Is ‘Malicious Actor’ Behind Fentanyl Overdoses?

By Pat Anson, Editor

The U.S. medical community is starting to pay more attention to the “burgeoning public health threat” posed by counterfeit prescription drugs made with illicit fentanyl.

And for the first time, public health researchers are suggesting that a “malicious actor” could be poisoning people intentionally with fake pills.

“The steep recent increase in overdose deaths and near-deaths nationwide involving fentanyl signals a new chapter in the epidemic of opioid use. Throughout the United States and Canada, seizures of pill presses, large quantities of active pharmaceutical ingredient in powder form, and counterfeit pills have been reported,” wrote Traci Green, PhD, Boston University School of Medicine, and Michael Gilbert, MPH, Epidemico Inc., in a research letter published in JAMA Internal Medicine.

“These highly potent pills could have been created by a malicious actor to intentionally poison consumers or attract the attention of law enforcement to redistributors.”

Green and Gilbert offered no evidence to support their theory, but said it was one of several "plausible hypotheses."

“I’m not going to really comment on speculation, because we deal in fact,” said DEA spokesman Rust Payne. “If you’re a drug trafficker, you don’t want to poison people. You want a regular customer base.”

Green and Gilbert were commenting on a case study also published in JAMA Internal Medicine that looked at 8 patients in the San Francisco area who were hospitalized late last year after ingesting fake alprazolam (Xanax) tablets that were later found to contain fentanyl. One victim was a baby boy just eight months old. All of the patients eventually recovered.

A few months later, 12 people died and dozens more were hospitalized in the Sacramento area after overdosing on fake Norco pills that were also made with fentanyl.

“This case series represents a burgeoning public health threat. Clinicians should be aware of the potential for further outbreaks and serious toxic effects associated with counterfeit prescription medications,” wrote lead author Ann Arens, MD, California Poison Control Center.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is prescribed legally in patches and lozenges to treat chronic pain, but illicitly manufactured fentanyl is fast becoming a scourge around the country. Since the fall of 2013, illicit fentanyl is blamed for over 5,000 deaths and the number of overdoses appears to be accelerating.

Illicit fentanyl was typically mixed with heroin to boost its potency but is now appearing in pill form, often disguised to look like pain medication such as Norco and oxycodone.

As Pain News Network has reported, the DEA recently issued a report saying the U.S. faced an unprecedented “fentanyl crisis” that was likely to grow worse. The agency blamed heavy consumer demand and the “enormous profit potential” of counterfeit medication.

But Green and Gilbert believe there could be a more sinister motive behind the overdoses, the “malicious actor” who wants to poison people.

“This hypothesis cannot be entirely ruled out by the evidence presented by Arens et al, but it is less likely because the quantity of fentanyl identified in the counterfeit alprazolam tablets was significantly greater than would be required to harm unwitting consumers,” they wrote.

The dangerous potency of the pills could also be accidental or the result of an inexperienced pill manufacturer, the two researchers said. 

That is the more likely scenario, according to the DEA’s Payne, who says the pill press operations seized so far have been amateurish.

“If you’re just cutting fentanyl in a tablet in a lab somewhere, in someone’s garage or warehouse, you may be putting way too much fentanyl into a pill than anybody can withstand. And so that is what is going on right now,” Payne told PNN.

Regardless of the motive, Green and Gilbert called for an aggressive expansion in public health surveillance programs to detect new trends in drug use.

“New surveillance approaches and rapid expansion of evidence-based interventions are the missing parameters needed to shift the curve of the epidemic of opioid use,” they said.

PR Firm Hired to Boost CDC’s Image

By Pat Anson, Editor

The Centers for Disease Control and Prevention won’t disclose how much it is paying a Seattle-based public relations firm to provide research and analysis of the agency’s image in the pain community.

Nor will the CDC say why it hired the company – called PRR – as an image consultant.

“After consulting with our procurement and grants office, CDC isn’t able to discuss the specifics of this contract because it is an active procurement,” said CDC spokesperson Courtney Leland in an email to Pain News Network.

A spokesperson for PRR also declined to say why the firm was hired. But a source at the company indicated the primary reason was to analyze why the CDC’s opioid prescribing guidelines were so poorly received in the pain community and to find out "where they’ve gone wrong.”

“They’ve heard a lot of outrage about this,” the source said. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”

In recent weeks, PRR has been contacting “thought leaders” in the pain community to gauge their reaction to the CDC guidelines. This reporter was among those contacted and participated in a short telephone survey involving 10 questions, such as these:

“What about these guideline recommendations are worrisome to you and what about them are encouraging to you?” 

“Are these guideline recommendations a step in the right direction, in your opinion, or do you think the CDC is panicking?"

"Are these recommendations going to help solve the prescription opioid addiction problem?”

We gave PRR the names and contact information for about a dozen activists in the pain community who also wanted to participate in the survey. But we were later informed by PRR that the company “completed the required number of interviews, so we will not interview these individuals at this time.”

PRR handles communications, marketing and public relations for dozens of public and private organizations, including Starbucks, the Environmental Protection Agency, Waste Management, Nike, and the University of Washington. With offices in Seattle, Washington DC, Austin, TX, Norfolk, VA and Portland, OR, its services probably don’t come cheaply.

“To advance your vision and deliver meaningful results, we develop strategic marketing plans that can transform the marketplace, or an individual’s behavior. With multiple disciplines at our disposal, we can gather market intelligence and create strategic plans to achieve your goals,” PRR says on its website.

The CDC has been roundly criticized for its secrecy and lack of transparency in developing the opioid guidelines – which discourage primary care physicians from prescribing opioids for chronic pain. Since the guidelines were released in March, many pain patients have been taken off opioids or weaned to lower doses by their doctors. Others have been discharged by their doctors or coerced into more invasive pain treatments, such as spinal cord stimulators or epidural injections. 

A survey of pain patients released this week found that three out of four believe their pain is not being adequately controlled. Over half said they have contemplated suicide since the guidelines were released.

Virtually all of the nearly 2,000 patients surveyed – 97 percent – said they have never been addicted or required treatment for drug abuse. Reducing abuse and addiction are the primary goals of the CDC guidelines.  

Guidelines Webinar

The CDC also isn’t saying much about its decision to hire the University of Washington to help the agency conduct a series of training webinars this summer for healthcare providers to learn about the  guidelines. The agency did not say how much it is paying the university.

“Faculty and clinicians from the University of Washington School of Medicine were contracted to provide didactic and case-based training content and demonstrate and instruct providers on application of the Guideline in clinical settings,” Leland said. “University of Washington has had prior experience developing and disseminating clinical case studies to facilitate learning among clinicians on pain management for patients.”

Three of the four faculty members who have participated in the webinars are affiliated with Physicians for Responsible Opioid Prescribing (PROP), an organization that has lobbied the federal government for years to reduce opioid prescribing.

Jane Ballantyne, MD, is PROP’s president, and Mark Sullivan, MD, and David Tauben, MD, are PROP board members.

The fourth faculty member is James Robinson, MD, a professor of rehabilitation medicine who appears to have no association with PROP.  

“I believe in a rehabilitative approach to chronic pain,” Robinson is quoted as saying on the university’s website. “Key elements of this are empowering patients to optimize self-management of chronic pain disorders and encouraging them to take as much responsibility for self-management as is feasible.”

The University of Washington Medical Center received over $17.2 million last year for research, consulting, and grants from dozens of drug and medical device makers, many of which are involved in the field of pain management. Ballantyne, Sullivan and other faculty members at the university have previously played key roles in developing opioid regulations in the state of Washington, which has some of the toughest prescribing laws in the nation.

Since everyone chosen for the webinars appears to have a bias against opioid prescribing, we asked CDC why the agency was either unwilling or unable to have a more diverse panel of speakers. We were told CDC provides “timely, accurate, and credible information to clinicians.”     

