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.

FDA Should Tread Carefully with Stem Cell Regulation

(Editor’s note: This week FDA commissioner Scott Gottlieb said the agency would crack down on clinics that offer experimental stem cell treatments. While acknowledging that stem cells offer “significant promise” for treating chronic pain and other chronic conditions, Gottlieb said some clinics were preying on sick people desperate to find cures.

A. Rahman Ford has received stem cell treatment and has been closely following developments in stem cell research and regenerative medicine.)

By A. Rahman Ford, Columnist

On its face, FDA Commissioner Gottlieb's statement seems like a reasonable approach to regulating stem cell therapies.  He emphasizes the need to balance costs and benefits, and the need to protect vulnerable consumers from exploitation. 

I think all can agree with the Commissioner when he states that "these technologies hold the potential to significantly alter the course of a broad range of diseases."  These diseases are often accompanied by intense physical pain that pharmaceuticals cannot relieve.

Specifically, the Commissioner makes three heartening observations. First, he acknowledges the "significant promise for transformative and potentially curative treatments" offered by regenerative medicine.  This is a promise that mainstream pharmaceutical medicine has yet to fulfill, and one that those suffering from chronic pain need addressed immediately. 

Second, it is without question that regulatory clarity and the resolution of legal uncertainty regarding these therapies' use can be a good thing.  If there are in fact an irresponsible "select few," or a minority of unscrupulous, exploitative "bad actors" as the Commissioner claims, then legal action by the FDA against them is reasonable. 

fda commissioner scott gottlieb

Finally, the Commissioner seems to implicitly recognize how critical it is for the FDA to respect the distinction between medical products subject to agency oversight, and those which fall under the "practice of medicine," a distinction which Commissioner Gottlieb acknowledges is fraught with "close calls."

That said, as an advocate for patients seeking stem cell therapies, upon reading Commissioner Gottlieb's statement I am overall circumspect.  It is well known that the FDA has a rather unsettling history of issuing regulations that unduly restrict patients' access to stem cell therapies, specifically autologous stem cell therapies.  These are therapies that use cells harvested from one person, are minimally manipulated, and then administered to the same person. 

I've previously made my position on this "personal" stem cell therapy known, particularly the privacy implications involved. 

Restrictions such as the unduly burdensome "minimally manipulated" federal standard and the "same basic function" requirement are clear evidence of an intent to restrict.  So, the fact that Commissioner Gottlieb's statement reiterates the "same basic function" standard as a factor in requiring that a stem cell therapy be approved through a clinical trial, rather than it being part of the "practice of medicine," seems to indicate more of the same federal overreach.

Make no mistake, the potential dangers of stem cell therapy are real, and proactive effort to protect patients is far better than any reactive effort.  However, the potential dangers should not be overstated or exaggerated ostensibly toward the end of more unnecessary restrictive regulation. 

The FDA has a history of doing this.  For example, the New England Journal of Medicine published a commentary in March by then FDA Commissioner Robert Califf arguing that, aside from a few indications, the clinical use of autologous stem cell therapies has not been proven effective and can even be dangerous. 

Not only did the article ignore years of clinical data from medical practitioners, the one cited example of the danger of autologous stem cells was actually an example of allogeneic stem cell use -- stem cells from another person!

Thus, when the Commissioner asserts that the FDA will "aid in the effort to bring novel therapies to patients as quickly, and as safely, as possible," it simply belies history.  Likewise, overtures made toward any potential regulations being congruent with the 21st Century Cures Act are dubious.  The spirit of the Cures Act is clear; it calls for the "accelerated approval for advanced regenerative therapies." 

More federal regulation rarely, if ever, leads to acceleration of anything.  In fact, it almost always tends to slow things down.  Thus, unnecessary and unreasonably burdensome regulation by the FDA could contravene the will of Congress, and thus the will of the American people.

