CDC Guidelines Making Opioid Problem Worse

By Gary Nations, Guest Columnist

I’m a medically retired police officer with over 22 years of service. I have been in chronic pain management for many years now and my condition will never get better.

Throughout my time dealing with workers compensation and the public employee retirement system in Mississippi, I have been examined by no less than five medical doctors. Unfortunately for me, the conclusion is my condition is progressive and will only get worse.

I’ve had four neck surgeries and one lower back surgery due to on-the-job injuries. For the past few years I have found a pain management regimen that allows me to have somewhat of a normal life, although I still experience pain 24/7. I would love to see a substance that relieved pain without the problems caused by opioid medication.

The recent upswing in deaths from opioid abuse is tragic. However, the guidelines developed by the CDC for doctors to reduce opioid dosages for pain patients like me will cause more problems than it solves.

I believe some of the actions taken so far have created a vacuum and worsened the epidemic, which I believe is about to get much bigger.  Some people are going to abuse some type of substance no matter what. That’s an unfortunate fact that cannot be stopped.

Cutting the dose of medication for people in my position who need it will force them to violate the law to maintain their level of pain management and quality of life.

GARY NATIONS

This could prove a disaster, as we know many street drugs contain powerful opioids such as fentanyl, which the DEA has been very unsuccessful in stopping. Some of these street drugs are counterfeit. They appear to be a medication that a doctor would prescribe, yet they contain other drugs that cause people to overdose and die. From what I read and understand, this is what happened to the entertainer Prince. Some patients may also tire of the constant pain and commit suicide with street drugs.

The Declaration of Independence endows each citizen the right to life, liberty and the pursuit of happiness. I believe the CDC’s attempt to curb the opioid overdose and death rate is very noble. However, I also believe in the long run it will violate citizens’ rights, do much more harm than good and end up in the civil courts. As I’m sure you are aware, in some cases large sums of money are paid out each year in legal cases for “pain and suffering.”

There is no way the CDC can tell what medication and how much medication I or anyone else needs to attempt to maintain their current level of activity, quality of life and pursuit of happiness.  Only a qualified physician with medical training, medical records and medical images can understand what a patient may or may not need. The CDC needs to remember there are many people with very legitimate needs for these controlled substances. 

Last year was the first time in over ten years I could enjoy hunting and fishing again. I became active enough that I went from 255 pounds down to 215 pounds. I started feeling better and asked my doctor to drop my “breakthrough” pain meds from 120 to 90 per month. I’ve since realized I really need about 100 per month, but I get by.

The key here is I volunteered to stop taking 30 pills per month. Yes, my doctor was surprised.  However, because of rule changes, I can’t get my pain meds from that doctor anymore. I have to drive one hour each way to a pain management doctor to get my meds now. The long drive is very painful and the cost is higher.

Cutting my current pain management regimen will result in me being in more pain than I am now. It will cause me to be unable to exercise my right to hunt and fish. It will cause me to be unable to do yard work, such as mowing the lawn. Not being able to mow the lawn will result in an additional expense of $80 to $100 per month during the warm weather months.

It will cause me to once again be unable to travel and engage in some aspects of the only hobby I can currently enjoy, amateur radio. In other words, much of my liberty will be taken and my quality of life heavily impacted. My only income is Mississippi Public Employees Retirement System disability payments. Some citizens that are currently able to work with proper pain management may also have to seek disability if their doses are cut.

As I stated, I believe the effort to stop drug abuse and addiction is very noble. However, the route to solving this opioid problem should not include violating the rights of our disabled citizens or cause some patients to become criminals while trying to maintain what little normalcy and quality of life they have now.

I’m seeking your help to stop the CDC from punishing citizens that need to be on long term pain management and to get the CDC to reevaluate how it is handling a very important problem. I believe it’s time for someone to help us by filing for an injunction or a class action lawsuit to stop this craziness.

Gary Nations lives in Mississippi.

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

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Pain Mismanagement

By Jillian Drexler, Guest Columnist

I’ve been going to the same pain management doctor for over 8 months. While at these appointments, I see the physician assistant (PA) far more often than I see the doctor.

The PA is a very unpleasant person and lacks basic compassion and bedside manner. At an appointment last year, I was crying because of my pain and lack of sleep, and she couldn’t even be bothered to hand me a tissue. She was just more of her typical overbearing, sarcastic self.

Since I’ve been going there, I’ve been prescribed tramadol (which I’m allergic to), Lyrica (causes my wrists and ankles to swell and my pain to worsen), compound cream, lidocaine patches, Flector patches and a TENS unit. I’ve also had a few injections, with the most recent ones causing severe adverse effects.

They would have a better idea of what medications work and don’t work for me had they bothered to read the medication genetic testing report my primary care physician ordered. But, the pain management doctor turned down making copies on two occasions. They finally made a copy when I asked a medical assistant instead of the doctor or PA to make copies.

