Tax on Prescription Opioids Costly for Pain Patients

By Anastassia Gliadkovskaya, Kaiser Health News

Mike Angevine lives in constant pain. For a decade the 37-year-old has relied on opioids to manage his chronic pancreatitis, a disease with no known cure.

But in January, Angevine’s pharmacy on Long Island ran out of oxymorphone and he couldn’t find it at other drugstores. He fell into withdrawal and had to be hospitalized.

“You just keep thinking: Am I going to get sick? Am I going to get sick?” Angevine said in a phone interview. “Am I going to be able to live off the pills I have? Am I going to be able to get them on time?”

His pharmacy did not tell him the reason for the shortage. But Angevine isn’t the only pain patient in New York to lose access to vital medicine since July 2019, when the state implemented an excise tax on many opioids.

The tax was touted as a way to punish major drug makers for their role in the opioid epidemic and generate funding for treatment programs. But to avoid paying, scores of manufacturers and wholesalers stopped selling opioids in New York. Instead of the anticipated $100 million, the tax brought in less than $30 million in revenue, two lawmakers said in interviews. None of it was earmarked for substance abuse programs, they said.

The state’s Department of Health, which has twice this year delayed an expected report on the impact of the tax, did not respond to questions for this story.

The tax follows strong efforts by federal and New York officials to tamp down the use of prescription opioids, which had already cut back some supply. Now, with some medications scarce or no longer available, pain patients have been left reeling. And the law appears to have missed its target: Instead of taking a toll on manufacturers, the greater burden appears to have fallen on pharmacies that can no longer afford or access the painkillers.

Among them is Epic Pharma. Independent Pharmacy Cooperative, a wholesaler, confirmed it no longer sells medications subject to the tax, but still sells those that are exempt, which are treatments for opioid addiction methadone and buprenorphine and also morphine. AvKARE and Lupin Pharmaceuticals said they do not ship opioids to New York anymore. Amneal Pharmaceuticals, which manufactures Angevine’s oxymorphone, declined to comment, as did Mallinckrodt.

Since the tax went into effect, Cardinal Health, which provides health services and products, published an extensive 10-page list of opioids it does not expect to carry. Cardinal Health declined to comment.

The New York tax is slowly gaining attention in other states. Delaware passed a similar tax last year. Minnesota is assessing a special licensing fee between $55,000 and $250,000 on opioid manufacturers. New Jersey Gov. Phil Murphy proposed such a tax this year but was turned down by the legislature.

More Expensive Prescriptions

The company that makes the first point of sale within New York pays the tax. That isn’t always the drug maker. It can mean wholesalers selling to pharmacies here are assessed, explained Steve Moore, president of the Pharmacists Society of the State of New York.

Independent Pharmacy Cooperative (IPC) said about half its revenue from opioid sales in New York would have gone to taxes. Mark Kinney, the company’s senior vice president of government relations, said the law is putting companies in a very difficult position. When wholesalers like IPC left the opioid market, competitive prices went with them.

Without these smaller wholesalers, it’s hard for pharmacies to go back to other wholesalers “and say, ‘Hey, your prices aren’t in line with the rest of the market,’” Moore said.

Indeed, nine independent pharmacies told KHN that when they can get opioids they are more expensive now. They have little choice but to eat the cost, drop certain prescriptions or pass the expense along.

“We can trickle that cost down to the patient,” said a pharmacist at New London Pharmacy in Manhattan, “but from a moral and ethics point of view, as a health care provider, it just doesn't seem right to do that. It’s not the right thing to ask your patient to pay more.”

In addition, Medicare drug plans and Medicaid often limit reimbursements, meaning pharmacies can’t charge them more than the programs allow.

