Kolodny Clarifies His Conflicts of Interest

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has revised his conflict of interest statements for two articles he co-authored in the Journal of the American Medical Association (JAMA) to include his work in malpractice lawsuits involving opioid medication.

Kolodny, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), is a longtime critic of opioid prescribing. He recently testified as the “star witness” for Oklahoma in its opioid negligence lawsuit against Johnson & Johnson, a case the state won with a $572 million judgement against J&J.

“I am writing to provide additional information to clarify conflict of interest disclosures in 2 articles I published in JAMA in 2017 and 2018.  During this time, I received compensation for work as an expert in malpractice litigation involving opioid prescribing,” Kolodny wrote in a Sept. 4 letter to JAMA’s editors.

“When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”

The two JAMA articles in question, which were co-authored by former CDC director Thomas Frieden, MD, both dealt with the opioid crisis and the federal policy response to it.

JAMA disclosure policy is very clear and requires authors to list “all relevant financial interests, activities, relationships and affiliations,” including payments for employment, consultancies and expert testimony.

During the Oklahoma trial, Kolodny admitted under questioning by J&J lawyers that he was being paid $725 an hour by Nix Patterson & Roach, one of three law firms hired by Oklahoma to handle the case against J&J. Kolodny anticipated being paid up to $500,000 by the end the Oklahoma trial.

“I don’t think it should be a secret that I’m being compensated,” he said.  

Kolodny also acknowledged working for the law firm of Cohen Milstein Sellers & Toll in a similar capacity, also for $725 an hour. Cohen Milstein is heavily involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois. 

Kolodny’s work in opioid litigation was disclosed in the April 2018 JAMA article.

DR. ANDREW KOLODNY

DR. ANDREW KOLODNY

His revised disclosure statement for that article is vague, stating that he worked as “a medical expert for states and counties that have filed suits against opioid manufacturers and as an expert witness in malpractice cases involving opioid prescribing.” It does not identify which states, counties and law firms he worked for or what companies were being sued. 

JAMA policy calls for “complete disclosure of all potential conflicts of interest” covering a three-year period prior to an article being submitted. If an author received funding from the pharmaceutical industry, for example, he or she would be expected to identify the company involved.   

“It is encouraging that Dr. Kolodny has recognized that his very profitable work supporting plaintiffs in opioid lawsuits might constitute a conflict of interest when he writes about opioid policy and clinical practice,” said Bob Twillman, PhD, a healthcare policy consultant and former Executive Director of the Academy of Pain Management. “Of course, these aren't the only two articles Dr. Kolodny has co-authored, and he has done numerous presentations at professional meetings as well, so I wonder if he will seek to correct all the rest of those relevant disclosure statements.

“I think it's also interesting that, when I disclose my conflict, I am always required to specifically name the entity involved, yet Dr. Kolodny names neither the jurisdictions nor the law firms for which he was working. It seems a little like a double standard to me, and I wonder how the editorial boards of the relevant journals feel about that.”

In March 2017, Kolodny co-authored a research letter in JAMA Internal Medicine on a study he designed that looked into funding that patient advocacy groups and professional organizations received from opioid manufacturers. Many of those organizations publicly opposed the CDC’s controversial opioid prescribing guideline, which Kolodny and other PROP members helped draft.

“The CDC did not prompt or require organizations to disclose their financial associations as part of their comments. Disclosure, however, is one means of managing conflicts of interest,” Kolodny and his co-authors wrote. “Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

Kolodny’s disclosure statement for the 2017 article states that he was a member of PROP and Chief Medical Officer for the addiction treatment chain Phoenix House (which he has since left). It makes no mention of his work in opioid litigation or malpractice lawsuits, which may have begun at a later date.

Lucrative Sideline

Kolodny is not the only critic of opioid prescribing to develop a lucrative sideline as a medical expert or paid witness. Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive healthcare marketing practices, has also been paid handsomely for her testimony.

