Prescribed Opioids Not Linked to Veterans’ Heroin Use

By Pat Anson, Editor

A new study of U.S. military veterans found a strong link between heroin use and the abuse of opioid pain medication, but with an important caveat:  the heroin use was associated with the non-medical use of opioid painkillers.

Having chronic pain was also not found to be a significant risk factor for heroin use.

The ten-year study by researchers at Brown and Yale Universities followed nearly 3,400 veterans at nine Veterans Affairs facilities who were participating in the Veterans Aging Cohort Study (VACS).

Of the 500 veterans who started using heroin during the study, 386 of them also began using prescription painkillers non-medically.

"Our findings demonstrate a pattern of transitioning from non-medical use of prescription opioids to heroin use that has only been demonstrated in select populations," said study co-author David Fiellin, a Yale public health and medical professor and director of the VACS study.

"Our findings are unique in that our sample of individuals consisted of patients who were receiving routine medical care for common medical conditions."

Even after statistically accounting for other risks -- such as race, income, use of other drugs, post-traumatic stress disorder (PTSD) and depression -- researchers found that veterans who began misusing painkillers were 5.4 times more likely to begin using heroin. Other major risk factors for heroin use include being male (2.6 times greater risk) and abusing stimulant drugs (2.1 times greater risk).

Veterans who received a short-term prescription for an opioid medication had a 1.7 times greater risk of starting heroin. But having a long-term prescription for opioids was not found to be a significant risk factor. And neither was having chronic pain.

“In our final model, pain interference in daily life was not a significant predictor of heroin initiation,” said lead author Brandon Marshall, an assistant professor in the Brown University School of Public Health.

Despite those findings, researchers recommend that all veterans should be screened for painkiller abuse, including those with legal prescriptions.

"This paper shows that, as a general clinical practice, particularly for this population which does experience a lot of chronic pain and other risks for substance use including PTSD, screening for non-medical painkiller use, whether you are prescribing an opioid or not, may be effective to prevent even more harmful transitions to heroin or other drugs," said Marshall, adding that veterans have a "constellation of risks" for substance abuse.

The study, published in the journal Addiction, did not identify the source of the opioids that were used non-medically. The National Institutes of Health and the U.S. Department of Veterans Affairs supported the study.

Under a federal spending bill passed by Congress and signed into law last year by President Obama, the Veteran’s Administration is required to follow the CDC's “voluntary” opioid guidelines, which discourage opioid prescribing for chronic pain. Since those guidelines were adopted, many veterans have complained to Pain News Network that their opioid doses have been reduced and they live in daily pain.

“They just cut my meds to one oxycodone every 12 hours, which gives me absolutely no relief,” wrote Harvey Williams, a Vietnam vet. “There must be something that the Veterans Administration can do to treat severe pain in the Vets. It's not fair for us to be sprayed with Agent Orange, return back to the United States, develop diabetes and in turn have severe neuropathy and pain for the rest of our lives and not be treated.”

“My VA doctors did not exam me prior to (cutting) my prescriptions,” wrote retired Army Capt. William Green, a Desert Storm veteran. “I asked how they decided to start reducing when I was reporting ongoing 6-8 on 10 pain scale. He didn't even consult with the doctor I do get ongoing treatment from. The doctor said, ‘We don’t care. We are following CDC guidelines.’”

The VA provides health services to 6 million veterans and their families. Over half of the veterans treated by the VA have chronic pain.   

Counterfeit Pain Meds Found in Prince’s Home

By Pat Anson, Editor

Counterfeit pain medication laced with fentanyl was found in the home of the late pop star Prince, a source with knowledge of the investigation into the his death has told the Minneapolis Star Tribune.

Prince was found dead in his Paisley Park home on April 21 and speculation immediately focused on a possible opioid overdose. A medical examiner later reported that Prince died from an accidental overdose of fentanyl, but did not say where the drug came from.

Prince did not have a prescription for fentanyl, which is used in skin patches and lozenges to treat chronic pain. He died less than a week after his private plane made an emergency landing in Moline, Illinois, where paramedics reportedly treated him for an opioid overdose.

Recently, the Drug Enforcement Administration reported the U.S. was being “inundated” with hundreds of thousands of fake pills made with illicit fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine. Dozens of deaths have been blamed on the fake pills.

The Star Tribune’s source said Prince weighed only 112 pounds at the time of his death and had so much fentanyl in his system that it would have killed anyone.

Despite the finding, investigators still aren’t sure how the 57-year-old musician ingested the fentanyl. However, they are leaning toward the theory that he took fake pills disguised as hydrocodone, not knowing they contained fentanyl, according to the Star Tribune.

If so, that would make Prince the most high-profile victim of the fast growing fentanyl crisis. Several states in the Northeast and Midwest have recently reported that most of their fatal overdoses are now caused by illicit fentanyl, not opioid pain medication.

A source told the Associated Press that several pills found in Prince’s home were labeled as “Watson 385” – a stamp used to identify generic pills containing hydrocodone and acetaminophen sold under the brand name Lortab. When one of those pills was tested, it was found to contain fentanyl and lidocaine.

The Star Tribune reported that Prince was found in his home wearing a black shirt and pants — both were on backward — and his socks were inside-out. Prince appeared to have been dead for several hours before his body was found in an elevator.

In addition to fentanyl, sources told the newspaper that lidocaine, Percocet and alprazolam were found in Prince’s system. Alprazolam is the generic name for Xanax, an anti-anxiety medication. Counterfeit versions of Xanax made with fentanyl have also been blamed on several deaths.

“The counterfeit pills often closely resemble the authentic medications they were designed to mimic, and the presence of fentanyls is only detected upon laboratory analysis,” the DEA warned in an unclassified report last month.

“Fentanyls will continue to appear in counterfeit opioid medications and will likely appear in a variety of non-opiate drugs as traffickers seek to expand the market in search of higher profits. Overdoses and deaths from counterfeit drugs containing fentanyls will increase as users continue to inaccurately dose themselves with imitation medications.”

Two public health researchers recently speculated that a “malicious actor” may be intentionally poisoning people with counterfeit medication made with fentanyl. However, a DEA spokesman said that was unlikely.

“If you’re a drug trafficker, you don’t want to poison people. You want a regular customer base,” Rusty Payne said.

‘Weird and Cool’ Discovery Could Lead to Safer Opioid

By Pat Anson, Editor

A “weird and cool” discovery by a team of international researchers could lead to the development of a new opioid medication that relieves pain without the risk of abuse and overdose.

In a case of reverse engineering, scientists in the U.S. and Germany deciphered the atomic structure of the brain’s mu-opioid receptor and then designed a drug – called PZM21 – that activates the receptor without the typical side effects of opioids. In experiments on mice, PZM21 did not cause drug-seeking behavior and did not interfere with breathing – the main cause of death in opioid overdoses.

“With traditional forms of drug discovery, you’re locked into a little chemical box,” said Brian Shoichet, PhD, a professor of pharmaceutical chemistry at UC San Francisco’s School of Pharmacy.

“But when you start with the structure of the receptor you want to target, you can throw all those constraints away. You’re empowered to imagine all sorts of things that you couldn’t even think about before.”

Shoichet and colleagues at Stanford University, the University of North Carolina and the Friedrich Alexander University in Erlangen, Germany published their findings in the journal Nature.

