Will New Laws Punish Pain Patients?

By Pat Anson, Editor

Recent efforts by state and federal lawmakers aimed at punishing drug traffickers could wind up sending people to prison simply for seeking pain relief, according to critics.

This week the American Kratom Association (AKA) sent an action alert to members warning that a bill introduced by Sen. Chuck Grassley and Sen. Dianne Feinstein could be a “backdoor way” of banning kratom -- an herbal supplement that millions of people use as an alternative to opioid painkillers.

The “Stop the Importation and Trafficking of Synthetic Analogues Act of 2017” – also known as the SITSA Act – would give the Attorney General the power to list as a “Schedule A” substance any unregulated drug that has a chemical structure similar to that of a drug already listed as a controlled substance. A similar measure has been introduced in the House.

The bills are ostensibly aimed at banning chemical cousins or “analogues” of fentanyl, a powerful synthetic opioid blamed for thousands of overdose deaths that is increasingly appearing on the black market.

But kratom supporters fear the SITSA Act could also be used to ban kratom, something the Drug Enforcement Administration tried unsuccessfully to do last year, claiming it was an "opioid substance" with “a high potential for abuse.” Kratom is not an opioid, but it has opioid-like properties that reduce pain or act as a stimulant or depressant – much like a controlled substance.

“So now the anti-kratom bureaucrats in Washington want to ban kratom simply by claiming it has the same effects as an opioid – calling it an ‘analogue’ of the opioid,” said Susan Ash, the AKA’s founder and spokesperson. “After everything that we’ve fought successfully against and endured together as a movement, our lobbyists are concerned that this is now the perfect storm for banning kratom.”

Ash wants the SITSA Act to be amended to exclude natural botanicals like kratom. In its current form, she says the bill could impose prison sentences of up to 20 years for importers or exporters of kratom, which is made from the leaves of a tree that grows in southeast Asia.

Florida Law Stiffens Penalties for Fentanyl

A new law in Florida is also intended to crackdown on fentanyl dealers, but critics say it could wind up sending unsuspecting pain patients to prison as well.

Signed into law yesterday by Gov. Rick Scott, it requires mandatory minimum sentences for defendants convicted of selling, purchasing or possessing illicit fentanyl.

Anyone caught with as little as four grams of fentanyl would face a minimum of three years in prison. Sentences escalate depending on the amount of fentanyl seized and murder charges could be filed if someone dies of a fentanyl overdose.

Dealers often mix fentanyl with heroin or sell it in counterfeit pills disguised to look like oxycodone or other prescription painkillers. Many users have no idea they’re buying fentanyl, which is 50 to 100 times more potent than morphine.

"There's a massive problem with counterfeit pills," Greg Newburn, state policy director for Families Against Mandatory Minimums told the Miami New Times. "You have people who think they’re buying oxy pills who will end up getting labeled as traffickers in fentanyl.”

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Florida has been down this path before. According to an investigative series by Reason.com, mandatory minimum sentences in Florida for oxycodone and hydrocodone trafficking resulted in 2,300 people being sent to prison, most of them low-level drug users or patients who went to the black market seeking pain relief. 

“The signing of this bill by Gov. Scott is another example of using get tough drug policies for political gain,” said Tony Papa, Manager of Media and Artist Relations for the Drug Policy Alliance. “This is not going to stop the sale of heroin in Florida. It's another prosecutorial tool that will be used for bargaining by district attorneys in drug cases.  Under this new law many individuals will be subject to the death penalty for a 10 dollar bag of dope. It's totally insane!”

Wisconsin to Involuntarily Commit “Drug Dependents”

A bill that recently sailed through the Wisconsin legislature with little opposition would allow for the involuntary commitment of someone who is drug dependent. The bill’s sponsor, Assemblyman John Nygren, has a daughter who has struggled with heroin addiction and served time in jail.

Current Wisconsin law allows for the involuntary commitment of alcoholics if three adults sign a petition alleging that a person lacks self-control over their use of alcohol and whose health is substantially impaired. 

The new bill adds “drug dependence” to the list of reasons someone can by committed. Dependence is defined as a person’s use of one or more drugs that is beyond their ability to control and that substantially impairs their health or social functioning.

The bill is one of nearly a dozen anti-opioid measures sponsored by Nygren that Gov. Scott Walker asked to be approved in a special legislative session. It now heads to his office for consideration.

Aspirin Risky for Seniors 75 and Older

By Pat Anson, Editor

The old cliché about a doctor telling you to “take two aspirin and call me in the morning” isn’t such great advice after all. Especially for seniors aged 75 and older.

A daily dose of aspirin has long been recommended as a way to prevent a heart attack or stroke. But British researchers at the University of Oxford say the blood thinning effects of aspirin substantially raise the risk of gastrointestinal bleeding as patients grow older.

Their study, published in The Lancet medical journal, estimates that aspirin causes over 3,000 deaths in the U.K. annually.

“We have known for some time that aspirin increases the risk of bleeding for elderly patients. But our new study gives us a much clearer understanding of the size of the increased risk and of the severity and consequences of bleeds,” said lead author Professor Peter Rothwell.

“Previous studies have shown there is a clear benefit of short term anti-platelet treatment following a heart attack or stroke. But our findings raise questions about the balance of risk and benefit of long-term daily aspirin use in people aged 75 or over.”

Rothwell and his colleagues followed over 3,100 patients for 10 years who were prescribed a daily aspirin after a heart attack or stroke. For the patients under 65, the annual rate of bleeding severe enough to require hospitalization was about 1.5 percent. For patients aged 75-84, the annual rate rose to 3.5 percent and for patients over 85 it was 5 percent.

The researchers are not recommending that seniors stop taking aspirin. But they suggest that a proton-pump inhibitor – heartburn drugs – be prescribed along with aspirin to reduce the risk of bleeding.  They estimate that proton-pump inhibitors (PPIs) could reduce upper gastrointestinal bleeding by as much as 90% in patients receiving long-term aspirin treatment.

“While there is some evidence that PPIs might have some small long-term risks, this study shows that the risk of bleeding without them at older ages is high, and the consequences significant,” said Rothwell.

About half of adults aged 75 or older in the U.S. and Europe take aspirin or another anti-platelet drug daily .

FDA to Review All Abuse Deterrent Opioids

By Pat Anson, Editor

A week after asking that Opana ER be taken off the market, the head of the Food and Drug Administration has ordered a review of all opioid painkillers with abuse deterrent formulas to see if they actually help prevent opioid abuse and addiction.

The move is likely to add to speculation that the FDA may seek to prevent the sale of other opioid painkillers.

“We are announcing a public meeting that seeks a discussion on a central question related to opioid medications with abuse-deterrent properties: do we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic?” FDA commissioner Scott Gottlieb, MD, said in a statement.

Gottlieb said the FDA would meet with “external thought leaders” on July 10th and 11th to assess abuse deterrent formulas, which usually make medications harder for addicts to crush or liquefy for snorting and injecting. He did not identify who the thought leaders were.

“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction,” Gottlieb said. “Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations.”

In a surprise move last week, the FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing concerns that the oxymorphone tablets are being liquefied and injected. It’s the first time the agency has taken steps to stop an opioid painkiller from being sold.

“I am pleased, but not because I think that this one move by itself will have much impact,” Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP) told Mother Jones. “I’m hopeful that this signals a change at FDA—and that Opana might be just the first opioid that they’ll consider taking off the market. It’s too soon to tell.”

