Researchers Say NSAIDs Cause Heart Damage

By Pat Anson, Editor

Researchers have known for many years that non-steroidal anti-inflammatory drugs (NSAIDs) increase the risk of heart attack and stroke. Now they may finally be learning why the pain relievers can be harmful.

In experiments on heart cells from rats and mice, scientists at the University of California, Davis, found that NSAIDs reduced the activity of cardiac cells at pharmacological levels found in humans. Their study was recently published in the Journal of Molecular and Cellular Cardiology.

“We knew these non-steroidal anti-inflammatories had negative side effects for heart disease and stroke risk, “ said lead author Aldrin Gomes, a UC Davis associate professor of Neurobiology, Physiology and Behavior. “But now we have an idea of some of the mechanisms behind it.”

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

Several studies have found that NSAIDs increase the risk of cardiovascular disease and other health problems, but the exact cause has been unclear.

The UC Davis researchers compared naproxen, considered the safest over-the-counter NSAID, with a more potent anti-inflammatory, the prescription drug meclofenamate sodium (MS).

They found that MS increased reactive oxygen species, impaired mitochondrial function, decreased proteasome function, and increased cardiac cell death. Naproxen did not affect proteasome function or cause heart cells to die, but it did impair mitochondrial function and increase reactive oxygen species produced in cardiac cells.

“We were surprised to see that many of the NSAIDs we tested were causing the cardiac cell to die when used for prolonged periods,” said Gomes. “Some people are taking these drugs too often, and this is a problem. These drugs are abused.”

For moderate pain, Gomes suggests rubbing an anti-inflammatory topically onto the pained area, which would not expose the entire body to the drug. Taking an antioxidant like vitamin C before ingesting a NSAID may also reduce cardiac cell death.

Last year the U.S. Food and Drug Administration ordered warning labels for all NSAIDs to be strengthened to indicate they increase the risk of a fatal heart attack or stroke. The agency said studies have shown the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

The FDA said people who have a history of heart disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk. But the risk is also present for people who don't have heart problems.

“Everyone may be at risk – even people without an underlying risk for cardiovascular disease,” said Judy Racoosin, MD, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.

In a major study published recently in the European Heart Journal, a number of leading heart specialists warned that there is no "solid evidence" that NSAIDs are safe.

"When doctors issue prescriptions for NSAIDs, they must in each individual case carry out a thorough assessment of the risk of heart complications and bleeding. NSAIDs should only be sold over the counter when it comes with an adequate warning about the associated cardiovascular risks. In general, NSAIDs are not be used in patients who have or are at high-risk of cardiovascular diseases," said co-author Christian Torp-Pedersen, a professor in cardiology at Aalborg University in Denmark.

Prince Sought Addiction Treatment Before Death

By Pat Anson, Editor

The late pop icon Prince was planning to meet with an addiction treatment doctor in the hours before he died in a last ditch effort to kick an addiction to opioid painkillers, according to the Minneapolis Star Tribune.

Howard Kornfeld, MD, an opioid addiction specialist in California, was called by Prince representatives the night of April 20 because Prince “was dealing with a grave medical emergency,” according to William Mauzy, a prominent Minneapolis attorney working with the Kornfeld family.

Prince’s body was found the next morning in an elevator at his Minneapolis home. An autopsy has been performed and the body cremated, but the official cause of death has not yet been released. Foul play or suicide are not suspected.

Kornfeld, who runs Recovery Without Walls, an upscale addiction treatment center in Mill Valley, California, is considered a pioneer in the use of buprenorphine to treat both addiction and chronic pain. The medication has long been sold under the brand name Suboxone, but is usually prescribed just to treat addiction.

Kornfeld was unable to meet with Prince immediately, but planned to fly to Minneapolis for “a lifesaving mission” on April 22. 

“The plan was to quickly evaluate his health and devise a treatment plan,” Mauzy told the Star Tribune, which said several other sources corroborated Mauzy’s account.

Kornfeld’s son Andrew took a red-eye flight to Minneapolis on the morning of April 21 to lay the groundwork for Prince’s treatment program with his father. He was one of three people at Prince’s Paisley Park compound when the entertainer's body was found.

Mauzy said Andrew Kornfeld was the one who called 911 because the others “were in too much shock.” Kornfeld did not know the address and could only tell the dispatcher, “We’re at Prince’s house.”

Paramedics arrived within five minutes but were unable to revive the 57-year old Prince.

Sources told the Star Tribune that painkillers were found at the scene and have become the focus of the investigation.  Investigators are trying to determine where Prince got the pills and who prescribed them.

Andrew Kornfeld reportedly had a small amount of buprenorphine to give to Prince, but it was never administered, according to Mauzy.

The Star Tribune story appears to add credence to reports in TMZ and other tabloids that Prince suffered from chronic hip pain and was addicted to opioid pain medication. Just days before his death, TMZ said Prince’s plane made an emergency landing in Moline, Illinois, where he was briefly hospitalized for an overdose of Percocet. He left against medical advice and flew back to Minneapolis a few hours later.

Survey: Painkillers Bigger Problem than Alcohol

By Pat Anson, Editor

A new poll is adding further fuel to the fire over opioid abuse and the disproportionate amount of attention it gets compared to other health problems.

The survey by the Kaiser Family Foundation found that two-thirds of Americans consider the abuse of opioid pain medication an extremely or very serious problem. And four out of ten said they knew someone who was addicted to prescription painkillers, often a close friend or family member.

The problem is so serious that more Americans now consider painkillers a bigger problem than alcohol (66% vs. 57%), even though four times as many Americans die from alcohol related causes than from opioids.

Nearly 19,000 Americans died from prescription opioids in 2014, according to the Centers for Disease Control and Prevention. The National Institutes of Health estimates 88,000 people die annually from alcohol related causes.

Alcohol misuse is also estimated by NIH to cost the U.S. economy nearly $250 billion annually, while the “economic burden” of opioid abuse was estimated by the DEA at $53 billion in 2011.   

The Kaiser Foundation poll comes in the middle of an election season, as the White House and Congress consider various funding measures to address the so-called epidemic of opioid abuse and addiction.

