Civil Rights Case Gives Hope to Pain Patients

By Richard Dobson, MD, Guest Columnist

People with chronic disabling pain frequently complain that doctors discharge them from their practice because of the medications they take. Sometimes doctors refuse to accept patients who are taking opioid pain medications, even though the medications treat a legitimate medical condition.

There may be hope that such actions will be considered violations of the civil rights of patients.

This week the Civil Rights Division of the Department of Justice (DOJ) signed a formal agreement with Selma Medical Associates, a large primary care practice in Virginia, that may open the door for people with chronic pain to regain their full access to medical care.

Selma Medical refused to schedule a new patient appointment for a man who was taking the addiction treatment drug Suboxone. He filed a civil rights complaint asserting that his rights were violated because has a disability.

According to the complaint, Selma Medical “regularly turns away prospective new patients who are treated with narcotic controlled substances such as Suboxone.”

The DOJ and Selma Medical settled the complaint out-of-court. The full agreement can be read here.

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In essence, Selma Medical agreed to stop discriminating on the basis of disability, including opioid use disorder (OUD). The settlement identifies several specific ways that Selma Medical was violating the civil rights of people with disabilities.

“By refusing to accept the Complainant for a new family practice appointment solely because he takes Suboxone, Selma Medical discriminated against him by denying him the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of Selma Medical.

By turning away the Complainant and other prospective patients who are treated with narcotic controlled substances, including Suboxone, Selma Medical imposed eligibility criteria that screen out or tend to screen out individuals with OUD.

Further, Selma Medical failed to make reasonable modifications to policies, practices, or procedures, when such modifications are necessary to afford such goods, services, facilities, privileges, advantages, or accommodations to individuals with disabilities.”

In the agreement, Selma Medical agreed to stop discriminating now and in the future. The staff and administration are also required to undergo intensive training on the implementation of the Americans With Disabilities Act (ADA).

Importantly for pain patients, the agreement applies to people taking “narcotic medications” for any reason and is not limited to people who are taking Suboxone for OUD. The agreement does seem to imply that people taking opioid medications also have their civil rights violated if they are refused medical care on the basis of their diagnosis and their use of opioids.

A former staff attorney in the DOJ’s Civil Rights Division agrees.  

“This formal settlement agreement from DOJ affirms that discrimination in access to medical treatment based solely on an individual’s use of a particular medication — in this case, a narcotic controlled substance — may violate the law,” says Kate Nicholson, a pain patient and civil rights attorney who helped draft federal regulations under the ADA.

Anyone who has chronic pain and who is discharged from a practice or refused admission to a medical practice should let the medical staff know that this is a violation of the ADA. Show them the agreement between Selma Medical and the DOJ. Then if the medical practice still refuses care, file a formal complaint with the Office of Civil Rights. Instructions on filing can be found here.

As part of the settlement agreement, Selma Medical had to pay $30,000 to the complainant for “the discrimination and the harm he has endured, including, but not limited to, emotional distress and pain and suffering.” Selma Medical also had to pay a civil penalty of $10,000.

It seems to me that the substance of this agreement gives real hope to the chronic pain community that discrimination based on disability, even if the disability is based on pain, is illegal and violates their civil rights.

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Richard Dobson, MD, worked as a physician in the Rochester, New York area for over 30 years, treating and rehabilitating people suffering from chronic pain, mostly as the result of work or motor vehicle accidents.  He is now retired.  

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.

Doctors Call Probe of Opioid Deaths a ‘Witch Hunt’

By Cheryl Clark, Kaiser Health News

The Medical Board of California has launched investigations into doctors who prescribed opioids to patients who, perhaps months or years later, fatally overdosed.

The effort, dubbed “the Death Certificate Project,” has sparked a conflict with physicians in California and beyond, in part because the doctors being investigated did not necessarily write the prescriptions leading to a death. The project is one of a kind nationally, although a much more limited program is operated by North Carolina’s board.

So far, the board has launched investigations into the practices of about 450 physicians and referred the names of 72 nurse practitioners, physician assistants and osteopathic physicians to their respective licensing boards.

To date, the regulators have formally accused at least 23 doctors of negligent prescribing, and more accusations are expected. Some of the accusations, like one 63-page document filed against Dr. Frank Gilman, a San Diego internist, detail hundreds of prescriptions for one patient over four years, most of them by him. Gilman did not respond to a request for comment.

The project, first reported by MedPage Today, has struck a nerve among medical associations. Dr. Barbara McAneny, the American Medical Association president and an Albuquerque, N.M., oncologist whose cancer patients sometimes need treatment for acute pain, called the project “terrifying.” She said “it will only discourage doctors from taking care of patients with pain.”

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Using terms such as “witch hunt” and “inquisition,” many doctors said the project is leading them or their peers to refuse patients’ requests for painkiller prescriptions — no matter how well documented the need — out of fear their practices will come under disciplinary review.

The influential California Health Care Foundation also has pushed back against the project, saying it could harm patients.

Unusually aggressive for the board, the program is a reaction to the by now well-known phenomenon of physicians overprescribing opioids. Nationally, a host of policy changes and educational efforts have driven down the rate of opioid prescriptions in recent years.

The goal of California’s program, quietly launched four years ago, is not necessarily to link a doctor’s specific prescription to a specific patient’s death — although many of the cases do — but to find doctors whose patterns of prescribing are so dangerous they may lead to patients’ ultimately fatal addictions.

Sometimes a doctor was earmarked for investigation even though the cause of death included multiple drugs prescribed by many physicians, or suicide by overdose, board documents indicate.

Kimberly Kirchmeyer, executive director of the Medical Board of California, defended the project. She said the effort has found patterns of “gross negligence,” incompetence and excessive prescribing.

“I understand their frustrations,” she said of the complaining doctors, “but we do have to continue our role with consumer protection.”

She noted that part of the point of the project is to educate doctors and, through probation requirements, change the behavior of those who prescribe excessively.

“That’s education that could potentially save patients in the future,” said Kirchmeyer, whose agency licenses some 141,000 doctors.

Some consumer groups consider the board’s bold effort to find overprescribing doctors not aggressive enough.

“It’s long overdue,” said Carmen Balber, executive director of the nonprofit Consumer Watchdog. The board should investigate opioid-related deaths that occurred more recently, she said: “They need to get their act together and speed things up.”

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The agency thus far has looked at deaths only in 2012 and 2013 in which opioids were confirmed as a cause or contributing cause. It matched the names of the dead with the prescription drugs they filled, which are listed in the state’s prescription database. The database also shows the names of the doctors who prescribed to them. Physician experts reviewed those doctors’ prescribing history and selected those who appeared to prescribe drugs heavily.

Some doctors said they were especially angered that the letters they received concerned prescriptions they wrote as long as nine years ago.

McAneny, of the AMA, noted that prescribing practices now deemed unacceptable came out of public policies years ago that “compelled doctors to treat pain more aggressively for the comfort of our patients.” Also, payers have measured quality of care by whether their patients answered surveys about whether their pain was well-controlled.

“We’re [already] doing a lot of education to undo the damage” from those policies, she said.

Similarly, Dr. David Aizuss, a Los Angeles ophthalmologist who is president of the California Medical Association, said state and federal guidelines that took effect in 2014 and 2016 impose much more stringent prescribing precautions than “what was going on six or seven years ago.”

Many insurance plans and pharmacies in recent years have restricted dosages and durations of certain painkillers a physician may prescribe at one time.

Afraid to Prescribe

The crackdown on doctors has created fear, said Dr. Robert Wailes, a pain medicine specialist in Encinitas and chair of the California Medical Association’s Board of Trustees.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” he said.

Officially, the CMA stops short of saying the medical board should stop the project, perhaps to avoid any perception that the association condones overprescribing. But it has asked the board to hire an independent reviewer to assess the criteria the board is using to decide which physicians to investigate, and whether physicians in certain specialties or regions of the state are being targeted more than others.

Dr. Ako Jacintho, a San Francisco addiction medicine specialist, was notified by the board that he was in trouble over a year ago. A patient for whom he had prescribed methadone fatally overdosed in 2012. The letter said “a complaint” had been filed against him, and asked him to respond to the allegations or, if he delayed, face a citation or fine of $1,000 per day. (The medical board can file its own complaints against a doctor.)

The letter said the patient had died of “acute combined methadone and diphenhydramine intoxication.” Jacintho had refilled the patient’s prescription for methadone the day before but said a 10-milligram pill was not a toxic dose. And he said he never prescribed diphenhydramine, the antihistamine sold as Benadryl.

“The only way he would have died was if he had not taken it as directed, or had mixed it with a medication that was not prescribed,” Jacintho said.

As of Dec. 21, Jacintho was still waiting to hear if he would face a formal accusation.

Last year, the board rewrote those letters in a less accusatory tone — describing the “review” as routine — although it still threatens doctors with $1,000 fines.

In a much smaller subset of cases, it finds problems that result in formal accusations that can result in discipline, such as public reprimands or restrictions on a physician’s ability to practice.

You can’t even begin to understand how disrupting and upsetting this is. It’s not just a threat on your license; it’s a threat that you’ve not been a good physician.
— Dr. Paul Speckart

Despite its designation as a “Death Certificate Project,” the California effort has not focused only on doctors whose patients died. In an unknown number of overdose cases, the board has sent letters to living patients asking them to authorize their doctors to relinquish their medical records to the board, adding that those documents would otherwise be subpoenaed.

Dr. Paul Speckart, a San Diego internist, said three of his patients last year received board letters that seemed to question his quality of care when all he did was try to relieve their well-documented pain. The board has not filed any accusations against him.

“You can’t even begin to understand how disrupting and upsetting this is,” Speckart said. “It’s not just a threat on your license; it’s a threat that you’ve not been a good physician.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

 

Some California Pain Patients Forced to Buy Naloxone

By Pat Anson, PNN Editor

A new state law that mandates new prescription pads isn’t the only headache faced by doctors and pain patients in California.

Over a dozen bills passed by the state legislature and signed into law by former Gov. Jerry Brown are aimed at addressing the opioid crisis. One of them -- AB 2760 -- requires doctors to “offer” a prescription for naloxone to any patient deemed at high risk of an opioid overdose.  Naloxone (Narcan) rapidly reverses the effects of an opioid overdose and has been credited with saving thousands of lives.

