The FDA v. Your Stem Cells: An Insider’s View

By A. Rahman Ford, PNN Columnist

Mark Berman, MD, is a key player in the escalating conflict between stem cell therapy providers and the Food and Drug Administration.

Berman is co-founder of the California Stem Cell Treatment Center, a California-based clinic that specializes in stromal vascular fraction (SVF) stem cells, which are autologous cells derived from adipose tissue --- a patient’s own body fat.

Berman and his partner are defendants in a federal lawsuit filed by the FDA. The lawsuit claims that SVF products are considered “drugs” and “biological products” under the  Food, Drug and Cosmetic Act, and thus subject to federal regulation.

In June of this year, a federal judge in Florida upheld the agency’s position in a similar lawsuit against another stem cell company.

Berman maintains that FDA regulations for autologous cells are illegal and wants to set the record straight on the motives behind the agency’s crackdown on stem cells generally and against him and his partner, specifically.

DR. MARK BERMAN

In Berman’s view, the FDA’s assault against autologous stem cells has far less to do with the health, safety and welfare of patients, and much more to do with three other factors:

1. The pharmaceutical industry’s influence over FDA regulations.

2. The unfairness of the FDA’s clinical trial process, which preserves the position of large companies at the expense of smaller ones.

3. The medical establishment’s fear of the paradigm-shifting, market-disrupting effect of healing with one’s own stem cells.

Basic Training in Stem Cell Therapy

Berman was in many respects an accidental recruit to stem cell therapy. A cosmetic surgeon with a private practice in Beverly Hills since 1983, Berman is well known as one of the pioneers of facial rejuvenation using fat grafting.

In 2008, Berman was introduced to equipment developed by Dr. Hee Young Lee of Medikan that harvests fat in specialized syringes. Berman was intrigued and decided to purchase the equipment, which Dr. Lee said could also be used to isolate stem cells.

“Who knew? Plastic surgeons actually pioneered and advanced adipose stem cells,” says Berman.

Over the next couple of years, Berman learned more about adipose-derived SVF and how to isolate it. He also started discussing stem cell trials on orthopedic cases with Dr. Tom Grogan, a colleague in orthopedic surgery.

After a fact-finding mission to Japan in 2010, Berman and Grogan agreed to see patients. One of those patients was Berman’s wife, Saralee, who had significant hip pain after years of running marathons. Saralee was treated with adipose-derived SVF and “has remained pain free to this day,” according to Berman.

Another patient came to Berman for a face lift and said she wanted to get it done because she was scheduled to have both knees replaced in the 2-3 months. Instead, Berman and Grogan treated her knees with SVF cells for free. She demonstrated marked improvement and long-term freedom from pain.

“After seven years, we did a touch-up procedure on her and she continues to be pain free and functional,” says Berman.

In 2010, Berman and urologist Elliot Lander, MD, founded the California Stem Cell Treatment Center. Although successful, Berman and Lander never thought their SVF business would last.

“We figured we’d be good for two or three years of service and then ‘cells in a bottle’ would come along and replace adipose-derived SVF,” Berman told PNN. “It turns out that personal cell therapy may be a massively transformative technology for a variety of reasons and we’re here to stay unless the FDA can illegally have their way with us to protect Pharma and Academia.”

Early on, Berman and Lander treated orthopedic conditions associated with chronic pain – arthritis, back pain and inflammatory conditions. Not only did their patients experience pain relief, they began reporting improvement in other ancillary ailments as well.

“We quickly realized that by filtering the SVF, we could provide the cells via an IV for any variety of conditions,” Berman recalls. “Acute concussion heals overnight. Chronic traumatic brain injury may improve in many cases. Parkinson’s frequently responds well. We’ve had some good response with multiple sclerosis, Alzheimer’s and muscular dystrophy. ALS has not had good results. We’ve seen improvements with chronic heart conditions, COPD, and radiation necrosis following cancer treatments.”

Combating the ‘Unproven’ Disinformation Campaign

Their discoveries led Berman and Lander to publish a SVF safety study involving over 1,500 patients with various degenerative, inflammatory, and autoimmune conditions. They also formed the Cell Surgical Network, a network of physicians who use the same equipment and protocols taught by Berman and Lander. To date, the network has treated over 12,000 patients.

Berman maintains with conviction that “there’s no drug as safe as your own cells.” In fact, he and his family have all had successful personal stem cell treatments, as have most of the affiliate physicians in his network.

Yet news stories about “unproven stem cell procedures” persist. And Google recently went so far as to ban advertising for “unproven or experimental medical techniques,” including most stem cell therapies.

“It is sad and ridiculous that we can safely and effectively treat many people right now, but we’ve been fighting this false press that stem cells are dangerous and unproven when there’s virtually no danger and plenty of proof,” Berman says. 

“Saying it’s unproven denies how science advances. Most science does not rely upon placebo trials, something Pharma routinely takes advantage of to get a new version of an old drug on the market to exploit the public.”

The FDA As Proxy for Big Pharma

Berman has a theory why he and his partner have become targets of the FDA. It has to do with the power and influence of the pharmaceutical industry.

“When corporations get so big, and in this case actually finance government agencies, they end up controlling them in a variety of ways. They have many inside people that can facilitate their needs, but they also have pushed the FDA to write draconian regulations to keep smaller players out of the club as much as possible,” Berman explained.

“Physicians have the obligation to try to help their patients when they can – not to sit around while some sanctimonious academics or Big Pharma or FDA regulatory people decide we can try,” he adds.

Berman poses an intriguing question.

“Isn’t it interesting that no major pharmaceutical company has applied for an IND (new drug application) for personal cell therapy?” he asks.

“The answer is obvious: because they can’t own it.”

Berman believes FDA regulations are designed to protect Big Pharma from competition.

“The FDA has ignored clinicians’ and patients’ requests to be able to use their own cells for their own purposes. It’s absurd and it’s illegal.”

— Dr. Mark Berman

“Surgeons used to perform a lot more coronary bypass surgery, but Pharma developed stents and drugs to compete for the same patients,” he says. “Pharma and academia are the only two voices that matter to the FDA. The FDA has ignored clinicians’ and patients’ requests to be able to use their own cells for their own purposes. It’s absurd and it’s illegal.”

Berman and Lander intend to fight the FDA in court to the very end. A hearing date was scheduled for this month, but has been postponed until early next year.

“They’re trying hard to ruin us through the press and through these extensively long and unfair court proceedings that have been dragging out for over a year. If it’s not clear, we’re fighting for the basic civil and constitutional rights of our patients,” Berman says.

“We should be achieving new heights in healthcare and freedom yet there are so many people more interested in controlling us than letting us naturally rise to thrive.”

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Fentanyl Overdoses Spike in Seattle

By Pat Anson, PNN Editor

Public health officials in the Seattle area are warning about a spike in fentanyl-related overdoses that have killed at least 141 people in King County since June. As in other parts of the country, many of the deaths involve counterfeit oxycodone pills laced with illicit fentanyl.

Three of the recent overdose victims in King County are high school students who took blue counterfeit pills stamped with an “M” and a “30” – distinctive markings for 30mg oxycodone tablets that are known on the street as “Mexican Oxy” or “M30.”

