New Opioid Relieves Pain Without the ‘High’

By Pat Anson, Editor

Nektar Therapeutics has announced positive results from Phase III study showing that a new opioid medication significantly reduces pain without the high levels of euphoria that can lead to abuse and addiction.

The company also said the Food and Drug Administration has given the medication – known as NKTR-181 – “fast track” designation for the treatment of moderate to severe chronic pain, a status that allows for an expedited review of the drug.

Many pain sufferers say they do not get "high" or experience euphoria from opioid pain medication. But drug makers and government regulators are seeking to develop painkillers with less risk of abuse and addiction.  

"The data from this efficacy study are extremely important because they demonstrate that NKTR-181 produces strong analgesia in patients suffering from chronic pain while NKTR-181 has also demonstrated significantly lower abuse potential than oxycodone in a human abuse potential study," said clinical investigator Martin Hale, MD, medical director of Gold Coast Research.

"While standard opioid analgesics, including abuse-deterrent formulations, have been the most effective way to treat chronic pain, they are associated with serious safety concerns and many opioid-naïve patients fear taking them because of the potential for abuse and addiction.  The data for NKTR-181 suggest that it is a transformational pain medicine that could fundamentally change how we treat patients with chronic pain conditions."

The placebo controlled study involved 610 patients with moderate to severe chronic low back pain who had not taken opioids before. During the open-label phase of the study, pain scores dropped by an average of 65% in patients taking NKTR-181 twice daily.

The company said over half the patients (51.5%) on NKTR-181 reported their general overall status and quality of life "improved" or "very much improved" compared to patients taking a placebo. 

They also reported better overall quality of sleep, with less sleep disturbance and fewer sleep problems. There were no differences in daytime sleepiness on NKTR-181 versus placebo. The drug was generally well-tolerated, although some patients reported nausea, constipation and somnolence.

Nektar is currently conducting another Phase III study to evaluate the safety and tolerability of NKTR-181 in 638 patients with chronic low back pain or chronic non-cancer pain.

The company says NKTR-181 is the first opioid molecule to provide pain relief without high levels of euphoria and sedation. The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier in order to slow its rate of entry into the brain.

Nektar is a research-based biopharmaceutical company that discovers and develops new drugs for which there is a high unmet medical need. It has a pipeline of new investigational drugs to treat cancer, auto-immune disease and chronic pain.

Survey Shows Doctors Shunning Chronic Pain Patients

By Pat Anson, Editor

Chronic pain patients are not only having problems getting opioid medication, most are finding it hard just finding a doctor willing to treat their pain, according to a new survey.

Nearly 3,400 patients, doctors and healthcare providers responded to the online survey by Pain News Network and the International Pain Foundation, which was designed to assess the impact of the CDC’s opioid prescribing guidelines after one year.

The guidelines are voluntary and only intended for primary care physicians, but are being implemented throughout the U.S. healthcare system, often with negative consequences for patients. Over 70 percent of patients said they are no longer being prescribed opioid medication or are getting a lower dose. 

Asked if it has become easier or harder to find a doctor willing to treat their chronic pain, nearly half of patients said it was harder and 11% said they were not able to find a doctor. 

“I have been unable to find a doctor to treat my pain. I was going to a pain doctor but she suddenly dropped all her chronic pain patients to focus on surgery,” said a patient who added that he is now buying pain medication on the black market.

“I have found a new primary care doctor that is OK with prescribing Valium but stated she won't treat chronic pain because ‘the DEA is watching all of us,’” wrote another patient.

"I have been told by more than one doctor that they cannot legally prescribe over the guidelines. They are very concerned about being investigated and as a result refuse to treat pain with an appropriate dose of opioids," said another patient.

HAS IT BECOME EASIER OR HARDER TO FIND A DOCTOR TO TREAT YOUR CHRONIC PAIN?

"I was weaned off opiates last summer," said a patient. "My lower back and head are now in constant pain. I tried to hang myself last December but failed and spent a few days in hospital. Everyone thinks it was bad fall. Next time I won't fail."

"You have taken away my life. I am no longer a member of society, but more importantly, I can no longer function as a mother to two disabled children. I have exhausted all alternative methods of treatment. What do I do now? Illicit drugs or suicide?" asked one mother.

Doctors and healthcare providers are well aware that pain patients are losing access to treatment. Over two-thirds (67%) acknowledge that it is harder for patients to find a doctor.  A small number (9%) admit they’ve stopped treating chronic pain patients.

“I feel a standard of care for pain management has been needed, but the chronic pain patient is being lost in the process,” wrote a pain management provider. “For the first time in 5 years, I had to tell a patient I did not know what to do to help them. Pain management needs regulations, but should not cause the quality of life of chronic pain patients to suffer.”

"The manner in which (the guideline) was issued and received seemed to cause a response in which patients were basically titrated off all medication. Over half of my patients were treated this way," said a psychologist.

"Further, there appeared to be little or no assistance or cooperation in this process of removing a patient's analgesic medication. Overall, I believe that the response to CDC guidelines has harmed legitimate pain patients."

Doctors Worried About Prosecution

Why are some doctors shunning pain patients? They’re not worth the risk or hassle may be the simplest way to explain it. Consider some of the problems healthcare providers say they've dealt with in the past year:

• 59% say a pharmacy refused to fill an opioid prescription for a patient
• 57% say insurance refused to pay for a pain treatment they thought necessary
• 36% are worried about being prosecuted or sanctioned for prescribing opioids
• 20% have discharged a patient for failing a drug test
• 15% are referring more patients to addiction treatment
• 10% have lost a pain patient to suicide

Only 12 percent said their patients were better off without opioids and just 16% said their patients were getting safer and more effective treatment since the guidelines were released. Over a third (38%) believe their patients have more pain and a reduced quality of life.

The survey also found a sizeable number of doctors and providers who mistakenly believe the CDC guidelines are mandatory for everyone. While 70% correctly recognize them as voluntary, 20% think they are mandatory and 10% of healthcare professionals admit they simply don’t know.

"When a government agency suggests treatment guidelines, they will become the law. That is currently happening. We have reduced the number of pain patients and are no longer accepting new pain patients. The fear of prosecution is very real," wrote one pain management doctor.

"They are being interpreted as mandates and creating fear about ever using opioids to treat pain appropriately," said a provider who treats geriatric patients.

“(They) need to make it even more clear that these guidelines are geared for primary care and not experienced board certified pain doctors. Creating hysteria is what this is doing,” said a pain management doctor.

“While well meaning, the guidelines are incredibly biased and my colleagues are using them as an excuse to arbitrarily exclude patients from opioids when they clearly need them,” wrote an emergency room doctor.

ARE THE CDC GUIDELINES VOLUNTARY OR MANDATORY RULES EVERYONE HAS TO FOLLOW?

There is a strong divergence between patients and providers about the safety and effectiveness of opioids. Nearly two-thirds of doctors and providers (64%) think there are safer and better alternatives than opioids, while only about 7 percent of patients think so.    

