White House Steps Up Anti-Opioid Campaign

By Pat Anson, Editor

The Obama administration has unveiled a series of new initiatives aimed at treating addiction and educating doctors about prescription opioid abuse – amid growing signs the nation’s drug abuse epidemic is being fueled more and more by illegal opioids such as heroin and illicit fentanyl.

The new campaign, unveiled at the National Rx Drug Abuse and Heroin Summit in Atlanta, expands on a $1.1 billion funding proposal the President sent to Congress last month to address the nation’s growing drug problem.

One change that could greatly expand access to addiction treatment is a proposed rule by the Department of Health and Human Services (HHS) to double the number of prescriptions that a doctor can write for buprenorphine, an opioid used to treat addiction. Doctors currently are limited to 100 buprenorphine patients, but the new rule would expand that to 200 patients. The number of doctors trained and licensed to prescribe buprenorphine will also be increased.

HHS and the Substance Abuse and Mental Health Services Administration (SAMHSA) will also release over $100 million to expand access to addiction treatment.

"Expanding access to medication-assisted treatment for opioid-use disorders has been a top priority for this administration. Research clearly shows that this approach, when combined with behavioral therapies, is more effective at sustaining recovery and preventing overdose," said Michael Botticelli, director of the White House Office of National Drug Control Policy.

The policy changes and funding support stand to greatly benefit addiction treatment centers such as Phoenix House, whose medical director has lobbied for expanded access to buprenorphine treatment. Andrew Kolodny, MD, is also the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) which had five board members, including Kolodny, advising the CDC about its new opioid prescribing guidelines.

While buprenorphine is considered a “safer” opioid and has long been used to treat addiction (under the brand name Suboxone), it is prized by some addicts and can be abused. A 2013 study by SAMHSA found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for non-medical use of buprenorphine – meaning many users took the drug to get high.

“One of the most effective medications for opioid addiction is a drug called buprenorphine or Suboxone,” said Kolodny in an interview on C-SPAN last October.

A request to Phoenix House and Kolodny for comment on the HHS buprenorphine proposal went unanswered.

The White House also announced this week that 60 medical schools will require students to take some form of prescriber education, modeled after the CDC’s opioid guidelines, in order to graduate.

The lack of pain education in medical schools has long been recognized as a problem. A 2012 study published in the Journal of Pain called pain education "lackluster" in the U.S. and Canada. Few schools required a course in pain education and many did not have any pain courses.

A recent survey by Pain News Network and the International Pain Foundation (IPain) found that 8 out of 10 patients feel that hospital staffs are not adequately trained in pain management. Over half rated the quality of their pain care in hospitals as either poor or very poor.

Some fear the new White House plan is focused more on addiction treatment and limiting access to opioids than it is on educating doctors about pain management.  

“What remains astonishing is the total deafness to the needs of people in pain. It is as if people in pain don't exist and that they are not important,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“Focusing on opioid prescribing education in medical schools without also educating medical students about pain medicine is only going to further stigmatize people in pain and those who develop addictions. This is a true Back to the Future nightmare.  We will be practicing 1950's medicine for the most prevalent public health problems in America.  Absolutely astounding to me.”  

Six Fatal Fentanyl Overdoses in California

While the Obama Administration was announcing its new plan, health officials in Sacramento, California confirmed that six people died and over two dozen were hospitalized this month after ingesting a black market version of Norco, a widely prescribed opioid painkiller.

Legitimate Norco pills are a combination of hydrocodone and acetaminophen, but the “street” Norco was laced with fentanyl, a much more potent and potentially deadly opioid. Fentanyl is odorless and cannot be easily distinguished from other drugs.

“Some who have taken it stated that they were told that it was Norco.  However, results just released indicate that some of the pills that were retrieved have been tested and show that they did not contain Hydrocodone or Acetaminophen. The lab was able to identify the pills as containing Fentanyl instead.  This indicates that they are really Fentanyl pills that have been made to look like Norco,” the Sacramento County Division of Public Health said in a statement.

Fentanyl deaths have been rising around the country – at least 22 died from fentanyl overdoses in the Cleveland, Ohio area this month alone and dozens of deaths have been reported in West Virginia.

Last year the Drug Enforcement Administration issued a nationwide alert about the abuse, diversion and illegal manufacture of fentanyl. Thousands of people are believed to have died from fentanyl overdoses, but because of the nature of the drug it is impossible to tell whether it was prescribed legally and used for medical reasons or manufactured illegally and used recreationally. The CDC admits many fentanyl overdoses may have been misclassified as deaths caused by prescription painkillers.

Meanwhile, a report this week in Maine’s Portland Press Herald suggests that there is a correlation between rising heroin use and reduced access to prescription opioids. In recent years the number of people being treated for heroin addiction has nearly tripled in Maine, at a time when the number of prescriptions written for opioids dropped by 45 percent.

How Opioid Prescribing Guidelines Use Pseudoscience

By Michael Schatman and Jeffrey Fudin, Guest Columnists

Recently, we (along with our colleague, Dr. Jacqueline Pratt Cleary) published an open access article in the Journal of Pain Research, entitled “The MEDD Myth: The Impact of Pseudoscience on Pain Research and Prescribing Guideline Development.”

In this work, we address the issue of how governmental and managed care opioid guideline prescribing committees use the flawed concept of morphine-equivalent daily dose (MEDD or MME) to arbitrarily place limits on the amount of opioids that a clinician “should” prescribe to any patient with chronic pain -- as if all patients were identical. 

The article cites excellent research that exposes the invalid concept of MEDD – and while guideline authors are fully aware of that lack of evidence, they are hypocritically fine with using MEDD as a device to thwart chronic opioid use. In the case of opioids for chronic non-cancer pain, there is at least some evidence.  But for MEDD, there is no evidence.   

One reason the MEDD concept is not legitimate is pharmacogenomic differences – that is, due to each of our unique genetic compositions, various individuals and geographical groups metabolize some opioid analgesics differently.  These differences are often enormous. 

For example, it may require Person “A” 20 milligrams of hydrocodone to achieve adequate pain relief, while Person “B” (of the same gender and weight) may require 60 milligrams of the same drug for the same type of chronic pain condition.  Does this make Person “B” an addict?  Of course not.

We believe that by arbitrarily limiting the “appropriate” amount of an opioid that a physician should prescribe to a patient (which all recent guidelines – including the CDC’s guideline – call for), physicians feel compelled to limit the amount of opioid analgesic therapy that they prescribe – irrespective of the amount of relief that a patient with chronic pain receives. 

Is this good pain medicine practice?  Hardly.  However, in the eyes of the anti-opioid zealots who have dominated recent opioid prescribing guideline committees, their agenda of taking opioids out of the picture altogether for patients with chronic pain is evidently more important than is patient well-being.

Aside from the pharmacogentic issues, we also have conversion issues because of simple mathematics.  We cite data that clearly shows there are no universally accepted opioid equivalents.  Even if there were no issues with genetic variability, there is still no consensus on how to mathematically convert one opioid to another. For example, the state of Washington may decide on a different MEDD equivalent than the one New York state chooses.

Will the anti-opioid zealots admit that they have a non-scientifically-based agenda to take opioids out of the American chronic pain management discussion?  No – because if they were to do so, they would be seen as cruel or uncaring.  Rather, they emphasize that their concerns are for the well-being of patients and society.  Their logic suggests that if clinicians stop prescribing opioid analgesics altogether, then the unfortunate number of opioid-related overdoses and deaths will decrease dramatically. 

Not surprisingly, they lack the data that supports this assertion, yet the data are clear that when this happens, heroin use increases proportionally. 

As scientists and practitioners who work with patients with chronic pain every day, we see the damage in which these guidelines result.  For example, while the guidelines are described as “voluntary” by the committees that write them, that is clearly not the case.  Although the zealots deny the existence of a chilling effect on prescribing, there are data that suggest that progressively fewer physicians are willing to prescribe opioids since these non-evidence-based guidelines have surfaced.  Despite being touted as voluntary, physicians fear regulatory sanction should they disobey them, and accordingly are taking opioids out of their treatment armamentaria. 

Are we suggesting that opioid therapy be considered the first-line treatment for chronic pain?  Certainly not.  Chronic opioid therapy should be considered only when other available treatments have proven ineffective. However, given the for-profit health insurance industry’s business ethic of cost-containment and profitability, insurance access to many treatments that may be superior to opioid therapy are out of reach for the vast majority of Americans. We also have to remember that 20% of Americans live in underserved areas in which more sophisticated and safer treatment options are completely inaccessible.