Opana was reformulated by Endo in 2012 to make it harder to abuse, but addicts quickly discovered they could still inject it. The FDA said Opana was linked to serious outbreaks of HIV, Hepatitis C and a blood clotting disorder spread by infected needles.

Endo has yet to respond to the FDA request. If the company refuses to stop selling Opana, the agency said it would take steps to require its removal from the market by withdrawing approval.

“The request to voluntarily remove the product is one thing, but it comes with a lot of other questions that are unanswered,” Endo CEO Paul Campanelli reportedly said at an industry conference covered by Bloomberg. “We are attempting to communicate with the FDA to find out what they would like us to do.”

Patient advocates say it would be unfair to remove an effective pain medication from the market just because it is being abused by addicts.

“The FDA is following a political agenda, rather than its mandate to protect the public health,” said Janice Reynolds, a retired oncology nurse who suffers from persistent pain. “Depriving those who benefit from the use of Opana ER to stop people from using it illegally is ethically and morally wrong.”

Sales of Opana reached nearly $160 million last year. The painkiller is prescribed about 50,000 times a month.

"This is something that could potentially apply to other drugs in the future, as it may signal a movement by the FDA to start taking products off the market that don't have strong abuse-deterrent properties," industry analyst Scott Lassman told CorporateCounsel.com.

The FDA put drug makers on notice four years ago that they should speed up the development of abuse deterrent formulas (ADF).  Acting on the FDA's guidance, pharmaceutical companies spent hundreds of millions of dollars developing several new opioid painkillers that are harder to chew, crush, snort or inject.

Were they worth the investment? Not according to a recent study funded by insurers, pharmacy benefit managers and some drug makers.

The Institute for Clinical and Economic Review (ICER), a non-profit that recommends which medications should be covered by insurance and at what price, released a report last month that gave ADF opioids a lukewarm grade when it comes to preventing abuse.

“Without stronger real-world evidence that ADFs reduce the risk of abuse and addiction among newly prescribed patients, our judgment is that the evidence can only demonstrate a ‘comparable or better’ net health benefit (C+),” the ICER report states.

The insurance industry has been reluctant to pay for ADF opioids, not because of any lack of effectiveness in preventing abuse, but because of their cost. A branded ADF opioid like OxyContin can cost nearly twice as much as a generic opioid without an abuse deterrent formula.  According to one study, OxyContin was covered by only a third of Medicare Part D plans in 2015. Many insurers also require prior authorization before an OxyContin prescription is filled.  

FDA Gives Fast Track Designation to New Pain Med

By Pat Anson, Editor

The U.S. Food and Drug Administration has granted “fast track” designation to a new, non-opioid pain medication for patients with osteoarthritis and chronic low back pain -- even though the drug has a history of safety issues.

Tanezumab is an investigational humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body as a result of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from reaching the spinal cord and brain.

Tanezumab is the first NGF inhibitor to receive fast track designation from the FDA, a process that speeds up the development and review of new therapies to treat serious conditions with unmet medical needs.

“If approved, tanezumab would be the first in a new class of non-opioid chronic pain medications,” said Ken Verburg, Chief Development Officer, Neuroscience & Pain, Pfizer Global Product Development. “We believe it would represent an important medical advance in the treatment of debilitating osteoarthritis and chronic low back pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications.”

Pfizer is jointly developing tanezumab with Eli Lilly. The two drug makers are currently recruiting patients for Phase 3 studies of tanezumab in 7,000 patients with osteoarthritis, low back pain or cancer pain. Participants will be injected with tanezumab once every eight weeks for treatment periods ranging from 16 to 56 weeks, followed by a 24-week safety follow-up period.  Results from the clinical trials are not expected until next year.

"It is estimated that there are more than 27 million Americans currently living with osteoarthritis and 23 million living with chronic low back pain, many of whom fail to achieve adequate pain relief despite treatment with various types of pain medications,” said Christi Shaw, Senior Vice President and President, Lilly Bio-Medicines.

“We are committed to offering innovative solutions to people suffering from chronic pain conditions, and look forward to working closely with the FDA to facilitate the development of tanezumab.”

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 because of safety concerns. The agency ordered a partial halt to clinical studies after Pfizer said a small number of osteoarthritis patients receiving tanezumab experienced worsening of their disease and needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.” 

Most clinical studies of tanezumab did not resume until 2015. Pfizer says the current Phase 3 studies include risk mitigation measures for joint safety and sympathetic nervous system safety.

A clinical study of fasinumab, another nerve growth factor drug being developed by Teva and  Regeneron Pharmaceuticals, was stopped by the FDA last year after a patient showed signs of severe joint disease. Regeneron and Teva said they would redesign the study of patients with chronic low back pain to exclude participants with advanced osteoarthritis.

Fifth Georgia Overdose Linked to Fake Percocet

By Pat Anson, Editor

A fifth fatal overdose in Georgia has been linked to counterfeit painkillers being sold on the street as Percocet. 34-year old Robert Ketchup of Macon died Sunday in the intensive care unit of a hospital after he was found unconscious in his mother’s home on Thursday. According to the Atlanta Journal Constitution, Ketchup “had a bunch of pills on him.” 

In the past week, five deaths and dozens of hospitalizations have been linked to the yellow, oval shaped pills that have been circulating in central Georgia.

An analysis of the pills by the Georgia Bureau of Investigation found that they contained two synthetic opioids, cyclopropyl fentanyl and U-47700. The bureau says both drugs are “highly dangerous.”  

The U.S. Drug Enforcement Administration has been warning for over a year about counterfeit prescription drugs laced with fentanyl “inundating” the U.S. Until now, most of the fake pills have been disguised to look like the painkiller oxycodone or Xanax, an anti-anxiety medication.

“The counterfeit pills have the numbers 10/325 on one side and the word PERCOCET in all capital letters on the opposite side. On the counterfeit pills the word PERCOCET is not stamped as deep as the manufacturer typically does on their pills. Also on the counterfeit pills, the imprint of the name is also at an angle,” the Bibb County Sheriff's Office said in a statement. “Everyone is strongly encouraged to treat these pills or anything resembling these pills as hazardous.”

No arrests have been made and the source of the counterfeit pills is still unknown.  

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. It is available legally by prescription in patches, lozenges and sprays to treat severe pain, but illicitly manufactured fentanyl smuggled in from Mexico and China is blamed for thousands of overdose deaths in the U.S. and Canada.

Unsuspecting buyers, including some pain patients who were unable to get opioid medication legally, have no idea the drug they’re getting from a dealer or friend could be lethal.

"Mexican drug cartels are manufacturing fentanyl into Percocet pills, and oxycodone and other type pills as well, but it's a way for these bad people to make a very good living on the backs of addiction and that's what they are targeting," said DEA Special Agent in Charge Dan Salter.

The fentanyl problem appears to be growing worse, as even small-time drug dealers realize they can easily order the chemicals needed to make fentanyl, manufacture their own fake pills, and make millions of dollars selling them on the black market.

Last week federal agents seized 50 kilograms of N-Phenethyl-4-piperidinone (NPP), a fentanyl precursor, from a storage facility in Northborough, Massachusetts. Some of the boxes seized were marked UPS and “priority mail.” Others were labeled with Chinese characters.

