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.

10 Ways to Avoid Depression Over the Holidays

By Barby Ingle, PNN Columnist

Do you celebrate the holidays or do you secretly dread them? For some of us, the period between Thanksgiving and St. Patrick’s Day can be the most depressing time of the year.

The first reason is that we are exposed to less sunlight during the winter. We need light to maintain our physical, mental and emotional health. There are also societal pressures that can weigh heavily on pain patients, such as not being able to participate in holiday activities. The holidays can make us depressed, financially strained, anxiety ridden, and harder to be around.

Here are some early warning signs of depression:

• Difficulty concentrating, remembering details and making decisions

• Fatigue and decreased energy

• Feelings of guilt, worthlessness, hopelessness and/or helplessness

• Insomnia, early-morning wakefulness, or excessive sleeping

• Irritability, restlessness

• Loss of interest in activities or hobbies once pleasurable, including sex

• Overeating or appetite loss

• Persistent aches or pains, headaches, cramps, or digestive problems

• Persistent sad, anxious or "empty" feelings

• Thoughts of suicide or a suicide attempt

Take this seriously, as depression carries a high risk of suicide. Anybody who expresses suicidal thoughts or intentions should be taken very seriously. Do not hesitate to call your local suicide hotline immediately.

Depression can cause you to isolate yourself from others, decreasing your mobility and increasing drug dependence. A cycle begins where depression causes and intensifies the pain and stress on your body.

It can be hard to face the emotional aspects of pain, but it is important to look at the signs and be aware of them. Remember, pain causes depression, not the other way around! 

Depression can keep you from taking care of yourself. You cannot afford to let yourself fall into dark dreary moods. Be sure, no matter how you are feeling, that you are following the goals set for your care, such as taking the correct dose of medication at the correct time of each day.

It may take a little effort to keep healthy habits when you are depressed. Here are 10 tips fellow pain patients, friends with seasonal affective disorder (SAD), and I have used over the years.  

1. Use artificial light sources. The body’s internal biological clock can get really out of sync during the winter season. Bright light therapy becomes an important tool.

2. Try something new, such as a craft or hobby.

3. Progressive muscle relaxation, hypnosis and meditation can reduce stress and pain levels

4. Stop doing things you don’t enjoy and do things you like, such as listening to music or aroma therapy.

5. Physical therapy and exercise can break the cycle of pain and help relieve depression

6. Make a list of life’s blessings, reminding yourself what you have accomplished in life. Even if you can’t do it now, you could once and no one can take that from you.

7. Cognitive and behavioral therapies teach pain patients how to avoid negative and discouraging thoughts.

8. Change everyday routines to ward off physical and emotional suffering

9. Clean out or organize an area of the house. It could be as simple as clearing a bedside table or filing your medical records. Getting organized in one area of your life can help you manage other areas more successfully.

10. Seek professional help if you start feeling overwhelmed. Dealing with chronic pain can slow recovery from depression. Specialists should treat both problems together.  

Getting your depression under control will help you focus on managing your health. As you learn to let go of anxiety and stress, it will help lower pain levels and make the holidays more enjoyable.  

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.  

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.

Living in the Real World of Pain Care

By Ann Marie Gaudon, PNN Columnist

For years now, chronic pain patients in Canada and elsewhere have heard nothing but disingenuous and downright nonsensical information about opioid medication.

It’s beginning to feel like a cheese grater scraping on my very real nerves. No facts or just wrong facts from the government, regulators and the media. Are all of these players living in an alternate reality?

Rewind back to June 2, when pain patient and advocate Paul arranged a meeting between several physicians and pain patients. You can find out the whole story, as Paul told it to me, on this YouTube video. The sole doctor attending the meeting had one objective: To present (via PowerPoint no less) how “responsible and non-biased” leaders and physicians are when it comes to pain patients.

Indeed, the College of Physicians and Surgeons of Ontario put out “A Message to Patients Living with Chronic Non-Cancer Pain.” It tells us it is “never appropriate to abandon a patient on long-term opioid therapy or abruptly cut off or threaten to cut off a patient’s medication” and that “patients taking prescribed opioids should not be stigmatized.”

In its guideline for accepting new patients, the college also tells us that “physicians must accept new patients in a manner that is fair, transparent and respectful…”

However, doctors live in their own reality, far apart from their college. In the real world of pain care where I reside, doctors everywhere and every day: 

• Refuse to prescribe opioid medication for their patients

• Abandon pain patients altogether because they need opioid medication

• Drastically taper opioid medication against their patients’ wills and to the detriment of their health and quality of life

• Stigmatize and discriminate against patients, who are labeled as addicted and in need of treatment

• Refuse to accept new pain patients if they need opioid medication 

This picture of a doctor's window in Ontario reflects that reality:

What we experience in the real world doesn’t have any relation to what we are being told. I recently listened to a fascinating interview with Pulitzer Prize-winning journalist and author Christopher Hedges, who spoke about a “post-truth phenomena.”

