Why Heroin Overdoses Are Worse Than We Thought

By Pat Anson, Editor

The number of Americans who died from opioid overdoses – particularly from heroin – is significantly higher than previously reported, according to a new study published in the American Journal of Preventive Medicine.

Researchers at the University of Virginia refined the overdose data from 2014 death certificates and estimated that overdose death rates nationally were 24 percent higher for opioids and 22 percent higher for heroin. Deaths involving heroin were substantially underreported in Pennsylvania, Indiana, New Jersey, Louisiana, and Alabama.

A major weakness of the study is that it does not differentiate between opioid pain medication that was prescribed legally, and prescription opioids or illegal opioids that were obtained illicitly. All “opioids” are lumped together in one category.

Virtually every study about drug overdoses is flawed in some way, because each state has different rules and procedures for death certificates. The expertise of county coroners and medical examiners can also vary widely.

There were over 47,000 fatal overdoses nationwide among U.S. residents in 2014. However, about one-quarter of the death certificates failed to note the specific drug involved in an overdose.

“A crucial step to developing policy to combat the fatal drug epidemic is to have a clear understanding of geographic differences in heroin and opioid-related mortality rates. The information obtained directly from death certificates understates these rates because the drugs involved in the deaths are often not specified," said lead author Christopher Ruhm, PhD, Frank Batten School of Leadership and Public Policy, University of Virginia, Charlottesville.

Ruhm and his colleagues developed a more refined database that supplemented the death certificate data with additional geographic information from states and counties. The supplemental data had a substantial influence on state mortality rankings.   

For example, the opioid and heroin death rates in Pennsylvania, based solely on death certificates, were 8.5 and 3.9 deaths per 100,000 people, respectively. The corrected data doubled the death rates in Pennsylvania to 17.8 for opioids and 8.1 and for heroin.

“Geographic disparities in drug poisoning deaths are substantial and a correct assessment of them is almost certainly a prerequisite for designing policies to address the fatal drug epidemic,” said Ruhm.

The Centers for Disease Control and Prevention has also tried to refine the data from death certificates to make it more reliable.  A CDC study released last December used new software to scan the actual text of death certificates, including notes left by coroners. That study found that heroin, cocaine, fentanyl and anti-anxiety medication (benzodiazepines) were responsible for more overdose deaths in the United States than opioid pain medication.

A more reliable way to determine the cause of an overdose is through toxicology reports, which some states are now utilizing to better assess their drug problems. Pennsylvania recently found that fentanyl was involved in over half of its overdoses, followed by heroin, cocaine and anti-anxiety medications such as Xanax and Valium.  Opioid pain medication was ranked as the fifth most deadly drug. Toxicology reports have also determined that fentanyl is involved in over half the drug overdoses in Massachusetts.

Lessons About the Opioid Crisis from ‘Unbroken Brain’

By Roger Chriss, Columnist

The book “Unbroken Brain: A Revolutionary New Way of Understanding Addiction” by Maia Szalavitz offers invaluable insights about addiction. Her key point is that addiction should be seen as a learning disorder -- not a moral failing or brain disease.

Szalavitz says addiction treatment and drug policy should meet addicts where they are and deal with their reality, instead of using the moralistic or legalistic framework commonly seen in the opioid crisis.

Throughout the book, Szalavitz shares her own experiences with drug use in a way that does not mythologize addiction or recovery. Instead, her personal history highlights that there is no such thing as a typical addict and that addiction is not simply a moral failing or choice.

Szalavitz explains that addiction results from a complex combination of a person’s genetic makeup, early life experiences, and socio-cultural situation. Specifically, she states that: "There are three critical elements to it; the behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive.”

She likens addiction to dysfunctional self-medication, an effort to self-soothe and regulate internal states that have gone horribly wrong. This means that addiction is not about a substance, but about a person.

“Drugs alone do not ‘hijack the brain.’ Instead, what matters is what people learn -- both before and after trying them,” Szalavitz writes. “Addiction is, first and foremost, a relationship between a person and a substance, not an inevitable pharmacological reaction.”

Further, she states that “by itself, nothing is addictive; drugs can only be addictive in the context of set, setting, dose, dosing pattern, and numerous other personal, biological, and cultural variables.”

And there are several major risk factors for addiction, including severe early childhood trauma or abuse, existing mental illness, and serious life challenges. Particular emphasis is given to a history of abuse.

“In fact, one third to one half of heroin injectors have experienced sexual abuse, with the usual abuse rates for women who inject roughly double those for men. And in 50% of these sexual abuse cases, the offense was not just a single incident but an ongoing series of attacks, typically conducted by a relative or family friend who should have been a source of support, not stress,” wrote Szalavitz.

She also states that addiction is not just about euphoria: “Research now suggests that there are at least two distinct varieties of pleasure, which are chemically and psychologically quite different in terms of those effects on motivation. These types were originally characterized by psychiatrist Donald Klein as the ‘pleasure of the hunt’ and the ‘pleasure of the feast’.”

This means that addiction is about far more than just dopamine levels: “If dopamine is what creates the sense of pleasure, animals shouldn’t be able to enjoy food without it. Yet they do.”

Lower Risk of Addiction to Opioid Medication

On the subject of opioid medication, Szalavitz notes that about one in seven people do not tolerate opioids well enough to take them repeatedly and therefore have essentially no risk of opioid use disorder. Because of this and the importance of “set and setting” to addiction, she explains, “medical use of drugs carries a far lower risk of addiction than recreational use does.”

Because addiction involves a person in a particular sociocultural situation, she writes that “People with decent jobs, strong relationships, and good mental health rarely give that all up for intoxicating drugs; instead, drugs are powerful primarily when the rest of your life is broken.”

Approaches to addiction treatment that don't recognize the above are unlikely to succeed. Detox regimens, short-term medication therapy, and abstinence-only programs like Alcoholics Anonymous are generally inadequate. For instance, Szalavitz found a 2006 Cochrane Review that summarized the data plainly: “No experimental studies unequivocally demonstrated the effectiveness of AA.”

Instead, Szalavitz emphasizes the value of harm reduction, a process whose aim is to "meet the addicts where they are" and support them unconditionally, even if this means clean needle exchanges and safe injection sites.

“Don’t focus on whether getting high is morally or socially acceptable; recognize that people always have and probably always will take drugs and this doesn’t make them irrational or subhuman,” she wrote.

But American policy toward illegal drugs and attitudes toward medications with psychotropic effects are grounded in a moralistic view. “More generally, in the West, unearned pleasure has been labeled as sinful—the opposite of valued,” Szalavitz writes, explaining why any medication that helps a person feel good, or just not feel as bad, is viewed negatively. This has led to all manner of misguided policy in the War on Drugs.