The naloxone law does not require patients to fill the prescription, but some pain sufferers are being forced by pharmacists to buy naloxone if they want to get their opioid medications filled. For one patient, it was a choice between pain relief and putting food on the table.

“A medication I don't want, don't need, and didn't ask for, is being forced on me. As in holding my other medication hostage. And each dose of Narcan is $75 for the uninsured. Which I am, because my insurance company won't pay for it,” one reader wrote on PNN’s Facebook page.

“I had to go without groceries to purchase a medication I didn't want, need or ask for. Nine years of never ever breaking a rule, having any adverse effects EVER, and never failing all those ‘gotcha’ tests they inflict on pain patients. So now, in addition to being in pain, I'm hungry. This cannot be.”

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Another pain sufferer said she felt treated like a drug addict when a pharmacist forced her to buy Narcan, a nasal spray that contain naloxone.

“Blackmailed by Kaiser to pay $50 for Narcan before they would give me my pain meds. I am retired, disabled, and on fixed income,” wrote a woman who lives with severe arthritis. “I was an RN who worked holidays, weekends, nights, etc. Now this ‘greatest’ country treats me like some scum addict who shoots up illegal drugs.”

The requirement that doctors offer a naloxone prescription applies to so-called “high-risk” patients taking over 90 MME (morphine milligram equivalents) of opioids a day or those who are co-prescribed benzodiazepines, an anti-anxiety medication. Patients who have previously overdosed or have a history of substance abuse are also considered high risk.

But whether high-risk or low-risk, nothing in the law requires a patient to buy naloxone or empowers a pharmacist to withhold medications.

“The law does not make it mandatory for the patient to accept a prescription for naloxone or to fill it but only for the patient and physician to have a thoughtful conversation about whether it would be in the best interest of the patient,” Assemblyman Jim Wood, the bill’s sponsor, said in a statement to PNN.

The law does not make it mandatory for the patient to accept a prescription for naloxone or to fill it.
— CA Assemblyman Jim Wood

“We are beginning to hear circumstances where patients are being required to fill the naloxone prescription, and will investigate the circumstances where this is happening because that is not what the law states.”

Naloxone costs only pennies to make and syringes containing generic versions of the drug typically cost about $15 each. Branded and formulated versions such as Narcan are more expensive.

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Evzio, a kit that contains two auto-injectors of naloxone, retails for about $3,700 and its manufacturer has been accused of price gouging.  The company reportedly raised Evzio’s price by over 600% to “capitalize on the opportunity” of a “well established public health crisis.”

Whether it comes in a spray, injector or syringe, its impractical to expect anyone to give themselves a dose of naloxone.

“What the state and others fail to realize is many pain patients live alone. Even if one were to accidentally overdose and lose consciousness how are they supposed to administer the Narcan?” asks PNN columnist Rochelle Odell, who lives in California. “No one clearly thinks these grandiose ideas through.”

Law enforcement groups, pharmacists and the Medical Board of California supported passage of AB 2760, but the bill was opposed by the Academy of Family Physicians, American College of Emergency Physicians and the California Medical Association (CMA).

“Mandating that a specific medication be prescribed in a variety of situations, regardless of the individual patient characteristics, is inappropriate and places the government between a patient and his or her physician,” the CMA said.

Despite that warning, AB 2760 was passed unanimously by the state Assembly and Senate, signed by the governor, and became law on January 1st.

Prescription Pad Chaos

As PNN has reported, the law of unintended consequences also applies to AB 1753, which requires California doctors to use customized prescription pads for opioids that have uniquely serialized identification numbers.

The idea was to prevent counterfeiting and get more prescriptions filed electronically, but instead the early weeks of the law’s implementation have been marked by chaos. Many doctors were unaware of the new law or unable to get new prescription pads ordered before January 1st. As a result, pharmacists have refused to fill prescriptions written on old pads and patients have been sent away empty-handed.

“I just got my new prescription pads (Monday) at a cost of several hundred dollars, and the change is trivial,” Dr. Richard Buss, a family practice physician in Jackson, told the Sacramento Bee. “At the hospital here, I was next to a doctor who was trying to send a patient home after knee surgery, and the pharmacy wouldn’t honor his prescription because they were old forms.” 

Buss said this is the second year in a row that California doctors were not given proper notification of changes in their prescription pads. 

“They’re just changing prescription requirements, and then the doctors have to jump through the hoops suddenly, and I’m left with thousands of prescription blanks that are unusable, and that’s probably true for a lot of other doctors,” he said. 

Assemblyman Evan Low, who sponsored AB 1753, was unavailable to comment to PNN. In a January 7 letter to California’s Attorney General, Low blamed state regulators for the “unanticipated” confusion caused by his legislation. 

“I have been informed that numerous pharmacies have already turned away individuals holding prescriptions written on unserialized forms that are otherwise valid; in the face of possible discipline, dispensers are forced to decide between denying care to their patients and risking action against their license,” Low wrote. 

The California Medical Association is drafting new legislation to ensure a smoother transition to the new prescription pads, a process that usually takes weeks or months.

Are Opioid Prescriptions for Pets Diverted to Humans?

By Pat Anson, PNN Editor

Opioid prescriptions for pets have soared over the past decade and may have helped fuel the opioid epidemic in humans, according to a small and speculative study published in JAMA Network Open.

Researchers at the University of Pennsylvania's Perelman School of Medicine say there was a 41 percent increase in opioid MMEs (morphine milligram equivalents) prescribed to dogs, cats and other pets at an acute care veterinary hospital at Penn’s School of Veterinary Medicine from 2007 to 2017.  Some of the increase was attributed to more complex procedures performed in veterinary medicine, as well as a greater awareness of the importance of pain management in animals.

But the authors took their analysis a step further by suggesting -- without offering any evidence -- that some of the opioids were diverted for human use.

"As we are seeing the opioid epidemic press on, we are identifying other avenues of possible human consumption and misuse," said senior author Jeanmarie Perrone, MD, a professor of Emergency Medicine and the director of Medical Toxicology at Penn Medicine.

"Even where the increase in prescribed veterinary opioids is well intended by the veterinarian, it can mean an increased chance of leftover pills being misused later by household members, sold or diverted, or endangering young children through unintentional exposure. The results of this study suggest that by assessing the rate of veterinary opioid prescriptions, we can develop strategies to reduce both human and animal health risks associated with increasing use."

Perrone was one of three peer reviewers who helped the CDC develop its controversial 2016 opioid prescribing guideline. One of her co-authors is Lewis Nelson, MD, a longtime critic of opioid prescribing practices who belonged to the “Core Expert Group” that drafted the CDC guideline.

The researchers reviewed pharmacy records at Penn Vet's Ryan Hospital during the 10-year study window, analyzing trends in four opioids prescribed to animals: tramadol, hydrocodone, codeine and fentanyl. The vast majority of animal patients were dogs and cats, along with an assortment of rabbits, snakes and birds.

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"We found that the increased quantity of opioids prescribed by our hospital was not due to increased patient volume alone. It is likely that our goal of ensuring our patients are pain-free post-operatively, particularly for those requiring complex and invasive procedures, has driven our increased prescribing practices during this period," said lead author Dana Clarke, VMD, a professor of Interventional Radiology at Penn’s School of Veterinary Medicine.

"At the national level, we don't know the potential or extent of prescription diversion from animals to humans, and what impact this could have on the human opioid crisis."

Although the evidence of veterinary opioids being diverted to humans is largely anecdotal, many states have adopted measures that require background checks on pet owners. Twenty states require veterinarians to report their opioid prescriptions to a drug database, just as medical doctors do.

Maine and Colorado require background checks on a pet owner’s drug use before a veterinarian can even write a opioid prescription; while Alaska, Connecticut and Virginia limit the amount of opioids any one veterinarian can prescribe to a single animal.

Last year the Food and Drug Administration warned veterinarians to be cautious when prescribing opioids and be alert for people who may be using their pets to gain access to the drugs.

“We recognize that opioids and other pain medications have a legitimate and important role in treating pain in animals,” said FDA commissioner Scott Gottlieb, MD. “But just like the opioid medications used in humans, these drugs have potentially serious risks, not just for the animal patients, but also because of their potential to lead to addiction, abuse and overdose in humans who may divert them for their own use.”

A small study published in the American Journal of Public Health suggested that some pet owners are purposely injuring their animals to gain access to opioids. In a survey of 189 Colorado veterinarians, 13 percent reported they suspected an animal owner of purposefully injuring a pet to obtain opioid medication.

The 7 Golden Rules of Opioid Prescribing for Patients

By Jeffrey Grolig, MD, JD, Guest Columnist  

“Don’t do it!” is the advice often given to brand new physicians about whether to specialize in pain medicine. Increasing numbers of doctors are being fined, disciplined or arrested due to scrutiny caused by the nation’s opioid crisis. Every single opioid prescription, even the mildest painkiller, is being tracked, and prescription drug database searches tell the DEA and state board investigators who to watch.  

The unfortunate innocent victims of this crisis have been those legitimate patients who suffer in chronic pain, with up to 100 million in the United States alone. Each time a physician or pharmacy is attacked, thousands of pain patients must pay the price.

A pharmacy in my northern California town recently closed after the owner was charged with 200 counts of failing to properly keep records. Each count carries a $20,000 fine.

A local physician’s license was restricted for failure to warn in writing about the risks of combining sleeping pills with opioids. This family physician had already spent $56,000 in legal fees for previous documentation lapses.

A pulmonary specialist with English as his second language was arrested for prescribing codeine-containing cough syrup to four undercover DEA agents posing as patients. He is facing 20 years in prison and $2 million in fines.   

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I still accept pain patients, but my background as an attorney compels me to use “universal precautions,” something I advise every physician who prescribes opioids to do. This boils down to following what I call “The 7 Golden Rules of Opioid Prescribing.” If you, as the patient, understand that your doctor must follow these 7 golden rules, it will make it much easier for you to obtain excellent pain management, including opioids.  

