Surgeon General Issues ‘Landmark Report’ on Addiction

By Pat Anson, Editor

Calling addiction “America’s most pressing problem,” U.S. Surgeon General Vivek Murthy has released a landmark report on alcohol, drug abuse and substance use disorders. Nearly 21 million Americans are believed to suffer from some form of substance addiction.

“Alcohol and drug addiction take an enormous toll on individuals, families, and communities,” said Murthy. “Most Americans know someone who has been touched by an alcohol or a drug use disorder. Yet 90 percent of people with a substance use disorder are not getting treatment. That has to change.”

The voluminous report, Facing Addiction in America: The Surgeon General’s Report on Alcohol, Drugs, and Health, takes an in-depth look at the abuse of alcohol, illicit drugs, and prescription drugs.  Murthy called for a cultural shift in the way Americans view addiction.

SURGEON GENERAL VIVEK MURTHY, MD

"For far too long, too many in our country have viewed addiction as a moral failing," Murthy said. "This unfortunate stigma has created an added burden of shame that has made people with substance-use disorders less likely to come forward and seek help.

"We must help everyone see that addiction is not a character flaw. It is a chronic illness that we must approach with the same skill and compassion with which we approach heart disease, diabetes, and cancer."

Murthy was blasted by one critic for releasing the report in the final weeks of the Obama administration.

“The timing of Murthy’s report is despicable,” wrote Dr. Manny Alvarez, the senior managing health editor at Fox News. “For two years, he did nothing to develop national protocols to tackle opioid abuse and waited until a Republican was elected president to issue the first-ever report from a U.S. surgeon general dedicated to substance addiction. He could have used this platform to shape his legacy as surgeon general, but instead, it appears he chose to play politics while using our nation’s health as a pawn."

Murthy did send a letter to over 2 million physicians in August, encouraging them to follow CDC guidelines and not prescribe opioids as a first-line treatment for chronic pain.

The report released today, however, makes surprisingly few references to opioid prescribing or to the soaring number overdoses caused by heroin and illicit fentanyl. At times, the report acknowledges that efforts to reduce opioid prescribing may only be making the nation's opioid problem worse.

“Although only about 4 percent of those who misuse prescription opioids transition to using heroin, concern is growing that tightening restrictions on opioid prescribing could potentially have unintended consequences resulting in new populations using heroin,” the report states. “As yet, insufficient evidence exists of the effects of state policies to reduce inappropriate prescribing of opioid pain medications.”

As Pain News Network has reported, fentanyl overdoses have been escalating rapidly. In Massachusetts, nearly three out of four opioid overdoses this year have been linked to fentanyl, far outnumbering the number of deaths associated with prescription pain medication.

One of the findings of the Surgeon General’s report is that addiction treatment in the United States remains largely separate from the rest of health care and serves only a fraction of those in need of treatment. This “treatment gap” is attributed to a number of factors, including lack of access, cost, fear of shame, and discrimination. Many people are also not referred to treatment until there is a crisis, such as an overdose or arrest.

"This report comes at a critical point in time, drawing national attention to a public health epidemic that continues to sweep the country," said Shaun Thaxter, CEO of Indivior, the maker of the addiction treatment drug Suboxone. "We are encouraged by the proactive steps taken by the U.S. federal government to raise awareness about this chronic disease and ensure that patients have access to the treatment they need.”

Kolodny Leaves Phoenix House

In related news, Andrew Kolodny, MD, the founder and executive director of Physicians for Responsible Opioid Prescribing (PROP), has announced that he is no longer the chief medical officer at Phoenix House, which runs of chain of addiction treatment centers.

Kolodny is now co-director of opioid policy research at the Heller School for Social Policy & Management at Brandeis University

PROP, an advocacy group that seeks to reduce opioid prescribing, ended its association with Phoenix House earlier this year. The non-profit Steve Rummler Hope Foundation is now the “fiscal sponsor” of PROP, which allows PROP to collect tax deductible donations.

Time to Fight for Our Rights as Pain Patients

By Carol Levy, Columnist

Where exactly do the Drug Enforcement Administration and the Centers for Disease Control and Prevention stand on working with and helping those with chronic pain, as opposed to ignoring our voices and pleas?

At the Rally Against Pain in Washington, DC on October 22, the CDC was invited to come but no representatives attended.

The DEA notifies all that they will be banning kratom because it is “an imminent public health hazard.” But after a major hue and cry from the kratom community, a decision was made to conduct a new analysis of the herbal supplement and have a public comment period.

Why is it that kratom and medical marijuana, which many patients say are effective in relieving chronic pain, are poison to the powers that be in Washington?

Is it just the result of lobbying by the pharmaceutical industry in an effort to protect profits?

Is it another jab at us because they can't see our “invisible” illnesses and disorders?

Is it a result of the media and the public not knowing or caring about our plight?

October 7 was Trigeminal Neuralgia Awareness Day. Many of us tweeted and posted on Facebook about it, but the news media for the most part gave it a ho-hum. Do they have a policy of not reporting on a disorder if they don’t think enough people have it?  

Instead, the media seems content to repeat the hysteria laden stories and recycle articles about opioid medication abuse, while mostly ignoring those who may benefit from opioids or have them as their only treatment option.

While it is scary to see headlines about banning kratom and other substances many of us use for pain relief, it is worth remembering that an FDA advisory panel in 2009 voted to ban Vicodin and Percocet, because of their effects on the liver. No such ban was adopted, but they did change the amount permitted and how you can get them.

We need to be concerned about the “slippery slope” that comes with threatened bans. Instead of reacting with fear and wasting our emotional energy, we need to respond proactively. Better to get out paper and pen, and start sending letters and emails to your representatives in Congress and the FDA, DEA and CDC.

Kratom supporters won their battle, at least temporarily. Why can’t we?

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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.

Daughter Says Untreated Pain Led to Mother’s Suicide

By Pat Anson, Editor

Suicides are never easy to accept. Especially if they involve a loved one. Even more so if they could have been prevented.

Lacy Stewart says her mother never would have killed herself if she’d been given proper medical care for her chronic fibromyalgia pain.

“I feel angry about the way she was treated,” says Stewart, a registered nurse who believes the healthcare system not only failed to treat her mother, but drove Marsha Reid to suicide at age 59.

“Her life was taken from her is the way I feel,” says Stewart. “I know it was. A person can only handle so much pain for so long. It takes its toll on every area -- your mind, your body, everything. And she just couldn’t do it anymore. She’d had enough. Because nobody would help her. Nobody.” 

Stewart says her mother was fit and physically active – handling all the chores at her 10-acre farm in north Texas -- until she slipped on ice and landed hard on her face in 2009. Reid broke a few teeth and sustained nerve damage in the fall -- injuries that evolved into the classic symptoms of fibromyalgia: chronic widespread pain, anxiety, fatigue, insomnia and depression.