“One of the sad ironies of our current drug policy is that the same treatment providers who have been cheerleaders for the war on drugs and who advocate the ongoing criminalization of drug use also claim to want to destigmatize ‘the disease of addiction’,” she wrote.

“This approach is doomed to failure because “punishment cannot solve a problem defined by its resistance to punishment.” Moreover, it is cruelly counterproductive because “the uniquely moral nature of the way we treat addicts as both sick and criminal also reinforces stigma.” By contrast, understanding addiction as a learning disorder leads to harm reduction as the core of a more effective approach to treatment.

“Unbroken Brain” is not pedantic or moralistic. Indeed, Szalavitz says that part of the reason U.S. policy toward drug addiction has failed is that it is pedantic and moralistic. But she also says that people who now say that addiction is a "brain disease" are missing the point too. "Drug exposure alone doesn't cause addiction," she says in the conclusion of the book.

A person's situation and circumstances matter a lot in drug use and addiction. And treatment requires recognizing that even the most addicted person can still learn and make positive changes in their life when given the chance.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Fed Prosecutors to Target Doctors and Pharmacists

By Pat Anson, Editor

Attorney General Jeff Sessions has announced the formation of a special prosecution unit in the U.S. Justice Department to target opioid fraud and abuse.

The 12-member unit will not focus on the flourishing underground trade in heroin and illicit fentanyl, but will instead use healthcare data to identify doctors and pharmacies that prescribe or dispense large amounts of opioid pain medication, and prosecute those suspected of fraud or diversion.

“I have created this unit to focus specifically on opioid-related health care fraud using data to identify and prosecute individuals that are contributing to this opioid epidemic,” Sessions said in a speech at the Columbus Police Academy in Ohio.

“This sort of data analytics team can tell us important information about prescription opioids -- like which physicians are writing opioid prescriptions at a rate that far exceeds their peers; how many of a doctor's patients died within 60 days of an opioid prescription; the average age of the patients receiving these prescriptions; pharmacies that are dispensing disproportionately large amounts of opioids; and regional hot spots for opioid issues.”

For the next three years, Sessions said 12 experienced prosecutors will focus solely on investigating and prosecuting health care fraud related to prescription opioids, including pill mills and pharmacies that divert or dispense prescription opioids for illegitimate purposes.

The Opioid Fraud and Abuse Detection Unit will concentrate on 12 federal court districts around the country:

1. Middle District of Florida
2. Eastern District of Michigan
3. Northern District of Alabama
4. Eastern District of Tennessee
5. District of Nevada
6. Eastern District of Kentucky
7. District of Maryland
8. Western District of Pennsylvania
9. Southern District of Ohio
10. Eastern District of California
11. Middle District of North Carolina
12. Southern District of West Virginia

The Attorney General said preliminary data shows that nearly 60,000 Americans lost their lives to drug overdoses last year, but only in passing did he note that many of those deaths were caused by heroin and illicit fentanyl. In some states, such as Ohio, Pennsylvania and Massachusetts, more overdoses are linked to illicit fentanyl than any other drug. The CDC estimated that about one in four overdose deaths in 2015 involved prescription opioids.

Sessions said in recent years some government officials – who he did not identify -- have sent “mixed messages” about the harmful effects of drugs.

“We must not capitulate intellectually or morally to drug use. We must create a culture that is hostile to drug abuse. We know this can work. It has worked in the past for drugs, but also for cigarettes and seat belts. A campaign was mounted, it took time, and it was effective. We need to send such a clear message now,” Sessions said. “I issue a plea to all physicians, dentists, pharmacists: slow down. First do no harm.”

Last month the Justice Department announced the largest health care fraud takedown in history, resulting in the arrests of over 400 people around the country. Over 50 of the defendants were doctors charged with opioid-related crimes.

The department also announced the seizure and take down of AlphaBay – a large “dark net” website that hosted over 200,000 listings for synthetic opioids and other illegal drugs.

Sessions has long been a critic of marijuana legalization, but did not mention it in his Columbus speech. In May, he wrote a letter to congressional leaders asking them not to renew a federal law that prevents the Justice Department from interfering with state medical marijuana laws.

Pfizer Agrees to Support CDC Opioid Guideline

By Pat Anson, Editor

Since its release in March 2016, the CDC’s opioid prescribing guideline has had a chilling effect on chronic pain patients, as doctors, regulators, states and insurance companies have adopted the CDC’s "voluntary" recommendations as policies or even law.

As a result, it has become harder for many pain patients to get opioids prescribed or even find a doctor willing to treat them. We have tried to keep you informed and aware of these facts.

Now one of the world’s largest drug makers has agreed to not make any statements that conflict with the CDC guideline and to withdraw support for any organizations that challenge it. Pain News Network is among them.

In an agreement signed last month with the Santa Clara County, California Counsel’s Office, Pfizer promised to abide by strict standards in its marketing of opioids and to “not make or disseminate claims that are contrary to the ‘Recommendations’ of the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain.”

That voluntary guideline discourages primary care physicians from prescribing opioids for chronic pain, but has been widely implemented by many doctors, regardless of specialty.

Pfizer also agreed to stop funding patient advocacy groups, healthcare organizations or any charities that make “misleading statements” about opioids that are contrary to the CDC guidelines. Pfizer notified Pain News Network by email today that it was rescinding a $10,000 charitable grant awarded to PNN. Pfizer had sponsored PNN’s newsletter for the past year.  

"Kindly note Pfizer recently entered into an agreement with Santa Clara County, California that places limits on Pfizer’s ability to provide opioids-related funding to outside organizations.  After careful consideration, we regret to inform you that we are unable to support your request and must rescind the previous approval notification," the email said.

“This agreement is an important step in ensuring that doctors and patients in California receive accurate information about the risks and benefits of these highly addictive painkillers,” Santa Clara County Counsel James Williams said in a press release. “Such information is essential to curbing — and ultimately ending — the opioid epidemic plaguing Santa Clara County, the State of California, and many parts of the country.”

Santa Clara County was not pursuing any legal action against Pfizer, although it had filed a lawsuit against Purdue Pharma and four other opioid manufacturers, alleging that they falsely downplayed the risks of opioid painkillers and exaggerated their benefits.

“We applaud Pfizer’s willingness to work with us to combat the dramatic rise in opioid misuse, abuse, and addiction in California and the corresponding rise in overdose deaths, hospitalizations, and crime,” said Danny Chou, an Assistant County Counsel for the County of Santa Clara. “Pfizer has set a stringent standard that we expect all other opioid manufacturers to meet.”

Opioids make up only a tiny part of Pfizer’s business. The company sells just one opioid painkiller, an extended release and little known pain medication called Embeda.