“The facts don’t matter, we’re bombarded with lies…. Once facts are interchangeable with opinions, then it becomes an Alice in Wonderland kind of experience where nothing makes sense,” said Hedges

We are now living that experience, complete with mythology. The myth about pain patients is that they are cared for by an ethical medical establishment according to their own unique needs, and also recognized as valuable citizens deserving of human rights by a responsible government.

Mythologies were created by ancient peoples trying to make sense of the world. If you live in an alternate reality, you would need to create these narratives so that your distorted reality made sense to you.

For those of us whose bodies are pained and whose minds remain firmly planted on this earth, the myths about opioids are misrepresentations at best, pure hypocrisy and deceit at worst.

Sometimes peoples of the past got it wrong, but sometimes they got it right. Seventeenth century philosophers used the fundamental nature of knowledge and their reality to make sense of the world. Voltaire cautioned us not to take the myths too seriously.

"Those who can make you believe absurdities, can make you commit atrocities."

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for 33 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website.

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 for Urgent Review of Opioid Tapering Policy

By Pat Anson, PNN Editor

An open letter by healthcare professionals to the U.S. Department of Health and Human Services is warning that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and calls for an urgent review of tapering policies at every level of healthcare.

“This is a large-scale humanitarian issue,” the letter warns. “New and grave risks now exist because of forced opioid tapering.”

The joint letter, recently published online in the journal Pain Medicine, is signed by over a hundred physicians, academics and patient advocates – including some longtime critics of opioid prescribing.  

Among the signatories are Keith Humphreys, PhD, a Stanford University psychologist who has warned of a global opioid epidemic “driven by the overuse of legal painkillers,” David Juurlink, MD, a board member of Physicians for Responsible Opioid Prescribing (PROP) who has called the War on Pain “one of the most spectacular failures of modern medicine,” and Red Lawhern, PhD, a strident patient advocate who has blamed PROP’s founder for “the deaths of hundreds of chronic pain patients.”

One thing these strange bedfellows have in common is that they all agree forced tapering has gone too far and has become “a genuine threat to a large number of patients.”

“Countless ‘legacy patients’ with chronic pain who were progressively escalated to high opioid doses, often over many years, now face additional and very serious risks resulting from rapid tapering or related policies that mandate extreme dose reductions that are aggressive and unrealistic,” the letter states.

“Rapid forced tapering can destabilize these patients, precipitating severe opioid withdrawal accompanied by worsening pain and profound loss of function. To escape the resultant suffering, some patients may seek relief from illicit (and inherently more dangerous) sources of opioids, whereas others may become acutely suicidal.”

We’ve shared the stories of several of these patients, including Bryan Spece, a Montana man who killed himself in 2017 after his oxycodone dose was abruptly cut by as much as 70 percent.

To avoid severe withdrawal symptoms, the CDC recommends a "go slow" approach to tapering, starting with 10% per week; while the Department of Veterans Affairs recommends a taper of 5% to 20% every four weeks. These tapering guidelines are not being followed by many doctors, who often feel pressured by insurance companies, regulators and law enforcement to lower doses, regardless of the harm it might cause a patient.

“Currently, nonconsensual tapering policies are being enacted throughout the country without careful systems that attend to patient safety,” the Pain Medicine letter warns. “We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care — including prescribing, pharmacy, and insurance policies—and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.”

The letter also calls for pain management specialists and patient advisory boards to be included in future decisions about prescription opioids. They have often been excluded by federal agencies and commissions in previous decisions.

The letter in Pain Medicine is the second joint letter recently signed by healthcare professionals calling for a significant change in the nation’s opioid policies. A letter signed in October called on the CDC to make a “bold clarification” of its 2016 opioid guideline and to evaluate the impact it is having on pain patients — something the agency has not done.

Recall of High Dose Opioids Proposed in Canada

Marvin Ross, Guest Columnist

A citizen’s petition filed last year by Physicians for Responsible Opioid Prescribing (PROP) and other anti-opioid activists tried to get the FDA to ban high-dose opioid medications. Although the FDA has yet to decide on the petition’s merits, the very same proposal is now being made in Canada in an editorial in the Canadian Medical Association Journal (CMAJ).

Dr. David Juurlink, a Toronto physician and board member of PROP, penned the editorial with Matthew Herder, a lawyer from Dalhousie University in Halifax, Nova Scotia. They claim that high dose pills – such as those containing 100mg of morphine or 80mg of oxycodone -- are too risky and should be pulled off the market.