Stone’s Pharmacy in Lake Luzerne was losing money “hand over fist,” owner Leigh McConchie said. His distributor was adding the tax directly to his pharmacy’s cost for the drugs. That helped drive down his profit margins from opioid sales between 60% and 70%. Stone’s stopped carrying drugs like fentanyl patches and oxycodone, and though that distributor now pays the tax itself, the pharmacy is still feeling the effects.

“When you lose their fentanyl, you generally lose all their other prescriptions,” he said, noting that few customers go to multiple pharmacies when they can get everything at one.

If pharmacies have few opioid customers, those price hikes have less impact on their business. But being able to manage the costs is not the only problem, explained Zarina Jalal, a manager at Lincoln Pharmacy in Albany. Jalal can no longer get generic oxycodone from her supplier Kinray, though she can still access brand-name OxyContin.

New York’s Medicaid Mandatory Generic Drug Program requires insurers to provide advance authorization for the use of brand-name prescriptions, delaying the approval process. Sometimes patients wait several days to get their prescription, Jalal explained.

“When I see them suffer, it hurts more than it hurts my wallet,” she said.

One of Jalal’s customers, Janis Murphy, needs oxycodone to walk without pain. Now she is forced to buy a brand-name drug and pays up to three times what she did for generic oxycodone before the tax went into effect. She said her bill since the start of this year for oxycodone alone is $850. Lincoln Pharmacy works with Murphy on a payment plan, without which she would not be able to afford the medication at all. But the bill keeps growing.

“I’m almost in tears because I cannot get this bill down,” she said in a phone interview.

Several pharmacists raised concerns that patients who lose access to prescription opioids may turn to street drugs. High prescription prices can drive patients to highly addictive and inexpensive heroin. McConchie of Stone’s Pharmacy said he now dispenses twice as many heroin treatment drugs as he did a year ago. Former opioid customers now come in for prescriptions for substance use disorder.

Cost of Percocet Doubled

Trade groups and some physicians and state legislators opposed the tax before it went into effect, voicing concerns about a slew of potential consequences, including supply problems for pharmacists and higher consumer prices.

New London Pharmacy said one of its regular distributors stopped shipping Percocet, a combination of oxycodone and acetaminophen. Instead, the pharmacy orders from a more expensive company. The pharmacist estimated that a bottle of Percocet for which it used to pay $43 now costs up to $92.

“Even if we absorb the tax, we’re not getting a break from reimbursements either,” a pharmacist who spoke on the condition of anonymity explained, adding that insurance reimbursements have not increased in proportion to rising drug costs. “We’re losing.”

Latchmin Raghunauth Mondol, owner of Viva Pharmacy & Wellness in Queens, has also seen that problem. The pharmacy used to be able to purchase 100 15-milligram tablets of oxycodone for $15, but that’s now $70, she said, and the pharmacy is reimbursed only about $21 by insurers.

Other opioids are just not available.

Mondol said she has been unable to obtain certain doses of two of the most commonly prescribed opioids, oxycodone and oxymorphone—the drug Angevine was on.

After Angevine lost access to oxymorphone, his doctor put him on morphine, but it does not give him the same relief. He’s been in so much pain that he stopped going to physical therapy appointments.

“It’s a marathon from hell,” he said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

Patient Advocates Critical of Canadian Pain Task Force Report

By Pat Anson, PNN Editor

A new report from the Canadian Pain Task Force is being called “political propaganda” and “shameful” by patient advocates.

The 75-page report was released last week by the task force, an advisory panel created by Health Canada in 2018 to help it address the needs of nearly 8 million Canadians who live with chronic pain. Like many of their counterparts in the United States, Canadian pain patients often have trouble getting access to opioid medication because of fears the drugs will lead to misuse and addiction.

The task force said it released its second report “with a sense of urgency” because the COVID-19 pandemic had reduced access to healthcare and social services for many people. The report calls chronic pain a “legitimate disease” and said better efforts were needed to provide access to pain treatment, improve public awareness and reduce stigma associated with chronic pain.