In August, Fugh-Berman testified in California that she was paid $500 an hour for her work in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case, according to Northern California Record.

Fugh-Berman has written several op/eds claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were part of a “coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline.”

Fugh-Berman discloses on PharmedOUT’s website that she is a paid expert witness, but she won’t say who funds her organization.

“(We) are funded primarily by individual donations, mostly small donations but we have several major donors. We do not provide the names of our individual donors,” she said in an email to PNN.  

Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has also stoutly defended the CDC guideline and warned against excessive opioid prescribing.

“Most prescribing physicians feeding the opioid epidemic are well meaning, naïve, or just too busy to recognize the dangers,” he wrote in a physician guide for opioid prescribing published by Kaiser Permanente.

Over the past decade, Munzing has established a profitable career as an expert witness for the Medical Board of California, DEA, FBI and DOJ, working mostly on cases that involve doctors flagged for overprescribing opioids.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1.3 million in DOJ contracts since 2017 and is currently working on over two dozen DEA investigations.

After he left Phoenix House, Kolodny became the co-director of an opioid research program at Brandeis University that is funded with over $8.5 million federal grants, according to GovTribe.com.

Do Rx Opioids Really Increase Risk of Fatal Accidents?

By Pat Anson, PNN Editor

A recent study published in JAMA Network Open made headlines when it claimed that use of prescription opioids more than doubled the risk of causing a fatal car accident.  

Researchers at Columbia University Mailman School of Public Health looked at death certificates and toxicology tests on drivers involved in over 18,000 fatal two-vehicle accidents from 1993 to 2016. They found that 1,467 of the “crash initiators” tested positive for hydrocodone, morphine, oxycodone or other prescription opioids.    

The researchers reported their findings as “compelling evidence that use of prescription opioids by drivers is a significant contributing factor” in fatal crashes, which was a dog whistle for media outlets like CNN to warn, “Opioid epidemic spilling over onto roads.”

It turns out the evidence was not so compelling after all.

Like many states, Maryland faces growing rates of opioid abuse and addiction. But when researchers looked at opioid-related crashes in Maryland from 2006 to 2017, they found no significant increase in fatal accidents.

“The fact that opioid crashes in Maryland over the last 10 years have been more or less steady was a surprise,” Johnathon Ehsani, PhD, a professor at the Johns Hopkins Bloomberg School of Public Health told The Washington Post.

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That is striking, because Maryland is one of those states that has been quite severely affected by the overall opioid epidemic.”

Ehsani and his colleagues took another look at the toxicology data and realized it was misleading. The reason was simple: Because hospitals and first responders often give opioid medication to patients injured in accidents, autopsies will detect those opioids in patients who later die from their injuries. In other words, the drivers may not have been under the influence of opioids before the crash.

When researchers only looked at a sub-sample of drivers who died at the scene, they found that the use of prescription opioids was “considerably lower than those who died hours or days following the crash.”

“We applied a stricter definition than our other colleagues did,” said Ehsani, who published his findings in the less prominent journal Accident Analysis & Prevention. “We were more conservative in our case definition.”

The JAMA study apparently over-counted the number of opioid-related crashes by not differentiating between drivers who died at the scene and those who died after getting medical treatment with opioids.

"When determining the prevalence of opioid use in a population, it can be tricky to untangle the two circumstances," says Ehsani. "Thinking differently about the way in which researchers count cases has implications that can offer policymakers and public health professionals more meaningful results."

No one is suggesting that it’s okay to drive a vehicle while impaired by opioids. But it’s also not okay for researchers and prominent medical journals to use flawed data to suggest that patients using prescription opioids are more likely to cause fatal accidents.

In Maryland, they found just the opposite may be true.

“It could be that a number of people who are impaired by opioids choose not to drive,” Ehsani said. “It could be that there is some self-selection going on in that population or it could be that some of those who are most seriously impaired are unable to or don’t have access to a vehicle to drive.”