“This webinar series was developed to be a continuing education training opportunity to increase clinicians’ knowledge and competencies on prescription drug overdose and offer evaluation and management strategies to help address the issue,” Leland said.

During a webinar held on Wednesday, the primary advice given to physicians was not to prescribe opioids for chronic pain and to taper patients off opioids if they’ve already started.

“A successful taper makes a patient much better able to function. And generally their experience is the pain level either doesn’t change or is actually improved,” Ballantyne said.

Survey: Opioids Reduced or Stopped for Most Patients

By Pat Anson, Editor

Over two-thirds of pain patients say their opioid medication has been decreased or stopped since the CDC adopted its opioid prescribing guidelines, according to a new survey that also found over half of the patients have considered suicide since the guidelines were implemented.

A total of 1,978 patients participated in the survey, which was conducted through social media and online support groups in recent weeks. The survey was designed by Lana Kirby, a Florida paralegal and chronic pain sufferer who became frustrated by difficulties she faced in obtaining opioid pain medication.

Although unscientific, the survey results are the first broad indication of the impact the CDC guidelines are having on both physicians and patients. Those guidelines, which discourage primary care doctors from prescribing opioids for chronic pain, are meant to be voluntary but are being widely implemented by many different prescribers, according to survey.

“To a person, respondents report that they feel humiliated, degraded, shamed, and stigmatized by the loss of choice over their physician patient alliance and program of care,” said Terri Lewis, PhD, a patient advocate and researcher who conducted an analysis of the survey.

“Many now acknowledge that their doctor’s appointment conversation is all about keeping the physician safe from DEA oversight or license restrictions as opposed to optimizing the consumer’s activity and functioning levels.”

"I am afraid to tell the doctor what I need," said one patient.

“My doctor said he is afraid of the DEA and CDC,” said another.

“My doctor said I cannot be cured so there is no point in treating me for pain,” wrote one patient.

"Because my doctor was arrested other doctors have refused to take on his patients for treatment," said another.

Over 68% of patients said their opioid pain medication has been decreased or discontinued since the  guidelines were released in March.  Nearly 45% were warned by their doctor that additional decreases will be necessary. And just over 50% said they had considered suicide as a way to end their pain.

“It is important to note that CDC’s guidelines are directed to primary care physicians with the suggestion that they should be cautiously and conservatively applied to chronic pain patients with complex needs. That message does not seem to have been received at the physician level, as both primary care and Board Certified pain management practitioners are uniformly applying extreme prescribing restrictions to the regimens of those who replied, even where they had been in long term successful treatment for extensive periods of time without difficulty,” said Lewis.

Other survey findings:

• 75% of patients said they are not receiving adequate pain control
• 57% said they had been discharge or abandoned by a doctor because they need opioid treatment
• 44% said they had problems getting a prescription filled at a pharmacy
• 90% said their pain levels, activities and social interactions have worsened
• 97% said they have never been addicted or required treatment for drug abuse

Nearly four out of ten patients (39%) said they had been told by a doctor that they must have an operation or invasive procedure, or they will be discharged from the practice or have their medications reduced.

“Increasingly, respondents are being threatened with pain care protocols that are not optimal, such as epidural injections (or) installation of durable medical equipment. If they refuse, their access to oral medications, even where they have been used impactfully, is systematically reduced or suspended,” said Lewis.

The CDC has had very little to say about the impact of guidelines since their release. As Pain News Network has reported, a top CDC official recently wrote a letter to one patient saying the guidelines were only meant as a “guide” for primary care providers “as they work in consultation with their patients.”

“The Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making,” wrote Debra Houry,  Director of the CDC’s National Center for Injury Prevention, which oversaw the guidelines’ development.

The ‘Cone of Silence’ Returns to CDC

By Pat Anson, Editor

The Centers for Disease Control and Prevention drew a lot of criticism last year for its secrecy and lack of transparency while drafting its controversial opioid prescribing guidelines. 

Closed-door meetings were held by the “Core Expert Group” and other CDC advisory panels, which included hardly any experts in pain management, but did have several addiction treatment doctors and longtime critics of opioid prescribing.

The CDC’s penchant for secrecy on such an important public health issue was mockingly compared by Stephen Ziegler to Get Smart’s “Cone of Silence.”

But it was only when the agency was accused of bias, blatant violations of federal law, and a Congressional investigation was launched that CDC appointed a new expert panel to review the guidelines -- which were released in March essentially unchanged from the draft version.

The CDC apparently didn’t learn much from the experience.

This summer the agency has been holding a series of training webinars to educate healthcare providers about the guidelines -- and it invited as speakers some of the very same people who were removed from the first expert panel because they were perceived as being too biased.  

For example, this week’s webinar on the benefits and harms of opioid therapy was led by Jane Ballantyne, MD, who is president of Physicians for Responsible Opioid Prescribing (PROP), and Mark Sullivan, MD, who is a PROP board member.  PROP has lobbied the federal government for years to reduce opioid prescribing.

MARK SULLIVAN, MD

“We really don’t have good evidence of long term benefit from opioid therapy, but we do know it creates serious problems,” Sullivan advised the physicians and pharmacists listening to the webinar.

“We don’t want to be giving patients a month or multiple refills of opioids for acute pain problems, because that’s where long-term opioid therapy gets started and is difficult to discontinue.”

Last year Sullivan and Ballantyne co-authored a controversial article in the New England Journal of Medicine that claimed reducing pain intensity should not be the primary goal of doctors when treating chronic pain. They believe that other quality of life issues, such as better sleep, mood and physical function, are more important.

“It’s so easy for someone who’s been on opiates for a long time to believe they need the opiate, because if they stop taking it the pain gets worse,” said Ballantyne, who maintains that long-term opioid patients should be slowly tapered to lower doses or off opioids entirely.

“A successful taper makes a patient much better able to function. And generally their experience is the pain level either doesn’t change or is actually improved,” she said.

Both Sullivan and Ballantyne are employed as professors at the University of Washington School of Medicine, which according to a webinar disclaimer “received a contract payment” from the CDC.

Another professor at the University of Washington who participated in the webinars, David Tauben, MD, is also a PROP board member and served on the CDC's peer review panel for the guidelines.

Ballantyne, Sullivan and Tauben’s involvement with PROP are not disclosed in the disclaimer and some of their conflict of interest statements also appear incomplete.

JANE BALLANTYNE, MD

Sullivan’s disclaimer states he is “consulting with Chrono Therapeutics concerning development and testing of an opioid taper device,” but it fails to mention over $15,000 in consulting fees and travel expenses Sullivan received in 2015 from Pfizer, Janssen, Purdue Pharma, Roxane Laboratories or Teva Pharmaceuticals, according to a Medicare database.

No outside income from drug and medical device makers was reported for Tauben or Ballantyne in 2015, although Ballantyne did serve a few years ago as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies over their opioid marketing practices.

The CDC disclaimer also fails to mention that the University of Washington Medical Center received over $17.2 million last year for research, consulting, and grants from dozens of drug and medical device companies, many of which are involved in the field of pain management and are directly impacted by the CDC guidelines. Ballantyne, Sullivan and other professors at the university played key roles in the development of opioid regulations in the state of Washington, which has some of the toughest prescribing laws in the nation.

Still, the CDC maintains that its planners reviewed the webinar content “to ensure there is no bias.”

Unanswered Questions

How much is the CDC paying the University of Washington and PROP activists to participate in its opioid webinars? Why is only one side of the opioid debate being offered by a federal health agency? We posed those questions to the CDC and have yet to get an answer. 

We’ve also been unable to learn from CDC how much the agency is paying a Seattle-based marketing firm called PRR, which is conducting a research and communications analysis about the impact of the prescribing guidelines. PRR handles marketing, research and public relations for dozens of government agencies.

