Lyrica and Neurontin Linked to Opioid Overdoses

By Pat Anson, Editor

British researchers say two drugs commonly prescribed as alternatives for opioid pain medication are linked to a rising number of heroin overdose deaths in England and Wales.

Pregabalin and gabapentin belong to a class of nerve medications known as gabapentoids. They were originally developed to treat epileptic seizures, but are increasingly prescribed to treat neuropathy, fibromyalgia and other chronic pain conditions. The drugs are sold by Pfizer under the brand names Lyrica (pregabalin) and Neurontin (gabapentin).

Researchers at the University of Bristol reported in the journal Addiction that opioid overdose deaths in England and Wales involving gabapentoids increased from less than one per year prior to 2009 to 137 deaths in 2015. The increase coincided with a surge in pregabalin and gabapentin prescribing in Wales and England, from one million prescriptions in 2004 to over 10 million in 2015.   

Researchers say the increased prescribing has made the drugs easier to obtain and abuse, and addicts have found they enhance the effects of heroin. Experiments on laboratory mice found that pregabalin slows respiratory depression, increasing the risk of an opioid overdose.

"It is important that doctors and people dependent on opioids are aware that the number of overdose deaths involving the combination of opioids with gabapentin or pregabalin has increased substantially and that there is evidence now that their concomitant use - either through co-prescription or diversion of prescriptions - increases the risk of acute overdose deaths,” said Matthew Hickman, a Professor of Public Health and Epidemiology in the University of Bristol's School of Social and Community Medicine.

The idea that Lyrica and Neurontin are being abused may be surprising to many patients and doctors, but the drugs are increasingly being used by addicts. In a small 2016 study of urine samples from patients being treated at pain clinics and addiction treatment centers, over one in five 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,” said Poluru Reddy, PhD, medical director of ARIA Diagnostics in Indianapolis. “These findings reveal that there is a growing risk of abuse and a need for more robust testing.”

High Risk of Abuse in Prisons

Gabapentin and pregabalin are also being abused by inmates. Jeffrey Keller, MD, chief medical officer of Centurion, a private correctional company, says both drugs have a high abuse potential.  

“Gabapentin is the single biggest problem drug of abuse in many correctional systems,” Keller recently wrote in Corrections.com. “There is little difference (in my opinion) between Lyrica and gabapentin in both use for neuropathic pain or for abuse potential.”

Why would someone be so desperate to abuse them?

“If you are addicted, or even if you just like to get high once in a while, and you can’t obtain your preferred drugs of abuse because you are incarcerated, these are the drugs that can serve as an alternative in a pinch,” Keller wrote.
“It is critically important for medical professionals in corrections to know which seemingly benign drugs have the potential to be abused and diverted. Even if a particular inmate doesn’t care about getting high himself, he can still profit by selling these drugs to others who are. Vulnerable inmates can be (and are) bullied into obtaining these drugs for distribution.”

Gabapentin is approved by the FDA to treat epilepsy and neuropathic pain caused by shingles. It is also prescribed “off-label” for depression, migraine, fibromyalgia and bipolar disorder. About 64 million prescriptions were written for gabapentin in the U.S. in 2016, a 49% increase since 2011. Gabapentin is not scheduled by the DEA as a controlled substance.

Pregabalin is a Schedule V controlled substance, which means the DEA considers it to have a low abuse potential. Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, epilepsy, post-herpetic neuralgia caused by shingles and spinal cord injury. It is also prescribed off label to treat a variety of other conditions. Lyrica is Pfizer’s top selling drug, generates over $5 billion in annual sales, and is approved for use in over 130 countries.

The CDC’s opioid prescribing guidelines recommend both pregabalin and gabapentin as alternatives for opioids, without saying a word about their potential for abuse or side effects.

“Selected anticonvulsants such as pregabalin and gabapentin can improve pain in diabetic neuropathy and post-herpetic neuralgia. Pregabalin, gabapentin, and carbamazepine are FDA-approved for treatment of certain neuropathic pain conditions, and pregabalin is FDA approved for fibromyalgia management,” the guidelines state.

Opioids vs. NSAIDs for Chronic Pain

 By Roger Chriss, Columnist

The latest shot in the debate over opioids versus non-steroidal inflammatory drugs (NSAIDs) for chronic pain has been fired, with the Minneapolis Star Tribune reporting on a new study that found “patients with chronic pain fared no better with the potentially addictive painkillers than they did with non-opioid meds.”

The research was conducted by Erin Krebs, MD, who is investigating the efficacy of medications for osteoarthritis aspart of a study called the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE).

(Editor's note: Dr. Krebs appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which is the fiscal sponsor of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.)

Her research involved 240 veterans who were treated for back, hip and knee pain with either opioids or non-opioids for 12 months. She presented her findings recently at the Minneapolis VA Medical Center and the Society of General Internal Medicine.

"For long-term treatment of chronic back pain and osteoarthritis pain, non-opioid medication therapy is superior to opioid therapy for both pain and side effects,” Dr. Krebs said.

A summary of the SPACE research states that the “findings showed no significant advantage of opioid therapy compared with non-opioid medication therapy.”

Naturally, critics of opioid prescribing weighed in.

“If pain doctors still think these medicines are effective, then they have a lot of explaining to do and their competence and professionalism deserve to be challenged,” said Chris Johnson, MD, who is a board member of PROP as well as the Steve Rummler Hope Foundation.

But the study did not show that opioids were ineffective, only that non-opioids were more effective in this particular study. Thus, pain doctors are justified in claiming they are effective. Of course, so are NSAIDs, but this is not a new or surprise finding. Similar results have been obtained before, though only in shorter-term studies.

Dr. Krebs’ results are an important addition to our understanding of which medications are useful for certain types of pain management. In some cases, NSAIDs may be better than opioids, and in other cases, opioids may be better.

But a response like the one from Dr. Johnson is another example of over-generalization and simplification of a complex medical result, and how anti-opioid activists often spin research findings to fit their agendas.  

It also insults the expertise of physicians like Roger Chou, MD,  a Professor at Oregon Health & Science University’s School of Medicine and one of the lead authors of the CDC guidelines; and Sean Mackey, MD, Chief of the Division of Pain Medicine at Stanford University and immediate past president of the American Academy of Pain Medicine.

In a recent Medscape interview, Dr. Chou said, "I don't think there's anything inherently wrong with maintaining somebody on low doses of opioids, as long as it's doing what it's supposed to in terms of helping their pain and function and not causing harm." 

And in a recent Vox interview, Dr. Mackey said, "The fact is if you go looking, there’s clearly data out there that opioids improve pain. These drugs would have never been approved by the FDA if they didn’t."

