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.

Opioid Commission Member Calls Panel a ‘Charade’

By Pat Anson, Editor

The Trump Administration and Congress have so neglected the country’s opioid crisis that they have turned the work of the president's opioid commission into a "charade" and a "sham," according to one panel member.

In a wide ranging interview with CNN, former Democratic Rep. Patrick Kennedy lamented a lack of focus and funding the opioid crisis has received since President Trump declared the overdose and addiction epidemic a national public health emergency last October.

"This and the administration's other efforts to address the epidemic are tantamount to reshuffling chairs on the Titanic," said Kennedy.

"The emergency declaration has accomplished little because there's no funding behind it. You can't expect to stem the tide of a public health crisis that is claiming over 64,000 lives per year without putting your money where your mouth is."

PATRICK KENNEDY

Without funding and resources, Kennedy said he believes the opioid commission's work had become a charade.

"I do. I honestly do. It means nothing if it has no funding to push it forward.... this thing's a charade,”” he told CNN. "I have to be true to the way I feel. This is essentially a sham."

President Trump appointed the bipartisan panel in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

COMMISSION on combating drug abuse and the opioid crisis

After a series of public hearings, the commission released its final report in November, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.

But since the report’s release, little money has been set aside by Congress or the administration to implement the panel’s recommendations, except to increase border security and detect illegal drugs.

Last week President Trump proposed cutting the budget of the White House Office of National Drug Control Policy – which oversaw the opioid commission’s work -- by 95 percent.  After a year in office, the president has yet to appoint a permanent director for the office, which currently has a 24-year old deputy chief of staff fresh out of college with no prior experience in management or drug control policy.

"Everyone is willing to tolerate the intolerable -- and not do anything about it," said Kennedy, who is recovering from alcohol and opioid addiction, and is a prominent mental health advocate.

“I'm as cynical as I've ever been about this stuff,” he said. “We've got a human addiction tsunami, and we need all hands on deck."

Bertha Madras, another member of the opioid commission, told CNN the panel has never received any direct feedback from Trump about its work. But she praised the selection of presidential advisor Kellyanne Conway as the key point person for the administration in dealing with the opioid crisis.

"That is really a very significant issue, bringing the implementation directly into the White House, as opposed to having intra-agency meetings," said Madras, a professor of psychobiology at Harvard Medical School. "Having been in government 10 years ago or so, I know how difficult it is to be able to generate change without having executive leadership behind you."

When asked by CNN about Kennedy's critique, she praised him for the "passion and depth he brings to the problem," but said it was premature for her to comment until she sees how much money is eventually allocated for the opioid crisis.

Teen Misuse of Rx Opioids at Historic Lows

By Pat Anson, Editor

Misuse of opioid pain medication by American teenagers is at an historic low, according to a nationwide survey that also found prescription painkillers have become increasingly harder for teens to obtain.

Nearly 44,000 students in 8th, 10th or 12th grade were questioned about their drug use in the University of Michigan’s annual Monitoring the Future (MTF) survey. Overall, the number of teens drinking, smoking and abusing drugs is at the lowest level since the 1990’s, although marijuana use spiked upward in 2017.

While the so-called opioid epidemic continues to make national headlines, misuse of prescription painkillers by teenagers has been steadily falling for over a decade.

The survey found that 4.2% of 12th graders used “narcotics other than heroin” in the past year, down from 9.4% in 2002.

Only 35.8% of high school seniors said the drugs were easily available in the 2017 survey, compared to more than 54 percent in 2010.

“We’re observing some of the lowest rates of opioid use that we have been monitoring through the survey. So that’s very good news,” said Norah Volkow, MD, director of the National Institute on Drug Abuse. "The decline in both the misuse and perceived availability of opioid medications may reflect recent public health initiatives to discourage opioid misuse to address this crisis."

The misuse of the painkiller Vicodin continues a decade long decline, falling to 2.9% of high school seniors in 2017. That’s down from 10.5% of seniors in 2003. Similar declines were reported in the misuse of OxyContin.

Marijuana use by teenagers rose by 1.3% to 24 percent in 2017, the first significant increase in seven years.

“This increase has been expected by many,” said Richard Miech, lead investigator of the study. “Historically marijuana use has gone up as adolescents see less risk of harm in using it. We’ve found that the risk adolescents see in marijuana use has been steadily going down for years to the point that it is now at the lowest level we’ve seen in four decades.”

For the first time, the survey asked students about vaping.  Nearly 28 percent of high school seniors said they had used a vaping device in 2017. A little over half said the mist they inhaled was "just flavoring," about a third said they inhaled nicotine, and 11% said they vaped marijuana or hash oil.

