Patient Advocates Call on Brandeis to Fire Kolodny

By Pat Anson, Editor

A coalition of physicians, patient advocates and pain sufferers has written an open letter to Brandeis University asking for the dismissal of Andrew Kolodny, MD, a longtime critic of opioid prescribing who is co-director of opioid policy research at the university’s Heller School for Social Policy and Management.

Kolodny is the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that has lobbied politicians and regulators for years to enact stronger measures to limit prescribing of opioid pain medication.

“Dr. Kolodny has been prominent in a national campaign to deny chronic pain patients even minimal management of their pain.  His actions are directed toward forcing draconian restrictions or outright withdrawal of this class of medications from medical practice,” reads the letter to Brandeis President Ronald Liebowitz and other top administrators at the university.

“He calls for forced tapering of patients formerly prescribed opioids. Policy positions for which he advocates are leading to the deaths of hundreds of chronic pain patients by suicide or pain-related heart failure and medical collapse.”

The letter was drafted by Richard Lawhern, PhD, and signed by over 60 healthcare professionals and patient advocates, including pain management specialists Forest Tennant, MD, and Aimee Chagnon, MD. Lawhern is the corresponding secretary of the “Opioid Policy Correspondents List,” an ad hoc volunteer group that advocates for better pain care. The group receives no funding from outside sources.

To read the letter in its entirety, click here.

Kolodny is a controversial figure in the pain community and is often quoted in the news media as an expert on issues involving pain management, even though his professional background is in psychiatry and addiction treatment.  He often refers to opioid medication as “heroin pills” and has suggested that patients shouldn’t trust doctors who prescribe opioids.

“I wish I could tell you that you should trust your doctor and talk to your doctor about this, but that may not be the case,” Kolodny said on C-SPAN in 2015. “We have doctors even prescribing to teenagers and parents not recognizing that the doctor has just essentially prescribed the teenager the equivalent of a heroin pill.”

“Although Dr. Kolodny has a work history in public health and addiction psychiatry, he is neither qualified nor Board Certified in pain management -- a closely related field that has been profoundly and negatively impacted by his assertions concerning public policy. From his published articles and interviews, it is clear to many readers that he knows or cares little about chronic pain patients and their treatment,” Lawhern’s letter states.

In a series of Tweets earlier this year, Kolodny said patients on “dangerously high doses” of opioids should be tapered to lower doses even if they refuse. He then asked for specific examples of doctors “forcing tapers in a risky fashion.”

Dozens of people responded with examples of patients becoming seriously ill or committing suicide after forced tapering, which Kolodny ignored.   

The letter to Brandeis calls Kolodny "one of the most polarizing and hated figures in medicine" among people in pain.

“In our view and those of many people whom he has harmed, Dr. Kolodny makes no positive contribution to the work or reputation of Brandeis or its research centers.  To the contrary, we believe it is ethically and morally imperative that he be dismissed immediately from the University, before his presence further damages both your reputation and your financial endowments,” the letter states.

The university did not respond to a request for comment on the letter. Neither did Kolodny.

Brandeis is a well-regarded liberal arts and private research university located near Boston. The Heller School for Social Policy and Management is often ranked as one of the top ten schools in social policy.  Kolodny joined Heller last year as a senior scientist after resigning as chief medical officer at Phoenix House, which runs a chain of addiction treatment centers.

Kolodny and PROP played central roles in developing the 2016 CDC opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Although voluntary and only intended for primary care doctors, the guidelines have been widely adopted as mandatory by insurers, federal agencies and throughout the U.S. healthcare system.

In an online survey of over 3,100 pain patients and healthcare providers on the first anniversary of the guidelines’ release, most said the guidelines were harmful to patients, had not improved the quality of pain care, and failed to reduce opioid abuse and overdoses. Critics also cite anecdotal evidence that the guidelines have contributed to an increase in patient suicides.

Heroin Overdoses in ER's Surpass Rx Opioid Overdoses

By Pat Anson, Editor

The number of patients admitted and discharged from U.S. hospitals for abuse of opioid pain medication has declined significantly this decade, while the abuse of heroin and illicit fentanyl has surged, according to a new study that documents the shifting nature of the nation’s overdose crisis.

Researchers at Stanford University analyzed national trends in hospital inpatient and emergency department (ED) discharges for opioid abuse, dependence and poisoning from 1997 to 2014, the last year data was available.

They found that hospital admissions for overdoses from pain medication started falling in 2010, the same year that opioid prescriptions began declining.

At the same time, hospital discharge rates for heroin poisoning increased at an annual rate of over 31 percent. By 2014, heroin overdoses exceeded those from prescription opioids in emergency rooms by almost a 2 to 1 margin.

“After 2008, ED discharge rates for heroin poisoning increased more sharply than the rates for any opioid poisoning -- signaling that the scope of heroin harm is worse than previously suggested -- while discharges for prescription opioid poisoning recently began to decline in both the ED and inpatient settings,” researchers reported in the journal Health Affairs.

“While these changes could be the result of national and local policies aimed at reducing the prescribing of opioids, the expanded availability of heroin and new lethal illicit drugs, such as nonpharmaceutical fentanyl, could mean that they are being used instead of prescription opioids.”

The findings add evidence to recent public health concerns that people misusing or addicted to prescription opioids are switching to heroin and synthetic opioids such as fentanyl because they are cheaper and easier to get.

"This suggests that the expanded availability of lethal illicit drugs are being used to replace prescription opioids in some cases," said Tina Hernandez-Boussard, PhD, associate professor of medicine, of biomedical data sciences and of surgery at Stanford University School of Medicine.

source: health affairs

The Centers for Disease Control and Prevention has been reluctant to admit that efforts to reduce opioid prescribing could be backfiring, although their own statistics indicate otherwise.  Deaths involving heroin and synthetic opioids overtook overdoses linked to prescription opioids in 2016, the same year the CDC released its opioid prescribing guidelines.

As PNN has reported,  the CDC last week launched a public awareness campaign to combat the abuse of prescription opioids, a marketing effort driven by surveys and focus groups that completely ignores the scourge of heroin and illicit fentanyl.

“The campaign does not include messages about heroin. Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging. Heroin is a related topic that also needs formative research and message testing,” the CDC explained.

The Stanford study found that discharge rates for prescription opioid poisonings declined annually by about 5 percent from 2010 to 2014, while discharge rates for heroin poisoning increased at an annual rate of 31.4 percent from 2008 to 2014. The trend has likely worsened since 2014, as heroin and illicit fentanyl are even more widely available on the black market.

