New CDC Overdose Study Reduces Role of Pain Meds

By Pat Anson, Editor

The Centers for Disease Control and Prevention has quietly released a new report showing that illegal drugs like heroin, cocaine and fentanyl are responsible for more drug overdose deaths in the United States than opioid pain medication.

The report not only underscores the changing nature of the nation’s overdose epidemic, but undermines some of the rationale behind federal efforts to limit the prescribing of pain medication and public statements used to justify them.

In 2010, for example, the study found that oxycodone was the top drug involved in overdose deaths. But by 2014, the painkiller was ranked third, behind heroin and cocaine.

The anti-anxiety drug alprazolam, more widely known by the brand name Xanax, was ranked as the nation’s fourth deadliest drug; while the synthetic opioid fentanyl -- most of it probably illicit -- was ranked fifth and fast gaining ground.

Deaths linked to oxycodone and other prescription pain medications – although still significant, at about 16,000 a year -- remained relatively stable, even as the total number of drug overdoses increased by 23 percent, from 38,329 deaths in 2010 to 47,055 in 2014.

One of the CDC’s stated reasons for releasing its opioid prescribing guidelines earlier this year was that “the death rate associated with opioid pain medication has increased markedly,” a statement that now appears to be factually wrong, in light of the new study.

This online statement in a CDC analysis of overdoses also appears incorrect: "Prescription opioids continue to be involved in more overdose deaths than any other drug."

Both statements came from the CDC's National Center for Injury Prevention and Control. It was a different part of the agency, the CDC’s National Center for Health Statistics that arrived at this new evidence, after collaborating with the FDA in developing an enhanced method to study overdose deaths that allowed them to identify specific drugs.

The old method used by the CDC relies on death certificate codes, known as ICD codes, which can broadly categorize an overdose as “opioid related” without ever determining what the drug was, if it was legal, or even if it was the cause of death.

Using new software, researchers scanned the actual text in hundreds of thousands of death certificates, including notes written by coroners about the cause of death and other significant factors involved in an overdose.

“The literal text analysis method… leverages existing information on the death certificates for statistical monitoring of drug-involved mortality deaths. Assessments conducted during the methods development process demonstrate that these methods have high accuracy in identifying the drugs mentioned and involved in mortality as well as the corresponding deaths,” the researchers said in an analysis of the new method.

2014 OVERDOSE DEATHS BY DRUG

Source: CDC and FDA

The study, which covered overdoses from 2010 to 2014, found that many deaths involved multiple drugs or alcohol. Over three-quarters of the deaths involving oxycodone and hydrocodone, for example, involved other substances. Alcohol was involved in 15 percent of all drug overdoses. 

Anti-anxiety drugs like alprazolam (Xanax) and diazepam (Valium) were also involved in many deaths. Alprazolam was involved in about a quarter of the overdoses involving hydrocodone (26%), oxycodone (23%) and methadone (18%). The FDA recently expanded warning labels on all opioids and benzodiazepines, including alprazolam and diazepam, to discourage doctors from prescribing them together.

“The combinations of drugs in drug overdose deaths are important to consider when interpreting the study findings. Importantly, the most frequently mentioned drugs involved in drug overdose deaths were often mentioned with each other. For example, heroin and cocaine were involved concomitantly in more than 2,000 deaths. Another pair, oxycodone and alprazolam, were involved concomitantly in more than 1,000 deaths,” the report found. 

While the textual analysis of death certificates is an improvement over previous methods, researchers admit it still has flaws. It cannot distinguish between prescription fentanyl and illicit fentanyl; some deaths that refer to morphine may actually involve heroin; and some deaths classified as “unintentional” may have actually been suicides.  

It also cannot distinguish between the recreational use of a medication obtained illicitly and the medical use of a prescription by a legitimate patient.

Many pain sufferers believe they have been unfairly penalized by the CDC’s opioid prescribing guidelines as part of an effort to keep pain medication away from addicts and recreational users. Since the guidelines were released, many physicians have stopped prescribing opioids or sharply reduced the dosage, even if a patient has safely used the medication for years. 

Oddly, the CDC released this new study just a week after releasing its annual report on drug overdose deaths, which used the older, flawed method of analyzing overdoses.  Further adding to the confusion and questionable use of statistics, the White House Office of National Drug Control Policy and the CDC released three different estimates of the number of Americans that died of drug overdoses in 2015 (see “Opioid Overdose Statistics: As Clear as Mud”).  

An Open Letter to President-Elect Trump

By Percy Menzies, Guest Columnist

Dear President-Elect Trump,

You will soon have an extraordinary opportunity to save thousands of lives with one stroke of the pen! I am talking about reducing overdose deaths from opioid overdoses. How is this possible?

We have three highly effective medications for the treatment of opioid addiction, but they are grossly under-utilized, largely due to accessibility. Two of the three drugs used to treat opioid use disorder have restrictions that have no place when overdose deaths exceed 30,000 per year. These restrictions made sense at a different time, but these barriers are now inadvertently contributing to overdose deaths.

I am specifically talking about buprenorphine, the most widely used medication in the battle against the opioid epidemic. This medication, better known by its brand name Suboxone, is an opioid with a very safe profile. Its unique pharmacology makes it almost impossible to overdose.

There are barriers to the use of this medication which made sense 14 years ago, when heroin was not a public health issue, but today they are a hindrance to saving lives.

Buprenorphine is the only drug that requires physicians to complete eight hours of training and then apply to the Drug Enforcement Administration to obtain a special exemption to prescribe it. It gets worse. Physicians can only treat 30 patients with this medication in the first year, and then they must obtain permission from the DEA to increase the limit to 100 patients. The physician also has to keep clear records and can expect a visit from a DEA agent to look at the records. 

This is a major deterrent and way too few physicians have bothered to obtain the required exemption. Any physician who has a DEA license can prescribe an FDA-approved controlled substance without restriction, but they have to deal with this barrier to prescribe buprenorphine. 

These restrictions were put in place to prevent buprenorphine from joining the opioid “pill mills” when few anticipated heroin sweeping our cities and towns. At the present time, there is no strategy in place to cut off or curtail the supply of heroin, or heroin that is laced with super potent opioids like fentanyl. Deaths from prescription opioids are declining, while deaths from heroin and fentanyl are climbing. Indeed, prescriptions for opioids drugs have fallen between 12 -25%, but the overdoses deaths have not declined. 

Yes, buprenorphine is being diverted, but most experts believe that is due to the lack of treatment. Patients desperately seeking treatment are purchasing the drug on the streets. Many experts believe that if patients have expanded and easier access to buprenorphine, the diversion will drastically reduce and more patients will be in treatment and get away from heroin.

Several steps have been taken to address this catastrophic problem, but these steps are woefully inadequate. Expansion of the needle-exchange programs and the widespread distribution of the opioid overdose drug naloxone (better known by the brand name Narcan) are welcome and should be expanded, but they are at best palliative in nature. These measures do little to address the underlying addiction.

The federal government is increasing the patient limits for buprenorphine for selected specialists from 100 to 275, and will also allow nurse practitioners and physician assistants to complete the required training and obtain the DEA exemption to prescribe buprenorphine. These are welcome steps, but fall far short of the response required to expand treatment and reduce deaths. 

