How the CDC Misclassifies Opioid Overdoses

By Denise Molohon, Guest Columnist

I think the minute anyone without bias or personal agenda began reading through the CDC's proposed guidelines for opioid prescribing, they must seriously question many things.

Chief among them, the highly suspect "low to very low quality" evidence being presented to support their "strong recommendations," but also their dangerously skewed data; which ultimately could leave millions of chronic pain sufferers critically ill, without sound medical treatments, and with little to no quality of life.

In a recent CDC Morbidity and Mortality Weekly Report (MMWR) on drug and opioid overdose deaths, I found myself doing the exact same thing -- seriously questioning the data. In 2014, the report found that 28,647 people died of drug overdoses involving opioids, including heroin, a 14 percent increase over the previous year. 

However, the CDC admits in the MMWR, that "some overdose deaths may have been misclassified and the data has limitations.” I wondered how much was misclassified? Exactly what data has limitations and why?

I believe the American people have a right to transparency and full disclosure, not flawed data that is often presented in a confusing manner, such as the following qualifiers in the MMWR:

“At autopsy, toxicological laboratory tests might be performed to determine the type of drugs present; however, the substances tested for and circumstances under which the tests are performed vary by jurisdiction.”

“The percent of overdose deaths with specific drugs identified on the death certificate varies widely by state.”

"Approximately one fifth of drug overdose deaths lack information on the specific drugs involved. Some of these deaths might involve opioids."

 “Heroin deaths might be misclassified as morphine because morphine and heroin are metabolized similarly, which might result in an underreporting of heroin overdose deaths.”

 If heroin deaths are being misclassified as morphine, which results in the "underreporting" of heroin overdose deaths, then wouldn't the opposite also hold true? That there is "over-reporting" of morphine deaths, which are then misclassified as prescription opioid deaths? 

According to the Washington Post, CDC Director Tom Frieden admitted some heroin overdose deaths were counted twice!

Another egregious misclassification, which I find grossly unjustified, is the following:

"Historically, CDC has programmatically characterized all opioid pain reliever deaths (natural and semisynthetic opioids, methadone, and other synthetic opioids) as ‘prescription’ opioid overdoses."

On the surface this statement doesn't appear too concerning. Until you begin to take a closer look at what has been happening over the last 3-5 years with heroin and illicit fentanyl overdose deaths, and how both illegal and legal opioids have been lumped together into one category.

All opioid pain reliever deaths are counted as “prescription” opioid overdoses. Why?

“Natural opioids” includes those heroin deaths that were misclassified as morphine related overdose deaths, which no doubt contributed in some degree to that 14% increase in opioid overdose deaths in 2014.

But how many of these heroin deaths were misclassified? We may never know. The DEA reported last year in its National Heroin Threat Assessment Summary that, “Many medical examiners are reluctant to characterize a death as heroin-related without the presence of 6-monoaceytlmorphine (6-MAM), a metabolite unique to heroin, but which quickly metabolizes into morphine.  Thus many heroin deaths are reported as morphine-related deaths."

illicit fentanyl seized in ohio

“Synthetic opioids” includes not only prescribed fentanyl, which is a potent pain reliever, but illicit fentanyl overdoses,  which have skyrocketed over the last two years. Because most medical examiners and coroners did not routinely test for fentanyl in 2014, many illicit fentanyl/heroin overdose deaths were also probably counted as prescription opioid overdoses. 

Medical examiners and coroners are just now beginning to test for fentanyl because of the sharp rise in overdose deaths in the U.S. and Canada. Both the CDC and the DEA issued advisories about illicit fentanyl overdoses last year, but we don’t know exactly how many deaths there were.

Why is the data about opioid overdoses so flawed and what is the government doing about it?

A federal agency called the Substance Abuse and Medical Health Services Administration (SAMHSA) brought together groups of experts four times in 2003, 2007, 2010, and again in 2013. All agreed uniform standards and definitions were needed for classifying opioid-related deaths. Guidelines were developed in July 2013 by SAMHSA to provide uniform standard procedures for medical examiners, coroners and other practitioners.

The CDC is not only aware of these guidelines, but it recently recommended medical examiners and coroners in all states implement them “to ensure death reports are complete and accurate.”

