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.

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.

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.

The Opioid Risk Tool Has Been Weaponized Against Pain Patients

By Dr. Lynn Webster, PNN Columnist

I was surprised and deeply disappointed to learn this week that people have been denied opioid prescriptions due to their responses on the Opioid Risk Tool (ORT).

As a guest on the DPP Rally Talk Show with Claudia Merandi, I heard from a caller who told me that her doctor denied her an opioid prescription based on her ORT answers.

One particular answer seems to have caused the caller’s problem: She acknowledged her history of experiencing preadolescent sexual abuse. Apparently, the doctor used that as a reason to deny her access to opioid medication to treat her pain. This is a terrible misapplication of the tool.

The ORT is a self-assessment tool I developed and published about 15 years ago. It was developed at a time when we didn’t know the rate of opioid abuse in patients who were prescribed an opioid for noncancer pain. We needed a tool to help evaluate whether the risk of potential harm from opioids outweighed the good.

I never intended for doctors to use the ORT to determine who should or shouldn’t be prescribed an opioid. My goal was to help doctors identify patients who were at increased risk of misuse and addiction, so that they could receive more careful observation during treatment.

Since abuse and addiction are diagnosed by observing atypical behaviors, knowing which patients are at greatest risk for displaying those behaviors is useful in establishing appropriate levels of monitoring for abuse.

I was not alone in the belief that it was critical to assess patients for their risk potential.

In 2009, the American Pain Society and American Academy of Pain Medicine published a guideline for opioid prescribing. Its first recommendation stated: “Prior to initiating COT (chronic opioid therapy), clinicians should conduct a history, physical examination, and appropriate testing, including an assessment of risk of substance abuse, misuse, or addiction.”

Then, in 2016, the Centers for Disease Control and Prevention’s opioid-prescribing guideline recommended that “before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms.”

Several other opioid prescribing guidelines also recommended assessing patient risk before initiating therapy. These included the Washington State Department of Health, Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain, the American Society of Interventional Pain Physicians (ASIPP) Opioid Guidelines, and others.

Risk Factors for Opioid Abuse

Assessing the risk of developing opioid abuse is based on genetic and environmental factors, just as it is with other diseases. Accordingly, the ORT includes questions about family and personal history of substance abuse, since both areas contribute to genetic and environmental factors. 

Genetics are estimated to contribute between 50 to 60% of an individual's vulnerability to opioid addiction. By contrast, genetics contribute only about 30% to a person's vulnerability to marijuana.

A person with one addiction is seven times more likely to develop an addiction to a different class of drugs, so genetics plays a major role in determining who will and who will not develop an opioid use disorder (OUD). Additionally, life experiences -- which are part of one’s environment -- also play a role.

The ORT asks if there is a history of experiencing preadolescent sexual abuse. Studies indicate that preadolescent sexual abuse is believed to result in something clinically similar to post traumatic stress disorder (PTSD).

The National Institute of Drug Abuse (NIDA) has reported that 30 to 60% of women who are undergoing drug abuse treatment suffer from PTSD. One treatment center in New York City reports that more than 90% of women treated for substance abuse had experienced sexual or traumatic abuse. 

According to another NIDA report, victims of rape were 10 times more likely to have abused heroin and other stimulants than the general population. A study in 2000 also showed that a history of preadolescent sexual abuse tripled the risk of drug use disorders.

Many other studies have corroborated these studies, showing that preadolescent sexual abuse is a risk factor for substance abuse later in life. The most important of these is the seminal CDC-Kaiser Permanente Adverse Childhood Experience Study.

A Cruel Misapplication of ORT

Environmental and genetic factors should influence how closely a patient's opioid use is monitored. However, a history of experiencing preadolescent sexual abuse does not mean a person will necessarily develop an OUD. It is only a risk factor. It does not determine the outcome of using opioids, although it may partially indicate the level of monitoring, support, and education that would be appropriate.

It is a cruel misapplication of the ORT to use a background of sexual abuse as the only criterion to assess whether a patient should receive opioid therapy. The ORT is an important tool in mitigating harm that prescribing opioids could cause. It should not be weaponized to justify denying people in pain appropriate therapy. 

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. 

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.

Acetaminophen Linked to Hyperactivity and Behavior Problems in Children

By Pat Anson, PNN Editor

A new study is adding to the growing body of evidence linking maternal use of acetaminophen to hyperactivity and other behavioral problems in children. Acetaminophen – which is more commonly known as paracetamol outside the U.S. – is the world’s most widely used over-the-counter pain reliever.

British researchers have been following over 14,000 children born in 1991 and 1992 who are enrolled in the Avon Longitudinal Study of Parents and Children. The children’s health, cognitive skills, temperament and behavior were regularly evaluated as they grew older.

Children with mothers who regularly used acetaminophen in mid to late pregnancy were more likely to be hyperactive, less adaptable and to have conduct problems in their pre-school years. The attention and hyperactivity issues appear to lessen by age 7, although boys exposed to the drug were more likely to have conduct problems until age 9.

“We have shown that paracetamol consumption between 18 and 32 weeks gestation was associated with adverse trends in pre‐school child behaviour, but the associations were no longer present by the end of primary school (age 10‐11 years). Boys appeared to be more susceptible than girls to possible behavioural effects of the drug,” researchers reported in the journal Paediatric and Perinatal Health.

Acetaminophen is used by over half the pregnant women in the United States and European Union. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications.

Previous studies have linked maternal use of acetaminophen to asthma, autism and attention deficit disorder (ADHD) in children, as well as early puberty and slow language development in girls.