More importantly, statements like Dr. Johnson’s ignore the difficult challenges that people with chronic pain conditions face.

"Everything we know about pain is that this is a complex biopsychosocial phenomenon,” said Dr. Chou.

Or as Forest Tennant, MD, put it in Practical Pain Management: “A major point to be made about painful genetic diseases is that pain will almost always worsen as the patient ages.”

Chronic Pain is a Complex Problem

Chronic pain management is thus a long-term endeavor requiring as many tools as possible. What works for one person may be ineffective or even contraindicated in another person. NSAIDs may cause intolerable levels of nausea or gastrointestinal pain, and can be contraindicated in some patients because of kidney disease or bleeding disorders. A major study released this week also found that NSAIDs increase the risk of a heart attack.

The converse also holds. Some people do not tolerate opioids well, have too much brain fog or get constipated. And opioids may be contraindicated in a person with respiratory illness or a history of substance abuse. So having an effective alternative such as NSAIDs is important.

Thus, the “risk profile” of each person must be considered. No medication is perfectly safe. According to the FDA, as many as 20,000 people die from NSAID use every year.

At the same time, opioids have risks. Practical Pain Management reported in 2013 that mortality was higher in patients receiving opioids than other analgesics. The risk of addiction to opioids is well-publicized and makes good headlines, but in chronic pain patients it is less than 5 percent.

The unfortunate reality is that pain management is often a lifelong necessity for people who suffer from chronic pain disorders. Such people don’t have the luxury of ideological debates or moralistic disputes. They need a pain toolkit that is as well-equipped as possible, and they have to deal with medication trade-offs in order to address their medical problems.

Prescribing decisions are best left to experienced physicians who know their patients and the medical conditions they have, and can work with them on the risks and benefits of opioids and NSAIDs.

In reality, there is no “versus” here. Opioids and NSAIDs are both valuable tools for chronic pain management. To pretend that one is inherently better than the other is to miss the essential point: Both work and should be available for use as medically appropriate.

Roger Chriss suffers from 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.

NSAIDs Raise Risk of Heart Attack Within Days

By Pat Anson, Editor

Taking prescription strength non-steroidal anti-inflammatory drugs (NSAIDs) raises the risk of a heart attack as soon as the first week of use, according to a large new study published in The BMJ.

An international teams of researchers analyzed data from eight studies involving nearly 450,000 patients in Canada, Finland and Germany -- 61,460 of whom had a heart attack. They found that taking any dose of NSAIDs for one week, one month, or more than a month was associated with an increased risk of myocardial infarction. Researchers estimated that the overall risk of a heart attack was about 20 to 50% higher when using NSAIDs.

"Given that the onset of risk of acute myocardial infarction occurred in the first week and appeared greatest in the first month of treatment with higher doses, prescribers should consider weighing the risks and benefits of NSAIDs before instituting treatment, particularly for higher doses," wrote lead author Michèle Bally, PhD, an epidemiologist at the University of Montreal Hospital Research Center.

The NSAIDs of particular interest to the researchers were ibuprofen, diclofenac and naproxen, as well as the COX-2 inhibitors celecoxib and rofecoxib. COX-2 inhibitors work differently than traditional NSAIDs, by targeting an enzyme responsible for pain and inflammation.

“All NSAIDs, including naproxen, were found to be associated with an increased risk of acute myocardial infarction. Risk of myocardial infarction with celecoxib was comparable to that of traditional NSAIDS and was lower than for rofecoxib. Risk was greatest during the first month of NSAID use and with higher doses,” Bally wrote.

Several previous studies have also found that NSAIDs and COX- 2 inhibitors raise the risk of a heart attack, but the exact cause is unknown. Researchers at the University of California Davis reported last year that NSAIDs impaired the activity of cardiac cells in rodents.  

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are in so many different pain relieving products, including over-the-counter cold and flu products, that health officials believe many consumers may not be aware how often they use NSAIDs. 

In 2015, the U.S. Food and Drug Administration ordered that stronger warning labels be put on NSAIDs to indicate they increase the risk of a heart attack or stroke. The warning does not apply to aspirin.

“There is no period of use shown to be without risk,” said Judy Racoosin, MD, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products. “Everyone may be at risk – even people without an underlying risk for cardiovascular disease.”

The BMJ study was published the day after Canada released new guidelines that recommend NSAIDs as an alternative to opioid pain medication. The Canadian guideline makes no mention of the health risks associated with NSAIDs, but focuses on their “cost effectiveness.”

“NSAID-based treatment may have lower mean costs and higher effectiveness relative to opioids,” the new guideline states. “Naproxen-based regimens in particular may be more cost effective compared to opioids and other NSAIDs, such as ibuprofen and celecoxib.”

Opioid guidelines released last year by the U.S. Centers for Disease Control and Prevention, which the Canadian guideline was modeled after, also recommend NSAIDs as an alternative to opioids, but acknowledge the medications “do have risks, including gastrointestinal bleeding or perforation as well as renal and cardiovascular risks.”

Despite those risks, the CDC cited the low cost of NSAIDs and other non-opioid treatments as an “important consideration” for doctors.

“Many pain treatments, including acetaminophen, NSAIDs, tricyclic antidepressants, and massage therapy, are associated with lower mean and median annual costs compared with opioid therapy,” the CDC guideline states.

Canadian Opioid Guideline Modeled After CDC’s

By Pat Anson, Editor

Canada this week is officially adopting new guidelines for the prescribing of opioid pain medication that are very similar to those released by the U.S. Centers for Disease Control and Prevention a little over a year ago.

And, like the CDC guidelines, there is controversy over the role played by addiction treatment specialists and anti-opioid activists in drafting them.

The Canadian guideline, developed at the National Pain Centre at McMaster University and published in the Canadian Medical Association Journal, contains 10 recommendations for treating non-cancer chronic pain, most of them focused on reducing the use of opioid medication.

"Opioids are not first-line treatment for chronic non-cancer pain, and should only be considered after non-opioid therapy has been optimized," said Jason Busse, PhD, lead investigator for the guideline and an associate professor of anesthesia at McMaster University’s School of Medicine.  "There are important risks associated with opioids, such as unintentional overdose, and these risks increase with higher doses."

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the second highest rate of opioid prescribing in the world. Opioid overdoses are soaring in Canada, as they are in the United States, but increasingly the deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

The new guideline recommends that non-drug therapies, such as exercise and cognitive behavioral therapy, and non-opioid medications such as non-steroidal anti-inflammatory drugs (NSAIDs), be used first in treating patients with chronic pain. It is recommended that opioids only be prescribed if patients do not respond to non-opioid treatments, and only if they do not have a history of substance abuse or a psychiatric disorder.

