All Things Considered: Except Patients

By Pat Anson, Editor

National Public Radio’s All Things Considered is one of the most respected radio programs in the country, reaching nearly 12 million listeners each week.

So when All Things Considered aired a two-part series this week on the opioid prescribing guidelines being developed by the Centers for Disease Control and Prevention (CDC), many expected an in-depth and balanced report on America’s love-hate relationship with opioids – how a medicine that gives pain relief to millions is also responsible for the deaths of thousands who abuse it.

Host Robert Siegel said the nation was at a “turning point” in its complicated relationship with opioids. The broadcast interviewed pain specialists, a family physician, and various experts who said the CDC guidelines either go too far or are long overdue.

“We have a moral responsibility to address pain and suffering. And we do have a responsibility not to do harm, but you can do harm in either direction,” said Richard Payne, MD, of Duke University.

“The number of deaths is only the tip of the iceberg, that's just indicating the pyramid of problems that lies beneath,” said Jane Ballantyne, MD, President of Physicians for Responsible Opioid Prescribing (PROP).

Completely missing from the report was the voice of pain patients. Many noticed the omission and left comments on NPR’s website.   

“Please consider interviewing real chronic pain patients. Everyone seems to be making decisions about our treatment but no one asks us how these medications work for us,” wrote one pain sufferer.

“Sorry but NPR screwed up majorly on this piece – they had no panel of patients to give their thoughts – considering how terrible pain patients are treated, that would have been a good angle,” wrote Cary Brief.

“The recent public discussion on opiates, which paints all opiate users as addicts or drug-seeking, is not only unhelpful, it is exceedingly harmful to patients like myself who take their medications as prescribed,” said a woman who suffers from chronic back pain.

“I am amazed at my beloved NPR not doing their homework on this,” wrote Kristine Anderson. “You have just labeled yourself another media outlet getting your information from only the CDC (other than Dr. Payne perhaps) and creating feed off of their press releases, timely sent just as the guidelines comments were reopened and soon to close.”

Anderson also wrote she was disappointed that the broadcast included a lengthy interview with Ballantyne, a retired pain specialist who has recently emerged as a controversial figure in the debate over opioids. As Pain News Network has reported, Ballantyne is one of five PROP board members who are advising the CDC and her inclusion in a secret panel of experts is one of the reasons the agency delayed implementing the guidelines and reopened a public comment period.

Critics have said Ballantyne is biased, has a financial conflict of interest, and should be fired from her academic position at the University of Washington School of Medicine for advocating that pain intensity not be treated.

None of that was reported by All Things Considered, which gave Ballantyne a prominent role in the broadcast. Ballantyne told the program that during her lengthy career in pain management she and other doctors were sometimes abused and insulted by “awful” pain patients when they tried to wean them off opiates.

“If you give people opiates, they think you're the best thing since sliced bread. They love you. They just worship the ground you walk on. The moment you suggest that you want to try and get them down on their dose or, worse still, say you can't carry on prescribing - not that I do that myself; I never cut people off; I don't think people should be cut off, but I do try and persuade them to come down on their dose - they are so awful,” Ballantyne said.

“And you can see why people who are not seeped in this stuff - the young primary care physicians just don't know what to make of it. They don't want to be abused. They want to be loved like everybody else does. We go into medicine to try and help people. And when you get abused and, you know, insulted, you can see why it perpetuates itself.”

Ballantyne said patients on high doses of opiates “were absolutely miserable, were not doing well, were medically ill and always had severe pain." It was then that she and her colleagues began to think "the opiate wasn't helping, and maybe it was harming.”

You can listen to Ballantyne in the first part of NPR’s story, by clicking here.

The second part -- an interview with Dr. Wanda Filer, president of the American Academy of Family Physicians -- can be heard by clicking here.

Hospital’s Opioid Guidelines Had Significant Impact

By Pat Anson, Editor

An opioid prescribing guideline adopted in 2013 at Temple University Hospital in Philadelphia may provide a sneak peek at the possible impact of similar guidelines being considered by the Centers for Disease Control and Prevention (CDC).

