Feds Warn About Rapid Opioid Tapers

By Pat Anson, PNN Editor

Federal health officials are once again urging doctors not to rapidly decrease or abruptly stop prescribing opioid medication to chronic pain patients.

In an editorial published in the Journal of the American Medical Association (JAMA), three federal health officials warn that sudden opioid tapering significantly increases the risk of harm to patients, resulting in increased hospitalizations and emergency room visits.

“There are concerning reports of patients having opioid therapy discontinued abruptly and of clinicians being unwilling to accept new patients who are receiving opioids for chronic pain, which may leave patients at risk for abrupt discontinuation and withdrawal symptoms,” the editorial warns.

The editorial was written by Deborah Dowell, MD, of the Centers for Disease Control and Prevention, Wilson Compton, MD, of the National Institute on Drug Abuse, and Brett Girior, MD, of the U.S. Public Health Service. Dowell is one of the co-authors of the CDC’s controversial opioid guideline, which has been widely used as an excuse by doctors, insurers and pharmacies to impose mandatory limits on prescribing.  

Even before its release in March 2016, pain patients and advocates warned the CDC guideline would result in rapid tapering, patient abandonment and suicide.

But not until April of this year – after three years of needless deaths and suffering -- did the FDA and CDC start urging doctors to be more cautious in their tapering.

It then took another six months for the Department of Health and Human Services (HHS) to produce a 6-page guide for doctors on how to taper patients.

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“The HHS guide and current guidelines emphasize that tapering should be individualized and should ideally proceed slowly enough to minimize opioid withdrawal symptoms and signs. Physical dependence occurs as early as a few days after consistent opioid use, and when opioids have been prescribed continuously for longer than a few days, sudden discontinuation may precipitate significant opioid withdrawal,” the JAMA editorial warns.

The HHS tapering guide urges doctors not to dismiss pain patients and to share decision making with them when developing a taper program.

“If the current opioid regimen does not put the patient at imminent risk, tapering does not need to occur immediately. Take time to obtain patient buy-in,” the guideline cautions. “There are serious risks to non-collaborative tapering in physically dependent patients, including acute withdrawal, pain exacerbation, anxiety, depression, suicidal ideation, self-harm, ruptured trust, and patients seeking opioids from high-risk sources.”

The guide suggests tapers of 5% to 20% every four weeks, although slow tapers of 10% a month may be appropriate for patients taking opioids for more than a year.

A recent study of tapering in Vermont found only 5 percent of patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering. Many of those patients were hospitalized for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure.

Another recent study at a Seattle pain clinic found that tapered patients had an unusually high death rate, with some dying from suspected overdoses.

Meanwhile, not a single word of the CDC opioid guideline has changed since federal health officials finally acknowledged it was harming patients and needed clarification.

Health Canada Supports Use of Prescription Heroin to Treat Addiction

By Pat Anson, PNN Editor

Canada’s national health agency -- Health Canada – is supporting efforts to expand the use of pharmaceutical-grade heroin in treating opioid addiction.

A treatment center in Vancouver, BC is currently the only clinic in North America that provides diacetylmorphine -- prescription heroin – to opioid addicts. Other clinics may soon follow, after last month’s publication of the first clinical guideline for using injectable diacetylmorphine and hydromorphone to treat people with severe opioid use disorder.

Heroin is classified as a Schedule I controlled substance in the United States, making it illegal to prescribe for any purpose. But pharmaceutical grade heroin is legal in Canada, UK and several other European countries, where studies have found it is an effective way of treating — or at least managing — opioid addiction.

In a statement to PNN, Health Canada said it supports using diacetylmorphine to help create a safe drug supply for addicts who use dangerous street drugs and have failed at other forms of treatment.

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“Many stakeholders have been calling for a secure and predictable supply of pharmaceutical-grade opioids as an alternative to the contaminated illegal drug supply. Studies have shown that prescription opioids, such as injectable hydromorphone and diacetylmorphine (prescription-grade heroin), have been successful in helping to stabilize and support the health of some patients with opioid use disorder,” said Jennifer Novak, Executive Director of Health Canada’s Opioid Response Team.

