current quotas and will not stop with any new quota reductions,” said James Loranc.

“The logic (behind) this DEA proposal is completely untested, unproven, and unsupportable. The shortages being seen in hospitals and by pain patients will only get worse with further DEA cutbacks, leading to more mistakes, waste, and higher costs, not to mention additional pain,” said Valerie Padgett Hawk, Director of a Coalition of 50 State Pain Advocacy Groups.  

Hospitals Rationing Opioids

The shortages mainly involve injectable opioids such as morphine, hydromorphone and fentanyl, which are used to treat acute pain in patients recovering from surgery or trauma. Hospitals have been forced to ration opioids or use other pain medications that are not as effective.

“With limited availability of some opioids, operations may have to be postponed or cancelled.  In some cases, this could prove life‐threatening to the patient,” wrote Janis Orlowski, MD, Chief Health Care Officer for the Association of American Medical Colleges. “We urge the DEA to remember that opioids are also an important part of treatment regimens for controlling acute and chronic pain in a variety of patients – including trauma, postoperative and patients with advanced stage cancer – and any limits on quotas should not negatively impact access for patients that have a legitimate and critical need for these medications.”  

“Please, I beg you, don't do this. My dear friend Sarah takes painkillers for her rheumatoid arthritis. Even with the medication it's terrible; without it, I have no doubt she'll kill herself. Her mental health is already fragile,” wrote Kelsey Hazzard. “This regulation will destroy her.”  

“For the love of God let the doctors and pharmacists handle prescribing and filling prescriptions and allow the patients and doctors to worry about how much opioid pain medication they need to take. This is none of the DEA’s concern!” wrote Brandon Tull, a disabled police officer who shared the tragic story of Jennifer Adams, a Montana pain patient who recently committed suicide.

“That suicide will probably be the first in a long line if you continue this attack upon innocent chronic pain sufferers!”

The public comment period on the DEA proposal ended May 4th. The public was given only 15 days to comment in the Federal Register on the rule change. Public comment periods are usually between 30 and 60 days long, with some taking up to 180 days. Agencies are allowed to use shorter comment periods "when that can be justified."

"This shortened period for public comment is necessary as an element in addressing the largest drug crisis in the nation's history," the DEA said.

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25% in 2017, followed by a 20% cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Under the proposed rules, the DEA would be required to consult with states, Food and Drug Administration, Centers for Disease Control and Prevention, and the Department of Health and Human Services before setting opioid quotas. The rule change was triggered by a lawsuit filed against the DEA by West Virginia, alleging that the current quota system “unlawfully conflates market demand for dangerous narcotics” with the legitimate needs of pain patients.    

Although overdose deaths from heroin, illicit fentanyl and other street drugs now surpass those from pain medication, the DEA claims prescription opioids are gateway drugs to long-term substance abuse.

“(Opioid) users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers or without cost from the family medicine cabinet or from friends. Once ensnared, dependency on potent and dangerous street drugs may ensue,” the DEA said.

According to the National Institutes of Health (NIH), only about 5 percent of patients taking opioids as directed for a year end up with an addiction problem. And the DEA itself estimates that less than 1% of legally prescribed opioids are diverted.

Rx Drug Monitoring Not Reducing Opioid Abuse

By Pat Anson, Editor

Prescription drug monitoring programs (PDMPs) have long been promoted as a critical tool in the fight against opioid abuse and overdoses. PDMP’s in 49 states and the District of Columbia allow physicians and pharmacists to consult a prescription drug database to see if patients might be “doctor shopping” or selling their opioid medication.

But a new study has found little evidence that PDMPs are working and that they may in fact be driving some patients to the black market for cheaper drugs such as heroin.

Researchers at Columbia University's Mailman School of Public Health and University of California, Davis, analyzed 17 studies that looked at the effectiveness of PDMPs. Their findings are published online in the Annals of Internal Medicine.

“Evidence that PDMP implementation either increases or decreases nonfatal or fatal overdoses is largely insufficient, as is evidence regarding positive associations between specific administrative features and successful programs. Some evidence showed unintended consequences,” wrote lead author David Fink, MPH, a doctoral candidate in epidemiology at the Mailman School of Public Health.

What were those unintended consequences? Three studies that looked at heroin related overdoses found a “statistically significant” increase in heroin deaths after PDMPs were implemented.

"This suggested to us that heroin substitution may have increased after PDMP-inspired restrictions on opioid prescribing," says Silvia Martins, MD, a professor of epidemiology at Mailman and co-senior author. "We therefore caution that programs aimed at reducing prescription opioids should also address the supply and demand of illicit opioids."

Researchers believe that efforts to reduce doctor shopping and the diversion of prescription opioids may have backfired.

“A reduction in black market prescription opioids, although generally viewed as positive, also may generate unanticipated outcomes. For example, an ethnographic study of high-risk users in Philadelphia and San Francisco found that key drivers of the progression from prescription opioid to heroin use are the rising cost of the ‘pill habit’ and heroin’s easy availability and comparatively lower cost,” Fink said.

Heroin overdoses also rose after Purdue Pharma introduced a new and more expensive abuse deterrent formulation of OxyContin in 2010. According to one study, each death that was prevented by OxyContin's reformulation “was replaced with a heroin death.”

Fink and his colleagues say more studies are needed to examine the true effectiveness of PDMPs, which can vary widely from state to state.

Doctor Shopping Rare

Missouri is the lone state that has not adopted a statewide PDMP and one family physician would like to keep it that way.

In an unpublished study, John Lilly, DO, claims that PDMPs are not working because doctor shopping is rare to begin with. In 2016, doctor shopping was responsible for only 1.7% of all misused opioid prescriptions. The rest are stolen, borrowed or bought on the black market, or misused by the patients they were prescribed to.