Study Finds Rx Opioids Provide Limited Pain Relief

By Pat Anson, PNN Editor

Prescription opioids relieve pain, improve physical functioning and help people with chronic pain sleep. But the improvements are small and come with side effects such as vomiting.

Those are the findings from a new meta-analysis (a study of studies) published in the Journal of the American Medical Association (JAMA). Researchers at McMaster University in Canada reviewed 96 clinical trials involving over 26,000 participants who received either prescription opioids or a placebo.

The findings do little to resolve the debate over the safety and effectiveness of opioids.

"Despite widespread use, there is not enough known about the benefits and harms of opioids for chronic non-cancer pain," said lead author Jason Busse, DC, a researcher with the DeGroote Institute for Pain Research and Care at McMaster University.

"We found that, compared to a placebo, 12 per cent more patients treated with opioids will experience pain relief, 8 per cent more will notice an improvement in their physical functioning, and about 6 per cent more will find improvement in their sleep quality.”

One expert questioned the designs of the studies used in Busse’s analysis. Because most participants received a relatively low dose of opioids, it’s not surprising such a small number experienced pain relief, according to Stephen Nadeau, MD, a research advisor for the Alliance for the Treatment of Intractable Pain (ATIP).      

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“With few exceptions, doses of opioids achieved were low (median dose 45 MME), trials were short, and opioids were rapidly titrated,” said Nadeau, a neurologist at the VA Medical Center in Gainesville, Florida.

“Because the study designs in all but a handful of studies did not remotely emulate clinical practice, it cannot be inferred that the results of this analysis are applicable to management of the general population of patients requiring opioid management of moderate to severe chronic nonmalignant pain.”

None of the opioid studies reviewed by Busse and his colleagues lasted longer than six months and many were considered low-to-moderate quality evidence. But the same thing could be said about virtually every pain reliever on the market. There is no good quality evidence proving that acetaminophen, pregabalin, ibuprofen, gabapentin or any other non-opioid pain medication is safe or effective long-term.

But opioid critics were quick to focus on the Busse study as proof that opioids should rarely be prescribed for pain.

“The findings reported by Busse et al illustrate that most patients who are prescribed opioids for the treatment of chronic noncancer pain will not benefit from those drugs,” wrote Michael Ashburn, MD, and Lee Fleisher, MD, in a JAMA editorial. “Given the clear risk of serious harm, opioids should not be continued without clear evidence of a clinically important benefit.”

But the only significant side effect the Busse study found was a 6% risk of vomiting. The study drew no conclusions about opioids increasing the risk of addiction, overdose and death – although Busse says those risks should not be overlooked.

“Given their risks, modest benefits, and the comparable effectiveness of alternatives, our results support that opioids should not be first line therapy for chronic non-cancer pain," said Busse, a chiropractor who was the lead author of Canada’s opioid prescribing guideline.

The study was funded by the Canadian Institutes of Health Research and Health Canada.

Is JAMA Opioid Study Based on Junk Science?

By Pat Anson, Editor

You may have read about a research study published this week in the Journal of the American Medical Association (JAMA), which compared the effectiveness of opioid and non-opioid medications in treating chronic pain. 

The yearlong study of 240 patients found that opioids were not superior to pain relievers like acetaminophen and ibuprofen in treating chronic back pain or hip and knee pain caused by osteoarthritis.  Pain improved for 41% of the patients who took opioids, compared to 54% in the non-opioid group.  

It’s an interesting study – one of the few to look at the effectiveness of any pain relievers long term – but some critics are questioning the study’s methodology and the alleged anti-opioid bias of its lead author, Erin Krebs, MD, a researcher for the Department of Veterans Affairs.

First let’s look at some of the news coverage the study is getting.

“Opioids Don’t Treat Chronic Pain Any Better Than Ibuprofen” reads the headline in Newsweek, an article that never mentions the JAMA study was limited to patients with back pain or osteoarthritis.

“Opioids Don’t Beat Other Medications for Chronic Pain” was the headline in NPR.com, while the Chicago Tribune went with “Opioids no better than common painkillers for treating chronic pain.”