“Our findings add to a series of results concerning evidence of the possible adverse effects of taking paracetamol during pregnancy such as issues with asthma or behaviour in the offspring,” said lead author Professor Jean Golding of the University of Bristol.

“It reinforces the advice that women should be cautious when taking medication during pregnancy and to seek medical advice where necessary.”

Despite the findings, the UK’s National Health Service (NHS) maintains that it is “usually safe” for pregnant women to use paracetamol.

“Paracetamol has been used routinely during all stages of pregnancy to reduce a high temperature and for pain relief. There's no clear evidence it has any harmful effects on an unborn baby,” the NHS says on its website.

The FDA’s warning label for acetaminophen cautions people about the risk of liver damage and other side effects, but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

Mother Who Lost Son to OxyContin Vindicated by Purdue Settlement

By Mark Kreidler, Kaiser Health News

In the 15 years since she lost her son to a single OxyContin pill, Barbara Van Rooyan has had but one up-close look at the people representing the company that made it.

It was in a small courthouse in Abingdon, Va., where Van Rooyan and other relatives of OxyContin victims gathered for a sentencing hearing in 2007. Three executives of Purdue Pharma had pleaded guilty to federal charges related to their misbranding and marketing of the powerful opioid. The company had pleaded guilty as well.

Van Rooyan and the others in her group spoke during the sentencing, giving voice to their grief and their pain. They wanted the executives sent to jail for knowingly expanding an opioid crisis fast engulfing the country.

Instead, Purdue paid fines totaling $634 million. The executives served no time. The company was allowed to continue aggressively marketing its product, and the following year, sales of OxyContin reached $2 billion.

From 1999 to 2017, more than 700,000 people in the U.S. died of drug overdoses, according to the Centers for Disease Control and Prevention. In 2017, nearly 68% of the more than 70,000 recorded overdose deaths involved opioids, mostly illicit opioids such as fentanyl and heroin.

“I never really thought a whole lot about evil before this all happened,” Van Rooyan said recently, seated on a couch in the living room of her Irvine, Calif., home. “But to see this kind of malevolence or disregard for human life — I don’t know what else to call it but evil.”

The outcome in that Virginia courthouse was a far cry from last week’s news of a tentative mass settlement of many of the 2,000-plus lawsuits against the company, which could total upward of $12 billion and result in Purdue’s dissolution.

The potential settlement amount would include $3 billion from the Sackler family, owners of Purdue, whose fortune is estimated at $13 billion. The family has amassed that money over the past two decades, largely by selling OxyContin, an opioid painkiller.

‘The Lid Is Off’

Van Rooyan’s Purdue experience is a story of deception, sadness and frustration — yet when she tells it now, she emits a surprising spark of energy. That’s because Van Rooyan, part of the unlikely group of citizens who repeatedly took flailing swings at Purdue Pharma, is watching the giant fall.

Van Rooyan, who has studied the cases against Purdue closely, sees the paradox in the proffered settlement: Much of the payout would be financed by profits from the continued sale of OxyContin, under a new company that would be formed following a Chapter 11 bankruptcy.

But in some regard, she said, Purdue Pharma’s complicity in the opioid crisis has finally emerged into the general public’s view. “The world really knows now. They get it,” she said. “The lid is off, and all this stuff is bubbling out.”

That wasn’t the case on the night of July 4, 2004, when Van Rooyan and her husband, Kirk, got the call that changed their world. Barbara, then a professor of counseling at Folsom Lake College near Sacramento, was told that her son, Patrick Stewart, lay in a San Diego hospital, in a medically induced coma from which he was unlikely to emerge.

Patrick, a graduate of Oak Ridge High School in El Dorado Hills, Calif., and San Diego State University, died at age 24.

His friends told Barbara they had attended an Independence Day party at which someone offered her son an OxyContin pill, telling him it “was kind of like a muscle relaxant and it was FDA approved, so it was safe,” she said. Patrick, who had also consumed a couple of beers, was opioid intolerant and suffered respiratory failure in his sleep.

Barbara Van Rooyan holds picture of her son, Kirk

“At the time,” Van Rooyan said, “all I knew about Oxy was that Rush Limbaugh had been addicted to it.”

She was about to learn a lot more.

OxyContin Abuse

Van Rooyan channeled her grief through intense research into Oxy’s vast potential for damage despite the company’s sales pitches to the contrary. A slow-release pain treatment with a heavy dose of the narcotic oxycodone, it could be easily crushed or dissolved for a more intense and addictive high. Rampant abuse already had begun to be reported, particularly in the Appalachian area, author Beth Macy wrote in her national bestseller “Dopesick.”

Later in 2004, Van Rooyan found Ed Bisch, a Philadelphia man who had begun a website to expose Oxy abuse in the wake of his teenage son’s death. The following year, Van Rooyan and her husband, a plastic surgeon, petitioned the Food and Drug Administration to require that OxyContin be made more abuse-resistant, and that its use be strictly limited to severe pain.

“This was an exhausting process, which she and Kirk did as a labor of love to try to save others,” Bisch recalled.

Van Rooyan became the California arm of a grassroots movement known as RAPP — Relatives Against Purdue Pharma. The group, originally just four in number, protested at physician meetings funded by pharmaceutical companies and testified before Congress. Van Rooyan enlisted the help of U.S. Sen. Dianne Feinstein (D-Calif.), who wrote the FDA on her behalf and later sent Van Rooyan a letter of commendation.

But most members of Congress did not reply to Van Rooyan’s letters, she said. The FDA said its review needed more time — which turned out to be eight years. By then, Purdue already had reformulated OxyContin to make it more abuse resistant and to renew its patent, but the FDA declined to restrict its use to managing severe pain.

