Researchers Urge Caution on Ketamine Infusions

By Pat Anson, PNN Editor

With many chronic pain patients losing access to opioid medication, some are turning to ketamine as an alternative. Ketamine is approved by the FDA for depression, anesthesia and post-surgical acute pain, but a growing number of clinics provide off-label infusions of ketamine to treat difficult chronic pain conditions such as Complex Regional Pain Syndrome (CRPS).

Researchers at Duke University say doctors and pain patients should be cautious in their use of ketamine. In a study of nearly 300 patients who received ketamine infusions, over a third reported significant side effects such as hallucinations and visual disturbances.

The study findings were presented this week at the annual meeting of the American Society of Anesthesiologists (ASA).

"Despite the U.S. Food and Drug Administration's approval of ketamine for multiple uses, including general anesthesia and treatment of depression, the effects of using the drug at low doses to treat pain have not been extensively studied," said lead author Padma Gulur, MD, a  member of ASA's Committee on Pain Medicine and a professor of anesthesiology at Duke.

"Our research aimed to determine both short- and long-term side effects of low dose ketamine when used for pain treatment."

Gulur and her colleagues found 20 percent of the pain patients who used ketamine alone had side effects, while 15% experienced side effects from using ketamine in combination with other drugs.

Side effects directly linked to ketamine include hallucinations, vivid dreams, out-of-body experiences and unusual thoughts; while those who used ketamine and other drugs experienced sedation, visual disturbances and urinary dysfunction.

"More than one in three patients reported significant side effects from ketamine infusions that required ongoing monitoring or resulted in discontinuation of therapy. More research on the impact of ketamine use for pain on the population is needed," said Gulur.

Guidelines from the ASA, the American Society of Regional Anesthesia and Pain Medicine, and the American Academy of Pain Medicine only support ketamine infusions for CRPS and short-term acute pain. There is weak or no evidence from clinical trials to support ketamine infusions for spinal cord injury pain, neuropathic pain, phantom limb pain, postherpetic neuralgia, fibromyalgia, cancer pain, ischemic pain, migraine headache or low back pain.

“Excluding CRPS, there was no evidence supporting ketamine infusions for intermediate or long-term improvements in pain," the guidelines warn.

The FDA recently approved a ketamine-based nasal spray to treat depression, even though 2 out of 3 short term trials failed to prove its effectiveness. The Spravato nasal spray was effective in a longer trial, but only when taken with a conventional antidepressant.

Because of the risk of abuse and side effects, Spravato can only be administered in a doctor’s office, where patients can be observed for two hours after taking a dose. A single dose will cost about $900. Spravato is not recommended for pain.

There is some debate in the medical community about whether ketamine is an opioid, because it acts on opioid receptors in the brain. Stanford researchers urge caution about the long-term use of ketamine until more can be learned about possible side effects such as addiction. Some depressed patients taken off ketamine have shown signs of withdrawal and became suicidal.  

A recent review of ketamine found that it was a “superb drug” for short-term medical procedures that require anesthesia and was relatively safe as a treatment for chronic pain.

“There is a wealth of evidence indicating the value of ketamine in the treatment of severe pain including conditions such as trauma, fractures, abdominal and flank pain, low back pain, and extremity pain,” said lead author Jorge Palacios, MD, an anesthesiologist at Kaweah Delta Medical Center in Visalia, CA.  

“It is safe and effective to use in combination with injectable nonsteroidal pain medications as well as opioids and has gained greater acceptance as concern has grown with regard to opioid use.”

More Bad Data on Rx Opioids from Health Canada

By Marvin Ross, PNN Contributor

Canadian health officials are still blaming opioid prescriptions for Canada’s overdose crisis. A new report by the Canadian Institute for Health Information (CIHI) that was funded by Health Canada points out that more than 9,000 people died from opioid-related overdoses between January 2016 and June 2018.

“While many of these harms may be due to the use of illicit opioids, such as heroin or fentanyl, prescription opioids are also contributing to the public health issue,” the CIHI report found.

The data the report presents shows significant declines in opioid prescribing, but no evidence that prescriptions are to blame for the overdoses.

For example, the total quantity of opioids prescribed in Canada between 2016 and 2017 dropped more than 10 percent, while the number of prescriptions fell more than 400,000.

From 2013 to 2018, there was an 8% decrease in the number of people prescribed opioids.

Fewer Canadians are taking opioids long-term and the number on daily doses over 50 MME (morphine milligram equivalent) also declined, which is likely the result of people being tapered.

There were signs of aggressive tapering. The proportion of patients taking over 90 MME fell significantly, from 25.7 percent to 16.6 percent. And more people stopped taking opioids for at least 6 months than ever before.  

But there was no discussion anywhere in the CIHI report of whether these decreases were medically beneficial for the patients involved -- which surely must be a consideration. Healthcare should be about improving care for people, not just cutting them off.  

We do know anecdotally that these changes are making pain care worse. I personally experienced the reluctance to treat pain when I recently cracked a knee cap.

“What about pain control?” I asked the ER doc. Over-the-counter Tylenol was her answer. She said Tylenol 3 – which contains codeine -- would give me constipation, so she would not prescribe it. Anything stronger, she said, would make me fall down and that would not be to my benefit.

The Toradol shot she gave me worked for a few hours. Fortunately, I had some Tylenol 3 at home leftover from a tooth extraction. Thank goodness for dentists, but taking the Tylenol 3 for something other than what it was prescribed for made me an opioid abuser.

Evidence Lacking

As for prescriptions being a significant cause of the crisis, the CIHI report provided a footnote to a report from the Public Health Agency of Canada, which states that illicit fentanyl and its analogues appear to be fueling the crisis. Males between the ages of 30 and 39 were the most prevalent victims of overdose death. Further, 82% of the deaths involved multiple drugs.

What do those figures have to do with chronic pain patients who tend to be older and female?

Here is their proof: In 2016, over 20 million prescriptions for opioids were dispensed, which is equivalent to nearly one prescription for every adult over the age of 18, making Canada the second-largest consumer of prescription opioids in the world after the United States.

That’s an interesting fact, but it does not show that prescribing to people who need analgesics has fueled the increase in overdose deaths. It only means there are a lot of Canadian adults in pain.

They also cite a 2015 survey, which found only 2% of those who had a prescription for opioids misused them. A more recent 2017 survey found that nearly a third of people who used opioid medication did not have a prescription. That proportion increased to almost 50% for teens under the age of 18, and 88% of those were illegal drug users.