The Tribune article included a quote from one of the co-authors of the CDC opioid guidelines. "The fact that opioids did worse is really pretty astounding," said Roger Chou, MD. "It calls into question our beliefs about the benefits of opioids."

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Notice the news coverage strongly suggests that opioids are ineffective for all types of chronic pain – not just back pain and osteoarthritis.  Patients living with chronic pain from arachnoiditis, trigeminal neuralgia or some other intractable pain condition would probably disagree about that. And they'd find the idea of taking ibuprofen laughable, if not infuriating. But no one asked for their opinion.

Also unmentioned is that opioids are usually not prescribed for osteoarthritis or simple back pain, which are often treated with NSAIDs and over-the-counter pain relievers.

So, what JAMA has published is a government funded study designed to look at a treatment (opioids) that most people with back pain and arthritis never actually get.

“You've been had by anti-opioid advocates disguising their advocacy as science.  Krebs is well known in professional circles for this kind of distorted advocacy junk science,” wrote patient advocate Red Lawhern, PhD, in a comment submitted to the Philadelphia Inquirer after it published a misleading headline of its own, “Prescription opioids fail rigorous new test for chronic pain.”

“I suggest that you retract your article.  In its present form, it is propaganda not fact,” said Lawhern, a co-founder of the Alliance for the Treatment of Intractable Pain (ATIP). “Opioids have never been the first-line medical treatment of choice in lower back pain or arthritis. That role is served by anti-inflammatory meds, some of them in the prescription cortico-steroid family.  NSAIDs have a role to play, recognizing that they are actively dangerous in many patients if taken at high doses for long periods.  Hundreds of people die every year of cardiac arrest or liver toxicity due to high-dose acetaminophen or ibuprofen.” 

Who is Erin Krebs?  

Dr. Krebs is an associate professor at the University of Minnesota Medical School and a prolific researcher at the VA Medical Center in Minneapolis.

She was also an original member of the “Core Expert Group” – an advisory panel that secretly drafted the CDC’s controversial opioid guidelines while getting a good deal of input from the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). The guidelines recommend that opioids not be prescribed for chronic pain.

Krebs also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Some of her previous opioid research has been controversial. In a study published last year in the Annals of Internal Medicine, Krebs reviewed 67 studies on the safety and effectiveness of opioid tapering. Most of the studies were of poor quality, but nevertheless Krebs came to the conclusion that pain levels and the quality of life of patients “may improve during and after opioid dose reduction.”

ERIN KREBS, MD

ERIN KREBS, MD

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

PROP founder Andrew Kolodny, MD, read the review and liked it, tweeting that “dangerously high doses should be reduced even if patient refuses.”

But forced opioid tapering is never a good idea, according to a top CDC official.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial also published in the Annals of Internal Medicine. 

As for Krebs’ contention that there is “insufficient evidence” of adverse events associated with opioid tapering, that notion may be put to rest next month when the VA releases a new study showing that tapering has led to a growing number of suicides by veterans.

In a summary of the findings, which will be presented at the Rx Drug Abuse & Heroin Summit, VA researchers report that “opioid discontinuation was not associated with overdose mortality, but was associated with increased suicide mortality.”  

Who and what should we believe in the neverending debate about opioids? PNN columnist Roger Chriss wrote about Krebs’ opioids vs. non-opioids study last year, when the initial reports of its findings came out. Roger said prescribing decisions are best left to physicians who know their patients’ medical conditions – not researchers, regulators or the news media.

“In reality, there is no ‘versus’ here. Opioids and NSAIDs are both valuable tools for chronic pain management. To pretend that one is inherently better than the other is to miss the essential point: Both work and should be available for use as medically appropriate,” Roger wrote. 

CDC Releases More Faulty Research About Opioids

By Pat Anson, Editor

A new study by researchers at the Centers for Disease Control and Prevention estimates that opioid overdoses have shaved two and a half months off the average life span of Americans – a somewhat misleading claim because the study does not distinguish between legally obtained prescription opioids and illegal opioids like heroin and illicit fentanyl.