We are concerned about this ethical imbroglio, as it is extremely damaging to our patients who suffer from the disease of chronic pain.  To quote from our article, opioid prescribing guideline committees’ continued utilization of the antiquated and invalid concept of MEDD is “scientifically, ethically, and morally inexplicable.”

As a result of this highly unethical practice, “impressionist lawmakers and anti-opioid zealots are basing clinical policy decisions on flawed concepts that ultimately could adversely affect positive outcomes for legitimate pain patients.”

It’s difficult enough to suffer from chronic pain under the best circumstances.  What patients with pain and society in general certainly don’t need is a group of smug inexperienced pain policymakers, politicians, and managed care administrators impacting public policy by evoking pseudoscience. There is sufficient good science being published that demonstrates that their reliance upon the MEDD myth is highly disingenuous.

Michael E. Schatman, PhD, is a clinical psychologist who has spent the past 30 years working in multidisciplinary chronic pain management. Until recently, he served as the Executive Director of the Foundation for Ethics in Pain Care in Bellevue, WA.

Dr. Schatman is Editor-in-Chief of the Journal of Pain Research and Director of Research for the U.S. Pain Foundation.

Jeffrey Fudin, PharmD, is a Clinical Pharmacy Specialist and Director at the Pharmacy Pain Residency Programs at the Stratton Veterans Administration Medical Center in Albany, NY.  

Dr. Fudin is Diplomate to the American Academy of Pain Management and a Fellow of both the American College of Clinical Pharmacy and the American Society of Health-system Pharmacists. 

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.

Pain Patients Say Non-Opioid Meds ‘Do Not Help at All’

By Pat Anson, Editor

In recent weeks, several efforts have been launched to scale back the use of opioid pain medication in hospitals and emergency rooms.

The American Pain Society (APS) released new guidelines for post-surgical pain that encourage physicians to limit the use of opioids, and to give acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurontin), or pregabalin (Lyrica) to patients suffering from postoperative pain. Cognitive behavioral therapy and transcutaneous elective nerve stimulation (TENS) were also recommended by the APS for post-operative pain.

Similar measures were endorsed by an expert panel at the Jefferson College of Population Health in Philadelphia, which warned that relieving a patient’s post-surgical pain with opioids could lead to addiction.

“Clearly, giving patients what they want, or think they need, is not always in their best interest,” wrote lead author Janice Clark, RN, Jefferson College of Population Health.

But most pain patients aren’t getting what they want or what they need in hospitals -- pain relief --  according to an extensive survey of over 1,250 acute and chronic pain patients by Pain News Network and the International Pain Foundation (IPain).

Over half rated the quality of their pain care in hospitals as poor or very poor, and six out of ten patients said their post-surgical pain was not adequately controlled.

And many hospitals are already very reluctant to give patients opioids. Over half (53%) the patients in our survey say they were refused opioid pain medication while hospitalized.   

“If you end up in the emergency room you will NEVER be given opioid based pain meds. They use NSAIDs. That usually isn't good enough,” said a patient who suffers from rheumatoid arthritis and spinal stenosis.

“This obsession with preventing pain sufferers from receiving adequate care is cruel and unusual. Would you deny a diabetic access to medication to control their condition?”

WERE YOU EVER REFUSED OPIOID PAIN MEDICATION WHILE HOSPITALIZED?

“They didn't want to hand out an opiate but were sure happy to go get me some Xanax,” said a patient who was hospitalized for an undiagnosed heart problem, as well as back and rib pain. “Welcome to the American standard of schooling and healthcare.”

“I went to the ER for a broken arm, and they took x-rays and told me it was broken. I asked for pain meds, even asked for non-narcotic meds, and got NOTHING, not even an aspirin with a broken arm, nothing while they put a cast on it and nothing to fill when I left,” said another patient.

“The pharma companies are using everything they can to increase the drug costs and these newer drugs are less effective and much more expensive. Soon they'll be suggesting we not use anesthesia for amputations,” said another pain sufferer.

Patients overwhelmingly agreed in our survey that non-opioid medications and therapies were ineffective in relieving pain. Nearly two-thirds (65%) said they “did not help at all” and nearly one in four said they only “helped a little.”

Just 11% said non-opioid treatments were very effective or somewhat effective at relieving pain.

“If they intend to use ‘preferred treatments’ like NSAIDs and Lyrica/Neurontin, they should have a reason for using these more dangerous, less effective meds,” wrote one patient.

“They should know that Lyrica and Neurontin can take months to build in the patient's system in order to be effective, and that NSAIDs can cause heart problems, gastric bleeding, and other side effects which can cause a host of new problems for the patient.”

“Tylenol won't help me and I'm allergic to NSAIDs. Why not do something about the real druggies that ruined it for the real patients? They get their medicines! I won't go to the ER unless I'm dying!” wrote another patient.

WAS NON-OPIOID PAIN MEDICATION OR THERAPY EFFECTIVE IN RELIEVING YOUR PAIN?

“Advil or Tylenol just don't cut it. It's ridiculous that you would not be treated for chronic pain in and out of hospital setting,” said another pain sufferer.

“I'm not surprised there's a perception that pain care is poor, in hospital or out,” said David Juurlink, MD, an internist and clinical pharmacologist at Sunnybrook Health Sciences Centre in Toronto.

“It's important that patients understand that one major reason for this is that our available pain medications (principally acetaminophen, NSAIDs and opioids, but various other drugs as well), simply don't work well for many types of pain. I see this firsthand every day, and it highlights the need for research into novel drug therapies that treat pain safely and effectively,” said Juurlink, who is also a board member of Physicians for Responsible Opioid Prescribing (PROP) and was a consultant to the CDC during development of its opioid prescribing guidelines.

“It's especially important that people not conflate ‘poor pain care’ with ‘reluctance to use opioids,’ because opioids really are no better than our other options for treating pain -- chronic pain in particular -- and they can make pain worse in a very short period of time. This phenomenon (opioid-induced hyperalgesia) is something we're just starting to understand, but it's one of many reasons why patients can have pain that persists or even worsens despite therapy. It's one more reason why doctors and patients need to de-emphasize the role of opioids in managing pain.”

One patient in our survey wishes hospitals would allow medical marijuana to be used an alternative to opioids.

“It would be better and safer if cannabis was allowed in treating pain in hospitals,” they said. ”I don't use opioids every day because I use cannabis instead. When I am in hospital I am forced back on opioids and go through withdrawal when I leave the hospital. This would not be the case if I could keep using cannabis instead.”

Still another patient discovered a novel way to get opioids in the hospital: don’t ask for them.

“I ended up learning to ask for non-opioid painkillers. That way when the painkillers they gave me didn't work, they would actually suggest them,” he said.

To see the complete survey results, click here.

Pain Patients Tired of Being Labeled as Addicts

By Pat Anson, Editor

If there’s one thing that gets a pain patient frustrated or angry, it’s being labeled as an addict or a “drug seeker” in search of opioids.  So imagine hearing that from a doctor or nurse at a hospital where you’ve gone for treatment because your pain is out of control or unbearable.

But it happens all the time.

“I refuse to go to the ER for pain. Unless I feel I'm absolutely dying, I will not go. It isn't worth being made to feel like I'm only ‘putting on a show’ or I'm a junkie just trying to get high,” one pain sufferer told us. “In every situation I've experienced in going to the ER with a complaint (of) pain, I've been made to feel less than human and was automatically met with suspicion.”

“I was screamed at and humiliated by the front desk nurse in front of a whole lobby of people for having pain and no medication or treatment. Had nowhere to go and didn’t know what else to do. She was so angry at me, I was shocked. I couldn’t believe it,” said another pain patent.

“My husband experienced a ruptured appendix at home,” wrote one woman. “His hospital experience was a nightmare! I had to stay at the hospital 24/7 just to make sure that his pain was kept under control. He was ridiculed, humiliated and not believed to the point that he was ready to walk out.”

Those are some of the typical responses we received in a survey of over 1,250 acute and chronic pain patients by Pain News Network and the International Pain Foundation (IPain).  Nearly three out four patients surveyed said they currently take an opioid pain medication.

When asked if they ever felt labeled as an addict or drug seeker by hospital staff, nearly half (46%) said they often were and over a third (34%) said it happens sometimes. Only 20% of pain patents said they had not been labeled.

“I was treated like a drug seeker and humiliated in front of the staff and patients. This has happened several times,” wrote one pain sufferer.

