Feds Say Bankrupt Drug Lab Paid Millions in Kickbacks

By Pat Anson, Editor

A bankrupt drug testing lab with a checkered history has been linked to a large money laundering and pill mill operation in Tennessee.

According to an updated indictment in U.S. District Court in Knoxville, Confirmatrix Laboratory in Georgia and Sterling Laboratories in Seattle paid nearly $3 million in illegal kickbacks to have thousands of urine samples sent from patients at the Knoxville Hope Clinic (KHC). In return, the labs submitted false claims for urine drug testing to Medicare and TennCare, Tennesee’s Medicaid program.

“Confirmatrix, by and through its principals and agents, paid bribes and kickbacks to defendants Clyde Christopher Tipton and Maynard Alvarez in return for causing Medicare and TennCare beneficiaries from KHC to be referred to Confirmatrix for medically unnecessary drug screenings,” the indictment alleges.

“Medical providers at KHC prescribed opioids and other controlled substances to thousands of purported pain patients in exchange for grossly excessive fees. The vast majority of the prescriptions were unreasonable and medically unnecessary. Patients were required to keep follow-up appointments every 28 days to continue receiving their prescriptions. Providers at KHC ordered medically unnecessary Drug Screenings for every patient every 28 days.”

Tipton, Alvarez and six other defendants are accused of drug trafficking and money laundering in the long-running investigation of Tennessee pill mills. The ringleader of the pill mill scheme, a 53-year old grandmother named Sylvia Hofstetter, allegedly made millions of dollars while running clinics that prescribed 12 million opioid prescriptions. Prosecutors have alleged that at least nine patients at the clinics died from drug overdoses.

No one affiliated with Confirmatrix or Sterling Laboratories has been indicted so far in the case. Prosecutors say the   alleged kickbacks were paid from August 2013 to July 2016.

As PNN has reported, Confirmatrix filed for Chapter 11 bankruptcy last November, just two days after its headquarters near Atlanta was raided by FBI agents.  The company was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

A 2013 study by the Centers for Medicare and Medicaid Services (CMS) listed Confirmatrix as the most expensive drug lab in the country, collecting an average of $2,406 from Medicare for each patient tested, compared to the national average of $751. The bills from Confirmatrix were high because the company ran an average of nearly 120 different drug screens on each patient, far more than any other drug lab.

These and other abusive billing practices finally caused Medicare to lower its reimbursement rates for drug testing, which led to Confirmatrix’s financial problems.

Although it filed for Chapter 11 bankruptcy nine months ago, Confirmatrix remains in business and continues to bill patients and insurance companies for costly drug screens.

Some current and former patients at the Benefis Pain Management Center, a pain clinic in Great Falls, Montana, have received bills from a collection agency seeking well over $1,000 for drug screens that normally cost a few hundred dollars.

“Confirmatrix is out of network, hence I am stuck with the bill unless Benefis writes it off,” one patient told PNN. “I spoke to my insurance about it and they told me that there are labs in Montana that could have done the same thing and would have been covered by my insurance. She asked me, why they would go to a Georgia lab?”

In a statement to PNN in May, a Benefis official defended the clinic’s continued use of Confirmatrix, saying the company performs a valuable service and “waives many costs.”

“The company we have partnered with has an extensive patient assistance program, which is part of the reason they were selected. That company was selected two years ago because it was one of the few labs nationwide that offered quantitative and qualitative testing AND patient assistant programs,” said Kathy Hill, Chief Operating Officer at Benefis Medical Group.

Confirmatrix’s laboratory, office and warehouse space were recently put up for auction by the bankruptcy court under sealed bid.

An Inconvenient Footnote in the Opioid Crisis

By Roger Chriss, Columnist

The opioid crisis is now a national emergency. President Trump has instructed his administration “to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

The full strategy is not entirely clear. But so far, prevention, strict regulation and law enforcement are its core features. The Department of Justice recently announced the formation of its new Opioid Fraud and Abuse Detection Unit. The DEA has proposed a further reduction in opioid production quotas. And the FDA is working to reduce the flow of illicit fentanyl in the postal service.

Meanwhile, anti-opioid activist groups such as the Physicians for Responsible Opioid Prescribing (PROP) are pushing for stricter prescribing regulations and reduced prescribing levels.

As PROP stated in a letter to FDA Commissioner Scott Gottlieb, “Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control.”

Amid all this, people with persistent pain disorders are little more than an inconvenient footnote.

