Genetic Testing Company Raided by FBI

By Pat Anson, Editor

FBI agents have raided the headquarters of Proove Biosciences, a controversial genetic testing company that claims its DNA tests can improve the effectiveness of pain management and determine whether a patient is at risk of opioid addiction.

Over two dozen FBI agents appeared at Proove offices in Irvine, California Wednesday as part of a healthcare fraud investigation. They were later seen carrying dozens of boxes out of two buildings

“It is an ongoing investigation out of our San Diego office. It involves healthcare fraud. And unfortunately we are unable to say anything more about it at this time. The affidavit supporting the search warrant is under seal,” Cathy Kramer, an FBI special agent, told KABC-TV.

STAT News reported in February that the FBI and the Inspector General for the Department of Health and Human Services (HHS) were investigating possible criminal activity at Proove.

Former and current employees who were interviewed by the FBI told STAT the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

The HHS Inspector General issued a Special Fraud Alert in 2014 warning physicians that any payments, referrals, rent or reimbursements from lab testing companies could be seen as violations of anti-kickback laws.

Proove promotes itself as the “leader in personalized pain medicine” and claims its genetic tests can identify medications that would be most effective at treating pain. The company recently claimed that 94% of patients experienced significant pain relief within 60 days of treatment changes recommended by Proove. Critics say most Proove studies are not peer-reviewed and one genetic expert has called them “hogwash.”

According to STAT, doctors affiliated with Proove in California, Florida and Kentucky were also raided by the FBI. Proove said it was cooperating with the investigation, and that no arrests or charges have been made.

"Proove has been subject to a handful of inaccurate stories initiated by STAT News that we believe have contributed to this latest action," the company said in a statement. "While we originally chose not to dignify these outlandish accusations with a response, we now understand that we can no longer ignore these false stories based on unreliable sources, and filled with erroneous accusations... spread by a few disgruntled former employees and consultants.  Proove is confident that the facts supported by verifiable and reliable sources will clearly restore our reputation."

Proove Linked to Montana Pain Clinic

Proove is the second laboratory testing company raided by the FBI that has been linked to Benefis Pain Management Center, a pain clinic in Great Falls, Montana. 

As PNN has reported, FBI agents last November raided the offices of Confirmatrix Laboratories near Atlanta. Two days later, the company filed for Chapter 11 bankruptcy protection. Confirmatrix was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

In 2013, Medicare identified Confirmatrix as the most expensive urine drug testing lab in the country, charging an average of $2,406 for each Medicare patient.

Benefis has continued to send urine drug samples to Confirmatrix for testing even after the company filed for bankruptcy. Some Benefis patients have recently been contacted by collection agencies seeking payment for urine tests costing well over $1,000 that their insurance refused to pay for. Similar tests by other labs cost only a few hundred dollars.

According to its bankruptcy filing, Confirmatrix has 152 employees in 15 different states, including one employee in Montana who apparently works on site at the Benefis pain clinic. PNN has also learned that Proove Biosciences has had employees working at the clinic. A Proove “patient engagement representative” was employed there as early as May 2016.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” says Rodney Lutes, a physician assistant (PA) who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.  What they did is they had a technician there in the department and every day I would get a list from that technician of patients that they would like to try to include in the program.”

Lutes says he recommended the DNA test to many of his patients, but never received any money from Proove. He says some of his patients later complained that their insurance was billed for the DNA test.

“One of the things that bothered me was that I signed a lot of the papers, but they also had my supervising doc on all of those papers,” Lutes told PNN. “I also felt like she was the one that brought them (Proove) in there.”

Lutes is referring to Katrina Lewis, MD, a pain management specialist at Benefis who is listed as a member of Proove’s Medical Advisory Board.  Lewis plays a significant role at the pain clinic even though she only works there part time. 

“Dr. Lewis works for Benefis one week a month and has been instrumental in the development of our multidisciplinary approach and current protocols,” said Keri Garman, Director of Corporate Communications at Benefis.

In a statement emailed to PNN last month, Lewis said regular urine drug testing was necessary to ensure that “appropriate levels” of medication are present. Current clinic policy is that “high risk” patients should have a urine test at least once every two months.

“Presence of too high of a level of opioids or other substances in the urine can make it inappropriate and unsafe to continue prescribing opioids.  Presence of none of the prescribed opioids in the urine indicates the care plan is not being followed and further prescribing is medically unnecessary,” Lewis said.

Benefis: No Kickbacks from Testing Labs

PNN has made repeated requests to Benefis to clarify its relationship with Confirmatrix and Proove, and whether Lewis or any other Benefis employees were receiving compensation from the laboratories for referring business to them. 

“Benefis and its employees, including Dr. Katrina Lewis, do not receive kickbacks from Confirmatrix or Proove. As for any questions you have regarding the lab business practices of these facilities, these would be best answered by the companies directly,” Benefis spokesman Ben Buckridge said in a statement emailed to PNN last week. 

“We take these accusations and defamatory statements against our organization and staff seriously. We appreciate your diligence on this issue.” 

In an earlier statement, a Benefis official said the DNA tests are voluntary and only done on patients if they are appropriate.

“Patients have the option to decline this testing, however, it proves to be very helpful in determining treatment plans for our patients in many cases. This testing has not been readily available until recently,” said Kathy Hills, Chief Operating Officer of Benefis Medical Group.

“Genetic testing allows us to see if the patient is appropriately synthesizing specific medications and can drastically alter treatment plans, showing us that sometimes the medications are not effectively metabolizing and therefore not as effective, which is why some patients have needed high doses. Our partners in this have an extensive patient assistance program that waives many costs, and patients are not penalized or removed from opioids if they refuse to have a genetic test performed.”

But a recent copy of the clinic’s opioid policy obtained by PNN says the tests are not voluntary for everyone. 

“All patients on dosing levels at or higher than the maximum policy dose MUST be submitted for genetic testing,” the policy states. The word "must" is capitalized in the document. 

One Benefis patient who took the DNA test said Lutes recommended it.

“He said everyone was doing it and that the insurance would be billed, but if they did not pay for it then Benefis would. I think he said something about it being a $6,000 test,” she told PNN.  “To me it was a waste of time and money. The meds it said I should be taking either didn’t work, stopped working, or made me sick. And the meds I should not be taking I do just fine on.”