“The prescription drug monitoring programs will never catch the remaining 98.3 percent of the problem. That is why the death rate has not decreased despite 49 states having an operational PDMP,” Lilly wrote.  “There is now an alternative to prescription drugs that is easier to obtain and more powerful. Illicit fentanyl is now the preferred opioid and the PDMPs have absolutely no effect on its rapid rise. I would not be surprised if prescription opioid deaths start to fall, not due to the effectiveness of the PDMPs, but due to market competition from illicit fentanyl.”

If PDMP's were effective, Lilly says states that have them would see a decline in opioid overdoses. But in 2016, West Virginia had the highest opioid death rate in country -- over three times higher than Missouri's -- which ranked 25th.

Missouri’s Governor ordered the creation of a statewide PDMP last year, but the state legislature has so far resisted efforts to fund it. Critics say it doesn’t give doctors the necessary tools to prevent overprescribing, but allows law enforcement to track and prosecute physicians and pharmacists.  A spokesman for the Missouri State Medical Association called the program a “witch hunt against physicians.”

Walmart to Limit Rx Opioids for Acute Pain

By Pat Anson, Editor

Walmart has announced plans to restrict opioid prescriptions for short-term acute pain to no more than a 7-day supply.

The new policy, which is similar to one already adopted by CVS, will begin “within the next 60 days” and be implemented at all Walmart and Sam’s Club pharmacies in the United States and Puerto Rico.

“We are taking action in the fight against the nation’s opioid epidemic,” Marybeth Hays, executive vice president of Health & Wellness and Consumables for Walmart U.S. said in a statement.

“We are proud to implement these policies and initiatives as we work to create solutions that address this critical issue facing the patients and communities we serve.”

In addition to the 7-day limit on opioids for acute pain, Walmart and Sam’s Club pharmacists will also limit the dose to no more than 50 morphine milligram equivalent (MME) units per day. The company said its policy was “in alignment” with the Centers for Disease Control and Prevention’s opioid guidelines.

However, those 2016 guidelines are voluntary and only intended for primary care physicians who are treating chronic pain. They say nothing at all about pharmacists being required to limit the dose or duration of opioid prescriptions for acute pain:

“When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.”

Several states have already adopted policies that limit opioid prescriptions for acute pain to seven days or less. Walmart said when state law limits prescriptions to less than seven days, Walmart and Sam’s Club pharmacists will follow state law.

The company’s pharmacists will also be trained and required to counsel patients about the CDC’s guidelines, while “focusing on using the lowest effective dose for pain management for the shortest time possible.”

In 2020, Walmart and Sam’s Club will also require e-prescriptions for controlled substances such as opioids. The company said e-prescriptions are less prone to errors, cannot be altered or copied, and are electronically trackable.

By the end of August 2018, Walmart and Sam’s Club pharmacists will also have access to a controlled substance tracking system called NarxCare. NarxCare analyzes a prescription database to provide pharmacists with a patient’s “risk score” for potential drug abuse.

Breakthrough Blood Test Shows the ‘Color of Pain’

By Steve Weakley

A revolutionary new blood test developed by Australian researchers could give doctors instant insight into the severity of chronic pain by identifying colored biomarkers in the blood.  The “painHS” test uses advanced light spectrum analysis to identify the molecular structure of pain in immune cells.

“We are literally quantifying the color of pain,” explains neuroscientist Mark Hutchinson, PhD, a professor at the University of Adelaide Medical School in Australia.  “We’ve now discovered that we can use the natural color of biology to predict the severity of pain. What we’ve found is that persistent chronic pain has a different natural color in immune cells than in a situation where there isn’t persistent pain.”

Hutchinson and his colleagues discovered molecular changes in the immune cells of chronic pain patients. These pain biomarkers can be instantly identified through hyperspectral imaging, giving doctors the ability to measure a patient’s pain tolerance and sensitivity.

The test could potentially provide physicians with the first biology-based test to measure pain as the “5th vital sign” and to justify prescribing pain medication or other therapies.

Hutchinson was quick to point out that the test is not intended replace a patient’s description of pain to their physician.  Pain is subjective and varies from patient to patient, depending on their medical condition and many other factors.  Current tests used to measure pain in adults, such as the sad and smiley faces of the Wong-Baker pain scale, are so simple they were initially developed for young children.

“Self-reporting (by patients) is still going to be key but what this does mean is that those ‘forgotten people’ who are unable to communicate their pain conditions such as babies or people with dementia can now have their condition diagnosed and treated,” said Hutchinson, who believes the test could also revolutionize pain treatment in animals.

“Animals can’t tell us if they’re in pain but here we have a Dr. Doolittle type test that enables us to ‘talk’ to the animals so we can find out if they are experiencing pain and then we can help them."

Hutchinson says the test could also help speed the development of new drugs that could target particular kinds of chronic pain, and could eliminate the need for placebos in clinical trials by giving an instant indicator of a treatment’s effectiveness.

“We now know there is a peripheral cell signal, so we could start designing new types of drugs for new types of cellular therapies that target the peripheral immune system to tackle central nervous system pain,” he explained.

Hutchinson thinks the “painHS” test could be widely available to pain specialists and general practitioners in as little as 18 months and could provide a cost-effective tool to measure the severity of pain in patients with back problems, cancer, fibromyalgia, migraines and other conditions.

Several other blood tests have already been developed to diagnose patients with specific chronic pain conditions such as fibromyalgia.

IQuity Labs recently introduced a blood test that can identify fibromyalgia by analyzing ribonucleic acid (RNA) in blood molecules. EpicGenetics launched the first fibromyalgia blood test in 2013. That test looks for chemokines and cytokines, which are protein molecules produced by white blood cells.