The evidence clearly shows that the opioid crisis is being driven primarily by illegal drugs. Time magazine reports that in a large national survey, 60% of those who reported misusing opioid medication did so without a prescription. “About 40% of these people accessed opioids free from friends or relatives. Among people who developed addiction or other abuse disorders, 14% said they bought them from drug dealers or strangers," Time said.

Moreover, people who are addicted to heroin rarely get their start with opioids prescribed for a valid medical condition. A study in JAMA Psychiatry found that heroin addicts often have a history of abusing opioid medication because “prescription opioids are much more readily available to younger individuals, particularly as an initial drug of abuse, given the common belief that because prescription opioids are legal, they are considered trustworthy and predictable."

Few media reports mention the strict conditions under which opioids are prescribed in pain contracts between doctors and patients. As described in Pain Medicine News, a “Stipulations of Opioid Treatment Agreement” requires that patients on opioid therapy use only one pharmacy, undergo random urine drug screening, and abstain from alcohol.

Yet all of this goes largely ignored. The narrative of the opioid crisis has been streamlined and simplified to the point that chronic pain patients are either part of the problem, or at least getting in the way of the solution. The CDC guidelines and PROP, as well as state laws and regulations, treat pain patients as an afterthought. We are an inconvenient footnote.

But persistent pain cannot be ignored. Its physical and emotional impact is so costly, that a group of economists recently put a price tag on it.  They estimate that avoiding a single day of chronic pain is worth up $145 for the average person. That works out to nearly $53,000 per year.

This means pain management is extremely valuable to most people.
The pain of connective tissue disorders like Ehlers-Danlos syndrome and other incurable chronic pain conditions like adhesive arachnoiditis can be crippling. People living with these disorders need to have all options on the table because the worst has already happened and they are trying to survive as best as they can.

The Washington state opioid prescribing guideline states that "in carefully selected and monitored patients, opioids may provide effective pain relief if used as part of a comprehensive multimodal pain management strategy. A combination of pharmacologic, non-pharmacologic, and rehabilitative approaches in addition to a strong therapeutic alliance between the older patient and physician is essential to achieve desired treatment outcomes."

That excerpt is from the chapter on “Chronic Pain Management in Special Populations,” a group that arguably should include people with chronic, progressive, or degenerative disorders.

A similar statement from the CDC or even PROP that long-term opioid therapy can be useful for some patients when other pain treatments are ineffective would help keep all pain management options on the table.

We have a chance to stop the worsening crisis of pain mismanagement that is resulting from well-intentioned efforts to address the opioid crisis. A few words added to the CDC guideline or the position statements of groups like PROP could help chronic pain sufferers avoid the perils of being an inconvenient footnote.

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.

What Is Patient Advocacy?

By Barby Ingle, Columnist

In the last few years there has been a boom in people wanting to be patient advocates. Not the paid positions that are filled by someone who works for a hospital or medical provider, but those actually affected by chronic pain – patients and caregivers -- who freely volunteer their time, energy, and efforts to help the pain community.

Patient advocates work to support a cause or public policy to improve patient care and better our community. They write to legislators, testify on behalf of pain patients, share social media posts, encourage research, speak up publicly, and talk about bettering the pain community.

Other names we could be called are patient champions, supporters, backers, proponents, spokespersons, campaigners, fighters, and crusaders.

There is a lot of chatter in the pain community about what patient advocates should be doing, so I thought it would be good to point out some things an advocate should not do.

An advocate does not get involved for their own sake. Hopefully, their advocacy helps their own pain care, but that should not be the main goal of their actions.

Advocates should not take on the role to “get even” with someone, whether it’s a doctor, hospital, politician or another advocate. Far too often people get mad because they can’t get the care they need and speak up only to get back at whoever they think wronged them. Being a patient advocate should not be at the expense of others or to seek power and influence.

There are many types of advocacy, but what will ensure success and make a difference is to avoid the pitfalls of advocacy. If you are mentoring others, be sure to have strict confidentiality as health topics are a very sensitive subject. Refrain from abusive conduct, even if the people you are assisting are abusive. Remove yourself if that becomes the case.

Some people just don’t want the help or advocacy you offer. It could be a cultural conflict, mental issue, or just that you don’t gel with them for a variety of reasons. Be okay with that, let it go and help those who actually want your help.