The survey found that a large majority of Americans believe federal and state governments, doctors, and individuals who use prescription opioids are not doing enough to fight opioid addiction. Only about a third said police officers weren’t doing enough to enforce drug laws, a sign that many Americans don’t consider opioid abuse just a law enforcement issue.

Asked which policy efforts would be very or somewhat effective in reducing opioid abuse, over eight in ten said doctors and medical students should have better training in pain management and that there should be increased access to addiction treatment programs.  Less than half said putting warning labels on prescription opioids explaining the risk of addiction would be effective. Respondents were not asked if access to opioid pain medication should be reduced.

Policies Rated Very or Somewhat Effective in Fighting Opioid Abuse

• 88% Increase pain management training
• 86% Increase access to addiction treatment
• 84% Public education and awareness programs
• 83% Increase research about pain and pain management
• 82% Monitor doctors’ prescribing habits
• 63% Encourage disposal of extra pain meds
• 60% Reduce stigma of opioid addiction
• 48% Put addiction warning labels on opioid bottles

Putting the issue in perspective, while most Americans consider painkiller abuse a serious problem, the issue ranks well behind several other health problems such as cancer, diabetes, obesity and heart disease.

Health Problems Considered Extremely or Very Serious

• 86% Cancer
• 78% Diabetes
• 74% Lack of access to mental healthcare
• 73% Obesity
• 72% Heart disease
• 71% Contaminated drinking water
• 70% Heroin abuse
• 66% Painkiller abuse
• 61% Lack of access to healthcare
• 57% Environmental contamination
• 57% Alcohol abuse
• 54% Lack of access to affordable food

The Kaiser Foundation survey was conducted in mid-April in a random telephone sample of 1,201 American adults. The poll is estimated to have a sampling error of 3 percent.

To see the complete results of the Kaiser poll, click here.

FDA Approves New Version of Oxycodone

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended released version of the opioid painkiller oxycodone that has abuse deterrent properties unlike anything else on the market.

The drug – called Xtampza – can be ingested in capsule form, but users can also sprinkle the capsule contents on soft foods or into a cup, and then directly into the mouth.

The medication, which can also be ingested through a feeding tube, is the sixth opioid pain medication with an abuse deterrent formula to be approved by the FDA.  

Xtampza is made by Massachusetts-based Collegium Pharmaceutical (NASDAQ: COLL) with proprietary technology that combines oxycodone with fatty acid and waxes to form small spherical beads that are placed inside the capsule.

The beads are designed to resist breaking, crushing, chewing, dissolving and melting, methods long used by drugs abusers to snort or inject opioids.  

collegium pharmaceutical image

That novel approach is different from other abuse deterrent formulas, which generally make it harder for tablets to be crushed or liquefied; or come with a chemical irritant to discourage tampering.

“The FDA approval of Xtampza ER is a major milestone for Collegium. Our DETERx technology platform was developed internally and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids,” said Michael Heffernan, CEO of Collegium.

Another advantage of Xtampza is that it gives an alternative to patients who have trouble swallowing tablets or capsules, a condition know as dysphagia.  

"People like me live with dysphagia that prevents us from swallowing normally all the time. Up until this new drug coming out, people not able to swallow have had to rely on liquids and patches for relief - not being able to take their oxycodone," said PNN columnist Ellen Lenox Smith, who suffers from Ehlers Danlos syndrome and sarcoidosis. She testified in favor of Xtampza's approval for the U.S. Pain Foundation.

"Although this is a medication not compatible to my body, I testified on it's behalf for those people around the country not able to take their medications and thus not getting the relief they deserve. I am thrilled that this got approved so soon and that people will have this as an option and hope that this safer  formula will help to calm the nerves of all the people out there concerned about addiction to opiates," Smith said.

“Xtampza ER also allows for flexible dosing administration for patients with difficulty swallowing. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which can be very dangerous with currently marketed ER products,” said Dr. Jeffrey Gudin, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center.

Xtampza, which is designed to be taken twice a day by patients who need around-the-clock pain relief, comes with an FDA warning to take the medication with food. Taking it on an empty stomach could lead to inadequate pain control.

Collegium plans to launch Xtampza ER in the U.S. in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg and 40 mg oxycodone.

Tennessee Pain Clinics to Stop Using Opioids

By Pat Anson, Editor

One of the largest healthcare systems in Tennessee will no longer prescribe long term opioid pain medication to patients at two of its pain management clinics.

The move is the latest fallout from the prescribing guidelines released last month by the Centers for Disease for Prevention (CDC), which discourage the use of opioids for treating chronic pain. Although the CDC guidelines are voluntary and meant only for primary care physicians, many doctors around the country are adopting them and either weaning their patients off opioids or cutting them off entirely.

"This change was considered for several months in response to changing regulations and increasing national opiate addiction rates, and we began notifying physicians and patients of this decision in early April," Jerry Askew, Tennova Healthcare’s vice president of external relations said in a statement.

Tennova Healthcare is managed by the Sisters of Mercy, an organization of Roman Catholic nuns. Tennova operates a chain of 17 hospitals in Tennessee, but its new opioid policy only applies to patients at two pain clinics affiliated with Tennova hospitals in Knoxville and Turkey Creek.  

“After 30 days of your receipt of this letter, we no longer plan to provide long-term opiate pain medication to our patients,” Tennova said in a letter to patients.

“While pain medication therapy is widely used, non-opiate alternatives can be equally effective and can be generally safer for the patients who use them. The Center in Knoxville will continue to provide effective and compassionate treatment with non-opiate options including non-opioid pain medications, interventional procedures such as injections and radiofrequency ablations; referral to neurology and spine specialists; physical and aquatic therapy; weight loss strategies; acupuncture; massage therapy; and lifestyle counseling programs.”

But many of those alternative treatments do not work and are not covered by insurance, according to a recent survey of over 2,000 patients by Pain News Network and the International Pain Foundation. Three out of four patients said over-the-counter pain relievers did not help them at all and over half said non-opioid prescription drugs like Lyrica and Cymbalta are also ineffective.   