They’ve asked me more than once what opioids have worked for me in the past. I tell them and also explain that these medications have only been prescribed in the ER and after surgeries. Either way, I’m still denied the opioids I know can help alleviate some of my pain and improve my quality of life.

I’ve passed their drug tests and jumped through their hoops, only to get nothing in return but treatments that don’t work. On one occasion, the PA told me she didn’t know what I expected her to do about my fibromyalgia because that wasn’t her “baby.”

JILLIAN DREXLER

Often, they fail to realize I’m not just a patient, but a paying customer. And a very unhappy one, too. They don’t care though.

Patients are told they should play an active role in their treatment, but when we do, it doesn’t seem to matter. Nothing changes. We're perceived as drug seekers or told we’re exhibiting drug seeking behavior. It could never be that we’re in legitimate pain and hoping for relief.

I don’t ask for much from my medical team other than respect, answers and help with an improved quality of life. I’m 33 years old and this life wracked with pain isn’t living. I’m simply existing and missing out on so much in life. I’ve lost my ability to work, provide for my family and spend quality time with them.

I recently was denied for disability again. I wonder if the government ever considered just how many of us are forced to stop working because our pain medications were reduced or stopped entirely.

The CDC should have come up with something for us before putting their guidelines in place. It’s wrong and unfair that we are being punished for the actions of the guilty few. Because of this, the issue becomes an “us vs. them” situation. Addicts need love and treatment, just like any other patient, but while lifesaving measures are in place for them, we’re left feeling slighted and wondering if anyone cares about us. Already, far too many chronic pain patients have lost hope and feel there is no other option but to end their lives.

My governor recently announced plans to limit opioid prescriptions for acute pain to 7 days. Gov. John Kasich said it won’t effect chronic pain patients, but I tend to doubt that. I mean, how could it not? Ohio is considered one of the hardest hit states in the heroin and opioid epidemic.

Last September, a new state law was approved that allows doctors to prescribe medical marijuana to patients with qualifying medical conditions. The program won’t be in operation until September 2018.

If we’re going through such a difficult time getting opioids, I can just imagine how difficult it will be getting a medical marijuana card and then the marijuana itself. If a pain patient is still working, many would risk losing their jobs because some employers have publicly said they will have no tolerance for marijuana use for any reason.

Ultimately, there’s no win here for chronic pain patients, not as this time. We must stick together and fight for our right to a life of reduced pain. Respect, improved quality of life, and effective treatment aren’t too much to ask for. They wouldn’t take blood pressure medication away from someone who has hypertension or insulin from a diabetic, so why deny or take medications away from pain patients?

Jillian Drexler is from Cincinnati, Ohio. She lives with fibromyalgia, bulging and herniated discs in her neck and back, migraines, sciatica, and post tubal ligation syndrome (PTLS).

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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Addiction Treatment Initial Focus of Opioid Commission

By Pat Anson, Editor

President Trump’s commission on drug addiction and the opioid crisis held its first public meeting today, a two-hour session focused largely on expanding access to addiction treatment.

Chaired by New Jersey Governor Chris Christie, the commission is expected to make interim recommendations to the president in the next few weeks on how to combat drug abuse, addiction and the overdose epidemic, which is blamed for the deaths of nearly 60,000 Americans last year. A final report from the commission is due by October 1.

It is not clear yet how much of a role opioid prescribing and pain medication will play in the commission’s work. Most of its five members have publicly blamed overprescribing for causing the opioid epidemic.

“No offense, but that is where this came from,” said Massachusetts Gov. Charlie Baker, a commission member.

“The opioid crisis is ruining lots of people’s lives and lots of families across America," David Shulkin, Secretary of Veterans Affairs told the commission. "At the VA, my top priority is to reduce veteran suicides. And when we look at the overlap between substance abuse and opioid abuse, it’s really clear.

“We’ve been working on this for seven years and we’ve seen a 33 percent reduction in use of opioids among veterans, but we have a lot more to do.”

Shulkin did not mention that veteran suicides have soared during that period, and are now estimated at 20 veterans each day.

“We also need to look at pharmaceutical companies making generic drugs more tamper resistant and looking at making drugs that do not cause addiction,” said North Carolina Gov. Roy Cooper, a commission member.

Commission member Patrick Kennedy, a former congressman who has battled substance abuse himself, said there has been a “historic discrimination” against mental health and addiction treatment.

“I’m excited by the chance to kind of push for ways that we can hold insurance companies more accountable, so that the public sector doesn’t have to pick up the tab. Because its taxpayers that are picking up the tab when insurance companies continue to push folks with these illnesses off into the public system,” Kennedy said. “This is a cost shift that is a windfall for insurance companies if they can get rid of people who have mental health or addiction issues.”