“Health Canada has taken steps towards this objective, including making prescription opioids used in the treatment of severe opioid disorder more easily accessible to healthcare practitioners, reducing regulatory barriers, funding guidelines for opioid use disorder treatment, and supporting safe supply pilot projects in British Columbia.”

Pain patients and their advocates bristle at Health Canada’s willingness to liberalize the use of heroin to treat addiction – while it supports policies that limit access to opioid pain medication.

"While it's necessary to make every effort to keep those suffering from substance abuse alive, why has this come at the cost of pain patients' lives? Health Canada blamed these patients for overdose deaths they played no part in and consequently they can no longer access their necessary medicine. The most severe have been sent spiraling back into more suffering, disability, suicide, and to purchase street drugs out of sheer desperation,” says Ann Marie Gaudon, a PNN columnist, pain patient and advocate. 

“Health Canada acts like a hero trying to save those addicted while simultaneously refusing to admit that they have indeed added to the death toll by adding pain patients. Where is their help? It is nowhere to be seen in the homes of Canada." 

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the second highest rate of opioid prescribing in the world.   

In an effort to reduce the supply of prescription opioids, Canada adopted an opioid guideline in 2017 that is very similar to one released by the U.S. Centers for Disease Control and Prevention a year earlier. Both guidelines have had a negligible impact on the overdose rate, while pain patients on both sides of the border lost access to opioid medication or had their doses reduced to ineffective levels.

“Health Canada recognizes that some people who live with chronic pain have been unable to access opioid medications when needed to manage their pain,” Novak said. “We know that opioid medications are an important tool in the management of pain for some Canadians and are working with stakeholders and partners to promote opioid prescribing practices that balance the benefits and harms of these medications based on the individual needs of each patient.” 

Asked what Health Canada is doing to improve healthcare for pain patients, Novak said the agency was providing $3 million in funding to improve education in pain management for physicians, nurses, pharmacists and social workers.  

Three million dollars is a tiny fraction of the $253 billion spent on healthcare in Canada in 2018.

"It's a pittance but the very sad part is that it's all going right back into the same people and programs that made this whole mess to begin with,” says Gaudon. “Nothing new, no help on the horizon for those whose lives have been shattered. They talk as if they are doing something but they truly are not. It's pure rubbish."

Fentanyl Overdoses Spike in Seattle

By Pat Anson, PNN Editor

Public health officials in the Seattle area are warning about a spike in fentanyl-related overdoses that have killed at least 141 people in King County since June. As in other parts of the country, many of the deaths involve counterfeit oxycodone pills laced with illicit fentanyl.

Three of the recent overdose victims in King County are high school students who took blue counterfeit pills stamped with an “M” and a “30” – distinctive markings for 30mg oxycodone tablets that are known on the street as “Mexican Oxy” or “M30.”

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“Teenagers who are not heroin users are overdosing and dying,” said Brad Finegood of Public Health – Seattle & King County. “Do not consume any pill that you do not directly receive from a pharmacy or your prescriber. Pills purchased online are not safe.”

Gabriel Lilienthal, a 17-year-old student at Ballard High School in Seattle, died Sept. 29 from a fentanyl overdose.

“Gabe died from a fake OxyContin called an M30,” the teen’s stepfather, Dr. Jedediah Kaufman, a surgeon, told The Seattle Times. “With fentanyl, it takes almost nothing to overdose. That’s really why fentanyl is a death drug.”

Fentanyl is 50 to 100 times more potent than morphine. It is prescribed legally to treat severe pain, but in recent years illicit fentanyl has become a scourge on the black market, where it is often mixed with heroin and cocaine or used in the production of counterfeit pills. Illicit drug users often have no idea what they’re buying.