"This promising drug candidate was identified through an intensively cross-disciplinary, cross-continental combination of computer-based drug screening, medicinal chemistry, intuition and extensive preclinical testing," said Brian Kobilka, MD, a Nobel Prize winner and professor of molecular and cellular physiology at Stanford. It was Kobilka who first established the molecular structure of the opioid receptor.

Shoichet and his research team conducted roughly four trillion “virtual experiments” on UCSF computers, simulating how millions of different drug candidates could turn and twist in millions of different angles – called “molecular docking” -- to see how they fit into a pocket on the receptor and activate it. They avoided using molecules linked to the respiratory suppression and constipation typical of other opioids.

This led to the development of PZM21, which efficiently blocked pain in mice without producing the constipation and breathing suppression typical of other opioids. PZM21 also appears to dull pain by affecting opioid circuits in the brain only, with little effect on opioid receptors in the spinal cord. No other opioid has that effect, which Shoichet says is “unprecedented, weird and cool.”

The drug also didn’t produce the hyperactivity that other opioids trigger in mice by activating the brain’s dopamine systems. The mice did not display drug-seeking behavior by spending more time in chambers where they had previously received doses of PZM21.

“After we replicated the lab experiments and mouse studies several times, then I became excited about the potential of this new drug,” said Bryan Roth, MD, a professor of pharmacology and medicinal chemistry at University of North Carolina.

Researchers say more work is needed to establish that PZM21 is truly non-addictive, and to confirm that it is safe and effective in humans.

 “We haven’t shown this is truly non-addictive,” Shoichet cautioned. “At this point we’ve just shown that mice don’t appear motivated to seek out the drug.”

Acetaminophen Linked to Kids’ Behavior Problems

By Pat Anson, Editor

Another study has linked acetaminophen to attention deficit and other behavioral problems in children whose mothers used the over-the-counter pain reliever while pregnant.

"Children exposed to acetaminophen use prenatally are at increased risk of multiple behavioral difficulties,” said lead author Evie Stergiakouli, PhD, of the University of Bristol. “Given the widespread use of acetaminophen among pregnant women, this can have important implications on public health advice.”

The study, published in JAMA Pediatrics, involved nearly 7,800 mothers in the UK who used acetaminophen in 1991 and 1992.

Prenatal use of acetaminophen in the second and third trimesters was associated with a higher risk of behavior problems and hyperactivity in children. Use of acetaminophen at 32 weeks of pregnancy was also associated with a higher risk for emotional problems.

“We found stronger association between maternal acetaminophen use and multiple behavioral and emotional problem domains during the third trimester than during the second trimester, in agreement with previous studies that have included multiple measurement times during pregnancy," said Stergiakouli. 

"Given that there is active brain development and growth during the third trimester, this finding could indicate that there are developmental periods when the brain is more sensitive to acetaminophen exposure.” 

Acetaminophen (paracetamol) is one of the most widely used pain relievers in the world. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Researchers say over half the pregnant women in the United States and European Union use the drug.

"The risk of not treating fever or pain during pregnancy should be carefully weighed against any potential harm of acetaminophen to the offspring," said Stergiakouli. 

A recent study of over 2,600 Spanish women linked acetaminophen to autism and attention deficit problems in their children. Studies in Denmark and New Zealand have also linked acetaminophen with a higher risk of hyperkinetic disorders and attention-deficit hyperactivity disorder (ADHD).

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash.

5 Myths About the CDC Opioid Guidelines

By Pat Anson, Editor

In a recent survey of nearly 2,000 pain patients, over two-thirds said their opioid medication has either been reduced or stopped by their doctor since the CDC’s opioid prescribing guidelines were released.

That’s either a remarkable degree of compliance with guidelines that are supposed to be voluntary or a sign they are being rigidly adopted and implemented by physicians, regardless of the impact on patients. Judging by the comments we’ve received from readers, it’s the latter.

“With the new guidelines for opioids, I’ve been caught up in having my meds cut in half. I can’t physically function through the day and I suffer in pain, which doesn’t seem to mean anything to my physician,” said Brett.

“The specialist who manages my pain medications says that it is a federal guideline that they are not allowed to modify in any way, even according to patient need,” said Diane.

“The nurse told me that no other doctor would prescribe me this (opioid) medication, because the new law states only cancer patients and end of life patients could have long term opioids,” wrote Deanna.

These comments reflect some of the myths that have developed since the CDC guidelines were released in March. Let’s look at five of them.

Myth #1: The CDC prescribing guidelines are mandatory

False. The guidelines are voluntary and intended only for primary care physicians, yet they are being widely implemented by many prescribers, including pain management specialists and even some oncologists. Here is what the guidelines actually say:

"This guideline provides recommendations for the prescribing of opioid pain medication by primary care providers for chronic pain in outpatient settings outside of active cancer treatment, palliative care, and end-of-life care. Although the guideline does not focus broadly on pain management, appropriate use of long-term opioid therapy must be considered within the context of all pain management strategies… The guideline offers recommendations rather than prescriptive standards; providers should consider the circumstances and unique needs of each patient."

The voluntary nature of the guidelines was reinforced in a recent letter to a pain patient by Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention, which oversaw the guidelines’ development.

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain,” wrote Houry in her letter to Rich Martin, a retired pharmacist disabled by chronic back and hip pain. 

“The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

To see Houry’s letter and perhaps even print a copy for your doctor, click here.

Myth #2: The guidelines establish a limit on the highest dose of opioids

False. The guidelines recommend that prescribers should “use caution” when prescribing opioids at any dose and “additional precautions” when dosages exceed 50 mg (morphine equivalent) a day. Prescribers are warned to “generally avoid” increasing dosages over 90 mg a day, but are never told they cannot exceed it.

The guidelines are also written in a way that emphasize the dosing recommendations are mainly intended for new patients, not established patients who’ve been on high opioid doses for years without any problems. The guidelines recommend that physicians “collaborate” with those patients on a new treatment plan – a practice known as informed consent:

"Established patients already taking high dosages of opioids, as well as patients transferring from other providers, might consider the possibility of opioid dosage reduction to be anxiety-provoking, and tapering opioids can be especially challenging after years on high dosages because of physical and psychological dependence… For patients who agree to taper opioids to lower dosages, providers should collaborate with the patient on a tapering plan. Experts noted that patients tapering opioids after taking them for years might require very slow opioid tapers as well as pauses in the taper to allow gradual accommodation to lower opioid dosages."

Still, many patients say they are being abruptly tapered to lower doses without having any input into the decision.

“I have severe chronic pain issues along with fibromyalgia and was barely getting by on 150 mg opioids per 24 hours, and now am being tapered down to the new 90 mg in 24 hours. I have gone from being relatively functional to nearly home bound,” said Diane.

“My pain management doctor announced to me, that he and his two other partners in the pain management clinic, are reducing all non-cancer chronic pain patients to the CDC's guideline of 90 mg morphine equivalent.  He told me they had to follow these guidelines,” says Rich Martin. 

Myth #3: The guidelines require doctors to drop patients if they fail a drug test

False. The guidelines specifically recommend against this practice:

"Providers should not terminate patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources and the provider missing opportunities to facilitate treatment for substance use disorder."

Yet patients tell us they’re being dropped after just one failed test.

“I have been in pain management for the past 8 years. Suddenly, I went to my appointment one day the doctor rudely told me that I'm not welcome back and the reason I even have an appointment is because they want to tell me I failed my UA (urine test) for cocaine," wrote on patient.

"First of all, I don't do cocaine. I smoked weed. How come I would test positive for cocaine but not for weed?”