“Teenagers who are not heroin users are overdosing and dying,” said Brad Finegood of Public Health – Seattle & King County. “Do not consume any pill that you do not directly receive from a pharmacy or your prescriber. Pills purchased online are not safe.”

Gabriel Lilienthal, a 17-year-old student at Ballard High School in Seattle, died Sept. 29 from a fentanyl overdose.

“Gabe died from a fake OxyContin called an M30,” the teen’s stepfather, Dr. Jedediah Kaufman, a surgeon, told The Seattle Times. “With fentanyl, it takes almost nothing to overdose. That’s really why fentanyl is a death drug.”

Fentanyl is 50 to 100 times more potent than morphine. It is prescribed legally to treat severe pain, but in recent years illicit fentanyl has become a scourge on the black market, where it is often mixed with heroin and cocaine or used in the production of counterfeit pills. Illicit drug users often have no idea what they’re buying.

As PNN has reported, counterfeit oxycodone pills laced with fentanyl are appearing across the country and have been linked to hundreds of deaths. Yet this emerging public health problem gets scant attention from federal health officials, who are currently focused on an outbreak of lung illnesses associated with vaping that has resulted in 18 deaths.

‘Enough to Kill San Diego’

In San Diego last month, DEA agents found five pounds of pure fentanyl in the apartment of Gregory Bodemer, a former chemistry professor who died of a fentanyl overdose. Prosecutors say that amount of fentanyl was “enough to kill the city of San Diego” or about 1.5 million people.

Also found in Bodemer’s apartment was carfentanil, an even more powerful derivative of fentanyl, along with a pill press, powders, liquids and dyes used in the manufacture of counterfeit medication.  

Bodemer’s body was found in his apartment Sept. 27. Rose Griffin, a woman who also overdosed at the apartment and recovered, has been charged with drug possession and distribution.

Bodemer was an adjunct chemistry professor at Cuyamaca College in 2016. He had previously worked as a chemistry instructor at the U.S. Naval Academy in Annapolis, Maryland.

How Children Process Pain

By Dr. Lynn Webster, PNN Columnist

No one saw it happen. My three-and-a-half-year-old granddaughter was in the basement by herself when she broke her arm. My guess is that she was jumping on the couch or standing on the back of it. Either way, the accident left her screaming and crying -- a natural response to being frightened and injured.

At the time, it wasn’t clear if she was seriously hurt. But my daughter said she behaved very differently after previous falls left her with minor bumps and bruises.

In a recent column, "Teaching Children How to Cope With Pain," I wrote about how parents should respond to children when they injure themselves. Experiencing pain is part of life, and children develop their own reactions based on an almost infinite number of factors.

As adults, we tend to think about the physical trauma pain causes. We pay scant attention to how the young brain processes injuries or the images created in their minds as a result of them.

Children’s brains are unable to process trauma in the way adults do. This is due in part to the limited verbal ability young children have to express what they are feeling.

Still, they do integrate the experience of pain. And hopefully the lessons they learn about managing pain during childhood help them cope with pain when they reach adulthood.

Imagery and drawing are ways to help children effectively process their pain. The symbolic meaning of an image can be very revealing. Sigmund Freud described how imagery can reflect the feelings, attitudes and qualities of our environment.

Hermann Rorschach famously built on that idea to develop the Rorschach (or inkblot) test. The concept of the Rorschach test is that through drawing or interpreting images, children can convey the emotional loads they carry.

The first collection of children’s drawings of pain was published in 1885, well before Rorschach developed his test. It appeared in an article written by art reformer Ebenezer Cookie and illustrated how the stages of children’s development corresponded to the clarity of their drawings.

All trauma has the potential to affect a child’s development and perspective. This does not mean that all trauma damages the brain or renders a child unable to manage stress. In fact, trauma is a life experience that children must learn to manage without compromising their emotional development. That sets the stage for being able to handle pain effectively as they mature.

Velcro or Teflon

In his book “Hardwiring Happiness: The New Brain Science of Contentment, Calm, and Confidence,” neuropsychologist Rick Hanson says, “Your brain was wired in such a way when it evolved, it was primed to learn quickly from bad experiences but not so much from the good ones.”

That explains why traumatic memories so often stick in our brains while positive memories seem to slip away.

“It’s an ancient survival mechanism that turned the brain into Velcro for the negative, but Teflon for the positive,” Hanson concludes.

On the day of my granddaughter's injury, my daughter called and asked for help. Fortunately, my wife and I live nearby, so I rushed over immediately. Even before I entered her home, I began to wonder whether the injury my granddaughter experienced would be more Teflon than Velcro.

Usually when I arrive, my granddaughter calls my name and races to give me a hug. That didn't happen on the day she fell. Instead, she was clinging to her mother, who was trying and failing to console her and "make it all better."

It was obvious to me that my granddaughter had a fracture and needed to be taken to the emergency room.

After the orthopedic surgeon treated and cast her arm, my granddaughter experienced minimal pain. It was a bump in the road she would one day forget. Or would she? And should she?

Two weeks later, my granddaughter was at preschool, where the class was studying cloud formations. Each student was asked to draw clouds and explain what their Rorschach images meant to them.

Below, you can see my granddaughter's drawing, which she made by applying blobs of ink to the paper and folding it in half. Her interpretation of that image was that the clouds were “my broken bones.”

The separation of the clouds might have been the projection Freud would have expected from a child with a recent injury where bones were separated and had to be mended. 

It reinforced the lesson for me that young children are always processing and interpreting the events of their lives. These experiences create images and memories that are a part of their developing brains and personalities. 

Although my granddaughter is only three and a half, she is already forming her adult interpretation of pain, one layer at a time. Whether her experience will be more Teflon than Velcro, only time will tell.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find him on Twitter: @LynnRWebsterMD.

This column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Opioid Breathalyzer Test Developed

By Pat Anson, PNN Editor

Chronic pain patients have grown accustomed to having their urine -- and sometimes their blood and hair – analyzed for opioids and other drugs.

Someday soon they could be taking opioid breathalyzer tests.

In a small pilot study, researchers at the University of California, Davis have developed and successfully tested a device that collects minute droplets in breath that can be analyzed in a laboratory for morphine, hydromorphone (Dilaudid) and other opioids.

“Exhaled breath collection represents a painless, easily available, and non-invasive technique that would enable clinicians to make quick and well-informed decisions,” said lead author Cristina Davis, PhD, chair of the Department of Mechanical and Aerospace Engineering at UC Davis. "There are a few ways we think this could impact society."

While ostensibly developed to help doctors care for patients and monitor their drug use, Davis and her colleagues say opioid breathalyzer tests could someday be used in addiction treatment and by law enforcement during roadside field sobriety tests.

They reported their findings in the Journal of Breath Research.

IMAGE COURTESY OF CRISTINA DAVIS, UC DAVIS

“Breath offers the opportunity to collect a diagnostic biospecimen non-invasively and, eventually, a way to obtain near real-time results almost anywhere. Though this study did not utilize portable analytic systems, future breath drug detection platforms used to identify targeted compounds will be available for point-of-care use. This will enable opioid detection in many settings including roadside, drug treatment facilities, field emergency response, home, and rural areas with limited access to healthcare,” Davis wrote.

