Do 80% of Heroin Users Really Start With a Prescription?

By Roger Chriss, Columnist

U.S. Attorney General Jeff Sessions recently announced a new plan by the DEA to further tighten production quotas for opioid pain medication as a step in the fight against opioid abuse and addiction.

The proposal appears in the Federal Register with the following explanation:

“Users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers…. Once ensnared, dependency on potent and dangerous street drugs may ensue. About 80% of heroin users first misused prescription opioids. Thus, it may be inferred that current users of heroin and fentanyl largely entered the gateway as part of the populations who previously misused prescription opioids."

This is not a new claim by the DEA. In its 360 Strategy: Diversion Control, the DEA plainly states, “The connection between prescription opioid abuse and heroin use is clear, with 80% of new heroin abusers starting their opioid addiction by misusing prescription medications.”

Where does the 80% figure come from?

The DEA cites the National Institute on Drug Abuse (NIDA) as its source, while NIDA in turn references a 2013 study by the Substance Abuse and Mental Health Administration (SAMHSA).

SAMHSA pooled a decade's worth of data from the National Survey on Drug Use and Health and found that “four out of five recent heroin initiates (79.5 percent) previously used NMPR (nonmedical use of pain relievers)."

But the SAMHSA study did not examine how many of those heroin users had a valid prescription for opioids, so the DEA claim about users "first obtaining these drugs from their health care providers" is untrue. SAMHSA also notes that "the literature on transition from NMPR to heroin use is relatively sparse" and that the "vast majority" of people who abuse opioid medication never actually progress to heroin.

The abuse of opioid medication by heroin users also varies considerably by time, region and demographics -- so must users don't fit neatly into the 80% claim. A review article in The New England Journal of Medicine reports that prior nonmedical use of opioid medication was found in 50% of young adult heroin users in Ohio, in 86% of heroin users in New York and Los Angeles, and in 40%, 39%, and 70% of heroin users in San Diego, Seattle, and New York respectively.

Conversely, studies on the medical use of opioid analgesics show very low rates of opioid addiction. A review in the journal Addiction concluded that “The available evidence suggests that opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence.”

A 2016 article in The New England Journal of Medicine by Dr. Nora Volkow, Director of NIDA, also explains that “addiction occurs in only a small percentage of persons who are exposed to opioids—even among those with preexisting vulnerabilities.”

‘Opiophobia’ Returns

But despite this well-established information, the 80% statistic is being used to set policy and justify a supply-side approach to the opioid addiction crisis. States are citing the number as they pass new legislation to restrict opioid prescribing, health insurers are using it as they enact new policies to limit medical opioid use, and doctors are telling patients it’s one of the reasons they won’t prescribe opioids.

According to one addiction treatment specialist, the goal of the DEA quota reductions should be to take opioid prescribing back to levels where they stood two decades ago.

“We‘re back down to 2006 levels, but the goal should be to get us back down to 1995 levels. So this means many Americans are still going to be addicted until prescribing becomes more cautious,” Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), told STAT.  

But this assumes that pre-1995 opioid prescribing levels were adequate. According to Jeffrey Singer, MD, a Senior Fellow at the CATO Institute, that would be a mistake.

“It must be remembered that numerous studies throughout the 1970s, 1980s, and 1990s documented that patients were being undertreated for pain because of an irrational fear of opioids,” Singer wrote. “Policymakers need to disabuse themselves of the notion that the prescription of opioids to patients by doctors is at the heart of the problem. That notion has made too many patients suffer needlessly as the old ‘opiophobia’ of the 1970s and 1980s has returned.”

Moreover, it assumes that opioids have no clinical benefit. But they are medically very useful, not only in the acute and surgical setting, but also for a variety of chronic pain conditions, such as neuropathy and restless leg syndrome.

The 80% statistic is misleading and encourages faulty assumptions about the overdose crisis and medical care. It is shifting resources away from the public health interventions that would most likely help in the crisis and removes a valid medical treatment for people with a wide range of ailments.

To read and comment on the DEA’s quota proposal, click here. All comments must be received by May 4, 2018.

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.

Lessons from ‘Dark Paradise’ on the Opioid Crisis

By Roger Chriss, Columnist

The book “Dark Paradise: A History of Opiate Addiction in America” by David Courtwright lives up to its title. Starting as far back as the Revolutionary War, Courtwright gives substance and statistics about opioids in the United States. The book clearly shows that America has had one ongoing opioid crisis for its entire history.

Courtwright starts with the premise that “Over and over again the epidemiological data affirms a simple truth: those groups who, for whatever reason, have had the greatest exposure to opiates have had the highest rates of opiate addiction.”

He also takes pains to show how the demographics of addiction shifted over time, moving from men to women and back to men, from the upper class to the working class to immigrants and back again. Seemingly new twists and turns in the present opioid crisis are actually just variations on an old theme.