A Pained Life: The Shared Experience

By Carol Levy, Columnist

I'm watching TV. An ad for an eczema drug comes on.

“Sorry, I can’t make it,” a woman says to the person on the other end of a phone call. “It’s just my eczema again. But its fine.”

Later a co-worker asks, “Are you okay?”

As she scratches at her arm, she replies “Eczema. Its fine.”

The commercial is on a lot. Every single time I hear it, I get annoyed and then angry. You're itchy and have a patch or two of dry skin?  So what? It’s not the pain of CRPS or trigeminal neuralgia or another horribly painful condition. Big deal.

Then I catch myself.

I have a small area on my back, about the size of a quarter, right in the unreachable spot. It itches horribly. Sometimes it lasts for a short while, sometimes for days or even weeks. The doc has a name for it, notalgia paresthesia, but naming it is of no help.

There is not much to be done for it. I rub against the door jam, brush it hard with a hairbrush, put on all kinds of salves and ointments. Even the numbing meds don't help.

What if I had this itch in a lot of places on my body? What if I couldn't control not just one area on my back but a bunch of them? It would be unendurable.

I think of all the times I ask myself, the many times so many of us ask: “Why do other people have such a hard time understanding and accepting my pain? What if they could feel it, even if only for a minute?”

It's a good question. It begs an answer. But let's face it. It is unanswerable. Even the cliché “If you could walk in my shoes” never gets us anywhere.

Maybe there is another way. Not the theoretical, but the experiential.

What if we said: “Remember the pain when you broke your arm (or were injured or ill and in pain), how horrible that was? Imagine that pain being with you all the time. Imagine instead of a cast and some pills, there is no way to tame it, no way to know if the pain will ever go away or at least get better?”

Everyone at one time or another has been in our shoes, even if only for a snapshot in time. The shared experience is the cement for so much of life. A reminder of their time in pain time might be the foundation on which acceptance can be built.

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.

Medical Marijuana Reduces Opioid Use in Older Adults

By Pat Anson, Editor

Medical marijuana can significantly reduce pain levels in older adults and reduce their need for opioid pain medication, according to a small study of cannabis users. The findings add to growing -- and sometimes conflicting evidence -- that medical marijuana reduces demand for prescription opioids.

To gauge how effective medical marijuana is at managing chronic pain and reducing opioid use, researchers at Northwell Health, a healthcare network based in New York State, surveyed 138 patients who started using medical marijuana in the previous month. The patients have chronic conditions such as osteoarthritis, spinal stenosis, and chronic hip and knee pain.

The 20-question survey focused on how often they used marijuana, in what form they took it, how much it reduced pain and whether they were able to cut back their use of painkillers.

A month after they started using medical marijuana, most patients reported that their average pain score dropped from 9 (on a scale of 0-10) to a more moderate pain level of 5.6.

Nearly two-thirds said they were able to reduce or stop their use of painkillers, with 27% saying they were able to stop completely. Over 90% said they would recommend medical marijuana to others.

DRUG POLICY ALLIANCE

"My quality of life has increased considerably since starting medical marijuana," one patient said. "I was on opiates for 15 years."

"It (medical marijuana) is extremely effective and has allowed me to function in my work and life again. It has not completely taken away the pain, but allows me to manage it," another patient said.

About 45% of patients said they ingested marijuana using vaporized oil, 28% used pills and 17% used marijuana-laced oil. Most said they used marijuana daily, with 39% using it more than twice a day.

"What I'm seeing in my practice, and what I'm hearing from other providers who are participating in medical marijuana programs, is that their patients are using less opioids," said Diana Martins-Welch, MD, co-author of the study and a physician in the Division of Geriatric and Palliative Medicine at Northwell Health. "I've even gotten some patients completely off opioids."

Research in Israel also found that cannabis can significantly reduce chronic pain in elderly patients. But the evidence is less certain that it reduces opioid use.   

A recent study of Medicare and Medicaid patients found that prescriptions for morphine, hydrocodone and fentanyl dropped in states with medical marijuana laws, but daily doses for oxycodone increased. A second study found nearly a 6% decline in opioid prescribing to Medicaid patients in states with medical marijuana laws.  Both studies were conducted during a period when nationwide opioid prescribing was in decline.

A recent study by the RAND corporation found little evidence that states with medical marijuana laws experience reductions in the volume of legally prescribed opioids. RAND researchers believe some pain patients may be experimenting with marijuana, but their numbers are not large enough to have a significant impact on prescribing. 

Despite the uncertainty of the evidence, the Illinois Senate recently passed legislation that would expand the state’s medical marijuana program by allowing doctors to prescribe marijuana to any patient who is prescribed opioid medication.  The idea is to get patients off opioids before they become addicted or dependent on the drugs.

"We know that medical cannabis is a safe alternative treatment for the same conditions for which opioids are prescribed," said Sen. Don Harmon, the bills’ sponsor. "This legislation aims to stop dependence before it begins by providing an immediate alternative."

Although 29 states and the District of Columbia have legalized medical marijuana and a handful of states allow its recreational use, marijuana remains illegal under federal law.

Study Finds Opioid Medication Effective for Chronic Pain

By Pat Anson, Editor

Opioids have been used for thousands of years to provide relief from pain. But are they an effective treatment? Are they worth the risk of addiction? And do they improve quality of life?

Millions of chronic pain patients who use prescription opioids so that they can work, sleep, bathe and do simple household chores would quickly answer “Yes” to those questions.

But that’s a radical concept in an age of anti-opioid hysteria and propaganda. Prominent anti-opioid activists insist that “opioids are ineffective or can worsen both the pain and the long-term outcome." And the CDC's opioid prescribing guideline tells us there is “insufficient evidence to determine long-term benefits of opioid therapy for chronic pain.”  

