Senate Confirms Califf as FDA Commissioner

By Pat Anson, Editor

The U.S. Senate has overwhelmingly confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration after months of controversy over his ties to the pharmaceutical industry and criticism of the agency’s regulation of opioid pain medication.

The vote was 89-4 for Califf, a cardiologist and medical researcher at Duke University, who pledged earlier this month to use tougher language in warning labels for extended release opioids and to prioritize development of non-opioid alternatives for pain. Califf also endorsed the CDC’s controversial opioid prescribing guidelines, even though some of the FDA’s own experts believe the guidelines lack scientific evidence.

"If addiction to opioids and misuse of opioids is the enemy, then we underestimated the tenacity of the enemy," Califf told The Associated Press after his nomination was confirmed. "We've got to adjust."

Califf was pressured into changing the FDA’s opioid policies after his nomination was held up by Democratic presidential candidate Sen. Bernie Sanders of Vermont, and Sens. Joe Manchin of West Virginia (D) and Ed Markey of Massachusetts (D).

DR. ROBERT CALIFF

Manchin, Markey, Sen. Richard Blumenthal of Connecticut (D) and Sen. Kelly Ayotte of New Hampshire (R) voted against the nomination. Sanders was on the campaign trail and did not vote on the nomination.

"FDA stands for Food and Drug Administration, but over the last 20 years it really stands for ‘fostering drug addiction,' " Markey said in a speech on the Senate floor.

Both Markey and Manchin have vowed to “change the culture” at FDA to combat what they call a “pandemic” of opioid abuse and overdoses.

“I just think he’s the wrong person at this time of need for the position that we need to shake it up,” said Manchin. "The FDA needs new leadership, new focus and a new culture."

Califf founded Duke University’s Clinical Research Institute, which primarily works with and is funded by pharmaceutical companies. He listed over a dozen drug makers in a conflict-of-interest disclosure for a recent article he wrote in the New England Journal of Medicine.

“Dr. Califf has demonstrated a long and deep commitment to advancing the public health throughout his distinguished career as a physician, researcher, and leader in the fields of science and medicine.  He understands well the critical role that the FDA plays in responding to the changes in our society while protecting and promoting the health of the public,” said Dr. Stephen Ostroff, the FDA’s chief scientist, who has served as acting head of the agency for the past year.

Obama Rejects Limits on Opioid Prescribing

By Pat Anson, Editor

President Barack Obama declined to endorse a sweeping proposal by some governors to put limits on the number of opioid painkillers that doctors can prescribe, saying such a policy would be unfair to rural Americans who don’t have easy access to pain medication or addiction treatment programs.

"If we go to the doctors right now and say 'Don't overprescribe' without providing some mechanisms for people in these communities to deal with the pain that they have or the issues that they have, then we're not going to solve the problem,” Obama said. "Because the pain is real. The mental illness is real. In some cases, addiction is already out there. In some cases these are underserved communities when it comes to the number of doctors and nurses and practitioners."

Over the weekend, a committee of the National Governors Association unanimously voted to develop treatment guidelines that could include limits on opioid prescribing. The proposed guidelines could be voted on by the governors at their next meeting in August.

Although no specific figure was put on the number of opioid doses that could be prescribed at one time, Vermont Gov. Peter Shumlin (D) said it should be no more than 10 pills for treatment of acute pain. Shumlin has complained in the past that opioids “are passed out like candy in America.”

Shumlin’s proposal was quickly endorsed by Republican Gov. Matt Bevin of Kentucky, a sign that the guidelines would have bipartisan support among the nation’s governors.

President Obama met with the governors Monday at the White House and endorsed their bipartisan approach to addressing the so-called opioid epidemic.

"This is an area where I can get agreement from Bernie Sanders and Mitch McConnell. That doesn't happen that often," Obama said.

The president of the American Medical Association said Obama was right to question the potential consequences of putting additional restrictions on doctors and patients.

"The complexity of the problem makes it difficult to create a successful one-size-fits-all approach," Dr. Steven Stack said in a statement to the Associated Press.

WHITE HOUSE PHOTO

The proposed guidelines could also include policies similar to those adopted by insurer Blue Cross Blue Shield of Massachusetts, which requires prior authorization for opioid prescriptions. Some patients are also required to use a single pharmacy for their opioid prescriptions. The policies have resulted in a 50 percent reduction in claims for long acting opioids such as OxyContin, and a 25 percent reduction in claims for short-acting opioids, according to Blue Cross Blue Shield.