"There is little sign that the (opioid) crisis is abating in Canada," they wrote. "Ministerial recall of the most hazardous opioid formulations is a powerful regulatory tool that should be deployed to address one aspect of the crisis: the excessive prescribing of opioids for chronic pain."

Juurlink and Herder point to Vanessa's Law, which empowers the Canadian Minister of Health to recall drugs from the marketplace when they pose “a serious or imminent risk of injury to health.”

Vanessa's Law was introduced into Parliament in 2014 by Trevor Young, a government member, when his 15-year-old daughter tragically died from heart failure after taking a stomach drug called Prepulsid (Cisapride). That same year, Health Canada removed the drug, as did the EU and the UK. It is only available in the U.S. under special conditions.

Health Canada has always had the power to pull drugs off the market and issue safety alerts. As for Vanessa’s Law, Health Canada told me it “has not encountered a situation where it has been necessary to use its authority to order a mandatory recall.”

Obviously, there have been no valid safety reasons to limit high dose opioid prescriptions or it would have been done by now.

The CMAJ editorial claims that high dose opioids are potentially dangerous and that they increase the risk of accidental overdose, falls, fractures, cognitive impairment, worsening pain, motor vehicle accidents, and dependence. Of the five academic papers cited as evidence, four are authored by Juurlink himself or his research colleague at the Institute for Clinical and Evaluative Studies in Toronto. One of their papers was reported by this author in PNN as being erroneous and in need of correction. It was corrected, but it should have been retracted.

When the FDA sought public input into PROP’s petition, it received opposition from hundreds of patients and such groups as the American Academy of Pain Medicine (AAPM), the American Medical Association, the American Society of Anesthesiologists, and the American Pain Society. The AAPM said several of the petition’s underlying premises “are either false, misleading or speculative.”

“Perhaps the most serious problem with the petition is its cavalier assumption that in those patients in whom high doses are required, the change would be ‘unlikely to result in a significant inconvenience or hardship.’ Nothing could be farther from the truth. It is undisputed that many end-of-life patients require and benefit from opioid doses that are often quite high,” the AAPM said.

Other critics pointed out that taking high dose pills off the market would result in more lower dose pills being prescribed and stored in medicine cabinets, where they could potentially be stolen or diverted. It also raises the risk of a patient taking too many or too few low dose pills to get pain relief.

Dr. Juurlink has previously claimed that the long-term use of opioids results in an increase in pain called opioid induced hyperalgesia (OIH). He wrote about hyperalgesia in an earlier article in CMAJ, saying pain patients may think opioids are helping them, when they’re not.

“Why might some of these patients not be doing as well as they or their doctors perceive?” Dr. Juurlink asked.

Well, the answer is that Dr. Juurlink knows better. He knows better than the patient and he knows better than their doctor. He knows that they are not doing well. What can anyone say to that level of arrogance?

I did write a reply to his arguments in CMAJ and pointed out that his concept of hyperalgesia is simply a theoretical construct with no solid evidence in the research literature.

It is truly unfortunate and criminal that the response from some “experts” and politicians to the rising deaths we are seeing from overdoses is directed at pain doctors and their patients, when there is little evidence they are the main cause of the opioid problem.

As I pointed out in my last PNN article, the Minister of Health continues to blame the wrong people and is incapable of providing any evidence for her position. The coroner in British Columbia has already put out data on the source of opioids involved in overdose deaths. Fentanyl was involved in 3 out of 4 deaths and its source was illegal, not prescribed.

A very recent investigation by Global News Network in Canada found that the smuggling of illicit fentanyl into Canada via BC is the responsibility of a Chinese gang called the Big Circle Boys. The billions of dollars of profits they make is laundered through casinos in that province and to buy property in Vancouver. The police are aware but simply do not have the resources to counter any of this.

Instead, officials go after doctors and patients. One pain patient I am in contact with just e-mailed me that his doctor continues to reduce his opioids to the point that he is ready to leave this world.

“I can’t understand the thought process of my pain doctor who continues to taper away at my meds,” he wrote.

And neither can I.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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.

12 Gifts of Knowledge About Chronic Pain

By Pat Anson, PNN Editor

Are you looking for a special gift for a loved one over the holidays? How about a gift to yourself? If you live with chronic pain -- or want to have a friend or family member have a better understanding of what you're going through -- here are 12 books that would make great gifts.

These and other books can be found in PNN’s Suggested Reading section. I recently added new books on kratom, stem cell therapy and medical cannabis, along with books on the history of pain and the opioid crisis.

There’s even a book that might make you laugh out loud. Who knew chronic pain could be funny?

Click on the book's cover to see price and ordering information. Pain News Network receives a small amount of the proceeds -- at no additional cost to you -- for orders placed through Amazon.