Another area of disagreement is whether the guidelines are causing more harm than good. The vast majority of patients -- over 95 percent -- believe they have been harmful, while only 40 percent of doctors and providers think so. Nearly one in four healthcare professionals (22%) believe the guidelines have been helpful to patients, while only about 1% of patients think so.

"We have two problems in the U.S. A drug addiction problem and a chronic pain problem. We should not be attempting to treat one problem if that will also create a worsening problem in those that suffer from the other," wrote a primary care doctor. "We need to work on a solution to the addiction problem while still allowing those with chronic pain that need the opioids in order to sustain an acceptable quality of life."

The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11. For more on how the guidelines are affecting patients, click here.

To see the complete survey results, click here.

Heroin Tops Painkillers as Leading Cause of Overdoses

By Pat Anson, Editor

One in four drug overdoses in the United States can now be blamed on heroin, according to a new report by the Centers for Disease Control and Prevention that shows deaths linked to prescription painkillers falling.

The report found that fatal drug overdoses have more than doubled in the U.S. since 1999, with overdose death rates growing the fastest among whites and middle aged Americans.

In 2015, the overdose death rate was 16.3 per 100,000 people, up from 6.1 deaths per 100,000 in 1999. Ten percent of the deaths in 2015 were classified as suicides, 84% were accidental and the remainder undetermined.

The report by the CDC’s National Center for Health Statistics further documents the changing nature of the nation’s drug problem. Overdose deaths involving natural and semisynthetic opioid painkillers – such as hydrocodone and oxycodone – remain high, but have fallen from 29% of all overdoses in 2010 to 24% in 2015.

At the same time, deaths involving heroin have tripled, from 8% of overdoses in 2010 to 25% in 2015 – making heroin the leading cause of drug overdoses.

Deaths involving synthetic opioids, a category that includes both fentanyl and tramadol, rose from 8% of overdoses in 2010 to 18% in 2015. The U.S. has seen a surge in illicit fentanyl being sold on the black market, where it is often mixed with heroin or used to make counterfeit painkillers. More recent data from some states, like Massachusetts and Ohio, show that deaths involving fentanyl now exceed those linked to heroin and painkillers.

PERCENTAGE OF OVERDOSE DEATHS BY DRUG CATEGORY (SOURCE: CDC)

Perhaps the only bright spot in the report is that overdose deaths involving methadone have declined from 12% of deaths in 2010 to 6% in 2015.

The CDC analysis is based on death certificate codes, a database that is not always considered reliable because of wide variability in reporting from state to state.

“At autopsy, the substances tested for and the circumstances under which the toxicology tests are performed vary by jurisdiction,” wrote lead author Holly Hedegaard, MD, a medical epidemiologist with the National Center for Health Statistics.

“Additionally, drug overdose deaths may involve multiple drugs; therefore, a single death might be included in more than one category when describing the percentage of drug overdose deaths involving specific drugs. For example, a death that involved both heroin and fentanyl would be included in both the percentage of drug overdose deaths involving heroin and the percentage of drug overdose deaths involving synthetic opioids excluding methadone.”

Other highlights from the report:

• West Virginia, New Hampshire, Kentucky and Ohio had the highest overdose rates in 2015
• Nebraska, South Dakota, North Dakota and Texas had the lowest overdose rates
• The age-adjusted overdose death rate among whites in 2015 was 240% higher than in 1999
• The overdose rate for whites was nearly double that of blacks and three times higher than Hispanics
• Overdose deaths grew among all age groups, but surged over 500% for adults aged 55 to 64

The report helps document a disturbing increase in deaths among middle-aged white Americans, first reported by Princeton University researchers in 2015.

Anne Case and Angus Deaton estimated that a "lost generation" of nearly half a million Americans died from a quiet epidemic of chronic pain, suicide, alcohol abuse and drug overdoses from 1999 to 2013.  

“This change reversed decades of progress in mortality and was unique to the United States; no other rich country saw a similar turnaround,” Case and Deaton reported in the Proceedings of the National Academy of Sciences. “This increase for whites was largely accounted for by increasing death rates from drug and alcohol poisonings, suicide, and chronic liver diseases and cirrhosis.”

The rising death rate for middle-aged whites was accompanied by declines in physical health, mental health and employment, as well as increases in chronic joint pain, neck pain, sciatica and disability.

Study: Suboxone Usually Fails To Stop Opioid Use

By Pat Anson, Editor

A drug widely prescribed to treat opioid addiction fails so often that two-thirds of the pain patients who took it during addiction treatment wound up getting opioid prescriptions again, according to a large new study by the Johns Hopkins Bloomberg School of Public Health.

Researchers analyzed pharmacy claims for over 38,000 people who were prescribed Suboxone (buprenorphine) between 2006 and 2013, and found that 67 percent of them filled a prescription for an opioid painkiller in the year after Suboxone treatment.

Nearly half of the patients – 43 percent -- filled an opioid prescription during treatment. Most patients continued to receive similar amounts of opioids before and after Suboxone treatment.

Suboxone is a combination of two different medications: buprenorphine, a short-acting opioid similar to methadone, and naloxone, an anti-overdose drug.

During most of the years analyzed in the study, Suboxone was the only combination of buprenorphine and naloxone that was available. It is now sold under several different brand names.

The Johns Hopkins study, which was funded by Centers for Disease Control and Prevention, found that about two-thirds of the patients who received Suboxone stopped filling prescriptions for it after just three months.

The findings, published in the journal Addiction, raise questions about the effectiveness of Suboxone and addiction treatment in general, at a time when the federal government is spending hundreds of millions of dollars to subsidize the addiction treatment industry.

"The statistics are startling," said lead author G. Caleb Alexander, MD, "but are consistent with studies of patients treated with methadone showing that many patients resume opioid use after treatment."

Researchers say the continued use of pain medication during and after addiction treatment suggests that many patients did not have well-coordinated treatment for their addiction or their chronic pain.

“There are high rates of chronic pain among patients receiving opioid agonist therapy, and thus concomitant use of buprenorphine and other opioids may be justified clinically. This is especially true as the absence of pain management among patients with opioid use disorders may result in problematic behaviors such as illicit drug use and misuse of other prescription medications,” Alexander wrote.

Prescriptions for Suboxone and other brands of buprenorphine have soared in recent years as the U.S. grapples with an “opioid epidemic” that was initially fueled by painkillers, but is now increasingly caused by heroin and illicit fentanyl. Sales of buprenorphine now exceed $2 billion annually and are likely to keep growing.

Last year the federal government nearly tripled the number patients that can be treated with buprenorphine by an eligible physician. Raising the limit from 100 to 275 patients was intended to give addicts greater access to treatment, especially in rural areas where few doctors are certified to prescribe buprenoprhine.

An additional $1 billion in funding for addiction treatment was approved by Congress last year under the 21st Century Cures Act. Much of that money will be used to pay for buprenorphine prescriptions.