You got elected on a law-and-order platform and a promise to reduce the flow of heroin coming in from Mexico. Almost 50 years ago, Richard Nixon got elected on a similar platform.  He too faced an unprecedented public health epidemic of heroin addiction – one that is nowhere close to what we are facing today.  

President Nixon is remembered for taking a bold measure, which at that time was controversial. He initiated the opening of methadone clinics, which for the first time provided evidence-based treatment for heroin addicts. This measure reduced overdose deaths, protected society from criminal activity, and allowed these patients to become productive members of society.  For the first time in the dark and checkered history of our nation, addiction was treated as a chronic healthcare issue and not a criminal activity. 

Nixon went a step further to curb the supply of heroin coming into this country. He put political pressure on France to shut down the illegal labs processing Turkish-grown opium into heroin. Turkey also complied with the strong U.S. demand to curb the illegal cultivation of opium. Who can forget The French Connection, the thriller movie about this operation.

Mr. Trump, you have an extraordinary opportunity to lift the present restrictions on buprenorphine through executive order, to lure patients away from heroin and drastically reduce overdose deaths. Your action would provide increased treatment and not just palliative care.

Furthermore, you are in the best position to bring pressure on Mexico to eliminate the opium processing labs and drastically reduce heroin coming into this country.  An epidemic is best treated when effective treatment is combined with eliminating factors contributing to the spread of the epidemic. In this case, it is the supply of heroin.

This one single action will earn you the gratitude of tens of thousands of families terrified at hearing a knock on the door informing them of the death of a loved one. You will also earn the gratitude of millions of patients suffering from chronic pain, who have been needlessly cut off from prescription opioids because of the overreaction of regulators and many physicians.

You will be remembered in history for a bold action that saved a generation from succumbing to a man-made epidemic.

Percy Menzies, M. Pharm, is the president of the Assisted Recovery Centers of America, a treatment center based in St Louis, Missouri.

He can be reached at: percymenzies@arcamidwest.com

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.

Opioid Overdose Statistics: As Clear as Mud

By Pat Anson, Editor

We’ve written before about how confusing and muddied the statistics can be for overdose deaths from opioid pain medication. (see “Lies, Damned Lies, and Overdose Statistics”). Now the White House and the Centers for Disease Control and Prevention are adding to the confusion.

Last week a news release from the White House Office of National Drug Control Policy stated that 17,536 Americans died in 2015 from overdoses involving prescription opioids, a 4% increase from the year before.

This week the CDC reported in its Morbidity and Mortality Weekly Report that the number of overdoses involving painkillers was actually smaller.

“Natural opioids (including morphine and codeine) and semi-synthetic opioids (including commonly prescribed pain medications such as oxycodone and hydrocodone) were involved in more than 12,700 deaths in 2015,” a CDC news release said. The agency said that was a 2.6% increase from the year before.

We asked the CDC to explain the discrepancy and were given a third number

“Given the recent surge in illegally-made fentanyl, the CDC Injury Center is analyzing synthetic opioids (other than methadone) separately from other prescription opioids (natural, semi-synthetic, and methadone). Using this approach, the number of deaths involving prescription opioids was… 15,281 in 2015,” CDC spokesperson Courtney Leland said in an email.

“This number better reflects the deaths associated with prescription opioids given the changing nature of the epidemic and increasing surge of illicit opioids.”

And what about the White House estimate?

“Their analysis of 17,536 deaths in 2015 was calculated by including any death that involved: opium; natural and semi-synthetic opioids; methadone; and unspecified narcotics (opioids). You would need to check with them about their rationale/methodology,” Leland explained.

In other words, the White House Office of National Drug Control Policy knowingly counted a number of overdoses caused by illicit opioids as prescription drug deaths.

All of these numbers may make your eyes glaze over, but they demonstrate an important point about the nation’s so-called opioid epidemic: No one really knows how bad it is.  Which is startling, because it’s an important national issue and Congress just voted to spend another $1 billion to fight it.

They may want to get their numbers straight first.

One thing the White House and the CDC do agree on is that overdoses from illegal opioids such as heroin and fentanyl are soaring, and deaths involving opioid pain medication appear to be leveling off.

The CDC reported many troubling statistics about opioid overdoses, which claimed over 33,000 lives last year:  

• Death rates nationwide from synthetic opioids such as fentanyl increased by over 72%
• Death rates from synthetic opioids more than doubled in New York (136%), Connecticut (126%) and Illinois (120%).
• Heroin death rates nationwide increased by nearly 21%
• Deaths rates from heroin jumped even more in South Carolina (57%), North Carolina (46%), and Tennessee (44%).

Perhaps the only bright spot was that deaths associated with methadone dropped by 9 percent, which the CDC attributed to lower methadone doses and less prescribing.

The agency still believes there is an “ongoing problem with prescription opioids” and that the number of overdoses may be undercounted.  

“Regardless of the analysis strategy used, prescription opioids continue to be involved in more overdose deaths than any other drug, and all the numbers are likely to underestimate the true burden given the large proportion of overdose deaths where the type of drug is not listed on the death certificate,” the CDC explains in a separate report.

Questionable Data

The CDC continues to rely on death certificate codes for much of its data, which many experts find troubling because the codes do not reflect the cause of death --- only the conditions that exist at the time of death.  In other words, somebody could die from lung cancer, but if a doctor used morphine to help ease the dying patient’s cancer pain, a box could be checked on their death certificate indicating opioids were present at the time of death. The CDC would consider that an “opioid involved” death.

Other factors that raise questions about the reliability of the CDC’s data:

• Overdose deaths were based on data from only 28 states “with high quality reporting”
• Wide variability in the expertise and training of local medical examiners and coroners who complete death certificates
• Nearly 1 out of 5 death certificates nationwide do not include any drug data
• Some heroin deaths may have been misclassified as prescription drug deaths
• Some overdose deaths may have been counted twice.

Critics also say there is a disturbing tendency by the CDC to “cherry pick” data to dramatize the harm caused by prescription opioids, without ever discussing their benefits. For example, the agency referred to a recent report from the DEA this way:

“The Drug Enforcement Administration referred to prescription drugs, heroin, and fentanyl as the most significant drug-related threats to the United States. The misuse of prescription opioids is intertwined with that of illicit opioids; data have demonstrated that nonmedical use of prescription opioids is a significant risk factor for heroin use, underscoring the need for continued prevention efforts around prescription opioids.”

The CDC does not mention that the DEA also found that the prescribing and abuse of opioid pain medication is actually in decline, that the number of admissions to treatment centers for painkiller addiction is falling, and that less than 1% of prescription opioids are diverted. Nor does the CDC mention that the DEA found a “massive surge” in the production of counterfeit pain medication made with illicit fentanyl, which is probably killing quite a few patients seeking pain relief.  

The CDC cites its own research to make the claim that it “did not find evidence that efforts to reduce opioid prescribing were leading to heroin overdoses.” But the DEA report said just the opposite: Some prescription opioid users are switching to heroin when they are no longer able to obtain medication:

“Some abusers, when unable to obtain or afford CPDs (controlled prescription drugs), begin using heroin, a cheaper alternative that offers similar physiological effects. With the successful reduction in availability of controlled prescription drugs, more users may shift to abusing heroin.”

