North Carolina Investigating Pain Patient Advocate

By Pat Anson, PNN Editor

Dr. Thomas Kline, a North Carolina physician who is an outspoken advocate for chronic pain patients, is under investigation by his state’s medical board, PNN has learned.

Kline voluntarily surrendered his DEA license to North Carolina Medical Board investigators on Monday, which temporarily prohibits him from prescribing opioid pain medication and other controlled substances to his patients.

The reason for the investigation has not been made public. Kline’s practice in Raleigh, NC specializes in treating patients with chronic and rare diseases, including some on relatively high doses of opioid medication. Kline has been a vocal critic of efforts to rein in opioid prescribing.

"Dr. Kline surrendered his DEA license voluntarily, at the request of the NC Medical Board. In connection with the surrender of his DEA license, Dr. Kline also provided medical records of his patients to NC Medical Board,” Kline’s office said in a statement. 

“Dr. Kline will cooperate with the Board in order to ensure the well-being of his patients. Dr. Kline cares deeply about his patients and their needs at this time. However, he can no longer provide them with opiate pain medication.” 

The state medical board would not comment on the investigation.

DR. THOMAS KLINE

“At this point there has been no public action taken, so I’m not able to confirm or deny what may have occurred with this licensee,” said Jean Brinkley, a spokeswoman for the North Carolina Medical Board. “Investigations are confidential under North Carolina law, so until there’s been an action that’s made public, we can’t discuss it.”

The medical board has no public record of any complaint or disciplinary action against Kline. “As of now, Dr. Kline has an active medical license with no specific restrictions from the board,” Brinkley told PNN.

Without his DEA license, Kline will be unable to prescribe opioids and other controlled substances until the state’s investigation is completed. A typical “quality of care” investigation by the board takes six months to a year to complete, according to Brinkley.

“The average number of days to close a case, from the date it was opened to the date it was closed, was 104 days in 2019. But I will say quality of care cases, because of the need to obtain an independent medical review, typically take longer than that,” she said.

In public hearings, news stories, social media and his own YouTube channel, Kline seeks to expose some of the myths surrounding opioid medication and the damage done to millions of patients who’ve been abruptly tapered off opioids because of fears about addiction.

“This has never been done before in the history of medicine, at least in this country, where people are forced to stop taking medicine that is effective, is working, without side effects, against their will,” Kline says in his YouTube series, Medical Myths Revealed.

“I’ve talked to people that have post traumatic stress about going to the doctor. They lie awake for 3 or 4 days before they go see the physician for fear of another reduction in their pain medicine. This is just awful.”

Many of Kline’s patients will face the same fate, If they are unable to find a new doctor willing to prescribe opioid medication.

Last year the Food and Drug Administration warned doctors not to abruptly discontinue or rapidly taper patients on opioid medication. The agency said it received reports of “serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased.” The harm includes withdrawal symptoms, uncontrolled pain, psychological distress and suicide.

In another video, Kline said he researched federal law and could not find a single reference to “overprescribing” opioids.

“Is prescribing high doses a criminal act? No. We’re doctors. We prescribe what is needed. There is no dosage limit for opiates. You can use 1,000 milligrams a day or 10 milligrams a day. It doesn’t matter as long as you’re not getting side effects,” he said.

The CDC’s controversial 2016 opioid guideline recommends no more than 90 MME (morphine milligram equivalent) a day. Although the guideline is voluntary and only intended for primary care physicians treating chronic pain, it has been implemented as law or policy in dozens of states, and by the North Carolina Medical Board.

Over 2,000 people died of opioid overdoses in North Carolina in 2018. As in other states, the vast majority of the deaths involved heroin or illicit fentanyl, not prescription opioids.

Voltaren Arthritis Gel Approved for OTC Despite Safety Risks

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved three drugs for over-the-counter (OTC) sale that were previously only available by prescription. One of them is Voltaren Arthritis Pain, a topical gel made by GlaxoSmithKline.

The active ingredient in Voltaren gel is diclofenac, a non-steroidal anti-inflammatory drug (NSAID) that’s been linked to cardiovascular disease and other serious health problems. The gel contains a 1% solution of diclofenac sodium.

Voltaren Arthritis Pain was first approved by the FDA in 2007 as a prescription drug for the temporary relief of osteoarthritis joint pain in the hands, knees and feet. When taken as directed, the agency considers the gel safe to use.

“As a result of the Rx-to-OTC switch process, many products sold over-the-counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” said Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research.

“Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

The FDA said Voltaren Arthritis Pain may take up to 7 days to work. Consumers should stop using it and seek medical attention if their arthritis pain is not improved in 7 days or if they need to use the product for more than 21 days.

The warning label cautions that diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Liver damage may also occur if the gel is used more often or longer than directed, or when used with other products containing diclofenac. The label cautions that diclofenac and other NSAIDs increase the risk of heart attack, heart failure and stroke.

Diclofenac One of Riskiest NSAIDs

Diclofenac is not well-known in the United States, but it is the most widely used NSAID in the world. Some experts consider diclofenac so risky it should be banned as an OTC drug.

A large 2018 study in Denmark found that people using diclofenac were 50 percent more likely to have cardiovascular problems, such as atrial fibrillation, heart failure and stroke.

For every 1,000 people who used diclofenac, the study estimated that four would develop a major health problem within a year.

“It is time to acknowledge the potential health risk of diclofenac and to reduce its use. Diclofenac should not be available over the counter.”

— Dr. Morten Schmidt, Aarhus University Hospital

"It is time to acknowledge the potential health risk of diclofenac and to reduce its use," wrote lead author Morten Schmidt, MD, Aarhus University Hospital. “Diclofenac should not be available over the counter, and when prescribed, should be accompanied by an appropriate front package warning about its potential risks.”

Diclofenac was rated as one of the seven riskiest NSAIDs in a 2016 study published by the British Medical Journal. Researchers estimated the risk of heart failure doubled for people taking diclofenac at very high doses.

“The selective COX 2 inhibitors and diclofenac have repeatedly been associated with higher cardiovascular risk, and therefore it seems prudent to avoid them and consider lower risk naproxen at the lowest effective dose,” researchers warned.