“Yes, the CDC hired us to conduct this research but unfortunately that is all I can tell you at this time.  If you want to know more about the specifics of the study, it is best that you contact the CDC directly and they can answer your questions,” Katherine Schomer, a Research Group Account Director at PRR said in an email.

A source at PRR told Pain News Network that what the CDC really wants to know is why its opioid guidelines were so poorly received by the pain community and to find out "where they’ve gone wrong.”

“They’ve heard a lot of outrage about this, specifically from Pain News Network’s survey asking people with chronic pain how they felt about this. That in particular was something the CDC picked up on,” the source said. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”

That survey by PNN and the International Pain Foundation was conducted last fall, months before the CDC guidelines were finalized and released. Even then, many pain patients realized how disastrous the guidelines would be for them. 

Nearly 90% of the 2,200 respondents said they were worried or very worried that they would be unable to obtain opioid pain medication if the guidelines were implemented. Large majorities also predicted the guidelines would have a chilling effect on physicians; that doctors would prescribe fewer opioids or none at all; that use of heroin and other illegal drugs would increase; and that there would be more suicides in the pain community. 

Virtually all of those predictions have come true, with many patients complaining they are being weaned or taken off opioids, despite years of taking the medications safely.  Hundreds of thousands of counterfeit pain medications laced with fentanyl have appeared on the black market, enough to kill dozens of people and for the DEA to warn the nation is in the midst of a “fentanyl crisis.” 

Most disturbing of all are anecdotal reports of patients committing suicide because they are unable to obtain pain medication.

All of this is happening in plain sight, as the CDC conducts biased webinars and pays for marketing studies to figure out “where they’ve gone wrong” -- and while the agency refuses to acknowledge publicly that its guidelines have been harmful to patients and are being implemented far too widely.

The Cone of Silence indeed.

‘Wakeup Call’ for Neurontin Abuse

By Pat Anson, Editor

A drug that is often prescribed as an alternative to opioid pain medication is increasingly being abused by patients, according to a small study that found one out of five patients taking the drug illicitly.

Gabapentin – which is sold by Pfizer under the brand name Neurontin -- is approved by the Food and Drug Administration to treat epilepsy and neuropathic pain caused by shingles.

It is also prescribed “off-label” for a variety of other conditions, including depression, migraine, fibromyalgia and bipolar disorder.

In a study of urine samples from 323 patients being treated at pain clinics and addiction treatment centers, 70 patients were found to be taking gabapentin without a prescription.

“The high rate of misuse of this medication is surprising and it is also a wakeup call for prescribers. Doctors don’t usually screen for gabapentin abuse when making sure patients are taking medications, such as opioids, as prescribed. These findings reveal that there is a growing risk of abuse and a need for more robust testing,” said Poluru Reddy, PhD, medical director of ARIA Diagnostics in Indianapolis, IN. Reddy presented his study at the annual meeting of the American Association for Clinical Chemistry in Philadelphia.

Researchers found that of those patients taking gabapentin illicitly, over half (56%) were taking it with an opioid, about a quarter (27%) with an opioid and muscle relaxant or anxiety medication, and the rest with other substances. The urine samples came primarily from pain clinics in Indiana, Arizona, and Massachusetts.

“Little information exists regarding the significance of Gabapentin abuse among clinical patients. Until recently, it was considered to have little potential for abuse however this review has shown that a significant amount of patients are taking Gabapentin without physician consent. This could be due to the fact that recent studies have revealed that Gabapentin may potentiate the ‘high’ obtained from other central nervous system acting drugs,” wrote Reddy.

"Patient safety is Pfizer’s utmost priority.  We strongly support and recommend the need for appropriate prescribing and use of all our medicines," a spokesperson for Pfizer said in an email to Pain News Network.

Gabapentin is not scheduled as a controlled substance and when taken alone there is little potential for abuse. But when taken with other drugs, such as opioids, muscle relaxants, and anxiety medications like Valium and Xanax, researchers say gabapentin can have a euphoric effect.

Between 2008 and 2011 the number of emergency room visits for misuse or abuse of gabapentin increased by nearly five times, according to the Drug Abuse Warning Network. Side effects from gabapentin include weight gain, dizziness, ataxia, somnolence, nervousness and fatigue.

Increased Prescribing of Gabapentin

A report by IMS Health found that 57 million prescriptions for gabapentin were written in the U.S. in 2015, a 42% increase since 2011.

Gabapentin is one of several medications being promoted by the Centers for Disease Control and Prevention as a "safer"  alternative to opioids.  The American Pain Society recently recommended that gabapentin be considered for post-operative pain relief.

But the growth in gabapentin prescribing is drawing scrutiny in the UK, where the Advisory Council on the Misuse of Drugs (ACMD) recommended earlier this year that gabapentin and pregabalin (Lyrica) be reclassified as Class C controlled substances, which would make them harder to obtain.

“Both pregabalin and gabapentin are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants, they can cause drowsiness, sedation, respiratory failure and death,” said Professor Les Iverson, ACMD chairman, in a letter to Home Office ministers.

“Pregabalin causes a ‘high’ or elevated mood in users; the side effects may include chest pain, wheezing, vision changes and less commonly, hallucinations. Gabapentin can produce feelings of relaxation, calmness and euphoria. Some users have reported that the ‘high’ from snorted gabapentin can be similar to taking a stimulant.”

Gabapentin is "one of the most abused and diverted drugs” in the U.S. prison system, according to Jeffrey Keller, MD,  the chief medical officer of Centurian, a private company that provides prison healthcare services.

“Inmates show up at my jails all the time with gabapentin on their current medication list,” Keller wrote in Corrections.com. “It produces euphoria, a marijuana-like high, sedation, and, at high enough doses, dissociative/psychedelic effects. It works so well that it is used in the drug community to mellow out methamphetamine tweaking and to cut heroin. Since drug abusers know about these illicit uses of gabapentin on the streets, once they get to jail they often view gabapentin as an obtainable ‘jail substitute’ for their preferred drugs.

“Unfortunately, the abuse potential of gabapentin is not recognized much outside of jails and prisons. Community prescribers are generally unaware that gabapentin can be misused and (in my experience) are often incredulous and even disbelieving when told about ‘the dark side’ of gabapentin.”

Gabapentin (Neurontin) has a checkered history. Originally developed as a nerve drug, Pfizer agreed to pay $430 million in fines to resolve criminal and civil charges for illegally marketing Neurontin to treat conditions it was not approved for. According to some estimates, over 90% of Neurontin sales are for off-label uses.

In 1999, a Pfizer executive was so mystified by Neurontin’s popularity he called it the “snake oil of the twentieth century.”  

Fake Norco Nearly Killed California Woman

By Pat Anson, Editor

An article published online in the Annals of Emergency Medicine shows just how easy it is for someone to be fooled – and nearly killed – by counterfeit pain medication.

It tells the story of an unnamed 41-year old California woman who treats her chronic back pain with regular doses of Norco, a prescription medication that combines acetaminophen and hydrocodone.

She was one of dozens of people who died or were hospitalized in northern California after ingesting counterfeit Norco bought on the street that was laced with illicit fentanyl – a synthetic opioid that is 50 to 100 stronger than morphine.

"Street Norco is almost indistinguishable from brand-name Norco in appearance but can be lethal," said lead author Patil Armenian, MD, of the University of California San Francisco-Fresno.

"This new street drug's toxicity led to an unexpected cluster of fentanyl deaths in California this spring. These deaths in our area combined with an emergency patient who was concerned about pill appearance and exceedingly sleepy after her usual dose of medication led to our investigation."

The woman in question suffers chronic pain from a herniated disc and normally buys the Norco illicitly, 2 to 3 tablets at a time. The article does not explain why she buys them off the street.

The woman felt sleepy and became unconscious within 30 minutes of taking three of the counterfeit tablets. She next remembered waking up in a hospital emergency room. She told hospital staff the pills had the markings of Norco, but were beige in color instead of the usual white.