You should be trustworthy and honest in all the actions you take. An advocate is willing to disclose all personal conflicts of interest to those they are advocating for and with, so that any perceived or actual biases are known. We should not ever compromise our personal beliefs while advocating for others.

Advocacy is not creating more conflict or strife. A good patient advocate is going to work to solve problems, not create new ones. Advocates should not try to change what is working, but instead should work to stop unfair practices, abuse, and the under/over treatment of patients. We need to increase treatment options, services, and proper and timely care.

When we remove those barriers, advocates increase society’s ability to offer full opportunities for pain sufferers.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain FoundationShe is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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

Lyrica and Neurontin Face More Scrutiny

By Pat Anson, Editor

The safety and effectiveness of Lyrica (pregabalin) and Neurontin (gabapentin) – two non-opioid drugs widely used to treat chronic pain – are drawing new scrutiny from researchers and doctors who believe the medications are over-prescribed.

In a study published in PLOS Medicine, Canadian researchers say there is little evidence that gabapentinoids – a class of nerve medication that includes Neurontin and Lyrica – are effective in treating chronic low back pain. In their review of 8 clinical studies, the researchers also found the drugs have a “significant risk of adverse effects.”

Lyrica and Neurontin are commonly prescribed for fibromyalgia and neuropathic pain, but the researchers say the drugs are increasingly prescribed for chronic back pain, even though there is “no clear rationale” for it.

"Despite their widespread use, our systematic review with meta-analysis found that there are very few randomized controlled trials that have attempted to assess the benefit of using gabapentin or pregabalin in patients of chronic low back pain," wrote lead author Harsha Shanthanna, MD, an assistant professor at McMaster University in Hamilton, Ontario.

"They necessitate prolonged use and are associated with adverse effects and increased costs. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse.”

Shanthanna and his colleagues found that gabapentin showed “minimal improvement” in back pain compared to a placebo and pregabalin was “inferior” compared to other analgesics. There were no deaths or hospitalizations reported in any of the studies, but both drugs were associated with increased risk of dizziness, fatigue, visual disturbances, and diminished mental activity.

Lyrica and Neurontin are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in sales annually. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injuries. It is also prescribed off-label to treat other chronic pain conditions, including lower back pain.

Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses. Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for.

Sales of pregabalin and gabapentin have risen steadily in recent years, in part because of CDC prescribing guidelines that recommend the two drugs as alternatives to opioid pain medication. About 64 million prescriptions were written for gabapentin in the U.S. last year, a 49% increase since 2011.

“We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain.

“Patients who are in pain deserve empathy, understanding, time, and attention. We believe some of them may benefit from a therapeutic trial of gabapentin or pregabalin for off-label indications, and we support robust efforts to limit opioid prescribing. Nevertheless, clinicians shouldn’t assume that gabapentinoids are an effective approach for most pain syndromes or a routinely appropriate substitute for opioids.”

FDA Seeks Public Comment on Abuse of Lyrica

The U.S. Food and Drug Administration announced last week that it was seeking public comment on reports that pregabalin is being abused. The FDA action was in response to a formal notification from the World Health Organization (WHO) that it may place international restrictions on pregabalin to reduce the risk of abuse and diversion. The FDA has until September 30 to respond to WHO.

Reports indicate that patients are self-administering higher than recommended doses to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness. While effects of excessively high doses are generally non-lethal, gabapentinoids such as pregabalin are increasingly being identified in post-mortem toxicology analyses,” the FDA said in a notice published in the Federal Register.

Pregabalin is already classified as Schedule V controlled substance in the U.S. under the Controlled Substances Act, which means the DEA considers it to have a low potential for abuse.

The idea that Lyrica and Neurontin are being abused is surprising to many patients and doctors, but there are growing signs the drugs are being used recreationally.

Both Lyrica and Neurontin have been linked to heroin overdoses in England and Wales, where prescriptions for both drugs have soared in recent years.  Addicts have apparently found the medications enhance the effects of heroin and other opioids.

A small study of urine samples from patients being treated at U.S. pain clinics and addiction treatment centers found that one in five patients were taking gabapentin without a prescription.

Gabapentin and pregabalin are also being abused by prison inmates, according to Jeffrey Keller, MD, chief medical officer of Centurion, a private corrections company. 

“Gabapentin is the single biggest problem drug of abuse in many correctional systems,” Keller recently wrote in Corrections.com. “There is little difference (in my opinion) between Lyrica and gabapentin in both use for neuropathic pain or for abuse potential.”