As Pain News Network has reported, the point-of-care (POC) urine drug tests widely used by doctors are wrong about half the time -- frequently giving false positive or false negative results for drugs like oxycodone, methadone, methamphetamines and antidepressants.

According to one study, POC tests give false positive readings for cocaine about 12 percent of the time, and they fail to find signs of marijuana – a false negative -- about 21 percent of the time.

The guidelines suggest that prescribers not even test for THC – the active ingredient in marijuana:

"Providers should not test for substances for which results would not affect patient management or for which implications for patient management are unclear. For example, experts noted that there might be uncertainty about the clinical implications of a positive urine drug test for tetrahydrocannabinol (THC)."

The CDC admits urine drug tests “can be subject to misinterpretation” but recommends their use anyway, before opioid therapy begins and at least once annually thereafter.  If “unexpected results” are found, the guidelines say they should be verified by more expensive laboratory tests.

Myth #4: The guidelines will help reduce opioid abuse and overdoses

The early results are not promising. The prescribing of opioid pain medication was in decline years before the guidelines were issued, yet overdose death rates continued climbing. In recent months, opioid overdoses in several northeastern states have spiked, with most of the deaths blamed on illicit fentanyl smuggled into the country from China, Mexico and Canada.

Most disturbingly, drug traffickers are learning how to manufacture counterfeit pain medication with fentanyl. The DEA says the U.S. is being “inundated” with hundreds of thousands of these fake pills. It’s not just street addicts being victimized by the fentanyl scam. Some are pain patients who turned to the black market for relief because they could no longer get opioid prescriptions legally.

“Fentanyls will continue to appear in counterfeit opioid medications and will likely appear in a variety of non-opiate drugs as traffickers seek to expand the market in search of higher profits. Overdoses and deaths from counterfeit drugs containing fentanyls will increase as users continue to inaccurately dose themselves with imitation medications,” the DEA said in a report this summer.

counterfeit oxycodone

Pain patients predicted that illegal drug use would soar in a survey conducted by Pain News Network and the International Pain Foundation last October. Asked what would happen if the CDC guidelines were adopted, nearly 60% said pain patients would get their opioids through other sources or off the street. Another 72% said use of heroin and other illegal drugs would increase. And 78% predicted more patient suicides.

Could the CDC have seen this coming? In its urgency to get the guidelines adopted, the agency never took a hard look at the unintended consequences the guidelines could have:

"Concerns have been raised that prescribing changes such as dose reduction might be associated with unintended negative consequences, such as patients seeking heroin or other illicitly obtained opioids or interference with appropriate pain treatment. With the exception of a study noting an association between an abuse-deterrent formulation of OxyContin and heroin use… CDC did not identify studies evaluating these potential outcomes."

Myth #5: There are better alternatives than opioids

There are many different types of non-opioid medications, ranging from over-the-counter pain relievers like ibuprofen and acetaminophen to prescription drugs like Lyrica (pregabalin) and Neurontin (gabapentin). There are also several non-pharmacological treatments like acupuncture, massage, physical therapy, and cognitive behavioral therapy (CBT).

The CDC guidelines make it sound like these alternative treatments always work and are readily available to every patient:

"Many nonpharmacologic therapies, including physical therapy, weight loss for knee osteoarthritis, complementary and alternative therapies, psychological therapies such as CBT, and certain interventional procedures can ameliorate chronic pain. In particular, there is high-quality evidence that exercise therapy for hip or knee osteoarthritis reduces pain and improves function immediately after treatment.

Several nonopioid pharmacologic therapies (including acetaminophen, NSAIDs, and selected antidepressants and anticonvulsants) are effective for chronic pain. In particular, acetaminophen and NSAIDs can be useful for arthritis and low back pain. Selected anticonvulsants such as pregabalin and gabapentin can improve pain in diabetic neuropathy, post-herpetic neuralgia, and fibromyalgia."

But when we asked over 2,200 pain patients what they thought about these alternative treatments, most said they didn’t work. Three out of four patients said over-the-counter pain relievers “did not help at all” and 64% said the same about nonpharmacological treatments such as exercise and weight loss.

Non-opioid medications like Lyrica, Neurontin and Cymbalta fared a little better, with only about half of patients saying they did not help. But many also complained about side effects from the drugs, such as weight gain, anxiety and withdrawal symptoms.

Some patients are being coerced into treatments they don’t want, such as epidural steroid injections. Over a third of the patients recently surveyed by Lana Kirby, founder of Veterans and Americans United for Equality in Medical Care, said they have been told by a healthcare provider that they must have an operation or invasive procedure or they’ll no longer get opioids or be discharged from the practice.  

“Respondents are being threatened with pain care protocols that are not optimal, such as epidural injections and installation of durable medical equipment. If they refuse, their access to oral medications, even where they have been used impactfully, is systematically reduced or suspended,” said Terri Lewis, PhD, a patient advocate and researcher who analyzed the survey findings.

Over half the patients (57%) in that survey said they had been discharged by a doctor because they required opioid treatment. Of those who were discharged, only half were able to find a new physician.

Perhaps the most telling response in that survey is that half of the patients admit considering suicide as a way to end their pain.

“Patients increasingly report that they are harmed directly and indirectly as changes to their healthcare routines have resulted in limited access, reduced quality of healthcare interactions, and increased out of pocket cost,” said Lewis. “To a person, respondents report that they feel humiliated, degraded, shamed, and stigmatized by the loss of choice over their physician patient alliance and program of care.

"The regulatory changes have increased negative responses to them within their support system (treated like addicts, lack of care for emergencies, pharmacy hassles, and fear of physician). Many now acknowledge that their doctor’s appointment conversation is all about keeping the physician safe from DEA oversight or license restrictions as opposed to optimizing the consumer’s activity and functioning levels.”

In just five months, it is clear the guidelines are having a major impact on the pain community in the United States.  More people are suffering from untreated pain and more are dying from drug overdoses. Yet there is no sign the CDC has any intention to revise and clarify the guidelines or to dispel the myths that surround them.

Study: Long Term Opioid Use Rare After Surgery

Pat Anson, Editor

It’s become a popular belief that many people become addicted to opioid pain medication after surgery. According to a recent national survey, one in ten pain patients believe they became addicted or dependent on opioids after they started taking them for post-operative pain.

But a large new study in Canada found that long term opioid use after surgery is extremely rare, with less than one percent of older adults still taking opioid pain medication a year after major elective surgery.

The study, published in the journal JAMA Surgery, looked at over 39,000 “opioid naïve” patients (no opioid prescriptions in the prior year) over age 65 who had a heart, lung, colon, prostate or hysterectomy surgery from 2003 to 2010.

One year after the surgery, only 168 of the surviving patients were still prescribed opioids – a rate of just 0.4 percent.

“Exposure to opioids is largely unavoidable after major surgery because they are routinely used to treat postoperative pain,” wrote lead author Hance Clarke, MD, Toronto Western Hospital.

In a previous study, Clarke and his colleagues looked at opioid use after major surgery and found that about 3% of patients were still taking opioids after three months. They decided to do this follow-up study to see how many were still being prescribed opioids 180 days, 270 days and 365 days after surgery. They found a steady decline in opioid use throughout the year.

“The estimate of 0.4% of patients continuing to receive opioids at 1 year is consistent with some limited available data,” Clarke wrote. “Our study thus provides reassurance that the individual risk of long-term opioid use in opioid-naive surgical patients is low.”