As part of its agreement with Santa Clara County, Pfizer promised not to market opioids off-label for conditions they are not approved for and said it would “make clear” in its marketing that there are no studies supporting the use of opioids long-term for pain relief. Pfizer signed a nearly identical agreement with the city of Chicago last year to avoid litigation.

Interestingly, the CDC guideline suggests the use of gabapentin and pregabalin as alternatives to opioids for treating pain. Pfizer makes billions of dollars annually selling both of those drugs, under the brand names Neurontin and Lyrica.

In recent years, Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for. Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses.

Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries. Lyrica is also prescribed off-label to treat a wide variety of other chronic pain conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.

Feds Bust Operators of Bogus Medical Clinics

By Pat Anson, Editor

Hardly a day goes by without the U.S. Drug Enforcement Administration announcing a new drug bust or the sentencing of someone for drug trafficking. The announcements have become so routine they’re often ignored by the news media.

But a drug bust in Los Angeles this week is worth sharing, if only because it shows that the underground market for prescription painkillers is booming and criminals are eager to take advantage of it.

The DEA announced the indictment of 14 defendants and released details of a brazen scheme that involved a string of sham medical clinics, fake prescriptions and kickbacks to doctors who were paid “for sitting at home.”

The feds estimate that at least two million prescription pills – most of them painkillers – were diverted and sold to customers looking for pain relief or to get high.

Indictments by a federal grand jury allege the suspects established seven bogus medical clinics in the Los Angeles area. The clinics would periodically open and then close, after illegally obtaining large quantities of oxycodone, hydrocodone, alprazolam (Xanax) and other prescription drugs from pharmacies using fake prescriptions. The drugs were then sold to street level drug dealers.

Prosecutors say the ringleader of the scheme -- Minas Matosyan, aka “Maserati Mike” -- hired corrupt doctors to write fraudulent prescriptions under their names in exchange for kickbacks.

“This investigation targeted a financially motivated racket that diverted deadly and addictive prescription painkillers to the black market,” said David Downing, DEA Special Agent in Charge of the Los Angeles Division.

“The two indictments charge 14 defendants who allegedly participated in an elaborate scheme they mistakenly hoped would conceal a high-volume drug trafficking operation,” said Acting U.S. Attorney Sandra R. Brown.

The indictments describe how Matosyan would “rent out recruited doctors to sham clinics.”  In one example described in court documents, Matosyan provided a corrupt doctor to a clinic owner in exchange for $120,000. When the clinic owner failed to pay the money and suggested that Matosyan “take back” the corrupt doctor, Matosyan demanded his money and said, “Doctors are like underwear to me. I don’t take back used things.”

In a recorded conversation, Matosyan also discussed how one doctor was paid “for sitting at home,” while thousands of narcotic pills were prescribed in that doctor’s name and Medicare was fraudulently billed more than $500,000 for the drugs.

Prosecutors say the identities of doctors who refused to participate in the scheme were sometimes stolen. In an intercepted telephone conversation, Matosyan offered one doctor a deal to “sit home making $20,000 a month doing nothing.” When the doctor refused the offer, the defendants allegedly created prescription pads in the doctor’s name and began selling fraudulent prescriptions for oxycodone without the doctor’s knowledge or consent. 

The conspirators also issued fake prescriptions and submitted fraudulent billings in the name of a doctor who was deceased.

The indictment alleges that criminal defense attorney Fred Minassian tried to deter the investigation. After a load of Vicodin was seized from one customer, Matosyan and Minassian allegedly conspired to create fake medical records to throw investigators off track.

Matosyan, Minassian and 10 other defendants were arrested and arraigned in federal court. Authorities are still looking for the two remaining fugitives.

While the DEA continues to bust drug dealers and unscrupulous doctors, the diversion of opioid medication by patients is actually quite rare. A DEA report last year found that less than one percent of legally prescribed painkillers are diverted. The agency also said the prescribing and abuse of opioid medication is also dropping, along with the number of admissions to treatment centers for painkiller addiction.

Smart Underwear May Prevent Back Pain

By Pat Anson, Editor

We have smartphones, smart cars, smart appliances and smart watches.

So perhaps it was inevitable that someone would invent smart underwear.

That’s exactly what a team of engineering students at Vanderbilt University in Tennessee have done, although their underwear isn’t designed to park your car, count your steps or check your blood pressure.

They’ve invented a bio-mechanical undergarment that helps prevent back pain by reducing stress on back muscles. The device consists of two sections, one for the chest and the other for the legs, which are connected by straps across the middle back, with natural rubber pieces at the lower back and glutes. It looks like something Ben Affleck might wear in the latest Batman movie.

"I'm sick of Tony Stark and Bruce Wayne being the only ones with performance-boosting supersuits. We, the masses, want our own," jokes Erik Zelik, an assistant professor of mechanical engineering at Vanderbilt who led the design team.

"The difference is that I'm not fighting crime. I'm fighting the odds that I'll strain my back this week trying to lift my 2-year-old."

Zelik experienced back pain after repeatedly lifting his toddler son, which got him thinking about wearable tech solutions. Low tech belts and braces designed to give support to tired back muscles have been on the market for years, but many are bulky, uncomfortable or just plain unattractive.

VANDERBILT UNIVERSITY

"People are often trying to capitalize on a huge societal problem with devices that are unproven or unviable," said Dr. Aaron Yang, who specializes in nonsurgical treatment of the back and neck at Vanderbilt University Medical Center. "This smart clothing concept is different. I see a lot of health care workers or other professionals with jobs that require standing or leaning for long periods. Smart clothing may help offload some of those forces and reduce muscle fatigue."

The new, as yet unnamed device is designed so that users engage it only when they need it – like moving furniture or lifting 2-year old toddlers. A simple double tap to the shirt tightens the straps. When the task is done, another double tap releases the straps so the user can sit down comfortably and go about their business.  

The device can also be controlled by an app, with users tapping their phones to engage the smart clothing wirelessly via Bluetooth.

Eight people tested the undergarment by leaning forward and lifting 25 and 55-pound weights at a series of different angles. The device reduced activity in their lower back extensor muscles by an average of 15 to 45 percent for each task.

"The next idea is: Can we use sensors embedded in the clothing to monitor stress on the low back, and if it gets too high, can we automatically engage this smart clothing?" Zelik said.

The team unveiled the undergarment last week at the Congress of the International Society of Biomechanics in Brisbane, Australia, where it won a Young Investigator Award for engineering student Erik Lamers, one of the team members. The device makes its U.S. debut next week at the American Society of Biomechanics conference in Boulder, Colorado

The smart clothing project is funded by a Vanderbilt University Discovery Grant, a National Science Foundation Graduate Research Fellowship and a National Institutes of Health Career Development Award.