Limits on Opioid Medication Not Working

“Let me be blunt. Today there is not nearly enough drug treatment capacity in America to help most of the victims of the epidemic,” said Mitchell Rosenthal, MD, who founded Phoenix House, a nationwide chain of addiction treatment centers.

“Most terrifying is the reality that nothing we are doing today has been able to halt the spread of opioid addiction. Controlling prescription opioid medication has not done so. Prescription monitoring programs, strict limits on the number of pills physicians can prescribe, and the CDC pain management guidelines seem to have capped usage of prescribed opioid medications. But overdose deaths from heroin and highly potent synthetics like fentanyl have gone through the roof.”

One activist called for wider adoption of the CDC opioid guidelines and rigid enforcement if doctors don’t follow them. Gary Mendell, the CEO and founder of Shatterproof, a non-profit focused on preventing addiction, said each state should be held accountable and federal funding reduced to states if their prescribing exceeds a certain level.

“If every primary care doctor in this country followed the CDC guideline, you would cut by more than half, instantly, the number of new people becoming addicted,” said Mendell, whose son committed suicide after years of struggle with addiction. “We need a goal for the country. Divide it up by 50 states, a proper goal developed by the CDC, and then we need to publicize it and hold people accountable. Just like you would do in any business.”

Patrick Kennedy is a member of Shatterproof's board of advisors, and Andrew Kolodny, MD, founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) is a member of its "opioid overdose advisory board."

No pain patients or pain management experts testified before the commission or were appointed to the panel.

Watch below for a replay of today's meeting:

Will New Laws Punish Pain Patients?

By Pat Anson, Editor

Recent efforts by state and federal lawmakers aimed at punishing drug traffickers could wind up sending people to prison simply for seeking pain relief, according to critics.

This week the American Kratom Association (AKA) sent an action alert to members warning that a bill introduced by Sen. Chuck Grassley and Sen. Dianne Feinstein could be a “backdoor way” of banning kratom -- an herbal supplement that millions of people use as an alternative to opioid painkillers.

The “Stop the Importation and Trafficking of Synthetic Analogues Act of 2017” – also known as the SITSA Act – would give the Attorney General the power to list as a “Schedule A” substance any unregulated drug that has a chemical structure similar to that of a drug already listed as a controlled substance. A similar measure has been introduced in the House.

The bills are ostensibly aimed at banning chemical cousins or “analogues” of fentanyl, a powerful synthetic opioid blamed for thousands of overdose deaths that is increasingly appearing on the black market.

But kratom supporters fear the SITSA Act could also be used to ban kratom, something the Drug Enforcement Administration tried unsuccessfully to do last year, claiming it was an "opioid substance" with “a high potential for abuse.” Kratom is not an opioid, but it has opioid-like properties that reduce pain or act as a stimulant or depressant – much like a controlled substance.

“So now the anti-kratom bureaucrats in Washington want to ban kratom simply by claiming it has the same effects as an opioid – calling it an ‘analogue’ of the opioid,” said Susan Ash, the AKA’s founder and spokesperson. “After everything that we’ve fought successfully against and endured together as a movement, our lobbyists are concerned that this is now the perfect storm for banning kratom.”

Ash wants the SITSA Act to be amended to exclude natural botanicals like kratom. In its current form, she says the bill could impose prison sentences of up to 20 years for importers or exporters of kratom, which is made from the leaves of a tree that grows in southeast Asia.

Florida Law Stiffens Penalties for Fentanyl

A new law in Florida is also intended to crackdown on fentanyl dealers, but critics say it could wind up sending unsuspecting pain patients to prison as well.

Signed into law yesterday by Gov. Rick Scott, it requires mandatory minimum sentences for defendants convicted of selling, purchasing or possessing illicit fentanyl.

Anyone caught with as little as four grams of fentanyl would face a minimum of three years in prison. Sentences escalate depending on the amount of fentanyl seized and murder charges could be filed if someone dies of a fentanyl overdose.

Dealers often mix fentanyl with heroin or sell it in counterfeit pills disguised to look like oxycodone or other prescription painkillers. Many users have no idea they’re buying fentanyl, which is 50 to 100 times more potent than morphine.

"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.”

DEA PHOTO

Florida has been down this path before. According to an investigative series by Reason.com, mandatory minimum sentences in Florida for oxycodone and hydrocodone trafficking resulted in 2,300 people being sent to prison, most of them low-level drug users or patients who went to the black market seeking pain relief. 

“The signing of this bill by Gov. Scott is another example of using get tough drug policies for political gain,” said Tony Papa, Manager of Media and Artist Relations for the Drug Policy Alliance. “This is not going to stop the sale of heroin in Florida. It's another prosecutorial tool that will be used for bargaining by district attorneys in drug cases.  Under this new law many individuals will be subject to the death penalty for a 10 dollar bag of dope. It's totally insane!”