Addiction rates and trends from 100 years ago seem all too familiar. Courtwright tells us there were about 313,000 opium and morphine addicts in America prior to 1914, with many of them concentrated in the South. But who became addicted was different.

“The outstanding feature of nineteenth-century opium and morphine addiction is that the majority of addicts were women,” wrote Courtwright. “It was principally in those suffering from chronic ailments that use of these drugs led to addiction.”

At the time, opioids were used to treat everything from ennui and anxiety to social performance and sleep -- disorders that nowadays would be treated with other medications. The causes cited are also familiar. “In addition to laziness and incompetence (by physicians), greed was cited as a reason for continued abuse” and 19th century pharmacists “were notorious for their willingness to supply a user; opium and morphine were their bread and butter, and there is no steadier customer than an addict.”

The underground trade in opioids was already a major problem at the turn of the 20th century: “The ingenuity of the opiate smugglers knew no bounds. One supercargo reportedly packed $500 worth of opium into the false bottom of a snake cage.”

As they have today, lawmakers and policymakers responded vigorously, but often with hidden agendas and dubious statistics. In the 1910s, physician and scientist Hamilton Wright used scare tactics to push for legislation on domestic narcotic trafficking. Andrew DuMez of the Treasury Department used “grossly inaccurate” figures about addicts. And Congressman Henry Rainey tried to convince the American public “that addiction was a problem of massive dimensions.”

By the early 20th century, “Opium and morphine had fallen into such disfavor that some physicians began to worry that they might be withheld in even the most dire cases.” Then as now, lawmakers were often behind the curve on the crisis and used fear to advance personal agendas.

This raised concerns that are echoed today about opioid medications. “The present generation (of doctors) has been so thoroughly warned, both by teaching at college and by observation,” wrote New Hampshire physician Oscar Young in 1902, “that now they are in many instances so very afraid to give it, even for the worst pain, that the patient suffers agonies worse than any hell for want of one-eighth of a grain of morphine.”

The opioid pendulum had shifted so much by 1920 that the American Medical Association warned that opiates should not be denied to patients suffering from conditions “such as cancer, and other painful and distressing diseases.”

Although this new conservatism greatly reduced rates of iatrogenic addiction caused by medical treatment, opioids continued to be a problem, especially as heroin spread from New York City to the rest of the nation. Courtwright notes that “heroin addicts typically became addicted in adolescence or early adulthood” and that their addictions were rarely iatrogenic in nature.

Heroin succeeded in a way that no other illicit drug had before: “Heroin was the illicit drug par excellence. It spread throughout the country during the 1920's and 1930's because dealers and their customers came to appreciate its black-market virtues.”

World War II interrupted virtually all aspects of life in the United States, including opioid abuse and addiction. But developments in pharmaceutical research contributed to changes as well. “Indeed, one of the reasons why medical morphine addiction largely vanished during the twentieth century was that physicians had so many alternatives for inducing sleep, soothing nerves, and brightening mood.”

Interestingly, in the 1950s, “No one, least of all federal agents, regarded the use of opiates to alleviate intense, pathological suffering as inappropriate or illegal.”

But then heroin surged in popularity in the 1960’s. Courtwright carefully assembles statistics on addiction rates. There were an estimated 120,000 heroin addicts in the 1950’s. The number rose to 315,000 in late 1969 and by the end of 1971 there were 560,000 heroin addicts. That number has remained relatively stable. Today the National Institute on Drug Abuse estimates that there are 591,000 heroin addicts in the United States.

But there was little data on overdose fatalities until the 1970’s. Courtwright reports that heroin-related deaths rose from 1,980 in 1990 to 3,980 in 1996, double the peak death rate in the 1970’s. A key factor in the increasing fatality rate was the combined use of heroin with other drugs.

With the development of methadone maintenance in the 1960's, a new approach to heroin and other forms of opioid addiction arose. “Enforcement must be coupled with a national approach to the reclamation of the drug user himself,” said President Richard Nixon in 1971. But despite its documented effectiveness, Courtwright notes that methadone “never emerged as a coherent national response to heroin addiction.”

The history of opioids in “Dark Paradise” ends at the start of the 21st century. The book does not mention the rise of OxyContin, the movement to treat pain as a vital sign, or the recent spikes in opioid-related overdoses. Nor does it discuss the appearance of Mexican black tar heroin, illicitly manufactured fentanyl or darknet drug markets.

But it does tangentially address what works and what doesn’t. The “War on Drugs” has failed repeatedly, as have policies to criminalize addiction or institutionalize addicts. The three approaches that would probably do the most to help end the opioid crisis -- securing the medical opioid supply against theft and diversion, disrupting the illegal supply by attacking distribution networks, and providing treatment to the addicted -- have never really been tried with any consistency.