Pfizer did not respond to a request for comment.

VA Studies Find Little Evidence for Medical Cannabis

By Pat Anson, Editor

There is not enough evidence to support the effectiveness and safety of cannabis and cannabinoid products in treating chronic pain or post-traumatic stress disorder (PTSD), according to a pair of new studies published in the Annals of Internal Medicine.

Researchers at the U.S. Department of Veterans Affairs reviewed 27 clinical studies on the benefits and harms of cannabis in treating chronic pain, and found most of the studies were small, many had methodological flaws, and the long-term effects of cannabis were unclear because there was little follow-up in most of the studies.

None of the studies directly compared cannabis with opioid pain medication and there was no good-quality data on how cannabis affects opioid use, according to researchers.

“Although cannabis is increasingly available for medical and recreational use, little methodologically rigorous evidence examines its effects in patients with chronic pain. Limited evidence suggests that it may alleviate neuropathic pain, but evidence in other pain populations is insufficient,” wrote lead author Shannon Nugent, PhD, VA Portland Health Care System.

“Even though we did not find strong, consistent evidence of benefit, clinicians will still need to engage in evidence-based discussions with patients managing chronic pain who are using or requesting to use cannabis.”

Medical marijuana is legal in 28 states and the District of Columbia, and many patients are using it for pain relief. Up to 80 percent of people who seek medical cannabis do so for pain management and nearly 40 percent of those on long-term opioid therapy for pain also use cannabis. Veterans Affairs policy currently doesn’t allow for cannabis use in the huge VA healthcare system, even in states where it is legal.

According to a 2014 Inspector General’s study, more than half of the veterans being treated at the VA have chronic pain, as well as other conditions that contribute to it, such as PTSD.

‘Very Scant Evidence’ on Cannabis for PTSD

More than a third of the patients who use cannabis in states where it is legal list PTSD as their primary reason. But, as with chronic pain, VA researchers found “very scant evidence” to support the use of cannabis to treat PTSD.

“Despite the limited research on benefits and harms, many states allow medicinal use of cannabis for PTSD. The popular press has reported many stories about individuals who had improvement in their PTSD symptoms with cannabis use, and cross-sectional studies have been done in which patients with more severe PTSD reported cannabis use as a coping strategy,” wrote lead author Maya O’Neil, PhD, VA Portland Health Care System.

“However, it is impossible to determine from these reports whether cannabis use is a marker for more severe symptoms or is effective at reducing symptoms, or whether the perceived beneficial effects are the result of the cannabis, placebo effects, or the natural course of symptoms.” 

Clinical evidence may be lacking, but supporters of medical marijuana say they’ve seen plenty of anecdotal evidence that cannabis works for both pain and PTSD.

“They claim no benefits are shown but with the number of people we have met with PTSD that have been able to function and improve with the use of cannabis, I would say the ‘proof is in the pudding.’ Seeing their lives improve tremendously says a lot about success,” said Ellen Lenox Smith, a PNN columnist who is co-director of cannabis advocacy for the U.S. Pain Foundation and a caregiver under Rhode Island’s medical marijuana program. 

“We have not met a person yet that has not been enjoying the improved quality of their life using cannabis for PTSD. We fought a long hard battle to have it included as a qualifying condition and it was worth the battle. Patients are finding peace and calm they were not experiencing before using cannabis. Sleep has improved and without a good night rest, anyone's next day is a terrible struggle.”

Like it or not, the “horse is out of the barn” when it comes to cannabis use, according to an editorial also published in the Annals of Internal Medicine.

“Even if future studies reveal a clear lack of substantial benefit of cannabis for pain or PTSD, legislation is unlikely to remove these conditions from the lists of indications for medical cannabis,” wrote Sachin Patel, MD, Vanderbilt Psychiatric Hospital.

“It will be up to front-line practicing physicians to learn about the harms and benefits of cannabis, educate their patients on these topics, and make evidence-based recommendations about using cannabis and related products for various health conditions. In parallel, the research community must pursue high-quality studies and disseminate the results to clinicians and the public.”

Opioid Overdoses Rise in Intensive Care

By Pat Anson Editor

Opioid overdose deaths in intensive care units (ICUs) have risen sharply in recent years -- primarily due to heroin --  according to a large new study involving 162 U.S. hospitals in 44 states.