The research letter, published in the medical journal JAMA, looked at the leading causes of death in the U.S. from 2000 to 2015. Overall life expectancy rose during that period, from 76.8 years in 2000 to 78.8 years in 2015, largely due a decline in deaths from heart disease, cancer, stroke, diabetes and other chronic health conditions.

But deaths due to Alzheimer’s disease, suicide, liver disease, drug poisoning and opioid overdoses rose, collectively causing a loss of 0.33 years in life expectancy – most of it due to opioids.

“This loss, mostly related to opioids, was similar in magnitude to losses from all the leading causes of death with increasing death rates,” wrote lead author Deborah Dowell, MD, of the CDC’s National Center for Injury Prevention and Control.

“U.S. life expectancy decreased from 2014 to 2015 and is now lower than in most high-income countries, with this gap projected to increase. These findings suggest that preventing opioid related poisoning deaths will be important to achieving more robust increases in life expectancy once again.”

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Dowell was also one of the lead authors of the CDC’s 2016 opioid prescribing guidelines, which discourage physicians from prescribing opioids for chronic pain. She and her two co-authors in the JAMA study --  both of them CDC statisticians -- do not explain why they failed to distinguish between black market opioids and legal prescription opioids, a dubious use of statistics akin to lumping arsonists in the same category as smokers or Boy Scouts learning to build campfires.  

They also fail to even mention the scourge of heroin and illicit fentanyl sweeping the country, which now accounts for the majority of opioid overdoses in several states.  

But Dowell and her co-authors don't stop there. The say the actual number of deaths caused by opioids is “likely an underestimate” because information on death certificates is often incomplete and fails to note the specific drug involved in as many as 25% of overdose deaths. This is another disingenuous claim, because it fails to explain why the data on the other 75% of overdoses is faulty too. 

Epidemic of Despair

Other researchers have also tried to explain the disturbing decline in American life expectancy – which began over adecade ago for middle-aged white Americans. Princeton researchers Anne Case and Angus Deaton were the first to document that trend,  when they estimated that nearly half a million white Americans may have died early because of depression, chronic pain, suicide, alcohol and drug abuse, and other health problems – an epidemic of despair linked to unemployment, poor finances, lack of education, divorce and loss of social connections.

The evidence was right there for Deborah Dowell and her co-authors had they looked for it. The JAMA study found that over 44,000 Americans committed suicide in 2015, a 66% increase from 2000, and over 40,000 died from chronic liver disease or cirrhosis, another 66% increase. Opioid overdoses during that same period rose to 33,000 deaths. 

Which is the bigger epidemic?

As PNN has reported, the CDC ignored early warnings from its own consultant that the agency’s opioid guidelines were being viewed as “strict law rather than a recommendation,” causing many doctors to stop prescribing opioid pain medication. Chronic pain patients also feel “slighted and shamed” by the guidelines, and are increasingly suicidal or turning to street drugs. We’ve also reported that the CDC has apparently done nothing to study the harms or even the possible benefits the guidelines have caused since they were released 18 months ago.

Instead of going back in time and selectively mining databases to fit preconceived notions about opioids, perhaps it is time for the CDC to take a giant step forward and see what its opioid guidelines have actually done.

Researchers Warn Against Opioid Backlash

By Pat Anson, Editor

The backlash against opioid medication has gone too far and is depriving chronic pain patients of a treatment many have used successfully for years, according to a commentary published in a prominent medical journal. The article also questions the use of the term “opioid epidemic” in describing the nation’s festering drug problem.

“The movement to virtually eliminate opioids as an option for chronic pain refractory to other treatments is an overreaction,” wrote Kurt Kroenke, MD, and co-author Andrea Cheville, MD, in JAMA.Many patients currently receiving long-term opioids were started when opioids were still considered a viable treatment option and if satisfied with their pain control and using their medications appropriately should not be unilaterally compelled to wean off opioids.”