If converted, the NPP could have theoretically been used to make 19 million fentanyl tablets, with a street value of $570 million.

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Nearly 80 percent of the people who died of an overdose in Massachusetts last year ingested fentanyl.

Trump Opioid Commission to Hold First Meeting

By Pat Anson, Editor

The pain community will get its first glimpse this month at how the Trump administration may address the nation’s opioid crisis, when the president’s new Drug Addiction and Opioid Commission holds its first two meetings.

The commisison's first meeting will be held Friday June 16, followed by a teleconference on Monday June 26. Both meetings are open to the public.

Details on how to watch or listen to the meetings can be found in the Federal Register, here and here.

Chaired by New Jersey Governor Chris Christie, the commission will make recommendations to the president later this year on how to combat drug abuse, addiction and the overdose crisis, which is blamed for over 50,000 deaths in 2015.

The White House says the commission will “work closely” with President Trump’s son-in-law and senior advisor, Jared Kushner.

“I made a promise to the American people to take action to keep drugs from pouring into our country and to help those who have been so badly affected by them. Governor Christie will be instrumental in researching how best to combat this serious epidemic and how to treat those it has affected,” Trump said in a statement.  

The public can submit written comments to the commission by emailing the Office of National Drug Control Policy at commission@ondcp.eop.gov.

“I'd really like to see the commission recognize that addressing opioid use disorders through increasing access to treatment and through attempting to reduce the supply of opioids (both legal and illegal) will only go so far, and that, to be truly successful, they also must address inadequacies in the way we treat pain,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, which represents pain management physicians.

“Unless and until we reach a point where we can truly implement the kind of integrative pain care called for by every guideline and highlighted in the National Pain Strategy, we are going to be unable to succeed in addressing both of the public health crises we are encountering.”

Twillman helped draft and submit a letter to the commission signed by 73 different medical and patient advocacy groups calling for more federal funding of pain research and treatments.

“This longstanding underinvestment in pain research has resulted in a limited number of safe and effective chronic pain treatments, and according to the FDA, a field that is 'strikingly deficient' in high-quality evidence to assess risks and benefits of current treatments,” the letter states. “As a result, even highly knowledgeable health care providers are left without clear guidance, and may spend months to years with their patients experimenting with treatments in the hope of finding relief.”

Richard Martin, a retired Nevada pharmacist disabled by chronic back pain, says the first item on the commission’s agenda should be to withdraw and re-write the CDC’s opioid guideline, which discourages physicians from prescribing opioids for chronic pain.

“Since the Guideline was released, there are now tens of thousands of non-cancer pain patients on long term opioid prescription therapy who are being INVOLUNTARILY tapered down or off of their pain medications.  This has resulted in patients being under treated, left to suffer with debilitating pain.  Some of these patients have had their opioid medications abruptly discontinued throwing them into withdrawal,” Martin wrote in an email to the commission.

“There now abounds significant anecdotal evidence and significant documented media reports, that these patients who have been involuntarily tapered down or off their opioid medications, are committing suicide due to the intense pain that has resulted.” 

Background of Commission Members

In addition to Gov. Christie and Jared Kushner, the president has appointed to the commission Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman. No pain patients, pain management experts or practicing physicians were appointed to the panel.

Gov. Christie, who lost a close friend to painkiller addiction, has seen his home state of New Jersey ravaged by the opioid crisis, with 1,600 overdose deaths in 2015.  Christie championed a new state law that limits opioid prescriptions for acute pain to just five days.  

Gov. Cooper supports similar legislation now under consideration in North Carolina.  Over 1,100 North Carolinians died from opioid overdoses in 2015, with prescription opioids involved in about half of them.

Gov. Baker’s home state of Massachusetts lost over 2,000 people to opioid overdoses in 2016, most of them caused by heroin and illicit fentanyl. Baker apparently got an inside track on the commission when he discussed the opioid crisis with Ivanka Trump while sitting next to her during a National Governors Association dinner.

Bertha Madras recently authored an editorial in JAMA Psychiatry in which she claimed that prescription opioids “remain a primary driver of opioid-related fatalities” and called on the medical community to limit the supply of opioid medication.

Patrick Kennedy has battled substance abuse issues since he was teenager, including addiction to the painkiller OxyContin. He now works for Advocates for Opioid Recovery, a non-profit funded in part by Braeburn Pharmaceuticals, which makes an implant that dispenses the addiction treatment drug buprenorphine.

Genetic Testing Company Raided by FBI

By Pat Anson, Editor

FBI agents have raided the headquarters of Proove Biosciences, a controversial genetic testing company that claims its DNA tests can improve the effectiveness of pain management and determine whether a patient is at risk of opioid addiction.

Over two dozen FBI agents appeared at Proove offices in Irvine, California Wednesday as part of a healthcare fraud investigation. They were later seen carrying dozens of boxes out of two buildings

“It is an ongoing investigation out of our San Diego office. It involves healthcare fraud. And unfortunately we are unable to say anything more about it at this time. The affidavit supporting the search warrant is under seal,” Cathy Kramer, an FBI special agent, told KABC-TV.

STAT News reported in February that the FBI and the Inspector General for the Department of Health and Human Services (HHS) were investigating possible criminal activity at Proove.

Former and current employees who were interviewed by the FBI told STAT the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

The HHS Inspector General issued a Special Fraud Alert in 2014 warning physicians that any payments, referrals, rent or reimbursements from lab testing companies could be seen as violations of anti-kickback laws.

Proove promotes itself as the “leader in personalized pain medicine” and claims its genetic tests can identify medications that would be most effective at treating pain. The company recently claimed that 94% of patients experienced significant pain relief within 60 days of treatment changes recommended by Proove. Critics say most Proove studies are not peer-reviewed and one genetic expert has called them “hogwash.”

According to STAT, doctors affiliated with Proove in California, Florida and Kentucky were also raided by the FBI. Proove said it was cooperating with the investigation, and that no arrests or charges have been made.

"Proove has been subject to a handful of inaccurate stories initiated by STAT News that we believe have contributed to this latest action," the company said in a statement. "While we originally chose not to dignify these outlandish accusations with a response, we now understand that we can no longer ignore these false stories based on unreliable sources, and filled with erroneous accusations... spread by a few disgruntled former employees and consultants.  Proove is confident that the facts supported by verifiable and reliable sources will clearly restore our reputation."

Proove Linked to Montana Pain Clinic

Proove is the second laboratory testing company raided by the FBI that has been linked to Benefis Pain Management Center, a pain clinic in Great Falls, Montana. 

As PNN has reported, FBI agents last November raided the offices of Confirmatrix Laboratories near Atlanta. Two days later, the company filed for Chapter 11 bankruptcy protection. Confirmatrix was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

In 2013, Medicare identified Confirmatrix as the most expensive urine drug testing lab in the country, charging an average of $2,406 for each Medicare patient.

Benefis has continued to send urine drug samples to Confirmatrix for testing even after the company filed for bankruptcy. Some Benefis patients have recently been contacted by collection agencies seeking payment for urine tests costing well over $1,000 that their insurance refused to pay for. Similar tests by other labs cost only a few hundred dollars.