As PNN has reported, counterfeit oxycodone pills laced with fentanyl are appearing across the country and have been linked to hundreds of deaths. Yet this emerging public health problem gets scant attention from federal health officials, who are currently focused on an outbreak of lung illnesses associated with vaping that has resulted in 18 deaths.

‘Enough to Kill San Diego’

In San Diego last month, DEA agents found five pounds of pure fentanyl in the apartment of Gregory Bodemer, a former chemistry professor who died of a fentanyl overdose. Prosecutors say that amount of fentanyl was “enough to kill the city of San Diego” or about 1.5 million people.

Also found in Bodemer’s apartment was carfentanil, an even more powerful derivative of fentanyl, along with a pill press, powders, liquids and dyes used in the manufacture of counterfeit medication.  

Bodemer’s body was found in his apartment Sept. 27. Rose Griffin, a woman who also overdosed at the apartment and recovered, has been charged with drug possession and distribution.

Bodemer was an adjunct chemistry professor at Cuyamaca College in 2016. He had previously worked as a chemistry instructor at the U.S. Naval Academy in Annapolis, Maryland.

Opioid Breathalyzer Test Developed

By Pat Anson, PNN Editor

Chronic pain patients have grown accustomed to having their urine -- and sometimes their blood and hair – analyzed for opioids and other drugs.

Someday soon they could be taking opioid breathalyzer tests.

In a small pilot study, researchers at the University of California, Davis have developed and successfully tested a device that collects minute droplets in breath that can be analyzed in a laboratory for morphine, hydromorphone (Dilaudid) and other opioids.

“Exhaled breath collection represents a painless, easily available, and non-invasive technique that would enable clinicians to make quick and well-informed decisions,” said lead author Cristina Davis, PhD, chair of the Department of Mechanical and Aerospace Engineering at UC Davis. "There are a few ways we think this could impact society."

While ostensibly developed to help doctors care for patients and monitor their drug use, Davis and her colleagues say opioid breathalyzer tests could someday be used in addiction treatment and by law enforcement during roadside field sobriety tests.

They reported their findings in the Journal of Breath Research.

IMAGE COURTESY OF CRISTINA DAVIS, UC DAVIS

IMAGE COURTESY OF CRISTINA DAVIS, UC DAVIS

“Breath offers the opportunity to collect a diagnostic biospecimen non-invasively and, eventually, a way to obtain near real-time results almost anywhere. Though this study did not utilize portable analytic systems, future breath drug detection platforms used to identify targeted compounds will be available for point-of-care use. This will enable opioid detection in many settings including roadside, drug treatment facilities, field emergency response, home, and rural areas with limited access to healthcare,” Davis wrote.

Nine patients receiving opioids for cancer pain at the UC Davis Medical Center participated in the pilot study, along with three healthy people used as a control group. Participants exhaled through a glass tube surrounded by dry ice that captured and froze breath condensate. The breath samples was then analyzed in a lab using mass spectrometry and compared to opioid metabolites in blood samples and in doses given to patients.

"We can see both the original drug and metabolites in exhaled breath," Davis said.

Fully validating the breath test will require more data from larger groups of patients. UC Davis researchers are working towards the development of real-time, point-of-care breath tests that can be broadly used to detect opioids and other drugs.

Point-of-care (POC) urine drug tests are widely used by doctors to screen patients for illicit drugs and to make sure they’re taking medications as prescribed. Physicians like the immunoassay test strips because they can be performed in their offices, are inexpensive and give immediate results.

However, as PNN has reported, POC test results are wrong about half the time – and frequently give false positive or false negative results for drugs like marijuana, oxycodone and methadone.  Experts say doctors should never base a treatment decision or discharge a patient solely on the results of one POC test, and that confirmatory testing should always be performed by a laboratory. 

Report: DEA ‘Slow to Respond’ to Opioid Crisis

By Pat Anson, PNN Editor

DEA investigators should get easier access to prescription drug databases and electronic prescribing should be required for all opioids and other controlled substances, according to a new report from the Justice Department’s Office of Inspector General (OIG).