Backbone: Living With Chronic Pain Without Turning Into One by Karen Duffy

If you believe laughter is the best medicine, then “Backbone” is for you. In this funny and inspirational book, Karen Duffy recounts her struggles with chronic pain from sarcoidosis and how she learned to cope with it through perseverance and spunk. Duffy also offers tips to healthy people on how to be supportive to loved ones who live with chronic pain.

The Kratom Cure: Potent Plant for Pain, Anxiety, Addiction by Joanne Hillyer

In this beginner’s guide to kratom, Joanne Hillyer examines both the benefits and drawbacks of kratom and how it’s been used for centuries in southeast Asia as a natural stimulant and pain reliever. Hillyer also explores the various strains of kratom, where to get them, and the growing controversy over its use. Is kratom a dangerous narcotic that should be banned or a helpful and healing herb?

Real Food Heals by Seamus Mullen

“Iron Chef” star Seamus Mullen thought his career as a chef was over when he developed chronic joint pain and was diagnosed with rheumatoid arthritis. Mullen restored his health by changing his diet — and now avoids foods that are processed or inflammatory. In this cookbook, the celebrity chef shares his recipes for healthy eating with natural ingredients.

The Story of Pain: From Prayers to Painkillers by Joanna Burke

This book examines the history of pain since the 18th century, when many people believed that pain was a message from God and submission to pain was seen as redemptive. Today, pain is seen more as an evil that needs to be fought with painkillers and other therapies. Joanna Burke says knowing the history of pain can help us understand our own suffering and that of those around us.

Living Pain Free: Healing Chronic Pain with Myofascial Release by Amanda Oswald

Myofascial release expert Amanda Oswald explains how fascia — the main connective tissue in the body — is the key to restoring pain-free health and motion. She explains how stretches, exercises and other self-care techniques can relieve migraines, headaches, jaw pain, frozen shoulder, neck and back pain, pelvic pain and conditions such as fibromyalgia.

Heal Me: In Search of a Cure by Julia Buckley

Travel writer Julia Buckley went a a global quest to find an alternative treatment for Ehlers-Danlos syndrome. Buckley underwent a voodoo exorcism in Haiti, was doused with chicken blood in South Africa, and met a California masseur who believes he is guided by angels. Buckley says the best advice came from a Brazilian faith healer who taught her how meditation can help relieve pain.

American Overdose by Chris McGreal

Chris McGreal traces the history of the opioid crisis in the United States — starting with Purdue Pharma and OxyContin — and how it spread from Appalachia to the rest of the country. Purdue is not the only bad actor in the opioid crisis, as McGreal is also critical of the healthcare industry, law enforcement, politicians and regulators who adopted opioid policies based on greed, ignorance and political agendas.

The Medicalization of Marijuana by Michelle Newhart and William Dolphin

This book explores changing public attitudes about marijuana and its transformation from a stigmatized illegal drug to a promising new medical treatment. Individual stories capture how patients are using cannabis to treat chronic pain and other medical conditions, and how doctors are slowly accepting it as a form of medicine.

Stem Cells: The Healing Revolution by Dr. Raj Banerjee

This book answers some of the most basic questions about stem cell therapy and regenerative medicine. Dr. Raj Banerjee, who founded a clinic in St. Louis nearly two decades ago, shares the testimonials of his patients while exploring the history, challenges and benefits of stem cell therapy and how it can be used to treat a wide range of chronic pain conditions, including arthritis and degenerative disc disease.

Dopesick by Beth Macy

Journalist Beth Macy looks at the opioid crisis from multiple perspectives, including physicians and pharmacists, law enforcement and attorneys, community leaders and drug dealers. Macy examines opioid addiction with compassion and concern, but perpetuates many media-driven myths about pain patients and prescription opioids.

Unlearn Your Pain by Dr. Howard Schubiner

This is the third edition of Dr. Howard Schubiner’s book on the “Mind Body Syndrome” — the theory that many chronic pain conditions are the result of unresolved stress and emotional issues. Schubiner explains how to rid yourself of pain without drugs, surgery or psychotherapy by “unlearning” your pain.

The Furnace of Fire by Elaine Ballard

Elaine Ballard suffered a severe back injury when she was 22 years old. Fifty years later, she is confined mostly to bed and recently learned she has arachnoiditis. Ballard wrote this book to help educate other pain sufferers about arachnoiditis and to share how her Christian faith helped her through many difficult times and pain flares.

If there is a book or publication that's helped you manage chronic pain and might help others, let us know.

Taking Control of My Disability Case

By Mia Maysack, PNN Columnist

This stack of papers may not look like much, but it is my medically documented life beginning in the year 2002.

I personally highlighted them, so I can confidently report that the words “headache” and “migraine” are mentioned hundreds of times throughout.