According to its bankruptcy filing, Confirmatrix has 152 employees in 15 different states, including one employee in Montana who apparently works on site at the Benefis pain clinic. PNN has also learned that Proove Biosciences has had employees working at the clinic. A Proove “patient engagement representative” was employed there as early as May 2016.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” says Rodney Lutes, a physician assistant (PA) who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.  What they did is they had a technician there in the department and every day I would get a list from that technician of patients that they would like to try to include in the program.”

Lutes says he recommended the DNA test to many of his patients, but never received any money from Proove. He says some of his patients later complained that their insurance was billed for the DNA test.

“One of the things that bothered me was that I signed a lot of the papers, but they also had my supervising doc on all of those papers,” Lutes told PNN. “I also felt like she was the one that brought them (Proove) in there.”

Lutes is referring to Katrina Lewis, MD, a pain management specialist at Benefis who is listed as a member of Proove’s Medical Advisory Board.  Lewis plays a significant role at the pain clinic even though she only works there part time. 

“Dr. Lewis works for Benefis one week a month and has been instrumental in the development of our multidisciplinary approach and current protocols,” said Keri Garman, Director of Corporate Communications at Benefis.

In a statement emailed to PNN last month, Lewis said regular urine drug testing was necessary to ensure that “appropriate levels” of medication are present. Current clinic policy is that “high risk” patients should have a urine test at least once every two months.

“Presence of too high of a level of opioids or other substances in the urine can make it inappropriate and unsafe to continue prescribing opioids.  Presence of none of the prescribed opioids in the urine indicates the care plan is not being followed and further prescribing is medically unnecessary,” Lewis said.

Benefis: No Kickbacks from Testing Labs

PNN has made repeated requests to Benefis to clarify its relationship with Confirmatrix and Proove, and whether Lewis or any other Benefis employees were receiving compensation from the laboratories for referring business to them. 

“Benefis and its employees, including Dr. Katrina Lewis, do not receive kickbacks from Confirmatrix or Proove. As for any questions you have regarding the lab business practices of these facilities, these would be best answered by the companies directly,” Benefis spokesman Ben Buckridge said in a statement emailed to PNN last week. 

“We take these accusations and defamatory statements against our organization and staff seriously. We appreciate your diligence on this issue.” 

In an earlier statement, a Benefis official said the DNA tests are voluntary and only done on patients if they are appropriate.

“Patients have the option to decline this testing, however, it proves to be very helpful in determining treatment plans for our patients in many cases. This testing has not been readily available until recently,” said Kathy Hills, Chief Operating Officer of Benefis Medical Group.

“Genetic testing allows us to see if the patient is appropriately synthesizing specific medications and can drastically alter treatment plans, showing us that sometimes the medications are not effectively metabolizing and therefore not as effective, which is why some patients have needed high doses. Our partners in this have an extensive patient assistance program that waives many costs, and patients are not penalized or removed from opioids if they refuse to have a genetic test performed.”

But a recent copy of the clinic’s opioid policy obtained by PNN says the tests are not voluntary for everyone. 

“All patients on dosing levels at or higher than the maximum policy dose MUST be submitted for genetic testing,” the policy states. The word "must" is capitalized in the document. 

One Benefis patient who took the DNA test said Lutes recommended it.

“He said everyone was doing it and that the insurance would be billed, but if they did not pay for it then Benefis would. I think he said something about it being a $6,000 test,” she told PNN.  “To me it was a waste of time and money. The meds it said I should be taking either didn’t work, stopped working, or made me sick. And the meds I should not be taking I do just fine on.”

It is not clear whether the pain clinic's association with Proove or Confirmatrix had anything to do with Lutes’ firing in March. The 68-year old Lutes treated several hundred pain patients and was popular with many of them. 

Lutes was discharged for violating Benefis policy about record keeping, opioid dosage and urine drug testing, but feels he was “written up for violations that do not exist.” His supervising physician – Katrina Lewis – also requested removal from that role, meaning Lutes could no longer practice at Benefis as a physician assistant.

Since his dismissal, many of Lutes former patients who were on relatively high doses of opioids say their medication has been reduced or stopped entirely. One patient, whose opioid dose was cut significantly, committed suicide. Still others complain they were labeled and treated as addicts by clinic doctors and staff, and now have trouble finding new physicians in the Great Falls area. The ones who remain at Benefis say they are being told to take new tests and exams. 

Benefis says it cannot comment on the accusations because of patient and employee privacy rights.

“Unless Rodney Lutes, PA, or the patients with whom you are speaking will sign written releases allowing us to comment fully on the facts of their employment or their care, respectively, we are simply unable to engage in any further back and forth discussions.  We have provided all the information we are able given the legal limitations governing our industry,” Buckridge said.

FDA Wants Opana ER Sales Stopped

By Pat Anson, Editor

The U.S. Food and Drug Administration today asked Endo Pharmaceuticals to remove Opana ER from the market, citing concerns about safety risks when the tablets are liquefied and injected. It’s the first time the agency has taken steps to stop an opioid painkiller from being sold -- and oddly it has more to do with preventing HIV and Hepatitis C than it does in preventing opioid abuse.

“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb, MD. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

Opana ER is the brand name for Endo’s extended release opioid painkiller oxymorphone. It was first approved by the FDA in 2006 for the management of moderate to severe pain.  In 2012, after numerous reports that it was being abused and sold on the black market, Opana was reformulated by Endo to make it harder for addicts to crush or liquefy.

That same year, over a dozen cases of a serious blood clotting disorder and Hepatitis C in intravenous drug users were linked to the reformulated Opana in Tennessee. But it took another five years for the FDA to act.

In March, an FDA advisory panel voted 18-8 that the benefits of reformulated Opana no longer outweighed its risks. The agency found“a significant shift in the route of abuse” from snorting to injection. Injecting Opana was associated with outbreaks of HIV, Hepatitis C and a blood clotting disorder called thrombotic thrombocytopenic purpura. All can be spread intravenously by infected needles.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”

The FDA has requested that Endo voluntarily remove Opana from the market. Should the company refuse to do so, the agency intends to take steps to formally require its removal by withdrawing approval.

"Endo is reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward," the company said in a statement. "Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients."

According to Bloomberg, sales of Opana  reached nearly $160 million last year, about 4 percent of the company’s total revenue.

WHO Lists Fentanyl as ‘Essential Medicine’

By Pat Anson, Editor

At a time when hundreds – perhaps thousands – of Americans and Canadians are dying every month from overdoses of illicit fentanyl mixed with heroin or turned into counterfeit painkillers, it’s easy to lose sight of the fact that prescription fentanyl is an important and useful analgesic.  

We were reminded of that today by the World Health Organization (WHO), which added fentanyl skin patches and methadone to its list of essential medicines for treating cancer pain. WHO’s Essential Medicine List is not widely followed in developed countries – where prescription drugs are widely available – but it is used in many third world countries to guide decision making and increase access to medicines that are often in short supply.

"Safe and effective medicines are an essential part of any health system," said Dr. Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. "Making sure all people can access the medicines they need, when and where they need them, is vital to countries’ progress towards universal health coverage."

Fentanyl patches and methadone are two of the 30 drugs being added to the Essential Medicine List, raising the total to 433 medicines considered vital in addressing public health needs. WHO also added drugs for treating HIV, hepatitis C, tuberculosis and leukemia; and gave new advice about the use of antibiotics.

While illicit, black market fentanyl has become a deadly scourge across the U.S. and Canada, prescription fentanyl is legally available in patches, lozenges and sprays to treat severe pain.  