Tennessee has one of the highest rates of opioid abuse in the country. The state took a series of steps last year to limit opioid prescribing, such as requiring pharmacies to limit opioids to a 30 day supply and requiring doctors at pain clinics to regularly give patients urine drug tests.

"The bottom line is that fewer opioid prescriptions are being written and fewer Tennesseans are experiencing the downside and disastrous consequences of a painkiller addiction," said Douglas Varney, commissioner of the Department of Mental Health and Substance Abuse Services. "We are succeeding in reducing the number of prescriptions being written. We have helped more people into treatment and recovery and rallied a new generation of Tennesseans to live a life free of addiction."

But patient advocates say the crackdown on painkillers is unfairly focused on pain sufferers, not on the addicts who abuse opioid medication.

“I am seeing literally hundreds of reports from people who are being denied renewal of opioid meds which work well for them and are frequently the only medical treatments that give them any quality of life. Doctors are giving up their pain management practices for fear of prosecution by the DEA,” said Richard Lawhern, PhD, who became an advocate after his wife developed trigeminal neuralgia, a chronic facial pain disorder.

“I am convinced that the CDC guidelines are creating what we will later recognize to be a wave of patient suicides due to resurgent pain and hopelessness, as well as a surge in patients seeking out street drugs because they cannot function without pain relief and are being forced by their doctors to do so.”

In recent weeks, at least 14 people died and dozens were hospitalized in California after ingesting counterfeit pain medication made with illicit fentanyl, a powerful and deadly analgesic. Some of the victims were pain patients. Fake pain pills are being sold by dealers in the Sacramento and San Francisco Bay areas, and have also been intercepted at the California-Mexico border.

Counterfeit Pain Pills Spread in California

By Pat Anson, Editor

At least seven people in the San Francisco Bay Area sought medical help after ingesting counterfeit pain medication laced with fentanyl, according to a new report from the Centers for Disease Control and Prevention (CDC).  The cases were reported in Contra Costa, Alameda, San Francisco and Santa Clara counties.

The fake pills were disguised to look like Norco, a widely prescribed opioid pain medication that combines hydrocodone with acetaminophen.

The pills are similar to counterfeit medication blamed in recent weeks for 14 fatal overdoses in the Sacramento area, except that they contain promethazine, an antihistamine that acts as a sedative and is sometimes used to boost the “high” from illicit opioids.

At least one of the fake tablets was also found to contain cocaine.

california poison control system

The CDC said all of the Bay Area patients had symptoms of opioid intoxication, but recovered within 24 hours. The pills were obtained from friends or bought off the street.  The outbreak lasted about two weeks, from March 25 to April 5, but was not publicly reported until today. There was no explanation for the three week delay in reporting what the CDC considers a "serious public health threat."

“The distribution of counterfeit medications, especially those containing fentanyl, is an emerging and serious public health threat,” the CDC said. “Efforts to identify the source of the current counterfeiting are ongoing. Patients with signs and symptoms of acute opioid overdose including central nervous system and respiratory depression, and in whom larger doses of naloxone are required to reverse symptoms, should raise suspicion for intoxication with a counterfeit product containing fentanyl.”

The CDC calls opioid abuse “the fastest-growing drug problem in the United States” and has often blamed that trend on prescription pain medication. However, as Pain News Network has reported, prescriptions for most opioids have actually been in decline for several years, especially for hydrocodone, at a time when opioid overdose deaths are rising.

Illicit fentanyl is a dangerous and sometime deadly opioid that is 50 times more potent than morphine. It has been blamed for thousands of overdose deaths in the U.S. and Canada. Last year, the DEA issued a nationwide public health alert for acetyl fentanyl, a synthetic opioid produced by illegal drug labs in China and Mexico. Acetyl fentanyl is virtually identical to prescription fentanyl, a Schedule II controlled substance that is often used in patches to treat more severe forms of chronic pain.

Acetyl fentanyl typically is mixed with heroin and cocaine to make the drugs more potent, but is increasingly showing up in pill form – usually disguised as pain medication.

In February, a smuggler was caught with nearly 1,200 fake oxycodone pills at the California-Mexico border, the first time counterfeit pain medication made with fentanyl was seized at a border crossing in California.

In March, the DEA arrested four men in southern California who were operating four large pill presses to make counterfeit hydrocodone and Xanax, an anti-anxiety medication. At least two people died in Orange county late last year after ingesting fake Xanax made with fentanyl. Counterfeit medication has also recently been reported in Florida and Ohio.

Last month the CDC adopted guidelines that discourage primary care physicians from prescribing opioids for chronic pain. Several pain patients have told PNN recently that their doctors are now reducing their opioid doses or cutting them off entirely.

“Since the guidelines changed, my quality of life has been destroyed & relentless suffering has become my identity,” wrote a pain patient who said she lost access to the opioid medication she’s been using for pain relief for a dozen years.

“I never considered using drugs for anything other than what & how they were prescribed. I can't say the thought of seeking relief from constant suffering hasn't flirted with the possibility of something a little less legal, or regulated. The fact that I've considered something so obscene makes me sick, but the fact that my healthcare providers were forced to allow me to suffer & reach such a point of desperation is disgusting.”

In a survey of over 2,000 pain patients last fall by Pain News Network and the International Pain Foundation, 60 percent predicted patients would get opioids off the street or through other sources if the CDC guidelines were adopted. Another 70% said use of heroin and illegal drugs would increase.

Will CDC Opioid Guidelines Help Reduce Overdoses?

By Lynn Webster, MD, Guest Columnist

Politicians and some government officials tell us that the new CDC opioid guidelines will reduce deaths due to overdoses. But, based on the evidence we’ve seen so far, that is unlikely.

The latest CDC report shows a continual increase in opioid-related overdose deaths despite about a 25% decrease in the number of opioids prescribed.  This data demonstrates that an absolute reduction in opioid prescribing hasn’t resulted in the intended outcome – so far, at least. It may be counter-intuitive, but I think you’ll understand why in a moment.

