Rx Drug Monitoring Not Reducing Opioid Abuse

By Pat Anson, Editor

Prescription drug monitoring programs (PDMPs) have long been promoted as a critical tool in the fight against opioid abuse and overdoses. PDMP’s in 49 states and the District of Columbia allow physicians and pharmacists to consult a prescription drug database to see if patients might be “doctor shopping” or selling their opioid medication.

But a new study has found little evidence that PDMPs are working and that they may in fact be driving some patients to the black market for cheaper drugs such as heroin.

Researchers at Columbia University's Mailman School of Public Health and University of California, Davis, analyzed 17 studies that looked at the effectiveness of PDMPs. Their findings are published online in the Annals of Internal Medicine.

“Evidence that PDMP implementation either increases or decreases nonfatal or fatal overdoses is largely insufficient, as is evidence regarding positive associations between specific administrative features and successful programs. Some evidence showed unintended consequences,” wrote lead author David Fink, MPH, a doctoral candidate in epidemiology at the Mailman School of Public Health.

What were those unintended consequences? Three studies that looked at heroin related overdoses found a “statistically significant” increase in heroin deaths after PDMPs were implemented.

"This suggested to us that heroin substitution may have increased after PDMP-inspired restrictions on opioid prescribing," says Silvia Martins, MD, a professor of epidemiology at Mailman and co-senior author. "We therefore caution that programs aimed at reducing prescription opioids should also address the supply and demand of illicit opioids."

Researchers believe that efforts to reduce doctor shopping and the diversion of prescription opioids may have backfired.

“A reduction in black market prescription opioids, although generally viewed as positive, also may generate unanticipated outcomes. For example, an ethnographic study of high-risk users in Philadelphia and San Francisco found that key drivers of the progression from prescription opioid to heroin use are the rising cost of the ‘pill habit’ and heroin’s easy availability and comparatively lower cost,” Fink said.

Heroin overdoses also rose after Purdue Pharma introduced a new and more expensive abuse deterrent formulation of OxyContin in 2010. According to one study, each death that was prevented by OxyContin's reformulation “was replaced with a heroin death.”

Fink and his colleagues say more studies are needed to examine the true effectiveness of PDMPs, which can vary widely from state to state.

Doctor Shopping Rare

Missouri is the lone state that has not adopted a statewide PDMP and one family physician would like to keep it that way.

In an unpublished study, John Lilly, DO, claims that PDMPs are not working because doctor shopping is rare to begin with. In 2016, doctor shopping was responsible for only 1.7% of all misused opioid prescriptions. The rest are stolen, borrowed or bought on the black market, or misused by the patients they were prescribed to.

“The prescription drug monitoring programs will never catch the remaining 98.3 percent of the problem. That is why the death rate has not decreased despite 49 states having an operational PDMP,” Lilly wrote.  “There is now an alternative to prescription drugs that is easier to obtain and more powerful. Illicit fentanyl is now the preferred opioid and the PDMPs have absolutely no effect on its rapid rise. I would not be surprised if prescription opioid deaths start to fall, not due to the effectiveness of the PDMPs, but due to market competition from illicit fentanyl.”

If PDMP's were effective, Lilly says states that have them would see a decline in opioid overdoses. But in 2016, West Virginia had the highest opioid death rate in country -- over three times higher than Missouri's -- which ranked 25th.

Missouri’s Governor ordered the creation of a statewide PDMP last year, but the state legislature has so far resisted efforts to fund it. Critics say it doesn’t give doctors the necessary tools to prevent overprescribing, but allows law enforcement to track and prosecute physicians and pharmacists.  A spokesman for the Missouri State Medical Association called the program a “witch hunt against physicians.”

Walmart to Limit Rx Opioids for Acute Pain

By Pat Anson, Editor

Walmart has announced plans to restrict opioid prescriptions for short-term acute pain to no more than a 7-day supply.

The new policy, which is similar to one already adopted by CVS, will begin “within the next 60 days” and be implemented at all Walmart and Sam’s Club pharmacies in the United States and Puerto Rico.

“We are taking action in the fight against the nation’s opioid epidemic,” Marybeth Hays, executive vice president of Health & Wellness and Consumables for Walmart U.S. said in a statement.

“We are proud to implement these policies and initiatives as we work to create solutions that address this critical issue facing the patients and communities we serve.”

In addition to the 7-day limit on opioids for acute pain, Walmart and Sam’s Club pharmacists will also limit the dose to no more than 50 morphine milligram equivalent (MME) units per day. The company said its policy was “in alignment” with the Centers for Disease Control and Prevention’s opioid guidelines.

However, those 2016 guidelines are voluntary and only intended for primary care physicians who are treating chronic pain. They say nothing at all about pharmacists being required to limit the dose or duration of opioid prescriptions for acute pain:

“When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.”

Several states have already adopted policies that limit opioid prescriptions for acute pain to seven days or less. Walmart said when state law limits prescriptions to less than seven days, Walmart and Sam’s Club pharmacists will follow state law.

The company’s pharmacists will also be trained and required to counsel patients about the CDC’s guidelines, while “focusing on using the lowest effective dose for pain management for the shortest time possible.”

In 2020, Walmart and Sam’s Club will also require e-prescriptions for controlled substances such as opioids. The company said e-prescriptions are less prone to errors, cannot be altered or copied, and are electronically trackable.

By the end of August 2018, Walmart and Sam’s Club pharmacists will also have access to a controlled substance tracking system called NarxCare. NarxCare analyzes a prescription database to provide pharmacists with a patient’s “risk score” for potential drug abuse.

Study Finds Opioid Medication Effective for Chronic Pain

By Pat Anson, Editor

Opioids have been used for thousands of years to provide relief from pain. But are they an effective treatment? Are they worth the risk of addiction? And do they improve quality of life?

Millions of chronic pain patients who use prescription opioids so that they can work, sleep, bathe and do simple household chores would quickly answer “Yes” to those questions.

But that’s a radical concept in an age of anti-opioid hysteria and propaganda. Prominent anti-opioid activists insist that “opioids are ineffective or can worsen both the pain and the long-term outcome." And the CDC's opioid prescribing guideline tells us there is “insufficient evidence to determine long-term benefits of opioid therapy for chronic pain.”  

Except now there’s a review that says opioids are effective and the evidence was there all along.

Researchers at Brown University and Tufts University School of Medicine analyzed 15 clinical studies performed for the Food and Drug Administration that looked at the effectiveness of opioids in treating chronic non-cancer pain. Their findings were just published in the Journal of Pain Research.

“The recent claims that opioids lack efficacy for chronic pain have created controversy among physicians, prescribers, regulators, scientists, and the general public,” wrote lead author Nathaniel Katz, MD, president of Analgesic Solutions and a professor of anesthesia at Tufts University.

“This review was, therefore, performed in order to gather together the key evidence to facilitate understanding opioid efficacy within the paradigm of FDA studies required for approval, and to perform a meta-analysis in order to quantify opioid efficacy for chronic pain.”