Nine patients receiving opioids for cancer pain at the UC Davis Medical Center participated in the pilot study, along with three healthy people used as a control group. Participants exhaled through a glass tube surrounded by dry ice that captured and froze breath condensate. The breath samples was then analyzed in a lab using mass spectrometry and compared to opioid metabolites in blood samples and in doses given to patients.

"We can see both the original drug and metabolites in exhaled breath," Davis said.

Fully validating the breath test will require more data from larger groups of patients. UC Davis researchers are working towards the development of real-time, point-of-care breath tests that can be broadly used to detect opioids and other drugs.

Point-of-care (POC) urine drug tests are widely used by doctors to screen patients for illicit drugs and to make sure they’re taking medications as prescribed. Physicians like the immunoassay test strips because they can be performed in their offices, are inexpensive and give immediate results.

However, as PNN has reported, POC test results are wrong about half the time – and frequently give false positive or false negative results for drugs like marijuana, oxycodone and methadone.  Experts say doctors should never base a treatment decision or discharge a patient solely on the results of one POC test, and that confirmatory testing should always be performed by a laboratory. 

Can Pain Patients Sue the CDC?

By Carol Levy, PNN Columnist

Almost every report on the CDC opioid guideline that I’ve seen online gets this response from pain patients: “Class action lawsuit! Sue the CDC!” 

Many doctors cite the CDC’s opioid guideline when they stop writing prescriptions for opioids or reduce the amount they prescribe. Many of their patients say the tapering left them bedridden and unable to work because the pain returned to unbearable levels. Some even attempted or completed suicide as a result of no longer having the relief that opioids gave them.  

Is that enough grounds for a class action lawsuit against the CDC?  I am not an attorney, but I wondered if there is a basis for such a lawsuit.

Based on my research, the pain community does not meet the necessary legal criteria to do this.  

Aside from the difficulties of suing a federal agency, one of the many rule requirements in federal court to certify a class action lawsuit is this: “the class must show that the defendant acted in a way generally applicable to class members.” 

Few of us can point to the CDC guideline as the specific reason their doctor is no longer prescribing opioids at the same dose. It would need to be proven that all members of the class were treated in essentially the same way by the defendant CDC.

And it is doctors who changed their prescribing routines, not the CDC. Therefore, it appears we cannot form the requisite “class.” 

In addition, the CDC’s clarification of the guideline in June passed the buck by blaming individual practitioners for the guideline’s misuse:

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations. A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

So are there no actions we can take?

A recent decision by the New Hampshire Board of Medicine is one example of what happens when we do act. A patient reported his doctor to the board for refusing to continue prescribing opioids that had greatly helped his pain. As a result of the tapering, the patient’s pain became so unbearable he threatened suicide. At that point, the doctor refused to prescribe anymore opioids to the patient and dropped him. 

The board found that the doctor violated the ethical standards of professional conduct. He was fined, reprimanded, and ordered to take classes in pain management and record keeping.  

Another action is simply writing a letter, emailing or calling your federal and state representatives. Some of these people are working, intentionally or not, to hurt us.

The latest is a bill from Senator Joe Manchin of West Virginia and Sen. Mike Braun of Indiana. Neither have medical degrees, yet they have introduced a bill that instructs the FDA to tell doctors that opioids are "not intended for the treatment of chronic pain" except for cancer pain, end-of-life care or when no other pain treatment is effective.  

By telling our stories, by getting the authorities and legislators to understand what chronic pain is, and how it affects not only us but our families, community and the country, we can keep up the pressure. By submitting our complaints or filing lawsuits against individual doctors, we can be the voice of change. 

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

This column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Report: DEA ‘Slow to Respond’ to Opioid Crisis

By Pat Anson, PNN Editor

DEA investigators should get easier access to prescription drug databases and electronic prescribing should be required for all opioids and other controlled substances, according to a new report from the Justice Department’s Office of Inspector General (OIG).

The 77-page report is sharply critical of the Drug Enforcement Administration for its slow response to the opioid crisis and said the agency was “ill-equipped” to monitor suspicious orders and prevent diversion of prescription opioids.

“We found that DEA was slow to respond to the significant increase in the use and diversion of opioids since 2000. We also found that DEA did not use its available resources, including its data systems and strongest administrative enforcement tools, to detect and regulate diversion effectively. Further, we found that DEA policies and regulations did not adequately hold registrants accountable or prevent the diversion of pharmaceutical opioids,” the report found.

The OIG report focused exclusively on prescription opioids and did not evaluate the significant role that illicit fentanyl, heroin and other street drugs play in the opioid crisis. About two-thirds of opioid overdoses involve illicit drugs.

The report also contains some factual errors, such as the misleading but often repeated claim that “nearly 80 percent of people who began abusing illicit opioids during the 2000s started by abusing a prescription opioid.”

Less than one percent of legally prescribed opioids are diverted, but the report claims the “pervasive nature of prescription fraud” is so rampant that paper prescriptions for opioids should be prohibited. Instead, electronic prescribing should be mandated nationwide to prevent fraud and allow for better tracking of opioid prescriptions.

‘Puzzling’ Restrictions on Opioid Databases

The report also calls for greater law enforcement access to state run prescription drug monitoring programs (PDMPs). To protect patient privacy, several states require a subpoena or search warrant before giving DEA investigators access to their databases. The report calls the requirement “puzzling” and said it creates “significant challenges” for DEA investigators “who should be able to receive PDMP data and information.”

“We believe that the Department and DEA should continue to work with states to reach agreements that will enable DEA to have timely access to PDMP prescription data as needed… while also ensuring adequate protections for the important healthcare privacy interests of patients,” the report said.

Other recommendations from the report:

• DEA should develop a national prescription opioid enforcement strategy

• Require criminal background checks for all new prescribers and registrants

• Re-establish a nationwide early warning network to identify emerging trends in drug abuse   

• Expand DOJ opioid fraud units to additional U.S. Attorney’s Offices

In its response to the OIG, the DEA said the report “rightly identifies areas of improvement,” but said the agency has taken a number of steps to reduce the supply and diversion of prescription opioids.

The DEA said “only a minute fraction” of the more than 1.8 million registrants are involved in illegal activity. The agency said it had revoked about 900 registrations annually over the past eight years and reduced the supply of prescription opioids by 45 percent since 2017. Additional cuts in the opioid supply are proposed for 2020.

The Risks of Vaping THC

By Roger Chriss, PNN Columnist

An outbreak of vaping-associated pulmonary illness is getting national attention. Over 800 people have been sickened and 12 have died.

The CDC reported last week that vaping products containing tetrahydrocannabinol (THC) -- the psychoactive compound in marijuana – were involved in 77 percent of the illnesses. Several states responded with bans on vaping products and health alerts on vaping THC.

What do we know about the risks of vaping?

Vaping THC is so new that there is very little research. An animal study on vaping THC was published earlier this year. Performed on male and female rats, the study found that “repeated THC vapor inhalation in adolescent rats results in lasting consequences observable in adulthood."

Specifically, both sexes became tolerant to THC and male rats ate more. Interestingly, THC use did not change oxycodone self-administration in either sex, but increased fentanyl self-administration in female rats. There is no mention of lung effects.