"I'm cautiously optimistic that prescribing clinicians are positively reacting to the opioid crisis and therefore prescription opioids are contributing less to the overall drug epidemic," Hernandez-Boussard said. "That's the good news. The bad news is that although prescription opioid use decreased, heroin and methadone greatly increased.”

Anna Lembke, MD, an associate professor of psychiatry at Stanford and a board member of Physicians for Responsible Opioid Prescribing (PROP), says she has no doubt many people addicted to prescription opioids have switched to using heroin or illicit fentanyl.

"My patients have told me that's exactly what they did," said Lembke. "Heroin was cheaper and easier to get."

Would You Support a Boycott of CVS?

By Pat Anson, Editor

One of the most talked about issues in the pain community over the last two weeks has been CVS Health’s announcement that its pharmacists would soon start restricting doses of opioid pain medication and limit the supply of opioids for acute pain to 7 days.

The policy only applies to customers enrolled in CVS Caremark’s pharmacy benefit management program, but it quickly triggered an online backlash from pain patients – including many who called for a boycott of CVS.

“I refuse to patronize companies that practice medicine without a license,” wrote Jeannette on PNN’s Facebook page.

“Don’t go there anymore. Hit them in their pocketbook,” wrote Lauren.

“I very rarely use a CVS and will never go there for prescriptions or anything else,” said Jackie.

“I left CVS years ago for Walgreens and I’m guessing many more will be doing so,” wrote Amanda.

"CVS has some nerve. The use of opioids, or any other drug, really, is up to the doctor and his or her patients, not a pharmacist. This is a terrible precedent, which will drive an even bigger wedge between physicians and patients,” cardiologist Arthur Kennish, MD, told the American Council on Science and Health.

The CVS boycott soon had its own hashtag on Twitter.

“Wrong way to handle, CVS! I will join the #BoycottCVS. You make it more difficult for the sick w/ no impact on the crisis,” Stephanie tweeted.

The online outrage even spilled over onto CVS’ Facebook page, where many negative posts were apparently deleted by the company.

“CVS Pharmacy, why did you take down all your Posts and comments regarding your big announcement over overriding doctor's orders and limiting patients' rights to their pain medication?” asked Lauri. “Where did they all go?”

People are so passionate about this issue that we started an online poll asking if they would support a boycott of CVS. Click here if you’d like to participate.

Would a Boycott Work?

But while there’s plenty of online enthusiasm for a boycott, it’s unlikely to be effective without the support of patient advocacy groups.  An informal survey of pain organizations by PNN found most were critical of CVS’ decision, but opposed to a boycott.

“I think boycotting CVS is not a good idea. I think a better idea is working with them for better care and finding the good in what they are doing and amplifying the bad.  They want better education, they want better disposal, and many other things we all fight for,” said Paul Gileno, President of the U.S. Pain Foundation.  “I don't think a boycott would work or be effective and can come across in a negative way. We need a loud conversation with CVS.”

“I don’t typically like boycotts” said Barby Ingle, President of the International Pain Foundation and a PNN columnist. “But if enough people have a bad experience or don’t like the CVS policies, they will see a drop in the market and will have to reevaluate what their policies will be.

“I wouldn’t call it a boycott, I would call it a shift in patients understanding that we have power and that we can choose to go to the healthcare places that fulfill our needs. Unless CVS changes their practices, I can see them continuing to lose business.”

Penney Cowan of the American Chronic Pain Association did not respond to a request for comment.

One patient advocate who gave full support for a boycott was Cynthia Toussaint, the founder of For Grace, a non-profit that supports women in pain.

“The lack of patient advocacy support for the boycott is totally surprising,” Toussaint wrote in an email. “We’ve all been beating the ‘don’t get between a doctor and a patient’ drum for years, and now that we can put our names behind that, we’re being sheepish.

“For Grace is ON BOARD with the boycott! This is chilling news for the pain world - and I hope our support helps many people. We understand CVS’s very real concern about the opioid crisis, but this new policy is too heavy handed and will greatly harm the chronic pain community!”

CVS is not the first pharmacy to restrict access to opioid medication. In 2013, Walgreens gave its pharmacists a “secret checklist” to help them screen patients with opioid prescriptions. Any red flags, such as a prescription written by a new doctor or a patient paying in cash, could result in a prescription not being filled. The policy was implemented after Walgreens was fined $80 million by the Drug Enforcement Agency for violating the rules for dispensing controlled substances.

CVS has also been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

A Florida pharmacist who was fired this year by Sam’s Club for not following the company's opioid policy says pharmacies are driven by profit, not patient care, and a boycott is unlikely to change their bottom line. 

“Patients won't need to boycott. CVS doesn't want the business anyway,” says Karl Deigert, who was fired after complaining that patient rights were being violated at Sam’s Club, which is owned by Walmart.  “Corporations are only acting in their own best interest and have no concern for the patient. Patients can save their breath and energy as any complaints filed will fall on deaf ears. 

“Overzealous corporate policy makers have no desire or interest to protect the patients' well-being. Their policy making is self-serving to protect their assets from DEA scrutiny and monetary penalties. The corporations and the majority of retail pharmacists simply do not care to help the chronic pain patient population.”

The new opioid policy at CVS doesn’t go into effect until February 1, 2018. But CVS Caremark is already tightening the rules for some opioid prescriptions. 

A Caremark client who has been getting fentanyl pain patches at CVS for years was recently notified by letter that new limits are being placed on the patches “to help ensure that your use of opioid medication for pain management is safe and appropriate.” 

But is it really about safe and appropriate use?

The letter goes on to say the patient will still be able to get the fentanyl patches, but without prior authorization they “will have to pay 100 percent of the cost.”

Painful Opioid Statistics

By Roger Chriss, Columnist

The opioid crisis continues to worsen, and media coverage continues to be overly simplistic.

Vox recently reported the U.S. “absolutely dwarfs” all other countries in opioid prescriptions, in a story headlined “America’s huge problem with opioid prescribing, in one quote.”

"Consider the amount of standard daily doses of opioids consumed in Japan. And then double it. And then double it again. And then double it again. And then double it again. And then double it a fifth time. That would make Japan No. 2 in the world, behind the United States," Stanford psychiatry professor Keith Humphreys told Vox.

Although Humphreys’ statement is accurate, it is a misleading oversimplification that omits important context, including the rising rate of heroin and fentanyl-related deaths, and the shifting landscape of opioid prescribing.

First, this statistic represents an average (or mean). It does not include the variance, a measure of how many people use what quantity of opioids. The average person in the U.S. does not use any opioids at all. But people suffering from opioid addiction may use a large quantity of opioids every single day of the year.

In statistical work, reporting an average without the variance is considered sloppy at best, misleading or manipulative at worst.