Addicts long ago discovered that buprenorphine can be used to get high or to ease their withdrawal pains from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked it as the third most diverted opioid medication in the U.S. in 2014. 

How Have the CDC Opioid Guidelines Affected You?

By Pat Anson, Editor

Next month will mark the one year anniversary of opioid guidelines released by the Centers for Disease Control and Prevention – guidelines that discourage primary care physicians from prescribing opioids for chronic non-cancer pain.

At the time of their release, the CDC estimated that as many as 11.5 million Americans were using opioid medication daily for pain relief. Many of those patients now say their doses have been abruptly lowered or they are unable to obtain opioids at all.

That could be a good thing, depending on your point of view about the nation’s so-called “opioid epidemic.” Former CDC director Thomas Frieden, MD, has called the guidelines an “excellent starting point” to stop an epidemic fueled by “decades of prescribing too many opioids for too many conditions where they provide minimal benefit.”

Many pain patients disagree, saying they’ve used opioids safely and effectively for years. They say the guidelines have had a chilling effect on many of their doctors and are being implemented in ways that go far beyond what the CDC intended.  

“Last year, when the CDC ‘recommendations’ came out, the entire building of the only doctor's office I can go to decided they were rules, and cut me from 210 mg/day morphine to 90 mg. Now they say they can only give me 60 mg/day,” wrote Eli, one of hundreds of patients we’ve heard from in the past year.

“I'm in so much pain I can't properly care for myself, nor get to town for supplies when I need them. I've become increasingly more disabled and dependent on others.”

“My pain management doctor told me that the CDC required that all morphine be taken away from all Americans,” wrote a California woman who suffers from severe back pain. “He even stated that surgeons were sending home their post-surgery patients with Motrin, nothing else.

“What are you people in the CDC doing? Don't you realize how paranoid doctors can get? You may think using the term ‘guideline’ will help them understand what you are trying to do, but you have created a bunch of neurotic paranoids. Stop it. Do something before you kill all of us.”

“I am a 76 year old intelligent woman who is not an addict or an abuser, yet I am denied relief from unremitting pain even after 20 years of trying every drug and treatment modality available,” wrote Roberta Glick. “I am at a total loss as to what to do, how to fight, etc.  My physician is a strong supporter.  He is not the problem. He also is a victim of misguided CDC attempts to curb drug addiction.”

Are the CDC guidelines voluntary or mandatory? Have they improved the quality of pain care? Are patients being treated with safer and better alternatives? Most importantly, are soaring rates of opioid abuse and addiction finally being brought under control?

Those are some of the questions Pain News Network and the International Pain Foundation (iPain) are asking in an online survey of patients, doctors and other healthcare providers.

“I strongly believe that as these guidelines are implemented by doctors and hospitals around the country there are important lessons to learn from those who are affected by them,” says Barby Ingle, president of iPain and a PNN columnist.

“I hope that pain patients and providers participate in this survey so that we can begin to show how deep the impact actually is to the chronic pain community one year later.” 

The online survey consists of less than a dozen multiple choice questions, which should take only a few minutes to complete. Please take time out of your busy day and complete the survey by clicking here.

The survey findings will be released on March 15th, the first anniversary of the CDC guidelines. By taking the survey, you can also sign up to have the results emailed to you.

We Need to Admit Opioid Medications Are Dangerous

By Fred Kaeser, Guest Columnist

If chronic pain patients want continued access to opioid medications, we're going to have to admit they can be dangerous

There, I said it.

This has been bothering me for some time now, the apparent inability of many opioid medication users to admit that opioids can be dangerous. Read through the comments here at PNN or any other chronic pain forum and you'll hear a continuous drumbeat from many that opioids are safe when used for chronic pain. No ifs, ands, or buts.

The truth is no one really knows how safe or unsafe long-term opioid use is. No one knows because those studies have never been done.

But what many of us chronic pain patients do know is that popping a 10 mg oxycodone or its equivalent will pretty much do the job for us for a few hours or more.

And for many of us, it will do the job better than any other complimentary or alternative pain modality you can throw at us.

Of course, there are those who will tell us that opioid medications are dangerous. If you happen to be one of the 2.2 million people suffering from opioid medication addiction (OMA) you know they're dangerous. If you're one of the 4 million or so parents whose son or daughter suffers from OMA, you know they're dangerous. And if you're one of the nearly 30,000 parents whose son or daughter died last year from an opioid medication interaction, you really know they're dangerous.

So, opioid medications are dangerous – to them. But what about us chronic pain patients? If you are genetically predisposed to addiction, opioid medication is potentially dangerous to you. But even if you're not predisposed, opioid addiction is still possible. If the addiction rate is just 1% (which some believe), that means for the 11 million Americans who use opioid medication daily, they're dangerous for 110,000 of us. And if you believe the addiction rate is 10%, they're dangerous for 1.1 million of us.

Ever experience opioid withdrawal? Some of us have. How did you like going through that? Many would admit that was pretty dangerous. And if we didn't think it was, we sure thought that it sucked. And how about opioid medication misuse? Misuse our medications and risk respiratory distress or some other negative consequence? It can all be pretty dangerous.

Why do we need to admit opioids are dangerous?

Because to the average Joe and Jane America, we’ll seem pretty stupid if we don't. Policy makers and most of America have bought into the idea that opioids (legal and otherwise) pose a huge problem. If we don't jump on that bandwagon and work together to see how this problem can be effectively handled, we're only going to be left further behind. That train left the station and it isn’t coming back.

Continue to resist admitting that opioid medications can be dangerous, and all those that believe they are will continue to turn a deaf ear when we say we need them for pain relief. We only sound like the addict who is equally convinced that they need their drugs.

We can no longer afford to be seen as part of the problem. It is time that we are seen as part of the solution. And that starts with an open and honest dialog about the dangers of opioids, along with a similar dialog as to how chronic pain sufferers gain a quality of life when we take our medications responsibly -- which is the case the vast majority of the time.

We can argue that chronic pain patients should continue to have access to opioid medication, while at the same time agreeing that they can be dangerous and have created a problem for many in our society.

We can continue to lobby and fight for our right to adequate pain relief, while at the same time lend our efforts in the fight to minimize and reduce the horrors of addiction and death.

By doing so we will enhance our plight in the eyes of those that do not know what it is like to suffer daily the burdens of debilitating chronic pain.

By doing so we will be seen as reasonable and responsible in wanting to thwart the opioid problem. And even though we suffer, we are willing to fight for the greater good.

Most of us are pretty good at standing up and saying we deserve the medications that serve us so well. We can still do that when we also admit that they can be very dangerous.

Fred Kaeser, Ed.D, is the former Director of Health for the NYC Public Schools. Fred suffers from osteoarthritis, stenosis, spondylosis and other chronic spinal problems. He taught at New York University and is the author of What Your Child Needs to Know About Sex (and When): A Straight Talking Guide for Parents.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org.