While vaping with e-cigarettes is relatively new, inhaling THC via cannabis smoking is old. And there is an extensive literature on multiple harms.

A recent study of nearly 9,000 people found that regular cannabis use was significantly associated with greater risk of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) and pneumonia. The study used blood work to confirm use and had a control group, making its results more reliable than a simple population survey.

According to the National Institute on Drug Use, cannabis smoke contains multiple carcinogens and inhalation causes lung inflammation, increased airway resistance and hyperinflated lungs, a symptom of COPD

Josh Bloom at the American Council of Science and Health writes that the solubility and boiling point of THC and CBD in cannabis vaping products may play a role in the lung illnesses.

But complicating matters is the presence of other subtsances in vaping liquids and in the devices themselves. A newly published study in Scientific Reports on aerosols in tank-style e-cigarettes found levels of chromium, lead and nickel, all known carcinogens, in excess of OSHA permissible exposure limits.

Most cases of vaping-associated pulmonary illness involve illicit products. But one fatal case in Oregon involved someone who bought vaping products at two state-licensed cannabis dispensaries.

Some vaping illnesses involve people who report no use of THC products at all, though investigators are finding that these self-reports are not necessarily accurate. According to STAT News, eight patients in Wisconsin initially said they didn’t use THC products, but were later found to have used the drug.

In other words, we may not know what people were really vaping. Given that vaping THC is federally illegal and only marginally regulated in states where cannabis is legal, investigating the role of THC in the vaping outbreak is challenging.

But the emerging risks have led states like Washington to ban all flavored vaping products. And the FDA has asked the DEA to pursue criminal charges against anyone who sells illicit vaping products.

For patients who use cannabis products for pain relief, there are better alternatives than vaping. The Arthritis Foundation recently released new guidelines that recommend CBD oils and tinctures that can be taken orally.

It is not clear what this means for the cannabis industry. But Joe Tierney, known as the "Gentleman Toker,” told the Washingtonian that he would be shutting down his cannabis website.

“I don’t feel good about the industry any longer,” Tierney said. “I don’t think it’s safe to consume cannabis anywhere after all of my travels.”

Sorting out the risks of THC vaping will take time. At present there is only circumstantial evidence and intriguing ideas. It is possible that THC is one of several different causes or is just guilty by association. Beyond that, we have the unknowns of vaping itself, which may be too novel for anyone to fully understand the risks.

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 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 Target Online Pharmacies

By Pat Anson, PNN Editor

The FDA and DEA have sent warning letters to four online networks for illegally marketing unapproved and misbranded versions of opioid pain medication. The letters are the latest step in what appears to be an expanding federal and private crackdown on online pharmacies and websites that offer alternative health products and information.

The four online networks, which operate at least 10 websites, are Divyata, Euphoria Healthcare, JCM Dropship and Meds4U. The letters warn the companies to immediately stop selling illegal opioids to consumers.

“We cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” said acting FDA Commissioner Ned Sharpless, MD.

The FDA has issued letters of this type before, but this is the first time the agency has jointly issued warning letters with the DEA. The companies were given 15 days to respond.

“You knowingly or intentionally use the Internet to advertise the sale of controlled substances by directing prospective buyers to Internet sellers of controlled substances who do not possess a valid modified DEA registration,” one letter warns.

“Therefore, your websites are operating in violation of United States law, which may be enforced through criminal penalties and civil enforcement.”

The letter to Divyata alleges the company sells the opioid painkiller tramadol as an “agony reliever that ties with receptors of the mind and sensory system to diminish dimensions of torment.”

Euphoria Healthcare was warned for selling the opioid tapentadol under the name “Aspadol Tab” and claiming it is used “to treat moderate to severe pain that occurs for shorter to longer periods of time.” The FDA has never approved a drug called “Aspadol Tab.”

As PNN has reported, the FDA has previously cracked down on rogue online pharmacies selling counterfeit drugs or illegal medication. Often the websites reappear under new names or move offshore. As many as 35,000 online pharmacies operate worldwide. The vast majority are not in compliance with U.S. laws and many do not require a prescription, according to the Alliance for Safe Online Pharmacies.

The federal crackdown is not limited to opioids or prescription drugs. This month the Federal Trade Commission warned three companies selling CBD oils, tinctures, edibles and other products to stop making claims that CBD can be used to treat pain and other chronic illnesses.

Google Warns Online Publishers

Internet companies have also taken steps to reduce the flow of online traffic and advertising revenue to websites that offer alternative health information and products.

Today Google informed thousands of online publishers enrolled in its AdSense advertising partnership that it would restrict advertising on websites that promote or have content about recreational drugs, unapproved pharmaceuticals or supplements. The policy not only applies to illegal drugs such as heroin and cocaine, but includes several alternative treatments for pain, such as marijuana, CBD, kratom and other herbal supplements.

In effect, Google is telling online publishers their advertising revenue will be reduced or stopped if they provide information that Google considers inappropriate.

“Publisher restrictions identify content that is restricted from receiving certain sources of advertising. By content, we mean anything present on your page or app - including other advertisements and links to other sites or apps,” Google explained in a note to publishers.

“If your content is labeled with an inventory restriction, fewer advertising sources will be eligible to bid on it. In some cases this will mean that no advertising sources are bidding on your inventory and no ads will appear on your content.”

Pain News Network is a Google AdSense partner. We frequently publish content about kratom, CBD and other alternative pain treatments. It is unclear how Google’s advertising policy will affect PNN.

In addition to restrictions on advertising, recent changes to Google’s search engine algorithms have suppressed search results for hundreds of websites that offer alternative health information or products. As a result, many of these websites have already experienced a substantial drop in revenue and readers.

Facebook, Pinterest, Tumblr and other online social networks have also recently suspended or deleted dozens of alternative health pages for containing what Facebook considers “false, misleading, fraudulent, or deceptive claims or content.”

Pinterest said it relies on governmental bodies to decide what is appropriate. “We rely on information from nationally and internationally recognized institutions, including the CDC and WHO, to help us determine if content violates these guidelines,” Pinterest explained in an email to a website that was banned.

PNN’s account with Pinterest was suspended without warning in June for violating the company’s “spam policies.”  Our account was reactivated a week later with an apology.

“Sorry that your account was suspended. Occasionally good accounts get caught in the mix when we're looking for spammy accounts,” Pinterest said in an email.

The Power of the Pen

By Michael Emelio, Guest Columnist

It's my hope that this column can serve as a powerful example of the harm that can be caused when people are denied adequate pain management. And in so, I pray that it also serves as a lesson to doctors and is something that our lawmakers, CDC and DEA will take a moment to seriously consider.

To understand the full magnitude of the damage that's been caused, I implore you to read a guest column I wrote last year, in which I described how the opioid medication I take for intractable back pain was rapidly tapered to a lower dose, leaving me bedridden and disabled.

It's high time that the harm being inflicted on me and other innocent victims of the opioid crisis is both acknowledged and stopped!

While I can totally sympathize with a doctor's fear of repercussions from the DEA, there comes a point where it's no longer a valid or acceptable excuse. One of those points is when a doctor, with no medically valid reason, refuses to sufficiently treat a person's pain and it results in harm to that patient.