Van Rooyan pressed on, but for a long while, the opioid crisis felt to her like a topic hiding in plain sight. And fighting Purdue while still grieving the loss of son Patrick was taking a toll.

“Her determination was tireless,” Bisch said, “but eventually the frustration burned us out.”

And then came the turn.

A rash of high-profile opioid overdoses and deaths, from actor Heath Ledger to Tom Petty to Prince, put the topic squarely in the public eye — and 15 years after the death of Van Rooyan’s son, Purdue Pharma and other drugmakers were suddenly on the run.

(Editor’s note: Ledger, Petty and Prince all died from a lethal mix of opioids and other drugs that were apparently obtained on the street.)

Wants Purdue Settlement Spent on Treatment

Van Rooyan tracks every development related to Purdue, including a lawsuit in New York that alleges members of the Sackler family have been offloading their fortunes into private or offshore accounts to shield them from a settlement.

But she’s not out for vengeance. Her goals have changed.

“Do I want the records to be public? Do I want these people to have their business shut down? Yes, I do,” she said. “But more than vindictiveness, I want that money of theirs to go to treatment and rehab. If that happens, something good can come out of it.”

If she has a regret, it is that the case in Virginia ended in 2007 with no more than a fine. “If that result had been different — if people had gone to jail — it could have changed the trajectory of this,” she said.

Ana Venegas for KHN

But momentum finally appears to be gathering, and Van Rooyan finds herself identified as one of the trailblazers of the anti-OxyContin movement. She spends little time dwelling on that. Instead, she quotes her younger son, Andrew, who told her, “We didn’t want any of this — this is just the hand we were dealt. We need to play the cards the best we can.”

“She’s just a really strong person,” said Kirk Van Rooyan, who has been with Barbara throughout the ordeal, though he is not Patrick’s biological father. “There have been times when I’d think to myself, ‘How would I be doing if I were in her shoes?’ And the answer usually is, ‘Not as well as she’s doing.’”

Van Rooyan, a longtime artist, now spends much of her time volunteering with veterans in Orange County, Calif., helping them get back into the workforce and using art therapy to help them express themselves.

The art is special to Van Rooyan, she said, because it is part of what saved her in the aftermath of her son’s death.

“Patrick was the one who suggested I take my first class,” she said. After a few delays, she finally enrolled. It was about a month before that Fourth of July in 2004.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Stop Demonizing the ‘Holy Trinity’

Lynn Kivell Ashcraft, Guest Columnist    

If we are to have any hope of a rational, scientific discussion about the issues involved in both pain management and addiction treatment, we need to end patient shaming and the use of sensational language that has no basis in clinical practice.

First on my list is to stop using the term “Holy Trinity” when referring to the use of multiple medication classes to manage pain. It is a sensational propagandizing use of terminology that has no place in any meaningful clinical discussion.

Holy Trinity was a term coined by law enforcement when discussing the behavior of addicts. The original Holy Trinity – the so-called “Houston Cocktail” -- referred to the simultaneous ingestion of the short acting drugs hydrocodone (Vicodin), alprazolam (Xanax) and carisoprodol (Soma) by addicts. Other combinations of opioids, muscle relaxants and anti-anxiety drugs such as benzodiazepines are also used.

“The cocktail is commonly known on the black market as the ‘holy trinity’ and is particularly sought-after by addicts, but is also particularly dangerous,” is how the DEA describes the drugs in criminal complaints, search warrants and training guides.  

SOURCE: DEA TRAINING GUIDE

Taken together, the three drugs can be risky and cause respiratory depression, overdose and death. But when used under medical supervision, they enable individuals with painful and disabling conditions to improve their quality of life and restore bodily functions.

Holy Trinity was never used originally to refer to any medication combination prescribed by physicians caring for pain patients. But with the advent of the opioid crisis, the term is being used as a scare tactic by law enforcement and even some medical providers to deny patients a combination of medications previously used successfully.

The unintended consequence of this careless usage has been the deaths and needless renewal of pain and disability for patients who were being safely prescribed these medications.  

There is no one-size-fits-all treatment for chronic severe centralized pain. In fact, the current Pain Management and Dosing Guide from the American Pain Society lists opioids plus other central nervous system depressants and valium (a diazepine) as potential treatments for neuropathic pain.

It is well acknowledged that successful treatment often requires polypharmacy regimens tailored to the needs of individual patients to achieve pain relief and provide quality of life. The potential risks of using multiple medications can be reduced by prescribing both long-acting forms of these drugs and by directing patients to take them separately. 

To use the Holy Trinity as an inflammatory term is to demonize certain medications that have been abused by addicts while being used successfully by intractable pain patients. The use of this derogatory term has caused the undeserved transference of the deeply held negative societal bias against “addicts” onto some of the frailest and medically complex patients, many of whom are struggling to achieve some quality of life. 

According to the CDC, about 20 percent of adults in the U.S. have chronic pain and 8 percent have severe “high impact” chronic pain that frequently limits their life or work activities. The 2011 Institute of Medicine report puts the number of Americans with pain at 100 million, which is more than those living with diabetes, heart disease and cancer combined.

The difference between the two reports highlights some of the issues with using and understanding statistics.  However, no matter which report you use, both numbers represent a staggering number of Americans living in pain who deserve effective treatment.

Let’s lose the term Holy Trinity and allow doctors to prescribe whatever medications they deem necessary for the restoration of function and the relief of pain in their patients. Name calling and the use of disrespectful terminology doesn’t solve either the problem of addiction or the problem of pain.

