FDA Orders Stronger Warning Labels for Opioids

By Pat Anson, Editor

The U.S. Food and Drug Administration is strengthening the warning labels on the nation’s most widely used opioid painkillers. The FDA is adding a “black box” warning to immediate release (IR) opioid pain medications, such as hydrocodone and oxycodone, stating that they pose serious risks of misuse, abuse, addiction, overdose and death.

The FDA will also require additional safety labeling changes on all other opioid medications, warning they can interact with antidepressants and migraine medications, or cause impotence and infertility.

The actions are the latest in a series of steps taken by the Obama administration to combat the so-called epidemic of opioid abuse and addiction by reining in the use of opioid pain medications. Last week the Centers for Disease Control and Prevention released new guidelines that discourage primary care physicians from prescribing opioids for chronic pain,

The updated warning will state that IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (non-opioid analgesics or opioid combination products) are inadequate or not tolerated. Dosing information will also provide clearer instructions about the initial recommended dosage, dosage changes during therapy, and a warning not to abruptly stop treatment in a physically dependent patient.

A sample of the new black box warning label can be seen here:

"Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, MD, FDA commissioner.

“Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”

Califf, a cardiologist who was recently confirmed by the U.S. Senate, has also pledged to prioritize development of non-opioid alternatives for pain and to convene an expert advisory committee before approving any new drug applications for opioids that do not have abuse deterrent properties. 

In 2013, the FDA ordered labeling changes only for extended release opioids, a move that angered some politicians and addiction treatment specialists, who wanted stronger warning labels on all opioids. At the time, the agency said there was not enough evidence to support stronger warnings for IR opioids, which are intended for use every four to six hours.

Today’s action sweeps that earlier objection away.

“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, who opposed IR labeling changes three years ago.

“We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids,” she said.

As part of the new boxed warning on IR opioids, the FDA will requires a statement that chronic use of opioids by pregnant women could result in neonatal opioid withdrawal syndrome (NOWS), which may occur in a newborn exposed to opioids for a prolonged period while in utero.

“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products,” said Douglas Throckmorton, M.D., deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research.

Last week, the head of the American College of Obstetricians and Gynecologists (ACOG), disputed that claim in a response to the CDC guidelines, saying they overstated the risk to pregnant women and newborns.

“Neonatal abstinence syndrome is the most established risk to newborns from use of opioids in pregnancy, but it is expected and treatable, and does not appear to pose permanent risks to the neonate,” said ACOG president Mark DeFrancesco, MD.

“However, evidence shows that withdrawal from opioid use during pregnancy may be associated with complications including fetal demise.  While some studies have suggested an association between birth defects and other adverse outcomes with opioid use in pregnancy, the absolute risk of these problems is low and data demonstrating a causal connection are lacking.”

Sen. Edward Markey (D-Mass) applauded the label changes by the FDA, but said they should have come sooner.

“Today’s announced changes to the labels of opioid products will finally reflect what we have known about these drugs for decades - they are dangerous and addictive and can lead to dependency, overdose and death,” said Markey in a statement. “Whether it's immediate or extended release, or abuse-deterrent, the labels given by the FDA have done little to prevent opioid addiction. Unfortunately, it has taken FDA far too long to address the grave risks of these drugs that have claimed the lives of thousands this year alone.”

Markey said the FDA also needs to convene an external advisory committee whenever it considers a new opioid for approval, something Califf has promised to do.

Doctors Have Mixed Reaction to CDC Guidelines

By Pat Anson, Editor

Although generally supportive of the CDC’s new opioid prescribing guidelines, some doctors are worried that patients who need opioid pain medications may lose access to them.

The voluntary guidelines, which discourage the prescribing of opioids for chronic pain, are intended for primary care physicians, but are widely expected to have a ripple effect throughout the healthcare system and on anyone who prescribes opioids.

"If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable. If they produce unintended consequences, we will need to mitigate them. They are not the final word," said Patrice Harris, MD, the board chair-elect of the American Medical Association, the nation’s largest medical group.

Like many other medical organizations that submitted public comments on the CDC guidelines, the AMA said it had concerns about the poor quality of scientific evidence supporting several of the recommendations. But the dozen guidelines are largely unchanged from a draft version that was released last September.

“We remain concerned about the evidence base informing some of the recommendations; conflicts with existing state laws and product labeling; and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care; and the potential effects of strict dosage and duration limits on patient care,” said Harris, who chairs the AMA Task Force to Reduce Opioid Abuse.

The lack of clinical evidence was also pointed out by other physicians.

 “There are few well-controlled clinical studies on opioid-prescribing methods for chronic pain. While the guidelines will be updated as new data become available, concerns may be raised that appropriate access to opioids could be negatively affected by federal guidelines based on admittedly weak data,”  wrote William Renthal, MD, of the Department of Neurology at Brigham and Women’s Hospital in an editorial in JAMA Neurology.

The head of the American College of Obstetricians and Gynecologists (ACOG) said he was concerned the guidelines overstate the risks of opioids for women during pregnancy and after labor.

“ACOG agrees with the CDC that opioid should only be used for treatment of pain when alternatives are not appropriate or effective, but we also know that there are times, including during pregnancy and the postpartum period, when such use is both appropriate and safer than the alternative,” wrote ACOG president Mark DeFrancesco, MD. “Opioids may be needed to treat acute pain such as from cesarean delivery, kidney stones, sickle cell crisis or trauma in pregnancy, or as part of an established plan to treat problems associated with substance use disorders.”

DeFrancesco said the risk of birth defects and other problems caused by opioids was low and research demonstrating a connection was lacking.

“We are concerned that some of the CDC's patient education communications regarding use of opioids during pregnancy could discourage women from needed, appropriate care by overstating the risk of rare complications associated with opioid use during pregnancy and by understating the potential risk associated with opioid discontinuation, “ he said.