It is not clear whether the pain clinic's association with Proove or Confirmatrix had anything to do with Lutes’ firing in March. The 68-year old Lutes treated several hundred pain patients and was popular with many of them. 

Lutes was discharged for violating Benefis policy about record keeping, opioid dosage and urine drug testing, but feels he was “written up for violations that do not exist.” His supervising physician – Katrina Lewis – also requested removal from that role, meaning Lutes could no longer practice at Benefis as a physician assistant.

Since his dismissal, many of Lutes former patients who were on relatively high doses of opioids say their medication has been reduced or stopped entirely. One patient, whose opioid dose was cut significantly, committed suicide. Still others complain they were labeled and treated as addicts by clinic doctors and staff, and now have trouble finding new physicians in the Great Falls area. The ones who remain at Benefis say they are being told to take new tests and exams. 

Benefis says it cannot comment on the accusations because of patient and employee privacy rights.

“Unless Rodney Lutes, PA, or the patients with whom you are speaking will sign written releases allowing us to comment fully on the facts of their employment or their care, respectively, we are simply unable to engage in any further back and forth discussions.  We have provided all the information we are able given the legal limitations governing our industry,” Buckridge said.

FDA Wants Opana ER Sales Stopped

By Pat Anson, Editor

The U.S. Food and Drug Administration today asked Endo Pharmaceuticals to remove Opana ER from the market, citing concerns about safety risks when the tablets are liquefied and injected. It’s the first time the agency has taken steps to stop an opioid painkiller from being sold -- and oddly it has more to do with preventing HIV and Hepatitis C than it does in preventing opioid abuse.

“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb, MD. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

Opana ER is the brand name for Endo’s extended release opioid painkiller oxymorphone. It was first approved by the FDA in 2006 for the management of moderate to severe pain.  In 2012, after numerous reports that it was being abused and sold on the black market, Opana was reformulated by Endo to make it harder for addicts to crush or liquefy.

That same year, over a dozen cases of a serious blood clotting disorder and Hepatitis C in intravenous drug users were linked to the reformulated Opana in Tennessee. But it took another five years for the FDA to act.

In March, an FDA advisory panel voted 18-8 that the benefits of reformulated Opana no longer outweighed its risks. The agency found“a significant shift in the route of abuse” from snorting to injection. Injecting Opana was associated with outbreaks of HIV, Hepatitis C and a blood clotting disorder called thrombotic thrombocytopenic purpura. All can be spread intravenously by infected needles.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”

The FDA has requested that Endo voluntarily remove Opana from the market. Should the company refuse to do so, the agency intends to take steps to formally require its removal by withdrawing approval.

"Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward," the company said in a statement. "Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients."

According to Bloomberg, sales of Opana  reached nearly $160 million last year, about 4 percent of the company’s total revenue.

Study Finds No Evidence Copaiba Oil Relieves Pain

By Pat Anson, Editor

An essential oil made from the resin of a tree that grows in the Amazon rain forest shows promising results as a treatment for arthritis, but there is no clinical evidence to support its use, according to researchers at Florida Atlantic University.

Copaiba (koh-pey-buh) is an oleoresin obtained from the trunk of several pinnate-leaved leguminous trees. The resin has been used for centuries in folk medicine, and is also used in the manufacture of paint, varnish, perfume and soap. Brazil produces about 95 percent of the world’s supply of copaiba and exports more than 500 tons a year.

Essential oil made from copaiba is increasingly available in health food stores and online, where it is touted as a “wonderful analgesic” and “one of the most anti-inflammatory substances on earth.”

"Copaiba is an essential oil that is used topically with little or no side effects, but there is insufficient evidence to judge whether it reduces pain and inflammation in patients with arthritis," said Charles Hennekens, MD, senior academic advisor at Florida Atlantic’s College of Medicine and senior author of a commentary published in the journal Integrative Medicine.

"In case reports, individuals with joint pain and inflammation who used copaiba reported favorable results, however, this hypothesis is promising but as of yet unproven."

COPAIBA ESSENTIAL OIL

Hennekens and his colleagues say the evidence to support copaiba as a treatment for inflammatory arthritis is limited to basic research and uncontrolled clinical observations in humans. They caution that randomized trials are necessary to discern whether copaiba oil is effective or if it turns out to be "yet another beautiful hypothesis slain by ugly facts."

"Basic research has suggested mechanisms of benefit of this essential oil in treating inflammatory arthritis," said Hennekens. "Nonetheless, the only published data on copaiba on humans includes one case series and one small randomized trial of another inflammatory condition and not arthritis."

The researchers conclude that the totality of the evidence for copaiba is insufficient to judge either its benefits or risks for the relief of arthritis pain and inflammation. Despite this lack of evidence, sales of copaiba oils continue to increase as patients look for alternatives to pharmaceutical pain relievers.

"Copaiba should be first tested in a randomized trial against a placebo in patients with inflammatory arthritis," said Hennekens. "If such a trial shows a net benefit, then the next step would be direct randomized comparisons against NSAIDs and COXIBs (cyclo-oxygenase-2 inhibitors).”

AARP’s ‘Opioid Menace’ a Disservice to Pain Patients

(Editor’s note: The American Association of Retired Persons (AARP) recently published a series of special reports entitled "The Opioid Menace!"

The series focuses on the abuse of pain medication, claiming that many older Americans have become “new opioid dealers” who are fueling the opioid crisis by “selling their prescription painkillers to drug pushers.” Doctors are also blamed for the “sin of overprescription.”

PNN reader Rochelle Odell was upset about the lack of balance in the series, and sent this letter to AARP.)

Dear AARP Editor:

I have been a member of AARP since I turned 50, due to disability.  I suffer from Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD).  Like many long term CRPS patients, my spine is a mess.

I was appalled when I read your article on "The Opioid Menace.” Excuse me, but what a crock of you know what. Your organization has done a great disservice to the tens of millions of Americans who live with chronic pain, including many who are over the age of 50.

Did your reporters contact any of the major pain organizations? I doubt it, from reading your article. I am going to have to spend some time researching the correct numbers, but I believe opioid addiction among chronic/intractable pain patients is less than 5%, a far lower number than you referenced.