“It is especially important to include the word ‘fentanyl’ on the death certificate when the drug is a contributing cause of death,” the CDC said in a Health Advisory distributed on October 26, 2015.

Why fentanyl? Based on reports from states and drug seizure data, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl, which is often combined with heroin or even sold as heroin.

David J. Hickton, U.S. attorney for western Pennsylvania and co-chair of the Justice Department's National Heroin Task Force, told the Washington Post that "fentanyl and more potent heroin appear to have contributed to the 2014 spike in fatal overdoses."

According to the DEA's National Heroin Threat Assessment Summary, the overwhelming number of fentanyl overdose deaths are not attributable to pharmaceutical fentanyl but rather illicit fentanyl.

“There have been over 700 overdose deaths reported, and the true number is most likely higher because many coroners’ offices and state crime laboratories do not test for fentanyl or its analogs unless given a specific reason to do so,” the report warns. "While pharmaceutical fentanyl (from transdermal patches or lozenges) is diverted for abuse in the United States at small levels, this latest rash of overdose deaths is largely due to clandestinely-produced fentanyl, not diverted pharmaceutical fentanyl."

Note that the DEA is making a critical distinction between an illegal drug and a legal prescription drug. Why isn’t the CDC doing this?

In my opinion, for the CDC to lump all opioids together as "prescription" opioids or as "pain relievers" shows a highly dangerous bias, an unwillingness to address the soaring number of heroin and fentanyl overdoses, and a lack of competence in taking a responsible leadership role.

If the CDC can’t be counted on to clearly report on the data, sources and causes of overdose deaths, how can we trust their opioid prescribing guidelines?

Denise Molohon was disabled with Adhesive Arachnoiditis after multiple spinal surgeries.

Denise is a strong supporter and patient advocate for ASAP, the Arachnoiditis Society for Awareness & Prevention. She and her family live in Indiana.

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

Doctor's License May Be ‘Suspended Indefinitely’

By Pat Anson, Editor

The Montana Department of Labor and Industry is recommending that the medical license of Mark Ibsen, MD, be suspended indefinitely by the state Board of Medical Examiners for unprofessional conduct.

Ibsen has been at the center of a long-running debate in Montana over the prescribing of opioid pain medication. State investigators say Ibsen overprescribed opioids, kept poor records and risked the health of his patients, while supporters say he is one of the few doctors left in the state willing to treat chronic pain patients. The Board of Medical Examiners is scheduled to meet Thursday to decide Ibsen's fate.

“Opioid deaths are frighteningly common with one source estimating one death for every 500 opioid prescriptions written in America,” wrote Michael Fanning, Special Assistant Attorney General to the Montana Department of Labor and Industry.

But in his 62-page proposed order, Fanning dos not cite a single case where Ibsen’s prescribing practices led to someone’s death. Instead he focuses on Ibsen’s alleged emotional instability and poor record keeping.

“Dr. Ibsen’s charts did not contain satisfactory evidence that he attempted more conservative care short of chronic opioid therapy,” Fanning wrote. “While the charts include occasional references to mental or behavioral health and rare references to interventional services, there was no consistent evidence that the more conservative option had been attempted and failed before continuing opioid therapy.”

Fanning also said Ibsen overlooked “red flags” in a patient’s behavior that could indicate signs of opioid abuse or diversion, such as multiple requests for early refills of prescriptions, seeing multiple doctors, and multiple lost medications. Ibsen’s charts also did not include records of a written or oral contract with some patients about their opioid use.

Fanning’s proposed order also includes references to “erratic and unprofessional behavior” by Ibsen reported by a former spouse and medical associates. One psychological profile of Ibsen said he suffers from bipolar disorder and narcissism, and that Ibsen “fails to accept responsibility, projects blame onto others and believes that others have conspired against him.”

mark ibsen, md

The state medical board is under no obligation to accept Fanning’s recommendation of indefinite suspension of Ibsen’s license. Last year the board rejected a proposed order from a hearing officer that Ibsen be put on probation for 180 days.

"I don't think I've had fair treatment in three years with the board of medicine. They've rewritten the evidence and are redefining reality," Ibsen told Pain News Network. "I haven't been treated fairly at all. They continue to accuse me of horrible and heinous things for people that I've helped. And there's been no one harmed by anything that I've done."

