I Was Lied to by My Pharmacist

By Colleen Sullivan, Guest Columnist

I wrote an article years ago titled "Humiliated by a Pharmacist" about how difficult it is to be a chronic pain patient and to get prescriptions filled for pain medicines.

I would love to report things are better now, but sadly the truth is they aren't.

I was diagnosed with Mixed Connective Tissue Disease (MCTD) in 2001. Having MCTD basically means a person has two or more overlapping autoimmune conditions. Mine are dermatomyositis, rheumatoid arthritis and psoriatic arthritis. These are all very painful conditions to have.  

Since I've been dealing with MCTD for so many years, I've dealt with a lot of different pharmacists and learned a few things.

Whenever I enter a pharmacy for the first time, I like to speak with the manager, explain my conditions and what I need from them. Then, I ask what they need from me and if they are willing to work with me. I just want to make sure we understand each other and are on the same page. 

Picking up my prescriptions went smoothly for awhile. It was still stressful and scary to approach the dreaded pharmacy counter and hand over my prescription for an opioid. They still looked at the Rx and up at me with judgmental eyes. They still had an attitude and no empathy whatsoever.  

COLLEEN SULLIVAN

But I managed to find a place and a head pharmacist who was willing to work with me. It was a small pharmacy that wasn't part of a big chain and I thought they weren't going to be the "med police" like Walgreens. You know what I mean: Pharmacists who think they know more than your specialist and that it's somehow their job to judge if you're worthy of your medicine or not. 

This pharmacy is located in the same building as my pain specialist, which I thought was great.  First, if they have any questions or problems, my doctor is right upstairs. Second, it's super convenient being one floor below. I already have to drive 4 hours round trip to see my doctor in Homestead, Florida because there are no doctors in the Florida Keys willing to treat any pain patients. 

So, I went to this place and spoke to the owner and head pharmacist, Claude, who said it'd be no problem at all and he'd be happy to work with me. He assured me they have a special relationship with a drug distributor and a backup vendor as well. I was finally able to relax and not have a flare up every month from the stress of going to a pharmacy.  

Things were good for six months or so, but then suddenly the whole staff started acting weird towards me. Here we go again, I thought. They started insisting I call them days in advance every month to remind them I'm a customer of theirs and to order my medication. I didn't mind doing that, but the more I thought about it, isn't that their job?

They'd assure me on the phone that everything was good, they ordered it, and it'd be there for me when I needed it.  

Then one day I made the two hour drive there and handed over my prescriptions. They went to the back and whispered to one another. That made me extremely anxious. Then, they came up and said, "Sorry, we don't have it." 

I stood there frozen in disbelief before asking, "Don't you remember talking on the phone with me and assuring me you had it?"  

Claude just shrugged his shoulders and said, "I can't help you. Sorry. I can order it now." 

Order it now? That means I would have to make the 4-hour round trip drive the next day just to pickup a prescription.  

This happened from then on, almost every month. When they didn’t have my meds, sometimes Claude would nonchalantly say, "Just drive around and look for it."  

JUST DRIVE AROUND AND LOOK FOR IT?

If you walk into a new pharmacy with an opioid prescription, it never goes well.  They look at it, look back at you and say, “We don’t have it.” They don't look in the back. They don't check the computer. They just say no. 

One thing you should know about me is I really hate confrontation. Stress makes my conditions worse, so I try to avoid it at all costs. I never argue with them. I meekly walk away and, out of desperation, cry in my car. 

I kept trying to get my prescriptions filled at this small pharmacy, because each time they'd apologize profusely and say it was an oversight and won't happen again.  

One of the last times I went there, I called in advance again. Claude says, "No problem. I ordered it and it's here. I'm looking at it. No worries."  

I get there and he says "Nope, we don't have it. It’s a problem with the distributor. Wait a couple of days and they'll get it." The whole time he's talking, I'm thinking, “You lied to me. Why did you lie?” 

So I wait. Three days later, I call and Claude says he can't get it. I end up having to go to Walgreens -- and that's a whole other story -- but eventually Walgreens gets it for me that month with stipulations.   

But now I'm three days behind in my medication. I have to get infusions every month on a particular day and Claude is well aware of that. Being three days off means two 4-hour round trip drives a month instead of one.

The next month. I called a week ahead because Claude had assured me he would work it out. But on the call he says, "Sorry, it's still a problem with the distributor."  

Out of curiosity, I asked who was the distributor. He tells me it's Cardinal Health.  

I decided to call Cardinal myself and within 20 minutes I find out there is no issue on their end and they can ship it to that pharmacy within a day. I think, this is great! Problem solved and I don't have to keep bothering Claude.

I called the pharmacy to tell Claude the good news and he was furious that I called Cardinal. He's literally yelling at me over the phone saying, "How dare you!" and "Who do you think you are?"  

I thought I wasn't just helping myself, but the pharmacy as well with the distribution problem they kept telling me about. Claude then refuses to receive the shipment from Cardinal and says they no longer want my business because it's "too much work.” He says he's done with me and tells me not to come into his pharmacy again. 

After hanging up and crying for 20 minutes, I start to realize there never was a distribution problem. It was all just a lie and he’s angry at me because I figured it out. Keep in mind this is two days before I'm supposed to refill. Because of his lies, I now had 2 days to restart the process of finding a whole new pharmacy. 

Honesty, it's sad that chronically sick people are being treated like this by medical professionals. All Claude really had to do was be honest and say, "I'm not comfortable working with you anymore. I will fill them for you one more time, so you'll have a month to figure something else out."  

If he could've just been professional and told the truth, there would have been no problem.  

Colleen Sullivan lives in Florida.  

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

DEA Allowing More Production of Opioids

By Pat Anson, PNN Editor

Faced with growing concerns about drug shortages, the U.S. Drug Enforcement Administration has increased the production quotas for some opioid pain medications and other controlled substances.

The move is in response to reports that hospitals are experiencing shortages of injectable fentanyl, morphine and hydromorphone, which are used as analgesics to keep COVID-19 patients comfortable while on ventilators.

“DEA is committed to ensuring an adequate and uninterrupted supply of critical medications during this public health emergency,” acting DEA Administrator Uttam Dhillon said in a statement.  “This will ensure that manufacturers can increase production of these important drugs, should the need arise.”

The emergency order signed by Dhillon increases 2020 production quotas by 15 percent for some Schedule II controlled substances, including fentanyl, morphine, hydromorphone, codeine, ephedrine and pseudoephedrine, as well as other drugs used in their manufacture.

