Feds Say Bankrupt Drug Lab Paid Millions in Kickbacks

By Pat Anson, Editor

A bankrupt drug testing lab with a checkered history has been linked to a large money laundering and pill mill operation in Tennessee.

According to an updated indictment in U.S. District Court in Knoxville, Confirmatrix Laboratory in Georgia and Sterling Laboratories in Seattle paid nearly $3 million in illegal kickbacks to have thousands of urine drug test samples sent to them from patients at the Knoxville Hope Clinic (KHC). In return, the labs submitted false claims for "unnecessary" drug tests to Medicare and TennCare, Tennesee’s Medicaid program.

“Confirmatrix, by and through its principals and agents, paid bribes and kickbacks to defendants Clyde Christopher Tipton and Maynard Alvarez in return for causing Medicare and TennCare beneficiaries from KHC to be referred to Confirmatrix for medically unnecessary drug screenings,” the indictment alleges.

“Medical providers at KHC prescribed opioids and other controlled substances to thousands of purported pain patients in exchange for grossly excessive fees. The vast majority of the prescriptions were unreasonable and medically unnecessary. Patients were required to keep follow-up appointments every 28 days to continue receiving their prescriptions. Providers at KHC ordered medically unnecessary Drug Screenings for every patient every 28 days.”

Tipton, Alvarez and six other defendants are accused of drug trafficking and money laundering in the long-running investigation of Tennessee pill mills. The ringleader of the pill mill scheme, a 53-year old grandmother named Sylvia Hofstetter, allegedly made millions of dollars while running clinics that prescribed 12 million opioid prescriptions. Prosecutors have alleged that at least nine patients at the clinics died from drug overdoses.

No one affiliated with Confirmatrix or Sterling Laboratories has been indicted so far in the case. Prosecutors say the   alleged kickbacks were paid from August 2013 to July 2016.

As PNN has reported, Confirmatrix filed for Chapter 11 bankruptcy last November, just two days after its headquarters near Atlanta was raided by FBI agents.  The company was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

A 2013 study by the Centers for Medicare and Medicaid Services (CMS) listed Confirmatrix as the most expensive drug lab in the country, collecting an average of $2,406 from Medicare for each patient tested, compared to the national average of $751. The bills from Confirmatrix were high because the company ran an average of nearly 120 different drug screens on each patient, far more than any other drug lab.

These and other abusive billing practices finally caused Medicare to lower its reimbursement rates for drug testing, which led to Confirmatrix’s financial problems.

Although it filed for Chapter 11 bankruptcy nine months ago, Confirmatrix remains in business and continues to bill patients and insurance companies for costly drug screens.

Some current and former patients at the Benefis Pain Management Center, a pain clinic in Great Falls, Montana, have received bills from a collection agency seeking well over $1,000 for drug screens that normally cost a few hundred dollars.

“Confirmatrix is out of network, hence I am stuck with the bill unless Benefis writes it off,” one patient told PNN. “I spoke to my insurance about it and they told me that there are labs in Montana that could have done the same thing and would have been covered by my insurance. She asked me, why they would go to a Georgia lab?”

In a statement to PNN in May, a Benefis official defended the clinic’s continued use of Confirmatrix, saying the company performs a valuable service and “waives many costs.”

“The company we have partnered with has an extensive patient assistance program, which is part of the reason they were selected. That company was selected two years ago because it was one of the few labs nationwide that offered quantitative and qualitative testing AND patient assistant programs,” said Kathy Hill, Chief Operating Officer at Benefis Medical Group.

Confirmatrix’s laboratory, office and warehouse space were recently put up for auction by the bankruptcy court under sealed bid.

Lyrica and Neurontin Face More Scrutiny

By Pat Anson, Editor

The safety and effectiveness of Lyrica (pregabalin) and Neurontin (gabapentin) – two non-opioid drugs widely used to treat chronic pain – are drawing new scrutiny from researchers and doctors who believe the medications are over-prescribed.

In a study published in PLOS Medicine, Canadian researchers say there is little evidence that gabapentinoids – a class of nerve medication that includes Neurontin and Lyrica – are effective in treating chronic low back pain. In their review of 8 clinical studies, the researchers also found the drugs have a “significant risk of adverse effects.”