I developed the 7 golden rules by analyzing the most common documentation lapses of doctors who were disciplined or prosecuted. I included them when I wrote the “Physician Primer: Prescribe Like a Lawyer” to empower doctors to think and practice like a lawyer and not lose their careers over simple documentation errors.

If you write a cover letter like the one below to your current or prospective physician, touching on each and every one of these 7 golden rules, your pain control will vastly improve, I promise. 

Dear Doctor,

#1 I have a legitimate medical reason for needing opioids. My medical diagnosis is… (be specific: examples include diabetic neuropathy, failed spine surgery, spinal stenosis, CRPS, etc.). Attached is my MRI report (or EMG, CT, X-ray, Bone Scan, lab test, etc.) proving this.  

#2 I am not now, nor have I ever been addicted to prescription medication, illegal drugs or alcohol.   

#3 I have no depression, psychosis or bipolar disorder.  

#4 I understand all the risks of opioids and related medications, as well as my options for all non-opioid alternative treatments.  

#5 I am not taking benzodiazepines and drinking alcohol.  

#6 I have attached my last 12 months of medical records (not applicable if you have been with the same physician for one year).  

#7 These records reflect that I am an honest, compliant and responsible patient.  

Respectfully,  

Pain Patient

If you do not meet these criteria, it means you are in a higher risk category and would be better managed at a university medical center or a teaching hospital. To my knowledge, the DEA or state medical board has never raided a teaching hospital or university medical center. 

The best way a patient can signal to me they are responsible and low risk is to write a letter covering each of the 7 golden rules, attached to one year’s worth of medical records. This essentially does my work for me, and it makes it easy for me to decide whether or not to accept the patient.

If your doctor still won’t budge, hand him my free “Primer Flyer,” a pamphlet that explains risk management, that’s available on my website: ThePhysicianPrimer.com.

If all else fails, have him watch my YouTube video on The 7 Golden Rules of Opioid Prescribing for Doctors. 

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Jeffrey W. Grolig, MD, JD, is a board-certified specialist in Physical Medicine & Rehabilitation. He has taught at UC Davis Medical Center in both the departments of Family Practice and Physical Medicine & Rehabilitation. Dr. Grolig has formerly worked as a licensed attorney and has authored 6 books.

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.

Sen. Wyden Wants to Censor Pain Experts’ Opinions

By Lynn Webster, MD, Guest Columnist

In 2016, the Comprehensive Addiction and Recovery Act (CARA) created an advisory panel called the Pain Management Best Practices Inter-Agency Task Force and charged it to “develop a set of best practices for chronic and acute pain management and prescribing pain medication.”

The task force has just released its first draft report that makes several recommendations. One is to update the scientific evidence on which the Centers for Disease Control and Prevention’s controversial 2016 Guideline for Prescribing Opioids for Chronic Pain was based. Another goal is to expand areas already included in the guideline.

On December 18, 2018, just before the report was published, Oregon Senator Ron Wyden (D) wrote a letter to Alex Azar, Secretary of Health and Human Services (HHS). In it, he questioned the ability of several experts to serve impartially on the task force because of their alleged connections to the pharmaceutical industry. Specifically, Sen. Wyden worried that opioid manufacturers could exert “financial influence” on those task force members.

Wyden’s concerns about the HHS’s vetting practices would be understandable if the individuals who had been appointed to the advisory panel actually were receiving funds directly from industry. However, that is not the case.

Wyden’s letter specifically mentions Dr. Jianguo Cheng, president of the American Academy of Pain Medicine (AAPM), and Dr. Rollin Gallagher, editor-in-chief of the journal Pain Medicine.

In his letter, Wyden opposes Drs. Cheng and Gallagher’s participation primarily because of their association with AAPM, a professional medical organization that has registered concerns about the impact of the CDC’s opioid prescribing guideline on people in chronic pain.

Dr. Josh Bloom, the American Council on Science and Health’s Director of Chemical and Pharmaceutical Sciences, recently shared written communications from Drs. Cheng and Gallagher that make it difficult to see any logical reason to object to their participation on the panel.

SEN. RON WYDEN (D-OR)

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Since he became president-elect of the AAPM at the end of 2016, Dr. Cheng has had no financial ties to the pharmaceutical industry. Similarly, to ensure Pain Medicine’s editorial independence, Dr. Gallagher voluntarily ended his relationships — consulting or advisory— with the industry when he became editor-in-chief more than 10 years ago.

Ironically, the AAPM has long advocated for alternatives to opioids and generally supported the CDC guideline. However, they did have concerns about lack of evidence for some of the CDC’s recommendations. Other organizations, including the American Medical Association (AMA), have also criticized components of the CDC guideline.

Wyden has previously lodged a similar complaint with the National Academies of Sciences, Engineering, and Medicine, also challenging members selected for an FDA advisory panel because of a perceived conflict of interest. Following his complaint, Dr. Mary Lynn McPherson, professor at Maryland University School of Medicine, and Dr. Gregory Terman, who was the president of the American Pain Society, were removed from the panel. Here again, neither Dr. McPherson nor Dr. Terman personally received funds from Pharma. The University of Maryland and the American Pain Society, with which they were associated, did.

If Wyden’s reasoning were taken to its logical conclusion, no member of the AMA or any professional organization of pain experts critical of the CDC opioid guideline would be an acceptable member of the advisory panel. Also, most university faculty members would be disqualified because their universities accept funding, in one form or another, from industry.

Some people assume that any association with industry must create bias and cause conflicts of interest. Perhaps so, but that does not apply to the people Wyden is trying to silence. Further, membership in a professional association or serving as a faculty member of a university that receives industry support should not necessarily disqualify an individual to make an important contribution to committees. The goal should be to seek out the most qualified individuals.

There is danger associated with Wyden’s persistent efforts to purge advisory panels of members who have expressed views he doesn’t share. In essence, eliminating people with differing views from advisory panels stacks the deck. It creates a special-interest group that is empowered to influence policy without having to consider differing opinions. The irony is that this very attempt to limit bias creates bias.

Prohibiting experts with no direct connections to industries, like Drs. Cheng, Gallagher, McPherson and Teman, from participating on advisory panels seems to be a punitive gesture. Physicians and researchers, such as these four individuals, who actually care for patients are uniquely equipped to help advisory committees set best practices for pain management. And these panels cannot afford to lose the expertise that these individuals can provide.

If the vetting process includes removing all potential conflicts of interest, then it should also flag anyone who has ties to insurance, including Medicare. Clearly, insurance companies have a financial interest in which treatments are recommended.

Today, Wyden and others are calling to ban anyone with direct or indirect ties to Pharma from serving as a government adviser. Tomorrow, another industry could be targeted. For example, people who work in energy or university researchers who receive industry grants to study the weather might not be permitted to advise the government on climate change. This would likely mean the committees would be comprised of the least knowledgeable individuals.

Hopefully, the HHS and other governmental bodies will consider viewpoints from a broad swath of qualified experts and not just those whose perspectives they endorse. A functioning democracy must value and listen to all views.  

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Lynn Webster, MD, is a senior editor at Pain Medicine. He is also a vice president of scientific affairs for PRA Health Sciences and consults with pharmaceutical companies. Webster is a former president of the American Academy of Pain Medicine and author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.”

You can find him on Twitter: @LynnRWebsterMD. 

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

$2 Million in Donations Misused at U.S. Pain Foundation

By Pat Anson, PNN Editor

Over $2 million in funds were misappropriated by former U.S. Pain Foundation CEO Paul Gileno or used in questionable transactions with his family, according to a statement and tax returns released Thursday by the Connecticut based non-profit. Some of the money was paid to Gileno’s wife, sister and brothers.

The misuse of donor funds by Gileno was discovered in April 2018, which led to his resignation the following month. Until now, the extent of the fraud has not been disclosed to U.S. Pain’s staff, volunteers and donors.

“The former CEO was widely respected and beloved in the pain community, and took advantage of that trust in him. He was able to do this by both withholding key information and providing dishonest information that deceived staff and volunteers in leadership positions,” interim CEO and board chair Nicole Hemmenway said in a statement that curiously avoided using Gileno’s name.

“He controlled the organization’s operations, finances, records and bank accounts, as well as the Board process. His mismanagement and dishonesty left the records in disarray.”

According to Hemmenway, Gileno misappropriated nearly $1.9 million from U.S. Pain from 2015 to 2017. The non-profit raised over $7 million in donations during that period, meaning almost a third of it was misused by its founder and CEO.

The misuse of funds was characterized as an “excess benefit transaction” on U.S. Pain’s delinquent tax returns for 2016 and 2017, which were filed late last month with the IRS. An excess benefit transaction is when a payment made by a tax-exempt organization exceeds the actual value of that benefit.

The tax returns indicate the misappropriated funds were spent on “related party vendors” and “personal expenses,” but disclosed no other details. Hemmenway said additional excess benefits would be reported on U.S. Pain’s 2018 tax return.

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Gileno did not immediately respond to a request for comment, but has previously admitted misusing donor funds. “I made some big mistakes over the past few years and took money from US Pain for my personal use,” Gileno wrote in an email sent to U.S. Pain’s leadership last year.

Payments to Family Members

In addition to the nearly $1.9 million in misappropriated funds, U.S. Pain’s 2017 tax return indicates that about $160,000 was spent in transactions involving Gileno’s family.

Nearly $48,000 was paid to Gileno’s wife and nearly $12,000 to his sister. The tax return does not explain what those payments were for. Another $100,000 was spent on an investment in SMJ Homes Inc., a real estate investment company controlled by Gileno’s brothers. The tax return indicates the investment has already lost over half its value.  

There was apparently very little oversight or financial controls at U.S. Pain and Gileno was permitted by the board — which has legal and fiduciary responsibilities — to spend money as he wished.

“The former President/CEO controlled the board process. The records maintained under his leadership list the officers and directors… but contain no evidence that election of officers and directors occurred,” the tax returns said.

Gileno was paid a salary of $94,000 in 2017 and no salary in 2016. A $403,000 salary paid to Gileno in 2015 is now being characterized as an excess benefit.

PAUL GILENO

PAUL GILENO

Hemmenway was paid a salary of $49,900 in 2017 for her work as vice-president. She has been a key member of U.S. Pain since its founding in 2011. So have board members Wendy Foster and Ellen Lenox Smith.