Although some of those drugs have been listed for years on an FDA database of drug shortages, the DEA said as recently as three weeks ago that it was “unaware of any shortages of controlled substances at this time.”

In addition to pain medication, Dhillon’s order increases the annual production quota (APQ) for methadone, which is used primarily to treat opioid addiction. The order also raises the amount of Schedule III and IV controlled substances that can be imported into the United States, including ketamine, diazepam, midazolam, lorazepam and phenobarbital, which are also used to treat patients on ventilators.

“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of these substances as the country moves through this public health emergency,” Dhillon said in the order.

“Although the existing 2020 quota level is sufficient to meet current needs, DEA is acting proactively to ensure that — should the public health emergency become more acute — there is sufficient quota for these important drugs.”

Shortages Began Before Coronavirus

The DEA began aggressively cutting the supply of opioids in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

As recently as last December, the agency reduced 2020 production quotas for hydrocodone by 19 percent and oxycodone by 9 percent. The supply of hydromorphone, oxymorphone and fentanyl was also cut.

Some health officials warned months ago – before the coronavirus outbreak -- that the cuts went too far.

“Some of these medicines, injectable fentanyl and hydromorphone specifically, have been subject to recent and frequent shortages, hindering the ability of doctors and hospitals to conduct critical surgeries and essential patient care,” Corey Brown, Executive Director of Government Affairs for Sanford Health, which operates 44 hospitals in the Midwest, warned in an October 14 letter to the DEA.

“There remains a legitimate need to assure that patients needing surgery and those with short-term or chronic pain in hospitals (or hospice) have monitored access to pain management medications. We are concerned that additional reductions in quotas of these vital medicines may further impact the ability of medical professionals across the country to provide needed care and comfort to patients in a hospital or hospice setting.”  

Last week the DEA issued an order allowing drug manufacturers to increase their inventory of Schedule II controlled substances. But no increase in the production quota was made at the time. A senior DEA official told Reuters the quotas were “completely sufficient” to meet high demand.

The agency changed course after receiving a joint letter from the American Medical Association, American Society of Anesthesiologists, Association for Clinical Oncology and the American Society of Health-System Pharmacists warning that injectable drug shortages were affecting the care of coronavirus patients.  

“Injectable opioid medications such as these are vital for sedation, pain management, and interventional procedures. While oral dosage forms may be available, these are not clinically indicated for ventilation,” the letter said. “Without sufficient IV opioid supply, patients will suffer.”

Once the coronavirus emergency ends, DEA said it would “reevaluate demand and adjust APQ levels as needed.”

Pain, Prison and a Pandemic: Life Behind Bars for Former CEO of U.S. Pain Foundation

By Pat Anson, PNN Editor

Self-isolation, social distancing and good hygiene may be the order of the day for most of us during the COVID-19 crisis. But they are next to impossible for Paul Gileno.

“Basically 100 of us are locked in one building, all sharing the same bathrooms and common areas. I sleep on a top bunk in a room of 30 people which is all open,” says Gileno.

Gileno is the founder and former CEO of the U.S. Pain Foundation, which once billed itself as the nation’s largest advocacy group for pain patients. Today he is better known as Inmate #26388014 at Federal Prison Camp Schuylkill, a minimum-security facility in Minersville, Pennsylvania.

Like other federal prisons, Schuylkill has been locked down in an attempt to limit the spread of the coronavirus. All visits have been suspended and inmates spend little time outside of their cells and dorm areas.

“The CO's (correctional officers) and staff do not wear masks and they come from the outside world. They say they test them, but that consists of taking their temperature. They won’t let us out to get fresh air, only to go eat and come back which is less than 10 minutes,” Gileno says. 

In January, Gileno began serving a one-year sentence at Schuylkill for embezzling over $1.5 million from U.S. Pain. He could have gotten up to 25 years, but federal prosecutors agreed to ask for a lesser sentence when Gileno pleaded guilty to fraud and tax evasion.

“I was horrified how pain patients are treated in the outside world. In prison it’s 100 times worse,” wrote Gileno, who recently began corresponding with this reporter by letter and email.

“I am treated terrible here, all of the inmates are treated horrible here. Food is either expired or almost inedible and they are constantly doing raids, shakedowns and lockdowns, sometimes making us stand in the freezing cold for hours while they search our cells.”

Gileno abruptly resigned from U.S. Pain in 2018, but it took nearly a year for the Connecticut-based charity to disclose the full extent of the “financial irregularities” that he was accused of.  

An audit revealed that Gileno used the foundation’s bank account as his own personal piggy bank, writing checks to pay expenses such as his mortgage, car payments and a visit to Universal Studios.

There were also questionable business decisions that were far outside the scope of U.S. Pain’s mission, such as a $100,000 loan to Gileno’s brothers and $165,000 spent on a failed bakery.

The brazen misuse of donated funds somehow went undetected for three years by U.S. Pain’s board of directors and vice-president Nicole Hemmenway, who has been “interim CEO” ever since Gileno’s departure. The non-profit’s board and office staff remain largely the same.

PAUL GILENO

“I don’t know what else I can say about U.S. Pain, except I certainly made mistakes and I mismanaged. But I took full responsibility and I am paying the ultimate price in many ways,” Gileno wrote.

“Sadly the people I loved and respected and who I trusted and hired totally disowned me, left me and refused to handle this in a way where I did not suffer as much as I am suffering. I owned up to my mistakes and never thought I would be treated as I was. With that said, I want U.S. Pain to succeed and I want it to flourish.”  

Gileno says he sleeps on a two-inch mattress that has aggravated his chronic back pain. His only relief comes from ibuprofen or Advil, which he buys at a prison commissary. A doctor visits once a week, but sees only a handful of inmates.

“They are overwhelmed and do not care,” Gileno wrote. “I have met men in so much pain it’s tragic. We have no options here, no physical therapy, no medical attention, no access to any sort of therapy that can relieve some of our pain.

“I must say I am suffering more now in pain than ever before and my anxiety is at an all time high. And they do not treat that either.”

The worst part of prison life for the 47-year old Gileno is that he can’t see his wife and two sons due to the coronavirus lockdown. Schuylkill is a three-and-a-half-hour drive from their home in New York state. Telephone calls are limited to 15 minutes and emails are restricted.

Because of the pandemic, Attorney General William Barr recently ordered the early release of inmates from three federal prisons where coronavirus outbreaks have occurred. But so far there’s no word of that happening at Schuylkill.

“There is a lot of talk about freeing federal inmates but we have not been told anything nor have they informed us if there is a procedure in place,” Gileno says. “I am hoping they are not waiting until it gets here. I am one of the high risk patients they should put on home confinement. Besides all of my pain conditions and RSD, I have chronic asthma and chronic bronchitis.”