Except now there’s a review that says opioids are effective and the evidence was there all along.

Researchers at Brown University and Tufts University School of Medicine analyzed 15 clinical studies performed for the Food and Drug Administration that looked at the effectiveness of opioids in treating chronic non-cancer pain. Their findings were just published in the Journal of Pain Research.

“The recent claims that opioids lack efficacy for chronic pain have created controversy among physicians, prescribers, regulators, scientists, and the general public,” wrote lead author Nathaniel Katz, MD, president of Analgesic Solutions and a professor of anesthesia at Tufts University.

“This review was, therefore, performed in order to gather together the key evidence to facilitate understanding opioid efficacy within the paradigm of FDA studies required for approval, and to perform a meta-analysis in order to quantify opioid efficacy for chronic pain.”

‘Ample Evidence’ Opioids Work

The authors are careful to note that they did not try to study or minimize the risks of opioids but were simply trying to reach “an accurate assessment of their benefits.” The 15 placebo controlled studies they reviewed evaluated the effectiveness of hydrocodone, oxycodone, tramadol and other opioids for up to 3 months.

What did they find?

“There is an ample evidence base supporting the efficacy of opioid analgesics for at least 3 months’ duration,” Katz wrote. “This evidence base is at least as large as that for any other class of analgesics, and analysis of responders demonstrates clinically meaningful improvements.”

Nearly two-thirds of the patients (63%) who participated in the 15 studies demonstrated “a clinically meaningful response” to opioids as a treatment for chronic pain. Their physical function only improved marginally, and researchers say there was no positive or negative effect on the patients’ mood. Interestingly, adverse effects were similar in the patients who took opioids and those who were given placebos.  

In short, the authors found no reason to abandon opioids as a treatment for chronic pain.

“While the effectiveness of existing treatments for chronic pain leaves plenty of room for improvement, and considering that only a small minority of patients do not experience clinically meaningful treatment response, discarding all analgesics approved for chronic pain contradicts numerous treatment guidelines, international treatment guidelines, widespread patients experience, and the FDA approval process,” they wrote.   

Critics will no doubt question why the authors only reviewed studies that lasted 3 months or less. The answer is that high quality, placebo controlled studies longer than that simply don’t exist. Long term safety and efficacy studies are not required for a drug to get FDA approval -- which is why many anti-opioid activists and the CDC claim there is “no evidence” or "insufficient evidence" that opioids work long-term. It's also a misleading statement, because non-opioid pain medications and alternative treatments are not studied for long periods either.   

“The reason for the 3 months isn't because there aren't good studies that go beyond 3 months but that 3 months is the period of time the FDA requires for efficacy studies.  It is the regulatory standard for assessing long-term efficacy of placebo-controlled studies in chronic pain conditions,” explains pain management expert Lynn Webster, MD, who is vice president of Scientific Affairs at PRA Health Sciences. 

Webster says there are technical and ethical reasons researchers do not conduct longer studies of analgesics.

“It is very difficult to conduct longer studies that are placebo controlled because of the number of dropouts in the placebo arm and the ethical concerns of denying patients access to treatment," he told PNN. "It is true there aren't placebo-controlled studies longer than 3 months but there are extended open label studies that are 12 months.  As the article states, these extension studies show the efficacy (of opioids) is maintained.”  

Katz and his colleagues have worked as consultants to Endo, Pfizer, Purdue Pharma and other opioid makers, which they disclose in their article. Funding for the study was provided by Analgesic Solutions and several pharmaceutical companies.

Broader Public Health Campaign Needed for Drug Crisis

By Pat Anson, Editor

Overdose deaths in the United States involving illicit fentanyl and other synthetic opioids have surpassed those linked to prescription opioids, according to new research published in JAMA.  Researchers say drugs used to treat depression and anxiety are also involved in more overdoses than opioid pain medication.

The study by researchers at the Substance Abuse and Mental Health Services Administration (SAMHSA) mirrors a similar report released by the CDC in March. The findings further demonstrate how federal and state efforts to combat the overdose crisis are wrongly focused on prescription pain medication as the primary cause of the overdose crisis.

“These findings underscore the rapidly increasing involvement of synthetic opioids in the drug overdose epidemic and in recent increases in overdose deaths involving illicit and psychotherapeutic drugs," wrote lead author Christopher Jones, PharmD, SAMHSA.

“Lack of awareness about synthetic opioid potency, variability, availability, and increasing adulteration of the illicit drug supply poses substantial risks to individual and public health. Widespread public health messaging is needed.”

Over 19,400 overdoses were linked to synthetic opioids in 2016, while 17,087 deaths involved opioid pain medication.

Synthetic opioids such as fentanyl are far more potent than other opioids such as oxycodone. Fentanyl is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is often mixed with heroin and cocaine or used in the manufacture of counterfeit medication. It is assumed that illicit fentanyl and its chemical cousins account for the vast majority of deaths caused by synthetic opioids.  

Another key finding of the SAMHSA study is that psychotherapeutic drugs used to treat depression, anxiety and other mental disorders are now involved in more overdoses than any other class of medication. They include antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall.

DRUGS INVOLVED IN 2016 OVERDOSES

Over 25,000 overdoses in 2016 involved psychotherapeutic drugs.

That compares to nearly 13,900 deaths linked to the medications in 2010, an increase of 45 percent.

"I think what you're seeing in the data in the last couple of years is that the illicit drug supply has become substantially more dangerous than it has been, and there's this level of unpredictability and lack of awareness of what are exactly the substances that people are using that are contributing to the overdose risk," Jones told Medscape.