Ibsen has become something of a hero to pain patients, not only in Montana, but around the country. Many have trouble finding a doctor willing to prescribe opioids.

"I've become quite an advocate for the downtrodden pain patients. I promote medical marijuana as an exit strategy for people on opiates. I may be upsetting the status quo," said Ibsen.

Publicity about his case and financial problems recently forced Ibsen to close his Urgent Care Plus clinic in Helena. Ibsen was arrested in November, not for opioid prescribing, but for a misdemeanor domestic assault charge. He has pleaded not guilty.

Under Fanning's proposed order, Ibsen would be eligible to have his medical license reinstated, provided he was under "perpetual monitoring" by a professional assistance program. Ibsen says he will appeal if his license is restricted.

CDC Holds First Public Hearing on Opioid Guidelines

By Pat Anson, Editor

After months of controversy over its guidelines for opioid prescribing, the Centers for Disease Control and Prevention (CDC) held its first true public hearing today on the proposed guidelines – which many pain patients fear will make opioid pain medication much harder for them to obtain.

The CDC planned to implement the guidelines this month with little public input, but was forced to change course after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines, which would discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans use opioids for long-term chronic pain.

“We have heard some concerns about the process. We’ve done a lot, but want to be sure there will be no concern about the final guidelines when released,” said Debra Houry, MD, director of the CDC's National Center for Injury Prevention and Control, which is overseeing development of the guidelines.

“As a part of our response, we are proposing the establishment of a workgroup under the BSC (Board of Scientific Counselors) to review the guidelines and the feedback we have received from stakeholders, peer reviewers, and importantly the public. We want to ensure that this workgroup includes diverse perspectives of experts, stakeholders and consumers invested in reversing this epidemic, while cognizant of the need for safe and effective pain management.”

The CDC nominated a workgroup of ten health care experts to review the guidelines and advise its Board of Scientific Counselors, most of whom have expertise in workplace injuries, but little experience in pain management. Unlike a previous workgroup known as the “Core Expert Group,” the new workgroup has broader experience in pain management, pharmacy, primary care practice and patient advocacy:

• Erin Krebs, MD, MPH
• Mitchell H. Katz, MD
• Mark Wallace, MD
• Gregory Terman, MD, PhD
• Katherine Galluzzi, DO
• Christina Porucznik, PhD, MSPH
• Penney Cowan, American Chronic Pain Association
• Chinazo Cunningham, MD, MS
• Anne Burns, RPh
• Traci Green, PhD, MSC

Krebs and Porucznik were members of the original Core Expert Group, while Cowan and Terman were part of a "Stakeholder Review Group" that also advised the CDC.

The BSC approved the CDC's nominees with little discussion, although it encouraged the workgroup to add additional members, if needed. Only one member of the BSC voted against the nominations.

No members of Physicians for Responsible Prescribing (PROP) were nominated by the CDC to be part of the new workgroup. As Pain News Network has reported, five PROP board members advised the CDC during the initial drafting of the guidelines. PROP is funded by Phoenix House, which runs a chain of addiction treatment centers, and critics had complained the PROP members were biased and had conflicts of interest against the use of opioids.

Several pain patients said they wanted to see more patients in the workgroup. Penney Cowan of the American Chronic Pain Association was the only one nominated by the CDC.

“I want this panel and this group to have patients. You need to hear our side,” said Diane Gracely, who said she has been a chronic pain patient for 46 years. “The goal of the CDC is to reverse the prescription drug epidemic. I think this is inhumane to us chronic pain patients. The voices of chronic pain patients need to be heard by the CDC and the DEA. We need you to listen to us. You’re pushing more patients to the street for drugs and causing more suicides.”

The new workgroup is expected to meet at least four times to review the guidelines, a process that could delay finalizing the guidelines for several months.

“The guidelines will be an important and essential step in reversing the prescription drug epidemic, said Houry. “Given the lives lost and impacted every day, we have an acute sense of urgency to issue guidance quickly.”

That urgency was also stressed by CDC director Thomas Frieden, MD, who spoke briefly by telephone during the hearing.

“We know we don’t have ideal evidence, but we also know that we can’t wait,” said Frieden, who claimed prescription opioids were “fueling an increase in heroin use” and that their benefits were “largely unproven and uncertain.”