This isn’t the first time the CDC has been accused of cherry picking data for public consumption. The same complaint arose when the agency released its opioid prescribing guidelines, many of which relied on “weak” or “very weak” evidence to support the contention that opioids should not be prescribed for chronic pain.

Recent research published in the journal Pain Medicine also took the agency to task for dismissing evidence that opioids could be used safely long term, while making no mention of the significant risks posed by non-opioid pain medication.

“No common nonopioid treatment for chronic pain has been studied in aggregate over longer intervals of active treatment than opioids. To dismiss trials as ‘inadequate’ if their observation period is a year or less is inconsistent with current regulatory standards,” wrote lead author Daniel Carr, MD, President of the American Academy of Pain Medicine and Program Director of Pain, Research, Education & Policy at Tufts University School of Medicine.  

“Basing therapeutic decision-making upon durations of published clinical efficacy or effectiveness trials does not support choosing any drug or nondrug therapy over another. In fact, the opening words of the first recommendation of the CDC… make no mention of the overwhelmingly strong evidence for significant morbidity and mortality risk from the most likely nonopioid alternatives to opioid therapy for chronic pain: NSAIDs, coxibs (cox-2 inhibitors), and acetaminophen.”

Although the CDC guidelines are “voluntary” and only intended for primary care physicians, many patients have reported that their chronic pain is going untreated or under-treated because they are no longer able to obtain opioids or their doses have been drastically lowered by their physicians. Other patients have been abruptly “fired” by doctors who no longer want to treat chronic pain because they fear prosecution for overprescribing opioids. Still other patients are contemplating or have committed suicide.

Where are the statistics about that?

Misuse of Pain Meds by Teens Continues Decline

By Pat Anson, Editor

Two new studies this week paint a somewhat conflicting picture about the abuse of opioids by teens and pregnant women.

A survey of over 45,000 teens by the University of Michigan and the National Institutes of Health found that teenage drug abuse continues to decline, with a significant drop in the misuse of the painkiller Vicodin. A second study at the university found the number of babies born with opioid withdrawal symptoms has grown substantially, especially in rural areas.

The annual Monitoring the Future survey found that 4.8% of high school seniors had misused an opioid pain reliever in the past year, down from a peak of 9.5% in 2004. In the past five years alone, misuse of opioid pain medication by 12th graders has declined by 45 percent.

Only 2.9% of high school seniors reported the misuse of Vicodin in 2016, compared to nearly 10 percent a decade ago. Vicodin and other hydrocodone products were reclassified as Schedule II controlled substances in 2015, making them harder to obtain.

"Clearly our public health prevention efforts, as well as policy changes to reduce availability, are working to reduce teen drug use,”  said Nora Volkow, MD, director of National Institute of Drug Abuse.

The survey found a continued long-term decline in teenage use of many illicit substances, as well as alcohol and tobacco. The use of any illicit drug was the lowest in the survey’s history for eighth graders. One negative sign was an increase in the misuse of over-the-counter cough medicine by eighth graders.

Marijuana use in the past month by eighth graders fell to 5.4%, down from 6.5% in 2015. However, among high school seniors, nearly one in four reported marijuana use in the past month. There also continues to be a higher rate of marijuana use in the past year (38%) among 12th graders in states with medical marijuana laws.

"It is encouraging to see more young people making healthy choices not to use illicit substances," said National Drug Control Policy Director Michael Botticelli. "We must continue to do all we can to support young people through evidence-based prevention efforts as well as treatment for those who may develop substance use disorders.”

The majority of teens continue to say they get most of their opioid pain relievers from friends or relatives, either stolen, bought or given. The only prescription drugs seen as easier to get in 2016 than last year are tranquilizers, with 11.4 percent of eighth graders reporting they would be “fairly easy” or “very easy” to get.

More Babies Suffering from Opioid Withdrawal

The number of babies born with drug withdrawal symptoms from opioids grew substantially faster in rural communities than in cities, according to the University of Michigan study. The study did not distinguish between opioid pain medication and illegal opioids such as heroin.

Newborns exposed to opioids in the womb and who experience withdrawal symptoms after birth (neonatal abstinence syndrome) are more likely to have seizures, low birthweight, breathing, sleeping and feeding problems.

Researchers found that in rural areas, the rate of newborns diagnosed with neonatal abstinence syndrome increased from nearly one case per 1,000 births from 2003-2004 to 7.5 cases from 2012-2013. That's a surge nearly 80% higher than the growth rate of such cases in urban communities.

"The opioid epidemic has hit rural communities especially hard and we found that these geographical disparities also affect pregnant women and infants," says lead author and pediatrician Nicole Villapiano, MD, whose study was published in JAMA Pediatrics.

Using national data, researchers found that rural infants accounted for over 21 percent of all infants born with neonatal abstinence syndrome. In 2003, rural infants made up only 13 percent of the neonatal abstinence syndrome cases in the U.S.  

Maternal use of opioids in rural counties was nearly 70 percent higher than in urban counties. Rural infants and mothers with opioid-related diagnoses were more likely to be from lower-income families, have public insurance and be transferred to another hospital following delivery.

Villapiano says families in urban areas typically have better access to addiction treatment programs.

"We need to consider what kind of support moms with opioid disorders have in rural communities," she said.

Villapiano suggests that increasing the number of rural doctors authorized to prescribe the addiction treatment drug buprenorphine (Suboxone), as well as expanding rural mental health and substance abuse services, would be good first steps in reversing the trend in neonatal abstinence syndrome.

Surge in Fake Painkillers as Opioid Prescribing Drops

By Pat Anson, Editor

A decline in the abuse and diversion of prescription pain medication is being offset by a “massive surge” in the use of heroin and counterfeit painkillers, according to a comprehensive new report by the U.S. Drug Enforcement Administration.

The DEA’s 2016 National Drug Threat Assessment paints a stark picture of the illicit drug trade in prescription medication, fentanyl, heroin, marijuana, methamphetamine and cocaine.  Interestingly, the 194-page report doesn’t even mention kratom, the herbal supplement the DEA attempted to ban in August before postponing its decision after a public outcry.

"Sadly, this report reconfirms that opioids such as heroin and fentanyl - and diverted prescription pain pills - are killing people in this country at a horrifying rate," said DEA Acting Administrator Chuck Rosenberg. "We face a public health crisis of historic proportions. Countering it requires a comprehensive approach that includes law enforcement, education, and treatment." 

The diversion of prescription opioids has fallen dramatically, according to the DEA report, from 19.5 million dosage units in 2011 to 9.1 million in 2015. Less than one percent of the opioids legally prescribed are being diverted to the black market.

The agency says the prescribing and abuse of opioid medication is also dropping, along with the number of admissions to treatment centers for painkiller addiction.

“With the slightly declining abuse levels of CPDs (controlled prescription drugs), data indicates there is an increase in heroin use, as some CPD abusers have begun using heroin as a cheaper alternative to the high price of illicit CPDs or when they are unable to obtain prescription drugs,” the report states.

The increased use of heroin coincided with federal and state efforts to reduce the prescribing of opioids. So did the appearance of counterfeit pain medication made with illicit fentanyl – a synthetic opioid that is 50 to 100 times more potent than morphine.  