Smith’s daughter-in-law, Shaina Smith, was paid a salary of $76,700 in 2017 as director of state advocacy for the non-profit.

‘I Never Mislead Them’

Multiple sources familiar with U.S. Pain have questioned how Gileno was able to misappropriate funds for so long without Hemmenway or the board being aware.  Gileno himself has said they were kept informed.

“I never mislead them. They were part of US Pain for over 10 years and I talked with them daily,” Gileno wrote in an email to PNN last month. “Nicole and I were close like a brother and sister and I never hid one thing. I feel bad they are trying to use me as an excuse.”

Some insight into how U.S. Pain and its board operate is provided in a blog post by former board member Suzanne Stewart, who resigned last September after serving on the board for only a few months.    

“I don’t feel safe being involved with voting on big decisions yet being left in the dark much of the time. I don’t really know where money is going or where it comes from in all honesty,” she wrote.

In Thursday’s statement, Hemmenway acknowledged that “the organization should have had stronger financial controls” and said a “robust system of checks and balances” now requires U.S. Pain’s chair and chief financial officer to approve all expenditures.

“With these checks and balances in place, the organization is stronger than ever before,” Hemmenway said. “U.S. Pain fills a vital gap in support for the pain community and refuses to let the actions of one individual impede its efforts to educate, connect, empower, and advocate for those living with chronic pain.”

The statement gave no indication if others were implicated in the misuse of funds or if Hemmenway and the remaining board members will resign or be replaced.

Can Gabapentin Improve Your Sex Life?

By Pat Anson, PNN Editor

Over the years the nerve drug gabapentin (Neurontin) has been used to treat a cornucopia of chronic pain conditions, from fibromyalgia and diabetic neuropathy to hot flashes and shingles.

Gabapentin is so widely prescribed that a Pfizer executive once called the drug “the snake oil of the twentieth century” because researchers found it successful in treating just about everything they studied.

Add sexual function to the list.

In a small study, researchers at Rutgers University found that gabapentin improved sexual desire, arousal and satisfaction in 89 women with provoked vulvodynia, a chronic condition characterized by stinging, burning and itching at the entry to the vagina. Vulvar pain often occurs during intercourse, which leads to loss of interest in sex.

The improvements in desire, arousal and sexual satisfaction were small, but considered “statistically significant” in research parlance. Gabapentin did not improve lubrication or orgasm.

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"Our theory was that reducing pelvic floor muscle pain might reduce vulvodynia pain overall and thus improve sexual function," said Gloria Bachmann, MD, director of the Women's Health Institute at Rutgers and lead author of the study published in the Journal of Obstetrics and Gynecology.

"We found that women with greater muscle pain responded better in terms of pain and improved arousal than those with less pain, which suggests that Gabapentin be considered for treatment in women who have significant muscle tightness and spasm in the pelvic region.”

Does this mean gabapentin is a female version of Viagra? Not necessarily, says Bachmann, who stressed that the study only focused on women with vulvodynia.

“We didn't research the question of gabapentin enhancing sexual function in all women,” Bachmann wrote in an email to PNN. “The decision to give gabapentin to a woman who reports chronic vulvar pain and sexual dysfunction would have to be made on an individual basis, depending on her medical history and the results of her physical and pelvic examination.

“From the data, it appears that women with increased muscle tenderness of the pelvic floor may be the group who benefit most from gabapentin.”

Sales of gabapentin have soared in recent years — not because it improves sexual satisfaction — but because it is seen as a safer pain reliever than opioid medication.

Patients prescribed gabapentin often complain of side effects such as mood swings, depression, dizziness, fatigue and drowsiness.  Drug abusers have also discovered that gabapentin can heighten the effects of heroin, cocaine and other illicit substances, and it is increasingly being abused.

Fed Panel Releases Draft Report on Pain Management

By Roger Chriss, PNN Columnist

A federal advisory panel known as the Pain Management Best Practices Inter-Agency Task Force has released a draft report listing its recommendations for improving pain care in the United States. The content is both revealing and promising, because its recognizes the complex nature of chronic pain and the difficulty in treating it effectively.

The task force was formed as a result of the Comprehensive Addiction and Recovery Act (CARA) of 2016. Its mission is to identify gaps and inconsistencies in acute and chronic pain management and to propose possible solutions.

The 29 members who serve on the task force include representatives from the FDA, CDC, VA and Office of National Drug Control Policy; as well as academic and medical experts in pain management, addiction treatment, pharmacy, oncology, psychiatry and interventional medicine.

Interestingly, Harold Tu, MD, the lone dentist on the panel, is the father-in-law of Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP). Only one pain patient and advocate was appointed to the task force, Cindy Steinberg of the U.S. Pain Foundation.

PAIN MANAGEMENT INTER-AGENCY TASK FORCE

PAIN MANAGEMENT INTER-AGENCY TASK FORCE

The key findings of the task force are that pain management should be balanced, individualized, multidisciplinary and multi-modal. Pharmacological pain management requires careful screening and monitoring of patients to minimize risks, while non-pharmacological modalities, in particular physical therapy, also have a significant role to play. The needs of special populations such as children, women, older adults, and military personnel and veterans must also be recognized, according to the draft report.

The task force introduces a new term: “chronic relapsing pain conditions.” These conditions include a lengthy list of degenerative, inflammatory and neurologic conditions, such as multiple sclerosis, cancer, trigeminal neuralgia, lupus, Parkinson’s disease, postherpetic neuralgia, CRPS, porphyria, lupus, lumbar radicular pain, migraines and cluster headaches.

In other words, the draft report recognizes that pain is heterogeneous and the umbrella term of “chronic pain” is problematic. The report notes: “There are multiple potential causes of worsening pain that are often not recognized or considered. Non-tolerance-related factors include iatrogenic (medical related) causes such as surgery, flares of the underlying disease or injury, and increased ergonomic demands or emotional distress.”

The draft report gives considerable attention to the risks associated with high opioid doses and the use of benzodiazepines, but doesn’t entirely dismiss their use:

“Dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold. Much of the risk at higher doses appears to be associated with co-prescribed benzodiazepines.”

“Although the risk of overdose by benzodiazepine co-prescription with opioids is well established, this combination may still have clinical value in patients who have chronic pain and comorbid anxiety, which commonly accompanies pain, and in patients who have chronic pain and spasticity.”

The draft report also warns that medication shortages are worsening the quality of pain care: "Recurrent shortages in opioid and nonopioid medications have created barriers to the proper continuity of treatment in acute and chronic pain patients. This creates the unintended consequence of poor patient care.”

Importantly, the report devotes an entire section to the impact of the 2016 CDC opioid prescribing guideline. While recognizing the “useful general guidance” in it, the report notes that “an unintended consequence of the guideline is the forced tapering or patient abandonment that many patients with chronic pain on stable long-term doses of opioids have experienced."

The report concludes that the “CDC guideline was not intended to be model legislation for state legislators to enact,” but stops short of recommending that the guideline be revised. Instead, the task force recommends “educating stakeholders” about the intent of the guideline and its “core beneficial aspects.”

The depth of analysis in the draft report is clear from the 446 footnoted references, which includes the familiar names of Beth Darnall, PhD, Roger Chou, MD, and Lynn Webster, MD. Pain News Network is even cited as one reference.

The task force held two public hearings in May and September 2018. The task force will be accepting comments on its draft report by mail, email and online. After a 90-day public comment period, the report will be finalized and submitted to Congress.

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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.

Medicare Patients Face New Rx Opioid Rules in 2019

By Pat Anson, PNN Editor

The Centers for Medicare and Medicaid Services (CMS) will implement new safety rules on January 1 that could make it harder for over a million Medicare beneficiaries to get prescriptions filled for high doses of opioid pain medication. Prescriptions for opioid “naïve” patients – those who are new to opioids -- will also be limited to an initial 7-day supply, regardless of dose.

The new rules, which are modeled after the 2016 CDC opioid guideline, are intended to reduce the risk of opioid abuse and addiction. They only apply to patients enrolled in Medicare’s Advantage and Part D prescription drug programs, and exempt patients in palliative and hospice care or those being treated for “active” cancer-related pain.

But patients and advocates fear the rules give too much power to insurers and pharmacies, and could result in widespread confusion or patients being denied medications they’ve taken safely for years.

“I am concerned, just as happened with the CDC Guideline, the new CMS rules starting January 1 will be totally misinterpreted, misunderstood, and possibly weaponized to deny patients opioid pain meds,” says Rick Martin, a retired Las Vegas pharmacist disabled by chronic back pain. 

In recent weeks, Martin says he’s spoken with three pharmacists at major chains in the Las Vegas area and none of them had been briefed about the new CMS rules or how they will be implemented by insurers. 

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“Maybe the sponsors (insurers) are so overwhelmed, nothing will happen after January 1 or maybe some obscure person in the basement is waiting to install a computer program that will kick in January 1 and nobody will be expecting it. That would be utter chaos,” said Martin. 

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

‘Safety Edit’ for High Dose Prescriptions

Starting January 1, Medicare insurers will adopt drug management programs (DMPs) designed to flag patients who are deemed high risk – such as those who take opioids with anti-anxiety benzodiazepines or get opioid prescriptions from more than one doctor.

Any opioid prescription at or above 90 MME (morphine milligram equivalent) will trigger an automatic “safety edit” requiring pharmacists to talk with the prescribing doctor about the appropriateness of the dose. If satisfied with the explanation or if a prior authorization was already granted, the pharmacist could override the safety edit and fill the prescription. About 1.6 million Medicare beneficiaries met or exceeded a dose of 90 MME in 2016.

Insurance companies can impose their own “hard edit” for patients getting 200 MME or more, which will require pharmacists to contact the insurer before filling a prescription.  Insurers will also be given greater authority to identify patients at high risk of addiction and can even require they use “only selected prescribers or pharmacies.”

The bottom line for patients is that pharmacists and insurers – not doctors -- could be the final arbiters of whether a prescription is appropriate and should be filled.

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“If you get opioids from multiple doctors or pharmacies, your plan may talk with your doctors to make sure you need these medications and that you’re using them safely,” a Medicare advisory tells patients.