Two pediatric physicians are concerned the guidelines are only intended for patients 18 and older and do not address pain or opioid use by children.

“Unfortunately, the exclusion of children from the national discussion on pain is not new,” wrote Neil Schechter, MD, of Boston Children’s Hospital and Gary Walco, PhD, of Seattle Children’s Hospital in an editorial in JAMA Pediatrics. “Data clearly show that poorly treated pain in the young has deleterious long-term consequences on the development of pain systems and related responses, as well as psychological well-being. Furthermore, the long-term impact of pain on a developing organism may be quite different than on an adult and may suggest more aggressive, or at least different, interventions.”

Schechter and Walco urged the CDC to provide ”an explicit and definitive statement that this guideline should not be applied to those younger than 18 years of age for fear of untoward consequences.”

The Alliance for Balanced Pain Management (AfBPM), a coalition of patient groups and professional societies, said it was concerned about opioid dosing limits and the CDC recommendation that three days or less supply of opioids “often will be sufficient” to treat acute pain from surgery or trauma.

“When the CDC suggests the exact number of days and the precise dosing limit, the agency may be inserting itself too far, interfering with physician care of patients who live day to day with serious pain,” said Brian Kennedy, Alliance for Patient Access and a member of the AfBPM Steering Committee. “These guidelines mark a milestone in the national conversation about how we treat pain, both chronic and acute. Multimodal approaches to pain treatment make use of non-opioid treatments and have tremendous value for patients, but we shouldn’t tie physicians’ hands when it comes to treatment options.”

 “The data will never be perfect. The measures will never be perfect. The guidelines will never be perfect. And neither will clinicians and their performance,” wrote Thomas Lee, MD, of Press Ganey and Harvard Medical School in a JAMA editorial. “But by acknowledging these imperfections and trying to get better with the tools available, physicians can more effectively reduce the suffering of patients.”

1 in 6 Seniors Take Risky Drug Combinations

By Pat Anson, Editor

One in six older adults now regularly use potentially deadly combinations of prescription drugs, over-the-counter (OTC) medications and supplements, a two-fold increase over a five-year period, according to new research published in JAMA Internal Medicine.

Researchers at the University of Illinois at Chicago surveyed over 2,200 Americans between the ages of 62 and 85 and found that over half (54%) were taking some type of pain reliever in 2011.

Over 40 percent used aspirin; nearly 14% took non-steroidal anti-inflammatory drugs (NSAIDs); and about 11% used an opioid analgesic.

Only 44% were using a pain reliever in 2006.

Researchers identified 15 potentially life-threatening drug combinations of the most commonly used medications and supplements. Statins, anti-platelet drugs such as aspirin, and supplements (specifically omega-3 fish oil) accounted for the vast majority of interacting drug medications, some of which worsen cardiovascular problems. Opioids were not listed among the 15 risky combinations.

Nearly 15% of older adults regularly used at least one of the dangerous drug combinations in 2011, compared to 8% five years earlier.

"The risk seems to be growing, and public awareness is lacking," said Dima Mazen Qato, an assistant professor of pharmacy systems at the University of Illinois.

"Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk. For example, the use of clopidogrel in combination with the proton-pump inhibitor omeprazole, aspirin, or naproxen -- all over-the-counter medications -- is associated with an increased risk of heart attacks, bleeding complications, or death.”

As Pain News Network reported, European researchers also warned last week that aspirin and some types of NSAID’s could be harmful to patients with heart or kidney problems. The researchers said NSAIDs, in particular, raise cardiovascular risk and there is no "solid evidence" the drugs are safe.

"When doctors issue prescriptions for NSAIDs, they must in each individual case carry out a thorough assessment of the risk of heart complications and bleeding. NSAIDs should only be sold over the counter when it comes with an adequate warning about the associated cardiovascular risks,” said Christian Torp-Pedersen, a professor in cardiology at Aalborg University in Denmark.

In opioid prescribing guidelines released last week, the Centers for Disease Control and Prevention recommends "nonopioid pharmacologic therapy" such as acetaminophen and NSAIDs as the "preferred" treatments for chronic pain. Only briefly do the CDC guidelines even mention that NSAIDs have been associated with cardiovascular risks or that acetaminophen may cause liver failure. Instead, the 52-page guideline focuses on the risks of opioid addiction and abuse.

Over half of the risky drug combinations in the University of Illinois study involved over-the-counter medications or dietary supplements.

Feds Quietly Release National Pain Strategy

By Pat Anson, Editor

The U.S. Department of Health and Human Services (HHS) on Friday quietly released the National Pain Strategy, a comprehensive and ambitious “roadmap” to improve the quality of pain care in the United States. The 83-page report was overshadowed by the opioid prescribing guidelines released by the Centers for Disease Control and Prevention just a few days earlier.

Development of the National Pain Strategy (NPS) began over five years ago after the Institute of Medicine released a report calling for a “cultural transformation” in pain care, prevention, research, and education. Although the NPS was being closely watched by researchers, academics, regulators and professional societies, many long-suffering pain patients will be surprised to hear the U.S. even has a national pain strategy.

The Department of Health and Human Services (HHS) did little to publicize the NPS, issuing a single news release that wasn’t even posted on its own website 24 hours later.  There was no press briefing for reporters to explain why the NPS was developed or what its objectives are.

The announcement wasn't even made by HHS Secretary Sylvia Mathews Burwell, but by a lower ranking aide.

“Chronic pain is a significant public health problem, affecting millions of Americans and incurring significant economic costs to our society,”  Karen DeSalvo, MD, acting assistant secretary for health at HHS, said in the news release. “This report identifies the key steps we can take to improve how we prevent, assess and treat pain in this country.”