“In 2015, there was a marked surge in the availability of illicit fentanyl pressed into counterfeit prescription opioids, such as oxycodone. In many cases, the shape, colorings, and markings were consistent with authentic prescription medications and the presence of fentanyl was only detected after laboratory analysis,” the DEA said. “The rise of fentanyl in counterfeit pill form exacerbates the fentanyl epidemic. Prescription pill abuse has fewer stigmas and can attract new, inexperienced drug users, creating more fentanyl-dependent individuals.”

As Pain News Network has reported, the number of fentanyl related deaths has surged around the country. In Massachusetts – where there has been a marked effort to reduce opioid prescribing -- three out of four opioid overdoses are now being linked to illicit fentanyl.

In Ohio’s Cuyahoga County, the problem is even worse. The medical examiner there estimates 770 people will die from either fentanyl or heroin overdoses by the end of the year, ten times the number of overdose deaths from prescription opioids.

The DEA predicts the problem will only grow worse.

“Fentanyl will remain an extremely dangerous public safety threat while the current production of non-pharmaceutical fentanyl continues,” the agency warns. “In 2015 traffickers expanded the historical fentanyl markets as evidenced by a massive surge in the production of counterfeit tablets containing the drug, and manipulating it to appear as black tar heroin. The fentanyl market will continue to expand in the future as new fentanyl products attract additional users.”

Those who do manage to get their hands on prescription painkillers for recreational use are mostly getting them from friends or relatives. Less than 25% of the painkillers that are used non-medically are obtained directly from doctors.

Over two-thirds of the painkillers that are abused are bought, stolen or obtained for free from friends and relatives.

Despite the shifting nature of the opioid epidemic, government efforts to stop it continue to focus on punishing doctors who overprescribe and reducing patient access to opioids.

“I have several chronic pain conditions that I was managing with a doctor’s care and Norco,” one reader recently emailed Pain News Network. “The DEA closed his office out of the blue. I was left with no doctor, no medical records, and the responsibility of weaning myself off what meds I had left on my own. 

SOURCE OF PAINKILLERS USED NONMEDICALLY

SOURCE: DEA

“My life is in shambles and I live in constant pain with no mercy. How much medical proof of real pain does it take? They just run me around to see different doctors. All the money and time wasted. I can't imagine living the rest of my life like this.”

The Centers for Disease Control and Prevention says 52 Americans die every day from overdoses of prescription opioids, although the accuracy of its estimates has been questioned. Some deaths caused by heroin and illicit fentanyl are wrongly reported as prescription drug overdoses. Other deaths may have been counted twice.

‘Opioid Vaccine’ Could Revolutionize Addiction Treatment

By Pat Anson, Editor

Scientists at The Scripps Research Institute have developed an experimental vaccine that appears to significantly lower the risk of an overdose from prescription opioids and could someday revolutionize opioid addiction treatment. The vaccine also blocks the pain-relieving effects of opioid medication.

“We saw both blunting of the drug’s effects and, remarkably, prevention of drug lethality,” said co-author Kim Janda, PhD, a professor of chemistry at Scripps. “The protection against overdose death was unforeseen but clearly of enormous potential clinical benefit.”

Vaccines typically take advantage of the immune system’s ability to recognize and neutralize foreign invaders such as bacteria.

When injected, the opioid vaccine triggers an immune system response when two widely used painkillers -- hydrocodone and oxycodone -- are detected. Antibodies released by the immune system seek out the opioids and bind to the drugs' molecules, preventing them from reaching the brain.

“The vaccine approach stops the drug before it even gets to the brain,” said study co-author Cody Wenthur, PhD, a research associate at Scripps. “It’s like a preemptive strike.”

In tests on laboratory mice, scientists found that the opioid vaccine blocked the pain relieving effects of oxycodone and hydrocodone, as well as any euphoria. The vaccinated mice also appeared less susceptible to a fatal overdose.

“Our goal was to create a vaccine that mirrored the drug’s natural structure. Clearly this tactic provided a broadly useful opioid deterrent,” said study first author Atsushi Kimishima, a research associate at Scripps.

Currently, opioid addiction treatment relies on other opioids – such as methadone and buprenorphine (Suboxone) – to stifle cravings for opioids. But those drugs can be abused as well.  

Although some of the vaccinated mice succumbed to an opioid overdose, researchers found that that it took much longer for the drug to impart its toxicity. If this effect holds true in humans, the opioid vaccine could extend the window of time for emergency treatment if an overdose occurs.

The next step for researchers is to refine the dose and injection schedule for the opioid vaccine. It may also be possible to make the vaccine more effective. Scripps researchers are already working on vaccines to block the effects of heroin, fentanyl and other synthetic opioids.

The Scripps study has been published in the journal ACS Chemical Biology. The study was supported by the National Institute on Drug Abuse of the National Institutes of Health.

Heroin Vaccine

California-based Opiant Pharmaceuticals is developing a similar vaccine designed to treat heroin addiction. The company recently announced that it has obtained exclusive development and commercialization rights to an experimental heroin vaccine invented by scientists at the Walter Reed Army Institute of Research and the National Institute on Drug Abuse.   

“Aggressively addressing heroin addiction is part of Opiant’s mission,” Roger Crystal, MD, CEO of Opiant said in a news release. “In our view, this vaccine fits our plan to develop innovative treatments for this condition. The vaccine has promising preclinical data.”

Opiant’s first commercial product was Narcan, an emergency nasal spray that rapidly reverses the effects of an opioid overdose.

“Whilst our development of Narcan Nasal Spray to reverse opioid overdose has been a significant effort to address the unfortunate consequences of heroin addiction, we see the vaccine as having potential in addressing the disease itself,” said Crystal.

The Addict is Not Our Enemy

By Fred Kaeser, Guest Columnist

A number of people in chronic pain support the plight of those with addiction. Yet, over the past year and a half, I have read any number of derogatory statements and comments here on Pain News Network and on its corresponding Facebook page about people who are dealing and struggling with addiction.

Even a cursory review of the comment section on different articles will reveal rather quickly any number of folks who are dismissive of those dealing with addiction. Some express a real hatred.

One person actually suggested letting “all the druggies overdose, one by one.”

Another laments that “addicts can't die quick enough for me.”

Some express a sort of jealousy over addicts getting better treatment than they: “It's good to be an addict" and "Maybe I'd be better off being an addict.”

And then there are those who got all shook up over Prince's overdose, not so much from his death, but because it was linked to an opioid and that it might make it harder for them to obtain their own opioid medications.

And to think these comments come from the same people who beg others to better understand and accept their own need for better pain care!

It wasn't very long ago that the "drug addict" was scorned and forgotten: the druggie on the dark-lit street corner or the drunk in the back-alley. Pretty much neglected and left to fend for themselves.

But that started to change in the '70s and '80s, and nowadays the person suffering from addiction is recognized as someone who suffers from a very complex disease, is quite sick, and struggles to access the necessary care in order to recover. Societal attitudes towards those with an addiction now reflect empathy and a desire to help, as opposed to denunciation and dismissiveness.

We chronic pain patients are looking for the same acceptance and understanding that addicts were desperately seeking just a few short years ago. And that struggle took many, many decades, one might say centuries, to achieve. Our struggle is similar, and my guess is if we keep our eyes and focus on reasonable and rational argument, we too will achieve success in our struggle to obtain acceptable pain care and understanding.

But if some of us continue to see the enemy as the person who has an addiction, our fight for justice will suffer and be delayed.

