#PatientsNotAddicts Campaign Launched on Twitter

By Ken McKim, Guest Columnist

There’s a hashtag coming to a screen near you: #PatientsNotAddicts. Its importance to the millions of people who suffer from chronic illness cannot be overstated.

Words matter. Words are powerful. They can educate, but they can also blind. They can sway the opinions of millions of otherwise thoughtful and intelligent people through nothing more than simple repetition, even if the information they repeat is patently false.

In a 1992 study by McMaster University researchers, it was shown that people give more weight to something they hear repeated over and over again, than something they have only heard once. People will do this even if the person repeating the information has proven untrustworthy in the past on multiple occasions. Repeat it often enough, and a lie becomes the truth.

We see this all the time in life. It’s why advertising exists, and why politicians will never completely stop using negative campaign ads. Its how one discredited doctor was able to scare the daylights out of millions of Americans about the so-called dangers of vaccines, thus leading to a resurgence of diseases that had previously been all but eradicated, like measles and whooping cough.

This same tactic is now being used against medications that give relief to millions of people who are fighting cancer and chronic illness: opioid-based painkillers.

There’s no better way to ascertain public opinion on a subject than by Googling it. In this modern century of seemingly unlimited information, Google serves as society's mirror, reflecting back to us the truth of how we feel about any given subject. It’s not hyperbole to say that as Google goes so does the world, and this is especially true when it comes to the subject of opioids.

A recent search of Google using just the word “opioids” found that 50% of the search results had to do with addiction and abuse. Only 4% of the results dealt solely with the proper use of opioid pain medication.

It’s plain to see that media coverage on the subject of opioids skews overwhelmingly negative, and the average person researching the topic will come away with an equally negative (and unknowingly distorted) opinion of them.

It’s this negative societal view that the CDC was probably counting on to divert attention from their covert attempt to issue new prescribing guidelines to severely limit the prescribing of opioids. The webinar they held on the subject last September was an invitation only affair. No press releases were issued, and the period of time allotted for public comment was a paltry 48 hours (which was laughable considering most of the public had no idea this was taking place). 

If not for the vocal pushback from the chronic illness community and organizations like the Washington Legal Foundation, these new guidelines would already be a fact of life for all United States citizens. Sadly, these guidelines are now the law of the land for our wounded veterans, as part of the $1.1 trillion spending bill passed and signed into law by President Obama last December.

Taking opioids for pain does not automatically turn you into an addict, any more than eating M&Ms turns you into chocolate.

Chronic illness may be invisible, but the chronically ill can no longer afford to be. That’s why #PatientsNotAddicts is important. Words are powerful and repetition can be a tool for the truth as well as for lies.

Using this hashtag can help remind everyone that pain patients are ordinary people. They are your loved ones, friends, neighbors and co-workers. What they want more than anything (except for a cure, of course) is to recapture just a small piece of the life they had before their illness took hold, before the never-ending pain of their condition destroyed the lives they had built for themselves -- lives that included careers, birthday parties, graduations, playing with their kids and being intimate with their spouses or significant others.

For hundreds of millions of people, opioids help them do just that. To deprive them of that small ray of hope in the name of “protecting them” is nothing short of inhumane.  I believe we are better than that, America. Prove me right.

Ken McKim is an advocate for anyone with a chronic illness, and has made more than 43 videos on topics such as Crohn’s disease, lupus, depression, Ehlers-Danlos Syndrome, Complex Regional Pain Syndrome and much more. You can see his videos at Don’t Punish Pain and on his YouTube channel.

Ken began advocating for pain patients when his wife was diagnosed with Crohn’s – and he came to realize that the chronically ill were often stigmatized by society. That realization led him to make a 32-minute video called "The Slow Death of Compassion for the Chronically Ill."

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

Major Decline in Hydrocodone Prescribing

By Pat Anson, Editor

Prescriptions for Vicodin and other hydrocodone products declined dramatically in the United States after the opioid pain medication was rescheduled by the Drug Enforcement Administration to make it harder to obtain. But there may have been unintended consequences for cancer patients, according to a new study published in JAMA Internal Medicine.