“Of course she sought out help. Searching for doctors that would take her on, she encountered road block after road block. Many doctor’s offices would just flat out say, ‘We don’t take fibromyalgia patients,’” recalls Stewart.

“So you take that and couple it with the fact that pain medication is often required for these patients and now the CDC has regulations that deter a physician from wanting to prescribe pain medication at all and you end up here. Zero help for a woman suffering day in and day out for all these years. She lost her job, her home, her independence.”

MARSHA REID AND DAUGHTER LACY

In January, Reid checked into a hotel room and tried to kill herself by taking a full bottle of Xanax. The failed suicide attempt left Reid even more depressed and her health deteriorated further. She started having hallucinations, hearing voices and seeing dead people.

In July, Stewart drove her mother for five hours to see a pain management doctor.

“I was appalled at the treatment from the physician. We explained the pain and the issues with her mind, and he said he could only treat one or the other. Not both! Not the whole patient! When I brought up pain medication you would have thought I had asked him for heroin,” says Stewart.

“I'll never forget the conversation I had with him in the hall on the way out. I looked him in the eye and said the pain is so severe she will kill herself! It’s only a matter of time. He basically said his hands were tied because of the regulations and what I was asking was for him to lose his license! I was furious and felt betrayed by the field I loved, medicine.”

One treatment was suggested for her mother.

“They wanted her to go to water aerobics,” said Stewart. “The woman could barely take a bath and they wanted her to go to water aerobics! I read in the CDC (opioid) prescribing guidelines that they wanted doctors to use alternative measures for pain relief such as water aerobics and physical therapy. They never spent a day in pain in their lives, obviously. Because then they would know that is ridiculous. It’s almost a joke to me, the guidelines that I have read.”

Crisis in Pain Care

In recent months, Pain News Network has been contacted by dozens of pain patients who say they are contemplating suicide. It’s not just the difficulty in getting opioid pain medication. The growing crisis in pain care has reached a point where many patients are unable even to get a doctor’s appointment.

“I have been on a wait list for pain treatment for a year now. I am suffering needlessly and am questioning my ability to be able to live like this much longer,” said Isabel Etkind, a Connecticut woman who suffers from severe arthritis pain.

“I don't want to die but I can't live like this either. I know that many other people are experiencing the same thing, but knowing that does not really help! It is inhumane and cruel to treat people this way. If I were a dog, cat or horse, the animal rights people would be all over it, but torturing humans is OK. As is usually the case, the elderly, the military and the poor are suffering the most.”

Another woman, who suffers from chronic back pain, asked that we not use her name. She works in the emergency room of a hospital in southern California that recently adopted a policy of not prescribing opioids unless all other pain treatments have failed.

“Since November 1, we have seen a huge increase in overdoses from street drugs. Nearly all of these patients are chronic pain sufferers who are now getting their medications off the streets. A 33-year old fibromyalgia patient died from fentanyl overdose this week,” she wrote to PNN. “I understand the desperation these patients feel and try to educate the ER doctors about chronic pain from a layman's point of view. This new effort to stigmatize and demonize chronic pain sufferers has got to stop!

“We have full time jobs, pay mortgages, raise families. All this, while in levels of pain that normal people couldn't handle. We hate having to be chained to pill bottles and doctors and pharmacists. What other choice do we have? Curl up and die? I hope the new Trump administration will appoint people to DEA and CDC who will think of us as humans and help us instead of hurting us.”

Suicides Increasing

According to the CDC,  suicides increased by 24 percent from 1999 to 2014, and are now the 10th leading cause of death in the United States.  

In 2014, nearly 43,000 Americans killed themselves, three times the number of deaths that have been linked to prescription opioid overdoses.  

Marsha Reid died of a self-inflicted gunshot wound on November 2, leaving behind a grief stricken daughter who will always wonder if things would have turned out differently if her mother had gotten the pain treatment she needed

“She talked about this a lot, about suicide. That was her plan. She couldn’t deal with this much longer. And that’s what breaks my heart the most is that I was unable to help,” says Lacy Stewart.

“Just mention the heartache she has left behind. Because if another fibromyalgia patient is out there contemplating this and they come across this story, I want it noted that I lost my mom forever and I’m 32 years old. And I’ll never have her back.”

MARSHA REID

Is Cannabis Science's Pain Patch for Real?

By Pat Anson, Editor

A California company that claims to be developing a cannabis-based skin patch to treat chronic pain is “a fundamentally unsound company” with a long history of misleading the public and its own shareholders, according to analysts. The founder and former CEO of Cannabis Science has even accused the company’s current management team of fraud and deception.

At various times in its history, Cannabis Science has gone under the name Patriot Holdings, National Healthcare Technology, Brighton Oil & Gas, and Gulf Onshore. Now it has a slick new website, and is passing itself off as a pharmaceutical development company with a pipeline of cannabis-based drugs to treat asthma, HIV and chronic pain.

“I'm not sure if Cannabis Science is a biotech firm, an oil and gas exploration company, an educational university or a pot distributor, the only thing I am certain of is that Cannabis Science is in the business of moving money from public investors to executives' pockets,” wrote John Brody Gay in a lengthy analysis published by Seeking Alpha, an investing website.

Gay and other analysts say Cannabis Science is a classic “pump and dump” penny stock that produces little revenue, but a steady stream of press releases to promote its business activities, which never seem to come to fruition.

Often other websites are hired by pump and dumpers to publish their press releases or write glowing reviews about a company known as “advertorials.” Others are simply ignorant and don't do their homework. The publicity and fake news generates a brief flurry of interest in the company’s stock, which is when executives and other insiders often sell their shares. By raising the stock price by a few pennies, company insiders can double or triple the value of their holdings.

On November 2, Cannabis Science issued a press release saying it was developing skin patches to treat pain caused by fibromyalgia and diabetic neuropathy.

"The development of these two new pharmaceutical medicinal applications are just the tip of the iceberg for what we see as the future for Cannabis Science. While we strive to increase our land capacity for growth and facilities to produce our own product to supply our scientists with proprietary materials to make these formulations, we are also busy researching more potential needs for Cannabis related medical applications,” Cannabis Science CEO Raymond Dabney was quoted as saying in the news release.

Dabney is no stranger to accusations of deception and stock manipulation. In 2005, he admitted issuing 22 bogus news releases to promote another penny stock. For that he received a five year trading ban from British Columbia’s Securities Commission, according to Forbes and the Vancouver Sun.

A former CEO and president of Cannabis Science has also accused Dabney of fraud. Steve Kubby and other directors resigned after learning that Dabney, who was then working for Cannabis Science as a consultant, diverted company funds into a private account.