The major goals of the NPS are:

• Develop new methods to prevent and manage pain.
• Improve pain education of physicians
• Develop “integrated, interdisciplinary, patient-centered” pain management teams
• Provide better insurance coverage of pain treatment options
• Reduce barriers to pain care, especially for stigmatized and underserved populations.
• Increase public awareness and patient knowledge of treatment options and risks

The 800-pound gorilla of pain management – opioid pain medicine – is only briefly mentioned in the NPS, and not in a positive way.

“Evidence suggests that wide variations in clinical practices, inadequate tailoring of pain therapies to individuals, and reliance on relatively ineffective and potentially high risk treatments such as inappropriate prescribing of opioid analgesics, or certain surgical interventions, not only contribute to poor quality care for people with pain, but also increase health care costs,” the report says.

“Treatments that are ineffective, whose risks exceed their benefits, or that may cause harm for certain subgroups need to be identified and their use curtailed or discontinued.”

“We need to ensure that people with pain get appropriate care and that means defining how we can best manage pain care in this country,” said Linda Porter, PhD, director of the National Institute of Health’s Office of Pain Policy and co-chair of an interagency committee that helped develop the report.

“To achieve the goals in this report, we will need everyone working together to create the cultural transformation in pain prevention, care and education that is desperately needed by the American public,” said Sean Mackey, MD, who heads the Division of Pain Medicine at Stanford University and is co-chair of the interagency committee.

Still unclear is how the NPS will ever be implemented, since it relies on major policy changes and coordinated action involving medical schools, healthcare providers, insurers, government agencies, Congress and the White House. No estimate is provided on how much it will cost or where funding will come from.

“The NPS is riddled with vague terms and objectives -- which render the whole effort too subject to interpretation,” says David Becker, a patient advocate and author of “Quotes on Pain.” “I find it fascinating that despite the outcry from individuals regarding very specific concerns and problems, they are intent on imposing population based public health solutions on individuals. They can’t see the trees for the forest. And their plan is to help some nameless faceless pain sufferers with a very homogenized approach.

“The whole report reminds me of a Seinfeld episode when he says his show is all about nothing. The NPS is about some vague objectives -- even though the underlying philosophy, politics, privileges -- are only too clear. I guess those privileged pain specialists just don’t wish to be pinned down too much about what their pig in the poke is all about.”

The NPS was quickly endorsed by the American Pain Society (APS), a professional group that focuses on pain research.

“The National Pain Strategy gives the nation a blueprint for aggressive action to expand access to effective pain care,” said APS President Gregory Terman, MD. “Pain is a serious and often neglected public health problem that is draining our health care resources. It is responsible for inestimable lost wages, impaired worker productivity, and extracts a tragic personal toll on patients and their families.”  

Terman and several other APS members were involved in drafting the National Pain Strategy, as well as the CDC’s opioid prescribing guidelines.

“We believe several high impact policy initiatives will emerge from implementation of the National Pain Strategy, especially in helping primary-care physicians, who see that vast majority of pain patients, become more knowledgeable about pain mechanisms, pain assessment, and safe use of analgesic medications,” Terman said.

CDC Guidelines Urge Doctors Not to Test for Marijuana

By Pat Anson, Editor

One of the less publicized provisions in the Centers for Disease Control and Prevention’s opioid prescribing guidelines is a recommendation that doctors stop urine drug testing of patients for tetrahyrdocannabinol (THC), the psychoactive ingredient that causes the “high” for some marijuana users. The guidelines also discourage doctors from dropping patients if marijuana is detected.

Urine drug screens are conducted almost routinely by pain management physicians and other opioid prescribers for a variety of drugs, both legal and illegal.

Some doctors use a positive result for THC as an excuse to discharge patients from their practices, even in states where medical marijuana is legal.

While the CDC guidelines encourage physicians to conduct urine drug tests before starting opioid therapy and at least annually afterwards, they draw the line at THC.

“Clinicians should not test for substances for which results would not affect patient management or for which implications for patient management are unclear. For example, experts noted that there might be uncertainty about the clinical implications of a positive urine drug test for tetrahyrdocannabinol (THC).” the guidelines state.

"Clinicians should not dismiss patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources and the clinician missing opportunities to facilitate treatment for substance use disorder."

As Pain News Network has reported, “point-of care” (POC) urine drug tests, the kind widely used in doctor’s offices, frequently giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. One study found that 21% of POC tests for marijuana produced a false positive result. The test was also wrong 21% of the time when marijuana is not detected in a urine sample.

Not mentioned in the CDC guidelines is evidence that opioid overdose rates declined by nearly 25 percent in states where medical marijuana was legalized.

"We applaud the CDC's reasoned approach to the use of urine testing and its drawbacks when used on pain patients," said Ellen Komp, Deputy Director of California NORML. "Considering that opioid overdose deaths are significantly lower in states with medical marijuana programs, we are sorry the agency apparently didn't read the letter Elizabeth Warren recently sent to its chief calling for marijuana legalization as a means of dealing with the problem of opiate overdose."

That letter by Sen. Warren encouraged the CDC to adopt the guidelines and its restrictive approach to opioids “as soon as possible,” but also encouraged the agency to further study the impact legalization of medical and recreational marijuana could have on opioid overdose deaths.

The annual cost of drug testing in pain management is estimated at $2 billion per year. While POC tests are relatively cheap, more expensive laboratory testing can cost thousands of dollars and is often not covered by insurance.

New Warning About Over-the-Counter Pain Relievers

By Pat Anson, Editor

At a time when the U.S. Centers for Disease Control and Prevention is recommending that non-opioid pain relievers such as non-steroidal anti-inflammatory drugs (NSAIDs) be used to treat chronic and acute pain, European researchers are warning about health risks associated with those same over-the-counter pain medications.

In guidelines for primary care physicians released on Tuesday, the CDC said "nonopioid pharmacologic therapy" such as acetaminophen and NSAIDs are "preferred" treatments for chronic pain.

