CDC Blames Fentanyl for Spike in Overdose Deaths

By Pat Anson, Editor

The Centers for Disease Control and Prevention released a new report today estimating that 63,632 Americans died of a drug overdose in 2016 – a 21.5% increase over the 2015 total.  

The sharp rise in drug deaths is blamed largely on illicit fentanyl, a powerful synthetic opioid that has become a scourge on the black market. Deaths involving synthetic opioids doubled in 2016, accounting for about a third of all drug overdoses and nearly half of all opioid-related deaths.

For their latest report, CDC researchers used a new “conservative definition” to count opioid deaths – one that more accurately reflects the number of deaths involving prescription opioids by excluding those attributed to fentanyl and other synthetic opioids. Over 17,000 deaths were attributed to prescription opioids in 2016, about half the number that would have been counted under the “traditional definition” used in previous reports.

CDC researchers recently acknowledged that the old method "significantly inflate estimates" of prescription opioid deaths.

The new report, based on surveillance data from 31 states and the District of Columbia, shows overdose deaths increasing for both men and women and across all races and demographics.  A wider variety of drugs are also implicated:

• Fentanyl and synthetic opioid deaths rose 100%
• Cocaine deaths rose 52.4%
• Psychostimulant deaths rose 33.3%
• Heroin deaths rose 19.5%
• Prescription opioid deaths rose 10.6%

The CDC also acknowledged that illicit fentanyl is often mixed into counterfeit opioid and benzodiazepine pills, heroin and cocaine, likely contributing to overdoses attributed to those substances.

2016 DRUG RELATED DEATHS

West Virginia led the nation with the highest opioid overdose rate (43.4 deaths for every 100,000 residents), followed by New Hampshire, Ohio, Washington DC, Maryland and Massachusetts.  Texas has the lowest opioid overdose rate.

‘Inaccurate and Misleading” Overdose Data

The CDC's new method of classifying opioid deaths still needs improvement, according to John Lilly, DO, a family physician in Missouri who took a hard look at the government’s overdose numbers. Lilly estimates that 16,809 Americans died from an overdose of prescription opioids in 2016.

“Not all opioids are identical in abuse potential and likely lethality, yet government statistics group causes of death in a way that obscures the importance of identifying specific agents involved in deadly overdoses,” Lilly wrote in a peer reviewed article recently published in the Journal of American Physicians and Surgeons..

Lilly faults the National Institute on Drug Abuse (NIDA) -- which relies on a CDC database -- for using “inaccurate and misleading” death certificate codes to classify drug deaths. In its report for 2016, NIDA counted illicit fentanyl overdoses as deaths involving prescription opioids. As a result, deaths attributed to pain medication rose by 43 percent, at a time when the number of opioid prescriptions actually declined.

“That large an increase in one year from legal prescriptions does not make sense, particularly as these were being strongly discouraged,” Lilly wrote. “Rather than legal prescription drugs, illicit fentanyl is rapidly increasing and becoming the opioid of choice for those who misuse opioids... Targeting legal prescriptions is thus unlikely to reduce overdose deaths, but it may increase them by driving more users to illegal sources.”

Some researchers believe the government undercounts the number of opioid related deaths by as much as 35 percent because the actual cause of death isn’t listed on many death certificates.

“We have a real crisis, and one of the things we need to invest in, if we’re going to make progress, is getting better information,” said Christopher Ruhm, PhD, a professor at the University of Virginia and the author of a overdose study recently published in the journal Addiction.

Ruhm told Kaiser Health News the real number of opioid related deaths is probably closer to 50,000.

Opioid Hysteria Leading to Patient Abandonment

By Pat Anson, Editor

As the overdose crisis has worsened, doctors are under increasing pressure from law enforcement, regulators and insurers to reduce or stop prescribing opioids.

A nurse practitioner in the Seattle area – who asked to remain anonymous -- recently told us that she was closing her pain clinic because she was afraid of losing her license and going to prison. 

“This whole thing is making me literally sick to my stomach. I've cried a million tears for my patients already, and I'm just beginning,” she wrote.

“I will be carefully weaning them all down… or arranging transfer of care to anywhere the patient would like. What a joke that is. There is no one else prescribing effective doses of opioids for chronic pain patients.  If I am to be thrown in prison, it should be for that -- not for keeping them on therapy that enriches their lives."

Patient abandonment is a growing problem in the pain community. Patients safely prescribed opioids for years are being dropped by doctors – often without weaning or tapering -- after they fail a drug test, miss a pill count, or become disruptive during an appointment. Sometimes they’re dropped for no reason at all.

Such is the case of Chris Armstrong, a 50-year old Orlando, Florida man severely disabled by multiple sclerosis and trigeminal neuralgia, a chronic pain facial disorder sometimes called the “suicide disease.” For over six years, Armstrong’s pain was treated with relatively high doses of morphine and hydrocodone at Prospira’s National Pain Institute in Winter Park.

That came to abrupt ending in late December, when Armstrong’s 74-year old mother and caretaker was handed a brief letter during their last visit to the clinic.

"This letter is to inform you that I will no longer be your physician and will stop providing medical care to you,” wrote Cherian Sajan, MD. “I will continue to provide routine emergency and medical care to you over the next 30 days while you seek another physician.”  

No explanation was given for Armstrong’s dismissal. Dr. Sajan did not respond to a request for comment.

“To have the plug pulled just like that,“ says Chris. “There’s nothing in my record that I’ve ever done anything wrong. I was a model patient.”

“They discharged him and gave no reason,” Valerie Armstrong said.  “They gave us a name of another pain doctor which they scribbled on a piece of torn paper. We went to see him, but after a few visits, (that doctor) told my son he was discharging him as well, as he needs ‘long term care’ which they refuse to provide.”

At the National Pain Institute, Armstrong says he was prescribed 150 morphine equivalent units (MME) of opioid medication daily. The second doctor reduced that dose to 100 MME – still above the maximum dose of 90 MME recommended by the CDC.  

Chris has been unable to find a new doctor and believes he’s been red flagged as a patient who needs high doses of opioids. 

“I went to another one and he said he can’t do anything because his hands are tied because I’ve been ousted by another pain doctor,” he told PNN. “What am I going to do, if no one will see me because of that?”

CHRIS ARMSTRONG

“I have called every pain clinic in my area and no one will see my son because he has been discharged by the previous pain clinics,” says Valerie. “My son is bed-bound quadriplegic, only travels in a wheelchair and can barely talk or eat from trigeminal neuralgia pain. His health is extremely fragile, and he will surely die if he has to stop his pain medication abruptly. That happened once before and he went to the ER in an ambulance having seizures.”

Armstrong has only a few days left of his last prescriptions.

“We need help and we need it now. He only has a few days supply of his pills left and then I'm sure his body will give out from withdrawals,” says Valerie. “My son had never taken any kind of pain medication before going to the National Pain Institute six and a half years ago and now he is physically dependent on them. I have begged and pleaded with them to take him back and even called their corporate headquarters to no avail.”

There is often little recourse for patients like Chris Armstrong.  Malpractice and patient abandonment laws vary from state to state, but discharging a patient is generally considered legal, as long as it isn’t discriminatory.