That lack of awareness is due in part to poorly designed public health messaging. For example, last year the CDC launched a public relations campaign in 14 states that focused exclusively on warning of the risks associated with prescription opioids. Fentanyl, heroin and other drugs commonly involved in overdoses are not addressed in the Rx Awareness campaign because the CDC didn't want to risk “diluting” its primary message.

“Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging,” the CDC said.  

SAMHSA researchers say nearly 80 percent of the synthetic opioid overdoses in 2016 involved multiple drugs, indicating that many of the decedents are abusing a wide variety of substances. The most commonly involved drugs were another opioid (48%), heroin (48%), cocaine (22%), prescription opioids (21%), benzodiazepines (17%), alcohol (11%), psychostimulants (5%) and antidepressants (5%).

About 20 percent of the death certificates did not specify the type of drug involved, so the number of reported overdoses are likely underestimated.

Medical Marijuana Offers Little Benefit for Acute Pain

By Roger Chriss, Columnist

Colorado lawmakers are considering a bill that would let doctors recommend cannabis for short-lived acute pain. According to the Denver Post, the bill would allow doctors to recommend marijuana for any condition “for which a physician could prescribe an opiate for pain.”

State law currently allows Colorado doctors to recommend marijuana for nine long term medical conditions, including severe chronic pain. But Dr. Larry Wolk, the executive director of the Colorado Department of Public Health and Environment, cautioned that there isn’t enough evidence to support marijuana’s use for acute pain.

“We’re not set up … for this acute pain situation,” Wolk said at a hearing. “This would last maybe three days to a week. But, when you receive a (medical marijuana) card, it’s good for a year.”

Cannabis is one of the most studied substances in the world, but many basic questions about its medical use remain unexplored. Research has found that cannabis doesn’t work well for acute pain.

In 2008, Dr. Birgit Kraft led a small study of cannabis for acute inflammatory pain. Kraft used a double-blind, crossover protocol on 18 healthy female volunteers, evoking pain in several ways and treating it orally with a cannabis extract. It did nothing to reduce acute pain and may have increased it in some subjects.

"The surprising result of our study was the absence of any kind of analgesic activity of THC-standardized cannabis extract on experimentally induced pain using well-established human model procedures,” Kraft said in an interview with Science Daily. “Our results also seem to support the impression that high doses of cannabinoids may even cause increased sensitivity in certain pain conditions.”

A similar study with a more limited scope was performed in 2007 using smoked cannabis. In a randomized, double-blind, placebo-controlled, crossover study with 15 healthy volunteers, researchers tested sensitivity to capsaicin-induced pain. They concluded that there was a "window of modest analgesia for smoked cannabis, with lower doses decreasing pain and higher doses increasing pain.”

In other words, the best cannabis could muster was a mild benefit if a person could manage to hit a sweet spot between too little and too much.

A clinical study in 2006 on cannabis for post-surgical pain did not go so well. Researchers in Berlin used Cannador (a cannabis plant extract) on patients after surgery. None of the patients was able to achieve sufficient pain relief at any dose of Cannador. Several experienced significant side effects, including sedation and nausea. Importantly, the study had to be halted because of a severe adverse event in one patient.

And a 2018 study on “the good, the bad, and the ugly” about medical cannabis came to this conclusion: “Cannabinoids appear to be most effective in controlling neuropathic pain, allodynia, medication-rebound headache, and chronic noncancer pain, but do not seem to offer any advantage over nonopioid analgesics for acute pain.”

There is thus little evidence to suggest that cannabis may be useful for acute, short-lived pain. Instead, the available research points to nontrivial risks, including the possibility of increased pain and adverse reactions.

Better Options Available

Moreover, there are a wide variety of options for treating acute pain, from ibuprofen and other NSAIDs to acetaminophen, topical analgesics, lidocaine and other local anesthetics, and ultrasound therapy. It is more than a bit puzzling that Colorado would be seeking to replace opioids with cannabis when so many well-established options are readily available for acute pain.

For instance, the Journal of the American Dental Association published an analysis of the benefits and risks of analgesic medications in the management of acute dental pain. Results showed that ibuprofen plus acetaminophen offered the best outcome, with acetaminophen with oxycodone and diclofenac, ketoprofen, and difunisal also giving good results. The article concludes that the risks of opioid analgesics, in particular for children and adolescents, can be minimized by medically appropriate use of NSAIDs and acetaminophen.

Furthermore, cannabis does have side effects and risks. Some people do not tolerate it well, and cannabis use disorder reportedly develops in 9% or more of people who use it. Even CBD oil, arguably the safest form of cannabis, has side effects that include fatigue, diarrhea, and possible effects on liver enzymes.

Untreated or undertreated pain has significant clinical consequences, from impeding appropriate diagnostic testing and evaluation to impacting follow-up care and recovery. There are already reliable and effective options for acute and short-term pain management, with fewer risks and side effects than cannabis, few issues with misuse or abuse, and no legal conflicts between federal and state law.

Cannabis has important medical benefits, from controlling chemotherapy-induced nausea and reducing seizures in childhood epilepsy to helping with some chronic pain conditions. But the available evidence does not support cannabis for the management of short-lived acute pain.

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.

Death of Pain Patient Blamed on DEA Raid

By Pat Anson, Editor

The Montana pain community is in mourning over the tragic death of Jennifer Adams, a 41-year old Helena woman who suffered from intractable chronic pain. The Lewis and Clark County coroner has not yet released a cause of death, but friends say Adams died from a self-inflicted gunshot wound April 25.

Adams, a former police officer and mother of an 11-year old boy, lived with severe back pain from Reflex Sympathetic Dystrophy (RSD) and arachnoiditis, two painful and incurable diseases in her spine.

Friends say in her final months Adams suffered from extreme anxiety – fearing that her relatively high dose of opioid pain medication would be reduced or stopped by doctors.

