Purdue Settles OxyContin Lawsuit for $24 Million

By Pat Anson, Editor

Purdue Pharma has agreed to pay the state of Kentucky $24 million for misleading consumers about the risks of addiction to OxyContin. The settlement is the latest chapter in Purdue’s seemingly endless string of lawsuits over its popular and potent painkiller.

“Purdue Pharma created havoc in Kentucky, and I am glad it will be held accountable,” said Kentucky Attorney General Jack Conway. “Purdue lit a fire of addiction with OxyContin that spread across this state, and Kentucky is still reeling from its effects.”

Purdue did not admit to any wrongdoing in the settlement.

OxyContin was introduced in 1996 and soon became a blockbuster drug for Purdue, reportedly generating profits in excess of $10 billion. Many critics believe the drug also helped trigger an “epidemic” of opioid addiction and overdoses, causing the deaths of thousands of people nationwide.

Kentucky filed suit against Purdue in 2007 after company executives pleaded guilty in Virginia federal court to a felony count of falsely marketing OxyContin. Company sales representatives were encouraged to tell doctors the pain medication wasn’t additive and was less likely to be abused.

Purdue settled that case for $634 million and offered $500,000 to Kentucky, which the state refused.

This week’s $24 million settlement is over 50 times what Kentucky was originally offered. The money will be used to fund addiction treatment programs in Kentucky.

Purdue is still fighting a similar OxyContin lawsuit in Chicago. Another case in California was dismissed over the summer.

The original version of OxyContin could be easily crushed and liquefied by addicts to inject or snort for a quick high. OxyContin is now sold in an abuse deterrent formula that is harder to abuse.

“We are pleased to resolve this matter that arose from alleged conduct dating before July 2001, and long before we reformulated OxyContin to include abuse-deterrent properties.  This enables Purdue to focus on bringing additional innovative abuse-deterrent medicines to patients,” stated Philip C. Strassburger, Purdue Pharma’s General Counsel.

The reformulation hasn’t stopped the abuse of OxyContin. According to a large nationwide survey of nearly 11,000 opioid addicts who entered a treatment facility in 2012, over a quarter had used OxyContin at least once to get high in the previous 30 days.

Nearly 1,100 people died of overdoses in Kentucky last year, giving the state the dubious distinction of having the 4th highest overdose rate in the country. Many of those deaths are blamed on heroin, as well as prescription opioids.

Purdue as recently as this year was still trying to rein in aggressive marketing by its sales staff. In August, Purdue reached a settlement with New York’s Attorney General, admitting that its sales representatives contacted doctors in New York who were on a “No Call List.” The doctors had been red flagged by the company for possible abuse and diversion of opioids.

Purdue’s sales representatives, who amazingly were not required to check the company's No Call List, made over 1,800 sales calls to doctors on the list, even buying meals for about a third of them.  Some of those doctors were later arrested or convicted for illegal prescribing of opioids.

A company spokesman told Pain News Network that sales calls could have also been made to doctors on Purdue No Call Lists outside of New York.

Under the terms of the settlement, Purdue agreed to adopt more “red flags” to identify doctors who may be prescribing opioids inappropriately or illegally. Sales representatives will also be required to check the No Call List before contacting a provider and will be disciplined if they don’t

PROP and the ‘Opioid Lobby’

By Pat Anson, Editor

With its signature accomplishment under fire from pain patients, health professionals and even some congressmen, Physicians for Responsible Opioid Prescribing (PROP) is now engaged in a public campaign to discredit critics by labeling them as pawns of the “opioid lobby.”

PROP, an advocacy group funded by the addiction treatment chain Phoenix House, played a key role in drafting the controversial opioid prescribing guidelines developed by the Centers for Disease Control and Prevention (CDC). Five PROP board members serve on CDC panels that helped develop the guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

As many as 11 million Americans use opioids for long-term, chronic pain and many fear losing access to opioids if the guidelines are adopted.

The CDC planned to finalize the guidelines next month, but a wave of criticism that the guidelines are too restrictive, along with allegations that the agency violated federal law while secretly drafting them, forced the agency to reconsider.

“CDC’s plan was effectively blocked by intense pressure from the opioid lobby, which sees more cautious opioid use as a financial threat,” wrote PROP founder and Executive Director Andrew Kolodny, MD, in newsletter emailed Wednesday to PROP supporters. Kolodny is chief medical officer for Phoenix House.

“CDC was pressured into opening a federal docket on its draft guideline. This will tack months onto the process – it is also highly unusual – federal dockets are typically opened for public comment on proposed regulations – not for medical guidance issued by CDC,” Kolodny wrote.

In his “urgent request” to supporters, Kolodny asks them to visit this federal website and post comments in favor of the guidelines. He even offers several suggestions on what to write.

Over 600 comments have been received since the comment period opened on December 14 and many of the recent ones apparently are from PROP supporters. They often parrot instructions made by Kolodny in his newsletter.

“The medical community is urgently in need of guidance from CDC because aggressive opioid prescribing is harming pain patients and fueling an epidemic of addiction and overdose deaths,” wrote Janis McGrory, in a word-for-word rendition straight from Kolodny’s newsletter.

"I am in full support of the CDC guideline calling for more cautious opioid prescribing. My son died at the age of 26. He was a heroin user that started from prescribed opioids for a back injury," wrote Veronica Deborde. "I am sure if the opioid lobbyist lost a child to opioid use they wouldn't even consider blocking the CDC."

"The havoc that drug addiction can reap, not only on individuals but their entire family, is beyond devastating. Please don't let big pharma and financial implications weigh in on the issue of public safety," wrote pharmacist Sarah Randolph.

"Opioid Lobby" Funding

It’s not unusual for advocacy groups to urge their supporters to take action or to instruct them on what to do. Several groups opposed to the guidelines have been doing the exact same thing. But Kolodny takes it a step further, by challenging the integrity of non-profits, medical societies and others who oppose the guidelines.

“This is a big win for the opioid lobby,” Koldony said last week in a widely reported Associated Press story about the CDC’s decision to delay implementing the guidelines.

“The story here is how the opioid lobby is using the Cancer Action Network to discredit a public health effort to limit opioid prescribing,” Kolodny told The Hill.

“Here’s background on shady organization now attacking CDC’s draft opioid guideline,” Kolodny wrote in a Tweet.

As far back as September, Kolodny apparently knew the guidelines would generate controversy. That’s when he told the Milwaukee-Wisconsin Journal Sentinel that the U.S. Senate Finance Committee should release details of a 2012 investigation of opioid manufacturers’ ties to medical groups.

Why dig up a 3-year old investigation? Kolodny told the Journal Sentinel his goal was to discredit pain organizations who might oppose the guidelines.

"By making the findings of the investigation public and exposing the financial relationships between pain organizations and opioid makers, it will be harder for them to claim that it is the interests of pain patients they are lobbying for," he said.

Kolodny has found many other eager listeners in the news media, who have adopted his views about opioids, the addiction and overdoses they can cause, and the alleged influence of the so-called opioid lobby.

For example, in a story this week headlined, “Makers of OxyContin Bankroll Efforts to Undermine Prescription Painkiller Reform,” The Intercept reported that opioid manufacturers “are funding nonprofit groups fighting furiously against efforts to reform how these drugs are prescribed.”

Among the groups singled out in The Intercept’s “investigation” was the Power of Pain Foundation, which has accepted funds from Purdue Pharma, the manufacturer of OxyContin.

Power of Pain President Barby Ingle, who is also a PNN columnist, is furious her non-profit was dragged into the controversy over a relatively small amount of money.

“Yes, to date (over the past 9 years) Purdue has given $15,000 total, all unrestricted grants to our foundation. A bulk of it is being used to produce our Music Moves Awareness project which will feature the stories of 20 pain patients with different pain diseases, all doing different pain treatments, representing youth, young adult, adult, and elderly patients,” said Ingle, a pain sufferer who happens to be allergic to OxyContin.

“None of our 10 voting board members takes opioid medications for any chronic illness. I also personally serve on the 2015 Purdue Pharma Patient Board of Advisory which paid me $100 for my personal opinions on the pain community and access to care issues.”

Another group often singled out as being part of the “opioid lobby” is the American Academy of Pain Management, which reportedly gets 10% of its revenue (about $300,000) from opioid manufacturers.

“Some have said that this delay (in the CDC guidelines) is a victory for ‘the opioid lobby,’ but I think it’s not really a victory for anyone,” said Bob Twillman, Executive Director of the American Academy of Pain Management. “It might be a victory for tried-and-true methods of developing practice guidelines, and a victory for transparency, but a delay in producing reasonable, workable guidelines actually does everyone a disservice. That could have been prevented, had CDC used a proper process from the beginning.”

