CDC Ignored Warning About Opioid Guidelines

By Pat Anson, Editor

A consulting company hired by the Centers for Disease Control and Prevention warned the agency last year that many doctors had stopped prescribing opioid pain medication and that chronic pain patients felt “slighted and shamed” by the CDC’s opioid guidelines.

“Some doctors are following these guidelines as strict law rather than recommendation, and these physicians have completely stopped prescribing opioids,” PRR warned in a report to CDC in August 2016, five months after the CDC released its guidelines.

“Pain patients who have relied on these drugs for years are now left with little to no pain management options. Chronic pain is already stigmatized. Now chronic pain patients face the stigma of addiction, even when they are using opioids responsibly for pain management.”

PRR is a well-connected marketing and public relations firm based in Seattle that has worked for a number of companies and public agencies, including the Environmental Protection Agency, Starbucks, Nike, and the University of Washington.

PRR was hired by the CDC to improve the agency’s public image and to develop a communication strategy to help educate the public about the CDC’s controversial opioid guidelines.

Those guidelines, which discourage doctors from prescribing opioids for chronic pain, are voluntary and only intended for primary care physicians. But they’ve been widely adopted as mandatory throughout the U.S. healthcare system, causing additional pain and anxiety for millions of pain sufferers.

“Chronic pain patients feel or perceive that the CDC has failed them because doctors are making extreme generalizations in determining appropriate care for their pain patients,” PRR found.

The PRR report to CDC was obtained by Pain News Network under the Freedom of Information Act.  Excerpts from the report can be seen by clicking here.

PRR recommended that CDC take a number of steps to understand why the guidelines were being so poorly received by patients.

“CDC should consider conducting more research to understand the fears and concerns of patients with chronic pain conditions. Understanding this group’s perceptions and fears of the PDO (prescription drug overdose) guidelines will help the CDC more successfully communicate with patient advocacy groups and will help insure their targeted messages are being disseminated to patients,” PRR recommended.

“Overall, this will help CDC message and communicate to those living with chronic pain and help providers and patients understand best care options available to enhance and improve quality of life.”

No CDC Response to Recommendations

There is no evidence that CDC has followed through on the recommendations. When asked if the agency had conducted any research or surveys of pain patients in response to the PRR report, the CDC gave us only a brief and vaguely worded statement. Note the use of the word “will.”

“CDC will evaluate the uptake, utility, and public health impact of the guideline and will monitor and assess physician and patient response to the guideline; based on this information, we will update the guideline in the future, as needed.

CDC continues to develop resources for patients and providers about the risks and benefits of opioid therapy for chronic pain to improve the safety and effectiveness of pain treatment and reduce the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death.”

CDC pledged in March 2016 to make changes to the guideline “if new evidence becomes available” and said it was “committed” to evaluating the guideline’s impact – “both intended and unintended.”

But in the 17 months since that pledge was made, there has apparently been no effort by CDC to assess the guideline’s impact on pain care, doctors, patients, suicides, addiction or overdoses -- at least none that the agency will talk about.

“We’ve provided you our statement,” a CDC spokesperson said in an email.

PRR also declined to answer any questions about its report or if any follow-up research is being done.

“We are proud of our work, and we respect client communications protocols. Therefore, we refer you to the CDC to ask your questions directly,” said Jennifer Lynch, PRR’s business development manager.

For the record, this reporter was one of five individuals interviewed by PRR last summer, and asked a series of questions about the CDC guideline. Others who were surveyed include Barby Ingle of the International Pain Foundation, Paul Gileno of the U.S. Pain Foundation, chiropractor Sean Konrad, and Dr. Lynn Webster, a pain management expert and past president of the American Academy of Pain Medicine.   

“I was contacted by the PRR firm as well.  I was told that the CDC wanted to know what they did wrong with the opioid prescribing guidelines,” recalled Webster. “I think it is clear that the CDC should have had more input from the pain community in developing the opioid guidelines.

“Any intervention by the CDC or any government agency that affects millions of people should be accompanied with a plan to assess the effect of the intervention. In other words, the CDC should have planned to measure the effect on intended goals and any unintended consequences from the intervention.”

"CDC recommends close follow-up for patients who are using opioids to treat chronic pain, but they don’t seem to be eager to apply that same advice to their own intervention," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management. "CDC seems to be eager to evaluate the impact of its guideline in terms of metrics such as number of opioid prescriptions written, but they seem to have little concern about assessing the extent to which decreased prescribing is adversely affecting people with pain.

"In all the discussion about the evidence base supporting the guideline, what seems to have gotten lost is a need to develop the evidence base to show how effective or ineffective that intervention has been. Unfortunately, this lack of evaluation is consistent with CDC’s lack of interest in evaluating the prevalence and demographics of chronic pain itself."

Guidelines Made Pain Care Worse

There have been many unintended consequences caused by the guidelines. In a survey of over 3,000 patients and nearly 300 healthcare providers by PNN, eight out of ten patients said their pain and quality of life had grown worse. Many patients are having suicidal thoughts, and some are hoarding opioids or turning to illegal drugs for pain relief.   

Over half of the healthcare providers said they had stopped prescribing opioids or were prescribing lower doses. Many providers also believe the guidelines are ineffective or have made pain care worse:

• 40% believe CDC guidelines have been harmful to patients, while only 22% consider them helpful
• 67% believe guidelines have made it harder for pain patients to find a doctor
• 63% believe the guidelines have not improved the quality of pain care
• 66% believe guidelines have not been effective in reducing opioid abuse and overdoses
• 35% of providers are worried about being prosecuted or sanctioned for prescribing opioids

“I am not sure the CDC is aware of the increased legal trouble many physicians are experiencing as a result of the guidelines. Most of these physicians are just trying their best to help people in pain but are being accused of criminal conduct,” said Webster.

Webster was apparently the only pain management physician interviewed by PRR. The company also reviewed 11 online articles and blogs (about half written by doctors), which gave the guidelines mixed reviews.  PRR's bare bones analysis could hardly be called comprehensive, yet two federal health officials portrayed it as a ringing endorsement of the guidelines by physicians.

“Practitioners are excited to see action taken to address the PDO epidemic,” wrote Tonia Gray and John O’Donnell of the Substance Abuse and Mental Health Services Administration in an appendix to the PRR report. “From our scan of responses, PRR found that many agree this is a step in the right direction to help providers make informed decisions and stem the PDO issue.”

That assessment certainly doesn't reflect the thoughts of Dr. Webster.

“I would urge the CDC to reassess their process and attempt to understand the unfortunate consequences their well-intended but misinformed decisions have had,” said Webster.

“One presumably unintended consequence is the recommendations/guidelines have been adopted as rules and laws, which has resulted in a significant change in care for millions of patients.  The guidelines were never intended to do that – they lack the backing of scientific evidence to be treated as a law.”

CDC has made few efforts to remind doctors, insurers, politicians and state regulators that the guideline is voluntary and only intended for primary care physicians. One of the few was a letter from a top CDC official to Richard Martin, a retired Nevada pharmacist disabled by chronic back pain.

“All of you at the CDC and like-minded groups, individuals, etc. are causing hundreds of thousands, if not millions of people, to suffer in pain needlessly,” wrote Martin, who sent 27 letters and emails to the agency before getting a response from Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention.

