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.

Pam Bondi to Join Trump Opioid Commission

By Pat Anson, Editor

Less than three weeks before its final report is due, President Trump’s opioid commission is getting a new member --   Florida Attorney General Pam Bondi.

Bondi is a longtime supporter of the president, served as a member of his transition team, and was once rumored to be the next head of the White House Office of National Drug Control Policy. There was speculation back in March that Bondi would be named to the opioid commission, but it was not until last week that the White House confirmed it was President Trump's "intent to appoint" Bondi to the panel, which currently has five members.

Curiously, Bondi’s office blamed New Jersey Gov. Chris Christie, the chair of the opioid commission, for the six month delay in getting her on board. Both Bondi and Christie are lame ducks serving out their final months in elected office.

“The President always intended for the Attorney General to be on the Commission – however, Governor Christie choose (sic) to begin the Commission with only himself and four others,” Whitney Ray, Bondi’s spokesman, said in an email.

“The announcement (of Bondi's appointment) is protocol before the Executive Order is signed next week. The Attorney General will continue to work with President Trump, General Kelly, Kellyanne Conway and other leaders to combat the national opioid epidemic.“

Bondi's spokesman also reportedly said that the October 1 deadline for the commission to release its final report would be extended. No such announcement has been made and the White House website still doesn’t list Bondi as a commission member.

FLORIDA ATTORNEY GENERAL PAM BONDI

The Trump administration has also yet to issue an official declaration that the opioid crisis is a national emergency – something the President said he would do over a month ago.  

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said on August 10.

Bondi played a prominent in shutting down 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 heroin and illicit fentanyl.

“The problem is Bondi isn't doing enough about the heroin epidemic,” the Miami Sun Sentinel said in an editorial.  “Considering that Bondi was once touted as a potential Trump drug czar — and infamously failed to investigate Trump University after receiving a major donation from Trump — it's no surprise that she was named to the commission. But she's still living off her reputation from the pill mill crack down.

“In fact, if you Google Bondi and heroin, by far the most you'll read about is when she slammed a drug dealer for stamping Trump's name on a batch of heroin. You won't find any solutions to our crisis.”

In a recent interview with WMBB-TV, Bondi warned that drug dealers were putting heroin and illicit fentanyl into counterfeit medications.

"It's a national epidemic and it truly affects everyone, and parents need to really warn their kids, their teens, adults need to know, never take a pill from someone you don't know, even if they say it is a Tylenol, an Advil or an aspirin. Don't take anything from someone who you don't know," said Bondi.

The initial focus of Trump's opioid commission has been on educating, preventing and treating opioid addiction. An interim report released by the commission in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, 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, although they could be added to the commission’s final report.

In addition to Gov. Christie, 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. No pain patients, pain management experts or practicing physicians were appointed to the panel.

Is This the Opioid of the Future?

By Pat Anson, Editor

What do you call a pain reliever that doesn't have a name yet, is not FDA approved and may not be available for years?

Nektar Therapeutics calls it the "opioid of the future."

Nektar is a research-based pharmaceutical company that has developed a new type of opioid medication that shows promise in relieving moderate to severe pain, but without the risk of abuse and addiction of traditional opioids like oxycodone or hydrocodone.

The experimental pill -- which for the time being is called NKTR-181 --  has recieved “fast track” designation  from the Food and Drug Administration, but is at least a couple of years away from full FDA approval and a commercial launch.

That hasn't stopped Nektar from promoting NKTR-181. This week it hosted a lunch symposium on the drug at PainWeek -- an industry trade show underway in Las Vegas -- a sign of just how confident the company is that NKTR-181 will receive final approval from the FDA.

"We think we could see approval as early as the end of next year," says Steve Doberstein, PhD, Chief Scientific Officer of Nektar. "So we could see a launch of this product in the first part of 2019. That would be my aspiration. If we have to do more clinical trial work, it would be delayed."

The FDA usually requires at least two "Phase 3" clinical studies to prove a new drug's effectiveness. Nektar has only completed one -- a Phase 3 study of over 600 patients with chronic back pain who reported that their pain scores dropped by an average of 65% when taking NKTR-181 twice daily.

Nektar has also completed smaller safety studies that found recreational drug users had significantly less “drug liking” of NKTR-181 -- even at high doses -- when compared oxycodone. Participants also had less daytime sleepiness and fewer withdrawal symptoms.

"NKTR-181 is quite boring as far as abuse metrics go. Boring is good. That was our goal. It doesn't appear to cause euphoria," says Doberstein.

NKTR-181 is "boring" because of its slow rate of entry into the brain's central nervous system – which significantly reduces the “high” or euphoric effect that recreational users seek. Many pain sufferers don't feel that high when taking opioid medication, they just get pain relief. But in the current regulatory and political climate, the only way a new opioid will be approved by the FDA is if it has a low or non-existent abuse potential.

"We're very focused on the fact that one of the building blocks of solving this problem is going to be a safe pain medication for chronic pain patients to take," Doberstein told PNN. "The things that work best are opioids. But the existing conventional old-fashioned opioids -- oxycodone is 100 years old -- come with an unacceptable side effect profile for many patients. And we think we've made something that is legitimately better. It's the first time in a very long time that a new opioid molecule has been developed."  

Doberstein thinks NKTR-181 has such low potential for abuse that it will not need to come in an abuse deterrent formula that would make it harder to crush or liquefy. The FDA could still require one, however, which would delay the drug's commercialization even longer. The agency is currently reviewing the effectiveness of all drugs with abuse deterrent formulas.

The FDA also has a new opioid policy steering committee that is examining whether the agency sufficiently considers the risk of abuse during its evaluation of new opioids.  That could result in rule changes that Nektar would have to address. Anti-opioid activists and politicians could also pressure the FDA to require more clinical studies on the safety and potential abuse of NKTR-181.

Another potential obstacle is that Nektar still needs to partner with a larger pharmaceutical company to help produce and commercialize NKTR-181 -- which is when the no-name "opioid of the future" will likely get a makeover with a branded name to make it more marketable.

"This is the kind of medicine that we think could be quite significant. It could really change medical practice. That means we need a lot of education, and a lot of outreach to physicians, hospitals, payers, patient advocates and law enforcement. We have a lot to do. And its probably beyond us to do it ourselves. So we'll have a commercialization partner of some kind," said Doberstein, who told PNN he expects Nektar to announce its new partnership by the end of the year.

Dosing Tables for Painkillers 'Fraught with Danger'

By Pat Anson, Editor

Opioid dosing tables that are widely used by doctors, insurers and regulators to determine what constitutes a safe level of opioid medication are "fraught with danger" and could result in patients being under-dosed or overdosed, according to a leading physician's group.