Humphreys’ statement also fails to distinguish between the legal and illegal use of “pharmaceutical opioids,” a convenient term to refer to legally manufactured opioids, regardless of whether they are used for valid medical purposes, or diverted, shared or sold.

In other words, the much higher number of pharmaceutical opioids in the U.S. compared to Japan reflects both medical use and misuse.  

Further, this statistic assumes that Japan’s level of pharmaceutical opioid consumption is somehow better. In fact, Japan has a well-documented history of undertreating pain because of fears about opioid addiction. Pain is so poorly treated in Japan, according to The New York Times, that the government launched a campaign in 2007 urging patients to request pain relief, with hospital posters urging patients to “Tell Us About Your Pain.”

Japan continues to struggle with high levels of chronic pain. A 2015 review found a “high prevalence and severity of chronic pain, associated factors, and significant impact on quality of life in the adult Japanese population."

The Vox article also fails to point out that opioid prescribing in the U.S. peaked in 2010 and has been declining ever since. Yet opioid addiction and overdose deaths have been steadily rising, fueled largely by illegal opioids such as heroin and illicit fentanyl.

Vox is not alone in oversimplifying a complex problem. CNBC, for example, reported last year that “80 percent of the global opioid supply is consumed in the United States.”

Many others have repeated that claim, including Missouri Sen. Claire McCaskill, who recently tweeted that, "We have 5% of world population. 80% of opioids."

PolitiFact ran a fact check on McCaskill’s numbers and found them “greatly exaggerated.”

“While the United States is clearly the largest consumer of opioids, it, at most, accounts for roughly 30 percent of global consumption. We rate McCaskill’s claim False," PolitiFact said.

This is a significant issue in the opioid crisis. While some journalists, politicians, and even physicians name villains, people suffering from opioid addiction continue to get substandard treatment. And people who benefit from opioid therapy are struggling more and more to find physicians willing to prescribe and pharmacies willing to fill opioid prescriptions so they can have a reasonable quality of life.

No one is suggesting that the U.S. needs more opioids, particularly in the acute care setting. Opioids should be prescribed with close monitoring by physicians with experience in pain management. The research literature and public health studies agree that over-prescribing occurred, especially in pill mills and dubious pain clinics. In addition, drug theft and diversion are huge problems.

So while a statistic that invokes multiple doublings for comparative purposes sounds impressive, its context is much more important. We need to focus on the crisis as it really is, without exaggeration, if we hope to have meaningful progress ending it.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Fake Fentanyl Pills Found in 40 States

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 16 states, according to a new report that found the highly dangerous pills have spread from coast to coast.

“We have documented the spread of counterfeit pills made with illegal fentanyl throughout 40 states. There is documentation that counterfeits made with fentanyl have killed Americans in at least 16 of those states. The other 24 states probably have deaths attributable to counterfeits made with fentanyl, but because of limited awareness of the problem, those deaths may not have been investigated for counterfeit drugs,” said the report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy groups and other healthcare organizations.

The report is based on a review of court records, statements by law enforcement and public health agencies, and news reports.

Fentanyl is 50 to 100 times more potent than morphine. It is legally available in lozenges, patches and other medications to treat severe pain, but in recent years illicit fentanyl has become widely available on the black market, where it is often mixed with heroin or used in the production of counterfeit drugs.

Many addicts looking for a high or pain sufferers looking for relief have no idea what they’re buying. Experts say a single dose of fentanyl as small as two or three milligrams can be fatal.

“Up until now, it’s been difficult to grasp the scope and pervasiveness of the counterfeit drug problem,” said Dr. Marvin Shepherd, chairman of the PSM Board and former director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin’s College of Pharmacy. “We’ve had a number of examples of counterfeit pill seizures and tragic fentanyl-related deaths, but this report paints a picture of a nation under siege from fake and lethal drugs coming across our borders.”

Massachusetts, Pennsylvania, New Jersey, Ohio and several states now report they have more people dying from overdoses of illicit fentanyl than from prescription opioids. 

Most of the illicit fentanyl is manufactured in China and smuggled into the U.S. by drug cartels. In August, the Mexican military found over 140 pounds of powdered fentanyl hidden inside a tractor trailer rig at a checkpoint near Yuma, Arizona. The shipment, which had an estimated street value of $1.2 billion, also included nearly 30,000 counterfeit tablets made with fentanyl.

The fake pills are often designed to look like oxycodone or the anti-anxiety drug Xanax, and are hard to distinguish from the real thing.

“They’re relatively cheap (to make) and the profit margin is phenomenal,” said Lisa McElhaney, President of the National Association of Drug Diversion Investigators, during a recent seminar for pain management providers. “You’re talking about such a miniscule amount (of fentanyl). But it has such a heavy potency and purity level that it is fatal.”

McElhaney said the black market in prescription drugs used to be dominated by legally-made medications that were stolen or diverted from medicine cabinets, pharmacies or drug manufacturers. She now believes most of the pills sold on the street are counterfeit.

counterfeit oxycodone pills

“I would say 99% of what we are seeing on the street, bought and sold, is product from China, India, Mexico, or from second or third-hand distributors. It is not pharmaceutical grade, FDA approved fentanyl,” she said.

While the DEA and other law enforcement agencies have been warning of the fentanyl problem for years, federal health officials have been slow to recognize or even address it – focusing instead on limiting the use of opioid pain medication.

For example, the Centers for Disease Control and Prevention recently launched a new marketing campaign, using videos, online advertising, billboards, newspapers and radio ads to raise awareness about the risks of prescription opioids. The campaign completely ignores the role of fentanyl and heroin in the overdose crisis, because the CDC didn't want to risk “diluting” its primary message.

“Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging,” the CDC explained.

Politicians are also focused on prescription opioids. Several states have adopted or are considering laws that limit opioid prescriptions for acute pain to only a few days’ supply – a move that President Trump’s opioid commission appears to be considering as a recommendation in its final report.

“This is a prevention measure… to limit the number of drugs that are out there for improper diversion and to make sure that we don’t inadvertently turn people into addicts by giving 30, 60, 90 pills the first time,” said commission chairman Gov. Chris Christie of New Jersey, whose state has adopted a five day limit on new opioid prescriptions.

This week the Pharmaceutical Research and Manufacturers of America -- an organization that represents virtually every major drug maker – told the commission that it would support a 7-day limit on opioid prescriptions for acute pain.  

CVS Defends Rx Opioid Policy

By Pat Anson, Editor

CVS Health has released new details about its plan to limit the dose of opioid pain medication and restrict new prescriptions for acute pain to a 7-day supply.