When Chronic Wounds Don’t Heal

By Marisa Taylor, Kaiser Health News

Carol Emanuele beat cancer. But for the past two years, she has been fighting her toughest battle yet. She has an open wound on the bottom of her foot that leaves her unable to walk and prone to deadly infection.

In an effort to treat her diabetic wound, doctors at a Philadelphia clinic have prescribed a dizzying array of treatments. Freeze-dried placenta. Penis foreskin cells. High doses of pressurized oxygen. And those are just a few of the treatment options patients face.

“I do everything, but nothing seems to work,” said Emanuele, 59, who survived stage 4 melanoma in her 30s. “I beat cancer, but this is worse.”

The doctors who care for the 6.5 million patients with chronic wounds know the depths of their struggles. Their open, festering wounds don’t heal for months and sometimes years, leaving bare bones and tendons that evoke disgust even among their closest relatives.

Many patients end up immobilized, unable to work and dependent on Medicare and Medicaid. In their quest to heal, they turn to expensive and sometimes painful procedures, and products that often don’t work.

CAROL EMANUELE (KAISER HEALTH NEWS)

According to some estimates, Medicare alone spends at least $25 billion a year treating these wounds. But many widely used treatments aren’t supported by credible research. The $5 billion-a-year wound care business booms while some products might prove little more effective than the proverbial snake oil. The vast majority of the studies are funded or conducted by companies who manufacture these products. At the same time, independent academic research is scant for a growing problem.

“It’s an amazingly crappy area in terms of the quality of research,” said Sean Tunis, who as chief medical officer for Medicare from 2002 to 2005 grappled with coverage decisions on wound care. “I don’t think they have anything that involves singing to wounds, but it wouldn’t shock me.”

A 2016 review of treatment for diabetic foot ulcers found “few published studies were of high quality, and the majority were susceptible to bias.” The review team included William Jeffcoate, a professor with the Department of Diabetes and Endocrinology at Nottingham University Hospitals Trust. Jeffcoate has overseen several reviews of the same treatment since 2006 and concluded that “the evidence to support many of the therapies that are in routine use is poor.”

A separate Health and Human Services review of 10,000 studies examining treatment of leg wounds known as venous ulcers found that only 60 of them met basic scientific standards. Of the 60, most were so shoddy that their results were unreliable.

Paying for Treatments That Don't Work

While scientists struggle to come up with treatments that are more effective, patients with chronic wounds are dying.

The five-year mortality rate for patients with some types of diabetic wounds is more than 50 percent higher than breast and colon cancers, according to an analysis led by Dr. David Armstrong, a professor of surgery and director of the Southern Arizona Limb Salvage Alliance.

Open wounds are a particular problem for people with diabetes because a small cut may turn into an open crater that grows despite conservative treatment, such as removal of dead tissue to stimulate new cell growth.

More than half of diabetic ulcers become infected, 20 percent lead to amputation, and, according to Armstrong, about 40 percent of patients with diabetic foot ulcers have a recurrence within one year after healing.

“It’s true that we may be paying for treatments that don’t work,” said Tunis, now CEO of the nonprofit Center for Medical Technology Policy, which has worked with the federal government to improve research. “But it’s just as tragic that we could be missing out on treatments that do work by failing to conduct adequate clinical studies.”

Although doctors and researchers have been calling on the federal government to step in for at least a decade, the National Institutes of Health and the Veterans Affairs and Defense departments haven’t responded with any significant research initiative.

“The bottom line is that there is no pink ribbon to raise awareness for festering, foul-smelling wounds that don’t heal,” said Caroline Fife, a wound care doctor in Texas. “No movie star wants to be the poster child for this, and the patients … are old, sick, paralyzed and, in many cases, malnourished.”

kaiser health news

The NIH estimates that it invests more than $32 billion a year in medical research. But an independent review estimated it spends 0.1 percent studying wound treatment. That’s about the same amount of money NIH spends on Lyme disease, even though the tick-borne infection costs the medical system one-tenth of what wound care does, according to an analysis led by Dr. Robert Kirsner, chair and Harvey Blank professor at the University of Miami Department of Dermatology and Cutaneous Surgery.

Emma Wojtowicz, an NIH spokeswoman, said the agency supports chronic wound care, but she said she couldn’t specify how much money is spent on research because it’s not a separate funding category.

“Chronic wounds don’t fit neatly into any funding categories,” said Jonathan Zenilman, chief of the division for infectious diseases at Johns Hopkins Bayview Medical Center and a member of the team that analyzed the 10,000 studies. “The other problem is it’s completely unsexy. It’s not appreciated as a major and growing health care problem that needs immediate attention, even though it is.”

Commercial manufacturers have stepped in with products that the FDA permits to come to market without the same rigorous clinical evidence as pharmaceuticals. The companies have little incentive to perform useful comparative studies.

“There are hundreds and hundreds of these products, but no one knows which is best,” said Robert Califf, who stepped down as Food and Drug Administration commissioner for the Obama administration in January. “You can freeze it, you can warm it, you can ultrasound it, and [Medicare] pays for all of this.”

When Medicare resisted coverage for a treatment known as electrical stimulation, Medicare beneficiaries sued, and the agency changed course.

“The ruling forced Medicare to reverse its decision based on the fact that the evidence was no crappier than other stuff we were paying for,” said Tunis, the former Medicare official.

In another case, Medicare decided to cover a method called “noncontact normothermic wound therapy,” despite concerns that it wasn’t any more effective than traditional treatment, Tunis said.

“It’s basically like a Dixie cup you put over a wound so people won’t mess with it,” he said. “It was one of those ‘magically effective’ treatments in whatever studies were done at the time, but it never ended up being part of a good-quality, well-designed study.”

Questionable Research

The companies that sell the products and academic researchers themselves disagree over the methodology and the merits of existing scientific research.

Thomas Serena, one of the most prolific researchers of wound-healing products, said he tries to pick the healthiest patients for inclusion in studies, limiting him to a pool of about 10 percent of his patient population.

“We design it so everyone in the trial has a good chance of healing,” he said.

“If it works, like, 80 or 90 percent of the time, that’s because I pick those patients,” said Serena, who has received funding from manufacturers.

But critics say the approach makes it more difficult to know what works on the sickest patients in need of the most help.

Gerald Lazarus, a dermatologist who led the HHS review as then-director of Johns Hopkins Bayview Medical Center wound care clinic, said Serena’s assertion is “misleading. That’s not a legitimate way to conduct research.” He added that singling out only healthy patients skews the results.

The emphasis on healthier patients in clinical trials also creates unrealistic expectations for insurers, said Fife.

“The expensive products … brought to market are then not covered by payers for use in sick patients, based on the irrefutable but Kafka-esque logic that we don’t know if they work in sick people,” she said.