In October 2014 the DEA rescheduled hydrocodone from a Schedule III controlled substance to a more restrictive Schedule II medication because of its “high abuse potential.”

The rescheduling limits patients taking Vicodin, Lortab, Lorcet and other hydrocodone combination products to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill.

In the first year after rescheduling, the number of hydrocodone prescriptions in the U.S. plunged by 22 percent, from nearly 120 million to 93.5 million.

“Dispensed hydrocodone combination product prescriptions decreased substantially after rescheduling by the US Drug Enforcement Administration, with 26.3 million fewer hydrocodone combination product prescriptions and 1.1 billion fewer hydrocodone combination product tablets dispensed in the year after rescheduling,” wrote lead author Christopher Jones, PharmD, U.S. Department of Health and Human Services. “Most of this decline was due to the elimination of hydrocodone combination product prescription refills, consistent with the prohibition on prescription refills for schedule II medications.”

The decline in prescribing was seen in almost all healthcare specialties, including primary care, surgery, dentistry, emergency medicine and oncology. Nearly 187,000 fewer prescriptions for hydrocodone were written for cancer patients in the first year after rescheduling, a decline of nearly 21 percent.

“It appears that up-scheduling of hydrocodone accomplished the goal of the DEA,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and author of The Painful Truth. “The more important question is what impact this has had on the rate of abuse and patient access to the medication. It may be too early to know whether rescheduling has affected the rate of people abusing opioids or if it just forced some abusers to seek alternatives like heroin.

“The JAMA report suggests that even cancer patients found it more difficult to obtain hydrocodone. That should be alarming to the medical community and illustrate to policy makers and law enforcement there are consequences to every action and in this case some people have been subjected to more cost, inconveniences and abandonment without any data to suggest an improvement in abuse or overdoses.”

Interestingly, the number of hydrocodone prescriptions written by pain management specialists after rescheduling increased by 7 percent. And there was a modest 4.9% increase in the number of prescriptions for opioids other than hydrocodone, as some patients apparently switched to opioids that were easier to obtain.

"The uptick from pain specialists most likely reflects a transfer of narcotic provision from non-specialists to specialists. That is, a decrease in prescribing from those who have less training in prescribing opioid pain relievers offset to some extent by an increase from those who have more such training," said Stuart Gitlow, MD, Executive Director of the Annenberg Physician Training Program in Addictive Disease and past president of the American Society of Addiction Medicine.

Gitlow believes the large overall decline in hydrocodone prescribing was a sign that many of the refills being ordered before rescheduling "were ultimately determined to be unnecessary."

"This was not meant to address the overall opioid prescribing problem, but was rather filling one hole in the dike," Gitlow wrote in an email to Pain News Network. "There remains much left to do, such as removal of the cap for treatment of opioid use disorders in office settings, and availability of tapering to avoid having patients move to heroin when their supply of prescription narcotics is suddenly cut off."

Hydrocodone was once the most widely prescribed medication in the United States, with over 137 million prescriptions annually. Prescribing of hydrocodone was already in decline before rescheduling, because of growing concern the drug was being abused and diverted.

CDC Guideline: A Good Start that Needs Improvement

By Stefan Kertesz, MD, Guest Columnist

President Obama began his 2016 State of the Union address by referencing an American epidemic of opioid overdoses. He was right to do so. The Centers for Disease Control report that 2014 saw a record of 18,893 deaths related to opioid overdose, a category that includes both medications and heroin. Given a rising tide of deaths, it is only sensible to look closely at how opioids come into distribution. There is more than one path. Doctors write prescriptions, and the pills may be consumed properly or improperly. Or they can be sold, given to friends, or stolen. Heroin is incredibly cheap and potent these days. It’s often laced with other drugs and can cause overdose in ways that users can’t predict.