Florida’s Board of Medicine says a “health care practitioner can terminate a patient relationship at any time, but the practitioner may not abandon a patient” and should provide “continuity of care” until a patient can find a new doctor. To fulfill that requirement, the Florida Medical Association recommends that patients be given adequate notice in writing, be provided with medical care for at least 30 days, and be offered assistance in locating another practitioner – which Armstrong’s previous doctors did.

“There not a lot of strength in the law here,” says Diane Hoffman, a professor of health law at the University of Maryland Carey School of Law. “That makes it very challenging for chronic pain patients. And for physicians, they are trying to find the right place to be. Physicians are very risk averse in terms of the law.”

If patients have a complaint about a doctor, Hoffman says they should contact their state medical board or their state’s consumer protection office.

If you have an experience with patient abandonment that you’d be willing to share, Hoffmann is collecting patient experiences on the issue. You can send your story to her at:  patientstories@law.umaryland.edu

Dr. Forest Tennant Retiring Due to DEA Scrutiny

By Pat Anson, Editor

A prominent California pain physician and a longtime champion of the pain community has announced his retirement. Dr. Forest Tennant, and his wife and office manager, Miriam, have informed patients that they are closing their pain clinic in the Los Angeles suburb of West Covina, effective April 1.

“On strong legal and medical advice, as I am 77 and Miriam 76, we are closing the Veract Intractable Pain Medical Clinic and taking retirement. I will write no additional opioid prescriptions after this date,” Tennant wrote in a letter to patients. “We very much regret this situation as the clinic is filled with patients we consider beloved family and friends.”

Tennant’s retirement is largely due to an ongoing DEA investigation of his opioid prescribing practices.   DEA agents raided the Tennants’ home and clinic last November, while Tennant was testifying in Montana as a defense witness in the trial of doctor accused of negligent homicide in the overdose of two patients. The Tennants arrived home to find the front door of their home had been kicked in by DEA agents.

A DEA search warrant alleged that Tennant was part of a “drug trafficking organization” and had personally profited from the sale of high dose opioid prescriptions. Tennant has denied any wrongdoing and no charges have been filed against him, but the investigation remains open and the resulting stress and uncertainty have taken their toll.

“It’s hard to continue operating when they never closed my case, and so I’m going to retire and move on,” Tennant told PNN. “That’s on the advice of both my lawyers and my doctors."

DR. FOREST TENNANT  (courtesy montana public radio)

Tennant is a revered figure in the pain community because of his willingness to treat patients with intractable pain who were unable to find effective treatment elsewhere or were abandoned by their doctors. Many travel to California from out-of-state, and some are in palliative care and near death.

Tennant and his colleague, Dr. Scott Guess, treat about 150 intractable pain patients with a complex formula of high dose opioid prescriptions, hormones, anti-inflammatory drugs and other medications. 

Tennant says the DEA effectively forced him into retirement by refusing to drop the case.   

“You can’t do the kind of work I do and operate in legal uncertainty,” Tennant said. "You’ve got to have legal backing to treat these individuals. And I don’t know what the law is anymore.”

‘Many Patients Will Die’

This was a difficult day for Tennant's patients -- as many see their lives dependent on his continued care and treatment.

“I believe many of Dr. Tennant’s patients will die because they will never find another doctor to treat their painful condition,” says Gary Snook, a Tennant patient who lives with adhesive arachnoiditis, a painful and incurable inflammation in his spinal nerves. “I haven't decided if I will even look for another doctor, nobody will take a patient like me. And to be honest with you, I am tired of looking, tired of being treated like an addict, tired of being treated like a curiosity and nothing more, not a human being with a serious health issue that deserves to be treated.

"I am completely devastated for myself and my family, for Dr. Tennant and Miriam, for his patients and their families, and for all those who could have benefited from his continued breakthrough treatments and research," said Denise Molohon, another Tennant patient who lives with arachnoiditis, in an email.

"But I am most deeply saddened today for the entire chronic pain community - both patients and providers - for the tsunami of injustices perpetrated by DOJ/DEA and CDC in their cruelty, ignorance and haste to appear as though they are fighting the opioid overdose epidemic by ruining the lives of many innocent physicians. Their combined actions have had the tragic result of harming untold millions and leading to the senseless, needless deaths of patients all across our country whose only fault was suffering from horrific, intractable pain."

"The government has stepped in and stopped doctors from treating patients. They have created a hostile work environment for physicians who refuse to conform. Physicians who refuse to let their patients suffer. Addiction is a huge problem but so is intractable pain, yet those of us who play by the rules are the ones who suffer," said Kate Lamport, a Tennant patient who has arachnoiditis.

"Dr. Tennant and Mrs. Tennant have been a Godsend to all whom have crossed their paths and will never be forgotten by the thousands of lives they have touched and saved. Our blood is not on their hands, it is on the hands of those who have taken Dr. Tennant and every other doctor from us by way of fear." 

“Forest and Miriam treated me like a son as they did all their family, their patients. They did their best to take care of us," added Snook. "How could any doctor do so and pay $1,000 an hour in legal fees just to defend himself from false charges from the DEA?”

Tennant is referring all of his patients to new doctors, but in an age when many physicians are afraid of prescribing opioids, its unlikely they'll find similar care elsewhere.  Tennant has operated his pain clinic basically as a charity for years and charged patients little, if anything. He and his wife live modestly, and drive cars that are nearly 30 years old.

“They (the DEA) think my clinic has been operated to make a great deal of money. Some years it loses money. The last two years, it actually lost money. We subsidize it,” Tennant explained.

‘Highly Suspicious’ Prescribing

One medical professional who has been critical of Tennant's prescribing practices is Dr. Timothy Munzing, a Kaiser Permanente family practice physician who was hired by the DEA to review Tennant’s prescriptions.

Munzing was quoted in a DEA search warrant saying it was suspicious that “many patients are traveling long distances to see Dr. Tennant” and that they were prescribed “extremely high numbers of pills/tablets.”

“I find to a high level of certainty that after review of the medical records… that Dr. Tennant failed to meet the requirements in prescribing these dangerous medications. These prescribing patterns are highly suspicious for medication abuse/and or diversion,” Munzing wrote.

Munzing has worked for several years as a consultant for the DEA and the Medical Board of California, creating a lucrative second career for himself.

dr. timothy munzing

According to GovTribe, a website that tracks payments to federal contractors, Munzing is paid $300 an hour by the DEA. In the past few months, Munzing has been paid over $250,000 by the DEA to review patient records and testify as an expert witness in DEA cases.

The agency recently created a task force to focus on doctors like Tennant who prescribe high doses of opioids. The task force appears focused solely on the dose and number of prescriptions, not on the quality of life of patients or whether they’ve been harmed.   

After three years of investigation, the DEA has not publicly produced evidence that any of Tennant’s patients have overdosed, been harmed by his treatments, or that they are selling their drugs.

Tennant says he and his wife plan to retire to their home state of Kansas, where they have real estate investments. Once out of the picture, he hopes the medical profession and law enforcement will someday come to a sensible approach about how to deal with patients who need high doses of opioids.