‘Ample Evidence’ Opioids Work

The authors are careful to note that they did not try to study or minimize the risks of opioids but were simply trying to reach “an accurate assessment of their benefits.” The 15 placebo controlled studies they reviewed evaluated the effectiveness of hydrocodone, oxycodone, tramadol and other opioids for up to 3 months.

What did they find?

“There is an ample evidence base supporting the efficacy of opioid analgesics for at least 3 months’ duration,” Katz wrote. “This evidence base is at least as large as that for any other class of analgesics, and analysis of responders demonstrates clinically meaningful improvements.”

Nearly two-thirds of the patients (63%) who participated in the 15 studies demonstrated “a clinically meaningful response” to opioids as a treatment for chronic pain. Their physical function only improved marginally, and researchers say there was no positive or negative effect on the patients’ mood. Interestingly, adverse effects were similar in the patients who took opioids and those who were given placebos.  

In short, the authors found no reason to abandon opioids as a treatment for chronic pain.

“While the effectiveness of existing treatments for chronic pain leaves plenty of room for improvement, and considering that only a small minority of patients do not experience clinically meaningful treatment response, discarding all analgesics approved for chronic pain contradicts numerous treatment guidelines, international treatment guidelines, widespread patients experience, and the FDA approval process,” they wrote.   

Critics will no doubt question why the authors only reviewed studies that lasted 3 months or less. The answer is that high quality, placebo controlled studies longer than that simply don’t exist. Long term safety and efficacy studies are not required for a drug to get FDA approval -- which is why many anti-opioid activists and the CDC claim there is “no evidence” or "insufficient evidence" that opioids work long-term. It's also a misleading statement, because non-opioid pain medications and alternative treatments are not studied for long periods either.   

“The reason for the 3 months isn't because there aren't good studies that go beyond 3 months but that 3 months is the period of time the FDA requires for efficacy studies.  It is the regulatory standard for assessing long-term efficacy of placebo-controlled studies in chronic pain conditions,” explains pain management expert Lynn Webster, MD, who is vice president of Scientific Affairs at PRA Health Sciences. 

Webster says there are technical and ethical reasons researchers do not conduct longer studies of analgesics.

“It is very difficult to conduct longer studies that are placebo controlled because of the number of dropouts in the placebo arm and the ethical concerns of denying patients access to treatment," he told PNN. "It is true there aren't placebo-controlled studies longer than 3 months but there are extended open label studies that are 12 months.  As the article states, these extension studies show the efficacy (of opioids) is maintained.”  

Katz and his colleagues have worked as consultants to Endo, Pfizer, Purdue Pharma and other opioid makers, which they disclose in their article. Funding for the study was provided by Analgesic Solutions and several pharmaceutical companies.

Broader Public Health Campaign Needed for Drug Crisis

By Pat Anson, Editor

Overdose deaths in the United States involving illicit fentanyl and other synthetic opioids have surpassed those linked to prescription opioids, according to new research published in JAMA.  Researchers say drugs used to treat depression and anxiety are also involved in more overdoses than opioid pain medication.

The study by researchers at the Substance Abuse and Mental Health Services Administration (SAMHSA) mirrors a similar report released by the CDC in March. The findings further demonstrate how federal and state efforts to combat the overdose crisis are wrongly focused on prescription pain medication as the primary cause of the overdose crisis.

“These findings underscore the rapidly increasing involvement of synthetic opioids in the drug overdose epidemic and in recent increases in overdose deaths involving illicit and psychotherapeutic drugs," wrote lead author Christopher Jones, PharmD, SAMHSA.

“Lack of awareness about synthetic opioid potency, variability, availability, and increasing adulteration of the illicit drug supply poses substantial risks to individual and public health. Widespread public health messaging is needed.”

Over 19,400 overdoses were linked to synthetic opioids in 2016, while 17,087 deaths involved opioid pain medication.

Synthetic opioids such as fentanyl are far more potent than other opioids such as oxycodone. Fentanyl is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is often mixed with heroin and cocaine or used in the manufacture of counterfeit medication. It is assumed that illicit fentanyl and its chemical cousins account for the vast majority of deaths caused by synthetic opioids.  

Another key finding of the SAMHSA study is that psychotherapeutic drugs used to treat depression, anxiety and other mental disorders are now involved in more overdoses than any other class of medication. They include antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall.

DRUGS INVOLVED IN 2016 OVERDOSES

Over 25,000 overdoses in 2016 involved psychotherapeutic drugs.

That compares to nearly 13,900 deaths linked to the medications in 2010, an increase of 45 percent.

"I think what you're seeing in the data in the last couple of years is that the illicit drug supply has become substantially more dangerous than it has been, and there's this level of unpredictability and lack of awareness of what are exactly the substances that people are using that are contributing to the overdose risk," Jones told Medscape.

That lack of awareness is due in part to poorly designed public health messaging. For example, last year the CDC launched a public relations campaign in 14 states that focused exclusively on warning of the risks associated with prescription opioids. Fentanyl, heroin and other drugs commonly involved in overdoses are not addressed in the Rx Awareness campaign because the CDC didn't want to risk “diluting” its primary message.

“Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging,” the CDC said.  

SAMHSA researchers say nearly 80 percent of the synthetic opioid overdoses in 2016 involved multiple drugs, indicating that many of the decedents are abusing a wide variety of substances. The most commonly involved drugs were another opioid (48%), heroin (48%), cocaine (22%), prescription opioids (21%), benzodiazepines (17%), alcohol (11%), psychostimulants (5%) and antidepressants (5%).

About 20 percent of the death certificates did not specify the type of drug involved, so the number of reported overdoses are likely underestimated.

Death of Pain Patient Blamed on DEA Raid

By Pat Anson, Editor

The Montana pain community is in mourning over the tragic death of Jennifer Adams, a 41-year old Helena woman who suffered from intractable chronic pain. The Lewis and Clark County coroner has not yet released a cause of death, but friends say Adams died from a self-inflicted gunshot wound April 25.

Adams, a former police officer and mother of an 11-year old boy, lived with severe back pain from Reflex Sympathetic Dystrophy (RSD) and arachnoiditis, two painful and incurable diseases in her spine.

Friends say in her final months Adams suffered from extreme anxiety – fearing that her relatively high dose of opioid pain medication would be reduced or stopped by doctors.

“Jennifer had horrible anxiety that was eating her alive,” says Kate Lamport, a close friend who also has arachnoiditis. “She hadn’t lost her meds. But the fear of it drove her crazy. Every day she was so afraid.

“She was beautiful, inside and out. Her little boy was her everything. And I know she felt like the walls were just closing around her.”

Adams was a patient of Dr. Forest Tennant, a prominent California pain physician, whose home and office were raided last November by agents with the Drug Enforcement Administration. A DEA search warrant alleged that Tennant must be running a drug trafficking organization because many of his patients came from out-of-state and were on high doses of opioid medication.

JENNIFER ADAMS

Tennant, who has not been charged with a crime and denies any wrongdoing, recently announced plans to retire and close his clinic, in part because of the DEA investigation. Tennant is a revered figure in the pain community because of his willingness to see patients like Adams who have intractable pain from rare diseases like arachnoiditis.

“She’s a patient I saw in consultation. She was on a very good (pain) regimen, had a very good nurse practitioner and had good support,” said Tennant. “It’s a tragic situation. She was a lovely person. She was ill, no question about it.”