Why? Because the addict is not very different from us.  Irrespective of the reason why a drug or substance user becomes addicted, the addict just wants to feel better, just like us. The addict is sick, just like us. The addict wants relief from pain, just like us. Perhaps not from physical pain, but emotional and psychic pain. The addict wants proper medication, just like us. The addict needs help and assistance, just like us.

And sometimes the pain patient is the addict. Sometimes we are one in the same. A recent review of 38 research reports pegs the addiction rate among chronic pain patients at 10 percent. From a genetic predisposition standpoint, we must presume that some addicts have become addicted just because of their genes, just like some of us.

No one with an addiction started out wanting to become addicted, just like none of us wanted chronic pain. And while our government is trying to figure out how to minimize the spread of opioid addiction, it is not the addict's fault as to how it has decided to that.

In many ways those suffering from addiction are not very different from us who suffer from chronic pain. We both struggle for acceptance, we both require empathy and understanding from the world around us, and we both require treatment and proper care to lead better and more productive lives.

But, I firmly believe that as long as there are those of us in chronic pain who feel compelled to ridicule and demean those who are addicted, that we will only delay our own quest to receive the empathy we so justly deserve in our journey towards adequate pain care.

Empathy breeds empathy, and if we expect it for ourselves, we must be willing to extend it to others. And that includes the addict. 

Fred Kaeser, Ed.D, is the former Director of Health for the NYC Public Schools. He suffers from osteoarthritis, stenosis, spondylosis and other chronic spinal problems.

Fred taught at New York University and is the author of What Your Child Needs to Know About Sex (and When): A Straight Talking Guide for Parents.

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

Medical Marijuana Could Help Treat Addiction

By Pat Anson, Editor

Can marijuana be used to treat addiction?

Not according to the U.S. Drug Enforcement Administration, which classifies marijuana as a Schedule I controlled substance with “a high potential for abuse.” Adults who start using marijuana at a young age, according to the DEA,  are five times more likely to become dependent on narcotic painkillers, heroin and other drugs.

But a new study by Canadian researchers found that marijuana is helping some alcoholics and opioid addicts kick their habits.

"Research suggests that people may be using cannabis as an exit drug to reduce the use of substances that are potentially more harmful, such as opioid pain medication," says the study's lead investigator Zach Walsh, an associate professor of psychology at the University of British Columbia’s Okanagan campus.

“In contrast to the proposition that cannabis may serve as a gateway (drug) is an emerging stream of research which suggests that cannabis may serve as an exit drug, with the potential to facilitate reductions in the use of other substances. According to this perspective, cannabis serves a harm-reducing role by substituting for potentially more dangerous substances such as alcohol and opiates.”

In their review of 31 studies involving nearly 24,000 cannabis users, Walsh and his colleagues also found evidence that marijuana was being used to help with mental health problems, such as depression, post-traumatic stress disorder (PTSD) and social anxiety.

The review did not find that cannabis was a good treatment for bipolar disorder and psychosis.

"It appears that patients and others who have advocated for cannabis as a tool for harm reduction and mental health have some valid points," Walsh said.

With medical marijuana legal in over half of the United States and legalization possible as early as next year in Canada, Walsh says it is important for mental health professionals to better understand the risk and benefits of cannabis use.

"There is not currently a lot of clear guidance on how mental health professionals can best work with people who are using cannabis for medical purposes," says Walsh. "With the end of prohibition, telling people to simply stop using may no longer be as feasible an option. Knowing how to consider cannabis in the treatment equation will become a necessity."

The study was recently published in the journal Clinical Psychology Review. Walsh and some of his colleagues disclosed that they work as consultants and investigators for companies that produce medical marijuana.

Previous studies have found that use of opioid medication declines dramatically when pain patients use medical marijuana. Opioid overdoses also declined in states where medical marijuana was legalized..

Fentanyl & Heroin Changing U.S. Opioid Epidemic

By Pat Anson, Editor

A prominent Alabama physician says the U.S. opioid epidemic has changed so profoundly in the last 3 years that a serious reconsideration of government policy is needed.

Stefan Kertesz, MD, an associate professor at the University of Alabama at Birmingham School of Medicine, says heroin and illicit fentanyl are now the driving forces behind the opioid epidemic – not prescription pain medication.

“Reducing opioid prescribing is not going to save many lives at this point, even though it gives many officials a chance to look like they are doing something,” says Kertesz, who is also a primary care physician trained in internal medicine and addiction.

“If we have been reducing prescribing for several years, and the misuse of prescription pain relievers is near all-time lows… and overdoses are either staying very high or skyrocketing, then we need to change our assessment of the problem and refocus our response.”

STEFAN KERTESZ, MD

Kertesz cites recent data from Jefferson County, Alabama showing that most overdoses in the county are now linked to either fentanyl, heroin or a combination of the two. Only 15 percent of the overdoses are associated with prescription opioids.

In Ohio’s Cuyahoga County, about 11 people die each week from fentanyl or heroin overdoses. By the end of the year, the county medical examiner estimates that a total of 770 deaths will be caused by fentanyl or heroin, nearly ten times the number that will die from prescription opioid overdoses.  

source: cuyahoga county medical examiner

“Heroin and fentanyl have come to dominate an escalating epidemic of lethal opioid overdose, while opioids commonly obtained by prescription play a minor role,” Kertesz wrote in a commentary published in the journal Substance Abuse.

“The observed changes in the opioid epidemic are particularly remarkable because they have emerged despite sustained reductions in opioid prescribing and sustained reductions in prescription opioid misuse. Among U.S. adults, past-year prescription opioid misuse is at its lowest level since 2002. Among 12th graders it is at its lowest level in 20 years.”

Kertesz says the Centers for Disease Control and Prevention relied on faulty data and failed to address the changing nature of opioid abuse when it released its opioid prescribing guidelines in March. Since then, many pain patients have reported their opioid doses have been lowered or discontinued, while some have been discharged by their physicians and forced to seek treatment elsewhere.

He likened the situation to Pontius Pilate washing his hands.

“Discontinuation of prescribed opioids, coupled with encouragement to seek an inaccessible treatment, frees the physician from risk of prosecution or sanction. Inevitably, some patients so discharged will die from drugs they purchase on an increasingly lethal illicit market. At that point, an assertion of ‘clean hands’ by physicians, regulatory authorities or the federal government seems facile,” said Kertesz.

“The changing epidemiology of opioid overdose in 2016 offers no easy resolution to such difficult challenges. But it suggests that a relentless focus on physician prescribing for pain has become less relevant to correcting the forces behind a wave of deaths in 2016. Federal efforts to turn the tide risk becoming a riptide for patients, physicians and communities where access to evidence-based treatment remains a priority neglected for too long.”

By “evidence-based treatment,” Kertesz means access to addiction treatment medication such as buprenorphine and methadone, which is lacking in many parts of the country.

As Pain News Network has reported, the DEA says the U.S. is being “inundated” with illicit fentanyl produced in China and Mexico. Illicit fentanyl is often mixed with heroin to increase its potency or used in the manufacture of counterfeit pain medication.

Massachusetts recently reported that three out of four opioid overdoses in the state are now fentanyl-related.  Only about 20 percent of the overdose deaths in Massachusetts involve prescription opioids.