The guidelines also suggest that initial doses of opioids be limited to no more than 50 mg morphine equivalents daily (MED), and strongly recommend that doses not exceed 90 mg MED. The previous Canadian guideline suggested a ceiling of 200 mg MED. For patients who already exceed 90 mg MED, the guideline recommends the gradual tapering of opioids to the lowest effective dose or to discontinue opioid treatment altogether.

"The opioid epidemic has serious consequences for families and communities across Canada. We are committed to working with our partners to ensure a comprehensive response to this public health crisis, including supporting physicians in improving prescribing practices. I applaud the work that went into updating the prescription opioid guideline, and I urge healthcare professionals to apply the recommendations when prescribing these types of medications," said Jane Philpott, Canada's Minister of Health, in a statement.

A major difference with the CDC guideline, which is intended only for primary care physicians, is that the Canadian version applies to all prescribers, including family physicians, pain specialists and nurse practitioners.

The Canadian guideline was also developed with more transparency than the CDC guideline, which was initially drafted in secret meetings by an unidentified panel of experts.  Leaks later revealed that the panel included several academics and addiction treatment specialists, but only one retired doctor with experience in pain management.

PROP Involved in Canadian Guideline

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

Juurlink, an academic toxicologist at Sunnybrook Health Sciences Centre in Toronto, had an influential role on the Canadian Guideline Steering Committee; while Franklin and Sullivan, both of them Americans affiliated with the University of Washington, served on the Clinical Expert Committee.

Juurlink and Sullivan disclosed their involvement with PROP in their conflict of interest statements, while Franklin did not specifically name the group.

“These guidelines, which appear to be influenced by the extremely flawed and biased guidelines by the CDC in the United States, written by a small group of anti-opiate crusaders with strong ties to a large drug rehab chain, seem to reflect more attention to people with addictions and not people with pain,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, in written comments to the guideline.

PROP's founder and Executive Director, Andrew Kolodny, MD, was until recently chief medical officer of Phoenix House, which runs a chain of addiction treatment facilities in the U.S.

A news release on the guideline produced by McMaster University emphasizes that experts with “diverse views on the role of opioids” participated in drafting them and only those “without important financial or intellectual conflicts of interest” were allowed to vote on the recommendations.

Ulmer says the guidelines should have focused on improving pain education for physicians, which is limited in medical schools in both Canada and the U.S.

“Pain patients feel strongly the authors and policy makers behind these guidelines have missed another golden opportunity to create real change in this area of medicine. They would have impacted pain medicine far more positively if they had used their resources to develop forward thinking educational programs and incorporate them into the curricula in our teaching hospitals,” Ulmer wrote.

“By putting forth guidelines like this, at this time, to influence (or control) a profession that has little education and understanding about chronic pain is myopic and similar to the last attempt at guidelines will simply encourage more physicians to dump pain patients they now have. Or is that the real goal?”

One of the many unintendend consequences of the CDC guidelines in the United States is that pain patients are losing access to treatment. A recent survey of over 3,100 patients by PNN and the International Pain Foundation found that over 60 percent had a hard time or were unable to find a doctor willing to treat their chronic pain. Over 90 percent believe the CDC guidelines have harmed patients and worsened the quality of pain care. 

Although the CDC guidelines are voluntary and only intended for primary care physicians, they are being implemented and treated as mandatory by many prescribers, insurers, and federal and state agencies. Critics worry the same thing could happen in Canada.

“No guideline can account for the unique features of patients and their clinical circumstances, and the new guideline is not meant to replace clinical judgment. Patients, prescribers and other stakeholders, including regulators and insurers, should not view its recommendations as absolute,” wrote Drs. Andrea Furlan of the Toronto Rehabilitation Institute, and Owen Williamson of Monash University in Australia, in an editorial published in the Canadian Medical Association Journal.

British Columbia adopted its own mandatory version of the CDC guidelines nearly a year ago, and made them a legally enforceable standard of care for all prescribers. The move has yet to slow the rising tide of drug overdoses in British Columbia, which are now occurring at a rate of four deaths every day. Most of the overdoses are blamed on illicit fentanyl and other street drugs, not prescription opioids.

Hydrocodone Prescriptions Continue Falling

By Pat Anson, Editor

For the fifth year in a row, fewer prescriptions for the opioid painkiller hydrocodone were dispensed in the U.S. in 2016, according to a new report by the QuintilesIMS Institute, which tracks prescription drug use and spending.

The report adds further evidence that the nation’s overdose epidemic is being fueled by illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

About 7 million fewer prescriptions were filled last year for hydrocodone, which is usually combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone combination products.

As recently as 2012, hydrocodone was the #1 most widely dispensed medication in the nation, with 136 million prescriptions filled. Since then, hydrocodone prescriptions have fallen by over a third, to 90 million prescriptions.

Hydrocodone now ranks fourth, behind the thyroid drug levothyroxine (Synthroid), the blood pressure medication lisinopril (Zestril), and the statin atorvastatin (Lipitor).

Hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, making it harder to obtain. Opioid guidelines released last year by the CDC also probably had an impact, although hydrocodone prescriptions were falling long before the CDC and DEA acted.

HYDROCODONE PRESCRIPTIONS IN U.S. (MILLIONS)

Source: QuintilesIMS Institute

Prescriptions for hydrocodone and other opioids are likely to fall even further in 2017, because the DEA plans to reduce the supply of almost every Schedule II opioid pain medication by 25 percent or more "to prevent diversion." The 2017 quota for hydrocodone is being reduced by a third, to 58.4 million prescriptions, which the DEA considers an adequate supply.

Overall, QuintilesIMS reported 13 million fewer prescriptions for pain medicines in 2016, “as restrictions on prescribing and dispensing become increasingly common and impactful.” The company includes both narcotic and non-narcotic treatments in its pain medicine category.

Over 7 million more prescriptions were written last year for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 64 million prescriptions were written for gabapentin in 2016, a 49% increase since 2011.

More prescriptions are also being written for ibuprofen, a widely used pain reliever available both by prescription and in over-the-counter drugs. About 44 million prescriptions were filled for ibuprofen in 2016, a 19% increase since 2012.

The shift in prescribing away from opioids is hardly a surprise to pain sufferers. According to a recent survey of over 3,100 patients by PNN and the International Pain Foundation, over 70% said they were no longer prescribed opioids or were getting a lower dose since the CDC guidelines were released. About half of the doctors and pharmacists we surveyed also said they were writing or filling fewer opioid prescriptions, or had stopped them altogether.  