“I have learned that my personality and my image is such that I think its prohibiting a good debate and discussion as to how the country is going to deal with people with really severe pain,” he said.

For the record, Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

Doctor Shopping Has Always Been Rare

By Roger Chriss, Columnist

A commonly cited factor in the opioid crisis is "doctor shopping" -- the act of seeing multiple physicians in order to get an opioid prescription without medical justification. States like Indiana are passing prescribing laws with the specific goal of preventing doctor shopping in an effort to address the opioid crisis.

However, doctor shopping has not at any time in the past decade been a statistically significant factor in the opioid crisis.  The National Institute of Drug Abuse tells us that only one out of every 143 patients who received a prescription for an opioid painkiller in 2008 obtained prescriptions from multiple physicians "in a pattern that suggests misuse or abuse of the drugs." That’s a rate of about 0.7 percent.

The importance of doctor shopping over the last decade was not because of frequency -- it has more to do with quantity. Research shows that the 0.7% of people who doctor-shopped were buying about 2 percent of the prescriptions for opioid medications, constituting about 4% of the amount dispensed.

Moreover, these doctor-shoppers tended to be young, to pay in cash, and to see five or six prescribers in a short period of time, so they are easily identifiable and can be thwarted with prescription drug monitoring programs (PDMP’s).

Diversion prevention had long been seen as important. Back in 1999, the Drug Enforcement Administration published “Don’t Be Scammed by a Drug Abuser,” which included advice to doctors and pharmacists on how to recognize drug abusers and prevent doctor-shopping. And states like Washington specifically list doctor shopping among the indicators of opioid addiction in prescribing guidelines, making recognition and intervention key goals for prescribers. 

These efforts have paid off. A study in the journal Substance Abuse found that the number of prescriptions diverted fell from approximately 4.30 million (1.75% of all prescriptions) in 2008 to approximately 3.37 million (1.27% of all prescriptions) in 2012. The study concluded that “diversion control efforts have likely been effective.”

Similarly, Pharmacy Times reported a 40% decrease in doctor shopping in West Virginia between 2014 and 2015, thanks in part to efforts by that state’s Board of Pharmacy Controlled Substance Monitoring Program.

The Inspector General of the Department of Health and Human Services found in 2017 that among 43.6 million Medicare beneficiaries, only 22,308 “appeared to be doctor shopping.” That’s a minuscule rate of 0.05 percent.

“You have this narrative that there are these opioid shoppers and rogue prescribers and they’re driving the epidemic, and in fact the data suggests otherwise,” says Dr. Caleb Alexander, who co-authored a 2017 study in the journal Addiction.

"The study found that of those prescribed opioids in 2015, doctor shoppers were exceedingly rare, making up less than one percent of prescription opioid users,” Alexander told Mother Jones.

Doctor shopping is still a problem in other contexts. Opioids are not the only class of medication that people seek to obtain illicitly for a variety of reasons, from hypochondriasis to malingering. PDMPs and other law enforcement efforts have a useful role to play in addressing these issues, and the opioid crisis requires ongoing efforts to prevent drug theft and diversion at all levels of the supply chain.

But claims that doctor shopping is a significant factor in the opioid crisis are mistaken. Doctor shopping was not significant in 2008, and measures to reduce diversion have succeeded, making doctor shopping in 2018 that much rarer.

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.

Do Hungry Mice Have the Answer to the Opioid Crisis?

By Pat Anson, Editor

Yes, that a silly headline. There have been a lot of them lately on how to end the opioid crisis, most of them involving new ways of treating chronic pain without the use of addictive drugs.

Some of these ideas are sincere, some are strange and others are just plain silly. There were a quite a few this week that produced some interesting headlines.

“Staying hungry may suppress chronic pain” was the headline in a Chinese website that reported on a study conducted at the University of Pennsylvania. Researchers there found that laboratory mice that weren’t fed for 24 hours still felt acute short-term pain, but their chronic pain was suppressed by hunger.

“We didn't set out having this expectation that hunger would influence pain sensation so significantly," says J. Nicholas Betley, an assistant professor of biology in Penn's School of Arts and Sciences. "But when we saw these behaviors unfold before us, it made sense. If you're an animal, it doesn't matter if you have an injury, you need to be able to overcome that in order to go find the nutrients you need to survive."

Betley isn’t suggesting that chronic pain patients stop eating or starve themselves, but he believes the finding could pave the way to new pain medications that target brain receptors that control survival behavior.  

“Chronic pain relief: How marine snails may be able to help” was the headline used by WNDU-TV to report on a recent study at the University of Utah. 

Researchers there say a compound in the venom of cone snails could someday be used in pain medication. The venom paralyzes small fish so that hungry cone snails can slowly eat their prey alive.  

"We really hope that we will find a drug that could be as effective for severe pain as opioids but has far less side effects and is not addictive," says Russell Teichert, PhD, a research associate professor in the Department of Biology.

Interestingly, the cone snail study is funded with a $10 million grant from the U.S. Department of Defense. Human trials are expected to begin in a couple years.

“Why Tai Chi Works So Well for Pain Relief” was the headline in Time about a study by researchers at Tufts Medical Center. The headline is a bit misleading, because the study only included fibromyalgia patients and compared the effectiveness of tai chi to aerobic exercise in relieving pain.

The last thing many fibromylagia sufferers want to do is practice tai chi, but the Chinese martial arts exercise was found to be just as good or better than aerobics, which is sometimes recommended as a non-drug treatment for fibromyalgia.

“It is low risk and minimally invasive, unlike surgery, and it will not harm your organs, like long term drug use,” said Amy Price, a trauma survivor who lives with chronic pain.

“Kellyanne Conway Tells Students to Eat Ice Cream and Fries Rather than Take Deadly Drug Fentanyl”  is how Newsweek summed up a speech by a top presidential advisor to a group of college students.

“On our college campuses, you folks are reading the labels, they won’t put any sugar in their body, they won’t eat carbs anymore, and they’re very, very fastidious about what goes into their body. And then you buy a street drug for $5 or $10, it’s laced with fentanyl and that’s it,” said Conway, who oversees the Trump administration’s response to the opioid crisis.

“So my short advice is, eat the ice cream, have the French fry, don’t buy the street drug—believe me, it all works out.”

Conway probably said this tongue-in-cheek, but critics were quick to pounce.

“Was feeling bad about my McDonalds ice cream cone today until I realized it helped me avert opioid addiction. Thanks Kellyanne Conway!” Lola Lovecraft tweeted.

 “I was considering doing fentanyl but now thanks to Kellyanne I’m just gonna 'have the French fry” instead. Saved me from a life on the streets!” tweeted Mike Stephens.

Conway’s boss had zinger of his own after signing a $1.3 trillion spending bill on Friday.

“We’re also spending $6 billion on, as you know, various forms of drug control, helping people that are addicted,” said President Trump.  “The level of drugs that are being put out there and the power of this addiction is hard to believe. People go to the hospital for a period of a week and they come out and they’re drug addicts.”

No, Mr. President, that’s a myth. Studies have repeatedly shown that it is rare for hospital patients to become addicted to opioids.