Lynn Kivell Ashcraft is an Analytic Software Consultant and writer who lives in Arizona. Lynn has lived with chronic intractable pain for almost 30 years and works with Dr. Forest Tennant as part of the Arachnoiditis Research and Education Project. 

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

Overdoses Linked to Fake Pain Pills Draw Little Attention

By Pat Anson, PNN Editor

A mysterious lung illness linked to marijuana vaping has drawn nationwide attention this week. The CDC said there were 6 confirmed deaths and 380 cases of the illness, which one doctor warned was “becoming an epidemic.”

Even the White House has gotten involved in the vaping crisis, with President Trump calling for a ban on flavored e-cigarettes. “People are dying with vaping,” Trump said.

Meanwhile, an even more deadly health crisis continues to spread, drawing relatively little attention from the nation’s media and federal officials. Counterfeit blue pills made with illicit fentanyl are killing Americans from coast to coast.

This week, health officials in California’s Santa Clara County announced that 9 fatal overdoses have been linked to counterfeit oxycodone pills since January, including the recent deaths of a 15 and 16-year old.  

Local law enforcement has seized a large number of the blue tablets, which have an “M” stamped on one side and a “30” on the other side. They are virtually indistinguishable from real oxycodone.

“The extent of circulation of these fake pills is unknown; however, they had been consumed by several of the people who died,” Santa Clara Public Health Director Sara Cody, MD, said in a statement. 

“Many opioid pills, which are made to look like real prescription medications, are now made by counterfeiting organizations. These pills are not prescribed, stolen, or resold by or from verified pharmaceutical companies, and there is no connection between their appearance and their ingredients. Many patients may not be aware of the risks of taking a pill that does not come directly from a pharmacy.”  

Mexican Oxy

The overdoses in Santa Clara County are not an isolated situation. Over 700 miles away, the Yakima County Coroner’s Office in Washington State warned that three recent deaths involved fake oxycodone pills with the same distinctive markings. Yakima is used as a major distribution center by Mexican drug cartels.

"Most of the time it comes from Mexico, but we haven't been able to pinpoint exactly which batch it's from and who is actually dealing it," said Casey Schilperoort, a spokesperson for the Yakima County Sheriff's Office.

Known on the street as “Mexican Oxy,” the pills were also found at the scene of four fatal overdoses near San Diego over the summer.  Ports of entry near San Diego are major transit points for counterfeit oxycodone smuggled in from Mexico. The pills are usually transported in vehicles, often by legal U.S. residents acting as couriers. They sell on the street for $9 to $30 each and have spread across the country.

In February, New York City police announced the seizure of 20,000 fake oxycodone pills. Overdose deaths in New York City are at record levels and fentanyl is involved in over half of them. Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

This week federal prosecutors in Cleveland indicted ten people for trafficking in fake oxycodone and other illegal drugs. The leader of the drug ring, Jose Lozano-Leon, allegedly directed operations using a cell phone smuggled into his Ohio prison cell.

Prosecutors say Lozano spoke frequently with the co-defendants and others to arrange drug shipments from Mexico to northeast Ohio. The ring allegedly specialized in counterfeit oxycodone.

"In Ohio and other parts of the country, we are seeing an increase in these blue pills that at first glance appear to be legitimately produced oxycodone, but in fact are laced with fentanyl,” said DEA Special Agent in Charge Keith Martin.

Ironically, the indictments were filed in the same federal courthouse where a major lawsuit against opioid manufacturers and distributors is expected to get underway next month.  

One in Four Adults in England Take Addictive Meds

By Pat Anson, PNN Editor

Nearly 12 million people – about one in four adults in England -- are taking addictive prescription drugs to treat depression, anxiety, insomnia or chronic pain, according to a new review by Public Health England (PHE).

The review takes a cautionary view on the use of five drug classes – opioids, antidepressants, benzodiazepines, gabapentinoids, and so-called “z-drugs” such as zolpidem, zopiclone and zaleplon.

“The medicines we looked at help to make millions of people every year feel better and recover from their illness. Doctors can prescribe them because there is good evidence that they work, but they do have some risks,” the PHE report found.

Benzodiazepines, z-drugs, opioids and gabapentinoids are associated with dependence and withdrawal, while there’s a risk of withdrawal with antidepressants. When the drugs are taken in combination or in high doses, there is also risk of respiratory depression and overdose.  

About half the patients prescribed the drugs in England had been taking them for at least a year — a sign of dependence. But the report cautions doctors not to abruptly discontinue the drugs and to taper them gradually, if at all.

“There is a view that a sub-population of chronic pain patients can be prescribed long-term opioids at relatively stable doses so that their analgesia and functioning can be maintained with good adherence and tolerable side-effects,” the report found.

“We do not want to put anyone off safely using medicines that could help them. Stopping or limiting the use of medicines could also cause harm, including increasing the risk of suicide or making people try to get medicines or illegal alternatives from less safe sources, such as illegal websites or drug dealers.”

Increasing Use of Antidepressants and Gabapentinoids

Antidepressants were prescribed to about 7.3 million people in England or 17% of the adult population. Opioids were prescribed to 5.6 million patients, followed by gabapentinoids (1.5 million), benzodiazepines (1.4 million) and z-drugs (1 million). Prescriptions for opioids, benzodiazepines and z-drugs are dropping, while the use of antidepressants and gabapentinoids is growing. 