A blood serum analysis revealed the woman had significant amounts of fentanyl and U-47700, another type of synthetic opioid. Neither drug is an ingredient in brand-name Norco.

“Toxic effects of these compounds are similar to those of other opioids, namely, miosis, respiratory depression, coma, and possible death. To our knowledge, this is the first reported opioid toxidrome case with confirmed serum concentration of U-47700,” said Armenian, adding that the woman was discharged from the hospital and has completely recovered.

“This case highlights that fentanyl-laced Norco is spreading to other regions and may contain psychoactive ingredients other than fentanyl, such as U-47700, prompting emergency providers to remain vigilant in their care.”

As Pain News Network has reported, the Drug Enforcement Administration is warning the U.S. faces an unprecedented “fentanyl crisis” that is growing worse as drug dealers ramp up production of counterfeit medication. Dozens of Americans have died this year after ingesting counterfeit versions of oxycodone, Norco and Xanax that are virtually indistinguishable from the real medications. Even a few milligrams of fentanyl can be fatal.

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

Canada’s Fentanyl Crisis

Canada – which has been dealing with its own fentanyl crisis – may provide a preview of what’s in store for the U.S. Overdose deaths from fentanyl have reached such an urgent level that British Columbia Premier Christy Clark asked the federal government last week to restrict access to pill presses and to start screening “all small packages” entering the province for fentanyl. 

Earlier this year British Columbia declared a public health emergency and adopted new opioid prescribing guidelines that are even more stringent than those released by the Centers for Disease Control and Prevention.  

While the CDC’s guidelines are voluntary and intended only for primary care physicians, British Columbia’s guidelines are legally enforceable for all opioid prescribers because they set a “minimum standard of professional behaviour and ethical conduct.” The guidelines state that opioids should not be prescribed to treat headaches, fibromyalgia and low back pain.

In Ontario, the backlash against opioids has reached a point that palliative care doctors are worried they will no longer be able to give high doses to their patients – many of whom are dying from cancer and other chronic illnesses. Ontario’s Ministry of Health said public health plans next year would stop paying for high doses of hydromorphone, morphine and fentanyl patches.

“Our patients under palliative care deserve better than this,” Stephen Singh, MD, director of the Canadian Society of Palliative Care Physicians, told The Globe and Mail, adding that he was “appalled” by the government’s decision.

Study Depicts Half of Americans as Rx Abusers

 By Pat Anson, Editor

Over half of Americans “misused” their prescription drugs last year, according to a new report by a drug testing company that appears to draw several broad and misleading conclusions about the use of opioid pain medication.

Quest Diagnostics analyzed drug testing data from over 3 million patients and found that 54% had some type of prescription drug misuse in 2015 – down from 63% in 2011.

"The key takeaway from this massive, nationally representative analysis is that despite some gains, a large number of patients use prescription drugs inappropriately and even dangerously," said co-researcher Harvey W. Kaufman, MD, senior medical director for Quest Diagnostics.

"The CDC's recent recommendations to physicians to carefully weigh the risks and benefits of opioid drug therapy are a step in the right direction, but clearly more needs to be done to address this public health crisis."

The term “misuse” should be taken with a grain of salt, because it does not mean patients were abusing or addicted to prescription drugs – only that they did not take them as directed.

In 2015, for example, the study found that over half (55%) of the patients who had “inconsistent” test results did not have a prescribed drug in their system – meaning they no longer felt a need to take a medication, didn’t like the drug’s side effects, forgot to take it, or simply couldn’t afford it. It could also mean the drug was ineffective. the wrong drug was prescribed or the doctor made an incorrect diagnosis. There are literally dozens of reasons someone could stop taking a drug.

But patients who had no drugs detected – legal or illegal – were still classified in the “misuse" category.

Nevertheless, while acknowledging there were “methodology limitations” to the study, Quest made some sweeping conclusions about it in a press release, claiming that “the majority of American adults taking opioids and other commonly prescribed medications use them in ways that put their health at risk.”

But according to the study, opioids were not the most commonly misused class of medication. Depending on the age of the patient, that distinction went to amphetamines, benzodiazepines and marijuana. Opiates were the second most likely class of drugs to be misused by adults – but again that includes many patients who did not take opioids that were prescribed or had no drugs at all in their system.

This way of slicing the data has long been used by drug testing companies to make the abuse of opioids appear worse than it is and to justify more testing.

A similar study by Ameritox in 2012 found that nearly a third of older patients did not have a prescribed opioid detected in their urine -- and that was also considered misuse.

“This population has a risk of medication misuse and illicit drug use that warrants attention,” said Harry Leider, MD, who was then Chief Medical Officer of Ameritox. “This data provides a compelling rationale for routinely monitoring medication use in older patients on chronic opioids.”

Ameritox sponsored a study that same year claiming that patients should be drug tested at least four times annually if a doctor believes they are at risk misusing opioids.  The study was approved even though “there currently is a limited evidence base to support the expert panel’s recommendations.”

Guidelines adopted by the CDC earlier this year were also based on weak evidence. They recommend that physicians should use urine drug testing before starting opioid therapy and should re-test patients at least once annually.

As Pain News Network has reported, “point-of-care” urine drug tests that are widely used in doctors’ offices are wrong about half the time – frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone.

According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry -- “liquid gold” as some have called it – that is projected to reach $6.3 billion by 2019. The competition between drug screening labs is intense and several companies have been fined by the federal government for giving illegal kickbacks to physicians. Last year, Millennium Health agreed to pay $256 million to the federal government to settle fraud and kickback charges. The company later filed for chapter 11 bankruptcy protection.

‘No Opioids’ Hospital Gets Poor Medicare Rating

By Pat Anson, Editor

A New Jersey hospital touted for its policy of prescribing few opioid painkillers has received poor ratings from Hospital Compare, a Medicare website that tracks the quality scores of hospitals.

The one star overall rating for St. Joseph’s Regional Medical Center in Paterson, NJ puts it in the bottom 3 percent of hospitals nationwide.

St. Joseph rated below the national average on safety, complications, readmissions and deaths, patient experience, timeliness of care, and payment and value of care. The hospital was rated as average for mortality, effectiveness of care, and efficient use of medical imaging.

St. Joseph, which has one of the busiest emergency rooms in the nation, has received international attention for its Alternatives to Opiates program, which emphasizes treatments such as non-opioid pain relievers, trigger point injections, nerve blocks, music therapy and laughing gas (nitrous oxide). Opioid pain medication is only given as a last resort to ER patients.

St. Joseph’s opioid policy has been featured by CNN, The New York Times, National Public Radio, The Guardian and Agency French Presse (AFP). The hospital says it has received inquiries from around the world about its non-opioid alternatives.

"If you can sleep, if you can walk, then pain is not going to be your enemy. That's what our goal is, to make you functional in pain, not to eliminate it completely," St. Joseph’s Mark Rosenberg, MD, told AFP.

Medicare this week revised its Hospital Compare ratings for over 3,600 hospitals to make them more understandable and accessible to the public. Medicare bases its rating on 64 different quality measures and summarizes them into a unified rating of one to five stars. You can see how your own hospital is rated by clicking here.

“We have received numerous letters from national patient and consumer advocacy groups supporting the release of these ratings because it improves the transparency and accessibility of hospital quality information. In addition, researchers found that hospitals with more stars on the Hospital Compare website have tended to have lower death and readmission rates,” Medicare said in a statement.

St. Joseph is one of 133 hospitals in the country given a one-star rating. Sixteen percent of hospitals received two stars, 38% received three stars, 20% received four stars and only about 2% received the highest rating of five stars. There wasn’t enough data to give the remaining hospitals a rating.

The American Hospital Association unsuccessfully lobbied to block the new ratings from being released, saying they unfairly penalized teaching hospitals and those that serve low-income areas.