As for the source of these unprescribed drugs, the Public Health Agency states:

“There are many routes that allow for prescription opioids to be diverted for nonmedical use, including sharing with family members, ‘double doctoring,’ prescription fraud and forgery, street drug markets, thefts and robberies and Internet purchases, making it difficult to estimate the proportion diverted. Through its surveys, Health Canada found that the most common source of opioids used without a prescription was a family member.”

They have no idea how these drugs get out there and admit there are many routes, but conclude that most come from family members who have a prescription for them.

What proof do they put forth? This is the reference they provide in a footnote to prove something that is contentious and disputed:

“Health Canada. Baseline survey on opioid awareness, knowledge and behaviours for public education research report. Ottawa (ON): Prepared by Earnscliffe Strategy Group for Health Canada; 2017. Unpublished report.”

When they say unpublished, I assume that this report was never submitted to a peer reviewed journal. Or if it was, then it was rejected. Scientific research should be published in peer reviewed journals where a panel of experts in both methodology and subject matter determine if the study is any good and will add to our collective knowledge of the topic. That is how science is advanced.

Regardless, the Earnscliffe report is buried on a government website and they tell us it cost almost $100,000. The report is largely based on an online survey with self-selected participation. Because of this, “no estimates of sampling error can be calculated, and the results cannot be described as statistically projectable to the target population.”

In other words, they cannot claim that any of their findings are valid. Just saying that opioid prescriptions are diverted from family members does not make it true. As the report indicates, even the teens who participated in the survey were conflicted about where illicit prescription opioids come from:

“The most common way of obtaining opioids illegally was from a friend or relative with a prescription, and the most common reason for taking them was pain relief. When teens were asked where they thought people their age get illegal opioids, the most common source was a drug dealer or other stranger.”

So much for the alleged proof that the illegal market is mostly comprised of drugs diverted from legal prescriptions. The findings here are similar to my experience, where I used a prescription given for tooth pain for a knee fracture. If I did not have the pills leftover, I would have obtained what I needed from a relative.

The initial published report went on to disprove their own hypothesis on the role of opioid prescriptions by saying that about 2% of Canadians used illegal drugs in 2015, including the “use of crack, cocaine, ecstasy, speed or methamphetamines, hallucinogens or heroin and therefore was not specific to opioids.”

The Canadian government is simply blowing smoke when it comes to proof that prescribing is fueling opioid overdoses. Canadians can only hope that after the federal election we get a new health minister who is a bit more logical. But I am not holding my breath.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He is a regular contributor to the Huffington Post.

The information in this column 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.

Is Laughing Gas the Best Medicine for Labor Pain?

By Pat Anson, PNN Editor

A century ago, nitrous oxide – more commonly known as laughing gas -- was widely used in American hospitals to relieve labor pain during childbirth. But laughing gas fell out of favor as more Caesarean sections were performed and women opted more often for epidural injections for pain relief.  

Nitrous oxide is still commonly used in Europe and Australia to manage labor pain, and is beginning to regain popularity in the U.S. The inhaled anesthetic gas helps reduce anxiety and makes patients less aware of their pain, but does not eliminate it. 

“Nitrous oxide is easy for patients to use, relatively inexpensive, and will attract more patients looking for a birthing center, or more homelike type of delivery experience,” says Barbara Orlando, MD, an assistant professor of anesthesiology, perioperative and pain medicine at the Icahn School of Medicine at Mount Sinai, New York.

Orlando and her colleagues reviewed the medical records of nearly 2,000 women who used nitrous oxide during labor in five large university hospitals.

Many gave laughing gas high marks for pain control. The mean patient satisfaction rate for nitrous oxide was 7.4 (on a scale of 0 to 10). Their babies also had no adverse health effects.

Curiously, however, nearly 70 percent of the women who tried nitrous oxide switched to an epidural or another pain management method.  

“The high patient satisfaction rate and safety profile that we found should motivate other institutions nationwide to offer nitrous oxide as a pain management option to women in labor,” said Orlando, who presented her findings at the annual meeting of the American Society of Anesthesiologists (ASA).

“Although nitrous oxide did not prevent women in labor from requesting other pain management options like an epidural, we received positive feedback from patients who said they like laughing gas as an option to manage their pain.”

Epidurals injections allow mothers to stay awake and alert throughout delivery. But they are not without risks. A poorly placed needle can damage the spine permanently, as Dawn Gonzalez discovered a few years ago.

“The blind insertion of the epidural during birth is basically playing roulette for spinal damage. Normally birthing mothers are told the only side effect possible during epidurals is a spinal headache that lasts a few days,” said Gonzalez, who developed adhesive arachnoiditis, a chronic and disabling inflammation of her spinal nerves.  

The ASA has defended the use of epidurals, calling them “one of the most effective, safest and widely used forms of pain management for women in labor.”

In a large study of over a quarter million epidurals, the risk of complications was found to be low. An “unrecognized spinal catheter” – what Dawn Gonzalez experienced – occured in only one of every 15,435 deliveries. She thinks there are better odds and safer alternatives.

“Laughing gas, Lamaze, hypnotism, meditation, water birthing and even some medications are the absolute safest and most effective forms of labor pain relief. Every woman deserves to know that when she opts for any kind of invasive spinal anesthesia, the risks are very grave and by far much more common than anybody realizes,” Gonzalez said.

A Very Uncharitable Pew Stem Cell Policy Report

By A. Rahman Ford, PNN Columnist

The Pew Charitable Trust – an institution whose stated mission is to “encourage democratic participation” in accordance with its founders’ “emphasis on innovation” – has released a 52-page report on the FDA’s framework for regulating stem cells and regenerative medicine.

Far from democratic, the report is really a thinly-veiled hit piece on stem cell therapy – one of the few fields of medicine where innovation is actually occurring.

“In many cases, there is little reliable evidence to support claims that these so-called stem cell treatments will have any effect—or indeed that they contain stem cells at all, despite the claims made about them,” the Pew report found. “Beyond the potential physical, psychological, and financial harm to patients, the widespread availability of these unproven treatments could negatively affect the entire field of regenerative medicine.”

On its surface, the report’s professed aims of consumer safety and regulatory clarity are laudable and necessary. However, the report is clearly biased against stem cell clinics and fails to seriously consider the patient perspective in policymaking. And Pew’s curious selection of regenerative medicine “stakeholders” not only diminishes the report’s legitimacy, but reveals troubling undercurrents of industry and agency influence.