And when a doctor refuses to prescribe a reasonable opioid dose (especially one that is within the CDC opioid guideline) and it causes a patient's condition to significantly worsen, how are they not responsible for that harm?

Speaking with other patients, I've been hearing a familiar story quite a bit lately. So much in fact, that it appears to be becoming an epidemic. Doctors with no medically valid reason are either failing or refusing to prescribe even within the CDC’s 90 MME guideline, while using the same old "well the DEA threatens to take our licenses away" excuse. 

Not only is it getting old, but it's getting people hurt and worse. And when I say that excuse is killing me, I may just mean literally!

Since the tapering started, I've gained 55 pounds and my blood sugar and cholesterol have soared to alarming rates. So in addition to all the things I can no longer do and my pain and suffering increasing, I'm now at risk of both heart disease and diabetes. Irrefutably, this is a direct result of being bedridden 24 hours a day due to the med cuts.

But it doesn't stop there. Adding insult to injury, these med cuts are also robbing me of the only chance I have to improve my condition.

Surgery Not An Option

It cannot be emphasized enough that I've seen several highly-acclaimed surgeons, who are absolutely unanimous in what options I have. They've all said the same thing: Surgery is not an option for me and due to the nature of my condition I should avoid any invasive procedures as they can make my pain worse. This includes spinal injections, radiofrequency ablation, spinal cord stimulators and pain pumps, to name a few.

They've all said that the only viable options I have left are pain meds and physical therapy. The latter is essential because “mobility is crucial to help reduce the pain and improve function.” And to slow my rate of deterioration, I should do “as much physical therapy as possible." 

So by denying me the ability to complete physical therapy due to his forced med cuts, my doctor is not only robbing me of my only chance for improvement, he is directly causing my condition to worsen at an accelerated rate. Despite explaining all of this to him, my doctor informs me that he still plans on reducing my meds even further!

On what planet does this make any sense whatsoever? When you consider all the aspects of my condition and the damage the previous met cuts have already caused, how can this be helpful in any way, yet be a necessary or even a reasonable course of action?

Especially when I'm only at 60 MME, which is considerably less than the CDC's 90 MME guideline. Furthermore, I've been a patient of his for over a year and a half and have proven to take my medications responsibly the entire time, as well as the previous 18 years I've been in pain management.

“Because of the CDC guideline and the fear instilled by the DEA, my doctor is covering his ass and slowly killing me.”

— Micahel Emelio

Think about this for a minute. I have a medical need for pain meds because of an incurable condition that is causing such severe intractable pain that I'm bedridden to the point that I struggle to care for myself properly. It’s also a condition where surgery and invasive procedures are not an option, all other methods and medications have failed, and the only chance for improvement is through physical therapy. Then add the fact that my health is in a serious state of decline as a direct result of the med cuts, and he still wants to cut them even more?

Unless you're in this boat yourself, you can't fathom the level of stress this causes. I'm literally afraid I may have a heart attack from it.

You have to understand the impact that just one more med cut would have on me. I live alone, have no one to help me, and with the dose I'm currently at, I'm already struggling most days just to microwave a TV dinner, yet alone clean my house or even care for myself properly. If he cuts my meds any further, the effect it will have on my life will be devastating.

As I sat in my car outside his office, the only thing I could think about was that if he reduces my meds any further, not only will my pain be unbearable, but I won't even be able to care for myself anymore. Being alone and poor, I only see two options at that point: street drugs or suicide. 

Make no mistake. That is the hand that is being forced on people when intractable pain is not treated!

Never in a million years could I have imagined being in this position. But sadly, this is my reality. And the truly astonishing part of it all is that he could stop all this damage and immensely change my life for the better tomorrow, simply by prescribing 2 more tablets a day, which would still be within the CDC guideline.

But no! Because of the CDC guideline and the fear instilled by the DEA, my doctor is covering his ass and slowly killing me. It's both staggering and terrifying knowing how much control he has over my life with just the swipe of his pen.

Which brings me to an interesting point. In medical school they teach about a thing they call the "power of the pen." It means to make sure that what they prescribe doesn't cause harm to the patient. I just wish my doctor realized that the power of the pen works both ways!

Michael Emelio lives in Florida. Michael lives with severe degenerative disc disease, scoliosis and fibromyalgia. He has safely used opioid medication since 2001.

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.

Can Prayer Ease Chronic Pain?

By Dr. Lynn Webster, PNN Columnist

Does prayer lead to healing? Many religious people around the world believe that it does. According to the science, it may.

Medical researchers have looked into the effects of religion and spirituality on chronic health conditions, including chronic pain, for many years. The research has produced vastly different results. According to a review of studies in the Indian Journal of Psychiatry, prayer may contribute to healing, may worsen health, or may make no difference at all.

Helen Fosam, PhD, says in Clinical Pain Advisor, "a positive emotional state and a positive expectation of pain relief can lower pain and enhance clinical effect of treatment."

So if you believe prayer can ease your pain, it may happen.

Pain Is a Spiritual Condition

As I say in my book, The Painful Truth, pain is a bio-psycho-social-spiritual condition. However, it might make more sense to reverse the order and put “spiritual” first because, for many people, the spiritual dimension is the most important.

More times than I can remember, I’ve known people in pain to cry out to God for mercy, kneel in silent prayer, cross themselves or finger their rosary, practice yoga or meditation, wear crosses or angel pins or crystals, express a longing for heaven, mention attending religious services, or tell me about their belief in God.

Even religious skeptics who are in pain sometimes pray for themselves or ask others to pray for them.

The simple fact is that most people have a tendency to turn to God and faith when they are in need, including when they are in pain. Along with most other pain specialists, I have come to see this as generally a good thing, because relating to a God or a perceived spiritual reality beyond oneself can affect one’s pain experience positively.

Prayer As Meditation

Prayer is a specialized form of meditation. According to the National Center for Complementary and Integrative Health, meditation "may be helpful for a variety of conditions, such as high blood pressure, certain psychological disorders, and pain."

People who have faith in a higher power and turn to prayer may be availing themselves of the medical benefits of meditation.

Of course, not everyone who is in pain is religious or spiritual -- or wants to be. I’ve known many people with pain who have experienced a substantial increase in their life satisfaction without recourse to spiritual beliefs and practices. Some of them have practiced meditation, and some of them have not.

But if we’re interested in what promotes healing for those enduring long-term pain, we can’t ignore the interaction between belief and pain.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find him on Twitter: @LynnRWebsterMD. 

Green Without Envy

By Mia Maysack, PNN Columnist

In the opinion of some, at various points in my life I could've been considered a "pothead." 

If that is how you refer to the medicinal use of a plant that grows freely in nature, I own the judgement with pride.  

I've known people who sit around and smoke loads of grass to the point of everything being funny -- but they're too stoned to laugh. That has never been my intent or relationship with marijuana.

This is another element of living with chronic pain and illness that is severely misunderstood -- the desperation we feel for relief.  After you've tried countless traditional approaches to no avail or improvement, I don't care what anyone says. Every single person reaches their absolute limit or breaking point.

When others have discovered that marijuana is part of my care plan, I've been shunned and labeled as a drug addict by the very same people who puff cigarettes, drink alcohol into oblivion, cannot get through a day without coffee, and poison themselves with food-like-products from a drive-thru window.  