Only briefly do the CDC guidelines even mention that NSAIDs “have been associated with hepatic, gastrointestinal, renal, and cardiovascular risks” and that acetaminophen may cause liver failure. The 52-page guideline instead focus on the risks of addiction and abuse associated with opioids.

But in a major new study published this week in the European Heart Journal, researchers at 14 European universities and hospitals, including a number of leading heart specialists, warn that some NSAID’s raise cardiovascular risk and that there is no "solid evidence" the drugs are safe.

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

Some of the greatest cardiovascular risk comes from a class of NSAIDs known as COX-2 inhibitors. A COX-2 inhibitor called Vioxx was voluntarily pulled from the market by Merck in 2004, but many other COX-2 inhibitors, such as Diclofenac, are still widely used around the world for pain relief.   

"It's been well-known for a number of years that newer types of NSAIDs - what are known as COX-2 inhibitors, increase the risk of heart attacks. For this reason, a number of these newer types of NSAIDs have been taken off the market again. We can now see that some of the older NSAID types, particularly Diclofenac, are also associated with an increased risk of heart attack and apparently to the same extent as several of the types that were taken off the market," said Morten Schmidt, MD, a postdoctoral research fellow at Aarhus University in Denmark.

Diclofenac is the most widely used NSAID in the world. It is sold under a number of different brand names, including Cambia, Voltaren and Zorvolex.

A second study of NSAIDs, published this week in the New England Journal of Medicine, found that emergency room admissions can be significantly reduced if doctors stopped the “high-risk prescribing” of NSAIDs.

Researchers enrolled a group of primary care physicians in Scotland in an educational program aimed at reducing the exposure of patients with heart or kidney problems to NSAIDs like ibuprofen and aspirin, especially if the patients were taking anticoagulant drugs like warfarin. The study involved over 33,000 high risk patients.

After 48 weeks, the rate of hospital admissions for gastrointestinal ulcers or bleeding was significantly reduced, as was the rate of admissions for heart failure.

"Our previous work has shown that high-risk prescribing is common and often causes important harm. This new study shows that relatively simple interventions can significantly reduce high-risk prescribing in a lasting way, and are associated with reductions in emergency hospital admission for related complications,” said Professor Bruce Guthrie of the University of Dundee in Scotland.

High-risk prescribing and preventable drug-related complications are major concerns for healthcare providers around the world. Up to 4 per cent of emergency hospital admissions are caused by preventable adverse drug events, and in the United States the avoidable cost of drug-related hospital admissions was estimated at $19.6 billion in 2013.

The majority of drug-related emergency admissions to hospitals are caused by commonly prescribed drugs such as NSAIDs and acetaminophen.  Over 50 million people in the U.S. use acetaminophen each week for pain and fever – many not knowing the medication has long been associated with liver injury and allergic reactions such as skin rash. Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses.

A recent study in the British Medical Journal  found that acetaminophen was ineffective in treating low back pain and provides little benefit to people with osteoarthritis. And in a survey of over 2,000 pain patients by Pain News Network and the International Pain Foundation, 76 percent said that over-the-counter pain relievers “did not help at all” in relieving their pain.

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.

Opioid Battle Shifting from Chronic to Acute Pain

By Pat Anson, Editor

Efforts to limit prescribing of opioid pain medication are no longer confined to just chronic pain.

New York Sen. Kirsten Gillibrand (D) has introduced legislation that would require the Centers for Disease Control and Prevention (CDC) to issue guidelines for the safe prescribing of opioids for acute pain – generally pain that lasts for three months or less.

“When someone gets a tooth out and only needs medication for three days - why are they sent home from the doctor’s office with 30 Percocet?” asked Sen. Gillibrand.

The Preventing Overprescribing for Pain Act calls on the Secretary of Health and Human Services and the CDC to issue new guidelines for the use of opioids for acute pain within two years. New York Rep. Louise Slaughter (D) will introduce the bill in the House.

“We need to ensure these powerful medications are used safely while cutting down on the risk that extra pills could lead to possible abuse,” said Rep. Slaughter.

The CDC is currently focused on guidelines for primary care physicians to use when prescribing opioids for chronic pain -- which is pain that lasts for three months or more. 

Plans to implement the guidelines in January were delayed by the CDC after widespread criticism about its secrecy and lack of transparency during the drafting of the guidelines.

As many as 11 million Americans use opioids for chronic pain and many fear losing access to them if the guidelines are adopted. The CDC is currently reviewing the guidelines and no timetable has been set for their adoption.

“As the opioid epidemic continues to grow in New York and across the country, we can’t wait any longer to take action and curb this growing crisis,” said Gillibrand. “We have introduced bipartisan legislation that will help fix this problem by requiring the CDC to issue clear guidelines to help medical providers safely prescribe opioids for these common types of acute pain. I am urging my colleagues in Congress to pass this measure to help curb the growing opioid crisis.”

Gillibrand and Slaughter’s offices issued a joint news release citing a recent CDC report which found that in 2014 nearly 19,000 people died in the U.S. from overdose related to opioid pain relievers. Those statistics are somewhat muddied, however, because some overdose deaths may have been counted twice and some heroin deaths may have been misclassified as morphine deaths, according to CDC researchers.

With opioid prescriptions in decline for several years, many experts believe the still rising number of opioid deaths is attributable to a growing number of heroin and fentanyl overdoses, not from pain medication.

Do Non-Opioid Pain Meds Raise Risk of Suicide?

By Pat Anson, Editor

We received a lot of reader reaction to our story about Sherri Little, the 53-year old chronic pain sufferer who committed suicide with an overdose of medication in her Los Angeles hotel room last year (see “Sherri’s Story: A Final Plea for Help”).

“Numerous prescription medications in the decedent’s name were found throughout the hotel room including a bottle labeled Lyrica on the rim of the bathtub next to the decedent’s body,” reads the coroner’s report.

