FDA Approves New Long Acting Painkiller

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended release opioid pain medication with abuse deterrent properties.

Egalet Corporation announced Monday that the FDA has approved Arymo ER – a long-acting version of morphine -- for the management of pain severe enough to require daily, around-the-clock opioid treatment. It comes in the form of a pill that is very difficult to crush or liquefy, methods used by abusers to speed the release of an opioid into the bloodstream.

"With the majority of ER opioids in easy to abuse forms, it is important that healthcare professionals have additional treatment options like Arymo ER that are resistant to different methods of manipulation using a variety of tools," Bob Radie, president and CEO of Egalet said in a news release.

“Arymo ER has physical and chemical properties expected to make abuse by injection difficult which is important given it is the most common non-oral route of morphine abuse and the most dangerous.”

An FDA advisory panel recommended in a 18-1 vote last August that Arymo be approved. It is is the 7th opioid with abuse deterrent properties approved by the FDA. The other medications are OxyContin, Targiniq, Embeda, Hysingla, Morphabond, and Xtampza.

Arymo has been approved in three dosage strengths: 15 mg, 30 mg and 60 mg. Egalet plans to make the drug available in the first quarter of 2017.

Arymo is the first commercial product developed with Egalet’s Guardian technology, which incorporates the medication into a polymer matrix tablet to make it difficult to misuse or abuse.

“Guardian Technology results in tablets that are extremely hard, very difficult to chew, resistant to particle size reduction, and inhibit/block attempts at chemical extraction of the active pharmaceutical ingredient,” the company says in a statement on its website.

“In addition, the technology results in a viscous hydrogel on contact with liquid, making syringe-ability very difficult. These features are important to address the risk of accidental misuse (e.g., chewing) in patients with chronic pain, as well as intentional abuse using more rigorous methods of manipulation. “

The approval of abuse-deterrent medications is still somewhat controversial. Some medical professionals and anti-opioid activists say the technology does not completely prevent abuse and the drugs are still being misused by addicts.

Few Pain Patients Become Long-Term Opioid Users

By Pat Anson, Editor

Less than two percent of patients with prescriptions for opioid pain medication become long-term opioid users, according to a large new study published online in the journal Pain.

Researchers at Indiana University studied a nationwide database of over 10 million patients who filed insurance claims for opioid prescriptions between 2004 and 2013. The study was designed to look at opioid use by patients with psychiatric and behavioral problems, but in the process uncovered data indicating that the overall risk of long term opioid use for six months or more was relatively rare for most patients.

“Of the 10,311,961 incident opioid recipients, only 1.7% received long-term opioids during follow-up,” wrote lead author Patrick Quinn, PhD, of Indiana University, Bloomington.

“The probability of transitioning from first fill to long-term opioids was 1.3% by 1.5 years after the first prescription fill, 2.1% by 3 years, 3.7% by 6 years, and 5.3% by 9 years. Fewer than half of long-term recipients met a stricter long-term definition (at least 183 days supply) during follow-up. The likelihood of receiving long-term opioids by this stricter definition was 1.0% by 3 years.”

Addiction treatment specialists and public health officials have long claimed that even short-term use of opioid medication quickly raises the risk of addiction and death.

“The bottom line here is that prescription opiates are as addictive as heroin. They’re dangerous drugs,” CDC Director Thomas Frieden recently told the Washington Post. “You take a few pills, you can be addicted for life. You take a few too many and you can die.”

The Indiana University researchers did find a “relatively modest” increase in long term opioid use by patients with depression, anxiety and other mental health conditions, and those taking psychoactive drugs. Rates of long-term use were 1.5 times higher for patients taking medications for attention-deficit disorder (ADHD); three times higher for those with previous substance use disorders other than opioids; and nearly nine times higher for those with previous opioid use disorders.

Ironically, the strongest risk for long-term opioid use was in patients being treated with buprenorphine (Suboxone), an addiction treatment drug.

“Patients with OUDs (opioid use disorders) and buprenorphine or naltrexone prescription fills were at substantially greater risk of transitioning to long-term opioids earlier in follow-up than were patients without these conditions or medications,” Quinn wrote.

The researchers also found that patients with a history of suicidal or self-injuring behavior were at greater risk of using prescription opioids long-term.

 “It is likely that patients with psychiatric problems are more likely to experience more severe pain symptoms or greater pain-related functional impairment, perhaps leading providers to prescribe more aggressively to address pain-related concerns,” Quinn said. “It is also possible that patients with comorbid pain and psychiatric conditions may be more likely to seek care repeatedly or from multiple treatment providers because of their greater symptom severity or perceived need for care, resulting in a higher rate of opioid receipt in aggregate.”

Quinn and his colleagues do not rule out opioid therapy for pain sufferers with psychiatric problems, but recommend that they be given mental health counseling “in conjunction with the use of long-term opioid therapy.”