Please explain how a man-made drug produced in a lab is somehow safer than marijuana. The only difference is that the drug is regulated and thereby taxed. Arguably, that’s what all of this is about: Money.  

I haven't come across anything that eases my head or body pain. I have only been able to accumulate a short list of helpful remedies that can temporarily (but not always) assist in my co-existence with pain. 

For example, marijuana helps combat nausea, which aids with proper nourishment and hydration. And when you haven’t had a good night’s sleep in days or weeks, a marijuana-induced state of relaxation can mean the difference between restful sanity or a trip to the loony bin.  

There will always be people who abuse whenever they get an opportunity, in the same way that every church has sinners and one bad pizza doesn't mean all pizza joints are bad. The unfortunate choices of a few should not outweigh the credibility of many.

When I ingested my first opioid, it lifted the agony in a way I had never experienced before. I remember like it was yesterday. I thought for sure I was too sick to make it into work but chose to attempt this pill, solely out of desperation. It left me smiling ear-to-ear on my way to my beloved nursing job.

But as I pulled into the parking lot, I was struck with an overwhelming wave of sickness and could barely make it to the trash can before completely losing it. I had an allergic reaction to opioid medication and another potential treatment was biting the dust. 

I do not touch the stuff anymore, but that doesn't change the fact that opioids have proven to be extraordinarily helpful for a countless amount of people. And these same people who were given legitimate prescriptions are now being punished by having their medication taken away, often without a follow up plan or any notice. 

Healthcare providers are balancing on a sensitive tight rope between doing no harm while attempting to avoid ruining their good legal standing or that of their practice. This is causing many patients to feel abandoned, lost and isolated, with low quality of life and high suicide rates.

Peering into the window of someone else's life and judging them simply because you don't understand their thoughts, experiences or desperation is unacceptable.

It's easy to be judgemental and not care about the crisis in pain care if you or a loved one hasn't been personally affected by it. But this is a general societal crisis that affects young and old, rich and poor. Someday it will affect you.

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.

Low Dose Naltrexone a ‘Game Changer’

By Alex Smith, Kaiser Health News

Lori Pinkley, a 50-year-old from Kansas City, Mo., has struggled with puzzling chronic pain since she was 15.

She has had countless disappointing visits with doctors. Some said they couldn’t help her. Others diagnosed her with everything from fibromyalgia to lipedema to the rare Ehlers-Danlos syndrome.

Pinkley has taken opioids a few times after surgeries, but they never helped her underlying pain. Recently she joined a growing group of patients using an outside-the-box remedy: naltrexone. It is typically used to treat addiction to opioids or alcohol, in pill form or as a monthly shot.

As the medical establishment attempts a huge U-turn after two disastrous decades of pushing long-term opioid use for chronic pain, scientists have been struggling to develop safe, effective alternatives.

When naltrexone is used to treat addiction in pill form, it’s prescribed at 50 milligrams. But chronic pain patients say it helps their pain at doses of less than a tenth of that.

Low-dose naltrexone (LDN) has lurked for years on the fringes of medicine, and its zealous advocates worry it may be stuck there. Naltrexone, which can be produced generically, is not even manufactured at the low doses that seem best for pain patients.

Instead, patients go to compounding pharmacies or resort to DIY methods — YouTube videos and online support groups show people how to turn 50 mg pills into a low-dose liquid.

Some doctors prescribe it off label even though it’s not FDA-approved for pain.

University of Kansas pain specialist Dr. Andrea Nicol recently started prescribing LDN to her patients, including Pinkley. Nicol explained that for addiction patients it works by blocking opioid receptors — some of the brain’s most important feel-good regions. So it prevents patients from feeling high and can help patients resist cravings.

At low doses of about 4.5 mg, however, naltrexone seems to work differently.

“What it’s felt to do is not shut down the system, but restore some balance to the opioid system,” Nicol said.

Some of the hype over low-dose naltrexone has included some pretty extreme claims with limited research to back them, like using it to treat multiple sclerosis and neuropathic pain or even using it as a weight-loss drug.

In the past two years, however, there’s been a significant increase in new studies published on low-dose naltrexone, many strengthening claims of its effectiveness as a treatment for chronic pain, though most of these were small pilot studies.

Dr. Bruce Vrooman, an associate professor at Dartmouth’s Geisel School of Medicine, authored a recent review of low-dose naltrexone research.

Vrooman said that, when it comes to treating some patients with complex chronic pain, low-dose naltrexone appears to be more effective and well-tolerated than the big-name opioids that dominated pain management for decades.

“Those patients may report that this is indeed a game changer. It may truly help them with their activities, help them feel better.”

— Dr. Bruce Vrooman

“Those patients may report that this is indeed a game changer,” Vrooman said. “It may truly help them with their activities, help them feel better.”

So how does it work? Scientists think that for many chronic pain patients the central nervous system gets overworked and agitated. Pain signals fire in an out-of-control feedback loop that drowns out the body’s natural pain-relieving systems.

They suspect that low doses of naltrexone dampen that inflammation and kick-start the body’s production of pain-killing endorphins — all with relatively minor side effects.

Drug Companies Not Promoting LDN

Despite the promise of naltrexone, its advocates say, few doctors know about it. The low-dose version is generally not covered by insurance, so patients typically have to pay out-of-pocket to have it specially made at compounding pharmacies.

Advocates worry that the treatment is doomed to be stuck on the periphery of medicine because, as a 50-year-old drug, naltrexone can be made generically.

Patricia Danzon, a professor of health care management at the Wharton School at the University of Pennsylvania, explains that drug companies don’t have much interest in producing a new drug unless they can be the only maker of it.

“Bringing a new drug to market requires getting FDA approval, and that requires doing clinical trials,” Danzon said. “That’s a significant investment, and companies — unsurprisingly — are not willing to do that unless they can get a patent and be the sole supplier of that drug for at least some period of time.”

And without a drug company’s backing, a treatment like low-dose naltrexone is unlikely to get the promotional push out to doctors and TV advertisements that has made household names of drugs like Humira and Chantix.

 “It’s absolutely true that once a product becomes generic, you don’t see promotion happening, because it never pays a generic company to promote something if there are multiple versions of it available, and they can’t be sure that they’ll capture the reward on that promotion,” Danzon said.

The drugmaker Alkermes has had huge success with its exclusive rights to the extended-release version of naltrexone, called Vivitrol. In a statement for this story, the company said it hasn’t seen enough evidence to support the use of low-dose naltrexone to treat chronic pain and therefore is remaining focused on opioid addiction treatment.

Lori Pinkley said it’s frustrating that there are so many missing pieces in the puzzle of understanding and treating chronic pain, but she, too, has become a believer in naltrexone.

She’s been taking it for about a year now, at first paying $50 a month out-of-pocket to have the prescription filled at a compounding pharmacy. In July, her insurance started covering it.

“I can go from having days that I really don’t want to get out of bed because I hurt so bad,” she said, “to within a half-hour of taking it, I’m up and running, moving around, on the computer, able to do stuff.”

A recent review by British researchers found that LDN is safe to use and more clinical studies are needed on its potential uses. PNN readers have shared their positive experiences using LDN to treat Interstitial Cystitis and fibromyalgia.