“I was insulted, berated, and humiliated by hospital staff while seeking help for my chronic pain conditions,” said another.

DID YOU EVER FEEL YOU WERE LABELED AS AN ADDICT OR "DRUG SEEKER" BY HOSPITAL STAFF?

“I have panic attacks about going to the hospital because I have been treated so badly,” wrote one woman. “I've heard nurses say, ‘She's only here for the free meds.’ I've had nurses and doctors yell at me when I explain my pain symptoms and ask for something simple like a pillow, or an IV in a different spot. I've been told, ‘You’re in a hospital. You are supposed to be uncomfortable!’”

“Doctors have called me a liar when it comes to why I have previously been in the ER or hospital. I have been told I am no better than a street addict,” wrote a patient who has pancreatitis and lupus.

“The nurses that treated me saw on the state Rx monitoring website I was taking opioids (although I had already told them). They shut the curtain and told me to take a nap! I was not seen by a doctor and was told I was a drug seeker,” wrote a patient who was seeking treatment for abdominal pain. “I got up and left and a couple weeks later was diagnosed with diverticulitis and a serious infection that could have killed me. I had 2 1/2 feet of my intestine taken out.”

Asked if doctors were reluctant to give them opioid pain medication while they were hospitalized, 38% of pain patients said it happens often and 36% said sometimes. Only 26% said no.

“I had a doctor in an emergency room situation one time during an episode I was having, who actually stood in the open doorway of my room, I was still in the ER, and yelled at me as loud as he could, that he wasn't giving me any pain medicine,” said one patient.

“I understand why opioids are scary to prescribe and I do understand that there are a lot of people just looking to get high. But doctors and hospitals discriminate (against) all of us with real medical problems and it’s inhumane,” wrote another.

WERE DOCTORS RELUCTANT TO GIVE YOU OPIOID PAIN MEDICATION WHILE YOU WERE HOSPITALIZED?

“The nurses and doctors need to understand the difference between the 98% who are not drug seeking and be able to address the patients’ needs who present in front of them,” said Barby Ingle, president of IPain.  “Treatment based on misconceptions and poor pain understanding is not ethical or appropriate. We must create policies that support the pain patient and their individual needs.”

Even patients who do not take opioid medication said they were labeled as addicts or drug seekers --  just as often as those who take opioids.

“I am really sick of being looked at as if I am there for dope meds. Not all of us is addictive or crazy about pain meds,” wrote one patient.

“I am not a bad person. I am sick. I did not do this to myself, it was done to me in childhood trauma. I was abused, please don't abuse me more,” pleaded another patient.

“Everyone needs to be treated with compassion, respect, and have their concerns listened to. This is not happening. We need to start holding people accountable for how they treat people in pain,” says Janice Reynolds, a pain sufferer and retired palliative care nurse.

“I would encourage everyone when you have been to the ER or in the hospital to write a letter to the CEO of the hospital, the vice president of nursing, and the medical and nursing managers of the department you were in.  Tell them how you were treated, how they made you feel, what happened that didn’t work, and try to get names and write them down.  Do this for good treatment as well as bad treatment,” Reynolds wrote in an email Pain News Network.

“I have actually done this and while one letter may not be effective, you are a costumer and if they get several letters they may start seeing there is a problem.  I know at the hospital I worked at, we were always told about a positive or negative comment which mentioned us by name.”

Another way to lodge a complaint – or compliment – is in patient satisfaction surveys, which Medicare requires hospitals to conduct to prove they provide quality care. Medicare rewards hospitals that are rated highly by patients, while penalizing those who do not. 

However, Maine Sen. Susan Collins (R) and 25 of her colleagues in the U.S. Senate have sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell asking that Medicare stop asking patients about their pain care because that could lead to opioid overprescribing.

“We are concerned that the current evaluation system may inappropriately penalize hospitals and pressure physicians who, in the exercise of medical judgment, opt to limit opioid pain relievers to certain patients and instead reward those who prescribe opioids more frequently,” the letter states.

Pain patients say that’s nonsense. When we asked if patients should still be asked about their pain care in hospital satisfaction surveys, over 92% said yes and less than 3% said no.

“I find this notion that we would stop asking patients how well their pain was controlled in the hospital appalling,” said Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation. “Dropping these questions from the Medicare survey sends the message that pain relief is no longer part of a quality-of-care measure that hospital staff need be concerned about. Controlling patients’ pain is just not that important any more.  Is this really where we want to go?

SHOULD PATIENTS BE ASKED ABOUT THEIR PAIN CARE IN HOSPITAL SATISFACTION SURVEYS?

“We have moved from the war on drugs to the war on pain patients and now to the war on the very concept of appropriately treating pain.  This is a shameful perspective that condones a cavalier and uncaring attitude toward the pain and suffering of fellow human beings.  I wonder what the Senators who signed this letter would say about the responsibility for doctors and nurses in hospitals to relieve pain if it was their loved ones or themselves who was experiencing unrelieved pain in the hospital?”

A request to Sen. Collins’ office for an interview or statement on the survey findings went unanswered.

To see the complete survey results, click here.

Tomorrow we'll see how pain patients feel about non-opioid medications and whether they are effective in providing pain relief.

New Anti-Opioid Campaigns Launched

By Pat Anson, Editor

Two provocative anti-opioid campaigns were launched this week -- one aimed at educating parents and the other warning physicians about the risks associated with opioid pain medications.

A report by the National Safety Council claims that 99 percent of doctors are prescribing opioid pain medication longer than the three-day period recommended by the Centers for Disease Control and Prevention. Nearly a quarter (23%) of the doctors surveyed said they prescribe at least a month's worth of opioids to their patients.  

Guidelines for primary care physicians released last week by the CDC state that three days or less supply of opioids “often will be sufficient” for acute pain caused by trauma or surgery, and that 7 days supply “will rarely be needed.”

The small survey of 201 family medicine and internal medicine physicians by the National Safety Council (NSC) did not distinguish between acute and chronic pain in their questions, making the findings somewhat misleading.

“For what period of time do you ordinarily prescribe opioid pain medication?” is what the doctors were asked.

Acute pain was the most common reason (87%) opioids were prescribed, but doctors said they prescribe opioid pain medication for many other conditions that the NSC considers inappropriate, including:

• 72% Chronic back pain
• 63% Chronic joint pain
• 55% Dental pain
• 55% Neuropathic pain
• 32% Fibromyalgia
• 28% Chronic headaches

The NSC’s report on the survey findings also claim that acetaminophen and ibuprofen are far more effective at providing pain relief than opioids and that doctors “overestimate the efficacy of opioids and underestimate the impact of safer alternatives.”

"Opioids do not kill pain; they kill people," said Donald Teater, MD, medical advisor for the National Safety Council. "Doctors are well-intentioned and want to help their patients, but these findings are further proof that we need more education and training if we want to treat pain most effectively."

The NSC survey also found that 99% of the doctors “have seen patients with pill-seeking behavior or evidence of drug abuse,” but handled the situation in very different ways:

• 44% Continued to treat the patient, but without opioids
• 38% Referred patient to addiction treatment
• 10% “Fired” the patient
•    5% Treated patient for addiction themselves
•    1% Refilled the opioid prescription
•    1% Never had a patient abuse opioids

Nearly 90% of doctors said it was difficult or very difficult to refer a patient for addiction treatment. Most blamed their patients, saying they were unwilling or uncooperative. Lack of insurance for addiction treatments and long waiting lists were two other reasons often cited.

The National Safety Council is a nonprofit organization focused on preventing injuries and deaths. It is funded largely through corporate donations and the insurance industry. The NSC has long had an aggressive campaign against opioids and claims they are the root cause of the prescription drug overdose epidemic.

“Opioids are being overprescribed. And it is not children reaching in medicine cabinets who have made drug poisoning the #1 cause of unintentional death in the United States. Adults have been prescribed opioids by doctors and subsequently become addicted or move from pills to heroin,” the NSC says on its website.

"Would you give your child heroin?"

Linking opioid pain medication to heroin is the focus of an advertising campaign launched this week, called "You Decide Before They Prescribe."

Created by the Partnership for a Drug-Free New Jersey, the campaign encourages parents to tell their doctors to prescribe alternative pain medications instead of opioids to their children.

“Would you give your child HEROIN to remove a wisdom tooth?” asks a new billboard unveiled in New York’s Times Square. "Ask your dentist how prescription drugs can lead to heroin abuse."