“When it became clear that our company had become entangled in fraud and deception, we demanded answers. Instead, those behind the fraud illegally removed me. Yes, we could have fought it and won, but attorneys repeatedly warned us that it is only a matter of time before the SEC will be investigating the company’s many questionable activities,” said Kubby in the Independent Political Report. “Actually, these guys have done me a great favor, because they have removed me from a stinking mess and assumed the liability for themselves.”

Kubby himself was accused by the company of "using unauthorized company shares as collateral or consideration for his personal gain."

Calls to Cannabis Science and Dabney for comment on the allegations were not returned.

‘Substantial Doubt’ About Company

The bottom line in all of this is that Cannabis Science is nearly broke and considers its own future questionable, which it discloses in its most recent financial statement to the Securities and Exchange Commission.

“The Company is not currently in good short-term financial standing. We anticipate that we may only generate limited revenues in the near future and we will not have enough positive internal operating cash flow until we can generate substantial revenues,” the company said. “There is substantial doubt as to the Company's ability to continue as a going concern without a significant infusion of capital.”

In the first six months of 2016, Cannabis Science reported revenue of only $5,787, and debt and liabilities of over $5 million.

What the company has plenty of is stock. Nearly two billion shares of Cannabis Science are currently trading on the over-the-counter “pink sheet” market, and the company is authorized to release another billion shares whenever it wants. It pays its executives, debtors and vendors in newly issued shares, which are typically sold at opportune times.  

Chief Financial Officer Robert Kane, for example, was paid with 20,000,000 shares on March 8. In October, Kane sold over 9 million shares for $384,000.

Nice work if you can get it.

With more and more states legalizing both medical and recreational marijuana, the cannabis industry is estimated to be worth $7 billion and growing quickly. So is the opportunity for fraud.

The Financial Industry Regulatory Authority (FINRA) warned about a profusion of marijuana stock scams three years ago, advice that still holds true today for investors, as well as pain patients.

“Like many investment scams, pitches for marijuana stocks may arrive in a variety of ways – from faxes to email or text message invitations, to webinars, infomercials, tweets or blog posts,” FINRA said. “The con artists behind marijuana stock scams may try to entice investors with optimistic and potentially false and misleading information that in turn creates unwarranted demand for shares of small, thinly traded companies that often have little or no history of financial success.”

Cannabis Science was out with yet another press release today, this one talking about its plan to build a 33,000 square foot marijuana greenhouse in Nevada. No details were offered on when the greenhouse would be built, how much it would cost, or who would pay for it.

"It is such an incredible feeling to see our great plans finally coming to fruition," Dabney was quoted as saying.

Can Trump Make Healthcare Great Again?

By Barby Ingle, Columnist

As a chronic pain patient, I know that the Affordable Care Act (ACA) has not been so affordable for some people. Here in Arizona, monthly insurance premiums are going up 75 percent and the national average is seeing a double digit increase.

Running a foundation for the past decade, I have heard many stories of patients unable to afford proper and timely healthcare. Since the enactment of Obamacare in 2010, I've heard even more stories of regret, loss of care and rising costs. Premiums have gone up so much that many would rather pay the penalty for not having insurance, instead of getting it.

I am not sure if President-elect Donald Trump can "repeal and replace" the ACA in a timely manner. It will take an act of Congress to completely repeal ACA and eliminate the individual mandate.

We need to broaden healthcare access for all Americans, especially those of us living with chronic illnesses. Let’s look at the 7 steps proposed by Trump during the presidential campaign.

1. Completely repeal Obamacare and eliminate the individual mandate. No person should be required to buy insurance unless he or she wants to.

I agree with not mandating the purchase of insurance, but I also see why it was put into the plan. It was thought if we force everyone to pay into the system, it will be easier to bear the costs of caring for the elderly and disabled. 

Current enrollment for Obamacare shows that less than 12.7 million of the 40 million without insurance are now covered. That's progress, but even with subsidies, many people in pain (not on disability) are unable to afford coverage. Also, many with insurance were cut from their long-time providers as their plans were no longer accepted by the provider.

2. Modify existing law that prohibits the sale of health insurance across state lines. As long as the plan purchased complies with state requirements, any vendor ought to be able to offer insurance in any state. By allowing full competition in the market, insurance costs will go down and consumer satisfaction will go up.

This is one provision I would like to see. I travel currently for my pain management care. I would like to see the sale of health insurance across state lines, as I believe it will offer me better in-plan coverage. Paying out of network is very costly for patients like myself.

As we allow the free market to play a bigger role, we must also make sure that no one slips through the cracks simply because they cannot afford insurance. We must review basic options for Medicaid and work with states to ensure that those who want healthcare coverage can have it. I don’t believe that basic Medicaid covers enough treatments for chronic pain patients.

I would also want multiple patient representatives and caregivers to play a role on boards and advisory committees that make these decisions. There is no plan in place for the involvement of the patient voice that I am aware of.

3. Allow individuals to fully deduct health insurance premium payments on their tax returns.

I would like the ability to fully deduct my health insurance premiums. Businesses are allowed to take these deductions, so why wouldn’t Congress allow individuals the same exemptions?

4.  Allow more individuals to use Health Savings Accounts (HSAs). Contributions to HSAs should be tax-free and should be allowed to accumulate from year to year. These accounts could become part of the estate of the individual and could be passed on to heirs. HSA funds could then be used by any member of a family without penalty. 

As someone who has participated in an HSA in past years, I found that they were not a benefit for me as a chronic pain patient. I spent everything in my HSA account as fast as it went in from my husband’s paychecks.

But for others who don't have to worry about paying for long-term chronic care needs, I have seen the HSA system work and help spread out costs throughout the year. HSA accounts would be particularly attractive to healthy young people with high-deductible insurance plans.  

5. Require price transparency from all healthcare providers, especially doctors and healthcare organizations like clinics and hospitals. Individuals should be able to shop to find the best prices for procedures, exams or any other medical-related procedure.

I believe in 100% price transparency from all providers, insurance companies, pharmacies and hospitals. We should be able to easily see the costs of our care.

6. Give Medicaid block grants directly to the states. Nearly every state already offers benefits beyond what is required in the current Medicaid structure. The state governments know their people best and can manage the administration of Medicaid far better without federal oversight. States will have the incentives to seek out and eliminate fraud, waste and abuse.

I like this as well. Giving each state the ability to fund and provide their own Medicaid benefits will be beneficial. We have to cut down on fraud and get proper and timely access of care to those who need it most.

7. Remove barriers that prevent foreign drug makers from offering safe, reliable and cheaper products. Congress will need the courage to step away from the special interests and do what is right for America. Allowing consumers access to imported and cheaper drugs will save money.

We need more abuse resistant medications, along with drugs that are more affordable. I agree that allowing consumers access to imported drugs will give us more options and help cut prices.