When the CDC came out with their opioid guidelines in 2016, which by the way were just that -- guidelines for primary care physicians only -- my medications were stopped, like so many across the country, cold turkey no less. And I had been on pain medication for over 20 years.

My first treating physician didn't believe in pain medication unless absolutely necessary, so I underwent painful blocks for both upper and lower extremities, along with the implant of three different types of spinal cord stimulators and two pain pumps. The first one never worked and the second one, my body rejected.

I was poked and prodded, and my spine underwent such an assault that -- had I known then what I know now, I never would have agreed to.

I was given a variety of medications other than opioids, which never worked or caused side effects so severe, they certainly weren't worth taking. You name it, it was done to me before I was finally placed on an opioid regime only.

ROCHELLE ODELL

Now that I am "opioid free," my pain is off the scale. I no longer function. I have been house/bed bound since December. My vehicle sits dead in the garage. I have become too ill to even go to the doctor.

I contacted my Medicare Advantage insurance company for assistance due to my circumstances, but their willingness to help ended there.  See, I am supposed to find the energy to take a shower, get dressed, ride in a vehicle to a new primary care physician, then wait in the office and hope the physician can assist me. I can barely make it to the bathroom, let alone venture to a doctor's office. To top it off, my voice is now affected and I no longer talk on the phone.

I am but one among many across our nation, who has been adversely affected by these guidelines and false statistics. Your organization needs to research, then report the other side of the coin. Those of us who have lost the ability to function or live in severe pain, non-stop 24/7, 365 days a year, are suffering. Tell our story, please! 

Just because a person dies with prescription drugs in their system, does not mean they died of an overdose. It just means they had drugs in their system at the time of death. 

A chronic pain patient sees their pain management physician on a regular basis, usually monthly. We dutifully sign pain contracts and pee into the cup. It can be so degrading, but if we do not, we are labeled non-compliant and dropped.

A chronic pain patient guards their pain medication to a fault, they are too valuable for our survival to risk losing or selling. Yes, there are a few, very few, who use too many per month or divert them for money, but a good pain physician keeps track of that abuse, as do pharmacies.

Do illicit drug users do this? No, they only look forward to their next high. A chronic pain patient never gets high off their medication, their pain is that overwhelming. Illicit drug users steal and prostitute themselves to feed their habit. Unfortunately, even older Americans who have had their medications stopped or significantly reduced are now forced to search on the streets/internet for drugs for their pain.

Believe me, if I had the money and knew where to look, I might be tempted to do the same. But living on a fixed income precludes anything illegal. We didn't ask for these painful diseases, and we didn't ask that our careers be halted in our 40's and 50's in one fell swoop. If we could give our diseases back, we would in a heartbeat, including the drugs needed just to function.

Another issue is the fact many illicit drug users use heroin laced with fentanyl, along with mixing alcohol to obtain their high. Or the growing number of illicit drug factories that have been raided within the past year. Drug dealers are churning out hundreds of thousands of counterfeit fentanyl/oxycodone pills. Pill presses are shipped from China and the drug cartels south of the border, along with the illicit drugs required to make these pills. Did your reporters research this? No.

Living alone at 70 and not functioning has been a real test. Thankfully, I do my food shopping online, so my dog and I don't starve. It isn't the same as doing my own shopping, but I can purchase food including frozen and fresh.  I pay my neighbors a small amount to pull the weeds from my yard and pick up my dog's waste. But I am very close to just walking away from a home I have lived in for fifteen years, that's how severe my situation has become and I am not unique.

You only interviewed a very tiny group of people who claim to have gotten hooked on prescription drugs. AARP has overlooked the real problem, which is illicit drugs, not prescription drugs. I don't know where your reporters obtained their statistics, but they are far off base.

Like many elected officials and government regulators, AARP has grossly overlooked a significant number of people adversely affected by this false information. I could go on and on about the damage your article and incorrect information has caused to chronic pain patients. Quite frankly, I expected better from AARP.

Rochelle Odell lives in California.

To see the AARP series and watch a video version, click here.

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.

WHO Lists Fentanyl as ‘Essential Medicine’

By Pat Anson, Editor

At a time when hundreds – perhaps thousands – of Americans and Canadians are dying every month from overdoses of illicit fentanyl mixed with heroin or turned into counterfeit painkillers, it’s easy to lose sight of the fact that prescription fentanyl is an important and useful analgesic.  

We were reminded of that today by the World Health Organization (WHO), which added fentanyl skin patches and methadone to its list of essential medicines for treating cancer pain. WHO’s Essential Medicine List is not widely followed in developed countries – where prescription drugs are widely available – but it is used in many third world countries to guide decision making and increase access to medicines that are often in short supply.

"Safe and effective medicines are an essential part of any health system," said Dr. Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. "Making sure all people can access the medicines they need, when and where they need them, is vital to countries’ progress towards universal health coverage."

Fentanyl patches and methadone are two of the 30 drugs being added to the Essential Medicine List, raising the total to 433 medicines considered vital in addressing public health needs. WHO also added drugs for treating HIV, hepatitis C, tuberculosis and leukemia; and gave new advice about the use of antibiotics.

While illicit, black market fentanyl has become a deadly scourge across the U.S. and Canada, prescription fentanyl is legally available in patches, lozenges and sprays to treat severe pain.  

WHO’s inclusion of fentanyl patches and methadone on the essential list is limited to the treatment of cancer pain. An expert panel that reviewed the medicines noted “there is a need for additional opioid treatment options” for cancer pain. About a third of cancer patients worldwide are undertreated for pain, and patients living in low or middle income countries often have limited access to opioid painkillers.  

Other opioids already on the essential list (for treating pain and palliative care) are codeine, morphine, hydromorphone and oxycodone . Aspirin, ibuprofen and paracetamol (acetaminophen) are on it too, although the latter is “not recommended for anti-inflammatory use due to lack of proven benefit.”

Gabapentin Rejected

It’s also worth noting the medications that did not make the updated WHO list. Tramadol was not approved as a treatment for cancer pain, while gabapentin (Neurontin) was rejected as a treatment for neuropathic pain.

WHO’s expert panel gave a scathing review of the application made by the International Association for the Study of Pain and the International Association of Hospice and Palliative Care for the inclusion of gabapentin; noting there were many cases of bias and data manipulation in the clinical studies used to support it. Also noted was the $430 million fine paid by Pfizer in 2004 to settle civil and criminal charges for a “marketing scheme” to promote Neurontin for unapproved uses.    