One study found that only 0.6% of patients recovering from surgery were later diagnosed with opioid misuse. Another study found that only 1.1% of patients treated with opioids in a hospital emergency room progressed to long term use.

What is true is that there’s a growing shortage of opioid medication in hospitals and hospices, and that’s leading to medical errors and the unnecessary suffering of patients. The shortage is due in part to manufacturing problems and severe cuts in opioid production quotas ordered by the DEA.

President Trump is aware that opioid prescribing has declined significantly, but he’d like to see more.  This week he called for opioid prescriptions to be cut by a third over the next three years. “Doctors are way down now in their orders of the opioids, way down. It’s a great thing,” he said.

Let's hope the hungry mice and cone snails share their secrets soon.

Opioid Painkillers Top Selling Drug in 10 States

By Pat Anson, Editor

If you live in Oklahoma, the drug you’re most likely to be prescribed is the opioid painkiller Vicodin -- or some other combination of hydrocodone and acetaminophen.

In Texas, the #1 drug is Synthroid (levothyroxine) – which is used to treat thyroid deficiencies.

In California, its Lipitor (atorvastatin) – a statin used to treat high cholesterol.

And Tennessee has the unique distinction of being the only state in the country where the addiction treatment drug Suboxone (buprenorphine/naloxone) is the most prescribed drug.

These findings are part of an interesting study by GoodRx, an online discount drug company, on prescribing trends in all 50 states. GoodRx looked at pharmacy and insurance data from around the country – not just its own customers -- from March 2017 to February 2018.

It then developed a map to show how prescription trends can vary by region and by state.

Levothyroxine (Synthroid) is easily the top selling drug in the country. It’s #1 in 26 states (AR, AZ, CO, CT, FL, IA, KS, KY, LA, ME, MI, MN, MT, ND, NJ, NV, OR, PA, SD, TX, UT, VT, WA, WI, WV, WY).

Hydrocodone (Vicodin, Norco, Lortab) is #1 in 10 states (AK, AL, GA, ID, IL, IN, MS, NC, NE, OK), mainly in the South and Midwest. As recently as 2012, hydrocodone was the most widely prescribed medication in the country. Since then, hydrocodone prescriptions have fallen by over a third and it now ranks 4th nationwide.

Atorvastatin (Lipitor) is #1 in 5 states (CA, HI, MD, MO, VA) and so is lisinopril (MA, NH, NM, OH, RI), a medication used to treat high blood pressure.

There are a few outliers. New York, for example, is the only state that’s #1 in amlodipine (Norvasc), a blood pressure medication, and Delaware and South Carolina are the only states where the leading prescription drug is Adderall, a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD).   

That brings us to Tennessee, one of the states hardest hit by the opioid crisis. In 2012, doctors wrote 1.4 opioid prescriptions for every citizen in Tennessee, the second highest rate in the country. The state then moved aggressively to shutdown pill mills and expand access to addiction treatment -- which explains why Tennessee is #1 for Suboxone.

Prescriptions for opioid pain medication have dropped by 12% in Tennessee since their peak, but overdose deaths and opioid-related hospitalizations continue to climb, due largely to heroin and illicit fentanyl.  No other state even comes close to Tennessee in per capita prescriptions for Suboxone.  Addiction treatment has become such a growth industry that Tennessee has adopted measures to rein in the overprescribing of Suboxone.

CDC Admits Rx Opioid Deaths ‘Significantly Inflated’

By Pat Anson, Editor

Researchers with the Centers for Disease Control and Prevention have acknowledged that the agency’s methods for tracking overdose deaths are inaccurate and have significantly overestimated the number of Americans that have died due to prescription opioids.

In an editorial appearing in the American Journal of Public Health, four researchers in the CDC’s Division of Unintentional Injury Prevention say many overdoses involving illicit fentanyl and other synthetic black market opioids have been erroneously counted as prescription drug deaths.

“Availability of illicitly manufactured synthetic opioids (e.g., fentanyl) that traditionally were prescription medications has increased. This has blurred the lines between prescription and illicit opioid-involved deaths,” they wrote. “Traditionally, the Centers for Disease Control and Prevention (CDC) and others have included synthetic opioid deaths in estimates of ‘prescription’ opioid deaths. However, with IMF (illicitly manufactured fentanyl) likely being involved more recently, estimating prescription opioid–involved deaths with the inclusion of synthetic opioid–involved deaths could significantly inflate estimates.”

How inflated were the overdose numbers?  Using the agency’s “traditional definition” for prescription opioids, the CDC estimated that 32,445 Americans died from overdoses of pain medication in 2016.

Under a new “conservative definition” – one that excludes the “high proportion of deaths” involving synthetic opioids like fentanyl – the death toll from prescription opioids is cut nearly in half to 17,087 overdoses.

The researchers note that even that estimate is likely wrong for a variety of reasons:

• The number of deaths involving diverted prescriptions or counterfeit drugs is unknown
• Toxicology tests cannot distinguish between pharmaceutical fentanyl and illicit fentanyl
• Drugs are not identified on death certificates in 20% of overdose deaths
• Multiple drugs are involved in almost half of drug overdose deaths

The editorial by CDC researchers Puja Seth, Rose Rudd, Rita Noonan and Tamara Haegerich carries a disclaimer that their views “do not necessarily represent the official position” of the CDC.  But given the agency’s past reluctance to let employees speak to the media without prior approval, it’s highly unlikely the editorial was not cleared beforehand.

A spokesperson for the CDC said the agency first noticed the growing number of deaths caused by illicit fentanyl in  2015 and changed the way it calculated opioid overdoses that year. She said the explanation for the change was being published now "to document the method in peer-reviewed literature."

However, as one of our readers pointed out, the inflated overdose numbers can still be found on the agency's website, with only a vague explanation that some may be fentanyl-related:

"In 2016 there were 32,445 deaths involving prescription opioids, equivalent to about 89 deaths per day. This was an increase from approximately 22,598 in 2015. However, a significant portion of the increase in deaths was due to deaths involving synthetic opioids other than methadone, which likely includes illegally-made fentanyl."

President Trump's opioid commission warned last year that a better system was needed to keep track of overdose deaths. “We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the commission said in its final report.

The CDC has recently implemented a new overdose surveillance system in 32 states that supplements data from death certificates with toxicology tests and death scene investigations to more accurately reflect which drugs are involved in overdose deaths.

Lies and Damned Lies

We’ve written before about how confusing, flimsy and exaggerated the numbers can be for overdoses (see “Lies, Damned Lies, and Overdose Statistics”). Last October, PNN reported that the Drug Enforcement Administration changed its definition of prescription drug deaths for three consecutive years in an annual report, apparently in an effort to inflate the number of Americans dying of overdoses.

In 2016, we reported that within one week the CDC and the White House Office of National Drug Control Policy released three different estimates of the number of Americans that died from prescription opioids the year before. The numbers were wildly different, ranging from a low of 12,700 to a high of 17,536 deaths.

To be clear, one overdose is too many. But if we are ever going to find real solutions to the overdose crisis, we need to find accurate numbers to reflect what is causing so many drug deaths. Pinning the blame on prescription opioids, pain patients and prescribers has only led to a growing catastrophe in pain care –  where doctors are too fearful to prescribe opioids and patients can’t get treatment. 