Frieden to Resign as CDC Director

By Pat Anson, Editor

Dr. Thomas Frieden, who has headed the Centers for Disease Control and Prevention for nearly eight years and played a pivotal role in the agency’s opioid prescribing guidelines, plans to submit his resignation on January 20, the day of President-elect Donald Trump’s inauguration.   

Frieden disclosed his plans in a year-end interview with Reuters. The former New York City health commissioner did not say what he planned to do next.

Frieden’s resignation is not surprising, as incoming administrations usually do not retain the heads of federal agencies, most of whom are political appointees.  Food and Drug Commissioner Robert Califf, MD, who has only been in office for 10 months, has not been contacted by the Trump transition team and is also expected to be replaced, according to The Washington Post.

President-elect Trump has not yet said who his nominee will be to succeed Califf or who he will appoint to replace Frieden.

Frieden has an extensive background in epidemiology and infectious diseases, and his tenure at the CDC was marked by major efforts to combat outbreaks of the Ebola virus, fungal meningitis, influenza and the Zika virus. He also doggedly pursued a controversial campaign to put prescribing limits on opioid pain medication, an area traditionally overseen by the FDA.

“One of the most heartbreaking problems I’ve faced as CDC director is our nation’s opioid crisis,” Frieden recently wrote in a commentary published by Fox News. 

“This crisis was caused, in large part, by decades of prescribing too many opioids for too many conditions where they provide minimal benefit and is now made worse by wide availability of cheap, potent, and easily available illegal opioids: heroin, illicitly made fentanyl, and other, newer illicit synthetic opioids. These deadly drugs have found a ready market in people primed for addiction by misuse of prescription opioids.”

thomas frieden, md

But Frieden’s campaign to rein in opioid prescribing has failed to slow the soaring number of overdose deaths, which continued to rise throughout his tenure at CDC, killing 52,000 Americans last year alone.

His repeated claim that the use of prescription opioids by legitimate patients is “intertwined” with the overdose epidemic is also not supported by facts. Only a small percentage of pain patients become addicted to opioid medication or graduate to heroin and other illegal street drugs.

Yet Frieden remains a staunch supporter of the CDC guidelines, calling them an “excellent starting point” to prevent opioid abuse, even though the guidelines themselves state they are based on scientific evidence that is "low in quality."

“There are safer drugs and treatment approaches that can control pain as well or better than opioids for the vast majority of patients. We must reduce the number of Americans exposed to opioids for the first time, especially for conditions where the risks of opioids outweigh the benefits,” Frieden wrote.

“We must not forget what got us here in the first place. Doctors’ prudent use of the prescription pad and renewed commitment to treat pain more safely and effectively based on what we know now about opioids—as well as healthy awareness of the risks and benefits among patients prescribed these drugs—can change the path of the opioid epidemic.”

Frieden undoubtedly had good intentions, but his agency repeatedly showed a penchant for arrogance and contempt for the public while drafting the guidelines.  The CDC held no public hearings, and secretly consulted with addiction treatment specialists and special interest groups, but few pain patients or pain physicians.

The CDC finally unveiled the guidelines publicly in September 2015 to a select online audience. The agency didn’t make the guidelines available on its website or in any public form outside of the webinar, and allowed for only a 48-hour comment period. Only when faced with the threat of lawsuits and growing ridicule from patients, physicians and other federal agencies, did the agency reverse course and delay the guidelines for several months. They were released virtually unchanged in March 2016.

Although “voluntary” and meant only for primary care physicians, the guidelines have been widely adopted by pain specialists and other prescribers, and have even become law in several states. This was always the goal of the CDC.

Within a few months of their release, an online survey of nearly 2,000 pain patients found that over two-thirds had their opioid medication reduced or stopped by their doctors. Over half said they had contemplated suicide.

There have been anecdotal reports of suicides increasing in the pain community. A recent story we did about the suicide of a Vermont man who was cut off from opioids and abandoned by his doctor provoked quite a response from readers.

“This situation has got to be stopped before any more people commit suicide to escape the pain. I also suffer from chronic pain and my medications have been cut back so far they no longer work worth a damn,” Michael wrote to us.

“I'm facing the very same thing right now. I'm in utter agony,” said LadyV. “In my doctor’s office I was told I have to reduce you, wean you off. I through no fault of my own suffered a horrible spinal injury and now no one cares.”

“When I was forcibly weaned off my pain meds last spring, due to the push by the DEA and CDC, I wrote a letter to the White House,” wrote Judith Metzger. “I mentioned a need for them to be watching suicide statistics related to uncontrolled chronic pain. There was never any mention that I was suicidal. Still, I got several calls from a suicide crisis team in DC! Reading this tragic story makes it clear that my prediction was sadly correct. When will they ever listen?”

In his commentary for Fox News, Frieden said it was “important that we look upstream and prevent opioid use disorder in the first place.”

In his final weeks at the CDC, now may be a good time for Frieden to look downstream at the havoc his prescribing guidelines have created.

NSAIDs Raise Risk of Dying From Endometrial Cancer

By Pat Anson, Editor

Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) have long been thought to reduce the risk of some cancers. But a surprising new study suggests that regular use of the pain relievers may actually raise the risk of dying for women with endometrial cancer.