After years of steady decline, binge drinking appears to have hit bottom. Nearly 17 percent of 12th graders said they had five or more alcoholic drinks in a row sometime in the last two weeks. That’s a lot, but it's down from 31.5% in 1998.

FDA Head Tweets New Warning About Kratom

By Pat Anson, Editor

The head of the Food and Drug Administration is warning again about the marketing of kratom and other dietary supplements to treat opioid addiction – calling them “health fraud scams.”

“FDA believes strongly people addicted to opioids should have access to safe and effective, approved treatments for addiction. Unfortunately, unscrupulous vendors are trying to capitalize on opioid epidemic by illegally marketing products for these purposes,” FDA commissioner Scott Gottlieb, MD, warned on Twitter Friday.

Gottlieb was reacting to a story in The New York Times about the marketing of dietary supplements like “Opiate Detox Pro,” a blend of vitamins and amino acids said to have “amazing benefits” in reducing opioid withdrawal symptoms. 

Similar claims are made about kratom by websites such as HowtoQuitHeroin.com, which was founded by Jorge Fernandez, a recovering heroin addict.

“Kratom works. Kratom helps. It can help you to quit heroin. It can help you to quit Suboxone. It can help you to quit Oxycontin. And believe it or not, it can even help you to quit Methadone as well,” Fernandez claims.

Kratom is not approved by the FDA as a treatment for opioid addiction or any other health condition. But because kratom is classified as a dietary supplement, it’s not held up to the same regulatory standards as pharmaceutical drugs -- as long as vendors don’t make any misleading claims about its health benefits. That’s when the FDA can intervene by seizing kratom products or prohibiting their sale.

“They’re marketing products as dietary supplements with unproven claims about ability to treat addiction; or as all-natural alternatives to opioids. Health fraud scams like these can pose serious health risks,” Gottlieb tweeted. “FDA will continue to act when it learns of the deceptive sale or advertising of products that claim to effectively treat opioid use disorder, but which have not been proven safe and effective for these purposes.”

SCOTT GOTTLIEB, MD

Although Gottlieb didn’t specifically name kratom as one of those “health fraud scams,” there’s little doubt that’s one of the supplements he was referring to. Last month the FDA issued a public health advisory about kratom, warning that it was addictive and linked to dozens of overdose deaths.

“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” Gootlieb said at the time.

“I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules. Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In a survey of 6,150 kratom users last year by Pain News Network and the American Kratom Association, most said they used kratom as a treatment for chronic pain, depression or anxiety. But a fair number -- nearly 10 percent -- said the primary reason they used kratom was to treat opioid addiction.

“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.

“It has saved my life. I am a mother of four and have anxiety, depression, acute back pain, and I am an opioid addict. It has kept all these at bay for me,” one woman wrote. “I want to be there for my children, but the sad truth is I know I can't live with these conditions and not find something. It's a sad day when I have to turn to the streets again to have any kind of life.”

“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.

Last year, 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 and lobbying campaign by kratom supporters, saying it would wait for a medical evaluation and scheduling recommendation for kratom from the FDA. Although the FDA has warned the public about using kratom, its full report and recommendations have yet to be released.

3 Reasons the Opioid Crisis is Getting Worse

By Roger Chriss, Columnist

The opioid crisis is now a public health emergency. The CDC reports increasing rates of fentanyl overdoses.  And The Economist warns the crisis is entering “a new and deadlier phase.”

The strategy to stop the overdose epidemic has largely focused on the supply side: limiting access to prescription opioids. History seems to support this idea. Two hundred years ago, a tincture of opium called laudanum was widely used to treat all kinds of ailments.  The “epidemic of laudanum” didn’t end until 1906, when the federal government got involved and started regulating opium-based medications.

So it seemed natural to curtail opioid prescribing. Washington State issued prescription opioid guidelines in 2010, Oregon in 2012, and the CDC in 2016. Other states followed with laws limiting the number of days opioids could be prescribed for short term, acute pain. Health insurers like Kaiser Permanente and Intermountain Healthcare have also reduced coverage of prescription opioids and drug store chains like CVS will be limiting prescription length and dose. 

In a narrow sense, this is working. Prescription opioid levels peaked in 2010, as a result of lower production quotas mandated by the DEA and reduced prescribing in a variety of clinical settings.

But in a broader sense, the focus on prescription opioid levels is failing. Opioid addiction and overdose rates continue to climb, despite the reduced availability of prescription opioids. There are three reasons for this.

First, the main drivers in the crisis are now heroin and illicit fentanyl. Importantly, heroin is increasingly the first opioid of abuse.

“As the most commonly prescribed opioids - hydrocodone and oxycodone - became less accessible due to supply-side interventions, the use of heroin as an initiating opioid has grown at an alarming rate,” researchers recently reported in the journal of Addictive Behaviors.