WHO’s inclusion of fentanyl patches and methadone on the essential list is limited to the treatment of cancer pain. An expert panel that reviewed the medicines noted “there is a need for additional opioid treatment options” for cancer pain. About a third of cancer patients worldwide are undertreated for pain, and patients living in low or middle income countries often have limited access to opioid painkillers.  

Other opioids already on the essential list (for treating pain and palliative care) are codeine, morphine, hydromorphone and oxycodone . Aspirin, ibuprofen and paracetamol (acetaminophen) are on it too, although the latter is “not recommended for anti-inflammatory use due to lack of proven benefit.”

Gabapentin Rejected

It’s also worth noting the medications that did not make the updated WHO list. Tramadol was not approved as a treatment for cancer pain, while gabapentin (Neurontin) was rejected as a treatment for neuropathic pain.

WHO’s expert panel gave a scathing review of the application made by the International Association for the Study of Pain and the International Association of Hospice and Palliative Care for the inclusion of gabapentin; noting there were many cases of bias and data manipulation in the clinical studies used to support it. Also noted was the $430 million fine paid by Pfizer in 2004 to settle civil and criminal charges for a “marketing scheme” to promote Neurontin for unapproved uses.    

“The Committee acknowledged the serious issues on publication and outcome reporting bias as important ones,” the panel said. “The Expert Committee considered the uncertainty in efficacy estimates as a result of publication and outcome reporting biases in the currently available evidence for gabapentin. The Committee did not recommend inclusion of gabapentin on the EML (Essential Medicine List) for neuropathic pain on the basis of its uncertain benefits.”

While gabapentin is approved for neuropathic pain in the European Union and Australia, it is only approved for epilepsy and neuropathic pain caused by shingles in the U.S. Despite that limitation, gabapentin is widely prescribed “off label” to treat depression, anxiety, migraine, fibromyalgia and other chronic pain conditions.  About 64 million prescriptions were written in the U.S. for gabapentin in 2016, a 49% increase since 2011.

Utah Raid Uncovered Large Fentanyl Pill Ring

By Pat Anson, Editor

A drug bust in a Utah home last November has uncovered one of the largest counterfeit pill operations in U.S. history.

This week a federal grand jury in Salt Lake City indicted six individuals for manufacturing nearly 500,000 pills laced with illicit fentanyl that were disguised to look like the painkiller oxycodone and the anti-anxiety drug alprazolam (Xanax). The counterfeit pills were distributed throughout Utah and the United States to customers who ordered them online.

Fentanyl is a powerful synthetic opioid that it is 100 times more potent than morphine and 50 times more potent than heroin. In recent years, illicit fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada.

“What we feared and hoped somehow would stay away has arrived in spades,” said Brian Besser, the DEA’s agent in charge in Utah. “Fentanyl is as dangerous as it gets.”

According to documents filed in federal court, the pill ring was created by Aaron Shamo and Drew Crandall, both Utah residents who worked together at eBay, but quickly grew to include the other conspirators. Prosecutors say the defendants purchased pill presses, dies and stamps so the counterfeit pill markings would match those of legitimate pharmaceutical drugs. Some items were purchased legally and others, such as fentanyl and alprazolam, were illegally imported from China

The fake pills were sold on a “dark net online store” at a significant profit. Once sold, Shamo and Crandall used their co-conspirators to package the pills and ship them to customers. In less than a year, the operation mailed 5,606 drug orders totaling $2.8 million, according to court documents.

“Shamo’s customer base was extremely comprehensive and widespread, touching every corner of the United States,” Besser said. “It touched large cities and rural communities.”

The round blue tablets manufactured by the pill ring were offered for sale online as oxycodone 30mg tablets. The tablets were debossed with “A 215” on the bisected side, with an “M” on one side and a “30” above the bisect on the other side. The indictment alleges the defendants did not use oxycodone at all in the manufacturing process, but instead used illicit fentanyl.

Federal agents arrested Shamo last November. During a raid on Shamo’s suburban Salt Lake City home, agents discovered a pill press capable of manufacturing several thousand pills an hour. Agents also seized 70,000 pills and $1.2 million in cash stuffed in garbage bags.

Crandall fled to Australia with his girlfriend and was in Laos when agents raided Shamo’s house. He was arrested last month in Hawaii. A summons will be issued for the other four conspirators for their initial appearances in federal court.

Chronic Pain Patients Did Not Cause Opioid Epidemic

By Roger Chriss, Columnist

Contrary to common belief, chronic pain patients are not all opioid addicts and did not cause the opioid crisis. The vast majority of patients who are prescribed opioids rarely misuse or abuse them.

Opioid addiction is real and should not be ignored or downplayed, but we need to identify its true causes. Despite the growing number of restrictions on prescription opioids, overdoses and related deaths continue to rise, which strongly indicates that pain patients have very little to do with the so-called epidemic.

Some recent articles bear this out:

Science Daily reports that while the national death toll from opioid overdoses is soaring, only “a small minority of pain patients are represented in the mortality data.”

The journal Pain Medicine published research showing that most pain patients on low doses of short-acting opioids “have a low risk for developing a substance use disorder.”

Similarly, chronic pain patients generally do not experience dose escalation, but often remain stable at the same dose for months or even years. And according to the National Institute of Drug Abuse, doctor shopping by pain patients is rare.

For most chronic pain patients, opioid medications are part of a larger daily routine of pain management, and opioids are not craved any more than an athlete craves a vitamin supplement. Thus, the risks of opioid addiction among chronic pain patients is quite low overall, and there are well-established protocols such as the Opioid Risk Tool to screen patients and monitor those whose risk may be higher.

But all this evidence does not seem to convince regulators, politicians, the news media, and anti-opioid activists like Physicians for Responsible Opioid Prescribing (PROP). Fortunately, it can be clearly shown they are wrong and that chronic pain patients are unfortunate bystanders in the opioid epidemic.

First, there simply are not enough chronic pain patients on opioid therapy to account for the number of opioid and heroin addicts. The American Society of Addiction Medicine estimates that in 2016 there were over 2.5 million people addicted to prescription pain relievers or heroin.

There are at most 11.5 million chronic pain patients on opioid therapy. Even if 5 percent of them develop a substance abuse disorder, that would give us 575,000 opioid addicts. Where did the other 2 million addicts come from?

Second, people who suffer from chronic pain disorders are no longer prescribed opioids lightly or quickly. Instead, they start with NSAIDs like ibuprofen or naproxen, then onto anti-seizure medications like gabapentin or anti-depressants like amitriptyline or duloxetine, all the while also trying physical therapy, injections or other modalities. They are carefully screened, monitored and assessed along the way, with opioids considered only if everything else fails. This makes addiction a rare outcome.

Third, media coverage of the opioid epidemic and case literature on opioid use disorder routinely describe people becoming addicted to opioids after recreational use, trauma or surgery. It may be that “opioid addiction often starts with a prescription,” but it is usually a prescription for acute pain. And for many, the addiction starts with someone else’s prescription, perhaps taken from a family member or obtained from a friend.

Therefore, the treatment of chronic pain conditions can at most have only minimally contributed to the opioid epidemic. Chronic pain patients are not opioid addicts any more than a diabetic is an insulin addict, and in fact insulin is abused.