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

Do Addicts Need Safe Havens to Shoot Up?

By Barby Ingle, Columnist

Lately I have been having more trouble sleeping than usual. At 3 am one night while lying in bed, my mind wandered to the more than 50 personal friends I have lost to suicide, medical complications, delays in treatment, and other health issues since 2012.

By 4 am I was watching the news. I had turned on the TV because my husband moved into a position that activated his “snore button” and I wasn’t going to be able to fall back asleep with that noise.

Then a news promo came across the screen. Next up, the announcer said, we will be discussing a proposal in San Francisco to provide addicts with a supervised facility to shoot heroin and other illegal drugs. Clean needles would be provided at no cost.

They think this will reduce the chances of an overdose death. Similar proposals have been made in other cities, like New York, Seattle and Baltimore.

I couldn’t believe what I was hearing.

I hit rewind and played it again. It really was happening! With the flood of thoughts that came to me, I knew I would never get to sleep and started thinking about the implications if this type of clinic was allowed.

How many ways would it affect our society? What message is it sending? Do I want my tax dollars to go to this type of clinic? Shooting heroin is illegal and there are people who support this?

The CDC put opioid guidelines in place last year for medications that are legal, prescribed and monitored. The guidelines caused many physicians to cut off or lower opioid doses -- even though it was not what some doctors felt was best for their patients. This has led to more suicidal thoughts, attempts, and actual deaths in the pain community.

I know one lady who was unable to get her opioid prescription filled for months. When they finally filled it, she used all the medication at one time to try and kill herself. Why? She didn’t want to face not being able to get the medication again and to go through the withdrawal pain of being without it.

She didn’t die. She was found and placed in a coma in intensive care. When the woman awoke days later, she was angry that her life had been saved.  

We are cutting off pain patients from medication that is legal because abusers may overdose and die. Yet there are plans to give drug abusers who are choosing to behave illegally a safe-haven, while denying legitimate patients access to the care their providers deem necessary.

We already have naloxone and similar medications available for people who overdose. Due to the great lobbying efforts of the “stop the abuse” team, naloxone is now available without prescription in 33 states. So basically it’s wrong to prescribe opioids, but if you choose to abuse them, we want to provide a place for you to use them safely. I am flabbergasted.

Can the legit pain patient show up and get opioids at these clinics as well?

I know if I was a heroin addict where I would be living. I would have my butt planted in a safe-haven drug facility so I could never have to go through withdrawal, be monitored so I don’t overdose, not have to pay for the care, and live the life I want.

That sounds much better than the life of the chronic pain patient, who comes in monthly at their own expense to get a prescription refilled. They are often drug tested, and if anything suspicious is found in their system, they are often taken off opioids and abandoned by their doctors.

Let’s circle back with this argument. Currently, legit pain patients are getting cut off from legally prescribed medications that help them be more productive and live better lives. This leads to withdrawal, which can cause death, and an increase in suicidal thoughts and actions. Some start looking for illegal means to help alleviate their pain.

Are we going to at least provide them with Suboxone, naloxone or methadone to help them come off the opioids more humanely?

We are helping drug abusers find new ways to keep abusing, while chronic pain patients are being ignored and discounted.

Let us not forsake one group for another. We need to find ways that address both pain and addiction concurrently, that don’t affect either side negatively or take away the rights of one group to give more rights to another. Let’s lower suicide statistics for those in chronic pain and overdose statistics for those who are abusing. It can be done. Silly proposals to provide safe-haven drug facilities for illegal drug use are wrong.

I am so looking forward to hearing everyone’s opinion in the comment section. Maybe there is something I am missing as to why anyone would think this is a good idea?

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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

CDC 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.

Bias and Conflict of Interest in Opioid Guidelines Study

By Pat Anson, Editor

A new study published in JAMA Internal Medicine is claiming that some patient advocacy groups and medical organizations that opposed the Centers for Disease Control and Prevention’s opioid prescribing guidelines had a conflict of interest.

Ironically, the two main authors of the study appear to have a conflict of interest themselves, as well as a bias against opioid pain medication.

In their review of 158 organizations that made public comments on the CDC guidelines – which discourage doctors from prescribing opioids from chronic pain – researchers found that about one third (38%) of those that accepted funding from opioid manufacturers opposed the guidelines. This alleged conflict of interest should have been disclosed, they say.

“A major concern is that opposition to regulatory, payment, or clinical policies to reduce opioid use may originate from groups that stand to lose financially if sales of opioids decline,” wrote senior author G. Caleb Alexander, MD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health.

“Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

One of the co-authors who designed the study is Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid group that helped draft the CDC guidelines and was itself accused of numerous conflicts of interest. Kolodny is the former chief medical officer of Phoenix House, which runs a chain of addiction treatment centers and was PROP’s chief source of financial support until recently.

Alexander, who is a widely published researcher who has collaborated several times with Kolodny on other opioid-related studies, failed to disclose in the JAMA study that he has accepted funding from Otsuka Pharmaceuticals. The Japanese drug company makes Abilify, an anti-psychotic medication prescribed off-label to treat chronic pain. The amount paid to Alexander in 2015 was relatively small, a $668 fee for consulting, but according to the criteria used in his own study, it represents a conflict of interest.

Any amount of money accepted from an opioid manufacturer was considered a conflict of interest in Alexander and Kolodny’s study, whether it was a grant, gift, advertising or some other material support. No evidence was required to prove the money swayed an organization one way or another. In fact, nearly two-thirds (62%) of the organizations that accepted funding from opioid makers supported the CDC guidelines, disproving their own theory.   

“I’ll be the first to say that our method of assessing financial relationships is somewhat imprecise,” Alexander told Pain News Network. “This study was not designed for causal inference. This study doesn’t permit us to say what the effect of these funding relationships has been. But one has to wonder, when this amount of money is being spent, what the effects are.”

PROP and the “Opioid Lobby”

The claim that many medical organizations and patient advocacy groups have come under the influence of the “opioid lobby” has long been used by Kolodny.

“CDC’s plan was effectively blocked by intense pressure from the opioid lobby, which sees more cautious opioid use as a financial threat,” wrote Kolodny in a newsletter sent to PROP supporters in December 2015, after the CDC guidelines were temporarily delayed after a public outcry and threats of a lawsuit.

Kolodny’s smear campaign was widely covered uncritically by the news media, even though there was no evidence cited to support it.

“This is a big win for the opioid lobby,” Koldony told the Associated Press.

“The story here is how the opioid lobby is using the Cancer Action Network to discredit a public health effort to limit opioid prescribing,” Kolodny told The Hill.

“Here’s background on shady organization now attacking CDC’s draft opioid guideline,” Kolodny posted on Twitter.

Kolodny did not respond to a request for comment for this story.

Like his co-author, Alexander also is convinced there is a quid-pro quo between opioid manufacturers and groups that they fund.   