Equianalgesic dosing tables are used to calculate and convert opioid pain medication into milligrams of morphine equivalent daily doses -- often abbreviated as MEDD or MME. The Centers for Disease Control and Prevention, for example, has set 90mg MME as the highest recommended daily dose for most chronic pain patients in its opioid prescribing guideline.

But a new white paper by the Academy of Integrative Pain Management (AIPM) questions the science behind MME conversion tables and whether they are appropriate to use in a one-size-fits-all approach to pain care.

“We felt it was necessary to outline our concerns about the key concept of equianalgesic dosing,” said Bob Twillman, PhD, Executive Director of AIPM. “We have seen policymakers and payers both relying on this concept as if it was based on solid science, and as if individual differences in a number of factors wasn’t important in clinical practice. Doing so can expose patients to significant risks."

Some opioids have different mechanisms of action on opioid receptors in the brain. Patients could also have genetic or biological differences that slow or speed-up the absorption of opioids into the body -- making them either more potent or less effective. As a result, two patients taking identical doses of the same opioid could have different levels of it in their bloodstream an hour later.

None of these differences were recognized by the CDC, Centers for Medicare and Medicaid Services or the Department of Veterans Affairs when they set limits in their opioid guidelines on what constitutes a recommended "safe" dose of pain medication.   

"The practice of setting arbitrary milligram dosing cut-offs as suggested by various regulatory agencies and legally allowed by some states is an attempt to pigeon hole providers into ignoring the approach to medicine," the white paper states. "Rather than assigning irrational rules based on pseudoscience, the regulatory agencies including the CDC and state governments should be targeting ways to increase knowledge and education with regard to opioids to foster safe and efficacious prescribing practices."

Many different opioid calculators and apps are available to help doctors convert oxycodone, hydrocodone, tramadol and other opioid medications into MEDDs or MMEs. It's a common practice that may give physicians peace of mind in complying with government guidelines and insurance company policies. But for patients the benefits are less clear -- and so is the science.

“I’ve been researching and writing about the problems with equianalgesic dosing for the past several years," said Jeffrey Fudin, PharmD, lead author of the white paper. “As I studied this concept, I was shocked by the poor quality of the studies underlying it and by the dramatic clinical effects that could result from an uncritical use of published conversion tables.

"Add to that the fact that some opioid pain medications just don’t fit the concept because of their mechanisms of action, and you have the potential for some serious negative consequences if policies improperly use this information.”

How Chronic Pain Killed My Husband

By Meredith Lawrence, Guest Columnist

So much has been written about the opioid epidemic, but so little seems to be out there about what living with true chronic pain is like. My husband, Jay, lived and died in incredible pain at the age of 58.  As his wife, I lived that journey with him. 

Jay is no longer here to tell his story, but I want the world to see what I saw.  I want you to know how he went from working 60 hours a week doing hard physical labor, until his pain grew worse and he could not even get out of a chair on his own. 

I want you to know the deterioration Jay went through over the last ten years. I want you to know what a good day and a bad day is like when you live with chronic pain.  I want you to know exactly what happened when the doctor decreased his pain medication. And I want you to know how my husband finally made the decision to commit suicide. 

I want people to understand that when chronic pain runs your life, eventually you just want the pain to stop. 

First a bit of history.  I met Jay in 2005, when we both stopped drinking.  Two years later, Jay began to lose feeling in his legs and started having falls, as a result of compressed nerves in his spine. The pain was so bad Jay had to stop working and go on disability, which started his depressive episodes.

JAY LAWRENCE

Jay had a series of lower back and neck fusion surgeries.  This was when he was first prescribed painkillers, antidepressants and anti-anxiety medications.  From 2008 to 2011, Jay tried various treatments to control the pain that lingered even after a third back surgery.  These included steroid shots, nerve blocks and a spinal cord stimulator.  Ultimately he had a drug pump implanted that delivered morphine, in addition to the pain pills he was being prescribed.

In 2012, Jay was diagnosed with trauma induced dementia.  I believe that diagnosis was right, based on his symptoms, but not all of the doctors agreed.  Some believed the confusion was due to high doses of morphine and/or his sleep apnea.  

By 2016, Jay’s confusion and memory issues were increasing. He was on a steady dose of 120mg morphine daily, in addition to the medication he was receiving from his pain pump. 

Jay’s depression seemed to come and go, depending on the day and his pain levels.  He was weaned down on his Xanax to 2mg a day to help him sleep. He was aware of the risks of combining Xanax and morphine. 

JAY AND MEREDITH LAWRENCE

Let me tell you what a good day was like before they changed his medications. I worked a full time job from 2 pm to 10 pm five days a week. I would get home, and Jay would have my coffee ready for me at night.  We would stay up and watch TV until 2 or so.  When it was time for sleep, I went to bed and he slept in his recliner.

We started sleeping apart after his first surgery in 2007. He was more comfortable sitting up in the chair, but could never sleep more than three hours at a time.  He knew sleeping in bed would just keep me awake. 

A good day always meant it was not cold or raining.  On a good morning, he would be up first and get coffee started.  He would take our two miniature pinchers outside in the yard on their leash for potty time. 

We usually had at least one appointment a week, but if not we could have a nice quiet morning.  That meant coffee in front of the TV.  After a couple of hours of that, he might switch over to playing his computer games, but he was never far from his chair. 

A typical adventure for us would involve going to Walmart.  Jay was not able to walk through the store, but he hated using the handicapped carts. I could always see a look on his face when he had to do it.  After going to the store, we might have lunch or an early dinner at Steak n Shake or Cracker Barrel.  It always needed to be some place familiar and comfortable for him.  More than once we sat, ordered and then took our food home because he was in too much pain. 

In the summer we might walk the dogs after dinner.  Just a quick two block walk, but a lot of times he would have to stop halfway and go back home.  A couple of times I had to go get the car and pick him up because his legs just would not support him anymore. 

A bad day was awful for me to watch, and absolutely horrible for Jay to live. It meant no real sleep, just catnaps in the chair whenever he could.  He always made coffee for us, but on a bad day he would forget to add coffee to the coffee maker and we would just have hot water.  The pain was so much he was just distracted. 

On many bad days, I would look over and see tears just running down his face because he was in so much pain.  It also made Jay’s depression worse.  We spent many cold winter nights talking about how much pain would be too much and would make life not worth living.  It is the most horrible feeling in this whole world to hear the person you love most talk about ending their life. 

In January, 2017 Jay’s pain clinic decided they could no longer prescribe the high doses of morphine he was on.  In addition, they were not going to continue seeing him if he decided to stay on Xanax.  The Xanax was prescribed by another doctor, but they did not care.