Wisconsin to Involuntarily Commit “Drug Dependents”

A bill that recently sailed through the Wisconsin legislature with little opposition would allow for the involuntary commitment of someone who is drug dependent. The bill’s sponsor, Assemblyman John Nygren, has a daughter who has struggled with heroin addiction and served time in jail.

Current Wisconsin law allows for the involuntary commitment of alcoholics if three adults sign a petition alleging that a person lacks self-control over their use of alcohol and whose health is substantially impaired. 

The new bill adds “drug dependence” to the list of reasons someone can by committed. Dependence is defined as a person’s use of one or more drugs that is beyond their ability to control and that substantially impairs their health or social functioning.

The bill is one of nearly a dozen anti-opioid measures sponsored by Nygren that Gov. Scott Walker asked to be approved in a special legislative session. It now heads to his office for consideration.

How Medical Marijuana is Gaining Acceptance

By Ellen Lenox Smith, Columnist

There are articles being written around the country about the utilization of medical cannabis as an effective treatment for chronic pain and a broad range of other health problems.

I have been clipping these articles and saving them, for I think it is important that we support medical cannabis with “real” information from legitimate sources to defend against the scare tactics that undermine the truth about marijuana. I would like to share some of these exciting and encouraging cannabis stories.

A recent article in The New York Times looked at how New York City’s nursing homes are helping residents use medical marijuana under a program to treat illnesses with alternatives to pharmaceutical drugs.

It allows residents to purchase medical cannabis from a dispensary, keep it in locked boxes in their rooms, and take their medication on their own. In Washington State, at least a dozen assisted living facilities have also adopted formal medical marijuana policies due to patient demand.

Americans for Safe Access has helped open a research center in the Czech Republic to evaluate the impact of cannabis on the elderly. They realized that there has been little research on cannabis use by seniors, although places like Israel have been treating the elderly with it for years. Also, the Center for Medicinal Cannabis research at the UC San Diego is making seniors a research priority.

The New York Times also reported that no nursing home have lost financing or been penalized for allowing the use of cannabis by the Centers for Medicare and Medicaid Services. This is good news because the elderly tend to be reactive to prescription drugs and marijuana offers them an alternative.

The Washington Post reported on a survey of 37,000 middle and high school students in Washington State, which found that full marijuana legalization had no effect on the students’ propensity to use cannabis. The data coming from both Washington and Colorado strongly suggests that legalization in those states has not caused a spike in marijuana use among teens. In fact, in Colorado there has been a decrease.

An article by the Associated Press shared an amazing story of compassion in Georgia. State representative Allen Peake shepherds cannabis oil to hundreds of sick people who are allowed by state law to use medical marijuana but have no legal way of obtaining it. In Georgia, one is not allowed to cultivate, import or purchase cannabis.

Peake makes a monthly donation to a foundation in Colorado that supports research of medical cannabis. It adds up to about $100,000 a year. And each month a box full of cannabis products arrives at his office. Peake isn’t buying or selling marijuana – that would be a felony in Georgia. He skirts state law by giving it away for free.

An article in the Providence Journal tells the story of a young woman who sued a fabric company after it refused to hire her as an intern because she was a registered medical marijuana user. A judge recently ruled in favor of the woman.

“This decision sends a strong message that people with disabilities simply cannot be denied equal employment opportunities because of the medication they take,” said an ACLU attorney who represented the woman.

Does your state protect you? If not, you should consider contacting your state lawmakers to work on legislation to protect your right to use medical marijuana.

I understand there are significant frustrations about the cost of marijuana, lack of insurance coverage, limited distribution centers, and a shortage of doctors willing to write a marijuana prescription. But we have to keep up the advocacy to correct these injustices. Feel free to use these articles to help your cause and let’s look forward to the day that we are all treated equally across the country with access to affordable medication.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their website.

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.

Aspirin Risky for Seniors 75 and Older

By Pat Anson, Editor

The old cliché about a doctor telling you to “take two aspirin and call me in the morning” isn’t such great advice after all. Especially for seniors aged 75 and older.

A daily dose of aspirin has long been recommended as a way to prevent a heart attack or stroke. But British researchers at the University of Oxford say the blood thinning effects of aspirin substantially raise the risk of gastrointestinal bleeding as patients grow older.

Their study, published in The Lancet medical journal, estimates that aspirin causes over 3,000 deaths in the U.K. annually.

“We have known for some time that aspirin increases the risk of bleeding for elderly patients. But our new study gives us a much clearer understanding of the size of the increased risk and of the severity and consequences of bleeds,” said lead author Professor Peter Rothwell.

“Previous studies have shown there is a clear benefit of short term anti-platelet treatment following a heart attack or stroke. But our findings raise questions about the balance of risk and benefit of long-term daily aspirin use in people aged 75 or over.”