The CDC’s public comment period on the guidelines continues until January 13th. You can make a comment by clicking here. 

The proposed prescribing guidelines and the reasoning behind them can be found in a 56-page report you can see by clicking here.

(For the record, Andrew Kolodny and I had a somewhat cordial and professional relationship until a few months ago, when he became unhappy with Pain News Network coverage of opioid issues and stopped communicating with me. PROP President Jane Ballantyne also has not responded to repeated requests for comment on various articles we’ve written about her.

PROP has a standing invitation from PNN for an op/ed column about its views on opioids and/or the CDC guidelines, which we would be happy to publish. The same offer is extended to other groups with similar views.)

Researchers Say Chronic Pain Rewires Brain

By Pat Anson, Editor

Researchers at Northwestern University say a brain region that controls whether we feel happy or sad is rewired by chronic pain.

Their research on laboratory rats, published in the journal Nature Neuroscience, may have also uncovered a new treatment strategy that restores the brain and dramatically lessens pain.

'It was surprising to us that chronic pain actually rewires the part of the brain controlling whether you feel happy or sad," said corresponding author D. James Surmeier, chair of physiology at Northwestern University Feinberg School of Medicine. "By understanding what was causing these changes, we were able to design a corrective therapy that worked remarkably well in the models. The question now is whether it will work in humans."

The new treatment combines a Parkinson's drug, L-dopa, and a non-steroidal anti-inflammatory drug (NSAID), both of which are FDA approved. The combined drugs target brain circuits in the nucleus accumbens and completely eliminated chronic pain behavior when administered to rodents. The key is administering the drugs together and soon after an injury.

The scientists hope to begin a clinical trial on humans to further test their theory.

"The study shows you can think of chronic pain as the brain getting addicted to pain," said A. Vania Apkarian, a professor of physiology at Feinberg. "The brain circuit that has to do with addiction has gotten involved in the pain process itself."

The researchers found that a group of neurons thought to be responsible for negative emotions became hyper-excitable within days after an injury that triggers chronic pain. This change was triggered by a drop in dopamine, a neurotransmitter.

"These results establish chronic pain cannot be viewed as a purely sensory phenomenon but instead is closely related to emotions," Apkarian said.

When scientists gave the rats the NSAID and L-dopa, which raises dopamine levels, the changes in the brain were reversed and the animals' chronic pain behavior stopped. That suggests supplementing anti-inflammatories with a medication that activates dopamine receptors or raises dopamine levels might be an effective way of treating chronic pain or preventing the transition from acute to chronic pain.

Scientists also treated the rats with another Parkinson's drug, pramipexole, which activates dopamine receptors and mimics dopamine's effect. That drug also decreased the animals' pain-like behavior.

"It is remarkable that by changing the activity of a single cell type in an emotional area of the brain, we can prevent the pain behavior," said Marco Martina, an associate professor of physiology at Feinberg.

In addition to Parkinson’s, L-Dopa is used to combat anxiety and depression, and to improve the ability to concentrate and focus. L-Dopa is sold under the brand names Levodopa, Sinemet, Madopar, Stalevo, and Prolopa.

A recent study by British researchers also found that brain chemistry is changed by chronic pain.

Researchers at the University of Manchester used PET scans to measure the spread of opioid receptors in the brains of 17 arthritis sufferers and nine healthy control subjects. The number of opioid receptors was highest in the arthritis sufferers, suggesting their brain chemistry had changed and made them more resilient to pain. That could explain why some people are better able to cope with pain than others.

The University of Manchester study is being published in Pain, the official journal of the International Association of the Study of Pain.

Congress Investigating CDC’s Opioid Guidelines

By Pat Anson, Editor

A congressional committee has launched an investigation into efforts by the Centers for Disease Control and Prevention (CDC) to develop new guidelines for the prescribing of opioid pain medication. The controversial draft guidelines discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans take opioids daily for long term, chronic pain.

In a letter to CDC director Thomas Frieden, the chairman of the House Committee on Oversight and Government Reform questioned whether the agency broke federal law by appointing a biased advisory panel and refusing to disclose the identities of its members. Rep. Jason Chaffetz (R-Utah) asked Frieden to supply documents and information about the guidelines process “as soon as possible.”

At issue is the “Core Expert Group,” a panel composed of 17 members, most of them health researchers, state regulators and addiction treatment specialists. Although the CDC never publicly disclosed who was on the panel, their identities were leaked to Pain News Network and other websites. Critics charged that some members had conflicts of interests and strong biases against opioids. No patients or active pain management physicians are on the panel.

“Some groups have raised concern that the proposed guidelines may be insufficient to treat those suffering from chronic pain,” wrote Rep. Jason Chaffetz (R-Utah).  “We expect CDC’s guidelines drafting process to seek an appropriate balance between the risk of addiction and the need to address chronic pain. The CDC has utilized a ‘Core Expert Group’ in the drafting and development of opioid prescribing guidelines, raising questions as to whether CDC is complying with FACA (Federal Advisory Committee Act).”

Chaffetz’s letter was co-signed by five other committee members; Rep. Elijah Cummings (D- Maryland), Rep. Jim Jordan (R-Ohio), Rep. Matt Cartwright (D-Pennsylvania), Rep. Mark Meadows (R-North Carolina), and Rep. Gerald Connolly (D-Virginia).

Two members of the Core Expert Group are Jane Ballantyne, MD, and Gary Franklin, MD, who are the President and Vice-President, respectively, of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which runs a chain of addiction treatment centers.

Ballantyne and Franklin, who have been vocal critics of opioid prescribing, played key roles in the development of opioid regulations in Washington State, which has some of the toughest prescribing laws in the nation.

Ballantyne has served as a paid consultant to a law firm that is suing pharmaceutical companies over their opioid marketing practices. She also recently came under fire for co-authoring an article in the New England Journal of Medicine that said reducing pain intensity should not be the goal of doctors that treat chronic pain.

In all, five PROP board members are advising the CDC in different capacities, including its founder, Andrew Kolodny, MD, who has called opioid pain relievers “heroin pills.”   

Another member of the Core Expert Group is Lewis Nelson, MD, an emergency physician and toxicologist at New York University Langone Medical Center. Nelson has also compared prescription opioids to heroin and said the risks of taking them outweigh the benefits.

"As a civilization we somehow managed to survive for 50,000 years without OxyContin and I think we will continue to survive," Nelson recently told the Associated Press.

In his letter to Frieden, Chaffetz asked the CDC to provide all documents related to the selection of the Core Expert Group, as well as any documentation related to their meetings or advice they gave to the agency. They asked Frieden to provide the information by January 8th.

"CDC has received the letter and is complying with the request," a spokesperson for the agency told PNN.

The CDC recently announced it would delay implementing the guidelines, reopen a public comment period, and have the guidelines reviewed by its scientific advisory committee. As Pain News Network has reported, the agency also said the Core Expert Group and other outside advisers are expected to continue advising the CDC. 

Fed Panel 'Appalled' by Guidelines

Some of the sharpest criticism of the CDC has come from officials in other federal agencies, such as the Food and Drug Administration, which normally plays a lead role in setting guidelines for prescription drugs.

“I think we need to recognize that CDC wants to substantially limit opioid prescribing. Period,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, at a recent meeting of a federal pain research panel.

Hertz said the evidence cited to support the guidelines was “low to very low and that's a problem." She also told the National Institute of Health’s Interagency Pain Research Coordinating Committee that the FDA “did have an opportunity to look at the product and comment,” but otherwise was not involved in its development.

Other panel members expressed alarm that, although “voluntary” and meant for primary care physicians, the guidelines could quickly become policy throughout the country.

“I see how our state health department looks at CDC. They really take direction from CDC.  CDC has a great name for good reason. They’ve done incredibly good work in many areas,” one panel member said. “And I have to say this has really diminished my respect for CDC. I have to say that this process was horrible. I’m appalled, appalled at the process CDC used to develop these in secrecy, not allowing input from the pain community and pain physicians.”

“I think we cannot for one minute be naïve enough to imagine that these will be seen as recommendations and that state medical societies, boards of healing arts, legislators, will not jump all over this,” said Myra Christopher, of the Center for Practical Bioethics.

"This is a ridiculous recommendation from my perspective. Very low quality of evidence, yet a strong recommendation. How do you possibly do that?” asked Richard Ricciardi, PhD, of the Agency for Healthcare Research and Quality.

“I would be remiss and I’m certain so would many of my government colleagues if I didn’t go back to my director and say there’s a report coming out of the CDC that has very low quality of evidence and there’s a strong recommendation. That’s an embarrassment to the government.”