“The Committee acknowledged the serious issues on publication and outcome reporting bias as important ones,” the panel said. “The Expert Committee considered the uncertainty in efficacy estimates as a result of publication and outcome reporting biases in the currently available evidence for gabapentin. The Committee did not recommend inclusion of gabapentin on the EML (Essential Medicine List) for neuropathic pain on the basis of its uncertain benefits.”

While gabapentin is approved for neuropathic pain in the European Union and Australia, it is only approved for epilepsy and neuropathic pain caused by shingles in the U.S. Despite that limitation, gabapentin is widely prescribed “off label” to treat depression, anxiety, migraine, fibromyalgia and other chronic pain conditions.  About 64 million prescriptions were written in the U.S. for gabapentin in 2016, a 49% increase since 2011.

A Pained Life: Living on Hope

By Carol Levy, Columnist

"Never lose hope. Storms make people stronger and never last forever." Roy T. Bennett 

"He that lives upon hope will die fasting." Benjamin Franklin

"Hope is the thing with feathers That perches in the soul And sings the tune without the words And never stops at all."  Emily Dickinson

I could go on and on. Why am I in this mood?

I have an appointment tomorrow with a new doctor. He spoke at our trigeminal neuralgia support group some weeks back, so I know he understands the condition and the pain.

He also specializes in neuropathic pain. This is a source of pain that occurs as a result of diseases, lesions or injuries to the nervous system.

As a result of the many neurosurgical interventions I have had, this -- as opposed to “merely” trigeminal neuralgia -- appears to be the cause of my pain.

I was very lucky in that the worst of my trigeminal neuralgia pain -- constant, triggered and spontaneous – suddenly went into remission. Unfortunately, the eye pain that keeps me in pain and disabled remains.

Almost every doctor I have seen -- neurosurgeons, neurologists, ophthalmologists and neuro-opthalmologists -- have tended to have the same response to my plaintive cry: "What causes this pain when I use my eyes? Why do I still have it? Isn't there anything that can be done?”  

Shoulders are shrugged, eyebrows raised. “I dunno” is the usual response.

I have heard that answer too many times to count. I know this is the standard answer. I also know it is probably the true answer.

And yet.

I am anxious about my appointment tomorrow. Maybe this doctor, maybe he will be the one who finally says, “Yes. This is why your eye pain persists. Here is a prescription (or a treatment or heck, even a surgery, I'm game if it is a real answer). This will fix it.”

In my heart and mind, I know I am probably setting myself up for another disappointment.

But how do you stop hope? Especially when hope is all that keeps you going. Maybe today, maybe tomorrow. Maybe someday.  Maybe. Maybe. Maybe my pain will stop or be reduced to the level where I can work and be out in the world for as long and as much as I want. Dickinson said it. Hope "never stops at all.”

Bennett is wrong. My storm of living with pain has probably made me stronger. More resilient and more dogged, but it has lasted for 39 years. My storm of pain is a forever storm. Maybe it is time to let the hope go.

Franklin may have said it best, living on hope means that I die fasting and hungry. But what choice do I have?  Giving up hope would mean giving up the one thing that keeps me going. Even if the hope is false.

And who knows? Maybe tomorrow's doctor will have the magic pill.

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.

Chronic Pain Raises Risk of Dementia

By Pat Anson, Editor

Chronic pain has long been associated with a variety of health problems, including depression, anxiety, insomnia, high blood pressure and an impaired immune system. Now there’s something else to worry about.

A large new study by researchers at UC San Francisco has found that older people with chronic pain experience faster declines in memory and are more likely to develop dementia, an indication that chronic pain could cause changes in the brain. The study, published in JAMA Internal Medicine, appears to be the first to make this association.

UCSF researchers analyzed data from over 10,000 participants aged 60 and over who were enrolled an ongoing national study of older Americans. Patients were surveyed about their pain and cognition in 1998 and 2000.

Those who said they were persistently troubled by moderate or severe pain declined 9.2 percent faster in tests of their memory and cognitive ability over the next 10 years than those who said they were not troubled by pain.

The patients who complained about persistent pain also had a 7.7 percent greater chance of developing dementia.

“A persistent report of moderate to severe pain, which may reflect chronic pain, is associated with accelerated cognitive decline and increased dementia probability in a large population-representative data set of elders,” wrote first author Elizabeth Whitlock, MD, a postdoctoral fellow in the UCSF Department of Anesthesia and Perioperative Care.

“Clinicians should be aware of this association, which persisted after extensive statistical adjustment for confounding health and demographic factors. Patients reporting ongoing pain may be at higher risk for current and incident cognitive impairment and physical debility.”

Whitlock says the additional loss of memory in participants who reported persistent pain suggests that they will have a harder time with daily living tasks, such as managing their medications and finances.

"Elderly people need to maintain their cognition to stay independent," she said. "Up to one in three older people suffer from chronic pain, so understanding the relationship between pain and cognitive decline is an important first step toward finding ways to help this population."

The data that the researchers analyzed did not include information about opioid use, so researchers could not tell which of their participants were taking opioid painkillers. While opioid use could be the cause of the cognitive changes, so could the pain itself. For example, a recent study of chronic pain sufferers found that those who took non-steroidal anti-inflammatory drugs (NSAIDs) had nearly the same increased dementia risk as those taking opioids.

"This means we have to consider the potential direct effects of chronic pain on cognition," Whitlock said.

People who suffer from chronic pain tend to have diminished attention and impaired memory, and Whitlock says when pain is severe it could divert enough attention to interfere with the consolidation of memory. Another possibility is that the emotional stress of being in pain activates stress-hormone pathways in the body that have been implicated in cognitive decline. If either is the case, she said, then effectively treating the pain could protect cognition.

"This is something I really feel we can do something about as clinicians," Whitlock said. "It's part of taking care of the whole patient."

How Chronic Pain Changes Nerve Signals

By Pat Anson, Editor

Swedish researchers have developed a surprising new theory about what causes chronic nerve pain and why it is so difficult to treat.  

It has long been assumed that some sensory neurons only transmit pleasant tactile sensations, while others specialize in transmitting pain. But scientists at Karolinska Institutet have discovered that neurons that normally allow us to feel a caress or soft touch can switch roles and start signaling pain after nerve damage.