According to the Centers for Disease Control and Prevention (CDC), heroin and opioid overdoses are killing as many as 78 American a day, although the agency admits its numbers may not be accurate.

Vermont’s Shumlin has emerged as one of the nation’s most vocal critics of opioid prescribing practices. His state and others in the Northeast have been have been hit hard by opioid and heroin overdoses.

“As long as opioid medications remain the default mainstay therapies for chronic pain, these drugs will constitute an ever-present risk for diversion and addiction. We need to address the prescription opioid crisis at its source: opioid medications, as we know them, must be made obsolete,” Shumlin wrote in a recent letter to U.S. senators who are drafting legislation to reform the Food and Drug Administration and the National Institutes of Health (NIH).     

Shumlin urged the senators to provide additional funding to NIH for clinical research into affordable and non-addictive alternatives to opioids.

Take Our Survey About Hospital Pain Treatment

By Pat Anson, Editor

Over the last few months, we’ve received hundreds of reader comments about the poor quality of their pain care in hospitals and emergency rooms. Many said they their pain was not treated or undertreated, while others said they were misdiagnosed or labelled as addicts if they asked for pain medication.

In an effort to keep the dialogue going and see just how common these problems are, Pain News Network and the International Pain Foundation (IPain) are conducting a survey of pain sufferers about their treatment in hospitals. The survey, which you can take by clicking here, should only take a few minutes to complete.

One reason we’re doing the survey is because a group of U.S. senators recently proposed that Medicare no longer require hospitals to ask patients about the quality of their pain care. The senators believe questioning patients about their pain leads to over-prescribing "because physicians may feel compelled to prescribe opioid pain relievers" to improve their hospital's ranking in patient satisfaction surveys.

“Why would we want to reduce pain care or stop asking about a person’s comfort and pain levels?” asked Barby Ingle, president of IPain, who knows from experience what it’s like to go untreated or undertreated in a hospital. Barby recently wrote a column about ways to make your hospital stay easier.

“The International Pain Foundation has been hearing increasing stories of undertreated pain care in ER and hospital settings over the past few years,” she said. “With such a large outcry from pain patients across the country saying ‘don’t go the hospital for pain, they don’t know how to treat pain,’ we know there is a problem. How can it be addressed? Surveying the pain community will help put a spotlight on this issue and show lawmakers, providers, insurance companies, and the pain community that we need more focus on our pain care needs, not less.”

A recent development that will affect future pain care in hospitals is the release of new guidelines for post-surgical pain management. The American Pain Society is encouraging physicians to use opioids alongside “multimodal therapies” such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), Lyrica, Neurontin, and cognitive behavioral therapy to treat patients in post-operative pain.

“Cognitive behavioral therapy? Really? So you cut into my nerves and tissue and muscles for 6 hours, and the pain is all in my head?” is what Janet Lynn wrote about that idea.

“So when the NSAIDs shut down a person’s kidneys or cause massive stomach irritation and bleeding is it time to give a patient a narcotic pain med?” asked Sharon Storck

Even doctors aren’t immune from poor treatment in hospitals. Family practice physician Lisa Kehrberg, who has severe abdominal pain from visceral neuropathy, recently wrote about one of her experiences in a hospital (see “My Journey From Doctor to Chronic Pain Patient”)

“The first surprise was, after admission, they refused to treat my excruciating pain. I was doubled over, rocking, vomiting, and crying with the worst pain of my life. Worse than labor, appendicitis, or anything else I'd experienced,” wrote Dr. Kerhberg. “Doctor after doctor walked in and witnessed this and continued to refuse ordering opioids. After all the tests were complete and normal, the doctors were very rude to me and implied this was all a psychological problem.”

Has this ever happened to you? Are you satisfied with the quality of your pain care in hospitals? Take our survey and let us know, by clicking here.

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."  

Post-Surgical Pain Guidelines Reduce Use of Opioids

By Pat Anson, Editor

The American Pain Society (APS) has released new guidelines for post-surgical pain management that encourage physicians to limit the use of opioids and offer “multimodal therapies” to patients suffering from postoperative pain.

According to studies, more than half of patients who undergo surgery receive inadequate pain relief, which can heighten the risk of developing chronic pain, mood disorders and disability.