I begged the pain doctor -- yes, literally begged -- for some other option. The doctor said that if Jay continued the Xanax he would no longer see him.  He would not give another option for medications, and at one point even said that most of his patients with pain were “making it up.”

The last thing the doctor said to us will stick with me forever.  He said, “My patient’s quality of life is not worth losing my practice over.”

When we left that day, we were barely in the car and I knew what Jay was going to say to me.  I will never forget how sad his voice was when he told me this was it for him. He was not going to continue to live like this.

Through the month of February, as Jay’s medication was decreased, we spent time doing things we did not normally do.  We went out on Valentine’s Day, he bought me the first jewelry he had bought since my engagement ring, and we went out to a fancy restaurant for dinner.  Jay tried to cram in as many good memories as he could into that last month, but I knew it was costing him.

Jay’s next doctor’s appointment was scheduled for March 2, and we knew they were going to decrease his medications again.  The night before, he woke me up to tell me it was time.  I knew what that meant, but I tried to be strong for his sake.  We talked all night long about what it meant, and how it should be.  It was the saddest, strangest, longest night of my life. 

Jay knew he did not have enough pills to kill himself.  He also knew that if he were to try and purchase a gun, they would not sell it to him.  It would have been almost obvious what he was going to use it for. 

In the end, I bought the gun that Jay used -- and yes, we talked about the ramifications of that action.  We went to the park where we had renewed our vows in 2015.  We talked in the car for a while, and then we sat in the same place we had cut our wedding cake.  I was holding his hand when he pulled the trigger. .

Through the shock and horror, my immediate feeling was one of relief for Jay. To know that he was finally out of pain was a weight lifted off both of us.

Because I purchased the gun that Jay used to end his life, I was charged under our state's assisted suicide law.  This charge was later reduced to reckless endangerment, and I am currently on probation. People close to me want me to be quiet about my role in Jay’s death, and I was at first. But I cannot continue that way. 

I know Jay wanted me to put his story out there.  I know he wanted people to know what it was like to live with the pain he lived with daily. When the doctor took away Jay’s medications, they took away his quality of life. That was what led to his decision. Jay fought hard to live with his pain for a long time, but in the end fighting just was not enough. 

Something has to be done to wake up the doctors, insurers and regulators to make them see pain patients as real people. People with husbands, wives and children that love them.  People that are suffering and just barely holding on. 

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 represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CDC Ignored Warning About Opioid Guidelines

By Pat Anson, Editor

A consulting company hired by the Centers for Disease Control and Prevention warned the agency last year that many doctors had stopped prescribing opioid pain medication and that chronic pain patients felt “slighted and shamed” by the CDC’s opioid guidelines.

“Some doctors are following these guidelines as strict law rather than recommendation, and these physicians have completely stopped prescribing opioids,” PRR warned in a report to CDC in August 2016, five months after the CDC released its guidelines.

“Pain patients who have relied on these drugs for years are now left with little to no pain management options. Chronic pain is already stigmatized. Now chronic pain patients face the stigma of addiction, even when they are using opioids responsibly for pain management.”

PRR is a well-connected marketing and public relations firm based in Seattle that has worked for a number of companies and public agencies, including the Environmental Protection Agency, Starbucks, Nike, and the University of Washington.

PRR was hired by the CDC to improve the agency’s public image and to develop a communication strategy to help educate the public about the CDC’s controversial opioid guidelines.

Those guidelines, which discourage doctors from prescribing opioids for chronic pain, are voluntary and only intended for primary care physicians. But they’ve been widely adopted as mandatory throughout the U.S. healthcare system, causing additional pain and anxiety for millions of pain sufferers.

“Chronic pain patients feel or perceive that the CDC has failed them because doctors are making extreme generalizations in determining appropriate care for their pain patients,” PRR found.

The PRR report to CDC was obtained by Pain News Network under the Freedom of Information Act.  Excerpts from the report can be seen by clicking here.

PRR recommended that CDC take a number of steps to understand why the guidelines were being so poorly received by patients.

“CDC should consider conducting more research to understand the fears and concerns of patients with chronic pain conditions. Understanding this group’s perceptions and fears of the PDO (prescription drug overdose) guidelines will help the CDC more successfully communicate with patient advocacy groups and will help insure their targeted messages are being disseminated to patients,” PRR recommended.

“Overall, this will help CDC message and communicate to those living with chronic pain and help providers and patients understand best care options available to enhance and improve quality of life.”

No CDC Response to Recommendations

There is no evidence that CDC has followed through on the recommendations. When asked if the agency had conducted any research or surveys of pain patients in response to the PRR report, the CDC gave us only a brief and vaguely worded statement. Note the use of the word “will.”

“CDC will evaluate the uptake, utility, and public health impact of the guideline and will monitor and assess physician and patient response to the guideline; based on this information, we will update the guideline in the future, as needed.

CDC continues to develop resources for patients and providers about the risks and benefits of opioid therapy for chronic pain to improve the safety and effectiveness of pain treatment and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death.”

CDC pledged in March 2016 to make changes to the guideline “if new evidence becomes available” and said it was “committed” to evaluating the guideline’s impact – “both intended and unintended.”

But in the 17 months since that pledge was made, there has apparently been no effort by CDC to assess the guideline’s impact on pain care, doctors, patients, suicides, addiction or overdoses -- at least none that the agency will talk about.

“We’ve provided you our statement,” a CDC spokesperson said in an email.

PRR also declined to answer any questions about its report or if any follow-up research is being done.

“We are proud of our work, and we respect client communications protocols. Therefore, we refer you to the CDC to ask your questions directly,” said Jennifer Lynch, PRR’s business development manager.

For the record, this reporter was one of five individuals interviewed by PRR last summer, and asked a series of questions about the CDC guideline. Others who were surveyed include Barby Ingle of the International Pain Foundation, Paul Gileno of the U.S. Pain Foundation, chiropractor Sean Konrad, and Dr. Lynn Webster, a pain management expert and past president of the American Academy of Pain Medicine.   

“I was contacted by the PRR firm as well.  I was told that the CDC wanted to know what they did wrong with the opioid prescribing guidelines,” recalled Webster. “I think it is clear that the CDC should have had more input from the pain community in developing the opioid guidelines.

“Any intervention by the CDC or any government agency that affects millions of people should be accompanied with a plan to assess the effect of the intervention. In other words, the CDC should have planned to measure the effect on intended goals and any unintended consequences from the intervention.”

"CDC recommends close follow-up for patients who are using opioids to treat chronic pain, but they don’t seem to be eager to apply that same advice to their own intervention," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. "CDC seems to be eager to evaluate the impact of its guideline in terms of metrics such as number of opioid prescriptions written, but they seem to have little concern about assessing the extent to which decreased prescribing is adversely affecting people with pain.