Earlier this year the American Pain Society (APS) released guidelines for postoperative pain care that encourage the use of non-opioid medications such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurotin) and pregabalin (Lyrica).  The APS also said epidural injections could be used for pain relief during some surgeries.

A survey of over 1,200 pain patients by Pain News Network and the International Pain Foundation found that two-thirds of patients believe that non-opioid medication “did not help at all” in the hospital. Another 60 percent said their pain was not adequately controlled in the hospital after a surgery or treatment.

PROP Ends Affiliation with Phoenix House

By Pat Anson, Editor

Physicians for Responsible Opioid Prescribing (PROP), an influential and politically connected advocacy group that seeks to reduce opioid prescribing, is no longer directly affiliated with Phoenix House, which runs a nationwide chain of addiction treatment centers.

The Steve Rummler Hope Foundation is now the “fiscal sponsor” of PROP, which will allow PROP to collect tax deductible donations under the foundation’s 501 (c) (3) non-profit status. IRS regulations allow non-profits to form partnerships with like-minded organizations, allowing other groups to essentially piggyback off their non-profit status and collect donations.  

Like PROP, the foundation’s main goal is to reduce opioid prescribing. It is named after Steve Rummler, a Minnesota pain patient who became addicted to opioid medication while being treated for a back injury.

After several attempts at addiction treatment, Rummler relapsed and died of a heroin overdose at the age of 43.

“He struggled with the pain for a long time,” said Judy Rummler, Steve’s mother and chief financial officer of the foundation.  “He had what I think later was figured out to be some damage to the nervous system around his spinal cord because he had what he described as shooting electric shock-like sensations that would shoot up his back into his head and down his legs into his feet.”

Steve sought help from many doctors, but never received a treatable diagnosis. He started taking OxyContin for pain relief. 

“Once he was prescribed the opioids in 2005, then he didn’t care about getting answers anymore,” his mother said.

After Steve’s death in 2011, the Rummler family established the foundation with the goal of helping others who also struggle with chronic pain and addiction. It was PROP’s founder and chief executive, Andrew Kolodny, MD, who approached the foundation with the idea of joining forces.

“Basically as the fiscal sponsor we accept donations and we manage the funding. We don’t set any policy for him,” Judy Rummler told Pain News Network. “Obviously our missions are similar. We are very concerned about the overprescribing of opioids. Yet I know if my son were alive today he would probably be telling you what you hear from so many other pain patients; that he couldn’t live without them. But the problem was he died as a result of it.

“I know there are a lot of people who are going to be hurt by cutting back on the prescribing, but I just think a lot of them are addicted as my son was. Yet he would have been the first one to scream and yell about having his pills cutoff.”

The Rummler Foundation calls this tug-of-war between opioids and addiction “The Dilemma.” It advocates for wholesale change in the treatment of chronic pain, emphasizing “wellness rather than drugs” and the use of “a wide array of non-opioid options.”

Opioid medication should not be prescribed for chronic pain, according to Rummler.

“I would never say that it’s impossible for it to work for someone. I wouldn’t say that. But I would say there’s no evidence it would work. And it shouldn’t be prescribed that way,” she said.  “There are so many people dying. I hate to even use the term ‘abuse’ because I don’t think my son, really, I mean at the end he was an abuser, for sure. But it wasn’t abuse that got him addicted. It was the prescribing that got him addicted.”  

In addition to promoting awareness about opioid addiction, the Rummler Foundation sponsors prescriber education courses and provides free naloxone rescue kits to reverse the effects of opioid overdoses.

Links with PROP

The Rummler Foundation already has a lengthy association with PROP. Kolodny serves on the foundation’s medical advisory committee, as does Jane Ballantyne, MD, PROP’s president. The two groups have also participated together in several advocacy campaigns.

While PROP no longer considers itself “a program” of Phoenix House, Kolodny is still listed as the chief medical officer for the organization.

For several years, PROP lobbied the FDA, DEA and other federal agencies to reduce the prescribing of opioids with mixed success. Recently it played a significant role in the development of the CDC’s opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Kolodny, Ballantyne and three other PROP officers and board members served on panels advising the CDC.

As Pain News Network has reported, Ballantyne and two other PROP board members are currently participating in CDC funded webinars to teach prescribers how to implement the guidelines. Those guidelines, which were released in March, have already had a significant impact on the pain community. In a recent survey, over two-thirds of patients said their opioid medication has been reduced or stopped by their doctor. About half said they have considered suicide as a way to end their pain since the guidelines were released. 

In addition to his new affiliation with the Rummler Foundation, Kolodny is working with the Los Angeles-based Media Policy Center in developing a documentary on opioids and addiction. PROP is listed as one of the partners in the project, along with the Semel Institute of Neurobiology and the Geffen School of Medicine at UCLA.

The Media Policy Center (MPC), which declined to comment for this story, states on its website that it hopes to release the documentary in November and eventually air it on PBS.

“The best way to prevent deaths and overdose is through education,” MPC says in a statement on its GoFundMe campaign. “Many people have the misconception that opioids, such as OxyContin, are safe because they are prescription drugs, however, they are very addictive and once people lose access to their prescriptions or can no longer afford the drug they may turn to drugs like heroin.”

PNN has learned that several prominent doctors in the field of pain management have been approached to participate in a “debate” with Kolodny for the program. All have declined because they fear the documentary will be biased.

Study Finds Racial Disparity in ER Opioid Prescriptions

By Pat Anson, Editor

Black patients who visit hospital emergency rooms with back and abdominal pain are significantly less likely to receive opioid prescriptions than white patients, according to a large new study published in PLOS ONE

The study, led by researchers at Boston University Medical Center, looked at data involving over 36 million emergency room visits in the U.S. from 2007 to 2011. No previous studies have examined racial disparities involving opioid prescriptions in ER settings.

The researchers found that opioids were prescribed for blacks at about half the rate for whites for vague “non-definitive conditions” that do not have an easy diagnosis -- such as back and abdominal pain.

No racial prescribing differences were found for ER visits involving fractures, kidney stones or toothaches – which are easier to diagnose.

The authors concluded that ER doctors may be relying on subjective cues such as race when deciding whether to prescribe opioids.

“These disparities may reflect inherent biases that health care providers hold unknowingly, leading to differential treatment of patients based on their race,” wrote co-authors Yu-Yu Tien of the University of Iowa College of Pharmacy and Renee Y. Hsia of the University of California at San Francisco.

“Healthcare providers carry inherent human biases, which can impact their prescription practices, especially in situations that do not lend themselves well to objective decisions. Racial-ethnic minority patients, especially non-Hispanic blacks presenting with vague conditions often associated with drug-seeking behavior, may be more likely to be judged as ‘a drug-seeker’ relative to a non-Hispanic white patient, presenting with similar pain-related complains.”

The authors noted that a recent study in JAMA found that prescription opioid abuse and addiction were actually more likely among whites than Hispanics and non-Hispanic blacks.

“In light of this, our findings raises a perplexing question as to whether it is non-Hispanic blacks who are being under-prescribed, or is it non-Hispanic whites who are being over-prescribed. Paradoxically, then, while non-Hispanic blacks do not benefit from bias, they might be inadvertently benefitting by receiving fewer opioid medications and prescriptions,” they wrote.

In their analysis of emergency room visits, the researchers also found that uninsured patients and those on Medicaid were less likely to receive an opioid for “non-definitive conditions” than those with private insurance.