A major portion of the public health response has focused on doctors and their prescriptions (disclosure: I’m a primary care doctor trained in internal medicine and addictions). Most public health authorities believe a major contributor to the rising tide of overdoses has something to do with the prescriptions for opioids we write. Our tendency to write prescriptions for pills like hydrocodone or morphine rose precipitously from 2000 to 2011.

Everyone knows a story of someone who wheedles pills out of credulous physicians. Barring a few so-called pill mills (which alone cannot account for the rise in prescriptions), most doctors writing prescriptions for opioid pills do so in response to a patient with severe chronic pain. There are an estimated 100 million Americans with chronic pain, and between 5 and 8 million take opioids for that pain.

It stands to reason that among the patients who have received opioid prescriptions, surely some (or many) should not have received them. Many doctors have decided to prescribe less, starting in 2012, according to national data.

If prescribing went down while overdoses went up these past few years, it’s fair to say that there is room for argument about precisely how doctor’s prescriptions relate to overdoses. But few would argue there is no relationship at all. Thus, great hopes are pinned on the notion that getting doctors to prescribe differently (and less) for their patients with pain will be key.

Last year the Centers for Disease Control, after consulting an extensive array of experts and interest groups, prepared a draft guideline for doctors on prescribing opioids. In December they placed notice in the Federal Register seeking public commentary. By deadline on January 13, over 4,300 comments were received.

There is a reason this document excites so much passion. In part, organizations such as the American Cancer Society project this guideline will not be voluntary, but will carry force of law.

The hope is to prevent development of addiction and overdose that devastates countless families. Yet, there are those 5 to 8 million patients who receive opioids, some of whom believe that they are at risk of losing access to a crucial medication that is helping manage their pain, improve their quality of life and overall function. As medical boards, insurers and government agencies enforce this guideline, prescribing differently from the topline recommendations is likely to become onerous, leaving many patients in the lurch.

If you listen to this conversation between this 70-year old coal miner who suffered 18 major injuries, and a chief advocate (addiction specialist Dr. Andrew Kolodny) for the reduction of opioid prescribing, you feel the tension. You will hear the distress of a man who fears being confined to bed from his pain, and the concern of an addiction doctor who believes opioid pills have done harm, not good, even perhaps to the man to whom he is speaking.

The experts convened by the CDC include many I know and respect. They have taken a fairly strong stand. They conclude that the literature shows no evidence of enduring benefit from opioids, and that measurable harms are tied closely to dose. They urge careful assessment of risk and benefit. They urge aggressive use of urine drug testing to identify patients who take opioid medication differently from intended or use illicit drugs.

In 56 pages, they say a lot more. My primary care patients include several with chronic pain, and my practice lines up pretty closely with precisely what the guideline recommends. And despite that, I feel this guideline is not yet ready, not given the power we project it to have.

For reasons I shared with the CDC, I think it reaches a bit beyond the available science in some places, neglects it in others, and misconstrues how best to translate it in the care of our patients. It risks making opioids less available to patients who are benefiting from them. It is not far from where it needs to be, but it needs improvement.

Friends, some of them national leaders in primary care, addiction and pain medicine, have urged me to publish this concern broadly.

For people interested in learning more about these concerns, I offer them in linked piece at Medium.com. I offer it to show that one can take a different stand without rejecting the science or the underlying public health commitment that I fully share with the honorable drafters of the CDC’s draft Guideline. For the readers who believe I am right, or perhaps have also misconstrued the science, I welcome your thoughts.

Stefan Kertesz, MD, is an Associate Professor at the University of Alabama at Birmingham School of Medicine. Opinions expressed are solely his own and do not represent positions of any agency of the U.S. Federal Government or the State of Alabama.

This column is republished with permission by the author. It originally appeared in Medium.com, along with the comments submitted by Dr. Kertesz to the CDC about the guideline.

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.