Courtwright notes at the opening of “Dark Paradise” that “what we think about addiction very much depends on who is addicted.” But he also shows that we prefer to do very little beyond what is ideologically appealing or politically expedient. Instead, we keep trying the same things over and over and then act surprised when we get the same results. This is more commonly known as the definition of insanity than of paradise, dark or otherwise.

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.

More Americans Worried About Rx Drug Misuse

By Pat Anson, Editor

A recent study by the Centers for Disease Control and Prevention found that about one in four overdose deaths in 2016 involved prescription opioids. That’s a lot – but it’s far less than the number of Americans killed by illegal drugs such as heroin, cocaine and illicit fentanyl – which account for nearly two-thirds of all drug related deaths.

But a new survey shows that a growing number of Americans still blame the overdose crisis on prescription drugs.

The nationwide poll by the Associated Press and the NORC Center for Public Affairs at the University of Chicago found that 43 percent of Americans believe the misuse of prescription drugs is a serious problem in their community. That’s up from 33% two years ago. Only 37 percent see heroin as a serious concern locally.

The survey findings show that many Americans have a conflicted attitude about the opioid crisis and drug misuse in general.

For example, while over half (53%) believe prescription drug addiction is a disease that is treatable, a significant number (39%) think substance abuse is caused by mental illness. Forty-three percent think opioid addiction shows a lack of willpower or discipline, and nearly a third (32%) say it’s a character defect or a sign of bad parenting.

The stigma associated with drug addiction is strong. Fewer than 1 in 5 Americans are willing to associate closely with a friend, colleague or neighbor who is addicted to prescription drugs.  

"In the national effort to grapple with the enormous issue of opioid addiction, it is important to know the level of awareness and understanding of Americans who find themselves in the midst of an epidemic that is claiming growing numbers of lives," said Caitlin Oppenheimer, senior vice president of public health at NORC. "This survey provides important, and in some cases troubling, information."

Other survey findings:

• 13% of Americans had a relative or close friend die from an opioid overdose.
• 24% have an addicted relative, close friend, or say they themselves are addicted to opioids.
• Two-thirds say their community is not doing enough to make treatment programs accessible and affordable
• 64% would like to see more effort to crack down on drug dealers.

"The number of people who recognize how serious the opioid epidemic is in this nation is growing," said Trevor Tompson, vice president for public affairs research at NORC. "There is clearly a continuing challenge to ensure that what is learned about the crisis is grounded in fact."

The survey found that Facebook plays a dominant role in how Americans get their news – particularly about opioids. Of the 74 percent of adults who use Facebook, 41 percent say they have seen messages about opioids or deaths from overdoses. Fewer users of Twitter, Instagram and other social media platforms report seeing such information.

The nationwide survey of 1,054 adults was conducted online and using landlines and cell phones. The margin of sampling error is +/- 4.1 percentage points.

The Opioid Crisis Is Not Just About Pain Medication

By Roger Chriss, Columnist

The opioid crisis is no longer primarily about prescription opioids. Illicit fentanyl, heroin, cocaine and other black market drugs are now involved in more overdoses than pain medication.

However, the current response to the overdose crisis is still focused primarily on opioid prescribing. Arizona just approved  legislation to reduce opioid prescribing for injured workers. And President Trump has stated that he will push for a one-third reduction in opioid prescribing over the next three years. 

The ongoing media narrative reinforces this view. The crisis is blamed on prescription opioids, combined with manipulative marketing by manufacturers, pharma funded advocacy groups, and poor prescribing practices by physicians. Although these factors may have played a role in the onset of the crisis 20 years ago, the “opioid epidemic” has evolved far beyond that.

The National Institute on Drug Abuse summarizes the origins of the crisis this way:

"In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive."

The Centers for Disease Control and Prevention says there have been three “waves” to the crisis:

"The first wave of opioid overdose deaths began in the 1990s and included prescription opioid deaths. A second wave, which began in 2010, was characterized by heroin deaths. A third wave started in 2013, with deaths involving highly potent synthetic opioids, particularly IMF (illicitly manufactured fentanyl) and fentanyl analogs."

CDC researchers recently admitted that they significantly inflated the number of deaths involving prescription opioids for years.  They also acknowledged in an “Annual Surveillance Report of Drug-Related Risks and Outcomes” that high dose opioid prescribing has been in decline for over a decade:

“Between 2006 and 2016, the annual prescribing rate per 100 persons for high-dosage opioid prescriptions (>90 morphine milligram equivalents (MME)/day) decreased from 11.5 to 6.1, an overall 46.8% reduction and an average annual percentage change of 6.6%. The rate leveled off between 2006 and 2009, then decreased 9.3% annually from 2009 to 2016.”