The CDC’s own briefing papers make clear that the agency’s ultimate goal is for the guidelines to be widely adopted.

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings,” the agency says in documents obtained by Pain News Network.  “CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.”

Even though the guidelines may be several months away from being finalized, Congress last week passed and President Obama signed into law a federal spending bill that requires the Veterans Administration to adopt the CDC’s guidelines as official policy when VA doctors treat veterans suffering from chronic pain.

VA to Adopt CDC Opioid Guidelines

By Pat Anson, Editor

The massive $1.1 trillion spending bill passed by Congress and signed into law by President Obama last week contains an early Christmas present for the nation’s veterans.

Or it could be a lump of coal -- depending on your view about opioid pain medication.

Buried in the 2,009 page document is a provision requiring the Veteran’s Administration to implement a number of measures to stop the “overdose epidemic” among veterans, including adoption of the controversial opioid prescribing guidelines being developed by the Centers for Disease Control and Prevention (CDC).

Those guidelines, which discourage primary care physicians from prescribing opioids for chronic pain, have now become official government policy at a federal agency before they’re even finalized. 

“To address mounting concerns about prescription drug abuse and an overdose epidemic among veterans, the bill directs VA to adopt the opioid prescribing guidelines developed by the Centers of Disease Control; to develop IT systems to track and monitor opioid prescriptions; to ensure all VA medical facilities are equipped with opioid receptor antagonists to treat drug overdoses; and to provide additional training to medical personnel who prescribe controlled substances,” Sen. Barbara Mikulski (D-Maryland), Vice Chairwoman of the Senate Appropriations Committee, said in a summary of the omnibus bill sent to colleagues.

The VA was also instructed to report to Congress within 90 days on alternative treatments to opioids, as well as “how VA can better facilitate the use of safe and effective complementary and integrative health therapies for pain management.”  

The CDC, which recently delayed implementation of the opioid guidelines after widespread criticism from patients and advocacy groups, has repeatedly said the guidelines are “voluntary” and not intended for anyone other than primary care physicians.

But adoption of the guidelines by a federal agency that provides health care services to over 6 million patients is an early sign they will have a much broader impact, voluntary or not. Critics have warned that state regulators, licensing boards and professional medical societies could also adopt the CDC's guidelines, which would likely have a chilling effect on all doctors who prescribe opioids.

"This is disturbing. It doesn't help solve the opioid problem by codifying low evidence or no evidence recommendations," said Lynn Webster, MD, past president of the American Academy of Pain Medicine.

"The opioid crisis is serious, requiring thoughtful interventions that are evidence based.  There are many evidence based recommendations that could be promulgated but have been ignored.  I am very concerned that the soldiers who have sacrificed so much are not going to receive the treatment they deserve."

According to an Inspector General’s study, more than half of the veterans being treated at the VA experience chronic pain, as well as other conditions that contribute to it, such as post-traumatic stress disorder. Because veterans are at high risk of opioid abuse and overdose, the VA implemented the Opioid Safety Initiative in 2013 to discourage its doctors from prescribing the drugs. The number of veterans prescribed opioids fell by 110,000, but alarms were raised when some vets turned to street drugs or suicide to stop their pain.

"Veterans are now required to see a prescriber every 30 days, but at the El Paso VA, they are unable to get an appointment, so they go without, or they do something they shouldn't — they buy them on the street," Rep. Beto O'Rourke, (D-Texas), told Military Times. “At a minimum, these veterans are suffering and in some cases, I would connect that suffering to suicide."

Several veterans have written to Pain News Network recently about their difficulty obtaining opioids from the VA for their chronic pain.

“The VA will only prescribe 10 mg oxycodone 3 times a day. This gives me no relief at all and now I'm very worried about what may come next,” wrote an Army veteran with diabetic nerve pain who had a toe amputated. “When I asked to have this increased my VA PC (primary care) doc raised my gabapentin script and says if that doesn't work for my increased pain levels we may try Lyrica next . He ignores my statement that 15 mg of Oxy works in reducing my pain by 30%”

“After taking opiate pain meds for nearly 15 years, the VA has now decided to take them away. I had a decent life while on these, and now they have cut them in half, I am in constant pain. I wish some of these people that make these stupid decisions had to live like I do,” a Vietnam veteran who had a leg amputated above the knee wrote to PNN.

“The pain meds allowed me to have some semblance of a normal life. Now that is gone. I don't know what I am going to do. I can understand now why vets turn to alcohol and other street drugs, because you have to do something to take the edge off this constant pain. But do they care? Not one whit. They practically throw this stuff at you when I first started going, now it is up to me to figure out how I am going to make it without any of it.”

The federal spending bill provides $7.2 billion in funding for the CDC, which is $278 million more than last year.  That includes $70 million to support state efforts to address prescription opioid abuse – more than triple the amount included in last year’s bill. 

The bill also provides $3.8 billion to the Substance Abuse and Mental Health Services Administration (SAMHSA), which is $160 million more than last year.  Nearly $50 million is directed to address the “epidemic” of prescription drug and heroin overdose, $25 million is for addiction treatment in high-risk states, $12 million for naloxone distribution in 10 states; and $10 million for drug abuse prevention efforts in up to 20 states.

Illegal Fentanyl Major Cause of Rising Overdose Deaths

By Pat Anson, Editor

Drug overdose deaths in the United States rose by 6.5% last year, in large part fueled by the increasing use of illicit fentanyl in many parts of the country. Over 47,000 poisoning deaths were reported in 2014, according to a new report from the Centers for Disease Control and Prevention (CDC).

After declining in the two year previous years, the CDC said there was a 9% increase in the number of deaths involving opioids. In 2014, opioids were "involved" in 28,647 deaths, or nearly two-thirds of all overdoses.

The agency admits, however, that some deaths may have been misclassified and some of the data is suspect. For example, if a doctor or medical examiner reports that an opioid was found in someone’s system after they die, the agency considers the death “opioid related” whether the drug was used medically or non-medically. Overdose deaths from specific drugs identified on death certificates also vary widely from state to state, an indication some of the data may not be reliable.

The statistics are further muddied by the fact that legal and some illegal opioids are lumped together in the same category.

“Historically, CDC has programmatically characterized all opioid pain reliever deaths (natural and semi-synthetic opioids, methadone, and other synthetic opioids) as 'prescription' opioid overdoses,” the agency acknowledged in its report.

The largest increase in the rate of drug overdose deaths involved synthetic opioids, primarily fentanyl and tramadol, which nearly doubled from 1.0 deaths per 100,000 to 1.8 per 100,000.

Tramadol is a weaker acting opioid that many doctors began prescribing for pain after hydrocodone was reclassified as a Schedule II medication in 2014, making it harder for many patients to obtain hydrocodone. The number of tramadol prescriptions dispensed in the U.S. has nearly doubled since 2010, coinciding with a decline in hydrocodone prescriptions.

Fentanyl, which is also classified as a Schedule II controlled substance, is a powerful painkiller that is increasingly being abused by addicts. Drug dealers are lacing heroin with fentanyl to make it more potent, while others are cutting up fentanyl patches so they can smoked or ingested.  Earlier this year, the Drug Enforcement Administration issued a nationwide alert about the abuse, diversion and illegal manufacture of fentanyl.

Thousands of people have died from fentanyl overdoses in the U.S. and Canada, but because of the nature of the drug it’s impossible to tell whether it was prescribed legally and used for medical reasons or manufactured illegally and used recreationally.  

“Toxicology tests used by coroners and medical examiners are unable to distinguish between prescription and illicit fentanyl,” the CDC report said. “Based on reports from states and drug seizure data, however, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl, although this cannot be confirmed with mortality data. For example, five jurisdictions (Florida, Maryland, Maine, Ohio, and Philadelphia, Pennsylvania) that reported sharp increases in illicit fentanyl seizures, and screened persons who died from a suspected drug overdose for fentanyl, detected similarly sharp increases in fentanyl-related deaths.”

The agency also admits that some heroin deaths might be misclassified as morphine, a prescription drug, because morphine and heroin are metabolized similarly. That might contribute to an underreporting of heroin overdose deaths.

"The increasing number of deaths from opioid overdose is alarming," said CDC Director Tom Frieden, MD. "The opioid epidemic is devastating American families and communities. To curb these trends and save lives, we must help prevent addiction and provide support and treatment to those who suffer from opioid use disorders. This report also shows how important it is that law enforcement intensify efforts to reduce the availability of heroin, illegal fentanyl, and other illegal opioids."