Texas Legalizes 'Personal' Stem Cell Therapy

Furthermore, the FDA's prospective regulatory guidance must be viewed in the context of recent events in Texas.  On June 13, Texas governor Greg Abbot signed HB 810 into law, which made Texas the first state to legitimize the use of personal stem cell therapies statutorily. The signing of the bill was celebrated not only by stem cell advocates, but by the countless Americans who suffer from chronic, debilitating conditions for which the current medical services delivery model can offer only surgery and medication.  For many, it was a monumental step forward toward fulfilling the promise of regenerative medicine and realization of true health care.  

However, the FDA may have seen this move as reinforcing a "wild west" stem cell landscape, a landscape which it believes it must police.

All of us, including FDA officials, should be reminded that on February 28, at President Trump's first State of the Union speech (and on Rare Disease Day), the President took note of Sarah Hughes, a young attendee who had used her own stem cells to successfully treat Pompe’s Disease. The therapy normalized her immune system, alleviated her symptoms and helped reduce her medications from 22 to 8.

We must also remember the promise President Trump made to America's military veterans, many of whom suffer from painful, debilitating conditions that may be treated or cured by stem cells.  President Trump cares deeply about veterans' health.  He recently signed the Veterans Appeals Improvement and Modernization Act, which streamlines the process of veterans appealing claims over disability benefits.  He also signed a bill that will let more veterans bypass the Department of Veterans Affairs and instead receive treatment from private doctors. 

Finally, he signed legislation approving new tools to expand the VA's existing Telehealth Services, so veterans can schedule appointments and have video consultations from their mobile phones.  It seems obvious that President Trump would never support restricting veterans' access to the medical care they need, including stem cells.

I believe that President Trump, through his devotion to our veterans, the Congress through the Cures Act, and the American people through their need for medical alternatives, would strongly disagree with any unreasonable curtailment of stem cell therapies. 

The FDA must not defer to the opinion of "industry," and must prioritize the needs of Americans like Sarah Hughes and our suffering wounded warriors.  People are in pain and pills can’t always help them.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Dr. Ford is not affiliated with any stem cell treatment provider. He suffers from chronic inflammation in his digestive tract and is unable to eat solid food.

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.

FDA Expands Crackdown on Stem Cell Clinics

By Pat Anson, Editor

The Food and Drug Administration is stepping up its campaign against experimental stem cell therapies, which are increasingly being used to treat cancer, diabetes, neuropathy, back pain and other chronic illnesses.

On Friday, the FDA raided two stem cell clinics operated by California Stem Cell Treatment Centers, and seized five vials of a smallpox vaccine supplied by StemImmune in San Diego. The vaccine is mixed with stem cells derived from a patient’s body fat – known as adipose tissue -- and then injected back into the patient. The FDA considers that “an unapproved and potentially dangerous treatment” for cancer.

On Monday, the FDA also sent a warning letter to a stem cell clinic in Florida, which advertises stem cells derived from body fat to treat a variety of chronic illnesses, including rheumatoid arthritis, lupus and other autoimmune diseases. Three elderly women at the clinic went blind after having stem cells injected into their eyes in an attempt to treat macular degeneration.

in a lengthy statement announcing the crackdown,  FDA commissioner Scott Gottlieb, MD, said stem cell therapy and regenerative medicine hold “significant promise for transformative and potentially curative treatments,” but some “bad actors” were preying on sick people desperate to find cures.

“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb warned.

“In such an environment a select few, often motivated by greed without regard to responsible patient care, are able to promote unproven, clearly illegal, and often expensive treatments that offer little hope, and, even worse, may pose significant risks to the health and safety of vulnerable patients.”

Dr. Mark Berman, a co-founder of California Stem Cell Treatment Centers, told the Los Angeles Times that Gottlieb’s comments were "disparaging and misrepresentative," and showed "a lack of understanding" of stem cell treatments. 

As PNN has reported, hundreds of stem cell clinics have opened around the country in recent years, often mixing hope with hype to make claims such as “You don’t have to accept chronic pain as a fact of life.”  The treatments are expensive and usually not covered by insurance.  A clinic in Sacramento, for example, charges $5,000 for a single joint injection and $6,000 for a spinal injection.

FDA officials say there is not enough evidence to support some of the newer stem cell therapies – particularly when cells are harvested from a patient’s own body fat (adipose tissue).