Montana Doctor’s License to Be Suspended

By Pat Anson, Editor

The Montana Board of Medical Examiners voted unanimously Thursday to suspend the medical license of Dr. Mark Ibsen for unprofessional conduct, the latest chapter in a three year investigation into Ibsen’s opioid prescribing practices. A final order on the board’s ruling still needs to be drafted and voted on again. Ibsen has said he will appeal the decision.

The medical board accepted almost all of the recommendations made in a proposed order by Michael Fanning, Special Assistant Attorney General to the Montana Department of Labor and Industry, but it refused to consider lengthy allegations that Ibsen has “destructive psychological and behavioral issues.”

Ibsen was one of the last doctors in Montana willing to prescribe opioid pain medication to new patients, including many who drove hundreds of miles to see him. While that made Ibsen a folk hero of sorts in the pain community, it also attracted the attention of investigators who thought he was overprescribing opioids, and raising the risk of addiction and overdose.

“Opioid deaths are frighteningly common with one source estimating one death for every 500 opioid prescriptions written in America,” Fanning wrote in his 62-page proposed order, without citing a single case where Ibsen’s prescribing practices led to someone’s death or injury.

The case against Ibsen largely centered on nine pain patients and the incomplete records he kept on their treatment.

MARK IBSEN, MD

“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.”

Ibsen’s charts also did not include records of a written or oral contract with patients about their opioid use, which is a common requirement in pain management. Fanning said Ibsen also overlooked “red flags” in a patient’s behavior that could indicate signs of opioid abuse or diversion.

Last year a hearing officer recommended that Ibsen be put on probation for 180 days, but Fanning went much further, asking the board to suspend Ibsen’s medical license indefinitely. The board spent over seven hours reviewing the case and over 6,000 documents admitted as evidence before making its decision.  

“I just want to say that nothing has made me feel more ashamed to say that I am a Montanan born and raised than this kangaroo court in action,” said Gary Snook, who suffers from Arachnoiditis, a painful and disabling spinal cord disorder caused by botched spinal injections. He now gets medical treatment in California.   

“I am appalled by the total lack of understanding of the treatment of pain by these doctors. No wonder Montana has one of the highest disability rates in the nation,” Snook said in an email to Pain News Network.

“Overreaching is far too gentle a term for what occurred here. It felt like a witch hunt,” said Terri Lewis, PhD, a rehabilitation specialist and patient advocate.  “No doubt Dr. Ibsen, like many, has flaws, but holding this physician to a standard of perfection which exists in neither law nor practice makes no sense.  Maybe they will assign him a scarlet ‘O’ to wear on his chest.

“This is signal in the noise of our public confusion about the management of chronic pain.  This hearing process provides a good deal of insight into the conditions of care, or lack thereof, that both clinicians and patients find so challenging and threatening.”

One board member – who voted to suspend Ibsen’s license -- praised Ibsen for his compassion toward patients and said she hoped he would apply to have his license reinstated if he submits to professional oversight..

Publicity about the case and financial problems forced Ibsen last month 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.

CDC Still Holding Secret Meetings on Opioid Guidelines

By Pat Anson, Editor

A newly appointed advisory committee to the Centers for Disease Control and Prevention (CDC) has met twice in recent meetings that were not open to the public, Pain News Network has learned, a possible violation of federal open meetings law.

The committee of outside advisors – which the CDC calls a “Workgroup” – was appointed to review the agency’s controversial opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

“Workgroup meetings are not open to the public,” said CDC spokesperson Courtney Leland in an email to PNN. “CDC anticipates the workgroup will meet four times. Two meetings have been held to date and two are scheduled in the coming weeks.”

Ironically, the opioid guidelines were put on hold and the new workgroup was appointed after widespread complaints about the CDC’s lack of transparency and secrecy in developing the guidelines. None of the agency’s prior meetings about the guidelines were open to the public either.

“It sounds like the CDC hasn’t learned what a federal advisory committee is,” said Mark Chenoweth, general counsel to the Washington Legal Foundation (WLF), a pro-business group that threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA).