The new policy, which was announced last week, immediately sparked an online backlash from chronic pain patients, who fear they will no longer be able to refill their opioid prescriptions at CVS or will have to do it weekly.

“It's crazy what's going on. Every week going to doctors and pharmacists paying that extra money. This is a crime on the sick,” wrote Amy in a Facebook post.

“Even for new patients, this doesn't make sense,” wrote Jennifer in another online post. “After surgery some patients need these medications for longer than 7 days. Driving to the doctor to get a new script, then to the pharmacy to get more medication is not conducive to healing.”

“How can they single out medications and refuse when the doctor writes them for 30 days?” wrote Hazel. “Everyone should boycott them, not only for prescriptions but shopping there for anything. This is getting ridiculous!”

Asked to comment on these and other concerns, CVS Health emailed a statement to PNN answering a series of questions we had about its new opioid policy. We were not allowed to interview anyone at CVS directly.

The questions and answers below were edited for clarity:

PNN: Many of your customers with chronic pain believe they'll have to go to a CVS pharmacy four times a month to get their refills. Can you clarify that for them? 

CVS: The seven day quantity limit on opioid prescriptions, going into effect on February 1, 2018 for CVS Caremark's pharmacy benefit management (PBM) clients, applies only to prescriptions written for acute conditions, such as a minor surgery or dental procedure, that generally last only for a short duration. 

We recognize that there are patients with a legitimate need for pain medication, and our approach is carefully designed to ensure that those patients can access their medication in an appropriate manner.  We are dedicated to ensuring our retail and PBM approaches do not negatively affect patients who are in need of their chronic pain medication.   

PNN: What happens when a patient recovering from surgery needs opioid medication for more than 7 days? Do they go back to their doctor and get a new prescription?

CVS: Our program encourages safe and appropriate utilization of opioids by managing utilization in a manner consistent with the Guideline set forward by the CDC.  Our efforts to ensure safe and appropriate opioid use are designed to improve the quality of care and health outcomes for patients.  If a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: What about limiting opioid prescriptions to 90mg morphine equivalent (MME) doses? Some pain patients are prescribed more than that.

CVS:  The CDC recommends that clinicians prescribe the lowest effective opioid dose and use caution when prescribing opioids at any dosage.  Further, the Guideline indicates physicians should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. 

We are aligning our standard utilization to these limits for all patients who are not in active cancer treatment, palliative care, or hospice care.  However, if a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: You say you are following the CDC guideline, but the guideline is voluntary and only intended for primary care physicians treating chronic pain. You are making them mandatory for all doctors and all patients for all types of pain.

CVS: Given the toll opioid misuse has taken on our country, we believe it is appropriate to align our utilization management of opioids for our members with the Guideline set by the CDC.  Our efforts to ensure safe and appropriate opioid use are designed to improve the quality of care and health outcomes for patients.  Notably, if a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: Many patients complain that there's already a tendency by some pharmacists to refuse to fill opioid prescriptions to avoid hassles, extra work, etc. and to send them away without their medication. How will CVS make sure its pharmacists abide by your rules and not invent new ones?

CVS: Our opioid utilization management program will be consistently executed as a coverage determination across all pharmacies in our PBM retail network.  Pharmacists at CVS Pharmacy, or any of the other retail pharmacies in our network, will not be making independent medical judgments about the appropriateness of opioid prescribing or the length of such prescribing. Additionally, the program we have recently announced does not impact prescriptions filled for CVS Pharmacy retail customers who are not covered by the CVS Caremark PBM.   

Our pharmacists are committed to providing the highest level of care for their patients.  At our retail pharmacies, we are also strengthening counseling for patients filling an opioid prescription with a robust safe opioid use education program highlighting opioid safety and the dangers of addiction. 

'Cookie Cutter' Approach to Pain Care

CVS is not the first pharmacy to adopt rules that limit the dispensing of opioids, but it is the first major chain to set a 7-day limit on prescriptions for acute pain. Given recent trends, it is probably not the last.

Several states have already adopted laws that limit opioids to a few days' supply for acute pain. And yesterday a major pharmaceutical organization announced its support for a 7-day limit on new opioid prescriptions.  

Critics say this “cookie cutter” approach to pain care ignores the fact that when acute pain is poorly treated or untreated, it can turn into chronic pain in a matter of months or even weeks.

And chronic pain can worsen or cause other life-threatening health problems, including high blood pressure, stroke, heart attack, depression and suicide ideation.

Each patient is also different. A large new study published this week in JAMA Surgery looked at the different lengths of time patients needed opioid medication while recovering from 8 common surgical procedures.

While a 7-day supply of opioids was adequate for most patients recovering from an appendectomy, hysterectomy, hernia repair and other common surgeries, an analysis of over 215,000 surgery patients found that about 20 percent of them needed at least one refill of their prescription. Orthopedic and neurological procedures were the most likely to require a refill, and Medicare patients were the most likely group to need opioids for more than 7 days after a surgery.

“Although 7-day limits on initial opioid pain medication prescriptions are likely adequate in many settings, and indeed also sufficient for many common general surgery and gynecologic procedures, in the postoperative setting, particularly after many orthopedic and neurosurgical procedures, a 7-day limit may be inappropriately restrictive," wrote lead author Louis Nguyen, MD, of Brigham and Women’s Hospital, Harvard Medical School.

But not everyone finds fault in the cookie cutter approach. In an editorial also published in JAMA Surgery, a leading surgeon wrote that “any effort” to reduce the frequency of opioid prescriptions was a good thing.

“Unfortunately, we have reached a point that 100% elimination of pain has become not only the goal but the expectation. If a surgeon allows a patient to expect a pain-free recovery, he or she will see refill requests increase,” wrote Selwyn Rogers, MD, chief of surgery at the University of Chicago Medicine Trauma Center.

“Alternatives to narcotics should be recommended and incorporated as the foundation of pain management. It does not take much time to explain the use of acetaminophen and ibuprofen and then follow up with a stronger option if the pain is not adequately relieved. It is also useful to prepare the patient to expect some discomfort, realize that complete relief of all pain is impossible, and that the cost of trying is not worth it.”

Drug Makers Support 7-Day Limit on Rx Opioids

By Pat Anson, Editor

A leading organization of pharmaceutical companies announced today its support for a 7-day limit on opioid prescriptions for acute pain.  

The announcement -- made during a meeting of President Trump’s opioid commission – marks a significant shift for the industry and is likely to speed up efforts to have limits imposed nationwide on opioid medication for short-term pain.

“PhRMA is announcing for the first time our support to limit the supply of opioids to 7 days for acute pain management. Too often, individuals receive a 30-day supply of opioid medicines for minor treatments for short-term pain,” said Stephen Ubl, President and CEO of PhRMA, the Pharmaceutical Research and Manufacturers of America.  