Patient Satisfaction Surveys

In Medicare patient satisfaction surveys, conducted before St. Joseph’s opioid policy went into effect, patients generally gave the hospital below average ratings on issues such as pain care. Only 68 percent of patients said their pain was “always” well controlled at St. Joseph, and only 69 percent said they would definitely recommend the hospital.

Medicare recently announced that it would revise the pain questions on patient surveys, after politicians and anti-opioid lobbying groups complained that they promote opioid overprescribing. A Medicare funding formula requires hospitals to prove they provide quality care through patient surveys. The formula rewards hospitals that provide good care and are rated highly by patients, while penalizing those that are not. 

Critics claimed that three pain questions in the survey -- known as the Hospital Consumer Assessment of Healthcare Providers and Systems survey (HCAHPS) -- encourage doctors to overprescribe opioid pain medication to boost their hospital's scores.

Medicare officials said there was no evidence of that, but they would develop alternative questions about pain care for the survey. Public comments on the proposed change will be accepted until September 6, 2016. You can submit a comment by clicking here.

Sen. Wyden 'Hypocritical' About Healthcare Funding

By Pat Anson, Editor

Sen. Ron Wyden, who has raised serious allegations of bias and conflict of interest on federal health panels, has accepted nearly $2.7 million in campaign donations from the healthcare and insurance industries that he helps regulate, according to a review of campaign donations by Pain News Network.

Wyden accepted $2,060,004 from donors affiliated with pharmaceutical companies, hospitals, HMO’s, and healthcare professionals from 2011 to 2016, along with $636,861 from the insurance industry, according to OpenSecrets.org, which keeps a tabulation of campaign donations.

Some of Wyden's biggest donors were Blue Cross/Blue Shield, MetLife, Prudential and the American Health Care Association, which represents thousands of nursing homes.

The Oregon Democrat is the senior ranking minority member of the Senate Finance Committee, which has broad jurisdiction over tax and financial issues effecting healthcare and insurance, as well as Medicare, Medicaid and Obamacare.

“Senator Wyden himself is funded in part, by insurance companies and Pharma. Isn't it hypocritical for him to be critical of others with connections to Pharma? Why is there a different standard for him?” asks Lynn Webster, MD, former president of the American Academy of Pain Medicine.

“Senators shouldn’t be calling the kettle black. Senators should set an example for the rest of the country with regard to being free of conflicts of interest,” said patient advocate David Becker.

In recent months, Wyden has challenged the integrity of several pain experts and patient advocates on federal advisory committees, alleging they have a conflict of interest because they belong to organizations that accepted funding from drug makers.

He recently pressured the National Academy of Medicine to remove two doctors from a panel formed to advise the Food and Drug Administration about its policies on opioid pain medication.

SEN. RON WYDEN

In a lengthy letter to the president of the National Academy of Medicine, which appointed the panel, Wyden wrote that Dr. Gregory Terman and Dr. Mary Lynn McPherson both had “potential conflicts of interests and bias” because they belonged to organizations “with substantial ties to the pharmaceutical industry, specifically, opioid manufacturers.”   

Terman is the immediate past president of the American Pain Society (APS), which accepted over $350,000 in donations from drug makers in 2013, according to Wyden’s letter.  The senator listed Purdue Pharma, AstraZeneca, Endo, Pfizer and several other companies as APS donors.

Wyden said McPherson, a professor at the University of Maryland School of Pharmacy, also had significant ties to drug makers, and “received grants and residencies worth at least $300,000 that were sponsored – or paid directly – by opioid manufacturers.” 

Both Terman and McPherson were removed from the advisory panel within days of Wyden’s letter, along with two other doctors who specialize in pain management.

“It is incredibly hypocritical and disingenuous for anyone who accepts that much Pharma money to try to demonize the leadership of pain societies for accepting Pharma support, especially when there is no one else who will fund these societies,” said Michael Schatman, editor-in-chief of the Journal of Pain Research. “Greg Terman is ethically beyond reproach and exercised ethical leadership during his tenure as APS President.”

"Any implication that Dr. McPherson or her work has been compromised by association with pharmaceutical companies is deeply misguided," a University of Maryland spokesman said in a statement to the Associated Press.

"Serious Concerns" About Objectivity of Pain Panel

Wyden has raised similar concerns about conflicts of interest on the Interagency Pain Research Coordinating Committee (IPRCC) a federal panel that advises the government on pain care policies.

At a meeting last December, several members of the IPRCC were sharply critical of opioid guidelines then being developed by the Centers for Disease Control and Prevention, which discourage doctors from prescribing opioids for chronic pain. IPRCC members called the evidence used to justify the guidelines “ridiculous” and an “embarrassment to the government.”

INTERAGENCY PAIN RESEARCH COORDINATING COMMITTEE (iprcc)

That brought a rebuke from Wyden, who claimed in a February letter to Health and Human Services (HHS) Secretary Sylvia Burwell that he had “serious concerns about the objectivity of the panel’s members” and claimed they were trying to “weaken efforts” at CDC to rein in opioid prescribing. 

Wyden’s letter mentioned several members of the panel, including two patient advocates: Cindy Steinberg of the U.S. Pain Foundation and Penny Cowan of the American Chronic Pain Association. Both organizations are non-profits that accept donations from drug makers.

“I do not and have never been paid by a pharmaceutical company,” said Steinberg in an email to PNN. Steinberg, who suffers from chronic back pain, is National Policy Director for U.S. Pain Foundation and receives a small stipend of about $8,000 a year from the organization.

“I do this work despite my daily, debilitating chronic pain, often needing to lie flat in meetings to control the pain and lay across two plane seats to travel because I am passionate about improving pain care in this country,” said Steinberg.

Unhappy with the response to his first letter, Wyden followed up with another letter to Burwell last month, saying he had serious concerns about the agency’s “flawed conflict of interest policy.”

“Americans expect significant transparency when it comes to government policy making, particularly for an issue like the opioid crisis which is devastating communities in Oregon and across the country,” Wyden said in a statement. “I’m going to continue to demand accountability to ensure the manufacturers of these powerful prescription drugs aren’t having an undue influence on policies designed to reduce their usage.”

“Senator Wyden is misguided,” says Lynn Webster.  “I find irony in his attempt to purge members of the IRPCC that may have a different view than his just because they are associated with Pharma grants. It is anti-democratic.  We should invite different views not exclude them.”

Ironically, the CDC itself has been accused of bias for secretly impaneling a committee to help draft the guidelines and for holding a much maligned webinar for addiction treatment clinics, pharmacies, insurers and other special interest groups to provide input on the guidelines.

The CDC has a foundation that received over $157 million last year from donors, including Abbott Laboratories, Amgen, Medtronic, Johnson & Johnson, Merck, Quest Diagnostics and Pfizer, all companies which stand to benefit from the prescribing guidelines because they offer non-opioid treatments or tests.  The FDA also has a foundation that has accepted millions of dollars from many of the same companies.

“If Senator Wyden really wants to sanitize the panel, he will need to ask for removal of anyone who also has ties to insurance payers, including Medicare,” says Webster. “Since the FDA and CDC receive money from payers and Pharma, they should be stricken from the panel, too.  In fact since Medicare is a payer, anyone within HHS should not be allowed to be on the panel. They are too biased.”

Wyden’s one man campaign against bias recently led the FDA to revise its conflict of interest guidelines for advisory panels.  The proposed guidelines state that someone could be removed from a committee if there is any “appearance” of conflict, such as a non-profit accepting money from a company involved in a panel’s deliberations.

“This is an interest or relationship that could cause a reasonable person to question the member’s impartiality,” the guidelines state.

But activists say weeding out even the appearance of conflict could eliminate needed input from a medical or scientific expert, or a patient who would be directly impacted by FDA policy.  Virtually every medical school, professional association and non-profit involved in healthcare has accepted industry funding.