“Addressing the prescription drug overdose epidemic is one of CDC’s top priorities. Overprescription of opiates for pain is the key driver of this epidemic and we believe the epidemic can be reversed. Key areas will be to improve prescribing for both pain and for addiction. There are definite, often fatal risks, including both addiction and death with prescription opiates.”

The public can still comment on the CDC's prescribing guideline until January 13th. You can make a comment online by clicking here. 

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

The CDC and Profit Driven Drug Testing

(Editor’s Note: As part of its draft opioid prescribing guidelines, the Centers for Disease Control and Prevention (CDC) recommends that physicians “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.”  Mark Collen is an expert in this field and has submitted the following to the CDC.)

By Mark Collen, Guest Columnist

There are a number of conflating factors which have led to the CDC‘s recommendation for urine drug testing (UDT) in pain management -- none of which have to do with quality patient care. These include the federal government‘s complicity in the overprescribing of drugs, the unethical marketing of OxyContin by Purdue Pharma, the profit motive which drove drug testing patients in pain, and physicians‘ fears and inability to effectively treat pain.

We live in a drug addled society with Americans consuming record amounts of prescription drugs, including opioids. In other words, American healthcare providers are exceptional at writing prescriptions. Someone needs to tell them to, “Just say no.”

The pharmaceutical industry‘s direct-to-consumer advertising (DTCA) has driven demand for drugs and has contributed to the escalating cost of prescription medications. Both Congress and the FDA are largely responsible for this overprescribing public health issue since they have allowed DTCA to exist and spread.

What has not been investigated is the influence the incessant drug ads have had on the American culture and more importantly, the American psyche in terms of one‘s views on drug use, prescription or otherwise. Almasi and colleagues write, “DTCA pushes a ‘Brave New World‘  where if anything unpleasant should somehow happen, why, there‘s always [the sedative] soma to give you a holiday from the facts.” DTCA may influence the abuse of opioids and other drugs.

The pharmaceutical company Purdue Pharma was responsible for one of the most deceptive marketing campaigns in history with their medication OxyContin, a timed-release oxycodone. Art Van Zee writes, “A consistent feature in the promotion and marketing of OxyContin was a systematic effort to minimize the risk of addiction in the use of opioids for the treatment of chronic non–cancer-related pain.” As a result, OxyContin became the poster boy for prescription drug abuse and Purdue was fined $600 million to settle criminal complaints. That has had little impact on the Sackler family, Purdue‘s owners, with Forbes estimating their worth at $14 billion.

Although Purdue is not completely responsible for the current opioid abuse epidemic, they certainly have played a meaningful role. In addition, a congressional investigation suggested that the pharmaceutical industry has promoted opioid sales through a number of organizations including the American Pain Society and the American Academy of Pain Medicine, both of which write treatment guidelines. 

As opioid abuse and overdose deaths began to rise, so did the drug testing industry within pain management. Drug testing labs used a similar strategy as the pharmaceutical industry in promoting their wares and money was used as an incentive to drug test. 

In my 2012 article entitled, “Profit-Driven Drug Testing,” I presented Medicare data which showed a meteoric rise in drug testing:

“A deeper examination finds that between 2000 and 2009, the total number of CLIA-waived drug tests paid for by Medicare and conducted at physicians‘ offices increased approximately 3,172,910%; with 101 tests conducted in 2000 and 3,204,740 in 2009. Furthermore, during that same time period and within the specialty of anesthesiology, CLIA-waived drug tests increased 63,687,900%.”

The annual cost of drug testing in pain management is estimated at $2 billion per year. Unfortunately, that may be a gross underestimate since no study has ever evaluated the indirect costs of patient harm or harming the therapeutic patient-provider relationship—likely the most important aspect of pain management. A November, 2014 article in the Wall Street Journal reported that some physicians are making more money from drug testing patients than treating them.

Not unlike big pharma, there appears to be a dearth of integrity in the drug testing industry. Millennium Health, the largest drug tester in pain management, was recently fined $256 million by the U.S. Department of Justice and then filed for bankruptcy. This led to the discovery that the founders took $1.3 billion out of the business in 2014.