Gabapentinoids such as pregabalin (Lyrica) and gabapentin (Neurontin) were originally developed to treat epilepsy, but the drugs are increasingly prescribed in the UK to treat neuropathy and other types of chronic pain. PHE researchers found only marginal evidence that they are effective for pain and alarming signs that they are being misused. 

“Gabapentinoids have come to be used for a wider range of indications than is supported by the evidence or their licensing, and they have sometimes been prescribed in place of opioids or benzodiazepines in the likely-mistaken belief that they are less liable to misuse or dependence, and lack of awareness of the withdrawal problems that can arise when prescribing is stopped,” the report said. 

Prescriptions for opioids and gabapentinoids were 1.6 times higher in parts of England with more poverty. People in poor areas are also more likely to be prescribed medicines for longer periods. Prescription rates for women are about 1.5 times higher than for men. Prescription rates also increased with age.

DEA Proposes More Cuts in Rx Opioids

By Pat Anson, PNN Editor

For the fourth consecutive year, the U.S. Drug Enforcement Administration is proposing steep cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances.

In a notice published today in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 19 percent and oxycodone by 9 percent in 2020. The supply of hydromorphone, oxymorphone, and fentanyl would also be cut.

“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” acting DEA Administrator Uttam Dhillon said in a statement.

“DEA takes seriously its obligations to both protect the public from illicit drug trafficking and ensure adequate supplies to meet the legitimate needs of patients and researchers for these substances.”

In setting annual production quotas for controlled substances, DEA considers various factors such as medical need, estimates of retail consumption based on prescriptions, and forecasts from opioid manufacturers. Added to the mix this year is diversion.

The five opioids being cut are subject to special scrutiny under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which was signed into law by President Trump on October 24, 2018. The law requires DEA to estimate the amount of diversion of the five opioids and “make appropriate quota reductions.”

The agency estimated that 57 kilograms – about 125 pounds – of oxycodone were diverted or stolen in 2018, along with 24 kilograms (53 pounds) of hydrocodone. There was diversion of relatively small amounts of fentanyl, hydromorphone and oxymorphone last year.   

Cuts Began in 2016

The DEA first began cutting the supply of opioids in 2016 during the Obama administration and the trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

If approved, the 2020 production quotas would amount to a 60 percent decrease in the supply of hydrocodone since 2016 and a 48 percent cut in the supply of oxycodone.

While overdoses involving prescription opioids have been declining, they’ve been offset by a growing number of deaths attributed to illicit fentanyl, heroin and other street drugs. “Mexican Oxy” – counterfeit oxycodone pills laced with fentanyl – are being trafficked throughout the United States and are blamed for overdoses from New York City to San Diego.

In addition to the five opioids, the DEA is setting production quotas on more than 250 Schedule I and II controlled substances. The agency is proposing to increase the amount of marijuana that can be produced for research by almost a third, from 2,450 kilograms in 2019 to 3,200 kilograms -- almost triple what it was in 2018. The increase reflects growing interest in marijuana research.

Public comments on the DEA proposal will be accepted until October 10. To make a comment online, click here. The agency will publish another notice later in the year on its final decision and begin informing drug manufacturers of their quota allotment.

Kolodny Clarifies His Conflicts of Interest

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has revised his conflict of interest statements for two articles he co-authored in the Journal of the American Medical Association (JAMA) to include his work in malpractice lawsuits involving opioid medication.

Kolodny, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), is a longtime critic of opioid prescribing. He recently testified as the “star witness” for Oklahoma in its opioid negligence lawsuit against Johnson & Johnson, a case the state won with a $572 million judgement against J&J.

“I am writing to provide additional information to clarify conflict of interest disclosures in 2 articles I published in JAMA in 2017 and 2018.  During this time, I received compensation for work as an expert in malpractice litigation involving opioid prescribing,” Kolodny wrote in a Sept. 4 letter to JAMA’s editors.

“When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”

The two JAMA articles in question, which were co-authored by former CDC director Thomas Frieden, MD, both dealt with the opioid crisis and the federal policy response to it.

JAMA disclosure policy is very clear and requires authors to list “all relevant financial interests, activities, relationships and affiliations,” including payments for employment, consultancies and expert testimony.

During the Oklahoma trial, Kolodny admitted under questioning by J&J lawyers that he was being paid $725 an hour by Nix Patterson & Roach, one of three law firms hired by Oklahoma to handle the case against J&J. Kolodny anticipated being paid up to $500,000 by the end the Oklahoma trial.

“I don’t think it should be a secret that I’m being compensated,” he said.  

Kolodny also acknowledged working for the law firm of Cohen Milstein Sellers & Toll in a similar capacity, also for $725 an hour. Cohen Milstein is heavily involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois. 

Kolodny’s work in opioid litigation was disclosed in the April 2018 JAMA article.

DR. ANDREW KOLODNY

His revised disclosure statement for that article is vague, stating that he worked as “a medical expert for states and counties that have filed suits against opioid manufacturers and as an expert witness in malpractice cases involving opioid prescribing.” It does not identify which states, counties and law firms he worked for or what companies were being sued. 

JAMA policy calls for “complete disclosure of all potential conflicts of interest” covering a three-year period prior to an article being submitted. If an author received funding from the pharmaceutical industry, for example, he or she would be expected to identify the company involved.   

“It is encouraging that Dr. Kolodny has recognized that his very profitable work supporting plaintiffs in opioid lawsuits might constitute a conflict of interest when he writes about opioid policy and clinical practice,” said Bob Twillman, PhD, a healthcare policy consultant and former Executive Director of the Academy of Pain Management. “Of course, these aren't the only two articles Dr. Kolodny has co-authored, and he has done numerous presentations at professional meetings as well, so I wonder if he will seek to correct all the rest of those relevant disclosure statements.