Gileno is currently scheduled for release in November. When he gets out, Gileno would like to return to patient advocacy and perhaps run a support program for prisoners in pain.  

“I just hope people with pain know that I am always going to fight for them and all patients and that was always my goal when starting the foundation. I can’t wait to get out to be a patient advocate again and help who I can,” he wrote.

Coronavirus Is Now More Deadly Than Opioid Crisis

By Roger Chriss, PNN Columnist

The coronavirus pandemic is claiming lives daily. The number of confirmed infections worldwide passed one million today, with over 51,000 deaths.

Case counts in the United States are rising fast, with nearly a quarter of a million people infected and over 5,600 deaths. Over a thousand Americans are now dying every day from COVID-19.

This means that the pandemic is causing more deaths in the U.S. per day than the opioid crisis did in 2017, its worst year. Over 47,000 people died of opioid-related overdoses that year, according to the CDC, or about 128 people a day.

The worst is still ahead of us. The White House coronavirus task force projects that between 100,000 and 240,000 Americans will die from COVID-19.  

Other estimates are higher and some lower. Researchers at the University of Washington project that over the next four months approximately 81,000 people will die from the virus. In other words, the pandemic will kill more Americans in 2020 than opioids did in any year.

If things get worse, because the virus turns more virulent, medical resources dwindle or the public health response weakens, then the estimated death toll may rise into the millions.

Most of us couldn't do anything about the overdose crisis, because it was not an infectious disease epidemic. Practices like social distancing, scrupulous hygiene and self-isolating do not matter in a drug overdose crisis. But for a pandemic viral illness, they are vital.

The importance of distancing cannot be understated. As the University of Oxford Mathematical Institute explains, without distancing an infected person may pass the virus to three people in a week, which in six weeks leads to 1,093 new cases. However, if everyone reduces their contacts by a third, then each infected individual will only infect two others.

Hygiene is similarly important. Regular scrubbing of hands with soap and water, sneezing or coughing safely into an elbow, and strict avoidance of hand-to-face contact can help break the chains of transmission, reduce infection and prevent deaths.  

White House coronavirus response coordinator Dr. Deborah Birx told NBC News that keeping the number of deaths below 200,000 will require that “we do things almost perfectly.”

Early evidence suggests that social distancing and other public health measures are already helping in the San Francisco Bay area and the Seattle-Puget Sound area. But continued vigilance is needed.

“Our model looks at the data to determine if social distancing measures are slowing the spread of COVID-19,” said Dr. Daniel Klein, computational research team leader at the Institute for Disease Modeling. “While the results indicate an improvement, the epidemic was still growing in King County as of March 18th. The main takeaway here is though we’ve made some great headway, our progress is precarious and insufficient.”

Opioid overdoses led to far too many deaths. The pandemic stands to kill far more and lead to vastly more illness. There is a lot we can each do to avoid becoming sick ourselves and protect our families, friends and communities.  

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

AMA: Waive Limits on Opioids During Coronavirus Emergency

By Pat Anson, PNN Editor

The American Medical Association has released a new set of policy recommendations to help patients maintain access to opioids and other prescription drugs during the coronavirus pandemic. While many of the proposals involve substance abuse treatment, some are designed to protect chronic pain patients.

“These recommendations are to help guide policymakers reduce the stress being experienced by patients with an opioid use disorder (OUD) and pain as well as support efforts to continue harm reduction efforts in communities across the United States,” the AMA said in a statement.

The AMA is asking individual states to waive many of the requirements on filling prescriptions for opioids and other controlled substances during the coronavirus emergency.

• Waive limits on the dose and/or quantity of opioids and other controlled substances, as well as refills.

• Waive requirements for electronic prescribing of controlled substances, including requirements for an in-person evaluation of patients needing a refill.

• Waive drug testing and in-person counseling requirements for chronic pain patients needing refills.

• Allow for telehealth counseling to fulfill state prescribing and treatment requirements.

• Provide liability protection for physicians who prescribe controlled substances for patients the physician believes is compliant with prescription recommendations.

• Enhance home-delivery of medication for patients with chronic pain.

The AMA is recommending similar waivers for patients being treated for OUD, including the designation of addiction treatment drugs (buprenorphine, methadone, naltrexone) as “essential services,” allowing for 90-day prescriptions for buprenorphine, and suspending daily limits on residential and out-patient therapy.

The Drug Enforcement Administration recently waived federal requirements for in-person visits for controlled substance prescribing, allowing doctors and patients to connect remotely via telehealth. The AMA is encouraging states to take similar action for their own controlled substance regulations.  

Medicare Plan Would Require Insurers to Report Suspicious Opioid Prescribing

By Pat Anson, PNN Editor

Doctors, patients and advocates are reacting with alarm to a proposal by the Centers for Medicare and Medicaid Services (CMS) that would require insurance companies to report “substantiated or suspicious activities” by healthcare providers, including “inappropriate prescribing of opioids.” Insurers would also be authorized to unilaterally suspend payments to pharmacies for “credible allegations of fraud.”

If adopted, critics say the sweeping rule changes would have a chilling effect on providers and put insurance company profits ahead of patient well-being.

At issue is a notice published in the Federal Register last month, which details changes proposed for Medicare and Medicaid programs for 2021 and 2022. The notice has drawn little attention from the public, news media or healthcare organizations, which have been preoccupied with the coronavirus pandemic.

Many of the rule changes proposed by CMS are being made to implement the SUPPORT Act, which was passed by Congress in 2018 to reduce opioid abuse and promote substance abuse treatment.

Current CMS policy allows insurers – known as “plan sponsors” -- to voluntarily report potential fraud by doctors and pharmacists. The proposed rule change would require such reporting, when there is “credible evidence of suspicious activities of providers or suppliers related to fraud, and other actions taken by the plans related to inappropriate opioid prescribing.”

Insurers would report allegations to CMS through an internet portal, while the public would be encouraged to call a fraud tip hotline. Credible cases of “bad actors” would then be referred to law enforcement, according to CMS:

"Implementing these provisions will allow CMS, MA (Medicare Advantage) organizations and Medicare Part D plan sponsors to share data and information regarding bad actors, take swift action based on such data and information, and achieve enhanced outcomes in our efforts to fight the opioid crisis. In addition, this regulation will provide the means for more effective referrals to law enforcement based on plan sponsor reporting, ultimately resulting in reduced beneficiary harm and greater savings for the Medicare program.” 