“Recent dramatic increases in opioid-related overdose deaths in North America have heightened awareness around the risks associated with both short- and long-term opioid use for chronic pain. However, efforts undertaken to respond to the overdose crisis have led to challenging unintended consequences for people living with chronic pain,” the report found.

“Some people in Canada have been unable to access opioid medications, and others who previously relied on opioids to manage their pain have been unable to continue their medications, or have had significant adjustments to lower their prescriptions, sometimes against their will.”

The task force also released findings from surveys and interviews with nearly 2,000 Canadians – both patients and providers -- who often had “differing expectations” about how chronic pain should be treated. Patients complained of limited access to specialists, long wait times, and treatments that didn’t work or were harmful.

“Many people living with chronic pain have experienced trauma in the context of medical care. They may have had invasive investigations and procedures or negative interactions with health professionals. Such experiences can be damaging on their own, but when compounded with previous trauma can lead to more drastic challenges such as changes in sense of self, view of the world, and nervous system dysregulation, which may all contribute to increased pain and difficulties coping,” the report found.

‘Nothing New’

But outside of announcing $3.5 million in funding for three local health projects, no immediate steps were announced by Health Canada or its task force to improve pain care for Canadians. The panel is not expected to release its third and final report until December 2021.

“There is nothing new in this report,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, a patient advocacy group. “Have they forgotten this is a 3-year study, which will not be completed until 2021? In the meantime, while they fiddle, Canadians continue to suffer and die when the solutions are already there, yet we continue to spend over $3 million taxpayer dollars. So where is the sense of urgency?”

The task force outlined its “next steps” with a vaguely worded statement that “leadership and resources are needed to amplify, spread, and accelerate current activities, coordinate responses, address current gaps and inequities, and reduce the variability across jurisdictions.”    

“This is simply a carefully constructed document to create the appearance of having listened to patient input, and to suppress the substance of changes demanded by both patients and doctors. It is political propaganda of the worst sort,” said Richard Lawhern, PhD, a patient advocate and co-founder of the Alliance for the Treatment of Intractable Pain (ATIP).

“Contrary to the biased declarations of this report, there is no evidence that increased availability of prescription opioids in medical treatment has been a significant factor in causing the public health crisis.”

“Nothing illustrates the folly of government policies better that the rising number of pain sufferers who turn to street heroin because they can no longer get legal medication.”

— Chronic Pain Association of Canada

Ulmer was frustrated that the report didn’t more broadly address how efforts to prevent addiction and overdoses have harmed pain patients.

“The fact that addiction and overdose deaths continue to soar should convince them they have taken the wrong path. But it hasn’t. Now they have pain patients deprived of their medications, with reduced quality of life, increased pain, patients committing suicide, as they are no longer able to cope, with some seeking street drug dealers to see if they can find some relief,” Ulmer said.

“Nothing illustrates the folly of government policies better that the rising number of pain sufferers who turn to street heroin because they can no longer get legal medication.”
  
Ulmer said the report’s brief discussion of opioid medication was “illogical, gutless, and shameful” and called on the Canadian government to “cease their war on pain patients” by immediately withdrawing Canada’s opioid guideline – without waiting for a final report from the task force.

Understanding the Difference Between Prescription Fentanyl and Illicit Fentanyl

By Roger Chriss, PNN Columnist

The opioid overdose crisis is now being driven by fentanyl. But misunderstandings over what fentanyl is, where it comes from, how it is used and why have become so pervasive that they plague discourse and debate about the crisis. News reports about “fentanyl overdose deaths” appear almost daily.

October saw a particularly tragic death. As reported by the Daily Courier in Prescott, Arizona, a 14-year-old high school student died of an overdose after taking what investigators suspect was a counterfeit pill “laced with the potent narcotic painkiller fentanyl.”

The tragedy of this death cannot be overstated. Nor can thousands of other overdose fatalities caused by fentanyl. But the nature of the drug needs to be better understood if we are to prevent such deaths moving forward.