Similar ads will appear on trains and buses in New Jersey, and the organization eventually hopes the campaign will spread nationwide.

"40% of New Jersey parents still walk into a physician's office not understanding the link between prescription pain medicine and heroin – that opioids are a synthetic version of heroin," said Angelo Valente, Executive Director of Partnership for a Drug-Free New Jersey.

“The majority of New Jersey parents strongly agree that physicians should be legally required to discuss the risk of developing either a physical or psychological dependency on the prescription pain medication with patients prior to prescribing it." 

PARTNERSHIP FOR DRUG-FREE NEW JERSEY

Few Changes as CDC Releases Opioid Guidelines

By Pat Anson, Editor

After months of controversy, the Centers for Disease Control and Prevention (CDC) has released the final version of its opioid prescribing guidelines, which discourage primary care physicians from prescribing opioid medication for chronic pain. The dozen guidelines are largely unchanged from a draft version that was released last September.

You can see the guidelines yourself by clicking here.

“Management of chronic pain is an art and a science. The science of opioids for chronic pain is clear: for the vast majority of patients, the known, serious, and too-often-fatal risks far outweigh the unproven and transient benefits,” CDC director Thomas Frieden, MD, wrote in article published in the New England Journal of Medicine.

Although voluntary and intended only for primary care physicians, many experts believe the guidelines will quickly be adopted by other doctors who treat pain, as well as regulatory agencies, local governments,  and professional medical organizations. Many pain patients fear losing access to opioids as a result.

The guidelines state that “nonpharmacologic therapy and nonopioid pharmacologic therapy” are the preferred treatments for chronic pain, and that doctors should only consider opioids if the benefits in pain relief and function outweigh the risks of addiction and abuse. Even if opioids are prescribed, the CDC recommends that they be used in combination with other therapies.

The guidelines also recommend the use of immediate release opioids instead of extended release opioid medication and that doctors be cautious about prescribing doses higher than 50 morphine milligram equivalents (MME) per day. Doctors are strongly advised to avoid increasing doses over 90 MME per day.

For acute pain from injuries or medical procedures such as surgery, the CDC states that three days or less supply of opioids “often will be sufficient” and that 7 days supply “will rarely be needed.”

Doctors are also advised to consult prescription drug monitoring programs (PDMP) to determine if patients are abusing opioids or using dangerous combinations of medications. Urine drug testing is also recommended before starting opioid therapy and at least annually afterwards. The guidelines also discourage doctors from dropping patients if they fail to pass a drug test as that "could constitute patient abandonment and could have adverse consequences for patient safety."

The guidelines state that opioid pain medication and benzodiazepines should not be prescribed concurrently, and addiction treatment should be offered to patients who show signs of drug abuse.

“The new CDC guideline emphasizes both patient care and safety. We developed the guideline using a rigorous process that included a systematic review of the scientific evidence and input from hundreds of leading experts and practitioners, other federal agencies, more than 150 professional and advocacy organizations, a wide range of key patient and provider groups, a federal advisory committee, peer reviewers, and more than 4000 public comments.” Frieden wrote, without mentioning that the CDC initially sought very little input from the public or healthcare providers.

The CDC's own experts also admitted much of the evidence to support the guidelines was weak. The agency planned to implement the guidelines in January, but was forced to delay them after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines.

In response to critics, a new advisory committee was formed to review the guidelines, but after a handful of private meetings the committee endorsed the guidelines with few changes.  A potential legal problem for the CDC is that none of its advisory committees' meetings were open to the public. The committees also reviewed the guidelines with outside consultants without publicly disclosing who they were.

Last year the Washington Legal Foundation (WLF) threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA), which requires all such meetings to be open to the public.

"From the beginning we have been very disappointed in the manner CDC has conducted itself. We explained in detail last fall why we thought CDC had not acted in compliance with FACA. And while at first I was encouraged when CDC took steps to open up the process and perhaps try to compensate for some of its previous errors, I've seen nothing to suggest that it has really done so and in fact has just replaced one secret committee with another secret committee," said Richard Samp, WLF chief counsel. "I find it disappointing that a federal agency would not think it was incumbent to comply with federal law."

Samp told Pain News Network he was unsure if WLF would follow through on its threat to sue the agency and block the guidelines from being implemented.

"I can't say what if anything we plan to do from here or what anybody else plans to do," said Samp. "I just want to express our disappointment with the agency's procedural handling of this issue."

"We believe that this final version of the CDC guidelines leaves much to be desired," said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management. "Looking across the two preliminary drafts and the final version, we see virtually no evidence that comments submitted by thousands of people with pain, patient advocacy organizations, and pain management societies resulted in any changes to the 12 recommendations in the guideline."

Twillman said he was concerned the "soft limits" on opioid dosages in the guidelines would be adopted as a rule by physicians, leaving some patients untreated or undertreated.

"Our concern is that, based on experience when states have implemented similar guidelines, some clinicians will interpret these 'soft limits' and thresholds as absolute ceiling doses, and that people with pain will suffer needlessly as a result," Twillman said.

"I don't see how they will contribute much to improved outcomes for people in pain," said Lynn Webster, MD, past president of the American Academy of Pain Medicine and Vice President of scientific affairs at PRA Health Sciences. " I wish the CDC would have advocated for the millions of Americans with chronic pain while also trying to curb the opioid crisis.  We will never solve the opioid problem if we don't do a better job of treating pain.

"The CDC should have called upon Congress to insist payers be part of the solution and not continue to be the major barrier to improved outcomes for people in pain and with opioid addiction."

Many of the non-opioid treatments and therapies the CDC recommends -- such as cognitive behavioral therapy, massage and physical therapy -- are not covered by insurers. 

"The CDC’s recommendations are very sound. They're pointing out that when opioids are used long term for chronic conditions they are more likely to harm patients than help. If you continue to take opioids daily for months and months, the opioids don’t work very well," said Andrew Kolodny, Executive Director and founder of Physicians for Responsible Opioid Prescribing (PROP), in an interview with KPCC Radio in Los Angeles.

PROP, which was heavily involved in the initial drafting of the guidelines, is funded by Phoenix House, a chain of addiction treatment centers that stand to benefit from the guidelines' recommendations.

"Opioids don't work well long-term. That's the CDC's message. That's what the evidence tells us. Its the industry and groups that get funding from industry that are promoting this inappropriate treatment," said Kolodny, who is chief medical officer of Phoenix House.

In a survey of over 2,000 pain patients by Pain News Network and the International Pain Foundation, many predicted the guidelines will lead to more opioid abuse and addiction, not less.  Nearly 93% said they would be harmful to pain patients. Most also said that non-opioid treatments and therapies provide very little pain relief or none at all.

Study: Opioids Not Always in Patient’s Best Interest

By Pat Anson, Editor

An industry funded report is calling for greater use of non-opioid medication for post-surgical pain to combat what it calls the “frightening reality” of the opioid epidemic.

The report by an expert panel convened at the Jefferson College of Population Health in Philadelphia claims that relieving a patient’s acute pain with opioids is expensive and “not always in their best interest” because it could lead to addiction.

“The added costs attributable to misuse and abuse of opioid prescriptions originating in the acute care setting are considerable. With steadily increasing numbers of surgical procedures being performed, even small increments in the percentage of chronic opioid users will create an unsustainable societal burden,” wrote lead author Janice Clark, RN, Jefferson College of Population Health.

The report also endorsed efforts to have Medicare eliminate a requirement that hospitals ask patients about the quality of their pain care in patient satisfaction surveys.

“Patient satisfaction has been associated with greater inpatient use, higher health care and prescription drug use and expenditures, and increased mortality. Clearly, giving patients what they want, or think they need, is not always in their best interest,” wrote Clark and her two co-authors.  

“There is so much wrong with this article it is hard to know where to start,” says Janice Reynolds, a patient advocate and retired nurse who specialized in pain management and oncology. She called the report “opiophobic” and unethical.

“It is unconscionable these people say the person in pain cannot say whether his pain was well managed or not,” said Reynolds. “Pain is what the person says it is, existing when he says it does.  It is subjective.  Only the person experiencing it knows if treatment was effective or not, as well as whether he was treated in a compassionate, empathic manor. “

The report’s recommendations -- which are being published in the journal of Population Health Management -- are very similar to guidelines released last month by the American Pain Society, which also promote the use of non-opioid medication for post-surgical pain.

“A wide variety of effective alternatives to opioids for pain management are available and patients need to be educated on what strategies are most appropriate for their procedure,” wrote Clark, who said in an email to Pain News Network the Jefferson College report did undergo peer review prior to publication.