Ambiguity and Controversy in Regulatory Policy

The Pew report begins innocuously enough, by laying out the general landscape of regenerative medicine, federal regulation and FDA guidance. The report correctly notes the “complex and rapidly evolving” nature of regenerative medicine, as well as the legal ambiguity that pervades the FDA’s jurisdiction over enforcement.

The report accurately describes the controversy surrounding the FDA’s interpretation of “minimal manipulation” and “homologous use” standards, which determine whether a stem cell product is exempt from the agency’s pre-market approval requirements. It also notes that the FDA’s examples of what uses do or do not meet those standards – as stated in its guidance – are “inconsistent or arbitrary.”

The report’s recommendations are entirely based on stakeholder interviews. All 11 stakeholders supported the FDA’s crackdown on clinics, even though there are plenty of critics who think it is stifling innovation and patient access to stem cell therapy.

Rather than reduce regulation, Pew suggests that additional stakeholders like the Federal Trade Commission, National Institutes of Health and state governments should assist the FDA in its crackdown, adding even more layers of regulatory control.

The report also endorses the online censorship campaign against clinics and goes out of its way to essentially classify Texas and Alabama as “rogue states” for trying to actually expand the availability of stem cell therapy.

Rather than support a balanced and judicious approach that would both promote safety and innovations such as autologous stem cells, the report calls for “tighter control of the industry” to “lend legitimacy to the field and provide regulatory certainty, both of which are essential for developers seeking investment, as well as for payers that will eventually make insurance coverage decisions for these new treatments.”

To be sure, the resolution of regulatory ambiguity is a good thing for all parties. But the ambiguity should not be resolved in a manner that disadvantages the sick and disabled, as well as the small clinics that lack economic leverage to influence agency rule-making. Unfortunately, the Pew report privileges the wealth and influence of the healthcare industry in determining what policies are best. Patients and their interests are unceremoniously relegated to the back of the policy-making bus.

A Suspicious Selection of Stakeholders

As previously stated, the Pew report’s recommendations were derived from stakeholder interviews. Quite laughably, the report maintains that a “broad range of perspectives” were included. Of course, no practicing clinicians were included. Nor were any patient advocates interviewed. However, industry and academia were represented. In fact, one stakeholder was the former Chief Biotechnology Officer and Head of Scientific Strategy and Policy for Johnson & Johnson. Yes, that Johnson & Johnson.

The same Johnson & Johnson that, according to the New York Times, faces more than 100,000 lawsuits over its products. The same Johnson & Johnson that currently faces thousands of lawsuits over claims its baby powder has caused mesothelioma and ovarian cancer. The same Johnson & Johnson that recently agreed to pay a $117 million settlement for deceptive marketing of pelvic mesh implants and $8 billion for playing down the risks of the antipsychotic drug Risperdal. And yes, the same Johnson & Johnson that was found liable in the Oklahoma opioid trial.

So when the Pew report argues that stem cell clinics should be censored and persecuted for offering “dangerous” products and engaging in “deceptive” marketing practices, it is the absolute height of hypocrisy.

To make matters worse, that same former J&J “stakeholder” – who now sits on the board of biotech firm MacroGenics – worked for the FDA for 20 years reviewing and approving biologic products. This is the epitome of policymaking incest.

To appreciate the Pew report’s true motives, all one need do is peruse its references. The report’s end-notes are littered with citations to the work of the most public and commonly interviewed stem cell critics, all of whom are on the record as card-carrying regulationists.

Pew’s cherry-picking of sources reveals its true agenda. It is a meticulously-manicured industry-slanted propaganda piece masquerading as rational, objective stem cell policy.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column 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.

Study Finds Only 1.3% of Overdose Victims Had Opioid Prescription

By Pat Anson, PNN Editor

It’s long been a popular belief that prescription opioids fueled the nation’s opioid crisis and play a major role in overdose deaths. The CDC’s 2016 opioid guideline says as much.

“Sales of opioid pain medication have increased in parallel with overdose deaths,” the guideline states. “Having a history of an opioid prescription is one of many factors that increase risk for overdose.”

But a new study by researchers in Massachusetts has turned that theory on its head. Prescription opioids are usually not involved in overdoses. And even when they are, the overdose victim rarely has an active prescription for them – meaning the medications were diverted, stolen or bought on the street.  

“Commonly the medication that people are prescribed is not the one that’s present when they die. And vice versa. The people who died with a prescription opioid like oxycodone in their toxicology screen often don’t have a prescription for it,” says lead author Alexander Walley, MD, a researcher at Boston Medical Center and Associate Professor of Medicine at Boston University School of Medicine.

Walley and his colleagues analyzed nearly 3,000 opioid overdose deaths in Massachusetts from 2013 to 2015, a period when heroin overdoses were surging and the first wave of illicit fentanyl was entering the black market.

Toxicology screens showed that multiple drugs were involved in most of the overdoses, with heroin detected in 61% of the deaths and fentanyl in 45% of them.

Prescription opioids alone were detected in only 16.5% of the overdoses.

The researchers didn’t stop there. They wanted to know if the people who died had prescriptions for the opioid medications that killed them. To their surprise, only 1.3% of them did.  

“We were able to link individuals who died of an overdose to their prescription monitoring program records.  So we could see how many people who died of an opioid overdose had been prescribed a medication at the time of their death. It turns out that was a minority of the patients,” Walley told PNN.

“If it were only the opioids we prescribed that were killing people, then we would have a perfect match between what we prescribed and what people were dying from. But that only happens 1.3% of the time.”

Rx Opioid Myths Exposed

Walley’s study, published in the journal of Public Health Reports, is one of the first to compare overdose toxicology reports with data collected in Prescription Drug Monitoring Programs (PDMPs). The findings strongly suggest that patients with legitimate prescriptions rarely overdose. And they provide a more nuanced and detailed view of what we usually hear about opioid-related overdoses.

For example, only 6% of those who died with oxycodone in their system had an active prescription for it, meaning the other 94% were taking oxycodone that was diverted or perhaps leftover from an old prescription. Active prescriptions for tramadol, morphine, hydrocodone and hydromorphone were found in less than 1% of the people who died with the drugs in their system. 