“The people who are most active in helping make change do have costs associated with their activities,” said Barby Ingle, President of the International Pain Foundation (iPain), a non-profit advocacy group that accepts industry funding. “Many people in the chronic pain community are low income and are not able to donate to charities to keep them going. Stopping grant funding would cut off the patient voice, which is already limited due to the physical condition of many chronic pain patients.”

“Eliminating people who have any association with Pharma is, in essence, stacking the deck. It creates a special interest group that’s empowered to influence prejudicial policy. This attempt to limit bias is creating bias,” says Webster.

Webster, who is vice president of scientific affairs at PRA Health Sciences, has himself been a frequent target of conflict of interest claims. According to a database maintained by Medicare, Webster received over $1.5 million in funding from healthcare companies last year for consulting fees, travel expenses, and research funding.

In 2012, Webster and several other prominent pain physicians were targeted in a Senate Finance Committee investigation that looked into allegations that drug makers bankrolled misleading marketing information about opioids and helped create the opioid abuse epidemic.  That investigation quietly ended without any hearings or an official report.

Four years later, critics are still demanding that documents related to the investigation be released. A Wyden spokesman recently suggested the investigation could be re-opened.

“Senator Wyden, now the ranking member of the minority, is deeply committed to curtailing the crisis of opioid addiction, and that includes holding accountable those who contributed to its rise in the first place,” said Wyden spokesman Taylor Harvey in STAT. “The documents related to the 2012 investigation are currently being reviewed by Democratic investigations staff. Senator Wyden intends to take official action related to this investigation.”

Wyden Campaign Donations Doubled

In his deep blue state of Oregon, Wyden is widely expected to be re-elected this fall. And if Republicans lose control of the Senate, he would emerge as the powerful new chair of the Senate Finance Committee.

That’s one reason why Wyden’s campaign donations have nearly doubled in recent years. The senator has received over $13 million from donors and political action committees, and has over $7.7 million in cash on hand, according to his campaign committee’s latest report.

Only four percent of the money raised so far has come from small, individual donors. Over $6 million has come from large individual contributions and another $3 million has come from PAC’s.

Donors affiliated with Blue Cross/Blue Shield ($124,500) are Wyden’s single biggest contributor, followed by Nike ($123,322), Intel ($73,807), the lobbying firm of Akin Gump ($68,155) and the physicians’ group DaVita HealthCare Partners ($64,750).

Other contributors to Wyden from the insurance and healthcare industries include MetLife ($47,507), Prudential ($37,500), nursing home operator Prestige Care ($36,000), Kindred Healthcare ($37,700) and Vibra Healthcare ($35,300). The latter two operate patient rehabilitation centers.

Wyden is by no means alone in raising substantial campaign donations. The current chairman of the Senate Finance Committee, Utah Republican Orrin Hatch, has raised over $14.5 million in campaign contributions,  according to OpenSecrets.org, and Hatch isn’t even up for re-election until 2018. Blue Cross/Blue Shield, Pfizer, Amgen and several other healthcare companies are some of Hatch’s biggest contributors

While there doesn’t appear to be anything illegal about these donations and they are a matter of public record, patient advocates like Barby Ingle say Wyden’s fundraising and potential conflicts of interest should get the same kind of scrutiny he demands of others.

“There have been times iPain has turned down funding from companies and private donors because there were strings attached to accepting the funding,” says Ingle. “I wonder now, has a legislator ever turned down donations because they were given with strings attached? I do believe it is a conflict of interest if a majority of operational funds for the nonprofit come from pharmaceutical companies, but the rule should apply to legislators as well.”

A request for comment on this story from Wyden’s office went unanswered.

DEA: U.S. Facing ‘Fentanyl Crisis’

By Pat Anson, Editor

The United States is facing an unprecedented “fentanyl crisis” that is likely to grow worse as drug dealers ramp up production of counterfeit pain medication made with illicit fentanyl, according to a new report from the Drug Enforcement Administration.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is legally prescribed in patches and lozenges to treat severe chronic pain, but illicit fentanyl has recently emerged as a fast-growing scourge on the black market, where it is increasingly being used in the manufacture of counterfeit drugs.

“The counterfeit pills often closely resemble the authentic medications they were designed to mimic, and the presence of fentanyls is only detected upon laboratory analysis,” the DEA warns in the unclassified report.

“Fentanyls will continue to appear in counterfeit opioid medications and will likely appear in a variety of non-opiate drugs as traffickers seek to expand the market in search of higher profits. Overdoses and deaths from counterfeit drugs containing fentanyls will increase as users continue to inaccurately dose themselves with imitation medications.”

Dozens of Americans have died this year after ingesting counterfeit versions of oxycodone, Norco and Xanax, which are virtually indistinguishable from the real medications. Even a few milligrams of fentanyl can be fatal.

Tennessee bureau of investigation

The DEA said “hundreds of thousands of counterfeit prescription drugs” laced with fentanyl were on the market and predicted more would be produced because of heavy demand and the “enormous profit potential” of fake medication.

“The seizures of fentanyl-laced pills and clandestine pill press operations all across North America indicate that this is becoming a trend, not a series of isolated incidents,” the DEA said.

The report highlighted the fact that U.S. forensic laboratories tested over 13,000 seized drugs containing fentanyl in 2015, up sharply from less than a thousand cases two years earlier.

The DEA said counterfeit pills are being smuggled into the U.S. from Mexico and Canada. Traffickers usually purchase powdered fentanyl and pill presses from China, and pill press operations have recently been found in Los Angeles and New York.

The counterfeit drugs problem is so serious the DEA believes it is undermining efforts to limit opioid prescribing.

“The arrival of large amounts of counterfeit prescription drugs containing fentanyls on the market threatens to devalue such initiatives and replaces opioid medications taken off of the street,” the DEA said. “Although not all controlled prescription drug users eventually switch to heroin, fentanyl-laced pills give DTOs (drug trafficking organizations) broader access to the large controlled prescription drug user population, which is reliant upon diversion of legitimate pills. This could undermine positive results from the state Prescription Drug Monitoring Programs, as well as from legislative and law enforcement programs.”

As Pain News Network has reported, Massachusetts and Rhode Island recently said fentanyl was to blame for nearly 60 percent of their opioid overdose deaths.

Senators Urge DEA to Reduce Supply of Opioids

A group of U.S. Senators is urging the DEA to "aggressively combat the opioid epidemic," not by going after fentanyl traffickers, but by making legal opioids even harder to get.

In a letter to acting DEA administrator Chuck Rosenberg, Senators Dick Durbin (D-IL) Sherrod Brown (D-OH), Edward Markey (D-MA), Amy Klobuchar (D-MN), Angus King (I-ME), and Joe Manchin (D-WV) urged the agency to tighten its annual quotas for manufacturers to produce controlled substances.

"In effect, DEA serves as a gatekeeper for how many opioids are allowed to be legally sold every year in the United States. Yet, for the past two decades, DEA has approved significant increases in the aggregate volume of opioids allowed to be produced for sale," the letter states.

The Senators urged the agency to rollback a 25 percent increase in production quotas for Schedule II opioids that was implemented in 2013. Schedule II opioids include hydrocodone, a widely prescribed painkiller that was reclassified from a Schedule III to a Schedule II drug in 2014.

The Senators also said the DEA should make a mid-year adjustment in the quota to immediately reduce the supply of prescription opioids. The letter did not address the fentanyl crisis or the rapid growth in counterfeit medication.

Lower Back Pain Linked to More Drug Use

By Pat Anson, Editor

People with chronic lower back pain are more likely to have used illicit drugs -- including marijuana, cocaine, heroin and methamphetamine -- compared to those without back pain, according to new research published in the journal Spine.

The study also found that people with lower back pain who had used illicit drugs were somewhat more likely to have an active prescription for opioid pain medication (22.5% vs. 15%).

Lower back pain is the world’s leading cause of disability and most people will suffer from it at least once in their lives. Although nearly a quarter of the opioid prescriptions written in the U.S. are for low back pain, medical guidelines often recommend against it.