Insurers would be allowed to consider a wide range of factors to determine if opioid prescriptions are inappropriate, including a patient’s health condition, medical records, opioid dosage, refills, and even the “time and distance between a prescriber and the patient.”

Patient advocates say the plan gives too much power to insurers and wrongly assumes that prescription opioids play a major role in the opioid crisis.

“The regulations planned here will constitute a major regulatory burden on the practice of medicine and implicitly make the assumption that sponsors or pharmacists are better judges of patient benefit and risk than prescribers,” said Andrea Trescot, MD, Stephen Nadeau, MD, and patient advocate Red Lawhern, PhD, in a joint statement. 

“These rule changes assign major responsibilities and powers to Medicare Part D sponsors. Since these sponsors have a pecuniary interest in minimizing the drugs they pay for, profit rather than patient well-being will be the major driver of their procedures and protocols. Both physicians and advocates spend hours each week dealing with denial of care, including medications, by sponsors. The people denying the care are often not physicians and they make no attempt to access patient medical records to develop informed judgments.”

Under the CMS proposal, insurers would also be required to enroll patients deemed at risk for opioid abuse into “Drug Management Programs” that would limit which doctors and pharmacies they can see to obtain prescriptions for opioids and benzodiazepines, a class of anti-anxiety medication.  

‘Big Brother’ Approach

Although the CMS proposals have been publicly available on the Federal Register for over a month, only a few dozen comments have been received to date.

“This sounds like we (chronic pain patients) will be targeted for simply getting the care we need to sustain a basic level of living,” wrote one poster. “Often times, assumptions are made that we are drug seekers, drug abusers, and such. Sometimes it takes trying different medications and different doses to get to where we need to be in order to live life. This may look bad on paper to someone without clinical training, education, or experience. Things aren't always what they seem.” 

“My gosh you people are trying to fix a non-existent problem. The issue now is not prescription drugs that us senior citizens take. It is heroin and fentanyl analogs,” said another. “IT IS TIME WE AS A COUNTRY STOP TRYING TO FIX A MEDICAL ISSUE WITH LAW ENFORCEMENT. There is no need for the government to get between me and my doctor when it comes to my pain medication.”

Many posters are concerned that providers and patients could face sanctions over unproven allegations.

“I am EXTREMELY concerned for this ‘Big Brother’ approach you are taking yet again,” said another poster. “I do not have an addictive personality. What if someone decides to say I do? Then my doctor who is already living in fear of the DEA may go along with whatever determination this government decides to make about me.”   

“So the idea is to shut down doctors with a mere investigation? Based on accusation? Not even charged but only accused? This is truly a new low in individual rights,” said another. “I would think that doctors would almost entirely abandon controlled substances prescribing altogether. Perhaps the motivation for this.”  

While CMS says “a fraud hotline tip, without further evidence, is not considered a credible fraud allegation,” some worry that unsubstantiated claims could still result in sanctions against a provider.   

It was a complaint from a woman in upstate New York that recently led to a North Carolina doctor losing his DEA license. The woman doesn’t know Dr. Thomas Kline or any of his patients, but reported Kline to the state medical board because she didn’t like his tweets defending the use of opioid medication. Kline sees several patients from out-of-state, one of the red flags that CMS would consider suspicious.

“I think the sticky wicket is probably the words ‘credible allegations of fraud.’ Such as the Dr. Kline fiasco. THAT wasn't credible but the Board sure made it out to be,” says Rick Martin, a retired pharmacist and pain patient.   

What do you think of the CMS proposal? The public comment period ends April 6. To leave a comment, click here.

What If the Opioid Crisis Is Worse Than We Think?

By Roger Chriss, PNN Columnist

A recent study in the journal Addiction reports that the opioid crisis in the U.S. may be worse than we’ve been led to believe. The number of overdose deaths linked to legal and illicit opioids over the past two decades could be about 28 percent higher than reported.

Economists Andrew Boslett, Alina Denham and Elaine Hill looked at drug overdose deaths between 1999 and 2016 in the National Center for Health Statistics. Of 632,331 deaths, over one in five had no information on the drugs involved. The researchers estimated that as many as 72% percent of those deaths likely involved opioids. This yields an additional 99,160 deaths involving prescription opioids, heroin, fentanyl and other street drugs that were not counted.

This estimate may or may not be right, but it is definitely not new. Claims like this have been around for years.

In 2017, Business Insider reported on an investigation by CDC field officer Dr. Victoria Hall, who looked at the Minnesota Department of Health's Unexplained Death (UNEX) system. She found that 1,676 deaths in the state had “some complications due to opioid use,” but were not reported as opioid-related deaths.

A 2018 study at the University of Pittsburgh found that as many as 70,000 overdose deaths were missed because of incomplete reporting.

‘Cooking the Data’

It has long been suspected that the CDC’s opioid overdose death toll is faulty – either too high or too low, depending on your point of view. Public health data in the U.S. is shoddy, the result of a fractured and fragmented system that has little central guidance or administrative oversight. The overdose numbers aren’t as reliable as they should be, which raises suspicion they are being manipulated.

The Atlantic makes a similar point about the coronavirus outbreak.

"Everyone is cooking the data, one way or another. And yet, even though these inconsistencies are public and plain, people continue to rely on charts showing different numbers, with no indication that they are not all produced with the same rigor or vigor," wrote Alexis Madrigal. “This is bad. It encourages dangerous behavior such as cutting back testing to bring a country’s numbers down or slow-walking testing to keep a country’s numbers low.”

The implications of under-counting deaths in the overdose crisis require careful consideration. Political campaigns, public policy, state laws and regulations, and clinical practice are built on these numbers. For instance, the Trump administration was recently touting a 4% decline in overdose deaths, but that reduction may not exist.

Similarly, cannabis advocacy groups argue that state legalization has reduced overdose deaths. But again, that reduction may evaporate with better data. State laws and regulations are built on the assumption that trend lines were going in a particular direction. But maybe they aren’t.

Most important, policy groups have argued strenuously that reducing prescription opioid utilization would alleviate the overdose crisis. But if there are vastly more deaths than recognized, where does that leave these groups?

Of course, determining cause of death is a process fraught with difficulties. The New York Times reports that morgues are overburdened and understaffed, many suspected overdose deaths are not fully evaluated, and reporting on the cause of death is not standardized.

Making a probabilistic assessment is even more fraught. For instance, a recent attempt to use stool samples to measure how many rodents, birds and other wildlife are eaten by domestic cats was undone by the discovery that cat food manufacturers regularly change their ingredients.