A small study at the University of Virginia also found signs of racial bias involving pain care in a survey of white medical students. Researchers asked 222 medical students and residents a series of hypothetical questions about treating pain in mock medical cases involving white and black patients suffering pain from a kidney stone or leg fracture.  

Many of the students and residents were found to hold false beliefs, such as believing that black people's skin is thicker and that their blood coagulates faster than whites.  Half of those surveyed endorsed at least one false belief; and those who did were more likely to report lower pain ratings for black patients and were less accurate in their treatment recommendations for blacks.

Is ‘Malicious Actor’ Behind Fentanyl Overdoses?

By Pat Anson, Editor

The U.S. medical community is starting to pay more attention to the “burgeoning public health threat” posed by counterfeit prescription drugs made with illicit fentanyl.

And for the first time, public health researchers are suggesting that a “malicious actor” could be poisoning people intentionally with fake pills.

“The steep recent increase in overdose deaths and near-deaths nationwide involving fentanyl signals a new chapter in the epidemic of opioid use. Throughout the United States and Canada, seizures of pill presses, large quantities of active pharmaceutical ingredient in powder form, and counterfeit pills have been reported,” wrote Traci Green, PhD, Boston University School of Medicine, and Michael Gilbert, MPH, Epidemico Inc., in a research letter published in JAMA Internal Medicine.

“These highly potent pills could have been created by a malicious actor to intentionally poison consumers or attract the attention of law enforcement to redistributors.”

Green and Gilbert offered no evidence to support their theory, but said it was one of several "plausible hypotheses."

“I’m not going to really comment on speculation, because we deal in fact,” said DEA spokesman Rust Payne. “If you’re a drug trafficker, you don’t want to poison people. You want a regular customer base.”

Green and Gilbert were commenting on a case study also published in JAMA Internal Medicine that looked at 8 patients in the San Francisco area who were hospitalized late last year after ingesting fake alprazolam (Xanax) tablets that were later found to contain fentanyl. One victim was a baby boy just eight months old. All of the patients eventually recovered.

A few months later, 12 people died and dozens more were hospitalized in the Sacramento area after overdosing on fake Norco pills that were also made with fentanyl.

“This case series represents a burgeoning public health threat. Clinicians should be aware of the potential for further outbreaks and serious toxic effects associated with counterfeit prescription medications,” wrote lead author Ann Arens, MD, California Poison Control Center.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is prescribed legally in patches and lozenges to treat chronic pain, but illicitly manufactured fentanyl is fast becoming a scourge around the country. Since the fall of 2013, illicit fentanyl is blamed for over 5,000 deaths and the number of overdoses appears to be accelerating.

Illicit fentanyl was typically mixed with heroin to boost its potency but is now appearing in pill form, often disguised to look like pain medication such as Norco and oxycodone.

As Pain News Network has reported, the DEA recently issued a report saying the U.S. faced an unprecedented “fentanyl crisis” that was likely to grow worse. The agency blamed heavy consumer demand and the “enormous profit potential” of counterfeit medication.

But Green and Gilbert believe there could be a more sinister motive behind the overdoses, the “malicious actor” who wants to poison people.

“This hypothesis cannot be entirely ruled out by the evidence presented by Arens et al, but it is less likely because the quantity of fentanyl identified in the counterfeit alprazolam tablets was significantly greater than would be required to harm unwitting consumers,” they wrote.

The dangerous potency of the pills could also be accidental or the result of an inexperienced pill manufacturer, the two researchers said. 

That is the more likely scenario, according to the DEA’s Payne, who says the pill press operations seized so far have been amateurish.

“If you’re just cutting fentanyl in a tablet in a lab somewhere, in someone’s garage or warehouse, you may be putting way too much fentanyl into a pill than anybody can withstand. And so that is what is going on right now,” Payne told PNN.

Regardless of the motive, Green and Gilbert called for an aggressive expansion in public health surveillance programs to detect new trends in drug use.

“New surveillance approaches and rapid expansion of evidence-based interventions are the missing parameters needed to shift the curve of the epidemic of opioid use,” they said.

PR Firm Hired to Boost CDC’s Image

By Pat Anson, Editor

The Centers for Disease Control and Prevention won’t disclose how much it is paying a Seattle-based public relations firm to provide research and analysis of the agency’s image in the pain community.

Nor will the CDC say why it hired the company – called PRR – as an image consultant.

“After consulting with our procurement and grants office, CDC isn’t able to discuss the specifics of this contract because it is an active procurement,” said CDC spokesperson Courtney Leland in an email to Pain News Network.

A spokesperson for PRR also declined to say why the firm was hired. But a source at the company indicated the primary reason was to analyze why the CDC’s opioid prescribing guidelines were so poorly received in the pain community and to find out "where they’ve gone wrong.”

“They’ve heard a lot of outrage about this,” the source said. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”

In recent weeks, PRR has been contacting “thought leaders” in the pain community to gauge their reaction to the CDC guidelines. This reporter was among those contacted and participated in a short telephone survey involving 10 questions, such as these:

“What about these guideline recommendations are worrisome to you and what about them are encouraging to you?” 

“Are these guideline recommendations a step in the right direction, in your opinion, or do you think the CDC is panicking?"

"Are these recommendations going to help solve the prescription opioid addiction problem?”

We gave PRR the names and contact information for about a dozen activists in the pain community who also wanted to participate in the survey. But we were later informed by PRR that the company “completed the required number of interviews, so we will not interview these individuals at this time.”

PRR handles communications, marketing and public relations for dozens of public and private organizations, including Starbucks, the Environmental Protection Agency, Waste Management, Nike, and the University of Washington. With offices in Seattle, Washington DC, Austin, TX, Norfolk, VA and Portland, OR, its services probably don’t come cheaply.

“To advance your vision and deliver meaningful results, we develop strategic marketing plans that can transform the marketplace, or an individual’s behavior. With multiple disciplines at our disposal, we can gather market intelligence and create strategic plans to achieve your goals,” PRR says on its website.

The CDC has been roundly criticized for its secrecy and lack of transparency in developing the opioid guidelines – which discourage primary care physicians from prescribing opioids for chronic pain. Since the guidelines were released in March, many pain patients have been taken off opioids or weaned to lower doses by their doctors. Others have been discharged by their doctors or coerced into more invasive pain treatments, such as spinal cord stimulators or epidural injections. 

A survey of pain patients released this week found that three out of four believe their pain is not being adequately controlled. Over half said they have contemplated suicide since the guidelines were released.

Virtually all of the nearly 2,000 patients surveyed – 97 percent – said they have never been addicted or required treatment for drug abuse. Reducing abuse and addiction are the primary goals of the CDC guidelines.  

Guidelines Webinar

The CDC also isn’t saying much about its decision to hire the University of Washington to help the agency conduct a series of training webinars this summer for healthcare providers to learn about the  guidelines. The agency did not say how much it is paying the university.

“Faculty and clinicians from the University of Washington School of Medicine were contracted to provide didactic and case-based training content and demonstrate and instruct providers on application of the Guideline in clinical settings,” Leland said. “University of Washington has had prior experience developing and disseminating clinical case studies to facilitate learning among clinicians on pain management for patients.”

Three of the four faculty members who have participated in the webinars are affiliated with Physicians for Responsible Opioid Prescribing (PROP), an organization that has lobbied the federal government for years to reduce opioid prescribing.

Jane Ballantyne, MD, is PROP’s president, and Mark Sullivan, MD, and David Tauben, MD, are PROP board members.

The fourth faculty member is James Robinson, MD, a professor of rehabilitation medicine who appears to have no association with PROP.  