I've been in the process of pursuing Social Security disability for about three years, which is not uncommon. Many have abused the system and there's also a high volume of claims being submitted and reviewed every day.

It took me a long time to even get to the point of filing for disability.

What does filing say about me as a person? Will I be judged? They probably won't even believe it. There are so many out there that need and deserve this more than me.

I still have those thoughts from time-to-time, even though my chronic migraines and cluster headaches have impacted every aspect of my life in a negative way – including employment.

I do not take the collection of denial letters I have received personally, as they've got to do what they can to weed out whoever isn't entirely legitimate. I know that I am, so I'll keep fighting.   

In recent months, another denial letter came. They acknowledged I am unwell but still deem me “well enough.” I decide to appeal immediately, as they only give you 60 days to do so. I also hired legal representation to help me through the process.

When I called them to check on the progress of my case, their tone felt dismissive. I would get put on hold before finishing a sentence or receive roundabout answers to basic questions. I’d also be reminded -- as if I wasn't already aware -- that disability court dates are scheduling 23 months from now.

I don't mind waiting, considering the fact I have no choice.  But it seemed as though I was being slow walked on a hamster wheel and not moving forward at all. This week I chose to contact Social Security directly and they informed me that, according to their records, there is no appeal on file for me at this time.

What does this mean, exactly?  In short, my legal representatives have not been covering their responsibilities to me as their client. I've been scraping by with 26 cents to my name while relying on their word, which I've now been convinced means next to nothing. 

I asked a Social Security representative what my next steps should be to take control and clean up this mess. He instructed me to visit their website and file an online appeal, which has since been done. Since I can’t account for where exactly all the paperwork I've been sending to my "help" has been going, I plan to stop in my local Social Security office to hand my stack of medical records directly to them.

We are our own best advocates, but how do I advocate for myself?  This is one way. I am the one who knows and understands the extent of how this debilitation has derailed just about every goal or dream I've set my sights on. But I won’t let that define me. I am more than my illness and won't allow my case to be dismissed.

I'm aware that representing myself may very well set this process back even further, but I've come to the realization that if we want something done right, we've got to make it happen ourselves.

At first, I felt disheartened because this seems like a full-time job in itself. But when others do not hold up their end, I now see this as an opportunity to raise awareness, address policy, educate and ultimately claim ownership of my own life. Now and in the future.

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

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.

New Spinal Discs Grown from Stem Cells

By Steve Weakley

Scientists have moved a step closer to being able to replace degenerated spinal discs with new ones grown in a laboratory from a patient’s own stem cells.

Spinal discs are soft tissues that cushion the vertebrae and enable our backs to conform and perform the tasks of everyday movement. Over time, the discs can wear out and cause the bones of the spine to rub together and pinch nerves. This disc degeneration is one of the leading causes of back pain.

University of Pennsylvania researchers reported in the journal Science Translational Medicine that they have successfully grown and implanted replacement discs made from the stem cells of goats. The cells were grown in a laboratory in a disc shaped form and then implanted into the necks of goats.

After 8 weeks, MRI’s showed that the replacement discs functioned just as well or better than the goats’ original cervical discs. The implanted discs were left in for 20 weeks and became part of the animals’ own tissue.

Researchers told Medical News Today that this was a major step forward from previous experiments in which they implanted discs into rat tails. Goat discs are more comparable to humans in size, structure and function.

"I think it's really exciting that we have come this far, from the rat tail all the way up to human-sized implants," said co-senior author Harvey Smith, MD, a professor of Orthopaedic Surgery at the Hospital of the University of Pennsylvania.  

"Using a true tissue-engineered motion-preserving replacement device is not something we have yet done in orthopaedics. I think it would be a paradigm shift for how we really treat these spinal diseases and how we approach motion sparing reconstruction of joints.”

Current treatments for degenerative discs include spinal fusion or artificial implants.  Both have limited benefits and usually cannot restore full functionality. Artificial implants also break down and have be replaced.

"The current standard of care does not actually restore the disc, so our hope with this engineered device is to replace it in a biological, functional way and regain full range of motion," said co-senior author Robert Mauck, PhD, a professor for Education and Research in Orthopaedic Surgery.

"This is a major step, to grow such a large disc in the lab, to get it into the disc space, and then to have it to start integrating with the surrounding native tissue. That's very promising."

The researchers say the next step is longer and more extensive tests on goats, before working on a bioengineered human model.  If those tests are successful, they eventually hope to test the implants in human trials.

"We have every reason to be optimistic, and if it works, we can change the way we think about treating some of these disc diseases," said Smith.

Rising Overdoses Show CDC Guideline Not Working

By Pat Anson, PNN Editor

Rising suicides and drug overdose deaths led to another decline in U.S. left expectancy last year, according to two sobering reports released by the Centers for Disease Control and Prevention.