“Among very sick patients in the real world, it may be hard to find a product that’s clearly superior to the others in terms of its effectiveness, but we will probably never find that out since we will never get the funding to analyze the data,” added Fife, who has struggled to get government funding for a nonprofit wound registry she heads. Not surprisingly, she said, the registry data demonstrate that most treatments don’t work as well on patients as shown in clinical trials.

Patients say they often feel overwhelmed when confronted with countless treatments.

“Even though I’m a doctor and my wife is a nurse, we found this to be complicated,” said Navy Cmdr. Peter Snyder, a radiologist who is recovering from necrotizing fasciitis, also known as flesh-eating bacteria. “I can’t imagine how regular patients handle this. I think it would be devastating.”

To heal wounds on his arms and foot, Snyder relied on various treatments, including skin-graft surgery, special collagen bandages and a honey-based product. His doctor who treats him at Walter Reed National Military Medical Center predicted he would fully recover.

peter snyder examined at walter reed medical center (khnphoto)

Such treatments aren’t always successful. Although Emanuele’s wound left by an amputation (of her big toe) healed, another wound on the bottom of her foot has not.

Recently, she looked back at her calendar and marveled at the dozens of treatments she has received, many covered by Medicare and Medicaid.

Some seem promising, like wound coverings made of freeze-dried placenta obtained during births by cesarean section. Others, not — including one plastic bandage that her nurse agreed made her wound worse.

Emanuele was told she needed to undergo high doses of oxygen in a hyperbaric chamber, a high-cost treatment hospitals are increasingly relying on for diabetic wounds. The total cost: about $30,000, according to a Medicare invoice.

Some research has indicated that hyperbaric therapy works, but last year a major study concluded it wasn’t any more effective than traditional treatment.

“Don’t get me wrong, I am grateful for the care I get,” Emanuele said. “It’s just that sometimes I’m not sure they know what they’re using on me works. I feel like a guinea pig.”

Confined to a wheelchair because of her wounds, she fell moving from the bathroom to her wheelchair and banged her leg, interrupting the healing process. Days later, she was hospitalized again. This time, she got a blood infection from bacteria entering through an ulcer.

She has since recovered and is now back on the wound care routine at her house.

“I don’t want to live like this forever,” she said. “Sometimes I feel like I have I no identity. I have become my wound.”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Kaiser Permanente Prescribing Fewer, Cheaper Opioids

By Pat Anson, Editor

One of the largest medical organizations in California has significantly reduced high dose opioid prescribing for its patients and shifted many of them to generic opioids, according to the results of a new study by Kaiser Permanente of Southern California.

“You can treat pain differently without putting people on high doses of opioids,” said co-author Michael Kanter, MD, an executive with the Southern California Permanente Medical Group. “There is no proven benefit of long term opioid therapy.”

Researchers looked at prescription data for over 3 million Kaiser Permanente patients in southern California from 2010 to 2015, and found a 30 percent reduction in high dose opioid prescribing, along with a major decline in the prescribing of brand name opioids.

The medical group instituted system wide policies in 2010 that promoted safer prescribing and encouraged its 6,600 physicians to prescribe lower doses using cheaper, generic opioids.

The change in policy resulted in far fewer prescriptions being written for OxyContin, Opana, and brand name hydrocodone, oxycodone and codeine products. OxyContin was the first painkiller to have abuse deterrent properties, while Opana is being taken off the market because of concerns it is being abused.  Both are more expensive than generic opioids.

“This study adds promising results that a comprehensive system-level strategy has the ability to positively affect opioid prescribing,” Kanter and his colleagues wrote in the Journal of Evaluation in Clinical Practice.

Like other studies of its kind, however, the report did not assess whether there was any improvement in patient pain, function and quality of life, nor did it assess the impact of alternative pain therapies and treatments that were prescribed in lieu of opioids. Also unknown is whether the medical group’s policies resulted in fewer overdoses or cases of opioid misuse and addiction.

“But we did note that, generally speaking, patients were satisfied with the process that they went through,” said Kanter, adding that a subsequent research paper will be published on patient satisfaction.

Kanter told PNN that many pain patients take opioids long-term because of “therapeutic inertia” on the part of prescribers.

“We do know that some patients are just started on opioids for chronic pain, (their) doses may be increased over time, and they may be actually doing quite well pain-wise, but nobody takes the time to titrate their dose down and deescalate, and so a lot of the patients we think were just on too high of a dose for no real good reason,” Kanter explained. “Some of the patients, if not many, we think did just as well on lower doses.”

Several other medical groups and insurance companies have taken steps to reduce opioid prescribing, but the results so far have been mixed in terms of preventing overdoses.

As PNN has reported, opioid prescribing fell by 15 percent for members of Blue Cross Blue Shield of Massachusetts after the state's largest insurer adopted policies in 2012 that discourage the dispensing of opioid medication. The new policies failed to slow the growing number of opioid overdose deaths in Massachusetts, which more than doubled. Many of those deaths were not due to painkillers, but linked to heroin and illicit fentanyl.

Blue Shield of California says its Narcotic Safety Initiative has resulted in an 11% reduction in members using high dose opioids and prevented 25% of all new opioid users from using the drugs for more than 90 days.  

Like the Kaiser Permanente study, the Blue Cross Blue Shield initiatives in California and Massachusetts did not assess the impact on patient pain, function and quality of life after opioid prescribing was lowered.

The opioid overdose death rate in California is 4.9 deaths per 100,000 people, less than half the national average. From 2014 to 2015, the opioid overdose rate in California declined by 2 percent, while the national average rose by 16 percent. Click here to see trends in your state.

Stop Torturing Chronic Pain Patients

By Kim Miller, Guest Columnist

Have you heard the stories about people who suffer from unrelenting pain? 

These people, who we'll call "patients,” are trying to have a life whereby their pain is controlled enough to participate in some of life's little pleasures, such as cleaning the house, showering and spending time with family, while understanding that being completely pain free is unrealistic. 

These patients are often treated as if they're asking for something unreasonable. They are not typical patients, but their anomalies have little place in the medical community, like other patients with chronic conditions such as hypertension or diabetes.

Chronic pain patients are typically required to visit their medical providers once each month if they are being treated with opioids.  Along with these regular visits, chronic pain patients are subjected to signed contracts, random drug screens, reports from their state's Prescription Drug Monitoring Program (listing all scheduled medications, dates filled, names of pharmacies and prescribers' names), and random pill counts.  Any failure to comply or meet with these specifications can result in the patient being released or "fired" by the medical practice for breaking the pain contract.

Many of these patients have been subjected to abrupt tapering of their opioid medications or had them completely discontinued. 

The CDC opioid guidelines, the DEA, misinformed legislators, media hype, and anti-opioid zealots have combined to continually attack the nation's opioid crisis by restricting access to pain medications by legitimate, law abiding patients who are following all of the rules. 

