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.

"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

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.

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. 

“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.

“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.”

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.

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.”

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

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

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).      

“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.

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

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

“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

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.

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

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.”

‘Financial Irregularities’ Found at U.S. Pain Foundation

By Pat Anson, PNN Editor

The U.S. Pain Foundation released a statement late today accusing former CEO Paul Gileno of misusing funds and other unspecified “financial irregularities.” Gileno resigned at the request of the non-profit’s board of directors in May.

U.S. Pain is a 501 (c) (3) non-profit that claims to be the leading advocacy group representing chronic pain patients. Founded by Gileno in 2011, U.S. Pain has received several million dollars in grants and donations to raise awareness about chronic pain.

Until now, no explanation was ever made to U.S. Pain’s members, volunteers or donors about the reasons behind Gileno’s forced departure. The statement admitting funds were misused was released only after weeks of questioning by Pain News Network about Gileno’s resignation and the long delay in filing U.S. Pain’s 2016-2017 tax returns.

“As a result of an internal audit, we were dismayed to discover financial irregularities involving the former CEO of U.S. Pain Foundation. The Board of Directors immediately hired an independent attorney and a forensic accountant to investigate,” Nicole Hemmenway, interim CEO and chair of the board, said in the statement.

“The findings were clear that this individual had misused funds from the U.S. Pain Foundation. The Board concluded that the former CEO repeatedly misled and concealed information from the Board of Directors and staff. The Board demanded and received the former CEO’s immediate resignation.”

U.S. Pain’s statement – which notably doesn’t even use Gileno’s name – offered no specifics about how funds were misused or the amount of money involved.

Gileno said in an email to PNN that he, not the board, hired an attorney and accountant to review the organization’s financial records. His email did not specifically address the allegation of misusing funds.

(Update: In an email sent to his former colleagues three months ago, Gileno admitted embezzling funds from U.S. Pain. See “Ex-CEO Admits ‘I Took Money From U.S. Pain’)

“I am the one who hired the attorney and accountant back in February 2017. The board did not. I hired them to fix any issues we may have had so we can grow,” Gileno wrote. “They are trying to cover their asses for being (an) inadequate board I guess.

“Also, I never misled them. They were part of U.S. Pain for over 10 years and I talked with them daily. 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.” 

Missing Tax Returns

U.S. Pain’s failure to file tax returns for 2016 and 2017 could potentially put its tax-exempt status at risk. 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,” Hemmenway said in an email to PNN. “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.”

Tax returns open a window into how much money a non-profit has raised and how it was spent. Non-profit organizations like U.S. Pain 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, a hefty share of the $1.35 million in revenue the non-profit reported that year. Gileno says part of his salary was “back pay” for prior years when he was paid little or nothing at all.

paul gileno

The missing returns from 2016-2017 cover what appears to have been the most successful fundraising period in the non-profit’s history, when it received millions of dollars in donations, primarily from healthcare companies. The money funded a variety of U.S. Pain programs such as the Invisible Project, which raises awareness about chronic pain, and the Advocacy Network, which helps volunteers become patient advocates.

Insys Co-Pay Program

One program caught the attention of congressional investigators. “Gain Against Pain” was a $2.5 million prescription drug co-pay program funded by Insys Therapeutics, an Arizona drug maker that faces racketeering, fraud and other criminal charges over its marketing of Subsys, an expensive and potent fentanyl spray. Although Subsys is only approved for cancer patients in severe pain, Insys allegedly bribed doctors to prescribe it off-label for back pain and other chronic pain conditions, which resulted in the overdose deaths of hundreds of patients.

“It’s appalling that this organization partnered with Insys, which has a history of criminal behavior,” says Adriane Fugh-Berman, director of PharmedOUT, which seeks to expose unethical healthcare marketing. “It seems to fly in the face of their stated mission and seems like a betrayal of the patients they claim to represent.”

A report released by Sen. Clair McCaskill (D-MO) in February portrayed Insys donations to U.S. Pain and other non-profits as little more than marketing and public relations schemes aimed at getting more Subsys prescribed.

“These financial relationships were insidious, lacked transparency, and are one of the many factors that have resulted in arguably the most deadly drug epidemic in American history,” the McCaskill report found.

Gileno defended U.S. Pain’s acceptance of money from Insys. "This funding, like any funding we receive, does not influence our values,” he said in a statement in response to the McCaskill report.

Three months later, Gileno was gone from U.S. Pain and the organization moved quickly to disassociate itself from Insys. The co-pay program was shut down and U.S. Pain said it would no longer accept funding from Insys.

The first reports about the aggressive marketing and off-label use of Subsys began in 2014. By 2015, overdoses were so common that the Southern Investigative Reporting Foundation referred to Insys as “Murder Incorporated.”

When PNN asked Hemmenway if the board of directors was aware of the criminal investigation of Insys at the time the co-pay program was established in late 2016, she claimed the board was “misled” about the program and never adequately infomed. “The Board was not aware of this program before it started, nor did the Board approve it,” Hemmenway wrote in an email.

Gileno disagrees, saying Hemmenway and the board were kept informed.

“Nicole and board knew in December 2016. Not sure why they are lying. Everyone who worked at U.S. Pain knew about it. Nicole certainly has emails from me about it. I don't know what games they are playing but of course they knew,” Gileno said. “The board of directors have always been a part of every decision and (was) excited about having a co pay program to help people with pain.” 