“My doctor cut me off hydrocodone cold turkey last fall leading to an overnight in the hospital emergency room,” a patient with chronic back pain and anxiety told PNN. “For years I have been stable on a mix of hydrocodone and Valium. Last October my doctor said he would only fill one prescription and asked me to make a choice so I stayed with the Valium.”

“With the VA allowing me only 2 hydrocodone per day now, I get very little exercise and stay in bed a lot,” a 70-year old veteran wrote. “My quality of life has gone down considerably. Before the changes, I stayed quite active taking 4 hydrocodone a day.”

“I had an interventional pain management doctor scream at me that the guidelines were mandatory and he refused to write for any type of opioids even though I've been on the same level of hydrocodone for several years,” another patient said.

“I took hydrocodone pain medicine for 25 years as the doctor proscribed. Never called in for more, now I'm having to go a pain doctor and get steroid shots every 3 months,” wrote a patient with lives with chronic back pain.

Overall spending on prescription drugs in the U.S. reached $323 billion in 2016, a 4.8% increase that is less than half the rate of the previous two years. The QuintilesIMS report blames the slowdown in growth on increased competition among drug makers and efforts to limit price increases.

“New medicines introduced in the past two years continue to drive at least half of the total growth as clusters of innovative treatments for cancer, autoimmune diseases, HIV, multiple sclerosis, and diabetes become accessible to patients,” said Murray Aitken, Senior Vice President and Executive Director, QuintilesIMS Institute.

Better Analysis Needed on Non-Medical Use of Opioids

By Willem Scholten, PharmD MPA, Guest Columnist

A few months ago, the medical journal World Psychiatry published an article that focused on the global non-medical use of prescription drugs, particularly psychoactive substances such as opioids.

Unfortunately, the two authors -- Dr. Silvia Martins and Dr. Lilian Ghandour -- ignored the distinction between prescription and prescribed opioids, adding unnecessary confusion to the already complex debate about access to pain treatment. Further, Dr. Martins said in the Washington Post that the non-medical use of psychoactive substances could turn into a pandemic if we are not careful.

Both authors are affiliated with Columbia University’s Mailman Institute of Public Health, which claims to work in the interest of underserved people in developing countries. Access to effective pain treatment in developing countries is already now more difficult than in the U.S.

Elsewhere, I have demonstrated that access to prescribed opioids for adequate pain treatment is a problem for 5.5 billion people living in countries where opioid analgesics are not available or inaccessible for patients in need.

In most countries, the per capita consumption of legitimately prescribed opioid analgesics (as officially reported to the International Narcotics Control Board) remains much lower than in the U.S. and Canada, in extreme cases even up to 50,000 times lower.

Distinction Between “Prescribed” and “Prescription” is Key

There is a vast difference between prescription and prescribed opioids. Prescription opioids are intended to be prescribed as medicines. Prescribed medicines are actually prescribed by a physician and dispensed by a pharmacy.

About 75% of fatal overdoses from prescription opioids in the U.S. occur in people who have not been prescribed opioids during the three months preceding their deaths. Thus, the majority must have obtained these prescription opioids on the black or gray market.

Without referencing the data, Drs. Martins and Ghandour claim that prescription opioids are causing serious problems in other parts of the world. However, data from the European Monitoring Centre for Drug and Drug Addiction and the European Drug Report indicate that diversion of prescription opioids is not a serious problem in Europe. In other regions of the world, per capita prescription of opioids is very low.

Drs. Martins and Ghandour claim a high prevalence of non-medical use of prescription opioids in Saudi Arabia. However, those medicines are hardly ever prescribed in that country and medical consumption rates are only about 2.5 % of the U.S. volume. Therefore, Saudi Arabia’s non-medical use of prescription opioids can hardly originate from prescribed opioids.

Unfortunately, World Psychiatry refused to publish a letter I wrote with other experts which addressed the misunderstandings stemming from Drs. Martins and Ghandour’s article.

PROP and the Anti-Opioid Lobby

The anti-opioid lobby in the U.S. does not shy away from using arguments not based on facts, just like Drs. Martins and Ghandour in their article. For example, Physicians for Responsible Opioid Prescribing (PROP) perpetuates the mistaken conflation of prescription and prescribed opioids, advocating in the U.S. against the legitimate medical prescribing of opioid analgesics. PROP tries to justify its position using false statistics, as I demonstrated in a recent publication.

Moreover, PROP leadership participated in drafting the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. PROP Executive Director Dr. Andrew Kolodny disclosed his involvement, but PROP President Dr. Jane Ballantyne and PROP Vice President Dr. Gary Franklin did not list the group as a relevant conflict of interest on their disclosure forms.

The Steve Rummler Hope Foundation is the “fiscal sponsor” of PROP. Its vision is “a world where individuals with chronic pain receive integrated care focused on wellness rather than drugs.” For patients with moderate or severe pain, this can hardly be an effective and humane treatment. PROP’s close ties with the Steve Rummler Foundation are revealed by Dr. Kolodny’s and Dr. Ballantyne’s membership on its medical advisory committee.

Policies Should Balance All Public Health Interests

Indeed, it is correct to attend to the non-medical use of psychoactive substances. However, the situation outside the U.S. is really different. In many countries, patients have no access to adequate pain management. Measures to address non-medical use of opioids should not hamper access to effective pain management.

Policymakers in countries with a low per capita medical opioid consumption and low prescription rates should first analyse how prescription opioids that have not been prescribed enter circulation. The relationship between the non-medical use of prescription opioids and illicitly produced substances such as heroin should also be taken into consideration. Then, appropriate interventions to halt the diversion should be developed.

In parallel, policymakers should develop policies aimed at ensuring adequate provision of pain treatment as recommended by the World Health Organization. Optimal public health outcomes can only be attained when policies to minimize non-medical use are balanced with policies to maximize access to adequate pain management. Crafting such policies entails correctly distinguishing between prescribed and prescription opioids.

Willem Scholten, PharmD MPA, is an independent consultant for medicines and controlled substances at Willem Scholten Consultancy in the Netherlands. This has included work for DrugScience, Grünenthal, Jazz Pharmaceuticals, Mundipharma, Pinney Associates and the World Health Organization. Dr. Scholten is also a board member of International Doctors for Healthier Drug Policies.

He wishes to acknowledge Dr. Katherine Pettus for her contribution to this article.

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.

Will Pain Patients Participate in Drug Take Back Day?

By Pat Anson, Editor

Tomorrow is National Prescription Drug Take Back Day, an annual effort by the U.S. Drug Enforcement Administration to give people an opportunity to safely dispose of their unneeded and expired medications.