According to the FDA’s Adverse Events Reporting System, there have been over 19,000 serious medical cases involving diclofenac sodium since 2010, including 2,294 deaths.  

As PNN has reported, the FDA has effectively slammed the door shut on new opioid pain medications because of the controversy over opioid addiction and overdose. The agency is promoting the use of “safer” non-opioid drugs and recently approved a cocaine-based analgesic nasal spray.

Study Finds Acetaminophen Eases Social Pain

By Pat Anson, PNN Editor

Most everyone has faced rejection at some point in their lives, such as a divorce, losing a job or being “ghosted” by a friend. Being excluded from a relationship often triggers stress, anxiety, depression and sometimes even a desire for revenge.

Taking the pain reliever acetaminophen ­may not be a prescription for curing the blues, but it can ease social pain and help you forgive others, according to an unusual study published recently in the Annals of Behavioral Medicine. The study adds to a growing body of research that suggests over-the-counter pain relievers have psychological effects on humans.

Researchers in California enrolled 42 healthy young adults in a placebo-controlled trial to see if taking acetaminophen has an effect on social pain.

“Research has shown that physical pain and social pain are influenced by some of the same biological processes in the brain and body. Based on this research, we thought that acetaminophen, which is commonly used to treat physical pain, might also be able to reduce social pain,” explained senior author George Slavich, PhD, director of the UCLA Laboratory for Stress Assessment and Research.

For 20 consecutive days, a third of the study participants took 1,000mg of acetaminophen daily, while the rest took a placebo pill or no pill at all.

Participants also completed a daily questionnaire that assessed their level of social pain by asking them to think about a person who had wronged them recently. Did they I hope that person “gets what’s coming to them” for what they did?

From their answers, researchers developed a numerical “Hurt Feelings Scale” for every participant.

Over time, researchers found that acetaminophen significantly reduced hurt feelings, but only for participants who had a more forgiving attitude towards others.

“When combined with a tendency to forgive, taking acetaminophen substantially reduced how much social pain people felt over time. More specifically, participants taking acetaminophen who were high in forgiveness exhibited an 18.5% reduction in social pain,” said Slavich. “Based on the findings from our study, it appears as though acetaminophen acts synergistically with peoples' ability to forgive to alleviate the feelings of social pain that are commonly associated with rejection and exclusion.”

Slavich and his colleagues say anger and sadness are normal responses to social rejection, but can lead to long-term health consequences if they persist. However, the researchers stopped short of recommending acetaminophen as a treatment for social pain.  

“Experiencing a socially painful life event, like a relationship break-up, is one of the strongest predictors of developing depression in adolescence and adulthood. Social pain is also associated with decreased cognitive functioning and increased aggression and engagement in self-defeating behaviors, like excessive risk taking and procrastination,” Slavich said.

“Although the idea of prescribing acetaminophen to individuals undergoing difficult interpersonal situations may be attractive, we are not aware of any studies that have shown acetaminophen to be an effective prophylactic against psychiatric disorders for persons currently experiencing socially stressful circumstances.”

Similar Findings in Other Studies

A 2015 Ohio State study also found that acetaminophen seems to dampen human emotions. Student volunteers who took acetaminophen had fewer emotional highs and lows, and were less likely to react to images that normally produce an emotional response, such as pictures of a child crying or happily playing with a cat.

A second study at Ohio State found that acetaminophen can make people feel less empathy for the physical and emotional pain of others.

It’s not just acetaminophen. A review of studies at UC Santa Barbara concluded that ibuprofen and other over-the-counter pain relievers have an overlapping effect on us, both physically and emotionally.

"In many ways, the reviewed findings are alarming," wrote lead author Kyle Ratner, PhD, an assistant professor of psychology at UC Santa Barbara. "Consumers assume that when they take an over-the-counter pain medication, it will relieve their physical symptoms, but they do not anticipate broader psychological effects.”

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury, as well as heart, kidney and blood pressure problems.

Missouri Finds Managing Pain Without Opioids Isn’t Easy

By Lauren Weber, Kaiser Health News

Missouri began offering chiropractic care, acupuncture, physical therapy and cognitive-behavioral therapy for Medicaid patients in April, the latest state to try an alternative to opioids for those battling chronic pain.

Yet only about 500 of the state’s roughly 330,000 adult Medicaid users accessed the program through December, at a cost of $190,000, according to Josh Moore, the Missouri Medicaid pharmacy director. While the numbers may reflect an undercount because of lags in submitting claims, the jointly funded federal-state program known in the state as MO HealthNet is hitting just a fraction of possible patients so far.

Meanwhile, according to the state, opioids were still being doled out: 109,610 Missouri Medicaid patients of all age groups received opioid prescriptions last year.

The going has been slow, health experts said, because of a slew of barriers. Such treatments are more time-consuming and involved than simply getting a prescription.

A limited number of providers offer alternative treatment options, especially to Medicaid patients. And perhaps the biggest problem? These therapies don’t seem to work for everyone.

The slow rollout highlights the overall challenges in implementing programs aimed at righting the ship on opioid abuse in Missouri — and nationwide. To be sure, from 2012 to 2019, the number of Missouri Medicaid patients prescribed opioid drugs fell by more than a third — and the quantity of opioids dispensed by Medicaid dropped by more than half.

Still, overdoses linked to legal and illicit opioids killed an estimated 1,132 Missourians in 2018 and 46,802 Americans nationally, according to the latest data available. Progress to change that can be frustratingly slow.

“The opioids crisis we got into wasn’t born in a year,” Moore said. “To expect we’d get perfect results after a year would be incredibly optimistic.”

Despite limited data on the efficacy of alternative pain management plans, such efforts have become more accepted, especially following a summer report of pain management best practices from the U.S. Department of Health and Human Services. States such as Ohio and Oregon see them as one part of a menu of options aimed at curbing the opioid crisis.