“Jennifer had horrible anxiety that was eating her alive,” says Kate Lamport, a close friend who also has arachnoiditis. “She hadn’t lost her meds. But the fear of it drove her crazy. Every day she was so afraid.

“She was beautiful, inside and out. Her little boy was her everything. And I know she felt like the walls were just closing around her.”

Adams was a patient of Dr. Forest Tennant, a prominent California pain physician, whose home and office were raided last November by agents with the Drug Enforcement Administration. A DEA search warrant alleged that Tennant must be running a drug trafficking organization because many of his patients came from out-of-state and were on high doses of opioid medication.

JENNIFER ADAMS

Tennant, who has not been charged with a crime and denies any wrongdoing, recently announced plans to retire and close his clinic, in part because of the DEA investigation. Tennant is a revered figure in the pain community because of his willingness to see patients like Adams who have intractable pain from rare diseases like arachnoiditis.

“She’s a patient I saw in consultation. She was on a very good (pain) regimen, had a very good nurse practitioner and had good support,” said Tennant. “It’s a tragic situation. She was a lovely person. She was ill, no question about it.”

Several of Adams’ friends and fellow patients told PNN that the DEA raid frightened her. Like many others in the pain community, Adams feared losing access to opioid medication because many doctors have cut back on prescribing or stopped treating pain altogether.  

KATE LAMPORT AND JENNIFER ADAMS

“There’s more (suicides) coming. I don’t know how many people I’ve talked to that have a backup plan. We are the unintended consequences of the DEA’s actions,” said Lamport.

“Every day you get online and there’s another chronic pain patient that took their life. There’s another 20 that lost their medication. And she knew she couldn’t be a mom or work without it. And she didn’t want to be a burden. She was very prideful.”

“Before the raid she was very positive, keep fighting, that type of attitude. And the last couple of months she hasn't really been talking to anyone really consistently like she was,” said Heather Ramsdell. “I would characterize her mood as somber and scared with what's going on in this world and with her pain progressing, worrying about care.”

“She did not deserve to die. It’s just ridiculous. An entirely preventable loss of life. I think she was just totally freaked out over what was happening,” said Gary Snook. “We’re not drug addicts. We’re just sick people.”

“I think that Jennifer is collateral damage in that heinous DEA raid on Dr. Tennant,” says Dr. Mark Ibsen, a Helena physician who used to treat Adams. “We have a way to prevent these suicides and we’re completely ignoring it. Treating the patients in pain would prevent these suicides.”

Tennant does not believe Adams’ death is connected to the DEA raid.

“People who want to make that claim, that’s just simply false,” Tennant told PNN. “I think she was upset by the raid, like a lot of people, but I don’t believe you can make any assumption that there’s any connection.

“People have a lot of complaints about the government, but I think in this case and I want to make it abundantly clear, there is no connection to her pain care, her practitioners, or the DEA. This appears to be an independent, random event in a state that’s got a very, very high suicide rate.”

Adams’ last appointment with Tennant was in January. He said she was responding well to treatment and did not have a return appointment.

‘Disgusted’ by DEA Search Warrant

PNN has obtained a copy of an email that Adams sent to one of Tennant’s lawyers. Adams wrote that she was “truly disgusted” by the DEA raid and the allegations made against Tennant. Her patient records were among those seized by DEA agents. The search warrant claimed patients must be selling their opioid medication and funneling the profits back to Tennant. 

“My intention was and is to let you know a bit about myself and let you know that I am truly disgusted after reading the search warrant. I am NOT a drug dealer! I am not part of a drug cartel. I do not provide kickbacks to Dr. Tennant and I do not share my prescriptions. This whole situation has turned my life upside down once again,” Adams wrote. 

“It needs to stop. Legally speaking, someone has got to put an end to this obscene attack on patients with intractable pain, in particular; Adhesive Arachnoiditis.”

Adams said she developed adhesive arachnoiditis – a chronic inflammation of spinal nerves that causes them to stick together – after a failed back surgery and dozens of failed epidural injections. She also suffered a stroke during the birth of her son because of a botched epidural.

Before her career in law enforcement was cut short by chronic pain, Adams was a police officer in Helena and the first female deputy in Rosebud County, Montana.  She graduated third in her class at the Montana Law Enforcement Academy.

She was proud of her career and felt the DEA raid unfairly stigmatized her and other Tennant patients. 

“I also have had all my accomplishments stained!” she wrote. “I have had to fight day after day to survive the devastation of this ever-changing disease! Please do not dismiss me.”

Donations to a college trust fund for Jennifer's son, Joshua "Tuff" Adams, can be made to First Interstate Bank, 3401 N. Montana Avenue, Helena, MT 59602. You can also call the bank at (406) 457-7171.

Can a Junk Food Diet Cause Osteoarthritis?

By Steve Weakley

Does what’s in your gut influence the pain in your knees? New research on mice at the University of Rochester Medical School suggests that it might, but the results are far from conclusive.

Researchers fed one group of laboratory mice a high fat diet that included red meat and milkshakes, and another group of mice a healthier low-fat diet. Both groups of mice had their knees surgically damaged to mimic the effects of osteoarthritis -- “wear and tear” arthritis that is often associated with age, obesity or injury.

Twelve weeks of the high fat diet made the mice obese and diabetic and led to more seriously damaged joints. It also created an imbalance of harmful bacteria in their digestive tracts. 

One group of the fat mice were then given a supplement containing the prebiotic fiber oligofructose (also available as an over-the-counter probiotic).  The researchers said the supplement did not cause the mice to lose weight, but it did greatly improve their blood sugar levels and the balance of healthy bacteria in their gut.  More importantly, the study concludes, the mice that were given the supplement also had healthier joints than the control group.