These seven steps are just the start of what we need to make the system work better. The process will take years to figure out. Let’s keep our voices loud as patients and advocates, so that we keep the good parts of our healthcare system and increase access for those who need it by lowering costs and opening access to alternative treatments. We also need to address the abuse of opioid medication, while maintaining access for those that truly need it. 

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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

Studies Promote Epidurals Without Explaining Risks

By Pat Anson, Editor

Two recent studies presented at a meeting of anesthesiologists are promoting the benefits of epidurals to relieve pain during child birth. But a woman whose spinal cord was permanently damaged by an epidural says new mothers need to be told more about the risks involved.

First, about those studies.

A study of over 200 women presented at the annual meeting American Society of Anesthesiologists found that epidurals – in addition to relieving labor pain – also appear to lower the risk of postpartum depression for new mothers.

"Labor pain matters more than just for the birth experience. It may be psychologically harmful for some women and play a significant role in the development of postpartum depression," said Grace Lim, MD, director of obstetric anesthesiology at Magee Women's Hospital of the University of Pittsburgh Medical Center.

"We found that certain women who experience good pain relief from epidural analgesia are less likely to exhibit depressive symptoms in the postpartum period."

The second study found that women who chose nitrous oxide – laughing gas – to manage labor pain get only limited relief. And a majority wind up getting an epidural anyway once the pain starts.

"Nitrous oxide is gaining interest among expectant mothers as an option to manage labor pain and is becoming more widely available in the United States," said Caitlin Sutton, MD, an obstetric anesthesiology fellow at Stanford University School of Medicine. "However, we found that for the majority of patients, nitrous oxide does not prevent them from requesting an epidural. While nitrous oxide may be somewhat helpful, but epidural anesthesia remains the most effective method for managing labor pain."

Epidurals are effective at relieving pain, but how safe are they?

“By far the gas is safest form of pain relief for women during labor, along with other non-invasive methods,” says Dawn Gonzalez, whose spinal cord was accidentally punctured by an epidural needle during childbirth. “Epidural anesthesia is the most popular form of anesthesia during labor, but women are rarely warned about the long term, devastating effects and consequences that some women will encounter.”

The injury to Gonzalez’s spine during the botched epidural led to the development of adhesive arachnoiditis, a chronic inflammation that caused scar tissue to form and adhere to the nerves in her spine. She now suffers from severe chronic pain and is disabled. Gonzalez says the pain she experiences today is far worse than the temporary labor pain she would have experienced without an epidural.

“The blind insertion of the epidural during birth is basically playing roulette for spinal damage. Normally birthing mothers are told the only side effect possible during epidurals is a spinal headache that lasts a few days. True informed consent is missing from the equation,” says Gonzalez.

“I often wish I could go back and decline the epidural because arachnoiditis has completely turned my life and that of my family upside down. I had so many dreams for the future with my children, and there is so much I miss out on and will never reach due to being injured during my epidural.”

The American Society of Anesthesiologists (ASA) has long defended the use of epidurals, calling the risk of complications a “myth.” The ASA has called the procedure “one of the most effective, safest and widely used forms of pain management for women in labor.”

A study of over a quarter million epidurals by the Society for Obstetric Anesthesia and Perinatology also found the risk of complications to be low. An “unrecognized spinal catheter” – what Dawn Gonzalez experienced – occurred in about one in 15,435 deliveries.

She thinks there are better and safer alternatives.

“Laughing gas, Lamaze, hypnotism, meditation, water birthing and even some medications are the absolute safest and most effective forms of labor pain relief. Every woman deserves to know that when she opts for any kind of invasive spinal anesthesia, the risks are very grave and by far much more common than anybody realizes,” Gonzalez says. “We have a tendency to think it will ‘never happen to me,’ but you do take very serious risks for yourself and your child when opting for an obstetric epidural.”

One hundred years ago, laughing gas was widely used in hospitals to relieve pain during childbirth, but it fell out of favor as more Caesarean sections were performed and women needed more pain relief.  Nitrous oxide helps reduce anxiety and makes patients less aware of pain, but it does not eliminate it. 

In the laughing gas study of nearly 4,700 women who gave birth vaginally at a U.S. obstetric center, only 148 patients chose to use nitrous oxide. Nearly two out of three wound up getting an epidural once labor began.

DEA Bans Opioid Found in Fake Painkillers

By Pat Anson, Editor

The U.S. Drug Enforcement Agency is banning a powerful synthetic opioid linked to dozens of fatal overdoses -- including the death of the late pop star Prince.

Effective Monday, the DEA is classifying U-47700 as a Schedule I controlled substance, making the sale and possession of the drug a felony. Known in law enforcement circles as “pink,” U-47700 is about 8 times stronger than morphine. It was originally developed in the 1970’s as a prescription pain reliever, but was never used for that purpose.  

U-47700 is now being manufactured by illicit drug labs in China and smuggled into the United States, according to the DEA.

“Evidence suggests that the pattern of abuse of U-47700 parallels that of heroin, prescription opioid analgesics, and other novel opioids. Seizures of U-47700 have been encountered in powder form and in counterfeit tablets that mimic pharmaceutical opioids,” the DEA said in a notice published in the Federal Register.

“Abusers of U-47700 may not know the origin, identity, or purity of this substance, thus posing significant adverse health risks when compared to abuse of pharmaceutical preparations of opioid analgesics, such as morphine and oxycodone.”

The DEA said at least 46 overdose deaths have been linked to U-47700 since 2015, including 31 in New York and 10 in North Carolina.

The actual number of deaths is probably higher, according to NMS Labs, a private forensic laboratory in Pennsylvania. The lab said it confirmed U-47700 in toxicology tests involving over 80 deaths nationwide in the first nine months of 2016.

“The recent rise in use of these novel drugs of abuse is contributing to the spiraling of deaths associated with opioid abuse, and is being seen across the country. Their incidence of use is probably underestimated since these drugs are frequently a blind spot for many forensic labs, because they are novel and the labs are not looking for them in their routine procedures,” Dr. Barry Logan, Chief of Forensic Toxicology at NMS Labs said in a statement.

U-47700 and fentanyl, another synthetic opioid, were part of a deadly cocktail of drugs found in toxicology tests on Prince, who died of an accidental drug overdose in April. Investigators believe the musician may have thought he was taking a legitimate painkiller.

Fentanyl and U-47700 have also been linked to an outbreak of deaths and hospitalizations in California involving counterfeit pain medication. A 41-year old woman who suffers from chronic back pain purchased pills on the street designed to look like Norco, the brand name of a prescription drug that contains hydrocodone.  

The woman became unconscious within 30 minutes of taking three of the counterfeit tablets. She next remembers waking up in a hospital emergency room and told hospital staff the pills had the markings of Norco, but were beige in color instead of the usual white. A blood serum analysis revealed the woman had significant amounts of fentanyl and U-47700 in her system.