The problem is more complex than the lawmakers, CDC, and regulators would have us believe. Simply reducing the amount of opioids prescribed will not necessarily affect overdose death rates as you might expect. In fact, it might do just the opposite.

What happens is that, when we reduce the amount of opioids that are prescribed, we force many of those with opioid addictions to switch to illegal opioids such as heroin and synthetic fentanyl, which are far more dangerous than prescription opioids.

If the amount of opioid prescribing were reduced dramatically, it would likely reduce the number of deaths from prescription opioids. But there would almost certainly be a significant increase in abuse of other drugs. That could result in more overdoses than we’re seeing now. We’ve already seen more deaths due to the increased use of heroin, but heroin is only one of many illegal drugs that can be abused.

Reducing the supply side of the addiction problem does not address the demand for opioids, nor does it help address the needs of people with the disease of addiction.

Of course, additional “collateral harm” can occur with people in pain who benefit from opioids, and it is unacceptable to any person with compassion. Denying prescriptions to people who have been benefiting from opioids is a misguided attempt to save the lives of people with opioid addictions at the expense of people with pain.

People with pain will suffer, and that suffering won’t save the lives of people with addictions who turn to illegal substances. Additionally, in all likelihood, we will see an increase in suicides from people who just cannot live with their level of pain.

There are about 104 suicides per day (compared to 44 opioid-related overdoses per day). In my opinion, intractable pain is a contributing factor in many of these suicides. I suspect that, as we see more and more people denied opioids for their pain, we will see an increase in the number of suicides. I base this on my experience of seeing many patients commit suicide in my practice despite having access to all of the available treatments.

Severe pain is not always compatible with choosing to live.

Reducing deaths related to over-prescribing opioids would be a good thing and must be a priority. But, if we want to reduce the amount of opioids prescribed for people in pain, then we must provide them another, safer way to handle their pain.

Trading opioid-related deaths for either death related to illegal drugs or to suicides because of pain, is not an acceptable solution. We need something better to offer people in pain, and we need it soon.

Lynn R. Webster, MD, is past President of the American Academy of Pain Medicine, Vice President of scientific affairs at PRA Health Sciences, and the author of “The Painful Truth.”

This column is republished with permission from Dr. Webster’s blog.

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.

FDA Nearing Decision on Drug Implant

By Pat Anson, Editor 

The U.S. Food and Drug Administration is expected to finally make a decision next month on a new drug delivery system to treat opioid addiction – an implant that could also be used someday to treat pain and other chronic illnesses that require steady doses of medication.

The latest results from a Phase 3 double blind study of a buprenorphine implant called Probuphine would appear to boost its chances of winning FDA approval. Titan Pharmaceuticals (NASDAQ: TTNP) said over 85% of the patients who had the implant for six months abstained from using illicit opioids, compared to about 72% of patients who used oral buprenorphine film strips that were taken daily.

The study findings were recently presented at the annual meeting of the American Society of Addiction Medicine in San Francisco.

"This was the first head-to-head comparison study of Probuphine and sublingual buprenorphine, demonstrating the efficacy of a long-acting six month buprenorphine implant," said lead investigator Richard Rosenthal, MD, Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai. “If approved, Probuphine could help expand access to medication to treat opioid use disorders, providing people with a new option."

titan pharmaceuticals image

Probuphine is about the size of a matchstick and is implanted under the skin. For six months it delivers a steady dose of buprenorphine, a weaker acting opioid that’s long been used as an addiction treatment drug sold under the brand name Suboxone.

There are many advantages to an implant. The dosage is controlled and there’s little risk of abuse, diversion or overdose. Users also never have to remember to take a pill.

Probuphine’s path to the marketplace has been rocky at times. Titan and its partner, Braeburn Pharmaceuticals, were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study proving Probuphine’s effectiveness.  

Positive results from a Phase 3 trial were submitted in 2015 and in January of this year an FDA advisory committee voted 12 to 5 in favor of approving the implant. But then the agency added another delay by extending its decision date to May 27.  

The time may be ripe for approval this time around, as the FDA is under intense political pressure to do more to address the nation's opioid abuse epidemic. The Obama administration has proposed a rule change that would double the number of patients that a doctor can treat with buprenophine from 100 to 200. And Congress is considering funding proposals that would allocate another $1 billion to the war on drugs, with most of the money spent on addiction treatment.

Probuphine was developed using a patented implant technology called ProNeura, which is designed to provide continuous levels of medication in the blood. Titan is also developing implants to treat Parkinson’s disease and hypothyroidism, and its CEO told Pain News Network in a recent interview that ProNeura could also potentially be used to deliver pain medication.

“Clinical studies will need to be done to establish the ability, but the drug levels can certainly be delivered that are going to be beneficial for treating chronic pain,” said Titan CEO and President Sunil Bhonsle. “There are many applications for this technology and I think the medical community is now more in tune with looking at long-term delivery technology in the chronic disease setting.”

Prince Treated for Opioid Overdose Days Before Death

By Pat Anson, Editor

Pop icon Prince suffered from chronic pain and was treated for an opioid overdose just days before his death, according to tabloid reports.

Prince’s body was found Thursday in an elevator at his compound in Minneapolis. A cause of death has not yet been determined.

According to TMZ, Prince was treated at a hospital in Moline, Illinois last Friday when his private jet made an unscheduled landing after a concert in Atlanta. Initial reports were that Prince was treated at the hospital for the flu, but TMZ reported he may have needed emergency treatment for an overdose.

“Multiple sources in Moline tell us, Prince was rushed to a hospital and doctors gave him a ‘save shot’ ... typically administered to counteract the effects of an opiate,” TMZ said.

A “save shot” most likely means an injection of naloxone, a life-saving drug that quickly reverses the effects of an opiate overdoses.

TMZ later updated the story to say that Prince was actually given the injection by paramedics at a local airport and then taken to the hospital.

“Our sources further say doctors advised Prince to stay in the hospital for 24 hours. His people demanded a private room, and when they were told that wasn't possible ... Prince and co. decided to bail. The singer was released 3 hours after arriving and flew home,” TMZ said.