Researchers at Ohio State University studied over 4,300 women with endometrial cancer, 550 of whom died during the five-year study. Those who used NSAIDs regularly and had Type 1 endometrial cancer had a 66 percent higher risk of death.

The research findings are published in the Journal of the National Cancer Institute.

"This study identifies a clear association that merits additional research to help us fully understand the biologic mechanisms behind this phenomenon. Our finding was surprising because it goes against previous studies that suggest NSAIDs can be used to reduce inflammation and reduce the risk of developing or dying from certain cancers," said co-author Theodore Brasky, PhD, a cancer epidemiologist at The Ohio State University Comprehensive Cancer Center.

Over 60,000 women are diagnosed with endometrial cancer in the U.S. annually, making it the fourth most common cancer in women and the sixth leading cause of cancer death.

Endometrial cancer begins in the lining of the uterus and grows outward to surrounding organs. Type 1 tumors are less aggressive and are typically confined to the uterus, while Type 2 tumors tend to be aggressive and are at greater risk of spreading.

In the OSU study, the risk of dying was statistically significant in women who reported past or current NSAID use, but it was strongest among patients who used NSAIDs for more than 10 years and had ceased using them prior to their cancer diagnosis.

Interestingly, the use of NSAIDs was not associated with mortality from more aggressive Type 2 cancers.

"These results are intriguing and worthy of further investigation," said co-author David Cohn, MD, director of the gynecologic oncology division at the OSU cancer center. “While these data are interesting, there is not yet enough data to make a public recommendation for or against taking NSAIDS to reduce the risk of cancer-related death."

Aspirin, ibuprofen and other NSAIDs are believed to lower the risk of some cancers by reducing inflammation, which slows the development of blood vessels that support the growth of cancer tumors. Inhibition of inflammation may have the opposite effect in endometrial cancer, but the reasons why are unclear.

Previous studies have shown that NSAIDs have a preventive effect on colorectal cancer and several other cancer types.

“Observational evidence of a chemopreventive effect of aspirin and other NSAIDs has been reported for esophageal, gastric, lung, breast, prostate, and colorectal cancer. Most of these cancers develop after age 60 years,”  researchers at the University of California Irvine reported in The Lancet.

“Given the apparent delay in the chemopreventive effect of NSAIDs (about 10 years), optimum treatment might start at age 40–50 years. Most individuals who develop premalignant lesions do so in their 50s and 60s, several years before the appearance of cancer, so this age range might be the best time for cancer prevention.”

Low-dose aspirin is also believed to have cardiovascular benefits. For that reason, the OSU researchers recommend that women keep taking the pain relievers.  

"It is important to remember that endometrial cancer patients are far more likely to die of cardiovascular disease than their cancer so women who take NSAIDs to reduce their risk of heart attack -- under the guidance of their physicians -- should continue doing so,” said Cohn.

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”).  

Chronic Pain Patient Abandoned by Doctor Dies

By Pat Anson, Editor

This will be the first Christmas that Tammi Hale spends without her husband Doug in over 30 years.

The 53-year old Vermont man, who suffered chronic pain from interstitial cystitis, committed suicide in October after his doctor abruptly cut him off from opioid pain medication.

“His primary care provider kept trying to wean him off his opioid therapy, which worked at higher doses,” says Tammi. “My husband ran out (of medication) early a few times, so the doctor cut him off completely one day. Six weeks later he took his life as no medical establishment would treat his chronic pain.”

We’re telling Doug Hale’s story, as we have those of other pain patients who’ve committed suicide, because their deaths have been ignored or lost in the public debate over the nation’s so-called opioid epidemic.  Patients who were safely taking high doses of opioids for years are suddenly being cutoff or tapered to lower doses. Some are being abandoned by their doctors.

“I believe it will get worse with time. The docs are simply more interested in not risking their licenses than in treating chronic pain,” Tammi wrote to Pain News Network in a series of emails about her husband’s death.

Depression and suicidal thoughts are common for many people living with chronic pain and illness. According to a recent survey of over a thousand pain patients, nearly half have contemplated suicide.

DOUG HALE

But the problem appears to have grown worse as physicians comply with the “voluntary” prescribing guidelines released in March by the Centers for Disease Control and Prevention, which have been adopted as law in several states. Many doctors now fear prosecution and loss of their medical licenses if they overprescribe opioids. Some have chosen not to prescribe them at all.

While federal and state authorities track the number of drug overdose deaths, no one seems to be following the number of patients who are dying by suicide or from cascading medical problems caused by untreated chronic pain. Some in the pain community call this “passive genocide.” Tammi Hale compares it to the Holocaust.

“The Nazis eliminated the sick and the weak first, right? Makes you wonder,” she says. “I realize my comments are harsh, but I believe the public needs to be aware of the dangers any one of us could be facing with this silent epidemic.”  