Americans born in 2017 are expected to live 78.6 years, about one month less than those born in 2016. Life expectancy has fallen or remained flat in the U.S. for three consecutive years. The UK is the only other country in the industrialized world where life expectancy is dropping.

“Tragically, this troubling trend is largely driven by deaths from drug overdose and suicide. Life expectancy gives us a snapshot of the Nation’s overall health and these sobering statistics are a wakeup call that we are losing too many Americans, too early and too often, to conditions that are preventable,” CDC director Robert Redfield, MD, said in a statement.

Redfield, who almost lost a son to a drug overdose, has been nearly invisible since becoming CDC director in March. He has previously called the opioid epidemic “the public health crisis of our time” and pledged to “bring this epidemic to its knees.”

So far, the CDC’s strategies, including its controversial 2016 opioid prescribing guideline, are not working. As PNN has reported, the guideline may even be contributing to the rising number of suicides and overdoses.

Over 70,200 people died of a drug overdose in 2017 – the highest number on record and nearly a 10 percent increase from 2016. Deaths involving illicit 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 rate of heroin deaths also remained unchanged.

SOURCE: CDC

CDC researchers noted that their data is flawed. Drug overdose deaths often involve multiple drugs, and “a single death might be included in more than one drug category.” A death “involving” a specific drug also doesn’t mean that drug was the cause of death. It only means the drug was present at the time of death.  The competency of medical examiners and coroners who complete death certificates can also vary widely from state to state.

The CDC reported that over 47,000 people committed suicide last year, nearly 4 percent more than in 2016. Suicide is the 10th leading cause of death among all age groups – and the 2nd leading cause of death among adolescents and young adults aged 10 to 34.

Reports Ignored Role of Antidepressants, ADHD Drugs

The CDC reports did not explore the role of drugs used to treat depression, anxiety and attention deficit hyperactive disorder (ADHD) in either suicides or overdoses.

According to a recent study by the Substance Abuse and Mental Health Services Administration (SAMHSA), Xanax, Valium, Adderall and other psychotherapeutic drugs were involved in more overdoses in 2016 than prescription opioids.

A report this week from the Research Abuse Diversion and Addiction Related Surveillance System (RADARS), which tracks illicit drug use nationwide, underscores that emerging trend. RADARS found that the abuse of ADHD stimulants now exceeds the abuse of prescription opioids by Americans aged 19 or younger. The rising trend in “intentional exposures” to stimulants – which includes suicide – began in 2010 and is accelerating.    

PEDIATRIC CASES OF UNINTENTIONAL EXPOSURE (SOURCE: RADARS)

“There have been more pediatric exposures involving stimulants than pediatric exposures involving natural/semi-synthetic opioid analgesics in every quarter since 4th quarter 2014. The increase appears to be driven by exposures where the intent of the patient was suicide,” the RADARS report found. 

“Multiple factors may contribute to the observed increase in suspected suicide exposures. The increase may reflect overall increases in suicides in the United States. It may also be a result of increases in stimulant misuse.” 

In the 2nd quarter of 2018, there were 822 reported cases of intentional exposure to stimulants among young people, while there were 503 cases involving opioid analgesics.

New Therapy Helps Improve MS Symptoms

By Pat Anson, PNN Editor

An experimental stem cell therapy developed by Australian researchers is showing promise in treating patients with progressive multiple sclerosis (MS), the most difficult-to-treat form of the autoimmune disease.

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness, difficulty walking, paralysis, loss of vision, fatigue and pain. Most patients go through periods of remission before the condition worsens and turns into secondary progressive MS. In primary progressive MS, the disease steadily gets worse from the start, with no periods of remission.

Scientists at the University of Queensland extracted immune cells from patients who had either primary or secondary progressive MS. The cells – known as T-cells – were then “trained” in a laboratory to target and kill cells infected with the Epstein Barr virus.

When the altered T-cells were injected back into the bloodstream of 10 patients, seven said their symptoms improved. They had more energy, improved concentration, slept better, and had improved vision and balance. There were no serious side effects.

The Epstein Barr virus (EBV) has long been associated with MS, which is why the researchers targeted it. The virus also causes infectious mononucleosis, a glandular fever known as “mono.”

“Although this was an uncontrolled study, our finding of a substantial relationship between clinical response and EBV reactivity and polyfunctionality of the T-cell product, of which both the patients and examining neurologists were unaware, suggests that the clinical benefit might be due to the T cell therapy,” researchers reported in the journal JCI Insight.

“Our data add to the mounting evidence for a pathogenic role of EBV infection in MS. Because T-cells access all CNS (central nervous system) compartments, T-cell therapy targeting only EBV-infected B cells is a treatment modality that could offer favorable safety and durable efficacy.”