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients,” wrote Houry, who oversaw the development of the guideline. “The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

Houry’s letter to Martin was dated June 1, 2016, a full two months before CDC received the PRR report, suggesting that CDC was already aware that problems were developing with the guideline and that many physicians considered it mandatory.

CDC 'Propaganda'

To be clear, PRR’s review of patient and doctor attitudes about the guideline was only a small part of the work it performed for CDC. PRR also provided media training to CDC officials, analyzed news and social media coverage of CDC projects, developed logos and brands, shot promotional videos and pictures, and performed other work traditionally associated with public relations projects.

PRR also developed a series of fact sheets and graphics to help CDC promote the opioid guideline – many of which are still in use today.

The graphics advise doctors that “opioids are not first-line or routine therapy for chronic pain” and that physicians should “start low and go slow” when opioids are prescribed. They also encourage doctors to tell patients that “there is not enough evidence that opioids control chronic pain effectively long term.”

One PRR graphic claims that "as many as 1 in 4 people" who take opioids long-term become addicted. The graphic is based on a single study that even the author admits may have been biased and used unreliable data. A longtime critic of the CDC calls the graphic "propaganda."

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem. Other estimates put the addiction rate higher and some lower.

prr designed graphic

It’s been difficult to assess how much PRR was paid for its work. Invoices sent to CDC indicate the original budget for the project was $240,596, but there were numerous delays and changes in the work performed. The invoices have been heavily redacted by the agency at the request of PRR, which considers the information proprietary.     

CDC: Heroin and Fentanyl Crisis ‘Rapidly Expanding’

By Pat Anson, Editor

A new report from the Centers for Disease Control and Prevention further documents the “rapidly expanding” death toll linked to heroin and illicit fentanyl – an overdose crisis that the CDC continues to blame on prescription opioids.

The agency reported in its Morbidity and Mortality Weekly Report that nearly 13,000 American died from heroin overdoses in 2015, four times the number of heroin deaths in 2010.

Starting in 2013, deaths from illicitly manufactured fentanyl (IMF) also began to spike in the Northeast, Midwest and South -- what the agency calls the “third wave” of the overdose crisis.  Fentanyl is a powerful synthetic opioid 50 to 100 times more potent than morphine.

“The heroin and IMF drug market in the United States is rapidly expanding in the context of widespread prescription opioid misuse. As a result, opioid-involved deaths are cur­rently at peak reported levels,” the CDC reported.

“Increased heroin availability combined with high potency and relatively low price might have made heroin a viable substitute because its effects are similar to those of prescription opioids. The strongest risk factor for heroin use and dependence is misuse of or dependence on prescription opioids.”

But a second report from CDC that focused on more recent overdoses in Ohio tells a different story. Opioid pain medication plays a shrinking role in the Buckeye state’s overdose crisis.

heroin and fentanyl pills (DEA photO)

In the first two months of 2017, the CDC estimated that at least 259 people died in Ohio from overdoses of fentanyl or fentanyl analogs – compared to just 12 deaths involving heroin, 64 deaths linked to opioid pain medication, and 75 deaths involving benzodiazepines, a class of anti-anxiety medication that includes Xanax.

“Evidence from the toxicologic analyses of unintentional overdose deaths in Ohio from the beginning of 2017 indicate the increasing and substantial role of IMFs, and the declining presence of heroin and pharmaceutical opioids in overdose fatalities,” the CDC said.

A recent report from the DEA found a similar trend in neighboring Pennsylvania. Over half the drug deaths in Pennsylvania in 2016 were linked to fentanyl and just 25 percent involved painkillers.

‘The Medical Board Will Come After You’

How are politicians reacting to these new reports about the changing nature of the overdose crisis?

In Ohio they’re tightening the rules on prescription pain medication. New guidelines that went into effect yesterday limit opioid prescriptions for acute pain to just seven days for adults and five days for minors. Patients suffering from cancer or chronic pain are exempt from the rules -- although many doctors have been reluctant to prescribe to those patients because they fear scrutiny. Ohio’s governor didn’t mince words when he warned prescribers that they’ll be held accountable for any slip-ups.

"If you're a dentist, doctor, I don't care who you are, you violate these guidelines, the medical board will come after you," Gov. John Kasich said in the Cleveland Plain Dealer. "And you will be disciplined and perhaps even lose your license."

New Jersey Gov. Chris Christie, who chairs President Trump’s opioid commission, uses similar language that pins the blame on doctors.

“Four out five new heroin addicts start on prescription opioids. This is a problem that’s not just starting on our street corners. Where it’s really starting is our doctor’s offices and hospitals,” Christie told CNN.

Jeffrey Singer, MD, a senior fellow at the Cato Institute,  warns that this sort of “frightening and imprecise rhetoric” often lead to poorly designed policies that only make the problem worse.

“No matter how much regulators clamp down on the medical use of opioids the overdose rate grows. Yet the overwhelming majority of overdose victims are not patients receiving opioids for pain,” Singer wrote in Townhall.

“The opioid overdose problem requires a calm and reasoned approach, and a willingness to admit to previous policy mistakes. Rhetoric aimed at frightening the public does not foretell a propitious start.”

Controversial Genetic Testing Company in Receivership

By Pat Anson, Editor

A controversial genetic testing firm under federal investigation for healthcare fraud has been placed into court-ordered receivership – a form of bankruptcy – that could lead to the restructuring and sale of the company. The CEO and founder of Proove Biosciences has also left the company.

In an interview with STAT, former CEO Brian Meshkin blamed the company's financial problems on “erroneous and damaging” reports that were based on “false allegations” by disgruntled former employees.

Proove Biosciences specializes in DNA testing that the company claims can improve the effectiveness of pain management treatment and determine whether a patient is at risk of opioid addiction.

In June, FBI agents raided the company’s headquarters in Irvine, California. Former and current employees who were interviewed by STAT said the agents were focused on possible kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

In July, PNN reported that Proove was linked to a Medicare fraud case, in which three Indiana healthcare providers allegedly “caused Proove Bioscience… to falsely and fraudulently bill various health care programs for genetic tests... that were not medically necessary and never interpreted."

Proove was not named as a defendant in the Indiana case. In an email to PNN, Meshkin said Proove had cooperated with investigators.

“Proove has cooperated with both the FBI and US Attorney’s office on this case," said Meshkin. "With regards to tests being 'medically necessary', Proove received written and signed determinations of medical necessity supporting the tests ordered and billed to insurance carriers just like every other laboratory which requires such a determination on a test requisition form. Thus Proove operated appropriately and consistent with usual and customary practices."

Meshkin also defended Proove research, published in the Journal of Addiction Research & Therapy, which claimed to show the effectiveness of its genetic tests.The publisher of the journal, OMICS International, has been accused by the Federal Trade Commission (FTC) of deceiving researchers and readers about the true nature of its publications and peer review process.

"Proove can only speak to its experience with this particular journal,” Meshkin said in an email to PNN. "Specifically for papers submitted to this journal, our R&D team and academic collaborators engaged in documented, extensive peer-review, received suggested edits and provided responses to the suggested edits to the manuscripts submitted for review and publication. Thus, Proove would certainly consider the publications accepted from Proove-affiliated authors in that journal to be 'peer-reviewed'."