Interestingly, active prescriptions for two opioids used to treat addiction --- methadone and buprenorphine (Suboxone) – were found in about 3% of overdoses linked to the drugs.

Massachusetts pain patient David Wieland says the study findings confirm what he has long believed about the opioid crisis.

“The results of this study show that PROP (Physicians for Responsible Opioid Prescribing) and the anti-opioid zealots have been misleading the public for years, as it completely blows the myths they have been spinning out of the water,” Wieland said. “For years they have constantly blamed the majority of these overdose deaths on prescription pain medication. Even as prescribing numbers decreased and overdoses only skyrocketed, they still pushed forward with their lies and propaganda.”

Wieland says his own doctor bought into the myths, insisting that 75% of all overdose victims were pain patients who died by taking their opioid medication as prescribed.

“This was his excuse to further take me completely off my medication,” said Wieland. “Think I'm going to have to send this study to him along with a note reminding him about the supposed facts he tried to shove down my throat.”

Dr. Walley says regulators and public health officials should also take note, and that public education campaigns should not solely focus on the risks of prescription opioids. The CDC’s Rx Awareness campaign, for example, warns people about the abuse of prescription opioids, but says nothing at all about illicit opioids.

“Policy makers may too narrowly focus efforts on preventing the misuse of prescription opioids and devote inadequate resources to addressing heroin and illicit fentanyl use,” Walley said. “I think we can see that we don’t just have a prescription opioid problem. We have an illicit opioid problem. And I think our policy should reflect that.”

A Day in the Life of a Chronic Pain Sufferer

By Katie Burge, Guest Columnist

My day usually begins around 3 a.m., whether I want it to or not.  No matter what time I went to bed or how tired I am, I wake up in those pre-dawn hours, overwhelmed by excruciating pain and trembling from a panic attack caused by the pain. I wake up because I hurt too bad to stay asleep.

Don't get me wrong. I'm happy enough just to wake up at all - but what I wouldn't give some time to actually get a good night's sleep.

I grab a cup of coffee and debate whether or not I can "afford" to take a pain pill that will give me some modicum of relief. I have to be extremely careful with my medication.  I can't just take a dose because I'm in agony and need it. I don't get enough to allow myself that luxury. My monthly prescription for pain medication allows me to survive semi-comfortably for just over half the month.

It feels like I'm on an evil roller coaster ride, where my pain levels off for 3 or 4 hours, then spikes exponentially over the next few hours until I can take another dose.

As my day progresses, I try to choose the optimum time to take my pain medication, depending on what I need (or attempt) to accomplish for the day.  I struggle to take a shower, do the dishes or fix something to eat. Some of my time is spent writing.

One of the most important things in my life right now is advocating for better treatment for all chronic pain patients. I would like to be physically able to go to the state capitol or even to Washington DC to lobby for more compassionate treatment and to convince the bureaucrats there that pain patients are not to blame for the "opioid epidemic."

But that will have to wait until I can get my own pain reliably controlled.

When I do sleep, I dream about being able to do theater again, travel somewhere other than to a doctor's appointment or to run -- do any of a hundred things I’d like to do if I could exist away from the recliner that I essentially live in. It's the only place where I can find some degree of comfort.

For the past 20 years I have been dealing with increasingly severe chronic pain from a plethora of conditions like degenerative disc disease, failed back syndrome, spinal stenosis, spondylolisthesis, osteoarthritis, myofascial pain syndrome and fibromyalgia.

Any one of these conditions can generate enough pain to make a grown man cry like a little girl.  Combined, they can transform a normally relaxing shower into a study in torture -- where the droplets of water hitting my skin feel like daggers.

KATIE BURGE

Over the years, I think I've tried every treatment offered by medical science, as well as many alternative treatments - anything that might have the potential to take my pain down a notch or two. Once, I even started studying medical texts, trying to gain enough of an understanding of the logistics of pain that I could design a visualization exercise that would help me control it.

I never wanted to end up taking opioids. The pain medication I take is what's known as a "short-acting" or "immediate release" opioid, a type of drug that's actually designed for temporary acute pain, not round-the-clock chronic pain like I have.

Unfortunately, doctors are afraid to use the extended release medications that were actually designed for continuous pain.  This is the result of legal and political pressure from politicians who think they can solve the opioid epidemic by torturing pain patients. Somehow, they believe they can keep recreational drug users from overdosing by denying pain sufferers the legitimate medical use of opioids.

Short-acting opioids offer pain relief for a period of about four hours.  I am expected to make it a full 8 hours inbetween doses. That's where the evil roller coaster comes in. I take my medication, which gives me up to 4 hours relief, and then the pain spikes over the next 4 hours — making me feel worse than I did to start with.

It's up and down, up and down all day long and it's exhausting! If I was allowed to take the medication as it was made to be taken (every 4 hours), it would afford me more enough pain control that I could build a more normal life for myself. Doctors used to say it was safer and better that way, but that was before they became so afraid.

When it starts getting dark each day, I can feel the panic rising in my chest because soon it will be time to sleep and that means more pain. The depression and shame tend to crop up when it gets dark as well. The depression comes from being so isolated. As a person in pain, you spend a lot of time alone.

The shame comes from just being in pain in the first place, as society seems to tell us that we should be able to control our pain mentally, without medical or pharmaceutical intervention.

This is my day... EVERYDAY.

It's starting to get dark now, and the panic is boiling up again.

Katie Burge lives in Mississippi.  

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

The information in this column 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 Finds Mindfulness Reduces Pain and Despair

By Pat Anson, PNN Editor

“Mindfulness” may as well be a four-letter word to chronic pain patients. Many have tried mindfulness meditation – a form of cognitive behavioral therapy (CBT) – and found it does not relieve their pain.

“The quackery continues,” one reader told us. “This is a modern-day lobotomy experiment.”

“I have tried CBT and mindfulness. They made me feel much worse emotionally, paradoxically enough, and made me more acutely aware of the pain,” another patient said.

“We have ALL been through almost every other treatment you can think of including psychological therapy, mindfulness, yoga, etc. before given opiates. We still use these to help cope, but they do not really help much when all you want is to die to stop the pain you are in,” another patient wrote.

A new study at the University of Utah provides some intriguing evidence that mindfulness can enhance the quality of life, while also reducing pain and the need for opioids.

The study, published in the journal Science Advances, looked at data from four experiments involving 135 adults who took opioids daily for chronic pain.