Unfortunately, chronic pain patients are often treated like addicts and the doctors who prescribe to them are even called “drug dealers.” This is harming chronic pain patients, doctors and people suffering from opioid addiction.

Opioid therapy helps people with chronic pain disorders remain employed, care for themselves and their families, and contribute to and participate in their communities. They are achieving what modern medicine and society wants: people who can work, pay taxes, avoid becoming a burden, and enjoy some quality of life.

Restricting opioids is not slowing the opioid epidemic. The increased availability of naloxone and improved care by first responders and emergency departments is helping to reduce fatalities, but opioid addiction still needs treatment and at present there is not enough of it.

To be clear, chronic pain patients and opioid addicts are two distinct groups, both of which deserve care and support. Treating pain patients as addicts can lead to denial of care, which may actually increase the number of opioid addicts. And conflating chronic pain with opioid addiction may be delaying care for people struggling to find addiction treatment.

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.

Patient Suicide Blamed on Montana Pain Clinic

By Pat Anson, Editor

A 54-year old Montana man who apparently committed suicide earlier this month was a patient at a Great Falls pain clinic accused of mistreating patients and poorly managing their chronic pain. Bryan Spece was found dead in his Lewistown home on May 3.

“From what we know, about two weeks before his death, they had cut his pain pills back significantly. We’re not sure the exact amount. We’re trying to get ahold of his medical records,” said a family member. “When they called and told us that he’d been found with a gunshot wound, we thought someone had attacked him. Suicide was not even on our charts anywhere.”

BRYAN SPECE

"He was the last person anyone would have thought to take his own life. He was just not that guy," another family member said. "I know he was in a lot of pain and in a very dark spot."

Until recently, Spece was one of several hundred patients being treated at the Benefis Pain Management Center by Rodney Lutes, a physician assistant. The 68-year old Lutes was discharged by Benefis in March for unexplained reasons and the care of his patients was transferred to other providers at the clinic.

Many of Lutes' former patients – including some who were on relatively high doses of opioid pain medication – say they are now being “bullied” and treated like drug addicts by Benefis doctors and clinic staff. Their prescriptions for pain medication have been drastically reduced or stopped entirely. 

The Centers for Disease Control and Prevention recommends a "go slow" approach when patients are weaned or tapered to minimize symptoms of opioid withdrawal. The CDC says a "reasonable starting point" would be 10% of the original dose per week. Patients who have been on opioids for a long time should have even slower tapers of 10% a month, according to the CDC.

The Department of Veterans Affairs recommends a taper of 5% to 20% every four weeks, although in some extreme cases the VA says an initial rapid taper of 20% to 50% a day is needed

Bryan Spece's dose may have been reduced by 70 percent.

"I talked to him a few days before he died and he said they had cut him from 100 milligrams of oxycodone a day to 30. He was not doing well," a relative told PNN.

“He was one of my patients that I saw routinely. He was doing very well on the regimen I had him on,” said Lutes, who treated Spece for about three years and never saw signs of depression.

“My suspicion is that, like the rest of my patients, he got totally slammed at this pain clinic at Benefis and they probably took all his medicines away,” Lutes said. “Right now I am so angry about this happening. This was a good guy.”

According to his obituary, Spece was a gun collector, Marine Corps veteran, Oakland Raiders fan and belonged to a motorcycle club. Friends and family called him “Bonz.”

“He was a very loud fun loving kind of guy you always knew when Bonz walked into a room,” reads the obituary published in the Helena Independent Record.

But recently some noticed that Spece was depressed about his inability to work regularly because of chronic pain from carpal tunnel syndrome and an old back injury.

“He was having money issues with not being able to work as often because of the pain and with having his pain pills cut back. He was just very stressed, constantly, about it,” said a family member, who believes Benefis is "100%" responsible for Spece's death.

“The police found several text messages on his phone. He was talking to his friends there in Lewistown, stating ‘Come get my guns. I’m in so much pain, I might do something stupid.’ And then he’d laugh it off. So nobody thought he was really thinking about ending his life.”

"We extend our condolences to the family during this difficult time," Benefis spokesman Ben Buckridge said in a statement. Buckridge said Benefis could not comment any further because of patient and employee privacy rights.

“I lay awake wondering how many Bryans are also laying awake at the same time and I pray to God to please let them know that we are here for them,” says Re Ann Rothwell, a former patient of Lutes who claims Benefis dropped her “like a dirty diaper.”

Rothwell has organized a support group for Lutes’ patients and has reached about 100 of them so far. The group has formed an active online community and is trying to locate hundreds of other former Lutes' patients to offer them support. Rothwell worries there could be more suicides.

“I truly feel that we failed in the case of Bryan Spece and perhaps several others who have taken their lives because of Benefis' actions. They felt so alone and in despair that suicide was the only answer. We just do not know about them yet.  It truly breaks my heart,” she said in an email. “We just need to figure out how to reach those folks. Perhaps Bryan's death will help us find a few more folks on the brink, who we can pull back with love, support and hugs.”

In April, a disgruntled pain patient burned down a doctor's home near Great Falls, held the doctor's wife at gunpoint and killed himself during a standoff with police. David Herron was not a patient at the pain clinic, but suffered from chronic back pain and apparently had a long-standing grievance with the doctor, an orthopedic surgeon for Benefis.

The pain clinic is part of Benefis Health System, a non-profit community-based health organization that operates a hospital and provides a wide variety of medical services in Great Falls, a city of over 58,000 people in north central Montana. With over 3,000 physicians and other employees, Benefis is the largest employer in the area outside of government.

In a statement emailed to PNN last week, a Benefis pain management specialist outlined the clinic’s policy about opioid medication.

“Our clinic does not suddenly discontinue opioid prescriptions for patients unless we feel it is unsafe to continue prescribing them,” said Katrina Lewis, MD. “We know so much more now about how these drugs work than we did 20 years ago. The practice of medicine, procedures, and guidelines change over time, and we’re certainly seeing an evolution in how we care for people with chronic pain.

“We are following evidenced-based practice and recommendations of reputable pain societies in approaching the care we provide. We recognize that opioids absolutely have a place in the management of chronic pain for some patients. Our focus is to treat each patient individually with use of risk stratification and evaluation of patient pathology and co-morbidities.”

‘Dear Valued Patient’

But the form letters sent by Benefis to hundreds of Rodney Lutes’ patients in March could hardly be described as treating “each patient individually.” Patients were notified that Lutes was no longer practicing at the pain clinic, that they were being reassigned to new providers, and that their prescriptions would probably be changed. They were also told not to complain.

“Your new provider will do a thorough evaluation of all your medications and will likely make changes that he or she feels are in your best interests,” a form letter with the salutation “Dear Valued Patient” states. “Please be aware that arguing or complaining about changes in your prescriptions will not alter your clinician’s care plan.” 

“The prescriptions you will be given may not be what you are used to. It will be what is appropriate for your care,” another form letter says. “Verbal or written complaints to staff and management will not result in a change to your prescription.”

As PNN has reported, some patients also received letters stating that “all care providers” in the Great Falls area had been made aware of the changes at Benefis and “with what is going on with PA Lutes’ patients.” Many of those patients are now having trouble finding new doctors and feel they’ve been branded as addicts and drug seekers.