Massachusetts was the first state to begin using blood toxicology tests to look specifically for fentanyl. Toxicology tests are far more accurate than the death certificate codes used by the Centers for Disease Control and Prevention to classify opioid-related deaths. 

Surgeon General Issues ‘Landmark Report’ on Addiction

By Pat Anson, Editor

Calling addiction “America’s most pressing problem,” U.S. Surgeon General Vivek Murthy has released a landmark report on alcohol, drug abuse and substance use disorders. Nearly 21 million Americans are believed to suffer from some form of substance addiction.

“Alcohol and drug addiction take an enormous toll on individuals, families, and communities,” said Murthy. “Most Americans know someone who has been touched by an alcohol or a drug use disorder. Yet 90 percent of people with a substance use disorder are not getting treatment. That has to change.”

The voluminous report, Facing Addiction in America: The Surgeon General’s Report on Alcohol, Drugs, and Health, takes an in-depth look at the abuse of alcohol, illicit drugs, and prescription drugs.  Murthy called for a cultural shift in the way Americans view addiction.

SURGEON GENERAL VIVEK MURTHY, MD

"For far too long, too many in our country have viewed addiction as a moral failing," Murthy said. "This unfortunate stigma has created an added burden of shame that has made people with substance-use disorders less likely to come forward and seek help.

"We must help everyone see that addiction is not a character flaw. It is a chronic illness that we must approach with the same skill and compassion with which we approach heart disease, diabetes, and cancer."

Murthy was blasted by one critic for releasing the report in the final weeks of the Obama administration.

“The timing of Murthy’s report is despicable,” wrote Dr. Manny Alvarez, the senior managing health editor at Fox News. “For two years, he did nothing to develop national protocols to tackle opioid abuse and waited until a Republican was elected president to issue the first-ever report from a U.S. surgeon general dedicated to substance addiction. He could have used this platform to shape his legacy as surgeon general, but instead, it appears he chose to play politics while using our nation’s health as a pawn."

Murthy did send a letter to over 2 million physicians in August, encouraging them to follow CDC guidelines and not prescribe opioids as a first-line treatment for chronic pain.

The report released today, however, makes surprisingly few references to opioid prescribing or to the soaring number overdoses caused by heroin and illicit fentanyl. At times, the report acknowledges that efforts to reduce opioid prescribing may only be making the nation's opioid problem worse.

“Although only about 4 percent of those who misuse prescription opioids transition to using heroin, concern is growing that tightening restrictions on opioid prescribing could potentially have unintended consequences resulting in new populations using heroin,” the report states. “As yet, insufficient evidence exists of the effects of state policies to reduce inappropriate prescribing of opioid pain medications.”

As Pain News Network has reported, fentanyl overdoses have been escalating rapidly. In Massachusetts, nearly three out of four opioid overdoses this year have been linked to fentanyl, far outnumbering the number of deaths associated with prescription pain medication.

One of the findings of the Surgeon General’s report is that addiction treatment in the United States remains largely separate from the rest of health care and serves only a fraction of those in need of treatment. This “treatment gap” is attributed to a number of factors, including lack of access, cost, fear of shame, and discrimination. Many people are also not referred to treatment until there is a crisis, such as an overdose or arrest.

"This report comes at a critical point in time, drawing national attention to a public health epidemic that continues to sweep the country," said Shaun Thaxter, CEO of Indivior, the maker of the addiction treatment drug Suboxone. "We are encouraged by the proactive steps taken by the U.S. federal government to raise awareness about this chronic disease and ensure that patients have access to the treatment they need.”

Kolodny Leaves Phoenix House

In related news, Andrew Kolodny, MD, the founder and executive director of Physicians for Responsible Opioid Prescribing (PROP), has announced that he is no longer the chief medical officer at Phoenix House, which runs of chain of addiction treatment centers.

Kolodny is now co-director of opioid policy research at the Heller School for Social Policy & Management at Brandeis University

PROP, an advocacy group that seeks to reduce opioid prescribing, ended its association with Phoenix House earlier this year. The non-profit Steve Rummler Hope Foundation is now the “fiscal sponsor” of PROP, which allows PROP to collect tax deductible donations.

DEA Bans Opioid Found in Fake Painkillers

By Pat Anson, Editor

The U.S. Drug Enforcement Agency is banning a powerful synthetic opioid linked to dozens of fatal overdoses -- including the death of the late pop star Prince.

Effective Monday, the DEA is classifying U-47700 as a Schedule I controlled substance, making the sale and possession of the drug a felony. Known in law enforcement circles as “pink,” U-47700 is about 8 times stronger than morphine. It was originally developed in the 1970’s as a prescription pain reliever, but was never used for that purpose.  

U-47700 is now being manufactured by illicit drug labs in China and smuggled into the United States, according to the DEA.

“Evidence suggests that the pattern of abuse of U-47700 parallels that of heroin, prescription opioid analgesics, and other novel opioids. Seizures of U-47700 have been encountered in powder form and in counterfeit tablets that mimic pharmaceutical opioids,” the DEA said in a notice published in the Federal Register.

“Abusers of U-47700 may not know the origin, identity, or purity of this substance, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone.”

The DEA said at least 46 overdose deaths have been linked to U-47700 since 2015, including 31 in New York and 10 in North Carolina.

The actual number of deaths is probably higher, according to NMS Labs, a private forensic laboratory in Pennsylvania. The lab said it confirmed U-47700 in toxicology tests involving over 80 deaths nationwide in the first nine months of 2016.

“The recent rise in use of these novel drugs of abuse is contributing to the spiraling of deaths associated with opioid abuse, and is being seen across the country. Their incidence of use is probably underestimated since these drugs are frequently a blind spot for many forensic labs, because they are novel and the labs are not looking for them in their routine procedures,” Dr. Barry Logan, Chief of Forensic Toxicology at NMS Labs said in a statement.

U-47700 and fentanyl, another synthetic opioid, were part of a deadly cocktail of drugs found in toxicology tests on Prince, who died of an accidental drug overdose in April. Investigators believe the musician may have thought he was taking a legitimate painkiller.

Fentanyl and U-47700 have also been linked to an outbreak of deaths and hospitalizations in California involving counterfeit pain medication. A 41-year old woman who suffers from chronic back pain purchased pills on the street designed to look like Norco, the brand name of a prescription drug that contains hydrocodone.  

The woman became unconscious within 30 minutes of taking three of the counterfeit tablets. She next remembers waking up in a hospital emergency room and told hospital staff the pills had the markings of Norco, but were beige in color instead of the usual white. A blood serum analysis revealed the woman had significant amounts of fentanyl and U-47700 in her system.

Fentanyl is legally prescribed in patches and lozenges to treat severe chronic pain, but the DEA believes “hundreds of thousands of counterfeit prescription drugs” laced with illicit fentanyl are on the black market. The agency predicts more fake pills will be manufactured because of heavy demand and the “enormous profit potential” of counterfeit medication.

This temporary scheduling of U-47700 as a controlled substance will last for 24 months, with a possible 12-month extension if the DEA needs more data to determine whether it should be permanently banned.

Fentanyl Deaths Rise Again in Massachusetts

By Pat Anson, Editor

Nearly three out of four opioid overdoses in Massachusetts have been linked to fentanyl, far outnumbering the number of deaths associated with prescription pain medication, according to a new report from the Massachusetts Department of Public Health. 