According to the FTC complaint filed last August, OMICS  has created hundreds of "open access" online medical journals that publish articles with little or no peer review. Researchers are also charged significant fees to get their articles published by OMICS, a "pay to play" policy that some consider unethical because it diminishes the quality of academic journals and the peer review process.

Proove has aggressively promoted its genetic tests with healthcare providers around the country. A pain clinic in Montana, for example, had a Proove “patient engagement representative” employed on site at the Benefis Pain Management Center in Great Falls.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” said Rodney Lutes, a physician assistant who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.”

Lutes’ supervising physician at the clinic was Katrina Lewis, MD, a pain management specialist at Benefis who is listed as a member of Proove’s Medical Advisory Board.  Lewis apparently plays a significant role at the clinic, even though she only works there part time. Benefis has denied that Lewis or any of its employees received kickbacks from Proove for referring business to them.

STAT reported that Proove’s restructuring was apparently ordered by Mike Leavitt, a Proove board member, who also served as Utah governor and secretary of the Department of Health and Human Services. Leavitt’s investment firm, Leavitt Equity Partners, provided about $7 million in funding to Proove, according to Meshkin.

A former Proove manager told STAT that she initially felt good about going to work for the company, but soon had misgivings about Proove's research and billing practices.

“It sucked the life out of me, on an integrity level,” said Rhonda Frantz-Smith. “It got more and more corrupt.”

Petition Calls on FDA to Ban High Dose Opioids

By Pat Anson, Editor

A group of anti-opioid activists has filed a citizen petition with the Food and Drug Administration, asking the agency to remove most high dose opioid pain medications from the market.

The petition would apply to all opioid pills that exceed a daily dose of 90mg morphine equivalent units (MMEs), which the Centers for Disease Control and Prevention set last year as the highest recommended dose for primary care physicians and their patients.  

Such a ceiling, if adopted by the FDA, would take all OxyContin 80mg tablets off the market, as well as many other high-dose oral painkillers. A single OxyContin 80mg tablet, according to the petition, is equivalent to 160 MME.

Another example cited in the petition would be immediate release oxycodone 30mg tablets. If four such pills are taken daily, as they are often prescribed, that adds up to 180 MME.

The petition claims high dose opioid pills raise the risk of overdose and addiction, and are especially harmful to children.

“These products are just too dangerous, there's no need for them," said Pete Jackson, who lost his teenage daughter to an OxyContin overdose.

"These are not medicines. These are lethal weapons that should be removed from the market," said Andrew Kolodny, MD, an addiction treatment specialist and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), one of five anti-opioid activists who signed the petition. None are considered experts in pain management.

“Removing UHDU (ultra-high dosage unit) orally-administered opioids from the market will result in patients having to swallow more tablets or capsules. But this is unlikely to result in a significant inconvenience or hardship for patients,” the petition states. “For patients that may have difficulty swallowing it is important to note that opioid analgesics are available in liquid preparations, sublingual preparations, patches and suppositories.”

Opioids ‘Can Be Appropriate’

In a rare acknowledgement that opioids "can be appropriate" for some pain patients, Kolodny and the other petitioners wrote that "the benefits of prescribing high doses may outweigh the risks when treating severe pain from a life-limiting illness."

But then they make the dubious claim that flooding the market with lower-dose pills will somehow be safer. Reducing the potency of painkillers would mean patients need more to get pain relief – resulting in more pills being prescribed, stored in medicine cabinets, and possibly stolen or diverted – hardly a prescription for reducing abuse.

Having to take more pills could also be risky to patients.  

"With a very large number of pills to manage, they are going to be at more risk of taking the wrong number of pills and of having some of those pills swiped by others without them noticing," Stefan Kertesz, MD, an Alabama primary care physician, told the Associated Press.

“Given the significance of the nation’s opioid crisis, this petition and issue should be discussed by the scientific experts at FDA and we look forward to participating in such a discussion,” Purdue Pharma, the maker of OxyContin, said in a statement. “It is critical that we seek the appropriate balance of treating pain severe enough that requires opioid treatment for which alternative treatments are inadequate, with efforts combating the opioid crisis.”

The FDA had no immediate comment on the petition.  Any U.S. citizen can file a petition with the agency to seek the removal of a drug or medical device for safety issues.

In June, the FDA asked Endo Pharmaceuticals to take Opana ER off the market because it was being abused, the first time that sales of an opioid painkiller have been halted. FDA commissioner Scott Gottlieb, MD, has hinted the agency could take other painkillers off the market.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said in June.

To make a comment on the PROP petition to the FDA, click here.

Chronic Pain Patient: ‘They Are Killing Us Off’

By Pat Anson, Editor

Rob Hale isn’t sure how much longer he’ll live. Which is why the 51-year old Missouri man wants to share his story one more time, so people can see the impact the CDC's opioid prescribing guideline -- what Rob calls the “new cruelty” – is having on pain patients like himself.   

“That's it, man. I quit. I am too weak to continue. I'm beat. I hope some of you can live long enough to see some change in this new cruelty,” Rob wrote to me in an email. “Thank you so much, Pat, for providing me a platform in which to vent my frustration, pain, and anger at the system. I'm not sure if it helped anyone or not, but I hope it did.”

Rob first shared his story with us in a PNN guest column last December. At the young age of 27, he was diagnosed with ankylosing spondylitis, a degenerative and incurable form of arthritis that causes severe inflammation in spinal joints.

As the decades passed, the joints in Rob’s spine and neck became fused, and he was disabled and bedridden by chronic pain.

Relief only came from relatively high doses of opioid pain medication – as much as 600 MEMs (morphine equivalent units) a day. It reduced the pain enough for Rob to start working again, do chores around the house, and take care of his elderly father. Rob felt like his life was worth living again.

ROB HALE

Then came the CDC guidelines in 2016. Although they are voluntary and only intended for primary care physicians, Rob’s pain management doctors reduced his daily morphine dose to 120 MEMs, with the ultimate goal of getting it down to 90 MEMs – what the CDC recommends as the ceiling for high doses.

With his pain no longer being treated properly, Rob’s health deteriorated and he started taking high doses of Motrin, a prescription form of ibuprofen. He took so much Motrin it built up to toxic levels in his kidneys.  

“I was hospitalized in May, when my father couldn’t revive me in the morning. I woke up intubated, with IV’s and wires connected everywhere.  I was unconscious for 4 days, and when I finally awoke, I thought I had died and come back,” Rob said. “I was told if my dad hadn’t found me, I would have died within hours."

The cost to Medicare and taxpayers for that one stay in the hospital was $91,000 -- one of the unintended consequences of weaning or tapering a patient off high doses of opioids. Their healthcare costs often go up.

"None of that would have been necessary if I hadn't been denied my meds in the first place," Rob adds.

Rob was hospitalized a second time in June. His pain now grows worse every day, his health is failing, and he feels his time is running out.

“I nearly died, all because of this ‘opiate crisis.’ I just wanted to tell you that I’m home, albeit on oxygen, because my lungs are still filled with fluid, and I’m not sure how long I have to live,” he said.  “My old palliative care doctor and my current GP doctor think all of this that I’m going through right now is because of the trauma of the pain that I’ve been feeling since they started cutting me back.”

Rob feels he and other pain patients are being held responsible for an overdose crisis they didn’t create. He’s written letters to the CDC, FDA, DEA and to President Trump -- and only gotten form letters in return.