This process of restricting medications for patients in need has caused many to suffer needlessly and some to commit suicide.  Even patients who have had no negative side effects from opioids -- after taking them for years or even decades -- are now suffering due to no fault of their own.

The worst part of the current situation is that overdose deaths caused by illicit opioids, such as heroin, street-manufactured fentanyl, and fentanyl analogs like carfentenil (elephant tranquilizer) and U-47700, continue to rise.  Many media stories, as well as government reports and statements, do not differentiate between prescription opioids and illegal opioids when informing the public about the "opioid epidemic."  The misinformed public only hears about opioids causing more deaths, while the picture on the television shows pills in a prescription bottle.

Restricting access to legal opioid medication has no hope whatsoever of curtailing what is an epidemic of non-prescription drugs. 

The origins of the opioid crisis may have roots in the overprescribing of opioids, but a growing number of studies have found that opioid medications are no longer involved in the majority of fatal drug overdoses. Deaths categorized as "opioid related" often involve non-prescription opioids like heroin and illicit fentanyl, or benzodiazepines, alcohol, cocaine, methamphetamine and other substances.  

The vast and overwhelming evidence points to dangerous substances NOT prescribed by a medical provider, yet we're left with continued restrictions on medications needed by pain patients to have any quality of life.

This dangerous counter-intuitive trend not only deprives patients of pain relief, but is leading to a silent epidemic of suicide in the pain community. It is time to rethink the media and political hype, ditch the CDC guidelines, and stop torturing chronic pain patients.

Kim Miller is the advocacy director of the Kentuckiana Fibromyalgia Support Group and an ambassador with the U.S. Pain Foundation.

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.

A Pained Life: Starting at the Top

By Carol Levy, Columnist

I hear a lot of people say, “My doc is the best.”

It's important to believe that. But sometimes it is better to save the best for last.

I have trigeminal neuralgia, a painful condition that affects the trigeminal nerve around the eye, and was referred to my neuro-ophthalmologist -- let’s call him Dr. Smithson -- by a vascular specialist I had been seeing.

I had no idea that Dr. Smithson was one of the co-founders of the specialty of neuro-ophthalmology.  He was wonderful, not only terrific in his medicine, but a really nice and caring person. I was lucky to have been referred to him.

After two neurosurgeries, one that worked and one that resulted in devastating side effects, Dr. Smithson sent me to Dr. Marks in Pittsburgh for a specialized surgery that was named after him.

Unfortunately, Dr. Marks not only was unsuccessful, but the surgery left me with additional debilitating side effects.

After that, I was sent to California, where Dr. Kaplan did one surgery, and a year later Dr. Yee did another.

I did not know at the time that these doctors were the cream of the crop. All had their names in major neurosurgical textbooks.

From the outside, this may sound good. But from the inside, there was a problem. I was caught in a circle of specialists. I felt none of them could look outside of the circle and see things from a different perspective. I needed fresh eyes, so I went to see a neurologist at my local hospital.

“I came to see you because I need to have someone outside of the group I have been with take a fresh look. Maybe you can see or suggest something they have not thought of,” I told the doctor.

“That’s a good idea,” he said. After an examination, he told me, “I do have some ideas. I am thinking of prescribing a medication, but I want to look into it more. Come back in a month.”

Wow! Maybe somebody has something else to offer. I left the office filled with hope.

A month later I returned to his office, filled with anticipation. The neurologist came into the room and quickly burst my bubble.

“I talked to Dr. Smithson. He said what I wanted to prescribe is not a good idea,” he said.

It was just a medication. The worst that could happen was that it wouldn't work. It was no risk to this doctor, or to me, to at least try it. But Dr. Smithson’s name and reputation outranked everything else.

My doctors are the best. There is no argument there. But I wish I had started with the schnooks. Then there would have been no place to go but up!

My pedigree of the best, the brightest, and the most well-known has hurt me. I also have to explain that one doctor was behind all of these recommendations, so I don’t come off as a “doctor shopper.”

It is a conundrum. Is it worth going to the “lower level” so you have the top doctors in waiting? Or do you go to the top and then have no other options?

Maybe if I started in the other direction, I would have been just as disappointed – and wished I had started at the top.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

Poorly Treated Pain Main Reason for Opioid Misuse

By Pat Anson, Editor

Over a third of the U.S. adult population -- nearly 92 million Americans – used prescription opioids in 2015, according to a large new survey that found the primary reason people misuse opioid medication was to relieve pain.

The findings of the annual survey by the Substances Abuse and Mental Health Services Administration (SAMHSA), published in the Annals of Internal Medicine, seem likely to fuel another round of anti-opioid media coverage about the overdose crisis. 

The study estimated that 11.5 million Americans misused opioids in 2015, and nearly two million thought they were addicted and had an opioid use disorder. 

But a closer reading of the reasons behind the misuse indicates that pain is poorly treated by the healthcare system, especially for Americans who are economically disadvantaged or lack insurance.

“Misuse” in the survey was defined as using an opioid medication without a prescription, for reasons other than directed, or in greater amounts or more often than prescribed.

Asked what was the main reason behind their misuse, two-thirds (66%) of those who self-reported misuse said it was to relieve physical pain. Nearly 11 percent said it was to “get high or feel good” and less than one percent (0.6%) said they were “hooked” or addicted to opioids.

“Our results are consistent with findings that pain is a poorly addressed clinical and public health problem in the United States and that it may be a key part of the pathway to misuse or addiction. Because pain is a symptom of many pathologic processes, better prevention and treatment of the underlying disorders are necessary to decrease pain and the morbidity and mortality associated with opioid misuse,” wrote lead author Beth Han, MD, PhD, a SAMHSA researcher.

“Simply restricting access to opioids without offering alternative pain treatments may have limited efficacy in reducing prescription opioid misuse and could lead people to seek prescription opioids outside the health system or to use nonprescription opioids, such as heroin or illicitly made fentanyl, which could increase health, misuse, and overdose risks.”

That appears to be what is happening. The CDC recently acknowledged that opioid prescribing has been in decline since 2010, yet opioid overdoses are soaring around the country, reaching 33,000 deaths in 2015, many of them caused by illicit opioids.  The DEA reported last week that over half the overdoses in Pennsylvania in 2016 were linked to illicit fentanyl. Prescription painkillers were involved in only about 25% of the overdoses, behind fentanyl, heroin, benzodiazepines (anti-anxiety medication), and cocaine.

In the SAMHSA survey, only a third of those who misused opioids said they obtained them legally from a doctor. The rest said they were obtained for free from a friend or relative, or were bought or stolen.

In addition to physical pain, the survey found that economic despair was a leading factor associated with opioid misuse. Uninsured, unemployed and low-income adults had a higher risk of opioid misuse and use disorder. People who were depressed, had suicidal thoughts, or were in poor health also were at higher risk.