In November, the WLF sent a letter to CDC Director Tom Frieden warning that the agency “was required to comply with each of the numerous obligations that FACA imposes on such committees – including open all meetings to the public,” as well as publicly releasing minutes of the meetings and documents provided to advisory committees.

The new 10-member workgroup was appointed by the agency’s Board of Scientific Counselors (BSC) last week. Critics say a previous workgroup called the “Core Expert Group” had too many members biased against opioids, including one who had a financial conflict of interest. None of its meetings were open to the public.

“CDC developed its Draft Guideline with considerable input from an improperly established federal advisory committee,” said WLF chief counsel Richard Samp. “Any new, properly constituted committee should be directed to take a fresh look, rather than simply being asked to judge the existing proposal. In the absence of such a fresh look, any final guidance document issued by CDC will be tainted inescapably by the major role played in its formation by an illegally constituted federal advisory committee.”

Unlike the previous workgroup, the new advisory committee has broader experience in pain management, pharmacy, and primary care practice. One member is a longtime advocate for pain patients. Two were members of the original Core Expert Group, and two others were part of a "Stakeholder Review Group" that also advised the CDC. A complete list of members for the new workgroup can be found here.

The workgroup’s two meetings were held via conference call and an online meeting platform, according to Leland. The group’s chair is expected to present a report to the BSC on January 28. That short schedule suggests the new panel is only reviewing the work of the old one and is not initiating guidelines of its own.

Further information about the January 28 conference call, which is open to the public, can be found here. Ninety minutes have been set aside for public comments, with a maximum of two minutes per speaker.

Online Public Comment Period Ends

Meanwhile, today was the deadline for the public to submit online comments about the CDC’s draft guidelines. Over 4,000 comments have been received, many opposing the guidelines as being too restrictive, while others wish they were stronger.

The passionate and sometimes painful stories shared by commenters demonstrate the toll opioids can take, both when they are denied patients who need them and when they are abused.

“My son Luke was polite, popular, multi-sport, all-star athlete,” wrote Stacy Watson, who said her teenage son started taking opioids for a sports injury, but became addicted to painkillers and then heroin.  “Seemingly overnight, he became one of the hundreds of thousands of teens in our country addicted to prescription (Rx) painkillers. His life CHANGED & SO DID OUR FAMILIES. He went from being the person I described above to a stranger; the addiction devoured him and our family. It has been heartbreaking. He is 28 years old and now sits in a prison cell.”  

“My wife suffered from chronic pain. It was so heartless that you tied the hands of her doctors to prescribe the pain medication that she needed,” wrote Charles Martens. “You were not the ones that watched her suffer day in and day out until the day she died. Have some mercy and knock this restrictions crap off. Let the Doctors be Doctors for gosh sake.”

You can read more comments here.

Although the CDC’s voluntary guidelines are meant for primary care physicians, many experts say they will quickly be adopted by many prescribing doctors, medical societies and regulatory agencies. As Pain News Network has reported, under a recently enacted federal spending bill the Veterans Administration will be required to adopt them.

As many as 11 million American take opioids daily for chronic pain. Many pain patients report they already have trouble obtaining opioids or getting their prescriptions filled by pharmacies.

FDA Committee Approves New Drug Implant

By Pat Anson, Editor

An advisory committee to the U.S. Food and Drug Administration has approved a new drug delivery system to treat opioid addiction – an implant that could potentially be used to treat chronic pain and other diseases that require steady doses of medication.

The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12 to 5 in favor of the new drug application for Probuphine, a tiny implant about the size of a matchstick that contains buprenorphine, a drug already used to treat addiction that currently only comes in pills and oral film strips. The FDA is expected to make a final decision on Probuphine next month.

“You can never be 100 percent sure of anything,” said Sunil Bhonsle, CEO and president of Titan Pharmaceuticals (NASDAQ: TTNP), which partnered with Braeburn Pharmaceuticals in developing the implant. “The data clearly shows that this product can be of benefit to this patient population. And we hope the FDA will approve it.”