Researchers analyzed data from over 5,000 U.S. adults who participated in a nationally representative health study and found that nearly half (49%) of those who reported lower back pain admitted having a history of illicit drug use, compared to 43% of those without back pain.

Current use of illicit drugs (within the past 30 days) was much lower in both groups; 14% versus nine percent.

The study did not differentiate between recreational and medical marijuana use, nor did it draw a distinction between marijuana use in states where it is legal and where it is not. All marijuana use was considered "illicit."

All four illicit drugs in the survey were more commonly used by people with low back pain compared to those without back pain. Rates of lifetime use were 46.5% versus 42% for marijuana; 22% vs. 14% for cocaine; 9% vs. 5% for methamphetamine; and 5% vs. 2% for heroin.

Researchers said there was no evidence that illicit drug use causes lower back pain, only that there was an association between the two that bears watching when opioids are prescribed.

“The association between a history of illicit drug use and prescription opioid use in the cLBP (chronic lower back pain) population is consistent with previous studies, but may be confounded by other clinical conditions,” said lead author Anna Shmagel, MD, Division of Rheumatic and Autoimmune Diseases at the University of Minnesota.

“Mental health disorders, for example, have been associated with both illicit substance use and prescription opioid use in the chronic low back pain population. In the context of management, however, illicit drug abuse is predictive of aberrant prescription opioid behaviors. As we face a prescription opioid addiction epidemic, careful assessment of illicit drug use history may aid prescribing decisions.”

In a recent analysis of prescriptions filled for 12 million of its members, pharmacy benefit manager Prime Therapeutics found that nearly a quarter of the opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

In a 2014 position paper, the American Academy of Neurology said opioids provide “significant short term pain relief” for low back pain, but there was “no substantial evidence” that long term use outweighs the risk of addiction and overdose.

Woman Arrested in California Fentanyl Investigation

By Pat Anson, Editor

A 50-year old northern California woman has been arrested for drug trafficking after a federal grand jury indicted her for illegal possession and distribution of hydrocodone and fentanyl.  Mildred Dossman was arrested at her home in Sacramento. She faces up to 20 years in prison and a $1 million fine if convicted.

Federal prosecutors did not reveal many details in the indictment, but Dossman’s arrest appears to be connected to a wave of fentanyl overdoses earlier this year that killed at least 12 people and hospitalized dozens of others in the Sacramento area.

The fentanyl involved in those deaths was disguised as Norco, a prescription pain medication that combines hydrocodone with acetaminophen.

Dossman was allegedly involved in drug deals on January 18 and March 25 of this year – which fits the timeline of the fentanyl overdoses.

Fentanyl is a powerful opioid that is 50 to 100 times more potent than morphine. It is prescribed legally in patches and lozenges to treat severe chronic pain, but illicitly manufactured fentanyl is fast becoming a scourge across the U.S. and Canada, where it is blamed for thousands of fatal overdoses.  

In addition to the counterfeit Norco, fentanyl has also been found in fake oxycodone and Xanax tablets. The counterfeit medication appeared on the streets at about the same time the Centers for Disease Control and Prevention released controversial guidelines that discourage doctors from prescribing opioids for chronic pain.

“I've had one of these so called super Norco’s,” a 25-year old Sacramento man told Pain News Network in March.  “It had the markings of a regular prescription, M367. I only took a half just in case because of the news from the day and luckily I did. It was unlike any high I've had. It made me dizzy.  I couldn't see straight or sleep.”

“David” bought 16 of the fake Norco pills from a friend for $5 each, not knowing he was actually getting fentanyl. He initially began taking opioid pain medication for a herniated disc several years ago, but switched to street drugs after being abruptly cut off by his doctor. 

“I tried everything to get more and more prescription drugs prescribed. After that I had no choice but to turn to the street. It's a huge problem here in Sacramento,” said David. “Now there is such a high demand for the pills because of the increased regulations on them and not being able to scam an early refill. It has caused the price to spike on the streets and as soon as the word gets out someone has them they are immediately sold for ridiculous prices. It’s not all addicts and not all pain patients. The doctors around here are cutting people down on the amount they are prescribed, causing them to have nowhere else to turn but the neighborhood dealer.”

A DEA spokesman told PNN last month the U.S. was being “inundated” with illicit fentanyl, particularly in the Midwest and northeastern states. Massachusetts, Rhode Island, Ohio and Delaware recently reported an “alarming surge” in fentanyl related deaths. In some states, the number of deaths from fentanyl now exceeds those from prescription opioids.

“We think fentanyl and fentanyl overdoses have been underreported over the years in a lot of places. But we think people are now starting to pay more attention to it,” said DEA spokesman Rusty Payne.

CDC: Opioid Guidelines 'Not a Rule, Regulation or Law'

By Pat Anson, Editor

It’s no secret in the pain community that many patients are being taken off opioid pain medication or weaned to lower doses because of an overzealous reaction by doctors to the CDC’s opioid prescribing guidelines.

Those guidelines – which discourage opioid prescribing for chronic pain -- are meant to be voluntary and are intended only for primary care physicians. Yet they are having a chilling effect on many doctors and their patients.

One such patient, a retired Nevada pharmacist who took high doses of opioids for years for chronic back and hip pain, refused to be silent when his pain management doctor abruptly lowered his dosage to 90 mg (morphine equivalent) a day – the highest dose recommended by the CDC.  

Richard Martin wrote 27 letters to the CDC and didn’t mince words, saying doctors in the Las Vegas area “are scared shitless that the DEA will get them” and that their malpractice insurance rates would skyrocket if they didn’t follow the guidelines to the letter.

“All of you at the CDC and like-minded groups, individuals, etc. are causing hundreds of thousands if not millions of people to suffer in pain needlessly,” wrote Martin.

“The medical community has failed me. I was stable on my opioid regimen for over 6 years. No tolerance, no cheating, no hyperglasia and a pretty good quality of life. Last year my primary MD up and told me to go to a pain specialist. He would no longer provide me with opioid prescriptions. The first thing the pain doctor did was decrease my opioids. Of course I am in much more pain now. Due to my decreased level of activity my blood sugar levels have spiked. I used to be able to walk up to 3 miles every other day. Now I can’t go walking. I may have to start taking insulin.”  

To see all of Martin’s letter, click here.

Martin received two responses from the CDC. One appears to be nothing more than a form letter, in which a CDC official blandly wrote, “We are sorry to hear about your health problems.”

The other letter was from Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention, which oversaw the guidelines’ development. In her letter, Houry appears to acknowledge that the guidelines are being too widely implemented by doctors.

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain,” wrote Houry.

“Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

To see Houry’s letter in its entirety, click here.

Martin wrote back to Houry and challenged her to address the issue of patients being abruptly weaned from opioids more publicly.

DEBRA HOURY, MD

“My pain management doctor and his group are quoting your guidelines and more or less cowardly blaming you for the problem. Personally, I think they may be using this as an excuse to get rid of Medicare patients and perform more interventional injections or procedures,” he wrote in his follow-up letter, which you can see by clicking here.

“The CDC, in my opinion, should change the dosing guideline… The CDC should EMPHASIZE as you stated ‘The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication.’”  

Martin has yet to receive a response from Houry. When Pain News Network contacted the CDC about the letters, we were encouraged to post them. But the agency declined an offer to explain its position further.

Martin’s letter writing campaign hasn’t ended. He’s written to the American Association of Retired Persons (AARP) about the “huge tragedy unfolding across America” and has been contacted by Pharmacy Today magazine about having one of his letters published.

Patient Survey about CDC Guidelines

Another pain patient who is fighting back is Lana Kirby, a 60-year old retired paralegal who suffers from chronic back pain and several other chronic illnesses. Kirby and her husband recently moved to Florida, but found she can't find a doctor in that state willing to prescribe the pain medication she needs. So every three months, Kirby drives back to her home state of Indiana to see a doctor and get her prescriptions filled.