Last year the DEA and its local law enforcement partners collected nearly 900,000 pounds of unwanted medication – about 447 tons – at almost 5,400 collection sites in all 50 states.

“These results show that more Americans than ever are taking the important step of cleaning out their medicine cabinets and making homes safe from potential prescription drug abuse or theft,” said DEA Acting Administrator Chuck Rosenberg in a news release.

One of the main goals of the DEA is to get patients to dispose of unneeded opioid medication, to prevent the drugs from being stolen, shared or sold.

But with opioid medciation becoming harder to obtain due to federal and state guidelines – and the DEA itself reducing the supply of hydrocodone, oxycodone, and other painkillers by 25 percent or more --   are chronic pain patients going to participate in Drug Take Back Day?

A recent survey of over 3,100 patients by Pain News Network and the International Pain Foundation suggests that many will not. And that government efforts to limit the supply of opioids have turned many responsible patients into hoarders.

Nearly one in four patients – 22 percent – say they are hoarding opioid medications because they’re not sure if they’ll be able to get them in the future.

Nearly half say they are being prescribed a lower dose since the CDC released its controversial opioid guidelines, and almost one in four say they are no longer prescribed any opioids.

“The CDC guidelines have led to a lot of confusion and fear for patients and their doctors. If anything, I ask for more pain medication now because I don't know how much longer I'll be able to obtain it,” one patient wrote.

“I never abused my opiates and in fact have hoarded 30 precious pills,” said another patient.

“I am 65 years old, well educated, and very disabled by (fibromyalgia). I endure the pain, for as long as possible, (and only) then take the meds due to having to hoard the medication,” wrote another.

“It's a no win situation," said a patient. "To be able to get proper relief from a new injury or if surgery comes up, one must hoard enough to treat the additional pain or suffer through it.”

Although the supply of opioid medication has been in decline for years, the news media often makes it sound like painkillers are still being given out like candy, often relying on outdated or inaccurate information that doesn't reflect the current environment.

“The amount of prescription opioids consumed has quadrupled since 1999, and deaths are even higher. Since eight out of ten new heroin users began by abusing prescription painkillers, and most get their pills from family and friends, controlling access to the pills becomes increasingly important,” Judy Stone, MD, wrote in a Forbes article promoting Drug Take Back Day.

Yes, Dr. Stone, it is true that opioid overdoses are soaring, but in recent years that is primarily due to heroin and illicit fentanyl, not prescription opioids. Even the CDC admits that painkillers are no longer driving the opioid epidemic.

The DEA also tells us that less than one percent of legally prescribed painkillers are diverted, which means that 99% of pain patients are responsible about their use and storage of pain medication. Only a small percentage of patients become addicted to opioids and even fewer go on to use heroin.

All of which isn’t to say that Drug Take Back Day is a bad idea. But let’s not use it as another opportunity to stigmatize chronically ill patients who happen to need pain medication.

To find a drug collection site near you, click here.

West Virginia Moves to Stop Opioid Madness

By Kenny Brooks, Guest Columnist

When most people think of West Virginia, they think about mountains, coal mines and miners.  The number of coal miners in West Virginia suffering from black lung, cancer and other chronic illnesses plays a significant role in the state's high rate of disability, estimated at nearly 20 percent of the population. 

Many military veterans in West Virginia also suffer from lifelong pain and disability, as do injured public safety employees, police, firefighters and paramedics. I was severely injured as a paramedic in a work related accident and now live with arachnoiditis, a painful inflammation in my spine that will never go away.

All of this pain and disability has a significant impact on our state. The per capita income of West Virginia is only about $37,000 a year, making it one of the poorest states in the union.  About 23% of West Virginians live below the national poverty line.  We rank 5th highest in suicide and have the highest overdose death rate in the country.

West Virginia was one of the first states to crackdown on pill mills and doctors who overprescribe opioids, but opioid overdoses continue rising, especially from heroin, illicit fentanyl and addicts taking pain medication.

The CDC’s opioid prescribing guidelines only made things worse for real pain patients, causing many to be under treated or abandoned by doctors who took an oath to relieve pain and suffering.

West Virginia lawmakers have seen enough of this suffering. In an unprecedented move, the legislature this month passed Senate Bill 339, with the goal of restoring the integrity of chronic pain management in the state.

The bill was introduced by State Senator Tom Takubo, DO, a pulmonary physician who specializes in treating patients suffering from lung and breathing problems.  Dr. Takubo understands the ethical duty to act, and to help alleviate chronic suffering and pain from incurable chronic conditions.

Senate Bill 339 was approved unanimously by both the House and Senate, and was signed this week into law by the governor.  It recognizes that regulations have caused “patients seeking pain treatment to suffer from a lack of treatment options” and that “prescribers should have the flexibility to effectively treat patients who present with chronic pain.”

The bill also establishes a commission -- called the Coalition for Responsible Chronic Pain Management -- to advise the legislature if a “less cumbersome” manner exists to regulate pain care in the state.

The Coalition will consists of the following members:  The Dean of the School of Public Health at West Virginia University, a physician board certified in pain management, three physicians licensed to practice in West Virginia, a licensed pharmacist, a licensed chiropractor, a licensed physical therapist experienced in the area of chronic pain, and a consumer of healthcare services directly impacted by pain clinic regulations – in other words, a pain patient.

We have about a month before the appointments are made and I am hopeful that I will be appointed as the patient representative. I hope to bring to the Coalition not only my experience as a pain patient, but my experience as a paramedic.  I spent many hours in school years ago learning about medical and legal issues, and believe I have a unique perspective to bring to the table.

My goals are simple: to change the regulations and prescribing guidelines back to individualized patient centered care, not addiction centered algorithms. I am also concerned about doctors being afraid to treat pain patients due to legal reprisals.

I hope to bring a voice of reason to the Coalition, and to help other states look at what we are doing in West Virginia to stop the opioid madness.  

Kenny Brooks is an arachnoiditis survivor and former career firefighter in Montgomery County, Maryland.  He loves his family, his church, his dog, his friends, and he feels very blessed to have a great team of medical doctors and pharmacists who understand quality of life medical care. Kenny became more involved in politics following the sad consequences he witnessed in other arachnoiditis patients due to the CDC guidelines. 

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.

Limiting Opioids for Acute Pain Will Hurt Everyone

By Patricia Young, Guest Columnist

There is a bill in Congress that, if passed, will have a great negative impact on most people in this country. The legislation by Senators John McCain (R-AZ) and Kristen Gillibrand (D-NY) would limit your doctor’s ability to treat short term acute pain by restricting the supply of opioids to 7 days. This would be a prescription that could not be renewed.