Massachusetts was the first state to begin using blood toxicology tests to look specifically for fentanyl, a powerful synthetic opioid that is more potent and dangerous than heroin. Toxicology tests are far more accurate than the death certificate codes used by the Centers for Disease Control and Prevention to classify opioid-related deaths. 

Over 1,000 confirmed cases of unintentional opioid overdoses were reported in Massachusetts in the first nine months of 2016. During the third quarter (July-September), 74 percent of the deaths where a toxicology screen was available showed a positive result for fentanyl.

Almost all of those deaths are believed to involve illicit fentanyl, not pharmaceutical fentanyl that is prescribed to treat severe pain.

“The data released today are a sobering reminder of why the opioid crisis is so complex and a top public health priority,” said Secretary of Health and Human Services Marylou Sudders. “This is a crisis that touches every corner of our state, and we will continue our urgent focus expanding treatment access.”

Only about 20 percent of the overdose deaths in Massachusetts were associated with prescription opioids such as hydrocodone and oxycodone, a trend that has held fairly steady since 2014, even as the number of opioid prescriptions in the state has declined.

Massachusetts department of public health

 "I think this points to the fact that cutting scripts for legitimate pain patients and blaming doctors for overdose deaths is pointing fingers in the wrong direction and harming a lot of innocent people living with debilitating pain while doing nothing to reduce overdose deaths – a critical goal,” said Cindy Steinberg of the U.S. Pain Foundation, a patient advocacy group. “People living with the disease of chronic pain and those living with the disease of substance use disorder are two different populations of people with little overlap.

“If we are committed to doing all we can to stop overdose deaths then the only way we can do that is to really understand what exactly is causing them. The fact that illicit fentanyl is the cause points to the need for increased law enforcement efforts to interdict the supply coming into Massachusetts.”

According to the Drug Enforcement Administration, chemicals used to make illicit fentanyl are being smuggled in from China and Mexico. Illicit fentanyl is usually mixed with heroin or cocaine, and it is also appearing in counterfeit pain medication sold on the black market. The drug is so potent that a single pill could be fatal.

Rhode Island is also using blood toxicology tests to help determine the true nature of the opioid epidemic. The most recent data from that state shows that about two out of three opioid overdoses are linked to fentanyl.  Since 2012, overdoses from prescription opioids have fallen by about a third in Rhode Island.

“The shifts in prescription and illicit drug overdose deaths also began roughly when more focused efforts were undertaken nationally to reduce the supply of prescription drugs,” the Rhode Island Department of Health said in a statement.

The CDC uses death certificate codes – not toxicology tests -- in its reports on opioid overdoses. The codes do not indicate the cause of death, only the conditions or drugs that may be present at the time of death. Because of limitations in the data, many overdoses involving illicit fentanyl and heroin are being reported by the CDC as prescription opioid deaths.

Half of New York Overdoses Blamed on Fentanyl

By Pat Anson, Editor

Nearly half of the overdose deaths in New York City since July have been linked to fentanyl, according to a new report that adds to the growing body of evidence that illicit fentanyl is now driving the nation’s opioid epidemic – not prescription pain medication.

In an advisory sent to healthcare providers, New York’s health department said 47 percent of the city's confirmed overdose deaths since July 1 have involved fentanyl. That compares to 16% of overdoses involving fentanyl in all of 2015. So far this year, 725 people have died from drug overdoses in New York.

“Data suggest that the increased presence of fentanyl is driving the increase in overdose fatalities,” the alert said. “While fentanyl is most commonly found in combination with heroin-involved overdose deaths, fentanyl has also been identified in cocaine, benzodiazepine, and opioid analgesic-involved overdose deaths.”

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. Because of its potency, healthcare providers are being warned that additional doses of naloxone – which reverses the effects of an opioid overdose – may be needed when fentanyl is involved.

Fentanyl is available legally by prescription in patches and lozenges to treat more severe types of acute and chronic pain, but illicitly manufactured fentanyl has become a scourge across the U.S. and Canada, where it is often mixed with heroin and cocaine or used to make counterfeit pain medication.

Unsuspecting buyers, including some pain patients who were unable to get opioid medication legally, often have no idea the drug they’re getting from a dealer or friend could contain a lethal dose of fentanyl.

dea image of fentanyl

In addition to New York City, several states in the Northeast and Midwest have reported that fentanyl is now involved in about half of their overdose deaths.

The sharp increase in fentanyl-related deaths has coincided with new restrictions on the prescribing of opioid pain medication. In the past year, the Drug Enforcement Administration has issued two public safety alerts about fentanyl, but the Centers for Disease Control and Prevention has remained relatively quiet about the problem – focusing instead on opioid prescribing guidelines that were released in March of this year.  

Those guidelines have led many doctors to reduce doses or stop prescribing opioids altogether, but they have failed to make a dent in the number of Americans dying from overdoses. There have also been anecdotal reports of a rising number of suicides by patients unable to get opioid medication.

“I know five people who have committed suicide from being denied pain medication by doctors after the CDC came out with their ridiculous statements of the ‘epidemic’ of prescription opioid use,” says Nina Stephens, a Colorado woman who suffers from chronic pelvic pain. 

“Doctors are so afraid of getting in the middle of this epidemic mess with the FDA that they have decided to stop prescribing opioids to their patients, even those patients who are in desperate chronic pain. We are now treating our patients worse than dogs when it comes to pain.”

Stephens says she has to drive 4 hours each month to see a doctor who is still willing to prescribe opioids. A local pain management doctor just 20 minutes away said he would take Stephens off opioids and give her epidural injections instead, which she refused.

“I am truly afraid that soon I will have to drive even farther to find a doctor who will still be willing to prescribe pain pills to me each month or I will have to start looking at the black market.  Maybe a veterinarian would be willing to start treating me?  No wonder the suicide rate is going up so dramatically!” Stephens wrote in an email to PNN.

Canada’s Fentanyl Crisis

Counterfeit fentanyl pills started appearing in British Columbia about two years ago and have since spread throughout Canada. The fentanyl crisis is so severe a two-day conference was held in Calgary this week for healthcare providers and law enforcement.  There were 153 deaths associated with fentanyl in Alberta province during the first six months of 2016.

Some attendees want Alberta to declare a public health emergency – as British Columbia did in April. But Alberta’s Minister of Justice says the current fentanyl situation doesn’t warrant such a declaration.

“None of those powers will assist us in this case but they do give the government a significant ability to violate civil liberties,” said Kathleen Ganley. “We think it’s important we use those powers that have significant impact on Albertans only where they would be helpful to us.”

On display at the conference was an illegal pill press seized by law enforcement that is capable of producing 6,000 fentanyl laced pills per hour.

“Some of the tablets we’ve been seizing in Calgary have ranged from 4.6 milligrams to 5.6 milligrams per tablet—which is very high obviously, considering a lethal dose is two milligrams,” said Calgary police Staff Sgt. Martin Schiavetta in Calgary Metro.

Trump and Clinton Pursue Same Policies in Pain Care

By Pat Anson, Editor

Chronic pain patients hoping for a dramatic change in federal pain care policies as a result of the presidential election are likely to be disappointed.

Both Donald Trump and Hillary Clinton favor more restrictions on opioid prescribing, as well as expanded access to addiction treatment programs, which are essentially the same policies being pursued by the Obama administration.