“Overprescribing and dispensing can lead to patients taking opioids longer than necessary and excess pills falling into the wrong hands.”

PhRMA is a trade organization that represents over 3 dozen pharmaceutical companies, including AstraZeneca, Bayer, Allergan, Bristol-Myer Squibb, Eli Lilly, Johnson & Johnson, Merck, Pfizer, Teva, Novartis, GlaxoSmithKline, and Purdue Pharma.

“Our announcement is candidly an unprecedented step for the industry. We’ve always supported physician autonomy and the preservation of the physician-patient relationship, but as you know, given the scope of this (opioid) crisis,we believe this is the right thing to do,” Ubl said.

“I want to thank you and the industry for stepping forward," said commission chairman Gov. Chris Christie of New Jersey. “This is a prevention measure… to limit the number of drugs that are out there for improper diversion and to make sure that we don’t inadvertently turn people into addicts by giving 30, 60, 90 pills the first time. And so the fact that the pharmaceutical industry is willing to step up and acknowledge that there is something that needs to be done is an important first step.”

New Jersey, Ohio, New York and several other states have already implemented or are considering laws to limit the number of days opioids can be prescribed and dispensed for acute, short-term pain. This week Florida Gov. Rick Scott announced that he would support legislation for a 3-day limit on opioids for acute pain in his state. Strict conditions would have to be met to get a 7-day supply.   

A bill introduced in the U.S. Senate earlier this year would require doctors nationwide to limit the initial supply of opioids for acute pain to seven days, a prescription that could not be renewed.  The bill by Sen. John McCain and Sen. Kirsten Gillibrand was referred to the Senate Judiciary Committee in April, but has gone no further.

CVS Health announced last week that it would limit opioid medication for acute pain to 7 days in all of its pharmacies nationwide, starting February 1.

CVS will also limit opioid doses for both acute and chronic pain to 90mg morphine equivalent units, and patients would be required to try immediate release formulations before using extended release opioids.

‘Moonshot’ Needed for New Pain Treatments

Today’s meeting of President Trump’s opioid commission focused largely on expanding access to addiction treatment and developing new ways of treating chronic pain without the use of opioid medication. During the two-hour meeting, there was hardly any mention of illegal opioids or the scourge of heroin and illicit fentanyl now sweeping the country.

"Our nation needs a moonshot commitment to the development of non-opioid pain treatments. We need new therapies and we need them fast," said Jim Campbell, MD, President of Centrexion Therapeutics. "The abuse of opioids costs lives, but the other equally important issue is the problem of untreated pain. Untreated pain leads to lost work, depression, lack of sleep, social withdrawal and may even lead to suicide."

Commission member Patrick Kennedy, a former congressman in recovery from addiction, said the problems of pain, addiction, depression and suicide are all intertwined, and need better advocacy.

“Clearly, depression is rampant. The opioid crisis was driven by a depression crisis. And while we’re talking about the opioid crisis and overdose deaths, suicide is getting right up there, to the height of the AIDS epidemic itself,” said Kennedy. “Because these illnesses are so stigmatized, the advocacy is really anemic. There’s no one out there shaking the trees as if this were HIV and AIDS, like we saw in those crises.”

To watch a replay of the commission meeting, click here.

FDA Targets Rogue Online Pharmacies

By Pat Anson, Editor

The Food and Drug Administration is cracking down on over 500 online pharmacies that illegally sell potentially dangerous, unapproved versions of prescription drugs, including opioid pain medication, antibiotics and injectable epinephrine products. So far the crackdown doesn’t appear to be very effective, as many of the websites the FDA targeted remain online.

The FDA recently partnered with Interpol and other international law enforcement agencies in a global operation called Pangea X. The goal was to identify the makers and distributors of illegal prescription drugs and shut them down.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances. Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country. Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids.”

The FDA sent 13 warning letters to the operators of 401 websites informing them they were illegally selling unapproved prescription drugs.

screen shot from american pharmacy group website

One such letter went to the American Pharmacy Group in Silver Spring, Maryland, warning the company about selling an unapproved combination of hydrocodone and acetaminophen in 10/500mg doses.

The FDA asked drug manufacturers in 2011 to limit the strength of acetaminophen in prescription drugs to 325mg because of the risk of severe liver injury.

“There are currently no approved drug applications… for the hydrocodone products that contain 500 mg of acetaminophen offered for sale on your websites,” the FDA letter warned.  “Offering hydrocodone products for sale on your websites is particularly concerning given the potential for abuse and dependency, especially amid the growing epidemic of opioid abuse in the U.S.”

The FDA letter was dated September 19, 2017. But today a website affiliated with American Pharmacy Group was still selling the hydrocodone/acetaminophen combination in the 10/500mg dose as a “muscle relaxant.” A bottle of 30 pills could be purchased for $269 with 2-5 day delivery.  

In an online chat with “John” the pharmacy manager, I asked if a prescription was needed to get the painkiller.

“No you no need prescription no,” was his reply.

“Really? I don’t need a prescription to get that?” I asked

“No,” he answered again.

John then referred me to a “new” online pharmacy, one that was not on the list of 21 websites the FDA identified as being affiliated with American Pharmacy. It’s apparently easier to put a new website up than it is for federal agents to take an old one down.

In adddition to warning letters, the FDA seized nearly 100 website domain names, such as buyhydrocodoneonline.com, canadian-pharmacy24x7.com and buyklonopin.com.

As part of Pangea X, FDA inspectors also screened packages suspected of containing illegal drugs at international mail facilities (IMFs) in Chicago, Miami and New York. Those screenings resulted in nearly 500 parcels being seized.

“Our work to fight illegal online pharmacies is not over,” said Gottlieb. "We’ve recently tripled the staff we have in the IMFs to improve our ability to inspect packages that are suspected of containing illegal drugs, and we have doubled the number of cybercrime and port of entry special agents for the Office of Criminal Investigations,” Gottlieb said.

Interpol said it seized over $51 million in illicit and counterfeit medications during Operation Pangea X. Over 400 people were arrested worldwide, with 3,584 websites shut down.

ER Patients Less Likely to Use Opioids Long Term

By Pat Anson, Editor

Patients who are prescribed opioid pain medication for the first time in hospital emergency rooms are less likely to become long term opioid users than patients in other settings, according to a large new study by researchers at the Mayo Clinic.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

Jeffrey and her colleagues analyzed data for 5.2 million opioid prescriptions filled in emergency rooms from 2009 to 2015.