"In all the discussion about the evidence base supporting the guideline, what seems to have gotten lost is a need to develop the evidence base to show how effective or ineffective that intervention has been. Unfortunately, this lack of evaluation is consistent with CDC’s lack of interest in evaluating the prevalence and demographics of chronic pain itself."

Guidelines Made Pain Care Worse

There have been many unintended consequences caused by the guidelines. In a survey of over 3,000 patients and nearly 300 healthcare providers by PNN, eight out of ten patients said their pain and quality of life had grown worse. Many patients are having suicidal thoughts, and some are hoarding opioids or turning to illegal drugs for pain relief.   

Over half of the healthcare providers said they had stopped prescribing opioids or were prescribing lower doses. Many providers also believe the guidelines are ineffective or have made pain care worse:

• 40% believe CDC guidelines have been harmful to patients, while only 22% consider them helpful
• 67% believe guidelines have made it harder for pain patients to find a doctor
• 63% believe the guidelines have not improved the quality of pain care
• 66% believe guidelines have not been effective in reducing opioid abuse and overdoses
• 35% of providers are worried about being prosecuted or sanctioned for prescribing opioids

“I am not sure the CDC is aware of the increased legal trouble many physicians are experiencing as a result of the guidelines. Most of these physicians are just trying their best to help people in pain but are being accused of criminal conduct,” said Webster.

Webster was apparently the only pain management physician interviewed by PRR. The company also reviewed 11 online articles and blogs (about half written by doctors), which gave the guidelines mixed reviews.  PRR's bare bones analysis could hardly be called comprehensive, yet two federal health officials portrayed it as a ringing endorsement of the guidelines by physicians.

“Practitioners are excited to see action taken to address the PDO epidemic,” wrote Tonia Gray and John O’Donnell of the Substance Abuse and Mental Health Services Administration in an appendix to the PRR report. “From our scan of responses, PRR found that many agree this is a step in the right direction to help providers make informed decisions and stem the PDO issue.”

That assessment certainly doesn't reflect the thoughts of Dr. Webster.

“I would urge the CDC to reassess their process and attempt to understand the unfortunate consequences their well-intended but misinformed decisions have had,” said Webster.

“One presumably unintended consequence is the recommendations/guidelines have been adopted as rules and laws, which has resulted in a significant change in care for millions of patients.  The guidelines were never intended to do that – they lack the backing of scientific evidence to be treated as a law.”

CDC has made few efforts to remind doctors, insurers, politicians and state regulators that the guideline is voluntary and only intended for primary care physicians. One of the few was a letter from a top CDC official to Richard Martin, a retired Nevada pharmacist disabled by chronic back pain.

“All of you at the CDC and like-minded groups, individuals, etc. are causing hundreds of thousands, if not millions of people, to suffer in pain needlessly,” wrote Martin, who sent 27 letters and emails to the agency before getting a response from Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention.

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients,” wrote Houry, who oversaw the development of the guideline. “The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

Houry’s letter to Martin was dated June 1, 2016, a full two months before CDC received the PRR report, suggesting that CDC was already aware that problems were developing with the guideline and that many physicians considered it mandatory.

CDC 'Propaganda'

To be clear, PRR’s review of patient and doctor attitudes about the guideline was only a small part of the work it performed for CDC. PRR also provided media training to CDC officials, analyzed news and social media coverage of CDC projects, developed logos and brands, shot promotional videos and pictures, and performed other work traditionally associated with public relations projects.

PRR also developed a series of fact sheets and graphics to help CDC promote the opioid guideline – many of which are still in use today.

The graphics advise doctors that “opioids are not first-line or routine therapy for chronic pain” and that physicians should “start low and go slow” when opioids are prescribed. They also encourage doctors to tell patients that “there is not enough evidence that opioids control chronic pain effectively long term.”

One PRR graphic claims that "as many as 1 in 4 people" who take opioids long-term become addicted. The graphic is based on a single study that even the author admits may have been biased and used unreliable data. A longtime critic of the CDC calls the graphic "propaganda."

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem. Other estimates put the addiction rate higher and some lower.

prr designed graphic

It’s been difficult to assess how much PRR was paid for its work. Invoices sent to CDC indicate the original budget for the project was $240,596, but there were numerous delays and changes in the work performed. The invoices have been heavily redacted by the agency at the request of PRR, which considers the information proprietary.     

CDC: Heroin and Fentanyl Crisis ‘Rapidly Expanding’

By Pat Anson, Editor

A new report from the Centers for Disease Control and Prevention further documents the “rapidly expanding” death toll linked to heroin and illicit fentanyl – an overdose crisis that the CDC continues to blame on prescription opioids.

The agency reported in its Morbidity and Mortality Weekly Report that nearly 13,000 American died from heroin overdoses in 2015, four times the number of heroin deaths in 2010.

Starting in 2013, deaths from illicitly manufactured fentanyl (IMF) also began to spike in the Northeast, Midwest and South -- what the agency calls the “third wave” of the overdose crisis.  Fentanyl is a powerful synthetic opioid 50 to 100 times more potent than morphine.

“The heroin and IMF drug market in the United States is rapidly expanding in the context of widespread prescription opioid misuse. As a result, opioid-involved deaths are cur­rently at peak reported levels,” the CDC reported.

“Increased heroin availability combined with high potency and relatively low price might have made heroin a viable substitute because its effects are similar to those of prescription opioids. The strongest risk factor for heroin use and dependence is misuse of or dependence on prescription opioids.”

But a second report from CDC that focused on more recent overdoses in Ohio tells a different story. Opioid pain medication plays a shrinking role in the Buckeye state’s overdose crisis.

heroin and fentanyl pills (DEA photO)

In the first two months of 2017, the CDC estimated that at least 259 people died in Ohio from overdoses of fentanyl or fentanyl analogs – compared to just 12 deaths involving heroin, 64 deaths linked to opioid pain medication, and 75 deaths involving benzodiazepines, a class of anti-anxiety medication that includes Xanax.

“Evidence from the toxicologic analyses of unintentional overdose deaths in Ohio from the beginning of 2017 indicate the increasing and substantial role of IMFs, and the declining presence of heroin and pharmaceutical opioids in overdose fatalities,” the CDC said.

A recent report from the DEA found a similar trend in neighboring Pennsylvania. Over half the drug deaths in Pennsylvania in 2016 were linked to fentanyl and just 25 percent involved painkillers.

‘The Medical Board Will Come After You’

How are politicians reacting to these new reports about the changing nature of the overdose crisis?