“Stem cells derived from sources such as adipose tissue are being used to treat multiple orthopedic, neurologic, and other diseases. Often, these cells are being used in practice on the basis of minimal clinical evidence of safety or efficacy,” wrote Robert Califf, MD, Gottlieb’s predecessor as FDA commissioner, in a commentary published in the New England Journal of Medicine.

Some patients, however, have reported remarkable recoveries from chronic conditions often deemed untreatable. Sara Bomar, for example, was confined to a wheelchair after being diagnosed with arachnoiditis, a painful inflammation of nerves in her spinal column. She started walking again after a high dose infusion of stem cells made from adipose tissue.

“I am able to walk. I am able to workout at the Y. I am still careful. It’s not like I don’t ever have any pain, I do have a little bit from time to time. But it is nothing compared to what I had before,” Bomar told PNN.

Gottlieb said the FDA would release new guidelines in the fall to outline what types of stem cell therapy and regenerative medicine would be allowed. And he warned that more enforcement actions were coming, like the ones in Florida and California.

“I will not allow these activities to go unchecked. I’ve directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health,” Gottlieb said.

Some patients who have the resources are heading to Europe to get regenerative treatments that can't get in the U.S.  The Seattle Seahawks this week sent five more players to Germany to have their blood processed and re-injected to treat nagging injuries. The procedure involves withdrawing blood from the patient and then spinning it to produce a high concentration of platelet cells. The plasma is then injected back into the patient at the injury site, speeding up the healing process. Two other Seahawks have already had the procedure, along with athletes such as Kobe Bryant and Alex Rodriguez.

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?"

Pain Is a Vital Sign

By Roger Chriss, Columnist

Pain is a vital sign because it is vitally important. In fact, pain is what brings most people to a doctor, whether it’s their primary care physician or an emergency room doctor. And identifying the cause of the pain and figuring out how to address it is fundamental to medical care.

But pain cannot be objectively measured. And so some people trivialize or criticize its relevance.

“Unlike heart rate or blood pressure, there is no objective way to measure (pain). Doctors and nurses must depend on patients to report the intensity level of their pain, which provides an opening for addicts to abuse the system,” Hadley Manning recently wrote in an op/ed in The Oklahoman.  "Pain shouldn't be considered a vital sign."

The American Medical Association (AMA) also takes a dim view of pain, passing a resolution last year recommending that pain be removed as the “fifth vital sign” in professional medical standards.

"Just as we now know (the) earth is not flat, we know that pain is not a vital sign. Let's remove that from the lexicon," James Milam, MD, an AMA delegate told MedPage Today.

While it is true that there is no way to objectively measure pain, this is hardly unique to pain. After all, many health conditions that doctors deal with cannot be objectively measured:

• In gastroenterology: appetite, nausea, or fullness
• In neurology: numbness or tingling, muscle spasms, or loss of balance
• In ophthalmology: double vision, light sensitivity, or blind spots
• In otolaryngology: tinnitus, dizziness, or difficulty swallowing
• In psychiatry: anxiety, depression, mania, or psychosis

This is part of why medicine is both an art and a science. Clinicians have to work directly with people and not just numbers and algorithms. Various instruments exist to formalize this process, including disability indexes for the neck and lower back, and a method for measuring adult depression.

Pain is included in many such instruments. And there are instruments that attempt to quantify pain. For instance, the Mankoski Pain Scale tries to characterize pain in a clinically useful way. The 0 to 10 scale goes from “Pain free” to “Can’t be ignored for more than 30 minutes” to “Pain makes you pass out.”

A number of medical conditions involve pain severe enough to be incapacitating or even crippling. Prevention Magazine put together a list of “The 10 Most Painful Conditions,” which includes kidney stones, postherpetic neuralgia, and cluster headaches.

To be clear, the abdominal pain of kidney stones is not just a “tummy ache,” but more like having your kidney sucked out through your navel. The pain of neuralgia is not just “numb toes and other woes,” but the agonizing burning that makes even a light touch a terrifying prospect. And a cluster headache is not a big “ice cream headache,” but an utterly incapacitating attack. You lay on the floor in a fetal position without even the mental resources to wonder if anyone will help.