These trends are clearly visible at the state level. Maine’s Attorney General recently said “Fentanyl has invaded our state” and that most of the overdose deaths there were caused by multiple drugs. When pharmaceutical opioids were involved, most of the time they were “not prescribed for the decedent.”

FiveThirtyEight gave a detailed breakdown of drug deaths by state. In an article headlined “There Is More Than One Opioid Crisis,” Kentucky was actually found to have more overdoses involving gabapentin than oxycodone.

And in a recent Cleveland.com interview, FDA Commissioner Scott Gottlieb, MD, refers to the crisis as shifting “from a prescription-pill problem to one centered around deadly street drugs.”

In other words, prescription opioids have become only a small part of a crisis that now includes heroin, illicit fentanyl, and an increasing number of non-opioid drugs. In fact, we are fast approaching what will become the fourth wave of the crisis, one involving poly-drug abuse and overdoses, that will further challenge first responders, emergency rooms and addiction treatment facilities.

But still the response to the crisis has been focused on opioid prescribing. This may have made some sense a decade ago, when surveillance of the crisis was just starting. It made for good optics, but it was bad policy. Curbing prescribing is wreaking havoc with pain management, not only for chronic, progressive and degenerative disorders but also cancer and hospice patients. And it is not helping people who suffer from opioid addiction.

As Drs. Stefan Kertesz and Sally Satel point out: “Too many health care providers have started to see their fierce commitment to dose reductions as a badge of good citizenship, without any effort to measure the human outcomes of their own policies.”

Pain management expert Dr. Lynn Webster wrote this about the recently announced Medicare plan to reduce high dose opioid prescribing: “Such actions will not reduce opioid deaths related to heroin and illicit fentanyl which is the source of most overdose deaths. In fact the opposite effect may occur."

The opioid crisis will not be solved by focusing on prescription opioids. It is too late for that. Failure to recognize the evolving nature of the crisis will simply risk more fatal overdoses.  

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.

Living in Denial About the Overdose Crisis

By Ann Marie Gaudon, Columnist

Most of us know that denial of reality exists, but why is this so? How can humans with the ability to consider, evaluate, analyze and resolve complex problems ignore the facts? Even when ignoring the truth might lead to disastrous results?

Conceived by Sigmund Freud as a defense mechanism (to “defend” us against that which we do not want to feel), denial has been a concept for many decades. To over-simplify the premise, it’s a belief that something is either true or false when the facts say otherwise. Why would we do this? It’s because people experience a broad range of powerful emotions and intentions, such as greed, pride, revenge, fear, desire and a need for status – just to name a few. The have a strong influence over our ability to interpret facts.

When the Canadian government introduced the 2017 Canadian Guideline for Opioid Therapy, the creators were in denial. They ignored medical facts about chronic pain and turned pain sufferers into sacrificial lambs for people abusing illicit opioids. Patients and doctors tried to tell the truth but were not allowed a seat at the table with the so-called “experts.”

Chronic pain patients have never, ever, had their pain needs met and now they fare much worse. They are in more pain and experience more death and disability due to forced tapering and suicide.

Deniers yell loud and long that opioid pain medications are not effective, dangerous, addictive and will kill you in the end. Except that the evidence does not support that. Those with the worst pain have necessarily taken opioid medications to cope. It was their strongest weapon and were usually taken without danger, addiction or death. Opioids gave them effective pain relief that helped them regain function in everyday life.  Deniers will neither believe nor admit to this.

Let’s take a look at some of the strong influences which spur deniers to ignore the facts. We can see through many interviews and articles that McMaster University’s chosen group for creating the Canadian guideline enjoyed inflated reputations as “progressive thought leaders” who were “experts in pain management.” Add in the prestige and desire for status that comes from speaking engagements, media interviews, and more committees to participate in. Imagine the pride and prestige from conducting more studies (despite knowing little about the study area), and let’s not forget the enormous sums of monies paid to them by our government.

Greed, desire and a need for status can easily veto reality. So can feelings of morality and “doing the right thing” for people, while living under the fictitious perception that they are making positive inroads into addiction and overdose deaths while saving chronic pain patients from themselves.

In the real world, what has been the impact of the guideline on addiction? Nothing.

What has been the impact on pain patients? Devastation.

Most people can’t seem to figure out why the very same dreadful outcomes keep happening until they are knee-deep in it. Health Canada said this week that over 4,000 Canadians died from drug overdoses in 2017, the most ever. Most of those deaths – 72 percent – were caused by illicit fentanyl, not prescription pain medication.

Jordan Westfall, President of the Canadian Association of People Who Use Drugs, was bang on when he wrote in the Huffington Post that “it should shame this country to no end that our federal government is still afraid to see this epidemic for what it is in reality… What’s killing people is drug overdose and an apathetic government.”