In Ohio they’re tightening the rules on prescription pain medication. New guidelines that went into effect yesterday limit opioid prescriptions for acute pain to just seven days for adults and five days for minors. Patients suffering from cancer or chronic pain are exempt from the rules -- although many doctors have been reluctant to prescribe to those patients because they fear scrutiny. Ohio’s governor didn’t mince words when he warned prescribers that they’ll be held accountable for any slip-ups.

"If you're a dentist, doctor, I don't care who you are, you violate these guidelines, the medical board will come after you," Gov. John Kasich said in the Cleveland Plain Dealer. "And you will be disciplined and perhaps even lose your license."

New Jersey Gov. Chris Christie, who chairs President Trump’s opioid commission, uses similar language that pins the blame on doctors.

“Four out five new heroin addicts start on prescription opioids. This is a problem that’s not just starting on our street corners. Where it’s really starting is our doctor’s offices and hospitals,” Christie told CNN.

Jeffrey Singer, MD, a senior fellow at the Cato Institute,  warns that this sort of “frightening and imprecise rhetoric” often lead to poorly designed policies that only make the problem worse.

“No matter how much regulators clamp down on the medical use of opioids the overdose rate grows. Yet the overwhelming majority of overdose victims are not patients receiving opioids for pain,” Singer wrote in Townhall.

“The opioid overdose problem requires a calm and reasoned approach, and a willingness to admit to previous policy mistakes. Rhetoric aimed at frightening the public does not foretell a propitious start.”

Controversial Genetic Testing Company in Receivership

By Pat Anson, Editor

A controversial genetic testing firm under federal investigation for healthcare fraud has been placed into court-ordered receivership – a form of bankruptcy – that could lead to the restructuring and sale of the company. The CEO and founder of Proove Biosciences has also left the company.

In an interview with STAT, former CEO Brian Meshkin blamed the company's financial problems on “erroneous and damaging” reports that were based on “false allegations” by disgruntled former employees.

Proove Biosciences specializes in DNA testing that the company claims can improve the effectiveness of pain management treatment and determine whether a patient is at risk of opioid addiction.

In June, FBI agents raided the company’s headquarters in Irvine, California. Former and current employees who were interviewed by STAT said the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

In July, PNN reported that Proove was linked to a Medicare fraud case, in which three Indiana healthcare providers allegedly “caused Proove Bioscience… to falsely and fraudulently bill various health care programs for genetic tests... that were not medically necessary and never interpreted."

Proove was not named as a defendant in the Indiana case. In an email to PNN, Meshkin said Proove had cooperated with investigators.

“Proove has cooperated with both the FBI and US Attorney’s office on this case," said Meshkin. "With regards to tests being 'medically necessary', Proove received written and signed determinations of medical necessity supporting the tests ordered and billed to insurance carriers just like every other laboratory which requires such a determination on a test requisition form. Thus Proove operated appropriately and consistent with usual and customary practices."

Meshkin also defended Proove research, published in the Journal of Addiction Research & Therapy, which claimed to show the effectiveness of its genetic tests.The publisher of the journal, OMICS International, has been accused by the Federal Trade Commission (FTC) of deceiving researchers and readers about the true nature of its publications and peer review process.

"Proove can only speak to its experience with this particular journal,” Meshkin said in an email to PNN. "Specifically for papers submitted to this journal, our R&D team and academic collaborators engaged in documented, extensive peer-review, received suggested edits and provided responses to the suggested edits to the manuscripts submitted for review and publication. Thus, Proove would certainly consider the publications accepted from Proove-affiliated authors in that journal to be 'peer-reviewed'."

According to the FTC complaint filed last August, OMICS  has created hundreds of "open access" online medical journals that publish articles with little or no peer review. Researchers are also charged significant fees to get their articles published by OMICS, a "pay to play" policy that some consider unethical because it diminishes the quality of academic journals and the peer review process.

Proove has aggressively promoted its genetic tests with healthcare providers around the country. A pain clinic in Montana, for example, had a Proove “patient engagement representative” employed on site at the Benefis Pain Management Center in Great Falls.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” said Rodney Lutes, a physician assistant who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.”

Lutes’ supervising physician at the clinic was Katrina Lewis, MD, a pain management specialist at Benefis who is listed as a member of Proove’s Medical Advisory Board.  Lewis apparently plays a significant role at the clinic, even though she only works there part time. Benefis has denied that Lewis or any of its employees received kickbacks from Proove for referring business to them.

STAT reported that Proove’s restructuring was apparently ordered by Mike Leavitt, a Proove board member, who also served as Utah governor and secretary of the Department of Health and Human Services. Leavitt’s investment firm, Leavitt Equity Partners, provided about $7 million in funding to Proove, according to Meshkin.

A former Proove manager told STAT that she initially felt good about going to work for the company, but soon had misgivings about Proove's research and billing practices.

“It sucked the life out of me, on an integrity level,” said Rhonda Frantz-Smith. “It got more and more corrupt.”

Petition Calls on FDA to Ban High Dose Opioids

By Pat Anson, Editor

A group of anti-opioid activists has filed a citizen petition with the Food and Drug Administration, asking the agency to remove most high dose opioid pain medications from the market.

The petition would apply to all opioid pills that exceed a daily dose of 90mg morphine equivalent units (MMEs), which the Centers for Disease Control and Prevention set last year as the highest recommended dose for primary care physicians and their patients.  

Such a ceiling, if adopted by the FDA, would take all OxyContin 80mg tablets off the market, as well as many other high-dose oral painkillers. A single OxyContin 80mg tablet, according to the petition, is equivalent to 160 MME.

Another example cited in the petition would be immediate release oxycodone 30mg tablets. If four such pills are taken daily, as they are often prescribed, that adds up to 180 MME.

The petition claims high dose opioid pills raise the risk of overdose and addiction, and are especially harmful to children.

“These products are just too dangerous, there's no need for them," said Pete Jackson, who lost his teenage daughter to an OxyContin overdose.

"These are not medicines. These are lethal weapons that should be removed from the market," said Andrew Kolodny, MD, an addiction treatment specialist and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), one of five anti-opioid activists who signed the petition. None are considered experts in pain management.

“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. “For patients that may have difficulty swallowing it is important to note that opioid analgesics are available in liquid preparations, sublingual preparations, patches and suppositories.”

Opioids ‘Can Be Appropriate’

In a rare acknowledgement that opioids "can be appropriate" for some pain patients, Kolodny and the other petitioners wrote that "the benefits of prescribing high doses may outweigh the risks when treating severe pain from a life-limiting illness."

But then they make the dubious claim that flooding the market with lower-dose pills will somehow be safer. Reducing the potency of painkillers would mean patients need more to get pain relief – resulting in more pills being prescribed, stored in medicine cabinets, and possibly stolen or diverted – hardly a prescription for reducing abuse.