COURTESY BRAEBURN PHARMACEUTICALS

Once implanted under the skin, Probuphine is designed to deliver a steady dose of buprenorphine for six months. Buprenorphine is a weaker opioid that’s long been used as an addiction treatment drug sold under the brand name Suboxone. While it reduces cravings for opioids, buprenorphoine can also be abused and is prized by addicts as a street drug that can ease withdrawals pains from heroin.

The advantages of an implant are many. The dosage is controlled and there’s hardly any risk of abuse, diversion, or accidental overdose. Users also never have to remember to take a pill.

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study proving Probuphine’s effectiveness in treating opioid addiction.

The results of a six month, double-blind clinical trial on 177 patients, found that the implant was more effective than buprenorphine film strips in treating addiction. The implant’s insertion and removal were "generally well tolerated," although nearly one in four patients had a "mild" adverse event at the implant site.

Several members of the FDA's advisory committee, including its chairwoman, voted against approval, saying there was not enough evidence of Probuphine’s effectiveness after six months.   

"New treatment options for the millions of patients and their families suffering from opioid addiction are desperately needed, and we appreciate the Committee's comprehensive review of Probuphine," said Bhonsle. “There are many applications for this technology and I think the medical community is now more in tune with looking at long-term delivery technology in the chronic disease setting. So I think it’s probably accurate to say the time is right to expand the use of these technologies to different settings.”

Bhonsle says Titan is already looking at ways the implant can be used to treat Parkinson’s disease and hypothyroidism, adding that chronic pain could also be treated with an implant.

“Clinical studies will need to be done to establish the ability, but the drug levels can certainly be delivered that are going to be beneficial for treating chronic pain,” he told Pain News Network.    

Survey Finds Most Doctors Favor CDC Guidelines

By Pat Anson, Editor

Chronic pain patients and their doctors appear to be on opposite sides of the fence when it comes to controversial guidelines for opioid prescribing being drafted by the Centers for Disease Control and Prevention (CDC).

An email survey of over 1,600 doctors found that 87 percent of them “would welcome and use” the CDC guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. The survey was conducted by SERMO, a social network for healthcare providers.

Less than six out of ten doctors (59%) believe opioids should be used to treat chronic non-cancer pain. About half said they knew someone personally who has suffered from addiction to opioids.  

In personal comments, several doctors said they believed some patients were “doctor shopping” for opioids.

“It is often impossible to know whether a patient is drug seeking, and it's hard to deny them pain meds simply because my gut tells me so,” wrote one oncologist.

“I am frequently approached by patients with ‘acute’ complaints of pain. Since these patients are usually unknown to me, it is difficult to tell if these are truly ‘acute’ issues versus drug seeking,” said an urgent care physician.

“While there are some patients that need pain medications there are several that have now become addicted and I think physicians need more training in not only how to prescribe pain meds properly but also how to cut back appropriately as well,” wrote an internal medicine specialist.

“Physicians are the gateways to drugs. They have the prescription pad and ultimately they are the ones who make the call. They should be at the frontline of this epidemic and adequate education is required,” said a neurologist.

Asked what they thought was the “most important tactic" to curb opioid abuse, this is how doctors voted:

• 43% of doctors support broader use of prescription drug monitoring programs (PDMPs)
• 20% support more education for physicians on proper opioid prescribing
• 14% support increased access to addiction treatment programs
• 14% support more education for patients at risk of addiction
• 7% support increased access to Naloxone, a drug used to reverse the effects of an opioid overdose
• 2% support needle exchange programs

A large majority of doctors (82%) favor PDMP’s, but only 63% said they were registered with their state’s PDMP.

A survey of over 2,000 patients by Pain News Network and the Power of Pain Foundation found very different attitudes about the CDC’s opioid guidelines. Nearly 90% are worried they won’t be able to get opioid pain medication if the guidelines are adopted. A similar number believe the guidelines discriminate against pain patients and will be harmful to them.

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.

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.

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.)