The University of Rochester study concluded that prebiotics and the correction of gut bacteria might help protect against osteoarthritis caused by obesity. And one of the researchers, Dr. Robert Mooney, told Forbes that the study suggests osteoarthritis may be accelerated or even caused by inflammation.

"That reinforces the idea that osteoarthritis is another secondary complication of obesity--just like diabetes, heart disease, and stroke, which all have inflammation as part of their cause," said Mooney. "Perhaps, they all share a similar root, and the microbiome (digestive bacteria) might be that common root."

However a critique by Britain’s National Health Service (NHS) said that conclusion might be premature.

“It's presumptuous to conclude that an imbalance of gut bacteria could be directly linked to risk of osteoarthritis in humans from the results of a study in mice with artificially induced knee damage. As such, there's no compelling evidence that prebiotics would prevent or reverse osteoarthritis,” the NHS said.

“Aiming for a healthy weight through a good diet combined with physical activity is a better strategy for reducing the risk of osteoarthritis (as well as many other long-term conditions) than taking prebiotics to try to combat the effects of a poor diet. “

Osteoarthritis is a joint disorder that leads to progressive joint damage. It can affect any joint in the body but is most commonly felt in weight bearing joints such as the knees and hips. Nearly 40 percent of Americans over the age of 45 have some degree of knee osteoarthritis.

Previous studies have also found a link between a high fat diet and osteoarthritis.  Australian researchers reported last year that a diet rich in animal fats, butter and palm oil weakens cartilage and produces osteoarthritis-like changes in the knee.

"We also found changes in the bone under the cartilage on a diet rich in saturated fat," said Professor Yin Xiao of Queensland University of Technology’s Institute of Health and Biomedical Innovation. "Our findings suggest that it's not wear and tear but diet that has a lot to do with the onset of osteoarthritis.”

The University of Rochester researchers hope to include humans in future studies on the effects of diet on osteoarthritis.

Is Addiction or Untreated Pain Causing Patient Suicides?

By Pat Anson, Editor

A new op/ed in The New England Journal of Medicine focuses on an aspect of the overdose crisis that’s rarely discussed – how opioids are a “silent contributor” to the nation’s rising suicide rate. But critics say the article misses the mark on why a growing number of pain patients are having suicidal thoughts and taking their own lives.

Most people already know that drug overdoses are soaring in the United States, but few recognize that suicides are at their highest level in nearly 30 years. In 2016, more Americans died from suicides (44,965) than from opioid overdoses (42,249).

“The significant increases in both opioid-overdose deaths and suicide rates in our country have contributed to reduced life expectancy for Americans. These two epidemics are intermingled, and solutions to address the opioid crisis require that we tailor interventions to preventing opioid-overdose deaths due to suicidal intent,” wrote co-authors Maria Oquendo, MD, and Nora Volkow, MD.

Volkow is the longtime director of the National Institute on Drug Abuse, while Oquendo is a Professor of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania and past president of the American Psychiatric Association.

Volkow and Oquendo believe many suicides are misreported as “undetermined” or accidental drug overdoses, and that “the true proportion of suicides among opioid-overdose deaths is somewhere between 20% and 30%, but it could be even higher.”

They also engage in a familiar pattern of demonizing opioid pain medication, citing studies showing that patients with “opioid use disorder” (OUD) from prescription opioids are more likely to have suicidal thoughts and “whose motivation to live might be eroded by addiction.” 

“Notably, two populations that are more likely than others to receive opioid prescriptions — patients with chronic pain and those with mood disorders — are also at greater risk for suicide,” they wrote.

That may all be true. The suicide rate among chronic pain patients is probably increasing. But what’s puzzling is that Volkow and Oquendo never acknowledge the role that the federal government has played in contributing to that trend. Anecdotal evidence is building that suicides started climbing after the CDC released its 2016 opioid prescribing guidelines and pain medication became harder to get. 

"Over the last year, I have received wave after wave of reports of traumatized patients, with outcomes that include suicidal ideation, medical deterioration, rupture of the primary care relationship, overdose to licit or illicit substances, and often enough, suicide,” Stefan Kertesz, MD, a professor of medicine at the University of Alabama at Birmingham School of Medicine, recently told PNN.

Those suicides -- such as those of Bryan Spece and Jay Lawrence -- are rarely reported by the mainstream media or even acknowledged by government bureaucrats like Volkow, who was an early supporter of the CDC guidelines.

In a survey of over 3,100 pain patients on the one-year anniversary of the guidelines, over 40 percent told PNN they had considered suicide because their pain was poorly treated. Many patients feel the healthcare system has turned its back on them.

“Even though I can barely function my doctor wants to stop my meds completely. With no hope, suicide seems like the best and only choice to get relief from the pain. I never thought doctors would be so uncaring, along with the government,” wrote one patient.

“I never thought I would even consider suicide, but death looks good when every move you make is painful, 24 hours a day, 7 days a week. The guidelines are not fair to me, my husband, and my children. No one can judge anyone else's pain level,” said another patient.

“I frequently contemplate suicide. I lay in bed on many nights crying because there is no comfortable positions and the spasms are relentless,” said a disabled nurse in Maine who is no longer able to obtain opioids.

“In the past year, six chronic patients I know who were no longer able to get their pain medication have committed suicide. I personally have researched the quickest and surest way of ending my own life. And no, it doesn’t include opioids,” wrote another patient.

“I nearly committee suicide last summer and again last November because of undertreated pain,” said one woman. “It is ridiculous beyond belief when my neighbor’s dog gets prescribed pain meds for a torn claw and I get treated like a criminal for having a chronic pain condition.”

Undertreated Pain

Patient advocates say these suicidal thoughts are often not the result of addiction or OUD, but because chronic pain is increasingly untreated or undertreated.