The report calls for greater use of acetaminophen, non-steroidal anti-inflammatory drugs (NSAID’s) and preglabin (Lyrica) for post-surgical pain, as well as an injectable bupivacaine delivery system called Exparel that was developed by Pacira Pharmaceuticals, a New Jersey drug maker. 

The report was sponsored by Pacira and the company’s vice-president of medical health sciences, Richard Scranton, MD, was one of its co-authors.

At times the report reads like a promotion for Exparel, calling it an “innovative delivery system” that achieves “effective pain relief at substantially smaller doses.”

“In the acute pain space, where patients now ask for drugs by name, there is unprecedented risk of overprescribing, overuse, and misuse—particularly of opioid drugs. Exparel is an opioid alternative with equivalent pain control that reduces the need for postsurgical opioids and devices,” the report says.

“There should have been a disclosure up front that the company sponsoring the study makes Exparel,” said Reynolds.   

There is an acknowledgement on Page 2 of the 12-page report that Pacira Pharmaceuticals sponsored it, but the company is not identified as the maker of Exparel, which accounts for virtually all of the company's revenue.

Pacira Pharmaceuticals received a warning letter from the Food and Drug Administration in 2014 for its off-label promotion of Exparel, which was initially only approved for pain caused by bunion or hemorrhoid surgery. The U.S. Justice Department also subpoenaed the company for documents related to its marketing and sales of Exparel. 

“These additional materials suggest an extensive promotional campaign by Pacira to promote the use of Exparel in surgical procedures other than those for which the drug has been shown safe and effective,” the FDA letter states.

Pacira filed a lawsuit against the FDA claiming its first amendment rights were being violated. In an out-of-court settlement late last year, the FDA withdrew the warning letter and Exparel’s label was updated to state that it can be used for other types of postsurgical pain. The case was widely seen as a defeat for the FDA that could greatly expand the use of off-label marketing by drug companies.

A recent story by Stat questioned whether a $285 vial of Exparel provided any better pain relief than a $3 dose of bupivacaine after knee surgery.  The article also points out that other post-operative pain studies were conducted by researchers who received funding from Pacira.

Sneeze Alert: What It’s Like to Taper off Opioids

By Crystal Lindell, Columnist

As a result of feeling a bit better lately, I have been trying to go off all of my opioid pain medications, which at one point totaled as much as 60 mg a day — three, 8-hour time release 15 mg morphine pills and then as many as three, short-acting, 5 mg hydrocodone as needed.

I worked my way down from 60 mg a day to 15 mg a day over the course of a month, and then tried to drop down to zero. It did not go well. You can read more about that here.

A little over a week after trying to go cold turkey, for various reasons involving a fresh pain flare and horrific withdrawal symptoms, I ended up back on the drugs. And I have spent the last few months working with a team of doctors trying to figure all this out and attempting to slowly taper off those last 15 mg. 

This is what it’s been like:

Withdrawal is sneezing. Every three or four minutes. As soon as the opioids wear off at all — I’m sneezing.

And it’s anxiety. And waking up drenched in sweat. And it’s the kind of diarrhea that you have to learn to accept as a part of your life now. The kind that fills the toilet multiple times a day and leaves your legs weak. 

It’s calling your high school boyfriend at 2 p.m. on a Friday because you’re in Target having an anxiety attack for no reason and you need to talk to someone, anyone, or you might actually die right there between the fitting room and the yoga pants display. It’s immediately regretting that phone call and then having anxiety about why you made it in the first place.

It’s not sleeping. God is withdrawal not sleeping. You’re lucky if you get four hours in one night. And waking up at 3 a.m.   

It’s giving up, and then trying again tomorrow.

It’s realizing that cutting your pills in half and taking them in a different time configuration actually helps a lot. And it’s tracking every dose and every symptom in Google Keep.

It’s deciding that maybe dating isn’t the greatest idea when your fight or flight response is literally kicking in every time it takes a guy more than seven minutes to respond to a text message. It’s giving in and going out with a guy on a Tuesday night anyway because the escape is worth it.  

It’s doing a lot of things you aren’t proud of.

It’s your primary care doctor telling you that other people have no problems at all going off these drugs, then qualifying his statement with, “But, I mean, I believe you,” which somehow implies he doesn’t.

It’s reaching out to your old psychologist and pleading for help, and then getting referred to a psychiatrist who specializes in this sort of thing and finally finding one person on the whole entire Earth who actually has some idea of what you’re going through.

It’s a glass of wine, and a handful of Advil, and lots of sugar candy, as you try to find anything to help manage the symptoms.

It’s slow. Withdrawal is maddeningly slow. It’s going down 1.25 mg in a day and feeling like the world is ending and waking up more anxious than you’ve ever been. And wondering if you can actually do this.

And then it’s a post anxiety-crash four hours later, and being so tired that you can’t even move your arm to check your phone.

Withdrawal is multiple people calling you a drug addict to your face because your body is physically dependent on a medication you were given by a doctor. It’s multiple people saying you just need more willpower and more prayer and more desire to get off the drugs.

It’s wondering if maybe you are a drug addict.

It’s trying to eat Taco Bell because Taco Bell usually solves everything and then realizing that you can’t even stomach a cheesy gordita crunch because the withdrawal has destroyed your appetite. 

It’s working out to help the anxiety, and using the stupid Calm App for meditations that never work, and texting your best friend 72 times an hour so that you know you’re not alone. And then texting her again. And it’s breathing her oxygen for awhile because you don’t seem to have any of your own.

It’s intestinal cramping so severe that you’re literally doubled over in pain on the couch, crying out in pain, wondering if this is the end.

It’s deciding to go back to church because for some reason, for that hour each week, you feel maybe a little bit of peace.

Withdrawal is feeling weak.

It’s wondering if you’ll ever feel normal again. It’s wondering that over and over and over and trying to convince yourself that someday you will get a full night's sleep and you won’t wake up covered in sweat and you won’t have diarrhea first thing in the morning and you won’t have the crushing feeling of anxiety as you greet the day.

Withdrawal is trying to live a normal life while your body goes through hell every day. It’s trying to work and be a good friend and a decent human being when all you want to do is die. It’s trying to figure out how much information, exactly, you should give your boss about your opioid dependence.

It’s having a pain flare and thinking that maybe the drugs were doing more than you thought, and wondering if you’re even doing the right thing.

It’s saying that John Green quote about survival to yourself 59 times a day. The one that goes, “I'm not saying that everything is survivable. Just that everything except the last thing is.” And then it’s reminding yourself that this is probably not the last thing. 

And it’s reaching out to your Facebook friend who has the same chronic pain you have and him telling you that you have to do this — it’s important that you do this — because if you don’t the next best option is in-patient treatment and you don’t want that.

It’s trying to distract yourself with The Hobbit, and Spotlight and Downtown Abbey, and Facebook.

Withdrawal is still happening. It’s ongoing. It’s a long-term goal. A hope that one day you’ll be clean — whatever that means. 

It’s praying, and crying, and giving up, and trying again.

And it’s sneezing.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

E-coli Bacteria Used to Produce Morphine

By Pat Anson, Editor

While politicians and regulators in the U.S. try to decrease access to opioid pain medications, scientists are developing new techniques to mass produce them.

The latest development is at Kyoto University in Japan, where researchers have learned how to tweak E coli bacteria so that they pump out thebaine, a morphine precursor that can be modified to make opioid pain relievers.

The genetically modified Escherichia coli – a common gut microbe -- produces 300 times more thebaine than a recently developed method involving yeast.

"Morphine has a complex molecular structure; because of this, the production of morphine and similar painkillers is expensive and time-consuming. But with our E coli, we were able to yield 2.1 miligrams of thebaine in a matter of days from roughly 20 grams of sugar,” said lead author Fumihiko Sato of Kyoto University.

"Improvements in opiate production in this E. coli system represent a major step towards the development of alternative opiate production systems."

Sato’s study is published in the journal Nature Communications.

 Escherichia coli

Morphine is extracted from opium poppy sap in a process that typically takes up to a year. Morphine can then be converted to opiates such as codeine, hydrocodone or even heroin.

Scientists at Stanford University last year engineered the yeast genome so that it produces opiate alkaloids from sugar. The genetically altered yeast cells grow so rapidly they convert sugar into hydrocodone in just three to five days. That raised fears that opioids could be produced cheaply and easily, provided that one has access to the necessary yeast strain.