Fentanyl is not one drug. It is better thought of as a family of synthetic opioids that are structurally similar, and includes sufentanil and remifentanil. These are pharmaceutical fentanyls, used clinically as anesthetics and essential for medical procedures such as open heart surgery.

Collectively, these drugs are part of a super-family known as fentanyl analogues. There are dozens of such drugs. Some are compounds developed by pharmaceutical companies for legitimate medical use, and others are manufactured illegally for use as street drugs. These forms of fentanyl are commonly referred to as “illicitly manufactured fentanyl” by government agencies like the CDC. The DEA has classified “fentanyl-related substances” as Schedule I controlled substances, meaning they are illegal to manufacture, distribute or possess.

To make this even more complicated, the fentanyl drug carfentanil is used legally in the U.S. as a tranquilizer for elephants and other large animals. The DEA authorizes production of a minute quantity of carfentanil for veterinarians every year. But illicit carfentanil from overseas occasionally shows up on the street and causes fatal overdoses.

Further muddying matters is the new fentanyl-like street drug isotonitazene, which is known colloquially as “iso.” It is “fentanyl-like” in its risks and harms, but is not technically a fentanyl analogue. “Iso” is instead related to etonitazene. Neither of these drugs has any recognized medical use in humans.

Risks Are Very Different

In other words, there is a vast gulf between pharmaceutical fentanyl and illicitly manufactured fentanyl. The former is a tightly controlled Schedule II prescription medication, approved for use in hospitals and to treat breakthrough cancer pain. The latter is an illegal substance cooked up in illicit labs that is often added to heroin or used to make counterfeit pills, which are then sold on the street or online.

This distinction is critical for understanding the opioid overdose crisis. The risks of a prescription opioid like fentanyl when given for medical use to a legitimate patient are very different from the risks of an illicit opioid being used non-medically by a random street buyer. Importantly, the risks for medical use can be addressed and managed. The risks of illicit use are much harder to deal with and often prove fatal.

The distinction also leads to confusion. The abundance of fentanyl on the street is rarely a result of diversion, and is unrelated to the supply of pharmaceutical fentanyl. These are different drugs, much as the cocaine nasal spray recently approved by the FDA as a local anesthetic is completely separate from the cocaine bought on the street. Pain experts are now pushing for a new classification for illicit fentanyl analogues, in the hope of clarifying this difference.

But fentanyl has so saturated the street drug market that more than a name change will be needed. As Ben Westhoff explains in the book “Fentanyl, Inc.”, preventing future opioid deaths will require “sweeping new public-health initiatives, including treatment programs and campaigns to educate everyone, from users and medical providers to teachers and police, about the drugs’ dangers.”

Understanding the difference between pharmaceutical fentanyl and illicitly manufactured fentanyl is an essential step in the effort to reduce overdose deaths.

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 Expanding Surveillance of Prescription Drug Data

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration is making plans for a major expansion of its monitoring of prescriptions for opioids and other controlled substances, with the goal of identifying virtually every prescriber, pharmacy and patient in the country that shows signs of drug diversion or abusing their medication.

In a request for proposal (RFP) made in early September, the DEA asked software contractors to submit bids for the creation of a nationwide data system that would track “a minimum of 85 percent of all prescriptions” for Schedule II through V controlled substances. The RFP was first reported by the website Filter.

Critics say the surveillance program will have a chilling effect on many healthcare providers, who are already fearful of being flagged by law enforcement for prescribing and dispensing opioids and other medications to patients suffering from pain and other illnesses.  

“This RFP illustrates that the DEA, and U.S. Department of Justice more broadly, remains fixated on monitoring and scrutinizing the medical decisions of licensed health professionals while illegal fentanyl and heroin contribute to two-thirds of opioid-involved drug poisonings in the U.S.,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers.