“The biggest myth out there is that there’s a conflict between reducing our dependence on opioids and improving care for patients in pain,” Alexander told the AP last year. “It’s an artificial conflict, but there are lots of vested interests behind it.”

Does the opioid lobby even exist? Are patient advocacy groups so easily swayed by their funding sources? Kolodny and Alexander’s study presented little evidence of either, yet they still managed to get it published in an influential journal published by the American Medical Association.

“No one in the pharmaceutical industry has ever asked me or anyone that is on our voting board to publicly state a specific stance on any issue regarding treatment options. Not one pharmaceutical representative has ever asked anyone from iPain to comment on the CDC guidelines,” said Barby Ingle, a PNN columnist who is President of the International Pain Foundation (iPain), a patient advocacy group.

Ingle, who did submit her own personal comments on the CDC guidelines, says it is very difficult to get funding from drug makers.

“We have gotten to the point of not even applying for funding unless we are contacted,” said Ingle. “Even when notified of funds available, iPain did not receive the funding requested and it turned out to be a waste of time on our part.”

What is a Conflict of Interest?

“These people perhaps don’t quite understand what is the definition of a conflict of interest,” said Richard Samp, chief counsel of the Washington Legal Foundation, which threatened to sue the CDC for violating federal law when it drafted the opioid guidelines.

“As I understand conflict of interest under federal law, that generally means that somebody has been appointed to serve in one position, but they have some other financial or ideological interest that conflicts with the interests that they’re supposed to have,” Samp told PNN.

“That was the focus of our criticism of the process that CDC went through in adopting its draft guidelines, which were written with the assistance of an advisory group that included people who had very severe conflicts of interest. For example, one particular member of the group, Jane Ballantyne, was a paid consultant for a plaintiffs’ law firm that had a vested interest in suing opioid manufacturers.”

Dr. Ballantyne is the President of PROP, the organization founded by Kolodny. At least four other board members of PROP, including Kolodny himself, served on various CDC panels that advised the agency during the drafting of the guidelines, a matter that the agency refused to disclose for several months.   

“What they are talking about (in the JAMA study) is not a conflict of interest. They’re just talking about the fact that some people who file comments with federal agencies have a particular point of view,” said Samp. “Every citizen regardless of his or her point of view and regardless of his or her background has a right to comment on what our government is doing.”

Another way to look at whether there is a conflict of interest is offered by Stephen Ziegler, PhD, in a commentary for Pain News Network (see "CDC Guidelines Study: The Devil Is in the Details").

“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,” Ziegler wrote.

Ziegler says it’s time for the pain community and the addiction treatment community to end the finger pointing and bullying over opioids, and start finding common ground.

“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,” Ziegler wrote.

The American Academy of Pain Medicine (AAPM), an association of pain management physicians, also released a statement about the JAMA study, saying it agreed that “disclosure is one means of managing conflicts of interest.” 

While the AAPM cautiously supported the CDC guidelines, it also warned that their widespread implementation could lead to problems.

“It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately,” the AAPM said.

Since the guidelines were released in March 2016, many pain patients have complained to PNN that their opioid doses have been reduced or eliminated, and that it’s become difficult to find a doctor willing to treat chronic pain. Others have said they are contemplating suicide because their pain is going untreated.

FDA Approves New Long Acting Painkiller

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended release opioid pain medication with abuse deterrent properties.

Egalet Corporation announced Monday that the FDA has approved Arymo ER – a long-acting version of morphine -- for the management of pain severe enough to require daily, around-the-clock opioid treatment. It comes in the form of a pill that is very difficult to crush or liquefy, methods used by abusers to speed the release of an opioid into the bloodstream.

"With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools," Bob Radie, president and CEO of Egalet said in a news release.

“Arymo ER has physical and chemical properties expected to make abuse by injection difficult which is important given it is the most common non-oral route of morphine abuse and the most dangerous.”

An FDA advisory panel recommended in a 18-1 vote last August that Arymo be approved. It is is the 7th opioid with abuse deterrent properties approved by the FDA. The other medications are OxyContin, Targiniq, Embeda, Hysingla, Morphabond, and Xtampza.

Arymo has been approved in three dosage strengths: 15 mg, 30 mg and 60 mg. Egalet plans to make the drug available in the first quarter of 2017.

Arymo is the first commercial product developed with Egalet’s Guardian technology, which incorporates the medication into a polymer matrix tablet to make it difficult to misuse or abuse.

“Guardian Technology results in tablets that are extremely hard, very difficult to chew, resistant to particle size reduction, and inhibit/block attempts at chemical extraction of the active pharmaceutical ingredient,” the company says in a statement on its website.

“In addition, the technology results in a viscous hydrogel on contact with liquid, making syringe-ability very difficult. These features are important to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation. “

The approval of abuse-deterrent medications is still somewhat controversial. Some medical professionals and anti-opioid activists say the technology does not completely prevent abuse and the drugs are still being misused by addicts.

Few Pain Patients Become Long-Term Opioid Users

By Pat Anson, Editor

Less than two percent of patients with prescriptions for opioid pain medication become long-term opioid users, according to a large new study published online in the journal Pain.

Researchers at Indiana University studied a nationwide database of over 10 million patients who filed insurance claims for opioid prescriptions between 2004 and 2013. The study was designed to look at opioid use by patients with psychiatric and behavioral problems, but in the process uncovered data indicating that the overall risk of long term opioid use for six months or more was relatively rare for most patients.

“Of the 10,311,961 incident opioid recipients, only 1.7% received long-term opioids during follow-up,” wrote lead author Patrick Quinn, PhD, of Indiana University, Bloomington.

“The probability of transitioning from first fill to long-term opioids was 1.3% by 1.5 years after the first prescription fill, 2.1% by 3 years, 3.7% by 6 years, and 5.3% by 9 years. Fewer than half of long-term recipients met a stricter long-term definition (at least 183 days supply) during follow-up. The likelihood of receiving long-term opioids by this stricter definition was 1.0% by 3 years.”

Addiction treatment specialists and public health officials have long claimed that even short-term use of opioid medication quickly raises the risk of addiction and death.

“The bottom line here is that prescription opiates are as addictive as heroin. They’re dangerous drugs,” CDC Director Thomas Frieden recently told the Washington Post. “You take a few pills, you can be addicted for life. You take a few too many and you can die.”

The Indiana University researchers did find a “relatively modest” increase in long term opioid use by patients with depression, anxiety and other mental health conditions, and those taking psychoactive drugs. Rates of long-term use were 1.5 times higher for patients taking medications for attention-deficit disorder (ADHD); three times higher for those with previous substance use disorders other than opioids; and nearly nine times higher for those with previous opioid use disorders.

Ironically, the strongest risk for long-term opioid use was in patients being treated with buprenorphine (Suboxone), an addiction treatment drug.

“Patients with OUDs (opioid use disorders) and buprenorphine or naltrexone prescription fills were at substantially greater risk of transitioning to long-term opioids earlier in follow-up than were patients without these conditions or medications,” Quinn wrote.