“If your Medicare drug plan decides your use of prescription opioids and benzodiazepines isn’t safe, the plan may limit your coverage of these drugs. For example, under its DMP your plan may require you to get these medications only from certain doctors or pharmacies to better coordinate your health care.”

“The process they decided on -- having pharmacists confer with prescribers -- is really a good idea in the abstract, but in practice it's going to be very burdensome,” says Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. 

“I think that the mandated phone conversations between pharmacists and prescribers will turn out to be such a time-consuming endeavor that many prescribers will decide just to prescribe a low enough dose that those phone calls aren't triggered. The net effect, in many cases, I think, will be to encourage prescribers to drop their doses below that threshold.”

If a prescription is rejected by an insurer or pharmacist, patients have the option of paying for the medication in cash and/or filing an appeal.

“CMS officials have confirmed that Medicare prescription drug coverage involvement is limited to payment for medications. If a patient receives a denial of coverage, the patient has the right to pay out-of-pocket for that medication. A Medicare denial only applies to financial coverage. It has no authority to deny the prescription itself,” says Andrea Anderson, Executive Director of the Alliance for the Treatment of Intractable Pain (ATIP). 

ATIP is encouraging patients denied medication to contact a little-known CMS agency called the Beneficiary and Family Centered Care-Quality Improvement Program, where they can file an appeal or make a complaint.   

Medicare patients can also be proactive by talking with their doctor and pharmacist about the new rules before getting a prescription filled. They can also seek a prior authorization from their insurer to avoid the delays of a safety edit at the pharmacy.

Should Rx Opioids Be Limited for Cancer Patients?

By Pat Anson, PNN Editor

At a time when many chronic and acute pain patients are losing access to opioid medication, patients suffering from cancer pain are treated differently. They’re usually exempt from opioid guidelines that typically focus on limiting prescriptions for “noncancer pain.”

But some oncologists are starting to question whether opioids should be routinely prescribed to cancer patients.

“As an oncologist, I cannot help but reflect on that qualifier. It suggests that a cancer diagnosis gives us permission to prescribe opioids with impunity. Patients with cancer can become addicted, like anyone else. Yet oncologists use these potent, seductive drugs freely, perhaps without sufficient regard for the risk of dependence and abuse,” writes Alison Loren, MD, in an op/ed published in The New England Journal of Medicine.

“Treating patients who are terminally ill from cancer is an important indication for these drugs. But what about patients with cancer who aren’t dying, the ones we hope to cure? Woven into our language about the opioid epidemic is an implication that oncologists can hand out opioids as if there were no tomorrow. But for many people with cancer, there is now indeed a tomorrow.”

Loren, who is a professor at the Perelman School of Medicine at the University of Pennsylvania, says many patients whose cancer was once thought incurable are living for a decade or longer. Thanks to advances in cancer treatment, there are more than 15 million cancer survivors in U.S. and their ranks are growing

“With this progress comes new challenges. Especially poignant — albeit rare — is the one I face when I see a patient who is cancer-free but addicted to medications I’ve prescribed,” wrote Loren. “I am responsible for this predicament, and it feels monstrously cruel — second only to allowing the dependence to continue. Sometimes, like those with ‘noncancer pain,’ our patients veer into abuse.”

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A new study by researchers at the University of Colorado School of Medicine found signs of opioid abuse in a small percentage of cancer patients. Out of 811 patients given opioids after treatment for oral or oropharynx (neck) cancer, 68 patients (7%) were still using opioids six months later.

"You shouldn't need opioids at the six-month point," says Jessica McDermott, MD, an investigator at the CU Cancer Center. “We felt like (opioid misuse) was a long term problem for some of our head and neck cancer patients, but didn’t know how much of problem.”

McDermott doesn’t advocate taking opioids away from cancer patients, but says doctors should know which patients are more at risk of opioid misuse, such as those having a previous opioid prescription or a history of smoking and alcohol use.

"If a patient needed opioids for pain, I wouldn't keep them away, but especially if they have risk factors, I might counsel them more about the risks of addiction and misuse, and keep an eye on it," McDermott says.

Loren would take opioids away from a cancer patient at risk of misuse. She shared the story of a leukemia patient with a long history of substance abuse who was found dead in her hospital bed.

“Her leukemia was in remission. The possibility that she may have overdosed haunts me,” Loren wrote. “Oncologists are accustomed to giving opioids, but we must also be comfortable taking them away, and sometimes giving them in limited doses or not at all.”

How Chronic Pain Led Me to Illegal Drugs

(Editor's note: This column was written by someone I've known for several years and consider a friend. The author is intelligent, college educated and works full time. They also have a progressive and incurable chronic pain condition. Like a growing number of pain patients who are undertreated or have lost access to pain care, my friend has turned to illegal drugs for pain relief. For obvious reasons, we are not disclosing the author's name.) 

For me, it started with borrowing a couple hydrocodone pills from my uncle, who’d just had surgery and didn’t finish his prescription.  

Technically illegal? Yes. Illegal illegal? Not really. That’s what I told myself.

I run out of pain pills early every month — because they are prescribed to take one every six hours and only last about three. So I was happy to have a few more to get through those last few days before my refill.  

I always need more though, because the pain is always there. So I started to swap pills with my cousin, who also has chronic pain.  “Here, take 10 of mine today,” I’d offer.  

Then a few days later, I’d go back with, “Okay, now I need to borrow some pills from you. Maybe just five to get me through until my next refill?”  

I know she would never consider those drug deals. She would never consider herself a dealer. She goes to church for goodness sake. 

Eventually, I started to pay a little cash for 5mg pills from a friend of a friend, because it seems only fair to give him something in return.

I guess that’s about as “drug deal” as drug deals get. Here is money for you in exchange for drugs for me. There’s no way to really argue that.   

But it still didn’t feel like a drug deal. He’s doing me a favor, so I’m doing him a favor. We’re working professionals. We’re not meeting in a dark alley. Nobody has a gun on them. We’re just helping each other.

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Then I started buying marijuana to see if it would help with the pain.  I felt like marijuana was easier to get than my monthly pain pill prescription. And as long as I had the money, I could get as much as I wanted.  

I bought it from an old high school friend, who has a quiet house in the country and always invites me over for dinner. It felt more like buying homemade jewelry than buying homemade drugs. And she’d send me home with marijuana edibles that didn’t seem all that different than any other muffins my friends would bake for me.  

Recreational marijuana isn’t legal where I live, but it is in a lot of other places, so it’s still easy to justify this one to myself. My state is just a little behind. We’ll catch up. And soon buying an eighth won’t be much different than buying a pack of cigarettes.  

The marijuana doesn’t help me much other than putting me to sleep, so I hardly ever buy it. But if it did work — if it helped anywhere close to the way hydrocodone does — I would become a regular customer.  

Since I didn’t like it or use that much, I ended up selling some leftover marijuana to a friend’s uncle. That’s about when I officially became a dealer myself, I suppose.  

And now, I’m regularly buying extra hydrocodone from the local drug dealer. I meet up with him in the alley behind his apartment. He does not make drug dealing look glamorous. He never has enough money for his phone bill, he always needs a ride, and I’m pretty sure he uses the money I give him to buy heroin.  

I tell myself that most people would do what I was doing if they were enduring the kind of daily, debilitating chronic pain that I have. It’s either this or suicide.  

I try to get my doctor to increase my prescription and hold my breath every time they drug test me. So far, I’ve always passed. And so far, my prescription has yet to last me until the end of the month.  

All these illegal drugs get expensive. $10 for one 10mg hydrocodone. You can whip through $300 a week easily. Hydrocodone is more expensive than heroin and even harder to get.  

Sometimes I wonder if I should just take the leap and buy $20 worth of heroin, which would be more potent than $400 worth of hydrocodone pills. I know where I can get it now, thanks to my new connections to the local dealer.  

But so far, I’ve resisted. Not worth the possible side effects. Not worth the hassle. And not worth the potential legal issues. If I buy hydrocodone, I can slip them into one of my pill bottles with a legitimate label and the cops would have a hard time proving they weren’t mine. Heroin is a little more difficult to hide. 

I know some heroin users and they aren’t like the ones in the movies. They aren’t shooting up in dark alleys. They’re doing it in the morning to combat chronic pain. They’re doing it so they can go to work. They’re doing it because their legitimate doctor cut them off. They’re doing it so they can live their lives.  

And that’s what I'm doing, too. I bought 10 hydrocodone this morning, because I needed something to get me through the work day. Without opioid pain medication, I wouldn’t even be able to check my emails.  

I don’t know what the solution is, but I do know that when you’re in pain, you’ll do anything to make it stop. And as long as the only way to make it stop comes down to buying illegal drugs or killing myself, I’ll keep choosing illegal drugs — and pray that it doesn’t lead to me accidentally killing myself.  

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.

Feds Urge Doctors to Co-Prescribe Naloxone    

By Pat Anson, PNN Editor

Pain patients taking relatively modest doses of opioid medication should be co-prescribed naloxone, according to a recommendation released this week by the U.S. Department of Health and Human Services.

Naloxone is an overdose recovery drug administered by injection or nasal spray that rapidly reverses the effects of an opioid overdose. It has been credited with saving thousands of lives, although recently there has been controversy over a company exploiting demand for the drug by raising the cost of its naloxone injector over 600 percent.

“Given the scope of the opioid crisis, it’s critically important that healthcare providers and patients discuss the risks of opioids and how naloxone should be used in the event of an overdose,” said Adm. Brett Giroir, MD, assistant secretary for health and senior advisor for opioid policy at HHS.

“Co-prescribing naloxone when a patient is considered to be at high risk of an overdose, is an essential element of our national effort to reduce overdose deaths and should be practiced widely.”