Ameritox, the second largest drug tester, actually paid physicians to drug test their patients, and as a result was fined $16.3 million by the Justice Department. Calloway Laboratories is yet another drug testing lab that was prosecuted and it is going out of business.

This author asked Debra Maul, a whistleblower in the laboratory industry, for her comment on UDT in pain management for this paper. Debra wrote, “Personally, I believe it‘s all about the money. When I entered the laboratory business in 2003, it was very difficult to get physicians to test their patients. In 2007, when Millennium entered the industry with the POCT (point of care tests) business model, pain doctors significantly increased their patient testing, I believe, because they could make money on in-office testing. New labs were popping up everywhere promoting this business model.”

She continued, “If you look at the information the WSJ obtained from CMS regarding Medicare reimbursements for UDT, reimbursements for simple UDTs grew significantly from 2007 until reimbursements were cut in 2010. Then in 2011 and 2012, high tech drug testing took a big jump, I believe, due to laboratories promoting in-office analyzers and other high-tech testing equipment to doctors, so they could continue billing for UDTs. It will be interesting to see what happens with in-office testing and the entire UDT market, with the significantly reduced reimbursements this year.”

What follows is a list of drug testing labs and the amount they were reimbursed by Medicare for urine drug testing in 2012. These numbers come from Medicare‘s website and were provided by Debra Maul:

• Millennium: $109,031,768
• Ameritox: $99,553,258
• Aegis: $36,140,368
• Alere: $16,937,116
• AIT: $13,845,880
• Dominion: $12,551,313
• Calloway: $6,918,972

To complicate matters, healthcare providers do a poor job at treating chronic pain and opioids may not be the best choice for the long-term treatment of chronic, non-acute, non-malignant pain. Moreover, insurers have been known to reimburse for pain medication and not physical therapy. It is likely that a number of clinicians prescribe opioids because they don‘t know what else to do, and then perform random drug tests in hopes of mitigating any damage they may cause, but it does not work. There is a great need to develop and test cost effective, alternative interventions to pharmacotherapy for the treatment of chronic pain and illness in the primary care setting.

The overriding factor in this historical perspective is the consistent and negative impact industry has on medicine and in this case, pain medicine. A good example of how close the drug testing industry gets to individuals who write guidelines, please go to this link and note the presenter is the lead author of the CDC guideline (Dr. Deborah Dowell) and a conference sponsor is a drug testing lab (Ameritox). 

There is no question that industry has a negative influence on medicine. Stamatakis and colleagues write, “The industry has created means to intervene in all steps of the processes that influence healthcare research, strategy, expenditure and practice. These include evidence base production, evidence synthesis, understanding of harms issues, cost-effectiveness evaluation, clinical guidelines formation, healthcare professional education and direct influences on healthcare professional decisions.”

Urine drug testing in pain management costs an estimated $2 billion per year and there is no proof of efficacy. Moreover, it may cause patient harm and harm to the patient-provider relationship and thus increase healthcare costs even further. 

The desire for profits likely started and maintains UDT in pain management along with fear. Fear of prosecution has been attributed to the proliferation of drug testing by doctors treating chronic pain. Goldberg and Rich write, “This singular focus strongly suggests purposes beyond ensuring quality patient care, such as fear of regulatory scrutiny and potential legal liability.”

The CDC has turned a blind eye to a number of important issues regarding UDT in pain management, including its constitutionality and the fact that it was likely driven by profits. Group think can negatively influence treatment guidelines and that is likely to blame for the CDC urine drug test recommendation. Giving a person with pain a “choice” to either submit to a drug test or not receive pain medication is really the option to either submit to a search or suffer, and that is coercion. It exemplifies patriarchal medicine at its worst and is the antithesis of patient-centered care. 

James L. Madara, MD, CEO of the American Medical Association, was quoted as saying about the CDC guideline, "The guidelines and supporting discussion are devoid of a patient-centered view and any real acknowledgment or empathy of the problems chronic pain patients may face."

The CDC should not recommend UDT as part of the current guideline since there is no proof of efficacy, it may be unconstitutional, and was likely driven by profits and nurtured through fear. Furthermore, it is very expensive and may cause harm to the patient and patient-provider.

Mark Collen is an independent scholar and patient advocate. He serves on the editorial board of the Journal of Pain & Palliative Care Pharmacotherapy, and has peer reviewed manuscripts for journals including The Patient: Patient-Centered Outcomes Research, The American Journal of Pharmacy Benefits, and The Clinical Journal of Pain. 