Fentanyl is legally prescribed in patches and lozenges to treat severe chronic pain, but the DEA believes “hundreds of thousands of counterfeit prescription drugs” laced with illicit fentanyl are on the black market. The agency predicts more fake pills will be manufactured because of heavy demand and the “enormous profit potential” of counterfeit medication.

This temporary scheduling of U-47700 as a controlled substance will last for 24 months, with a possible 12-month extension if the DEA needs more data to determine whether it should be permanently banned.

Pain Patients Say Insurers Interfering with Treatment

By Pat Anson, Editor

It’s no secret that health insurance companies have been raising deductibles and co-pays, and generally making it harder for chronic pain patients to get treatment – whether it’s opioid pain medication or alternative therapy like massage or acupuncture.

But recent actions by some insurers have healthcare providers and patients saying the insurance industry has gone too far in its effort to reduce opioid abuse and is interfering with the doctor-patient relationship.

“My own insurance company just acted as a physician to remove the meds that I need by blackmailing a kind-hearted pain doctor,” says Jennifer Nelson, who has suffered from Reflex Sympathetic Dystrophy (RSD) in her left foot for nearly two decades.

The “blackmail” Nelson refers to is a form letter her pain management doctor received from Blue Cross/Blue Shield of Michigan warning that opioids, benzodiazepines and a muscle relaxant named Soma (carisoprodol) should not be prescribed together. Benzodiazepines such as Valium act as sedatives and are known to increase the risk of overdose when taken with opioids.

But Nelson says she’s used them safely for years to reduce pain, muscle spasms and to help her sleep.   

“Their threat is to pull their coverage from his office if even one patient tests positive for both opioids and benzodiazepines. So now my health insurance has become Big Brother?” said Nelson in an email to Pain News Network. She also included a copy of the form letter sent to her physician.

JENNIFER NELSON

“There is no legitimate medical indication for this combination of controlled substances,” the letter from Blue Cross/Blue Shield (BCBS) says. “If the diagnosis is opioid abuse or dependence, the continued use of sedatives is contradicted and the continued use of opioid analgesics is against DEA regulations. If the diagnosis is legitimately chronic pain, benzodiazepines are still contradicted as they lead to a downward spiral of pain control and function.”   

The only downward spiral Nelson feels is from having her Valium tapered.

“The muscle spasms came back with a vengeance,” she says. “The second night I woke up and I thought someone was pulling my leg off.”

 “I am very concerned that an insurance company states there is ‘no legitimate medical indication’ for the combination of opioids, benzo's and Soma,” says Lynn Webster, MD, past president of the American Academy of Pain Medicine.

“No (insurance) payer nor the DEA should be making this type of dogmatic statement.  Such a statement will be used by the DEA to prosecute any provider who prescribes this combination.  It is inappropriate for either a payer or the DEA to determine what a legitimate medical indication is for any single or combination of drugs prescribed.”  

Webster agrees that combining benzodiazepines with opioids is risky, but says Blue Cross/Blue Shield went too far.

“What is most lacking from the letter is an alternative.  BCBS has a responsibility to offer alternatives to the providers on how to treat anxiety in people who also have pain and or opioid addiction and anxiety,” Webster wrote in an email to PNN.

“I agree the combination of opioids and benzos and other CNS depressants should be avoided, but if the payer wants to practice medicine then they should make it clear that they will pay for cognitive therapy and other alternatives as long as it is needed or pay for other medications that are not as risky as benzos. It is unacceptable to just abandon people with pain, anxiety and/or addiction.”

Aetna “Super Prescribers” Warned  

The insurance company Aetna sent a similar letter to nearly 1,000 physicians in August, warning them about their opioid prescribing habits. The doctors were identified as “super prescribers” by Aetna after a review of insurance claims.

"You have been identified as falling within the top 1 percent of opioid prescribers within your specialty," the letter states.

Aetna’s chief medical officer told The Washington Post the letter was not meant as a threat, but merely a note of caution.

"We're asking you to look at your practice...and identify if the way you're prescribing narcotics is best practice," said Harold Paz, MD. "And if it's not, here's an opportunity to improve."

Kaiser Permanente – an HMO -- is also urging doctors in its network to reduce opioid dosages to those recommended by the Centers for Disease Control and Prevention. The CDC’s guidelines say prescribers “should avoid increasing dosage” over 90 mg of morphine equivalent units a day.

“That dose does nothing for me,” says Scott Michaels, who at age 55 is permanently disabled by severe back pain, arthritis and other chronic illnesses.

Michaels has a genetic condition that causes him to metabolize opioids quickly. For seven years, he’s been taking a daily opioid dose of 330 mg of morphine equivalent units – nearly four times what CDC and Kaiser Permanente recommend as a ceiling.

“I have a terrible metabolism so the medication goes right through me, hence the high dose. As of last month, Kaiser is reducing me 10% a month until I’m at 90 mg. I have no choice they said. The pain is already coming back and they don’t care,” said Michaels, who asked that we not use his real name.

“Kaiser is an insurance company and provider. To me that is a conflict of interest. I just don’t know what to do. It can’t be legal to withhold medication that has proven for me to work.”

Jennifer Nelson was also on a high dose of opioids that is now being reduced by her doctor to reach the levels recommended by the CDC. She says her health has deteriorated significantly and she’s worried about become bedridden.

“I lived a very high functioning life. My biggest fear is my seven year old not having a Mom to walk him to the bus stop," Nelson says. “Nineteen years and I've never overdosed or used my meds incorrectly. I submit to random urine tests and pill counts, and educated myself on my meds. So what do we do? Can insurance companies legally threaten doctors like that? And why are they quoting CDC guidelines when doing so? I'm infuriated. Exhausted, unable to sleep, gritting my teeth in pain, but infuriated.”

Insurers say their efforts to wean patients off high doses of opioids are producing results. Blue Cross/Blue Shield of California says its Narcotic Safety Initiative has resulted in an 11% reduction in members using the very highest doses and “prevented” 25% of all new opioid users from using the drugs for more than 90 days.  

Will these new policies also reduce the number of people dying from opioid overdoses?

Blue Cross/Blue Shield of Massachusetts – one of the first insurers to adopt tougher prescribing policies – says it has reduced the dispensing of opioids to its members by 15 percent since 2012.    But the new policies failed to slow the growing number of opioid overdose deaths in Massachusetts, which more than doubled.

Marijuana Legalized in Several More States

By Ellen Lenox Smith, Columnist

As we ponder the results of the presidential election, let’s not forget to celebrate the success throughout the country in increasing the number of states allowing access to medical and recreational marijuana.