Doctor Insisted on Weaning

Doug Hale began facing a life with intractable chronic pain in 1999, after a surgery left him with interstitial cystitis, a painful inflammation of the bladder. According to his wife, Doug tried physical therapy, antidepressants, epidurals, nerve blocks, TENS, cognitive behavioral therapy, and several different medications before finally turning to opioids for pain relief. High doses of methadone and oxycodone for breakthrough pain were found to be effective.

But a few years ago, Doug’s primary care provider (PCP) started urging him to wean to a lower dose.

“The PCP insisted on weaning. Although Doug clearly had documented malabsorption issues, the PCP persisted on weaning. The pressure to wean was unbelievable,” says Tammi.

“It came to a head in May of 2016. The PCP gave Doug one month to wean completely from 120mg/day of methadone and 20 mg/day of oxy. We knew this was impossible.”

Tammi says Doug checked himself into a 7 day detox program, where he was weaned to 40 mg of methadone a day. The doctor agreed to prescribe that amount, but it was not enough to relieve Doug’s pain. He started taking extra doses. 

“He ran out a week early in late August. The PCP abandoned Doug, stating ‘I'm not going to risk my license for you. The methadone clinic can deal with you.’” 

But the methadone clinic refused to treat Doug because they saw him as a chronic pain patient, not as an addict. “Had he turned to street drugs they could have treated him, but because he didn't break the rules they couldn't help,” Tammi explained.

Doug tried to detox at home, which Tammi calls a “brutal” experience. On October 10th, after being turned down by other healthcare providers, Doug went to his former doctor one last time to beg for help and was refused. The doctor said again that he didn’t want to risk his license.

“Doug left the office still thrashing in pain and despondent,” Tammi recalls. “The next day, my dear, sweet thoughtful husband of 32 years; a father, son, brother, uncle, and friend, well loved by many, dragged a chair to a remote spot in our back yard. A spot we could not see from the house, the road, or by the neighbors. 

“He shot himself in the head to escape his pain. He made sure we could still live in our home and not be plagued by gruesome memories. I just wish the medical establishment had an ounce of the compassion that he did.” 

“Can’t take the chronic pain anymore. No one except my wife has helped me. The doctors are mostly puppets trying to lower expenses.”

— Doug Hale

“Can’t take the chronic pain anymore. No one except my wife has helped me,” Doug wrote in a suicide note. “The doctors are mostly puppets trying to lower expenses, and (do not accept) any responsibility. Besides people will die and doctors have seen it all. So why help me.”

Tammi says she has been comforted by an outpouring of love and support from her family, friends and community. Doug’s suicide surprised many.

“Doug did make vague references about suicide during the summer due to the desperation and pain. He was just such a tough guy, he survived so much that my reaction, and others after the fact, was no. Not Doug. He's like the bionic man. Too much of a warrior to give up,” said Tammi.

“At his memorial so many people commented on what an inspiration he was to them. To graciously bear the path of pain and his never-give-up attitude made them reevaluate their own daily issues. I guess you could say his legacy was love and to never quit.”

Tammi consulted with a medical malpractice attorney after Doug's death, who told her the chances of winning a lawsuit against the doctor were slim. The cost of legal action would have also been prohibitive, after so many years of dealing with Doug’s medical expenses.

Tammi and Doug may never get their day in court, but she is determined to share his story in the hope that patients, doctors and regulators learn from it.

“My promise to him was to share with others. He was thrown away like a piece of trash, but his life and the life of all humans is precious.  All patients deserve to be treated respectfully,” she wrote. “Hopefully some changes will come in time before the holocaust grows too much larger.”  

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?

FDA Designates CRPS Drug as ‘Breakthrough Therapy’

By Pat Anson, Editor

The U.S. Food and Drug Administration has designated an experimental drug as a potential breakthrough therapy for Complex Regional Pain Syndrome (CRPS), a chronic and disabling neurological disease for which there is no cure or treatment.

Neridronic acid was discovered by Abiogen Pharma, an Italian drug maker, and is jointly being developed with Grünenthal, a German pharmaceutical company.

The Breakthrough Therapy designation by the FDA came after the companies reported the results of a Phase II clinical trial showing a significant reduction in pain and symptoms of CRPS with neridronic acid treatment. The drug has already received fast track and orphan drug designations from the FDA.

The agency considers a new drug as a breakthrough therapy if it is intended to treat a serious condition and if preliminary clinical evidence demonstrates substantial improvement over current treatments. There are no current FDA approved treatments for CRPS, which is also known as Reflex Sympathetic Dystrophy (RSD).

"It is very encouraging to see that the FDA recognizes the urgent need for new treatments for patients with CRPS and has granted neridronic acid the status of a Breakthrough Therapy. This supports our efforts to develop an efficacious treatment option to these patients,” said Klaus-Dieter Langner, MD, Chief Scientific Officer of Grünenthal. “We are committed to working closely with the FDA to bring neridronic acid to patients with CRPS as fast as possible.”

In the Phase II study, neridronic acid or a placebo was administered intravenously to 464 patients with CRPS type 1, when the disease is in its early stages. The study ended in November.  