St. Louis chiropractor Ross Mattox, an assistant professor at chiropractic school Logan University, sees both uninsured patients and those on Medicaid at the CareSTL clinic. He cheered Missouri’s decision to expand access, despite how long it took to get here.

“One of the most common things I heard from providers,” he said, “is ‘I want to send my patient to a chiropractor, but they don’t have the insurance. I don’t want to prescribe an opioid — I’d rather go a more conservative route — but that’s the only option I have.’”

And that can lead to the same tragic story: Someone gets addicted to opioids, runs out of a prescription and turns to the street before becoming another sad statistic.

“It all starts quite simply with back pain,” Mattox said.

Practical Barriers

While Missouri health care providers now have another tool besides prescribing opioids to patients with Medicaid, the multistep approaches required by alternative treatments create many more hoops than a pharmacy visit.

The physicians who recommend such treatments must support the option, and patients must agree. Then the patient must be able to find a provider who accepts Medicaid, get to the provider’s office even if far away and then undergo multiple, time-consuming therapies.

The effort and cost that go into coordinating a care plan with multiple alternative pain therapies is another barrier.

“Covering a course of cheap opioid pills is different than trying to create a multidisciplinary individualized plan that may or may not work,” said Leo Beletsky, a professor of law and health sciences at Northeastern University in Boston, noting that the scientific evidence of the efficacy of such treatments is mixed.

And then there’s the reimbursement issue for the providers. Corry Meyers, an acupuncturist in suburban St. Louis, does not accept insurance in his practice. But he said other acupuncturists in Missouri debate whether to take advantage of the new Medicaid program, concerned the payment rates to providers will be too low to be worthwhile.

“It runs the gamut, as everyone agrees that these patients need it,” Meyers stressed. But he said many acupuncturists wonder: “Am I going to be able to stay open if I take Medicaid?”

Structural Issues 

While helpful, plans like Missouri’s don’t address the structural problems at the root of the opioid crisis, Beletsky said.

“Opioid overutilization or overprescribing is not just a crisis in and of itself; it’s a symptom of broader structural problems in the U.S. health care system,” he said. “Prescribers reached for opioids in larger and larger numbers not just because they were being fooled into doing so by these pharmaceutical companies, but because they work really well for a broad variety of ailments for which we’re not doing enough in terms of prevention and treatment.”

Fixing some of the core problems leading to opioid dependence — rural health care “deserts” and the impact of manual labor and obesity on chronic pain — requires much more than a treatment alternative, Beletsky said.

And no matter how many alternatives are offered, he said, opioids will remain a crucial medicine for some patients.

Furthermore, while alternative pain management therapies may lessen opioid prescriptions, they do not address exploding methamphetamine addiction or other addiction crises leading to overdoses nationwide — even as a flood of funds pours in from the national and state level to fight these crises.

“Prescribers reached for opioids in larger and larger numbers not just because they were being fooled into doing so by these pharmaceutical companies, but because they work really well for a broad variety of ailments.”

— Dr. Leo Beletsky, Northeastern University

The Show-Me State’s refusal to expand Medicaid coverage to more people under the Affordable Care Act also hampers overall progress, said Dr. Fred Rottnek, a family and addiction doctor who sits on the St. Louis Regional Health Commission as chair of the Provider Services Advisory Board.

“The problem is we relatively cover so few people in Missouri with Medicaid,” he said. “The denominator is so small that it doesn’t affect the numbers a whole lot.”

But providers like Mattox are happy that such alternative treatments are now an option, even if they’re available only for a limited audience.

He just wishes it had been done sooner.

“A lot of it has to do with politics and the slow gears of government,” he said. “Unfortunately, it’s taken people dying — it’s taken enough of a crisis for people to open their eyes and say, ‘Maybe there’s a better way to do this.’”

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

American Agony: A New Book Exposes the War Against Pain Patients

By Pat Anson, PNN Editor

A provocative new book is shining a light on the opioid crisis in ways that may surprise you. In “American Agony: The Opioid War Against Patients in Pain,” author Helen Borel accuses government bureaucrats, law enforcement and the media of inciting opioid hysteria with a steady drumbeat of misinformation and propaganda about opioids – resulting in the needless suffering of millions of Americans and the deaths of thousands by suicide.   

“American pain patients are at risk of being underdosed, tapered without consent, and most horrible of all, cold-turkeyed. All without legal or medical protections to rescue them from the horrors of sudden withdrawal symptoms and cardiovascular and other complications leading to death arising out of this sudden disruption in their physiologic equilibrium,” Borel wrote.

“Further muddying the opioid hysteria waters are outright confabulations by the feds (HHS, CDC, DEA) who gossip about nonexistent drug abuse by patients on medically, ethically and legally prescribed opioid analgesics. And these same autocrats should feel guilty about the multitude of suicides their thoughtless actions have caused and are still causing. For shame!”

As a registered nurse, psychotherapist and medical writer, Borel was already familiar with important role of opioid medication, which she calls the “best treatment for most chronic pain.”

But her interest was piqued by reading Pain News Network and other online outlets, where she learned about the suffering and suicides of patients, the harassment and prosecution of doctors, and the disastrous impact of the 2016 CDC opioid guideline on American pain care.

“When I saw on Twitter the people talking about what was going on, I went to your website and other sites, and I saw all the information,” Borel told PNN.

“And I began to get angry that people were not being medicated. And I said to myself I’d like to bring all this information together in one place where everyone could access it.”

American Agony does just that. It’s a comprehensive examination of the opioid crisis, including a detailed look at its heroes and villains. There is no shortage of the latter, from the “haughty federal horde” that drew up the CDC guideline to the “American Nazis in full DEA regalia” who harassed doctors and lied to the press and public about opioid therapy.

Borel says the DEA should be dissolved, reorganized and rebranded as the Illicit Drug Enforcement Administration (IDEA), an agency focused solely on controlling illegal drugs    

“Until the government gets out of medical care, and out of proscribing severe limits on opioid therapy, grief will be a daily presence in pain patients lives. Others who can’t wait for common sense to infuse itself into mini-brained government officials will continue to end their lives in suicides. Now, there’s an epidemic the CDC should be working to eliminate!” she wrote.