Frieden also used the overdose study to lobby for his agency’s much criticized effort to enact new guidelines for opioid prescribing. Frieden told the Associated Press that Americans were “primed” for heroin use because of their exposure to opioid pain medications.

"We want to make sure we don't go so fast that there are questions about our process, but we certainly don't want to see any further delay," Frieden said, explaining a recent decision to delay implementing the guidelines and seek more public input.

"But there is no way we can wait for better evidence while so many people are dying," he said.

Decline in Teen Opioid Abuse Continues

By Pat Anson, Editor

An annual survey that tracks teenage drug abuse continues to show a decline in the misuse of prescription opioid pain relievers, as well as heroin, alcohol, cigarettes, amphetamines and other substances.

The University of Michigan's Monitoring the Future Study (MTF) has tracked drug abuse among 8th, 10th, and 12th graders since 1975. This year’s survey included nearly 45,000 students at 382 public and private schools in the United States.

The MTF survey tracked the steady rise in teenage abuse of prescription opioids in the 1990's, before the trend reversed itself in the last decade. For the fifth year in a row, the survey found there was a significant decline in the misuse of opioids by teens (reported in the survey as “Narcotics Other Than Heroin”).

About 5% of 12th graders reported using an opioid pain medication in the last year, including 4.4% who used Vicodin and 3.7% who used OxyContin.

The number of teens reporting that prescription opioids were “fairly easy” or “very easy” to get also continues to drop.

Most teens abusing prescription opioids reported getting them from friends or family members. About one-third reported getting them from their own prescriptions.

"The recent declines in the abuse of prescription pain medicines among teens are encouraging. The Partnership has been working for quite some time through both our Above the Influence program and the Medicine Abuse Project to help educate teens, parents and communities about the risks of medicine abuse and we are glad to see continued progress," said Marcia Lee Taylor, President and CEO of the Partnership for Drug-Free Kids.

“While today's news about substance use among teens is mostly positive, we cannot let that take our focus off of the prescription drug and heroin crisis among other age groups.”

Despite widespread media reports about the so-called heroin “epidemic” in adults – heroin use among teens is at its lowest level since the MTF survey began. Past year use of heroin fell to 0.5% of 12th graders, an all-time low.

Use of several other illicit drugs – including MDMA (known as Ecstasy or Molly), amphetamines and synthetic marijuana – also showed a noted decline in this year's data. Use of alcohol and cigarettes reached their lowest points since the study began.

Marijuana, the most widely used illicit drug, did not show any significant change. After rising for several years, teenage marijuana use has leveled out since 2010, but still remains stubbornly high. In 2015, 12% of 8th ­graders, 25% of 10th­ graders and 35% of 12th­ graders reported using marijuana at least once in the past year. For the first time ever, daily marijuana use exceeds daily tobacco use among 12th graders.

"We are heartened to see that most illicit drug use is not increasing, non-medical use of prescription opioids is decreasing, and there is improvement in alcohol and cigarette use rates," said Nora D. Volkow, M.D., director of the National Institute of Drug Abuse, which funded the MTF survey.

"However, continued areas of concern are the high rate of daily marijuana smoking seen among high school students, because of marijuana’s potential deleterious effects on the developing brains of teenagers, and the high rates of overall tobacco products and nicotine containing e-cigarettes usage."

One growing area of concern is the abuse of Adderall and other prescription amphetamines, which are typically used to treat Attention Deficit Disorder (ADHD) but are widely perceived as a study aid.  About 7.5% of 12th graders used those drugs in the past year.

CDC Relying on Same Experts for Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control and Prevention (CDC) will continue to rely on the same panel of experts to advise the agency about its opioid prescribing guidelines – even though some of the experts are allegedly biased and have conflicts of interest.

The CDC announced last week that it would review and delay implementing the controversial guidelines, after they drew widespread criticism from pain patients, advocacy groups, and medical societies. On Monday the agency also began accepting new public comments on the guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

The review of the guidelines will be conducted by the Board of Scientific Counselors (BSC) for the CDC’s National Center for Injury Prevention and Control. The CDC is developing the guidelines to combat what has been called an "epidemic" of prescription drug abuse, addiction and overdoses. As many as 11 million Americans use opioids for long-term chronic pain.

“We will be asking the BSC, the members of which represent expertise along the spectrum of injury and violence issue areas, to approve formation of a workgroup to review the draft guideline and comments received on the guideline, and present recommendations about the guideline to the BSC,” said Leslie Dorigo, a CDC spokesperson.

“Our intent is for the workgroup to be comprised of members of the original Core Expert Group, members of the BSC, and individuals who represent the perspectives of patients living with chronic pain and who have additional pain medicine expertise.”

The “Core Expert Group” has 17 members and is composed primarily of public health researchers and state regulators. At least two of its members have drawn the ire of critics who say they shouldn’t serve on the panel.

Jane Ballantyne, MD, and Gary Franklin, MD, are the President and Vice-President, respectively, of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which runs a chain of addiction treatment centers. Three other board members of PROP will also continue to advise the CDC in their roles as stakeholders and peer reviewers, according to Dorigo.

“For the life of me, I can’t understand why CDC insists on retaining such obvious bias on their panel, as it flies in the face of their scientific integrity,” said Jeffrey Fudin, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).

“I find it hard to believe that CDC can’t find a single qualified physician to speak against opioids that is free from potential conflict.  With all that has been drudged up in the professional literature and lay press regarding potential or postulated physician conflicts, CDC’s behavior is nothing less than reverse discrimination.”

Ballantyne and Franklin, who have been vocal critics of opioid prescribing, played key roles in the development of opioid regulations in Washington State, which has some of the toughest prescribing laws in the nation.

dr. jane ballantyne

Ballantyne recently come under fire for co-authoring an article in the New England Journal of Medicine that said reducing pain intensity should not be the goal of doctors that treat chronic pain. That caused a prominent pain physician to call on Ballantyne to resign or be fired from her academic position at the University of Washington School of Medicine.

“To suggest that physicians should no longer treat pain intensity and let patients suffer goes beyond any sort of decency or concern for humanity,” said Forest Tennant, MD, who has treated pain patients for over 40 years.

Ballantyne’s ties to the pharmaceutical industry have also drawn attention. She has served as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies over their marketing of opioids.

“I do have difficulty with someone like Ms. Ballantyne in particular because, quite apart from PROP, she appears to have a very strong conflict of interest and is on the payroll of plaintiff’s attorneys who have a lot of money to be made by suing manufacturers,” said Richard Samp, chief counsel for the pro-business Washington Legal Foundation, which has threatened to sue the CDC over its alleged violations of a federal open meetings law while drafting the guidelines.

“They have a strong interest in making sure that the CDC is critical of current prescribing practices, because that would strengthen their current lawsuits. For that reason, I can’t see how somebody who is on the payroll of plaintiff’s law firms is an appropriate person to be on the committee,” Samp told Pain News Network.  

Ballanytne could not be reached for comment.

“CDC takes conflict of interest seriously, and worked to eliminate or minimize sources of bias of the experts involved in the guideline development and peer review,” said the CDC’s Dorigo. “Our Core Expert Group was composed of a diverse group of subject matter experts—with substantial knowledge on several aspects of opioid prescribing. The group includes primary care professional society representatives, state agency representatives, an expert in guideline development methodology, and other subject experts.”

Dorigo said the CDC plans to add pain patients and pain management physicians to the new workgroup, but had not determined how many. The agency will hold a public conference call on January 7th to get input from the public on the composition of the panel. The workgroup will present its recommendations to the BSC in a public hearing at an undetermined date.

The Washington Legal Foundation’s chief counsel called that a “step in the right direction,” but emphasized that any deliberations of the workgroup need to be held publicly or it would be a violation of federal law. The Core Expert Group never met publicly.

“The problem was that this group met in secret and the materials submitted to that group were not made publicly available and the deliberations of that group and the materials they produced were never made public,” Samp said.

Fudin believes the CDC needs to start from scratch and appoint a completely new set of experts to advise it.

"In order to regain whatever shred of credibility CDC has left with pain clinicians, a new board should consist of all new members and include board certified pain clinicians that have active current practices with a focus on pain therapeutics in non-cancer pain.  In addition, it requires experts in public health, a psychiatrist, psychologist, and legal counsel with expertise in pain, plus matched expertise in addiction medicine,” Fudin said.

“We are happy to see that the CDC has asked its Board of Scientific Counselors to impanel a committee including additional members, which it should have done in the beginning,” said Bob Twillman, Executive Director of the American Academy of Pain Management.