In other words, there are many known problems and occasional surprises in public health data, so any estimate has to be treated with caution. But if opioid overdoses are vastly undercounted, then we should reassess the policies and politics of the crisis.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

DEA Allowing Telehealth for Opioid Prescriptions

By Pat Anson, PNN Editor

Pain patients who are self-isolating during the coronavirus outbreak may be able to get an opioid prescription without visiting their doctor.

In an update on its COVID-19 Information Page, the U.S. Drug Enforcement Administration said prescribers and patients can connect remotely via telehealth – also known as telemedicine --  to get a prescription for opioids and other controlled substances.  

The exemption from the Controlled Substances Act was made possible by the public health emergency declared on January 31 by Health and Human Services Secretary Alex Azar.  On March 16, Azar and Acting DEA Administrator Uttam Dhillon agreed to allow telemedicine to be used for the prescribing of Schedule II through Schedule V opioids and other controlled substances.

“While a prescription for a controlled substance issued by means of the Internet (including telemedicine) must generally be predicated on an in-person medical evaluation, the Controlled Substances Act contains certain exceptions to this requirement,” the DEA said.

“For as long as the Secretary’s designation of a public health emergency remains in effect, DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation.”

The exemption applies to both new prescriptions and renewals, provided the following conditions are met:

• The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of their professional practice.

• The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system

• The practitioner is acting in accordance with federal and state laws.

Doctors were already allowed under federal law to use telehealth to prescribe controlled substances, but only if they had previously conducted an in-person medical evaluation of the patient. The exemption essentially waves that first face-to-face meeting.

“During this uncertain time, DEA remains flexible and committed to ensuring that the nation’s drug supply chain is uninterrupted,” Dhillon said in a statement. “DEA continues to work with our public health partners to explore options that ensure those in need of vital prescriptions are able to get them, while still adhering to safe practices such as social distancing.”

‘Unaware of Any Shortages’

The DEA also said it was working with the FDA to monitor the supply of medications and was “unaware of any shortages of controlled substances at this time.”

That is a misleading statement, because there are 145 drugs currently listed in an FDA database of drug shortages, including several opioids that are primarily used for anesthesia during medical procedures. The drugs were in short supply even before the coronavirus outbreak.

Last month, the FDA said it was notified by a drug manufacturer that it was experiencing a shortage of one medication due to the coronavirus outbreak. The drug was not identified.

Many ingredients and raw materials used in drug manufacturing are imported from China and India. According to a recent study, nearly two-thirds of the world’s supply of acetaminophen comes from China.

Emergency Refills

Some states are also taking steps to ensure that patients are not deprived of medications during the coronavirus outbreak.

Florida Surgeon General Scott Rivkees issued an emergency order authorizing the use of telemedicine for prescribing opioids and other controlled substances “only for an existing patient for the purpose of treating chronic nonmalignant pain without the need to conduct a physical examination.”

This Washington State Medical Commission authorized pharmacists to grant emergency 72-hour refills for prescriptions that are not maintenance medications. A 30-day emergency supply of maintenance medications was authorized if a pharmacist is unable to obtain refill authorization from the prescriber.

Maintenance medications are drugs used to treat conditions that are chronic or long-term, such as high blood pressure, heart disease, diabetes and, presumably, chronic pain.

The Washington State Department of Health also asked insurance companies to allow patients to get a one-time refill of their prescriptions before the end of the waiting period between refills.

Overdose Deaths Fell by 4.1% in 2018

By Pat Anson, PNN Editor

A new analysis by the CDC has confirmed earlier estimates that drug overdose deaths in the U.S. decreased by 4.1% in 2018, the first decline in the nation’s overdose rate in nearly three decades.

The decline was led by a drop in overdoses involving prescription opioids (-13.5%) and heroin (-4.1%). Much of that progress was offset by a 10% increase in deaths involving synthetic opioids, a category that includes illicit fentanyl and fentanyl analogs.

Fentanyl and other synthetic opioids were involved in 31,335 overdose deaths -- nearly half of the 70,237 drug deaths in 2018 and over two-thirds of the 46,802 opioid deaths.

The 14,975 deaths linked to prescription opioids represent about 22% of the total number of fatal overdoses.

“Decreases in overdose deaths involving prescription opioids and heroin reflect the effectiveness of public health efforts to protect Americans and their families,” CDC Director Robert Redfield, MD, said in a statement. “While we continue work to improve those outcomes, we are also addressing the increase in overdose deaths involving synthetic opioids. We must bring this epidemic to an end.”

U.S. DRUG OVERDOSE DEATHS IN 2018

SOURCE: CDC

Synthetic opioid deaths in 2018 increased in the Northeast, South and West and remained stable in the Midwest. The highest synthetic opioid death rate (34 deaths for every 100,000 people) occurred in West Virginia, which also has the highest death rate involving prescription opioids (13.1 deaths per 100,000 people).

Seventeen states experienced declines in prescription opioid deaths in 2018, with no states experiencing significant increases.

While opioid prescribing has been declining since 2012, much of the CDC’s public messaging remains focused on reducing the use of opioid pain medication.

“Because of the reductions observed in deaths involving prescription opioids, continued efforts to encourage safe prescribing practices, such as following the CDC Guideline for Prescribing Opioids for Chronic Pain might be enhanced by increased use of nonopioid and nonpharmacologic treatments for pain,” wrote Nana Wilson, PhD, a CDC epidemiologist and lead author of the study.

“Additional public health efforts to reduce opioid-involved overdose deaths include expanding the distribution of naloxone, addressing polysubstance use, and increasing the provision of medication-assisted treatment.”

Wilson and her colleagues noted that an increase in overdose deaths among African-American and Hispanics showed a need for “culturally tailored interventions” to address health and other societal factors.   

While the decline in overdose deaths in 2018 is encouraging, preliminary CDC data indicates the trend is not continuing into 2019. Deaths are increasing from synthetic opioids, cocaine, methamphetamine and psychostimulants such as attention deficit disorder drugs.

Overdose deaths often involve multiple drugs, so a single death might be included in more than one category and be counted multiple times. The quality of the data also varies widely from state to state. Only 39 states have good to excellent overdose data, according to the CDC.

Confusion Over Ibuprofen as Coronavirus Treatment

By Pat Anson, PNN Editor

With the number of coronavirus cases growing to nearly 200,000 worldwide, so is confusion about which over-the-counter pain reliever should be used to treat its symptoms. Some health experts say acetaminophen – known as paracetamol outside the U.S. – is better than ibuprofen, aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

"We recommend paracetamol, not ibuprofen for self-medicating," Christian Lindmeier, a spokesman for the World Health Organization said today.