Second, according to the National Survey on Drug Use and Health, approximately 75% of all opioid misuse starts with people taking medication that was not prescribed to them. These pills are sourced from friends, stolen from other people’s prescription bottles, or purchased online illegally.

Contrary to common belief, opioid therapy for chronic pain conditions rarely leads to misuse or addiction. Most addictive behaviors start during adolescence, usually with substances like alcohol or tobacco, long before anyone gets their hands on opioid medication.

Third, nearly 10% of drug overdoses are intentional.

"Hidden behind the terrible epidemic of opioid overdose deaths looms the fact that many of these deaths are far from accidental. They are suicides,” wrote Dr. Maria Oquendo, President of the American Psychiatric Association, in a blog for the National Institute on Drug Abuse.

In other words, the crisis may have started with prescription opioids, but it has evolved. We are now facing a crisis driven primarily by heroin, illicit fentanyl, and other street drugs, as well as social and economic conditions that have led to an "epidemic of despair."

Therefore, the current intense focus on prescription opioids -- from the CDC’s Rx Awareness campaign to the recommendations of the President Trump’s opioid commission -- is woefully off target. Reducing access to prescription opioids has not decreased addiction and overdose rates, and may actually be making them worse.

Exactly what will be required to end the crisis is not clear. But an essential step is to understand the nature of the crisis as it stands today so as to end the opioid disconnect.

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.

Trump Commission Seeks More Limits on Rx Opioids

By Pat Anson, Editor

President Trump’s opioid commission released its final report Wednesday, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.   

“This crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment,” the commission said in its report.

The president established the commission in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

“Our people are dying. One hundred seventy-five people a day, every day, are dying in the United States from this epidemic,” said commission chairman Gov. Chris Christie of New Jersey, one of five politicians who served on the six member panel.

“If a terrorist organization was killing 175 Americans every day on American soil, what would you be willing to pay to make it stop? I think we’d be willing to do anything and everything to make it stop. And that’s the way we now need to see this, because this is an attack from within. We are killing ourselves.”

The commission’s 131-page report did not spell out how much money would be needed to implement the panel’s wish list of 56 recommendations.

Chief among them was to get drug makers and the National Institutes of Health to work together developing new non-opioid painkillers and addiction treatment medications.

“It is inexcusable that the major pharmaceutical companies in this country have stood on the sidelines during this crisis. And they have,” said Christie.

New Prescribing Guideline to Supplement CDC's

The commission is also recommending that a new set of guidelines for opioid prescribing be developed to “supplement” the guideline released last year by the Centers for Disease Control and Prevention.  It was not immediately clear if the new guidelines would replace, weaken or strengthen the CDC’s recommendations, or simply expand their use throughout the healthcare system.

“An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty practices to supplement the CDC guideline that are specifically targeted to primary care physicians,” the report says.

The commission recommended that federal regulators require patients to give informed consent about the risks and alternatives to opioid painkillers before the medication is prescribed to them. The panel also called for a new “national curriculum and standard of care” for opioid prescribers, and that pharmacists be trained to recognize and deny “inappropriate prescriptions.”

The commission urged the federal government to work with states to improve the toxicology data on overdose deaths by developing uniform forensic drug testing. Critics say the current data now being used by federal agencies is flawed or cherry-picked. 

“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 report says.

No Limit on Opioid Supply for Acute Pain

The commission did not recommend that supply limits be placed on opioid prescriptions for short term pain, as many expected. Several states have already enacted 5 or 7-day limits on opioids for acute pain. The panel also did not endorse the development of marijuana-based medications, which many pain sufferers are now using as an alternative to opioids.

Most of the commission’s other recommendations deal with cracking down on drug traffickers and the illicit drug market, expanding the drug court system, and increasing access to addiction treatment.

Gov. Christie refuted criticism of President Trump for declaring the overdose crisis a public health emergency, instead of a national emergency. Only $57,000 in federal funding is currently set aside to deal with a public health emergency.

“The president did exactly what I asked him to. I wanted this to be a public health emergency because I wanted HHS (Department of Health and Human Services) to administer the funds, not FEMA (Federal Emergency Management Agency). No offense to FEMA. They’re busy with some other things and it’s not there area of expertise,” Christie said.

“Now it’s incumbent upon Congress to step up and put money in the public health emergency fund, so the president can utilize that. And that should happen without delay in the view of the commission.”

In addition to Christie, commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Florida Attorney General Pam Bondi, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman.

In its fifth and final hearing, the commission heard testimony from several people who lost loved ones to opioid addiction and overdose. The panel never asked for or received testimony from pain sufferers, patient advocates or pain management physicians.