With E coli, Sato says that such a production risk is unlikely.

"Four strains of genetically modified E coli are necessary to turn sugar into thebaine," explains Sato. "E coli are more difficult to manage and require expertise in handling. This should serve as a deterrent to unregulated production."

In 2011, Sato and colleagues engineered E coli to synthesize reticuline, another morphine precursor. In the new system, the team added genes from other bacteria and enzyme genes from two strains of opium poppies, Coptis japonica, and Arabidopsis.

"By adding another two genes, our E coli were able to produce hydrocodone, which would certainly boost the practicality of this technique," Sato said. "With a few more improvements to the technique and clearance of pharmaceutical regulations, manufacturing morphine-like painkillers from microbes could soon be a reality."

Opioid pain medications are widely available in the United States, where the focus is often on their potential misuse. But the World Health Organization estimates that 5.5 billion people worldwide have little or no access to opioids because of their limited supply and high cost.

From Bad to Worse for Pain Patients?

By Pat Anson, Editor

Has the pendulum swung too far against pain patients?

The answer is "Yes" according to some leading pain management experts at the annual meeting of the American Academy of Pain Medicine (AAPM) in Palm Springs.  The AAPM represents 2,400 physicians and health care providers, including some who have stopped prescribing opioid pain medication because they fear prosecution or sanctions if they prescribe to patients who might abuse the drugs.

"There are a variety of primary care doctors that are dropping out altogether (from prescribing opioids). They will not allow it. They're saying everybody has to go to a pain management expert or you don't get anything. And its abrupt," said Bill McCarberg, MD, President of the AAPM. "For that group of patients, you're cutting everybody off inappropriately. There are some of those patients who probably need those medications, who do better with medications."

McCarberg, who volunteers at a health clinic in San Diego, says even opioids with abuse deterrent properties are difficult to prescribe because they are expensive and usually not covered by insurance. He is not optimistic about the continued use of opioids in pain management.

"In my experience over the last year its gotten worse and I think a year from now it will be even worse," McCarberg said. "When you come back here in five years, in ten years, we'll be having the discussion about the pendulum being over here, patients suffering.  About you getting shoulder surgery and getting nothing but acetaminophen to treat your shoulder because nobody is willing to give you more (opioids). That's what I worry about."

"I think that's right. I think the pendulum has swung in the direction of things being worse for patients very rapidly and very dramatically. And I don't think its finished swinging yet," says Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

"I think its the general atmosphere, the whole focus on opioid overdoses and all of that stuff.  That's what is driving the CDC's actions and every bit of the press that's out there is about that problem. And until we get the other side of the story out there and point out that not treating pain has negative consequences too, including people dying, until we can get that story out there and get some traction with it, patients are in a bad place."

PROP President Speaks to AAPM

Although the AAPM has "very significant concerns" about the quality of evidence and "negative bias" in some of the CDC's proposed opioid prescribing guidelines, it invited a controversial figure who helped draft them to its annual meeting. Jane Ballantyne, MD, who is president of Physicians for Responsible Opioid Prescribing (PROP), served on a CDC advisory panel known the "Core Expert Group." The CDC guidelines discourage primary care physicians from prescribing opioids for chronic pain.

Ballantyne, who gave a talk at the AAPM meeting on "Pain Curriculum Development for Primary Care Practitioners," recently come under fire for co-authoring an article in the New England Journal of Medicine that said reducing pain intensity should not be the primary goal of doctors that treat chronic pain. 

Several patient advocates asked AAPM to remove Ballantyne from the program.

"How, in good conscience, can you include someone with her views about pain teach other physicians, or influence future curriculum for physicians, on how to effectively treat pain? It is clear from her writings that she doesn’t understand pain, or painful disease processes. Should someone with views like this be influencing our present and future doctors?" wrote Ingrid Hollis of Families for Intractable Pain Relief in a letter to the AAPM.

"While I appreciate your concerns about including Dr. Ballantyne as a member of the faculty, the Academy will not comply with your request that it remove her from the program," responded Phil Saigh, Jr., Executive Director of AAPM. "The Academy is committed to the free exchange of information and perspectives among pain physicians and other clinicians.  It is this commitment that ensures that diverse perspectives are examined rather than creating a one-size-fits-all approach to education. To remove Dr. Ballantyne from the program would not be true to that commitment."

Ballantyne's presentation was low key and did not focus on opioid use. She spoke about improving pain curriculum in medical schools, an area where there is broad agreement that change is needed. 

"Pain education has been really, really bad. And a large part of the problem, in terms of primary care, is actually managing those with chronic pain and not having received any education on how to do that," said Ballantyne, who explained that her own education and training in the 1970's focused on pain medication and injections, and did not include other disciplines such as psychology.

"The evidence suggests strongly that entry level pain management training is widely inadequate across all disciplines in the United States. Only a few medical schools in Canada and the U.S. offer courses on pain," she said. "The young primary care physicians that I work with are suddenly faced with this extremely complex disease, chronic pain, and they have only been taught to see it in a unitary way. That's what leads to a very simple treatment goal, which is simply to reduce pain intensity.

JANE BALLANTYNE, MD

"When we treat chronic pain we do an awful lot more or want to achieve an awful lot more than simply reducing pain intensity. We want to improve people's lives. We want to help them function better. We want to improve their state of mind and their mood, and have to pay attention to all the other factors that contribute to the disease. Chronic pain is a complex disease that is not simply a focus on pain intensity. And that's one thing we can really help in our teaching."  

Drug Tests Scare Off Some Chronic Pain Patients

By Pat Anson, Editor

Urine drug testing has become standard protocol for many patients who are prescribed opioid pain medication. But a new study suggests the practice may be counterproductive, because it increases the odds a patient won’t come back for further treatment.

In a study involving 723 chronic pain patients being treated at a pain clinic, researchers at the University of Houston and the University of Texas Medical Branch at Galveston found that nearly a quarter (23.75%) who were given a urine drug screen on their first visit failed to show up for the next appointment. 

The odds were even higher for those who tested positive for an illicit drug, but the “no show” trend also applied to patients whose drug tests were negative.

“Even those who tested negative for illicit substances in the UDS (urine drug screen) were more likely to be no-shows compared to those who did not get tested. This raises concerns that the UDS administered early in the doctor-patient relationship might have an inadvertent impact on injuring patient expectations of trust,” the researchers reported in the journal Pain Physician.

Only about 10% of those who weren’t tested skipped their follow-up appointment.

“It is a balancing act,” said Partha Krishnamurthy, director of the Institute for Health Care Marketing at the University of Houston’s Bauer College of Business. “On one hand, concerns about patient safety and public health necessitate the monitoring of patients on opioid medications. On the other hand, aggressive monitoring may interfere with the therapeutic alliance.”

Routine use of urine drug tests is one of the main recommendations in the CDC’s draft guidance for opioid prescribing, which calls for primary care physicians to “use urine drug testing before starting opioid therapy and consider urine drug testing at least annually.”

The scientific research behind that recommendation is considered weak, as is much of the evidence that standard “point of care” urine drug tests are reliable or accurate.

“I've only been saying that UDT (urine drug tests) harms patients and the patient/provider relationship for the past seven years and not a single physician, researcher, or healthcare provider of any kind supported my position.  I guess common sense wasn't enough but now we have evidence,” said Mark Collen, an independent scholar and patient advocate. 

“As I've stated previously in regards to UDT, the entire pain community will end up on the wrong side of history and it looks like that's beginning to occur.”     

Researchers say one possible solution to the high-rate of patient “no shows” is for doctors to delay drug screening of new patients until they’ve had a chance to develop rapport and trust with them.

“Not testing is not an option,” the researchers said, while at the same time warning that routine testing may only make prescription drug abuse worse.

“If the patients are disengaging from the clinic, where are they going? Is the illicit market place their next stop? Thus, while UDS may induce the problematic patients to go away from the clinic, the problem of opioid misuse may continue to persist.”

FDA Endorses CDC Opioid Guidelines

By Pat Anson, Editor

In a move that may have more to do with politics than healthcare, the U.S. Food and Drug Administration has set aside the advice of its own experts by endorsing the CDC’s controversial guidelines for opioid prescribing.

The move is part of several sweeping changes the FDA is making in its opioid policies, including some that the agency has resisted in the past. The most significant change is support for the CDC’s proposed opioid guidelines, which are designed to combat the so-called epidemic of opioid addiction and overdoses.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco.