As the CDC researchers say in their editorial, "inaccurate conclusions” not only mask what’s driving the overdose crisis -- they mask the solutions too.

“Obtaining an accurate count of the true burden and differentiating between prescription and illicit opioid-involved deaths are essential to implement and evaluate public health and public safety efforts,” they wrote. “If deaths involving synthetic opioids—likely IMF—are categorized as prescription opioid overdose deaths, then the ability to evaluate the effect of interventions targeting high-risk prescribing practices on prescription opioid–involved deaths is hindered. Decreases in prescription opioid–involved deaths could be masked by increases in IMF deaths, resulting in inaccurate conclusions. ”

A Nightmare Experience With Surgery

By Rochelle Odell, Columnist

I have been warning my “healthy” family and friends that the opioid epidemic and the backlash against prescription opioids would affect them at some point. My recent nightmare of a surgery may prove that the time may now be at hand. 

On February 2, I underwent what normally would be minor surgery to remove a catheter -- called a portacath -- that had become dislodged. For patients with Complex Regional Pain Syndrome (CRPS), there is no such thing as a minor procedure and my experience became a prime example of what could go wrong.

My friend Debbie drove me to the hospital where the surgery was performed. I have undergone over 40 procedures for CRPS and I always become apprehensive, as any patient facing surgery should be. I told Debbie I did not have a warm toasty feeling about the surgery. I was frightened, a feeling I don't usually experience. But this time I did.

Before I was taken back to pre-op, Debbie asked me if I would like to pray. Thankful for the thought, I responded yes. It did not alleviate the feeling of dread nagging at me, but I hoped God would protect me.

Once in pre-op, the nurse went over my extensive allergy list. Believe me, it's long. I am allergic to almost all antibiotics, including penicillin, along with some opioids like Demerol and methadone, as well as aspirin and NSAID's. Betadine causes blisters and a horrible rash. I’m also allergic to most medical tape, including cloth, plastic, silk and paper tapes. The only one I can tolerate is Hypafix. It's a soft adhesive that allows the skin to breathe. I was very vocal about that.

The nurse asked what kind of surgery I was about to undergo and why. I told her it was because I don't have any good veins, never have, and that a catheter was a necessary evil. Without one, if I were to pass out or become very ill, dying could be a real possibility.

I told her she would only got two tries for the IV line I would need for surgery. I am not a pin cushion and multiple needle pricks could cause a major pain flare. She started the IV on the second try.

The surgeon and anesthesiologist then came to see me. I explained how nervous I was and that I honestly was very close to walking out. I should have done that. I could tell the surgeon had no clue what CRPS was or how to treat me post-op. That is not unusual, a lot of doctors have no clue what it is, and that extra steps are needed to keep a major pain flare from happening.

Even the anesthesiologist seemed clueless about CRPS. I thought that odd, since anesthesiologists are often pain management physicians. He kept telling me don't worry, once in the operating room I would be out soon.

Four hours later I was taken to the operating room. I told the anesthesiologist that I forgot to add fentanyl to my allergy list. It gives me a smothering feeling and can't breathe. I also told him I wanted an LMA mask, because being intubated causes my asthma to flare. He told me he would use the mask, but he wanted to use fentanyl and that if I stopped breathing he would intubate me.

What is wrong with this explanation? Use something other than fentanyl and you won't have to intubate me. I also asked the surgeon to place me on IV antibiotics, as I have a long history of staph and MRSA infections.

Upon coming out of anesthesia, my throat was killing me. I knew he must have intubated me and used a drug I didn't want. The pain was excruciating. I was given small doses of Dilaudid and oxycodone, which did absolutely zip for me.

They also gave me IV Tylenol. Really, Tylenol post-op in a CRPS patient? The recovery room nurse was trying to console me as I was in tears.  Any nurse I dealt with said they were trying to make sure I didn't die of an opioid overdose. That took the cake, the minuscule doses I received were obviously not working, so an opioid overdose certainly would not happen.

One nurse told me my pain was emotional pain. I should have screamed at her to get away from me, but I was in so much pain I couldn't think clearly. I was kept for observation overnight, which brought more problems and the realization that the very thing I warned my healthy family and friends about was indeed at hand.

What kind of pain control do patients get now after surgery?  My surgeon was responsible for ordering all my meds, but how is a man who has no clue what CRPS is going to manage my pain? A man I had only seen one time before the surgery.

My RN was very sweet, but she too was stating what I think must be the hospital's policy. They do not want to provide opioid pain management.  Everyone is so convinced the opioid epidemic was and is caused by prescription opioid medication. It dawned on me, ignorance is alive and well and it must be contagious.

My ordeal continued to worsen. I looked at my surgery sites. Not only were my upper chest and right arm covered in the tell-tale orange color from Betadine, but there was medical tape. A big painful and very itchy rash had developed.

My skin was driving me nuts. I asked the nurse to remove the tape and use non-stick pads and Hypafix, but she refused. Didn't anyone read my allergy list? Why ask for one if you are going to ignore it? The surgeon ordered Benadryl cream for my arm. It helped a little and I did get one injection of IV Benadryl, but that was it. I received less medication in the hospital than I was taking at home.

After a long painful night, I told the nurse I would refuse to see the surgeon. Anyone who causes a patient as much pain as he did is one I will not see again. The nurse said he had to see me in order to release me. I told her to tell him to have a different doctor release me, as I did not want to see him. I was livid. The morning I was released I removed the tape, as I could no longer tolerate it. She helped me cover the area with sterile gauze.

As soon as I got home I cleaned the surgery area thoroughly and made an occlusive dressing over the two surgical sites. The next morning my whole upper right chest was covered with tiny blisters and a nasty looking rash. My friend took pictures for me.  The asthma flare I was afraid of was in full swing and I was running a temperature of 102.  I could barely breath and my pain was completely out of control.

I had a temperature for three weeks, and six weeks later I am still coughing up yellow gunk. That could have easily been prevented, but what do I know, I am just the patient.  Because I refused to see the surgeon for a post-op checkup, my primary care provider sent me a letter informing me I was trying to direct my care and was argumentative. He would only treat me for 30 more days and I needed to find a new primary care physician.

In the past I might have been upset with a letter like that, but since this opioid epidemic has affected me so negatively, I simply do not want to be seen by any physician who doesn't try to understand how sick I am. I was in so much pain.  Wouldn't you try to direct your care at that point?

My ordeal has not ended. As of this writing, the whole port area and catheter tubing are swollen and look infected. Have I gotten it checked yet? Nope. I have literally been frozen in place by fear, a fear I have never experienced before. I know this will require more surgery to remove and replace the portacath. Just thinking about it scares me.

All of this could have been avoided if my allergy list had been read, if there had been adequate pain management, and if IV antibiotics had been started. If this is the future of medical care, I may reconsider seeing any doctor. It just isn't worth the stress and pain.

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

Trump Calls for More Cuts in Opioid Prescriptions

By Pat Anson, Editor

President Trump is calling for further reductions in the prescribing of opioid pain medication and for some drug dealers to get the death penalty.