An autopsy was performed on the body of 57-year old entertainer this morning, but preliminary findings and a toxicology analysis could take days or weeks.

"As part of a complete exam, relevant information regarding Mr. Nelson's medical and social history will be gathered," the coroner said in a statement, referring to Prince as Rogers Nelson, his birth name. TMZ said authorities were trying to obtain Prince’s hospital records in Moline.

"We have no reason to believe it was suicide," said Carver County Sheriff Jim Olson, who also refused to address reports that Prince had overdosed last week.

"I'm not able to confirm that at this time at all," Olson said. "There have been so many rumors out that I've read about. I don't know if I can dispel all the rumors that are out there."

Prince reportedly suffered from hip problems for over a decade and needed a double-hip replacement. But as a devout Jehovah’s Witness, he would not have a blood transfusion, which made surgery nearly impossible.

“Prince has suffered for years,” a source told The National Enquirer in January. “It’s harder for him to get around.”

The Enquirer said years of strutting and dancing onstage had taken a toll on Prince’s joints and he may have suffered from severe osteoarthritis. 

“If he ignores the doctor’s advice, his walking will become impaired,” said Dr. Stuart Fischer, who did not treat Prince. “He’ll need a cane or a wheelchair for the rest of his life.”

Prince appeared hobbled and used a cane during the 2013 Grammy Awards, but in the past he has also used canes as a fashion accessory.

Prince was seen leaving a Walgreens pharmacy the night before his death. It was his fourth visit to the pharmacy this week. An employee there said he looked frail, according to TMZ.

Don't Flinch From Prescribing Pain Medications

By Forest Tennant, MD, Guest Columnist

By now chronic pain patients and practitioners are well aware of the new Center for Disease Control and Prevention (CDC) “Guidelines for Opioids for Chronic Pain” released on March 15, 2016. Although these guidelines have been, and will continue to be, strongly criticized for the process by which they were created, they are now published.

One of the often stated goals of CDC, despite widespread skepticism from many pain specialists, is that they did not want to limit access to pain care. Let’s take them at their word.

A major “bone of contention” regarding the guidelines is the recommendation that a daily dose of opioid should seldom go over 90 mg equivalents of morphine a day. In the CDC’s words:

“Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to 50 morphine milligram equivalents (MME) or more per day, and should avoid increasing dosage to 90 MME or more per day or carefully justify a decision to titrate dosage to 90 MME or more per day.”

Thankfully, few chronic pain patients require more than 90 MME for pain management. Be alert, however, to the fact that 90 MME in the guidelines is not a maximum ceiling dose but a “trigger” or “call” for a medical-necessity evaluation, including a possible consultation or referral to a pain specialist.

My personal objection about all the new opioid prescribing guidelines, including CDC’s, is that they seem to want all patients on high-dose opioids to be managed by pain specialists rather than primary care physicians (PCPs).

Unfortunately we don’t have enough pain specialists to medically manage these legitimate, suffering patients who can’t function or leave the couch without an opioid dosage above 90 MME.

While the intent of the CDC to have the most serious pain patients managed strictly by pain specialists may be laudable, this won’t solve our nation’s epidemic of untreated and undertreated chronic pain. Incidentally, the new guidelines rightfully mention all the risks of high-dose opioids, such as addiction, diversion, and overdose; but they wrongfully fail to mention all the serious, life-shortening, and physiologic impairments that are the risks of undertreated, severe, chronic pain.

Sadly, without opioids, some of these unfortunate individuals will suffer immense physical dysfunction, endocrine failure (see Hormone Testing and Replacement), cardiovascular collapse, immune dysfunction, dementia, and premature death.

This memo is a plea to not discharge severe pain patients who are currently taking over 90 MME or avoid and deny patients who may need this level of opioid in the future. Be aware that the CDC guidelines do not prohibit dosages over 90 MME—what they rightly recommend is that physicians do an assessment and document medical necessity for dosages above that level.

Here are my personal practice policies and recommendations for dealing with past, current, and future patients who require over 90 MME:

The pain practitioner has to clearly state, in the patient’s chart, that the patient has severe chronic pain due to a specific underlying cause. For a patient to receive high-dosages of opioids, the physician must obtain and document the history, relevant physical exam, laboratory data, informed consent, and past records of treatments that have been tried.

Opioids should not be prescribed in isolation. Rather than just continuing to increase the dose, the physician needs to revisit what other modalities are being used or have been tried. These include: non-opioid medications such as an anticonvulsant if the pain has neuropathic elements, (being certain to titrate up to an effective dose); a topical medication such as Lidoderm patch, Voltaren gel, etc.; a physical therapist-guided home exercise program and other physical activities, including massage; consultation with an interventionist if appropriate; assessment and treatment of co-occurring anxiety or depression.

The new guidelines, in my opinion, could worsen a growing problem of access to medication. Already, in some locales, patients can’t obtain prescriptions and insurance companies don’t want to pay for opioids (or much else!!). If patients need a high, costly opioid dosage, they must personally determine the limits of their insurance coverage and identify pharmacies that will supply opioid medications.

We physicians can help but none of us has the time or influence to help every pain patient with his or her personal supply of medication and insurance issues. Simply stated, a patient must be an active rather than traditional, passive patient: pain patients must now join advocacy groups and begin to lobby for their right to obtain opioids and avoid an agonizing existence and premature death.

Millions of chronic pain patients now take opioids responsibly and constructively. While opioids aren’t for everybody, many pain patients who are taking high-dose opioids have enhanced their overall health, achieved a decent quality of life, and have likely extended their life span. These patients don’t abuse, divert, or overdose on their opioids, and they don’t develop hyperalgesia or the need to continually escalate their dosage. Isn’t it time we pay as much attention to these worthy folks as those who non-comply, abuse, and overdose?

Dr. Forest Tennant is pain management specialist in West Covina, California who has treated chronic pain patients for over 40 years. He has authored over 300 scientific articles and books, and is Editor Emeritus of Practical Pain Management.

This column is republished with permission by Practical Pain Management, which featured the opinions of several other practitioners on the CDC guidelines this month. You can see them all by clicking here.

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.