‘Crazy Psychiatrists’

Borel holds particular disdain for the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) and its founder, Dr. Andrew Kolodny, a psychiatrist and addiction treatment specialist who has testified as a highly paid expert witness in lawsuits against opioid manufacturers.

“I think the government is stupid and they have a lot of hubris. That includes PROP, the tiny little band of crazy psychiatrists, the craziness and the haughtiness and the nonsense of PROP,” says Borel. “I think Freud would be appalled at these psychiatrists. They don’t have any feelings for patients. I don’t understand it.”

Borel dedicates chapters in her book to the “Suboxone Hoax,” “DEA Gestapo Actions” and the “Ominous Overreach of the Department of Justice.”

She also has a lengthy section on steps that pain patients can take to protect themselves, such as demanding the enforcement of HIPAA and other privacy laws, suing for negligence and medical malpractice, and refusing to pay for unnecessary medical exams and tests.     

“The more of these negligent practices that can be published, the sooner the public will stop putting up with the murdering of American pain care promulgated by the DOJ, the DEA and the VA,” she wrote. “You do not have to put up with the cold-turkeying of your opioid medication. This is flat out medical malpractice, will lead to rapidly declining health, unbearable pain, thoughts of suicide and too often suicide itself.”

American Agony is featured in PNN’s Suggested Reading section, along with other informative books on chronic pain and pain management.

Four Indicted in Compound Pain Cream Scam

By Pat Anson, PNN Editor

Greed and fraud have gone hand-in-hand in the opioid crisis, with drug and genetic test companies, pain clinics, spine surgeons, information technology vendors, addiction treatment doctors and even patient advocacy groups profiting from opioid hysteria or pushing bogus treatments.

You can add to the list pharmacies making compound pain creams.

A federal grand jury has indicted four people in Southern California for healthcare fraud, mail fraud, illegal kickbacks and money laundering as part of a scheme that defrauded two insurers into paying $22 million for medically unnecessary compound pain creams. Some of the creams cost as much as $15,000 per tube.

The fraudulent bills were sent to the U.S. military’s TRICARE health plan and the International Longshore and Warehouse Union’s Pacific Maritime Association Welfare Plan.

Prosecutors say the Orange County-based Professional Compounding Pharmacy (PCP) paid marketers about half of the payments it received from insurers as an incentive to recruit doctors and patients willing to write or accept pain cream prescriptions.

Patients were given $200 each to receive treatment at two bogus pain clinics and to participate in “sham clinical pain studies” on the effectiveness of compound creams as an alternative to opioids.

Among those arrested were James Bell, the owner of PCP and two medical marketing companies, and Dr. Michael Edwards, a Huntington Beach physician who allegedly set up the phony clinics.

Prosecutors say TRICARE was defrauded out of $19 million and the ILWU Plan lost $3 million. The scheme peaked in the first half 2015 and continued into 2016. The fraudulent billings dropped significantly in the second half of 2015, when the insurers reduced their reimbursement rates for compound creams.

This isn’t the first time compound creams have caught the attention of federal investigators.  A 2018 report from the Office of Inspector General for the Department of Health and Human Services found over 500 pharmacies had suspiciously high costs for compound creams and other topical medications billed to Medicare.

Medicare spending for topical medications has skyrocketed, rising from $13.2 million in 2010 to $323.5 million in 2016. Most were prescribed for pain, using ingredients such as lidocaine, a non-opioid anesthetic, or diclofenac, an anti-inflammatory drug.

Do compound pain creams work? A 2019 study at Walter Reed National Military Medical Center concluded the creams should not be used to treat chronic pain. One month after treatment began, researchers found no significant differences in the pain scores of patients who used compound creams and those who used placebo creams.

Study Finds Dentists Overprescribe Opioids

By Pat Anson, PNN Editor

Over half of the opioid prescriptions written by dentists in the United States exceed the 3-day supply recommended by pain management guidelines, according to a large new study that also found a stronger dose than necessary was prescribed nearly a third of the time.

The findings, published in the American Journal of Preventive Medicine, are important because dentists are responsible for about 10% of the opioids prescribed in the U.S.

“Dental procedures like extractions can leave patients with a lot of pain that needs to be managed, and many dentists are doing a wonderful job of managing their patients’ pain appropriately and responsibly,” said Jessina McGregor, a researcher in the Oregon State University College of Pharmacy. “But our findings suggest that there’s room for improvement among some dentists, improvement that could make a huge difference in our society as we try to combat the opioid crisis.”

McGregor and her colleagues reviewed insurance records from over half a million dental visits from 2011 to 2015. The study period was before the CDC released its controversial opioid guideline in 2016, so the findings may not reflect current practices in dental pain management.

Nevertheless, the study is the largest to date of dental visits in the U.S. that resulted in an opioid prescription.

Fifty-three percent of the time, patients were given more than the 3-day supply of opioids recommended by the CDC for most types of acute, short-term pain. Some dental associations recommend no more than two days’ supply – even for dental procedures associated with the severe pain.

In addition to the excess number of pills, researchers say the dose of opioids prescribed by dentists was stronger than what was medically necessary 29% of the time.

Men, young adults aged 18-34, and people living in the South were most likely to be prescribed opioids that were stronger than needed.

“One large potential area for improvement is the almost 30% percent of opioids that were prescribed following procedures where the pain intensity was expected to be mild and manageable by non-opioid analgesics like ibuprofen or acetaminophen,” said McGregor.

“Our statistical models suggest that even something as simple and straightforward as substituting a lower-potency opioid like hydrocodone for oxycodone could make an enormous reduction in overprescribing, as much as a 20% reduction.”

Researchers say prescribing guidelines tailored to dentists and oral pain are urgently needed to reduce excess prescribing . A small 2016 study of patients who had their wisdom teeth removed found that over half the opioids prescribed went unused. That suggests as many as 100 million excess pain pills are prescribed annually by dentists.

Anti-opioid activists have long claimed that young people can easily became addicted to opioids after dental surgery. But a large 2018 study found that the risk of long-term opioid use after wisdom tooth removal is relatively rare. The study of over 70,000 teens and young adults found that only 1.3% were still being prescribed opioids months after their initial prescription.