Several states have passed or are considering similar measures to limit the initial supply of opioid medication to a week or less.

I am not sure how these senators came up with the magic number of 7 days for all types of acute pain, but this will cause much undue suffering for innocent people.

As a registered nurse who worked in hospitals and nursing homes for 32 years, I have firsthand knowledge of what happens when acute pain goes untreated. Patients who suffer from acute pain often cannot sleep and become agitated at a time when rest is imperative for healing.

There are many painful and complicated surgeries that make a blanket 7 day restriction on opioid medication absurd. Post-surgical patients often do not stay in the hospital long and the continuation of pain medicine is vital to their healing process. Gastrointestinal surgery often results in an open wound requiring constant dressing changes for weeks.

Most people will eventually be adversely affected if such a bill if passed. Pain is real and comes with most surgeries and many medical conditions.

I recently had arthroscopic hip surgery. I had not been prescribed pain medicine for over a year. At one time I was taking opiates daily, but taking them in that fashion never worked for my chronic pain issues and caused adverse reactions, such as gastroparesis and severe sleep apnea. However, I knew that I would not do well after hip surgery without some pain relief.

I told my surgeon about the adverse reactions and he gave me a prescription for Percocet to use for the first 2 weeks following surgery. I felt good that this doctor had my history and I trusted him to regulate my pain medicine.

I had my surgery done as an outpatient and returned home the same day. My husband took the prescriptions signed by my surgeon to the pharmacy and returned with all of the medications, except for the Percocet. By this time I really needed some pain relief and called the pharmacy to see what happened. I was told that they were not going to fill the prescription for Percocet. They told me my Medicare Advantage Plan (Aetna) was rejecting payment for it.

This was the type of news you just do not need after a painful surgery! I immediately went from feelings of anger to hopelessness. In a couple of weeks I was going to begin 3 months of grueling physical therapy so I could walk again. I also wondered what people did for pain after more complicated surgeries which take longer to recover from. What is happening? Is the government regulating our healthcare so that an insurance company or Medicare can deny coverage for a surgeon’s prescription for post-op pain?

I explained to my pharmacy that my prescription for Percocet was for acute pain following a surgery. The pharmacy decided to look into it. I was fortunate, I was allowed this one prescription filled, but no more. The pharmacy said they would not fill another prescription for a painkiller even if prescribed by my surgeon.

I was only partially relieved now. I knew I had a painful road ahead with 3 months of physical therapy. I looked at the bottle of pain pills and thought this must last throughout my 6 month estimated recovery time. I made the decision to not take a pain pill that day. Yes, I was having a great deal of pain, but I felt I had to take them sparingly. I lost several nights of sleep due to pain because I was afraid to use my pain medicine.

By the 6th day post-op, I had only taken 3 Percocet pills and my pain level was an 8 while lying still. I called my insurance company to verify that I would get no more prescription coverage for pain medicine as the pharmacy had said. I was told different information. My insurance would allow coverage for another prescription, if my surgeon writes one, as long it was not over 180 pills for a month.

My fears about pain during physical therapy were eased and I was relieved that I could start taking my pain pills as prescribed. But why would a pharmacy tell me the wrong information?

This may be why people have to go to several pharmacies to get pain prescriptions filled. It is not because they are addicts or misusing their medication, but because pharmacies are too afraid to fill legitimate prescriptions.

Do cookie cutter rules and policies for pain treatment really promote healthcare for everyone? Or are they simplistic solutions to try and put a band aid on a problem that is completely different -- the disease of addiction?

Patricia Young lives in Florida. In a previous guest column, Patricia shared her experience about being falsely accused of having a “history of addiction.”

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.

Prescriptions Plummet in Medical Marijuana States

By Pat Anson, Editor

Medical marijuana is giving some serious competition to the prescription drug industry. A new analysis of Medicaid claims found that prescriptions to treat pain, nausea, seizures, psychosis and depression plummeted in the 23 states and District of Columbia where medical marijuana was legal in 2014.

If all 50 states had medical marijuana laws that year, researchers say the potential savings to Medicaid and taxpayers would have been over a billion dollars.

“We found statistically and economically meaningful reductions in prescription drug use associated with the laws. This finding suggested that patients in states with such laws were substituting medical marijuana for prescription drugs,” W. David Bradford and Ashley Bradford, a father-daughter team of researchers at the University of Georgia, reported in the journal Health Affairs.

Previous studies have shown that prescriptions for opioid pain medication have fallen in states where medical marijuana is legal.

The new study was more comprehensive and included nine clinical areas that cannabis could be used to treat: anxiety, depression, glaucoma, nausea, pain, psychosis, seizures, sleep disorders, and spasticity (muscle spasms).

Five of the nine clinical areas had significant drops in prescribing where medical marijuana was legal:

• 17% decline in anti-nausea medication
• 13% decline in antidepressants
• 12% decline in psychosis medication
• 12% decline in anti-seizure drugs
• 11% decline in pain medication

The study found no significant association between medical marijuana laws and drugs used to treat anxiety, glaucoma, sleep disorders or spasticity.

“There is no question that we see patients constantly turning to cannabis, to get off their other medications, mainly to eliminate the side effects they are experiencing.  At this time, this is a huge advantage to us all -- we get a healthier solution to help us with our medical issues and Medicare and Medicaid are seeing a reduction of costs,” said Ellen Lenox Smith, a PNN columnist, medical marijuana user and caretaker in Rhode Island.

“However, until we are able to receive insurance reimbursement like Germany started providing in March, we have to still pay out of pocket. So until we are treated fairly like this in the U.S., we will continue to be paying more for this safer help than if we went to the pharmacy to purchase medication with our co-pays. For me, however, the cost is worth the quality of life I have been able to achieve using cannabis.”

In the current study, researchers cautioned that using fewer prescription drugs is not necessarily a good thing for every marijuana user.

“Our findings do raise important questions about individual behavior. For example, it is plausible that forgoing medications with known safety, efficacy, and dosing profiles in favor of marijuana could be harmful under some circumstances,” said the Bradfords. “In addition, patients who switch from a prescription drug that requires regular physician monitoring to marijuana may interact with their doctor less often, and their adherence to other important treatment regimens could suffer.”

Previous studies have found a significant decline in use of opioid medication by patients who use marijuana and that marijuana users are not at greater risk of alcohol and drug abuse.

Currently medical marijuana is legal in 29 states and the District of Columbia.

Insufficient Evidence: How Opioid Deniers Spin Studies

By Roger Chriss, Columnist

Opioid medications are coming under fire again as being ineffective for chronic pain management.