May I add that what has never been killing people are chronic pain patients and their medications. Remorse and shame are powerful motivators for living in denial. Deniers continue to believe that punishing patients will somehow decrease the alarming rate of overdose deaths.

Chronic pain patients have always known the emperor has no clothes. It is a fact that all over North America prescriptions for opioids continue to go down, while overdose deaths continue to go up.  Does this suggest a statistically significant relationship between prescription analgesics and overdose deaths?  Yet the deniers continue with the same old agenda, despite the disastrous situation they have created.

There is an annoying little fact about denial. It doesn’t work in the long-term. Reality always wins out and when that happens, the next step for the deniers will be to place misdirected blame onto someone else. Count on it. It’s already happening. Doctors put the blame on the guideline’s creators and the creators reply, “No, no, no…it’s the doctors who have misunderstood the guideline.”

Here’s a message to the Canadian government and to the plethora of advisory groups, committees, response teams, et cetera and ad nauseam that are funded with taxpayers’ money to deny the facts:

When you are consistently creating the same disastrous outcome over and over again, you are in denial. And if this shameful situation continues, it will only lead to more suffering and deaths.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for 33 years and works part-time as her health allows. For more information about Ann Marie's counseling services, 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 represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

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.

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.

Bill Would Create 3-Day Limit on Opioids for Acute Pain

By Pat Anson, Editor

A bipartisan bill has been introduced in Congress that would impose a national 3-day limit on opioid prescriptions for acute short-term pain and authorize another $1 billion to subsidize the addiction treatment industry.

The CARA 2.0 Act is a follow-up to the Comprehensive Addiction and Recovery Act of 2016. It is sponsored by four Democrats and four Republicans: Senators Rob Portman (R-OH), Sheldon Whitehouse (D-RI), Amy Klobuchar (D-MN), Maria Cantwell (D-WA), Shelley Moore Capito (R-WV), Dan Sullivan (R-AK), Maggie Hassan (D-NH), and Bill Cassidy (R-LA).

“The opioid epidemic truly is a national crisis that is affecting families and communities across the country, and in West Virginia, we’ve become far too familiar with its consequences,” Sen. Capito said in a statement. “While we’ve accomplished a lot in terms of drawing attention to the drug epidemic and providing resources to help address it, it’s painfully clear that we still have a long way to go and need to be doing even more.

Several states have already enacted measures to limit opioid prescriptions for acute pain – usually limiting them to five or seven days’ supply. CARA 2.0 would make a 3-day limit mandatory nationwide for “pain with abrupt onset and caused by injury or other process that is not ongoing.”

The bill would exempt patients with chronic pain and cancer, as well as those in hospice and palliative care. It is not clear how the 3-day limit would apply to patients recovering from surgery or for those whose pain lasts longer than 3 days.

Under the bill the U.S. Attorney General would be authorized not to renew or register the licenses of physicians to prescribe controlled substances if they do not abide by the initial 3-day limit.

It also requires doctors to consult with the prescription drug monitoring database (PDMP) in their state before writing a prescription for a controlled substance to make sure a patient isn’t already getting opioid treatment. Prescribers who repeatedly fall “outside of expected norms or standard practices” would be reported to law enforcement and their state licensing boards.

The latter provision was initially proposed by Sen. Cassidy under the Protection from Overprescribing Act.

"I’m glad the Protection from Overprescribing Act is included in this bill, so law enforcement gets the information they need to identify providers who are overprescribing and fueling this crisis,” said Cassidy, who is a licensed physician.”  “In Louisiana, there is about one opioid prescription for every person. I and other physicians took an oath to first, do no harm. Some doctors are selling these prescriptions for profit. This is doing harm and it must be stopped.”

If passed, the bill raises the penalty for opioid manufacturers who fail to report suspicious orders for opioids from $10,000 to up to $500,000.

States would be allowed waive the limit on the number of patients a physician can treat with buprenorphine (Suboxone), an addiction treatment drug. There is currently a cap of 100 patients per physician.

The bill also seeks to create a national network of addiction treatment facilities, to be funded by $200,000,000 in grants annually from 2019 to 2023. The grants would only be available to large non-profit treatment programs that already have facilities nationwide, such as Phoenix House. 

Sessions Tells Pain Patients to ‘Tough It Out’

By Pat Anson, Editor

Take two aspirin and call me in the morning.

That old cliché is finding new life – at least in the mind of U.S. Attorney General Jeff Sessions --- who suggested twice this week that aspirin is the solution to the nation’s opioid crisis.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a Wednesday visit to the U.S. Attorney’s office in Tampa. "People need to take some aspirin sometimes and tough it out.”

During his 25-minute speech, the Tampa Bay Times reported that Sessions veered away from his prepared remarks to cite the example of White House chief of staff Gen. John Kelly, who refused to take opioid painkillers after recent minor surgery.