“I believe in a rehabilitative approach to chronic pain,” Robinson is quoted as saying on the university’s website. “Key elements of this are empowering patients to optimize self-management of chronic pain disorders and encouraging them to take as much responsibility for self-management as is feasible.”

The University of Washington Medical Center received over $17.2 million last year for research, consulting, and grants from dozens of drug and medical device makers, many of which are involved in the field of pain management. Ballantyne, Sullivan and other faculty members at the university have previously played key roles in developing opioid regulations in the state of Washington, which has some of the toughest prescribing laws in the nation.

Since everyone chosen for the webinars appears to have a bias against opioid prescribing, we asked CDC why the agency was either unwilling or unable to have a more diverse panel of speakers. We were told CDC provides “timely, accurate, and credible information to clinicians.”     

“This webinar series was developed to be a continuing education training opportunity to increase clinicians’ knowledge and competencies on prescription drug overdose and offer evaluation and management strategies to help address the issue,” Leland said.

During a webinar held on Wednesday, the primary advice given to physicians was not to prescribe opioids for chronic pain and to taper patients off opioids if they’ve already started.

“A successful taper makes a patient much better able to function. And generally their experience is the pain level either doesn’t change or is actually improved,” Ballantyne said.

Survey: Opioids Reduced or Stopped for Most Patients

By Pat Anson, Editor

Over two-thirds of pain patients say their opioid medication has been decreased or stopped since the CDC adopted its opioid prescribing guidelines, according to a new survey that also found over half of the patients have considered suicide since the guidelines were implemented.

A total of 1,978 patients participated in the survey, which was conducted through social media and online support groups in recent weeks. The survey was designed by Lana Kirby, a Florida paralegal and chronic pain sufferer who became frustrated by difficulties she faced in obtaining opioid pain medication.

Although unscientific, the survey results are the first broad indication of the impact the CDC guidelines are having on both physicians and patients. Those guidelines, which discourage primary care doctors from prescribing opioids for chronic pain, are meant to be voluntary but are being widely implemented by many different prescribers, according to survey.

“To a person, respondents report that they feel humiliated, degraded, shamed, and stigmatized by the loss of choice over their physician patient alliance and program of care,” said Terri Lewis, PhD, a patient advocate and researcher who conducted an analysis of the survey.

“Many now acknowledge that their doctor’s appointment conversation is all about keeping the physician safe from DEA oversight or license restrictions as opposed to optimizing the consumer’s activity and functioning levels.”

"I am afraid to tell the doctor what I need," said one patient.

“My doctor said he is afraid of the DEA and CDC,” said another.

“My doctor said I cannot be cured so there is no point in treating me for pain,” wrote one patient.

"Because my doctor was arrested other doctors have refused to take on his patients for treatment," said another.

Over 68% of patients said their opioid pain medication has been decreased or discontinued since the  guidelines were released in March.  Nearly 45% were warned by their doctor that additional decreases will be necessary. And just over 50% said they had considered suicide as a way to end their pain.

“It is important to note that CDC’s guidelines are directed to primary care physicians with the suggestion that they should be cautiously and conservatively applied to chronic pain patients with complex needs. That message does not seem to have been received at the physician level, as both primary care and Board Certified pain management practitioners are uniformly applying extreme prescribing restrictions to the regimens of those who replied, even where they had been in long term successful treatment for extensive periods of time without difficulty,” said Lewis.

Other survey findings:

• 75% of patients said they are not receiving adequate pain control
• 57% said they had been discharge or abandoned by a doctor because they need opioid treatment
• 44% said they had problems getting a prescription filled at a pharmacy
• 90% said their pain levels, activities and social interactions have worsened
• 97% said they have never been addicted or required treatment for drug abuse

Nearly four out of ten patients (39%) said they had been told by a doctor that they must have an operation or invasive procedure, or they will be discharged from the practice or have their medications reduced.

“Increasingly, respondents are being threatened with pain care protocols that are not optimal, such as epidural injections (or) installation of durable medical equipment. If they refuse, their access to oral medications, even where they have been used impactfully, is systematically reduced or suspended,” said Lewis.

The CDC has had very little to say about the impact of guidelines since their release. As Pain News Network has reported, a top CDC official recently wrote a letter to one patient saying the guidelines were only meant as a “guide” for primary care providers “as they work in consultation with their patients.”

“The Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making,” wrote Debra Houry,  Director of the CDC’s National Center for Injury Prevention, which oversaw the guidelines’ development.

The ‘Cone of Silence’ Returns to CDC

By Pat Anson, Editor

The Centers for Disease Control and Prevention drew a lot of criticism last year for its secrecy and lack of transparency while drafting its controversial opioid prescribing guidelines. 

Closed-door meetings were held by the “Core Expert Group” and other CDC advisory panels, which included hardly any experts in pain management, but did have several addiction treatment doctors and longtime critics of opioid prescribing.

The CDC’s penchant for secrecy on such an important public health issue was mockingly compared by Stephen Ziegler to Get Smart’s “Cone of Silence.”

But it was only when the agency was accused of bias, blatant violations of federal law, and a Congressional investigation was launched that CDC appointed a new expert panel to review the guidelines -- which were released in March essentially unchanged from the draft version.

The CDC apparently didn’t learn much from the experience.

This summer the agency has been holding a series of training webinars to educate healthcare providers about the guidelines -- and it invited as speakers some of the very same people who were removed from the first expert panel because they were perceived as being too biased.  

For example, this week’s webinar on the benefits and harms of opioid therapy was led by Jane Ballantyne, MD, who is president of Physicians for Responsible Opioid Prescribing (PROP), and Mark Sullivan, MD, who is a PROP board member.  PROP has lobbied the federal government for years to reduce opioid prescribing.

MARK SULLIVAN, MD

“We really don’t have good evidence of long term benefit from opioid therapy, but we do know it creates serious problems,” Sullivan advised the physicians and pharmacists listening to the webinar.

“We don’t want to be giving patients a month or multiple refills of opioids for acute pain problems, because that’s where long-term opioid therapy gets started and is difficult to discontinue.”

Last year Sullivan and Ballantyne co-authored a controversial article in the New England Journal of Medicine that claimed reducing pain intensity should not be the primary goal of doctors when treating chronic pain. They believe that other quality of life issues, such as better sleep, mood and physical function, are more important.

“It’s so easy for someone who’s been on opiates for a long time to believe they need the opiate, because if they stop taking it the pain gets worse,” said Ballantyne, who maintains that long-term opioid patients should be slowly tapered to lower doses or off opioids entirely.

“A successful taper makes a patient much better able to function. And generally their experience is the pain level either doesn’t change or is actually improved,” she said.

Both Sullivan and Ballantyne are employed as professors at the University of Washington School of Medicine, which according to a webinar disclaimer “received a contract payment” from the CDC.

Another professor at the University of Washington who participated in the webinars, David Tauben, MD, is also a PROP board member and served on the CDC's peer review panel for the guidelines.

Ballantyne, Sullivan and Tauben’s involvement with PROP are not disclosed in the disclaimer and some of their conflict of interest statements also appear incomplete.

JANE BALLANTYNE, MD

Sullivan’s disclaimer states he is “consulting with Chrono Therapeutics concerning development and testing of an opioid taper device,” but it fails to mention over $15,000 in consulting fees and travel expenses Sullivan received in 2015 from Pfizer, Janssen, Purdue Pharma, Roxane Laboratories or Teva Pharmaceuticals, according to a Medicare database.