Lyrica has a warning label that states the anti-seizure drug “may cause suicidal thoughts or actions.” At least two other medications Sherri was taking – the sleep aid Ambien and the sedative Klonopin  -- also have labels warning they may worsen depression or suicidal thinking.

Several readers wondered – as we did – why doctors would prescribe the drugs to Sherri, who had been suicidal for at least two years.

SHERRI LITTLE

“The off label use of antidepressants and anti-seizure meds for pain control is criminal. People are dying! And it's not because they're addicts! It's because the healthcare professionals have become compliant and have agreed to go against all common decency and sense,” wrote Arianne Grand-Gassaway, a chronic pain patient.

Many doctors are turning to non-opioid drugs like Lyrica to manage pain because they’re considered safer and less addictive. Worldwide sales of Lyrica topped $6 billion for Pfizer in 2014, up 19 percent from the previous year.  

“When a suicide occurs it is hard to know with certainty whether medications like Lyrica contributed to the suicide or pain itself was the primary cause,” said Lynn Webster, MD, past President of the American Academy of Pain Medicine and Vice President of scientific affairs at PRA Health Sciences.  “I feel the risk of suicide is many times greater for inadequately treated moderate to severe pain than with patients on these medications.”

Webster says the cocktail of drugs Sherri Little was taking for her pain, anxiety and depression was not unusual.

“It is very common to prescribe an anticonvulsant like Lyrica with a sleep aid. Lyrica is viewed as a safer medication than most options. Most people with moderate to severe chronic pain have difficulty sleeping so drugs like Ambien and Lunesta are routine.  Klonopin is also very commonly prescribed for an anxiety disorder or muscle spasm. It is also used to facilitate sleep," said Webster.

The Food and Drug Administration added suicide to the warning labels for Lyrica and Klonopin  after a review of nearly 200 clinical studies found that patients taking antiepileptic drugs had almost twice the risk of suicidal thought or behavior than patients taking a placebo. 

The risk is small – about 1 in every 500 patients – but don't tell that to the families of the four patients in the clinical studies who killed themselves.

After reading Sherri Little’s story, one reader told us Lyrica made her suicidal.

“I went to my doctor in January after being on Lyrica for a month. It seemed to be helping my nerve pain so she upped my dose to 50 milligrams twice a day,” said Allison Lindsay Shorter. “A couple of days later I started having deep thoughts like I was out of control of my emotions. My anxiety was sky high. I argued for no reason with everyone. I had feelings of hurting myself and whoever got in my way.”

Shorter told her boyfriend she wanted to kill herself and hid his cellphone before swallowing a bottle of muscle relaxers. She was rushed to the hospital and survived.

“I felt out of control when I had all those thoughts and actions, I was scared of myself because I could not control anything. It felt like a demon or evil spirit,” said Shorter. “I knew then it was the damn medication.”

In addition to Lyrica, Shorter was taking 18 other medications to treat a long list of conditions, including fibromyalgia, complex regional pain syndrome, and neuropathy. At one time she was also taking Neurontin (gabapentin), another antiepileptic drug often prescribed for pain that comes with a  label warning of suicide, depression, panic attacks and dangerous impulses.

Why do doctors prescribe medication with such risky side effects?

“Most doctors are probably aware of the suicide risks but the general belief is that risk of suicide from the medication is very low and the risk of suicide from undertreated pain is much greater,” says Webster, who recently wrote a column on patient suicide (see “A Doctor’s Perspective on Patient Suicide”).

“The potential risks have to be continually weighed against the potential benefits.  Lack of treatment carries significant risk too. Suicide is at least three times more likely in the chronic pain population than the general population.  The risk appears to increase with the number of medical diagnoses. In my opinion the risk of suicide due to pain, treated or untreated, far exceeds the risk of suicide from these medications, prescribed alone or in combination.”

Webster fears the current backlash against opioids and efforts to further limit opioid prescribing will lead to more pain going untreated.

“This is a serious topic and I am afraid there are going to be many more suicides due to the anti-opioid movement.  Very sad,” Webster wrote in an email to Pain News Network.  

Ironically, small doses of an opioid may actually reduce the risk of suicide, according to a recent small study in Israel. Researchers at the University of Haifa gave 40 suicidal patients small doses of buprenorphine and found it reduced their suicidal thoughts after just one week.

Just as opioids reduce physical pain, researchers think it can ease mental pain.

“I think they’re onto something. However, buprenorphine acts on a number of different opioid receptors and it’s still unclear which one or ones are playing a role in the anti-suicidal effects,” psychiatrist Joan Striebel told New Scientist.  “I hope this work spurs more interest in what specific molecules could be involved in suicidal thought.”

Hospital Pain Care Needs Improvement

By Barby Ingle, Columnist 

Most hospital staffs are poorly trained in pain management, in my opinion. They are used to acute emergency situations and seeing many of the same ones over and over. So when a “zebra” (someone with a complex chronic condition) gets pushed in on a stretcher, they tend to have thoughts like these:

“Oh boy, I am going to have to work.”

“I don’t believe that this person is as bad as they say.”

“I have seen others in worse physical condition and this person looks ‘normal’ so they can’t be experiencing what they say is going on.”

I had an emergency room doctor tell me once that I didn’t have a blocked bladder. He got out a machine to measure how full my bladder was, but I think he never even turned it on. He said my bladder was empty.

I was in so much pain at the time that I told him he was reading it wrong and that my bladder was extremely full and hurt dramatically. I begged him use a catheter on me. Finally, probably after being sick of hearing me cry out in pain, he let the nurse use a catheter. Guess what? I was right. After my bladder was drained, the pain subsided and I was released to go home. The doctor apologized.