Several of Adams’ friends and fellow patients told PNN that the DEA raid frightened her. Like many others in the pain community, Adams feared losing access to opioid medication because many doctors have cut back on prescribing or stopped treating pain altogether.  

KATE LAMPORT AND JENNIFER ADAMS

“There’s more (suicides) coming. I don’t know how many people I’ve talked to that have a backup plan. We are the unintended consequences of the DEA’s actions,” said Lamport.

“Every day you get online and there’s another chronic pain patient that took their life. There’s another 20 that lost their medication. And she knew she couldn’t be a mom or work without it. And she didn’t want to be a burden. She was very prideful.”

“Before the raid she was very positive, keep fighting, that type of attitude. And the last couple of months she hasn't really been talking to anyone really consistently like she was,” said Heather Ramsdell. “I would characterize her mood as somber and scared with what's going on in this world and with her pain progressing, worrying about care.”

“She did not deserve to die. It’s just ridiculous. An entirely preventable loss of life. I think she was just totally freaked out over what was happening,” said Gary Snook. “We’re not drug addicts. We’re just sick people.”

“I think that Jennifer is collateral damage in that heinous DEA raid on Dr. Tennant,” says Dr. Mark Ibsen, a Helena physician who used to treat Adams. “We have a way to prevent these suicides and we’re completely ignoring it. Treating the patients in pain would prevent these suicides.”

Tennant does not believe Adams’ death is connected to the DEA raid.

“People who want to make that claim, that’s just simply false,” Tennant told PNN. “I think she was upset by the raid, like a lot of people, but I don’t believe you can make any assumption that there’s any connection.

“People have a lot of complaints about the government, but I think in this case and I want to make it abundantly clear, there is no connection to her pain care, her practitioners, or the DEA. This appears to be an independent, random event in a state that’s got a very, very high suicide rate.”

Adams’ last appointment with Tennant was in January. He said she was responding well to treatment and did not have a return appointment.

‘Disgusted’ by DEA Search Warrant

PNN has obtained a copy of an email that Adams sent to one of Tennant’s lawyers. Adams wrote that she was “truly disgusted” by the DEA raid and the allegations made against Tennant. Her patient records were among those seized by DEA agents. The search warrant claimed patients must be selling their opioid medication and funneling the profits back to Tennant. 

“My intention was and is to let you know a bit about myself and let you know that I am truly disgusted after reading the search warrant. I am NOT a drug dealer! I am not part of a drug cartel. I do not provide kickbacks to Dr. Tennant and I do not share my prescriptions. This whole situation has turned my life upside down once again,” Adams wrote. 

“It needs to stop. Legally speaking, someone has got to put an end to this obscene attack on patients with intractable pain, in particular; Adhesive Arachnoiditis.”

Adams said she developed adhesive arachnoiditis – a chronic inflammation of spinal nerves that causes them to stick together – after a failed back surgery and dozens of failed epidural injections. She also suffered a stroke during the birth of her son because of a botched epidural.

Before her career in law enforcement was cut short by chronic pain, Adams was a police officer in Helena and the first female deputy in Rosebud County, Montana.  She graduated third in her class at the Montana Law Enforcement Academy.

She was proud of her career and felt the DEA raid unfairly stigmatized her and other Tennant patients. 

“I also have had all my accomplishments stained!” she wrote. “I have had to fight day after day to survive the devastation of this ever-changing disease! Please do not dismiss me.”

Donations to a college trust fund for Jennifer's son, Joshua "Tuff" Adams, can be made to First Interstate Bank, 3401 N. Montana Avenue, Helena, MT 59602. You can also call the bank at (406) 457-7171.

Is Addiction or Untreated Pain Causing Patient Suicides?

By Pat Anson, Editor

A new op/ed in The New England Journal of Medicine focuses on an aspect of the overdose crisis that’s rarely discussed – how opioids are a “silent contributor” to the nation’s rising suicide rate. But critics say the article misses the mark on why a growing number of pain patients are having suicidal thoughts and taking their own lives.

Most people already know that drug overdoses are soaring in the United States, but few recognize that suicides are at their highest level in nearly 30 years. In 2016, more Americans died from suicides (44,965) than from opioid overdoses (42,249).

“The significant increases in both opioid-overdose deaths and suicide rates in our country have contributed to reduced life expectancy for Americans. These two epidemics are intermingled, and solutions to address the opioid crisis require that we tailor interventions to preventing opioid-overdose deaths due to suicidal intent,” wrote co-authors Maria Oquendo, MD, and Nora Volkow, MD.

Volkow is the longtime director of the National Institute on Drug Abuse, while Oquendo is a Professor of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania and past president of the American Psychiatric Association.

Volkow and Oquendo believe many suicides are misreported as “undetermined” or accidental drug overdoses, and that “the true proportion of suicides among opioid-overdose deaths is somewhere between 20% and 30%, but it could be even higher.”

They also engage in a familiar pattern of demonizing opioid pain medication, citing studies showing that patients with “opioid use disorder” (OUD) from prescription opioids are more likely to have suicidal thoughts and “whose motivation to live might be eroded by addiction.” 

“Notably, two populations that are more likely than others to receive opioid prescriptions — patients with chronic pain and those with mood disorders — are also at greater risk for suicide,” they wrote.

That may all be true. The suicide rate among chronic pain patients is probably increasing. But what’s puzzling is that Volkow and Oquendo never acknowledge the role that the federal government has played in contributing to that trend. Anecdotal evidence is building that suicides started climbing after the CDC released its 2016 opioid prescribing guidelines and pain medication became harder to get. 

"Over the last year, I have received wave after wave of reports of traumatized patients, with outcomes that include suicidal ideation, medical deterioration, rupture of the primary care relationship, overdose to licit or illicit substances, and often enough, suicide,” Stefan Kertesz, MD, a professor of medicine at the University of Alabama at Birmingham School of Medicine, recently told PNN.

Those suicides -- such as those of Bryan Spece and Jay Lawrence -- are rarely reported by the mainstream media or even acknowledged by government bureaucrats like Volkow, who was an early supporter of the CDC guidelines.

In a survey of over 3,100 pain patients on the one-year anniversary of the guidelines, over 40 percent told PNN they had considered suicide because their pain was poorly treated. Many patients feel the healthcare system has turned its back on them.

“Even though I can barely function my doctor wants to stop my meds completely. With no hope, suicide seems like the best and only choice to get relief from the pain. I never thought doctors would be so uncaring, along with the government,” wrote one patient.

“I never thought I would even consider suicide, but death looks good when every move you make is painful, 24 hours a day, 7 days a week. The guidelines are not fair to me, my husband, and my children. No one can judge anyone else's pain level,” said another patient.

“I frequently contemplate suicide. I lay in bed on many nights crying because there is no comfortable positions and the spasms are relentless,” said a disabled nurse in Maine who is no longer able to obtain opioids.

“In the past year, six chronic patients I know who were no longer able to get their pain medication have committed suicide. I personally have researched the quickest and surest way of ending my own life. And no, it doesn’t include opioids,” wrote another patient.