“The simple truth is this: They are killing us off - all of us chronic pain patients. We are, quite simply, a drain on the system, and the whole system would function much better without us. They'll get what they want, too. Before long, we'll all be gone - whether by our own hands, or by complications from our untreated pain, like me,” Rob wrote.

"I sure hope something changes soon. I’m not ready to give up the ghost yet, but I’m so weak that I can hardly type.  Why are they doing this to us, man?"

New Federal Task Force to Address Opioid Prescribing

By Pat Anson, Editor

The federal government is forming another advisory panel to study and develop "best practices" for treating acute and chronic pain. And for the first time, the feds are seeking nominations from the public for members to serve on the panel, who would represent pain patients and pain management experts.

The Pain Management Best Practices Inter-Agency Task Force was authorized by the Comprehensive Addiction and Recovery Act of 2016 – also known as the CARA Act – a landmark bill signed into law last year to address the nation's addiction and overdose crisis.

While much of CARA is focused on preventing and treating opioid addiction, the law also calls for the Department of Health and Human Services (HHS) to form a task force to recommend solutions to “gaps or inconsistencies” in pain management policies among federal agencies.

Currently, the Centers for Disease Control and Prevention, Food and Drug Administration, Centers for Medicare and Medicaid Services, Department of Veterans Affairs, and the Department of Defense all have different regulations and guidelines for opioid medication.

“This Task Force represents a critical piece of HHS’s five-point strategy to defeat the opioid epidemic, which includes advancing the practice of pain management,” HHS Secretary Tom Price said in a news release.

“Top experts in pain management, research, addiction and recovery can help us reassess how we handle the serious problem of pain in America.”

The task force could have as many as 30 members representing a broad spectrum of interests in pain management, according to a notice being published in the Federal Register:

The members of the Task Force shall include currently licensed and practicing physicians, dentists, and non-physician prescribers; currently licensed and practicing pharmacists and pharmacies; experts in the fields of pain research and addiction research, including adolescent and young adult addiction; experts on the health of, and prescription opioid use disorders in, members of the Armed Forces and veterans; and experts in the field of minority health.

The Members of the Task Force shall also include… representatives of pain management professional organizations; the mental health treatment community; the addiction treatment community, including individuals in recovery from substance use disorder; pain advocacy groups, including patients; veteran service organizations; groups with expertise on overdose reversal, including first responders; State medical boards; and hospitals.

Members will also be appointed to represent Veterans Affairs, Department of Defense, Office of National Drug Control Policy, and “relevant HHS agencies.” The latter most likely includes the FDA and CDC. The Drug Enforcement Administration, an agency in the Department of Justice, will apparently not have a representative on the task force.

Pain patients and pain management experts have been poorly represented – and in some cases excluded – from previous federal advisory panels that addressed opioid prescribing and addiction. Some panel meetings were also closed to the public.

President Trump’s opioid commission, for example, includes three governors, a former congressman, and a Harvard professor who has been a longtime critic of opioid prescribing. No patients, pain management experts or practicing physicians were appointed, and the commission only heard testimony from addiction treatment advocates during its one public meeting.

That was better than the CDC, which held no public hearings while preparing the initial draft of its opioid prescribing guideline in 2015. As PNN has reported, the “Core Expert Group” and various stakeholders that advised the CDC were dominated by special interest groups and addiction treatment specialists, including five board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Only after a public outcry and threats of a lawsuit did the agency delay the release of the guideline, seek public comment and form a new advisory panel.

Are you interested in becoming a member of the new task force on pain management or know someone who might?

Information on how to nominate individuals – including self-nominations -- can be found by clicking here. Applications are due by Wednesday, September 27. All nominations must be submitted via email to the attention of Vanila Singh, MD, Chief Medical Officer at PainTaskforce@hhs.gov.

Members of the task force who are not government employees will receive per diem pay and reimbursement for travel expenses. All task force meetings will be open to the public.

Is China Doing Enough to Stop Fentanyl Smuggling?

By Pat Anson, Editor

China has been an "incredible partner" in cracking down on illicit fentanyl and other synthetic opioids, according to Health and Human Services Secretary Tom Price.

"When a particular drug is identified as being a problem, China has been an incredible partner in helping to stop the production of drugs like fentanyl in China," Price told The Associated Press during a visit to China this week.

A closer look suggests otherwise. Mexican drug cartels continue to smuggle alarming amounts of fentanyl – usually produced in China -- into the U.S. and Canada, where it is often mixed with heroin or turned into counterfeit painkillers.

Consider these recent news reports:

The Mexican military last Saturday seized 63.8 kilograms of fentanyl (over 140 pounds) at a checkpoint just yards from the U.S. border near Yuma, Arizona. The newspaper El Financiero reported the powdered fentanyl was found hidden inside a tractor trailer rig, along with nearly 30,000 tablets made with the chemical. The shipment had an estimated street value of $1.2 billion – by far the largest seizure ever of illicit fentanyl.

A week earlier, DEA agents confiscated 30,000 more counterfeit pills at a traffic stop near Tempe, the largest seizure of fentanyl tablets in Arizona history. The Tucson News reported the drugs were connected to the Sinaloa drug cartel.   

The fake pills were designed to look like oxycodone -- an "M" and a "30" were stamped on the blue tablets.

"This massive seizure removed thousands of potentially lethal doses of this powerful narcotic off the streets," said DEA Special Agent in Charge Doug Coleman. 

COUNTERFEIT PILLS SEIZED IN TEMPE, ARIZONA (DEA PHOTO)

It doesn’t take much fentanyl to kill someone – the chemical is 50 to 100 more potent than morphine. Many addicts looking for a high or pain sufferers looking for relief have no idea what they’re buying on the black market.  Experts say a single dose of fentanyl as small as two or three milligrams can be fatal.  

New Jersey’s Attorney General said this week that a suspected drug dealer arrested in March with 14 kilograms of fentanyl – less than a quarter of what was seized in Mexico last weekend -- was enough “to kill more than half the population of the state.” The “super potent” fentanyl, believed to have been shipped from China, “could have yielded upward of five million lethal doses," according to Attorney General Christopher Porrino.

“Fentanyl is commonly mixed with heroin or cocaine for sale on the street, or is sold in powder compounds or counterfeit pills disguised as heroin, oxycodone or Xanax,” Porrino’s office said in a statement.  “Given the tiny size of a lethal dose, drug users are dying because dealers are careless about how much fentanyl they put in such mixes and pills."

Federal prosecutors say a drug ring busted earlier this year in San Antonio, Texas produced hundreds of thousands of counterfeit pills laced with fentanyl and sold them over the Internet to customers all over the country. DEA agents believe several people may have died after ingesting the pills, which were disguised to look like oxycodone, Adderall or Xanax.  

According to the San Antonio Express News, at least 70 packages of fake pills being shipped through the U.S. Postal Service were intercepted. Another 120 packages ready for shipment were seized when the drug ring was finally shutdown, along with four commercial pill press machines. Prosecutors say the fentanyl was obtained from China.

“I’ve never seen a case like this,” said Assistant U.S. Attorney Joey Contreras. “The quantities they’re able to distribute, and in anonymity, are staggering.”