“Things are getting worse, not better, with the epidemic of opioid misuse, abuse, and dependence. It’s time we all took a step back to look at what is working and what we need to change to impact this crisis.”

Califf’s nomination to be the next Commissioner of the FDA has been held up in the U.S. Senate, in large part by senators who want the FDA to go much further than it has in restricting access to opioid pain medication.  

ROBERT CALIFF, MD

“We need to change the culture of the FDA, and that will not happen if the person at the helm is not a champion who is committed to pushing back against the pressure to continually approve new opioid medications given the significant risks to public health,” said West Virginia Sen. Joe Manchin (D), who has criticized Califf for his ties to the pharmaceutical industry and threatened to filibuster his nomination.

In a news release issued late Thursday, Califf said FDA would “re-examine the risk-benefit paradigm for opioids,” use tougher language in warning labels on extended release opioids, and prioritize development of non-opioid alternatives for pain.  The FDA also promised to convene an expert advisory committee before approving any new drug applications for opioids that do not have abuse deterrent properties, one of Manchin's key demands.   

“I was very disappointed that Califf would release a statement like this as talk of blocking his nomination for FDA Commissioner grows in the Senate amid concerns that he was ‘soft’ on a range of issues, including genetically modified salmon, e-cigarettes, and regulation of opioids,” said Anne Fuqua, a chronic pain sufferer and patient advocate.

“I am concerned his desire for career advancement is interfering with the oath he took to ‘first do no harm’ when he became a physician.  This statement is heavily focused on the potential harms of opioids. Though it says they will seek to balance individual and societal risks, it seems that the need to prevent people from making poor choices will be given priority over providing care to individual pain sufferers for whom opioid therapy has proven to be an essential element of care. “

The FDA’s opioid policy changes are further outlined in a “special report” in the New England Journal of Medicine that was co-authored by Califf.

“We will start by launching a broad reexamination of our approach, considering how best to apply existing policies to this problem, which policies need to be improved and updated, and whether new policies must be developed,” Califf wrote.

“Accordingly, we are supporting the CDC’s Guideline for Prescribing Opioids for Chronic Pain. The draft guideline received extensive public comment, and we look forward to participating in the process when the CDC finalizes it soon. We are also supporting the Surgeon General’s efforts to engage the clinical community in a concerted approach to curbing inappropriate prescribing and proactively treating opioid addiction, while reinforcing evidence-based approaches to treating pain in a manner that spares the use of opioids. Until clinicians stop prescribing opioids far in excess of clinical need, this crisis will continue unabated.”

Some of the FDA’s own experts have been highly critical of the CDC’s proposed guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans use opioids daily for chronic pain and many fear losing access to them if the guidelines are adopted.

“I think we need to recognize that CDC wants to substantially limit opioid prescribing. Period,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, at a December meeting of a federal pain research panel. Hertz said the evidence cited to support the guidelines was “low to very low and that’s a problem.” Other panel members said they were “appalled” by the guidelines, calling them an “embarrassment to the government.”

The CDC planned to implement the guidelines last month, but delayed doing so after widespread complaints about its secrecy and lack of transparency during the guidelines' development. The CDC is now reviewing changes to the guidelines recommended by an advisory committee.

“I guess it shouldn't surprise me that the FDA is selling out by endorsing the CDC guidelines,” said Kim Miller, a pain sufferer and patient activist. “Could it be the FDA was not wanting to be made to look irrelevant in light of the CDC taking care of what many see as the FDA’s territory? Either way, it's an extremely gloomy looking horizon if you're a pain patient. Just when you think it can't get any worse, it always does.”

"It is a sad day for chronic pain patients in this country. The unintended consequences of these guidelines will bring about a true epidemic; not the media manufactured so-called epidemic of overdoses from opioids," said Chrystal Weaver, a Florida woman who suffers from Complex Regional Pain Syndrome. "The last figure I heard quoted for veterans taking their life is around 42 per day. When you take away the only tool we have to help lessen the pain from war injuries you'll see that number skyrocket from 42 per day to perhaps 500 per day. It will be the same story for non-veterans as well."

Earlier this week, the Obama administration said it would ask Congress for $1.1 billion in extra funding to help fight the opioid abuse epidemic. Most of the money would be used on expanding addiction treatment programs.

Will ‘Secret Deliberations’ Lead to Lawsuit Against CDC?

By Pat Anson, Editor

The Washington Legal Foundation is “keeping its options open” on a potential lawsuit to block the Centers for Disease Control and Prevention (CDC) from implementing its controversial guidelines for opioid prescribing. At issue is whether the CDC violated the Federal Advisory Committee Act (FACA) by developing the guidelines in secret and with little public input.

The CDC contends the guidelines are urgently needed to stop the so-called epidemic of opioid addiction and overdoses, while millions of chronic pain patients fear they will lose access to opioids if the guidelines are adopted.

Last week a “workgroup” appointed by the CDC recommended to the agency’s Board of Scientific Counselors (BSC) that the guidelines by adopted with few changes. The 10-member workgroup spent only three weeks reviewing a dozen complex guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. The panel met four times during that period and all of its meetings were closed to the public.

“Why is CDC so afraid of transparency here? That’s my question,” asked Mark Chenoweth, general counsel to the Washington Legal Foundation (WLF), a pro-business group that has threatened to sue the agency for its “culture of secrecy” and “blatant violations” of FACA.

FACA clearly states that “each advisory committee meeting shall be open to the public,” as well as any records, reports, minutes or other documents provided to or created by the committee.

The CDC has taken the position that the BSC is an advisory committee, but the workgroup is not.

“The BSC charged the workgroup with developing a report of its observations on the draft guideline and its underlying evidence,” said CDC spokesperson Courtney Leland. “Under FACA, the time for public input is when the BSC meets to deliberate on the work prepared by the workgroup.  This meeting, held on January 28, was a public meeting announced in the Federal Register, and included a public comment period.“

But the WLF’s legal team disputes that interpretation of the law.

“I don’t see why you can provide input to the government through secret deliberations simply because you’re providing your advice to an advisory committee rather than to the government itself. The whole point of the law is to make sure that advice that comes to the government and is relied on by government is a product of open deliberations,” said WLF chief counsel Richard Samp, who believes the guidelines were quickly reviewed to prevent any further delays in their implementation.  

The CDC planned to adopt the guidelines in January, but was forced to delay them after widespread criticism about its secrecy and lack of transparency during the guidelines' development.

“They want this to go on quickly. Obviously their existing advisory committee doesn’t have the expertise on its own, so it had to go outside of its ranks to do it,” said Samp. “But it realized that if the group was going to meet four or five times, it was going to drag on for months. And so the only way to do it quickly was to do what they have done.”

“If one wanted to test the legality of this sort of working group workaround on FACA, this is an excellent fact pattern on which to test it,” said Chenowith.

Asked by Pain News Network if the WLF would go to court before or after the guidelines are implemented, Chenowith and Samp were non-committal, but hinted they were prepared to take action in federal court in Atlanta, where the CDC is based.

“It never does any good to wait until final agency action. By that time people have really suffered some severe damage,” said Samp. “I assume one’s interest in these sort of cases is to prevent the agency from adopting guidelines and that’s why you sue early to try to prevent them from taking into account the recommendations before they make their final decision. One could easily file that in federal district court in Atlanta if one wanted to.”

WLF has a lengthy history of taking the government to court for regulations and laws effecting free speech, the environment, health care, and drugs. WLF describes itself as a public interest law firm “that regularly litigates to ensure that federal administrative agencies comply with statutes designed to ensure procedural fairness.” It often supports business groups and companies in litigation against  government agencies, and has represented or acted in behalf of pharmaceutical companies such as Johnson & Johnson and Purdue Pharma, the maker of OxyContin. 

"We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants," a spokesman for Purdue Pharma told Pain News Network.

That connection to a major opioid producer has led to insinuations that WLF and other organizations that accept funding from the so-called “opioid lobby” are somehow tainted. That charge is often made by Physicians for Responsible Opioid Prescribing (PROP), which supports the guidelines and had some of its board members on CDC committees that helped draft them.

A recent story by the Associated Press pointed out that nearly a third of the members of the Interagency Pain Research Coordinating Committee have financial connections to opioid makers. That same committee criticized the CDC for developing the opioid guidelines with little scientific evidence to support them.

“The apparent conflicts of interest on the panel underscore the pervasive reach of pharmaceutical-industry dollars, even among federal advisers who are supposed to be carefully vetted for such connections before serving,” the AP story said.