Pain and Addiction Should Be Treated Separately

By Emily Ullrich, Columnist

Once again, the lack of humanity, honesty, and desire to provide quality pain care to patients on the part of doctors, hospitals, and medical and government organizations has astounded me.

Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), whose name seems to be six degrees of separation from all movements to thwart proper pain care, has submitted a petition asking Medicare to stop requiring hospitals to survey patients about the quality of their pain management.

A group of U.S. senators has gone even further, introducing the PROP Act in Congress, which would prevent Medicare by law from making "any assessments" of pain in hospitalized patients.

As I and others have written, pain is not merely discomfort. It is unhealthy and can even be life-threatening. If a patient is left in severe, unattended pain during a hospital stay, their acute pain can become chronic, triggering a host of other medical problems, such as high blood pressure, impaired immune function, ulcers, rashes, anxiety and depression. So, reporting one’s pain care while hospitalized is essential to the outcome of healing.

But, according to Kolodny and others who signed his petition, asking patients about their pain care leads to “dangerous pain control practices” and “aggressive opioid use.”

My question is, since patient surveys have contained pain evaluating questions for years, where is the evidence that doctors have over-medicated patients so their hospitals will have satisfactory survey ratings?

My guess is there is none. I have been hospitalized and suffered untreated or undertreated pain many times. I not only filled out surveys, but called hospital administrators, wrote the Joint Commission for hospital accreditation, and more, and STILL received sub-par pain care from doctors.

I am not alone. A recent survey of over 1,200 patients by Pain News Network and the International Pain Foundation found that over half rated the quality of their pain care in hospitals as either poor or very poor.

My next question is why doesn’t Kolodny want people to know about our pain? I suspect I know the answer.

As mentioned earlier, Kolodny can be traced back to nearly every movement to intervene in the proper medication of pain patients. In addition to running PROP, he is chief medical officer for the addiction treatment chain Phoenix House, and seemingly has an elaborate plan to have every patient on opioids be treated as an “addict.”  

This brings me to one final question. Why doesn’t any major American media outlet look into the conspicuous ulterior motives of Kolodny, PROP and Phoenix House? I am not much on conspiracy theories, but at this point I am compelled to say there might be something there, but our government and society are already so brainwashed to associate pain with addiction that no media outlet will touch it. Not to mention the political funding and special interest groups that also have a stake in this.

It all boils down to money. Healthcare in this country is treating pain on a financial hierarchy. The Obama administration has bought into the CDC guidelines on opioid prescribing, and the passing of the PROP Act will only further the notion that pain and addiction are one in the same.

Despite what we are being told, pain and addiction are two different issues, which need to be addressed separately. If this havoc wreaking discrimination continues, there will be no such thing as pain care left in this country.

Emily Ullrich suffers from Complex Regional Pain Syndrome (CRPS), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, Endometriosis,  Interstitial Cystitis, migraines, fibromyalgia, osteoarthritis, anxiety, insomnia, bursitis, depression, multiple chemical sensitivity, and chronic pancreatitis

Emily is a writer, artist, filmmaker, and has even been an occasional stand-up comedian. She now focuses on patient advocacy for the International Pain Foundation, as she is able.

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.

Pain Clinic Settles Discrimination Case

By Pat Anson, Editor

An Indiana pain management clinic has agreed to pay $30,000 to settle a federal claim that it discriminated against a pain patient by refusing to treat him.

In an unusual twist, the discrimination case filed by the U.S. Justice Department against Pain Management Care of South Bend was not based on the man’s rights as a pain patient – but because of his HIV status. The Americans with Disabilities Act (ADA) is intended to protect all people from being discriminated against because of physical or mental disability.

According to the Justice Department, the patient was referred to Pain Management Care (PMC) in November, 2014 after the closure of another pain clinic where he had been treated. The patient sought bi-monthly cortisone injections, which he had been receiving for pain management from his previous doctor.

After sending the results of an MRI exam and other medical records to PMC, the patient received a voicemail message from a clinic employee stating that Dr. Joseph Glazier would not treat him “due to the risks involved with needles and blood due to (his) condition of being HIV positive.”    

The patient asked PMC to change its position but was still refused treatment. He was not able to find another pain management doctor willing to treat him until several months later.

“PMC’s discriminatory denial caused (the patient) to endure six months without needed pain management care and to experience emotional distress,” federal prosecutors said.

The case against PMC was filed on April 7th and quickly settled out-of-court, with Dr. Glazier agreeing to pay the patient $20,000 and a $10,000 civil penalty. PMC must also develop a non-discrimination policy, provide ADA training to its staff, and submit annual reports to the government. The consent decree still needs a judge’s approval.

PMC’s website now contains this notice: “Pain Management Care, P.C., does not discriminate on the basis of disability, including HIV. All individuals, including persons with HIV, have an equal opportunity to treatment from Pain Management Care, P.C.”

“The Justice Department is committed to eradicating discrimination resulting from the unfounded fear and dangerous stereotype that someone with HIV would pose a threat to a medical provider,” said Principal Deputy Assistant Attorney General Vanita Gupta, head of the Justice Department’s Civil Rights Division.  “Discrimination by those in the medical profession breaks a trust critical to ensuring access to appropriate treatment for all.”

This settlement is part of the department’s Barrier-Free Health Care Initiative, a partnership of the Civil Rights Division and U.S. Attorney’s Offices to target enforcement efforts on access to healthcare for individuals with disabilities. 

The Americans with Disabilities Act was signed into law by President H. W. Bush in 1990. It is intended to protect against discrimination based on “physical or mental impairment that substantially limits one or more major life activities.”

For more information on the obligations of healthcare providers under the ADA, you can call the Justice Department’s toll-free hotline at 800-514-0301. ADA complaints may be filed by email to ada.complaint@usdoj.gov or by clicking here.

U.N. Report: War on Drugs a Failure

By Pat Anson, Editor

The international war on drugs has been a costly failure that has created a “public health and human rights crisis,” according to a new report commissioned by the United Nations, which is meeting in special session this week to discuss global drug policy.