The research findings, published in the Annals of the American Thoracic Society, analyzed data from over four million ICU patients from 2009 to 2015. Of those, 21,705 were patients who overdosed on opioids, most commonly heroin. Deaths from overdoses averaged 7 percent during the study period, but rose to 10 percent by 2015.

“Although our data are not definitive, they suggest that overdoses from heroin, rather than prescription opioids, appear to be a major contributor to the rise in critical care mortality for this population,” wrote lead author, Jennifer Stevens, MD, an associate director of the medical intensive care unit at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School.

“Not only did the number of opioid-related overdose patients requiring ICU care increase above and beyond the increasing supply of critical care admissions, the mortality among this population increased as well, leading us to estimate that there was a near doubling of ICU deaths.”

Researchers say ICU patients admitted for a heroin overdose were significantly more likely to die than those who overdosed on prescription opioids. Mortality was “not significantly associated” with overdoses linked to prescription painkillers.

The study also found that overdose patients admitted to ICUs required increasingly more sophisticated and costly intensive care, such as high-cost renal replacement therapy or dialysis. The cost of caring for these patients increased from $58,517 to $92,408 during the study period.

"This study tells us that the opioid epidemic has made people sicker and killed more people, in spite of all the care we can provide in the ICU, including mechanical ventilation, acute dialysis, life support and round-the-clock care," said Stevens.

Among the opioid overdose patients, 25 percent experienced aspiration pneumonia, 15 percent rhabdomyolosis (release of dead muscle fiber into the bloodstream), 8 percent anoxic brain injury and 6 percent experienced septic shock. Ten percent of the patients who overdosed needed mechanical ventilation. ICU’s in Massachusetts, Indiana and Pennsylvania had substantially higher overdose death rates.

A new study this week found the number of Americans who died from opioid overdoses – particularly from heroin – is significantly higher than previously reported. Researchers at the University of Virginia refined the overdose data from 2014 death certificates and estimated that overdose death rates nationally were 22 percent higher for heroin. Deaths involving heroin were substantially underreported in Pennsylvania, Indiana, New Jersey, Louisiana, and Alabama.

"The pace of the opioid epidemic continues to increase," said Stevens. "Those of us who work in hospital intensive care units need to make sure we have the tools we need to help patients with opioid use disorders when they are at their sickest, because there doesn't appear to be any end to this epidemic in sight."

I Am an Addict

By Stephanie Whitaker, Guest Columnist

I am an addict. I admit it and I'm not ashamed of it.

I am addicted to life. I am addicted to minimal pain. I am addicted to doing laundry, washing dishes, cleaning the house, cooking, and taking out the trash. I am addicted to grocery shopping and running errands. I am addicted to participating in my kids' activities, going camping, road trips, and visiting quirky little out of the way attractions few people know about.

I am addicted to eating out, going to the movies, and visiting various fairs throughout the year. I am addicted to hanging out with friends, staying up late, and talking about anything and everything.

STEPHANIE WHITAKER

STEPHANIE WHITAKER

I am addicted to animals, having them, loving them, knowing they will always be there for me and cuddling with me when I'm not feeling well. I am addicted to being dedicated and loyal to my friends, family, and a lover if I should ever have another.

I am addicted to working, being an inspiration to kids through various social groups, and participating in and attending fundraisers. I am addicted to life and everything that it has to offer. If being an addict to all of these things is wrong, I don't want to be right.

Unfortunately, that's not how my life is. I am consumed every minute of every day by pain, nausea, and fatigue. I have to allot my energy each day to do the bare minimum, so that I don't end up in bed for days at a time when I overdo it.

I have to take multiple medications and supplements many times a day to keep my body going. I have physical limitations, dietary restrictions, and minimal contact with the world outside of a doctor's office. Why? Because I am not being treated for the many chronic pain conditions that I have.

Why? Because I am not being treated for the many chronic pain conditions that I have. I am being treated as a drug addict, even though I've never done drugs, have no history of abuse, and have clean toxicology screens every time I walk into an appointment.

This is what is happening in our society because the politicians, CDC, FDA, DEA, big pharma, and insurance companies have decided that we are not worth treating. Our health is nothing but a mere commodity in our country, instead of a basic human right. We have had our dignity, pride, confidence, support networks, even family and friends stripped away because they are under the impression that if we need opioids then we are addicts.

If that were the case, then shouldn't diabetics be stripped of insulin, amputees be denied prosthetic devices, epileptics not receive their anti-seizure meds, cancer patients not get chemo, and kidney failures not get dialysis? What about babies not getting their formula or breast milk to grow and develop properly?