Rothwell and his colleagues followed over 3,100 patients for 10 years who were prescribed a daily aspirin after a heart attack or stroke. For the patients under 65, the annual rate of bleeding severe enough to require hospitalization was about 1.5 percent. For patients aged 75-84, the annual rate rose to 3.5 percent and for patients over 85 it was 5 percent.

The researchers are not recommending that seniors stop taking aspirin. But they suggest that a proton-pump inhibitor – heartburn drugs – be prescribed along with aspirin to reduce the risk of bleeding.  They estimate that proton-pump inhibitors (PPIs) could reduce upper gastrointestinal bleeding by as much as 90% in patients receiving long-term aspirin treatment.

“While there is some evidence that PPIs might have some small long-term risks, this study shows that the risk of bleeding without them at older ages is high, and the consequences significant,” said Rothwell.

About half of adults aged 75 or older in the U.S. and Europe take aspirin or another anti-platelet drug daily .

FDA to Review All Abuse Deterrent Opioids

By Pat Anson, Editor

A week after asking that Opana ER be taken off the market, the head of the Food and Drug Administration has ordered a review of all opioid painkillers with abuse deterrent formulas to see if they actually help prevent opioid abuse and addiction.

The move is likely to add to speculation that the FDA may seek to prevent the sale of other opioid painkillers.

“We are announcing a public meeting that seeks a discussion on a central question related to opioid medications with abuse-deterrent properties: do we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic?” FDA commissioner Scott Gottlieb, MD, said in a statement.

Gottlieb said the FDA would meet with “external thought leaders” on July 10th and 11th to assess abuse deterrent formulas, which usually make medications harder for addicts to crush or liquefy for snorting and injecting. He did not identify who the thought leaders were.

“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction,” Gottlieb said. “Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations.”

In a surprise move last week, the FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing concerns that the oxymorphone tablets are being liquefied and injected. It’s the first time the agency has taken steps to stop an opioid painkiller from being sold.

“I am pleased, but not because I think that this one move by itself will have much impact,” Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP) told Mother Jones. “I’m hopeful that this signals a change at FDA—and that Opana might be just the first opioid that they’ll consider taking off the market. It’s too soon to tell.”

Opana was reformulated by Endo in 2012 to make it harder to abuse, but addicts quickly discovered they could still inject it. The FDA said Opana was linked to serious outbreaks of HIV, Hepatitis C and a blood clotting disorder spread by infected needles.

Endo has yet to respond to the FDA request. If the company refuses to stop selling Opana, the agency said it would take steps to require its removal from the market by withdrawing approval.

“The request to voluntarily remove the product is one thing, but it comes with a lot of other questions that are unanswered,” Endo CEO Paul Campanelli reportedly said at an industry conference covered by Bloomberg. “We are attempting to communicate with the FDA to find out what they would like us to do.”

Patient advocates say it would be unfair to remove an effective pain medication from the market just because it is being abused by addicts.

“The FDA is following a political agenda, rather than its mandate to protect the public health,” said Janice Reynolds, a retired oncology nurse who suffers from persistent pain. “Depriving those who benefit from the use of Opana ER to stop people from using it illegally is ethically and morally wrong.”

Sales of Opana reached nearly $160 million last year. The painkiller is prescribed about 50,000 times a month.

"This is something that could potentially apply to other drugs in the future, as it may signal a movement by the FDA to start taking products off the market that don't have strong abuse-deterrent properties," industry analyst Scott Lassman told CorporateCounsel.com.

The FDA put drug makers on notice four years ago that they should speed up the development of abuse deterrent formulas (ADF).  Acting on the FDA's guidance, pharmaceutical companies spent hundreds of millions of dollars developing several new opioid painkillers that are harder to chew, crush, snort or inject.

Were they worth the investment? Not according to a recent study funded by insurers, pharmacy benefit managers and some drug makers.

The Institute for Clinical and Economic Review (ICER), a non-profit that recommends which medications should be covered by insurance and at what price, released a report last month that gave ADF opioids a lukewarm grade when it comes to preventing abuse.

“Without stronger real-world evidence that ADFs reduce the risk of abuse and addiction among newly prescribed patients, our judgment is that the evidence can only demonstrate a ‘comparable or better’ net health benefit (C+),” the ICER report states.

The insurance industry has been reluctant to pay for ADF opioids, not because of any lack of effectiveness in preventing abuse, but because of their cost. A branded ADF opioid like OxyContin can cost nearly twice as much as a generic opioid without an abuse deterrent formula.  According to one study, OxyContin was covered by only a third of Medicare Part D plans in 2015. Many insurers also require prior authorization before an OxyContin prescription is filled.  