The 54-page report by the Johns Hopkins–Lancet Commission on Drug Policy and Health found that many drug policies are based on ideas about drug use and dependence that “are not scientifically grounded” and have been particularly harmful to pain patients.

The commission estimates that about 5.5 billion people worldwide do not have adequate access to controlled drugs for the management of pain. 

“Inequity of access to controlled drugs for pain management and other clinical uses is now a public health and human rights crisis,” the report found. “Yet the obligation to prevent abuse of controlled substances has received far more attention than the obligation to ensure their adequate availability for medical and scientific purposes, and this has resulted in countries adopting laws and regulations that consistently and severely impede accessibility of controlled medicines.”

The commission said there were many “myths and exaggerations” about opioid use that have stigmatized people who use the drugs. And rather than lowering the risk of abuse and addiction, drug prohibition was making the problem worse by forcing some people to turn to the streets for opioids.

“Prohibition creates unregulated illegal markets in which it is impossible to control the presence of adulterants in street drugs, which add to overdose risk,” the commission said. “The idea that all drug use is dangerous and evil has led to enforcement-heavy policies and has made it difficult to see potentially dangerous drugs in the same light as potentially dangerous foods, tobacco, and alcohol.”

Four mothers who lost their children to drugs have been invited by the Canadian government to attend the U.N. assembly on drug policy. One of them is Jennifer Woodside of Vancouver, whose 21-year son Dylan died of an overdose two years ago after he took a pill he thought was oxycodone, but was actually laced with illicit fentanyl.

 “This is a big epidemic,” Woodside told The Globe and Mail. “I think we’ve got our head in the sand if you think it can’t affect you.”

“The war on drugs has been a war on our families,” said Lorna Thomas, who also lost a son to an overdose of oxycodone and will attend the U.N. conference. “The starting point for it, that we were going to punish people out of using drugs has failed. People will continue to use drugs and we need to acknowledge that reality and keep people safe.”

As Pain News Network has reported, counterfeit pain medications laced with fentanyl began appearing in the U.S. this year and are blamed for a dozen overdose deaths in California and Florida. Coincidentally, the fake pain pills appeared just as the Centers for Disease Control and Prevention (CDC) finalized new guidelines that discourage primary care physicians from prescribing opioids for chronic pain.  Many patients fear losing access to opioids because of the guidelines.

“These CDC guidelines are brand spanking new. I think it’s hard to draw any sort of conclusions from that,” said Rusty Payne, a spokesman for the Drug Enforcement Administration. “I don’t think the Mexican cartels are paying one lick of attention to what the CDC guidelines are. What they see are thousands and thousands of addicts that they can push a product on, whether it be heroin or now fentanyl. And introducing it in pill form is just another way to make a lot of money."

The U.N. report on drug policy recommends decriminalizing nonviolent drug offenses and phasing out the use of military forces to enforce drug laws.

“Policies meant to prohibit or greatly suppress drugs present a paradox. They are portrayed and defended vigorously by many policy makers as necessary to preserve public health and safety, and yet the evidence suggests that they have contributed directly and indirectly to lethal violence, communicable disease transmission, discrimination, forced displacement, unnecessary physical pain, and the undermining of people’s right to health,” the report concludes.

The president of Columbia, which has long been on the front lines of the war on drugs, will urge the U.N. to radically change drug policies.

"Vested with the moral authority of leading the nation that has carried the heaviest burden in the global war on drugs, I can tell you without hesitation that the time has come for the world to transit into a different approach in its drug policy," President Juan Manuel Santos wrote in a column published in The Guardian.       

"No other nation has had to endure the terrible effects of the world drug problem in such magnitude and over such extended period of time as Colombia. The international community can rest assured that, when we call for a new approach, we are not giving up on confronting the problem; we are moved by the aim of finding a more effective, lasting and human solution."

Fake Oxycodone Seized at US-Mexican Border

By Pat Anson, Editor

Federal prosecutors this week filed charges against an alleged smuggler caught at the California-Mexico border with nearly 1,200 fake oxycodone pills, the latest sign that Mexican drug cartels are targeting pain patients in the U.S.

The pills were made with illicit fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. Counterfeit fentanyl pills are blamed for 11 deaths and dozens of overdoses in recent weeks in the Sacramento area, where they were disguised to look like Norco pain medication. Some of the victims were patients who sought painkillers on the street because they couldn’t obtain them legally.

Fake oxycodone, Percocet and Xanax pills have also been appearing in Florida, where they are blamed for at least one death.

19-year old Sergio Linyuntang Mendoza Bohon of Tijuana, Mexico was arrested at the Otay Mesa port of entry on February 10. Border patrol agents became suspicious when they saw “an unnatural looking bulge” in his underwear.

A search turned up 1,183 tablets labeled as oxycodone and 5.4 grams of powdered fentanyl. Laboratory tests later determined the pills were made with fentanyl, not oxycodone.

“This investigation involves the first interdiction of counterfeit oxycodone pills containing fentanyl that were smuggled from Mexico into the U.S. at the local ports of entry,” said Dave Shaw, special agent in charge for Homeland Security in San Diego.

FILE PHOTO of otay mesa border crossing

“While this time we’ve successfully prevented a potentially deadly drug from reaching the streets, we face an uphill battle stemming from the rapidly growing demand for pharmaceutical painkillers on the black market.”

Last year, the DEA issued a nationwide public health alert for acetyl fentanyl, a synthetic opioid produced by illegal drug labs in China and Mexico. Acetyl fentanyl is virtually identical to fentanyl, a Schedule II controlled substance that is often used in patches to treat more severe forms of chronic pain.

Acetyl fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada. It typically is mixed with heroin and cocaine to make the drugs more potent, but is now showing up in pill form – sometimes disguised as pain medication.

“These criminals are putting fentanyl into fake pills and passing them off as legitimate prescription medications.  Fentanyl is extremely powerful and can very easily lead to overdose deaths,” said William Sherman, DEA Special Agent in Charge.

“Unsuspecting individuals who illegally purchase oxycodone could potentially die from the ingestion of what turns out to be fentanyl tablets,” said U.S. Attorney Laura Duffy. “We are very concerned that these counterfeit pills could cause serious harm to users. Even miniscule amounts of fentanyl can have devastating consequences for those who abuse it or literally even touch it.”