Is It Too Early to Declare Victory in the Opioid Crisis?

By Pat Anson, PNN Editor

Wisconsin’s two U.S. Attorneys are taking a victory lap on the one-year anniversary of threatening letters they sent to 180 doctors, physician assistants and nurse practitioners in the state. The letters warned the providers that if they continue to prescribe “relatively high levels” of opioid medication — above doses recommended by the CDC — they could face civil or criminal prosecution.

In a joint news release this week, Scott Blader and Matthew Krueger, U.S. Attorneys for the Western and Eastern Districts of Wisconsin, said there has been “a substantial decrease in opioid prescribing” among providers who received the warning letters.

“Thanks partly to this initiative and the consistent efforts by the Wisconsin medical community to stem over-prescribing, Wisconsin has seen substantial progress in the fight against opioid abuse,” the news release claimed. “Total opioid prescriptions in Wisconsin have declined by 30 percent between 2016 and 2019, according to data from the Wisconsin Prescription Drug Monitoring Program. The letters sent by the United States Attorneys appear to have amplified this downward trend.” 

The release did not indicate if any provider who received the warning letter had been charged with a crime or if any of their patients has been harmed by their prescribing. The two U.S. Attorneys’ offices did not respond to a request for further information.

President Trump also claimed progress was being made in the overdose crisis during his State of the Union address on Tuesday.

“We are curbing the opioid epidemic, Drug overdose deaths declined for the first time in nearly 30 years. Among the states hardest hit, Ohio is down 22 percent, Pennsylvania is down 18 percent, Wisconsin is down 10 percent — and we will not quit until we have beaten the opioid epidemic once and for all,” Trump said.

Fentanyl Deaths Increasing

A closer look at the overdose numbers shows that it’s way too early to declare victory. A CDC report last week found that drug deaths declined over 4% in 2018, led by a significant drop in overdoses involving hydrocodone, oxycodone and other painkillers. But deaths linked to illicit fentanyl and other street drugs are surging – threatening to reverse the overall trend.

“One thing that we’re seeing is that the decline doesn’t appear to be continuing in 2019. It appears rather flat, maybe actually increasing a little bit,” said Robert Anderson, PhD, Chief of the Mortality Statistics Branch, National Center for Health Statistics. “We do know that deaths due to synthetic opioids like fentanyl are continuing to increase into 2019 and we’re seeing increases similarly with cocaine and psychostimulants with abuse potential, the methamphetamine deaths."

The most recent overdose stats from Wisconsin are also revealing, as the following two charts will show. While deaths in the state involving prescription opioids began declining in October 2017 -- over a year before the U.S. Attorneys even sent their warning letters – overdoses linked to fentanyl and other synthetic opioids are rising.

SOURCE: WISCONSIN DEPARTMENT OF HEALTH SERVICES

Nearly twice as many Wisconsinites are dying from heroin and fentanyl overdoses than from prescription opioids – a fact that is omitted in the news release from the U.S. Attorneys.

The only mention of fentanyl was the kind available by prescription. Prosecutors took credit for a Wausau physician being sentenced to three months in prison for writing “fraudulent fentanyl prescriptions” to six patients.  

A better representation of what’s happening in Wisconsin – and around the nation – is last month’s arrests of over three dozen people accused of trafficking illicit fentanyl, heroin and cocaine in Milwaukee. The drugs were allegedly shipped from Puerto Rico and Mexico, meaning drug cartels thousands of miles away recognize that there’s a demand for street drugs in Wisconsin’s largest city.

In 2019, 370 people died of drug overdoses in Milwaukee County. It was iIlicit fentanyl — not prescription opioids — that was the leading cause of death.

That doesn’t deserve a victory lap.

DEA: Fentanyl 'Primary Driver' of Overdose Crisis

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has released the 2019 National Drug Threat Assessment, a comprehensive report that outlines the threats posed to the nation by drug traffickers and the abuse of illicit drugs.

Not surprisingly, the annual report found that illicit fentanyl is the “primary driver” behind the overdose crisis, with fentanyl and its analogs involved in more overdose deaths than any other illicit drug. Fentanyl is a synthethic opioid 50 to 100 times more potent than morphine. The drug is prescribed legally to treat severe pain, but illicit versions of fentanyl have flooded the black market.

Of growing concern to the DEA is the appearance of illegal pill press operations in the U.S. that are manufacturing millions of counterfeit painkillers and other medications, using fentanyl powder smuggled in from China and Mexico.

“Fentanyl will remain a serious threat to the United States as record numbers of individuals suffer fatal overdoses from illicit fentanyl sourced to foreign clandestine production,” the report warns.

“Clandestine fentanyl pill pressing operations will likely increase as DTOs (drug trafficking organizations) seek to appeal to the large pill abuser population in the United States, with counterfeit fentanyl-containing pills continuing to be associated with clusters of overdoses and deaths due to inconsistent mixing and often unexpectedly high potency.”

With China cracking down on illicit fentanyl laboratories, the DEA expects the primary source of fentanyl production to shift to Mexico and India.  

Fewest Prescription Opioids Since 2006

One bright spot in the DEA report is the continuing decline in overdoses involving prescription opioids. As PNN reported, overdose deaths involving natural and semisynthetic opioids, which include painkillers such as oxycodone and hydrocodone, were 3.8% lower in 2018 than in 2017.   

The DEA said the supply of prescription opioids is now at its lowest level since 2006. DEA production quotas for hydrocodone and oxycodone have been cut nearly in half since 2016, with further cuts proposed for 2020.

But while the retail supply of opioid medication has fallen dramatically, the diversion of opioids and other controlled drugs by medical professionals and wholesale distributors – so-called “lost in transit” diversion – has soared. There were 18,604 lost in transit reports filed in 2018, nearly six times the number reported in 2010.

“It is unclear if these dosage units are being diverted, destroyed, or truly lost. Although representative of only a small number of DEA registrants, diversion by physicians, nurses, and other medical professionals and their staff remains a threat to communities across the United States,” the report warns.