“I nearly committee suicide last summer and again last November because of undertreated pain,” said one woman. “It is ridiculous beyond belief when my neighbor’s dog gets prescribed pain meds for a torn claw and I get treated like a criminal for having a chronic pain condition.”

Undertreated Pain

Patient advocates say these suicidal thoughts are often not the result of addiction or OUD, but because chronic pain is increasingly untreated or undertreated.

“The diagnosis of OUD is overwhelmingly made by physicians who are untrained in making the diagnosis,” says Stephen Nadeau, MD, a Professor of Neurology and Clinical Health Psychology at the University of Florida College of Medicine. “Most patients in chronic pain are under-dosed and/or suffer from inadequately treated depression. We don’t know the exact figures on prevalence of under-dosing but we do have studies that suggest that depression is detected only 20% of the time.”

“There is emerging data to suggest that increasing numbers of opioid overdose-related deaths may be a consequence of undertreatment of both pain and depression.  But the dominant public narrative is demanding even less treatment of pain when opioids are the chosen therapy,” says Red Lawhern, PhD, co-founder of the Alliance for the Treatment of Intractable Pain, a patient advocacy group.    

Lawhern believes many suicides can be attributed to the “epidemic of despair” first documented by Princeton researchers Anne Case and Angus Deaton.  They believe that the reduced life expectancy of Americans is not just due to substance abuse, but linked to unemployment, poor finances, lack of education, divorce, depression and loss of social connections – issues that Volkow and Oquendo fail to address.

“Their article is seriously deficient for failure to mention that both substance abuse and suicide generally are closely associated with depression and isolation -- both of which are consequences of economic hard times.  It is simply wrong to imply that opioid use disorder (itself an incorrect term) is the ‘cause’ of suicide, when both are driven jointly by socio-economic factors,” Lawhern wrote in an email.

What can be done to prevent suicides in the pain community? Volkow and Oquendo say more doctors should be trained to recognize the warning signs of suicide and patients should be screened for suicide risk and then referred for addiction treatment. Nowhere do they suggest better pain management.   

Counterfeit Pill Problem ‘Getting Worse by the Day’

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 22 states, according to a new report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy and healthcare organizations. Counterfeit pills laced with fentanyl have now been found from coast to coast in 43 states.

“This updated report shows that the illegally-imported fentanyl problem is getting worse by the day,” said Dr. Marvin Shepherd, chairman of the PSM Board.

Fentanyl is 100 times more potent than morphine. It is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is typically mixed with heroin or cocaine. Rogue manufacturers also press it into counterfeit prescription pills such as Vicodin, Percocet and Xanax.

Unsuspecting buyers – including pain sufferers looking for relief -- often have no idea what they’re getting.

According to a recent CDC report, drug deaths involving fentanyl (19,413) surpassed overdoses linked to prescription opioids (17,087) in 2016.

COUNTERFEIT PERCOCET

“The annual count of overdose deaths from prescription opioids has remained constant since 2011, but deaths from fentanyl poisoning have spiked since then. As fentanyl-laced pills mimicking legitimate medication have flooded the illicit drugs supply, prescription drug users have been poisoned by the counterfeits,” the PSM report found. 

“The tally of deaths because of counterfeit pills made with fentanyl is probably undercounted because lab protocols lagged behind this shift and weren’t testing for fentanyl.”

The pills are difficult to trace, as Minnesota prosecutors admitted last week when they announced that no criminal charges would be filed in the accidental overdose death of Prince. The music icon died two years ago after taking counterfeit painkillers that were “an exact imitation” of Vicodin.

“Prince thought he was taking Vicodin and not fentanyl,” said Carver County Attorney Mark Metz, adding that dozens of counterfeit pills were found in Prince’s home, many of them stored in aspirin bottles.

Investigators were unable to determine how or where Prince obtained the fake pills, but they are readily available online for anyone who cares to look. According to one report, there are as many as 35,000 online pharmacies operating worldwide. Many do not require a prescription and are selling counterfeit medications. Their customers include some pain patients who are no longer able to obtain opioids legally from doctors and are looking for other sources.

‘Criminals Are Pretty Smart’

“They’re looking, maybe innocuously, for medicine online. They’re searching for ‘fentanyl online’ or ‘Percocet buy.’  Not because they want to buy medicine on the Internet, but rather they just want to find medicine,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies, an industry supported non-profit.

“The criminals are pretty smart. They know that there’s a market out there and they know they can offer these medicines to patients for good reasons, bad reasons or otherwise that are looking for those medicines. And they are going to get duped because they are very likely buying from a website that is selling it illegally.”

The National Association of Boards of Pharmacy recently evaluated 100 websites selling medications and found that almost all were operating illegally and selling drugs without a prescription. Over half (54%) were selling controlled substances and 40% were offering drugs that are frequently counterfeited with fentanyl.

The marketing and selling of counterfeit medicine goes beyond just online pharmacies. Drug dealers are increasingly using Facebook, Twitter and message boards to reach customers. PNN recently received this sales pitch from one dealer:

"We have pharmaceutical drugs for your health illness especially for Chronic Pain, Anxiety, Depression, Panic Disorder. ADHD, Xanax Bars, Narcolepsy pills, Antidepressants, Antipsychotics, Benzodiazepines, Narcotics, Opiates, weight loss/fat burner. We do overnight secure shipping."

Warning unsuspecting buyers about the easy availability of these drugs poses a dilemma for law enforcement and policy makers.

“We have ethical tension around all of this. On the one hand, we certainly don’t want to be educating people that you can buy controlled substances or prescription drugs on the Internet without a prescription, counterfeit or otherwise. That’s just dangerous. But we also don’t want to be in a position of not warning them or not making a policy response to the fact that this currently exists,” Baney told PNN.

It is relatively easy to tell the difference between a legitimate online pharmacy and an illegal one. The URL’s for websites that end with “.Pharmacy” (not .com or .net) are certified by the National Association of Boards of Pharmacy and are in compliance with laws and practice standards. You can also visit buysaferx.pharmacy to verify whether a website is legitimate.

Do 80% of Heroin Users Really Start With a Prescription?

By Roger Chriss, Columnist

U.S. Attorney General Jeff Sessions recently announced a new plan by the DEA to further tighten production quotas for opioid pain medication as a step in the fight against opioid abuse and addiction.

The proposal appears in the Federal Register with the following explanation:

“Users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers…. Once ensnared, dependency on potent and dangerous street drugs may ensue. About 80% of heroin users first misused prescription opioids. Thus, it may be inferred that current users of heroin and fentanyl largely entered the gateway as part of the populations who previously misused prescription opioids."

This is not a new claim by the DEA. In its 360 Strategy: Diversion Control, the DEA plainly states, “The connection between prescription opioid abuse and heroin use is clear, with 80% of new heroin abusers starting their opioid addiction by misusing prescription medications.”

Where does the 80% figure come from?

The DEA cites the National Institute on Drug Abuse (NIDA) as its source, while NIDA in turn references a 2013 study by the Substance Abuse and Mental Health Administration (SAMHSA).