The 32 recommendations were developed by a panel of nearly two dozen experts that reviewed over 6,500 scientific studies. Most of the recommendations were adopted unanimously.

“The intent of the guideline is to provide evidence-based recommendations for better management of postoperative pain, and the target audience is all clinicians who manage pain resulting from surgery,” said lead author Roger Chou, MD, a prominent researcher who also co-authored the proposed opioid prescribing guidelines developed by Centers for Disease Control and Prevention.

Like the CDC guidelines, the APS guidelines encourage the use of non-pharmacological therapies and non-opioid medications, such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurotin) and pregabalin (Lyrica). Those treatments would be used along with opioids for post-operative pain.

“Because of the availability of effective non-opioid analgesics and non-pharmacologic therapies for postoperative pain management, the panel suggests that clinicians routinely incorporate around the clock non-opioid analgesics and non-pharmacologic therapies into multimodal analgesia regimens,” the guideline states.

“Systemic opioids might not be required in all patients. One study suggests that it should be avoided when not needed, because limited evidence suggests that perioperative opioid therapy might be associated with increased likelihood of long-term opioid use, with its attendant risks.”

Chou says using multiple approaches to pain management provides better pain relief than a single analgesic.

“Randomized trials have shown that multimodal anesthesia involving simultaneous use of combinations of several medications -- acting on different pain receptors or administered through different techniques -- are associated with superior pain relief and decreased opioid consumption compared with use of a single medication administered by one technique,” Chou said.

The APS panel also recommends that non-pharmacological therapies, such as cognitive behavioral therapy and transcutaneous elective nerve stimulation (TENS), can be used as effective adjuncts to pain medication.

Other recommendations in the APS guidelines include:

• Adults and children can be given acetaminophen and/or NSAIDs for postoperative pain management
• Oral administration of opioids is preferred over intravenous (IV) administration
• Spinal analgesia (epidurals) is appropriate for major thoracic and abdominal procedures
• Use of benzodiazepines, tramadol and ketamine is not recommended for postoperative pain.
• Clinicians should consider giving preoperative doses of celecoxib (Celebrex) to adult patients
• Gabapentin (Neurotin) and pregabalin (Lyrica) can be considered for postoperative pain relief.  The drugs are associated with lower opioid requirements after surgery.

The guidelines recommend the physicians consult with a pain management specialist when a patient has a tolerance for opioids, or a history of substance abuse or addiction.

“Adequate pain treatment should not be withheld from patients with active or previous opioid addiction because of fears of worsening addiction or precipitation of relapse. In addition to the ethical requirement to address postoperative pain, poorly treated pain can be a trigger for relapse,” the guidelines say. “An interdisciplinary approach using pharmacologic and nonpharmacologic interventions might be required to achieve successful postoperative outcomes and should be considered as part of the perioperative management plan in these patients.”

The APS post-operative pain guidelines, which are being published in the Journal of Pain, was endorsed by the American Society for Regional Anesthesia. A link to the guidelines can be found here.

Shocked by Senators’ Letter on Patient Surveys

By Janice Reynolds, Guest Columnist

Last week I felt like my world had shattered.  Sounds extreme, I know, but someone who I believed in had turned on me both as a professional and someone living with persistent pain. It was not only me that Sen. Susan Collins (R-Maine) denied, but the pain community as a whole. 

An article and editorial in the Portland Press Herald told how Collins and 25 other senators had written a letter to the Secretary of Health and Human Services questioning whether patients should be asked about their pain control in hospital satisfaction surveys. After reading it, I felt sucker punched.  I have always supported and believed in Susan Collins, but how can I now? 

“I believe the pendulum has swung too far in favor of controlling pain, although I am not suggesting that the pain people experience is not real,” Collins said, although the rest of her letter certainly suggests that she does just that. (See “Senators Seek to Silence Pain Patients”)

The comment that I find truly disturbing is, “Currently, there is no objective diagnostic method that can validate or quantify pain. Development of such a measure would surely be a worthwhile endeavor.” 

The pain community has battled this notion forever. In 1968 Margo McCaffery wrote that pain is what the person says it is and exists when the patient says it does.  She was heavily ridiculed for that, although the World Health Organization included it in both their position statements on cancer pain and on chronic pain, and considers pain treatment a human right.