Temple University’s guidelines, which discourage opioid prescribing for many emergency room patients suffering from acute or chronic pain, resulted in an “immediate and sustained impact” on rates of opioid prescribing, according to research published in the Journal of Emergency Medicine.

In a study of over 13,000 patient visits, the rate of opioid prescribing was quickly reduced by about a third, falling from nearly 53% of emergency room visits before the guideline to about 34% a year later. The patients were being treated for dental, neck, back and chronic non-cancer pain.

The opioid guidelines were supported by all 31 of the hospital’s emergency room physicians who completed a survey on their prescribing practices. Most of the doctors (97%) felt the guideline facilitated discussions with patients when opioids were withheld, and nearly three-quarters said they encountered “less hostility” from patients since adoption of the guideline.

temple university hospital

Only 13% of the doctors believe patients with legitimate reasons for opioids were denied appropriate care. A large majority – 84% of the doctors -- disagreed or strongly disagreed that patients were denied appropriate pain relief.

The researchers did not ask any pain patients what they thought about their hospital care.

“Emergency physicians have identified themselves as targets for patients who seek opioids for nonmedical purposes, yet it can be difficult for clinicians to distinguish drug seeking behavior from legitimate need. Recognizing the importance of clinician discretion at the bedside, adherence to our guideline was voluntary,” said Daniel del Portal, MD, Assistant Professor of Clinical Emergency Medicine at the Lewis Katz School of Medicine at Temple University, who was principal investigator of the study.

The CDC also considers its draft guidelines voluntary for primary care physicians, although many experts believe they will quickly be adopted as “standards of practice” by all doctors who prescribe opioids – just as they were at the hospital.

The Temple University guidelines differ from those of the CDC because they are designed specifically for emergency room physicians. They discourage doctors from prescribing opioids for dental pain, back pain, migraines, gastroparesis or chronic abdominal pain; and recommend that patients not be discharged with more than 7 days supply of opioids (the CDC recommends 3 days supply). The hospital’s guidelines also recommend that long acting opioids such as OxyContin, morphine and methadone not be prescribed; and that “less addictive therapies” such as NSAIDs or acetaminophen be used instead for pain relief.  

“We acknowledge the myriad challenges to addressing issues of chemical dependence and opioid abuse. We do not pretend that a guideline alone will solve this problem, but rather we believe that guidelines are one of a number of tools that should be considered in parallel,” said del Portal.

“In contrast to electronic prescription drug monitoring programs, which show promise but require significant infrastructure and regulation, an easily implemented guideline empowers physicians and protects patients from the well documented dangers of opioid misuse.”

He also acknowledged that limits on opioid prescribing may result in more drug abuse and addiction.

“Heroin overdose deaths have continued to rise, even more dramatically since the plateau of nationwide opioid prescriptions
after 2011. While experts point to the rise in opioid prescriptions as a major contributor to heroin deaths, we are mindful that limiting the supply of opioids may provide a catalyst for drug substitution,” he said. 

The public comment period on the CDC's draft guideline 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.

Most Patients Still Prescribed Opioids After Overdose

By Pat Anson, Editor

The vast majority of chronic pain patients continue to be prescribed opioids after a non-fatal overdose, usually from the same doctor who prescribed the pain medication that led to the overdose, according to new research published in the Annals of Internal Medicine.

In the study of nearly 2,850 patients who were treated for an opioid overdose, 91% were prescribed another opioid within 300 days of the overdose. About 70% of the prescriptions were written by the same provider. Data for the study was collected from insurance claims filed from 2000 to 2012.

"Our finding that almost all patients continue to be prescribed opioids after overdose is highly concerning,” wrote lead author Marc Larochelle, MD, Boston Medical Center. “The overdoses we detected were captured in routine claims data and treated in emergency departments or inpatient settings and thus represent identifiable events when information sharing might lead to improved care and outcomes. Further research is needed to determine whether providers continuing to prescribe opioids after an overdose are aware of the event and, if so, how they respond in counseling patients.”

The researchers found that about 7% of pain patients had a second overdose and those who were prescribed high doses of opioids had twice the risk of a repeat overdose.

Even more disturbing is that over half of the overdose patients (58%) were prescribed benzodiazepines, anti-anxiety medication that includes brand names such as Valium and Xanax.