A previous study of 82 CRPS patients in Italy found that those who were treated with infusions of neridronic acid experienced significant and persistent reductions in pain.

Neridronic acid is currently being evaluated in a Phase III clinical trial. If successful, the drug could be the first FDA-approved treatment for CRPS, which is characterized by severe, burning pain that usually begins in the arms or legs after an injury or surgery. The pain often spreads throughout the body.

"Grünenthal is highly dedicated to improving the lives of patients with pain as well as rare diseases with limited treatment options. This is an area of high unmet medical need,” Gabriel Baertschi, CEO of the Grünenthal.

The company recently purchased Thar Pharmaceuticals, which is developing an oral form of zoledronic acid for the treatment of CRPS. That drug is also undergoing a Phase III study.

Neridronic acid is an investigational aminobisphosphonate. According to the Reflex Sympathetic Dystrophy Syndrome Association (RSDSA), bisphosphonates have been used for years overseas to treat CRPS.

“We need options and if this can help patients and encourage other medications and treatment options to come onto the market for CRPS’ers, it’s a great thing,” said Barby Ingle, who suffers from CRPS/RSD and is President of the International Pain Foundation.

“We saw with fibromyalgia and Lyrica that once it (fibromyalgia) had a medication designated it gained more awareness and acceptance in society, leading to better access to care. The same could happen with a CRPS designation for a medication, leading to greater treatments and a cure in the future.”

Pain Relievers Linked to Hearing Loss in Women

By Pat Anson, Editor

Long-term use of acetaminophen and ibuprofen raises the risk of hearing loss in older women, according to a new study published in the American Journal of Epidemiology.

Researchers at Brigham and Women’s Hospital in Boston analyzed data from over 55,000 women between the ages of 48 and 73 enrolled in the Nurses’ Health Study, a long-term study that began in 1976.

They found that about 1 in 6 women who used ibuprofen or acetaminophen for at least six years suffered some degree of hearing loss. No such link was found in the women who used regular doses of aspirin.

“Although the magnitude of higher risk of hearing loss with analgesic use was modest, given how commonly these medications are used, even a small increase in risk could have important health implications,” said senior author Gary Curhan, MD, a physician in the Channing Division of Network Medicine at Brigham and Women’s Hospital.

“Assuming causality, this would mean that approximately 16.2 percent of hearing loss occurring in these women could be due to ibuprofen or acetaminophen use.”

Curhan noted the study was limited to mostly older, white women participating in the Nurses’ Health Study and that further investigation with larger and more diverse populations would be needed to better understand the connection between hearing loss and pain reliever use.

The researchers have previously published findings that indicate high frequency use of non-steroidal anti-inflammatory drugs (NSAIDS) and acetaminophen is associated with hearing loss in men and younger women. High doses of aspirin have also been associated with hearing loss.

The new study did not look at why the medications affect hearing, but previous research suggests the pain relievers affect blood and oxygen flow to sensitive parts of the ear that may compromise hearing.

About two- thirds of women in the U.S. over the age of 60 report some degree of hearing loss.

“Hearing loss is extremely common in the United States and can have a profound impact on quality of life,” said Curhan. “Finding modifiable risk factors could help us identify ways to lower risk before hearing loss begins and slow progression in those with hearing loss.”

Many people wrongly believe that over-the-counter pain relievers are relatively safe because they are available without a prescription. But studies have linked NSAIDs and acetaminophen to cardiovascular disease, hypertension, kidney problems and liver failure.

“I worry that people think NSAIDs and acetaminophen are completely safe, and that they don’t need to think about their potential (side effects),” Curhan told Time.  “But particularly for people who are taking them for chronic pain, I try to encourage them to look at why they are having the pain, not what they can take to try to treat the pain.”

Veterans More Likely to Have Chronic Pain

By Pat Anson, Editor

Nearly one out of ten U.S. military veterans suffers from chronic severe pain, according to an extensive new survey that found the prevalence of pain higher in veterans than nonveterans, particularly in veterans who served during recent armed conflicts.

The survey by the National Institutes of Health provides the first national estimate of severe pain in both veterans and nonveterans.

The prevalence of severe pain – defined as pain that occurs "most days" or "every day" and bothers the individual "a lot" – was 9.1% for veterans and 6.4% for nonveterans.

“Our analysis showed that veterans were about 40 percent more likely to experience severe pain than nonveterans,” said Richard Nahin, PhD, lead author of the analysis.

“Younger veterans were substantially more likely to report suffering from severe pain than nonveterans, even after controlling for underlying demographic characteristics. These findings suggest that more attention should be paid to helping veterans manage the impact of severe pain and related disability on daily activities.”

The study is based on data from a survey of over 67,000 adults (6,647 veterans and 61,049 nonveterans) who responded to questions about the persistence and intensity of their pain. The vast majority of veterans were men (92%), while most of the nonveterans were women (56%). The survey did not identify any specific aspects of military service, including branch of the armed forces, years of service, or whether the veteran served in a combat role.