The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

This story is part of a partnership that includes KCUR, NPR and Kaiser Health News, a nonprofit news service covering health issues. KHN is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Arthritis Foundation Releases First CBD Guideline

By Pat Anson, PNN Editor

The Arthritis Foundation has become the first major patient advocacy group to release guidelines on the use of cannabidiol (CBD) to treat arthritis pain.  

About 54 million Americans have been diagnosed with arthritis. According to a recent national survey, 79 percent of arthritis patients are currently using CBD, have tried it in the past, or are considering it.

CBD infused products – from edibles to lotions to beverages -- are rapidly going mainstream, even though there is little scientific evidence to support their use. There has also been little guidance for consumers on what products to use or in what doses — until now.

“We are intrigued by the potential of CBD to help people find pain relief and are on record urging the FDA to expedite the study and regulation of these products,” the Arthritis Ffoundation said in a statement.

“While currently there is limited scientific evidence about CBD’s ability to help ease arthritis symptoms, and no universal quality standards or regulations exist, we have listened to our constituents and consulted with leading experts to develop these general recommendations for adults who are interested in trying CBD.”  

CBD is largely extracted from a hemp, a marijuana strain that has only trace amounts of THC, the active ingredient that makes people high.

"Millions of people in the U.S. are likely trying to use cannabinoids to treat pain, and many are doing this in ways that might cause more harm than good, especially when they use high doses of THC," said Daniel Clauw, MD, a professor of anesthesiology at the University of Michigan who was one of the experts the foundation consulted.

"It's important that the Arthritis Foundation has taken a stand on CBD,” Clauw said in a statement. “Right now, it appears to be fairly safe and might help certain types of pain. It's far better to give this guidance, even if preliminary, because otherwise people will have no guidance whatsoever." 

DRUG POLICY ALLIANCE

The new guideline is largely cautionary and does not explicitly recommend CBD as a treatment, stating only that it “may help” with arthritis-related symptoms such as pain, insomnia and anxiety.

When taken in moderate doses, experts say CBD has no major safety issues, although it may interact with some drugs commonly taken for arthritis, such as naproxen (Aleve), celecoxib (Celebrex), tramadol (Ultram), gabapentin (Neurontin), pregabalin (Lyrica) and some antidepressants.

The Arthritis Foundation recommends taking CBD in oral sprays or tinctures so the liquid can be taken under the tongue and be absorbed directly into the bloodstream.

Experts say a “go slow” approach is best, starting with a few drops twice a day and increasing the dose gradually over a period of weeks until an effective dose is reached.

The guideline strongly discourages inhaling or vaping CBD because of the risk of respiratory problems. It also discourages taking CBD in edibles, such as gummies and cookies, because the dosing is unreliable. Experts say the effectiveness of topical lotions and creams with CBD is unclear because they often contain other ingredients.

Other key takeaways from the guideline:

• CBD should never be used to replace disease-modifying drugs that help prevent permanent joint damage in inflammatory types of arthritis.

• CBD use should be discussed with your doctor in advance, with follow-up evaluations every three months or so.

• Buy from a reputable CBD company that has each batch tested for purity, potency and safety by an independent laboratory and provides a certificate of analysis.  

Unlike prescription drugs approved by the Food and Drug Administration, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects. 

The Federal Trade Commission recently warned companies that make CBD products to stop making unsubstantiated claims that cannabidiol can be used to treat arthritis and other chronic pain conditions.

Former Director of U.S. Pain Foundation Questions Misuse of Funds

By Pat Anson, PNN Editor

A former board member of the U.S. Pain Foundation is raising questions about how former CEO Paul Gileno was able to misappropriate over $2 million in funds from the Connecticut-based non-profit. 

Gileno pleaded guilty to fraud and tax evasion charges in June and is awaiting sentencing.  Federal prosecutors say Gileno used donated funds in the charity’s bank account to write checks to himself and other people for his own personal benefit. The money was used to pay Gileno’s mortgage, car payments, loans to his brothers, and a visit to Universal Studios in Orlando, Florida. The misuse of funds allegedly went undetected for three years.

“I still find it difficult to believe that nobody else who’d been in upper management of the foundation for several years, knew anything regarding the going out and coming in of money/funds,” former board member Suzanne Stewart recently wrote in her blog.

Stewart was a volunteer “ambassador” at U.S. Pain before she was appointed to the board in January, 2018 – a tumultuous time in the charity’s history, as the extent of the misuse of funds was just becoming known. Stewart resigned from the board 8 months later and has remained relatively silent about her board experience, until now.

Stewart wrote in her blog that she was initially excited to join the board, but soon realized something was amiss when she called another board member.

“I called to ask her a few questions, such as: ‘What was it like, being on the Board? What do we do as Board Members etc?’ She laughed & told me that ‘there was no real Board of Directors’. She added that they’d never even had a board meeting!” said Stewart, who lives with Complex Regional Pain Syndrome and other chronic pain conditions.

SUZANNE STEWART

“I was a bit disappointed at hearing this news. But it was soon confirmed. The Board of Directors of the US Pain Foundation, were actually just photographs on the USPF website, prior to January, 2018. There was no true Board of Directors. There had been no board meetings or elections.”

Gileno founded the Connecticut Pain Foundation in 2006 after he was disabled by a back injury. In 2011, he launched U.S. Pain and registered as a charity in the state. Connecticut state law requires non-profits to have annual board meetings and to elect their directors and officers.

“So I’m guessing there was there no secretary or treasurer? I’m guessing this means that nobody had to get permission to write checks?” Stewart asks. “Didn’t they have to answer to anyone about how or where to spend donation monies? How does the President, Vice President & Executive Director & other upper management, not know what & where money is coming in and/or going out?”

According to an audit and U.S. Pain’s tax returns, Gileno misappropriated over $2,055,000 from the charity from 2016 to 2018.  Nicole Hemmenway, the current acting CEO, was vice-president and board chair at the time. Two other longtime board members, Wendy Foster and Ellen Lennox Smith, still serve as directors. And Lori Monarca remains as Executive Office Manager, according to U.S. Pain’s website.

Only Gileno has been charged with a crime.

“It seems to me that when upper management realized that things had somehow gotten out of hand and that the USPF might be slipping away, they decided to get lawyers and accountants involved in an attempt to ‘fix’ a situation that they’d created. It seemed to have finally become something larger that they could no longer handle alone,” Stewart wrote.

“Over the following months, I found out what a mess things were and I immediately wanted to resign. I was advised by one of the attorneys, that ‘it wouldn’t look good’ for USPF, if anyone on the Board resigned during that time.”

The board asked for and received Gileno’s resignation in May 2018, although it wasn’t publicly disclosed until December that “financial irregularities” were behind his sudden departure.

Gileno did not comment on Stewart’s post, but praised her work as a patient advocate.

“I can say that I have always admired Suzanne and she is an amazing advocate and I respect her dearly. She has an amazing and supportive husband and family,” Gileno said in an email.  

‘The Very Last Straw’

Stewart eventually resigned because she was unhappy with decisions being made by Hemmenway and the rest of the board. A redacted version of Stewart’s resignation letter was posted on her blog, in which she complained about being “left in the dark” and not knowing “where money is going or where it comes from.”