At issue is whether ibuprofen and other NSAIDs interfere with the body’s immune system and make coronavirus symptoms worse. The debate was kicked off Saturday by a tweet from France’s Health Minister.

“Taking anti-inflammatory drugs (ibuprofen, cortisone, ...) could be an aggravating factor of the infection. If you have a fever, take paracetamol,” said Dr. Olivier Véran, a neurologist.

That same day, the French government reported "grave adverse effects" linked to the use of NSAIDs in coronavirus patients and released new guidelines saying “the treatment of a fever or of pain linked to COVID-19 or to any other respiratory viral disease should be paracetamol.”

But the UK’s Royal Pharmaceutical Society (RPS) disputed whether there was enough evidence to make such a recommendation.

“There is not currently enough information on ibuprofen use and COVID-19 to advise people to stop using NSAIDs. There is currently no published scientific evidence that ibuprofen increases the risk of catching COVID-19 or makes the illness worse. In addition, there is also no conclusive evidence that taking ibuprofen is harmful for other respiratory infections,” the RPS said in a statement.

The Medical University of Vienna also chimed in, calling reports that it had found a connection between ibuprofen use and worse coronavirus symptoms "fake news."

But other experts agreed that NSAIDs can weaken the immune system.

“Despite all of their beneficial effects, it has long been known that anti-inflammatories can have a depressive effect on parts of our immune systems,” Dr. Amir Khan of Britain’s National Health Service said in Al Jazeera. “If we take medicines that dampen this immune response, such as ibuprofen, this can lead to us not fighting off the infection as effectively, potentially leading to a longer illness with a higher risk of complications.

“Paracetamol is not an anti-inflammatory medication and can be used to effectively treat fever as well as mild to moderate pain and can, therefore, be used safely to help treat the fever associated with the coronavirus.”

The NHS also updated its recommendations, cautioning that while there is no strong evidence that ibuprofen makes coronavirus worse, “until we have more information, take paracetamol to treat the symptoms of coronavirus.”

‘Don’t Give Her Ibuprofen!’

The New York Post reported that a 4-year old British girl suffering coronavirus symptoms had difficulty breathing and took a turn for the worse after taking ibuprofen. Amelia Collins had a cough, fever and other flu-like symptoms.

“To those of you that have children please read. If your child has symptoms of corona virus, DO NOT give them ibuprofen,” Amelia’s father posted on Facebook. “Within an hour of giving her [ibuprofen] she dropped dramatically. She was panting while trying to breathe, her heart rate was very rapid, she couldn’t keep her eyes open, couldn’t lift her head up, her body was shaking, she started being sick on herself and her temperature had risen.”

Amelia’s parents called for an ambulance. Fortunately, paramedics were able reduce her fever without taking her to a hospital.

“Now she’s back on [acetaminophen] she’s back to just being her poorly self. The paramedics only told us while here that were not to give her ibuprofen!” the father said.

In 2015, the U.S. Food and Drug Administration warned that “everyone may be at risk” and ordered new warning labels for ibuprofen and other NSAIDs to indicate they increase the risk of a fatal heart attack or stroke.

But acetaminophen also has issues. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. Acetaminophen is the active ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – and many consumers have no idea how much acetaminophen they’re taking.

Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses, including 25,000 hospitalizations and hundreds of deaths.

The Other Opioid Crisis: Patient Abandonment and Denial of Treatment

By Georgia Carroll, Guest Columnist 

I am a patient advocate and pain sufferer. I have the usual pains associated with rheumatoid arthritis, a bad knee and a few bulging lumbar discs. But my personal story is nothing compared to what most of the patients I work with are going through. 

I represent only a small fraction of the tens of millions of patients across the U.S. who have been abandoned by their doctors and denied treatment for the pain caused by diseases, injuries and mental health conditions. They are the unintended victims of efforts to curb opioid overdose deaths, even though studies show less than 2% of overdoses involve prescription opiates written for the deceased.  

Leaving these patients without medical care is inhumane and only exacerbates the opioid crisis, forcing some to turn to the street for relief. The victims of this abuse have been crying out for help since before 2013 and nothing has been done. They have been left to suffer, deteriorate and die. Lack of action to protect these patients has elevated the opioid crisis to a self-fulfilling phenomenon.  

Frankly, I was ignorant of how bad the situation was until a few months ago, when our doctor was arrested. For the last five years, he and I have been focused on teaching patients to integrate alternative therapies into their treatment regimens to help them reduce opioid dosages and frequencies.   

Now it is in my backyard and we are the victims, because no one gave a damn about 50 million suffering souls.

We are not drug addicts looking for the next high. We are medical patients who need doctors to responsibly prescribe the opiates we need for relief.

GEORGIA CARROLL

None of the legislation passed in recent years does anything to protect doctors from ill-conceived prosecution or their patients from being abandoned. The Department of Justice, DEA and local law enforcement have not been able to effectively diminish the availability of street drugs, much less stop their distribution. So they misinterpret and pervert the CDC opioid guideline to make their own rules for investigation and prosecution of the “low hanging fruit" of prescribers diligently treating their patients.

Physician intimidation is unacceptable. Patient abandonment is unacceptable.  

A case in point: The doctor of most of the patients for whom I advocate was arrested and the clinic closed without warning last November. The staff were threatened and intimidated, and medical records and computers confiscated, including the external hard drive backup.  In a flash, the doors were locked and 7,000 patients were abandoned with no recourse and no source for prescription refills, even blood pressure and insulin, much less chronic pain, panic attacks or depression. 

It took 10 days for the local district attorney to return the backup drive for patient records. It was blank, completely scrubbed.  We asked the DA to make medical records available to the patients so they could engage new physicians. They refused. Not their responsibility. "Clinic should have had backup," we were told. 

On day 73, after many letters from patients and doctors requesting the files and two street demonstrations, they finally agreed to download individual patient's records to a disc, on request, to be picked up at the DA's office in person or by a representative. 

Doctors and medical facilities across the country are refusing to write prescriptions for opiates to anyone, for fear of suffering a similar fate.  Instead, they are pushing patients to expensive and repetitive injections or surgery.  

Our doctor has been "flagged" by other local doctors, who refuse to even see a patient with his name on the medical files or prescription, even though he is highly respected by most of them. Call it "Not Me Next Syndrome."

The hundreds of patients I work with have now been without effective pain and mental health disorder medications for over 120 days, with no relief in sight.  They have been through the agony of withdrawals unassisted. What recourse do they have?  Continued debilitating suffering, accelerated physical and mental health decline, street drugs and the ultimate relief of suicide.  

These are the calls I receive almost daily. How would you advise them?  How would you manage your symptoms or those of a loved one?  How would you cope?  