They found that only 1.1% percent of “opioid naïve” patients with private insurance progressed to long term opioid use. That compares to 2% of patients in non-emergency settings. Long term use was defined as someone getting 10 or more refills or more than a 120 day supply of opioids in a year.

About 3 percent of Medicare beneficiaries used opioids long term after getting them in an ER, with disabled Medicare patients the most likely ER patients to progress to long term use (13.4%).

Only 3.3% of opioid doses for privately insured patients in the ER exceeded 90mg morphine equivalent units (what the CDC considers a high daily dose). That compares to 7.2% of doses in non-emergency settings.  The duration of prescriptions was also lower for ER patients.

"Less than 5 percent of opioid prescriptions from the ER exceeded 7 days, which is much lower than the percentage in non-emergency settings. Further research should explore how we can replicate the success of opioid prescribing in emergency departments in other medical settings," said Jeffery, whose study is published online in the Annals of Emergency Medicine.

The use of opioid medication in hospital emergency rooms has become a contentious issue for both patients and physicians, with many patients complaining that they are profiled and labeled as drug seekers when they seek treatment at an ER for pain.

“I refuse to go to the ER for pain. Unless I feel I'm absolutely dying, I will not go. It isn't worth being made to feel like I'm only ‘putting on a show’ or I'm a junkie just trying to get high,” one pain sufferer told us.

In a survey of over 1,250 pain patients last year by PNN and the International Pain Foundation, 80 percent said they had felt labeled as an addict or drug seeker by hospital staff. Asked if doctors were reluctant to prescribe opioid medication while they were hospitalized, over two-thirds said it happens often or sometimes. To see the complete survey results, click here.

“I had a doctor in an emergency room situation one time during an episode I was having, who actually stood in the open doorway of my room, I was still in the ER, and yelled at me as loud as he could, that he wasn't giving me any pain medicine,” said one patient.

Some hospitals, such as Temple University Hospital in Philadelphia, have adopted guidelines that discourage opioid prescribing to ER patients. The voluntary policy quickly won broad support from Temple’s physicians.

In a survey by the hospital, only 13% of Temple’s ER doctors thought patients with legitimate reasons for opioids were denied appropriate care. A large majority – 84% of the doctors -- did not believe patients were denied appropriate pain relief.

“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,” said Daniel del Portal, MD, Assistant Professor of Clinical Emergency Medicine at the Lewis Katz School of Medicine at Temple University.

CDC Launches New Campaign Against Rx Opioids

By Pat Anson, Editor

The Centers for Disease Control and Prevention has launched a new awareness campaign to combat the abuse of prescription opioids, a marketing effort driven by surveys and focus groups that completely ignores the increasing role of heroin and illicit fentanyl in the nation’s overdose crisis.

The Rx Awareness campaign uses videos, online advertising, billboards, newspapers and radio ads designed to increase awareness “about the risks of prescription opioids and stop inappropriate use.” The campaign will initially run for 14 weeks in Ohio, Kentucky, Massachusetts, and New Mexico, with a broader release expected as additional states receive funding through CDC programs. No estimate of the cost of the campaign was released.

“The U.S. Department of Health and Human Services (HHS) is committed to using evidence-based methods to communicate targeted messages about the opioid crisis and prevent addiction and misuse in every way we can,” HHS Secretary Tom Price, MD, said in a statement. 

But little "evidence" is actually presented in the Rx Awareness campaign, which primarily uses slogans and emotional, “real-life accounts” of people recovering from opioid addiction or who have lost loved ones to a prescription opioid overdose.

“Prescription opioids can be addictive and dangerous,” a woman says in an online banner ad.

“One prescription can be all it takes to lose everything,” a man says in another ad.

Although addictive behavior typically starts during adolescence, the Rx Awareness campaign is targeting adults aged 25-54 who have used prescription opioids at least once either medically or recreationally.

“We learned that adults between the ages of 45 and 54 had not yet been targeted by a broad-reaching campaign. This information was reinforced by surveillance data indicating that the population with the highest fatality rate from opioid overdoses was non-Hispanic white adults ages 45–54,” the CDC said in an unusually detailed explanation of the marketing research behind the campaign.

“We also found a need for communication efforts to deliver primary prevention messages to younger audiences ages 25–35, who are less likely to experience chronic pain but may be exposed to opioids for other reasons, such as having a sports injury or undergoing a dental procedure.”

The four states initially being targeted all have soaring rates of opioid overdoses, but in recent years most of the deaths have been linked to heroin and illicit fentanyl, not prescription opioids. 

The latest report from the Massachusetts Department of Public Health, for example, shows prescription opioids were involved in only 15 percent of opioid-related overdose deaths in the state during the first quarter of 2017. Fentanyl was involved in 81 percent of the Massachusetts deaths and heroin in 39 percent of them. 

But fentanyl and heroin are not even addressed in the Rx Awareness campaign, because the CDC didn't want to risk “diluting” its primary message.

“The campaign does not include messages about heroin. Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging. Heroin is a related topic that also needs formative research and message testing,” the CDC said.

One of the video testimonials featured in the campaign is the story of Steve Rummler, a Minnesota man with chronic back pain who became addicted to painkillers. Rummler died of a heroin overdose at the age of 43.

His mother Judy, who appears in the video, founded the non-profit Steve Rummler Hope Foundation, an anti-opioid activist group. The Rummler foundation is the “fiscal sponsor” of Physicians for Responsible Opioid Prescribing (PROP), a designation that allows PROP to collect tax deductible donations using the foundation’s non-profit status. PROP founder Andrew Kolodny, MD, is listed as a member of the Rummler foundation's medical advisory committee, as is PROP President Jane Ballantyne, MD.

The CDC said it developed the videos and other campaign material using a “mixed-method design integrating data from in-depth interviews and a quasi-experimental, one-group retrospective post-then-pretest (RPTP) survey was used to assess target audiences’ responses to campaign messages.”

In the other words, the campaign is driven by marketing research -- not Secretary Price's "evidence-based methods." The CDC said most participants in focus groups thought the campaign material was "attention grabbing, believable and meaningful." Many also said they would share the video testimonials with others.   

“This campaign is part of CDC’s continued support for states on the frontlines of the opioid overdose epidemic,” said CDC Director Brenda Fitzgerald, MD. “These heartbreaking stories of the devastation brought on by opioid abuse have the potential to open eyes – and save lives.”

CVS to Limit Opioid Prescriptions

By Pat Anson, Editor

CVS Health has announced plans to further restrict the filling of opioid prescriptions at its pharmacies by limiting the dose and supply of opioids for acute pain to seven days. The new policy only applies to customers enrolled in the CVS Caremark pharmacy benefit management program, which provides pharmacy services to over 2,000 health and insurance plans.