The DEA predicts “a steady decrease” in the supply of opioids over the next several years and that prescription drug abusers “may shift to abusing heroin, illicitly produced synthetic opioids, and methamphetamine to obtain similar effects, which may further increase overdose deaths through at least 2020.”

The DEA said the threat posed by psychostimulants such as methamphetamine and cocaine is “worsening and becoming more widespread.” While most cocaine users prefer to snort or inject the drugs, law enforcement agencies are starting to find cocaine in tablet or pill form.

“Whether these instances are harbingers of a new trend, an experiment, or simply the result of accidental contamination within poly-drug operations remains to be seen. Tableting and capsulizing cocaine may allow traffickers to capitalize on the considerably larger CPD user market with a different version of cocaine, further maximizing profits,” the DEA said.

Finally, while the DEA officially considers the herbal supplement kratom a “drug of concern” and once tried to ban it, there is once again no mention of kratom in its annual drug threat assessment.

Drug Overdose Deaths Fell 4% in 2018

By Pat Anson, PNN Editor

Drug overdose deaths in the United States dropped in 2018 for the first time in nearly three decades, according to a new CDC report that highlights the rapidly changing nature of the overdose crisis. While deaths linked to many prescription opioids declined, overdoses involving illicit fentanyl, cocaine and psychostimulants rose.

There were 67,367 drug overdose deaths in the U.S. in 2018, a 4.1% decline from 2017 when there were 70,237 fatal overdoses.

The rate of overdose deaths involving natural and semisynthetic opioids, which includes painkillers such as oxycodone and hydrocodone, was 3.8% lower. There were nearly 2,000 fewer deaths linked to painkillers in 2018 than there was the year before.

However, the decline in deaths involving opioid medication was more than offset by a continuing spike in overdoses linked to synthetic opioids other than methadone, which primarily involves illicit fentanyl and fentanyl analogs. The death rate in that category rose 9% from 2017 to 2018.

SOURCE: CDC

While the overall trend is encouraging, a top CDC official was cautious about preliminary data for drug deaths in 2019.

“One thing that we’re seeing is that the decline doesn’t appear to be continuing in 2019. It appears rather flat, maybe actually increasing a little bit,” said Robert Anderson, PhD, Chief of the Mortality Statistics Branch, National Center for Health Statistics.

“We do know that deaths due to synthetic opioids like fentanyl are continuing to increase into 2019 and we’re seeing increases similarly with cocaine and psychostimulants with abuse potential, the methamphetamine deaths."

Overdose deaths often involve multiple drugs, so a single death might be included in more than one category and be counted multiple times. A death that involved both fentanyl and cocaine, for example, would be classified by CDC researchers as an overdose involving both synthetic opioids and cocaine.

“There’s a lot of overlap between these categories and so a death may be actually counted in multiple categories, in two or more in many instances, making it difficult to partition the decline,” said Anderson. “We really don’t have a good handle on how best to do that.”  

Opioid Prescriptions Decline Significantly

A second CDC study on opioid prescribing shows that prescriptions have declined significantly in 11 states with prescription drug monitoring programs (PDMPs) that participate in the Prescription Behavior Surveillance System (PBSS). The 11 states include California, Ohio, Texas and Florida, and represent over a third of the U.S. population.

The decline in opioid prescriptions in the states ranged from 14.9% to 33% from 2010 to 2016, indicating that prescriptions were falling long before the CDC released its controversial opioid guideline in March, 2016. Significant declines were also noted in high dose opioid prescriptions, the average daily dose and in prescriptions obtained from multiple providers.

Despite the nearly decade-long decline in prescriptions, CDC researchers continue to blame opioid medication for the ongoing overdose crisis, offering little evidence to support that view.

“PDMP data collected by PBSS indicate that steady progress is being made in reducing the use and possible misuse of prescription-controlled substances in the United States. However, some persons who were misusing prescription opioids might have transitioned to heroin or illicitly manufactured fentanyl, a change that has made the drug overdose epidemic and associated overdose rates more complex,” researchers said.

“Because the opioid overdose epidemic began with increased deaths and treatment admissions related to opioid analgesics in the late 1990s, initiatives to address overprescribing might eventually result in fewer persons misusing either prescription or illicit drugs. Reduction in overprescribing opioids might lead ultimately to a decrease in overall overdose deaths.”

PDMP data for the CDC study came from the PBSS monitoring program at Brandeis University, where Dr. Andrew Kolodny is Co-Director of the Opioid Policy Research Collaborative. Kolodny is the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an activist group that has long been critical of opioid prescribing.

Healthcare Technology Vendor Took Kickbacks to Promote Rx Opioids

By Pat Anson, PNN Editor

A decade ago, electronic health records (EHRs) were touted as a major innovation that would allow doctors to maintain a digital record of their patients’ medical history, diagnoses, prescriptions and insurance claims. A 2009 federal law encouraged doctors and hospitals to adopt EHRs with over $19 billion in funding to upgrade their information technology.

It didn’t take long for someone to game the system and use EHRs to commit fraud on a massive scale.

Practice Fusion, a San Francisco health information technology developer, agreed this week to pay $145 million to resolve criminal and civil allegations that it took kickbacks from drug companies to promote their products to physicians using its EHR software.

Federal prosecutors didn’t release the names of the drug companies, but according to Reuters, Practice Fusion solicited and received $1 million in kickbacks from OxyContin maker Purdue Pharma.

In return, Practice Fusion created an EHR alert advising physicians to switch new pain patients from immediate-released opioids to extended release opioids like OxyContin. From 2016 to 2019, the alert was triggered 230 million times, according to prosecutors.

“Practice Fusion’s conduct is abhorrent.  During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids,” Christina Nolan, U.S. Attorney for the District of Vermont, said in a statement. 

“The companies illegally conspired to allow the drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care, including the need for pain medication and prescription amounts.”

Prosecutors say Practice Fusion took kickbacks from more than a dozen pharmaceutical companies, allowing them to design the phony alerts and determine when a healthcare provider received them. “Numerous prescriptions” were written as a result. The federal case is the first criminal action against a vendor of electronic health records.