“We do our best to care for our patients and regret that this transition has been difficult for some. We realize we have opportunities to improve our communication with patients and will be working on that as a team moving forward. We are always looking at new ways to improve the patient experience, and we value patient feedback,” Nikki Phillips, Office Manager at the Benefis Pain Clinic, said in last week’s emailed statement.

What’s happening at Benefis is a microcosm of what’s happening all over the country. Patients are being abruptly weaned off opioids or being abandoned by doctors and pain clinics that are fearful of running afoul of the CDC’s “voluntary” prescribing guidelines, the DEA, or their own medical liability insurers.  Some providers are steering patients toward surgeries or costly “interventional” procedures that they don’t want.

At PNN, we hear regularly from chronic pain patients who were able to lead stable and productive lives for years on relatively high doses of opioids – a medical treatment that many are now denied and are told doesn't work. Many pain sufferers are in despair, increasingly disabled and having suicidal thoughts.

Until the needs of those patients are taken into consideration and appropriately balanced with society's need to prevent addiction, there will be more Bryan Speces and more grieving families.

“This man was the most happy-go-lucky man. He adored his grandchildren. He was a good time, all of the time. If he hadn’t been in so much pain, I don’t think he would have had a negative thought,” a family member told us.

“He lost a sister 12 years ago to suicide and he was always so broken up about that. He’s always said he would never do that.”

Spece’s death is still classified as a homicide because his autopsy report is incomplete. The Fergus County coroner is still awaiting results from toxicology tests.

Law Firm Wants Transparency in Medicare Opioid Policy

By Pat Anson, Editor

A Washington-based legal firm is calling for more openness and transparency by the Centers for Medicare and Medicaid Services (CMS) as it establishes new rules that are likely to limit access to opioid pain medication for millions of Medicare patients.

“While opioid abuse undoubtedly presents a serious public health issue, CMS should take steps to foster transparency and avoid harming patients and providers alike by offering them a meaningful opportunity to participate in the development of policies that could limit pain management,” wrote Michelle Stilwell, a staff attorney for the Washington Legal Foundation (WLF), a non-profit law firm that generally supports business groups and companies in litigation against government agencies.

At issue are mandatory rules being developed by CMS for 2018 that would bring Medicare opioid policies into alignment with the “voluntary” prescribing guidelines released last year by the Centers for Disease Control and Prevention.

CMS wants to set a daily ceiling on opioid pain medication at 90mg morphine equivalent dose (MED). If a dose exceeds that level, Medicare insurers would be expected to impose a "soft edit" that would automatically block the prescription from being filled until the edit is overridden by a pharmacist.

Stilwell wrote on the WLF's blog that patients and providers were given little opportunity to see and comment on a Call Letter announcing the rule changes, while the insurance industry was.

“CMS’s changes will inevitably lead to even tighter restrictions on opioid prescriptions—which directly affects the patient community.  Many patients, doctors, and healthcare providers already complain that rules designed to prevent the improper prescribing of opioids are complicating patients’ legitimate access to appropriate medication,” said Stilwell. 

“But instead of directing this Call Letter at the affected patient community and granting that community an adequate opportunity to comment on the new opioid overutilization criteria, CMS directed it only to insurance companies.  In reality, opioid consumers and providers are given little to no notice or opportunity to comment."

As PNN has reported, the insurance industry appears to have played a major role in drafting the CMS rules, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of insurers, law enforcement agencies and government regulators formed to combat insurance fraud. The HFFP met to discuss the white paper in a “special session” last October that was not open to the public.

Stilwell said the HFFP “operates largely in the dark” and may be in violation of the Federal Advisory Committee Act (FACA), which requires open meetings for all federal advisory panels. This week the WLF filed a Freedom of Information Act Request seeking more information about HFPP membership and meetings.

Major insurers such as Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation participate in the HFPP.

“It is time for CMS to bring HFPP into compliance with FACA requirements.  Doing so will reduce the risk that a court may invalidate any CMS policies found to have been adopted at least in part in reliance on HFPP recommendations.  It would also enable any patients affected by changes in opioid reimbursement policies to play a role in the development of HFPP’s opioid-related recommendations,” Stilwell wrote.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policies often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

In addition to limits on opioid prescribing, CMS plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who regularly prescribe high doses of opioids. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged. Insurers would be required to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.

FDA to 'Take Whatever Steps We Can’ to Stop Opioid Abuse

Meanwhile, the new commissioner of the Food and Drug Administration is calling on the agency to “take whatever steps we can” to ensure that opioids are only prescribed under “appropriate clinical circumstances.”

In a blog post on the FDA website, Scott Gottlieb, MD, announced the formation of an Opioid Policy Steering Committee to develop additional tools and strategies the FDA can use to prevent opioid abuse.

“Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction,” he wrote.

Gottlieb wants the committee to focus on three areas:

scott gottlieb, MD

• Consider mandatory education for health care professionals about opioid prescribing recommendations and how to identify patients at risk of abuse.
• Establish limits on the dose and quantity of opioid medication that are more closely tailored to the medical condition a patient is being treated for.
• Review the process the FDA uses to evaluate and approve new opioid medications.

Gottlieb cited some questionable statistics to dramatize the extent of the opioid prescription problem.

“In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids,” he wrote.

The new FDA commissioner may want to check his facts. As PNN has reported, a news release last December from the White House Office of National Drug Control Policy stated that 17,536 Americans died in 2015 from overdoses involving prescription opioids.

A CDC news release a few days later provided an an even lower estimate; that over 12,700 Americans died from pain medications in 2015.

When asked to explain the discrepancy, PNN was given a third estimate by the CDC, which put the number of deaths involving prescription opioids at 15,281 in 2015.

Gootlieb's post links to a CDC website that provides a fourth estimate, which is based on a "standard analysis approach" that combines all overdoses caused by natural, semi-synthetic, and synthetic opioids. Such an approach is misleading, because it counts overdoses caused by illicit fentanyl as prescription drug deaths. 

"Unfortunately, information reported about overdose deaths does not distinguish pharmaceutical fentanyl from illegally-made fentanyl," the CDC said, which Gottlieb neglected to mention in his blog post.

Poorly Treated Pain Linked to Opioid Misuse

By Pat Anson, Editor

A provocative new study has found that untreated or poorly treated pain is causing many young adults to self-medicate and turn to the black market for pain relief. The research adds to a growing body of evidence that efforts to limit opioid prescribing are leading to more opioid misuse and addiction, not less.

The study, published in the Journal of Addiction Medicine, involved nearly 200 young adults in Rhode Island who used opioid pain medication “non-medically” – meaning they didn’t have a prescription for opioids or used them in a way other than prescribed. About 85 percent had experienced some type of injury or health condition that caused severe pain.

Three out of four said they started misusing opioids to treat their physical pain. Most went to see a doctor to treat their pain, but about a third -- 36 percent of the women and 27 percent of the men -- said their doctor refused to prescribe a pain medication.

“In addition to being denied medication to treat severe pain by a physician, a significant percentage (20%) of young NMPO (non-medical prescription opioid) users who reported experiencing a high level of pain did not try to obtain treatment from a doctor for reasons including the belief that they would be denied prescription painkillers and/or having no health insurance,” said lead author Brandon D.L. Marshall, PhD, of Brown University School of Public Health.

“Pervasive negative perceptions of healthcare providers (and/or the medical system in general), and also issues related to accessing healthcare resources, may also underlie the high prevalence of professionally unmitigated physical pain in this population of young adults who use NMPOs in Rhode Island.”