FDA Gives Fast Track Designation to New Pain Med

By Pat Anson, Editor

The U.S. Food and Drug Administration has granted “fast track” designation to a new, non-opioid pain medication for patients with osteoarthritis and chronic low back pain -- even though the drug has a history of safety issues.

Tanezumab is an investigational humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body as a result of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from reaching the spinal cord and brain.

Tanezumab is the first NGF inhibitor to receive fast track designation from the FDA, a process that speeds up the development and review of new therapies to treat serious conditions with unmet medical needs.

“If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications,” said Ken Verburg, Chief Development Officer, Neuroscience & Pain, Pfizer Global Product Development. “We believe it would represent an important medical advance in the treatment of debilitating osteoarthritis and chronic low back pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications.”

Pfizer is jointly developing tanezumab with Eli Lilly. The two drug makers are currently recruiting patients for Phase 3 studies of tanezumab in 7,000 patients with osteoarthritis, low back pain or cancer pain. Participants will be injected with tanezumab once every eight weeks for treatment periods ranging from 16 to 56 weeks, followed by a 24-week safety follow-up period.  Results from the clinical trials are not expected until next year.

"It is estimated that there are more than 27 million Americans currently living with osteoarthritis and 23 million living with chronic low back pain, many of whom fail to achieve adequate pain relief despite treatment with various types of pain medications,” said Christi Shaw, Senior Vice President and President, Lilly Bio-Medicines.

“We are committed to offering innovative solutions to people suffering from chronic pain conditions, and look forward to working closely with the FDA to facilitate the development of tanezumab.”

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 because of safety concerns. The agency ordered a partial halt to clinical studies after Pfizer said a small number of osteoarthritis patients receiving tanezumab experienced worsening of their disease and needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.” 

Most clinical studies of tanezumab did not resume until 2015. Pfizer says the current Phase 3 studies include risk mitigation measures for joint safety and sympathetic nervous system safety.

A clinical study of fasinumab, another nerve growth factor drug being developed by Teva and  Regeneron Pharmaceuticals, was stopped by the FDA last year after a patient showed signs of severe joint disease. Regeneron and Teva said they would redesign the study of patients with chronic low back pain to exclude participants with advanced osteoarthritis.

Fifth Georgia Overdose Linked to Fake Percocet

By Pat Anson, Editor

A fifth fatal overdose in Georgia has been linked to counterfeit painkillers being sold on the street as Percocet. 34-year old Robert Ketchup of Macon died Sunday in the intensive care unit of a hospital after he was found unconscious in his mother’s home on Thursday. According to the Atlanta Journal Constitution, Ketchup “had a bunch of pills on him.” 

In the past week, five deaths and dozens of hospitalizations have been linked to the yellow, oval shaped pills that have been circulating in central Georgia.

An analysis of the pills by the Georgia Bureau of Investigation found that they contained two synthetic opioids, cyclopropyl fentanyl and U-47700. The bureau says both drugs are “highly dangerous.”  

The U.S. Drug Enforcement Administration has been warning for over a year about counterfeit prescription drugs laced with fentanyl “inundating” the U.S. Until now, most of the fake pills have been disguised to look like the painkiller oxycodone or Xanax, an anti-anxiety medication.

“The counterfeit pills have the numbers 10/325 on one side and the word PERCOCET in all capital letters on the opposite side. On the counterfeit pills the word PERCOCET is not stamped as deep as the manufacturer typically does on their pills. Also on the counterfeit pills, the imprint of the name is also at an angle,” the Bibb County Sheriff's Office said in a statement. “Everyone is strongly encouraged to treat these pills or anything resembling these pills as hazardous.”

No arrests have been made and the source of the counterfeit pills is still unknown.  

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. It is available legally by prescription in patches, lozenges and sprays to treat severe pain, but illicitly manufactured fentanyl smuggled in from Mexico and China is blamed for thousands of overdose deaths in the U.S. and Canada.

Unsuspecting buyers, including some pain patients who were unable to get opioid medication legally, have no idea the drug they’re getting from a dealer or friend could be lethal.

"Mexican drug cartels are manufacturing fentanyl into Percocet pills, and oxycodone and other type pills as well, but it's a way for these bad people to make a very good living on the backs of addiction and that's what they are targeting," said DEA Special Agent in Charge Dan Salter.

The fentanyl problem appears to be growing worse, as even small-time drug dealers realize they can easily order the chemicals needed to make fentanyl, manufacture their own fake pills, and make millions of dollars selling them on the black market.

Last week federal agents seized 50 kilograms of N-Phenethyl-4-piperidinone (NPP), a fentanyl precursor, from a storage facility in Northborough, Massachusetts. Some of the boxes seized were marked UPS and “priority mail.” Others were labeled with Chinese characters.