“We hope the new members will be representative of the pain community, including both clinicians and people with pain, and that their contributions to the committee process will be weighed equally with the opinions of the existing group. We’re a little concerned because all of this is taking place in yet another opaque process, but we have little choice but to trust the CDC to get it right this time.”

The CDC’s public comment period on the guidelines continues until January 13th. You can make a comment by clicking here. 

The proposed prescribing guidelines and the reasoning behind them can be found in a 56-page report you can see by clicking here.

CDC Made Few Changes in Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control Prevention (CDC) has made few changes in its draft guidelines for opioid prescribing, three months after they were widely criticized by pain patients and healthcare providers.

The agency still maintains that “non-pharmacological therapy” and non-opioid pain relievers are the “preferred” treatments for chronic pain, while admitting there is little evidence to support many of its recommendations. The guidelines also fail to address other issues, such as the lack of insurance coverage for many of the treatments the CDC advocates.

The proposed guidelines for primary care physicians were publicly released for the first time today as the CDC opened a 30-day public comment period on them. You can make a comment by clicking here.

The dozen guidelines can be found in a 56-page report, along with the reasoning behind them. You can see the report by clicking here.

“This guideline provides recommendations that are based on the best available evidence that was interpreted and informed by expert opinion. The clinical scientific evidence informing the recommendations is low in quality,” the report states.

“To inform future guideline development, more research is necessary to fill in critical evidence gaps. The evidence reviews forming the basis of this guideline clearly illustrate that there is much yet to be learned about the effectiveness, safety, and economic efficiency of long-term opioid therapy.”

The CDC was roundly criticized for the way it prepared and handled the initial release of the guidelines in September to a select online audience.  The agency never made the guidelines available on its website or in any public form outside of the webinar, and only a 48-hour public comment period was allowed afterwards. The CDC also came under fire for secretly consulting with “experts” that included special interest groups and addiction treatment specialists, but few pain patients or pain physicians.

After getting feedback from critics, the CDC said it would make changes in its recommendations, but only a few changes can be found in the dozen guidelines released today:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks to the patient.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.  

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should generally avoid increasing dosage to ≥90 MME/ day

6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three or fewer days usually will be sufficient for most nontraumatic pain not related to major surgery.

7. Providers should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Providers should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, providers should work with patients to reduce opioid dosage and to discontinue opioids.

8. Before starting and periodically during continuation of opioid therapy, providers should evaluate risk factors for opioid-related harms. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid prescribing opioid pain medication for patients receiving benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

Most of the dozen guidelines are strongly recommended by the CDC, even though the evidence used to support them was considered “limited” or there was “very limited confidence in the effect” of the recommendations.

Changes in Draft Guidelines

Some changes were made in guideline #5, which warns physicians to avoid giving patients high doses of opioids. The new guideline suggests that patients already taking high dosages “should be offered the opportunity to re-evaluate their continued use of opioids at high doses,” instead of having their medication abruptly changed to a lower dose.

However, no mention is made of a CYP450 genetic test, which can determine if a patient may need high doses of opioids.

“The CYP450 omission is disturbing since 20 percent of the population has some defect. How can you have a prescribing policy without CYP450 testing?” asked Gary Snook, a Montana man who needs extremely high doses of opioids to relieve pain from adhesive arachnoiditis. “It makes me wonder, are these doctors really qualified to put forth this draft that will have such an impact on so many that live in severe 24/7 pain? I think not!”

One significant change, in guideline #10, acknowledges that the results of urine drug tests are often wrong or misinterpreted. It recommends drug testing before opioid therapy begins and then annually, but random drug testing is discouraged. The guideline also recommends that providers not test for substances such as marijuana, which may not affect the efficacy of pain management.  

If there are “unexpected results” from a urine drug test, the guideline says patients should not be terminated from a doctor’s practice, but should be counseled or offered treatment for substance abuse.

Pain Patients Urged to Comment

“I feel it's critical that members of the pain community, or people whose loved ones suffer from chronic pain, to take this rare second chance to refer to each of the guidelines and make their feelings known,” said Kim Miller, a pain patient and advocate..

“I feel it's important to keep your feelings out of comments to official government entities. Professionals are more receptive to calm remarks.  There's no need to be inflammatory; other agencies, law firms, and numerous medical providers have already expressed their disappointment and disapproval of the previous draft guidelines.  At this point, sticking to the facts is all that's necessary.”

The CDC is emphasizing the revised guidelines are voluntary and “intended to improve communication” between doctors and their patients.

Debra Houry, MD, the CDC official who oversaw development of the guidelines, even put out a Tweet, saying, “Patients & providers should decide together how to best treat long-term chronic pain.”

But critics say the guidelines, when adopted, could quickly become a standard of practice for state medical boards and professional healthcare societies, giving physicians little choice but to comply with them.

“These ‘guidelines’ are not looked at merely as suggestions,” Miller said. “When the CDC suggests there's no need for concern, after all these are only guidelines, it couldn't be further from the truth.  The pain community must be sure to give these guidelines very serious consideration, your medical providers will be.”

After the public comment period ends, the CDC says the guidelines will be reviewed by a scientific advisory group, which will then appoint another working group to refine the guidelines further.  The agency has not released a timetable or said if outside consultants who helped draft the initial guidelines will still be part of the process.

The CDC was criticized for consulting with five board members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which runs a chain of addiction treatment centers. Critics say PROP has a conflict of interest when it advocates that pain patients be given greater access to addiction treatment.

My Life with Fibromyalgia: An Open Letter to CDC

(Editor’s Note: The Centers for Disease Control and Prevention today reopened for public comment its proposed guidelines for opioid prescribing. Comments, which will accepted until January 13, 2016,  can be made by clicking here.)

By Emma Christensen, Guest Columnist

The over-regulation of opioid medications is so very wrong for pain patients. To withdraw their access to opioid medications is reckless and punitive.

Having lived with fibromyalgia for over 15 years, searching for credible medical help and treatment has been one of the most trying experiences of my life.

One physician I sought help from was so at a loss for treating the pain I was experiencing that he put me on heavy doses of morphine. When I learned more about the medication he put me on, I began to question if I truly needed that much in order to live. 

When another physician told me I was very young to be on that high of a dosage, I searched and found literature that supported using a low dosage of morphine to take the edge off of the pain. This method of pain reduction was done in order to allow patients to function using additional alternative solutions such as Tai Chi exercise, foam rolling and trigger point therapy to help reduce significant amounts of their pain. Eventually, I tried these methods and was able to step down to the lowest dose (15mg) that is available for doctors to prescribe.

emma christensen

This low dosage worked well. I felt like I was improving and having the first bits of success in pain reduction that did not require a pill or large amounts medication.  It was just enough to take the edge off the pain. This allowed me to begin to move, exercise, and use other alternative methods of pain relief.  However, it was not possible to do this without the opioid cutting into that first layer of pain. 

I describe pain as an onion -- I had just begun to peel it.  I could not do this without relying upon the small amounts of morphine I was prescribed.

I hate the fact that I have to take this medication. I hate the fact that there is not a better solution. However, all things considered, would you rather pay for a person to be on disability and all that goes with that? Or would you rather have them remain functional and working at a job supporting themselves? I chose to be functional and working, thereby keeping my self-respect and dignity.

The day someone wants to walk a day in my shoes with this painful condition, is the day that they can tell me how my doctor and I can treat my condition.  The pain is unbearable, horrific, and relentless. If I stop any of the methods I use to fight it, it can revert to the levels it was at before I began fighting it; as if I had never done anything to fight it at all.

The low dose morphine has helped me stay functional and keep my job all these years. It takes the edge off of the horrific pain that comes with having fibromyalgia. If anything, I have been more responsible than you have, as the “monitors of society” that wish to deprive me of the one thing that allows me to remain functional.

For years, I have taken only a 15 mg dose and not more, as was originally prescribed. I am prescribed two pills a day for 30 days. I have the extra burden of having to pick up the prescription in person and to sign for it, for each refill. For me, this means I must take time off from work to get the script (if my doctor’s office is not open on Saturday morning). This is another burden.  How much more difficult do you want to make my life?  Why can’t a quarterly prescription be available for someone like me who has a history of appropriate medication usage?

I am frightened to go without the medication because my pain is real. It hurts, fibromyalgia hurts, and it brings me to tears. Just moving my arms and legs is excruciating due to the myofascial knots and inflamed fascia that I endure with this condition.

If you want to question my need for this medication, go nose to nose with me and tell me why. Tell me what other solution you suggest that is just as good and will do what I need it to do, so I can work and keep my job. I have been out there trying every solution I can find for the last 15 years.

If you think you can solve the pain, solve it! Let me or any other person who lives with chronic pain be the judge of your solution, not you. It is very obvious to those of us living in chronic pain that the CDC’s opioid guidelines are being made by people who do not experience chronic pain themselves!