CVS said its opioid policy would “give greater weight” to the Centers for Disease Control and Prevention's opioid prescribing guideline, which discourages doctors from prescribing opioids for chronic pain.

“The CDC Guideline should become the default approach to prescribing opiates, a scenario in which physicians would have to seek exceptions for those patients who need more medication or longer duration of therapy,” Troyen Brennan, MD, CVS’ Chief Medical Officer wrote in a post on Health Affairs Blog.

But the new CVS policy actually goes beyond the voluntary recommendations of the CDC guideline, which was only intended to give advice to primary care physicians who treat chronic pain.

Beginning February 1, CVS will limit all opioid prescriptions for acute pain to seven days. For both acute and chronic pain, opioid doses must not exceed 90mg morphine equivalent units and patients will be required to try immediate release formulations, before using extended release opioids.

The policy will apply to all 90 million CVS customers enrolled in commercial, employer or Medicaid health plans. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide.

In announcing the policy, CVS rejected complaints that it and other healthcare providers were adopting a “heavy-handed, cookie cutter” approach to patient care – decisions best left between a patient and their doctor.

“To be sure, prescriber autonomy and respect for the physician-patient relationship are of paramount importance. However, there is little evidence to show that past opioid prescribing habits are necessary or appropriate, and there is a great deal of evidence that they have produced significant harm,” said Brennan.

“We see firsthand the impact of the alarming and rapidly growing epidemic of opioid addiction and misuse,” said Larry Merlo, CEO of CVS Health. 

“With this expansion of our industry-leading initiatives, we are further strengthening our commitment to help providers and patients balance the need for these powerful medications with the risk of abuse and misuse.” 

Opioids Have Been Costly for CVS

Patient safety may not be the only factor behind CVS’ decision to limit opioid prescriptions. In recent years, the company has been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

As PNN has reported, CVS recently agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the painkiller hydrocodone by employees.

In 2016, CVS also paid a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged opioid prescriptions. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores. Another forger obtained over 200 prescriptions for hydrocodone and methadone by forging the name of an emergency room physician.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

As a result of these and other fines, CVS pharmacists were already under pressure to be wary of filling opioid prescriptions. Many started calling doctors to make sure the prescriptions were legitimate and some even refused to fill the prescriptions of longtime customers.

Alcohol Sales Continue

CVS was widely praised for its decision to stop selling cigarettes a few years ago, a move that cost the company $2 billion in lost tobacco sales.  According to Marketplace, the company has also removed transfats from its branded food products and reduced displays of candy near its cash registers.

The healthier offerings apparently do not apply to alcohol, however, a substance that causes far more addiction, death and health problems than opioid medication. This week an advertising flier for CVS stories in California prominently displays a selection of inexpensive beer, wine and hard liquors.

CVS did not respond to a query from PNN about whether it intends to limit the amount and frequency of alcohol purchases, as it is planning to do for opioid pain medications.    

CVS Health (NYSE: CVS) stock has fared poorly in the past year and company insiders have sold nearly $100 million in shares. Among the sellers, according to Barrons, was CEO Merlo – who has sold $26 million in shares so far in 2017, including $20 million in September alone.

Trump Opioid Commission Delays Final Report

By Pat Anson, Editor

The chairman of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis has asked for – and apparently been granted – a one month delay in releasing the panel’s final report.

In a letter posted on the White House website, New Jersey Gov. Chris Christie said the commission’s “research and policy development are still in progress,” and that he was extending the deadline from October 1 to November 1.

Christie said the opioid commission would hold its third public hearing September 27 at the White House. A notice published in the Federal Register indicates the meeting will focus on pain management and the diversion of opioid pain medication.

“The meeting will consist of statements to the Commission from invited government, nonprofit, and business organizations regarding Innovative Pain Management and Prevention Measures for Diversion followed by discussion of the issues raised,” the statement says. No list of attendees is included.

Christie’s letter also says the opioid commission will visit an Ohio medical center to learn about “innovative pain management strategies” and will meet in New Jersey with representatives of the pharmaceutical industry “to talk about partnership opportunities with the National Institutes of Health and the Food and Drug Administration.”

Until now the focus of the opioid commission has been on treating opioid addiction. An interim report released in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioid medication, and increased efforts to detect and stop the flow of illicit fentanyl into the country. There are no specific recommendations aimed at reducing access to prescription opioids or providing different forms of pain management.

Bondi Joins Commission

Another possible sign of a shift in the commission’s direction is the recent appointment of Florida Attorney General Pam Bondi to the panel. Bondi is now listed as member of the commission on the White House website,  although there has been no official announcement by the Trump administration. She is the fifth politician appointed to the six member panel.

Bondi played a prominent in shutting down on Florida’s pill mills several years ago, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to street drugs like heroin and illicit fentanyl. Many pain patients in Florida still have trouble finding pharmacies willing to fill their opioid prescriptions.

Bondi recently joined other state attorneys general in asking pharmaceutical companies for information about their marketing, production and distribution of opioids.

“Florida citizens continue to become addicted to opioids and die daily -- meanwhile, prescription drug manufacturers, distributors and the medical profession all point fingers at each other as the cause of this national crisis,” Bondi said in a statement. “This far-reaching multistate investigation is designed to get the answers we need as quickly as possible. The industry must do the right thing. If they do not, we are prepared to litigate.”

Bondi also recently joined the National Association of Attorneys General in asking the insurance industry to do more to reduce opioid prescriptions and combat opioid abuse.

“Insurance companies can play an important role in reducing opioid prescriptions and making it easier for patients to access other forms of pain management treatment. Indeed, simply asking providers to consider providing alternative treatments is impractical in the absence of a supporting incentive structure,” the attorneys general said in a letter to an insurance industry trade group.

“Insurance companies thus are in a position to make a very positive impact in the way that providers treat patients with chronic pain.”

In addition to Bondi and Christie, opioid commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman.

The Trump administration has still not officially declared that the opioid crisis is a national emergency – something the President said he would do in August.  

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.”

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.

New HIV Guidelines Discourage Use of Opioids

By Pat Anson, Editor

Opioid pain medication should not be considered as a first-line treatment for people living with HIV, even though chronic pain is a significant health problem that affects up to 85% of HIV/AIDS patients, according to new guidelines released by the Infectious Diseases Society of America.

The voluntary guidelines, the first to address treating chronic pain in HIV patients, urge physicians to begin with non-drug treatments such as cognitive behavioral therapy, yoga, physical therapy, hypnosis and acupuncture. Only when those treatments fail do the guidelines recommend medications such as gabapentin (Neurontin), pregabalin (Lyrica), anti-depressants, and medical cannabis.