China has promised before to crackdown on illicit manufacturers of fentanyl.  In February, China’s National Narcotics Control Commission announced that it was “scheduling controls” on four fentanyl-class substances. The move came after several months of talks with U.S. officials and was widely praised by the DEA.

“These actions will undoubtedly save American lives and I would like to thank my Chinese counterparts for their actions on this important issue," Acting DEA Administrator Chuck Rosenberg said in a news release.

President Trump’s opioid commission is taking a dimmer viewer of China’s efforts. In its interim report to the president last month, the commission warned that illicit fentanyl was “the next grave challenge on the opioid front” and that stronger efforts were needed from China to stop fentanyl smuggling.

“We are miserably losing this fight to prevent fentanyl from entering our country and killing our citizens. We are losing this fight predominately through China. This must become a top tier diplomatic issue with the Chinese; American lives are at stake and it threatens our national security,” the commission said.

Painkillers Stolen from Dying Patients

By Melissa Bailey, Kaiser Health News

Nothing seemed to help the patient — and hospice staff didn’t know why.

They sent home more painkillers for weeks. But the elderly woman, who had severe dementia and incurable breast cancer, kept calling out in pain.

The answer came when the woman’s daughter, who was taking care of her at home, showed up in the emergency room with a life-threatening overdose of morphine and oxycodone. It turned out she was high on her mother’s medications, stolen from the hospice-issued stash.

Dr. Leslie Blackhall handled that case and two others at the University of Virginia’s palliative care clinic, and uncovered a wider problem: As more people die at home on hospice, some of the powerful, addictive drugs they are prescribed are ending up in the wrong hands.

Hospices have largely been exempt from the national crackdown on opioid prescriptions because dying people may need high doses of opioids. But as the nation’s opioid epidemic continues, some experts say hospices aren’t doing enough to identify families and staff who might be stealing pills.

And now, amid urgent cries for action over rising overdose deaths, several states have passed laws giving hospice staff the power to destroy leftover pills after patients die.

Blackhall first sounded the alarm about drug diversion in 2013, when she found that most Virginia hospices she surveyed didn’t have mandatory training and policies on the misuse and theft of drugs. Her study spurred the Virginia Association for Hospices and Palliative Care to create new guidelines, and prompted national discussion.

Most hospice patients receive care in the place they call home. These settings can be hard to monitor, but a Kaiser Health News review of government inspection records sheds light on what can go wrong. According to these reports:

• In Mobile, Ala., a hospice nurse found a man at home in tears, holding his abdomen, complaining of pain at the top of a 10-point scale. The patient was dying of cancer, and his neighbors were stealing his opioid painkillers, day after day.
• In Monroe, Mich., parents kept “losing” medications for a child dying at home of brain cancer, including a bottle of the painkiller methadone.
• In Clinton, Mo., a woman at home on hospice began vomiting from anxiety from a tense family conflict: Her son had to physically fight off her daughter, who was stealing her medications. Her son implored the hospice to move his mom to a nursing home to escape the situation.

In other cases, paid caregivers or hospice workers, who work largely unsupervised in the home, steal patients’ pills. In June, a former hospice nurse in Albuquerque, N.M., pleaded guilty to diverting oxycodone pills first by recommending prescriptions for hospice patients who didn’t need them and then intercepting the packages with the intention of selling the drugs herself.

Hospice, available to patients who are expected to die within six months, is seeing a dramatic rise in enrollment as more patients choose to focus on comfort, instead of a cure, at the end of life.

The fast-growing industry serves more than 1.6 million people a year. Most of hospice care is covered by Medicare, which pays for hospices to send nurses, aides, social workers and chaplains, as well as hospital beds, oxygen machines and medications to the home.

There’s no national data on how frequently these medications go missing. But “problems related to abuse of, diversion of or addiction to prescription medications are very common in the hospice population, as they are in other populations,” said Dr. Joe Rotella, chief medical officer of the American Academy of Hospice and Palliative Medicine, a professional association for hospice workers.

“It’s an everyday problem that hospice teams address,” Rotella said. In many cases, opioid painkillers or other controlled substances are the best treatment for these patients, he said. Hospice patients, about half of whom sign up within two weeks of death, often face significant pain, shortness of breath, broken bones, or aching joints from lying in bed, he said. “These are the sickest of the sick.”

Earlier this year in Missouri, government investigators installed a hidden camera in a 95-year-old hospice patient’s kitchen to investigate suspected theft. A personal care aide was charged with stealing the patient’s hydrocodone pills, opiate painkillers, and replacing them with acetaminophen, the active ingredient in Tylenol. Hospice nurses in Louisiana and Massachusetts also have been charged in recent years with stealing medication from patients’ homes.

But many suspected thefts don’t get caught on hidden cameras, or even reported.

In Oxnard, Calif., in 2015, a person claiming to be a hospice employee entered the homes of five patients and tried to steal their morphine, succeeding twice. The state cited the hospice for failing to report the incidents.

In Norwich, Vt., in 2013, a family looked for morphine to ease a dying patient’s shortness of breath. But the bottle was missing from the hospice-issued comfort care kit. The family suspected that an aide, who no longer worked in the home, had stolen the drug, but they had no proof. State inspectors cited the hospice, Bayada Home Health Care, for failing to investigate.

David Totaro, spokesman for Bayada Home Health Care, told KHN that situations like that are “very rare” at the hospice, which takes precautions, such as limiting medication supply, to prevent misuse.

There is no publicly available national data on the volume of opioids hospices prescribe.  But OnePoint Patient Care, a national hospice-focused pharmacy, estimates that 25 to 30 percent of the medications it delivers to hospice patients are controlled substances, according to Erik Jung, a vice president of pharmacy operations.

Jung said company drivers deliver medications in unmarked cars to prevent attempted robberies, which have happened on occasion.

Little Oversight of Hospice Medication

Two recent studies suggest hospice doctors and social workers across the country are not prepared to screen patients and families for drug misuse, nor to address the theft of pain medication.

For family members struggling with addiction, bottles of pills lying around the house can be hard to resist. Sarah B., a 43-year-old construction worker in Vancouver, Wash., said when her father entered hospice care at his home in Oregon, she was addicted to opioids, stemming from a hydrocodone prescription for sciatica.

After he died, hundreds of pills were left on his bedside table. She took them all, enough Norco, oxycodone and morphine to last a month.

“I have some shame about it,” said Sarah, who declined to give her full last name because of the nature of her actions.

Sarah, who was one of her father’s primary caretakers, said the hospice “didn’t talk about addiction or ask if any one of us were addicts or any of that.”

“No one gave us instructions on how to dispose of all the medications that were left,” she added.

Medicare requires hospices to establish a safe way to administer drugs to each patient — by identifying a reliable caregiver, staff member or volunteer to manage the drugs or, if need be, relocating the patient. And it requires hospices to set policies, and talk to families, about how to safely manage and dispose of medications.

But there’s little oversight: Unlike nursing homes, hospices may go years without inspection, and even when they are cited for noncompliance, they rarely face any consequence except coming up with a plan to improve.

And in most states, hospices have little control over the pills after a patient dies. The U.S. Drug Enforcement Administration encourages hospice staff to help families destroy leftover medications, but forbids staff from destroying the meds themselves unless allowed by state law. Leftover pills belong to the family, which has no legal obligation to destroy them or give them up.