Participants were randomly assigned to two groups that participated in eight weeks of support group therapy or eight weeks of a meditation program called Mindfulness-Oriented Recovery Enhancement (MORE), which was primarily designed to treat addiction. Patients in the MORE group were asked to focus on rewarding experiences, such as watching a beautiful nature scene.

At the beginning and end of the study, researchers collected electroencephalogram (EEG) data from the participants, using electrodes on the face and scalp to track their eye movements, smiles, frowns, changes in heart rate, and brain function.

Researchers say patients in the MORE group had fewer cravings for opioids and became more responsive to pleasant images by using mindfulness. They also reported significantly less pain, more positive emotions, enhanced joy and more meaning in life compared to patients in the therapy group.

IMAGE COURTESY UNIVERSITY OF UTAH

"Previous research shows that prolonged use of opioids makes our brains more sensitive to pain and less receptive to the joy one might normally experience from natural rewards, like spending time with loved ones or appreciating a beautiful sunset," said lead author Eric Garland, PhD, an associate dean for research at the University of Utah College of Social Work.

“This blunted ability to experience natural positive feelings leads people to take higher and higher doses of opioids just to feel okay, and ultimately propels a downward spiral of opioid dependence and misuse. Because of this downward spiral, scholars are increasingly referring to chronic pain and opioid misuse as 'diseases of despair.'"

Garland developed MORE as a mindfulness therapy to promote positive psychological health while simultaneously addressing addiction, pain and stress. MORE teaches mental training techniques to help people find meaning in the face of adversity, while simultaneously alleviating physical and emotional pain by cultivating positive feelings and experiences.

"MORE teaches people to better notice, appreciate and amplify the good things in life, while also deriving meaning and value from difficult situations," said Garland.

Previous studies on mindfulness using MRI imaging found that changes in the brain do occur during meditation, making people less sensitive to pain. Meditation activated brain regions associated with the self-control of pain, while deactivating regions that process sensory information.

You can take a free 20-minute guided meditation at Meditainment.com. The online mindfulness program takes you into a “secret garden” of your own imagination, designed to help your pain seem less important.

8 of 10 Doctors Won’t Take New Patients on Opioids

By Pat Anson, PNN Editor

Nearly three quarters of primary care doctors (72%) worry that chronic pain patients will use illicit drugs if they lose access to prescription opioids, according to a new survey by Quest Diagnostics. And 77% believe the stigma surrounding drug addiction impairs patient care.

Despite those concerns about patient stigma and illegal drug use, the online survey of 500 physicians found that 8 out of 10 are reluctant to take on new patients who are currently prescribed opioids.

“Quest Diagnostics undertook this research so that we could provide insights into the evolving drug crisis and the potential role of physicians’ perspectives about their patients in drug misuse and use disorders,” said Harvey Kaufman, MD, Senior Medical Director, Quest Diagnostics.

“We found that primary care physicians, who are on the front lines of the drug epidemic, are well-intentioned but under-prepared and may miss some of the drug misuse risks affecting their patients.”

Quest compared the survey results to an analysis of 4.4 million drug tests ordered by physicians for patients prescribed opioids and other controlled substances. The findings suggest that many physicians have a poor understanding of their patients’ drug use.

For example, Quest found that over half of patients (51%) showed signs of misusing a prescribed drug, yet 72% of physicians believe their patients take controlled medications as prescribed.

Quest broadly defines drug “misuse” by including the absence of a prescribed medication. Many patients choose not to take a drug because they can’t afford it, don’t like its side effects, or feel they don’t need it. Patients required to have drug tests are also not representative of the general population.

Other key findings:

• 62% of doctors believe the opioid crisis will morph into a prescription drug crisis

• 24% of patients combined legal medications with other non-prescribed drugs or illicit substances

• 95% of doctors are confident in their ability discuss drug misuse with patients, but only 55% actually do

• 70% of doctors wish they had more training on how to taper patients off opioids.

• 75% of doctors wish they had more training on addiction

The Quest lab tests also found concerning results about the misuse of gabapentin (Neurontin), an anti-convulsant drug increasingly prescribed to treat pain. Over 13% of patients showed signs of misusing gabapentin in 2018, making it the mostly commonly misused prescription drug.

Nearly 8 out of 10 doctors (78%) said they often prescribe gabapentin as an alternative to opioids, but only 34% were concerned about its misuse.

“A vast majority of physicians recognize the need for more tools to prevent opioid drug misuse and substance use disorders, and that is why many are tightening opioid prescribing and turning to gabapentin as an alternative,” said pain specialist Jeffrey Gudin, MD, Senior Medical Advisor, Quest Diagnostics.

“While gabapentin may not have opioids’ addictive potential, it can exaggerate euphoric effects when combined with opioids or anxiety medications. This drug mixing is dangerous.”

Gabapentin and pregabalin (Lyrica) belong to a class of nerve medication known as gabapentinoids. A recent study found gabapentinoids increase the risk of suicide, overdose, traffic accidents and injuries in younger people. Sales of gabapentinoids have tripled in recent years in the United States, where they are often promoted in prescribing guidelines as safer alternatives to opioids.

What Are Health Risks of Vaping CBD?

By Roger Chriss, PNN Columnist

An outbreak of lung illnesses linked to vaping is raising important questions about the safety of vaping cannabis products. The cause is still unclear, but the CDC reports about 76% percent of the patients who became ill vaped products containing THC – the psychoactive ingredient in cannabis. Only about 17% reported vaping a cannabidiol (CBD) product.

At present, very little is known about CBD vaping safety. The World Health Organization’s 2017 report on cannabidiol looked at oral, sublingual and intranasal routes of administration. When the WHO wrote that “CBD is generally well tolerated with a good safety profile,” it was not considering vaping at all.

The Food and Drug Administration still considers CBD in food and drugs sold commercially to be illegal, unless the product falls under the Food, Drug and Cosmetic Act. Vaping CBD does not, and so there has been no testing or regulatory action.

There have been no good human studies on CBD vaping. Research generally looks at CBD in edibles and liquids, or smoked using traditional means.

It is not known what happens to CBD under vaping temperatures, if there are thermal degradants, or important chemical reactions between CBD and other ingredients in vaping liquids or other drugs.

A recent lung tissue study found concerning results about inhaling CBD while using steroids. CBD helps reduce inflammation, but “acts as an antagonist with steroids, overriding the anti-inflammatory potential of steroids when used in combination.”