SEN. SUSAN COLLINS (R-MAINE)

So much of what Collins said appears to be from the Centers for Disease Control and Prevention (CDC) and Physicians for Responsible Opioid Prescribing (PROP). The comments rather prove my belief that the CDC’s attack on opioids and addiction is really more of an attack on people with pain, no matter the reason. To see the letter and the list of senators who signed it, click here.

The next day the Press Herald had an editorial which proved even worse. “Collins and the other senators question whether it’s wise to put such a high premium on these subjective judgments. Prompt pain relief is appropriate for some patients, but overuse of painkillers can cause harm, and a person in pain will not always be the best judge of whether the care was appropriate,” the paper said.

Please note they are no longer distinguishing between acute pain, pain in a cancer setting, pain in a non-cancer setting, or end of life pain.  They also ignore the fact that “no prompt treatment of pain” causes harm as well (that is why they call it torture). Both articles claim opioids are gateway drugs for heroin. Of course, no acknowledged expert in pain management was even consulted for the articles (because they are all in the pockets of the evil pharmaceutical companies mu-ha-ha-ha).  Interestingly, nobody seems to care that non-opioid pain medication is also brought to us by pharmaceutical companies.

What about these patient satisfaction surveys?  Are they really a problem or is this more hype to discredit people with pain?

As a hospital nurse for over 20 years I cannot think of one time where a provider wrote a prescription for opioid pain medication just to avoid getting a bad patient satisfaction score.  In reality the problem is the exact opposite; doctors and nurses who are bad at pain management, who don’t believe a patient’s report of pain, and who lack the knowledge to effectively relieve pain really don’t give a darn about a bad evaluation. 

There are, unfortunately, still many providers who fit into those categories.  I can’t tell you the number of times I got in trouble with a physician for advocating for a patient. But there are many providers who are good at pain management, knowledgeable, and compassionate as well.  I imagine these are the ones the senators really have a problem with.

Could someone please give me a definition of overprescribe?  It seems, in this case, it would mean prescribing any opioid or making a legitimate effort to manage a patient’s pain. 

In a hospital setting there are many reasons for opioids to be used, as it is the only medication shown to be effective for severe pain.  People can be in pain due to surgical procedures, trauma, intractable pain (pain was out of control at home), broken bones, pain flares, post stoke pain, shingles, gallstones, kidney stones, cellulitis, deep vein thrombosis, myocardial infarctions, cancer metastasis, organ impingement by a tumor, and many more reasons including comorbidities when someone is dying. 

Most times there is a combination of opioids, non-opioids, and non-pharmaceutical interventions (such as warmth or cold, physical therapy; some hospitals even have therapeutic touch and Reiki available).  Many patients’ may have opioids ordered but never need them all. There are also times when opioids are ordered, correctly, for reasons other than pain (gasp).  One thing we know is that untreated or undertreated pain in surgical or trauma cases can lead to persistent chronic pain

The person experiencing the pain knows it best.  Managing it should be a partnership between patient and provider.  There will never be an objective test for most types of pain, partially because it occurs for many different reasons. Someone may have multiple reasons for pain as well, which complicates it even further. 

Pain has a long history of stigma, prejudice and bias.  It may be the stoic nature of many cultures, and partly the bully syndrome that perceives someone in pain as weaker.  People in pain have been seen as malingers, drug seekers, liars, tricksters, and worse.  In women it has been called anxiety or worse. 

The senators want to eliminate two questions used in patient satisfaction surveys: “How often was your pain well-controlled?” and “How often did the hospital staff do everything they could to help you with your pain?”

To say the person experiencing pain is not the best judge of those questions is ludicrous.

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

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.

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.”

Senators Seek to Silence Pain Patients

By Pat Anson, Editor

We’ve run several columns recently about the poor quality of pain care in hospitals and how many pain sufferers are treated as drug seeking addicts. Emily Ulrich’s column about her mistreatment in hospitals (“The Danger of Treating ER Patients as Drug Seekers”) really hit a nerve, generating hundreds of comments on our website and Facebook page from readers who shared their own hospital horror stories.

This makes a recent letter from a bipartisan group of U.S. senators all the more striking, because it seeks to silence hospital patients who are unhappy about their pain care.

In the letter to Health and Human Services Secretary Sylvia Mathews Burwell, Sen. Susan Collins (R-Maine) and 25 of her colleagues claim that many pain sufferers get opioid pain relievers far too easily in hospitals. To see the letter and the list of senators who signed it, click here.