SAMHSA pooled a decade's worth of data from the National Survey on Drug Use and Health and found that “four out of five recent heroin initiates (79.5 percent) previously used NMPR (nonmedical use of pain relievers)."

But the SAMHSA study did not examine how many of those heroin users had a valid prescription for opioids, so the DEA claim about users "first obtaining these drugs from their health care providers" is untrue. SAMHSA also notes that "the literature on transition from NMPR to heroin use is relatively sparse" and that the "vast majority" of people who abuse opioid medication never actually progress to heroin.

The abuse of opioid medication by heroin users also varies considerably by time, region and demographics -- so must users don't fit neatly into the 80% claim. A review article in The New England Journal of Medicine reports that prior nonmedical use of opioid medication was found in 50% of young adult heroin users in Ohio, in 86% of heroin users in New York and Los Angeles, and in 40%, 39%, and 70% of heroin users in San Diego, Seattle, and New York respectively.

Conversely, studies on the medical use of opioid analgesics show very low rates of opioid addiction. A review in the journal Addiction concluded that “The available evidence suggests that opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence.”

A 2016 article in The New England Journal of Medicine by Dr. Nora Volkow, Director of NIDA, also explains that “addiction occurs in only a small percentage of persons who are exposed to opioids—even among those with preexisting vulnerabilities.”

‘Opiophobia’ Returns

But despite this well-established information, the 80% statistic is being used to set policy and justify a supply-side approach to the opioid addiction crisis. States are citing the number as they pass new legislation to restrict opioid prescribing, health insurers are using it as they enact new policies to limit medical opioid use, and doctors are telling patients it’s one of the reasons they won’t prescribe opioids.

According to one addiction treatment specialist, the goal of the DEA quota reductions should be to take opioid prescribing back to levels where they stood two decades ago.

“We‘re back down to 2006 levels, but the goal should be to get us back down to 1995 levels. So this means many Americans are still going to be addicted until prescribing becomes more cautious,” Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), told STAT.  

But this assumes that pre-1995 opioid prescribing levels were adequate. According to Jeffrey Singer, MD, a Senior Fellow at the CATO Institute, that would be a mistake.

“It must be remembered that numerous studies throughout the 1970s, 1980s, and 1990s documented that patients were being undertreated for pain because of an irrational fear of opioids,” Singer wrote. “Policymakers need to disabuse themselves of the notion that the prescription of opioids to patients by doctors is at the heart of the problem. That notion has made too many patients suffer needlessly as the old ‘opiophobia’ of the 1970s and 1980s has returned.”

Moreover, it assumes that opioids have no clinical benefit. But they are medically very useful, not only in the acute and surgical setting, but also for a variety of chronic pain conditions, such as neuropathy and restless leg syndrome.

The 80% statistic is misleading and encourages faulty assumptions about the overdose crisis and medical care. It is shifting resources away from the public health interventions that would most likely help in the crisis and removes a valid medical treatment for people with a wide range of ailments.

To read and comment on the DEA’s quota proposal, click here. All comments must be received by May 4, 2018.

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.

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.

Rescheduling Hydrocodone May Have Increased Abuse

By Pat Anson, Editor

Four years ago that the U.S. Drug Enforcement Administration ordered the rescheduling of hydrocodone from a Schedule III controlled substance to the more restrictive category of Schedule II.  The move was intended to reduce the diversion and abuse of hydrocodone, which at one time was the most widely prescribed drug in the United States.

It turns out the rescheduling may have had the unintended effect of increasing the diversion and abuse of opioid medication by elderly Americans.

According to a new study by researchers at the University of Texas Medical Branch (UTMB), hydrocodone prescriptions for Medicare beneficiaries declined after the rescheduling, but opioid-related hospitalization of elderly patients increased for those who did not have a prescription for opioids.

"The 2014 federal hydrocodone rescheduling policy was associated with decreased opiate use among the elderly," said lead author Yong-Fang Kuo, PhD, a professor of Preventive Medicine and Community Health at UTMB.

"However, we also observed a 24 percent increase in opioid-related hospitalizations in Medicare patients without documented opioid prescriptions, which may represent an increase in illegal use."

Kuo and her colleagues say Medicare beneficiaries are among the largest consumers of prescription opioids. They speculated that opioid abuse by the elderly may be a coping mechanism to deal with poor health and depression, and that opioid diversion may be a sign of drug dealing.

“An economic purpose may relate to monetary gains from the diversion and sale to others,” Kuo wrote. “It is important for prescribers to understand that their elderly Medicare beneficiaries might be obtaining opioids from sources that are not documented in their medical records. There is a need for additional research on why, where, and how these Medicare enrollees are obtaining opioids.”

The UTMB research team analyzed a large sample of Medicare Part D enrollment and claims data from 2012 through 2015. Their study was published in the Journal of the American Geriatrics Society.

The reclassification of hydrocodone to a Schedule II controlled substance limited patients to an initial 90-day supply and required them to see a doctor for a new prescription each time they need a 30-day refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.

In 2012, over 135 million prescriptions were written in the U.S. for hydrocodone products such as Vicodin, Lortab and Norco.  That fell to 90 million prescriptions by 2016.

Overall Opioid Prescribing Down

Hydrocodone isn't the only opioid medication to see steep declines in prescribing. The volume of opioid prescriptions filled last year dropped by 12 percent, the largest decline in 25 years according to a new report by the IQVIA Institute.  Opioid prescriptions have been falling since 2011, while dispensing of addiction treatment drugs like buprenorphine (Suboxone) and methadone have risen sharply.

“The U.S. opioid epidemic is one of the most challenging public health crises we face as a nation," said Murray Aitken, IQVIA senior vice president and executive director of the IQVIA Institute for Human Data Science.

“Our research and analytics revealed that 2017 saw new therapy starts for prescription opioids in pain management decline nearly 8 percent, with a near doubling of medication-assisted therapies (MATs) for opioid use dependence to 82,000 prescriptions per month. This suggests that healthcare professionals are prescribing opioids less often for pain treatment, but they are actively prescribing MATs to address opioid addiction."

All 50 states and Washington DC had declines in opioid prescribing of 5 percent or more in 2017, with some of the states hardest hit by the opioid crisis -- like West Virginia and Pennsylvania --  showing declines of over 10 percent. Nevertheless, the number of Americans overdosing continues to rise due to increased use of black market drugs like illicit fentanyl, heroin and cocaine, which now account for about two-thirds of all drug deaths.

Documentary Looks at Pain Relief as Human Right

By Steve Weakley

A new documentary calls pain relief a basic human right.  That is one of the tantalizing premises of “Hippocratic,” a film about the life of one of the pioneers of palliative care in India, Dr. M.R. Rajagopal.  

For over 20 years, Rajagopal has battled conditions that cause palliative care patients in India to suffer needlessly. Despite being home to most of the world’s legally grown opium, morphine and other opioid medications are often inaccessible in India to patients dying of cancer and other chronic illnesses.   

Rajagopal points out that the Indian Narcotics Act of 1987 reduced prescriptions of opiates in his country by 94 percent in just 12 years.  Under that law, even a minor mistake in prescribing opioids could send a doctor to prison for 10 years. 