The researchers identified a small RNA molecule (microRNA) in neuron cells that regulates how touch is perceived. Levels of the molecule drop after neurons are damaged, which raises levels of a specific ion channel that makes the nerves sensitive to pain.

"Our study shows that touch-sensitive nerves switch function and start producing pain, which can explain how hypersensitivity arises," says Professor Patrik Ernfors at Karolinska Institutet's Department of Medical Biochemistry and Biophysics.

"What's interesting about our study is that we can show that the RNA molecule controls the regulation of 80 per cent of the genes that are known to be involved in nerve pain. My hope, therefore, is that microRNA-based drugs will one day be a possibility."

The research was primarily conducted on mice but also verified in tests on human tissue, where low microRNA levels could be linked to high levels of the ion channel and vice versa, suggesting that the mechanism is the same in humans. Researchers believe the study findings, published in the journal Science, could lead to more effective pain treatments   

"It's vital that we understand the mechanisms that lead to chronic nerve pain so that we can discover new methods of treatment," says Ernfors. "The pharmaceutical companies have concentrated heavily on substances that target ion channels and receptors in pain neurons, but our results show that they might have been focusing on the wrong type of neuron."

Neuropathy and chronic nerve pain are common conditions, but the drugs available to treat them have limited efficacy. One widely used medication that blocks ion channels -- gabapentin (Neurontin) – is only effective in about half of the patients who take it, according to Ernfors.

The Opioid Blame Game

By Roger Chriss, Columnist

Nearly 40 years after it was published, a short letter to the editor in The New England Journal of Medicine is today being blamed by various media outlets for having “kicked off” or “fueled” or “sparked” the opioid epidemic.

The one paragraph letter, written by researchers at Boston University Medical Center, has attracted media attention because of a new letter to the editor by Canadian academics Pamela Leung, Erin Macdonald, MD, PhD, Irfan Dhalia, MD, and David Juurlink, MD, PhD. They claim that the 1980 letter “was heavily and uncritically cited as evidence that addiction was rare with long-term opioid therapy.”

The authors are not the first to notice this. The New Yorker made the same claim in 2013, to little effect.

Now, however, the media has latched onto the 1980 letter’s statement that “addiction is rare in medical patients with no history of addiction,” by declaring it to be the spark that ignited an explosion of opioid overdoses and deaths.

If only it were that simple.

The opioid epidemic has already been blamed on OxyContin and Purdue Pharma, drug seeking pain patients, physician overprescribing and pill mills, and even a small study by Russell Portenoy, MD, in 1986.

But conspicuously absent are many other contributing factors, including:

• Managed healthcare looking for cheap treatment options
• Health insurers pushing to reduce healthcare costs
• Employers expecting workers to return to work sooner
• Patients wanting a quick pain cure

Another commonly cited villain is the campaign to treat pain as the "5th Vital Sign.” But that did not occur in a vacuum. The rise of chronic pain paralleled increasing levels of acute pain, for reasons such as:

• Better trauma care for car crash and gunshot victims
• Early and aggressive cancer care
• Increasing rates of diabetic neuropathy and amputation
• More injection therapy and surgery to treat damage and deterioration in the spine and joints

Medical care improved in many important ways in the 1980’s, including the advent of minimally invasive surgery and chemotherapy for a wide variety of cancers, as well as the discovery of drugs that turned once deadly diseases like AIDS and leukemia into chronic conditions that could be medically managed. There have also been many well-intentioned attempts to treat increasingly common degenerative diseases and disorders that may have caused more pain in some patients.

In other words, there is plenty of blame to go around. But media coverage ignores these larger issues.

Instead, CNN draws a parallel between the 1980 letter and a lawsuit filed last week by Ohio’s Attorney General against five opioid manufacturers. And the CBC’s coverage includes a link to a 2011 YouTube video produced by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), perhaps because David Juurlink himself is on the PROP Board of Directors. An old lecture on the evils of opioids is beside the point here

The real question here is: Does finger pointing at a NEJM letter from 1980 help people today who are suffering from opioid addiction?

The research literature on opioid addiction in the 1970’s and 80’s strongly resembles today’s efforts. Even high school health classes back then discussed methadone clinics and medication-assisted treatment, the importance of long-term maintenance therapy, and the value of safe injection sites and needle exchange programs for heroin users.

This leads to a far more important question: Why aren’t we using these treatments more widely?

This blame game isn’t helping opioid addicts. As media reports identify the 1980 letter as another target of blame for the opioid crisis, we should be asking why we’ve made so little progress since then in treating addiction.

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.

New Drug Testing Guideline Warns Against Fraud

By Pat Anson, Editor

A new guideline on the use of drug testing by the American Society of Addiction Medicine (ASAM) warns against expensive and unnecessary tests that have led to “unethical and/or fraudulent activities.”

The ASAM is a professional society that represents over 4,300 physicians and specialists in addiction treatment. Its new guideline – the first attempt to set national standards for clinical drug testing – could also influence primary care providers and pain management specialists who are increasingly testing their patients for opioid misuse.  

"Drug testing is a valuable tool for supporting patients in addiction treatment, and this comprehensive set of recommendations should prove useful to providers in a variety of addiction treatment settings," said Margaret Jarvis, MD, Chair of ASAM's Quality Improvement Council.

The new guideline, developed by an 11-member expert panel, is published in the Journal of Addiction Medicine.

“ASAM is acutely aware that this document will be released in a context where a lack of clarity about the appropriate use of drug testing has led not only to inconsistent clinical practice, but also unethical and/or fraudulent activities,” the guideline says.

“One of the purposes of this document is to clarify appropriate clinical use of drug testing and, in so doing, shine a light on drug-testing practices that are clearly outside of these boundaries. The delineation of appropriate treatment practices will confer multiple benefits; most importantly, it will improve patient care. At the same time, it will reduce waste and fraud.”

Drug testing has grown into a multi-billion dollar industry – what some call “liquid gold” – largely because so many doctors who treat addicts and chronic pain patients require them to submit to urine drug screens. Many experts consider the “point-of-care” immunoassay tests widely used in doctors’ offices unreliable because they often give false negative or false positive results.