“Across the country, physicians rely on electronic health records software to provide vital patient data and unbiased medical information during critical encounters with patients,” said Ethan Davis, Principal Deputy Assistant Attorney General.

“Kickbacks from drug companies to software vendors that are designed to improperly influence the physician-patient relationship are unacceptable.  When a software vendor claims to be providing unbiased medical information – especially information relating to the prescription of opioids – we expect honesty and candor to the physicians making treatment decisions based on that information.”

Practice Fusion offers free EHR software to smaller, independent physician practices. The software is used by 112,000 health care providers who see 5 million patient visits each month. Practice Fusion was purchased in 2018 by Chicago-based Allscripts for $100 million in cash.

“Since learning of this matter we have further strengthened Practice Fusion’s compliance program. Allscripts recognizes the devastating impact that opioids have had on communities nationwide, and we are using our technology to fight this epidemic,” an Allscripts spokesman said.

Arizona Drug Bust Shows Fentanyl Crisis Growing

By Pat Anson, PNN Editor

In one of the largest fentanyl busts in state history, nearly 170,000 counterfeit pills made with illicit fentanyl have been seized in Phoenix, Arizona. A DEA task force and Phoenix police seized the pills during a traffic stop on January 22, arresting two suspects who were under surveillance.

The blue pills were stamped with an “M” and a “30” – distinctive markings for 30mg fake oxycodone tablets known on the street as “Mexican Oxy” or “M30.” The total street value of the drugs was estimated at $3 million.

"These 169,000 pills, it can have a varying amount of fentanyl. They have no quality control, and what makes them that much more deadly is they look like legitimate oxycodone pills. They don't contain an active ingredient. It is just fentanyl with other ingredients," said DEA Spokesperson Erica Curry. 

"We are talking about a very deadly substance in such small quantities it can be lethal to anyone who doesn't have an opioid tolerance built up."

DEA PHOTO

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. Counterfeit pills laced with illicit fentanyl have been appearing around the country and are linked to thousands of overdose deaths. In 2019, law enforcement agencies seized over 1.4 million fentanyl pills in Arizona alone.

According to a recent DEA analysis, about one in every four counterfeit pills have a potentially lethal dose of fentanyl.

Street Drug Users Aware of Fentanyl

Who would be foolish or desperate enough to take a street drug that might kill them? Do overdose victims even know the fake pills they’re buying contain fentanyl?

The answer in many cases is yes, according to a new study of street drug users in Vancouver, British Columbia – the first major North American city to see an influx of illicit fentanyl.  

The study drew on data collected from over 300 people recruited at drug treatment sites in 2018. The participants completed a brief survey on their drug use and provided a urine sample that researchers tested for fentanyl and other substances.

About 60 percent of those tested had fentanyl detected in their urine. Of those, nearly two-thirds (64%) knew they had taken fentanyl.

"This research shows the majority of people who use fentanyl know they're doing so," says Dr. Jane Buxton, an epidemiologist and professor at the University of British Columbia, who is corresponding author of the study published in the International Journal of Drug Policy.

"Making people who use drugs aware of the presence of fentanyl in the drug supply isn't enough; we need harm reduction services, substance use treatment, overdose prevention resources, and pharmaceutical alternatives to the toxic drug supply to reduce the devastating impact of fentanyl and its analogues on our communities."

The fentanyl crisis in British Columbia is growing worse by the year.  A similar study in 2015 found only 29% of participants tested positive for fentanyl, with only 27% aware that they'd used it.

When fentanyl first appeared in the illicit drug supply, many users took fentanyl unknowingly because dealers secretly added it to heroin, counterfeit pills and other street drugs. It’s no secret today. According to preliminary data from the BC Coroner, fentanyl or its analogues were found in 85 percent of fatal overdoses in 2019.

Researchers do not fully understand the reasons people knowingly take fentanyl. Some users are aware it is present in the illicit supply of opioids and have no other choice, while others may prefer the experience of taking fentanyl.

"This research lays groundwork that will help us learn more about why fentanyl use is increasing," said lead author Mohammad Karamouzian, a PhD student at UBC's School of Population and Public Health. "These findings will also contribute to more effective messaging campaigns and harm reduction strategies to help reduce preventable deaths and support the health of people who use substances, their families, and their communities."

Another key finding of the study was that people who used fentanyl were more likely to have also recently used heroin or crystal meth.  Those who used cannabis were less likely to use fentanyl.

Surgery Patients Given Tylenol for Post-Operative Pain

By Pat Anson, PNN Editor

Another hospital is touting the benefits of not giving opioid analgesics to patients after minimally invasive surgeries.

Surgeons at Houston Methodist Hospital say they were able to significantly reduce opioid prescriptions given to patients recovering from hernia repair, reflux surgery and other minimally invasive GI-related procedures by treating them with acetaminophen (Tylenol) for post-operative pain.

In a study involving over 400 surgery patients reported in the Journal of Thoracic and Cardiovascular Surgery, Houston Methodist surgeons compared patients treated with acetaminophen to a control group of patients given opioids.

Patients who were treated with acetaminophen had fewer post-operative complications (3%) than those given hydrocodone or tramadol (15%).  They were also significantly less likely to be discharged from the hospital with an opioid prescription than patients in the control group (10% vs. 87%).  

"Just a decade ago we routinely prescribed narcotics to treat pain at home after surgery," said lead author Min Kim, MD, head of the division of thoracic surgery at Houston Methodist Hospital. "We wanted to determine if we could manage pain at home after surgery with over-the-counter pain medication. We developed and implemented the pre-emptive pain control program, which led to excellent pain control at home without requiring prescription narcotics."

Patients in the pre-emptive pain management group received long-acting local anesthetics at each incision. They were also given scheduled doses of acetaminophen or naproxen in the hospital and at home.

"This study provides us with a strategy to successfully manage pain after surgery using over-the-counter pain medication. This led to fewer narcotic prescriptions which proactively decreases the chance of patients becoming addicted to narcotics," Kim said.