Another time I was taken to the hospital with multiple kidney stones. The ER rooms were full and patients on stretchers were lining the hallways. I was quietly crying from pain, curled up in a ball on my stretcher, watching as other patients were being paid attention to and given pain care. What were they doing different than me? They were loud and obnoxious.

I finally reached my breaking point. I allowed myself to yell out in pain and a few choice words also followed. In less than a minute, a nurse who had told me before that she couldn't give me anything for pain until they got me in a room was beside me with a dose of pain medication.

I know my body. Most people living with a chronic condition know their body and what is new, different, worse, or better. We just know. It’s time that providers trust us and realize that we are there for a reason. The vast majority of us are not trying to score opioids, but trying to get relief because we have reached our breaking point. 

One of the most important issues in an emergency room after lifesaving measures is the patient’s pain care. This is especially true in an acute situation, which is typically why we go to the emergency room in the first place. I don’t know many people who go to the ER or are hospitalized for chronic pain only.

The need for optimal pain care during hospitalization is high, but unfortunately proper and timely pain care is hit and miss at best.  

That’s why Pain News Network and the International Pain Foundation (IPain) are conducting a survey of pain patients about their treatment in hospitals.

The survey, which you can take by clicking here, will help us document how bad the problem is and what can be done to fix it.

Patients who try to be their own best advocate and take personal responsibility for their health should not be discarded because addicts or a small number of pain patients are abusing medications. Yes, abuse needs to be addressed. But pain should not be neglected. Controlling pain is important to the overall outcome of the emergency situation.

In past columns I have discussed the importance of asking for your pain medication at least 30 minutes before you may need them while in the hospital. That is because hospital nurses are trained to wait for you to ask for the medication before they order it -- even if the provider has it marked in your chart that pain medication is allowed. If you do not know to ask, your pain cycles and levels will become harder to control. I have been in this situation many times myself.

I know if I go to the hospital closest to my house, I will not get as good assistance with pain management as I would if I drove a little farther to another hospital. I have to consider other issues as well, such as how long I may have to stay at the hospital, will they have my regular medications, and will they have a staff that understands reflex sympathetic dystrophy and the secondary challenges that come with treating a ‘thick case file’ patient.

When I know I am being listened to as a valuable and knowledgeable patient and team member in my care, my pain will be better managed and I will rate the hospital higher in patient satisfaction surveys. When my underlying condition is not addressed, they’ll get a negative review.

Should a doctor be worried about how I am going to score them? Not if they treat me fairly, individually and as part of my treatment team. Does this mean they should just hand me whatever I ask for? No. It means that they need to use my personal assessment of pain as part of the planning for my care. Not doing so is neglecting the patient.

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

More information about Barby can be found at her website.

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

Education Campaign Launched for OTC Pain Relievers

By Pat Anson, Editor

You’ve probably seen the numbers. The Centers for Disease Control and Prevention estimates that over 47,000 Americans died of drug overdoses in 2014. Over 60 percent of them involved some type of opioid, a category that includes both prescribed pain medications and illegal drugs such as heroin.

Rarely mentioned by the CDC is the number of Americans harmed by over-the-counter (OTC) pain relievers such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs). Acetaminophen overdoses kill about 150 Americans every year and send 78,000 to the hospital.

With opioids becoming harder to obtain for chronic pain sufferers, many are turning to OTC pain relievers – often excessively. A recent survey of pain patients found that 43% knowingly took more than the recommended dose of OTC pain medicine and 28% experienced complications from an overdose.

To help consumers learn more about the risks posed by OTC pain medications, the Alliance for Aging Research has released two animated videos about how to safely choose, take, and store OTC pain relievers. They explain the difference between acetaminophen – which is widely found in products like Tylenol and Nyquil – and NSAIDs, which includes both ibuprofen and aspirin.

"With so many options, it is important for someone to choose an OTC medication that does the best job of treating their pain, while also being aware of its potential risks to their health," said Lindsay Clarke, Vice-President of Health Programs for the Alliance for Aging.

"For older adults, understanding their options is even more important, as age may increase the risk of certain OTC pain medication side effects. These films offer a great overview of what someone needs to know before taking their OTC pain medication."

The videos were produced with support from McNeil Consumer Healthcare, the maker of Tylenol and Motrin.

A survey of over 1,000 pain sufferers by the American Gastroenterological Association (AGA) found that many routinely ignore OTC medicine labels, putting them at risk of serious side effects such as stomach bleeding, ulcers, liver damage, and even death.

"Pain is incredibly personal, but taking more than the recommended dose of OTC pain medicine can cause significant stomach and intestinal damage among other complications," said Byron Cryer, associate dean at the University of Texas Southwestern Medical Center, Dallas.

Gastroenterologists say most patients who experience complications from overdoses of OTC medicine are trying to manage chronic pain or arthritis. Eight out of ten (79%) also report taking multiple symptom OTC medication in the past year for allergies, cold or flu symptoms – which can greatly increase their exposure to both acetaminophen and ibuprofen.

“It is a growing concern because people living with chronic pain and taking multiple medicines often don’t recognize the side-effects of taking too much,” explained Charles Melbern Wilcox, MD, professor of medicine in the division of gastroenterology and hepatology at the University of Alabama at Birmingham.

Sherri’s Story: A Final Plea for Help

By Pat Anson, Editor

“I’ve been thinking about ending my life if I don’t get the help I need.”

Those are chilling words for anyone to hear. And in the last two years of her life, Sherri Little said them often to family, friends and doctors.  After decades of struggling with chronic pain from fibromyalgia, inflammatory bowel disease, severe colitis and other conditions, the 53-year old California woman was desperate and depressed when she checked into the emergency room at Cedars-Sinai Medical Center in Los Angeles on July 3, 2015.

What happened over the next four days is not entirely clear, but we know that Sherri took her own life. Her body was found in the bathtub of a hotel room across the street from Cedars-Sinai on the morning of July 7, with several prescription bottles and an empty bottle of wine nearby. Sherri had been sober for many years.