More veterans (65%) than nonveterans (56%) reported having some type of pain in the previous three months.  They were also more likely to have severe pain from back pain, joint pain, migraine, neck pain, sciatica and jaw pain.

Younger veterans (8%) were substantially more likely to suffer from severe pain than nonveterans (3%) of similar ages.

“These findings show that we still have much more to do to help our veterans who are suffering from pain,” said Josephine Briggs, MD, director of the National Center for Complementary and Integrative Health (NCCIH). “This new knowledge can help inform effective health care strategies for veterans of all ages. More research is needed to generate additional evidence-based options for veterans managing pain.”

Veterans Complain About VA Pain Care

The survey adds to the growing body of evidence that military veterans are more likely to suffer from physical and mental health issues, and that their problems are not being adequately addressed by the Veterans Administration, which provides health services to 6 million veterans and their families. According to a recent VA study, an average of 22 veterans commit suicide each day.

One of them was Peter Kaisen. In August, the 76-year old Navy veteran committed suicide outside a VA Medical Center in Northport, New York.  Kaisen’s widow told Newsday that her husband had chronic back pain, but VA doctors had told him there was nothing more they could do to ease his suffering.

According to a 2014 Inspector General’s study, more than half of the veterans being treated at the VA have chronic pain, as well as other conditions that contribute to it, such as depression and post-traumatic stress disorder.

In recent months, dozens of veterans have complained to Pain News Network that their treatment grew worse after the VA adopted the Centers for Disease Control and Prevention’s opioid prescribing guidelines, which discourage doctors from prescribing opioids for chronic pain.

“I am a Vietnam era veteran who has had testicular cancer, prostate cancer, hip joint cancer, and have been living with an inoperable spinal cord tumor,” wrote Tommy Garrett. “I cannot get the VA to prescribe OxyContin that civilian doctors have had me on for 17 years.”

“I received epidurals for 10 years and also I received pain medication for 6 years. The VA quit giving me epidurals and also took me off Vicodin,” said Mitch Kepner. “(Before) I was active and now I just lay around and do nothing wishing I was dead. I have no life, everything I do is a struggle. I don't want pity. I don't want compassion. I don't want (anything) from anybody. I just want Vicodin back so I can function.”

After several years of taking morphine to relieve pain from chronic arthritis, Vietnam veteran Ron Pence had his dosage cut in half by VA doctors – who want him to take Cymbalta, a non-opioid originally developed to treat anxiety. After reading about Cymbalta's side effects, Pence refused to take it.

“Why start something like that when what I was taking had no side effects for me and was working fine? I am sure the pills they are pushing will end in a lot more deaths and terrible disabilities and suffering,” wrote Pence in a PNN guest column.

“We are in one of the most advanced countries in the world medically, yet the doctors and politicians will not use that knowledge to ease pain and suffering. We have to find a solution.”

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.

Cutbacks in Opioid Prescribing Are Not Working

By Pat Anson, Editor

Where is the evidence that reduced opioid prescribing is lowering rates of addiction and preventing overdose deaths?

Opioid prescribing has been in decline for years, but overdose deaths from heroin and fentanyl are soaring around the country, particularly in the East and Midwest. The Centers for Disease Control and Prevention reported this week that 33,091 people died from opioid overdoses last year, a 16% increase from 2014.

Most of the increase was attributed to heroin and illicit fentanyl. For the first time, deaths involving those illegal opioids now outnumber those from prescription opioids.

Yet doctors remain under enormous pressure from lawmakers, regulators, hospitals, insurers, medical societies and the media to reduce their opioid prescribing. Two recent examples come from healthcare providers in Pennsylvania.

Geisinger Health System, a large healthcare provider with nearly 1,600 physicians serving over three million people in Pennsylvania, is preaching the benefits of reduced prescribing.

"Opioids are not the answer," Mellar Davis, MD, a palliative care physician at Geisinger, said in a news release. "Chronic pain rehabilitation, exercise, cognitive behavioral therapies, acupuncture, yoga or tai chi are all better options than opioids.”

PinnacleHealth Medical Group, a smaller network of more than 200 primary care providers in central Pennsylvania, released an update on the opioid reduction program it began in 2014. Opioid prescribing by PinnacleHealth physicians has fallen by 20 percent, and a spokesperson says there is some evidence the program is helping to reduce overdoses in its coverage area.

“According to our internal data, our admissions for overdoses have declined in our primary zip codes.  This data was not tracked by what type of drug (prescribed or street) that led to the overdose,” Kelly McCall, public relations manager for PinnacleHealth said in an email.

“While the medical group initiative would not be the sole reason for this decline, as PinnacleHealth is part of several community wide initiatives to curb drug abuse, it does demonstrate that the reduction initiatives haven’t caused an increase in misuse of other drugs and has been part of multiple system-wide efforts to address drug misuse.” 

With so many doctors cutting back on opioid prescribing, overdose deaths in Pennsylvania should be falling, right?