At a rally in New Hampshire this weekend, Trump outlined for the first time his strategy to combat the nation’s so-called opioid epidemic.

“DEA should reduce the amount of Schedule II opioids -- drugs like oxycodone, methadone and fentanyl -- that can be made and sold in the U.S. We have 5 percent of the world’s population, but use 80 percent of the prescription opioids,” Trump said in prepared remarks.

“I would also restore accountability to our Veterans Administration. Too many of our brave veterans have been prescribed these dangerous and addictive drugs by a VA that should have been paying them better attention.”

Trump said the Food and Drug Administration has been “too slow” in approving opioid pain medication with abuse deterrent formulas. And he said he would “lift the cap” on the number of patients that a doctor can treat with addiction treatment drugs.

donald trump

But the Republican nominee seemed confused about the difference between abuse deterrent formulas and addiction treatment drugs like buprenorphine (Suboxone).

"The FDA has been far too slow to approve abuse-deterring drugs. And when the FDA has approved these medications, the rules have been far too restrictive, severely limiting the number of authorized prescribers as well as the number of patients each doctor can treat," he said.

There are no limits on doctors for prescribing abuse deterrent drugs, but there are for the buprenorphine. In August, the Obama administration nearly tripled the number of patients that a doctor can treat with buprenorphine.

Trump also seemed unaware that the DEA recently said it would reduce the production quota for many opioids by 25 percent or more.

Trump claimed the Obama administration has worsened the nation’s drug problem by commuting the sentences of drug traffickers and by releasing “tens of thousands” of drug dealers early from prison. He also pledged to stop the flow of illegal drugs into the country.

“We will close the shipping loopholes that China and others are exploiting to send dangerous drugs across our borders in the hands of our own postal service. These traffickers use loopholes in the Postal Service to mail fentanyl and other drugs to users and dealers in the U.S.” said Trump.

“When I won the New Hampshire primary, I promised the people of New Hampshire that I would stop drugs from pouring into your communities. I am now doubling-down on that promise, and can guarantee you – we will not only stop the drugs from pouring in, but we will help all of those people so seriously addicted get the assistance they need to unchain themselves.”

Like Trump, Hillary Clinton has also promised to expand access to addiction treatment, but in more detail. Her Initiative to Combat America's Deadly Epidemic of Drug and Alcohol Addiction would allocate $10 billion in block grants to states to help fund substance abuse programs.  

Clinton also wants doctors to undergo training in opioid prescribing before they are licensed to practice and to require that they consult prescription drug databases before writing prescriptions for controlled substances.

One area where Clinton differs with Trump is that she puts less emphasis on law enforcement. Saying she wants to “end the era of mass incarceration,” Clinton has called for low-level drug offenders to get treatment and not just be locked up.

“For those who commit low-level, nonviolent drug offenses, I will reorient our federal criminal justice resources away from more incarceration and toward treatment and rehabilitation. Many states are already charting this course — I will challenge the rest to do the same,” Clinton wrote in an op/ed published in the New Hampshire Union Leader.

hillary clinton

In their public statements, neither Trump or Clinton have given any indication that they believe that  federal policies affecting pain care, such as the CDC’s opioid prescribing guidelines, have gone too far. If anything, they want to go further.

Clinton has endorsed a proposed tax on opioid pain medication sponsored by West Virginia Sen. Joe Manchin (D). If approved, the so-called Lifeboat Act would raise $2 billion annually to fund addiction treatment programs. The tax would be the first federal tax on a prescription drug ever levied on consumers.  

During a roundtable discussion about opioid overdoses in West Virginia, Clinton called the tax “a great idea” and said it was “one of the reasons why I am such an admirer of Sen. Manchin.”

Pain News Network has asked the Trump campaign where the Republican nominee stood on the opioid tax. We have yet to get a response.

An Open Letter to DEA About Banning Kratom

By Rebecca Shanks, Guest columnist

Dear DEA,

Several years ago, I was diagnosed with Ehlers Danlos syndrome and spondylolysis, which in turn caused degenerative disc disease. Like most people, I was prescribed narcotic painkillers.

At first, they prescribed MS Contin. That's a pretty powerful drug for a first time narcotic user, and it made me sick. I took back the pills and handed them to the doctor, who replaced it with methadone.

There still, I couldn't do much except zone out on the couch and sleep. I was lucky if they didn't send me to the restroom vomiting. I got tired of that, and they prescribed Percocet and Vicodin. I was to take the Percocet three times a day, and if I had breakthrough pain, I was to take a Vicodin. 

REBECCA SHANKS

After a while, like so many chronic pain sufferers, I became more than dependent on painkillers, got addicted, and found my life spiraling out of control.

In 2008, I lost everything and everyone. I lost my husband. I lost my children. I lost my home and wound up moving into a hotel room.

Finally, I was approached by my grandfather, God bless his soul, and he had a heart-to-heart talk with me that something had to change. I took his advice with tears in my eyes, and I went to rehab.

After rehab, while I was clean, the pain was becoming unbearable. Tylenol, ibuprofen and other NSAIDs that were given to me in place of narcotics did absolutely nothing.

I was scared. I knew that it would only be a matter of time before I had to go back on the pills and run the risk of addiction yet again.

That's when I met a woman who ran an herb shop and she told me about kratom. I had nothing to lose by trying it, and when I did, I was more than surprised. It worked. My pain was gone and I didn't have any of the horrible side effects of the pills that were pushed down my throat. It truly was a miracle. 

When I was in pain, I would take kratom and a few minutes later would be able to easily go back to whatever it was I was doing. There was no sleeping all day. There was no drunken fog. I have been using kratom for a few years now.  When I don’t take it, on days that my pain is not that bad, I feel nothing more than a headache.

I got my life back. I got my children back. My ex-husband and I are on very good terms, residing in the same vicinity with nary an argument between us. I have even chased the dream of being an author and have already published one book under a pen name, with two more in the works that will be released soon. I am now a productive member of society, and the mother I should have always been.

DEA, if you ban kratom, what will happen to me? Will I have to go back to the pills, run the risk of addiction once again, and be unable to do anything aside from sleep all day, or zone out on the couch? 

Will I have to just suck up the pain? In that scenario, I will still be in bed all day, screaming and crying out of sheer misery, wanting it to end. My children do not need to bear witness to that.

In any of those scenarios, I will no longer be productive, and I see myself winding up on disability, unable to work. I don't want that. The taxpayers don't want that either, not when I am doing so well on my own.

But if I choose the other route, and continue to use kratom, I become a felon. I run the risk of being shipped off to prison, for doing nothing more than trying to manage my pain while still being a productive member of society. 

So what would you have us do, DEA? Which path should I choose? Right now, I'm not sure. All I know is that I am afraid of what will happen to my life and my family should you choose to continue with this ban. 

By banning kratom, you are not hurting the drug addicts that you have a war with. You are hurting every day, productive citizens. You are hurting mothers, fathers, grandparents and other people, who you would never even know took kratom unless they told you. The plant is that mild.

DEA, I beg you to please stop this. You can stop this. Please listen to the people. 

Rebecca Shanks is the mother of two children and lives in Illinois. Under the pen name J. Theberge, she published her first book, Subject Alpha, and is currently working on two other books. When she isn't working, Rebecca is active in her children's education and promoting autism awareness.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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