“I attest this is the first drink of alcohol in 16 years -- just to give me the courage to end my life alone,” Sherri wrote in a suicide note found in her hotel room.

“Several documents found inside the location underscored her pain, suffering and suicidal ideations,” reads the coroner’s report. “A check of the decedent’s laptop also contained a pictured document written by the decedent titled ‘Why I Killed Myself’ by Sherri Little.”

We’re telling Sherri’s story --- with the help of her mother, friends and patient advocate – not in a ghoulish attempt to recreate her final days, but to lend a name, a face and a voice to the untold number of chronic pain sufferers who have also been overwhelmed by pain, depression and loss of hope.  Like Sherri, many felt abandoned by a healthcare system that was unwilling or simply unable to treat them.

sherri little

Over 42,000 Americans killed themselves in 2014 according to the CDC, but experts believe the actual number is higher. Many suicides go unreported or are misclassified as accidental, covered up by grieving family members or accommodating medical examiners.

Sherri’s death was no accident, but it’s taken several months for her mother to come to terms with it.

“I’ve got to get her story out there,” said Lynda Mannion, Sherri’s mother. “She got to the point in the last year or so she could hardly eat solid food at all. She was just drinking her nutrition. I guess she must have lost 20 to 30 pounds in the last year.

“She would say, ‘I can’t go on living like this. If I can’t get some help, if somebody doesn’t believe me, I just can’t go on living like this.’ She didn’t seem to be extremely afraid of dying, considering the alternative, living with the pain she was in. But I never expected her to do it.”

A few months before she died, Sherri gave an interview to Tina Petrova in Toronto for a soon-to-be released documentary called Pain Warriors. 

“Sherri Little and I first became friends on Facebook, united by our common passion of pain patient advocacy. She initially reached out to me after hearing that I had a film in development I was producing on chronic pain and said, ‘Do I have a story for you!’ And indeed, she did,” says Petrova.

In this short clip, Sherri doesn’t talk about suicide and appears hopeful about her future.

But just weeks later, Sherri wrote the following in an email to Petrova:

“I was acutely suicidal last night after being verbally abused by a doctor who can't even get me any pain relief anymore,” said Sherri. “In a last ditch effort to save my life I am going to Cedar Sinai ER in LA with my patient advocate.”

Sherri was referring to Lisa Blackstock, a professional advocate who founded Soul Sherpa to help guide patients through the healthcare system. Blackstock had been a volunteer at Cedars-Sinai for several years and knew her way around one of the most respected hospitals in Los Angeles. 

The day before she went to the hospital, Sherri was still having suicidal thoughts.

“I woke at 3am today, ready to give up the fight and end my life. This is not dramatic or blaming of you, but just a statement of fact: my life has not been worth living for 2 years,” Sherri wrote in an email to Blackstock.

The two women went to Cedars-Sinai together and were in the emergency room for 11 hours before Sherri was finally admitted as a patient with severe abdominal pain on the evening of July 3rd.

Over the next two days, Sherri was examined by doctors and a psychiatrist, who concluded she was a “moderate” suicide risk because she had never actually tried to take her own life.

“Patient is at moderate risk of harm to self, but does not meet criteria for involuntary psychiatric treatment at this time,” the psychiatrist wrote in Sherri’s medical records, which were provided to Pain News Network by her mother.

cedars-sinai medical center

Sherri was scheduled for a colonoscopy on July 6, but never had the procedure.  For reasons that are not clear, she became frustrated with her treatment and left the hospital the night before.

“She left against medical advice,” Sherri’s discharge notes say. “Efforts were made to talk to her about the seriousness of her decision. She explained that she understood but, however, would like to leave against medical advice.”

Lisa Blackstock didn’t learn about Sherri’s release until it was too late.

“Despite a HIPAA release (patient release form) on file naming me as Sherri's contact, the doctor did not contact me and decided there was no reason to place her on a 72-hour involuntary hold,” Blackstock wrote in a letter to the coroner’s investigator. “Sherri was allowed to leave the hospital, in pain and suicidal, and the physicians responsible for her care failed miserably.

“I am a long-term volunteer at Cedars, and, until this incident, had great respect for them.  Changes in healthcare law have resulted in substandard care for many patients depending upon their insurance coverage types, as well as hospital administrators dictating care for patients rather than skilled physicians.”

A spokeswoman for Cedars-Sinai said the hospital was unable to comment and wouldn’t even confirm Sherri had been a patient there.

“State and federal privacy laws prevent hospitals from releasing information about patients without their consent, including whether an individual may or may not be a current or former patient,” wrote Sally Stewart in an email to PNN.

Cocktail of Medications

Long before she was admitted to Cedars-Sinai, Sherri was prescribed a potent cocktail of medications for her pain and depression; including the opioids tramadol and hydrocodone, as well as Lyrica (pregabalin), Ambien (zolpidem), and Klonopin (clonazepam).    

Lyrica, Ambien and Klonopin have all been linked to increased risk of suicide.  

Lyrica has an FDA warning label that states the drug “may cause suicidal thoughts or actions” and Ambien’s label warns that “depression or suicidal thinking may occur.”

Klonopin belongs to a class of sedatives known as benzodiazepines, which are increasingly being linked to overdoses, especially when combined with opioids. Klonopin’s label also warns of “suicidal behavior and ideation.”

Why were doctors prescribing these drugs to someone who was suicidal? And why did Cedars-Sinai release Sherri with the drugs in her possession?

“They discharged her with all of them at Cedars, which I found just incredibly irresponsible,” says Blackstock.

According to the autopsy report, the coroner found only trace amounts of opioids and Ambien in Sherri’s system, but apparently never looked for the other drugs. Her official cause of death is listed vaguely as “combined effects of medications.”