If converted, the NPP could have theoretically been used to make 19 million fentanyl tablets, with a street value of $570 million.

dea photo

Nearly 80 percent of the people who died of an overdose in Massachusetts last year ingested fentanyl.

Why We Must Ditch the Term 'Chronic Pain'

By Janice Reynolds, Guest Columnist

The term “chronic pain” is being used as a weapon against people living in pain.  People who are prejudiced and biased against pain sufferers often use it in derogatory way, to imply their pain is not that bad or that they are even lying about it.

Over 15 years ago, some members of the American Society for Pain Management Nursing, including myself, recognized the negative connotation of the term and attempted to change it to “persistent pain,” obviously without much success. 

“Chronic” only means a time frame of 3 months or more. No one knows how it became a term to mean a “type” of pain. 

When I was an oncology nurse, I did some research on the biological differences between cancer pain and “non-cancer” pain, and didn’t find any. No one knew how the differentiation came to be. There was no evidence to support it.

Chronic pain does not exist as an entity; it applies to many different types of pain syndromes and diseases. So when someone says there is no evidence to support using opioids for chronic pain or that opioids make chronic pain worse, these are outright lies. Or if you want to be kinder, false assumptions based on erroneous evidence. Research based on false principles.

One of the things the so-called opioid epidemic has done is given some validity to these prejudices and biases to justify the war on people in pain. The abuse by politicians and the media is too complicated to go into here, but when you have someone like Sen. Susan Collins of Maine saying pain management is important for cancer patients or end-of-life care, but addiction is a bigger problem for chronic pain patients, then it is obvious that “chronic pain” is being used as a bludgeon.

What is one thing people in pain, advocates and providers can do?

Stop using the term “chronic pain” and start using the condition or disease that causes the pain.

I have persistent post craniotomy pain, for example. You might have pain from fibromyalgia. Or pain from arachnoiditis, rheumatoid arthritis, shingles, migraine, peripheral neuropathy, Ehlers-Danlos syndrome, and so on.  Be specific. There are many reasons for back pain, neuropathies and other syndromes.

When we talk or write about persistent pain, use the terms “people in pain” or “people living in pain.” I want organizations to throw the term “chronic pain” out as well. How much more supportive is the name “American Association for People in Pain” as opposed to the American Chronic Pain Association?

This will be a difficult paradigm to change, especially for professionals and journalists. But without change, “chronic pain” will continue to be used as a tool for hate.  

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

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.

How to Advocate for 'Generation P'

By Barby Ingle, Columnist

There is so much talk about Generation X, Y and now Z, it got me thinking about what generation I belong to. There are psychological, cultural and sociological dimensions to identifying with a generation.

I decided that I am with Generation P -- the “P” standing for chronic pain. Typically, a generation is defined by being born during a specific time period, but pain affects all ages without discrimination. Therefore, you belong to Generation P if you are living with daily pain, no matter what your age.

What does it mean to be part of Generation P? When you become a chronic pain patient, you begin to be left behind by your old generation and become part of a new generation where the main theme is survival. We have to focus on recreating a new life, instead of living the one we had. Our attitudes and important factors in life are reevaluated and change. We need to learn how to navigate through the healthcare system, understanding that there are not many who are treated properly when it comes to pain care.

Being a successful contributor to Generation P starts with self-advocacy. If we don’t stand up for ourselves, things won’t get better. We must learn how to change policy, change laws, change the service system we have access to, and change public attitudes.

I have seen many people with chronic pain fight for their right to fully participate in all aspects of life, despite their disabilities. I have had to do this myself. This is where our awakening begins.

We must learn to put in great effort and use our energy pennies wisely to get the care that we need. We use problem solving to get through our days, and once we learn to do that effectively, we can begin to advocate for others having similar troubles. We must work to improve pain care, protect rights and stop discrimination. We must stop abusive treatment and make pain care more fair, equal and humane. We can do this by removing barriers that prevent access to pain care, so we can better participate in society and have our voice heard.

We must be sensitive and understanding to others who are trying to overcome the challenges of living with chronic pain. We need to be persistent in our search for good care and determined that our efforts will make progress despite setbacks.  

Advocates should listen and be objective. This is the most effective way to get the care we need. We must recognize our own prejudices and tendencies. We shouldn’t second guess or judge what someone else’s pain experience is. We need to trust their judgement. If something works for them but not us, that’s okay because we will continue the search to find what works for us.

How effective we are depends on how we handle our situations and challenges. We must constantly reevaluate our situations and attitude. We must be polite but firm. We must learn to work with others without controlling them. We must also pay attention to privacy and confidentiality for others so we can maintain credibility.

When it comes to advocacy, we recognize that there are millions of ways to do it, but that we all have the same hope and that when we use our voice for good we not only help Generation P, but also those who are Generation X, Y, and Z. One day they too will become members of Generation P.