Congratulations to voters in Florida, North Dakota and Arkansas for approving medical marijuana and providing a choice for patients to turn to. Also, Montana succeeded in expanding its medical marijuana program to include post-traumatic stress as a qualifying medical condition, along with raising the limit on the number of patients a doctor can certify from 3 to 25.

We are so happy for patients in these states! It will take time for them to get their programs up and running. Patience will be needed, but at least they are now on the right road. It will involve years of tweaking the program as patients learn to navigate the system.

Voters in California, Nevada, Massachusetts and Maine also approved the legalization of marijuana for recreational use. A recreational ballot proposal in Arizona was defeated.

It is very important that we keep and improve the integrity of medical marijuana programs as states expand into recreational use. This will become a big money maker for states and I assume the movement will grow fairly quickly as more states realize they can make billions of dollars in tax revenue.

I have always felt that recreational use was not our battle, preferring instead to focus on patients having access to medical marijuana. I appreciate that some want marijuana for use socially, but there are many of us struggling to live life with more dignity, which the use of medical marijuana provides for us. All citizens in the United States deserve the same rights and we are now over halfway there.

Our dream is for all people in this country to have medical marijuana as a choice. All deserve proper education on its use, a variety of strains to accommodate their various needs, patients and caregivers should be allowed to grow their own plants, and marijuana should be available at compassion centers or dispensaries at affordable prices. Also, we look forward to more consistency in qualifying medical conditions, which vary widely from state to state.

If you are in need of advocating in your state to improve your program or to try to get legislation to move forward, feel free to be in touch.

Ellen Lenox Smith suffers from Ehlers Danlos syndrome and sarcoidosis. Ellen and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition.

For more information about medical marijuana, visit their 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.

What Will Trump Election Mean for Pain Care?

By Pat Anson, Editor

The day after one of the biggest political upsets in American history, millions of chronic pain patients are wondering what a Donald Trump administration will mean for them.

President-elect Trump has repeatedly vowed to “immediately repeal and replace Obamacare,” but has not clearly defined what he would replace the Affordable Care Act with. Trump has also supported reductions in the supply of oxycodone, hydrocodone and other Schedule II opioids.

But perhaps the biggest change will be in leadership positions at federal agencies that set health care policies. That happens whenever a new administration takes office, but the changing of the guard this time will almost certainly mean the departure of several politically appointed administrators who played key roles in setting policies that many pain sufferers consider anti-patient.   

Health and Human Services (HHS) Secretary Sylvia Burwell – who presided over key policy decisions such as the CDC’s opioid prescribing guidelines and Medicare’s decision to drop pain questions from patient surveys – will be replaced.

Also likely to depart are CDC director Dr. Thomas Frieden, FDA commissioner Dr. Robert Califf, acting DEA administrator Chuck Rosenberg, and Surgeon General Dr. Vivek Murthy. All have endorsed policies harmful to pain patients.  

Murthy recently sent letters to over 2 million physicians urging them “not to prescribe opioids as a first-line treatment for chronic pain.”

Rosenberg has called medical marijuana "a joke" and recently tried to criminalize kratom as a Schedule I controlled substance, a move the DEA withdrew after widespread opposition from the public and some members of Congress.

In his short time as FDA commissioner, Califf has overruled some of the FDA’s own experts in endorsing the CDC guidelines and has instituted a series of policies at FDA aimed at reducing opioid prescribing.

Frieden’s departure from the CDC will likely lessen the influence of Physicians for Responsible Opioid Prescribing (PROP) at the agency. PROP founder Dr. Andrew Kolodny has a long association with Frieden, having worked for him when Frieden was commissioner of New York City’s Health Department. PROP President Dr. Jane Ballantyne continues to serve as a consultant to CDC, despite complaints that she has a conflict of interest.

The new heads of the CDC and DEA will be appointed by president-elected Trump, while the HHS Secretary, FDA commissioner, and the Surgeon General are nominated by the president and confirmed by the Senate.

According to Politico, one of the front runners to be nominated by Trump as HHS Secretary is Dr. Ben Carson, a former Republican presidential candidate and retired brain surgeon, who Trump has called a “brilliant” physician.

"I hope that he will be very much involved in my administration in the coming years," Trump said at a campaign rally.

Other names being mentioned for HHS Secretary are Florida Gov. Rick Scott, former House Speaker Newt Gingrich, and Rich Bagger, a pharmaceutical executive on leave from Calgene who is the executive director of Trump's transition team.

None of this means that a Trump administration will reverse any of the pain care policies at CDC, FDA and other federal agencies. Like most Republicans, Trump wants to reduce government regulations, not increase them. But as PNN reported last month, the president-elect has already indicated he supports measures to limit the supply of opioids.

“DEA should reduce the amount of Schedule II opioids -- drugs like oxycodone, methadone and fentanyl -- that can be made and sold in the U.S. We have 5 percent of the world’s population, but use 80 percent of the prescription opioids,” Trump said in prepared remarks at a campaign rally in New Hampshire. “I would also restore accountability to our Veterans Administration. Too many of our brave veterans have been prescribed these dangerous and addictive drugs by a VA that should have been paying them better attention.”

Trump wants the FDA to speed up the approval of opioid pain medication with abuse deterrent formulas. And he wants to increase the number of patients that a doctor can treat with addiction treatment drugs like buprenorphine (Suboxone).

"The FDA has been far too slow to approve abuse-deterring drugs. And when the FDA has approved these medications, the rules have been far too restrictive, severely limiting the number of authorized prescribers as well as the number of patients each doctor can treat," he said.

The president-elect has also pledged to stop the flow of fentanyl and other illegal drugs into the country.

“We will close the shipping loopholes that China and others are exploiting to send dangerous drugs across our borders in the hands of our own postal service. These traffickers use loopholes in the Postal Service to mail fentanyl and other drugs to users and dealers in the U.S.” Trump said.

“When I won the New Hampshire primary, I promised the people of New Hampshire that I would stop drugs from pouring into your communities. I am now doubling-down on that promise, and can guarantee you – we will not only stop the drugs from pouring in, but we will help all of those people so seriously addicted get the assistance they need to unchain themselves.”

Trump has personal dealings with addiction, having lost a brother to alcoholism at age 43. Watching the long downward spiral of his older brother Fred led Trump to a life-long aversion to alcohol, drugs and tobacco.

Fentanyl Deaths Rise Again in Massachusetts

By Pat Anson, Editor

Nearly three out of four opioid overdoses in Massachusetts have been linked to fentanyl, far outnumbering the number of deaths associated with prescription pain medication, according to a new report from the Massachusetts Department of Public Health. 

Massachusetts was the first state to begin using blood toxicology tests to look specifically for fentanyl, a powerful synthetic opioid that is more potent and dangerous than heroin. Toxicology tests are far more accurate than the death certificate codes used by the Centers for Disease Control and Prevention to classify opioid-related deaths. 