The 77-page report is sharply critical of the Drug Enforcement Administration for its slow response to the opioid crisis and said the agency was “ill-equipped” to monitor suspicious orders and prevent diversion of prescription opioids.

“We found that DEA was slow to respond to the significant increase in the use and diversion of opioids since 2000. We also found that DEA did not use its available resources, including its data systems and strongest administrative enforcement tools, to detect and regulate diversion effectively. Further, we found that DEA policies and regulations did not adequately hold registrants accountable or prevent the diversion of pharmaceutical opioids,” the report found.

The OIG report focused exclusively on prescription opioids and did not evaluate the significant role that illicit fentanyl, heroin and other street drugs play in the opioid crisis. About two-thirds of opioid overdoses involve illicit drugs.

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The report also contains some factual errors, such as the misleading but often repeated claim that “nearly 80 percent of people who began abusing illicit opioids during the 2000s started by abusing a prescription opioid.”

Less than one percent of legally prescribed opioids are diverted, but the report claims the “pervasive nature of prescription fraud” is so rampant that paper prescriptions for opioids should be prohibited. Instead, electronic prescribing should be mandated nationwide to prevent fraud and allow for better tracking of opioid prescriptions.

‘Puzzling’ Restrictions on Opioid Databases

The report also calls for greater law enforcement access to state run prescription drug monitoring programs (PDMPs). To protect patient privacy, several states require a subpoena or search warrant before giving DEA investigators access to their databases. The report calls the requirement “puzzling” and said it creates “significant challenges” for DEA investigators “who should be able to receive PDMP data and information.”

“We believe that the Department and DEA should continue to work with states to reach agreements that will enable DEA to have timely access to PDMP prescription data as needed… while also ensuring adequate protections for the important healthcare privacy interests of patients,” the report said.

Other recommendations from the report:

  • DEA should develop a national prescription opioid enforcement strategy

  • Require criminal background checks for all new prescribers and registrants

  • Re-establish a nationwide early warning network to identify emerging trends in drug abuse   

  • Expand DOJ opioid fraud units to additional U.S. Attorney’s Offices

In its response to the OIG, the DEA said the report “rightly identifies areas of improvement,” but said the agency has taken a number of steps to reduce the supply and diversion of prescription opioids.

The DEA said “only a minute fraction” of the more than 1.8 million registrants are involved in illegal activity. The agency said it had revoked about 900 registrations annually over the past eight years and reduced the supply of prescription opioids by 45 percent since 2017. Additional cuts in the opioid supply are proposed for 2020.

Feds Target Online Pharmacies

By Pat Anson, PNN Editor

The FDA and DEA have sent warning letters to four online networks for illegally marketing unapproved and misbranded versions of opioid pain medication. The letters are the latest step in what appears to be an expanding federal and private crackdown on online pharmacies and websites that offer alternative health products and information.

The four online networks, which operate at least 10 websites, are Divyata, Euphoria Healthcare, JCM Dropship and Meds4U. The letters warn the companies to immediately stop selling illegal opioids to consumers.

“We cannot allow rogue online pharmacies to continue to fuel the crisis by illegally offering opioids for sale and circumventing the important safeguards that have been put in place for opioids to help protect the public health,” said acting FDA Commissioner Ned Sharpless, MD.

The FDA has issued letters of this type before, but this is the first time the agency has jointly issued warning letters with the DEA. The companies were given 15 days to respond.

“You knowingly or intentionally use the Internet to advertise the sale of controlled substances by directing prospective buyers to Internet sellers of controlled substances who do not possess a valid modified DEA registration,” one letter warns.

“Therefore, your websites are operating in violation of United States law, which may be enforced through criminal penalties and civil enforcement.”

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The letter to Divyata alleges the company sells the opioid painkiller tramadol as an “agony reliever that ties with receptors of the mind and sensory system to diminish dimensions of torment.”