Wrong.

According to a lengthy and detailed report by the U.S. Drug Enforcement Administration, drug-related overdose deaths increased by over 23 percent in Pennsylvania last year.

Heroin was involved in over half of those deaths (55%), followed by fentanyl (27%), cocaine (24%) and the sedative Xanax (21%).

Prescription pain medications such as oxycodone (19%) and hydrocodone (6%) play a relatively minor role in Pennsylvania’s overdose epidemic.

Sadly, Pennsylvania’s heroin and fentanyl crisis has only worsened in 2016. On a single day in Philadelphia last month, nearly 50 people overdosed on a “bad batch” of heroin that was most likely mixed with illicit fentanyl.

Pennsylvania lawmakers have responded to this crisis by going after pain medication. Governor Tom Wolf signed legislation last month that reduces the number of painkillers than can be prescribed in emergency rooms and to minors, establishes mandatory education in safe prescribing for doctors, and creates more drop-off locations for unused prescription drugs.

All of that is well and good – and may prevent some deaths – but there is no evidence that it will have much of impact on the overall problem. It also serves as a diversion from the real issue, which is fentanyl and heroin.

While it is often argued that many heroin users start out with prescription opioids, the vast majority are not legitimate pain patients. They obtained the pain meds illegally, used them non-medically, and got hooked. Taking opioids away from pain patients has not stopped people from using heroin or fentanyl – and it may actually be making the problem worse by forcing some patients to turn to streets drugs for pain relief.

But the head of the Centers for Disease Control and Prevention still sees the two problems as being "intertwined."

"The epidemic of deaths involving opioids continues to worsen," said CDC Director Tom Frieden, MD. "Prescription opioid misuse and use of heroin and illicitly manufactured fentanyl are intertwined and deeply troubling problems. We need to drastically improve both the treatment of pain and the treatment of opioid use disorders."

“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,” Stefan Kertesz, MD, a primary care physician and an associate professor at the University of Alabama School of Medicine, recently told PNN. “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.”

It’s not just Pennsylvania that has gone down the wrong rabbit hole. In October, the CDC released a report complimenting Blue Cross Blue Shield for its efforts to reduce opioid prescribing in Massachusetts. The CDC said over 21 million fewer opioid doses were dispensed to Blue Cross Blue Shield members in the state from 2012 to 2015.

What happened to overdose deaths during that period? Fueled by fentanyl and heroin, opioid overdoses in Massachusetts more than doubled – which neither the CDC nor Blue Cross Blue Shield were all that eager to discuss.  The CDC told Pain News Network it will "take time" before overdoses start to decline and that “assessing what happened before and after the policy at the mortality level is inappropriate."

CDC Guidelines Causing "Passive Genocide"

The message is clearly going out to doctors around the country that they better cutback their opioid prescribing, even though reducing the supply of pain medication has had little or no impact on addiction and overdose rates. Some critics believe the CDC’s own prescribing guidelines, which discourage opioid prescribing for chronic pain, have actually caused more harm than good.

“The CDC guidelines have become an epidemic. More and more organizations and offices have signed on with them and people are being treated shamefully and unethically,” says Janice Reynolds, a retired nurse, pain sufferer and patient advocate. “These so called guidelines are a major part of the passive genocide of people living with pain. The stress related to them is also increasing the number of diseases and deaths we are seeing. I am sure if someone really looked at it, we would see more deaths from them than the so-called addiction epidemic.”

You would think medical organizations would be rising to defend pain patients from the anti-opioid hysteria, but just the opposite is happening. At a pain care summit this week in Washington DC, hosted by the physician’s group Alliance for Balanced for Pain Management, the focus was clearly on prescribing fewer opioids.

The keynote speaker at the summit was not a pain patient or even a pain doctor, but Ryan Leaf, a failed NFL quarterback who struggled for decades with painkiller addiction, and is now in recovery after serving a prison term for burglarizing homes for oxycodone and Vicodin. Hardly the poster child for responsible opioid use.

The Alliance also released a promotional video promoting the need for “multimodal analgesia,” which is described as a “personalized, multi-prong approach” to pain management that includes nerve blocks, epidurals, injections, physical therapy, acupuncture, massage and biofeedback, among other treatments.

Opioids are only mentioned in passing, with the caveat that “they are hardly the only pain treatment or the best treatment.”

Former Insys Executives Arrested for Bribing Doctors

By Pat Anson, Editor

The former CEO of Insys Therapeutics and five other former company executives have been arrested on federal charges of racketeering and bribing doctors to prescribe a potent painkiller off-label.

The arrests culminate a lengthy investigation into the Arizona drug maker, which has been accused of sordid sales practices that led to the overdose deaths of hundreds of pain patients.  

The fentanyl-based painkiller, called Subsys, has FDA approval for breakthrough cancer pain. The Insys executives allegedly bribed and gave kickbacks to doctors to prescribe the oral spray off-label for patients suffering from conditions such as joint pain and post-traumatic stress disorder.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

“Patient safety is paramount and prescriptions for these highly addictive drugs, especially fentanyl, which is among the most potent and addictive opioids, should be prescribed without the influence of corporate money,” U.S. Attorney Carmen Ortiz said in a statement. 