The article failed to point out that some of the committee members most critical of the CDC are federal employees of the Food and Drug Administration and the Agency for Healthcare Research and Quality (AHRQ), who as government workers are not allowed to accept financial contributions.

“I would be remiss and I’m certain so would many of my government colleagues if I didn’t go back to my director and say there’s a report coming out of the CDC that has very low quality of evidence,” said Richard Ricciardi, AHRQ, during a December meeting. “That’s an embarrassment to the government.”

The AP story also didn’t mention that the CDC itself has a foundation that accepts funding from healthcare companies such as Abbott Laboratories, Amgen, Medtronic, Johnson & Johnson, Merck, Quest Diagnostics and Pfizer, some of which stand to benefit from stricter opioid guidelines because they offer non-opioid treatments for chronic pain. The CDC Foundation accepted over $157 million from donors last year.  

Lyrica and Neurontin Face UK Restrictions

By Pat Anson, Editor

Two drugs often recommended as safer alternatives to opioid pain medication could face new restrictions in the UK because of increasing reports they are being abused.  

British health officials say the prescription drugs pregabalin and gabapentin, which are sold by Pfizer under the brand names Lyrica and Neurontin, are being used by drug abusers to get high, resulting in dozens of overdose deaths.

Since 2012, at least 38 deaths involving pregabalin and 26 involving gabapentin have been reported in the UK.

The prescribing of pregabalin and gabapentin in the UK has soared by 350% and 150%, respectively, in the last five years.  Both medications are anti-seizure drugs widely prescribed to treat epilepsy, neuropathy, fibromyalgia and anxiety.

The UK Advisory Council on the Misuse of Drugs (ACMD) is recommending that gabapentin (Neurontin) and pregabalin (Lyrica) be reclassified as Class C controlled substances – which would mean prescriptions would only be valid for one month and there can be no refills.

“Both pregabalin and gabapentin are increasingly being reported as possessing a potential for misuse. When used in combination with other depressants, they can cause drowsiness, sedation, respiratory failure and death,” said Professor Les Iverson, ACMD chairman, in a letter to Home Office ministers.

“Pregabalin may have a higher abuse potential than gabapentin due to its rapid absorption and faster onset of action and higher potency. Pregabalin causes a ‘high’ or elevated mood in users; the side effects may include chest pain, wheezing, vision changes and less commonly, hallucinations. Gabapentin can produce feelings of relaxation, calmness and euphoria. Some users have reported that the ‘high’ from snorted gabapentin can be similar to taking a stimulant.”

The letter warns there is a risk of addiction for both drugs, as well as misuse and diversion.

“The use of gabapentin and pregabalin by the opioid abusing population either together or when opioids are unavailable reinforces the behavior patterns of this high-risk population. There is a high risk of criminal behavior stimulated by the wish to obtain gabapentin and pregabalin,” said Iverson.

Lyrica is Pfizer’s top selling drug and generates worldwide sales of over $5 billion annually. Pfizer said the recommendation to reclassify the drugs and limit their prescribing could be harmful to patients.

“We are concerned that the advice contains a number of inaccuracies and some potentially misleading information, and is contrary to the totality of the safety data available for pregabalin and gabapentin,” the company said in a statement reported on the Pulse website. “Controlling the supply of these products across the whole UK, would be a disproportionate measure that would impact on patients and their quality of life, and could also result in additional economic and operational burden on an already strained healthcare system.”

Earlier this month a study of 440 drug abusers in Ireland found that 39 tested positive for pregabalin in their urine. Only ten of them had been prescribed the drug. Other drugs detected in pregabalin positive patients were opiates, cocaine, benzodiazepine and cannabis, according to the Irish Examiner.

The study called the abuse of pregabalin a “serious emerging issue.” Recreational users of pregabalin in Belfast call the drug “Budweisers” because it induces a state similar to drunkenness.

Neurontin (gabapentin) is approved by the FDA to treat epilepsy and neuropathic pain, but is widely prescribed “off-label” for a variety of other conditions, including depression, migraines, fibromyalgia and bipolar disorder. In 1999 a Pfizer executive was so mystified by Neurontin’s growing use he called it the “snake oil of the twentieth century.”  

Committees Support CDC Opioid Guidelines

By Pat Anson, Editor

Two advisory committees expressed broad support Thursday for the controversial guidelines for opioid prescribing being developed by the Centers for Disease Control and Prevention (CDC). Those guidelines discourage primary care physicians from prescribing opioids for chronic non-cancer pain and recommend other therapies such as over-the-counter pain relievers, acupuncture, and cognitive behavioral therapy.

One newly formed committee --- which the CDC calls a “workgroup” --- did express “significant concern” about the cost of those alternative pain therapies and whether they are covered by insurance. The workgroup's report to the CDC’s Board of Scientific Counselors (BSC) also suggested that the guidelines be “framed with positive rather than negative language” that supports “integrated care for people with chronic pain.” It also recommends the impact of the guidelines be monitored for “unintended consequences” after they are implemented. 

The BSC voted to support the workgroup’s report, which can be found here.

“The BSC voted unanimously: to support the observations made by the BSC Opioid Guideline Workgroup; that CDC adopt the guideline recommendations that, according to the workgroup’s observations, had unanimous or majority support; and that CDC further consider the guideline recommendations for which the workgroup had mixed opinions,” said CDC spokesperson Courtney Leland in an email to Pain News Network.

“CDC is taking the BSC’s recommendations, as well as comments received from the public, into consideration in revising the guideline. The guideline is a priority for our agency. Given the lives lost and impacted every day, we have an acute sense of urgency to issue guidance quickly.”

The CDC planned to implement the guidelines this month with little public input, but was forced to change course after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines. In response to critics, the 10-member workgroup was formed three weeks ago and met four times by teleconference to review the guidelines. A potential legal problem for the CDC is that none of the workgroup’s meetings were open to the public. The workgroup also reviewed the guidelines with outside consultants without publicly disclosing who they were.

The Washington Legal Foundation (WLF) has threatened to sue the agency for its “culture of secrecy” and “blatant violations” of the Federal Advisory Committee Act (FACA), which requires meetings to be open to the public.

Over 4,300 online comments were received by CDC during a public comment period that ended earlier this month. Many opposed the guidelines as being too restrictive, while others wished the guidelines were stronger to combat the so-called epidemic of opioid abuse and overdoses.  There were passionate arguments on both sides, but in the end the workgroup decided that the case for the guidelines was stronger.

“Comments from patients and family members, in particular, expressed the desire that patient-centered care is enhanced rather reduced by these Guidelines. Members felt that the guidelines could be implemented in a manner consistent with patient centered care,” the workgroup said in its report.

As many as 11 million Americans use opioids for long-term chronic pain and many fear losing access to the drugs if the guidelines are adopted.

“The purpose of the guideline is to help to primary care providers offer safer, more effective care for patients with chronic pain and to help reduce opioid abuse disorder and overdose from these drugs,” said Debra Houry, MD, director of the CDC’s National Center for Injury Prevention and Control, which is overseeing development of the guidelines.

"The guideline itself is not a rule, regulation or law. It is not intended to deny access to opioid pain medication as an option in pain management. It is not intended to take away physician discretion and decision making.”

“Pain specialists and their patients fear the Guidelines will not be used that way though and adoption by boards, professional organizations, and insurers will pressure even specialty pain providers to taper patients,” said Anne Fuqua, a chronic pain sufferer and patient advocate. “Pain patients nationwide have been experiencing dose reductions and losing access to care altogether for several years, with the situation becoming more acute in the past year.  In an environment where physicians are tapering patient doses or ceasing opioid prescribing altogether, I feel these guidelines will serve like an accelerant in a growing fire.”

Although the CDC has said it doesn’t want the guidelines implemented until they are finalized, Fuqua said many doctors are already doing just that. She said her faith in democracy “took a swift kick in the teeth” as she listened to the workgroup’s presentation during a conference call. Fuqua was not given an opportunity to speak, although the president and founder of Physicians for Responsible Opioids Prescribing (PROP) were given time to address the BSC in support of the guidelines they helped draft.

“There were 28 comments supporting the Guidelines and 4 dissenters. One physician made statements partially supportive of our needs. CDC will no doubt use this ‘overwhelming support’ to justify adoption of the guidelines. I fear they see us as simply a casualty of war, much like those with tuberculosis who were quarantined to prevent disease spread. The only difference is that harming us doesn't save other lives,” she said.

CDC has not released a timetable on when it plans to finalize or implement the guidelines.