Kroenke is a research scientist at the Regenstrief Institute and a professor at the Indiana University School of Medicine. Cheville is a professor and chair of research in the Department of Physical Medicine and Rehabilitation at the Mayo Clinic. She was recently elected to the National Academy of Medicine.

Kroenke and Cheville say many of the medications recommended as safer alternatives to opioids, such as acetaminophen and NSAIDs, provide little pain relief and have risky side effects. Others, such as pregabalin, gabapentin and antidepressants, may work for some pain disorders but have little benefit for others.

“Many patients respond better to one analgesic than another, just as patients with other medical conditions have differential medication responses,” they wrote. “Given the small analgesic effect on average of most pain drugs, the few classes of analgesic options, and the frequent need for combination therapy, eliminating any class of analgesics from the current menu is undesirable.”

Kroenke and Cheville say only a small minority of pain patients who start using opioids go on to use them long-term, yet medical literature and the mass media are filled with references to the so-called “opioid epidemic.”

“Excessive use of phrases like opioid epidemic should be avoided. An epidemic generally suggests a disease that is widespread and usually highly contagious rather than limited to a minority of those exposed,” they said. “Most patients receiving an initial opioid prescription do not proceed to chronic use and among the subset that do use long-term opioids, the majority neither misuse nor experience an overdose.

“An unintended consequence of excessive concerns raised about opioids could be an increasing reluctance among clinicians to prescribe even small amounts of opioids for a limited time for acute pain, including for patients discharged from the emergency department, those who are recuperating from surgical procedures, or persons with severe dental pain.”

A bill recently introduced in Congress would strictly limit opioids to just 7 days for acute pain, a prescription that could not be renewed. Maine, New Jersey, Ohio and several other states are adopting similar measures to limit opioid prescribing.

Kroenke and Cheville say few long-term studies have been conducted on the safety and effectiveness of any pain medications, and more research is needed on alternative therapies like cognitive behavioral therapy and medical marijuana before opioids are abandoned as a treatment option.

“Clinicians must be careful of replacing the opioid epidemic with a marijuana epidemic,” they warned. “Imperfect treatments do not justify therapeutic nihilism. A broad menu of partially effective treatment options maximizes the chances of achieving at least partial amelioration of chronic pain.”

CDC Guidelines Study: The Devil Is in the Details

By Stephen Ziegler, PhD, Guest Columnist

JAMA Internal Medicine has published a research letter that purports to be an examination of the relationship between funding from opioid manufacturers and opposition to the prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in March of 2016.

The authors examined the written comments made to the CDC during the open comment period, asserted that those who had received funding were more likely to oppose the CDC guidelines, and concluded that their “findings demonstrate that greater transparency is required about the financial relationship between opioid manufacturers and patient and professional groups.”

The following commentary, while critical of information contained in the article written by Caleb Alexander, Andrew Kolodny and others, nevertheless concludes with some positive suggestions for the future.

Illicit Opioids: The Harms Associated With Conflation of Data

The research letter, like many articles authored by those who are rightly concerned about addiction and overdose, begins by asserting that an association exists between increases in opioid prescribing and “large increases in addiction and overdose deaths in the United States.”

However, there are several problems with such a statement. First, association is not causation. For example, while a positive association exists between the size of a fire and the number of fire engines on the scene, fire engines for the most part do not cause fires -- they are only associated with it. Further, it is misleading and harmful to lump all opioids, prescription and illicit, together.

While conflating the two may help create better headlines and fuel the hysteria, such conflation is misleading because studies continue to indicate that two opioids, illicit fentanyl and heroin, are major drivers in the alarming increase in addiction and overdose, not prescription opioids.

Moreover, lumping all opioids together can be harmful because it ignores the size and complexity of the problems associated with the use and abuse of illicit and licit drugs. Because drug abuse remains a moving target, it is important to draw distinctions between a variety of factors and sources so that solutions can be tailored and refined. One size does not fit all.