“For millions of patients who are suffering from illness or injury, prompt delivery of pain control which may or may not include opioid pain relievers is proper and humane,” the letter states. “Yet inappropriate use of opioid pain relievers does not provide any clinical benefit and may actually pose a risk of harm. The evidence suggests that physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance on quality measures.”

At issue is a Medicare funding formula that requires hospitals to prove they provide quality care through patient satisfaction surveys. The formula rewards hospitals that provide good care and are rated highly by patients, while penalizing those who do not. 

Collins and her colleagues asked Burwell for a “robust examination” of the patient surveys – and strongly suggested that questions about pain management be eliminated. The Medicare survey has 32 questions for patients about their hospital experience, including two that ask if a patient's pain was "well-controlled" during their hospital stay and if hospital staff did "everything they could" to help a patient with pain.

“Currently, there is no objective diagnostic method that can validate or quantify pain. Development of such a measure would surely be a worthwhile endeavor,” the letter says. “In the meantime, however, 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.”

Some doctors agree with that sentiment.  

“I’ve just had conversations with several physicians in the last week and they were saying they felt pressured by patient satisfaction surveys,” Andrew MacLean, deputy executive vice president and general counsel of the Maine Medical Association, told the Portland Press Herald. “This type of inquiry would be helpful and we applaud the senator’s efforts.”

More people suffer from chronic pain than heart disease, diabetes and cancer combined, and pain is a major reason why people even seek admission to a hospital; so the senators are proposing that the opinions of a large segment of hospital patients be ignored, not that it isn't happening already. Pain patients frequently tell us they go without appropriate pain treatment in hospitals because they are quickly labeled as drug seekers. Some have horrific stories of mistreatment.

“My sister had Complex Regional Pain Syndrome (CRPS/RSD), went to 3 different hospitals was treated the same way. Finally she got a doctor that did his job, only to find out she had stage 4 cancer. She died less than 2 months from the time she got diagnosed,” wrote Melissa.

“My 13 year old daughter went in with chest pain and they told me she was having an anxiety attack. They did nothing. Two days later we found out from the children's hospital that she had a hole in her heart and could have died. ER doctors are the absolute dumbest, cruelest people I have ever met,” said Shannon.

“I used to work in an ER. Patient came in with tremors, talked of pain. She was quickly diagnosed as a pregnant drug addict who received no care and was sent home,” wrote another reader anonymously. “Two days later her husband brought her back demanding treatment. Doctor wanted to put her into rehab when she went into labor along with seizures. It wasn't drugs it was meningitis. She and the baby BOTH died.”

“I take Norco for chronic back pain. I go to the ER for a different medical issue and I get the looks and nothing to relieve my pain. I recently herniated a second disk in my back and was given nothing in the ER. I refuse to go to another one. If I am bleeding out or literally dying I don't know if I would go into another ER. All they do is judge because they can't feel my pain,” wrote Mistye Staten.

“Last time I was in the hospital and asked for medicine to control the pain I was told no. I said I at least wanted Ibuprofen and the nurse yelled at me to stop asking for narcotics,” said Amanda Hunt.

A recent study at Temple University Hospital in Philadelphia found that the rate of opioid prescribing dropped by about a third after tougher guidelines were adopted to discourage doctors from prescribing the drugs.

Only 13% of the doctors believed patients with legitimate reasons for opioids were denied appropriate care after the guidelines were implemented. A large majority – 84% of the doctors -- disagreed or strongly disagreed that patients were denied appropriate pain relief. Ironically, the researchers did not ask any pain patients what they thought about their hospital care.

Senator Alleges Conflict of Interest in Fed Pain Panel

By Pat Anson, Editor

An influential U.S. senator is raising questions about possible conflicts of interest on a federal panel that was highly critical of the CDC’s controversial opioid prescribing guidelines.

“I was alarmed to read of efforts by the members of the Interagency Pain Research Coordinating Committee (IPRCC) to weaken efforts underway at the Centers for Disease Control and Prevention (CDC) to develop guidance on opioid prescribing practices,” wrote Oregon Sen. Ron Wyden (D) in a letter sent to Health and Human Services Secretary Sylvia Burwell.

As Pain News Network has reported, several members of the IPRCC said the guidelines were “ridiculous” and “an embarrassment to the government” at a December meeting.