“I think it's also interesting that, when I disclose my conflict, I am always required to specifically name the entity involved, yet Dr. Kolodny names neither the jurisdictions nor the law firms for which he was working. It seems a little like a double standard to me, and I wonder how the editorial boards of the relevant journals feel about that.”

In March 2017, Kolodny co-authored a research letter in JAMA Internal Medicine on a study he designed that looked into funding that patient advocacy groups and professional organizations received from opioid manufacturers. Many of those organizations publicly opposed the CDC’s controversial opioid prescribing guideline, which Kolodny and other PROP members helped draft.

“The CDC did not prompt or require organizations to disclose their financial associations as part of their comments. Disclosure, however, is one means of managing conflicts of interest,” Kolodny and his co-authors wrote. “Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

Kolodny’s disclosure statement for the 2017 article states that he was a member of PROP and Chief Medical Officer for the addiction treatment chain Phoenix House (which he has since left). It makes no mention of his work in opioid litigation or malpractice lawsuits, which may have begun at a later date.

Lucrative Sideline

Kolodny is not the only critic of opioid prescribing to develop a lucrative sideline as a medical expert or paid witness. Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive healthcare marketing practices, has also been paid handsomely for her testimony.

In August, Fugh-Berman testified in California that she was paid $500 an hour for her work in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case, according to Northern California Record.

Fugh-Berman has written several op/eds claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were part of a “coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline.”

Fugh-Berman discloses on PharmedOUT’s website that she is a paid expert witness, but she won’t say who funds her organization.

“(We) are funded primarily by individual donations, mostly small donations but we have several major donors. We do not provide the names of our individual donors,” she said in an email to PNN.  

Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has also stoutly defended the CDC guideline and warned against excessive opioid prescribing.

“Most prescribing physicians feeding the opioid epidemic are well meaning, naïve, or just too busy to recognize the dangers,” he wrote in a physician guide for opioid prescribing published by Kaiser Permanente.

Over the past decade, Munzing has established a profitable career as an expert witness for the Medical Board of California, DEA, FBI and DOJ, working mostly on cases that involve doctors flagged for overprescribing opioids.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1.3 million in DOJ contracts since 2017 and is currently working on over two dozen DEA investigations.

After he left Phoenix House, Kolodny became the co-director of an opioid research program at Brandeis University that is funded with over $8.5 million federal grants, according to GovTribe.com.

The Visible Few Pain Patients

By Dr. Lynn Webster, PNN Columnist

I receive several emails a week from people who ask for help because their treatment options have been limited or eliminated. They are in terrible pain, and they don’t know what to do.

One such person, Sharon Berenfeld, MD, recently shared an experience she had visiting her doctor.

“Dr. Webster, I came across a publication of yours. It struck a nerve with me. My pain is intractable. I have tried everything,” she wrote. “Before the exam room door even closed, [my doctor] announced to me, ‘If you think I’m just here to refill your pills, you can leave now.'

"I left in tears. I was being judged and punished for having a complication from cancer treatment. I completely understand the opioid crisis. But I feel impotent to do anything."

Who Are the Visible Few?

Earlier this year, Fox News' three-part series, Treating America's Pain: Unintended Victims of the Opioid Crackdown, showed the terrifying circumstances of people in pain and doctors under siege. One individual’s decision to commit suicide as a result of the crackdown on opioid prescribing embodies the struggles of people in pain and their providers' inability to meet their needs.

The visible few are the small number of people whose stories have been heard by journalists, media consumers and government officials. Their stories reflect millions of Americans suffering from chronic pain who live in the shadows and are invisible to most of us. 

The needs of people in pain and the challenges providers face when treating them have been overshadowed by the government's attempts to deal with the opioid crisis. The well-intentioned CDC Guideline for Prescribing Opioids for Chronic Pain has affected 20 million Americans with severe disabling pain.

It also is having consequences for everyone else in the healthcare system. Prescription opioids have been demonized and blamed for our current drug crisis.

Unintended Consequences

The CDC guideline was supposed to be voluntary. However, in practice, the guideline has been treated as a policy with the strength of a law, and it has had severe unintended consequences. Many people are worse off in its wake. Here is a summary of the most substantial effects of the guideline.

• Providers feel pressured to reduce the amount of opioids that they prescribe, regardless of their patients' individual needs. About 70% of physicians have reduced their opioid prescribing or stopped it completely.

• Insurance companies set prescription limits based on the guideline. In some cases, they override physicians' recommendations. That means insurers, rather than doctors, are making decisions about how to treat pain.

• Pharmacy chains are also limiting the amount of opioids they dispense, based on the guideline rather than on doctors' prescriptions..

• The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services have set dosage limits. Providers advocating for patients who need higher amounts must navigate a complicated appeals process.

• State attorneys general have used the guideline to evaluate whether a doctor is prescribing for a legitimate medical purpose. Deviation from the guideline has been used to accuse doctors of criminal conduct.

• In a desperate search for pain relief, some patients have turned to street drugs.

Where We Are Now

The CDC guideline has left a trail of misunderstanding in its path. Its authors acknowledged misapplication of the guideline in the New England Journal of Medicine, emphasizing that their intention was to provide guidance rather than to establish a mandate.

"Difficulties faced by clinicians in prescribing opioids safely and effectively, growing awareness of opioid-associated risks, and a public health imperative to address opioid overdose underscored the need for the guidance,” they wrote.