No outside income from drug and medical device makers was reported for Tauben or Ballantyne in 2015, although Ballantyne did serve a few years ago as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies over their opioid marketing practices.

The CDC disclaimer also fails to mention that the University of Washington Medical Center received over $17.2 million last year for research, consulting, and grants from dozens of drug and medical device companies, many of which are involved in the field of pain management and are directly impacted by the CDC guidelines. Ballantyne, Sullivan and other professors at the university played key roles in the development of opioid regulations in the state of Washington, which has some of the toughest prescribing laws in the nation.

Still, the CDC maintains that its planners reviewed the webinar content “to ensure there is no bias.”

Unanswered Questions

How much is the CDC paying the University of Washington and PROP activists to participate in its opioid webinars? Why is only one side of the opioid debate being offered by a federal health agency? We posed those questions to the CDC and have yet to get an answer. 

We’ve also been unable to learn from CDC how much the agency is paying a Seattle-based marketing firm called PRR, which is conducting a research and communications analysis about the impact of the prescribing guidelines. PRR handles marketing, research and public relations for dozens of government agencies.

“Yes, the CDC hired us to conduct this research but unfortunately that is all I can tell you at this time.  If you want to know more about the specifics of the study, it is best that you contact the CDC directly and they can answer your questions,” Katherine Schomer, a Research Group Account Director at PRR said in an email.

A source at PRR told Pain News Network that what the CDC really wants to know is why its opioid guidelines were so poorly received by the pain community and to find out "where they’ve gone wrong.”

“They’ve heard a lot of outrage about this, specifically from Pain News Network’s survey asking people with chronic pain how they felt about this. That in particular was something the CDC picked up on,” the source said. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”

That survey by PNN and the International Pain Foundation was conducted last fall, months before the CDC guidelines were finalized and released. Even then, many pain patients realized how disastrous the guidelines would be for them. 

Nearly 90% of the 2,200 respondents said they were worried or very worried that they would be unable to obtain opioid pain medication if the guidelines were implemented. Large majorities also predicted the guidelines would have a chilling effect on physicians; that doctors would prescribe fewer opioids or none at all; that use of heroin and other illegal drugs would increase; and that there would be more suicides in the pain community. 

Virtually all of those predictions have come true, with many patients complaining they are being weaned or taken off opioids, despite years of taking the medications safely.  Hundreds of thousands of counterfeit pain medications laced with fentanyl have appeared on the black market, enough to kill dozens of people and for the DEA to warn the nation is in the midst of a “fentanyl crisis.” 

Most disturbing of all are anecdotal reports of patients committing suicide because they are unable to obtain pain medication.

All of this is happening in plain sight, as the CDC conducts biased webinars and pays for marketing studies to figure out “where they’ve gone wrong” -- and while the agency refuses to acknowledge publicly that its guidelines have been harmful to patients and are being implemented far too widely.

The Cone of Silence indeed.

‘Wakeup Call’ for Neurontin Abuse

By Pat Anson, Editor

A drug that is often prescribed as an alternative to opioid pain medication is increasingly being abused by patients, according to a small study that found one out of five patients taking the drug illicitly.

Gabapentin – which is sold by Pfizer under the brand name Neurontin -- is approved by the Food and Drug Administration to treat epilepsy and neuropathic pain caused by shingles.

It is also prescribed “off-label” for a variety of other conditions, including depression, migraine, fibromyalgia and bipolar disorder.

In a study of urine samples from 323 patients being treated at pain clinics and addiction treatment centers, 70 patients were found to be taking gabapentin without a prescription.

“The high rate of misuse of this medication is surprising and it is also a wakeup call for prescribers. Doctors don’t usually screen for gabapentin abuse when making sure patients are taking medications, such as opioids, as prescribed. These findings reveal that there is a growing risk of abuse and a need for more robust testing,” said Poluru Reddy, PhD, medical director of ARIA Diagnostics in Indianapolis, IN. Reddy presented his study at the annual meeting of the American Association for Clinical Chemistry in Philadelphia.

Researchers found that of those patients taking gabapentin illicitly, over half (56%) were taking it with an opioid, about a quarter (27%) with an opioid and muscle relaxant or anxiety medication, and the rest with other substances. The urine samples came primarily from pain clinics in Indiana, Arizona, and Massachusetts.

“Little information exists regarding the significance of Gabapentin abuse among clinical patients. Until recently, it was considered to have little potential for abuse however this review has shown that a significant amount of patients are taking Gabapentin without physician consent. This could be due to the fact that recent studies have revealed that Gabapentin may potentiate the ‘high’ obtained from other central nervous system acting drugs,” wrote Reddy.

"Patient safety is Pfizer’s utmost priority.  We strongly support and recommend the need for appropriate prescribing and use of all our medicines," a spokesperson for Pfizer said in an email to Pain News Network.

Gabapentin is not scheduled as a controlled substance and when taken alone there is little potential for abuse. But when taken with other drugs, such as opioids, muscle relaxants, and anxiety medications like Valium and Xanax, researchers say gabapentin can have a euphoric effect.

Between 2008 and 2011 the number of emergency room visits for misuse or abuse of gabapentin increased by nearly five times, according to the Drug Abuse Warning Network. Side effects from gabapentin include weight gain, dizziness, ataxia, somnolence, nervousness and fatigue.

Increased Prescribing of Gabapentin

A report by IMS Health found that 57 million prescriptions for gabapentin were written in the U.S. in 2015, a 42% increase since 2011.

Gabapentin is one of several medications being promoted by the Centers for Disease Control and Prevention as a "safer"  alternative to opioids.  The American Pain Society recently recommended that gabapentin be considered for post-operative pain relief.

But the growth in gabapentin prescribing is drawing scrutiny in the UK, where the Advisory Council on the Misuse of Drugs (ACMD) recommended earlier this year that gabapentin and pregabalin (Lyrica) be reclassified as Class C controlled substances, which would make them harder to obtain.

“Both pregabalin and gabapentin are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants, they can cause drowsiness, sedation, respiratory failure and death,” said Professor Les Iverson, ACMD chairman, in a letter to Home Office ministers.

“Pregabalin causes a ‘high’ or elevated mood in users; the side effects may include chest pain, wheezing, vision changes and less commonly, hallucinations. Gabapentin can produce feelings of relaxation, calmness and euphoria. Some users have reported that the ‘high’ from snorted gabapentin can be similar to taking a stimulant.”

Gabapentin is "one of the most abused and diverted drugs” in the U.S. prison system, according to Jeffrey Keller, MD,  the chief medical officer of Centurian, a private company that provides prison healthcare services.

“Inmates show up at my jails all the time with gabapentin on their current medication list,” Keller wrote in Corrections.com. “It produces euphoria, a marijuana-like high, sedation, and, at high enough doses, dissociative/psychedelic effects. It works so well that it is used in the drug community to mellow out methamphetamine tweaking and to cut heroin. Since drug abusers know about these illicit uses of gabapentin on the streets, once they get to jail they often view gabapentin as an obtainable ‘jail substitute’ for their preferred drugs.

“Unfortunately, the abuse potential of gabapentin is not recognized much outside of jails and prisons. Community prescribers are generally unaware that gabapentin can be misused and (in my experience) are often incredulous and even disbelieving when told about ‘the dark side’ of gabapentin.”