Several drug testing laboratories have also paid heavy fines to settle fraud and kickback charges after they bilked Medicare, Medicaid, private insurers, and patients for unnecessary and expensive lab tests. The practice was so egregious that the Department of Health and Human Services issued a Special Fraud Alert in 2014 to warn physicians not to accept any payments, referrals, rent or reimbursements from drug testing companies.

The new ASAM guidelines say drug tests "should be widely used in addiction treatment settings," but warn that negative or positive findings about a patient’s use of drugs do not necessarily mean they have a substance use disorder. A patient who consumes poppy seeds, for example, could have a positive finding for morphine.

“The list of potential sources of false positives is too extensive to list here, but a few noted examples include; cough suppressants resulting in positive opioid results, ephedrine in cold medicine resulting in positive result for amphetamines, and antidepressants resulting in positive opioid results,” the guideline says.

“There are known limitations to urine immunoassays for opiate use and providers should be cautious when interpreting their results. Providers should carefully review the testing report produced by the laboratory to ensure they understand which opiates and opioids a test is capable of detecting.”

The ASAM’s expert panel said there was no “magic formula” to determine how often a patient should be drug tested. Testing should be done at least weekly at the beginning of addiction treatment, according to the guideline, and at least monthly in patients in stable recovery. Testing should be performed on a random schedule, when possible.

The guideline also cautions physicians not to be confrontational with patients if a test has an unexpected finding.

“Drug testing should function as a therapeutic tool, so a provider's response to test results should not be confrontational. This approach can perpetuate an ‘us versus them’ mentality that reduces the effectiveness of drug testing to support recovery,” the guideline says.

The ASAM guideline also advises physicians on other issues such as urine tampering, patient confidentiality, practitioner education, and how to select reliable tests and laboratories.

Utah Raid Uncovered Large Fentanyl Pill Ring

By Pat Anson, Editor

A drug bust in a Utah home last November has uncovered one of the largest counterfeit pill operations in U.S. history.

This week a federal grand jury in Salt Lake City indicted six individuals for manufacturing nearly 500,000 pills laced with illicit fentanyl that were disguised to look like the painkiller oxycodone and the anti-anxiety drug alprazolam (Xanax). The counterfeit pills were distributed throughout Utah and the United States to customers who ordered them online.

Fentanyl is a powerful synthetic opioid that it is 100 times more potent than morphine and 50 times more potent than heroin. In recent years, illicit fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada.

“What we feared and hoped somehow would stay away has arrived in spades,” said Brian Besser, the DEA’s agent in charge in Utah. “Fentanyl is as dangerous as it gets.”

According to documents filed in federal court, the pill ring was created by Aaron Shamo and Drew Crandall, both Utah residents who worked together at eBay, but quickly grew to include the other conspirators. Prosecutors say the defendants purchased pill presses, dies and stamps so the counterfeit pill markings would match those of legitimate pharmaceutical drugs. Some items were purchased legally and others, such as fentanyl and alprazolam, were illegally imported from China

The fake pills were sold on a “dark net online store” at a significant profit. Once sold, Shamo and Crandall used their co-conspirators to package the pills and ship them to customers. In less than a year, the operation mailed 5,606 drug orders totaling $2.8 million, according to court documents.

“Shamo’s customer base was extremely comprehensive and widespread, touching every corner of the United States,” Besser said. “It touched large cities and rural communities.”

The round blue tablets manufactured by the pill ring were offered for sale online as oxycodone 30mg tablets. The tablets were debossed with “A 215” on the bisected side, with an “M” on one side and a “30” above the bisect on the other side. The indictment alleges the defendants did not use oxycodone at all in the manufacturing process, but instead used illicit fentanyl.

Federal agents arrested Shamo last November. During a raid on Shamo’s suburban Salt Lake City home, agents discovered a pill press capable of manufacturing several thousand pills an hour. Agents also seized 70,000 pills and $1.2 million in cash stuffed in garbage bags.

Crandall fled to Australia with his girlfriend and was in Laos when agents raided Shamo’s house. He was arrested last month in Hawaii. A summons will be issued for the other four conspirators for their initial appearances in federal court.

Research Uncovers Why Some Pain Meds Don’t Work

By Pat Anson, Editor

An international team of researchers may have discovered why some pain medications are inneffective: they target receptors on the surface of nerve cells that have moved out of reach.

Their findings, published in the journal Science Translational Medicine, may lead to the development of a new class of pain medication that is more potent and less prone to side effects than opioids and non-steroidal anti-inflammatory drugs (NSAIDs).

"Opioids and NSAIDs do not work for everyone and have unacceptable side effects, particularly when used over a long period of time," said Nigel Bunnett, PhD, a professor of surgery and pharmacology at Columbia University Medical Center.

"However, previous efforts to develop more effective analgesics have been stalled by our limited understanding of the mechanisms that allow nerves to sense and transmit pain signals."

Many pain medications work by targeting protein receptors on the surface of nerve cells that transmit pain signals. One receptor – known as the neurokinin 1 receptor (NK1R) -- causes pain and inflammation when activated.

In a series of laboratory experiments on rodents, Bunnett and his colleagues discovered that NK1R, when stimulated by pain, quickly moves from the cell surface to inside the cell membrane, where it continues to function outside the reach of pain medication. Researchers found that when they added a lipid (fat molecule) to painkillers that can cross the cell membrane, they effectively blocked NK1R and provided potent and durable pain relief to the rodents.

"From these experiments, we have demonstrated that designing NK1R inhibitors that are capable of reaching the endosomal network within nerve cells may provide much longer-lasting pain relief than currently available analgesics," said Bunnett. "We think that modification of many existing compounds, as we did with NK1R inhibitors, may have the potential to enhance the effectiveness of many different classes of medications."

The next step for researchers is to see if the same results can be found in humans. If proven, it could mean that current pain medications could be redesigned to make them more effective.

"This is a proof-of-concept study that shows that we can re-engineer current pain drugs and make them more effective. The challenge is now to translate the technology into human clinical trials. This is a complex and challenging path – but the ultimate benefits to patients with nerve pain are potentially highly significant," said Dr. Meritxell Canals of Monash Institute of Pharmaceutical Sciences at Monash University in Australia.

The study was supported by grants from Australia’s National Health and Medical Research Council, the Australian Research Council, and Takeda Pharmaceuticals.