Former CEO Michael Babich and the other Insys executives are also charged with misleading and defrauding insurance companies that were reluctant to approve payments for Subsys when it was prescribed for non-cancer patients. The company created a special “reimbursement unit” that was dedicated to obtaining prior authorization from insurers, often by falsely claiming they were for patients with medically urgent cancer diagnoses.

“As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression,” said Harold Shaw, Special Agent in Charge of the FBI’s Boston Field Division.  “In doing so, they contributed to the growing opioid epidemic and placed profit before patient safety."

The Southern Investigative Reporting Foundation released a report last year, headlined “Murder Incorporated,”  that blamed aggressive sales practices at Insys for the overdose deaths of hundreds of pain patients.  CNBC also accused the company of “putting profits before patients as it makes millions off your pain.”

In June, federal agents arrested two Insys sales representatives for bribing doctors to prescribe Subsys. Some physicians were wined and dined at upscale restaurants in New York City, while others were taken to private tables at a strip club and given free drinks. According to the indictment, the salesmen were instructed to "expect and demand" that doctors hired by Insys to speak at promotional events prescribe "large quantities" of Subsys. The doctors obliged, prescribing over $5 million worth of Subsys in 2014, much of it billed to private insurers or Medicare.

Doctors are allowed to prescribe drugs for conditions not approved by the FDA, a practice known as off-label prescribing, but drug makers are not permitted to market or promote medications for off-label use.

According to Open Payments, a government website that tracks industry payments to doctors, Insys paid over $6 million to nearly 7,800 doctors last year for food, beverages, travel, lodging and speaker fees. The payments were 30 times more than what the company reported spending on research.

Subsys is a lucrative product for Insys and its biggest moneymaker. According to the Healthcare Bluebook, 30 spray bottles of Subsys currently cost about $5,600.

Abuse Deterrent Pain Medications Deserve Support

Barby Ingle, Columnist

It's no secret that the abuse of pain medication and illegal opioids has led to a growing public health problem across the country. The numbers are alarming and they are growing.

Also alarming is the number of people who suffer with chronic pain. According to the Institute of Medicine, one in three Americans – about 100 million people – have been affected with a condition that causes pain.

Since 2002, I have been battling Reflex Sympathetic Dystrophy (RSD), a progressive neuro-autoimmune condition that affects multiple systems in the body. The worst symptom for me is the constant burning fire pain. It feels like someone put lighter fluid in me, lit it, and I can’t put the fire out. I know firsthand how difficult the journey for pain relief can be, particularly the sidelong glances and disbelief from medical professionals.

The challenges are complex and multi-layered, and I always applaud solutions that help to balance pain management with the cost that prescription drug abuse has on society. Promising technological advancements in recent years are proving to be an important part of the battle.

Among these are so-called "abuse deterrent formulas" (ADFs) of commonly prescribed opioid pain medications that are being developed to prevent some of the deadliest forms of opioid abuse. The formulas generally make it harder to crush or liquefy pills for snorting or injecting.

These tamper deterring formulas of pain medications provide patients with the same pain relief as conventional opioids, but incorporate breakthrough technology designed to protect against tampering and abuse.

Since Purdue Pharma introduced a reformulated abuse deterrent version of OxyContin (oxycodone ER) in 2010, the “nonmedical” or recreational use of OxyContin has fallen dramatically.  

source: radars system

Several states are considering legislation in 2017 to improve patient access to these new abuse deterrent formulas of painkillers. As bills are introduced and updated, the International Pain Foundation and other pain organizations track them on our websites, put out action alerts and ask for the pain patient community to get involved by sharing their stories.

ADFs have received widespread support as part of a comprehensive effort to combat prescription drug abuse and promote appropriate pain management, including from the Office of National Drug Control Policy, the Community Anti-Drug Coalitions of America, members of Congress, and the National Association of Attorneys General — including California Attorney General Kamala Harris, who was recently elected to the U.S. Senate.

Abuse of pain medications has led to a growing public health problem nationwide. Each year approximately 4.5 million Americans use prescription pain medications for non-medical purposes, contributing to more than 14,000 overdose deaths annually.

To date, the Food and Drug Administration has approved abuse-deterrent labeling for seven drugs (OxyContin, Targiniq, Embeda, Hysingla, Morphabond, Xtampaza, and Troxyca), with two other abuse-deterrent opioids under review.

This technology is only part of the solution, but it is a solution nonetheless. Patients that have struggled with addiction or substance abuse in the past, those who live with others who are current or recovering addicts, and those who live with teens or young adults who may seek opioids for recreational use can all benefit from ADFs.

For the sake of those with legitimate, life-altering pain and for the safety of those prone to abuse these medications, I urge our lawmakers to stand up for policies that preserve and improve patient access to ADF technology.

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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