Last year Vice reported on public health warnings in North Carolina after 90 people became sick with headaches, nausea, hallucinations and other health problems after vaping CBD products. Adulterants appear to have been the problem, and Vice noted that vape oils are poorly regulated and sometimes contain chemicals that “when heated in a vape and inhaled, can cause serious lung irritation.”

A recent study on the quality of CBD liquids used in e-cigarettes is also concerning, finding that “the quality control of manufacturers and the relative safety of these products is uncertain.”

An AP investigation last month found that in lab tests on 30 CBD vape products, ten samples contained synthetic marijuana such as K2 or spice, while others had no CBD at all.

Some states with legalized cannabis do require testing of CBD vapes. But it’s not clear what to test for, and even the lab methods for testing have yet to be validated. It is also not known which cutting agents, adulterants and contaminants should be cause for concern. Lung tissue is fragile, vulnerable in ways the GI tract is not, and not well studied. So testing regimes may ultimately require information we currently lack.

Oversight of cannabis testing is limited. California’s Sequoia Analytical Labs was found to be falsifying lab results last year. Plus, many CBD vapes come from the gray or black markets, or are home-brewed, making attempts at quality control irrelevant. As a result, CBD vaping safety is an open question, assuming it is even possible to make a safe CBD vape.

Fortunately, new research may help. Researchers are testing vaporized cannabis extracts on rats. This will allow for studying the effects of THC and CBD in animal models in a way that closely mimics human behavior.

Such information is urgently needed. Animal studies on vaping are raising concerns about lung cancer risk, but such research may not be representative of how humans vape, limiting their value.

There is ongoing debate on what CBD is good for. And now we also have to consider how CBD should be administered. It may be possible to create a low-risk CBD vape product. But at present we don’t really know how to do it.

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 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.

Should Opioids Be Sold Over-The-Counter?

By Crystal Lindell, PNN Columnist

There are currently two opioid crises going on. Too many people are dying of overdoses and too many chronic pain patients are being denied the medications they need to function. 

I have a solution for both — make hydrocodone and other opioid medications available over-the-counter without a prescription.

Yes, I know the idea of adding more opioids to the overdose crisis sounds counter-intuitive. But hear me out, because this is the solution that both pain patients and illegal drug users should be fighting for.

In short, it would make it much easier for pain patients to treat their symptoms, while also providing a safe supply for those dealing with addiction.

But isn’t hydrocodone dangerous and addictive? Well yes, it is. But so is alcohol and so is tobacco. So let’s compare.

According to the CDC, cigarette smoking is responsible for more than 480,000 deaths annually in the United States, including more than 41,000 deaths resulting from secondhand smoke. As for alcohol, the CDC says it causes about 88,000 deaths per year.

How does that compare to hydrocodone? According to the DEA, of the 1,826 hydrocodone exposures reported to poison control centers in 2016, only two resulted in deaths. That’s right, two.

Another report by the CDC estimates there were 3,199 overdose deaths involving hydrocodone in 2016. But many of those deaths involved other drugs and we don’t know whether the pills were prescribed or not.  

Both estimates pale in comparison to the number of people dying from alcohol and tobacco.  

Yes, the number of deaths might go up if hydrocodone is sold over-the-counter. However, if you factor in how many lives we could save, we would come out far ahead.  

And you know what? The acetaminophen found in hydrocodone products like Vicodin could cause an overdose before the hydrocodone does.  

“The scientifically and medically accepted amount to produce a fatal overdose of hydrocodone is 90 mg. Thus, 18 (5mg) Vicodin pills can lead to an overdose,” explains an addiction recovery website.

“This already puts an individual far above the liver’s tolerance of acetaminophen at 5,400 mg, meaning an individual would experience two separate overdoses if they managed to consume this many pills.”  

Although opioid tolerance can greatly impact how much would be needed to cause an overdose, the fact remains that the acetaminophen might actually be the most dangerous part of the medication. The solution for that? Sell hydrocodone over-the-counter without the acetaminophen.   

Patients Turning to Street Drugs

How do we save lives by giving people more access to drugs? To answer that you have to understand how people are actually dying as a result of the opioid crisis.  

Here’s a hint: it’s not usually caused by hydrocodone. 

First, the misguided fight against the opioid epidemic has led to many doctors refusing to prescribe any opioid medications. Unfortunately, taking medications away from people who need them to function doesn’t somehow result in them magically fighting through the pain. Instead, it just pushes them to take more acetaminophen or some dangerous illegal drug that we’re trying to curb.  

When that happens, people are left to find illegal alternatives — and what they discover is that heroin and illicit fentanyl are actually cheaper than hydrocodone sold on the black market.  

Our system of prohibition is forcing pain patients and illegal drug users to turn to street drugs. We are doing something wrong when it’s easier and cheaper to take heroin or fentanyl than it is to take hydrocodone.  

Making hydrocodone over-the-counter would create a safe supply and would undoubtedly save a lot of lives. It would also have the added benefit of saving patients a lot of money on doctor visits.   

We are at a point when the war on drugs is doing more harm than good for everyone. It’s time for us to consider more radical solutions to these issues. And making hydrocodone available over-the-counter should be at the top of that list.  

Decriminalize Opioids

Thankfully, the country seems to be moving in this direction somewhat. Cannabis is being legalized recreationally, as everyone realizes how pointless marijuana prohibition is. And just this month, Democratic Presidential Candidate Andrew Yang announced his proposal to decriminalize opioids.  

“We need to decriminalize the possession and use of small amounts of opioids,” Yang says on his website. “Other countries, such as Portugal, have done so, and have seen treatment go up and drug deaths and addiction go down. When caught with a small quantity of any opioid, our justice system should err on the side of providing treatment.” 

No, Yang is not likely to win. And no, his proposal doesn’t go far enough. But it’s a start — and will hopefully start to shift the conversation.  

Is there anything we can do as patients to help this cause? Honestly, I believe there is. I constantly see pain patients and advocacy groups post disparaging comments about people who use drugs illegally. I understand why it’s easy to blame them for the crackdown on opioids. But they aren’t the ones who put the new regulations in place — for that you can blame the CDC, DEA and FDA.  

Instead of fighting illegal users, we should be trying to work with them as part of a common cause — decriminalization and legalization. It’s a fight we can all get behind.  We can post about that stance online and we can tell our loved ones why it’s important to us. We can also tell our elected officials. You can reach your federal representatives in the House here, and in the Senate here.