Euphoria Healthcare was warned for selling the opioid tapentadol under the name “Aspadol Tab” and claiming it is used “to treat moderate to severe pain that occurs for shorter to longer periods of time.” The FDA has never approved a drug called “Aspadol Tab.”

As PNN has reported, the FDA has previously cracked down on rogue online pharmacies selling counterfeit drugs or illegal medication. Often the websites reappear under new names or move offshore. As many as 35,000 online pharmacies operate worldwide. The vast majority are not in compliance with U.S. laws and many do not require a prescription, according to the Alliance for Safe Online Pharmacies.

The federal crackdown is not limited to opioids or prescription drugs. This month the Federal Trade Commission warned three companies selling CBD oils, tinctures, edibles and other products to stop making claims that CBD can be used to treat pain and other chronic illnesses.

Google Warns Online Publishers

Internet companies have also taken steps to reduce the flow of online traffic and advertising revenue to websites that offer alternative health information and products.

Today Google informed thousands of online publishers enrolled in its AdSense advertising partnership that it would restrict advertising on websites that promote or have content about recreational drugs, unapproved pharmaceuticals or supplements. The policy not only applies to illegal drugs such as heroin and cocaine, but includes several alternative treatments for pain, such as marijuana, CBD, kratom and other herbal supplements.

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In effect, Google is telling online publishers their advertising revenue will be reduced or stopped if they provide information that Google considers inappropriate.

“Publisher restrictions identify content that is restricted from receiving certain sources of advertising. By content, we mean anything present on your page or app - including other advertisements and links to other sites or apps,” Google explained in a note to publishers.

“If your content is labeled with an inventory restriction, fewer advertising sources will be eligible to bid on it. In some cases this will mean that no advertising sources are bidding on your inventory and no ads will appear on your content.”

Pain News Network is a Google AdSense partner. We frequently publish content about kratom, CBD and other alternative pain treatments. It is unclear how Google’s advertising policy will affect PNN.

In addition to restrictions on advertising, recent changes to Google’s search engine algorithms have suppressed search results for hundreds of websites that offer alternative health information or products. As a result, many of these websites have already experienced a substantial drop in revenue and readers.

Facebook, Pinterest, Tumblr and other online social networks have also recently suspended or deleted dozens of alternative health pages for containing what Facebook considers “false, misleading, fraudulent, or deceptive claims or content.”

Pinterest said it relies on governmental bodies to decide what is appropriate. “We rely on information from nationally and internationally recognized institutions, including the CDC and WHO, to help us determine if content violates these guidelines,” Pinterest explained in an email to a website that was banned.

PNN’s account with Pinterest was suspended without warning in June for violating the company’s “spam policies.”  Our account was reactivated a week later with an apology.

“Sorry that your account was suspended. Occasionally good accounts get caught in the mix when we're looking for spammy accounts,” Pinterest said in an email.

The Power of the Pen

By Michael Emelio, Guest Columnist

It's my hope that this column can serve as a powerful example of the harm that can be caused when people are denied adequate pain management. And in so, I pray that it also serves as a lesson to doctors and is something that our lawmakers, CDC and DEA will take a moment to seriously consider.

To understand the full magnitude of the damage that's been caused, I implore you to read a guest column I wrote last year, in which I described how the opioid medication I take for intractable back pain was rapidly tapered to a lower dose, leaving me bedridden and disabled.

It's high time that the harm being inflicted on me and other innocent victims of the opioid crisis is both acknowledged and stopped!

While I can totally sympathize with a doctor's fear of repercussions from the DEA, there comes a point where it's no longer a valid or acceptable excuse. One of those points is when a doctor, with no medically valid reason, refuses to sufficiently treat a person's pain and it results in harm to that patient.

And when a doctor refuses to prescribe a reasonable opioid dose (especially one that is within the CDC opioid guideline) and it causes a patient's condition to significantly worsen, how are they not responsible for that harm?

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Speaking with other patients, I've been hearing a familiar story quite a bit lately. So much in fact, that it appears to be becoming an epidemic. Doctors with no medically valid reason are either failing or refusing to prescribe even within the CDC’s 90 MME guideline, while using the same old "well the DEA threatens to take our licenses away" excuse. 