Charles Pattavina, MD, president of the Maine Medical Association, told the Portland Press Herald that "there is no clinical indication for opioid medication for the treatment of chronic pain."

And Stanford psychiatrist Anna Lembke, MD, said in Vox that “if opioids worked long-term, I would have no problem with patients taking them.”

But sweeping generalizations like these oversimplify a complex situation. Chronic pain is a highly heterogeneous feature of a wide variety of diseases and disorders. And opioids are a broad class of pain medications that come in different doses and are administered by different routes.

Thus, a claim that opioids do not work for chronic pain is too simplistic. Medical researchers investigate carefully posed questions about specific drugs and conditions using the statistical method known as hypothesis testing.

Researchers cannot and do not investigate if “opioids” work for “chronic pain.” Good research is more narrowly focused, such as these clinical studies:

“Tapentadol extended release for the management of chronic neck pain”

“Effectiveness and Safety of Once-Daily Extended-Release Hydrocodone in Individuals Previously Receiving Immediate-Release Oxycodone for Chronic Pain”

“Oxycodone for neuropathic pain in adults”

The results are equally specific. In the first example above, the authors conclude that “our results suggest that tapentadol ER, started at 100 mg/day, is effective and well tolerated in patients with moderate-to-severe chronic neck pain, including opioid-naïve subjects.” Similarly precise statements are found in any such article.

Sometimes researchers will perform a meta-analysis or review in which they assemble a collection of existing research articles and, after a statistical analysis, attempt to draw broader conclusions. Examples include:

“Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects”

“Opioids for chronic pain: new evidence, new strategies, safe prescribing”

“The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop”

The last article above is often cited by opioid deniers, even though it concludes that “evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving chronic pain and function.”

"Evidence is insufficient” means that no determination can be made one way or the other about opioid medications. It does not prove that opioids are ineffective for chronic pain.

This leads to the final defense of opioid deniers: Demand an impossibly high standard of evidence. Specifically, they want the “gold standard” of clinical research: a double-blind, placebo-controlled, randomized trial of a specific drug for a particular condition.

To satisfy this standard, we would have to test every opioid medication against every medical condition causing chronic pain in a variety of different groups of people. This would mean thousands of trials, each performed multiple times, before any meaningful conclusions could be drawn about opioid medications in general. The time and costs involved would be prohibitive in the extreme.

So instead we use observational data and statistical methods to derive reasonable conclusions, as found in the articles above. This approach is widely used in many areas of medical research. In pain research, it has clarified how certain opioid medications can be used to address various chronic pain conditions.

To be clear, opioid therapy can help manage a variety of forms of chronic pain. Not all pain, and not for all patients. And always under the care and guidance of medical professionals.

The goal of opioid therapy is to improve quality of life, and available evidence strongly supports that it does so.

Roger Chriss suffers from 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.

Patients Could Be Jailed in Florida Drug Crackdown

By Pat Anson, Editor

The Florida legislature is close to passing a bill that would require mandatory minimum sentences for anyone convicted of selling, purchasing or possessing illicit fentanyl.

Critics say the legislation could result in pain patients being sent to jail when they unwittingly buy counterfeit painkillers on the black market that are made with fentanyl.

House Bill 477 was approved unanimously by the Florida House this week.  Similar legislation is under consideration in the Senate. Both bills would put fentanyl, carfentanil, and their chemical cousins in the same drug class as heroin.

Fentanyl is a synthetic opioid 50 to 100 more potent than morphine.  It is available legally by prescription to treat severe pain, but illicitly manufactured fentanyl has become a scourge across the U.S. and Canada, where it is usually mixed with heroin or used to make counterfeit drugs.

As currently written, the House bill requires anyone convicted of having as little as 4 grams of fentanyl to get a mandatory three year prison term; 14 grams would carry a 15-year sentence; and 28 grams would result in 25 years behind bars.

Judges would have zero discretion to alter the sentences. If the drugs result in someone dying, suspects would face a charge of first degree murder.

While the legislation is primarily aimed at cracking down on dealers, critics say patients desperate for pain relief could also face prison if they buy counterfeit oxycodone and other painkillers laced with fentanyl.

"There's a massive problem with counterfeit pills," Greg Newburn, state policy director for Families Against Mandatory Minimums told the Miami New Times.

"You have people who think they’re buying oxy pills who will end up getting labeled as traffickers in fentanyl. A handful of pills could get you three years. If you buy just 44 pills, you could end up with 25 years in prison."

Newburn was surprised the Florida legislature didn’t learn its lesson from previous efforts to require lengthy prison terms for oxycodone and hydrocodone traffickers. Rigid enforcement of the law led to 2,300 people being sent to prison, including some patients who were simply look for pain relief, according to Reason.com.

"When you look back on how the last mandatory-minimum heroin law was applied, you see that it targeted not just just traffickers but a lot of low-level offenders, people who were never supposed to be targeted by the bill in the first place," said Newburn. "We had a heroin mandatory-minimum law for 18 years. Lawmakers promised us it would deter drug use, but now we’re in the midst of the worst heroin crisis we’ve ever seen. And the answer to that is to pass another mandatory minimum?"

Florida was one the first states where counterfeit pills laced with fentanyl began to appear. In early 2016, nine people died in Florida’s Pinellas County after ingesting counterfeit Xanax, an anxiety medication.

“Hundreds of thousands of counterfeit prescriptions pills, some containing deadly amounts of fentanyl, have been introduced into U.S. drug markets, exacerbating the fentanyl and opioid crisis,” the DEA warned in a report last year. “Motivated by enormous profit potential, traffickers are exploiting high consumer demand for prescription medications by producing inexpensive, fraudulent prescription pills containing fentanyl.”

As opioid prescriptions have become harder to obtain, some pain patients are turning to the black market for relief. In a recent survey of over 3,100 patients by PNN and the International Pain Foundation, 11 percent said they had obtained opioids illegally on the black market in the year after the CDC’s opioid guidelines were released.    

FDA Bans Use of Codeine and Tramadol in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration is tightening restrictions on the use of codeine and tramadol in young children.

The agency says the opioid medications carry "serious risks" for children under the age of 12, including slowed or difficult breathing and possibly even death. The FDA is also recommending against the use of codeine and tramadol by breastfeeding mothers due to possible harm to their infants.

Codeine is approved to treat mild pain and cough, while tramadol is used to treat moderate pain. Codeine is usually combined with other medicines, such as acetaminophen, in prescription pain medication, as well as in some over-the-counter (OTC) cough and cold remedies. The FDA action only applies to prescription codeine.