Over 1,000 confirmed cases of unintentional opioid overdoses were reported in Massachusetts in the first nine months of 2016. During the third quarter (July-September), 74 percent of the deaths where a toxicology screen was available showed a positive result for fentanyl.

Almost all of those deaths are believed to involve illicit fentanyl, not pharmaceutical fentanyl that is prescribed to treat severe pain.

“The data released today are a sobering reminder of why the opioid crisis is so complex and a top public health priority,” said Secretary of Health and Human Services Marylou Sudders. “This is a crisis that touches every corner of our state, and we will continue our urgent focus expanding treatment access.”

Only about 20 percent of the overdose deaths in Massachusetts were associated with prescription opioids such as hydrocodone and oxycodone, a trend that has held fairly steady since 2014, even as the number of opioid prescriptions in the state has declined.

Massachusetts department of public health

 "I think this points to the fact that cutting scripts for legitimate pain patients and blaming doctors for overdose deaths is pointing fingers in the wrong direction and harming a lot of innocent people living with debilitating pain while doing nothing to reduce overdose deaths – a critical goal,” said Cindy Steinberg of the U.S. Pain Foundation, a patient advocacy group. “People living with the disease of chronic pain and those living with the disease of substance use disorder are two different populations of people with little overlap.

“If we are committed to doing all we can to stop overdose deaths then the only way we can do that is to really understand what exactly is causing them. The fact that illicit fentanyl is the cause points to the need for increased law enforcement efforts to interdict the supply coming into Massachusetts.”

According to the Drug Enforcement Administration, chemicals used to make illicit fentanyl are being smuggled in from China and Mexico. Illicit fentanyl is usually mixed with heroin or cocaine, and it is also appearing in counterfeit pain medication sold on the black market. The drug is so potent that a single pill could be fatal.

Rhode Island is also using blood toxicology tests to help determine the true nature of the opioid epidemic. The most recent data from that state shows that about two out of three opioid overdoses are linked to fentanyl.  Since 2012, overdoses from prescription opioids have fallen by about a third in Rhode Island.

“The shifts in prescription and illicit drug overdose deaths also began roughly when more focused efforts were undertaken nationally to reduce the supply of prescription drugs,” the Rhode Island Department of Health said in a statement.

The CDC uses death certificate codes – not toxicology tests -- in its reports on opioid overdoses. The codes do not indicate the cause of death, only the conditions or drugs that may be present at the time of death. Because of limitations in the data, many overdoses involving illicit fentanyl and heroin are being reported by the CDC as prescription opioid deaths.

Does Canada Need ‘Enforceable’ Opioid Guidelines?

By Pat Anson, Editor

Canada should adopt nationwide “enforceable guidelines” to limit the prescribing of opioid pain medication and doctors should be sanctioned if they fail to follow them, according to a new commentary in the Canadian Medical Association Journal.

The head of the Chronic Pain Association of Canada called the proposed guidelines “another sad effort to punish people with pain.”

Like the United States, Canada has been hit by a wave of opioid overdoses – deaths increasingly attributed to heroin and illicit fentanyl, not pain medication. According to one estimate, over 1,000 Canadians have died so far this year from fentanyl overdoses.

But, like its neighbor to the south, Canada has been trying to fix the opioid problem by restricting access to pain medication.

“This crisis is only getting worse, and Canada urgently needs to implement effective measures aiming at and addressing the underlying drivers of the opioid epidemic,” writes lead author Benedikt Fischer, PhD, of the Centre for Addiction and Mental Health at the University of Toronto.

Fischer and his two co-authors specialize in addiction, mental health and epidemiology, not in pain management.

“Evidence of the therapeutic effectiveness of prescription opioids for pain is rather limited. Data show some benefits for treatment of acute pain, but evidence to support using opioids to treat long-term chronic pain is weak and insufficient,” they wrote.

Only in passing do Fischer and his colleagues even mention the rising number of deaths in Canada being blamed on illicit fentanyl – a synthetic opioid 50 to 100 times more potent than morphine.   

They propose several measures similar to the opioid prescribing guidelines released by the U.S. Centers for Disease Control and Prevention:

• Prescribe opioids in “the lowest possible dose and for the shortest possible duration”
• Establish prescription drug monitoring systems across Canada
• Develop a “national surveillance system” for opioid-related overdoses and emergency room visits
• Expand access to opioid addiction treatment

One key difference from the so-called “voluntary” guidelines of the CDC is a recommendation that Canada adopt “enforceable guidelines” that would allow for opioids to be prescribed only as “an exceptional treatment” and only when there is “good scientific evidence” for their use.

The guidelines would be similar to professional medical standards recently adopted in British Columbia and Nova Scotia, which make physicians in those provinces liable for professional, civil or even criminal sanctions if they don’t follow them.

Critics say the guidelines are having a chilling effect on both patients and prescribers.

“Limiting prescriptions of opioids will do absolutely nothing to stop this problem and just the notice of intent has already made the problem for pain sufferers worse,” said Barry Ulmer, executive director of the Chronic Pain Association of Canada.

“They are forcing patients on high doses to come off their medications, stopping family doctors from actually working with patients who have been in their care for years, and even giving names of patients on high doses to the police as potential dealers. One doctor had his practice visited by police with 3 names of patients and took their files for investigation.”

Like the United States, Ulmer says the debate over opioids in Canada is being led by addiction treatment specialists, not by pain management physicians.

As an example, he cites this month’s National Opioid Conference in Ottawa, which is being hosted by Canada’s Minister of Health. The invited keynote speaker is David Juurlink, MD, an academic toxicologist at Sunnybrook Health Sciences Centre in Toronto, who is also a board member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played an influential role in drafting the CDC guidelines.

“It is not a conference on opioids, but an addiction conference or more probably an effort to restrict opioids or just prohibit them,” said Ulmer. “It is clear what direction they are going in when they invite Juurlink to be the keynote speaker and have not invited some of the preeminent doctors who are experts in the use of opioids. Tantamount to medical malpractice. They don’t want to talk about the illicit problem because that destroys their whole argument.”

Health Canada is currently conducting a review of Canada’s opioid prescribing guidelines, which have not been updated since 2010. The Centre for Addiction and Mental Health in Toronto – Canada’s largest addiction treatment hospital -- released a report today urging Health Canada to pull all high-dose opioid medications off the market, according to The Globe and Mail.

CDC Satire Gets Taken Seriously

By Pat Anson, Editor

Everyone likes to be in on a good joke, but an article recently published online as medical satire is being taken seriously by some pain patients and healthcare professionals.

The article, published by Gomer Blog, claims the Centers for Disease Control and Prevention has released new recommendations urging doctors to ignore patients who have a pain score greater than 4. Pain levels are commonly measured on a scale of 1 to 10.