If we all take up this cause together, there is real hope we can make progress.  

Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. She has hypermobile Ehlers Danlos syndrome. 

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.

Discovery of Brain Protein Could Lead to New Chronic Pain Treatments

By Pat Anson, PNN Editor

Researchers have identified a protein in the brain that appears to play a prominent role in the maintenance of long-term pain -- a discovery that could lead to new treatments that stop short-term acute pain from progressing to chronic pain.

The protein RGS4 (Regulator of G protein signaling 4) is found in brain circuits that process pathological pain, mood and motivation.

"Our research reveals that RGS4 actions contribute to the transition from acute and sub-acute pain to pathological pain states and to the maintenance of pain," says Venetia Zachariou, PhD, a professor in The Friedman Brain Institute at the Icahn School of Medicine at Mount Sinai in New York City.

"Because chronic pain states affect numerous neurochemical processes and single-target drugs are unlikely to work, it's exciting to have discovered a multifunctional protein that can be targeted to disrupt the maintenance of pain."

In studies on genetically modified mice, Zachariou and her colleagues found that genetic inactivation of RGS4 did not affect acute pain, but it promoted recovery from nerve injuries, chemotherapy-induced neuropathy and peripheral inflammation. Mice lacking RGS4 developed all the expected symptoms of a nerve injury, but recovered within 3 weeks and returned to physical activity.

The transition from acute to chronic pain is accompanied by numerous adaptations in immune, glial and neuronal cells, many of which are still not well understood. Chronic pain patients experience a number of debilitating symptoms besides pain, such as sensory deficits, depression and loss of motivation

Researchers believe future drugs that target RGS4 could prevent acute pain from transitioning to chronic pain. Currently available medications for chronic pain only treat the symptoms – not the underlying condition – and have major side effects.

Dr. Zachariou's laboratory is conducting further investigation into the actions of RGS4 in the spinal cord and mood-regulating areas of the brain to better understand the mechanism by which the protein affects sensory and pain symptoms.

Their findings are published online in The Journal of Neuroscience.

The New Norm for Chronic Pain Patients

By Rochelle Odell, PNN Columnist 

Come the new year, I will start my 28th year battling Complex Regional Pain Syndrome (CRPS). Like so many high impact pain patients, I have been experiencing a pain flare that isn't improving and prevents me from doing many tasks. I am praying it will get better and not become my new norm.  

I have been a palliative care patient for a couple of months now. Palliative care is not what many people think it is. My meds did not get increased and I still live at home. A home health RN visits me twice a week, takes my vital signs, asks how I am doing, how is my pain, and what doctor do I see next.  

I was evaluated this time last year for Transitional Care Management or TCM. It’s usually for patients getting out of the hospital and is short term -- only two to three months at the most. A medical doctor evaluated me and told me I was “high functioning” but needed assistance. High functioning? I have no help and only have me to depend on. I have to function to some degree just to survive. 

My RN tells me palliative care is meant to help patients be as comfortable as possible. They used to be able to give their patients pain meds, but now all they can give is Toradol, a non-steroidal anti-inflammatory drug, which does me no good because I am deathly allergic to NSAID's and aspirin. She is compassionate and caring and says what is happening to me and others in pain is "Just not right." I have to agree with her. 

Perhaps part of this new norm is reading so much negativity coming from our not so illustrious leaders in DC, along with blurbs from the CDC and the FDA. To me it appears to be getting worse as opposed to getting better.  

Is my increased pain clouding what I am reading? I don't believe so. Many of us suffering from high impact pain -- about 20 million Americans – are unable to get opioid medication. Even those suffering from life ending cancer are being turned away. That is nothing but plain cruelty. 

There is a core group of pain patients, probably numbering a few thousand, that is trying to change things. We call and write our elected officials and various government offices that have deemed it their duty to destroy our lives piece by piece.

Those that are physically able can attend a Don't Punish Pain Rally. There is another DPP rally coming up October 16. I have only been able to attend one rally. It's hard when one is in extreme pain and with limited funds to be able to travel to the rallies.  

Why Are We Being Treated This Way?

What is happening to us? Why are our physicians, those trained to treat and care for us, turning their backs on us? Why are we being shunned? Why are we being treated like we did something wrong?  

Why are people who abuse drugs being treated with compassion and care but not us? They hurt their families, they steal, they destroy their bodies, they seemingly don't care. We don't do any of that. Our pain is caused by diseases we never asked for. We care, we want to live and we want to participate in life.   

They get clean needles, clean rooms to shoot up in, free Narcan, and in Canada they are giving Dilaudid (hydromorphone) to those who abuse drugs. Dilaudid is an opioid used for treating severe pain. I was on Dilaudid three years ago. Not anymore.  

I just read about a county in England that is going to provide medical grade heroin twice a day to drug addicts. Why? The police are hoping it will lower crime in the area. I bet they have lines form they never expected.  

So now those who abuse are getting free heroin. Yet pain patients are kicked to the curb. How can physicians care for one who abuses their body but refuse to treat a human being suffering from intractable pain? I don't mean to sound so cold when it comes to those who abuse, but people in pain are suffering unrelenting pain because of them.   

If we ask for meds, ask for referrals or refuse a treatment we know will have adverse effects, we are accused of being non-compliant and dropped by our doctors. I believe the loss of compassion from our physicians is why many of us are having these unexplained pain flares that are becoming our new norm.  

I have been reading on social media that patients on opioids who move or are dropped are finding it impossible to get a new primary care physician. I saw my PCP last week and asked her about it. She emphatically told me "they" would not accept new patients who are on or had been on opioids. I was afraid to ask who “they” were, but am assuming it's all or most of the doctors in this area. 

I am sorry for all my friends in pain and for those I don't know who are in pain. I am sorry we are being treated like addicts. That those in healthcare would turn a blind eye to us. My heart breaks for those who feel the only solution is to take their life to end the pain. That is so wrong. Human beings are being pushed to that point by those elected to represent us and those in healthcare who are supposed to care but don't. I am so very sorry. 

Rochelle Odell lives in California.

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

This column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Approves New Lilly Migraine Drug

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved Eli Lilly’s Reyvow (lasmiditan) for the treatment of migraine with or without aura. Reyvow is the first migraine treatment that acts by binding to serotonin receptors in the brain and depressing central nervous system activity. 