Benzodiazepines are known to greatly increase the chances of an overdose. A recent CDC study found that about 80% of unintentional overdose deaths associated with opioids also involved benzodiazepines.

Due to limits in the data, researchers had no way of knowing why physicians continued to prescribe opioids after their patients overdosed.

“We could not determine reasons for the treatment patterns after the overdose; however, some prescribers may have been unaware that the opioid overdose had occurred,” said Larochelle. “In some cases, overdoses may have reflected therapeutic error rather than opioid misuse. In these and other cases, providers may have believed that the risk–benefit ratio favored continued opioid prescribing.”

In an editorial published in the Annals of Internal Medicine, Jessica Gregg, MD, called the study’s findings “astonishing.”

“Prescribing guidelines are clear that adverse events, such as overdose, are compelling reasons to withdraw prescription opioids. Therefore, it is tempting, and it would be easy, to attribute these results to poor care, bad decisions, or sloppy prescribing,” wrote Gregg, who is an associate professor of medicine at Oregon Health & Science University. “However, the problem goes well beyond individual prescribers' practices. These prescribing behaviors occur in a context in which substantial -- even deadly -- mistakes are inevitable. For instance, it is likely that many of the prescribers in the study did not know about their patients' overdoses.

“There are currently no widespread systems in place, either within health plans or through governmental organizations, for notifying providers when overdoses occur. Until such systems exist, providers will be left to act with dangerously limited knowledge. They will be unlikely to decrease or withdraw a patient's opioid prescription after an overdose if they have no knowledge that the event occurred.”

To make doctors more aware that their patients may have had overdoses, the researchers recommend that overdose data be included in prescription drug monitoring programs (PDMPs) which are now currently used to track prescriptions.

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.)

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 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.

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.

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. 

Can Marijuana Help Treat Heroin Addicts?

By Pat Anson, Editor

There’s a new twist to the rising use of heroin in the United States – and what can be done to help addicts in recovery.

A recent study by researchers at Columbia University found that medical marijuana improves the treatment outcome of heroin addicts. Patients who were given dronabinol -- a prescription drug that contains THC, the active ingredient in marijuana -- had lower withdrawal symptoms compared than those given a placebo. In addition, patients who smoked marijuana regularly during the outpatient phase of treatment had fewer sleeping problems, less anxiety and were more likely to finish treatment.

"One of the interesting study findings was the observed beneficial effect of marijuana smoking on treatment retention," the researchers concluded.

"Participants who smoked marijuana had less difficulty with sleep and anxiety and were more likely to remain in treatment as compared to those who were not using marijuana, regardless of whether they were taking dronabinol or placebo."

The Columbia study appears in the journal Drug and Alcohol Dependence.

According to High Times, several other studies have reached similar conclusions. Studies at the New York Psychiatric Institute found that opiate addicts who consumed marijuana intermittently were less likely to start using opioids again, compared to those who never used marijuana or used it habitually.

Earlier this year, researchers at the RAND Corporation and the University of California, Irvine reported similar results in a study for the National Bureau of Economic Research – going so far as to suggest that marijuana is a good substitute for opioid pain medication.

“Many medical marijuana patients report using marijuana to alleviate chronic pain from musculoskeletal problems and other sources. If marijuana is used as a substitute for powerful and addictive pain relievers in medical marijuana states, a potential overlooked positive impact of medical marijuana laws may be a reduction in harms associated with opioid pain relievers,” they wrote. “We find that states permitting medical marijuana dispensaries experience a relative decrease in both opioid addictions and opioid overdose deaths compared to states that do not.”

And what happens in states where regulations make it harder to obtain prescription opioid medication?

There were unintended consequences in Washington, one of the first states in the country to impose strict new guidelines on opioid prescribing. From 2008 to 2014, the number of deaths from prescription opioids in Washington fell from 512 to 319. But over the same period, the number of heroin deaths almost doubled, to nearly 300.

But the surge in heroin use wasn’t confined to Washington. According to the National Survey on Drug Use and Health, the number of heroin users nationwide rose from 161,000 in 2007 to 289,000 in 2013, an increase of nearly 80%. During the same period, the U.S. Centers for Disease Control and Prevention (CDC) reported the number of poisoning deaths involving heroin rose from 3,041 to 8,257, an increase of 172%.