“When you torture someone for political reasons, they can sign a confession and escape.  Here, (pain patients) don’t even have that option… they can’t fight back.  It’s a very one-sided war,” says Rajagopal.

In “Hippocratic,” Rajagopal points out that medicine and the profit motive compound the lack of effective pain care.  About 80 percent of the healthcare industry in India is privatized, and when doctors prescribe opiates they often steer patients toward expensive name brand drugs, when nearly identical generics cost only pennies.  He warns against unchecked medical profits and makes a passionate plea for universal health care.

The 88-minute film is most moving in the moments where it demonstrates the power of compassion as the primary purpose of treatment.  A four-year old girl, writhing and screaming in unbearable pain, is seen reaching up and kissing Rajagopal on his forehead after he administers her medicine.

You can watch a trailer for “Hippocratic” below:

In 2014, Rajagopal won an award for extraordinary activism from Human Rights Watch, a non-profit that has done extensive work on human rights abuses and the suffering of palliative care patients worldwide.

As PNN has reported, Human Rights Watch is now investigating the treatment of chronic pain patients in the United States.

“People we interviewed who didn’t have access to appropriate medications for their pain were essentially giving testimony that was almost exactly the same as the testimony we were getting from the victims of police torture,” said Diederik Lohman, Director of Health and Human Rights for Human Rights Watch.  “People were facing tremendous suffering that actually could be relieved pretty easily through very inexpensive palliative care and pain management.”

“Hippocratic” had a limited release in U.S. theaters last month, but can still be seen in New York City, Seattle, Fresno and a handful of other cities. It can also be rented online by clicking here.

Sessions Wants More Cuts in Opioid Production

By Pat Anson, Editor

Attorney General Jeff Sessions has proposed further tightening in the supply of opioid pain medication to punish drug makers who allow too many of their painkillers to be diverted and abused.

Under the proposal, the Drug Enforcement Administration – which is overseen by the Justice Department – must consider whether an opioid medication is being misused, abused or causing overdoses when it sets annual production quotas for drug makers.

“The current regulations, issued initially in 1971, need to be updated to reflect changes in the manufacture of controlled substances, changing patterns of substance abuse and markets in illicit drugs, and the challenges presented by the current national crisis of controlled substance abuse,” the DEA said in a notice to be published in the Federal Register.  

WHITE HOUSE PHOTO

“Under this proposed new rule, if DEA believes that a company’s opioids are being diverted for misuse, then they will reduce the amount of opioids that company can make,” Sessions said. "It’s a common sense idea: the more a drug is diverted, the more its production should be limited." 

The cuts in opioid production could be ordered even if a drug maker has no direct role in the diversion.

"If DEA believes that a particular opioid or a particular company’s opioids are being diverted for misuse, then DEA would be able to reduce the amount that can produced in a given year. These smarter limits will encourage vigilance on the part of opioid manufacturers," the agency said in a statement.

The public has only 15 days to comment on the rule change. Public comment periods in the Federal Register are usually between 30 and 60 days long, with some taking up to 180 days. Agencies are allowed to use shorter comment periods "when that can be justified."

"This shortened period for public comment is necessary as an element in addressing the largest drug crisis in the nation's history," the DEA said. To see the rule change and make a comment, click here. Comments must be submitted on or before May 4.

The DEA has already made substantial cuts in opioid production quotas, reducing them by 25 percent in 2017, followed by another 20 percent cut in 2018. This year’s cuts were ordered despite warnings from drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

Last week the DEA said it would allow three drug makers to increase their production of injectable opioids because of shortages that left hospitals scrambling to find effective analgesics to treat patients suffering from acute pain. The shortages of injectable fentanyl and morphine are largely due to manufacturing problems, although some critics say the DEA itself is partly responsible.

DEA ‘Asleep at the Switch’

The proposed rule change was triggered by a lawsuit filed against the DEA by West Virginia, alleging that the current quota system “unlawfully conflates market demand for dangerous narcotics with the amount of legitimate medical needs.”    

“The DEA -- the agency tasked with effectively limiting how many opioid pain pills can be manufactured -- has been asleep at the switch and unwilling to recognize fatal flaws within its own system,” said West Virginia Attorney General Patrick Morrisey. The lawsuit was put on hold after Sessions directed the DEA to change its rules.

Under the proposed rules, the DEA would be required to get input from states, Food and Drug Administration, Centers for Disease Control and Prevention and the Department of Health and Human Services before setting opioid quotas.

Since becoming Attorney General, Sessions has been almost singularly focused on prescription opioids as the cause of the addiction and overdose crisis, even though about two-thirds of all overdoses are caused by black market drugs such as illicit fentanyl, heroin and cocaine. Less than one percent of legally prescribed opioids are diverted, according to the DEA’s own figures.

In February, Sessions said pain sufferers should “tough it out” and take aspirin, rather than turn to opioids for pain relief. "Sometimes you just need to take two Bufferin or something and go to bed," he said.

WHITE HOUSE PHOTO

Last week, Sessions visited a controversial memorial near the White House that features a wall of 22,000 engraved white pills -- each pill representing the face of someone who supposedly died from a prescription opioid overdose in 2015.

As PNN has reported, the National Safety Council’s traveling exhibit misrepresents the number of Americans who overdosed on pain medication. The CDC recently admitted that its methods for counting overdoses “significantly inflate estimates.”

More misinformation and half-truths are being published in the Federal Register to justify changes in the DEA quota system.  

“(Opioid) users may be initiated into a life of substance abuse and dependency after first obtaining these drugs from their health care providers or without cost from the family medicine cabinet or from friends. Once ensnared, dependency on potent and dangerous street drugs may ensue,” the notice says.

“About 80% of heroin users first misused prescription opioids. Thus, it may be inferred that current users of heroin and fentanyl largely entered the gateway as part of the populations who previously misused prescription opioids.”  

The notice is referring to a single but often-cited survey, which found that most heroin users in addiction treatment also abused prescription opioids. But experts say most addicts try a variety of different substances – such as tobacco, marijuana, alcohol and illicitly obtained opioid medication – before moving on to heroin. It is rare for a legitimate patient on legally prescribed opioids to make the transition to heroin.  

Dear AARP: Stop Picking on Pain Patients

(Editor’s Note: Last year PNN columnist Rochelle Odell wrote an article critical of the American Association of Retired Persons (AARP) for publishing a special report entitled “The Opioid Menace.” The report claimed that many older Americans had become “new opioid dealers” who were fueling the opioid crisis by “selling their prescription painkillers to drug pushers.”

AARP recently published a new bulletin, which focuses on how scammers are bilking Medicare for $60 billion annually. Once again, AARP claims that Medicare fraud "puts deadly pills on the street" and helps fuel the opioid crisis. In response, Rochelle wrote this open letter to AARP’s editors.)

Dear AARP Editors,

I received the AARP Bulletin and at first found your cover story on Medicare fraud interesting. Fraud is a major problem that will need patients, physicians and law enforcement to resolve. It causes healthcare costs to rise, which many of us on Social Security and fixed incomes can’t afford to pay.