Marijuana Medication: Hope or Hype?

By Pat Anson, Editor

A Las Vegas company that is developing a new cannabis-based treatment for chronic pain has lost money since its inception and there is “substantial doubt” about its ability to survive, according to reports filed with the Securities and Exchange Commission (SEC).

But don’t give up on GB Sciences just yet, says its new chairman and CEO.

“We’re not as financially lame as you might suspect,” John Poss told PNN. “We’ve really done some interesting and groundbreaking research into cannabis.”

Last week GB Sciences issued a press release touting an application by its subsidiary, Growblox Life Sciences, for a patent on new treatments for chronic pain and heart conditions. The company claims to be developing “novel pain formulations” that are substantially free of delta-9 tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis.

"These new chronic pain and heart formulas adhere to GB Science's strategy of commercializing complex mixtures of cannabis-derived compounds whose pharmaceutical activity does not require THC,” Poss said in the news release.

But a review of GB Sciences’ most recent quarterly report with the SEC could raise some doubts among pain patients and investors about whether the company has the resources to develop a cannabis medication. At the end of 2016, GB Sciences had no revenue and over $28 million in debt and liabilities.

“These factors, among others, raise substantial doubt about the Company's ability to continue as a going concern,” the quarterly report says.

But Poss maintains GB Sciences turned a corner in March after raising $9 million from investors. A marijuana grow facility in Las Vegas has also come on line and will soon be producing revenue. Poss thinks the company will be breakeven in cash flow by early next year and could launch a small pilot study of its cannabis medication.  

“Either we have something or we don’t. And we’ll find out within a year. If we have something or at least a strong indication that we have something, then our ability to raise money to do a formal clinical trial is greatly enhanced,” said Poss, who hopes to eventually partner GB Sciences with another larger company.

“Before we make bold statements about spending $100 million, we need to spend half a million and find out if it works, which not everyone can do. And we can do that.”   

GB Sciences’ stock (GBLX) trades on the over-the-counter “Pink Sheet” market for about 26 cents a share. Historically, the company paid its executives, creditors, and partners with millions of new shares, stock options and warrants, which diluted the value of existing shares. It also gave the company a reputation as a “pump and dump” operation, which Poss says he is working hard to change.

Where is Cannabis Science’s Pain Patch?

Another financially challenged company is California-based Cannabis Science, which claims to be developing a variety of cannabis-based pain therapies. When we first told you about this “fundamentally unsound company” last November, it had just released a press release announcing plans to develop a cannabis-based skin patch to treat fibromyalgia and diabetic neuropathy. 

In February, another press release was issued by Cannabis Science saying the company was working on the “final packaging” of the pain patch and would be distributing it to marijuana dispensaries in California “very soon.”

In March, a third press release said the pain patches “are about to hit the market.”

There’s been no further word from Cannabis Science about the pain patch, although the internet is full of stories about the “revolutionary” pain patch “that delivers powerful pain-fighting medicine through the skin and into the bloodstream.” There’s even a creepy video on YouTube in which a robotic computer-generated voice claims “there’s a strong possibility that the patches even cure these health problems.”

Which would be terrific news – if the patches actually existed. Calls and emails to the company asking for an update on the patch were not returned. 

At the time of its first press release on the pain patch, Cannabis Science stock (CBIS) was trading for less than six cents a share. Three months later – no doubt fueled by the hype over its pain patch -- the stock doubled in value to nearly 13 cents a share. During that time, company insiders sold over 12,000,000 shares for over $500,000.  

That’s not a bad take for executives working for a company that generated only $9,263 in revenue during all of 2016 and posted an operating loss of nearly $10 million.

“At this time, our ability to generate any significant revenues continues to be uncertain.  There is substantial doubt about our ability to continue as a going concern,” Cannabis Science says in its annual report to the SEC, which was filed last month.

“The Company is undercapitalized, and will be reliant on outside financing from sales of securities or issuance of debt instruments.  Management expects many traditional lenders will be reluctant to provide the Company with capital in light of its financial condition and the nature of its expected business; so that any financing activities will likely be expensive and result in dilution to stockholders of the Company.”

All of this should be no surprise to people familiar with Cannabis Science CEO Raymond Dabney, who is no stranger to accusations of stock manipulation. In 2005, Dabney admitted issuing 22 bogus news releases to promote another penny stock in Canada. For that he received a five year trading ban from British Columbia’s Securities Commission, according to Forbes and the Vancouver Sun.

At various times in its history, Cannabis Science has gone under the name Patriot Holdings, National Healthcare Technology, Brighton Oil & Gas, and Gulf Onshore.

“I'm not sure if Cannabis Science is a biotech firm, an oil and gas exploration company, an educational university or a pot distributor, the only thing I am certain of is that Cannabis Science is in the business of moving money from public investors to executives' pockets,” wrote John Brody Gay in a lengthy analysis published by Seeking Alpha, an investing website.

Gay and other analysts say Cannabis Science is a classic pump and dump penny stock that produces little revenue, only a steady stream of press releases to promote its business activities, which never seem to come to fruition.

Often other websites are hired by pump and dumpers to publish their press releases or write glowing reviews about a company known as “advertorials.” The publicity generates a flurry of interest in the company’s stock, which is when executives and other insiders often sell their shares.

In 2014, the SEC issued an investor alert about marijuana stock scams, warning specifically about false and exaggerated claims made in press releases. The advice still holds true today for investors, as well as pain patients.

“Fraudsters often exploit the latest innovation, technology, product, or growth industry – in this case, marijuana – to lure investors with the promise of high returns.  Also, for marijuana-related companies that are not required to report with the SEC, investors may have limited information about the company’s management, products, services, and finances.  When publicly-available information is scarce, fraudsters can more easily spread false information about a company, making profits for themselves while creating losses for unsuspecting investors,” the SEC said.

In March, the SEC charged the founder of a California--based marijuana company with fraud for falsely touting “record” revenue numbers in press releases.

Medbox founder Vincent Mehdizadeh bragged in a text message that “the only thing we are really good at is public company publicity and stock awareness.  We get an A+ for creating revenue off sheer will but that won’t continue.” 

Mehdizadeh settled the SEC charges by agreeing to pay $12 million in penalties.