The researchers also found that patients with a history of suicidal or self-injuring behavior were at greater risk of using prescription opioids long-term.

 “It is likely that patients with psychiatric problems are more likely to experience more severe pain symptoms or greater pain-related functional impairment, perhaps leading providers to prescribe more aggressively to address pain-related concerns,” Quinn said. “It is also possible that patients with comorbid pain and psychiatric conditions may be more likely to seek care repeatedly or from multiple treatment providers because of their greater symptom severity or perceived need for care, resulting in a higher rate of opioid receipt in aggregate.”

Quinn and his colleagues do not rule out opioid therapy for pain sufferers with psychiatric problems, but recommend that they be given mental health counseling “in conjunction with the use of long-term opioid therapy.”

New CDC Overdose Study Reduces Role of Pain Meds

By Pat Anson, Editor

The Centers for Disease Control and Prevention has quietly released a new report showing that illegal drugs like heroin, cocaine and fentanyl are responsible for more drug overdose deaths in the United States than opioid pain medication.

The report not only underscores the changing nature of the nation’s overdose epidemic, but undermines some of the rationale behind federal efforts to limit the prescribing of pain medication and public statements used to justify them.

In 2010, for example, the study found that oxycodone was the top drug involved in overdose deaths. But by 2014, the painkiller was ranked third, behind heroin and cocaine.

The anti-anxiety drug alprazolam, more widely known by the brand name Xanax, was ranked as the nation’s fourth deadliest drug; while the synthetic opioid fentanyl -- most of it probably illicit -- was ranked fifth and fast gaining ground.

Deaths linked to oxycodone and other prescription pain medications – although still significant, at about 16,000 a year -- remained relatively stable, even as the total number of drug overdoses increased by 23 percent, from 38,329 deaths in 2010 to 47,055 in 2014.

One of the CDC’s stated reasons for releasing its opioid prescribing guidelines earlier this year was that “the death rate associated with opioid pain medication has increased markedly,” a statement that now appears to be factually wrong, in light of the new study.

This online statement in a CDC analysis of overdoses also appears incorrect: "Prescription opioids continue to be involved in more overdose deaths than any other drug."

Both statements came from the CDC's National Center for Injury Prevention and Control. It was a different part of the agency, the CDC’s National Center for Health Statistics that arrived at this new evidence, after collaborating with the FDA in developing an enhanced method to study overdose deaths that allowed them to identify specific drugs.

The old method used by the CDC relies on death certificate codes, known as ICD codes, which can broadly categorize an overdose as “opioid related” without ever determining what the drug was, if it was legal, or even if it was the cause of death.

Using new software, researchers scanned the actual text in hundreds of thousands of death certificates, including notes written by coroners about the cause of death and other significant factors involved in an overdose.

“The literal text analysis method… leverages existing information on the death certificates for statistical monitoring of drug-involved mortality deaths. Assessments conducted during the methods development process demonstrate that these methods have high accuracy in identifying the drugs mentioned and involved in mortality as well as the corresponding deaths,” the researchers said in an analysis of the new method.

2014 OVERDOSE DEATHS BY DRUG

Source: CDC and FDA

The study, which covered overdoses from 2010 to 2014, found that many deaths involved multiple drugs or alcohol. Over three-quarters of the deaths involving oxycodone and hydrocodone, for example, involved other substances. Alcohol was involved in 15 percent of all drug overdoses. 

Anti-anxiety drugs like alprazolam (Xanax) and diazepam (Valium) were also involved in many deaths. Alprazolam was involved in about a quarter of the overdoses involving hydrocodone (26%), oxycodone (23%) and methadone (18%). The FDA recently expanded warning labels on all opioids and benzodiazepines, including alprazolam and diazepam, to discourage doctors from prescribing them together.

“The combinations of drugs in drug overdose deaths are important to consider when interpreting the study findings. Importantly, the most frequently mentioned drugs involved in drug overdose deaths were often mentioned with each other. For example, heroin and cocaine were involved concomitantly in more than 2,000 deaths. Another pair, oxycodone and alprazolam, were involved concomitantly in more than 1,000 deaths,” the report found. 

While the textual analysis of death certificates is an improvement over previous methods, researchers admit it still has flaws. It cannot distinguish between prescription fentanyl and illicit fentanyl; some deaths that refer to morphine may actually involve heroin; and some deaths classified as “unintentional” may have actually been suicides.  

It also cannot distinguish between the recreational use of a medication obtained illicitly and the medical use of a prescription by a legitimate patient.

Many pain sufferers believe they have been unfairly penalized by the CDC’s opioid prescribing guidelines as part of an effort to keep pain medication away from addicts and recreational users. Since the guidelines were released, many physicians have stopped prescribing opioids or sharply reduced the dosage, even if a patient has safely used the medication for years. 

Oddly, the CDC released this new study just a week after releasing its annual report on drug overdose deaths, which used the older, flawed method of analyzing overdoses.  Further adding to the confusion and questionable use of statistics, the White House Office of National Drug Control Policy and the CDC released three different estimates of the number of Americans that died of drug overdoses in 2015 (see “Opioid Overdose Statistics: As Clear as Mud”).  

An Open Letter to President-Elect Trump

By Percy Menzies, Guest Columnist

Dear President-Elect Trump,

You will soon have an extraordinary opportunity to save thousands of lives with one stroke of the pen! I am talking about reducing overdose deaths from opioid overdoses. How is this possible?

We have three highly effective medications for the treatment of opioid addiction, but they are grossly under-utilized, largely due to accessibility. Two of the three drugs used to treat opioid use disorder have restrictions that have no place when overdose deaths exceed 30,000 per year. These restrictions made sense at a different time, but these barriers are now inadvertently contributing to overdose deaths.

I am specifically talking about buprenorphine, the most widely used medication in the battle against the opioid epidemic. This medication, better known by its brand name Suboxone, is an opioid with a very safe profile. Its unique pharmacology makes it almost impossible to overdose.

There are barriers to the use of this medication which made sense 14 years ago, when heroin was not a public health issue, but today they are a hindrance to saving lives.

Buprenorphine is the only drug that requires physicians to complete eight hours of training and then apply to the Drug Enforcement Administration to obtain a special exemption to prescribe it. It gets worse. Physicians can only treat 30 patients with this medication in the first year, and then they must obtain permission from the DEA to increase the limit to 100 patients. The physician also has to keep clear records and can expect a visit from a DEA agent to look at the records. 

This is a major deterrent and way too few physicians have bothered to obtain the required exemption. Any physician who has a DEA license can prescribe an FDA-approved controlled substance without restriction, but they have to deal with this barrier to prescribe buprenorphine. 