“Several non-Federal IPRCC members, their organizations, or both, appear to be recipients of funding from major pharmaceutical companies that manufacture opioids or related products at levels that raise serious concerns regarding the potential for conflicts of interest,” wrote Wyden. “These financial and professional relationships raise serious concerns about the objectivity of the panel’s members that deserve additional review.”

december, 2015 meeting of iprcc.

Wyden mentioned several of the panel members by name, including Myra Christopher and Dr. Richard Payne of the Center for Practical Bioethics, Penney Cowan of the American Chronic Pain Association and Cindy Steinberg of the U.S. Pain Foundation. All three non-profit organizations get a substantial portion of their funding from pharmaceutical companies, including Purdue Pharma, the manufacturer of OxyContin. Purdue gave over $100,000 to U.S. Pain Foundation in 2014, according to Wyden.

“I do not and have never been paid by a pharmaceutical company,” said Steinberg, who became a patient advocate after she suffered a serious back injury in an accident. Steinberg, who is National Policy Director for U.S. Pain Foundation, currently receives a small stipend of about $8,000 a year.

“I am fortunate in that my husband works to supports us.  I do this work despite my daily, debilitating chronic pain, often needing to lie flat in meetings to control the pain and lay across two plane seats to travel because I am passionate about improving pain care in this country,” Steinberg said in an email to Pain News Network.

“If anyone watches the video of the IPRCC meeting they will see that they had to bring in a special small sofa for me to lie on every hour so that I could participate. I am proud to do this work and am honored to represent the voice of millions of disempowered Americans who suffer from the pernicious disease of chronic pain and desperately need more and better treatment options."

Penney Cowan, another member of the federal panel mentioned by Wyden, also serves on the CDC “workgroup” that recently endorsed the agency’s recommended guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.  

“When treating a person with pain, a health care provider needs to determine what is best for that individual based on physical examination, test results and what is important to the individual. The recommendations seem very clear on that point,” Cowan wrote in an email to PNN. “The American Chronic Pain Association advocates for a balanced approach to pain management - that means that all therapies such as PT (physical therapy), counseling, biofeedback and stress management, OT (occupational therapy), nutritional guidance and more should be available and used based on their appropriateness for each individual.”

Wyden’s letter does not mention that some IPRCC members who were most critical of the CDC guidelines 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.

The senator’s letter and an Associated Press story about it also fail to 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,  companies which stand to benefit from the CDC guidelines because they offer non-opioid treatments or tests. The CDC Foundation accepted over $157 million from donors last year.  

Up to 11 million Americans use opioids daily to treat their chronic. A survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation found that many fear losing access to opioid pain medication if the guidelines are adopted.

Constipation Ad Leads to Laughs and Anger

By Pat Anson, Editor

Next to the game itself, probably the one thing people talk about the most to day after the Super Bowl are the TV commercials.

One commercial that is making quite a few lists as one of the worst is by drug maker AstraZeneca promoting its opioid induced constipation (OIC) drug. The black and white commercial features a constipated man envious of others (even a dog) who can easily go to the bathroom.

“The Super Bowl is known for inspiring lots of eating and lavish spreads of food. So why would advertisers pay millions to air ads focusing on constipation?” asked Eric Deggans of National Public Radio.  “There may never be a great time to air ads like this, but to broadcast such spots in an event where viewers are eating stuff like guacamole dip and pizza surely is the worst.”

“Nothing livens up a Super Bowl like a commercial about opioid-induced constipation,” said ESPN’s Dan Graziano on Twitter.

“Opioid Induced Constipation commercial during the Superbowl? Should have aired that during the Pro Bowl. Nobody gives a sh** about it,” wrote Don on Twitter.

Most of the Tweets aimed for laughs, but one by comedian and talk show host Bill Maher quickly went viral – and not because most people thought it was funny.

“Was that really an ad for junkies who can’t sh**? America, I luv ya but I just can’t keep up,” wrote Maher.

The depiction of opioid patients as “junkies” really got under the skin of pain sufferers and patient advocacy groups, some of whom are sponsored by AstraZeneca.

“You’re a funny guy but for many #chronicpain is real and opioids are needed for quality of life,” replied CreakyJoint.org on Twitter.

“This has to be the dumbest f***ing tweet I have read all day. Don’t ever become sick, sir. Just be glad for your perfect DNA,” wrote Ryan Stevens.