However, some states are taking action. In the past three years, Ohio, Delaware, New Jersey and South Carolina have passed laws giving hospice staff authority to destroy unused drugs after patients die. Similar bills moved forward in Illinois, Wisconsin and Georgia this year.

In Massachusetts, one of the states hit hardest by drug overdose deaths, VNA Care Hospice and Palliative Care advises families to empty leftover pills into kitty litter or coffee grounds before disposal — a common practice to prevent reuse, since flushing them down the toilet is now considered environmentally hazardous.

But families “don’t have to comply,” said VNA Care medical director Dr. Joel Bauman. “Our experience is maybe only half do. We don’t know what happens to these medications. And we have no right, really, to further inquire.”

Hospices across the country told KHN they take precautions, including counting pills when nurses visit the homes, limiting the volume of each drug delivery, giving families locked boxes for medication and giving patients random urine tests. They also said they prescribe medications that are harder to misuse, such as methadone.

Some, like VNA Care, have also started screening families of patients for history of drug addiction, and writing up agreements with families outlining the consequences if drugs go missing.

But “there’s so much moral distress” about punishing dying patients for family members’ actions, said Bauman. He said he tries to avoid doing that: “Why should we fire a patient for having inappropriate pill counts, when it may not be their fault in the first place?”

Though Blackhall helped spark a national discussion about hospice drug diversion, she said she’s also worried about restricting access to painkillers. Hospices must strike a balance, she said.

“It’s important to treat the horrible suffering that people have from cancer,” said Blackhall. But substance abuse is another form of suffering which is “horrible for anyone in the family or community that might end up getting those medications.”

Kaiser Health News (KHN), a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

KHN’s coverage of end-of-life and serious illness issues is supported by The Gordon and Betty Moore Foundation.

Feds Say Bankrupt Drug Lab Paid Millions in Kickbacks

By Pat Anson, Editor

A bankrupt drug testing lab with a checkered history has been linked to a large money laundering and pill mill operation in Tennessee.

According to an updated indictment in U.S. District Court in Knoxville, Confirmatrix Laboratory in Georgia and Sterling Laboratories in Seattle paid nearly $3 million in illegal kickbacks to have thousands of urine drug test samples sent to them from patients at the Knoxville Hope Clinic (KHC). In return, the labs submitted false claims for "unnecessary" drug tests to Medicare and TennCare, Tennesee’s Medicaid program.

“Confirmatrix, by and through its principals and agents, paid bribes and kickbacks to defendants Clyde Christopher Tipton and Maynard Alvarez in return for causing Medicare and TennCare beneficiaries from KHC to be referred to Confirmatrix for medically unnecessary drug screenings,” the indictment alleges.

“Medical providers at KHC prescribed opioids and other controlled substances to thousands of purported pain patients in exchange for grossly excessive fees. The vast majority of the prescriptions were unreasonable and medically unnecessary. Patients were required to keep follow-up appointments every 28 days to continue receiving their prescriptions. Providers at KHC ordered medically unnecessary Drug Screenings for every patient every 28 days.”

Tipton, Alvarez and six other defendants are accused of drug trafficking and money laundering in the long-running investigation of Tennessee pill mills. The ringleader of the pill mill scheme, a 53-year old grandmother named Sylvia Hofstetter, allegedly made millions of dollars while running clinics that prescribed 12 million opioid prescriptions. Prosecutors have alleged that at least nine patients at the clinics died from drug overdoses.

No one affiliated with Confirmatrix or Sterling Laboratories has been indicted so far in the case. Prosecutors say the   alleged kickbacks were paid from August 2013 to July 2016.

As PNN has reported, Confirmatrix filed for Chapter 11 bankruptcy last November, just two days after its headquarters near Atlanta was raided by FBI agents.  The company was founded by Khalid Satary, a convicted felon and Palestinian national that the federal government has been trying to deport for years.

A 2013 study by the Centers for Medicare and Medicaid Services (CMS) listed Confirmatrix as the most expensive drug lab in the country, collecting an average of $2,406 from Medicare for each patient tested, compared to the national average of $751. The bills from Confirmatrix were high because the company ran an average of nearly 120 different drug screens on each patient, far more than any other drug lab.

These and other abusive billing practices finally caused Medicare to lower its reimbursement rates for drug testing, which led to Confirmatrix’s financial problems.

Although it filed for Chapter 11 bankruptcy nine months ago, Confirmatrix remains in business and continues to bill patients and insurance companies for costly drug screens.

Some current and former patients at the Benefis Pain Management Center, a pain clinic in Great Falls, Montana, have received bills from a collection agency seeking well over $1,000 for drug screens that normally cost a few hundred dollars.

“Confirmatrix is out of network, hence I am stuck with the bill unless Benefis writes it off,” one patient told PNN. “I spoke to my insurance about it and they told me that there are labs in Montana that could have done the same thing and would have been covered by my insurance. She asked me, why they would go to a Georgia lab?”

In a statement to PNN in May, a Benefis official defended the clinic’s continued use of Confirmatrix, saying the company performs a valuable service and “waives many costs.”

“The company we have partnered with has an extensive patient assistance program, which is part of the reason they were selected. That company was selected two years ago because it was one of the few labs nationwide that offered quantitative and qualitative testing AND patient assistant programs,” said Kathy Hill, Chief Operating Officer at Benefis Medical Group.

Confirmatrix’s laboratory, office and warehouse space were recently put up for auction by the bankruptcy court under sealed bid.

Lyrica and Neurontin Face More Scrutiny

By Pat Anson, Editor

The safety and effectiveness of Lyrica (pregabalin) and Neurontin (gabapentin) – two non-opioid drugs widely used to treat chronic pain – are drawing new scrutiny from researchers and doctors who believe the medications are over-prescribed.

In a study published in PLOS Medicine, Canadian researchers say there is little evidence that gabapentinoids – a class of nerve medication that includes Neurontin and Lyrica – are effective in treating chronic low back pain. In their review of 8 clinical studies, the researchers also found the drugs have a “significant risk of adverse effects.”

Lyrica and Neurontin are commonly prescribed for fibromyalgia and neuropathic pain, but the researchers say the drugs are increasingly prescribed for chronic back pain, even though there is “no clear rationale” for it.

"Despite their widespread use, our systematic review with meta-analysis found that there are very few randomized controlled trials that have attempted to assess the benefit of using gabapentin or pregabalin in patients of chronic low back pain," wrote lead author Harsha Shanthanna, MD, an assistant professor at McMaster University in Hamilton, Ontario.

"They necessitate prolonged use and are associated with adverse effects and increased costs. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse.”

Shanthanna and his colleagues found that gabapentin showed “minimal improvement” in back pain compared to a placebo and pregabalin was “inferior” compared to other analgesics. There were no deaths or hospitalizations reported in any of the studies, but both drugs were associated with increased risk of dizziness, fatigue, visual disturbances, and diminished mental activity.

Lyrica and Neurontin are both made by Pfizer and are two of the company’s top selling drugs, generating billions of dollars in sales annually. Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles, and spinal cord injuries. It is also prescribed off-label to treat other chronic pain conditions, including lower back pain.

Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses. Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for.

Sales of pregabalin and gabapentin have risen steadily in recent years, in part because of CDC prescribing guidelines that recommend the two drugs as alternatives to opioid pain medication. About 64 million prescriptions were written for gabapentin in the U.S. last year, a 49% increase since 2011.