Gabapentin (Neurontin) has a checkered history. Originally developed as a nerve drug, Pfizer agreed to pay $430 million in fines to resolve criminal and civil charges for illegally marketing Neurontin to treat conditions it was not approved for. According to some estimates, over 90% of Neurontin sales are for off-label uses.

In 1999, a Pfizer executive was so mystified by Neurontin’s popularity he called it the “snake oil of the twentieth century.”  

Fake Norco Nearly Killed California Woman

By Pat Anson, Editor

An article published online in the Annals of Emergency Medicine shows just how easy it is for someone to be fooled – and nearly killed – by counterfeit pain medication.

It tells the story of an unnamed 41-year old California woman who treats her chronic back pain with regular doses of Norco, a prescription medication that combines acetaminophen and hydrocodone.

She was one of dozens of people who died or were hospitalized in northern California after ingesting counterfeit Norco bought on the street that was laced with illicit fentanyl – a synthetic opioid that is 50 to 100 stronger than morphine.

"Street Norco is almost indistinguishable from brand-name Norco in appearance but can be lethal," said lead author Patil Armenian, MD, of the University of California San Francisco-Fresno.

"This new street drug's toxicity led to an unexpected cluster of fentanyl deaths in California this spring. These deaths in our area combined with an emergency patient who was concerned about pill appearance and exceedingly sleepy after her usual dose of medication led to our investigation."

The woman in question suffers chronic pain from a herniated disc and normally buys the Norco illicitly, 2 to 3 tablets at a time. The article does not explain why she buys them off the street.

The woman felt sleepy and became unconscious within 30 minutes of taking three of the counterfeit tablets. She next remembered waking up in a hospital emergency room. She told hospital staff the pills had the markings of Norco, but were beige in color instead of the usual white.

A blood serum analysis revealed the woman had significant amounts of fentanyl and U-47700, another type of synthetic opioid. Neither drug is an ingredient in brand-name Norco.

“Toxic effects of these compounds are similar to those of other opioids, namely, miosis, respiratory depression, coma, and possible death. To our knowledge, this is the first reported opioid toxidrome case with confirmed serum concentration of U-47700,” said Armenian, adding that the woman was discharged from the hospital and has completely recovered.

“This case highlights that fentanyl-laced Norco is spreading to other regions and may contain psychoactive ingredients other than fentanyl, such as U-47700, prompting emergency providers to remain vigilant in their care.”

As Pain News Network has reported, the Drug Enforcement Administration is warning the U.S. faces an unprecedented “fentanyl crisis” that is growing worse as drug dealers ramp up production of counterfeit medication. Dozens of Americans have died this year after ingesting counterfeit versions of oxycodone, Norco and Xanax that are virtually indistinguishable from the real medications. Even a few milligrams of fentanyl can be fatal.

Fentanyl is legally prescribed in patches and lozenges to treat severe chronic pain, but the DEA said “hundreds of thousands of counterfeit prescription drugs” laced with illicit fentanyl are on the black market. The agency predicts more fake pills will be manufactured because of heavy demand and the “enormous profit potential” of fake medication.

Canada’s Fentanyl Crisis

Canada – which has been dealing with its own fentanyl crisis – may provide a preview of what’s in store for the U.S. Overdose deaths from fentanyl have reached such an urgent level that British Columbia Premier Christy Clark asked the federal government last week to restrict access to pill presses and to start screening “all small packages” entering the province for fentanyl. 

Earlier this year British Columbia declared a public health emergency and adopted new opioid prescribing guidelines that are even more stringent than those released by the Centers for Disease Control and Prevention.  

While the CDC’s guidelines are voluntary and intended only for primary care physicians, British Columbia’s guidelines are legally enforceable for all opioid prescribers because they set a “minimum standard of professional behaviour and ethical conduct.” The guidelines state that opioids should not be prescribed to treat headaches, fibromyalgia and low back pain.

In Ontario, the backlash against opioids has reached a point that palliative care doctors are worried they will no longer be able to give high doses to their patients – many of whom are dying from cancer and other chronic illnesses. Ontario’s Ministry of Health said public health plans next year would stop paying for high doses of hydromorphone, morphine and fentanyl patches.

“Our patients under palliative care deserve better than this,” Stephen Singh, MD, director of the Canadian Society of Palliative Care Physicians, told The Globe and Mail, adding that he was “appalled” by the government’s decision.

Study Depicts Half of Americans as Rx Abusers

 By Pat Anson, Editor

Over half of Americans “misused” their prescription drugs last year, according to a new report by a drug testing company that appears to draw several broad and misleading conclusions about the use of opioid pain medication.

Quest Diagnostics analyzed drug testing data from over 3 million patients and found that 54% had some type of prescription drug misuse in 2015 – down from 63% in 2011.

"The key takeaway from this massive, nationally representative analysis is that despite some gains, a large number of patients use prescription drugs inappropriately and even dangerously," said co-researcher Harvey W. Kaufman, MD, senior medical director for Quest Diagnostics.

"The CDC's recent recommendations to physicians to carefully weigh the risks and benefits of opioid drug therapy are a step in the right direction, but clearly more needs to be done to address this public health crisis."

The term “misuse” should be taken with a grain of salt, because it does not mean patients were abusing or addicted to prescription drugs – only that they did not take them as directed.

In 2015, for example, the study found that over half (55%) of the patients who had “inconsistent” test results did not have a prescribed drug in their system – meaning they no longer felt a need to take a medication, didn’t like the drug’s side effects, forgot to take it, or simply couldn’t afford it. It could also mean the drug was ineffective. the wrong drug was prescribed or the doctor made an incorrect diagnosis. There are literally dozens of reasons someone could stop taking a drug.

But patients who had no drugs detected – legal or illegal – were still classified in the “misuse" category.

Nevertheless, while acknowledging there were “methodology limitations” to the study, Quest made some sweeping conclusions about it in a press release, claiming that “the majority of American adults taking opioids and other commonly prescribed medications use them in ways that put their health at risk.”

But according to the study, opioids were not the most commonly misused class of medication. Depending on the age of the patient, that distinction went to amphetamines, benzodiazepines and marijuana. Opiates were the second most likely class of drugs to be misused by adults – but again that includes many patients who did not take opioids that were prescribed or had no drugs at all in their system.

This way of slicing the data has long been used by drug testing companies to make the abuse of opioids appear worse than it is and to justify more testing.

A similar study by Ameritox in 2012 found that nearly a third of older patients did not have a prescribed opioid detected in their urine -- and that was also considered misuse.

“This population has a risk of medication misuse and illicit drug use that warrants attention,” said Harry Leider, MD, who was then Chief Medical Officer of Ameritox. “This data provides a compelling rationale for routinely monitoring medication use in older patients on chronic opioids.”

Ameritox sponsored a study that same year claiming that patients should be drug tested at least four times annually if a doctor believes they are at risk misusing opioids.  The study was approved even though “there currently is a limited evidence base to support the expert panel’s recommendations.”

Guidelines adopted by the CDC earlier this year were also based on weak evidence. They recommend that physicians should use urine drug testing before starting opioid therapy and should re-test patients at least once annually.

As Pain News Network has reported, “point-of-care” urine drug tests that are widely used in doctors’ offices are wrong about half the time – frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone.

According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry -- “liquid gold” as some have called it – that is projected to reach $6.3 billion by 2019. The competition between drug screening labs is intense and several companies have been fined by the federal government for giving illegal kickbacks to physicians. Last year, Millennium Health agreed to pay $256 million to the federal government to settle fraud and kickback charges. The company later filed for chapter 11 bankruptcy protection.