“There is no robust evidence that recently enacted policies regarding prescription opioids are responsible for large-scale shifts to heroin,” the CDC’s Courtney Lenard recently told Alcoholism & Drug Abuse Weekly. Only about 1 in 25 people who use prescription opioids recreationally start using heroin within five years, she said.

Should Patients Learn to Live with Chronic Pain?

By Pat Anson, Editor

Chronic pain patients should learn how to live with their pain and pain relief should not be the primary focus of doctors who treat them, according to two influential physicians in a commentary published in the New England Journal of Medicine.

“Is a reduction in pain intensity the right goal for the treatment of chronic pain?” ask Jane Ballantyne, MD, and Mark Sullivan, MD. "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 at the population level."

“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," they wrote in answer to their question.

Ballantyne is President of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to end the overprescribing of opioid pain medication. She is also a member of the “Core Expert Group” the Centers for Disease Control and Prevention (CDC) is consulting with in drafting new guidelines for opioid prescribing.

Sullivan is a professor of Psychiatry and Behavioral Sciences 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.

In their commentary, Ballantyne and Sullivan say it’s a mistake for doctors to treat chronic pain sufferers the same way they would treat patients who are terminally ill or have short-term acute pain. They also recommend that doctors be less reliant on pain scales, such as the Wong-Baker pain scale, to measure pain intensity.

“Reliance on pain-intensity ratings tends to result in the use of opioid treatment for patients with mental health or substance abuse problems who are least likely to benefit from opioid treatment and most likely to be harmed by it,” they wrote.

“Borrowing treatment principles from acute and end-of-life pain care, particularly a focus on pain-intensity scores, has had unfortunate and harmful consequences. The titrate-to-effect principle fails when pain is chronic, because our best chronic-pain treatments don't produce an immediate or substantial change in pain intensity.”

Instead of relying on opioids for pain relief, Ballantyne and Sullivan say chronic pain patients need “multimodal treatment” that includes physical and behavioral therapy. They also stress that patients should learn to accept pain and get on with their lives.

“Many of the interdisciplinary and multimodal treatments recommended in the National Pain Strategy use coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity. Willingness to accept pain, and engagement in valued life activities despite pain, may reduce suffering and disability without necessarily reducing pain intensity,” they wrote.

Ballantyne is one of five PROP board members who are advising the CDC about its opioid prescribing guidelines. Those guidelines, which recommend “non-pharmacological” and non-opioid treatments for chronic pain, are scheduled to be finalized in January 2016. A draft version of the guidelines was released in September and can be found here.

In a survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation, 9 out of 10 said more people will suffer than be helped by the guidelines. Large majorities also predicted that doctors would prescribe fewer or no opioids, there would be more suicides in the pain community, and that the guidelines will result in more addiction and overdoses, not less.

Will CDC Guidelines Promote Addiction Treatment?

By Alison Knopf, Editor of Alcoholism & Drug Abuse Weekly

The quick answer to the question “Will treatment providers be able to treat patients coming in addicted to opioids because they have been thrown off their pain medications next year?” is no. The treatment system can’t even treat all the patients who need help now. But this question is on the minds of federal policymakers as the federal Centers for Disease Control and Prevention (CDC) works on its forthcoming guidelines for physicians on prescribing opioids, due out next January (see ADAW, Nov. 16).

While the pain community is creating the loudest noise about the forthcoming guidelines, charging that they are not addicts and don’t want to be lumped in with them, the treatment community has on the one hand seen the benefits of decreasing the amount of prescription opioids available, but also seen the downside: patients who are dependent or addicted, who cannot successfully taper off the pain medications, will switch to heroin. Many started as legitimate pain patients.

But for some, when their doctors felt they no longer needed the pain medication, or thought the patient was doctor-shopping, or simply decided to go along with the calls to reduce the amount of prescriptions for opioids, it was difficult to stop, and they sought illicit sources of opioids.