“We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain.

“Patients who are in pain deserve empathy, understanding, time, and attention. We believe some of them may benefit from a therapeutic trial of gabapentin or pregabalin for off-label indications, and we support robust efforts to limit opioid prescribing. Nevertheless, clinicians shouldn’t assume that gabapentinoids are an effective approach for most pain syndromes or a routinely appropriate substitute for opioids.”

FDA Seeks Public Comment on Abuse of Lyrica

The U.S. Food and Drug Administration announced last week that it was seeking public comment on reports that pregabalin is being abused. The FDA action was in response to a formal notification from the World Health Organization (WHO) that it may place international restrictions on pregabalin to reduce the risk of abuse and diversion. The FDA has until September 30 to respond to WHO.

“Reports indicate that patients are self-administering higher than recommended doses to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness. While effects of excessively high doses are generally non-lethal, gabapentinoids such as pregabalin are increasingly being identified in post-mortem toxicology analyses,” the FDA said in a notice published in the Federal Register.

Pregabalin is already classified as Schedule V controlled substance in the U.S. under the Controlled Substances Act, which means the DEA considers it to have a low potential for abuse.

The idea that Lyrica and Neurontin are being abused is surprising to many patients and doctors, but there are growing signs the drugs are being used recreationally.

Both Lyrica and Neurontin have been linked to heroin overdoses in England and Wales, where prescriptions for both drugs have soared in recent years.  Addicts have apparently found the medications enhance the effects of heroin and other opioids.

A small study of urine samples from patients being treated at U.S. pain clinics and addiction treatment centers found that one in five patients were taking gabapentin without a prescription.

Gabapentin and pregabalin are also being abused by prison inmates, according to Jeffrey Keller, MD, chief medical officer of Centurion, a private corrections company. 

“Gabapentin is the single biggest problem drug of abuse in many correctional systems,” Keller recently wrote in Corrections.com. “There is little difference (in my opinion) between Lyrica and gabapentin in both use for neuropathic pain or for abuse potential.”

Pfizer did not respond to a request for comment.

Trump Declares Opioid Crisis National Emergency

By Pat Anson, Editor

President Donald Trump said he would declare the opioid crisis a national emergency, just two days after his administration said a declaration wasn’t necessary.

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said outside the clubhouse of his golf course in Bedminster, New Jersey.  “We’re going to draw it up and we’re going to make it a national emergency. It is a serious problem the likes of which we have never had.”

In a brief statement after the President’s remarks, the White House said Trump had instructed the administration “to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

An estimated 142 Americans are dying every day from drug overdoses of all kinds, not just opioids. Prescription painkillers are often blamed as the cause of the problem, although deaths linked to opioid medication have leveled off in recent years. Heroin and illicit fentanyl are currently driving the overdose crisis and in some states are involved in over half of the overdose deaths.  

A White House commission last week urged the president to declare a national emergency, but administration officials indicated as recently as Tuesday that such a declaration wasn’t necessary because the administration was already treating the opioid crisis as an emergency.

“We believe at this point that the resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” said Health and Human Services Secretary Tom Price.

New Jersey Gov. Chris Christie, who chairs the opioid commission, applauded the apparent change of heart.

“It is a national emergency and the President has confirmed that through his words and actions today, and he deserves great credit for doing so. As I have said before, I am completely confident that the President will address this problem aggressively and do all he can to alleviate the suffering and loss of scores of families in every corner of our country,” Christie said in a statement.

“This declaration is only one of many steps we must take on the federal level to reduce the death toll and help people achieve long-term recovery – but it’s a start. I’m committed to working with the President and my fellow commissioners to end the opioid overdose epidemic,” said commission member and former congressman Patrick Kennedy.

It was not immediately clear what steps the administration will take now that an emergency has been declared. A 10-page interim report released by the opioid commission recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, and increased efforts to detect and stop the flow of illicit fentanyl into the country.

There are no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report, which is due in October. Prescriptions for opioid medication – long a target of addiction treatment and anti-opioid activists – have been in decline for several years. The DEA has plans to reduce the supply of many painkillers even more in 2018.

Other measures recommended by the commission:

• Grant waivers to states to eliminate barriers to mental health and addiction treatment
• Increase availability of naloxone as an emergency treatment for opioid overdoses
• Amend the Controlled Substance Act to require additional training in pain management for all prescribers
• Prioritize funding to Homeland Security, FBI and DEA to quickly develop fentanyl detection sensors
• Stop the flow of synthetic opioids through the U.S. Postal Service
• Enhance the sharing of data between prescription drug monitoring programs (PDMPs)

No estimate was provided on the cost of any of these measures.

In a statement on Tuesday, President Trump suggested that law enforcement and abstinence should be used to address the opioid crisis. 

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don’t start, they won't have a problem.  If they do start, it's awfully tough to get off," Trump said, according to a White House transcript.

DEA Proposes Further Cuts in Opioid Supply

By Pat Anson, Editor

The U.S. Drug Enforcement Administration has proposed an additional 20 percent reduction in the manufacture of many opioid painkillers, including oxycodone, hydrocodone, codeine and morphine. The proposed cuts in the opioid supply, which would be effective in 2018, are in addition to those imposed by the DEA in 2017.   

“Demand for these opioid medicines has dropped,” the DEA said in a news release, citing sales data released by the QuintilesIMS Institute, which tracks prescription drug use. About 7 million fewer prescriptions were filled for hydrocodone in 2016, the fifth consecutive year that hydrocodone prescriptions have dropped.

“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” said DEA Acting Administrator Chuck Rosenberg. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”

Many pain patients tell PNN that demand for opioid medicine has not dropped, but that doctors are increasingly reluctant to write opioid prescriptions because of increased oversight by the DEA, insurance companies, and federal and state regulators.  

“It is discrimination, plain and simple. I have a well-documented chronic pain condition. Social Security has deemed me 100 percent disabled,” wrote Lora Lemons. “No other chronic condition that requires medication to combat the disease is flagged the way pain producing diseases are.”

“I am prepared to commit suicide if my pain meds are drastically cut,” wrote a woman who has adhesive arachnoiditis, a chronic and disabling spinal condition. “We don't want to die, but the legislators in the federal and state governments are going to force it for those in intractable pain.”

“No other disease medication is scrutinized. We, as patients, are being denied, dismissed, overlooked and discriminated against by our physicians, due to all the scrutiny associated with treating chronic pain disease with opioid medications. Our doctors are afraid to treat us humanely and adequately,” said Candi Simonis.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Despite those deep cuts, the DEA remains under political pressure to combat the overdose epidemic by reducing the opioid supply even further. Last month, a group of 16 U.S. senators wrote to Rosenberg saying additional cuts “are necessary to rein in this epidemic.”

The DEA published notice of its intent in the Federal Register and is accepting public comments on the proposal until September 6.

Click here to post your comment on the 2018 production quotas.

Trump: ‘Fire and Fury’ for North Korea, But Not Opioids

By Pat Anson, Editor

President Trump has decided not to declare a national emergency to combat the opioid crisis, despite a recommendation from a White House commission that he declare an emergency to speed up federal efforts to fight it. The decision was announced just minutes after the president threatened "fire and fury" against North Korea over its nuclear program.