Participants were between the ages of 18 and 29, used opioids at least once non-medically in the past 30 days, and were enrolled in the Rhode Island Young Adult Prescription Drug Study (RAPiDS). Most also used heroin, marijuana, cocaine, LSD or another illegal drug more than once a week.

“Although this is a small study and we can't draw conclusions from it, I do think it sheds light on what can be unintended consequences if we are not willing to treat pain in people with increased risk factors and co-morbid mental health disorders,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “These results may reflect the increased number of physicians who are unwilling to prescribe an opioid if there are risk factors or maybe just unwilling to prescribe an opioid.  It also shows that a consequence of not treating severe pain in people who also have significant risk of abuse may lead to illicit drug use and more harm."

Participants in the study who did not see a doctor for their pain had a variety of reasons:

• 48% Thought they could handle the pain or manage it with over-the-counter drugs
• 25% Thought they would be denied a prescription painkiller
• 40% Don’t like seeing a doctor
• 25% Had no health insurance

This was not the first study to find a correlation between poorly treated pain and drug abuse. A 2012 study of young adults who misused opioids in New York City and Los Angeles found that over half self-medicated with an opioid to treat severe pain. One in four had been denied a prescription opioid to manage severe pain.

A recent study of 462 adults who injected drugs in British Columbia found that nearly two-thirds had been denied prescription opioids. Nearly half had also been accused of drug seeking.

A recent survey of over 3,100 pain patients by PNN and iPain found that 11% had obtained opioids illegally for pain relief and 22% were hoarding opioids because they weren’t sure if they’d be able to get them in the future. Large majorities believe the CDC opioid guidelines were failing to prevent opioid abuse and overdoses (85%), and were harmful to pain patients (94%).

Montana Urine Tests Sent to Bankrupt Drug Lab

By Pat Anson, Editor

Imagine getting an unexpected medical bill for over $1,500 that your insurance won’t cover. You can’t afford to pay it, have already missed several weeks of work due to chronic back pain, and you’re worried about losing your job.

That’s the dilemma faced by a Montana woman, one of the patients at a Great Falls pain clinic who are getting unusually large bills for urine drug testing at a laboratory over 2,000 miles away in Georgia. 

“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?” said the patient, who asked that we not reveal her identity.

The lab in question is Confirmatrix Laboratory, a financially troubled company near Atlanta that specializes in urine drug testing.

For the last two years, Confirmatrix has conducted drug screens for the Benefis Pain Management Center, which is part of Benefis Health System, a non-profit community-based health organization that operates a hospital and provides other medical services in Great Falls.

As PNN has reported, some current and former patients at the Benefis pain clinic believe they are being unfairly labeled and treated as addicts. Many are having their opioid doses reduced or stopped completely. All are required to take regular drug tests to prove they’re not abusing their pain medication.

“For the safety of our patients, regular urine drug screens are conducted to ensure the appropriate levels of prescribed medications, and only those medications, are present,” says Katrina Lewis, MD, a pain management specialist at Benefis.  “Presence of too high of a level of opioids or other substances in the urine can make it inappropriate and unsafe to continue prescribing opioids.  Presence of none of the prescribed opioids in the urine indicates the care plan is not being followed and further prescribing is medically unnecessary.”

Urine drug testing is not uncommon at pain clinics, but the selection of Confirmatrix is. The company was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

Satary was arrested in 2001 and served more than three years in federal prison after pleading guilty to running a counterfeit CD operation in the Atlanta area valued at $50 million. At the time, it was the largest counterfeit music case in U.S. history, according to the Atlanta Journal Constitution.

Khalid and jordan satary (instagram photo)

Shortly after his release from prison, Satary founded Confirmatrix, Nue Medical Consulting and GNOS Medical, a medical billing firm, and then transferred his interests in the companies over to his son Jordan, a recent high school graduate.

The Journal Constitution reported in 2014 that Satary was subject to a federal deportation order, but immigration officials were unable to find a country willing to accept him. He still apparently lives in the U.S.

On November 2nd of last year, the FBI and the Georgia Department of Health and Human Services served search warrants at Confirmatrix and GNOS Medical, and agents removed documents from both facilities.

The agencies have not said what prompted the raids and no charges have been filed against either company.

Just two days after the search warrants were served, Confirmatrix filed for Chapter 11 federal bankruptcy protection, with Satary’s son Jordan the largest shareholder to sign the petition in the Northern District Court of Georgia. GNOS Medical is listed as one of the creditors that Confirmatrix owes money to.

“Although historically very profitable,” Confirmatrix CEO Ann Durham told the court the company “began experiencing financial troubles when recent changes to Medicare’s reimbursement rates resulted in a decrease (in) revenue from its toxicology business.”

Drug testing has indeed been a very profitable business for Confirmatrix and other drug labs. 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, not only by Confirmatrix but other drug labs such as Millennium Health, finally caused Medicare to lower its reimbursement rates for drug testing.

Millennium filed for Chapter 11 bankruptcy in 2015, soon after paying a $256 million dollar fine to settle fraud and kickback charges, and to reimburse the government for unnecessary urine and genetic tests.

Under its Chapter 11 filing, Confirmatrix is still able to conduct business and perform lab tests, but it is exploring options for a possible sale of the company or a restructuring “to focus its operations on the blood testing business.” 

The company said it has 152 employees in 15 different states, including one employee in Montana who apparently works at the Benefis pain clinic in Great Falls.

“They had a gal who was there every day, I assume working there full time, and she was responsible for collecting the samples, processing them, and shipping them off to the lab,” said Rodney Lutes, a physician assistant who was discharged by Benefis in March. 

Benefis did not respond to inquiries from PNN about whether a Confirmatrix employee works at the pain clinic or if Benefis receives a commission or compensation from Confirmatrix for doing business with the company. According to clinic policy, patients on high doses of opioids "should have a minimum of one urine drug test every two months."

In a statement, a Benefis official said Confirmatrix 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. This company does not send its patients to collections for an inability to pay a bill,” said Kathy Hill, Chief Operating Officer at Benefis Medical Group.

But some Benefis patients are getting letters from collection agencies demanding payment for Confirmatrix drug screens that cost well over $1,000, the same tests that Medicare is charged about $150 for under its new reimbursement rates. A call to Confirmatrix for comment was not returned.

Other patients say they are getting bills for drug tests they’ve already paid for, and that Benefis has lost some of their billing and medical records. Still other patients are surprised to learn they may be legally responsible for drug tests that their insurance company refused to pay for.  

“Confirmatrix is out of network, hence I am stuck with the bill unless Benefis writes it off,” said one woman, a chronic pain sufferer for over 30 years, whose opioid dose was recently reduced substantially. “In the last 6 weeks I have been dropped to one third of the dosage I was on with intentions that I will be dropped even more. I have no desire to live, because this is not living.”

In April, a suicidal patient at Benefis Health System burned down his doctor's home and killed himself during a standoff with police. David Herron was not a patient at the Benefis pain clinic, but suffered from chronic back pain and apparently had a long-standing grievance with his doctor, an orthopedic surgeon.

The incident prompted Benefis to upgrade security procedures at its facilities, including training employees to handle active shooter situations, according to the Great Falls Tribune, which reported that "danger presents itself in the form of patients who are drug addicted looking for an early prescription."