“In more than 20 years practicing primary care in safety-net health settings, I have come to think of the patients at highest risk as my patients -- those with lower levels of education and income and higher rates of unemployment and uninsurance, our society's most vulnerable members,” wrote Karen Lasser, MD, Boston Medical Center and Boston University School of Medicine, in an editorial published in the Annals of Internal Medicine.

“The fact that uninsured persons were twice as likely as those with insurance to report prescription opioid misuse and also had higher rates of use disorders augments the urgency of expanding insurance coverage. With insurance, persons suffering from pain could seek medical care rather than relying on opioids prescribed for others or purchased illegally.”

Over 72,000 American adults participated in the SAMHSA survey. Each interview lasted about an hour and participants received $30 in cash afterwards.

Trump Opioid Commission Calls for National Emergency

By Pat Anson, Editor

A White House commission on combating drug addiction and the opioid crisis has recommended that President Trump declare a national emergency to speed up federal efforts to combat the overdose epidemic, which killed over 47,000 Americans in 2015.

“If this scourge has not found you or your family yet, without bold action by everyone, it soon will. You, Mr. President, are the only person who can bring this type of intensity to the emergency and we believe you have the will to do so and to do so immediately,” the commission wrote in an interim report to the president.

The 10-page report was delayed by over a month, which New Jersey Gov. Chris Christie attributed to over 8,000 public comments the commission received after its first meeting in June. Christie, who chairs the commission, said the panel wanted to carefully review each comment.

In addition to declaring a national emergency, the commission recommended a variety of ways to increase access to addiction treatment, mandate prescriber education about the risks and benefits of opioids, and prioritize ways to detect and stop the flow of illicit fentanyl into the country.

There were no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report, which is due in October.

“We urge the NIH (National Institutes of Health) to begin to work immediately with the pharmaceutical industry in two areas: development of additional MAT (medication assisted treatment)... and the development of new, non-opioid pain relievers, based on research to clarify the biology of pain,” Christie said. “The nation needs more options that are not addictive.  And we need more treatment for those who are addicted.”

“I think we also have to be cognizant that the advent of new psychoactive substances such as fentanyl analogs and heroin is certainly replacing the death rate due to prescription opioids. That is going to continue until we have a handle on the supply side of the issue,” said commission member Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School.

“If we do not stop the pipeline into substance use, into addiction, into problematic use, into the entire scenario of poly-substance use, we are really not going to get a good handle on this.”     

Other measures recommended by the commission:

• Grant waivers to states to eliminate barriers to mental health and addiction treatment
• Increase availability of naloxone as an emergency treatment for opioid overdoses
• Amend the Controlled Substance Act to require additional training in pain management for all prescribers
• Prioritize funding to Homeland Security, FBI and DEA to quickly develop fentanyl detection sensors
• Stop the flow of synthetic opioids through U.S. Postal Service
• Enhance the sharing of data between prescription drug monitoring programs (PDMPs)

No estimate was provided on the cost of any of these measures.

Gov. Christie also spoke about eliminating pain levels as a “satisfaction criteria” for healthcare providers being evaluated and reimbursed for federal programs like Medicare.

“We believe that this very well may have proven to be a driver for the incredible amount of prescribing of opioids in this country. In 2015, we prescribed enough opioids to keep every adult in America fully medicated for three weeks. It’s an outrage. And we want to see if this need for pain satisfaction levels, which is part of the criteria for reimbursement, is part of the driver for this problem,” Christie said.  

Last year, the Centers for Medicare and Medicaid Services (CMS) caved into pressure from politicians and anti-opioid activists by dropping all questions related to pain in patient satisfaction surveys in hospitals.  CMS agreed to make the change even though there was no evidence that the surveys contributed to excess opioid prescribing

Do You Use Alcohol to Relieve Chronic Pain?

By Rochelle Odell, Columnist

I’m in a Complex Regional Pain Syndrome (CRPS/RSD) support group and one of our members recently asked if any members were turning to alcohol because their pain medication had been reduced or stopped.

It piqued my interest, so I began researching the topic. There aren’t many current studies or reports, but it’s a valid question since alcohol is much easier to obtain than pain medication.

Alcohol was among the earliest substances used to relieve physical pain and, of course, many people use it to cope with emotional pain.

According to the National Institute on Alcohol Abuse and Alcoholism, as many as 28% of people with chronic pain turn to alcohol to alleviate their suffering.

Another study from 2009 found that about 25% of patients self-medicated with alcohol for tooth pain, jaw pain or arthritis pain.

There is no documented increase in alcohol use by chronic pain patients at this time, although I would hope there are studies in process that further clarify the question and problems arising from it -- especially with opioid pain medication being reined in and so many patients left with nothing to relieve their pain.

There are many reasons why a person may self-medicate with alcohol.

“People have been using alcohol to help cope with chronic pain for many years. Many people also may use alcohol as a way to manage stress, and chronic pain often can be a significant stressor,” Jonas Bromberg, PsyD, wrote in PainAction.

“One theory about why alcohol may be used to manage chronic pain is because it affects the central nervous system in a way that may result in a mild amount of pain reduction. However, medical experts are quick to point out that alcohol has no direct pain-relieving value, even if the short-term affects provide some amount of temporary relief. In fact, using alcohol as a way to relieve pain can cause significant problems, especially in cases of excessive use, or when it is used with pain medication.”

Constant, unrelenting pain is definitely a stressor -- that's putting it mildly -- but I’ve never added alcohol to my pain medication regimen. I was always afraid of the possible deadly side effects, coupled with the fact my mother was an alcoholic who mixed her medication with it. That's a path I have chosen not to go down.

Bromberg also tells us that men may be more likely to use alcohol for pain relief than women, and people with higher income also tend to use alcohol more to treat their chronic pain.

Interestingly, the use of alcohol is usually not related to how intense a person’s pain is or how long they’ve had it. It was the regularity of pain symptoms – chronic pain -- that seemed most related to alcohol use, according to Bromberg.

Those who self-medicate with alcohol for physical or emotional pain often use it with a variety of substances, both legal and illegal.

Researchers at Boston University School of Medicine and Boston Medical Center reported last year in the Journal of General Internal Medicine that in a study of nearly 600 patients who screened positive for illicit drugs, nearly 90 percent had chronic pain. Over half of them used marijuana, cocaine or heroin, and about half reported heavy drinking.

“It was common for patients to attribute their substance use to treating symptoms of pain,” the researchers reported. “Among those with any recent heavy alcohol use, over one-third drank to treat their pain, compared to over three-quarters of those who met the criteria for current high-risk alcohol use.”