As I got towards the end of the bulletin, my anger began to rise as I read "The Opioid-Medicare Connection." You claim that “shady doctors are writing bogus prescriptions for opioid painkillers” using stolen Medicare ID numbers and that “the pills are then sold on the street for huge profits.”

“The practice is shockingly common, and the impact is severe. For Medicare, it means covering the cost of countless millions of high-priced pills that never should have been prescribed. At the same time, prescription opioids are responsible for an estimated 95 overdose deaths a day in the United States,” the article claims, without ever citing a source for that information. 

It brought me back to last summer when AARP published "The Opioid Menace." Why is AARP constantly attacking opioid pain medication? Why do you continually write misleading information about opioids? Could it be dollar motivated? 

Then I read about AARP's survey on medical marijuana, which found that a majority of older Americans “think marijuana is effective for pain relief and should be available to patients with a doctor’s recommendation.”  I have to disagree with the survey findings. There are many of us who have tried medical cannabis and received zero benefit. It did nothing for my pain. 

Then it dawned on me, of course insurance providers such as AARP would like more patients to use cannabis. As it becomes harder for us to get prescription opioids, many pain patients are turning to cannabis, a treatment that AARP and other insurers don't have to pay for. How much will that fatten your bottom line?

I find it hard to believe stolen Medicare ID numbers play that big of a role in the opioid crisis. Prescriptions for opioid medication are tracked more than ever, with doctors, pharmacists and insurers having instant access to databases to see just how many prescriptions a patient is getting.

I have been on Medicare since 1997 due to becoming disabled by Complex Regional Pain Syndrome (CRPS). There has never been a time that I did not have to present a picture ID when picking up an opioid prescription. And if I was unable to pick them up myself, a friend or relative had to present my ID confirming it was indeed for me, along with my current address.

Please explain how the "shady doctors" you referred to in your article are able to pull off this "shockingly common" fraud and make “huge profits.” As in last year's Opioid Menace article, AARP uses minimal references to support these claims. It was interesting you referenced only one physician who did this, only one. 

Medicare just published a new rule starting in 2019, which impose new limits on high dose opioids and requires “high risk” patients to see a specific physician and use a specific pharmacy. Think of the money you can save now. More patients paying out of pocket for medical cannabis and prescription opioids being reduced or stopped. 

Whatever happened to AARP being there for us older Americans?

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

Prominent Pain Doctor Faces Hundreds of Lawsuits

By Pat Anson, Editor

Imagine spending your retirement defending yourself against hundreds of lawsuits in courthouses around the country – all of them alleging that you played a key role in starting the opioid crisis and that you were indirectly responsible for thousands of overdose deaths.

“It is mind boggling to me and its frightening, actually. I don’t know how I’m going to defend myself,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “Right now, we’re just trying to keep our head above the water.”

Webster has been named as a defendent in so many class action lawsuits – along with Purdue Pharma, Johnson & Johnson, Endo, Janssen and other opioid manufacturers – that he’s lost track. He knows of at least 80 lawsuits but believes there are many more.

“I think it could be several hundred,” he says.

The latest one was filed this week by Salt Lake County, Utah -- where Webster lives -- alleging that drug makers employed him in deceptive marketing practices that downplayed the risks of addiction and overdose. Like the other lawsuits by states, counties and cities, Salt Lake County seeks to recover taxpayer money spent on treating addiction, combating opioid abuse and policing opioid related crimes.    

DR. LYNN WEBSTER

“Utah’s opioid crisis stems directly from a callously deceptive marketing scheme that was spearheaded by certain opioid manufacturers and perpetuated by prominent doctors they bankrolled,” the lawsuit alleges.

“Dr. Webster’s advocacy of opioids was designed to create a veneer of impartiality. But Dr. Webster was a forceful proponent of the concept of ‘pseudoaddiction,’ the notion that addictive behaviors should be seen not as a warning, but as indicators of undertreated pain. The only way to differentiate between the two, Dr. Webster claims, was to increase a patient’s dose of opioids.”

Until he retired from clinical practice in 2010, Webster operated the Lifetree Pain Clinic in Salt Lake City. The lawsuit makes a point of mentioning that at least 20 of Webster’s patients died from overdoses and that he was investigated – but never charged with a crime -- by the DEA and the U.S. Senate Finance Committee.

“Most of what they have in there, at least about me, is false. And I think I can prove that,” Webster told PNN.

A footnote in the lawsuit contains the curious but important disclaimer that “Salt Lake County asserts no claim against Dr. Webster arising from his medical practice. The claims against Dr. Webster relate solely to his participation, as a KOL and otherwise, in Manufacturing Defendants deceptive marketing campaign.”

'Key Opinion Leader'

KOL is an acronym for “key opinion leader” – a euphemism for doctors alleged to be so influential that they helped convince other physicians to prescribe more opioids. Webster and three other pain doctors -- Russell Portenoy, Perry Fine and Scott Fishman -- are portrayed in the lawsuits as KOLs who greedily accepted millions of dollars in payments from drug makers in return for their promotion of opioids.

“It's mind boggling to think how four individuals can be accountable for essentially brainwashing all of the doctors in the country to do something intentionally to make pharmaceutical countries rich. How can anyone think that is plausible? It’s crazy,” says Webster. “Most of the pharmaceutical companies that they’ve listed I never received a dime from.”

According to the Salt Lake County lawsuit, Webster was “handsomely rewarded for his efforts,” receiving nearly $2 million from opioid manufacturers from 2009 to 2013. Webster says that dollar amount is unfair and misleading because most of it stems from his work as a researcher. He is currently Vice President of Scientific Affairs at PRA Health Sciences, a clinical research company.

“If you’re a principal investigator in a research program that has contracted with a pharmaceutical company, that money goes under your name. But its money to conduct a trial. Not a penny of it goes to me,” says Webster. “I have received compensation for consultant work and advisory boards. My consultant work is because of my area of expertise. That’s not unusual. And I do not speak for a company’s product. I do not benefit at all because I personally have no shares in any pharmaceutical company.”

Since retiring from clinical practice, Webster has become an outspoken critic of efforts by the government and insurance industry to limit opioid prescribing -- which he believes have gone too far and unfairly punish pain patients, while ignoring the larger issue of illicit fentanyl, heroin and other black market drugs.

He's written a book, called "The Painful Truth" and self-financed a PBS documentary by the same name.  Webster also comments frequently on PNN about opioid related issues.

With so many lawsuits hanging over him, Webster’s financial future is uncertain.  He says he and his fellow KOLs could be bankrupted by legal fees before any of the lawsuits come to trial.

“We don’t have any big pocket that’s going to pay for anything,” he said. “If a jury decided to award money from us, they wouldn’t get any money, because there is no money. We would be all bankrupt by the time we got to court.”

Drug makers, on the other hand, do have big pockets. And during the 1990’s many of the same law firms now involved in opioid litigation helped win big settlements with the tobacco industry worth upwards of $200 billion.  That includes the law firm of Hagens Berman, which is handling the Salt Lake County lawsuit. The firm also represents the city of Seattle in a nearly identical lawsuit against opioid makers, in which Webster is named as a KOL.