Of course, pain can also be psychiatric in origin. The book Is It All In Your Head? True Stories of Imaginary Illness by neurologist Suzanne O’Sullivan, MD, describes how medically unexplained symptoms can be psychosomatic in nature but are nonetheless clinically real, and how a skilled specialist can make the distinction between organic and psychiatric causes of pain.

Thus, pain is a vital sign that cannot be ignored. It is the primary way that the human body communicates its needs and troubles. And it is the means by which people describe their medical problems.

Claims that patient complaints about pain create an “opening for addicts to abuse the system” ignore how healthcare works. Physicians don’t just look at a patient’s “pain score” and then write a prescription. They assess and evaluate the patient, and come to a diagnosis based on a combination of their clinical skills, lab work and testing.

And physicians sometimes err on the side of caution about patients’ descriptions of pain. The National Institutes of Health found that pain is often underestimated in women and racial minorities and often undertreated in socioeconomically disadvantaged groups.

While some patients may exploit the desire of a physician to help, it is also true that some physicians may ignore a patient’s legitimate need for help. Facile critiques that oversimplify the complexities of modern pain management diminish both the hard work of healthcare professionals and the suffering of people dealing with painful medical disorders.

Although pain is personal, subjective and not readily measured, it is very real. To diminish its importance because of an impractical standard of objectivity is to miss the fact that medicine is about relieving suffering.

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.

4 F’s That Can Help Lower Pain Levels

By Barby Ingle, Columnist

So far in my monthly series on alternative pain treatments, we’ve looked at 4 A’s (acupressure, acupuncture, aromatherapy, art therapy), 4 C’s (Calmare, Chinese medicine, chiropractic, craniosacral therapy) and 4 E’s (energy therapy, electromagnetic therapy, equine therapy, exercise).

I like my alphabet series because it offers pain sufferers a look outside the tool box for therapies they may not have considered. I know that insurance does not cover many of these treatments. And I know that nothing I am suggesting is going to cure anyone, but it may offer some pain relief. I suppose that’s the cheerleader in me -- keep going even if your team is losing and find a way to win.

Looking through the reader comments to my series, I found one from “Fred” that I liked:

"You read many commenters who say, 'I've tried them all, nothing works.' Wrong! There are hundreds, possibly thousands of potential alternative/complimentary pain modalities. Anyone claiming, 'I've done 'em all,' that person would have to be like 150 years old, given the time and dedication many require to show real effectiveness! NO ONE has done 'em all. There's always something left to try."

I want to thank Fred for his comment and to let him know that I agree with him. Far too often we say that we have tried everything and nothing works. But that doesn’t mean we should stop looking or trying.

The four F’s we’ll look at this month are faith healing, Feldenkrais Method, food, and functional medicine. Please contact a trained provider who can clear you before you try any of these suggestions, especially when it comes to movement and nourishment.  

Faith Healing

Faith healing is the practice of prayer or rituals that solicit divine intervention in spiritual and physical healing. This practice can include the “laying on of hands” and miracles.

I personally don’t know anyone who had a full recovery from divine intervention, but I did have a near death experience that taught me some important lessons.

I learned that I needed to have more patience with people and that human connection has a purpose. It helped me see my purpose in life and why I was here on earth. It didn’t take away my physical pain, but it helped me learn how to stay positive through it.

Many others have claimed miraculous recoveries through prayer. According to a Newsweek poll, 72 percent of Americans believe that praying to God can cure someone. I do believe it can happen, I just haven’t seen it yet.

In a report on faith healing, the American Cancer Society tells us that "available scientific evidence does not support claims that faith healing can actually cure physical ailments" and warns that "death, disability, and other unwanted outcomes have occurred when faith healing was elected instead of medical care for serious injuries or illnesses."

When parents have used faith healing instead of medical care, some children have died that otherwise would have been expected to live. Similar outcomes are found in adults who rely solely on faith healing.