“I’m offended. Ad NOT for junkies but for people with CHRONIC pain who HAVE to have medicine to SURVIVE,” tweeted Caroline Evans.

“I am appalled at this, basically calling all people with pain junkies and making the side effect OIC seem like its no big deal,” said Paul Gileno, U.S. Pain Foundation. 

AstraZeneca paid CBS big money for its one minute spot, perhaps as much as $10 million – yet the commercial never even mentions the drug’s name, Movantik, which the British drug maker introduced in 2014.

The commercial may also have the unintended effect of giving more ammunition to those who want to further restrict access to opioid pain medication, a major goal of the Obama administration.

"Next year, how about fewer ads that fuel opioid addiction and more access to treatment," asked White House Chief of Staff Denis McDonough on Twitter.

"Our Administration is determined to control opioid addiction as a public health threat," replied White House press secretary Josh Earnest.

What Alternatives do Pain Patients Have?

By Pat Anson, Editor

When the Food and Drug Administration last week endorsed the CDC’s controversial guidelines to limit opioid prescribing, the agency promised it would prioritize development of non-opioid alternatives for chronic pain relief.

“We are also working closely with industry and the National Institutes of Health to develop additional alternative medications that alleviate pain but do not have the addictive properties of opioids,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco, who co-authored a “special report” on the FDA's new opioid policies the New England Journal of Medicine.   

“The FDA has approved non-opioid medications for treatment of various chronic-pain syndromes, including gabapentin (Neurontin), pregabalin (Lyrica), milnacipran (Savella), duloxetine (Cymbalta), and others, and a number of promising development programs are in the pipeline. But we need more. The FDA will use all the tools at its disposal to move these alternatives along as expeditiously as possible, while remaining mindful that all medicines have risks.”

The four drugs mentioned by Califf all have mixed track records, and many chronic pain sufferers have told Pain News Network the medications either don’t relieve their pain or have intolerable side effects.

“Gaba (Neurontin) did nothing for me and Lyrica seemed to help a very little with nerve pain but it made me very shaky, as if I drank a gallon of coffee,” wrote Pam Cushion.

“The side effects of Cymbalta were more than I could bear. I got terrible pains in the skin on my upper back and shoulders, and it made me feel downright awful,” said Tracy W.

“As opiate medications are lowered, my Lyrica dosage has gone up. It does have side effects like weight gain and next day fogginess,” wrote Kenneth McKenna. “I look for physicians to use other medicines in a similar fashion, (due to of the opioid restrictions) which may turn out to be a worse problem than the opioids themselves.”

Both Lyrica and Neurontin are coming under scrutiny in the UK because of increasing reports they are being abused by addicts to get high. Since 2012, over 60 overdose deaths in the UK have been linked to pregabalin and gabapentin.

Researchers in British Columbia also recently warned about the limitations of gabapentin, pregabalin, duloxetine, and venlafaxine (Effexor) when used to treat neuropathic pain.

“The best available evidence now indicates that as few as one in ten people can expect much pain relief from these drugs,” said Dr. Aaron Tejani, a Clinical Assistant Professor in the Faculty of Pharmaceutical Sciences and a member of the University of British Columbia's (UBC) Therapeutics Initiative Working Group. “Many people who improve are getting a placebo effect, or would improve in time without any drug treatment.  Others end up sedated, with impaired thinking, balance disturbance, dry mouth, or other side effects that cause more harm than good.”

The drugs may be ineffective for most patients, but Tejani says many doctors continue to prescribe them because of an exaggerated belief in their effectiveness. From 2005 to 2014, the number of British Columbians receiving pregabalin increased by 17 fold, according to UBC Therapeutics. Over three times as many prescriptions for duloxetine were written during that period, while gabapentin prescriptions nearly doubled. The use of venlafaxine, mostly for depression or anxiety, has been stable.

“Increasing evidence suggests that drugs have relatively little useful role for most patients with chronic pain. We should be much more cautious about prescribing them, and warn patients about their side effects,” said Dr. Tom Perry, a Clinical Assistant Professor in the Department of Anesthesiology, Pharmacology and Therapeutics and Chair of the UBC Therapeutics Initiative team.

Califf Nomination Still Stalled

The FDA’s sudden reversal on many of its opioid policies may have been intended to reduce opposition in the U.S. Senate to Robert Califf’s nomination as the agency’s new commissioner. Early indications are that strategy may not have worked.