These restrictions were put in place to prevent buprenorphine from joining the opioid “pill mills” when few anticipated heroin sweeping our cities and towns. At the present time, there is no strategy in place to cut off or curtail the supply of heroin, or heroin that is laced with super potent opioids like fentanyl. Deaths from prescription opioids are declining, while deaths from heroin and fentanyl are climbing. Indeed, prescriptions for opioids drugs have fallen between 12 -25%, but the overdoses deaths have not declined. 

Yes, buprenorphine is being diverted, but most experts believe that is due to the lack of treatment. Patients desperately seeking treatment are purchasing the drug on the streets. Many experts believe that if patients have expanded and easier access to buprenorphine, the diversion will drastically reduce and more patients will be in treatment and get away from heroin.

Several steps have been taken to address this catastrophic problem, but these steps are woefully inadequate. Expansion of the needle-exchange programs and the widespread distribution of the opioid overdose drug naloxone (better known by the brand name Narcan) are welcome and should be expanded, but they are at best palliative in nature. These measures do little to address the underlying addiction.

The federal government is increasing the patient limits for buprenorphine for selected specialists from 100 to 275, and will also allow nurse practitioners and physician assistants to complete the required training and obtain the DEA exemption to prescribe buprenorphine. These are welcome steps, but fall far short of the response required to expand treatment and reduce deaths. 

You got elected on a law-and-order platform and a promise to reduce the flow of heroin coming in from Mexico. Almost 50 years ago, Richard Nixon got elected on a similar platform.  He too faced an unprecedented public health epidemic of heroin addiction – one that is nowhere close to what we are facing today.  

President Nixon is remembered for taking a bold measure, which at that time was controversial. He initiated the opening of methadone clinics, which for the first time provided evidence-based treatment for heroin addicts. This measure reduced overdose deaths, protected society from criminal activity, and allowed these patients to become productive members of society.  For the first time in the dark and checkered history of our nation, addiction was treated as a chronic healthcare issue and not a criminal activity. 

Nixon went a step further to curb the supply of heroin coming into this country. He put political pressure on France to shut down the illegal labs processing Turkish-grown opium into heroin. Turkey also complied with the strong U.S. demand to curb the illegal cultivation of opium. Who can forget The French Connection, the thriller movie about this operation.

Mr. Trump, you have an extraordinary opportunity to lift the present restrictions on buprenorphine through executive order, to lure patients away from heroin and drastically reduce overdose deaths. Your action would provide increased treatment and not just palliative care.

Furthermore, you are in the best position to bring pressure on Mexico to eliminate the opium processing labs and drastically reduce heroin coming into this country.  An epidemic is best treated when effective treatment is combined with eliminating factors contributing to the spread of the epidemic. In this case, it is the supply of heroin.

This one single action will earn you the gratitude of tens of thousands of families terrified at hearing a knock on the door informing them of the death of a loved one. You will also earn the gratitude of millions of patients suffering from chronic pain, who have been needlessly cut off from prescription opioids because of the overreaction of regulators and many physicians.

You will be remembered in history for a bold action that saved a generation from succumbing to a man-made epidemic.

Percy Menzies, M. Pharm, is the president of the Assisted Recovery Centers of America, a treatment center based in St Louis, Missouri.

He can be reached at: percymenzies@arcamidwest.com

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.

Opioid Overdose Statistics: As Clear as Mud

By Pat Anson, Editor

We’ve written before about how confusing and muddied the statistics can be for overdose deaths from opioid pain medication. (see “Lies, Damned Lies, and Overdose Statistics”). Now the White House and the Centers for Disease Control and Prevention are adding to the confusion.

Last week a news release from the White House Office of National Drug Control Policy stated that 17,536 Americans died in 2015 from overdoses involving prescription opioids, a 4% increase from the year before.

This week the CDC reported in its Morbidity and Mortality Weekly Report that the number of overdoses involving painkillers was actually smaller.

“Natural opioids (including morphine and codeine) and semi-synthetic opioids (including commonly prescribed pain medications such as oxycodone and hydrocodone) were involved in more than 12,700 deaths in 2015,” a CDC news release said. The agency said that was a 2.6% increase from the year before.

We asked the CDC to explain the discrepancy and were given a third number

“Given the recent surge in illegally-made fentanyl, the CDC Injury Center is analyzing synthetic opioids (other than methadone) separately from other prescription opioids (natural, semi-synthetic, and methadone). Using this approach, the number of deaths involving prescription opioids was… 15,281 in 2015,” CDC spokesperson Courtney Leland said in an email.

“This number better reflects the deaths associated with prescription opioids given the changing nature of the epidemic and increasing surge of illicit opioids.”

And what about the White House estimate?

“Their analysis of 17,536 deaths in 2015 was calculated by including any death that involved: opium; natural and semi-synthetic opioids; methadone; and unspecified narcotics (opioids). You would need to check with them about their rationale/methodology,” Leland explained.

In other words, the White House Office of National Drug Control Policy knowingly counted a number of overdoses caused by illicit opioids as prescription drug deaths.

All of these numbers may make your eyes glaze over, but they demonstrate an important point about the nation’s so-called opioid epidemic: No one really knows how bad it is.  Which is startling, because it’s an important national issue and Congress just voted to spend another $1 billion to fight it.

They may want to get their numbers straight first.

One thing the White House and the CDC do agree on is that overdoses from illegal opioids such as heroin and fentanyl are soaring, and deaths involving opioid pain medication appear to be leveling off.

The CDC reported many troubling statistics about opioid overdoses, which claimed over 33,000 lives last year:  

• Death rates nationwide from synthetic opioids such as fentanyl increased by over 72%
• Death rates from synthetic opioids more than doubled in New York (136%), Connecticut (126%) and Illinois (120%).
• Heroin death rates nationwide increased by nearly 21%
• Deaths rates from heroin jumped even more in South Carolina (57%), North Carolina (46%), and Tennessee (44%).

Perhaps the only bright spot was that deaths associated with methadone dropped by 9 percent, which the CDC attributed to lower methadone doses and less prescribing.

The agency still believes there is an “ongoing problem with prescription opioids” and that the number of overdoses may be undercounted.  

“Regardless of the analysis strategy used, prescription opioids continue to be involved in more overdose deaths than any other drug, and all the numbers are likely to underestimate the true burden given the large proportion of overdose deaths where the type of drug is not listed on the death certificate,” the CDC explains in a separate report.

Questionable Data

The CDC continues to rely on death certificate codes for much of its data, which many experts find troubling because the codes do not reflect the cause of death --- only the conditions that exist at the time of death.  In other words, somebody could die from lung cancer, but if a doctor used morphine to help ease the dying patient’s cancer pain, a box could be checked on their death certificate indicating opioids were present at the time of death. The CDC would consider that an “opioid involved” death.

Other factors that raise questions about the reliability of the CDC’s data:

• Overdose deaths were based on data from only 28 states “with high quality reporting”
• Wide variability in the expertise and training of local medical examiners and coroners who complete death certificates
• Nearly 1 out of 5 death certificates nationwide do not include any drug data
• Some heroin deaths may have been misclassified as prescription drug deaths
• Some overdose deaths may have been counted twice.