Bohon faces up to 20 years in prison if convicted of unlawfully importing a controlled substance. His next court appearance is scheduled for May 2.

Public Health Emergency in Canada

British Columbia this week became the first province in Canada to declare a public health emergency due to a spike in fentanyl overdoses. Health officials say 201 overdose deaths were recorded in the first three months of 2016. 

Counterfeit fentanyl pills disguised as oxycodone started appearing in Canada about two years ago, where they are often called “greenies” when sold on the street.

ROYAL CANADIAN MOUNTED POLICE photo

“When it's mixed into these tablets it's highly variable from one to the next. So an individual who uses a pill they bought off the street that contains fentanyl may crush up a tablet, inject it and be fine but with the next one they do they may overdose.” Dr. Matthew Young, a substance abuse epidemiologist in Ottowa, told Vancouver Metro.

Like the United States, Canada has a serious problem with opioid abuse and addiction. Young says efforts to reduce opioid prescribing may have contributed to the current wave of fentanyl overdoses.

“That also created a market where organized crime stepped in and started selling these counterfeit tablets containing fentanyl,” he said.

Joint Commission Defends Hospital Pain Standards

(Editor’s Note: As Pain News Network has been reporting, an intense lobbying effort is underway to stop requiring U.S. hospitals to ask patients about the quality of their pain care. Critics contend the practice creates a financial incentive for hospitals to treat pain and leads to “aggressive opioid use.”  The Joint Commission, which accredits hospitals and sets pain management standards, released this statement about the controversy, which we thought you should see in its entirety.)

By David Baker, MD

In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame. Often, The Joint Commission’s pain standards take that blame.  We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.

The Joint Commission’s standards require that patients be assessed for pain, and if they are experiencing pain, then it should be managed. The standards DO NOT require the use of drugs to manage a patient’s pain; and when a drug is appropriate, the standards do not specify which drug should be prescribed.

Our foundational standards are quite simple. They are: 

DAVID BAKER, MD

• The hospital educates all licensed independent practitioners on assessing and managing pain.
• The hospital respects the patient's right to pain management.
• The hospital assesses and manages the patient's pain. (Requirements for this standard follow)
  1. The hospital conducts a comprehensive pain assessment that is consistent with its scope of care, treatment, and services and the patient's condition.
  2. The hospital uses methods to assess pain that are consistent with the patient's age, condition, and ability to understand.
  3. The hospital reassesses and responds to the patient's pain, based on its reassessment criteria.
  4. The hospital either treats the patient's pain or refers the patient for treatment. Note: Treatment strategies for pain may include pharmacologic and nonpharmacologic approaches. Strategies should reflect a patient-centered approach and consider the patient's current presentation, the health care providers' clinical judgment, and the risks and benefits associated with the strategies, including potential risk of dependency, addiction, and abuse.

Despite the stability and simplicity of our standards, misconceptions persist, and I would like to take this opportunity to address the most common ones:

Misconception #1: The Joint Commission endorses pain as a vital sign

The Joint Commission does not endorse pain as a vital sign, and this is not part of our standards. Starting in 1990, pain experts started calling for pain to be “made visible.” Some organizations implemented programs to try to achieve this by making pain a vital sign. The original 2001 Joint Commission standards did not state that pain needed to be treated like a vital sign. The only time that The Joint Commission referenced the fifth vital sign was when The Joint Commission provided examples of what some organizations were doing to assess patient pain. In 2002, The Joint Commission addressed the problems in the use of the 5th vital sign concept by describing the unintended consequences of this approach to pain management and described how organizations had subsequently modified their processes. 

Misconception #2: The Joint Commission requires pain assessment for all patients

This requirement was eliminated in 2009.

Misconception #3: The Joint Commission requires that pain be treated until the pain score reaches zero.

There are several variations of this misconception, including that The Joint Commission requires that patients are treated by an algorithm according to their pain score. In fact, throughout our history we have advocated for an individualized patient-centric approach that does not require zero pain. The introduction to the “Care of Patients Functional Chapter” in 2001 started by saying that the goal of care is “to provide individualized care in settings responsive to specific patient needs.”

Misconception #4: The Joint Commission standards push doctors to prescribe opioids

As stated above, the current standards do not push clinicians to prescribe opioids. We do not mention opioids at all:
The note to the standard says: Treatment strategies for pain may include pharmacologic and nonpharmacologic approaches. Strategies should reflect a patient-centered approach and consider the patient's current presentation, the health care providers' clinical judgment, and the risks and benefits associated with the strategies, including potential risk of dependency, addiction, and abuse.

Misconception #5: The Joint Commission pain standards caused a sharp rise in opioid prescriptions.

This claim is completely contradicted by data from the National Institute on Drug Abuse (Figure 1).

The number of opioid prescriptions filled at commercial pharmacies in the United States from 1991 to 2013 shows the rate had been steadily increasing for ten years prior to the standards’ release in 2001. It is likely that the increase in opioid prescriptions began in response to the growing concerns in the U.S. about under treatment of pain and efforts by pain management experts to allay physicians’ concerns about using opioids for non-malignant pain. Moreover, the standards do not appear to have accelerated the trend in opioid prescribing. If there was an uptick in the rate of increase in opioid use, it appears to have occurred around 1997-1998, two years prior to release of the standards.

The Joint Commission pain standards were designed to address a serious, intractable problem in patient care that affected millions of people, including inadequate pain control for both acute and chronic conditions. The standards were designed to be part of the solution. We believe that our standards, when read thoroughly and correctly interpreted, continue to encourage organizations to establish education programs, training, policies, and procedures that improve the assessment and treatment of pain without promoting the unnecessary or inappropriate use of opioids. 

The Joint Commission is committed to working to dispel these misunderstandings and welcomes dialogue with the dedicated individuals who are caring for patients in our accredited organizations.

David Baker, MD, is Executive Vice President of Healthcare Quality Evaluation at The Joint Commission

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.