Unclear Methodology Used to Classify Comments

Another problem with the JAMA article was the lack of measurement clarity regarding content analysis and how the authors categorized (coded) the comments that were submitted to the CDC during the open comment period.

According to the authors, the comments were classified as belonging in one of four mutually exclusive categories: “supportive, generally supportive with recommendations, generally not supported with recommendations, and not supportive.”

While it is unclear whether the coding occurred before or after the comments were reviewed, one section of the paper the authors pointed out that about 6% of the comments “were coded as supportive by 1 reviewer and not supportive by the other; a third reviewer adjudicated these cases.”

The first question that comes to mind is: who was the reviewer? Since it is likely that the authors were not randomly selected, it remains unclear what criteria was used to adjudicate disputes related to coding, especially when we know that two reviewers were at opposite ends of the spectrum and the coding scheme was central to the study.

Along these same lines, what constitutes opposition to the CDC guidelines? Was opposition binary (yes/no), was it mixed (and if so, where was the line), or did opposition exist along a range (strong or weak)?

When dealing with qualitative data (words as opposed to numbers), there are tendencies in terms of direction, but the devil is in the details. This is notable because there were likely many different reasons commentators and organizations were not supportive of the CDC prescribing guidelines, such as, but not limited to:

  1. The secretive nature of the entire process
  2. The short time frame the CDC allotted for public comments (initially less than 24 hours)
  3. Allegations that the process violated the Federal Advisory Committee Act
  4. Strong recommendations based on weak evidence
  5. Committee membership that lacked balance and broad stakeholder involvement
  6. An anti-prescription opioid agenda or bias by some committee members
  7. The fixation on dosing limits ignored the problems associated with converting dosage from one opioid to another, the differences in patients, and the potential for unintentional overdose at any dosage level
  8. The lack of balance and selective nature of the literature cited in the guidelines
  9. The failure to recognize that non-pharmacologic therapy and alternatives to opioids may not be effective or covered by insurance
  10. An ironic lack of transparency and full disclosure concerning potential conflicts of interest among those involved in the guidelines at various levels from start to finish

Conclusion

While the reduction of harms associated with the use of prescription drugs and illicit opioids such as heroin remains essential to improving the public health, it serves no laudable purpose to continually lump all opioids together.

Drug abuse is a highly complex bio-psycho-social phenomenon that requires recognition that not all people, nor problems, are the same. We must also not lose sight of the fact that millions of Americans are suffering from chronic pain, alternatives to opioids may not be as effective or covered by insurance, and the overwhelming majority who take prescription opioids use them responsibly.

In regards to the conflicts of interest issue, while the authors eventually admitted that the “CDC did not prompt or require organizations to disclose their financial associations as part of their comments,” I agree that disclosing real or potential conflicts of interest in the future is good for all involved. However, such disclosure should not be limited to just the pharmaceutical industry. It should also include government agencies and those in the substance abuse community.

I have and continue to provide consultation to government and the pharmaceutical industry about the need for balanced solutions that help ensure appropriate access, while at the same time prevent abuse. I care about the under-treatment of pain, as I am sure that those in the substance abuse community care about those suffering from addiction.

Consequently, what both the pain community and the substance abuse community need to focus on is finding common ground and forging balanced solutions, since finger pointing, bullying or taking a zero-sum game approach only impedes progress.

Stephen J. Ziegler, PhD, is a Professor Emeritus of Public Policy at Indiana University-Purdue University in Fort Wayne, Indiana.

Dr. Ziegler conducts research, provides continuing medical education, and consults on the topics of opioid risk management and the impact of drug regulation and enforcement on the treatment of pain. He has been published in several peer reviewed journals and serves as a reviewer for several journals such as the Journal of Opioid Management, Pain Medicine, Cancer, and the Journal of Medical Ethics. Prior to obtaining his law degree, Dr. Ziegler worked as a police detective and as a Task Force Officer for the U.S. Drug Enforcement Administration.

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.