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But the “guidance” released by HHS could involve millions of patients who are not necessarily at high risk and have been taking opioids safely for years.  It urges doctors to “strongly consider” prescribing naloxone to patients under these circumstances:

  • Patients prescribed opioids at a dose of 50 morphine milligram equivalents (MME) or more per day

  • Have respiratory conditions or obstructive sleep apnea (regardless of opioid dose)

  • Have been prescribed benzodiazepines (regardless of opioid dose)

  • Have a mental health or non-opioid substance use disorder such as excessive alcohol use

  • Are receiving treatment for opioid use disorder

  • Have a history of illegal drug use or prescription opioid misuse

The HHS guidance was issued days after an FDA advisory committee voted 12 to 11 in favor of adding language to opioid warning labels recommending that naloxone be co-prescribed.  Some panel members objected to the labeling because of the additional cost involved and because it does not address deaths caused by illicit opioids, which account for the vast majority of opioid overdoses.

The guidance notes that most health insurance plans, including Medicare and Medicaid, will cover at least one form of naloxone. For patients without insurance, the guidance suggests contacting a state or local program that may supply naloxone for free or at low cost.

Naloxone costs only pennies to make and syringes containing generic versions of the drug typically cost about $15 each. But formulated and branded versions that have a more sophisticated delivery system are much pricier. According to Health Care Bluebook, a package of two nasal sprays of naloxone sold under the brand name Narcan will cost about $135.  Evzio, a kit that contains two auto-injectors of naloxone, retails for about $3,700.   

A recent U.S. Senate report found that Kaleo, a privately-owned drug maker, jacked up the price of Evzio by over 600% to “capitalize on the opportunity” of a “well established public health crisis.” As a result, the report estimates the U.S. government paid over $142 million in excess costs to Kaleo for prescriptions covered by Medicare.  

The new HHS guidance mirrors that of the 2016 CDC opioid guideline, which encourages physicians to consider prescribing naloxone to pain patients on “higher opioid dosages” of 50 MME or more.

“I’m personally against it, because I don’t think most patients who require opioids for pain management are at risk of overdose,” said Andrea Anderson, Executive Director, Alliance for the Treatment of Intractable Pain (ATIP).  “I also don’t think naloxone helps unless you’re with other people, which makes more sense for those who are using illicit opioids rather than those who rely on opioids for routine pain relief. 

“I don’t think the government should require patients to buy medications for which they do not have a proven need. This sounds like another one of those good ideas in theory but poor in practice.”

U.S. Pain Foundation Suspends Fundraising

By Pat Anson, PNN Editor

The U.S. Pain Foundation, which is under investigation for financial irregularities and the misuse of funds by its former CEO, has stopped soliciting donations.

In a statement posted on U.S. Pain’s website, interim CEO Nicole Hemmenway said the Connecticut-based non-profit has “ceased soliciting funds.” For many charities this is a key time of year for fundraising, but as PNN has reported, U.S. Pain’s registration with the Connecticut Department of Consumer Protection, which regulates charities in the state, has expired. Without an active registration, U.S. Pain cannot legally solicit donations in Connecticut.

(Update: U.S. Pain’s charitable solicitation registration was renewed by the Connecticut Department of Consumer Protection on January 4, 2019) 

In her statement, Hemmenway said U.S. Pain would renew its registration once its delinquent tax returns – known as 990 Returns – for 2016 and 2017 are filed.  She blamed former CEO Paul Gileno for the long delay in filing them.

“The delay in filing the 2016 and 2017 Returns can be attributed to inaccurate and incomplete financial records maintained by the former CEO. The delayed preparation of the 990 Returns in turn delayed the renewal of our charitable solicitation registration in the state of Connecticut, which expired as of November 30,” she said.

“We are cooperating with the Connecticut Department of Consumer Protection, which has not opened a formal investigation into U.S. Pain. Once the 990 Returns are available, we anticipate the registration will be renewed. In the interim, we have ceased soliciting funds. In addition to working with the Department of Consumer Protection, we initiated a meeting regarding the former CEO’s actions with the Office of the Connecticut Attorney General.”

NICOLE HEMMENWAY

NICOLE HEMMENWAY

To be clear, Hemmenway and U.S. Pain’s board of directors did not contact Connecticut Attorney General George Jepsen’s office until this month, when they became aware that PNN was planning to publish stories about the foundation’s delinquent tax returns and other questionable activities.

Hemmenway and the board have been aware of Gileno’s alleged embezzlement for some time. An internal audit found evidence of “financial irregularities” and possible criminal acts several months ago. The board requested and received Gileno’s resignation on May 29.

On September 5th, Gileno confessed in an email that he “took money from US Pain for my personal use.” The email was sent to over a dozen key leaders at U.S. Pain, including board members Ellen Lenox Smith, Wendy Foster and Suzanne Stewart. Stewart resigned from the board soon afterward, saying she felt “kept in the dark about many things.”

Only recently has any of this been brought to the attention of law enforcement, or U.S. Pain’s members, volunteers and donors.

(Update: In a December 20 press release, U.S. Pain said the financial irregularities were discovered in April and that “appropriate authorities” were notified in early June. Hemmenway has not responded to a request to identify who or what agency was contacted. PNN has been unable to verify any contact between U.S. Pain and law enforcement until early December.)

“It does seem like they will blame it all on me which makes me sad but I guess their legal counsel thought it was the best route for them to take no responsibility and to ignore all of the good I have done and the lives I have changed,” Gileno said in an email to PNN.

“I guess they don’t want to discuss that they all were part of US Pain for over 8 years and Nicole was Vice President since we changed from CT Pain Foundation to US Pain Foundation in January 2011. I took responsibility for any mistakes and worked to rectify it ASAP so the organization I created and founded could continue to help others. I did not hide this and it seems they only brought this out because you discovered it and pressed them.” 

PAUL GILENO

PAUL GILENO

PNN has asked Hemmenway if the audit found evidence that others besides Gileno misused donated funds. She has not responded to that and other questions, such as how much money was misappropriated, what it was spent on, and for how long the misuse occurred.

“We did not previously comment on these matters on the advice of counsel, due to the ongoing investigation,” Hemmenway said in her statement.

U.S. Senator Wants Audit Details

U.S. Senator Ron Wyden (D-OR), the ranking member of the Senate Finance Committee, also wants to know if others are involved.

In a letter sent to Hemmenway yesterday,  Wyden asked for a copy of the audit and a detailed accounting of whether “any other employees, contractors, board members, volunteers or people otherwise associated with the foundation (have) been implicated in the misuse of funds.”

Wyden also asked for an explanation of why U.S. Pain’s membership was grossly inflated and how a $2.5 million donation from Insys Therapeutics, a controversial drug maker under criminal investigation, was spent on a prescription co-pay program called Gain Against Pain. As PNN has reported, Gileno and Hemmenway — who is board chair — disagree on whether the board even authorized the co-pay program.

“There are conflicting accounts of when the foundation’s board of directors was made aware of Gain Against Pain. Please clarify when the foundation’s board learned of the program’s existence, and when it learned of funding from Insys,” Wyden asked. “Were there any conditions connected to any of the donations from Insys to the foundation or the Gain Against Pain program?”

As Stat News has reported, Wyden and other senators have questioned the relationship that Insys and other drug makers have with patient advocacy groups, saying their donations present a conflict of interest. Over the years healthcare companies have donated several million dollars to U.S. Pain.

In a letter sent yesterday to Health and Human Services Secretary Alex Azar, Wyden suggested that it may be inappropriate for Cindy Steinberg, U.S. Pain’s National Director of Policy and Advocacy, to continue serving on a federal pain management advisory board because of “the legal and financial control issues faced by the U.S. Pain Foundation.”

As PNN has reported, Wyden himself has accepted donations from industries that he helps regulate. According to OpenSecrets, Wyden has received over $2.5 million in campaign donations over the last five years from individuals or PACs affiliated with healthcare and insurance companies.

Study Finds Rx Opioids Provide Limited Pain Relief

By Pat Anson, PNN Editor

Prescription opioids relieve pain, improve physical functioning and help people with chronic pain sleep. But the improvements are small and come with side effects such as vomiting.

Those are the findings from a new meta-analysis (a study of studies) published in the Journal of the American Medical Association (JAMA). Researchers at McMaster University in Canada reviewed 96 clinical trials involving over 26,000 participants who received either prescription opioids or a placebo.

The findings do little to resolve the debate over the safety and effectiveness of opioids.

"Despite widespread use, there is not enough known about the benefits and harms of opioids for chronic non-cancer pain," said lead author Jason Busse, DC, a researcher with the DeGroote Institute for Pain Research and Care at McMaster University.

"We found that, compared to a placebo, 12 per cent more patients treated with opioids will experience pain relief, 8 per cent more will notice an improvement in their physical functioning, and about 6 per cent more will find improvement in their sleep quality.”

One expert questioned the designs of the studies used in Busse’s analysis. Because most participants received a relatively low dose of opioids, it’s not surprising such a small number experienced pain relief, according to Stephen Nadeau, MD, a research advisor for the Alliance for the Treatment of Intractable Pain (ATIP).      

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“With few exceptions, doses of opioids achieved were low (median dose 45 MME), trials were short, and opioids were rapidly titrated,” said Nadeau, a neurologist at the VA Medical Center in Gainesville, Florida.

“Because the study designs in all but a handful of studies did not remotely emulate clinical practice, it cannot be inferred that the results of this analysis are applicable to management of the general population of patients requiring opioid management of moderate to severe chronic nonmalignant pain.”

None of the opioid studies reviewed by Busse and his colleagues lasted longer than six months and many were considered low-to-moderate quality evidence. But the same thing could be said about virtually every pain reliever on the market. There is no good quality evidence proving that acetaminophen, pregabalin, ibuprofen, gabapentin or any other non-opioid pain medication is safe or effective long-term.

But opioid critics were quick to focus on the Busse study as proof that opioids should rarely be prescribed for pain.

“The findings reported by Busse et al illustrate that most patients who are prescribed opioids for the treatment of chronic noncancer pain will not benefit from those drugs,” wrote Michael Ashburn, MD, and Lee Fleisher, MD, in a JAMA editorial. “Given the clear risk of serious harm, opioids should not be continued without clear evidence of a clinically important benefit.”

But the only significant side effect the Busse study found was a 6% risk of vomiting. The study drew no conclusions about opioids increasing the risk of addiction, overdose and death – although Busse says those risks should not be overlooked.

“Given their risks, modest benefits, and the comparable effectiveness of alternatives, our results support that opioids should not be first line therapy for chronic non-cancer pain," said Busse, a chiropractor who was the lead author of Canada’s opioid prescribing guideline.