If people with these conditions are not being denied proper treatment to have a high quality of life, then why are we being singled out because we have chronic pain conditions that we didn't ask for or want? If we are addicts, then so is everyone else that needs some form of medication or therapy to survive, grow, be productive, and have a healthy quality of life.

Quit singling out pain patients. The majority of overdose deaths are not pain patients, but drug users that obtain their supply on the streets, not from the medical community. We deserve better.

Yes, I'm an addict. I miss and grieve the all of the things I am addicted to, and will not stop fighting to get them back!

Stephanie Whitaker lives with interstitial cystitis, pelvic floor dysfunction, fibromyalgia, overactive bladder, IBS-C, chronic fatigue, myofascial pain syndrome, pudendal nerve damage, and PTSD -- and all of the anxiety and depression that comes along with them. She is a mother of two who lives in Maryland. 

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.

Brain Scans Link Fibromyalgia and Pelvic Pain

By Pat Anson, Editor

Fibromylagia and urological pelvic pain would seem to have little in common. The former causes widespread body pain, while the latter is marked by chronic inflammatory pain in the bladder or prostate.

But researchers at the University of Michigan have stumbled upon something that both conditions share – besides being difficult to treat.

While examining MRI brain scans of over 1,000 participants enrolled in the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network  -- also known as the MAPP study – they found that people with fibromyalgia or chronic urological pelvic pain both have increased “gray matter” in their brains. Gray matter is tissue in the brain that helps transfer signals between nerves.

"Interestingly, when we put these individuals into the brain imaging scanner, we found that those who had widespread pain had increased gray matter and brain connectivity within sensory and motor cortical areas, when compared to pain-free controls," says Richard Harris, PhD, an associate professor of anesthesiology and rheumatology at Michigan Medicine.

Harris and colleagues want to know if widespread pain, thought to be a marker of centralization in the nervous system, actually originates in the brain. So it was a bit of a surprise to find additional gray matter in the brains of people with urological pelvic pain, a condition that can be caused by interstitial cystitis or chronic prostatitis.

"What was surprising was these individuals with widespread pain, although they had the diagnosis of urological chronic pelvic pain, were actually identical to another chronic pain disorder: fibromyalgia," said Harris.

In addition to the MRI scans, study participants were also asked to draw on a body map where they were experiencing pain. Many of those with pelvic pain indicated they had widespread body pain.

"This study represents the fact that pelvic pain patients, a subset of them, have characteristics of fibromyalgia," Harris says. "Not only do they have widespread pain, but also they have brain markers indistinguishable from fibromyalgia patients."

Harris hopes the study will lead to new ways of treating chronic pain -- as there might be similarities across pain conditions if both show widespread pain.

"We think that this type of study will help treat these patients because if they have a central nerve biological component to their disorder, they're much more likely to benefit from targets that affect the central nervous system rather than from treatments that are aimed at the pelvic region," Harris said.

Trump Declares Opioid Crisis National Emergency

By Pat Anson, Editor

President Donald Trump said he would declare the opioid crisis a national emergency, just two days after his administration said a declaration wasn’t necessary.

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said outside the clubhouse of his golf course in Bedminster, New Jersey.  “We’re going to draw it up and we’re going to make it a national emergency. It is a serious problem the likes of which we have never had.”

In a brief statement after the President’s remarks, the White House said Trump had instructed the administration “to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

An estimated 142 Americans are dying every day from drug overdoses of all kinds, not just opioids. Prescription painkillers are often blamed as the cause of the problem, although deaths linked to opioid medication have leveled off in recent years. Heroin and illicit fentanyl are currently driving the overdose crisis and in some states are involved in over half of the overdose deaths.  

A White House commission last week urged the president to declare a national emergency, but administration officials indicated as recently as Tuesday that such a declaration wasn’t necessary because the administration was already treating the opioid crisis as an emergency.

“We believe at this point that the resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” said Health and Human Services Secretary Tom Price.

New Jersey Gov. Chris Christie, who chairs the opioid commission, applauded the apparent change of heart.

“It is a national emergency and the President has confirmed that through his words and actions today, and he deserves great credit for doing so. As I have said before, I am completely confident that the President will address this problem aggressively and do all he can to alleviate the suffering and loss of scores of families in every corner of our country,” Christie said in a statement.