In a separate article in the JAMA Network, the guideline's authors said, “The number of people experiencing chronic pain is substantial, with U.S. prevalence estimated at 11.2% of the adult population. Patients should receive appropriate pain treatment based on careful considerations of the benefits and risks of treatment options.”

There are other signs of recognition that the guideline has been misinterpreted. For example, CDC Director Robert Redfield, MD, wrote in a letter to Health Professionals for Patients in Pain (HP3), “The CDC is working diligently to evaluate the impact of the guideline and clarify its recommendations to reduce unintended harm.”

The American Medical Association's House of Delegates passed a series of resolutions on the guideline at an interim meeting in November 2018.

“Physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the morphine milligram level thresholds found in the CDC guidelines for prescribing opioids,” the AMA delegates said.

There is also some light being shined on the issue in a report by The Pain Management Best Practices Inter-Agency Task Force.

“There is no one-size-fits-all approach when treating and managing patients with painful conditions. Individuals who live with pain are suffering and need compassionate, individualized and effective approaches to improving pain and clinical outcomes. This is a roadmap that is desperately needed to treat our nation’s pain crisis,” said Vanila Singh, MD, task force chair and chief medical officer of the HHS Office of the Assistant Secretary for Health.

As the opioid odyssey continues, there are signs that the visible few are beginning to be heard. This is an important step to helping the invisible millions with chronic pain receive the care they deserve.

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.

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.

Outcomes Matter When Opioids Are Tapered

By Roger Chriss, PNN Columnist

The drug overdose crisis has led to a rethinking of pain management. Prescription opioids are now seen as risky medications with potentially serious side effects, including addiction and overdose. As a result, there is an increasing push to discontinue or taper patients on long-term opioid therapy.

A recent op/ed in the Annals of Internal Medicine by physicians Roger Chou, Jane Ballantyne and Anna Lembke claims there is “little benefit” from long-term opioid use and “many patients” would benefit from tapering. They even suggest that the use of addiction treatment drugs such as Suboxone should be expanded to include pain patients dependent on opioids.

“Evidence indicates that long-term opioid therapy confers little benefit versus nonopioid therapy, particularly for function. Opioid use disorder (OUD) occurs in a subset of patients, and quality of life may be adversely affected despite perceived pain benefits,” they wrote.

“We argue that achieving effective, safe, and compassionate tapers requires implementing and incentivizing tapering protocols, recognizing prescription opioid dependence as a distinct clinical condition necessitating treatment, and expanding the indication for buprenorphine formulations approved for OUD to include prescription opioid dependence.”

It should be noted Chou is one of the co-authors of the CDC’s controversial opioid prescribing guideline, while Ballantyne and Lembke are board members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). Ballantyne, who is president of PROP, was part of the “core expert group” that advised the CDC when it was drafting its guideline.

What Happens to Tapered Patients?

The goal of improving patient safety is admirable. However, there is relatively little data on what happens to patients during tapering or after opioids are discontinued. The evidence is mixed at best.

A 2018 review in Pain Medicine of 20 studies involving over 2,100 chronic pain patients found that most patients had less pain or the same amount of pain when tapering was completed. But the studies were not controlled and the evidence was of marginal quality, with large amounts of data missing.

A 2019 study in the journal Pain evaluated outcomes in 49 former opioid users with chronic pain. The findings showed that about half the patients reported their pain to be better or the same after stopping opioids, while the other half reported their pain was worse.

There are risks associated with tapering that also need to be considered, such as uncontrolled pain, suicide, overdose and early death. The tapering process itself can be extremely challenging and patient outcomes after discontinuation are not necessarily positive.

A recent study in the Journal of General Internal Medicine looked at what happened to chronic pain patients being treated at a large urban healthcare system in the year after they were tapered.

For about 5 percent of patients, “termination of care” was the primary outcome – a vague category that means there was no record of them seeking further treatment. Some of those patients may have miraculously gotten better and required no healthcare. And some may have died.

“These findings invite caution and demonstrate the need to fully understand the risks and benefits of opioid tapers,” the authors warned.

Another study in the same journal is also concerning. Researchers at the University of Washington followed 572 patients who were treated with opioids at a Seattle pain clinic. About 20 percent of the patients died, a high mortality rate, but the death rate was even higher for patients who were tapered. Seventeen of them died from a definite or possible overdose.

“In this cohort of patients prescribed COT (chronic opioid therapy) for chronic pain, mortality was high. Discontinuation of COT did not reduce risk of death and was associated with increased risk of overdose death,” the authors concluded.

"We are worried by these results, because they suggest that the policy recommendations intended to make opioid prescribing safer are not working as intended," said lead author Jocelyn James, assistant professor of general internal medicine at the University of Washington School of Medicine. "We have to make sure we develop systems to protect patients."

In other words, opioid discontinuation does not necessarily lead to better outcomes, as Chou, Ballantyne and Lembke suggest. The blind push to taper patients at all costs to reduce opioid prescribing can have tragic consequences — which no one seems to be tracking.

“Crucially, today’s opioid prescribing metrics take no count of whether the patient lives or dies. Data from two recent studies strongly suggest it is time to start counting. The sooner quality standards are revised in favor of genuine patient protection, the better,” says Stefan Kertesz, MD, an Alabama physician and researcher.

Outcomes matter. And they need to be reasonable for the patient. A person with a self-limiting condition like low back pain may well benefit from opioid discontinuation. But some patients with more chronic conditions do not get better, and their needs cannot go ignored.

The Canadian Psychological Association emphasizes caution and patient safety in a recent position paper on the opioid crisis:  “Tapering must always be done gradually under physician or nurse practitioner supervision, with the patient's consent, and with ongoing support and monitoring of pain and functioning, as well as management of withdrawal symptoms."