“The very last straw for me was when the Interim CEO & the rest of the Board, contemplated not telling the USPF ‘In-person’ support group leaders that they were no longer covered by insurance. I was the only Board member who said that I’d have no part of that,” wrote Stewart, who did not respond to a request for comment from PNN for this story.

Hemmenway also did not respond to a request for comment. In a statement last December, she said that Gileno “repeatedly misled and concealed information from the Board of Directors and staff.”

Gileno maintains that he kept the board informed.

“They are trying to cover their asses for being (an) inadequate board I guess,” Gileno told PNN last year. “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.”

Whether the board knew about the misuse of funds or not, nonprofit experts say board members have a fiduciary responsibility to provide oversight and know how money is being spent. 

“U.S. Pain board members claim they did not know about their former CEO’s misuse of funds. This, however, does not change the fact that they should have known, and are, in fact, required by law to have controls in place to ensure those funds are used for the benefit of its stakeholders,” says Stefanie Lee Berardi, a patient advocate and grant writer who worked in nonprofit management.

“Serving on a board of directors is a great opportunity to contribute your time and talent to non-profit organizations who are doing great work. However, you should know that when you accept that position, you have a legal responsibility to use good judgement when making decisions on behalf of the organization, to put the organization’s interests before your own, and to ensure the organization is legally compliant.”

Gileno remains under investigation by the Connecticut Attorney General’s office, which may seek a court order to prevent him from ever serving again as a nonprofit officer or director.

Under state law, a Superior Court Judge could remove non-profit directors “engaged in fraudulent or dishonest conduct or gross abuse of authority or discretion,” but no such action against U.S. Pain appears likely.

“As much as we would like to have seen their entire board ousted, the truth of the matter is that the only way that happens is if the state shuts them down. So far, with the completion of their audit, they have likely done enough to satisfy the state,” said Berardi, who thinks U.S. Pain should find new directors and officers to manage the organization. 

“If we are looking at best practices for board management, they absolutely should have a comprehensive plan for recruitment, induction, development, and succession. These board functions should be enumerated in the bylaws, updated at regular intervals, and formally adopted,” she said. “Recruiting ‘new blood’ should just be regular order.” 

(Update: On October 1, 2019 U.S. Pain announced the appointment of Shawn Dickens to its board of directors, filling the seat vacated by Suzanne Stewart nearly a year earlier.)

At one time, U.S. Pain claimed to be the nation’s largest pain patient advocacy group, with over 90,000 members and nearly a quarter of a million social media followers. It was a dubious claim, as the non-profit later admitted having only 15,000 people on an email subscriber list.  

According to the audit and U.S. Pain’s 2018 tax return (the organization’s 2016 and 2017 returns were delinquent and filed late), the charity spent over $1.2 million last year on salaries, employee benefits, lawyers, accountants, tax penalties and business losses – including a failed attempt to operate a bakery.

Should Heroin Be Used to Treat Addiction?

By Pat Anson, PNN Editor

Some Canadian doctors are using novel approaches to treat opioid addiction, everything from safe injection sites to opioid vending machines to prescription heroin.

A new proposal would take the concept a step further by establishing the first clinical guideline for using hydromorphone and pharmaceutical grade heroin to treat people with severe opioid use disorder. The idea is to provide a safer supply to opioid addicts who currently use illicit heroin, counterfeit pills and other street drugs, which are often laced with fentanyl.

"Offering injectable opioid treatments is an effective way for clinicians to address the toxicity of the fentanyl-adulterated drug supply and help people achieve stability so they can focus on other aspects of their lives to get well, such as housing, employment, and connecting with family," says Dr. Christy Sutherland, Medical Director of PHS Community Services Society in Vancouver, BC.

Sutherland is one of the co-authors of the guideline, which is published in the Canadian Medical Association Journal. In 2018, nearly 4,500 Canadians died from opioid overdoses, with about 75% of the deaths involving fentanyl, a synthetic opioid that’s become a scourge on the black market.

"Opioid use disorder is a public health emergency nationwide; unfortunately, resources for the treatment of opioid addiction have been scarce and guidelines outlining best practices for innovative treatments have been lacking. This guideline is a blueprint for health practitioners to step up and provide evidence-based care," says Dr. Nadia Fairbairn, British Columbia Centre on Substance Use and the University of British Columbia, Vancouver, BC.

Heroin is classified as a Schedule I controlled substance in the United States, making it illegal to prescribe. But pharmaceutical grade heroin (known as diacetylmorphine) is legal in Canada, UK and several other European countries.

Studies have found that heroin-assisted treatment is effective in treating opioid addiction in patients who have failed at other treatment methods, such as methadone.

Under the proposed guideline, injectable heroin (diacetylmorphine) and hydromorphone (Dilaudid) could be used to treat severe opioid addiction in patients who do not respond to oral medication or use illicit injectable opioids.

It would be up to each Canadian province to decide whether to adopt the guideline.

Pharmaceutical heroin and safe injection sites are controversial issues in the U.S. But a recent analysis by the RAND Corporation advocates their use to combat opioid addiction.

“Given the increasing number of deaths associated with fentanyl and successful use of heroin-assisted treatment abroad, the U.S. should pilot and study this approach in some cities,” said Beau Kilmer, co-director of the RAND Drug Policy Research Center. “This is not a silver bullet or first-line treatment. But there is evidence that it helps stabilize the lives of some people who use heroin.”

What About Pain Patients?

Pain patient advocates in Canada were taken aback by the proposal to liberalize the use of heroin to treat opioid addiction. Opioid pain medication is increasingly difficult to obtain in Canada, as it is in the United States, because of restrictive guidelines.

“It is indeed shocking. Pain patients continue to be marginalized, stigmatized, ignored and left to suffer,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada.  “I do think it is ridiculous to say opioid use disorder is a public health emergency. The population they are addressing no doubt has to be addressed, but in terms of numbers it is minuscule to those suffering pain, yet the number of dollars expended for both is just out of whack.

“People suffering pain cannot obtain help or even maintain access to medication they have been stable on for years. Something is sadly wrong. What is a public health emergency is the epidemic of undertreated chronic pain. They should get their blinders off. We have well over 1 million Canadians suffering from high impact pain, yet they are pretty much marginalized.”

One of those Canadians is Dan Wallace, a retired military veteran and police detective who lives with chronic knee and shoulder pain.

“I applaud the efforts made and others that are contemplated for the near future that would allow those who are addicted to obtain legally prescribed heroin that would keep them from the tainted street drug supply,” Wallace said. “Where I have a problem is with the complete dismissal of medical care to the many legacy patients who were previously prescribed opioids to manage their pain.”

Wallace used opioid medication for over 20 years before being tapered. He now has trouble walking and sleeping because of what he calls “a tortuous and cruel degree of pain.”

“I and others like me aren’t looking for a handout of free heroin because we haven’t been able to control ourselves and have become addicts. No one deserves to be treated like throw-away patients yet pain patients are just that. Why is it that their lives matter while simultaneously ours do not?” Wallace asks.

“I have never abused any substance in my life. Does my suffering ever help a single person who will now be getting prescribed heroin so they don’t have to buy illegal street drugs? Health Canada should be deeply ashamed at the needless suffering, disability, and deaths of pain patients they have caused.”