Generation P is the now of pain care. It is up to us to create social change, carve a path for better and timely pain care, and increase awareness about chronic pain.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

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.

Trump Opioid Commission to Hold First Meeting

By Pat Anson, Editor

The pain community will get its first glimpse this month at how the Trump administration may address the nation’s opioid crisis, when the president’s new Drug Addiction and Opioid Commission holds its first two meetings.

The commisison's first meeting will be held Friday June 16, followed by a teleconference on Monday June 26. Both meetings are open to the public.

Details on how to watch or listen to the meetings can be found in the Federal Register, here and here.

Chaired by New Jersey Governor Chris Christie, the commission will make recommendations to the president later this year on how to combat drug abuse, addiction and the overdose crisis, which is blamed for over 50,000 deaths in 2015.

The White House says the commission will “work closely” with President Trump’s son-in-law and senior advisor, Jared Kushner.

“I made a promise to the American people to take action to keep drugs from pouring into our country and to help those who have been so badly affected by them. Governor Christie will be instrumental in researching how best to combat this serious epidemic and how to treat those it has affected,” Trump said in a statement.  

The public can submit written comments to the commission by emailing the Office of National Drug Control Policy at commission@ondcp.eop.gov.

“I'd really like to see the commission recognize that addressing opioid use disorders through increasing access to treatment and through attempting to reduce the supply of opioids (both legal and illegal) will only go so far, and that, to be truly successful, they also must address inadequacies in the way we treat pain,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, which represents pain management physicians.

“Unless and until we reach a point where we can truly implement the kind of integrative pain care called for by every guideline and highlighted in the National Pain Strategy, we are going to be unable to succeed in addressing both of the public health crises we are encountering.”

Twillman helped draft and submit a letter to the commission signed by 73 different medical and patient advocacy groups calling for more federal funding of pain research and treatments.

“This longstanding underinvestment in pain research has resulted in a limited number of safe and effective chronic pain treatments, and according to the FDA, a field that is 'strikingly deficient' in high-quality evidence to assess risks and benefits of current treatments,” the letter states. “As a result, even highly knowledgeable health care providers are left without clear guidance, and may spend months to years with their patients experimenting with treatments in the hope of finding relief.”

Richard Martin, a retired Nevada pharmacist disabled by chronic back pain, says the first item on the commission’s agenda should be to withdraw and re-write the CDC’s opioid guideline, which discourages physicians from prescribing opioids for chronic pain.

“Since the Guideline was released, there are now tens of thousands of non-cancer pain patients on long term opioid prescription therapy who are being INVOLUNTARILY tapered down or off of their pain medications.  This has resulted in patients being under treated, left to suffer with debilitating pain.  Some of these patients have had their opioid medications abruptly discontinued throwing them into withdrawal,” Martin wrote in an email to the commission.

“There now abounds significant anecdotal evidence and significant documented media reports, that these patients who have been involuntarily tapered down or off their opioid medications, are committing suicide due to the intense pain that has resulted.” 

Background of Commission Members

In addition to Gov. Christie and Jared Kushner, the president has appointed to the commission Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman. No pain patients, pain management experts or practicing physicians were appointed to the panel.

Gov. Christie, who lost a close friend to painkiller addiction, has seen his home state of New Jersey ravaged by the opioid crisis, with 1,600 overdose deaths in 2015.  Christie championed a new state law that limits opioid prescriptions for acute pain to just five days.  

Gov. Cooper supports similar legislation now under consideration in North Carolina.  Over 1,100 North Carolinians died from opioid overdoses in 2015, with prescription opioids involved in about half of them.

Gov. Baker’s home state of Massachusetts lost over 2,000 people to opioid overdoses in 2016, most of them caused by heroin and illicit fentanyl. Baker apparently got an inside track on the commission when he discussed the opioid crisis with Ivanka Trump while sitting next to her during a National Governors Association dinner.

Bertha Madras recently authored an editorial in JAMA Psychiatry in which she claimed that prescription opioids “remain a primary driver of opioid-related fatalities” and called on the medical community to limit the supply of opioid medication.

Patrick Kennedy has battled substance abuse issues since he was teenager, including addiction to the painkiller OxyContin. He now works for Advocates for Opioid Recovery, a non-profit funded in part by Braeburn Pharmaceuticals, which makes an implant that dispenses the addiction treatment drug buprenorphine.

Genetic Testing Company Raided by FBI

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

Proove Linked to Montana Pain Clinic

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

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

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

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

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

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

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

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

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

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

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

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

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

Benefis: No Kickbacks from Testing Labs

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

FDA Wants Opana ER Sales Stopped

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

Study Finds No Evidence Copaiba Oil Relieves Pain

By Pat Anson, Editor

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

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

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

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

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

COPAIBA ESSENTIAL OIL

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

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

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

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