Having to take more pills could also be risky to patients.  

"With a very large number of pills to manage, they are going to be at more risk of taking the wrong number of pills and of having some of those pills swiped by others without them noticing," Stefan Kertesz, MD, an Alabama primary care physician, told the Associated Press.

“Given the significance of the nation’s opioid crisis, this petition and issue should be discussed by the scientific experts at FDA and we look forward to participating in such a discussion,” Purdue Pharma, the maker of OxyContin, said in a statement. “It is critical that we seek the appropriate balance of treating pain severe enough that requires opioid treatment for which alternative treatments are inadequate, with efforts combating the opioid crisis.”

The FDA had no immediate comment on the petition.  Any U.S. citizen can file a petition with the agency to seek the removal of a drug or medical device for safety issues.

In June, the FDA asked Endo Pharmaceuticals to take Opana ER off the market because it was being abused, the first time that sales of an opioid painkiller have been halted. FDA commissioner Scott Gottlieb, MD, has hinted the agency could take other painkillers off the market.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said in June.

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

Chronic Pain Patient: ‘They Are Killing Us Off’

By Pat Anson, Editor

Rob Hale isn’t sure how much longer he’ll live. Which is why the 51-year old Missouri man wants to share his story one more time, so people can see the impact the CDC's opioid prescribing guideline -- what Rob calls the “new cruelty” – is having on pain patients like himself.   

“That's it, man. I quit. I am too weak to continue. I'm beat. I hope some of you can live long enough to see some change in this new cruelty,” Rob wrote to me in an email. “Thank you so much, Pat, for providing me a platform in which to vent my frustration, pain, and anger at the system. I'm not sure if it helped anyone or not, but I hope it did.”

Rob first shared his story with us in a PNN guest column last December. At the young age of 27, he was diagnosed with ankylosing spondylitis, a degenerative and incurable form of arthritis that causes severe inflammation in spinal joints.

As the decades passed, the joints in Rob’s spine and neck became fused, and he was disabled and bedridden by chronic pain.

Relief only came from relatively high doses of opioid pain medication – as much as 600 MEMs (morphine equivalent units) a day. It reduced the pain enough for Rob to start working again, do chores around the house, and take care of his elderly father. Rob felt like his life was worth living again.

ROB HALE

Then came the CDC guidelines in 2016. Although they are voluntary and only intended for primary care physicians, Rob’s pain management doctors reduced his daily morphine dose to 120 MEMs, with the ultimate goal of getting it down to 90 MEMs – what the CDC recommends as the ceiling for high doses.

With his pain no longer being treated properly, Rob’s health deteriorated and he started taking high doses of Motrin, a prescription form of ibuprofen. He took so much Motrin it built up to toxic levels in his kidneys.  

“I was hospitalized in May, when my father couldn’t revive me in the morning. I woke up intubated, with IV’s and wires connected everywhere.  I was unconscious for 4 days, and when I finally awoke, I thought I had died and come back,” Rob said. “I was told if my dad hadn’t found me, I would have died within hours."

The cost to Medicare and taxpayers for that one stay in the hospital was $91,000 -- one of the unintended consequences of weaning or tapering a patient off high doses of opioids. Their healthcare costs often go up.

"None of that would have been necessary if I hadn't been denied my meds in the first place," Rob adds.

Rob was hospitalized a second time in June. His pain now grows worse every day, his health is failing, and he feels his time is running out.

“I nearly died, all because of this ‘opiate crisis.’ I just wanted to tell you that I’m home, albeit on oxygen, because my lungs are still filled with fluid, and I’m not sure how long I have to live,” he said.  “My old palliative care doctor and my current GP doctor think all of this that I’m going through right now is because of the trauma of the pain that I’ve been feeling since they started cutting me back.”

Rob feels he and other pain patients are being held responsible for an overdose crisis they didn’t create. He’s written letters to the CDC, FDA, DEA and to President Trump -- and only gotten form letters in return.

“The simple truth is this: They are killing us off - all of us chronic pain patients. We are, quite simply, a drain on the system, and the whole system would function much better without us. They'll get what they want, too. Before long, we'll all be gone - whether by our own hands, or by complications from our untreated pain, like me,” Rob wrote.

"I sure hope something changes soon. I’m not ready to give up the ghost yet, but I’m so weak that I can hardly type.  Why are they doing this to us, man?"

New Federal Task Force to Address Opioid Prescribing

By Pat Anson, Editor

The federal government is forming another advisory panel to study and develop "best practices" for treating acute and chronic pain. And for the first time, the feds are seeking nominations from the public for members to serve on the panel, who would represent pain patients and pain management experts.

The Pain Management Best Practices Inter-Agency Task Force was authorized by the Comprehensive Addiction and Recovery Act of 2016 – also known as the CARA Act – a landmark bill signed into law last year to address the nation's addiction and overdose crisis.

While much of CARA is focused on preventing and treating opioid addiction, the law also calls for the Department of Health and Human Services (HHS) to form a task force to recommend solutions to “gaps or inconsistencies” in pain management policies among federal agencies.

Currently, the Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, and the Department of Defense all have different regulations and guidelines for opioid medication.

“This Task Force represents a critical piece of HHS’s five-point strategy to defeat the opioid epidemic, which includes advancing the practice of pain management,” HHS Secretary Tom Price said in a news release.

“Top experts in pain management, research, addiction and recovery can help us reassess how we handle the serious problem of pain in America.”

The task force could have as many as 30 members representing a broad spectrum of interests in pain management, according to a notice being published in the Federal Register:

The members of the Task Force shall include currently licensed and practicing physicians, dentists, and non-physician prescribers; currently licensed and practicing pharmacists and pharmacies; experts in the fields of pain research and addiction research, including adolescent and young adult addiction; experts on the health of, and prescription opioid use disorders in, members of the Armed Forces and veterans; and experts in the field of minority health.

The Members of the Task Force shall also include… representatives of pain management professional organizations; the mental health treatment community; the addiction treatment community, including individuals in recovery from substance use disorder; pain advocacy groups, including patients; veteran service organizations; groups with expertise on overdose reversal, including first responders; State medical boards; and hospitals.

Members will also be appointed to represent Veterans Affairs, Department of Defense, Office of National Drug Control Policy, and “relevant HHS agencies.” The latter most likely includes the FDA and CDC. The Drug Enforcement Administration, an agency in the Department of Justice, will apparently not have a representative on the task force.

Pain patients and pain management experts have been poorly represented – and in some cases excluded – from previous federal advisory panels that addressed opioid prescribing and addiction. Some panel meetings were also closed to the public.