In a speech in Manchester, New Hampshire, a state hit hard by the overdose epidemic, Trump outlined his plan to combat the nation’s opioid and addiction crisis by cracking down on drug dealers, opioid manufacturers and doctors who overprescribe pain medication.

“We’re going to cut nationwide opioid prescriptions by one third over the next three years,” Trump said. “We’re also going to make sure that virtually all prescriptions reimbursed by the federal government follow best practices for prescribing. We’ll ensure that opioid addiction is not subsidized by the American taxpayer. The best way to beat the drug crisis is to keep people from getting hooked on drugs to begin with.”

The president did not spell out precisely how opioid prescribing would be reduced. His administration has proposed new rules that would make it harder for Medicare beneficiaries to obtain high doses of opioid medication by rigidly adhering to the CDC’s voluntary opioid prescribing guidelines. Under the Medicare plan, insurers could refuse to pay for opioid prescriptions that exceed the dose levels recommended by the CDC.

Opioid prescriptions peaked in 2010 and the Drug Enforcement Administration has cut opioid production quotas nearly in half over the last two years – which has led to shortages of pain medication at some hospitals and hospices.  

The president also said the nation “must get tough” with high volume drug traffickers.

“The ultimate penalty has to be the death penalty,” Trump said. “Drug traffickers kills so many thousands of our citizens every year and that’s why my Department of Justice will be seeking much tougher penalties than we’ve ever had. And we will be focusing on the penalty that we talked about previously for the big pushers, the ones that are really killing so many people.

"Whether you are a dealer or doctor or trafficker or a manufacturer, if you break the law and illegally peddle these deadly poisons, we will find you, we will arrest you, and we will hold you accountable."

Trump said tougher border security was needed to stop the flow of illegal drugs and called for an nationwide advertising campaign to encourage children to avoid drug use.

“Spending a lot of money on great commercials showing how bad it is,” he said.

Last October, the president declared the opioid crisis a public health emergency, a designation that stopped short of the national state of emergency sought by his opioid commission. Critics have said the Trump administration has done little to fund or execute a coherent strategy to combat the overdose problem. 

Prescription Opioids Rarely Lead to Heroin Use

By Roger Chriss, Columnist

A recent Politico column by three anti-opioid activists asserts that “opioid use disorder is common in chronic pain patients”  and that the nation’s overdose crisis “stems largely from the overprescribing of opioids.”

Andrew Kolodny, MD, Jane Ballantyne, MD, and Gary Franklin, MD --  who are the founder, president, and vice-president, respectively, of Physicians for Responsible Opioid Prescribing (PROP) – also wrote that “many individuals become addicted to prescription opioids through medical or non-medical use, and then switch to heroin after becoming addicted."

This claim is an oversimplification of the tragedy that is heroin addiction. It both ignores the complex trajectory of drug use that culminates in heroin and omits the known risk factors of the people who suffer from heroin addiction. It also runs counter to the known data about various forms of opioid addiction, which clearly shows that most people on opioid therapy do not develop problems with misuse, abuse or addiction, and rarely move on to heroin.

The National Institute on Drug Abuse (NIDA) estimates that about 10 percent of patients prescribed opioids develop an opioid use disorder. And only about 5 percent of those who misuse their medication ever make the transition to heroin.

Further, the number of people addicted to prescription opioids -- about two million -- has been stable for over five years, while rates of heroin use have been rising, suggesting there is not a strong corelation between the two.

From 2002 to 2016, the number of Americans using heroin nearly tripled, from 214,000 to 626,000. Overdose deaths involving heroin also soared during that period.

The reasons behind this are complex and not fully understood. One theory is that heroin became more popular when prescription opioids became harder to obtain and abuse. According to a study by the RAND Corporation, the introduction of abuse-deterrent OxyContin in 2010 was a major driver in the shift to heroin.

Heroin use is also strongly associated with mental illness and childhood trauma. Studies have found that 75 percent of people with heroin addiction have another mental illness, with about half showing signs of psychiatric problems or post-traumatic stress disorder (PTSD) before age 16. At least half were abused or neglected as children, with especially high rates of sexual abuse.

In addition, it is well established in psychiatry that certain mental health disorders – such as borderline personality and bipolar disorder -- have a significantly increased risk of substance use.

Thus, heroin use and addiction is far more complex than just a result of opioid misprespcribing. Most people placed on opioid therapy do not misuse their medication, and the few who do become addicted rarely transition to heroin. Recent studies also suggest that more people are starting on heroin without prior exposure to other opioids.

Heroin addiction is most often the tragic outcome of a shattered childhood or mental illness, and not simply a result of medication exposure. To claim that heroin addiction stems largely from pain management is a disservice to both addicts and pain patients, and will only further the suffering of both groups by diverting attention from the real issues.

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.

Hospital Opioid Shortages Cause Pain & Medical Errors

By Pauline Bartolone, Kaiser Health News

Even as opioids flood American communities and fuel widespread addiction, hospitals are facing a dangerous shortage of the powerful painkillers needed by patients in acute pain, according to doctors, pharmacists and a coalition of health groups.

The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs given to patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.

As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.

In the institute’s survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock. In another case, a patient was mistakenly given too much sufentanil, which can be up to 10 times more powerful than fentanyl, the ideal medication for that situation.

In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can.

Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases.

Other patients are languishing in pain because preferred, more powerful medications aren’t available, or because they have to wait for substitute oral drugs to kick in.

The American Society of Anesthesiologists confirmed that some elective surgeries, which can include gall bladder removal and hernia repair, have been postponed.

In a Feb. 27 letter to the U.S. Drug Enforcement Administration, a coalition of professional medical groups — including the American Hospital Association, the American Society of Clinical Oncology and the American Society of Health-System Pharmacists — said the shortages “increase the risk of medical errors” and are “potentially life-threatening.”

In addition, “having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients,” the group wrote.

The shortages involve prefilled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.

Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications.

Small Mistakes Lead to Big Errors

Giving the wrong dose of morphine, for example, “can lead to severe harm or fatalities,” explained Mike Ganio, a medication safety expert at the American Society of Health-System Pharmacists.

Calculating dosages can be difficult and seemingly small mistakes by pharmacists, doctors or nurses can make a big difference, experts said.

Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, said it would be easy for medical mistakes to occur during a shortage. For instance, in a fast-paced environment, a nurse could forget to program an electronic pump for the appropriate dose when given a mix of intravenous fluids and medication to which she was unaccustomed.

“The system has been set up safely for the drugs and the care processes that we ordinarily use,” said Dr. Beverly Philip, a Harvard University professor of anesthesiology who practices at Brigham and Women’s Hospital in Boston. “You change those drugs, and you change those care processes, and the safety that we had built in is just not there anymore.”

Chicago-based Marti Smith, a nurse and spokeswoman for the National Nurses United union, offered an example.

“If your drug comes in a prefilled syringe and at 1 milligram, and you need to give 1 milligram, it’s easy,” she said. “But if you have to pull it out of a 25-milligram vial, you know, it’s not that we’re not smart enough to figure it out, it just adds another layer of possible error.”