Chronic Pain Patients Did Not Cause Opioid Epidemic

By Roger Chriss, Columnist

Contrary to common belief, chronic pain patients are not all opioid addicts and did not cause the opioid crisis. The vast majority of patients who are prescribed opioids rarely misuse or abuse them.

Opioid addiction is real and should not be ignored or downplayed, but we need to identify its true causes. Despite the growing number of restrictions on prescription opioids, overdoses and related deaths continue to rise, which strongly indicates that pain patients have very little to do with the so-called epidemic.

Some recent articles bear this out:

Science Daily reports that while the national death toll from opioid overdoses is soaring, only “a small minority of pain patients are represented in the mortality data.”

The journal Pain Medicine published research showing that most pain patients on low doses of short-acting opioids “have a low risk for developing a substance use disorder.”

Similarly, chronic pain patients generally do not experience dose escalation, but often remain stable at the same dose for months or even years. And according to the National Institute of Drug Abuse, doctor shopping by pain patients is rare.

For most chronic pain patients, opioid medications are part of a larger daily routine of pain management, and opioids are not craved any more than an athlete craves a vitamin supplement. Thus, the risks of opioid addiction among chronic pain patients is quite low overall, and there are well-established protocols such as the Opioid Risk Tool to screen patients and monitor those whose risk may be higher.

But all this evidence does not seem to convince regulators, politicians, the news media, and anti-opioid activists like Physicians for Responsible Opioid Prescribing (PROP). Fortunately, it can be clearly shown they are wrong and that chronic pain patients are unfortunate bystanders in the opioid epidemic.

First, there simply are not enough chronic pain patients on opioid therapy to account for the number of opioid and heroin addicts. The American Society of Addiction Medicine estimates that in 2016 there were over 2.5 million people addicted to prescription pain relievers or heroin.

There are at most 11.5 million chronic pain patients on opioid therapy. Even if 5 percent of them develop a substance abuse disorder, that would give us 575,000 opioid addicts. Where did the other 2 million addicts come from?

Second, people who suffer from chronic pain disorders are no longer prescribed opioids lightly or quickly. Instead, they start with NSAIDs like ibuprofen or naproxen, then onto anti-seizure medications like gabapentin or anti-depressants like amitriptyline or duloxetine, all the while also trying physical therapy, injections or other modalities. They are carefully screened, monitored and assessed along the way, with opioids considered only if everything else fails. This makes addiction a rare outcome.

Third, media coverage of the opioid epidemic and case literature on opioid use disorder routinely describe people becoming addicted to opioids after recreational use, trauma or surgery. It may be that “opioid addiction often starts with a prescription,” but it is usually a prescription for acute pain. And for many, the addiction starts with someone else’s prescription, perhaps taken from a family member or obtained from a friend.

Therefore, the treatment of chronic pain conditions can at most have only minimally contributed to the opioid epidemic. Chronic pain patients are not opioid addicts any more than a diabetic is an insulin addict, and in fact insulin is abused.

Unfortunately, chronic pain patients are often treated like addicts and the doctors who prescribe to them are even called “drug dealers.” This is harming chronic pain patients, doctors and people suffering from opioid addiction.

Opioid therapy helps people with chronic pain disorders remain employed, care for themselves and their families, and contribute to and participate in their communities. They are achieving what modern medicine and society wants: people who can work, pay taxes, avoid becoming a burden, and enjoy some quality of life.

Restricting opioids is not slowing the opioid epidemic. The increased availability of naloxone and improved care by first responders and emergency departments is helping to reduce fatalities, but opioid addiction still needs treatment and at present there is not enough of it.

To be clear, chronic pain patients and opioid addicts are two distinct groups, both of which deserve care and support. Treating pain patients as addicts can lead to denial of care, which may actually increase the number of opioid addicts. And conflating chronic pain with opioid addiction may be delaying care for people struggling to find addiction treatment.

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.

Can Vitamin D and Good Sleep Reduce Pain?

By Pat Anson, Editor

Vitamin D supplements, along with good sleeping habits, could help manage chronic pain from fibromyalgia, rheumatoid arthritis, back pain and other conditions, according to a new study.

The importance of vitamin D – the “sunshine vitamin” – in maintaining bone strength and overall health has long been known.  But recent research has focused on the role it plays in inflammation, musculoskeletal pain and sleep disorders.

“Vitamin D status seems to have an important role in the bidirectional relationship observed between sleep and pain,” said senior author Dr. Monica Levy Andersen in the Journal of Endocrinology. “We can hypothesize that suitable vitamin D supplementation combined with sleep hygiene may optimize the therapeutic management of pain-related diseases, such as fibromyalgia."

Andersen and her colleagues at Universidade Federal de Sao Paulo in Brazil reviewed 35 clinical studies of vitamin D, and concluded that vitamin D supplements could increase the effectiveness of pain treatments by stimulating an anti-inflammatory response.

"This research is very exciting and novel. We are unraveling the possible mechanisms of how vitamin D is involved in many complex processes, including what this review shows - that a good night's sleep and normal levels of vitamin D could be an effective way to manage pain," said Sof Andrikopoulos, assistant professor at the University of Melbourne and Editor of the Journal of Endocrinology.

Sources of Vitamin D include oily fish and eggs, but it can be difficult to get enough through diet alone. Ultraviolet rays in sunlight are a principal source of Vitamin D for most people.

Several recent studies have found an association between chronic pain and low levels of Vitamin D in the blood.  Researchers at National Taiwan University Hospital found low levels of serum vitamin D in over 1,800 fibromyalgia patients. Danish researchers have also found an association between lack of sunlight and multiple sclerosis.

But some question quality of the studies and whether Vitamin D supplements do any good.

“Evidence does not support vitamin D supplementation for the treatment of multiple sclerosis and rheumatoid arthritis or for improving depression/mental well-being,” wrote Michael Allan, a professor of Family Medicine and director of Evidence Based Medicine at the University of Alberta in the Journal of General Internal Medicine.

Allan says much of the research is of low quality. He doesn’t dispute the overall health benefits of Vitamin D – such as building strong bones and teeth -- but thinks taking supplements is unnecessary and could even be harmful in large doses.

"The 40 year old person is highly unlikely to benefit from vitamin D," said Allan. "And when I say highly unlikely, I mean it's not measurable in present science."