President Trump’s opioid commission, for example, includes three governors, a former congressman, and a Harvard professor who has been a longtime critic of opioid prescribing. No patients, pain management experts or practicing physicians were appointed, and the commission only heard testimony from addiction treatment advocates during its one public meeting.

That was better than the CDC, which held no public hearings while preparing the initial draft of its opioid prescribing guideline in 2015. As PNN has reported, the “Core Expert Group” and various stakeholders that advised the CDC were dominated by special interest groups and addiction treatment specialists, including five board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Only after a public outcry and threats of a lawsuit did the agency delay the release of the guideline, seek public comment and form a new advisory panel.

Are you interested in becoming a member of the new task force on pain management or know someone who might?

Information on how to nominate individuals – including self-nominations -- can be found by clicking here. Applications are due by Wednesday, September 27. All nominations must be submitted via email to the attention of Vanila Singh, MD, Chief Medical Officer at PainTaskforce@hhs.gov.

Members of the task force who are not government employees will receive per diem pay and reimbursement for travel expenses. All task force meetings will be open to the public.

Is China Doing Enough to Stop Fentanyl Smuggling?

By Pat Anson, Editor

China has been an "incredible partner" in cracking down on illicit fentanyl and other synthetic opioids, according to Health and Human Services Secretary Tom Price.

"When a particular drug is identified as being a problem, China has been an incredible partner in helping to stop the production of drugs like fentanyl in China," Price told The Associated Press during a visit to China this week.

A closer look suggests otherwise. Mexican drug cartels continue to smuggle alarming amounts of fentanyl – usually produced in China -- into the U.S. and Canada, where it is often mixed with heroin or turned into counterfeit painkillers.

Consider these recent news reports:

The Mexican military last Saturday seized 63.8 kilograms of fentanyl (over 140 pounds) at a checkpoint just yards from the U.S. border near Yuma, Arizona. The newspaper El Financiero reported the powdered fentanyl was found hidden inside a tractor trailer rig, along with nearly 30,000 tablets made with the chemical. The shipment had an estimated street value of $1.2 billion – by far the largest seizure ever of illicit fentanyl.

A week earlier, DEA agents confiscated 30,000 more counterfeit pills at a traffic stop near Tempe, the largest seizure of fentanyl tablets in Arizona history. The Tucson News reported the drugs were connected to the Sinaloa drug cartel.   

The fake pills were designed to look like oxycodone -- an "M" and a "30" were stamped on the blue tablets.

"This massive seizure removed thousands of potentially lethal doses of this powerful narcotic off the streets," said DEA Special Agent in Charge Doug Coleman. 

COUNTERFEIT PILLS SEIZED IN TEMPE, ARIZONA (DEA PHOTO)

It doesn’t take much fentanyl to kill someone – the chemical is 50 to 100 more potent than morphine. Many addicts looking for a high or pain sufferers looking for relief have no idea what they’re buying on the black market.  Experts say a single dose of fentanyl as small as two or three milligrams can be fatal.  

New Jersey’s Attorney General said this week that a suspected drug dealer arrested in March with 14 kilograms of fentanyl – less than a quarter of what was seized in Mexico last weekend -- was enough “to kill more than half the population of the state.” The “super potent” fentanyl, believed to have been shipped from China, “could have yielded upward of five million lethal doses," according to Attorney General Christopher Porrino.

“Fentanyl is commonly mixed with heroin or cocaine for sale on the street, or is sold in powder compounds or counterfeit pills disguised as heroin, oxycodone or Xanax,” Porrino’s office said in a statement.  “Given the tiny size of a lethal dose, drug users are dying because dealers are careless about how much fentanyl they put in such mixes and pills."

Federal prosecutors say a drug ring busted earlier this year in San Antonio, Texas produced hundreds of thousands of counterfeit pills laced with fentanyl and sold them over the Internet to customers all over the country. DEA agents believe several people may have died after ingesting the pills, which were disguised to look like oxycodone, Adderall or Xanax.  

According to the San Antonio Express News, at least 70 packages of fake pills being shipped through the U.S. Postal Service were intercepted. Another 120 packages ready for shipment were seized when the drug ring was finally shutdown, along with four commercial pill press machines. Prosecutors say the fentanyl was obtained from China.

“I’ve never seen a case like this,” said Assistant U.S. Attorney Joey Contreras. “The quantities they’re able to distribute, and in anonymity, are staggering.”

China has promised before to crackdown on illicit manufacturers of fentanyl.  In February, China’s National Narcotics Control Commission announced that it was “scheduling controls” on four fentanyl-class substances. The move came after several months of talks with U.S. officials and was widely praised by the DEA.

“These actions will undoubtedly save American lives and I would like to thank my Chinese counterparts for their actions on this important issue," Acting DEA Administrator Chuck Rosenberg said in a news release.

President Trump’s opioid commission is taking a dimmer viewer of China’s efforts. In its interim report to the president last month, the commission warned that illicit fentanyl was “the next grave challenge on the opioid front” and that stronger efforts were needed from China to stop fentanyl smuggling.

“We are miserably losing this fight to prevent fentanyl from entering our country and killing our citizens. We are losing this fight predominately through China. This must become a top tier diplomatic issue with the Chinese; American lives are at stake and it threatens our national security,” the commission said.

Painkillers Stolen from Dying Patients

By Melissa Bailey, Kaiser Health News

Nothing seemed to help the patient — and hospice staff didn’t know why.

They sent home more painkillers for weeks. But the elderly woman, who had severe dementia and incurable breast cancer, kept calling out in pain.

The answer came when the woman’s daughter, who was taking care of her at home, showed up in the emergency room with a life-threatening overdose of morphine and oxycodone. It turned out she was high on her mother’s medications, stolen from the hospice-issued stash.

Dr. Leslie Blackhall handled that case and two others at the University of Virginia’s palliative care clinic, and uncovered a wider problem: As more people die at home on hospice, some of the powerful, addictive drugs they are prescribed are ending up in the wrong hands.

Hospices have largely been exempt from the national crackdown on opioid prescriptions because dying people may need high doses of opioids. But as the nation’s opioid epidemic continues, some experts say hospices aren’t doing enough to identify families and staff who might be stealing pills.

And now, amid urgent cries for action over rising overdose deaths, several states have passed laws giving hospice staff the power to destroy leftover pills after patients die.

Blackhall first sounded the alarm about drug diversion in 2013, when she found that most Virginia hospices she surveyed didn’t have mandatory training and policies on the misuse and theft of drugs. Her study spurred the Virginia Association for Hospices and Palliative Care to create new guidelines, and prompted national discussion.