Lyrica and Neurontin are commonly prescribed for fibromyalgia and neuropathic pain, but the researchers say the drugs are increasingly prescribed for chronic back pain, even though there is “no clear rationale” for it.

"Despite their widespread use, our systematic review with meta-analysis found that there are very few randomized controlled trials that have attempted to assess the benefit of using gabapentin or pregabalin in patients of chronic low back pain," wrote lead author Harsha Shanthanna, MD, an assistant professor at McMaster University in Hamilton, Ontario.

"They necessitate prolonged use and are associated with adverse effects and increased costs. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse.”

Shanthanna and his colleagues found that gabapentin showed “minimal improvement” in back pain compared to a placebo and pregabalin was “inferior” compared to other analgesics. There were no deaths or hospitalizations reported in any of the studies, but both drugs were associated with increased risk of dizziness, fatigue, visual disturbances, and diminished mental activity.

Lyrica and Neurontin are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in sales annually. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injuries. It is also prescribed off-label to treat other chronic pain conditions, including lower back pain.

Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but 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. 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.

Sales of pregabalin and gabapentin have risen steadily in recent years, in part because of CDC prescribing guidelines that recommend the two drugs as alternatives to opioid pain medication. About 64 million prescriptions were written for gabapentin in the U.S. last year, a 49% increase since 2011.

“We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain.

“Patients who are in pain deserve empathy, understanding, time, and attention. We believe some of them may benefit from a therapeutic trial of gabapentin or pregabalin for off-label indications, and we support robust efforts to limit opioid prescribing. Nevertheless, clinicians shouldn’t assume that gabapentinoids are an effective approach for most pain syndromes or a routinely appropriate substitute for opioids.”

FDA Seeks Public Comment on Abuse of Lyrica

The U.S. Food and Drug Administration announced last week that it was seeking public comment on reports that pregabalin is being abused. The FDA action was in response to a formal notification from the World Health Organization (WHO) that it may place international restrictions on pregabalin to reduce the risk of abuse and diversion. The FDA has until September 30 to respond to WHO.

“Reports indicate that patients are self-administering higher than recommended doses to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness. While effects of excessively high doses are generally non-lethal, gabapentinoids such as pregabalin are increasingly being identified in post-mortem toxicology analyses,” the FDA said in a notice published in the Federal Register.

Pregabalin is already classified as Schedule V controlled substance in the U.S. under the Controlled Substances Act, which means the DEA considers it to have a low potential for abuse.

The idea that Lyrica and Neurontin are being abused is surprising to many patients and doctors, but there are growing signs the drugs are being used recreationally.

Both Lyrica and Neurontin have been linked to heroin overdoses in England and Wales, where prescriptions for both drugs have soared in recent years.  Addicts have apparently found the medications enhance the effects of heroin and other opioids.

A small study of urine samples from patients being treated at U.S. pain clinics and addiction treatment centers found that one in five patients were taking gabapentin without a prescription.

Gabapentin and pregabalin are also being abused by prison inmates, according to Jeffrey Keller, MD, chief medical officer of Centurion, a private corrections company. 

“Gabapentin is the single biggest problem drug of abuse in many correctional systems,” Keller recently wrote in Corrections.com. “There is little difference (in my opinion) between Lyrica and gabapentin in both use for neuropathic pain or for abuse potential.”

Pfizer did not respond to a request for comment.

Trump Declares Opioid Crisis National Emergency

By Pat Anson, Editor

President Donald Trump said he would declare the opioid crisis a national emergency, just two days after his administration said a declaration wasn’t necessary.

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said outside the clubhouse of his golf course in Bedminster, New Jersey.  “We’re going to draw it up and we’re going to make it a national emergency. It is a serious problem the likes of which we have never had.”

In a brief statement after the President’s remarks, the White House said Trump had instructed the administration “to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

An estimated 142 Americans are dying every day from drug overdoses of all kinds, not just opioids. Prescription painkillers are often blamed as the cause of the problem, although deaths linked to opioid medication have leveled off in recent years. Heroin and illicit fentanyl are currently driving the overdose crisis and in some states are involved in over half of the overdose deaths.  