“Substance use” (not abuse) was defined as use of illegal drugs, misuse of prescription drugs, or high risk alcohol use. I had not heard of this term before, it’s usually called substance abuse.  Perhaps these researchers were onto something really important that needs further study, particularly with opioid medication under fire.

“While the association between chronic pain and drug addiction has been observed in prior studies, this study goes one step further to quantify how many of these patient are using these substances specifically to treat chronic pain," they added.

What this information shows is that if one is on pain medication, using alcohol or an illegal substance does not make one unique. It is certainly not safe, but it does occur. We are all struggling to find ways to cope with chronic pain, and if someone is denied one substance they are at high risk of turning to another.

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

Indiana Doctor Killed in Dispute Over Pain Meds

By Pat Anson, Editor

A gunman who fatally shot an Indiana doctor this week was upset because the physician refused to prescribe opioid pain medication to his wife, according to police.

Dr. Todd Graham was confronted Wednesday afternoon in the parking lot outside a South Bend medical center by 48-year Michael Jarvis. After a brief argument, Jarvis shot Graham twice in the head. Jarvis then drove to a friend’s house and killed himself, according to the South Bend Tribune.

An investigation later determined that Jarvis’ wife had an appointment with Graham Wednesday morning and the doctor declined to prescribe an opioid medication for her chronic pain.

“It was Dr. Graham’s opinion that chronic pain did not require prescription drugs,” St. Joseph County Prosecutor Ken Cotter said at a news conference Thursday. "He did what we ask our doctors to do. Don't over-prescribe opioids.”

DR. TODD GRAHAM

Michael Jarvis was present during his wife's appointment and argued with Graham. Jarvis eventually left, but returned in the afternoon with a gun and confronted the doctor outside the medical center.

"Make no mistake, this was a person who made a choice to kill Dr. Graham. This is not a fallout from any opioid epidemic or any opioid problems. That probably leads us into an examination of what is happening with the opioid problem in our community, and frankly, in our whole nation," said Cotter.

Cotter said Jarvis had a “confrontation” with Graham before Wednesday, but did not go into details.

"This was a very targeted attack," said Commander Tim Corbett of Saint Joseph County Metro Homicide. "I am a firm believer -- and I think Ken feels the same way -- that if Jarvis would have got inside that building, although there wouldn't have been any specific target, it's like trapping an animal in a corner: they're going to come out fighting. I truly believe this could have escalated into a mass shooting. I do believe that."

Mrs. Jarvis was apparently unaware of her husband’s plans.

"It was clear that she didn't know what he was doing. She's suffering as well," Cotter said.

The 56-year old Graham was married and had three children. His obituary can be seen here. Graham's wife learned of her husband’s death through social media, according to the South Bend Tribune.

Several of Graham’s patients left messages about him on the Tribune’s website.

“He was a very caring person. I am lost of words my heart is breaking for his wife and family,” wrote one patient.

“Dr. Graham has been my Dr. for 3 years. After 3 accidents, and surgeries he has helped me tremendously. My condolences to his wife. He will be missed,” wrote another.

The Indiana shooting was the third in recent months involving a pain patient and a doctor.

In June, a gunman shot and wounded two people at a Las Vegas pain clinic before taking his own life.  The shooter, who suffered from chronic back pain, had been denied pain medication during an unscheduled appointment.

In April, a disgruntled pain patient in Great Falls, Montana burned down a doctor's home, held the doctor's wife at gunpoint and killed himself during a standoff with police.

Pennsylvania Overdoses Soar, But Not from Painkillers

By Pat Anson, Editor

A new study by the U.S. Drug Enforcement Agency underscores the changing nature of the nation’s overdose crisis and the diminishing role played by opioid painkillers.

In an analysis of 4,642 drug related overdose deaths in Pennsylvania last year, the DEA found that over half of those deaths (52%) involved fentanyl or fentanyl related substances. In many cases, toxicology reports found multiple drugs in the bodies of those who died.

Heroin was the second most frequently identified drug (45%), followed by benzodiazepines (33%), a class of anti-anxiety medication, and cocaine (27%).  

Prescription opioid medication was the fifth most common type of drug found. Painkillers were involved in 25 percent of the Pennsylvania overdoses, while ethanol (alcohol) was ranked 6th at nearly 20 percent.

Overall, the number of overdoses in the state was 37 percent higher than in 2015, according to the DEA report. Pennsylvania's overdose rate was 36.5 deaths per 100,000 people, twice the national average.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine, and is available legally by prescription to treat severe chronic pain. In recent years however, illicit fentanyl has become a deadly scourge across the U.S. and Canada, where it is often mixed with heroin or used in counterfeit painkillers. Illicit fentanyl is believed to be involved in the vast majority of the fentanyl-related deaths in Pennsylvania.    

DRUGS INVOLVED IN PENNSYLVANIA OVERDOSES (2016)

SOURCE: DEA

The DEA report was prepared in conjunction with the University of Pittsburgh’s School of Pharmacy Program Evaluation Research Unit (PERU). Unlike other reports on overdose deaths, the PERU analysis excluded suicides and included toxicology reports, a methodology that is considered more reliable than the ICD codes traditionally used by the CDC and other federal agencies to determine the drugs involved in overdoses.

“The expertise of PERU in the analysis and interpretation of public health data, which is outside of the traditional scope of law enforcement intelligence analysis, resulted in the creation of this comprehensive report that can be used to implement effective strategies to address the overdose crisis,” said Gary Tuggle, Special Agent-in-Charge of DEA’s Philadelphia Field Division.

Perhaps the most striking aspect of the report was the presence of anti-anxiety drugs in so many of the overdoses, and the smaller role played by prescription opioids. Toxicology reports found opioid medication in 1,181 of the overdose deaths, with oxycodone involved in most of them.

Still, more Pennsylvanians died with Xanax (alprazolam) in their system than oxycodone (846 vs. 679). And the anti-anxiety drugs clonazepam (Klonopin), diazepam (Valium), oxazepam and lorazepam (Ativan) were also involved in hundreds of overdoses.

The existence of valid prescriptions was not analyzed in the DEA report, which did not assess whether medications were diverted or obtained fraudulently.

In 2016, approximately 13 people died of a drug-related overdose in Pennsylvania each day. 

Although painkillers were not involved in most of those deaths, efforts at fighting the overdose crisis are still largely focused on reducing access to legally prescribed opioid medication.

Last month, Independence Blue Cross, the largest health insurer in the Philadelphia area, said it would limit the prescribing of opioids in its network to just five days for acute pain. Independence already limits the quantity of opioids that physicians can prescribe. The company claims that policy has reduced "inappropriate" opioid use by its members by nearly 30 percent.

Deaths from prescription opioids in Philadelphia started declining in 2013, a year before Independence started limiting access to painkillers.