Health and Human Services Secretary Tom Price said an emergency declaration wasn’t necessary because the administration was already treating the opioid crisis as an emergency. But he wouldn’t rule it out in the future.

“We believe at this point that the resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” Price said at a news conference.  

Last week, New Jersey Gov. Chris Christie, who chairs the president's opiod commission, made a personal plea to Trump to declare a national emergency, saying 142 Americans were dying every day from drug overdoses.

“If this scourge has not found you or your family yet, without bold action by everyone, it soon will. You, Mr. President, are the only person who can bring this type of intensity to the emergency and we believe you have the will to do so and to do so immediately,” Christie said.

“Our country needs you, Mr. President. We know you care deeply about this issue. We also know that you will use the authority of your office to deal with our nation’s problems.”

President Trump met with First Lady Melania Trump, Secretary Price and other administration officials for a briefing on the overdose crisis at the Trump National Golf Club in Bedminster, New Jersey. Gov. Christie was not present.

Trump did not mention a national emergency during the public portion of the briefing, but said drug abuse was a “tremendous problem and we’re going to get it taken care of.” He suggested that law enforcement and abstinence should be used to address it.

“The best way to prevent drug addiction and overdose is to prevent people from abusing drugs in the first place. If they don’t start, they won't have a problem.  If they do start, it's awfully tough to get off.  So we can keep them from going on, and maybe by talking to youth and telling them, ‘No good, really bad for you’ in every way.  But if they don’t start, it will never be a problem,” Trump said, according to a White House transcript.

The opioid briefing was quickly overshadowed by the looming crisis with North Korea, when a reporter asked the president about North Korea’s growing nuclear capabilities.

“North Korea best not make any more threats to the United States.  They will be met with fire and fury like the world has never seen,” Trump said. “He has been very threatening beyond a normal state.  And as I said, they will be met with fire, fury, and, frankly, power, the likes of which this world has never seen before.”

Neither Trump nor Secretary Price laid out any specific steps to combat the overdose crisis. Price said his department was still “talking about what should be done” and developing a strategy.

Trump said the administration was acting to stop the flow of illegal drugs by being “very, very strong on our southern border and, I would say, the likes of which this country certainly has never seen that kind of strength."

New Mexico Congresswoman Reintroduces Opioid Tax

By Pat Anson, Editor

A New Mexico congresswoman has reintroduced a bill that would require pharmaceutical companies to pay a tax on all opioid pain medication they make or import. The money raised would be earmarked for addiction treatment, prevention and research.

Democratic Rep. Michelle Lujan Grisham first introduced the Heroin and Opioid Abuse Prevention and Treatment Act last December. The bill went nowhere, but was quietly reintroduced by Lujan Grisham last month. It’s been referred to the House Committee on Ways and Means.

The legislation, which is very similar to a bill introduced last year by West Virginia Sen. Joe Manchin (D), would raise an estimated $2 billion annually by levying a one cent excise tax on every milligram of opioid pain medication. Excise taxes are not paid directly by consumers, but are levied on producers or merchants, who often pass the tax on to customers by including it in a product’s price.

Sen. Manchin’s bill – dubbed the LifeBOAT Act – would have placed the opioid tax directly on consumers. It was co-sponsored by several Democratic senators and endorsed by Democratic presidential nominee Hillary Clinton, but was not supported by any Republicans and died in the GOP controlled Senate.   

REP. MICHELLE LUJAN GRISHAM

Rep. Lujan Grisham says her legislation would create a “permanent source of funding” to treat addicts, prevent opioid addiction, and develop new pain management techniques. It is co-sponsored by Reps. David Cicilline (D-RI), Katherine Clark (D-MA), Raul Grijalva (D-AZ), and Collin Peterson (D-MN).

“The opioid epidemic has killed too many people, ripped too many families apart, and destroyed too many communities,” Rep. Lujan Grisham said in a press release when her bill was first introduced last year. “Our law enforcement agencies and health care providers are already overburdened and stretched to their limits. People are dying because they do not have the help they need. My bill will help fund the programs necessary to fight this epidemic.” 

In 2015, New Mexico had the eighth highest opioid death rate in the country – a rate that includes overdoses from illegal opioids such as heroin and illicit fentanyl, as well as prescription opioids. The state was recently awarded $9.5 million in federal funding to fight opioid and heroin abuse.

Rep. Lujan Grisham is a lawyer who served as New Mexico’s Secretary of Health under former Gov. Bill Richardson.  She was first elected to Congress in 2012 and was easily re-elected last year by a 2 to 1 margin. Lujan Grisham has announced plans to run for governor in 2018.

Why Heroin Overdoses Are Worse Than We Thought

By Pat Anson, Editor

The number of Americans who died from opioid overdoses – particularly from heroin – is significantly higher than previously reported, according to a new study published in the American Journal of Preventive Medicine.

Researchers at the University of Virginia refined the overdose data from 2014 death certificates and estimated that overdose death rates nationally were 24 percent higher for opioids and 22 percent higher for heroin. Deaths involving heroin were substantially underreported in Pennsylvania, Indiana, New Jersey, Louisiana, and Alabama.

A major weakness of the study is that it does not differentiate between opioid pain medication that was prescribed legally, and prescription opioids or illegal opioids that were obtained illicitly. All “opioids” are lumped together in one category.

Virtually every study about drug overdoses is flawed in some way, because each state has different rules and procedures for death certificates. The expertise of county coroners and medical examiners can also vary widely.

There were over 47,000 fatal overdoses nationwide among U.S. residents in 2014. However, about one-quarter of the death certificates failed to note the specific drug involved in an overdose.

“A crucial step to developing policy to combat the fatal drug epidemic is to have a clear understanding of geographic differences in heroin and opioid-related mortality rates. The information obtained directly from death certificates understates these rates because the drugs involved in the deaths are often not specified," said lead author Christopher Ruhm, PhD, Frank Batten School of Leadership and Public Policy, University of Virginia, Charlottesville.

Ruhm and his colleagues developed a more refined database that supplemented the death certificate data with additional geographic information from states and counties. The supplemental data had a substantial influence on state mortality rankings.   

For example, the opioid and heroin death rates in Pennsylvania, based solely on death certificates, were 8.5 and 3.9 deaths per 100,000 people, respectively. The corrected data doubled the death rates in Pennsylvania to 17.8 for opioids and 8.1 and for heroin.

“Geographic disparities in drug poisoning deaths are substantial and a correct assessment of them is almost certainly a prerequisite for designing policies to address the fatal drug epidemic,” said Ruhm.

The Centers for Disease Control and Prevention has also tried to refine the data from death certificates to make it more reliable.  A CDC study released last December used new software to scan the actual text of death certificates, including notes left by coroners. That study found that heroin, cocaine, fentanyl and anti-anxiety medication (benzodiazepines) were responsible for more overdose deaths in the United States than opioid pain medication.

A more reliable way to determine the cause of an overdose is through toxicology reports, which some states are now utilizing to better assess their drug problems. Pennsylvania recently found that fentanyl was involved in over half of its overdoses, followed by heroin, cocaine and anti-anxiety medications such as Xanax and Valium.  Opioid pain medication was ranked as the fifth most deadly drug. Toxicology reports have also determined that fentanyl is involved in over half the drug overdoses in Massachusetts.