The study was funded by the Canadian Institutes of Health Research and Health Canada.

Human Rights Watch: CDC Guideline Needs Revision

By Pat Anson, PNN Editor

Federal and state efforts to reduce opioid prescribing have harmed pain patients across the country and caused many doctors to arbitrarily cutoff or taper patients who need opioid medication, according to a new report from Human Rights Watch.

“Not Allowed to Be Compassionate” -- a 99-page report by the New York based non-profit -- highlights the many unintended consequences of the 2016 CDC opioid guideline, which discourages doctors from prescribing opioids for chronic pain. The report recommends the CDC revise the guideline to explicitly state that patents should not be involuntarily tapered off opioids and that some patients may require high doses.

“Many individuals with chronic pain are being involuntarily tapered from essential medicines that are vital to their daily functioning, depriving them of their right to health,” the report found.

“Health care providers in some cases are even turning away such individuals, insurance companies and programs are refusing coverage, and state governments are preventing physicians from using their medical judgement to provide appropriate care.”  

Although voluntary and only intended for primary care physicians, the CDC guideline has been widely adopted by regulators, law enforcement and insurance companies, with little or no effort made to measure its impact on pain patients and the quality of their care.

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One of the most surprising things Human Rights Watch learned, according to researcher Laura Mills, is how little the government knows — or is willing to say — about cutbacks in opioid prescribing.  

“We went into this report hoping we’d be able to find some data. And what we found is, if there is data, none of it has been published,” Mills told PNN. “We don’t know how many people committed suicide. We don’t know how many people are alive or dead within a year of tapering. We don’t know how many people are hospitalized.

“And that’s a huge risk because essentially we’re letting dramatic policy changes take effect very quickly. Many of these may be justified, but we aren’t measuring in real time what’s happening. At least none of these organizations are doing it in a way that’s public.”

‘Agonizing Pain Like Torture’

The report tells the story of Maria Higginbotham, a Seattle-area woman with an aggressive form of degenerative disc disease. Multiple surgeries not only failed to relieve her pain, they left her with adhesive arachnoiditis, a chronic inflammation of spinal nerves.

Although bedridden and in constant pain, Higginbotham’s doctor is planning to reduce her dose of opioid medication by 75 percent to comply with the CDC guideline.  

“I’m 57 years old and I’m almost completely bedridden due to agonizing pain like torture,” Higginbotham said. “I cannot hold my 15-month-old grandson. I cannot hold my beloved dogs, I can’t bend over to touch them. I cry out in my sleep because I can’t find a way to get comfortable.

“I can barely get myself off of my toilet. Sometimes I have to get off the couch by getting on my hands and knees and pulling myself up because I can’t stand up it hurts so badly.”  

Higginbotham’s doctor told Human Rights Watch he had no choice but to cut her opioid dose, even though he knows the medication is helping her. 

“There’s a lot of talk in the pain medicine world that if you do not get people down to 90 morphine equivalents, you set yourself up for a liability, especially if something were to happen to that patient,” he said. “We still feel like we’re vulnerable to being held liable for patients if they’re over that guideline limit, even when you know they’re not addicted and they’re benefiting (from opioids).”  

You can learn more about Maria Higginbotham and the Human Rights Watch report in this video:

Right to Health

Although the consequences to pain patients like Maria Higginbotham have been “catastrophic,” Human Rights Watch stopped short of calling them a human rights violation.  International law gives cancer and palliative care patients a right to pain management, but it is less clear about non-cancer pain. Chronic pain patients may have a “right to health,” but they don’t have a right to opioids.

“While opioid analgesics are the cornerstone of cancer pain management, these medications do not play a central role in chronic pain management and are, indeed, controversial. The available evidence suggests that effective treatment of chronic pain requires a multidisciplinary approach, using pharmacological and non-pharmacological tools,” the report found.

“Nonetheless, the right to health clearly applies to chronic non-cancer pain patients, as does the prohibition of torture, cruel or degrading treatment or punishment, and some of the same broad principles that apply to pain management for palliative care patients apply to chronic non-cancer pain patients.” 

In addition to a revision of the CDC guideline, Human Rights Watch is calling for better insurance coverage of alternative pain therapies and a new system of metrics that measure not just “crude reductions in opioid prescribing,” but also a patient’s quality of life and quality of pain care.

How U.S. Pain Foundation Inflated Its Membership

By Pat Anson, PNN Editor

The U.S. Pain Foundation has long claimed to be “the leading chronic pain advocacy organization in the country,” with volunteers in 50 states and nearly a quarter of a million social media followers.

“What started as a small grassroots group now has 90,000 members nationwide and a network of 1,000 volunteers,” a U.S. Pain press release said in 2017.  

Impressive numbers like that helped the Connecticut based non-profit rise to national prominence in the pain community and raise several million dollars in donations from major healthcare companies such as Pfizer, Lilly, AstraZeneca, Novartis and Johnson & Johnson.

But PNN has learned that the tabulation of U.S. Pain’s membership and followers is unreliable and misleading. At best, they’re a product of bad metrics and marketing hype. At worst, they’re evidence of consumer fraud.  

“If they’re talking about members, then they should have a verified roll of members. And if they’ve inflated that number and there’s no rational basis for coming up with the number that they’re telling the public, then that could potentially be considered consumer fraud,” says attorney Seth Perlman, who has represented non-profits for 30 years.

In recent months, U.S. Pain has announced it is “undergoing a complete revamp of its transparency policies and procedures.” One of the first things the organization did was significantly downsize its membership from 90,000 to 15,000.

U.S. PAIN FOUNDATION 2016 PROMOTION

U.S. PAIN FOUNDATION 2016 PROMOTION

What happened to the 75,000 missing members?

“We have changed the way we classify and report members,” interim CEO and board chair Nicole Hemmenway said in an email to PNN. “Previously, ‘members’ included mailing list subscribers, support group participants, INvisible Project readers, anyone who received our print materials, and people who attend our events. Now the term ‘member’ has been redefined as the number of individuals who have signed up for our mailing list.”

Hemmenway has been interim CEO since May, when U.S. Pain’s founder and longtime CEO Paul Gileno resigned at the request of the board of directors.  “As the new leader, I am heading up a review and revision of our governance and transparency policies,” Hemmenway said. 

But full transparency has been slow in coming. Not until last week did Hemmenway and the board disclose the reason behind Gileno’s forced resignation. An internal audit found evidence of “financial irregularities” and that Gileno embezzled an undisclosed amount of money from the non-profit.  

“I am sad to say that I made some big mistakes over the past few years and took money from US Pain for my personal use. I make no excuses for this,” Gileno confessed in an email sent to U.S. Pain’s leadership.  

We asked Gileno why U.S. Pain’s membership numbers were so high while he was CEO. 

“Our stats were based on email sign ups, social media sign ups and in-person sign ups,” Gileno said. “I have no clue why they were reduced.” 

In addition to the steep drop in membership, U.S. Pain has also seen a decline in its social media following. At one time, the organization claimed to have 59,000 followers on Twitter.

That was reduced to about 13,000 followers after Twitter purged from its system millions of fake and inactive accounts. 

from US Pain foundation 2018 promotion

from US Pain foundation 2018 promotion

“The (Twitter) reform takes aim at a pervasive form of social media fraud,” The New York Times reported. “Many users have inflated their followers on Twitter or other services with automated or fake accounts, buying the appearance of social influence to bolster their political activism, business endeavors or entertainment careers.”  

Some of the followers that U.S. Pain has on Twitter were apparently bought and paid for in a promotional scheme to sign up new followers. Hemmenway says the board never authorized such an expenditure. 

“Based on records, in 2016, $515 was spent on a Twitter digital marketing initiative under previous leadership. This is not something the Board or others within the organization were aware of or approved,” Hemmenway said. 

Hemmenway has been a key member of U.S. Pain since it was founded in 2011, serving as vice-president until Gileno’s departure. According to Gileno, she oversaw the non-profit’s social media efforts. “Nicole and the board have always been in charge of that, as was director of communications,” Gileno told PNN. 

Even after the Twitter purge, U.S. Pain still appears to have an unusual number of suspicious followers. StatusPeople.com, a website that analyzes Twitter data, estimates that only a third of @US_Pain’s 13,000 followers are legitimate. The rest are either fake or inactive.

SOURCE: STATUSPEOPLE.COM

SOURCE: STATUSPEOPLE.COM

There is no similar way to analyze the legitimacy of U.S. Pain’s 216,000 followers on Facebook, a social media platform where you can also buy followers.

Consumer Fraud Issue

Marketing that misleads or exaggerates may be all too common in the for-profit world, but it’s risky business for a charity dependent on donations and public goodwill. Taken too far, it could lead to allegations of civil or even criminal misconduct, according to attorney Seth Perlman. 

“That’s only an issue if they use those numbers to impress upon the donating public or their supporters about how widespread their message is. And how much awareness the organization has with the public. If they’re using it as a way to inducing people to support the organization, it’s a potential consumer fraud issue,” said Perlman. “If you mislead the public and present information that is incorrect and is purposely inflated, the regulators take an extremely dim view of that.  

“It’s almost always a civil matter, unless it rises to the level of an absolute egregious fraud where there is absolutely no basis for making the claims that they did and it was simply a rip off.  Then that could turn into criminal (fraud). But the civil remedies are significant, including removal of the board of directors.” 

As PNN has reported, U.S. Pain is now under investigation by the Connecticut Attorney General’s office and the Connecticut Department of Consumer Protection, which regulates charities in the state.  Because its registration as a charity recently expired, U.S. Pain at this time cannot legally solicit donations in Connecticut. 

Federal prosecutors at the U.S. Attorney’s Office would neither confirm or deny if they were investigating U.S. Pain and its former CEO, although Gileno anticipates going to prison for fraud or tax evasion.  

“I will have to go to jail maybe as long as 3 years for taking the money from US Pain,” Gileno said in his confession. 

U.S. Pain is also in danger of losing its tax-exempt status.  The non-profit’s tax returns for 2016 and 2017 have not been filed and are delinquent.  Under IRS rules, a non-profit that does not file returns for three consecutive years automatically loses its tax exemption. Hemmenway blames Gileno for the long delay in filing, but expects the tax returns to be completed in coming weeks. 