"He goes, ‘I’m not taking any drugs,’" Sessions said, drawing a laugh while imitating Kelly. "But, I mean, a lot of people — you can get through these things."

"That remark reflects a failure to recognize the severity of pain of some patients," said Bob Twillman, PhD, executive director of the Academy of Integrative Pain Management.

JEFF SESSIONS

"It’s an unconscionable remark," Twillman told the Tampa Bay Times. "It further illustrates how out of touch parts of the administration are with opioids and pain management."

Sessions made similar statements Tuesday night at a Heritage Foundation event marking the birthday of President Ronald Reagan.

"Sometimes you just need to take two Bufferin or something and go to bed," said Sessions, who added that his goal in 2018 was to see a continuing decline in opioid prescriptions, which have been falling since 2010.

“We had a 7 percent decline last year in actual prescriptions of opioids. We think doctors are just prescribing too many,” he said. “These pills become so addictive. The DEA says a huge percentage of the heroin addiction starts with prescriptions. That may be an exaggerated number. They had it as high as 80 percent. We think a lot of this is starting with marijuana and other drugs too.”

Sessions was referring to a single but often-cited survey, which found that most heroin users in addiction treatment also abused prescription opioids. The fact is most addicts try a variety of different substances – such as tobacco, marijuana, alcohol and opioid medication – before moving on to heroin. It is rare for a legitimate patient on legally prescribed opioids to use heroin.  

The Drug Enforcement Administration – an agency that Sessions oversees – has ordered a reduction in the supply of prescription opioids in 2018. That’s in addition to steep cuts in opioid production quotas the DEA imposed in 2017.  The agency ignored dozens of public comments warning that further reductions this year in the opioid supply could create shortages.  

FDA Report Calls Kratom an Opioid

By Pat Anson, Editor

The herbal supplement kratom contains opioids and should not be used to treat any medical condition, according to a new analysis by the U.S. Food and Drug Administration. The report seems likely to trigger a renewed effort to classify kratom as an illegal Schedule I substance under the Controlled Substances Act.

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” said FDA Commissioner Scott Gottlieb, MD, in a lengthy statement.

“It’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties.  Millions of Americans have discovered kratom in recent years, using it to treat chronic pain, anxiety, depression, and addiction.

In 2016, the Drug Enforcement Administration attempted to list two of kratom’s active ingredients as Schedule I substances. The DEA suspended its plan after a public outcry, and said it would wait for a scheduling recommendation and medical evaluation of kratom from the FDA.

The new report may prompt the DEA to try again.  In a computer analysis using what the FDA calls Public Health Assessment via Structural Evaluation (PHASE) methodology, FDA researchers identified 25 chemical compounds in kratom that share structural similarities with opioid analgesics such as morphine. Like painkillers, the substances bind to mu-opioid receptors in the brain and – according to the computer models -- act the same way as opioids.

“The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids,” Gottlieb said.

FDA Analysis Called ‘Junk Science'

Critics of the FDA analysis say it contains numerous errors and signs of confirmation bias.

"The failure of the FDA to justify its attempt to schedule kratom using traditional and well-accepted scientific methods has apparently driven the FDA to move into the world of junk science.  Using computer modeling is very susceptible to bias in the assumptions the are built into the computer algorithms.  In short, the old adage of 'garbage in – garbage out' applies to such dramatic testing standards," said Dave Herman, chairman of the American Kratom Association (AKA), a pro-kratom consumer group.

In addition to its analysis, the FDA released a detailed report on 36 deaths associated with kratom over the past several years. The agency admits all but one of the overdose deaths involved other drugs and “could not be fully assessed.” There was only one death involving a person who had no prior opioid use.  

“We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom. In addition, a few assessable cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the anti-diarrheal medicine, loperamide,” Gottlieb said.

"It is more of the same useless rhetoric from FDA," says Jane Babin, a molecular biologist who authored a report last year for the AKA that discredited many of the reports linking overdoses to kratom.

"Bottom line:  36 deaths over 3, 5, 7 or more years that they can't prove were caused by kratom, versus 16,000 deaths from killer street opioids," Babin wrote in an email. 

In a survey of 6,150 kratom users by Pain News Network and the AKA, most reported they used kratom as a treatment for chronic pain, depression, anxiety or addiction. Many say the herb is safe, effective and has literally saved their lives

“Kratom is the one thing that has kept me from using opiates and other illegal substances. I've been able to stay clean for 3 years now. It's given me my life back,” one survey respondent wrote.

“Kratom is the only reason I was finally able to end my addiction to hydrocodone. It is nowhere near as potent as hydrocodone, and you can't overdose” said another.

“I've had several friends who have died from heroin overdose. If they knew about kratom they may still be alive today,” wrote another kratom user.