A White House commission last week urged the president to declare a national emergency, but administration officials indicated as recently as Tuesday that such a declaration wasn’t necessary because the administration was already treating the opioid crisis as an emergency.

“We believe at this point that the resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” said Health and Human Services Secretary Tom Price.

New Jersey Gov. Chris Christie, who chairs the opioid commission, applauded the apparent change of heart.

“It is a national emergency and the President has confirmed that through his words and actions today, and he deserves great credit for doing so. As I have said before, I am completely confident that the President will address this problem aggressively and do all he can to alleviate the suffering and loss of scores of families in every corner of our country,” Christie said in a statement.

“This declaration is only one of many steps we must take on the federal level to reduce the death toll and help people achieve long-term recovery – but it’s a start. I’m committed to working with the President and my fellow commissioners to end the opioid overdose epidemic,” said commission member and former congressman Patrick Kennedy.

It was not immediately clear what steps the administration will take now that an emergency has been declared. A 10-page interim report released by the opioid commission recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, and increased efforts to detect and stop the flow of illicit fentanyl into the country.

There are 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. Prescriptions for opioid medication – long a target of addiction treatment and anti-opioid activists – have been in decline for several years. The DEA has plans to reduce the supply of many painkillers even more in 2018.

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 the 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.

In a statement on Tuesday, President Trump suggested that law enforcement and abstinence should be used to address the opioid crisis. 

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don’t start, they won't have a problem.  If they do start, it's awfully tough to get off," Trump said, according to a White House transcript.

DEA Proposes Further Cuts in Opioid Supply

By Pat Anson, Editor

The U.S. Drug Enforcement Administration has proposed an additional 20 percent reduction in the manufacture of many opioid painkillers, including oxycodone, hydrocodone, codeine and morphine. The proposed cuts in the opioid supply, which would be effective in 2018, are in addition to those imposed by the DEA in 2017.   

“Demand for these opioid medicines has dropped,” the DEA said in a news release, citing sales data released by the QuintilesIMS Institute, which tracks prescription drug use. About 7 million fewer prescriptions were filled for hydrocodone in 2016, the fifth consecutive year that hydrocodone prescriptions have dropped.

“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” said DEA Acting Administrator Chuck Rosenberg. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”

Many pain patients tell PNN that demand for opioid medicine has not dropped, but that doctors are increasingly reluctant to write opioid prescriptions because of increased oversight by the DEA, insurance companies, and federal and state regulators.  

“It is discrimination, plain and simple. I have a well-documented chronic pain condition. Social Security has deemed me 100 percent disabled,” wrote Lora Lemons. “No other chronic condition that requires medication to combat the disease is flagged the way pain producing diseases are.”

“I am prepared to commit suicide if my pain meds are drastically cut,” wrote a woman who has adhesive arachnoiditis, a chronic and disabling spinal condition. “We don't want to die, but the legislators in the federal and state governments are going to force it for those in intractable pain.”

“No other disease medication is scrutinized. We, as patients, are being denied, dismissed, overlooked and discriminated against by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications. Our doctors are afraid to treat us humanely and adequately,” said Candi Simonis.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Despite those deep cuts, the DEA remains under political pressure to combat the overdose epidemic by reducing the opioid supply even further. Last month, a group of 16 U.S. senators wrote to Rosenberg saying additional cuts “are necessary to rein in this epidemic.”

The DEA published notice of its intent in the Federal Register and is accepting public comments on the proposal until September 6.

Click here to post your comment on the 2018 production quotas.

Trump: ‘Fire and Fury’ for North Korea, But Not Opioids

By Pat Anson, Editor

President Trump has decided not to declare a national emergency to combat the opioid crisis, despite a recommendation from a White House commission that he declare an emergency to speed up federal efforts to fight it. The decision was announced just minutes after the president threatened "fire and fury" against North Korea over its nuclear program.

Health and Human Services Secretary Tom Price said an emergency declaration wasn’t necessary because the administration was already treating the opioid crisis as an emergency. But he wouldn’t rule it out in the future.

“We believe at this point that the resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” Price said at a news conference.  