Most hospice patients receive care in the place they call home. These settings can be hard to monitor, but a Kaiser Health News review of government inspection records sheds light on what can go wrong. According to these reports:

• In Mobile, Ala., a hospice nurse found a man at home in tears, holding his abdomen, complaining of pain at the top of a 10-point scale. The patient was dying of cancer, and his neighbors were stealing his opioid painkillers, day after day.
• In Monroe, Mich., parents kept “losing” medications for a child dying at home of brain cancer, including a bottle of the painkiller methadone.
• In Clinton, Mo., a woman at home on hospice began vomiting from anxiety from a tense family conflict: Her son had to physically fight off her daughter, who was stealing her medications. Her son implored the hospice to move his mom to a nursing home to escape the situation.

In other cases, paid caregivers or hospice workers, who work largely unsupervised in the home, steal patients’ pills. In June, a former hospice nurse in Albuquerque, N.M., pleaded guilty to diverting oxycodone pills first by recommending prescriptions for hospice patients who didn’t need them and then intercepting the packages with the intention of selling the drugs herself.

Hospice, available to patients who are expected to die within six months, is seeing a dramatic rise in enrollment as more patients choose to focus on comfort, instead of a cure, at the end of life.

The fast-growing industry serves more than 1.6 million people a year. Most of hospice care is covered by Medicare, which pays for hospices to send nurses, aides, social workers and chaplains, as well as hospital beds, oxygen machines and medications to the home.

There’s no national data on how frequently these medications go missing. But “problems related to abuse of, diversion of or addiction to prescription medications are very common in the hospice population, as they are in other populations,” said Dr. Joe Rotella, chief medical officer of the American Academy of Hospice and Palliative Medicine, a professional association for hospice workers.

“It’s an everyday problem that hospice teams address,” Rotella said. In many cases, opioid painkillers or other controlled substances are the best treatment for these patients, he said. Hospice patients, about half of whom sign up within two weeks of death, often face significant pain, shortness of breath, broken bones, or aching joints from lying in bed, he said. “These are the sickest of the sick.”

Earlier this year in Missouri, government investigators installed a hidden camera in a 95-year-old hospice patient’s kitchen to investigate suspected theft. A personal care aide was charged with stealing the patient’s hydrocodone pills, opiate painkillers, and replacing them with acetaminophen, the active ingredient in Tylenol. Hospice nurses in Louisiana and Massachusetts also have been charged in recent years with stealing medication from patients’ homes.

But many suspected thefts don’t get caught on hidden cameras, or even reported.

In Oxnard, Calif., in 2015, a person claiming to be a hospice employee entered the homes of five patients and tried to steal their morphine, succeeding twice. The state cited the hospice for failing to report the incidents.

In Norwich, Vt., in 2013, a family looked for morphine to ease a dying patient’s shortness of breath. But the bottle was missing from the hospice-issued comfort care kit. The family suspected that an aide, who no longer worked in the home, had stolen the drug, but they had no proof. State inspectors cited the hospice, Bayada Home Health Care, for failing to investigate.

David Totaro, spokesman for Bayada Home Health Care, told KHN that situations like that are “very rare” at the hospice, which takes precautions, such as limiting medication supply, to prevent misuse.

There is no publicly available national data on the volume of opioids hospices prescribe.  But OnePoint Patient Care, a national hospice-focused pharmacy, estimates that 25 to 30 percent of the medications it delivers to hospice patients are controlled substances, according to Erik Jung, a vice president of pharmacy operations.

Jung said company drivers deliver medications in unmarked cars to prevent attempted robberies, which have happened on occasion.

Little Oversight of Hospice Medication

Two recent studies suggest hospice doctors and social workers across the country are not prepared to screen patients and families for drug misuse, nor to address the theft of pain medication.

For family members struggling with addiction, bottles of pills lying around the house can be hard to resist. Sarah B., a 43-year-old construction worker in Vancouver, Wash., said when her father entered hospice care at his home in Oregon, she was addicted to opioids, stemming from a hydrocodone prescription for sciatica.

After he died, hundreds of pills were left on his bedside table. She took them all, enough Norco, oxycodone and morphine to last a month.

“I have some shame about it,” said Sarah, who declined to give her full last name because of the nature of her actions.

Sarah, who was one of her father’s primary caretakers, said the hospice “didn’t talk about addiction or ask if any one of us were addicts or any of that.”

“No one gave us instructions on how to dispose of all the medications that were left,” she added.

Medicare requires hospices to establish a safe way to administer drugs to each patient — by identifying a reliable caregiver, staff member or volunteer to manage the drugs or, if need be, relocating the patient. And it requires hospices to set policies, and talk to families, about how to safely manage and dispose of medications.

But there’s little oversight: Unlike nursing homes, hospices may go years without inspection, and even when they are cited for noncompliance, they rarely face any consequence except coming up with a plan to improve.

And in most states, hospices have little control over the pills after a patient dies. The U.S. Drug Enforcement Administration encourages hospice staff to help families destroy leftover medications, but forbids staff from destroying the meds themselves unless allowed by state law. Leftover pills belong to the family, which has no legal obligation to destroy them or give them up.

However, some states are taking action. In the past three years, Ohio, Delaware, New Jersey and South Carolina have passed laws giving hospice staff authority to destroy unused drugs after patients die. Similar bills moved forward in Illinois, Wisconsin and Georgia this year.

In Massachusetts, one of the states hit hardest by drug overdose deaths, VNA Care Hospice and Palliative Care advises families to empty leftover pills into kitty litter or coffee grounds before disposal — a common practice to prevent reuse, since flushing them down the toilet is now considered environmentally hazardous.

But families “don’t have to comply,” said VNA Care medical director Dr. Joel Bauman. “Our experience is maybe only half do. We don’t know what happens to these medications. And we have no right, really, to further inquire.”

Hospices across the country told KHN they take precautions, including counting pills when nurses visit the homes, limiting the volume of each drug delivery, giving families locked boxes for medication and giving patients random urine tests. They also said they prescribe medications that are harder to misuse, such as methadone.

Some, like VNA Care, have also started screening families of patients for history of drug addiction, and writing up agreements with families outlining the consequences if drugs go missing.

But “there’s so much moral distress” about punishing dying patients for family members’ actions, said Bauman. He said he tries to avoid doing that: “Why should we fire a patient for having inappropriate pill counts, when it may not be their fault in the first place?”

Though Blackhall helped spark a national discussion about hospice drug diversion, she said she’s also worried about restricting access to painkillers. Hospices must strike a balance, she said.

“It’s important to treat the horrible suffering that people have from cancer,” said Blackhall. But substance abuse is another form of suffering which is “horrible for anyone in the family or community that might end up getting those medications.”

Kaiser Health News (KHN), a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.