If I had a choice, I would not use this medication. I would not take morphine if I did not need it. I am against using illegal drugs.  In my lifetime, I have worked in two police departments, was married to a cop, and my father-in-law was a chief of police. Additionally, I hold a Master’s degree in Public Administration. I know full well what the abuse of drugs does to families and society.

However, that doesn’t give you the right to tell me and my doctors how to treat my condition.

Blanket mandates of restriction, without credible analysis of the situation, is not a substantial enough reason to deny a class of people who are suffering and in pain their medication.  Proposed regulations should not only solve an administrative problem; but, enhance the medical profession and the support the pain patient simultaneously. Any proposals that do not measure up to this standard are beneath consideration for good practices and reasonable implementation by professional public administrators. 

Like any other crime, incidences of abuse and misuse must be regulated and substantiated in a court of law following the principles of due process. To do otherwise is punitive and unjust towards people who are innocent of such allegations.

There is another reason I felt inspired to write this open letter to the CDC.  It is my education that requires me to respond. If I do not respond and say something now while I have a chance, I could be responsible for my own loss if they take away my medication. 

We all have to stand firm to let the CDC administrators know that they cannot make decisions in a vacuum.  If we allow them to get away with this, then we are less of a democracy and more dictatorship run by administrators who do not know the negative effect that they are having on our society.  My degree is all about building a "good society." Arbitrary rules against pain patients are not the solution to this problem.  You cannot solve a law enforcement issue by doing the minimum of public administration.

If you want to help chronic pain patients, such as myself, put your energies into finding a cure for the pain patients that require these medications to cope with their daily lives; remove the barriers to treatment. You can have my medical case files; my treatments are an open book, as far as I am concerned. I have never misused my medications and do not ever plan to. Please stop persecuting those of us who are ill and find a better way to spend your time.  I am one voice, but I speak for many people who are in pain.

This open letter to the CDC is intended to invite, stimulate and encourage further discussion and commentary on this most important issue of pain management and law enforcement of illegal drugs.

Emma Christensen lives in Illinois. She was diagnosed with fibromyalgia in 2000 after a whiplash injury from a vehicle accident. Emma is currently working to be certified as a fibromyalgia health coach and hopes to help others navigate their way through treatments in order to feel and be better.  She has a Facebook support group called Fibromyalgia Solutions.

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.

Will CDC Start Listening to Chronic Pain Patients?

By Pat Anson, Editor

Friday’s announcement by the Centers for Disease Control and Prevention (CDC) that it will reconsider and delay implementing its controversial draft guidelines for opioid prescribing throws open a process that’s been largely concealed from the public.

But will it lead to changes in the guidelines themselves? And will the agency start listening to pain patients who fear losing access to opioid pain medication?

There are many different opinions from experts and activists who’ve been closely following the debate.

“A delay will not stop the inevitable, nor will a few months serve as a cooling blanket for the medical professionals and patients that are outraged by the approach CDC has taken on these guidelines.  CDC’s behavior was so outlandish that is caused an avalanche of pushback,” said Jeffrey Fudin, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).

“It is heartening to see that CDC has decided to do now what it really should have done in the beginning, and I hope the result is a set of recommendations that everyone can support,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

“Some have said that this delay is a victory for ‘the opioid lobby,’ but I think it’s not really a victory for anyone; it might be a victory for tried-and-true methods of developing practice guidelines, and a victory for transparency, but a delay in producing reasonable, workable guidelines actually does everyone a disservice. That could have been prevented, had CDC used a proper process from the beginning.”

The process that CDC used in developing the guidelines was unusually secretive and one-sided for a public agency. As Pain News Network has reported, the CDC handpicked outside advisers dominated by special interest groups and addiction treatment specialists, most of whom were determined to rein in opioid prescribing. The CDC’s panel of experts and stakeholders included five board members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. Few patient advocates and pain physicians were included in the process.

Not surprisingly, the resulting draft guidelines discourage primary care physicians from prescribing opioids for chronic pain. “Non-pharmacological therapy” such as exercise and cognitive behavioral therapy were recommended instead, along with non-opioid drugs such as over-the-counter pain relievers.

The guidelines were unveiled to a select online audience in September and only a brief 48-hour window was allowed for public comment. That sparked an outcry from the pain community. In a survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation, large majorities complained that non-opioid treatments didn’t work for them or were not covered by insurance. Others predicted the guidelines would cause even more addiction and overdoses, not less.

The CDC largely ignored the complaints and said it would continue with plans to implement the guidelines in January, as planned.

Only in recent weeks, when the CDC started getting “feedback” from others did the agency reconsider. It was threatened with a lawsuit by the pro-business Washington Legal Foundation and officials from other federal agencies mocked the guidelines as “ridiculous” and “an embarrassment to the government.”

“CDC appreciates the feedback we have received to date, which has informed and strengthened the document thus far, and we look forward to receiving further input to improve the way opioids are prescribed,” said Debra Houry, MD,  the CDC official in charge of developing the guidelines, in an email Friday to stakeholders.

The agency now says it will reopen the public comment period for 30 days, starting on Monday, December 14th. The draft guidelines will also be reviewed by a scientific advisory panel, which will appoint a new work group to consider changes, a process that could take several months or more.

“I think it's a good idea to get broader input. Some have been critical of CDC, but the criticism has swirled primarily around the process itself, particularly the need for more input. More input can't hurt. It's my sense that the draft guidelines themselves have generally been well-received,” said David Juurlink, MD, a PROP board member who served on one of the CDC’s advisory committees. 

“Regarding the Washington Legal Foundation, I note that they've lobbied previously on behalf of Exxon Mobil, Philip Morris and Purdue Pharma. People can infer from this what they will.”

Jeff Fudin thinks the review process is yet a smokescreen.

“It seems to me that CDC is forming more committees and more layers to shield liability and hide behind their transgressions.  Rather than do this, I’d like to see a committee formed to examine how CDC’s actions around the guidelines happened in the first place, including but not limited to the choice of committee members and all potential conflicts and alliances among participants. Only after we understand how the CDC went awry can a fair scientific board be put in place to avoid a snowball of transgressions,” Fudin said in an email to Pain News Network. 

“The CDC realizes that they created a fire storm with their politically driven guidelines,” said Lynn Webster, MD, past president of American Academy of Pain Medicine. “It is good that they have heard the crescendoing opposition to what they have done.  We will have to see if it is just a maneuver to appease the concerns or if they are truly interested in working to be more inclusive and scientific in developing the guidelines.

“There are two fundamental concerns with the proposed guidelines.  The first is the secretive process and inclusion of advisers who are biased and prejudicial against opioids.  The other major concern is that the recommendations do not match the level of evidence.  This is what is most bizarre from the CDC, since the CDC is supposed to be a scientific body which uses best evidence in proposing health recommendations for the country. They failed to follow this principle in this case.”

Another bizarre part of the process is that – outside of September’s webinar -- the CDC has never made the guidelines available on its website, in a news release, or in any public forum. That will finally change on Monday when the draft guidelines are published in the federal register.

CDC Delays Opioid Prescribing Guidelines

By Pat Anson, Editor

Faced with the threat of lawsuits and growing ridicule from patients, physicians and other federal agencies, the Centers for Disease Control and Prevention (CDC) has apparently decided to delay for several months plans to implement its controversial opioid prescribing guidelines for chronic pain.

Today the agency filed a formal notice in the federal register that it was opening a 30-day public comment period on the guidelines, which had been scheduled for adoption in January. The guidelines would discourage primary care physicians from prescribing opioid pain medication in an effort to end what has been called an “epidemic” of addiction and overdoses.

“In response to feedback, CDC is posting its draft opioid prescribing guideline for chronic pain in the Federal Register for 30 days of public comment. In addition, in early 2016 the CDC National Center for Injury Prevention and Control’s Board of Scientific Counselors (BSC), a federal advisory committee, will review the draft guideline. CDC will ask the BSC to form a workgroup to review the guideline and public comments and present recommendations to the BSC,” the CDC said in a statement to Pain News Network.   

The public comment period will run from December 14th  until January 13, 2016.

The CDC unveiled the guidelines in September to a select online audience and then only allowed a 48-hour public comment period. The agency was roundly criticized for its secrecy during the drafting of the guidelines and for consulting with special interest groups, but few pain patients or pain physicians. The agency never made the guidelines available on its website or in any public form outside of the webinar.

A spokesperson told PNN the guidelines will finally become available for public scrutiny on Monday when they are published in the federal register.