“This declaration is only one of many steps we must take on the federal level to reduce the death toll and help people achieve long-term recovery – but it’s a start. I’m committed to working with the President and my fellow commissioners to end the opioid overdose epidemic,” said commission member and former congressman Patrick Kennedy.

It was not immediately clear what steps the administration will take now that an emergency has been declared. A 10-page interim report released by the opioid commission recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, and increased efforts to detect and stop the flow of illicit fentanyl into the country.

There are no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report, which is due in October. Prescriptions for opioid medication – long a target of addiction treatment and anti-opioid activists – have been in decline for several years. The DEA has plans to reduce the supply of many painkillers even more in 2018.

Other measures recommended by the commission:

  • Grant waivers to states to eliminate barriers to mental health and addiction treatment
  • Increase availability of naloxone as an emergency treatment for opioid overdoses
  • Amend the Controlled Substance Act to require additional training in pain management for all prescribers
  • Prioritize funding to Homeland Security, FBI and DEA to quickly develop fentanyl detection sensors
  • Stop the flow of synthetic opioids through the U.S. Postal Service
  • Enhance the sharing of data between prescription drug monitoring programs (PDMPs)

No estimate was provided on the cost of any of these measures.

In a statement on Tuesday, President Trump suggested that law enforcement and abstinence should be used to address the opioid crisis. 

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don’t start, they won't have a problem.  If they do start, it's awfully tough to get off," Trump said, according to a White House transcript.

DEA Proposes Further Cuts in Opioid Supply

By Pat Anson, Editor

The U.S. Drug Enforcement Administration has proposed an additional 20 percent reduction in the manufacture of many opioid painkillers, including oxycodone, hydrocodone, codeine and morphine. The proposed cuts in the opioid supply, which would be effective in 2018, are in addition to those imposed by the DEA in 2017.   

“Demand for these opioid medicines has dropped,” the DEA said in a news release, citing sales data released by the QuintilesIMS Institute, which tracks prescription drug use. About 7 million fewer prescriptions were filled for hydrocodone in 2016, the fifth consecutive year that hydrocodone prescriptions have dropped.

“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” said DEA Acting Administrator Chuck Rosenberg. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”

Many pain patients tell PNN that demand for opioid medicine has not dropped, but that doctors are increasingly reluctant to write opioid prescriptions because of increased oversight by the DEA, insurance companies, and federal and state regulators.  

“It is discrimination, plain and simple. I have a well-documented chronic pain condition. Social Security has deemed me 100 percent disabled,” wrote Lora Lemons. “No other chronic condition that requires medication to combat the disease is flagged the way pain producing diseases are.”

“I am prepared to commit suicide if my pain meds are drastically cut,” wrote a woman who has adhesive arachnoiditis, a chronic and disabling spinal condition. “We don't want to die, but the legislators in the federal and state governments are going to force it for those in intractable pain.”

“No other disease medication is scrutinized. We, as patients, are being denied, dismissed, overlooked and discriminated against by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications. Our doctors are afraid to treat us humanely and adequately,” said Candi Simonis.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Despite those deep cuts, the DEA remains under political pressure to combat the overdose epidemic by reducing the opioid supply even further. Last month, a group of 16 U.S. senators wrote to Rosenberg saying additional cuts “are necessary to rein in this epidemic.”

The DEA published notice of its intent in the Federal Register and is accepting public comments on the proposal until September 6.

Click here to post your comment on the 2018 production quotas.

Study Finds Rain Not Linked to Joint Pain

By Pat Anson, Editor

The debate over weather’s influence on pain is heating up again, with the release of a new study that showed warmer temperatures -- not rainy conditions -- are associated with an increase in online searches about joint pain.

The apparent increase in knee and hip pain may be due to increased outdoor physical activity, according to researchers who reported their findings in PLOS ONE.

Investigators used Google Trends to analyze how often people used Google’s search engine to look up words and phrases associated with hip pain, knee pain and arthritis. Then they compared the results with local weather conditions at 45 U.S. cities. The weather data included temperature, precipitation, relative humidity and barometric pressure - conditions previously associated with increases in musculoskeletal pain.

Researchers found that as temperatures rose, Google searches about knee and hip pain rose steadily, too. But knee-pain searches peaked at 73 degrees Fahrenheit and became less frequent at higher temperatures. And searches for hip-pain peaked at 83 degrees and then tailed off.

Surprisingly, rain actually dampened search volumes for both knee and hip pain.