“I will continue to strongly pressure the FDA to strengthen its oversight of opioid medications and will continue to push for the strongest possible framework for drug approval to ensure that the agency doesn’t simply continue to approve ever stronger and more deadly opioid medications under this new process,” said Sen. Joe Manchin (D) of West Virginia, one of five senators who are blocking Califf’s nomination.

Manchin has been particularly critical of the FDA’s failure on several occasions to accept the advice of its advisory committees, which have been reluctant to support the approval of new opioids. Last week Califf promised to appoint new advisory panels to review every new opioid that doesn’t have abuse deterrent properties.

“I believe the FDA should use the advisory committee’s expert advice for all opioid medications, including abuse-deterrent formulations, which are just as addictive and can be just as deadly as non-abuse deterrent opioids. The FDA also needs to commit to adhering to the recommendations that the advisory committee puts forward,” said Manchin.

Sen. Edward Markey (D) of Massachusetts also believes the FDA policy changes “fall short of what is needed.”

“While this is a good start, even more is required to ensure the FDA’s approval process protects Americans from the dangers of opioid painkillers,” Markey said in a statement. "Whether an opioid is abuse deterrent or not hasn’t prevented tens of thousands of people who have had their wisdom teeth removed or experienced lower back pain from getting addicted to these painkillers. That is why the FDA must change its decision not to seek expert advice about the risks of addiction before it approves abuse-deterrent opioids.”

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.  

Wide Disparity in Opioid Doses in Veteran Overdoses

By Pat Anson, Editor

The difference between controlling chronic pain and risking an opioid overdose can vary widely from patient to patient, according to a new study that found the threshold for safe prescribing may be lower than many doctors think.

Researchers at the University of Michigan Medical School and the Veteran Administration’s Ann Arbor Healthcare System studied the medical records of 221 veterans who died from accidental opioid overdoses and compared them to an equal number of veterans who took opioids for chronic pain, but did not overdose.

The average dose that the overdose victims had been prescribed was over 70 percent higher than what the comparison group received. The average daily dose for the overdose patients was 98 MEM (morphine-equivalent milligrams), compared to about 48 MEM for those who did not overdose.

But the researchers did not find a specific dose that clearly differentiated between patients at risk and those not at risk for overdose. In fact, some overdose victims had prescriptions for well under 50 MEM daily.

Despite that discrepancy, the researchers recommend lowering the recommended dosage threshold below 100 MEM. Lowering the number of high doses, they say, would help more people than it hurts.

“As the United States grapples with the rising toll of accidental overdoses due to opioids, our findings suggest that changing clinical practices to avoid escalating doses for patients with chronic pain could make a major difference in the number of patients who die,” said first author Amy Bohnert, PhD, an epidemiologist at the University of Michigan.

Bohnert was part of the “Core Expert Group” that helped draft the CDC’s controversial guidelines for opioid prescribing. Two co-authors, Joseph Logan and Deborah Dowell, work at the CDC’s National Center for Injury Prevention and Control, which oversaw the guidelines’ development.

The CDC guidelines recommend that primary care physicians start at the “lowest effective dosage” of opioids and should avoid increasing dosages over 90 MEM. Even a daily dose as low as 50 MEM increases overdose risk, according to the guidelines.

“Avoiding prescribing large doses also has the benefit of reducing the amount of the medications going to patients’ homes that has the potential to be taken by others who live with the patient, like children and teenagers,” said Bohnert. “This is important because an opioid that is a larger dose per pill, compared to a smaller one, is going to be deadly to a child or adult who hasn’t been taking the medication regularly.”

The study, which was funded by the Veterans Administration, is published in the journal Medical Care.

The study was based on the veterans’ medical, pharmacy and death certificate records. It did not include those who died by suicide using opioids, or veterans receiving hospice or palliative care.

Veterans were selected only if they filled a prescription for an opioid medication and had a diagnosis of chronic pain during the years 2002 to 2009. The researchers included veterans who had been prescribed codeine, morphine, oxycodone, hydrocodone, oxymorphone, hydromorphone, fentanyl, meperidine, pentazocine, propoxyphene, or methadone.

Under a federal spending bill passed by Congress and signed into law by President Obama, the Veteran’s Administration is required to follow the “voluntary” CDC opioid guidelines. The VA provides health services to 6 million veterans and their families. Over half of the veterans treated by the VA are in chronic pain.   

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.”