“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans,” Nick Kozauer, MD, acting deputy director of the FDA’s Division of Neurology Products, said in a statement. “We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine.”  

Migraine affects a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause blurriness, light sensitivity and visual disturbances known as aura.

The effectiveness of Reyvow tablets was demonstrated in two double-blind, placebo-controlled studies involving nearly 3,200 patients experiencing a migraine attack. In one study, only about 32% of patients receiving 200mg of Reyvow were pain free after two hours, but that compares to 15% taking a placebo — enough to be considered statistically significant.

"As a physician who specializes in the treatment of migraine and headache disorders, I commonly treat patients who are looking for acute treatment options that offer the chance for pain freedom during migraine attacks. This approval is especially significant because migraine pain is so often severe and incapacitating," said Jan Brandes, MD, a neurology professor at Vanderbilt University and paid consultant to Lilly.

The most common side effects for patients in the Reyvow clinical trials were dizziness, fatigue, a burning or prickling sensation in the skin (paresthesia), and sedation.  An FDA warning label will caution patients not to drive or operate machinery for at least eight hours after taking Reyvow. The drug should also not be taken with alcohol or other serotonin depressants.

Reyvow is not approved for the preventive treatment of migraine. Lilly did not say when Reyvow would be available or how much it would cost.

In recent years, the FDA has approved several new migraine therapies, including injectable drugs to prevent migraine and neuromodulation devices that use electrical pulses to disrupt pain signals.

Migraine can be triggered by various factors including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet. Women are three times more likely to suffer from migraine than men.

Feds Warn About Rapid Opioid Tapers

By Pat Anson, PNN Editor

Federal health officials are once again urging doctors not to rapidly decrease or abruptly stop prescribing opioid medication to chronic pain patients.

In an editorial published in the Journal of the American Medical Association (JAMA), three federal health officials warn that sudden opioid tapering significantly increases the risk of harm to patients, resulting in increased hospitalizations and emergency room visits.

“There are concerning reports of patients having opioid therapy discontinued abruptly and of clinicians being unwilling to accept new patients who are receiving opioids for chronic pain, which may leave patients at risk for abrupt discontinuation and withdrawal symptoms,” the editorial warns.

The editorial was written by Deborah Dowell, MD, of the Centers for Disease Control and Prevention, Wilson Compton, MD, of the National Institute on Drug Abuse, and Brett Girior, MD, of the U.S. Public Health Service. Dowell is one of the co-authors of the CDC’s controversial opioid guideline, which has been widely used as an excuse by doctors, insurers and pharmacies to impose mandatory limits on prescribing.  

Even before its release in March 2016, pain patients and advocates warned the CDC guideline would result in rapid tapering, patient abandonment and suicide.

But not until April of this year – after three years of needless deaths and suffering -- did the FDA and CDC start urging doctors to be more cautious in their tapering.

It then took another six months for the Department of Health and Human Services (HHS) to produce a 6-page guide for doctors on how to taper patients.

“The HHS guide and current guidelines emphasize that tapering should be individualized and should ideally proceed slowly enough to minimize opioid withdrawal symptoms and signs. Physical dependence occurs as early as a few days after consistent opioid use, and when opioids have been prescribed continuously for longer than a few days, sudden discontinuation may precipitate significant opioid withdrawal,” the JAMA editorial warns.

The HHS tapering guide urges doctors not to dismiss pain patients and to share decision making with them when developing a taper program.

“If the current opioid regimen does not put the patient at imminent risk, tapering does not need to occur immediately. Take time to obtain patient buy-in,” the guideline cautions. “There are serious risks to non-collaborative tapering in physically dependent patients, including acute withdrawal, pain exacerbation, anxiety, depression, suicidal ideation, self-harm, ruptured trust, and patients seeking opioids from high-risk sources.”

The guide suggests tapers of 5% to 20% every four weeks, although slow tapers of 10% a month may be appropriate for patients taking opioids for more than a year.

A recent study of tapering in Vermont found only 5 percent of patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering. Many of those patients were hospitalized for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure.

Another recent study at a Seattle pain clinic found that tapered patients had an unusually high death rate, with some dying from suspected overdoses.

Meanwhile, not a single word of the CDC opioid guideline has changed since federal health officials finally acknowledged it was harming patients and needed clarification.

Experimental Drug Rebuilds Cartilage in Knee Osteoarthritis Patients

By Pat Anson, PNN Editor

An experimental treatment shows promise in slowing the progression of knee osteoarthritis by increasing the thickness of cartilage in the knee joint, according to results of an early clinical trial published in the Journal of the American Medical Association (JAMA).

Researchers at the University of Maryland School of Medicine gave 549 volunteers with knee osteoarthritis injections of the drug sprifermin or a placebo. Sprifermin is a disease modifying drug that stimulated the production of cartilage-producing cells in animal studies.

The researchers found that participants who received a 100 microgram dose of sprifermin either twice or once yearly experienced a statistically significant but slight gain in joint cartilage thickness after two years.  Those given smaller doses had smaller gains in cartilage that were not statistically or clinically significant.

"While the increase in cartilage thickness is a positive sign, we do not know at this point whether it has any clinical significance," said lead investigator Marc Hochberg, MD, a Professor of Medicine at UMSOM. "It is not known whether those who experience increased cartilage thickness over time will be able to avoid or delay knee replacement surgery."

Interestingly, patients treated with a high dose of sprifermin did not experience any significant improvement in their arthritis symptoms – such as pain and stiffness -- compared to those given lower doses or placebo injections.

All of the injections were stopped after 18 months. The Phase 2 study is designed to continue for a total of five years and future analyses of the findings are planned.

About 10 percent of Americans over age 60 have knee osteoarthritis, a progressive condition caused by the breakdown of joint cartilage. Knee osteoarthritis causes pain, physical disability, lower quality of life and is associated with early death and cardiovascular problems.

The pain is usually treated with over-the-counter pain relievers, anti-inflammatory drugs, steroid injections, and sometimes surgery. No disease-modifying osteoarthritis drugs have been approved in the United States or Europe.

Arthroscopic and knee replacement surgeries are increasingly being used to treat knee osteoarthritis. But a number of recent studies have found the arthroscopic surgery does not relieve knee pain any better than physical therapy or over-the-counter pain relievers. Researchers have also found that about a third of patients who had knee replacement surgery continued to have pain after the procedure.