A list of the dozen draft guidelines that were released in September can be found here. They recommend “non-pharmacological therapy” as the “preferred” treatment for non-cancer pain, and state that limited quantities and doses of opioids should be prescribed for both acute and chronic pain. The CDC later said the draft guidelines were being revised, but didn't release the changes.

Last week, a key government panel that oversees pain research indicated it would file a formal objection to the guidelines. Politico reported that the National Institute of Health’s Interagency Pain Research Coordinating Committee believes there is little or no evidence to support many of the prescribing guidelines. Some committee members reportedly called the agency’s recommendations “ridiculous” and “an embarrassment to the government” during a meeting.

Sharon Hertz, a top FDA official, was quoted as saying the evidence used to support the guidelines "is low to very low and that's a problem."

Another top official in the Department of Health and Human Services told the research committee the CDC’s guidelines were “shortsighted” and there was a rush to judgement.

"You know, damn the torpedoes. Full speed ahead," said Wanda Jones, principal deputy assistant secretary for health at HHS.

The Washington Legal Foundation (WLF) also signaled it was prepared to file a lawsuit to stop the guidelines from being implemented, accusing the CDC of “blatant violations” of federal law for not holding public hearings and refusing to publicly identify members of its advisory committees.

“The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers,” wrote WLF chief counsel Richard Samp to CDC director Tom Frieden.

In a survey of over 2,000 patients by Pain News Network and the Power of Pain Foundation, over 90% said the guidelines were discriminatory and would be more harmful than helpful to pain patients. Most said they had already tried non-opioid treatments, such as massage, acupuncture and cognitive behavioral therapy, and found that they didn’t work or were not covered by insurance. Many predicted the guidelines would lead to more suicides in the pain community, and cause more addiction and overdoses, not less.

Naltrexone ‘Changed Life’ of Fibromyalgia Patient

By Donna Gregory Burch

The pain in Janice Hollander’s legs was so excruciating that she wanted to cut them off. Diagnosed with fibromyalgia in 2013, she’d progressed through the normal litany of prescription drugs doled out by physicians – Lyrica, Cymbalta, gabapentin, muscle relaxers and narcotics – all without finding relief.

Then she happened to catch an episode of the Dr. Oz Show where a guest discussed using low-dose naltrexone (LDN) as a treatment for chronic pain. A few days later, she convinced her doctor to write a prescription and took her first dose of LDN.

“After about seven days, my pain lessened,” said Hollander of Michigan. “It lessened by 10 or 20 percent. That was huge! Even just that little bit of lessening was huge.”

After four weeks, the depression that had been stymying her for years lifted. At six weeks, she saw a noticeable increase in her energy levels. Her brain fog improved, and her memory returned.

Hollander has been taking LDN for about year now, and she’s probably one of its biggest fans within the fibromyalgia community. She regularly shares her success story in online support groups.

Hollander still has fibromyalgia symptoms, but they are more manageable thanks to LDN.

“I would say my leg pain is pretty much gone,” she said. “[LDN] has completely changed my life. I don’t know that I would be here today if it wasn’t for it. I don’t think I could go for another year in the misery I was in.” 

A growing number of fibromyalgia sufferers like Hollander are finding relief using LDN. It’s an unusual discovery since LDN is best known in the addiction treatment community. The U.S. Food and Drug Administration approved LDN to treat addiction to certain opiate drugs in 1984.

janice hollander

Dr. Jarred Younger, who conducted two LDN/fibromyalgia studies at Stanford University, believes LDN has an anti-inflammatory effect on the brain.

“This is one of the few drugs that can do that in the brain because it crosses the blood-brain barrier,” Younger said.

In simple terms, the brain contains microglial cells that look for problems within the central nervous system. When they discover an abnormality, these cells release chemicals into the body that cause fatigue, pain, cognitive disturbances and other symptoms common among fibromyalgia patients. In a healthy person, these chemicals are intended to slow down the body, to force it to rest, so that it can heal from whatever has caused the abnormality. In fibromyalgia, some researchers hypothesize this normal central nervous system response gets activated and doesn’t shut off.

“It’s like the central nervous system thinks you have an infection when you don’t,” Younger explained.

Fibromyalgia sufferers often speculate about what caused their condition, and researchers have debated various triggers for years. Viruses (herpes, Epstein Barr, etc.), chronic stress, genetics, obesity, aging and pollution are suspects, but according to Younger, it could be all of these.

He believes LDN works because it calms the microglial cells and reduces brain inflammation.

Penn State University researcher Ian Zagon posits a different mechanism behind LDN. Zagon’s opioid blockade hypothesis surmises that LDN blocks the brain’s opioid receptors, essentially tricking the body into increasing production of natural pain-suppressing chemicals.

Theoretically, both hypotheses could be correct.

Younger’s two Stanford University studies showed LDN outperformed Lyrica, Cymbalta and Savella, the three drugs currently approved to treat fibromyalgia in the U.S., and it did so with minimal side effects. The most common side effects are headache, insomnia, vivid dreams and nausea – all of which usually disappear over time.

“Probably 65 percent of people get an appreciable decrease of symptoms,” Younger said.

But more research is needed to confirm these early findings.

Next year, Younger will conduct at least two LDN/fibromyalgia studies at his new facility, the Neuroinflammation, Pain and Fatigue Lab at the University of Alabama at Birmingham.

One study will try to parse out the most effective dose of LDN for fibromyalgia. Most LDN users are prescribed the drug off-label, between 1.5mg and 4.5mg daily. But some rheumatologists have shared anecdotal accounts that certain patients respond better to higher doses, ranging up to 9mg.

A second trial will pair LDN with dextromethorphan, a common cough suppressant that’s believed to work similarly to LDN.

But many fibromyalgia sufferers aren’t waiting for the research. They’ve found ways to secure a prescription and try LDN for themselves.

Linda Elsegood, founder of the U.K.-based LDN Research Trust, has helped thousands of people gain access to LDN. She credits LDN with stabilizing her multiple sclerosis. At her worst, Elsegood was wheelchair bound, had no control of her bowels or bladder and had lost much of her sight and hearing. After 18 months on LDN, she was able to walk again on her own and had a reversal of most of her symptoms.

After her remarkable recovery, she wanted to educate others on the benefits of LDN.

“I wanted people to know that there is a choice, if you’ve been told, like me, that there’s nothing else that can be done for you,” she said. “Look into LDN. Do your research. … It is amazing the number of people who’ve found LDN works for them for so many different conditions.”

In addition to fibromyalgia, early research has found LDN to be useful in reducing the symptoms of certain autoimmune and central nervous system conditions, including multiple sclerosis, Crohn’s disease, rheumatoid arthritis and others.

But few doctors know about LDN as an emerging treatment, so it can be difficult to get a prescription.

“Some doctors are too busy to read the information,” Elsegood explained. “Some will not think outside of the box. It’s not what they learned in medical school, so they’re not prepared to consider something that is alternative. Other doctors won’t prescribe it because there aren’t enough trials.”

Unfortunately, it’s unlikely that any of the major drug companies will ever study LDN because it’s an older, generic drug and little profit can be made from it. So it falls to innovative researchers, like Younger, who secure donations and grants to fund trials.

Patients often encounter doctors who refuse to prescribe LDN even though it has a proven safety record and a low risk of side effects. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website. For those who can’t find an LDN-friendly doctor locally, there are physicians who offer phone and online LDN consults.

“My advice is to always research it yourself, and then address it with your doctor,” Hollander said. “And if your doctor won’t agree to letting you try it, then find a doctor who will.

“I would drive to Florida to get it if I had to. It makes that big of a difference. I just wish more doctors would prescribe it, and more people would find help with it.”

For a list of helpful LDN resources, visit www.fedupwithfatigue.com/low-dose-naltrexone.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained symptoms. Donna is the founder of Fed Up with Fatigue, a blog devoted to helping those with fibromyalgia and ME/CFS live better with these conditions.

Donna is an award-winning journalist whose work has appeared online and in local newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

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.

Controversy Grows over Journal Article on Pain Treatment

By Pat Anson, Editor

It’s not uncommon for colleagues in the medical profession to disagree. Egos and different medical backgrounds can sometimes lead to heated discussions about the best way to treat patients. But those arguments are usually kept private. 

That is why it is so unusual for a prominent pain physician to publicly call for another doctor to resign or be fired from her faculty position at a prestigious medical school.

“I believe she should resign her academic post,” says Forest Tennant, MD, referring to Jane Ballantyne, MD, a professor at the University of Washington School of Medicine, who recently co-authored a controversial article in the New England Journal of Medicine (NEJM) that said reducing pain intensity should not be the goal of doctors who treat chronic pain. The article also suggests that patients should learn to accept their pain and move on with their lives.