"We were surprised by how consistent the results were throughout the range of temperatures in cities across the country," said Scott Telfer, a researcher in orthopedics and sports medicine at the University of Washington School of Medicine.

Searches about arthritis, which was the study's main impetus, had no correlation with weather conditions.

"You hear people with arthritis say they can tell when the weather is changing," he said. "But with past studies there's only been vague associations, nothing very concrete, and our findings align with those."

What do the findings mean?

Because knee and hip-pain searches increased until it grew warm, and rainy days tended to slightly reduce searches for hip and knee pain, the researchers speculate that changes in outdoor physical activity may be primarily responsible for those searches.

"What we think is much more likely explanation is the fact that people are more active on nice days, so more prone to have overuse and acute injuries from that and to search online for relevant information,” Telfer said, adding that web searches are often the first response people have to health symptoms.

Researchers in Australia recently reported that cold, rainy weather has no impact on symptoms associated with back pain or osteoarthritis. Warmer temperatures did slightly increase the chances of lower back pain, but the amount of the increase was not considered clinically important. 

A previous study on back pain and weather by The George Institute for Global Health had similar findings, but received widespread criticism from the public, a sign of just how certain many people are that weather affects how much pain they feel.

“I know it is going to rain or have a thunderstorm before the weather person announces it on the news,” says Denee Hand, who suffers back pain from arachnoiditis, a chronic inflammation of the spinal membrane. She says the pain spreads down to her toes when the weather changes. 

“It is like my nervous system and muscles react to the coming weather and finally I get pain that feels like the tops of both my feet are being crushed,” she said in an email to PNN. “I have compression of the spinal cord with nerve damage to my nerves from the scar tissue and when the weather changes the scar tissue presses down against the damaged nerves.”

Researchers at the University of Manchester recently ended a study involving thousands of people who used smartphone apps to report their pain levels, giving investigators the ability to compare the pain data with real-time local weather. Researchers are now analyzing the database compiled over the last 15 months and will release their results next spring.

Trump: ‘Fire and Fury’ for North Korea, But Not Opioids

By Pat Anson, Editor

President Trump has decided not to declare a national emergency to combat the opioid crisis, despite a recommendation from a White House commission that he declare an emergency to speed up federal efforts to fight it. The decision was announced just minutes after the president threatened "fire and fury" against North Korea over its nuclear program.

Health and Human Services Secretary Tom Price said an emergency declaration wasn’t necessary because the administration was already treating the opioid crisis as an emergency. But he wouldn’t rule it out in the future.

“We believe at this point that the resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” Price said at a news conference.  

Last week, New Jersey Gov. Chris Christie, who chairs the president's opiod commission, made a personal plea to Trump to declare a national emergency, saying 142 Americans were dying every day from drug overdoses.

“If this scourge has not found you or your family yet, without bold action by everyone, it soon will. You, Mr. President, are the only person who can bring this type of intensity to the emergency and we believe you have the will to do so and to do so immediately,” Christie said.

“Our country needs you, Mr. President. We know you care deeply about this issue. We also know that you will use the authority of your office to deal with our nation’s problems.”

President Trump met with First Lady Melania Trump, Secretary Price and other administration officials for a briefing on the overdose crisis at the Trump National Golf Club in Bedminster, New Jersey. Gov. Christie was not present.

Trump did not mention a national emergency during the public portion of the briefing, but said drug abuse was a “tremendous problem and we’re going to get it taken care of.” He suggested that law enforcement and abstinence should be used to address it.

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don’t start, they won't have a problem.  If they do start, it's awfully tough to get off.  So we can keep them from going on, and maybe by talking to youth and telling them, ‘No good, really bad for you’ in every way.  But if they don’t start, it will never be a problem,” Trump said, according to a White House transcript.

The opioid briefing was quickly overshadowed by the looming crisis with North Korea, when a reporter asked the president about North Korea’s growing nuclear capabilities.

“North Korea best not make any more threats to the United States.  They will be met with fire and fury like the world has never seen,” Trump said. “He has been very threatening beyond a normal state.  And as I said, they will be met with fire, fury, and, frankly, power, the likes of which this world has never seen before.”

Neither Trump nor Secretary Price laid out any specific steps to combat the overdose crisis. Price said his department was still “talking about what should be done” and developing a strategy.

Trump said the administration was acting to stop the flow of illegal drugs by being “very, very strong on our southern border and, I would say, the likes of which this country certainly has never seen that kind of strength."