One of the dilemmas faced by the FDA and DEA is that kratom products are currently classified as dietary supplements, and there are few regulatory standards applied to their importation or ingredients. The only requirement for kratom vendors is that they don't make unsubstantiated health claims. Classifying kratom as a Schedule I controlled substance would radically change that, making it a felony to possess or sell kratom, and likely creating an underground black market for the herb.

Montezuma's Revenge: FDA to Limit Diarrhea Pills

By Pat Anson, Editor

Federal efforts to combat the opioid crisis entered a surprising new phase today, with the Food and Drug Administration asking Johnson & Johnson and other drug makers to limit the number of anti-diarrhea pills they sell.

You read that right.

FDA commissioner Scott Gottlieb, MD, said the “unprecedented and novel action” was needed because Imodium and other over-the-counter formulations of loperamide are being abused by opioid addicts.  

The FDA wants J&J and other drug makers to limit the number of pills in loperamide packaging so that there are just enough to treat short-term diarrhea, such as traveler’s diarrhea. – also known as Montezuma’s Revenge.

“Abuse of loperamide has been increasing in the United States. When used at extremely high and dangerous doses, it’s seen by those suffering from opioid addiction as a potential alternative to manage opioid withdrawal symptoms or to achieve euphoric effects of opioid use,” Gottlieb said in a statement.

“When higher than recommended doses are taken we’ve received reports of serious heart problems and deaths with loperamide, particularly among people who are intentionally misusing or abusing high doses.”

Last year the FDA added a warning label to loperamide products cautioning consumers not to ingest high doses. The agency believes further safety measures are needed to make it harder for people to buy loperamide in large quantities. The FDA is suggesting that loperamide be sold in packages containing a two day supply of eight 2-milligram capsules. Imodium packages currently contain as many as 42 capsules.

“The abuse of loperamide requires the purchase of extremely large quantities. Often this is done through the purchase of large bottles of loperamide, which is a common configuration in which the pill form of the medication is currently packaged,” said Gottlieb. “Today’s action is intended to change how the product is packaged, to eliminate these large volume containers. We know that many of the bulk purchases of these large volumes are being made online through major online web retailers.”

The FDA is also considering changes in how opioid medication for acute short-term pain is packaged. Several states have enacted laws that require first time prescriptions for acute pain be limited to 5 or 7 days’ supply

“If more immediate release opioid drugs, in particular, were packaged in three or six-day blister packs; then more doctors may opt for these shorter durations of use. Additionally, provided the FDA concluded that there was sufficient scientific support for these shorter durations of use, this could provide the basis for further regulatory action to drive more appropriate prescribing,” Gottlieb said.

Some users of Imodium are unhappy the medication now comes in blister packs – saying the packages are too hard and frustrating to open at an urgent time of need.

“There's nothing worse than having diarrhea and you can't get the package open,” one woman wrote on the Imodium website. “The only way I can get it open is to find a pair of scissors and cut it open. I tried one time to tear it open with my teeth and ended up cutting my lip.”

“Your product inside the box is quite good. I just wonder who convinced Imodium powers that be to change the blister units in which the caplets are packaged. I have almost lost my religion trying to tear open at the suggested/new perforation. It is horrible!” another woman wrote.

“Had to make 3 trips to the bathroom while trying to get the caplet wrapper open, packaging needs changing,” said another reviewer.

Does Genetic Testing for Opioid Addiction Really Work?

By Roger Chriss, Columnist

Prescient Medicine recently announced LifeKit Predict, a gene screening test to determine who is at risk for opioid addiction. The company states that it “can identify with 88% specificity that someone may have a risk for opioid dependency” and “provides assurance -- with 97% sensitivity -- that an individual may not have increased genetic risk for opioid dependency.”

Those are strong claims. The idea that medical conditions and behavior can be predicted by gene variants is appealing. But any such test has to answer two questions:

Is it possible in principle? And does it work in practice?

Genes and Behavior

The pathway from gene variant to behavior is very complicated. Research on the genetics of opioid addiction has found “evidence for genetic susceptibility to substance use disorders” in twin studies, but non-genetic factors are known to play a significant role as well.

Moreover, the connection between gene test results and clinically useful information is complicated. Genetic testing often finds pathogenic variants with no clinical significance. A person can be a perfect match for a rare disorder in the most advanced genetic test available but have no symptoms, so at a clinical level that person does not have the disorder. Only in a handful of cases does a specific gene variant lead to a precise fate: Huntington's disease is the standard example in textbooks.

Addiction is generally thought of in terms of the biopsychosocial model of medicine, as Maia Szalavitz explains in her book, Unbroken Brain.

“There are three critical elements to it; the behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive,” she wrote.

The National Institute on Drug Abuse reports that “genetic factors account for between 40 and 60 percent of a person’s vulnerability to addiction; this includes the effects of environmental factors on the function and expression of a person’s genes.”