“For somebody in her position as a professor at a university to call for physicians to quit treating pain – or pain intensity – whether acute, chronic, whether rich, poor, disabled or what have you, is totally inappropriate. And it’s an insult to the physicians of the world and an insult to patients. And frankly, she should not be a professor.” Tennant told Pain News Network.

“To suggest that physicians should no longer treat pain intensity and let patients suffer goes beyond any sort of decency or concern for humanity.”

Tennant is a pain management specialist who has treated patients for over 40 years at his pain clinic in West Covina, California. He’s authored over 300 scientific articles and books, is editor emeritus of Practical Pain Management, and is highly regarded  in the pain community for accepting difficult, hard-to-treat patients that other doctors have given up on.

dr. forest tennant

Tennant was surprised the influential, peer-reviewed New England Journal of Medicine, which reaches over 600,000 people each week, even published the article.

“I know that they’re biased and they’ve got all their medical device people there and all their academia and all that, but I think they have a responsibility also. They are supposedly representing medicine,” says Tennant. “Why do I have a medical degree if I’m not supposed to treat pain intensity? Give me an answer to that. She didn’t have an alternative did she?”

dr. jane ballantyne

Exactly what Ballantyne and co-author Mark Sullivan, MD, meant to say is open to interpretation. Pain News Network has been unable to get comment from either about the controversy.

They began their article by saying “pain that can be relieved should be relieved,” but then veer off in another direction, stating that chronic pain should not be treated with opioid pain medication.

“Is a reduction in pain intensity the right goal for the treatment of chronic pain? We have watched as opioids have been used with increasing frequency and in escalating doses in an attempt to drive down pain scores — all the while increasing rates of toxic drug effects, exposing vulnerable populations to risk, and failing to relieve the burden of chronic pain,” they wrote, dismissing the pain intensity scales that are widely used by physicians to measure pain levels.

“We propose that pain intensity is not the best measure of the success of chronic-pain treatment. When pain is chronic, its intensity isn't a simple measure of something that can be easily fixed.”

Ballantyne and Sullivan offered no alternative “fixes” for pain treatment, other than patients learning to live with pain and sitting down for a chat with their doctors.

“Nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient's experiences and offer empathy, encouragement, mentorship, and hope,” they wrote.

Angry Comments from Readers

The article infuriated both patients and physicians, including dozens who left angry comments on the NEJM website.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote Michael Shabi, who identified himself as a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation. I have had 21 neurological surgeries and procedures and live in constant pain. So why in the heck do you people have such a problem in hearing us?” asked pain patient Kerry Smith.

“Only an idiot might conclude that one can dismiss the effects of living with a healthcare problem that reminds you of its presence with every move you make,” wrote Terri Lewis, PhD, a specialist in rehabilitation.

Both Ballantyne and Sullivan have lengthy careers in medicine and have been active in organizations that discourage the use of opioids. 

According to the University of Washington website, Ballantyne received her medical degree from the Royal Free Hospital School of Medicine in London and trained in anesthesiology at John Radcliffe Hospital in Oxford. She moved to Massachusetts General Hospital in Boston in 1990 and then to the University of Washington in 2011, as a Professor of Education and Research and as Director of the UW Pain Fellowship. 

Last year Ballantyne was named president of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. She also serves as an expert adviser to the Centers for Disease Control and Prevention (CDC) as it develops controversial new guidelines that discourage primary care physicians from prescribing opioids. Ballantyne is one of five PROP board members who are advising the CDC on the guidelines.

Sullivan is a Professor of Psychiatry and Behavioral Sciences -- also at the University of Washington School of Medicine -- and is executive director of Collaborative Opioid Prescribing Education (COPE), a program that educates healthcare providers about safe opioid prescribing practices. He is also a PROP board member.

Sullivan has authored several research articles on opioids, including a recent one warning about the co-prescribing of sedatives and opioids.

“He’s not as well known,” says Tennant. “He doesn’t carry the public influence that she does. She’s sitting on federal committees, advising CDC that pain patients should not be treated and the intensity scale should not be used. I cannot imagine anyone making that statement. I can’t imagine the New England Journal of Medicine publishing it. The atrocity here is just awful.

dr. mark sullivan

“Any semblance of decency left among physicians in PROP, if that’s what they believe, then I think the whole organization ought to close its doors. I didn’t know they were going to say we didn’t want pain treated at all. They said they wanted to use opioids responsibly. Well, that’s fair. But that’s not what she said.”

Tennant is urging the pain community to contact Paul Ramsey, the CEO of UW Medicine and Dean of the School of Medicine to ask that Ballantyne be fired. He’s gotten a few takers, including Becky Roberts, who suffers from arachnoiditis.

“I do not feel she should be teaching new medical students. Professor influence is big when you are a student. I am sure if any one of them read her article, most were probably shocked,” Roberts said in an email to Pain News Network.

“They did not get into medicine because they are uncaring. Compassion for other human beings is why they went to medical school. To help heal human beings is their goal. I really do think she needs to be removed from that position. How long has she been teaching this kind of logic?”

The UW School of Medicine has about 4,500 students enrolled in undergraduate, professional, and post-graduate programs. 

New Skin Patch Delivers Pain Relief with Ibuprofen

By Pat Anson, Editor

There are many different types of skin patches already on the market to treat pain --- containing everything from lidocaine to capsaicin to powerful opioids like fentanyl. Now British researchers say they’re a step closer to developing the first transdermal patch containing ibuprofen.

Researchers at the University of Warwick have formed a company called Medherent to produce and patent an adhesive patch that can deliver a high dose of ibuprofen through the skin for as long as 12 hours to treat conditions such as back pain, arthritis and neuralgia.

Their patch differs from others already on the market because the medication is embedded into the polymer matrix that sticks the patch to the patient’s skin. The embedding technology allows the patch to contain 5 to 10 times the amount of analgesic currently used in medical patches.

"Many commercial patches surprisingly don't contain any pain relief agents at all, they simply soothe the body by a warming effect,” says University of Warwick research chemist Professor David Haddleton.

image courtesy of medherent

“Our technology now means that we can for the first time produce patches that contain effective doses of active ingredients such as ibuprofen for which no patches currently exist. Also, we can improve the drug loading and stickiness of patches containing other active ingredients to improve patient comfort and outcome."

The researchers are now testing other analgesics to see if they too can be embedded into the polymers. So far they’ve had good results with methyl salicylate – a wintergreen-scented chemical used in some topical liniments and gels.

“We believe that many other over the counter and prescription drugs can exploit our technology and we are seeking opportunities to test a much wider range of drugs and treatments within our patch," says Haddleton.

In an email to Pain News Network, Medherent’s CEO said the technology is compatible with a wide range of drugs, including opioids. The company is currently seeking partners to help develop the patches.

"Our first products will be over-the-counter pain relief patches and through partnering we would expect to have the first of those products on the market in around 2 years,” said Nigel Davis. “In addition to our pain relief products, our technology also works with drugs in many other therapeutic areas. We can see considerable opportunities in working with pharmaceutical companies to develop innovative products using our next generation transdermal drug-delivery platform."

Adding opioids to the mix is tricky business, because some opioid patches already on the market are being abused. According to CBCNews, transdermal patches containing fentanyl are blamed for over 600 deaths in Canada. Addicts have learned they can cut up fentanyl patches to smoke or ingest them  

Asked if Medherent’s patch technology would prevent similar abuse, Davis said, “We hope so but need to do more work on that before we make claims of that sort. “

Decision on Opioid Implant Nears

Meanwhile, Titan Pharmaceuticals (NASDAQ: TTNP) has announced that the Food and Drug Administration has scheduled a meeting with the company next month to discuss its new drug application for Probuphine, an implant containing buprenorphine, a weak acting opioid used to treat addiction.

Ironically, some addicts have learned they can get high by abusing buprenorphine and it is prized as a street drug that can ease withdrawal pains from heroin. Buprenorphine, which is more widely known under the brand name Suboxone, is currently only available in pills and oral films.

The Probuphine implant would be difficult to abuse. About the size of a matchstick, it is designed to be inserted subcutaneously under the skin of the upper arm, where it can release steady doses of buprenorphine for as long as six months.

Titan and its partner, Braeburn Pharmaceuticals, believe the implant technology could someday be used to deliver other medications, including opioids for pain relief.

image courtesy of titan pharmaceuticals

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study of Probuphine’s effectiveness. Since then, the companies have conducted a study showing that the implant was more effective than buprenorphine tablets in treating addiction. The companies are hoping for FDA approval in 2016.