“In all my years as a paralegal, I've never seen anything like this,” she told PNN.  “Quite frankly, if an attorney were to take this to Federal Court, it would be a slam dunk due to the damages occurring on an ongoing basis and the ‘avoidable decline.’ We all know it costs a lot more to take care of a bedbound person than someone who can take care of themselves.  And if that means using opioids, that is the way it should be.  But as far as I know, no one has found an attorney with the resources to take on a case like this.”

Kirby is conducting an online survey of pain patients, asking if their opioid doses have been lowered since the CDC guidelines came out or if they have been discharged or abandoned by their doctors.

“The reason I did the survey was because I was talking to hundreds of pain patients everyday online and they all were saying the same thing,” she said. “Having a legal background, I felt that the damages needed to be documented and quantified in order to prove what was going on and the volume of people affected.”

To take Kirby’s survey, click here.

Lies, Damned Lies, and Overdose Statistics

By Pat Anson, Editor

“There are three kinds of lies: Lies, damned lies, and statistics.”

That famous quote, often attributed to British Prime Minister Benjamin Disraeli, was first used by Mark Twain in 1906. One hundred and ten years later, we still don’t know who said it first or why.

Which brings us to overdoses -- and the confusing, sometimes exaggerated, and often contradictory statistics on how many Americans are dying daily from opioid pain medication.  

According to the nation’s news media, anywhere from dozens to hundreds of Americans are dying every day from drug overdoses -- or as the Los Angeles Times boldly claimed today, “Overdose deaths now total 130 every day, or roughly the capacity of a Boeing 737.”

A Boeing 737? Really?

According to Boeing, a 737 can hold between 85 and 215 passengers, depending on the model. But maybe the Times is just giving us a ballpark estimate -- which may be entirely appropriate, given the muddled and murky reporting we get on overdoses.

The Times story got me curious about how other news organizations are reporting the overdose numbers. Here is a sampling:

“100 Americans die of drug overdoses each day.” The Washington Post

 “Dozens of Americans die daily from overdoses of pain relievers, heroin and other opioids.” Associated Press

“The United States averages 110 legal and illegal drug overdose deaths every day.”  Pittsburgh Post Gazette

“The number of these deaths reached...  about 125 Americans every day.” New York Times

 “More than 120 Americans die of opiate overdoses every day.” Logan Daily News

           “44 people in the U.S. die every day from overdose of prescription painkillers.” Des Moines Register

“More than 40 Americans die every day from prescription opioid overdoses.” Fox News

“Roughly 78 Americans die every day from overdoses of opioids.” Fox News

Yes, that’s right, Fox News reported two different estimates. To be fair, the numbers depend on whether you're counting all drug overdoses, opioid overdoses alone, or just prescription painkiller overdoses. Still, the numbers are all over the map and probably confusing to most readers.

Advocacy groups and politicians also play the numbers game:

“Every day, 46 Americans die from using prescription painkillers.” American Association of Retired Persons

“Every day, about 60 people die from opioid overdoses -- 44 from narcotic painkillers and 16 from heroin.” Physicians for Responsible Opioid Prescribing

“Over 130 Americans die every day from opioid and heroin overdoses.”  The Police Assisted Addiction Recovery Initiative

“Each day, 129 people die from drug overdoses in our country.”  Sen. Patrick Leahy (D-Vermont)

“Every day, 51 Americans die as a result of prescription opioid overdose.” Sen. Joe Manchin (D-West Virginia)  

So who is right? According to the Centers for Disease Control and Prevention, 28,647 Americans died from opioid overdoses in 2014, which works out to about 78 per day -- the number most often reported by the nation’s news media.

It is also a very misleading number, because many of those deaths include overdoses from heroin, illicit fentanyl and other illegal opioids. Take out the illegal drugs and the CDC admits that only about “half of all opioid overdose deaths involve a prescription opioid.”

That estimate too is misleading, because some heroin and illicit fentanyl deaths are wrongly reported as prescription opioid overdoses, because the coroner or medical examiner never actually performed a toxicology test on the deceased. The CDC admits that as well, but not too loudly.

So the next time you see someone report on the number of overdose deaths in the United States (and tries to fill a Boeing 737 in the process), remember that quote about “Lies, damned lies, and statistics.”

And thank either Mark Twain or Benjamin Disraeli for reminding us that statistics don’t always tell the truth.

Two Drug Combo More Effective for Fibromylagia

By Pat Anson, Editor

Two drugs commonly prescribed for fibromyalgia – Lyrica and Cymbalta – are more effective in treating the disorder when used together, according to a new study by Canadian researchers.

Lyrica (pregabalin) is an anti-seizure nerve drug, while Cymbalta (duloxetine) works primarily as an anti-depressant. Both have been used for years to treat fibromyalgia -- a poorly understood disorder characterized by deep tissue pain, fatigue, insomnia, and mood swings. Until now no one has studied how effective the two drugs could be when used in combination.

"We are very excited to present the first evidence demonstrating superiority of a duloxetine-pregabalin combination over either drug alone," said lead author Ian Gilron, MD, Director of Clinical Pain Research at Queen’s University in Kingston, Ontario.

“The results of this trial suggest that combining pregabalin with duloxetine can safely improve outcomes in fibromyalgia including pain relief, physical function and overall quality of life.”

This was a small study – only 41 fibromyalgia patients participated – and the researchers admit that larger trials are needed to see if the results can be replicated. The new research was published in the journal Pain.

The study is the latest in a series of clinical trials -- funded by the Canadian Institutes of Health Research -- which Gilron and his colleagues have conducted on combination therapies for chronic pain conditions. By studying promising drug combinations, they hope to show physicians how to make the best use of current treatments.

"The value of such combination approaches is they typically involve drugs that have been extensively studied and are well known to health-care providers," says Gilron.

Patients in the study were divided into three groups that either took pregabalin alone, duloxetine alone or a combination of the two for six weeks. Doses were gradually increased in the study to the maximum tolerated dose. When used in combination, patients could only tolerate relatively low doses of pregabalin and duloxetine, suggesting the drugs have an overlap effect when used together.

“The pharmacological diversity of a pregabalin-duloxetine combination is a mechanistically appealing feature that increases the likelihood of additive analgesic actions although there could similarly be some additive adverse effects with this combination. Even at significantly lower doses during combination therapy, superior global pain relief during combination therapy would suggest a greater additive effect for pain reduction than for side effects,” said Gilron.

The biggest side effect of the pregabalin-duloxetine combination was drowsiness, and the researchers admit that reduced physical activity caused by drowsiness could have contributed to pain reduction. 

Patients have long complained of other side effects from pregabalin and duloxetine when used separately, such as weight gain, nervousness, and brain fogginess. Many have also reported severe withdrawal symptoms and “brain zaps” when trying to get off the drugs. The study apparently didn’t address those issues. 

Lyrica (pregabalin) is one of Pfizer’s top selling drugs and generates over $5 billion in revenue annually. In addition to fibromyalgia, Lyrica is approved by the Food and Drug Administration to treat chronic pain associated with epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury. The drug is also prescribed “off label” to treat lumbar spinal stenosis, the most common type of lower back pain in older adults.

Cymbalta (duloxetine) generated sales of $5 billion for Eli Lilly until its patent expired in 2013 and cheaper generic versions of duloxetine became available. Cymbalta is approved for fibromyalgia, neuropathy, osteoarthritis, depression and anxiety.

Only one other medication – Savella – is approved by the FDA for fibromyalgia, but it is not as widely used as the other drugs.

Fibromyalgia was initially thought to be a musculoskeletal disorder, but research now suggests it's a disorder of the central nervous system - the brain and spinal cord. Researchers believe that fibromyalgia amplifies painful sensations by affecting the level and activity of brain chemicals responsible for processing pain signals. It affects twice as many women as men.