This was a Phase I trial, where the primary goal of researchers is to make sure a treatment is safe to use. More advanced studies with a larger number of patients are needed to see how well altered T-cells actually work on MS.

Is My Life Worth Anything to Doctors and Politicians?

By Beth Sweet, Guest Columnist

I keep a journal and usually write about my symptoms and medical appointments. But today I vented and afterwards realized this might be something I should share.

I'm doing really bad with writing lately. It's just so hard to find the motivation to do anything. Between pain, exhaustion, migraines and IBS every day, I feel like crap! I'm so sick of feeling like this. I just want to feel like a normal human being again and not wake up every day realizing that isn't going to happen.

Lately I've been wondering if I even have fibromyalgia or if I was misdiagnosed. We have tried so many treatments for it and none of them work. I feel like a guinea pig half the time. Do doctors even know what they are doing?

I've tried over 19 medications and treatments. So far, the only thing that helps is what all the doctors say isn't recommended for fibro and that's oxycodone. I'm in my own body, know what I feel, and what works. But I'm too afraid to ask my doctor for a therapeutic dose instead of a bare minimum dose that only gets me a few hours of relief a day.

All because of this damned opioid epidemic!

They freak out about addicts overdosing on opioid medication, but addicts will find a fix even without prescriptions. What about chronic pain patients who are killing themselves because they can't get treatment for their pain?

I wish the politicians and lawmakers could suffer from chronic pain for a while and get treated like we are. I bet then the laws would change! I don't think they could survive it.

BETH SWEET

I'M SICK OF PAIN! Sick of crushing, aching, searing, cramping, stabbing, stiff, radiating, grinding, burning, tingling, constant pain. When I sit, stand, walk or lay in one position for too long. Headaches and migraines over half the month. PAIN ALL THE TIME!

But I can't ask a doctor for what I know works because everyone is in a panic about opioids. I am on the lowest possible dose. I get just enough for 4-6 hours of relief a day! God forbid I have a flare that makes it nearly impossible to move and lasts for days. It's not fair!

I want to go to church.

I want to go to my kids’ events

I want to be able to earn an income and be a functioning member of society

I want to not have my kids feel like they must take care of me. It's supposed to be the other way around!

I want to get well, but that's never going to happen. I must live with the fact that I am going to feel like crap on varying levels for the rest of my life.

Think about that. If someone told you that from this moment until the day you die you are going to be in pain, exhausted and unable to lead a normal life. That we don't know how to cure you or even if there is a cure. We aren't even sure what's wrong with you. We've tried everything and none of it has worked. Maybe it's all in your head.

How would that make you feel? Frustrated? Hopeless? Pissed? Sad?

And what if those same people who told you they don't fully understand your illness will not give you the one drug that gives you relief because "it's not an approved treatment for your diagnosis." They’ve already admitted knowing very little about it anyway!

What if they treated you like a drug addict because you asked for a medication that finally gives you some pain relief?  I have no problem getting medication for my thyroid, insulin resistance, anemia, IBS or any of my other health issues. But God forbid I ask for treatment for chronic pain.

I don't take those meds to get high. I don't even understand how people do, they don't affect me that way. I take them to get some of my life back. Is my life worth anything to these doctors and politicians?  I'm 38 and a hermit because of my pain and health issues. I've been sick for years and getting worse.  

I want to make something clear. I'm not going to kill myself. I have my family to live for. Even when my life feels worthless, I think of them. But not every chronic pain paint has that because this illness causes isolation and hopelessness. And no, we aren't in pain because we are depressed. We are depressed because we are in pain. There is a difference, so please stop giving us antidepressants to use as pain meds!

Stop ignoring chronic pain patients. Some are at the point where they can't take the pain anymore and the doctors that could save their lives are too concerned with the opioid epidemic to help!

I hope to find a doctor someday that thinks my life is worth living.

Beth Sweet lives in Michigan.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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.

Scoring Goals With Your Goals

By Barby Ingle, PNN Columnist

When it comes to living with chronic pain and illness, the way we motivate ourselves and achieve goals can change. I know it did for me.

There are two types of goals: mastery and performance. Before I had a chronic illness, I was performance oriented. I was wrapped up in demonstrating my competence and abilities, especially when it came to my job. Suddenly that was not possible anymore. I had to adapt, change and learn how to master by goals if I was going to manage the chronic pain portion of my life. That’s where I am now.

Knowing someone’s goals helps us understand what motivates them and predict if there is a likelihood of achieving and sustaining their goals. It can also help us decide if we have a similar goal that can be worked on together, if we should partner with them or if we should move on to someone else.

In a doctor-patient relationship, if a doctor can’t help you achieve your goals with the tools and resources they have to offer, then it’s probably time to find a new doctor.