Last week, New Jersey Gov. Chris Christie, who chairs the president's opiod commission, made a personal plea to Trump to declare a national emergency, saying 142 Americans were dying every day from drug overdoses.

“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,” Christie said.

“Our country needs you, Mr. President. We know you care deeply about this issue. We also know that you will use the authority of your office to deal with our nation’s problems.”

President Trump met with First Lady Melania Trump, Secretary Price and other administration officials for a briefing on the overdose crisis at the Trump National Golf Club in Bedminster, New Jersey. Gov. Christie was not present.

Trump did not mention a national emergency during the public portion of the briefing, but said drug abuse was a “tremendous problem and we’re going to get it taken care of.” He suggested that law enforcement and abstinence should be used to address it.

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don’t start, they won't have a problem.  If they do start, it's awfully tough to get off.  So we can keep them from going on, and maybe by talking to youth and telling them, ‘No good, really bad for you’ in every way.  But if they don’t start, it will never be a problem,” Trump said, according to a White House transcript.

The opioid briefing was quickly overshadowed by the looming crisis with North Korea, when a reporter asked the president about North Korea’s growing nuclear capabilities.

“North Korea best not make any more threats to the United States.  They will be met with fire and fury like the world has never seen,” Trump said. “He has been very threatening beyond a normal state.  And as I said, they will be met with fire, fury, and, frankly, power, the likes of which this world has never seen before.”

Neither Trump nor Secretary Price laid out any specific steps to combat the overdose crisis. Price said his department was still “talking about what should be done” and developing a strategy.

Trump said the administration was acting to stop the flow of illegal drugs by being “very, very strong on our southern border and, I would say, the likes of which this country certainly has never seen that kind of strength."

New Mexico Congresswoman Reintroduces Opioid Tax

By Pat Anson, Editor

A New Mexico congresswoman has reintroduced a bill that would require pharmaceutical companies to pay a tax on all opioid pain medication they make or import. The money raised would be earmarked for addiction treatment, prevention and research.

Democratic Rep. Michelle Lujan Grisham first introduced the Heroin and Opioid Abuse Prevention and Treatment Act last December. The bill went nowhere, but was quietly reintroduced by Lujan Grisham last month. It’s been referred to the House Committee on Ways and Means.

The legislation, which is very similar to a bill introduced last year by West Virginia Sen. Joe Manchin (D), would raise an estimated $2 billion annually by levying a one cent excise tax on every milligram of opioid pain medication. Excise taxes are not paid directly by consumers, but are levied on producers or merchants, who often pass the tax on to customers by including it in a product’s price.

Sen. Manchin’s bill – dubbed the LifeBOAT Act – would have placed the opioid tax directly on consumers. It was co-sponsored by several Democratic senators and endorsed by Democratic presidential nominee Hillary Clinton, but was not supported by any Republicans and died in the GOP controlled Senate.   

REP. MICHELLE LUJAN GRISHAM

Rep. Lujan Grisham says her legislation would create a “permanent source of funding” to treat addicts, prevent opioid addiction, and develop new pain management techniques. It is co-sponsored by Reps. David Cicilline (D-RI), Katherine Clark (D-MA), Raul Grijalva (D-AZ), and Collin Peterson (D-MN).

“The opioid epidemic has killed too many people, ripped too many families apart, and destroyed too many communities,” Rep. Lujan Grisham said in a press release when her bill was first introduced last year. “Our law enforcement agencies and health care providers are already overburdened and stretched to their limits. People are dying because they do not have the help they need. My bill will help fund the programs necessary to fight this epidemic.” 

In 2015, New Mexico had the eighth highest opioid death rate in the country – a rate that includes overdoses from illegal opioids such as heroin and illicit fentanyl, as well as prescription opioids. The state was recently awarded $9.5 million in federal funding to fight opioid and heroin abuse.

Rep. Lujan Grisham is a lawyer who served as New Mexico’s Secretary of Health under former Gov. Bill Richardson.  She was first elected to Congress in 2012 and was easily re-elected last year by a 2 to 1 margin. Lujan Grisham has announced plans to run for governor in 2018.

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.

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.

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

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.