Thus, genes may play a significant role, but many other factors are also at work. A genetic test to identify an increased risk for opioid addiction is plausible in principle. But non-genetic factors make it tricky in practice.

Real World Performance

Prescient Medicine has not yet validated its product with large-scale testing in the clinical setting. There have been no clinical studies of efficacy, nor real-world reports of success or failure rates with the LifeKit Predict tool. These findings are important to know for effective use.

In research published on LifeKit Predict, Prescient acknowledges that “the use of genetic algorithms to determine predictive risk scores is still a relativey [sic] new science. Prospective, longitudinal studies are needed to better definne [sic] the breadth of the test’s importance."

A prospective trial of chronic pain patients with LifeKit Predict to see who develops opioid use disorder would be optimal. But for a variety of reasons, including ethical considerations, this test may not be practicable. Instead, Prescient could test people on long-term opioid therapy who did not develop opioid use disorder and compare the results with people who did develop opioid use disorder. Findings here would shed light on the validity of the 16 gene alleles that Prescient is using.

For now, Prescient is reporting on sensitivity and specificity. These two terms have a precise meaning in statistics, but the following medical example captures the essentials:

A molar (butterfly) rash is very sensitive for lupus but not very specific. It is rarely seen in any disorder other than lupus, so if a person has it, lupus should be suspected. But it is only seen in about half of people with lupus, so not having a butterfly rash doesn't mean you can rule out lupus.

But the sensitivity and specificity of LifeKit Predict in the ranges given by Prescient represent a significant risk for false positives and false negatives, potentially limiting the real-world value of the test.

GenomeWeb reported that Yale University professor Joel Gelertner, an expert in genetics and addiction, was skeptical that LifeKit’s “predictive power would hold up when applied to larger datasets, and argued that in the absence of better validation, physicians should not use this type of testing."

Further, LifeKit has not been compared with established tools for opioid risk assessment. The Current Opioid Misuse Measure (COMM-9) and the Opioid Risk Tool (ORT) are both simple and familiar instruments for evaluating the major risk factors for opioid use disorder.

Both COMM-9 and ORT are very inexpensive, easy to use, and give results quickly. By contrast, a gene test is expensive and requires weeks to get results. It is not clear at this point if a gene test offers any advantages over these existing instruments.

Opioid addiction risk is at present more readily assessed using tools that are already available and understood. Prescient has developed a novel and intriguing new tool, but still must prove its reliability in clinical settings before the costs and risks of such a test can be justified.

For now it is probably premature to expect this kind of genetic testing to be as useful as it would need to be to be adopted clinically.

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.

FDA Warns Promoters of Herbal Addiction Treatments

By Pat Anson, Editor

The U.S. Food and Drug Administration is following through on its threat to crackdown on companies selling kratom and other herbal supplements as treatments for opioid addiction and withdrawal.

The FDA and the Federal Trade Commission (FTC) have sent joint warning letters to the distributors of 15 herbal supplements for illegally marketing unapproved products.

“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” said FDA Commissioner Scott Gottlieb, MD. “People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims.”

The companies used websites or social media to make claims about their products' ability to cure, treat or prevent opioid withdrawal and addiction.

TaperAid, for example, claims its “17 all-natural organic herbs” can relieve symptoms of withdrawal and even reduce tolerance to opioid painkillers.

“Use of TaperAid may increase sensitivity to opioids. You may need to lower your usual intake of opioids to account for reduced tolerance,” the company claimed. “People using short acting opioids (which includes many pain management medications and heroin) will notice a significant lowering of tolerance to their opiate of choice.”

TaperAid’s website and Facebook account have been taken down, although a TaperAid review can still be found on YouTube.

“Opioid addiction is a serious health epidemic that affects millions of Americans,” said acting FTC Chairman Maureen Ohlhausen. “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments.”

In addition to the warning letters, the FTC released a “fact sheet” warning consumers about companies that promise miracle cures or fast results.

“Dietary supplements – such as herbal blends, vitamins, and minerals – have not been scientifically proven to ease withdrawal or to treat opioid dependence,” the FTC warned. “Products like Kratom, which some claim can help, are actually not proven treatments, and can be addictive and dangerous to your health.”

The FDA issued a public health advisory about kratom last November, saying there was “no reliable evidence to support the use of kratom as a treatment for opioid use disorder.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties.  Millions of Americans have discovered kratom in recent years, and use it to treat addiction, chronic pain, anxiety and depression. The herb is not approved by the FDA for any medical condition. 

In 2016, the Drug Enforcement Administration attempted to list kratom’s two active ingredients as Schedule I controlled substances, which would have made it a felony to possess or sell kratom. The DEA suspended its plan after a public outcry, saying it would wait for a scheduling recommendation and medical evaluation of kratom from the FDA. Over a year later, that report has still not been released.