I continue to say my daily prayers and remain a believer that all things are possible, even if I haven’t seen it yet personally. But I will continue with my other treatment options.  

Feldenkrais Method

The Feldenkrais Method is a type of exercise therapy devised and named after Moshé Feldenkrais. The method is claimed to reorganize connections between the brain and body, and to improve body movement and the psychological state.

I am a big believer in these techniques, used by Dr. Victor Pedro, who treats multiple friends of mine. I have seen them go into remission and remain well for years, although this treatment is not cost-effective for many.  

Supporters of the Feldenkrais Method claim it can repair impaired connections between the motor cortex and the body, which benefits body movement and improves their sense of well being. They also believe that it can be helpful with many pain conditions such as autism and multiple sclerosis. 

The Feldenkrais Guild of North America claims that this treatment option allows people to rediscover their innate capacity for graceful, efficient movement and that these improvements will often enhance function in other aspects of life. The treatment consists of repetitive movements with proper body alignment, done with or without a provider.

You can watch many videos online to learn and practice the Feldenkrais Method of exercise. Here is a sample:

Food

The food that we put in our bodies is one of the underlying causes of inflammation, which increases chronic pain. This is also one area that we have complete control over and don’t need insurance to cover.

I myself have used a low-carb, high fat diet – known as the ketogenic or paleo diet -- to help lower inflammation and lose weight. I thought the diet was going to be much more expensive, but it turned out costing about the same as what I was spending on my regular food budget.

I also discovered I was not as hungry or constantly looking for snack foods as I was when I was eating my regular “American” diet. We underestimate how inflammation plays a major role in chronic pain. Knowing what foods can increase inflammation can make a big difference in how we manage pain.

One of the things I have done with my diet is add some “super foods.” Several research studies have shown that the compounds in these natural foods can reduce inflammation and even block pain signals. Research also shows that super foods can increase brain chemicals, such as serotonin, which can stop depression and make you feel happier.

The super foods that you could add to your diet to deal with chronic pain naturally include burdock root, hot peppers, yogurt, fresh ginger root, cannabis, turmeric, fenugreek leaves, onions, strawberries, garlic, olive oil, and salmon.

For more information on the ketogenic diet, I suggest reading Quick & Easy Ketogenic Cooking by Maria Emmerich.

Functional Medicine

I believe functional medicine (FM) is the future of conventional medicine. In FM, the provider works to address the root cause of disease and views the body as one system, not a collection of independent organs to be treated separately. This type of care lets us focus on treating the whole body, not just the symptoms.

I have had providers who were specialists who only looked at one body part or organ and were not willing to consider that it was all interlinked. Finding providers who believe in FM was very important to me. Having this patient centered approach to my care helped me be my own best advocate and helped my providers do a better job getting me into a state of remission and controlled pain levels.

My providers spend time with me, between 45 to 90 minutes per visit. We go over my medical history, genetic vs. environmental aspects, and lifestyle factors. I love functional medicine because it helps support individualized treatment.

With the sharp increase in people who have one or more chronic illnesses such as diabetes, heart disease, mental illness, autoimmune disorders and  cancer, we need a system of care that puts the spotlight on everyone as a whole person.

The old way of practicing medicine is going out the window. We need to demand that all providers are on board with FM practices. We no longer want to be cookie cutter patients. We each need a unique approach to our care, and it is possible with better training for providers, research, and patient engagement.

Most providers are not adequately trained to assess the underlying causes of chronic diseases. Most can’t even adequately provide strategies such as nutrition, diet and exercise to treat and prevent future illnesses in their patients.

As patients we must push for FM and a more holistic approach. Finding a provider who is trained in FM involves them understanding disease origins, prevention, and treatment of chronic illnesses. With FM the unique genetic and environment of each patient is considered and an integrative, science-based care approach is employed using both traditional and alternative treatment options. As we focus on both internal (mind, body, and spirit) and external (physical and social environment) we will see greater improvements with our health, life and overall ability to function.

Do you have any suggestions? What alternative pain therapies have you tried that succeeded?  The more we share, the more others can see what they are able to do, what new treatments are available, and what old ones they may have overlooked.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International 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.