Webster is also named in a string of lawsuits filed by the law firm of Simmons Hanly Conroy, which represents dozens of states, counties and cities. Simmons will pocket one-third of the proceeds from any opioid settlement,  which could run into hundreds of billions of dollars.

Simmons is well connected politically, having donated $219,000 to the re-election campaign of Missouri Sen. Claire McCaskill (D), who coincidentally released a report in February that's highly critical of patient advocacy groups and medical associations for accepting money from opioid manufacturers.

It is against these political, financial and legal forces that Webster must find a way to defend himself.

“The body of the allegations are inaccurate, misleading and irresponsibly paint a picture which ignores the realities of Dr. Webster’s compassionate commitment to alleviating suffering in his chronic pain patients,” Peter Striba, Webster’s attorney, wrote in a letter to the Salt Lake Tribune. “It is estimated that there are approximately one-hundred million chronic pain patients in our Country, and it is very telling that their suffering and their medical condition is entirely absent in the narrative of the Complaint.” 

Memorial Misrepresents Overdoses Linked to Rx Opioids

By Pat Anson, Editor

A provocative memorial to overdose victims makes its debut in Washington DC this week, where it is likely to draw more attention to opioid addiction and the overdose crisis.  

Modeled after the Vietnam Veterans Memorial, the National Safety Council’s traveling exhibit features a wall of 22,000 engraved white pills, each pill representing the face of someone who died from a prescription opioid overdose in 2015. To dramatize the point, a new pill is etched at the exhibit every 24 minutes, to represent how often a person supposedly dies from an overdose of pain medication.

Prescribed to Death: A Memorial to the Victims of the Opioid Crisis has already appeared in Chicago, Pittsburgh and Atlanta, and will be on display at President’s Park near the White House from April 11 to 18.

"We hope that putting a face on the statistics of the thousands lost to this epidemic inspires a greater sense of urgency among all stakeholders to continue their work to eliminate preventable drug overdose deaths," Deborah Hersman, president and CEO of the National Safety Council (NSC), said in a statement. 

NATIONAL SAFETY COUNCIL IMAGE

But like nearly everything else having to do with the overdose crisis – the exhibit misrepresents and exaggerates how many people actually died from prescription opioids, while ignoring the larger role played by illegal opioids and other black market drugs, which now account for about two-thirds of all overdoses.  

Twenty-two thousand people did not die from prescription opioids in 2015. According to revised estimates by the CDC, there were 17,536 deaths involving opioid medication that year. And some critics believe the actual number is even lower.

But that’s not stopping the NSC and the White House from promoting the memorial and its false statistics.

"The decision to bring the memorial to Washington is part of President Trump and First Lady Melania Trump's efforts to raise awareness about the crisis and to make us each part of solution," said Kellyanne Conway, counselor to the President. 

An NSC video shared by the White House on its Twitter account claims that “commonly prescribed pain medications are at the root of the crisis” and that “92,000,000 Americans were prescribed opioids in one year. 22,000 of them died from an overdose.”

‘Significantly Inflated’ Estimates

Where does the 22,000 number come from? It was not taken out of thin air or invented -- at least not by the National Safety Council. The NSC says it is based on CDC mortality data from 2015 -- when 22,598 overdoses were initially blamed on opioid pain relievers.

However, as PNN has reported, CDC researchers recently admitted that number and many other overdose estimates are wrong, because they included deaths involving illicit fentanyl and other synthetic opioids that “significantly inflate estimates.”

A more accurate number to blame on opioid pain medication, according to one CDC critic, is 16,610 overdoses – a number that has remained relatively stable over the last few years.  It’s also about 25% lower than the number of pills on display in the NSC exhibit.

When PNN asked the NSC to explain the discrepancy, we were emailed a nonsensical response by a spokesperson that only bends the truth further:

“The number of pills on the wall – 22,000 – represents the number of people who overdosed on prescribed opioids or prescribed fentanyl. However, some of the faces represent people who eventually overdosed on heroin. All of these addictions, however, began with prescribed medications.”

For starters, the notion that all addictions begin with prescriptions is -- to put it kindly -- misinformed. Toxicology tests also cannot differentiate between prescription fentanyl and illicit fentanyl, although the latter is now believed to be responsible for more overdoses than any other drug. And why would the faces of people who overdosed on heroin be included in a memorial to victims who died from prescription opioids?

The National Safety Council is a nonprofit that promotes itself as a "data-driven organization" focused on preventing unnecessary injuries and deaths. It was established by labor unions in 1913 to improve workplace safety but is now funded largely by corporations, including the insurance industry.

For several years the NSC has had an aggressive marketing campaign against the use of opioid medication.

"Opioids do not kill pain. They kill people," says NSC medical advisor Donald Teater, MD, on the organization’s website.

The NSC recently released a 32-page report called “Prescription Nation 2018” that calls prescription opioids “a gateway drug to heroin” that were "liberally prescribed, setting the stage for a flood of people suffering from opioid use disorder, overdose and death.”

An NSC analysis found that just 13 states and Washington DC have implemented adequate policies to prevent opioid overdoses, such as adopting prescribing guidelines and mandating prescriber education. The report says 29 states are lagging in adopting such policies and 8 of them are failing. 

The organization did not respond to a request for an interview. 

DEA Takes Steps to Reduce Hospital Opioid Shortages

By Pat Anson, Editor

In response to a growing number of complaints about shortages of opioid pain medication in U.S. hospitals, the Drug Enforcement Administration is allowing some drug makers to increase their production of injectable opioids.

The shortages were first reported last summer but have intensified in recent months – leaving some hospitals scrambling to find morphine, fentanyl and other injectable opioids to treat patients suffering from acute pain after surgery or trauma. The shortages are largely due to manufacturing problems at Pfizer, which controls 60 percent of the market for injectable opioids.

“DEA is working closely with the U.S. Food and Drug Administration, drug manufacturers, wholesale distributors and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. These include certain injectable products that contain morphine, hydromorphone, meperidine, and fentanyl,” the agency said in a statement.

The DEA said it gave permission to three other drugs makers to produce the injectable drugs after Pfizer “voluntarily surrendered” part of its quota allotment.

“It is important to note that an increase in DEA procurement quotas to various manufacturers cannot alone prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products,” the agency said.

But critics say the DEA itself is partly responsible for the shortages. The agency may not control how companies manufacture drugs – but it has a big say on the amount. Under federal law, the DEA sets annual production quotas for each drug maker to produce opioids and other controlled substances.

Because of growing concerns about the overdose crisis, the DEA ordered a 25 percent reduction in opioid manufacturing in 2017 and an additional 20 percent cut in 2018. This year’s cuts were ordered despite warnings from three drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

A group of 16 U.S. Senators – led by Illinois Democrat Dick Durbin – urged the DEA to make the production cuts. 

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the senators wrote in a September 2017 letter to then acting DEA administrator Chuck Rosenberg.

According to Kaiser Health News, shortages of injectable opioids have led to an increasing number of medical errors and left trauma patients suffering in pain. Some hospitals are rationing opioids like Dilaudid, and using nerve blocks, acetaminophen and muscle relaxants instead.

The DEA said it would make further adjustments to opioid quotas if they are needed and would “also consider other measures that may be necessary.”