Critics also say there is a disturbing tendency by the CDC to “cherry pick” data to dramatize the harm caused by prescription opioids, without ever discussing their benefits. For example, the agency referred to a recent report from the DEA this way:

“The Drug Enforcement Administration referred to prescription drugs, heroin, and fentanyl as the most significant drug-related threats to the United States. The misuse of prescription opioids is intertwined with that of illicit opioids; data have demonstrated that nonmedical use of prescription opioids is a significant risk factor for heroin use, underscoring the need for continued prevention efforts around prescription opioids.”

The CDC does not mention that the DEA also found that the prescribing and abuse of opioid pain medication is actually in decline, that the number of admissions to treatment centers for painkiller addiction is falling, and that less than 1% of prescription opioids are diverted. Nor does the CDC mention that the DEA found a “massive surge” in the production of counterfeit pain medication made with illicit fentanyl, which is probably killing quite a few patients seeking pain relief.  

The CDC cites its own research to make the claim that it “did not find evidence that efforts to reduce opioid prescribing were leading to heroin overdoses.” But the DEA report said just the opposite: Some prescription opioid users are switching to heroin when they are no longer able to obtain medication:

“Some abusers, when unable to obtain or afford CPDs (controlled prescription drugs), begin using heroin, a cheaper alternative that offers similar physiological effects. With the successful reduction in availability of controlled prescription drugs, more users may shift to abusing heroin.”

This isn’t the first time the CDC has been accused of cherry picking data for public consumption. The same complaint arose when the agency released its opioid prescribing guidelines, many of which relied on “weak” or “very weak” evidence to support the contention that opioids should not be prescribed for chronic pain.

Recent research published in the journal Pain Medicine also took the agency to task for dismissing evidence that opioids could be used safely long term, while making no mention of the significant risks posed by non-opioid pain medication.

“No common nonopioid treatment for chronic pain has been studied in aggregate over longer intervals of active treatment than opioids. To dismiss trials as ‘inadequate’ if their observation period is a year or less is inconsistent with current regulatory standards,” wrote lead author Daniel Carr, MD, President of the American Academy of Pain Medicine and Program Director of Pain, Research, Education & Policy at Tufts University School of Medicine.  

“Basing therapeutic decision-making upon durations of published clinical efficacy or effectiveness trials does not support choosing any drug or nondrug therapy over another. In fact, the opening words of the first recommendation of the CDC… make no mention of the overwhelmingly strong evidence for significant morbidity and mortality risk from the most likely nonopioid alternatives to opioid therapy for chronic pain: NSAIDs, coxibs (cox-2 inhibitors), and acetaminophen.”

Although the CDC guidelines are “voluntary” and only intended for primary care physicians, many patients have reported that their chronic pain is going untreated or under-treated because they are no longer able to obtain opioids or their doses have been drastically lowered by their physicians. Other patients have been abruptly “fired” by doctors who no longer want to treat chronic pain because they fear prosecution for overprescribing opioids. Still other patients are contemplating or have committed suicide.

Where are the statistics about that?

Misuse of Pain Meds by Teens Continues Decline

By Pat Anson, Editor

Two new studies this week paint a somewhat conflicting picture about the abuse of opioids by teens and pregnant women.

A survey of over 45,000 teens by the University of Michigan and the National Institutes of Health found that teenage drug abuse continues to decline, with a significant drop in the misuse of the painkiller Vicodin. A second study at the university found the number of babies born with opioid withdrawal symptoms has grown substantially, especially in rural areas.

The annual Monitoring the Future survey found that 4.8% of high school seniors had misused an opioid pain reliever in the past year, down from a peak of 9.5% in 2004. In the past five years alone, misuse of opioid pain medication by 12th graders has declined by 45 percent.

Only 2.9% of high school seniors reported the misuse of Vicodin in 2016, compared to nearly 10 percent a decade ago. Vicodin and other hydrocodone products were reclassified as Schedule II controlled substances in 2015, making them harder to obtain.

"Clearly our public health prevention efforts, as well as policy changes to reduce availability, are working to reduce teen drug use,”  said Nora Volkow, MD, director of National Institute of Drug Abuse.

The survey found a continued long-term decline in teenage use of many illicit substances, as well as alcohol and tobacco. The use of any illicit drug was the lowest in the survey’s history for eighth graders. One negative sign was an increase in the misuse of over-the-counter cough medicine by eighth graders.

Marijuana use in the past month by eighth graders fell to 5.4%, down from 6.5% in 2015. However, among high school seniors, nearly one in four reported marijuana use in the past month. There also continues to be a higher rate of marijuana use in the past year (38%) among 12th graders in states with medical marijuana laws.

"It is encouraging to see more young people making healthy choices not to use illicit substances," said National Drug Control Policy Director Michael Botticelli. "We must continue to do all we can to support young people through evidence-based prevention efforts as well as treatment for those who may develop substance use disorders.”

The majority of teens continue to say they get most of their opioid pain relievers from friends or relatives, either stolen, bought or given. The only prescription drugs seen as easier to get in 2016 than last year are tranquilizers, with 11.4 percent of eighth graders reporting they would be “fairly easy” or “very easy” to get.

More Babies Suffering from Opioid Withdrawal

The number of babies born with drug withdrawal symptoms from opioids grew substantially faster in rural communities than in cities, according to the University of Michigan study. The study did not distinguish between opioid pain medication and illegal opioids such as heroin.

Newborns exposed to opioids in the womb and who experience withdrawal symptoms after birth (neonatal abstinence syndrome) are more likely to have seizures, low birthweight, breathing, sleeping and feeding problems.

Researchers found that in rural areas, the rate of newborns diagnosed with neonatal abstinence syndrome increased from nearly one case per 1,000 births from 2003-2004 to 7.5 cases from 2012-2013. That's a surge nearly 80% higher than the growth rate of such cases in urban communities.

"The opioid epidemic has hit rural communities especially hard and we found that these geographical disparities also affect pregnant women and infants," says lead author and pediatrician Nicole Villapiano, MD, whose study was published in JAMA Pediatrics.

Using national data, researchers found that rural infants accounted for over 21 percent of all infants born with neonatal abstinence syndrome. In 2003, rural infants made up only 13 percent of the neonatal abstinence syndrome cases in the U.S.  

Maternal use of opioids in rural counties was nearly 70 percent higher than in urban counties. Rural infants and mothers with opioid-related diagnoses were more likely to be from lower-income families, have public insurance and be transferred to another hospital following delivery.

Villapiano says families in urban areas typically have better access to addiction treatment programs.

"We need to consider what kind of support moms with opioid disorders have in rural communities," she said.

Villapiano suggests that increasing the number of rural doctors authorized to prescribe the addiction treatment drug buprenorphine (Suboxone), as well as expanding rural mental health and substance abuse services, would be good first steps in reversing the trend in neonatal abstinence syndrome.