“Because of the inaccurate and incomplete information provided by the former CEO, it has taken a significant amount of time to compile accurate books and records,” she said. “The organization has been working diligently with its new team to prepare the 2016 and 2017 returns, with the goal of filing them by the end of the year.”

U.S. Pain Foundation Under Investigation

By Pat Anson, PNN Editor

The Connecticut Attorney General’s office has opened an investigation into allegations of financial irregularities and embezzlement at the U.S. Pain Foundation, PNN has learned.

“I can confirm that our office has had contact with a representative from the U.S. Pain Foundation and that our office has opened an investigation into this matter. We’re unable to comment further,” said Jaclyn Severance, a spokesperson for Connecticut Attorney General George Jepsen.

U.S. Pain released a statement late Friday accusing former CEO Paul Gileno of misusing funds. Gileno resigned at the request of the non-profit’s board of directors in May and later sent an email to U.S. Pain leadership confessing to the crime.

“I am sad to say that I made some big mistakes over the past few years and took money from US Pain for my personal use. I make no excuses for this,” Gileno wrote.

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Until last week no explanation was made to U.S. Pain’s members, volunteers or donors about the reasons behind Gileno’s resignation. The Connecticut-based non-profit has still not disclosed the amount of money stolen, when the thefts occurred, or if others were involved.

“We have been working diligently to rectify the situation. Steps that we’ve taken include alerting the appropriate legal authorities and cooperating fully in the investigation; seeking restitution of the misused funds; implementing a more robust system of checks and balances; and hiring a new interim chief financial officer, new counsel, and a new tax accountant,” U.S. Pain said.

PNN has confirmed the state Attorney General’s Office was recently contact by U.S. Pain, but lawyers there say the non-profit probably should have acted sooner.

“There is no requirement under the law to report embezzlement, but it is typically in their best interest to do so,” said Severance.

U.S. Pain was founded by Gileno in 2011 and has received several million dollars in mostly corporate donations to fund programs that raise awareness about chronic pain.

Lapsed Registration

The Connecticut Department of Consumer Protection, which regulates charities in the state, recently opened a second investigation of U.S. Pain after its registration lapsed on December 1. Without an active registration, U.S. Pain cannot legally solicit charitable donations in Connecticut. 

“They have not submitted renewal paperwork. So technically they’re not supposed to be soliciting in Connecticut,” said spokesperson Lora Rae Anderson. “They can’t make phone calls or put ads in Connecticut newspapers. They cannot actively solicit in the state.” 

In addition to U.S. Pain’s legal problems, it is in danger of losing its tax-exempt status. The non-profit’s tax returns for 2016 and 2017 have not been filed and are delinquent.  Under IRS rules, a non-profit that does not file returns for three consecutive years automatically loses its tax exemption. U.S. Pain’s 2015 tax return was filed in October 2017, over a year overdue.

“Because of the inaccurate and incomplete information provided by the former CEO, it has taken a significant amount of time to compile accurate books and records,” interm CEO and board chair Nicole Hemmenway said in an email to PNN last week.

Hemmenway has been a key member of U.S. Pain since its founding and sources say it is unlikely she was unaware of the financial irregularities that Gileno is accused of.

Tax returns open a rare window into how much money a non-profit has raised and how it was spent. Non-profits are not required by law to disclose who their donors are or the size of their donations, but their tax returns need to provide a detailed account of what was spent on salaries, travel, office supplies, accounting and other expenses. According to U.S. Pain’s 2015 tax return, Gileno was paid a salary of $403,000.  

Fentanyl and Heroin Linked to 70% of Overdoses

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention released another report today documenting the changing nature of the overdose crisis and the decreased role that prescription opioids have in drug deaths.  About 70% of fatal overdoses in 2016 involved either illicit fentanyl or heroin.

CDC researchers used “literal text analysis” to study death certificates from 2011 to 2016, looking for drugs listed as the cause of death, significant conditions contributing to that death, and a description of how the death occurred.  Alcohol, nicotine and other non-drug substances were not included in the analysis.

Researchers found that the opioid painkiller oxycodone was the most frequently mentioned drug involved in 2011 overdoses, but by 2016 oxycodone had fallen to 6th place, behind fentanyl, heroin, cocaine, methamphetamine and the anti-anxiety drug alprazolam (Xanax).

TOP 10 DRUGS MENTIONED IN 2016 OVERDOSE DEATHS

Source: CDC

CDC researchers noted that many overdose deaths involve multiple drugs.

“We’ve had a tendency to think of these drugs in isolation. It’s not really what’s happening,”  lead author Holly Hedegaard, PhD, told the Huffington Post.

For example, fentanyl and cocaine were mentioned in nearly 4,600 deaths, while oxycodone and alprazolam were mentioned in more than 1,500 deaths. 

The CDC has already released a preliminary estimate on overdoses for 2017 using a different form of analysis. But the results are largely the same. Over 70,200 people died of a drug overdose in 2017 – the highest number on record. Deaths involving fentanyl and other synthetic, mostly black market opioids surged 45 percent, while deaths involving natural or semisynthetic opioids, mostly painkillers such as oxycodone and hydrocodone, remained flat.      

The number of opioid prescriptions in the United States has been falling since 2011, but opioid medication remains a favorite target for regulators. The DEA has proposed another round of cuts in the supply of opioid pain medication – a 10% reduction in manufacturing quotas in 2019 for oxycodone, hydrocodone, morphine and three other opioids. Some of the medications are already in short supply, forcing hospitals to use other pain relievers to treat surgery and trauma patients.

The Trump Administration says opioid pain relievers are “frequently misused” and that reducing their supply will help prevent addiction, abuse and overdoses. There is little or no evidence that is true.

Ex-CEO Admits ‘I Took Money From U.S. Pain’

By Pat Anson, PNN Editor

The founder and former CEO of the U.S. Pain Foundation admitted over three months ago that he “made some big mistakes” and took money from the non-profit for his own personal use.

Paul Gileno resigned at the request of U.S. Pain’s board of directors in May, but the reasons behind his departure have only emerged in the last few days. In a statement posted Friday on the non-profit’s website, interim CEO and board chair Nicole Hemmenway publicly acknowledged for the first time that an internal audit six months ago had uncovered “financial irregularities” involving Gileno.

“The findings were clear that this individual had misused funds from the U.S. Pain Foundation,” Hemmenway wrote.

That Gileno had embezzled money from the non-profit has been known to the leadership of U.S. Pain for some time. He confessed to it in an email on September 5th. PNN has obtained a copy of the email and Gileno has acknowledged writing it.

“I am sad to say that I made some big mistakes over the past few years and took money from US Pain for my personal use. I make no excuses for this. I did take money and I will pay the ultimate price,” Gileno wrote.

“I did mismanage money and wasn’t as strict on budgets as I should have been, but it never effected what we did (nor) did it hurt our growth.”

PAUL GILENO

PAUL GILENO

Gileno sent the email to over a dozen key people at U.S. Pain, including board members Wendy Foster, Ellen Lenox Smith and Suzanne Stewart – who resigned from the board a few weeks later. Other recipients include Cindy Steinberg, National Director of Policy and Advocacy; Shaina Smith, Director of State Advocacy;  Lori Monarca, Executive Office Manager; Casey Cashman, Director of Fundraising and Emily Lemiska, Director of Communications.

U.S. Pain’s volunteers, ambassadors, and donors were left in the dark and never informed about the audit or Gileno’s confession. And the non-profit continued to solicit and accept donations as if nothing was wrong.

Only after inquiries from PNN about Gileno’s resignation and the lengthy delay in filing U.S. Pain’s tax returns did the organization release Friday’s statement. The statement offered no specifics on the financial irregularities that were found, the amount of money stolen, when the thefts occurred, or if others were involved.

‘I Never Took a Salary’

Gileno founded U.S. Pain in 2011 and it quickly grew into a nationwide patient advocacy group that received millions of dollars in mostly corporate donations.

Gileno claimed in his email that “I never took a salary… nor did I receive any benefits." But U.S. Pain’s 2015 tax return indicates Gileno was paid a salary of $403,000. The non-profit’s tax returns for 2016 and 2017 have not been filed and are delinquent, which could potentially jeopardize U.S. Pain’s tax exempt status.

In February, U.S. Pain was criticized in a congressional report for participating in a $2.5 million prescription co-pay program funded by Insys Therapeutics, an Arizona drug maker accused of bribery, fraud and other criminal charges. The co-pay program was scrapped soon after Gileno’s departure.

In his email, Gileno said he never took kickbacks from Insys or other drug makers.

“I always put the person with pain first and never accepted money from pharmaceuticals to do their bidding not once. If you are questioning this then that makes me sad because it never happened and you don't really know me,” Gileno wrote.

“I have also worked with the US Attorney in MA (Massachusetts) to deal with US Pain’s relationship with INSYS.  I cooperated with the FBI and HHS (Health and Human Services). Once again so you can feel better not one time did I take or accept money from a pharmaceutical to push a drug. They are using me to help them deal with INSYS and build whatever case they are building.” 

Last month a former Insys vice-president pleaded guilty in federal court in Boston to charges of bribing doctors to prescribe Subsys, a potent fentanyl spray made by Insys that has been blamed for the overdose deaths of hundreds of pain patients.

A spokesperson for the U.S. Attorney’s Office would not say if Gileno is a co-operating witness in the Insys case or if U.S. Pain is under investigation. “Per Department of Justice policy, we can neither confirm nor deny investigations,” said Liz McCarthy, U.S. Attorney’s Office – District of Massachusetts.

Gileno, who has two young sons, was remorseful in the email and asked for forgiveness. He anticipates serving jail time.

“My life is ruined right now because of my mistakes,” he wrote. “I am deeply truly sorry. It was selfish to take money from US Pain.

“When they finally give me charges to plead guilty to, either tax evasion or fraud or whatever they come up with, there will be a sentencing and they will need character letters or testimony of the person I am besides the taking of the money. If you reach out to me privately that you would like to stay in contact, it would mean the world to my boys and myself if you would send one in.”