Several states have begun to introduce bills to protect doctors from prosecution for doing their job and patients from being cut off cold turkey from their prescribed opiates. But these individual state efforts are inadequate given the number of patients across the country already affected. Patient abandonment and denial of care is now a national public health epidemic and demands immediate, emergency action. 

Georgia Carroll lives in Texas.

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

People With Chronic Pain Must Prepare for Coronavirus

By Dr. Lynn Webster, PNN Columnist

The new coronavirus, COVID-19, is real. It is not a political fabrication and it is not a hoax. Its dangers have not been exaggerated. With over 1,300 confirmed cases in the United States as I write this, we are now in the acceleration state of the pandemic.

In Italy, there were only three confirmed cases of coronavirus less than a month ago. Now there are over 12,000 cases and 827 deaths. The Italian government has ordered all shops, bars and restaurants to close, and a nationwide lockdown prevents 60 million people from traveling outside areas where they live.

What History Teaches Us About Pandemics

Although the trajectory of this coronavirus is difficult to predict, we can look at the history of other viruses to know what might happen in the U.S.  

Within a week or two, there will probably be tens of thousands of Americans who have the coronavirus. Most likely, the virus will remain a threat for at least a year. We almost certainly will not see a vaccine before then. By the time we have developed a vaccine, the virus will have infected millions of Americans and will probably have mutated in unpredictable ways.  

As I wrote in a previous column, the people with an increased risk for severe symptoms and possibly dying of COVID-19 are seniors and those with chronic illness. Of course, people in chronic pain are part of this high-risk group.  

The lethality of COVID-19 was initially reported to be about two percent, but the World Health Organization now estimates the overall fatality rate to be 3.4 percent. For people over age 60 or with underlying health problems, the rate is even higher. 

We still don't know how many people have been infected, so it is impossible to know the true rate of mortality (the number of deaths compared to the number of people diagnosed). As we improve our ability to test for the virus, hopefully we will see the rate of mortality decrease, although the number of deaths will continue to climb.  

The 1918 Spanish flu infected one-third of the world's population. Even though the pandemic lasted only 15 months, it still killed between 50 million and 100 million people worldwide. An estimated 670,000 of them were Americans. Adjusted for population growth, that would be more than 1.8 million Americans today.  

Just ten years ago, the H1N1 swine flu virus infected 60.8 million people worldwide. Up to half a million lived in the U.S. and 12,469 of them died. The swine flu spread slowly compared to coronavirus. In April 2009, a 10-year-old boy in California became the first American to test positive for the H1N1 virus. By October, President Obama had declared swine flu a national emergency.  

One of the takeaways of past pandemics is that we must recognize the speed at which a virus can spread and the importance of preparing as early as possible. 

It's Essential to Plan for the Coronavirus 

Every person in the United States should have a plan in place for dealing with the coronavirus. In the best-case scenario, our lives will be relatively unaffected. But we would be remiss to count on the best outcome. Wishful thinking won't help us. Preparedness may. 

One of my colleagues told me that during Hurricane Katrina, hundreds of patients in the Mississippi area with intrathecal delivery systems for conveying pain medications to the spinal canal were unable to be seen by their physicians. Many of the pumps ran dry during and after the hurricane because patients could not reach their doctors or the doctors could not obtain medications from the a compounding pharmacy. Patients experienced a tremendous increase in pain and many were forced into severe opioid withdrawal. 

Pain patients weren’t the only ones who suffered. Intra-abdominal pumps delivering insulin also ran dry. Thousands of patients experienced insulin withdrawal or diabetic coma. Many people with complex medical problems, including cancer, could not receive life-sustaining therapies. Some people died. 

Questions To Ask Your Doctor 

Think of COVID-19 as another natural disaster, and anticipate the same potential problems. Begin your planning immediately by talking with your doctor. Some of the questions to cover are: 

• In the event of widespread sickness and quarantines, will the doctor’s office be open?

• Can you get medicines delivered if you are not able to leave your home?

• What if your doctor is ill? Will they have someone who can fill in for them?

• How much medicine will you need to ride out a community-wide quarantine?  

Some experts recommend stockpiling additional medication in case of an emergency.  Ask your provider how they feel about that. 

How long can you last if there are supply problems and your doctor, nurse practitioner or pharmacist can't get your medication? What are your options? You may need to go to a different doctor. However, that can be problematic because fewer doctors are accepting new pain patients.

Also, if you do need to find another doctor, the prescription monitoring database may show that you have obtained medications from two or more different providers. You may be labeled as a doctor shopper. Ask your doctor how to avoid this problem. When meeting with your provider, be transparent about your concerns. Avoid panicking.

If you are infected, the virus may affect your ability to breathe. Opioids can add to breathing difficulties caused by viral infections, so be prepared to reduce the amount of your medication. Discuss with your doctor how to decrease your dose to remain safe.  

Be prepared to ask your doctor the right questions and come up with a plan together. Think of coronavirus as a serious threat, but trust that you can prepare to mitigate the harm.  

This is like war. But the invader is not a human enemy. It is an enemy of humans. It is an infection.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed are those of the author alone and do not reflect the views or policy of PRA Health Sciences.

Tweet Led to Dr. Kline Losing His DEA License

By Pat Anson, PNN Editor

A complaint from a woman in upstate New York launched the investigation that recently led to a North Carolina doctor losing his DEA license. Julie Roy doesn’t know Dr. Thomas Kline or any of his patients, but claimed he was dangerous and that “someone can die” because Kline believes opioids are rarely addictive.

Kline surrendered his DEA license to investigators with the North Carolina Medical Board last month.  He is still able to practice medicine but can no longer prescribe opioids and other controlled substances, leaving his 34 patients in medical limbo. All of them suffer from chronic pain and rare diseases that other doctors are increasingly unwilling to treat because they fear coming under scrutiny for opioid prescribing

“I do feel bad for the patients that were affected,” Roy told North Carolina Health News, which first reported on her role in the Kline investigation.

Roy became upset with Kline because he has been an outspoken advocate for pain patients online. Roy’s 26-year old son died from a heroin overdose and she took offense when Kline posted a Tweet last year stating that “opiates work fine without addiction potential” in 99.5% of people.    

She tweeted the North Carolina Medical Board on May 15, saying “this is a doctor that you allow to have an active license. He would love to prescribe every person on earth an opioid.”

NORTH CAROLINA HEALTH NEWS

That same day, Roy made a formal complaint with the medical board against Kline, making a series of unsubstantiated claims about the doctor.