The CDC confirmed to ADAW that there will be a guideline that “addresses treatment for opioid use disorder.” The draft guidelines leaked in September specifically recommended that an opioid agonist (methadone or buprenorphine) be arranged for patients who need treatment for an opioid use disorder. The CDC said the guidelines are continuing to be revised. Below is the wording of that recommendation from the September draft:

“Providers should offer or arrange evidence-based treatment (usually opioid agonist treatment in combination with behavioral therapies) for patients with opioid use disorder.”

SAMHSA Working With CDC

But how the primary care physician determines whether a patient has an opioid use disorder is unclear. The Substance Abuse and Mental Health Services Administration (SAMHSA) expects there to be a change in prescribing practices — that’s the whole point of the guidelines. But according to Robert Lubran, director of the Division of Pharmacologic Therapies at SAMHSA’s Center for Substance Abuse Treatment (CSAT), it’s up to the physicians who are prescribing the medications to come up with a referral plan for their patients.

“I go back to what Westley Clark always said,” Lubran told ADAW, referring to the former director of CSAT. “He said the physician has to have an exit strategy for a patient he isn’t going to be prescribing opioids for anymore.” The physician has to determine if the patient is dependent on or addicted to the medication. Dependence is a normal result of regular opioid intake, addiction is pathological, but both will result in withdrawal symptoms when opioids are stopped suddenly. Someone who is dependent can be slowly tapered off the opioids and endure the craving that ensues. Someone who is addicted cannot stop and will seek opioids from another source.

“There has to be a place where the doctor can refer someone when the doctor determines that the patient can’t be safely tapered down because they are addicted,” said Lubran. A treatment provider specializing in opioid use disorders, such as an opioid treatment program (OTP) or office-based opioid treatment (OBOT), would be a good solution, he said. “We’re working with the CDC to make sure the guidelines include information on where to refer these patients,” Lubran told ADAW.

“We’re already struggling on the traditional medicine side with how a patient goes from being a pain patient to being an addict,” said Lubran. “They discharge them, but what about referrals? More states and counties need to be involved in recommendations for care,” said Lu, adding that insurance companies need to be involved as well.

Guidelines Not Mandatory

Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AA-TOD), said that as far as he knows, OTPs have not been involved in the development of the CDC guidelines. However, he expressed skepticism about the effect of the guidelines. “Will there be a reaction by physicians? Will this really change their practice patterns? Will there necessarily be a wholesale dumping of patients who are getting pain medications? I would hope not. But if that is the result, I would ask how we are going to know whether these patients will show up in treatment, or go into the street for drugs?”

Furthermore, said Parrino, these are just guidelines from the CDC. “Doctors aren’t even required to read the stuff,” he said. “They’ll issue a big press statement, yes. But it’s like package inserts. Do you really think every physician will be watching their computer for the guide-lines, saying ‘Now I need to change my medical practice?’”

The CDC itself says as much. “It is important to note that, like other CDC guidelines, including prevention and treatment of sexually treated diseases, the guidelines are intended to support informed clinical decision-making but are not mandatory (that is, physicians are not required to follow these guidelines),” according to Courtney Lenard of the CDC’s press office. The CDC’s guide-line is meant to “help primary care doctors provide safer, more effective care for patients with chronic pain” and at the same time “help reduce use, abuse and overdose from these powerful drugs,” the CDC’s press office told us last week. “The guideline is intended for primary care providers who treat adult patients (age 18 and older) for chronic pain in outpatient settings, and is not intended for patients who are in active cancer treatment, palliative care or end-of-life care.”

Asked if restrictions on prescription opioids will lead to increased use of heroin, however, the CDC continued to stick to the federal official answer, which is: No. “There is no robust evidence that recently enacted policies regarding prescription opioids are responsible for large-scale shifts to heroin,” said Lenard, adding that only 1 in 25 people who use prescription opioids nonmedically start using heroin within five years. However, she added that this “translates into a major and growing epidemic of heroin use given how widespread the misuse of prescription opioids has become.” Stopping the misuse of prescription opioids is the best way to stop the heroin epidemic, according to the CDC.

This article is republished with permission of Alcoholism & Drug Abuse Weekly, which provides news and analysis of federal and state public policy developments, private sector business developments, and provider issues and innovations in addiction treatment.