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.

How Fish Got Hooked on Hydrocodone

By Pat Anson, Editor

We hear it all the time from PNN readers. They don’t trust academic research about opioids and addiction, and feel much of it is biased or just plain fishy.

You can certainly say the latter about a new study by researchers at the University of Utah.

They devised a system that allows zebrafish, a small tropical fish popular in home aquariums, to self-administer doses of the painkiller hydrocodone. In less than a week, researchers say the fish were hooked on hydrocodone and showed signs of drug-seeking behavior and withdrawal.

"We didn't know if zebrafish would be a relevant model for opioid addiction, much less self-administer the drug," said Randall Peterson, PhD, a professor of Pharmacology and Toxicology, and senior author of the study published in the journal Behavioral Brain Research.

"What is exciting about this work is that we see many of the hallmarks of addiction in zebrafish. This could be a useful and powerful model."

How is this useful and how does it relate to people?

Zebrafish have more in common with people than you might think. They have 70 percent of the genes that humans have, including similar biological pathways that can lead to addiction. Like people, zebrafish have a μ-opioid receptor and two neurotransmitters, dopamine and glutamate, that trigger the natural reward system in the brain.

"Drugs of abuse target the pathways of the pleasure centers very effectively," said first author Gabriel Bossé, PhD. "These pathways are conserved in zebrafish, and the fish can experience some of the same signs of addiction and withdrawal as people."

Bossé and Peterson tested their system in a tank with a food dispenser equipped with a motion detector that the fish could trigger by swimming nearby. It didn’t take long for the zebrafish to learn how to get food.

Then the researchers removed the food dispenser and replaced it with one that injected small doses of hydrocodone into the water when a fish swam nearby. A continuous flow of water flushed the tank, which forced the fish to trigger the dispenser to receive another dose of hydrocodone.

Over the course of five days, the fish learned how to self-administer the drug. You can watch a demonstration below:

"The fish needed to perform an action to get the drug rather than receiving it passively," said Bossé. "Drug-seeking has been modeled before in rodents and primates, but having a model to study this in zebrafish could move the [study of addiction] forward."

The drug-seeking behavior increased when the zebrafish were forced to receive the opioid in progressively shallower water, a stressful environment that unconditioned fish would normally avoid.

"This was important, because we forced the fish to do more work to receive the drug, and they were more than willing to do more work," said Peterson.

The researchers took their experiment a step further by exposing the conditioned fish to naloxone, a drug used to treat overdoses that blocks opioid receptors. Sure enough, naloxone appeared to reduce the fish’s drug-seeking behavior.

The researchers believe their zebrafish model can lead to new drug therapies, because it can be used to rapidly test thousands of different chemical compounds. They also believe the genetic make-up of zebrafish can be altered to explore the specific biological pathways associated with addiction.

Zebrafish do have other qualities humans can learn from. Researchers at Duke University are studying proteins that enable a zebrafish to completely heal its spine -- even after it was severed. They hope this knowledge will someday lead to new therapies to repair damaged spinal cords in humans.

The Importance of Pain Management in Wound Care

By Janice Reynolds, Guest Columnist

A recent article by Kaiser Health News on the difficulty of healing chronic wounds caught my attention.  After reading it several times, I was concerned with the message it was sending -- it seemed much like the misleading articles we see on the evils of opioids or how pain management is not being done right.

One of the red flags was the lack of any mention of skin and wound nurses. Or the important relationship pain management has in wound healing.

In the world of wound care, skin and wound nurses are the experts.  They are usually asked to consult by physicians and surgeons in managing wounds. Wound clinics may be run by them or in partnership with a physician. Our local clinic is managed by a skin and wound nurse and a foot physician.

While I never did the certification for Skin, Ostomy and Wound Care, I did manage my hospital’s wound team for a couple of years, so I studied as much as I could.  I also presented at several medical conferences on pain management in wound care. Those are my qualifications for this input.

Like pain management, wound care is very difficult, as there are so many different types of wounds and different ways patients respond to them.