Opioid Addiction Rare After Surgery

Few patients actually become addicted after surgery. A 2016 Canadian study, for example, found that long term opioid use after surgery is rare, with less than one percent of older adults still taking opioids a year after major elective surgery.

Another large study in the British Medical Journal found only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or experienced a non-fatal overdose.

Nevertheless, many hospitals have reduced their use of opioids or stopped giving them to patients altogether.

A statewide effort in Michigan reduced the number of opioid pills given to patients after common operations from an average of 26 pills per patient to 18. The surgeries included minor hernia repair, appendix and gallbladder removal, and hysterectomies. Most were minimally invasive laparoscopic surgeries.

In Ohio, patients at Akron General Hospital are getting acetaminophen, gabapentin and non-steroidal anti-inflammatory drugs (NSAIDs) to manage their pain after elective colorectal operations. Surgeons say over 75 percent of them are sent home without an opioid prescription.

And in Vermont, a 2017 state law requires doctors to use non-opioid pain relievers as first-line treatments for post-operative plan. If they are prescribed opioids, patients are initially limited to no more than 10 pills.

Houston Methodist Hospital is expanding its pre-emptive pain management program to include patients recovering from pulmonary surgery.

Production of Two Excedrin Brands Halted

By Pat Anson, PNN Editor

Spot shortages of Excedrin are being reported after a pharmaceutical company halted production of two leading brands of the pain reliever due to “inconsistencies” in their ingredients.

GlaxoSmithKline (GSK) says consumers are not at risk, but as a precaution it has indefinitely suspended all production and distribution of Excedrin Extra Strength and Excedrin Migraine.

“Through routine quality control and assurance measures, we discovered inconsistencies in how we transfer and weigh ingredients for Excedrin Extra Strength Caplets and Geltabs and Excedrin Migraine Caplets and Geltabs,” GlaxoSmithKline said in a statement.

“Based on the available data, GSK believes that the product does not pose a safety risk to consumers. However, as a precautionary measure, GSK Consumer Healthcare has voluntarily implemented a discontinuation of production and distribution.”

Some drug stores in upstate New York have already run out of Excedrin Extra Strength and Excedrin Migraine. GSK said other Excedrin products are still available and urged consumers to ask their pharmacist for advice on alternative pain relievers.

“We are working hard to resolve the issue as quickly as possible, but at this point in time cannot confirm a definite date as to when supply will resume,” the company said.

In 2012, an Excedrin manufacturing plant in Lincoln, Nebraska was shut down for several months after Excedrin bottles were found to contain broken tablets and stray tablets for other medications. That led to a recall and shortages of Excedrin products around the world.

At the time, the Excedrin brand was owned by Novartis. An FDA investigation found that Novartis failed to adequately investigate hundreds of consumer complaints of foreign products found in over-the-counter drugs produced at the Nebraska plant. Novartis spent millions of dollars re-tooling the plant and shifted some production to third-party manufacturers.

GSK now holds majority ownership of Excedrin through a joint venture with Novartis. GSK did not say where the new production problems originated.

FDA Approves Cocaine Nasal Spray

By Pat Anson, PNN Editor

FDA advisory committees have taken a dim view of opioid medications recently, soundly rejecting new drug applications for the “opioid of the future” oxycodegol and a new extended-release version of oxycodone.

There was also a split 13-13 vote on a relatively mild opioid painkiller – a combination of tramadol and the anti-inflammatory drug Celebrex..

Advisory committee recommendations are not binding on the FDA, but the votes reflect a growing reluctance to approve any new medication that may worsen the so-called opioid epidemic.

"We can't approve a drug in the midst of a public health crisis," said advisory committee member Steve Meisel, PharmD, who voted no on oxycodegol.

FDA advisors may be rejecting opioids out of hand, but cocaine is a different story. The agency this month quietly approved a nasal solution containing cocaine hydrochloride (HCI) for use as a local anesthetic. The nasal spray, made by the Lannet Company, is intended to relieve pain in mucous membranes during surgeries and procedures in the nasal cavities of adults.

"The FDA's approval of our Cocaine HCl product, the first NDA approval to include full clinical trials in the company's history, marks a major milestone in Lannett's 70+ years of operations," said Tim Crew, chief executive officer of Lannett in a news release.

"We believe the product has the potential to be an excellent option for the labeled indication. We expect to launch the product shortly, under the brand name Numbrino."

Numb-rino. Get it?

While cocaine is well-known as a drug of abuse, it is classified by the DEA as a Schedule II controlled substance, alongside hydrocodone and oxycodone. Cocaine’s use in medicine is not unheard of. It was commonly used as an alternative to morphine in the last half of the 19th Century until it fell out favor because of high rates of addiction.

Numbrino is not the first nasal spray containing cocaine to be approved by the FDA. In 2017, the agency approved the nasal solution Goprelto, which is also intended for use during surgeries and procedures in nasal cavities. 

Nevertheless, the FDA’s approval of a drug containing cocaine was so unusual that Snopes conducted a fact check to see if it was true. An FDA spokesperson confirmed to Snopes that Numbrino was approved, along with warning labels and other safeguards to discourage its abuse.

“Cocaine hydrochloride nasal solution contains cocaine, a Schedule II substance with a high potential for abuse. However, when used according to the directions provided in the labeling, physical dependence and withdrawal symptoms are unlikely to develop because this drug is for single use during diagnostic procedures and surgeries,” the FDA said.

“To minimize these risks, the labeling suggests that health care facilities using the drug implement effective accounting procedures, in addition to routine procedures for handling controlled substances. Notably, this will be used as an anesthetic by trained health care professionals during diagnostic procedures and surgeries, not by patients directly. It is not available by prescription.”

Numbrino was approved without any of the controversy that surrounds opioid painkillers. In 2018, the FDA’s approval of Dsuvia — a single use opioid intended for severely wounded soldiers and trauma patients — was panned by critics, who called the drug a “dangerously unnecessary opioid medication." Like Numbrino, Dsuvia is not available by prescription and can only be administered by a healthcare professional.