“It seems highly unlikely that a board would be unaware of a $2.5 million dollar program or that a president would be able to okay something like that without informing the board,” says Fugh-Berman, who co-authored an article critical of U.S. Pain’s “cozy relationship with its funders.”  

“Where did that money go? And the fact that it was used to make it easier for patients to get a highly addictive fentanyl drug that was made by the sponsor of that program is highly unethical.”

A non-profit expert told PNN it is unusual for a board to be unaware of a major program. 

“If a president initiates a program without the board’s approval, that’s a major problem. The board must decide what kind of program an organization conducts. It’s a board’s fiduciary responsibility and it’s important that the board meets its responsibility,” said Seth Perlman, an attorney who has represented non-profits for 30 years.

U.S. Pain board member Ellen Lenox Smith declined a request to comment for this story. Board member Wendy Foster did not respond to a request for comment.

‘Help Clean Up This Mess’

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 in September. In her partially redacted resignation letter, Stewart said she initially felt “it was my duty to stick by Nicole & the other Board members & our legal team, to help clean up this mess.”

But Stewart grew frustrated because she was “kept in the dark about many things” and decided it was time to leave.   

“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,” wrote Stewart, who also declined to comment for this story.

“It's sad to see the organization I started from nothing, in my bed on my lap top change so much and almost seem not to care about people with pain,” says Gileno. “I can’t believe after all of the things I have done and all of the work I have done to help the pain community I am being vilified.”

“We are determined not to let the actions of one individual interfere with or diminish our efforts to serve people with pain,” said Hemmenway. “As the new leader, I am heading up a review and revision of our governance and transparency policies. Due to our leadership changes over the past year, we feel this is an important step for the organization’s continued growth.”

One such “revision” was to significantly downsize U.S. Pain’s membership, from 90,000 to 15,000 members. More about that next week.

The Overdose Crisis Is Not Just About Rx Opioids

By Roger Chriss, PNN Columnist

The CDC last week released its latest report on drug overdoses in 2017.  The death toll was the highest recorded, with over 70,000 Americans dying from drug poisoning. Deaths involving illicit fentanyl and other black market synthetic opioids surged 45 percent, while deaths involving opioid pain medication remained unchanged.

Although the death toll for 2018 may be a bit lower, it is premature to declare as the Washington Post did that “the opioid epidemic may be receding.”

Instead, the crisis is evolving.

“Fentanyl deaths are up, a 45 percent increase; that is not a success,” Dan Ciccarone, PhD, a professor at the University of California, San Francisco, told the New York Times. “We have a heroin and synthetic opioid epidemic that is out of control and needs to be addressed.”

The available data for 2018 supports this. There have been over 1,500 overdoses in Massachusetts so far this year and the details of those deaths are sobering. Fentanyl was present in 90 percent of toxicology reports during the second quarter of 2018, a three-fold increase since 2014. Prescription drugs of any form were found in only 17 percent of reports.

Public health data from Connecticut is similar. Illicit opioids were found in nearly 80 percent of the 867 people who died of an unintentional opioid overdose in 2016.

Current data is also showing that drugs like methamphetamine are having a significant impact on overdose rates. Kaiser Health News reports that amphetamine related hospitalizations – mostly involving meth – are surging and that more than 10,000 people died of meth-related drug overdoses last year.

The opioid overdose crisis is no longer primarily about prescription opioids used medically, or even exclusively about opioids. And studies of long-term opioid therapy are not showing increasing rates of overdose.

Medscape reported on a recent study that found cancer patients had a much lower risk of dying from an opioid overdose than the general population. The study looked at opioid deaths from 2006 through 2016, a period that saw rapidly rising overdose rates. Opioid death rates jumped from 5.33 to 8.97 per 100,000 people in the general population during that period, but among cancer patients, opioid deaths rose from 0.52 to 0.66 per 100,000.

Another recent study found that the use of opioids in treating pain from sickle cell disease was “safe” and rarely results in overdoses  

“What our study uniquely shows is that, using this large nationwide database, that deaths in a hospital setting related to opioid toxicity or overdose almost never happen among those with sickle cell disease," Oladimeji Akinola Akinboro, MBBS, of Boston University School of Medicine told Medpage. "This suggests that current patterns of opioid use in this population is safe, assuming we continue the same risk-mitigation strategies."

In other words, long-term pain management in disorders like cancer and sickle cell disease is not associated with increased rates of fatal overdose. Both of these studies have important limitations, in particular the possibility that some overdose deaths went uncounted. But the low rates of overdose in these groups suggests that with careful patient screening and monitoring, opioids can be used safely.

More can and should be done. Opioids are being prescribed more cautiously to children and teens. This is important, in light of a new JAMA study on wisdom tooth extraction, which found that over 5% of young people who had their wisdom teeth removed and received opioids for pain control went on to receive an opioid abuse-related diagnosis.

The overdose crisis is fast evolving into a poly-drug substance use problem. Addiction expert Michael Botticelli, the former director of National Drug Control Policy, told WBUR that a better understanding is needed of why people use drugs, not just which drugs they use.

"The data are pretty clear that we have a drug use epidemic and a drug overdose epidemic,” he said. “I think we have to really be careful that our strategies speak to all of those issues.”

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.