Performance oriented goals (also known as ego goals) are characterized by the belief that success is the result of superior ability. Performance oriented individuals seek to outperform others and demonstrate their ability.

When patients are working to complete this type of goal, they’re often concerned about how they will be judged relative to others. An example of this would be a patient who wants their doctor to love them the most and call them their “best” patient. They are competing against other patients in a game with only one winner.

I believe mastery goals will prove to be more effective in the long run. Mastery goals are also known as learning goals. They are goals where the person is focused on learning, mastering tasks, self-improvement and developing new skills. An example of a master-oriented goal would be organizing your medical records.

When a chronic pain patient masters a skill at their own pace and level – not competing with others --- it increases their resilience, quest for knowledge and enjoyment of life. One of my favorite quotes is “Winners don’t always win, but they never give up.” When we become mastery goal setters, we can accomplish more without societal pressures and take our time knowing that we will make mistakes and its okay.

Setting a mastery goal starts with taking a moment to think about what you want to accomplish over the next few weeks or months. Is there something you have been wanting to try? Something that will take you longer than others who are healthier? Are you up for that challenge?

Ask yourself what you want to learn. Then make it a learning goal. You do this by being specific. Don’t just say, “I want to organize my medical records.” Do you want your records in notebooks, on a computer, a USB, or in your patient portals? Do you want to update or correct your records” and send copies to your doctors? Do you want to start from today and only do new records or go back and organize everything?

Remember, your goal should be achievable in a few weeks or months. Otherwise you are setting yourself up for failure. Decide on a goal that is attainable. What past skills do you have that can help you out? Think through your goal to make sure it is realistic. Are you able to work on multiple goals at the same time or do you need to break this one down further to make it doable? Think about your current abilities and how they will help you achieve your goal.

How will you measure your success? Decide at the start how you will measure your progress. Try to organize five pages of medical records a day or do whatever you can. On some days you’ll accomplish more than others.

Ready to “goal” for it? Share in the comment section below what your goal will be in 2019. Sharing your goal can help you stay motivated. I wish each of you well on your goals and success in accomplishing the activities you set out to accomplish!  

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

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.

Faulty Medical Devices Blamed for Thousands of Deaths

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration said today it would take steps to modernize and improve its oversight of medical devices in the wake of a scathing new report that found faulty devices were responsible for over 83,000 deaths and 1.7 million injuries worldwide in the last decade.

The “Implant Files” project, a year-long joint investigation by the International Consortium of Investigative Journalists (ICIJ) and over 50 media partners, found that the FDA approved many devices with little clinical testing and rarely pulled them off the market when problems arose.

Spinal cord stimulators have some of the worst safety records among the 4,000 devices tracked by the FDA, the ICIJ found. Stimulators are implanted near the spine and send electric currents to block pain signals from reaching the brain. The devices are often touted as safer alternatives to opioid pain medication and about 60,000 are now implanted annually.

But a review of FDA data found over 500 deaths and 80,000 injuries involving stimulators since 2008. Patients reported being shocked or burned by the devices and many had them removed.  

“I thought I would have a wonderful life,” a disabled 45-year old South Carolina man told the Associated Press. “But look at me.”

Jim Taft’s doctor told him a spinal cord stimulator would cloak the chronic pain in his severely injured right arm and make him “good as new.” But a wire in the device broke and after an operation to repair it, Taft said it shocked him so many times he had trouble sleeping and fell down a flight of stairs. The stimulator was removed within a year of being implanted and Taft is now bedridden.  

“This is my death sentence,” Taft said from his bed. “I’ll die here.”

Outdated FDA Review Process

Artificial hips, pain pumps, spinal disc replacements and hundreds of other devices were also found to be faulty, raising concern about the level of scrutiny they received before going on the market.   

“In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence,” Professor Derek Alderson, president of the Royal College of Surgeon, told The Guardian.  “This is a risk to patient safety and public confidence.”

FDA commissioner Scott Gottlieb, MD, said his agency would modernize its “outdated” 40-year old review process for medical devices.

“The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging,” Gottlieb said in a statement.

“Advances in material science, digital health, 3D printing and other technologies continue to drive an unparalleled period of invention in medical devices. It’s vital that the FDA’s regulatory approach continue to evolve and modernize to safely and efficiently advance these opportunities. Not only must we keep pace with this complexity and innovation, but we must also stay ahead of the new and evolving risks that sometimes accompany this progress.”

Gottlieb said about 20% of medical devices are based on technology that is more than 10 years old. He said the FDA would consider releasing a list of those devices in order to stimulate the use of newer technologies.

“To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market. However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device,” Gottlieb said.

Do you have a medical device and want to check its safety record? The ICIJ has a database of over 70,000 recalls, safety alerts and safety notices in 11 countries. You can search by the device name or manufacturer by clicking here.