Not only is it getting old, but it's getting people hurt and worse. And when I say that excuse is killing me, I may just mean literally!

Since the tapering started, I've gained 55 pounds and my blood sugar and cholesterol have soared to alarming rates. So in addition to all the things I can no longer do and my pain and suffering increasing, I'm now at risk of both heart disease and diabetes. Irrefutably, this is a direct result of being bedridden 24 hours a day due to the med cuts.

But it doesn't stop there. Adding insult to injury, these med cuts are also robbing me of the only chance I have to improve my condition.

Surgery Not An Option

It cannot be emphasized enough that I've seen several highly-acclaimed surgeons, who are absolutely unanimous in what options I have. They've all said the same thing: Surgery is not an option for me and due to the nature of my condition I should avoid any invasive procedures as they can make my pain worse. This includes spinal injections, radiofrequency ablation, spinal cord stimulators and pain pumps, to name a few.

They've all said that the only viable options I have left are pain meds and physical therapy. The latter is essential because “mobility is crucial to help reduce the pain and improve function.” And to slow my rate of deterioration, I should do “as much physical therapy as possible." 

So by denying me the ability to complete physical therapy due to his forced med cuts, my doctor is not only robbing me of my only chance for improvement, he is directly causing my condition to worsen at an accelerated rate. Despite explaining all of this to him, my doctor informs me that he still plans on reducing my meds even further!

On what planet does this make any sense whatsoever? When you consider all the aspects of my condition and the damage the previous met cuts have already caused, how can this be helpful in any way, yet be a necessary or even a reasonable course of action?

Especially when I'm only at 60 MME, which is considerably less than the CDC's 90 MME guideline. Furthermore, I've been a patient of his for over a year and a half and have proven to take my medications responsibly the entire time, as well as the previous 18 years I've been in pain management.

Because of the CDC guideline and the fear instilled by the DEA, my doctor is covering his ass and slowly killing me.
— Micahel Emelio

Think about this for a minute. I have a medical need for pain meds because of an incurable condition that is causing such severe intractable pain that I'm bedridden to the point that I struggle to care for myself properly. It’s also a condition where surgery and invasive procedures are not an option, all other methods and medications have failed, and the only chance for improvement is through physical therapy. Then add the fact that my health is in a serious state of decline as a direct result of the med cuts, and he still wants to cut them even more?

Unless you're in this boat yourself, you can't fathom the level of stress this causes. I'm literally afraid I may have a heart attack from it.

You have to understand the impact that just one more med cut would have on me. I live alone, have no one to help me, and with the dose I'm currently at, I'm already struggling most days just to microwave a TV dinner, yet alone clean my house or even care for myself properly. If he cuts my meds any further, the effect it will have on my life will be devastating.

As I sat in my car outside his office, the only thing I could think about was that if he reduces my meds any further, not only will my pain be unbearable, but I won't even be able to care for myself anymore. Being alone and poor, I only see two options at that point: street drugs or suicide. 

Make no mistake. That is the hand that is being forced on people when intractable pain is not treated!

Never in a million years could I have imagined being in this position. But sadly, this is my reality. And the truly astonishing part of it all is that he could stop all this damage and immensely change my life for the better tomorrow, simply by prescribing 2 more tablets a day, which would still be within the CDC guideline.

But no! Because of the CDC guideline and the fear instilled by the DEA, my doctor is covering his ass and slowly killing me. It's both staggering and terrifying knowing how much control he has over my life with just the swipe of his pen.

Which brings me to an interesting point. In medical school they teach about a thing they call the "power of the pen." It means to make sure that what they prescribe doesn't cause harm to the patient. I just wish my doctor realized that the power of the pen works both ways!

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Michael Emelio lives in Florida. Michael lives with severe degenerative disc disease, scoliosis and fibromyalgia. He has safely used opioid medication since 2001.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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.