During the last major opioid shortage in 2010, two patients died from overdoses when a more powerful opioid was mistakenly prescribed, according to the institute. Other patients had to be revived after receiving inaccurate doses.

Pfizer Manufacturing Problems

The shortage of the three medications, which is being tracked by the FDA, became critical last year as a result of manufacturing problems at Pfizer, which controls at least 60 percent of the market of injectable opioids, said Erin Fox, a drug shortage expert at the University of Utah.

A Pfizer spokesman, Steve Danehy, said its shortage started in June 2017 when the company cut back production while upgrading its plant in McPherson, Kansas. 

The company is not currently distributing prefilled syringes “to ensure patient safety,” it said, because of problems with a third-party supplier it declined to name.

That followed a February 2017 report by the U.S. Food and Drug Administration that found significant violations at the McPherson plant. The agency cited “visible particulates” floating in the liquid medications and a “significant loss of control in your manufacturing process [that] represents a severe risk of harm to patients.” Pfizer said, however, that the FDA report wasn’t the impetus for the factory upgrades.

Other liquid-opioid manufacturers, including West-Ward Pharmaceuticals and Fresenius Kabi, are deluged with back orders, Fox said. Importing these heavily regulated narcotics from other countries is unprecedented and unlikely, she added, in part because it would require federal approval.

DEA Reduced Opioid Supply

At the same time, in an attempt to reduce the misuse of opioid painkillers, the Drug Enforcement Administration called for a 25 percent reduction of all opioid manufacturing last year, and an additional 20 percent this year.

“DEA must balance the production of what is needed for legitimate use against the production of an excessive amount of these potentially harmful substances,” the agency said in August.

When the coalition of health groups penned its letter to the DEA last month, it asked the agency to loosen the restrictions for liquid opioids to ease the strain on hospitals.

The shortages are not being felt evenly across all hospitals. Dr. Melissa Dillmon, medical oncologist at the Harbin Clinic in Rome, Ga., said that by shopping around for other suppliers and using pill forms of the painkillers, her cancer patients are getting the pain relief they need.

Dr. Shalini Shah, the head of pain medicine at the University of California-Irvine health system, pulled together a team of 20 people in January to figure out how to meet patients’ needs. The group meets for an hour twice a week.

The group has established workarounds, such as giving tablet forms of the opioids to patients who can swallow, using local anesthetics like nerve blocks and substituting opiates with acetaminophen, ketamine and muscle relaxants.

“We essentially have to ration to patients that are most vulnerable,” Shah said.

Two other California hospital systems, Kaiser Permanente and Dignity Health in Sacramento, confirmed they’re experiencing shortages, and that staff are being judicious with their supplies and using alternative medications when necessary.

At Helen Keller Hospital’s emergency department in Sheffield, Ala., earlier this month, a 20-year-old showed up with second-degree burns. Dr. Hamad Husainy said he didn’t have what he needed to keep her out of pain.

Sometime in January, the hospital ran out of Dilaudid, a drug seven times more potent than morphine, and has been low on other injectable opioids, he said.

Because Husainy’s patient was a former opioid user, she had a higher tolerance to the drugs. She needed something strong like Dilaudid to keep her out of pain during a two-hour ride to a burn center, he said.

“It really posed a problem,” said Husainy, who was certain she was in pain even after giving her several doses of the less potent morphine. “We did what we could, the best that we could,” he said.

Bernell, the St. Louis nurse, said some trauma patients have had to wait 30 minutes before getting pain relief because of the shortages.

“That’s too long,” said Bernell, a former intensive care nurse who now works in radiology.

Dr. Howie Mell, an emergency physician in Chicago, said his large hospital system, which he declined to name, hasn’t had Dilaudid since January. Morphine is being set aside for patients who need surgery, he said, and the facility has about a week’s supply of fentanyl.

Mell, who is also a spokesman for the American College of Emergency Physicians, said some emergency departments are considering using nitrous oxide, or “laughing gas,” to manage patient pain, he said.

When Mell first heard about the shortage six months ago, he thought a nationwide scarcity of the widely used drugs would force policymakers to “come up with a solution” before it became dire.

“But they didn’t,” he said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

What the JAMA Opioid Study Didn’t Find

By Roger Chriss, Columnist

A recent opioid study published in the Journal Of the American Medical Association (JAMA)  evaluated pain management in patients with hip and knee osteoarthritis and low back pain.

The study by VA researcher Erin Krebs, MD, and colleagues found that “treatment with opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months.”  

That finding was widely and erroneously reported in the news media as meaning that opioids are ineffective for all types of chronic pain.

But the most fascinating result of the study – the one not being reported -- is what wasn’t found. The 108 people in the study who took opioids for a year did not develop signs of opioid misuse, abuse or addiction, and did not develop opioid-induced hyperalgesia – a heightened sensitivity to pain.

And no one died of an overdose.

This is significant because it runs counter to commonly held beliefs in the medical profession about the risks of prescription opioids. Here are a few recent examples:

“Opioids are very addictive and their effectiveness wanes as people habituate to the medication,” Carl Noe, MD, director of a pain clinic at the University of Texas Medical Center wrote in an op/ed in The Texas Tribune.

Don Teater, MD, a family physician in North Carolina, also believes that people on long-term opioid therapy experience dose escalation, which leads to hyperalgesia. “Opioids cause permanent brain changes,” Teater told USA Today.

Krebs herself has made similar comments. "Within a few weeks or months of taking an opioid on a daily basis, your body gets used to that level of opioid, and you need more and more to get the same level of effect,” she told NPR.

But the Krebs study didn’t see any of that happen.

Krebs and colleagues closely monitored the 108 people in the opioid arm of the study, using “multiple approaches to evaluate for potential misuse, including medical record surveillance for evidence of ‘doctor-shopping’ (seeking medication from multiple physicians), diversion, substance use disorder, or death.” They also had participants complete the “Addiction Behavior Checklist” and assessed their alcohol and drug use with surveys and screening tools.

What did Krebs find in the opioid group after 12 months of treatment?

“No deaths, ‘doctor-shopping,’ diversion, or opioid use disorder diagnoses were detected,” she reported. “There were no significant differences in adverse outcomes or potential misuse measures.”

Health-related quality of life and mental health in the opioid group did not significantly differ from the non-opioid group – and their anxiety levels actually improved.  

These are observational findings in the study. They were not a part of what Krebs and colleagues were specifically trying to measure. As the study notes: “This trial did not have sufficient statistical power to estimate rates of death, opioid use disorder, or other serious harms associated with prescribed opioids.”

ERIN KREBS, MD

But they are valuable observations. They note what didn’t happen in the study. Over 100 people were put on opioid therapy for a year, and none of them showed any signs of dose escalation or opioid-induced hyperalgesia, or any evidence of opioid misuse, abuse or addiction.

Krebs told the Minneapolis Star Tribune that this “could reflect the fact that the study did not enroll patients with addiction histories, and because the VA provided close supervision to all participants during the yearlong study.”

In other words, Krebs and colleagues used an opioid prescribing protocol that achieved an admirable level of patient safety. Their approach is similar to what many pain management practices currently pursue and what the CDC and various state guidelines recommend: Risk assessment before initial prescribing and careful monitoring over time.