"We know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize these medicines much faster than usual, casing dangerously high levels of active drug in their bodies," said Doug Throckmorton, MD, deputy director for regulatory programs, at the FDA Center for Drug Evaluation and Research.

"This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk."

In a review of adverse event reports from 1969 to 2015, the FDA said it identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18. The agency also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol by children.

The majority of serious side effects with both codeine and tramadol occurred in children younger than 12, and some cases occurred after a single dose.

The FDA is requiring drug makers to add a tougher warning to the labels of codeine and tramadol products, alerting healthcare providers and parents that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12.

The new labeling also cautions against their use in adolescents between 12 and 18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease. Breastfeeding mothers will also be warned not to use the medications.

The FDA said it is considering additional regulatory action for the OTC codeine products that are available in some states. It is also considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines, including codeine, to treat cough in children.

The agency did not recommend or suggest any alternatives to codeine and tramadol to treat childrens' cough or pain. OTC medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) also have risks and side effects.

"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe," said Throckmorton.

In 2015, the FDA approved the use of OxyContin in children ages 11 to 16  who are in severe pain, a move widely panned by addiction treatment activists who claimed kids would get easily hooked on the painkiller. 

New Test Identifies Poor Drug Metabolizers

By Pat Anson, Editor

We hear regularly from readers who say they were discharged by their doctor after failing a urine drug test. Often it’s a case of an opioid painkiller not being found, which leads the doctor to believe a patient is selling or diverting their medication.

“The doctor said after 12 years of never having a bad urinalysis or anything ever happening, such as lost medication, asking to receive more or an early prescription, they said no medication was in my system. No one would retest and I was cut off cold turkey!” a pain patient recently told us.

“I went through hell trying to clear my name, horrible withdrawal with no doctor supervision or help, was labeled and thought I would die. This is a terrible way to treat anyone, especially someone with an untreatable life-long pain condition.”

Why are patients being falsely accused? In many cases, it’s because they have genetic differences that make them a low or high metabolizer of certain opioids. A painkiller like hydrocodone, for example, can quickly be utilized or pass through their system -- with little or no trace of the drug left behind.

Urine drug tests that are typically done in a doctor’s office -- known as point-of-care (POC) tests – do not identify these poor drug metabolizers. And studies show that about 30 percent of POC tests have “false negative” findings about opioid medication.

“Just because it may not show up in their system may not mean that they’re not taking it. There are two rational justifications for that. One is a bad drug test and the other is a patient may be a poor or ultra-rapid metabolizer of the medication that is being prescribed to them,” said David McCrea, CEO of Insight Diagnostics.

“I think most (doctors) understand how faulty the point of care tests can be, especially pain physicians. But I’m not sure the average physician understands how much a person’s individual metabolism can affect their drug test.”

Insight Diagnostics recently began offering a new testing service – called Genetically Enhanced Medication Monitoring (GEMM) – that combines a saliva-based genetic test with a laboratory test that more precisely identifies drug molecules in a patient’s urine. When used together, the two tests can reassure a doctor that a patient is telling the truth about their drug use.

“This is a game changing test that will allow physicians to uncover why some patients say, ‘I am taking my medication, I am taking it as prescribed and it’s just not showing up.’ This is scientific information that can validate a patient’s assertion,” McCrea told PNN.

“Certainly there are going patients that are going to try and game the system. But for those patients that are in chronic pain and are doing what they signed their pain contracts to do, this allows for a deeper dive for the physician to determine whether the patient is actually taking their medication, or they can’t metabolize it or they over-metabolize it.”

McRae says GEMM costs "a couple hundred dollars at the most” and is covered by Medicare and most private insurers. It doesn’t offer immediate results, as POC tests do, but the findings are far more accurate. They can also help physicians identify medications that will be metabolized normally by a patient and will be more effective. 

Genetic tests cannot be used to explain “false positive” findings from a POC test – the detection of a drug that isn’t actually there. But laboratory testing can. Retesting a urine sample is more expensive, but it can help prevent patients from being falsely accused – something that happens far too often.   

A recent survey of doctors and health care providers by PNN and the International Pain Foundation found that 20 percent had discharged a patient for failing a drug test in the past year. About four percent of patients said they had been "fired" by a doctor over a failed test.

“I failed a drug test which said I was positive for 4 drugs I have never taken in my life and was negative for opiates when I was taking Norco. My doctor abruptly stopped treating me even after I demanded my sample be retested,” a patient told us. “These drug tests are not reliable and should not be used and pain contracts should be illegal since they are forced on the patient.”

Click here to see a short promotional video about GEMM.

No Opioid Painkillers Prescribed to Prince

By Pat Anson, Editor

Nearly a year after pop superstar Prince was found dead of an accidental drug overdose in his Minnesota home, we still don’t know where he obtained the fentanyl that killed him.

Court documents released today show that none of the opioid painkillers found in Prince’s home were prescribed to him. At least one opioid prescription bottle bore the name of Kirk Johnson, Prince’s former drummer and a longtime friend. Other opioid medications were found stashed throughout Prince’s Paisley Park home near Minneapolis.

“The controlled substances were not contained in typical prescription pill bottles, but rather, were stored in various other containers such as vitamin bottles. Bottles containing these controlled substances were located in multiple areas of the complex, including Prince’s Bedroom,” a search warrant said. 

“Investigators have been searching for the source of the controlled substances found in Prince’s residence. Through this investigation, interviews with those who were at Paisley Park the morning Prince was found deceased have provided inconsistent and, at times, contradictory statements.” 

Assistants to the entertainer told investigators that “Prince recently had a history of going through withdrawals” and they had arranged a meeting for him to meet with an addiction treatment specialist.

Prince was found dead in an elevator at his home on April 21, 2016 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, a potent synthetic opioid that is used in skin patches and lozenges to treat severe pain. Illicit fentanyl is widely sold on the black market, where it is often mixed with heroin or used to make counterfeit painkillers.

Prince 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.

The Minneapolis Star Tribune reported last year that 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.

According to the newspaper, some of the pills found in Prince’s home were labeled as “Watson 853” – a stamp used to identify generic pills containing hydrocodone and acetaminophen that are sold under the brand name Lortab. When one of those pills was tested, it was found to contain fentanyl and lidocaine.

A week before he died, Dr. Michael Schulenberg wrote an oxycodone prescription for Prince under Johnson's name to protect the singer’s privacy, according to investigators.  But in a statement released today, Schulenberg's attorney denied prescribing opioids to Johnson or "any other person with the intent that they would be given to Prince."

The Star Tribune reported that investigators turned over the results of their investigation to the U.S. attorney’s office earlier this year.  No arrests have been made and no charges have been filed.