The guidelines recommend against using opioids because of the risk of misuse, addiction and overdose. Opioid medication should only be considered as a second- or third-line therapy when other treatments prove to be inadequate.

"Opioids are never first-line," said the guidelines' lead author, Douglas Bruce, MD, chief of medicine at Cornell Scott-Hill Health Center, and associate clinical professor of medicine at Yale University.

“Additional clinical trials are needed to assess the effectiveness of the long-term use of opioids in neuropathic pain in PLWH (persons living with HIV). Although short-term use may provide some relief, these medications may be of limited success in chronic neuropathic pain.”

Nearly half of HIV patients suffer from neuropathic pain, likely due to inflammation or injury to the central or peripheral nervous system caused by the infection. Musculoskeletal pain, such as low-back pain and joint pain from osteoarthritis, is also common.

"It has been long known that patients with HIV/AIDS are at high risk for pain, and for having their pain inadequately diagnosed and treated," said Peter Selwyn, MD, co-chair of the guidelines and a professor at the Albert Einstein College of Medicine. “This is an aging population and the changing clinical manifestations of HIV, complexity of the disease and additional challenges related to substance abuse make treatment complicated. These guidelines help provide clarity in treating these patients."

The guidelines recommend that physicians consult with a palliative care or pain management specialist when HIV patients have an advanced illness or near the end of life.

"Because HIV clinicians typically are not experts in pain management, they should work closely with others, such as pain specialists, psychiatrists and physical therapists to help alleviate their patient’s' pain," said Bruce.

Restricting Opioid Doses Won’t Help the Overdose Crisis

By Roger Chriss, Columnist

As the overdose crisis worsens, new strategies and policies are being considered, including a recent petition to remove so-called high-dose opioids from the market.

The petition asks the FDA to ban opioid pills that, when taken as directed, would add up to a daily dose equivalent to more than 90mg of morphine. It is signed by leaders of several anti-opioid activist groups, including Physicians for Responsible Opioid Prescribing (PROP).

"The existence of these products implies that they're safe. They're not,” says Andrew Kolodny, MD, Executive Director and founder of PROP. "These are not medicines. These are lethal weapons that should be removed from the market.”

Before we start removing access to pain medication, it’s incumbent upon us to analyze the question of prescription opioid doses and what role, if any, they have in the overdose crisis.

First, higher doses of opioids are more dangerous. That is obvious, since most substances become dangerous at a sufficiently high dose, or as the Swiss physician Paracelsus supposedly said, “The dose makes the poison.” It is reasonable to conclude that higher doses of an opioid would be riskier.

But there is no inherent implication about safety in the existence of any substance. There is nothing "safe" about chemotherapy drugs, anti-seizure medication or anti-anxiety drugs, just as there is nothing safe about tobacco or alcohol.

Moreover, the opposite of safe is not necessarily dangerous, since something that is "dangerous" can still be clinically beneficial. Open heart surgery is dangerous, but beneficial to someone dying from heart disease.

Conspicuously absent from the signatories of the PROP petition are any physician groups or doctors involved in pain management. Asked to comment on the petition, the President of the Society of Palliative Care Pharmacists told Pharmacy Times that while she agreed that opioid abuse is an urgent concern, she dose not believe that removing high-dose opioids from the market would be the best way to combat the overdose crisis.

“Let’s put our efforts together in an interdisciplinary approach and train providers to accurately assess their patients rather than pulling certain drugs from the market, because there may be cancer patients or others who are truly benefiting from these high-dose opioids,” said Rabia Atayee, PharmD.

The petition argues that people who currently take high-dose opioid medication can simply take two or more lower-dose pills. This would supposedly reduce the risk of overdose when high-dose pills are stolen or diverted.

“Removing UHDU (ultra-high dosage unit) orally-administered opioids from the market will result in patients having to swallow more tablets or capsules. But this is unlikely to result in a significant inconvenience or hardship for patients,” the petition states.

In other words, there would be a trade off. The risk of an overdose would be lower for a person who gets an opioid analgesic from a friend to deal with severe pain. But a person with a disorder like achalasia that impairs swallowing or a GI disorder that impairs absorption may be harmed by having to take more pills.

Unintended Consequences

The strength of the arguments is only one factor here. The unintended consequences of this petition should also be considered. One obvious effect would be an increase in the total number of pills, which would exacerbate concerns about over-prescribing. There would be more pills to steal or divert, and more potential problems in securing the opioid supply chain from manufacturer to pharmacy, a major source of diverted pills that often goes unremarked and unpunished.

Another likely effect is increased activity on the black market. In 2010, when Purdue Pharma brought out its abuse deterring form of OxyContin, some abusers started switching to illegal drugs, including heroin. An uncomfortable outcome of this well-intentioned change is that a public health policy meant to prevent abuse and addiction may have made the overdose crisis worse.

A similar outcome could result from this petition: Drug abusers who are intent on having a high-dose opioid pill may shift to street drugs.

Another possible outcome is that opioid doses keep getting smaller and smaller. If a daily dose of pills containing 90mg of a morphine equivalent (MME) is considered “dangerous,” then what about 80 MME? Or 70 MME? If the changes recommended in this petition do not work, will we try more restrictions in doses and prescribing? Clear measures of the success or failure of the proposal should be defined in a petition like this one, but they are not.

We already have vast quantities of data about the opioid crisis. According to the CDC, opioid prescribing peaked in 2010 and has been in decline ever since, yet overdose rates keep rising. 

The average daily dose of opioids started falling even earlier, in 2006. By 2015, it had declined to nearly 48 MME -- well below the dose sought in the petition.

AVERAGE DAILY PER CAPITA MORPHINE EQUIVALENT DOSE (MME)

Source: CDC/QuintilesIMS

In other words, reducing the amount and dose of prescription opioids is inversely correlated with the number of overdoses. Of course, correlation is not causation, but the negative correlation does not bode well for the effects of this petition. Based on this data, the best we can reasonably hope for is small benefits on the margins of the overdose crisis, at the expense of people who benefit from high-dose prescription opioids.

And this petition will do nothing to improve treatment for people suffering from opioid use disorder or to reduce the risks of people overdosing on heroin or illicit fentanyl. These are key features of the opioid crisis, and a policy that claims to beat addiction without addressing them should be greeted with skepticism.

Instead of new restrictions, perhaps the CDC and state guidelines can be updated to include recommendations that physicians and pharmacists discuss with patients the safe storage and disposal of opioid medications.

Before we ban a medication for having too much of a chemically active ingredient for people who abuse it, we should do whatever we can to ensure that the people who benefit from it are not harmed.

To make a comment on the PROP petition to the FDA, click here.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.