The Krebs study provides rare and detailed observations of what happens when people are put on long-term opioid therapy. A lot of what is claimed about dose escalation, opioid-induced hyperalgesia, and misuse or abuse didn't happen at all.

This outcome demonstrates that long-term opioid therapy can be safe and effective, and may be useful in treating other chronic conditions, from intractable neuropathies to painful genetic disorders. That’s worth reporting too, isn’t it?

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Overuse of Acetaminophen Increases During Flu Season

By Pat Anson, Editor

Acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus.

Recent guidelines released by the UK’s National Institute for Health Care Excellence (NICE) even recommend acetaminophen (paracetamol) for treating sore throat pain.

But a large new study warns that too many cold and flu sufferers take too much acetaminophen – which has long been associated with liver damage and allergic reactions such as skin rash.

Researchers at the University of Pittsburgh and Boston’s University’s Slone Epidemiology Center surveyed nearly 14,500 U.S. adults about their use of acetaminophen in the preceding 30 days. The study, which was sponsored by Johnson & Johnson, was conducted over a five-year period, from 2011 to 2016.

Investigators found that 6.3% of acetaminophen users exceeded the recommended maximum adult daily dose of 4,000 mg on at least one day during a week that they used acetaminophen.

Usage patterns grew during the cold and flu season. The odds of taking more than 4,000 mg of acetaminophen increased to 6.5% compared to 5.3% during the off-season.

This was primarily due to increased use of over-the-counter medications designed to treat upper respiratory cold and flu symptoms.

"This is the first multi-year, year-round study that includes detailed data on how consumers used acetaminophen medications," said Saul Shiffman, PhD, of Pinney Associates and the University of Pittsburgh. "The study findings suggest the importance of educating consumers about acetaminophen and counseling them about appropriate use and safe dosages of these medications.

"Getting this message out is especially important during cold/flu season, when people may be more likely to treat illness symptoms with acetaminophen combination products, sometimes without even realizing they contain acetaminophen."

The use of acetaminophen (paracetamol) is even more pronounced in France, according to a new study published in the British Journal of Clinical Pharmacology.

There was a 53% increase in the use of paracetamol in France between 2006 and 2015, and 1000 mg tablets of paracetamol (which are not available in the United States) are now the most-used drug among French adults. There is also a trend towards larger doses. Consumption of 1000 mg tablets increased by 140 percent in France over the ten-year study; while consumption of 500 mg tablets decreased by 20 percent.

Compared to other countries in Europe, France ranked first in paracetamol usage and third in the consumption of mild opioids such as tramadol and codeine. The French use of strong opioids such as morphine was among the lowest in Europe.

"To our knowledge, this is the first published study analysing consumption trends for both non-opioids and opioids over the last decade in France. Long-term surveillance over the past 10 years has highlighted quantitative and qualitative changes in analgesic consumption patterns in France," said study co-author Philippe Cavalié, PhD, of the French National Agency for Medicines and Health Products Safety.

"The very widespread analgesics consumption that we have documented raises the concern of overuse and misuse, as well as addiction to opioids."

The U.S. Food and Drug Administration asked drug makers in 2011 to limit acetaminophen doses to 325 mg per tablet or capsule. The FDA also requires a “Boxed Warning” label – the agency’s strongest warning – to call attention to serious risks.

Over 50 million people in the U.S. use acetaminophen each week for pain and fever – many unaware of the risk of liver injury and allergic reactions. Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses, including 25,000 hospitalizations and 450 deaths.

For more information about acetaminophen and how to avoid overdosing, visit KnowYourDose.org.

It's a Myth America Consumes 80% of World’s Opioids

By Roger Chriss, Columnist

Getting the facts right about the opioid crisis is essential. And the claim that the United States consumes 80% of the world’s supply of opioid medication -- while having only 5% of the world’s population -- is incorrect.

This “80/5” claim is popular and persistent. Senator Claire McCaskill tweeted about it last year. Recently Consumer Safety and the Reporter Newspapers repeated it. And news organizations like The Guardian, Business Insider, CNN and ABC News have all reported the “80/5” claim as fact at various times. 

The truth is that Americans consumed only about 30% of the world’s opioid medication in 2015. And the U.S. has about 4.4% of the world’s population.  That's still a lot, but nowhere near "80/5."

So where does the claim that the U.S. consumes 80% of the world’s opioids come from? It took a little digging to find out.

In 2014, Nora Volkow, MD, director of the National Institute on Drug Abuse, submitted the following testimony to the U.S. Senate Caucus on International Narcotics Control:

"The number of prescriptions for opioids (like hydrocodone and oxycodone products) have escalated from around 76 million in 1991 to nearly 207 million in 2013, with the United States their biggest consumer globally, accounting for almost 100 percent of the world total for hydrocodone (e.g., Vicodin) and 81 percent for oxycodone."

A footnote reveals where Volkow got that information. It came from a 2008 report from the International Narcotics Control Board, which states:

“In 2008 the United States accounted for over 99 per cent of the global consumption of hydrocodone and 83 per cent of the global consumption of oxycodone.”

This ultimately seems to be the origin of the “80 percent” part of the claim. At one time, the U.S. was responsible for over 80% of the world’s consumption of one particular type of opioid medication: oxycodone.

But the numbers vary significantly for each type of opioid. According to the Global Commission on Drugs, the U.S. consumed 57.3% of the world’s morphine in 2013. And Statista reports that in 2015 the U.S. consumed 29.3% of the world’s supply of prescription fentanyl, followed closely by Germany at 23.7 percent.

The U.S. at one time did consume 99% of the world’s supply of hydrocodone. But as a Pain Medicine article by Mark Rose explains, that is because “other countries with adequate opioid access prefer dihydrocodeine or low-dose morphine to hydrocodone for moderate to moderately severe pain.”

Hydrocodone prescriptions have actually plummeted in the U.S. since 2014, when it was rescheduled by the DEA as a Schedule II controlled substance.

So what are the real numbers for opioid consumption?

As Politifact notes while debunking McKaskill’s “80/5” claim, “while the United States is clearly the largest consumer of opioids, it, at most, accounts for roughly 30 percent of global consumption.”

At present, however, there are opioid shortages in some hospitals and hospices. The Philadelphia Inquirer recently reported that morphine, hydromorphone (Dilaudid), and fentanyl — staples of pain control and sedation in hospital settings — are in short supply.

“The shortage of hydromorphone is beyond acute,” Beverly Philip, vice president of scientific affairs for the American Society of Anesthesiologists, told the Inquirer.

The shortage is due, in part, because the DEA has lowered annual production quotas for fentanyl, hydromorphone, and morphine over the last two years by 35 to 46 percent.

This demonstrates the risk of persistent false claims. As Sally Patel, MD, wrote in an excellent Politico piece about the opioid crisis: “We need to make good use of what we know about the role that prescription opioids plays in the larger crisis.”

Otherwise we’ll find ourselves awash in a false narrative while enduring very real pain.

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.

Is JAMA Opioid Study Based on Junk Science?

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

Who is Erin Krebs?  

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

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

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

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

ERIN KREBS, MD

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

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

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

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

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

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

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

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