Were the same drugs that Sherri took for her pain and depression – which were ineffective in helping either – used as instruments in her death? 

We may never know the answer.

“I have fought to get help for the disease I am dying of – pseudomembranous colitis – for years without help from anyone,” Sherri wrote in her suicide note. “I do not want to be resuscitated. There is nothing left for me but to be tied to a hospital bed in great pain.” 

Sherri was divorced and did not have any children. But a close circle of friends and loved ones are anxious to have her story told and her memory preserved.

“She was beautiful from the time she was little. She was beautiful up to the day she died.  She looked 20 years younger than she was,” recalls Sherri’s mother, Lynda.

“She loved to help people. She wanted to help people and she couldn’t understand why nobody would help her. She would have been there for anybody.”

“Sherri was one of those rare people that could light up the room upon entering,” recalls her friend, Tina Petrova. “During the all too short time I knew Sherri, her key focus above all was advocating for pain patients, speaking up, getting involved. Her search for treatments for her own painful conditions took a back seat to her passion to help others.

“I can just see her high above us saying, “But you have to DO SOMETHING!’”

Sherri’s advocacy will continue, thanks to a website Petrova created to honor Sherri's memory and the documentary that she’s producing on chronic pain in North America.

What can the rest of us learn from Sherri’s struggle?

Perhaps those lessons are best learned through her own words -- and the advice that Sherri gave to other pain sufferers:

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.

Law Enforcement and Pain Patients

By John Burke, Guest Columnist

I first need to tell you that I spent 48 years in law enforcement and recently retired in 2015 after commanding a large enforcement initiative in southwestern Ohio. I have extensive experience in  prescription drug abuse as it pertains to law enforcement and have written a monthly article for the past 15 years in Pharmacy Times magazine on the topic of drug diversion.

I am the past national president of the National Association of Drug Diversion Investigators and current president of the International Health Facility Diversion Association. In short, I am no stranger to the issues surrounding the abuse and diversion of pharmaceuticals.

I am also a self-declared pain patient advocate who strongly believes that the vast majority of controlled substances that are consumed in the U.S. are taken by legitimate pain patients.  Pain patients have no real lobbying group that can apply pressure on politicians – who are often oblivious to the plight of pain patients as they scramble to get reelected!

In 1990, I was fortunate enough to be assigned to form and command the Cincinnati Police Department’s Pharmaceutical Diversion Unit (PDU). In the early 1970’s I had seen prescription drug abuse on the streets and knew that it was a much bigger problem than was being hailed by the news media. In starting PDU, I made a point to try and educate the media on the subject, and we were very successful in doing that as it was a brand new issue as far as they knew and they flocked to our press conferences.

JOHN BURKE

In addition to the arrests, we provided community education on prescription drug abuse, but sadly we said very little about a victim I got to know well -- the chronic pain patient. I can’t honestly say that pain patients entered my mind in those days, as we stayed focused on those illegally diverting pharmaceuticals. We also specialized on the diversion of medications inside healthcare facilities, a huge problem that exists still today.

We entered a time in the 1990’s when pain patients were deemed to be undertreated, new opioid medications were developed and marketed, and as we entered the 21st century, pain pill abuse started to skyrocket. Most of this century has seen a concentration on pharmaceutical diversion issues, with the spotlight on OxyContin until Purdue Pharma successfully marketed an abuse deterrent formulation in 2010. Since then, heroin has exploded onto the illicit drug scene, accelerating the overdose death rate as even the smallest of communities cry for help.

I saw a chronic pain patient up close and personal about 10 years ago. She was my mother-in-law and she came to live with my wife and I in our home. She had been a pain patient since elementary school. Her leg was permanently fused together and over the years she fought doctors who insisted that amputation was the best route to take for her welfare.

One day, her husband came to me and said that his wife was experiencing a particularly bad time with her pain relief and was moaning most of the night, unable to sleep. Since I had participated in dozens of continuing education programs with renowned pain specialists, I did know a little about pain management -- at least enough to ask if they had told her doctor so that her pain medication could be adjusted.

The answer was that she doesn’t take any pain medication due to the fact that her former doctor, several decades deceased, had told her never to take anything stronger than an aspirin or she would get addicted! I was shocked at this and advised him to go back to her current doctor and request some pain medication for a person who had suffered with daily pain for over 60 years at this point.

Her young physician told her that she was unable to prescribe a controlled substance, something that was blatantly false, but was nonetheless a reality for this almost lifetime pain patient. I then assisted them in finding a pain specialist and after one visit she was prescribed a pain patch and immediately started using something she should have had access to years before.

Her relief was incredible. Although not pain free by any means, she came crying to me that it was by far the most significant pain relief she had ever had in her life. No doubt it was, when aspirin was the only analgesic she was taking for chronic pain. This pain had flourished for decades due to the advice of a well-intentioned, but misinformed physician, who warned her about addiction issues when her pain was becoming unbearable.

I offer no apologies for the aggressive prosecutions of criminal doctors and those who prey on drug addicts by prescribing or dispensing controlled substances merely to line their pockets rather than to provide quality pain care. These people had no intention to provide pain relief to patients, and in the end did great damage to legitimate patients by giving the public the erroneous thought that virtually all people on pain meds are nothing more than addicts!

Every presentation I give, I make it a point to remind the audience that the vast majority of pain medications are prescribed by competent caring prescribers, dispensed by caring pharmacists, and end up in the hands of those who desperately need these drugs to perform every day functions we take for granted.

Right now there is incredible pressure by uninformed politicians to suggest some drastic changes in how opioids are prescribed and dispensed in this country. Law enforcement has plenty of good laws to go after the outliers vigorously, and I strongly urge we continue to do that, but with the full realization that the plight of pain patients’ needs to be protected in the meantime. Balance is important in most things in life and this issue is certainly no exception.

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.