The Gomer Blog story even has a purported quote from the CDC's director:

“Look, here’s the deal.  When you say your pain is 1, 2, 3, or 4, that’s actually believable to health care providers, so we’ll give you Tylenol, maybe even an NSAID,” explained the Director of the CDC Dr. Thomas Frieden.  “When you start getting into that 5 through 9 territory, it starts getting a little suspicious.  And we all know that pain of 10 or greater than 10 is, well, honestly, just bullsh*t.  So greater than 4?  Ignore.”

That would be funny, except for the fact I can actually see Frieden saying that.

Another quote from the story is from a fictitious doctor:

“In today’s health care climate half of my day is spent arguing with patients about opioids,” said primary care physician Jamela Wilson.  “The other half of my day?  Arguing with patients’ significant others about opioids.”

I could see an actual doctor saying that, too.

Not a word of the Gomer Blog story is true. But in the current Bizarro World of pain care -- where Medicare is afraid to ask patients about their pain treatment, the CDC hires a PR company to improve its image, and the DEA declares kratom an "imminent public health hazard" and then decides maybe its not -- well, some people have trouble sorting fact from fiction. And who can blame them?

“Is this true? I'd love to see you guys write something about this,” asked one PNN reader, who included a link to a nurse’s training center in Florida that republished the Gomer Blog story on its website.  

The FTC Training Center, which says that its mission is “to support the lifelong education of nurses,” never mentions that the Gomer Blog story is meant as satire. The post was made by Florvilus Nessley, a program director at FTC, who offers training and certification for nurses on hepatitis, dementia, the Zika virus, urinary tract infections and therapeutic hypothormia. Interesting curriculum, Florvilus. 

Calls and emails to the FTC Training Center were not immediately returned, as they say.

Gomer Blog describes itself as a “satirical medical news website created by a bunch of wannabe stand up comedians who ended up in healthcare.”

Recent Gomer Blog posts include articles about an infectious disease clinic handing out free chastity belts and hospitals blocking TV coverage of the presidential election to promote healing.

I can see that happening, too.

Zebrafish Could Help Repair Human Spinal Cord Injuries

By Pat Anson, Editor

A freshwater fish popular in many home aquariums might hold the key to repairing damaged spinal cords in humans.

In a study published in the journal Science, Researchers at Duke University say the zebrafish is able to completely heal its spine -- even after it was severed -- because of a protein that helps to rebuild damaged spinal nerves.

"This is one of nature's most remarkable feats of regeneration," said the study's senior investigator Kenneth Poss, a professor of cell biology and director of the Regeneration Next initiative at Duke. "Given the limited number of successful therapies available today for repairing lost tissues, we need to look to animals like zebrafish for new clues about how to stimulate regeneration."

Poss and his colleagues say when the zebrafish's spinal cord is severed, dozens of genes are activated by the injury. Within days, they produce new molecules and proteins to bridge the gap between the severed spine. One of the proteins, called connective tissue growth factor (CTGF), appears to play a key role in regenerating glia nerve cells.

Within 8 weeks, new nerve tissue has filled the gap in the spinal cord and the zebrafish has fully reversed its paralysis.

"The fish go from paralyzed to swimming in the tank. The effect of the protein is striking," said lead author Mayssa Mokalled, a postdoctoral fellow at Duke. “We thought that these glial cells and this gene must be important.”

The zebrafish belongs to the minnow family and is native India, Pakistan and the Himalayan region. It is widely used in scientific research because if it’s regenerative abilities, and was the first vertebra to be cloned. A 2012 study published in The Journal of Neuroscience also documented the fish’s ability to bridge the gap between spinal nerve cells.

Humans and zebrafish share many genes, and the human CTGF protein is nearly 90% similar in its amino acids to the zebrafish’s.

Remarkably, when Duke researchers added the human version of CTGF to the severed spinal cords in zebrafish, it boosted regeneration and the fish began swimming two weeks after the injury.

Healing damaged spinal cords is more complex in mammals, in part because scar tissue forms around the injury. Researchers say CTGF is probably not sufficient on its own for people to regenerate their spinal cords, but further animal studies are needed.

"Mouse experiments could be key," Mokalled says. "When do they express CTGF, and in what cell types?"

The Duke research team also plans to follow up with other proteins that were secreted after injury, which may provide further hints into the zebrafish's ability to regenerate nerve cells.

"I don't think CTGF is the complete answer, but it's a great thing to have in hand to inform new ways to think about the real challenge of trying to improve regeneration," Poss said.

This research was supported by the National Institutes of Health, the Max Planck Society, and Duke University School of Medicine. Duke is seeking patent applications related to the research.

Medicare Pain Questions Being Dropped in 2017

By Pat Anson, Editor

Hospital patients will no longer be asked about the quality of their pain care under new rules released this week by the Centers for Medicare and Medicaid Services (CMS) for 2017.

Medicare uses a funding formula that rewards hospitals that provide good care and are rated highly in patient satisfaction surveys. Critics claimed that three questions in the survey asking patients about the quality of the pain care created a financial incentive for doctors to prescribe opioid pain medication to boost their hospital’s scores.

The three questions being dropped, which don’t even mention opioids, are as follows:

During this hospital stay, did you need medicine for pain?

During this hospital stay, how often was your pain well controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

CMS said it was still developing and field testing alternative pain questions to replace the ones being eliminated.

“Today’s final rule would address physicians’ and other health care providers’ concerns that patient survey questions about pain management in the Hospital Value-Based Purchasing program unduly influence prescribing practices," CMS said in a statement.

"While there is no empirical evidence of such an effect, we are finalizing the removal of the pain management dimension of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey… to eliminate any financial pressure clinicians may feel to overprescribe medications.”

The American Medical Association (AMA), one of the groups that lobbied CMS to drop the pain questions, applauded the move.

"CMS understands that these policies effect how physicians practice medicine and how patients receive treatment," said AMA President Andrew Gurman, MD, in a statement. "By listening to our concerns, CMS made clear that patient care was the top priority. We look forward to continuing to work with CMS to improve patient health and enhance access to affordable quality care."

CMS was under intense political pressure to drop the pain questions. Twenty-six U.S. senators sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell claiming “physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance."

Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group,also said the patient survey "fosters dangerous pain control practices."

But a top Medicare official disputed those claims in an article published in JAMA, saying “nothing in the survey suggests that opioids are a preferred way to control pain.”

Pain patients have long complained about the poor quality of their treatment in hospitals. In a survey of over 1,250 patients by Pain News Network and the International Pain Foundation, nine out of ten said patients should be asked about their pain care in hospital satisfaction surveys. Over half rated the quality of their pain treatment in hospitals as poor or very poor, and over 80 percent said hospital staffs are not adequately trained in pain management.