There are wounds from bites (I saw one where a pig took a chunk out of a kid’s calf), diabetic ulcers, peripheral ulcers caused by poor circulation, pressure sores, burns, trauma, and cancer. Some surgical wounds get infected and have to be reopened, or just don’t heal correctly to start with. 

As mentioned in the article, necrotizing fasciitis is difficult to heal and, in extreme cases, amputation is used to stop it. Radiation therapy can cause severe irritation and lead to a skin breakdown. Thrush, fungus, and moist desquamation caused by constant moisture can also cause a skin breakdown. There are so many more.

Pain is a huge issue in the management of wounds.  Entire chapters on pain are included in textbooks on Skin and Wound Care.  Pain inhibits wound healing, increases the likelihood of infection, and creates stress and anxiety.  This all effects quality of life. This is fact, not opinion.

There is pain related to the wound itself and what is called incidental pain – pain that is caused by dressing changes, debridement or other types of medical care. Of course, some patients are unfortunate enough to already have acute or chronic pain from another condition, in addition to the wound itself.

Opioids have always been the core of wound pain management, whether they’re delivered intravenously, orally (pills), or even topically.

I was once expressing frustration to my airline seat partner, who was a physician, on the difficulty I had trying to get my hospital to allow me to try a morphine gel compound which went directly in the wound. There had been several studies which had good results.  He looked at me in surprise and said, “I usually just drip morphine into the wound.”

Providers in wound care are like those in pain management. Some are very good, some adequate, some just barely make an attempt, and then there are those who deny the pain exists, blame the patient, say it only lasts for a minute, and so on.  This unfortunately has changed for the worse.

There are two large issues effecting the healing of chronic wounds and neither are the development of better dressings.  The first, but not the greatest problem, is money. Wound care is expensive.  It can be the cost of the dressing material or the expense of treating a patient at home.  Many insurers are selective about what they will pay for, and patients without insurance are tremendously lacking in adequate treatment.

The hysteria over opioids and pain management in general has greatly affected wound care. Opiophobia, fearmongering, McCarthyism, and my personal favorite -- yellow journalism -- have changed the way some providers look at and treat pain. In the War on Drugs, patients with wounds have also been causalities.    

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them. 

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.

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.

How Chronic Pain Changes Family Dynamics

By Lana Barhum, Columnist

Chronic pain can have a strong impact on the relationships we have with our families. Most of us are glad and appreciative when we have families that help us get through some really tough days and make life more enjoyable. Unfortunately, for many pain sufferers the support of family is lacking.

Chronic pain can make you angry, moody and intolerant.  As a result, we sometimes take our frustrations out on those closest to us.  Sometimes we just want to be left alone and our loved ones, even though they have good intentions, won’t leave us alone.  Further, we can feel guilty for what we put our family through and try to make up for it, often feeling like we fall short.

As a single mother who lives with chronic pain, I feel like I fall short sometimes when it comes to being there for my boys.  I hurt on most days, but on the days where the pain is tolerable, I do everything I can to be there for them. On days when the pain is bad, I just want to be left alone.  I feel guilty my boys don’t have the mother I “think” they need and deserve.

Some days, I tell them I am hurting and pray they forgive me for being irritable, tired and wanting to be left alone. Other days, I feel like a version of myself I can’t be proud of.

It might be something different that gives you guilt and makes you feel like you fall short.  Perhaps you don’t speak up about your pain because you are afraid to be a “complainer.” Maybe you have spoken out, and felt your family wasn’t supportive. Or maybe your family reached out and you just prefer not to be a burden them.

Family Roles Change

Many people with chronic pain feel their families do not understand or believe their pain.  I, too, have felt that way.  This is upsetting because chronic pain is invisible.  It changes from day-to-day and there is no way to prove the extent of it or how to get others to believe it. 

The person who is physically hurting may start taking on a dependent status, which can lead to depression and feelings of helplessness.  Another family member may start to handle the majority of the family responsibilities and start to feel resentful. 

All these factors -- alone and combined -- cause stress on even the best relationships, leading to arguments, conflicts, isolation, withdrawal and discord in the family structure.