“The diagnosis of OUD is overwhelmingly made by physicians who are untrained in making the diagnosis,” says Stephen Nadeau, MD, a Professor of Neurology and Clinical Health Psychology at the University of Florida College of Medicine. “Most patients in chronic pain are under-dosed and/or suffer from inadequately treated depression. We don’t know the exact figures on prevalence of under-dosing but we do have studies that suggest that depression is detected only 20% of the time.”

“There is emerging data to suggest that increasing numbers of opioid overdose-related deaths may be a consequence of undertreatment of both pain and depression.  But the dominant public narrative is demanding even less treatment of pain when opioids are the chosen therapy,” says Red Lawhern, PhD, co-founder of the Alliance for the Treatment of Intractable Pain, a patient advocacy group.    

Lawhern believes many suicides can be attributed to the “epidemic of despair” first documented by Princeton researchers Anne Case and Angus Deaton.  They believe that the reduced life expectancy of Americans is not just due to substance abuse, but linked to unemployment, poor finances, lack of education, divorce, depression and loss of social connections – issues that Volkow and Oquendo fail to address.

“Their article is seriously deficient for failure to mention that both substance abuse and suicide generally are closely associated with depression and isolation -- both of which are consequences of economic hard times.  It is simply wrong to imply that opioid use disorder (itself an incorrect term) is the ‘cause’ of suicide, when both are driven jointly by socio-economic factors,” Lawhern wrote in an email.

What can be done to prevent suicides in the pain community? Volkow and Oquendo say more doctors should be trained to recognize the warning signs of suicide and patients should be screened for suicide risk and then referred for addiction treatment. Nowhere do they suggest better pain management.   

Counterfeit Pill Problem ‘Getting Worse by the Day’

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 22 states, according to a new report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy and healthcare organizations. Counterfeit pills laced with fentanyl have now been found from coast to coast in 43 states.

“This updated report shows that the illegally-imported fentanyl problem is getting worse by the day,” said Dr. Marvin Shepherd, chairman of the PSM Board.

Fentanyl is 100 times more potent than morphine. It is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is typically mixed with heroin or cocaine. Rogue manufacturers also press it into counterfeit prescription pills such as Vicodin, Percocet and Xanax.

Unsuspecting buyers – including pain sufferers looking for relief -- often have no idea what they’re getting.

According to a recent CDC report, drug deaths involving fentanyl (19,413) surpassed overdoses linked to prescription opioids (17,087) in 2016.

COUNTERFEIT PERCOCET

“The annual count of overdose deaths from prescription opioids has remained constant since 2011, but deaths from fentanyl poisoning have spiked since then. As fentanyl-laced pills mimicking legitimate medication have flooded the illicit drugs supply, prescription drug users have been poisoned by the counterfeits,” the PSM report found. 

“The tally of deaths because of counterfeit pills made with fentanyl is probably undercounted because lab protocols lagged behind this shift and weren’t testing for fentanyl.”

The pills are difficult to trace, as Minnesota prosecutors admitted last week when they announced that no criminal charges would be filed in the accidental overdose death of Prince. The music icon died two years ago after taking counterfeit painkillers that were “an exact imitation” of Vicodin.

“Prince thought he was taking Vicodin and not fentanyl,” said Carver County Attorney Mark Metz, adding that dozens of counterfeit pills were found in Prince’s home, many of them stored in aspirin bottles.

Investigators were unable to determine how or where Prince obtained the fake pills, but they are readily available online for anyone who cares to look. According to one report, there are as many as 35,000 online pharmacies operating worldwide. Many do not require a prescription and are selling counterfeit medications. Their customers include some pain patients who are no longer able to obtain opioids legally from doctors and are looking for other sources.

‘Criminals Are Pretty Smart’

“They’re looking, maybe innocuously, for medicine online. They’re searching for ‘fentanyl online’ or ‘Percocet buy.’  Not because they want to buy medicine on the Internet, but rather they just want to find medicine,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies, an industry supported non-profit.

“The criminals are pretty smart. They know that there’s a market out there and they know they can offer these medicines to patients for good reasons, bad reasons or otherwise that are looking for those medicines. And they are going to get duped because they are very likely buying from a website that is selling it illegally.”

The National Association of Boards of Pharmacy recently evaluated 100 websites selling medications and found that almost all were operating illegally and selling drugs without a prescription. Over half (54%) were selling controlled substances and 40% were offering drugs that are frequently counterfeited with fentanyl.

The marketing and selling of counterfeit medicine goes beyond just online pharmacies. Drug dealers are increasingly using Facebook, Twitter and message boards to reach customers. PNN recently received this sales pitch from one dealer:

"We have pharmaceutical drugs for your health illness especially for Chronic Pain, Anxiety, Depression, Panic Disorder. ADHD, Xanax Bars, Narcolepsy pills, Antidepressants, Antipsychotics, Benzodiazepines, Narcotics, Opiates, weight loss/fat burner. We do overnight secure shipping."

Warning unsuspecting buyers about the easy availability of these drugs poses a dilemma for law enforcement and policy makers.

“We have ethical tension around all of this. On the one hand, we certainly don’t want to be educating people that you can buy controlled substances or prescription drugs on the Internet without a prescription, counterfeit or otherwise. That’s just dangerous. But we also don’t want to be in a position of not warning them or not making a policy response to the fact that this currently exists,” Baney told PNN.

It is relatively easy to tell the difference between a legitimate online pharmacy and an illegal one. The URL’s for websites that end with “.Pharmacy” (not .com or .net) are certified by the National Association of Boards of Pharmacy and are in compliance with laws and practice standards. You can also visit buysaferx.pharmacy to verify whether a website is legitimate.