Mark is also the founder of PainExhibit.org, an online art exhibit from artists with chronic pain, which seeks to educate healthcare providers and the public about chronic pain through art, and to give a voice to the many who suffer in silence.

This column is an abbreviated version of the comment Mark has submitted to the CDC. The full version of Mark’s comment can be read here.

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

CDC ‘Not Aware’ of Website Issues

By Pat Anson, Editor

The start of the New Year means the deadline is fast approaching for people to submit their comments about the opioid prescribing guidelines proposed by the Centers for Disease Control and Prevention (CDC). The deadline is January 13th to comment on the draft guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

So far, nearly 1,500 comments have been received at the regulations.gov website, and while the process appears to have gone smoothly for most users, some have complained to Pain News Network about the website loading slowly, not accepting comments, "internal errors" and other “technical difficulties.”

One couple even sent us a series of screen shots showing some of the problems the website was having around Christmas.

“I have multiple screen shots for days of being told the site was experiencing technical difficulties and to send an email. Another saying due to internal error they were unable to retrieve docket info, etc.,” wrote Jerry and his wife Sharon, who asked that we not use their last name.

The CDC says the website was undergoing maintenance the weekend of December 19-20, but the agency is unaware of any other period when the website was down.

“CDC is not aware of issues with submitting comments via Regulations.gov. People should be able to submit a comment through the docket without any issues. Once submitted, they should receive a receipt confirming the submission. There might be a slight delay in comments appearing online given the holiday,” said CDC spokesperson Courtney Leland in an email to PNN. She urged anyone experiencing a problem to call the Regulations.gov help desk (1-877-378-5457).

The delay in posting comments has contributed to the frustration of some posters, especially those who were already suspicious of the CDC, given the agency’s secrecy and lack of transparency when the guidelines were first drafted.

“My comment wasn't posted on the CDC opioid issue – I’m not surprised,” said David Becker, who submitted a lengthy comment accusing the agency of trying to “subjugate people in pain to forces beyond their control.”

Becker complained to the CDC and his comment appeared on the website the next day.

The CDC says it is not trying to censor or silence anyone – but is reviewing all comments for personal information, inappropriate language and other issues before posting them. That delay causes a discrepancy between the numbers of comments received and the number posted on the website.

 “There were comments pending posting while CDC contacted individuals who had included personal, private information in their comments. CDC contacted the commenters to ensure that they agreed to have their personal information publicly posted. CDC has completed contacting those commenters and their comments have been posted. The only comments currently waiting to post are those that the docket managers need to review and catalog before public posting,” said Leland, adding that no comments had been rejected as inappropriate for posting.

Another issue that has led to frustration is the limit on characters, not words, used in comments. The limit is 5,000 characters, including spaces, something the CDC says it is unable to change, and posters say is too limiting and confusing.

“The site certainly isn’t very (user) friendly is it?” asked Janice Reynolds, a retire nurse and pain sufferer. “I read ‘words’ when it actually said characters.  So even though it looked like I was under the ‘word’ limit it would say I had too many characters.  I finally recognized what it was saying and divided the paper in two (pain patient and pain management nurse) and did them separately.  That worked however it still wouldn’t let me download a file.  It was frustrating.  So it was really operator error with a poor instruction manual.”

Still another issue that has raised concern is efforts by some organizations to get their followers to submit form letters as comments. Physicians for Responsible Opioid Prescribing (PROP), for example, sent a newsletter last week to supporters urging them to submit comments in favor of the guidelines. In his “urgent request” to supporters, PROP founder Andrew Kolodny, MD, even had several suggestions on what to write.

But in its “Tips for Submitting Effective Comments,” the government says that tactic won’t work. It’s not the number of comments that come in, pro or con, but the quality.

“Many in the public mistakenly believe that their submitted form letter constitutes a ‘vote’ regarding the issues concerning them. Although public support or opposition may help guide important public policies, agencies make determinations for a proposed action based on sound reasoning and scientific evidence rather than a majority of votes. A single, well-supported comment may carry more weight than a thousand form letters,” the regulations.gov website states.

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

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

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.)

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.