Chronic Pain and Marriage

Chronic pain is the worst on couples. Studies show relationships where one partner has health issues are more likely to end compared to those where health is not an issue.

A 2014 study from the University of Michigan looked at 20 years of data on over 2,700 married couples and found that 75% of the marriages in which a spouse had a long-term health problems ended in divorce. Divorce was even more common when the wife got sick. 

The partner in pain isn’t the only one struggling.  In fact, according to the Caregiver Action Network, spouses who become caregivers are six times more likely to become depressed.

It is difficult to adapt when your spouse or partner develops a health condition or gets injured, resulting in permanent pain.  After all, everyday life has changed and so has the future you planned together. Both partners have to make adjustments, which can lead to fear and anxiety.  Healthy spouses can also try to shield themselves from the reality of chronic illness, adding further stress and strain to the relationship.

My Experience

I wish I could share some good advice and personal experiences on how to make family relationships work despite chronic pain. But I can only commiserate.

I was diagnosed with rheumatoid arthritis and fibromyalgia in 2008, and everything went downhill from there.  My marriage didn’t survive chronic illness.  My family didn’t understand and they still don’t. I have been depressed – even suicidal.   I have struggled in more ways than I am willing to admit.

Dealing with lack of support from the people who are supposed to be there for you isn’t easy by any means.  I have been fortunate because I made many new friends since have being diagnosed, who understand my struggles and who have been there for me when I couldn’t rely on family. 

And even when people bailed on me, I learned to support and hold myself up.  I got help from a professional in dealing with my depression and learned to cope with the many challenges chronic illness and pain brought into my life.  I take better care of myself because I need to be there for my boys, and I remind myself daily these experiences make me stronger, wiser and better, with or without family support.  

The Take Away

All families face obstacles, but some just aren’t strong enough to bear the fallout from chronic pain and illness.   The extent of family disruption depends on the seriousness of the pain and illness, as well as the parties involved. In some cases, major health issues bring families together. For others, even the simplest challenges tear families apart.

The fact is, families take work.  And we always have two choices.  We either keep trying or we give up.  Sadly, too many give up.

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit 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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Spouse Criticism Makes Back Pain Worse

By Pat Anson, Editor

Not one likes being criticized. But people with chronic back pain take it harder – physically and emotionally – when having an argument with a loved one.

Even a brief fight with a spouse can significantly worsen lower back pain, according to the findings of a small study published in the journal Pain.

Researchers at Rush University in Chicago – who have been studying the emotional, cognitive and social aspects of pain – enrolled 71 couples in a study to see how patients with degenerative discs, spinal stenosis or herniated discs coped with criticism from a spouse.

Researchers watched as the couples engaged in a 10 minute discussion that focused on how the partner with back pain could improve their ability to cope with pain. The patients were then put through a structured activity that included walking, bending, lifting and sitting while the spouse watched.

Pain levels and how the couple interacted were coded by researchers, who watched for signs of hostility or criticism.

Patients who felt they were criticized by a spouse not only experienced more anxiety, anger and sadness, but their pain levels increased for as long as three hours. Women and patients who were depressed seemed most sensitive to criticism.

“Results support the hypothesis that spouse criticism and hostility - actually expressed or perceived -- may worsen CLBP (chronic low back pain) patient symptoms. Further, women patients and patients high in depressive symptoms appeared most vulnerable to spouse criticism/hostility,” wrote lead author John Burns, PhD, principal investigator at the Acute and Chronic Pain Research Lab at Rush University.

Researchers were surprised to see that even when a partner was supportive – and expressed concern about a patient's pain or gave “helpful” suggestions – the interaction was still perceived as negative by patients.

“Because the study required both patient and spouse to cooperate enough to participate, they generally got along just fine,” Burns told Reuters Health. “Even with these fairly happy couples, spouses uttered enough critical and hostile comments to negatively affect patient pain and function.”

Previous research has also found that how couples interact with each other can play a significant role in pain levels. A recent study found that even just holding hands reduces pain intensity.