“He is giving out information regarding opioids that is not correct and could cause harm,” she wrote. “I am very concerned as pain patients believe what he says. He says opioids are only addictive to someone who is genetically prone plus a ton of other misinformation.”

Roy even claimed that Kline might be “suffering from substance use disorder himself.”

“The man should not have an active license with his pro opioid perception. The information he puts out alone could cause harm. I would like you to verify (t)hat he is not writing opioid prescription,” Roy wrote.  

Kline Caught Off Guard

Kline responded in writing to Roy’s complaint in July, telling the medical board the information he shared about opioids was accurate and backed up by research. He also denied taking opioids or having a substance use disorder.

“Ms. Roy has lost a son to opiate addiction. Losing a child is the worst of all tragedies. This tragedy could have been avoided with the new knowledge I am presenting in my published research and public talks urging for early identification and treatment of opiate addiction to stop deaths in people like Ms. Roy’s son,” Kline said.

Because none of his patients were harmed by his prescribing and no other complaints were filed against him, Kline thought that would be the end of the matter – even when the medical board asked to review the records of nine of his patients.

Kline was caught off guard when investigators made a surprise visit to his office in Raleigh on February 17 and told him to surrender his DEA license. He did so voluntarily, not realizing at the time that it was unlikely he’d ever get the license back.  

No formal charges have been made against Kline and the medical board won’t comment on the status of the investigation — which could drag on for several more months.

Kline says he’s been able to find new doctors for a handful of his patients, but others are suffering due to untreated pain or running low on their prescriptions.

Ironically, Roy was once a pain patient herself and was on long-term opioid therapy after a failed back surgery. She told NC Health News that her pain medication stopped working, so she switched to buprenorphine (Suboxone), another opioid that’s usually prescribed to treat addiction.

Should Gabapentin Be Used to Treat Alcohol Abuse?

By Pat Anson, PNN Editor

Gabapentin (Neurontin) is so widely prescribed for so many different conditions that a Pfizer executive infamously compared it to “snake oil” in a 1999 email.

“Gabapentin is the snake oil of the twentieth century. It has been successful in just about everything they have studied,” said Christopher Wohlberg, who was a Pfizer Medical Director at the time.

Although only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, gabapentin is widely prescribed off-label to treat fibromyalgia, anxiety, depression, ADHD, migraine, bipolar disorder, restless leg syndrome and a growing number of other conditions.  

Already the 6th most widely prescribed drug in the United States, gabapentin is also being touted as a treatment for alcohol abuse.

In a small study published in JAMA Internal Medicine, researchers found that gabapentin was effective in treating patients with alcohol use disorder (AUD) – problem drinking that has become severe. Compared to a placebo, gabapentin significantly increased abstinence and reduced heavy drinking days, especially for those who suffer from symptoms of alcohol withdrawal.

“The weight of the evidence now suggests that gabapentin might be most efficacious after the initiation of abstinence to sustain it and that it might work best in those with a history of more severe alcohol withdrawal symptoms,” concluded lead author Raymond Anton, MD, an addiction psychiatrist and professor at the Medical University of South Carolina.

“Armed with this knowledge, clinicians may have another alternative when choosing a medication to treat AUD and thereby encourage more patient participation in treatment with enhanced expectation of success.”

As many as 30 million Americans have AUD, but only about a million are taking a medication to help them reduce drinking or maintain abstinence. The FDA has approved three drugs (naltrexone, disulfiram and acamprosate) for the treatment of alcohol abuse.

Side Effects and Abuse

The suggestion that gabapentin should also be prescribed for AUD comes at a time when the drug is already under scrutiny for its abuse and side effects, including an association with a growing number of suicide attempts. Patients prescribed gabapentin often complain of mood swings, depression, dizziness, fatigue and drowsiness.    

Although the CDC’s controversial 2016 opioid guideline calls gabapentin and its chemical cousin pregabalin “first-line drugs” for neuropathic pain, a recent clinical review found little evidence that either drug should be used off-label to treat pain.

Gabapentin does not carry the same risk of addiction and overdose as opioid pain relievers, but illicit drug users have discovered that gabapentin can heighten euphoria caused by heroin and other illicit opioids. Should a drug like that be used to treat addiction?

Hundreds of clinical studies are underway to find new uses for gabapentin, not only for alcohol abuse, but for a cornucopia of conditions such as obesity, insomnia, breast cancer, asthma, menopause and overactive bladder. One recent study even found that gabapentin improves sexual desire in women with vulvodynia.

Instead of finding new uses for an old medication, maybe it’s time to come up with a new drug.

Dangerous New Street Drug Found in Counterfeit Painkillers

By Pat Anson, PNN Editor

A dangerous new street drug that’s even stronger than fentanyl has been found in counterfeit opioid painkillers seized during a police raid on Canada’s eastern seaboard.

Like fentanyl, isotonitazene is a potent synthetic opioid that is many times stronger than heroin or morphine. In recent months, isotonitazene was detected in over a dozen overdose deaths in Illinois and Indiana, where it was mixed with cocaine. The drug has also recently been found in New Brunswick and Alberta, and has been connected to at least two overdose deaths in Calgary.

Now it is being used to make counterfeit pain medication.

Police in Halifax, Nova Scotia seized 1,900 white tablets from a Halifax home last month while conducting a drug investigation. The pills were sent to Health Canada for a laboratory analysis, which confirmed the tablets were made with isotonitazene.

The pills have an “M” on one side and the number “8” on the other side – making them virtually identical to an 8mg Dilaudid (hydromorphone) tablet.

SOURCE: HALIFAX POLICE

“The appearance of the pill may lead people to believe they are consuming a different drug. Given the potency of the drug, a person may need several doses of naloxone to counter an overdose caused by isotonitazene,” Halifax police said in a statement.

No overdoses have been linked to isotonitazene in Halifax, but police are urging anyone who consumes the pills to seek immediate medical attention.

The Center for Forensic Science Research and Education released a public safety alert last November, when isotonitazene was first linked to overdoses deaths in the Midwest.

“Pharmacological data suggest that this group of synthetic opioids have potency similar to or greater than fentanyl based on their structural modifications,” the alert warns. “The toxicity of isotonitazene has not been extensively studied but recent association with drug user death leads professionals to believe this new synthetic opioid retains the potential to cause widespread harm and is of public health concern.”

Although law enforcement and public health officials have only recently become aware of the threat posed by isotonitazene, illicit drug users have been warning each other about isotonitazene for several months in online message boards.

“I wanted to let the community know that the potency is far above the 60x morphine that's listed online. Everyone should be VERY careful when handling this compound,” one poster warned on Reddit.