The use of prescription opioids should always take patient risks and benefits into consideration. It also requires knowing about outcomes when taking patients off opioids. At present there is too much interest in numbers and too little interest in people.

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.

Americans More Likely To Get Opioid Prescriptions After Surgery

By Julie Appleby, Kaiser Health News

Americans and Canadians are seven times more likely to fill a prescription for opioid pain pills in the week after surgery than Swedes, says a study published Wednesday, one of the first to quantify international differences.

More than 75% of patients in the U.S. and Canada filled a prescription for opioids following four common surgeries, compared with 11% of Swedes, researchers report in JAMA Network Open. Americans also received the highest doses of opioids.

So, are Americans and Canadians wimpier than Swedes when it comes to pain, or is something else going on?

“There are a lot of tough people in lots of places,” demurred Mark Neuman, an associate professor of anesthesiology at the University of Pennsylvania Perelman School of Medicine and a co-author of the study.

He pointed to a host of other potential factors, from cultural differences to variations in marketing, regulation and long-standing, ingrained prescribing habits.

“It’s possible that in the U.S. people think about opioids as pain relief in a drastically different way than in other places,” he said.

Researchers examined four types of surgeries — minimally invasive types of appendectomy and gallbladder removal, as well as arthroscopic surgery to repair a torn meniscus in the knee and breast tumor removal. All the surgeries occurred from 2013 to March 2016, a time of growing concern about opioid dependence in the United States but before more recent guidelines suggesting that fewer pills are needed following many common surgeries.

Even so, “for the same exact surgery, the same exact tissue trauma, we have seven times more people in the U.S. getting opioids,” said Neuman.

On average, patients in the U.S. filled prescriptions for about 33 pills, each equivalent to 5 milligrams of oxycodone, he said, although the type of drug varied. Swedes who filled prescriptions had an average of 26 pills, while Canadians had 22.

Canadians and Swedes were also far more likely to get codeine or tramadol — painkillers that rely on a different mechanism in the body and are considered weaker types of opioids. Americans were far more likely to get hydrocodone or oxycodone, some of which were heavily marketed to physicians by drugmakers. States and cities are currently suing manufacturers, alleging they misrepresented the drugs’ risks and didn’t properly monitor suspiciously large sales, contributing to the opioid crisis.

The study does not comment on the marketing aspect but did note two factors that might account for some of the difference in the types of drugs prescribed. One is that, during the research period, low-dose codeine was available over the counter in Canada. Tramadol is still not classified as a controlled substance there, although it has been a controlled substance in Sweden since 2007 and in the U.S. since 2014.

“While prescribers may view these so-called weak opioids as safer alternatives, data suggests that both codeine and tramadol have the potential for misuse and life-threatening adverse effects,” the study says.

The U.S. and Canada were chosen because they have the highest per capita consumption rate of opioids in the world. Sweden was picked as a European counterpoint because researchers could obtain detailed prescription information from databases there.

While the study was large — following about 129,000 patients in the U.S. with job-based insurance, 84,600 in Canada’s Ontario province and 9,800 in Sweden — it did have limitations. For one, researchers could not track how many pills patients actually took of those prescribed, or the number of patients who didn’t fill prescriptions they were given. Secondly, they don’t have data on how well patients felt their pain was controlled following surgery.

“It’s possible that in Sweden everyone’s pain treatment is less than in the U.S., although I think that is unlikely,” said Neuman, noting that other studies have shown that patients in the U.S. often do not take all the pills they’ve been prescribed following surgeries.

Fewer Pills Being Prescribed

In addition, for certain types of surgeries, patients do not report greater dissatisfaction when prescribed fewer pills after surgery. Researchers in Michigan, for example, recently reported on what happened after dozens of hospitals recommended new prescribing guidelines — drawn up after studying how many pills patients actually took — following certain surgeries. While recommendations were often for far fewer than 30 tablets, researchers found no increase in reported pain.

Like the group in Michigan, some academic medical centers and other experts have recently issued guidelines calling for fewer pills following many procedures. Those grew out of concern that patients with what is called acute pain — the kind following surgical procedures, for example — were given far too many pills.

An analysis of Medicare data by Kaiser Health News with researchers at Johns Hopkins Bloomberg School of Public Health, for example, found prescribing from 2011 to 2016 exceeded levels now recommended by organizations like Johns Hopkins. For example, Medicare patients took home 48 pills in the week following coronary artery bypass, 31 following laparoscopic gallbladder removal, 28 after a lumpectomy and 34 after minimally invasive hysterectomies.

According to postsurgical guidelines spearheaded by Johns Hopkins last year, those surgeries should require at most 30 pills for a bypass, and 10 pills for minimally invasive gallbladder removal, lumpectomy and minimally invasive hysterectomy.

Postsurgical opioid use can lead to long-term dependency in a small but significant percentage of patients, studies have shown, but unused pills can also be a danger. Those tablets can make their way to the street or fall into the hands of other family members.

Researcher Dr. Chad Brummett, who worked on the guidelines in Michigan, said he thinks prescribing amounts in the U.S. and Canada have likely dipped in recent years, given the increased attention. Still, he cautioned that the amounts likely remain too high in both countries and that the new study illustrates the wide disparity between North America and at least one European country.

“We know that marketing in the U.S. has affected prescribing in all domains, including surgery,” said Brummett. “This study and others show that [surgeons] in the U.S. and Canada can drastically reduce prescribing standards without adversely affecting patient care.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.