“DEA agents have no business second guessing health care providers’ decisions on medical need and patient care. That’s a job for state licensing boards – and only when there is a valid complaint to investigate.”

‘Unlimited Access’ to Prescription Data

Hundreds of medications would be covered under the DEA’s surveillance program, including drugs used to treat pain, opioid use disorder, anxiety, and attention deficit hyperactivity disorder (ADHD).  Under the program, DEA investigators would have “unlimited access” to prescription data compiled over the last five years, including the names of prescribers and pharmacists, types of medication, quantity, dose, refills and forms of payment.

The names of patients would be encrypted, but if investigators suspect a medication was being abused or diverted, they could get a subpoena to quickly identify the patients involved.

“The subpoena process would be that we would generate a DEA Administrative Subpoena and send it to you for the unmasking of specified patients. The data provider would then need to respond to us providing the unmasked patient information that was requested within three business days,” the DEA said in response to a contractor who inquired how the subpoena process would work.      

Asked how many DEA investigators would have access to the prescription data, the agency said there could be over a thousand.

“We would start with 1,100 users and would renegotiate if more were needed. It is unlikely that 1,100 users will all access the system concurrently but is hypothetically possible in the future,” the agency replied.

Why the DEA is seeking to expand its monitoring of opioid prescriptions is unclear. In recent years, the number of prescriptions has fallen by about a third and the DEA itself estimates that less than one percent of legally prescribed opioids are diverted.

Bypassing PDMPs

State-run prescription drug monitoring programs (PDMPs) already track much of the information DEA is seeking, but law enforcement access to the data usually requires an active investigation or warrant – no data mining or fishing expeditions allowed. To maintain patient privacy, some states prohibit sharing prescription data with federal or out-of-state law enforcement agencies. Last year, the DEA had to sue Colorado to get access to the state’s PDMP data.

The DEA’s plan would bypass these privacy safeguards and effectively create a national PDMP for law enforcement. The agency would even be allowed to share some prescription data with unnamed “outside agencies and/or organizations without prior review by the Contractor.”      

The DEA did not respond to multiple requests for comment. In the RFP, the agency said it was required by law to maintain “comprehensive, detailed, accessible, and timely prescription, pharmacy, and prescriber information.”

Much of the data mining the agency is planning appears to go beyond the prescription data that is currently covered by PDMPs.  For example, the DEA wants to know the distance patients travel to see their doctors and pharmacies; whether patients living at the same address are getting the same drugs; whether a patient pays in cash for their medications; and whether a patient is getting a combination of opioids and benzodiazepines to treat their pain and anxiety.

“This DEA program will increase the fear associated with prescribing and dispensing controlled medications, making it even more difficult for people with pain, opioid use disorder, anxiety, insomnia, and ADHD to access individualized treatment. More such patients will be left in despair. It’s as though the federal government is unaware or does not care that the U.S. is in the midst of a suicide epidemic,” Barnes told PNN. 

‘Appalling for People’s Health’

The software contractor is also expected to provide DEA with a list of top prescribers and pharmacies that are writing and filling prescriptions for fentanyl, oxycodone, hydrocodone, buprenorphine and other opioids. The inclusion of buprenorphine is troubling to substance abuse treatment experts, because it is a primary ingredient of Suboxone. 

“The impact of including buprenorphine will be appalling for people’s health,” said Dr. Hannah Cooper, the chair of substance use disorder research at Emory University. Cooper fears the DEA surveillance program would make doctors and pharmacies reluctant to supply Suboxone to patients who need addiction treatment. 

“The idea that patient-level data is available to the DEA is quite frightening. We don’t want to make people worry that their decisions will be monitored by this highly punitive federal agency,” Cooper told Filter. “If you’ve been inhabiting a space where you’ve been persecuted by the federal government for some time, and they now have access to your private medical information, there will be tremendous consequences for population health and health equity.”

“This program will undoubtedly decrease the prescribing of controlled medications, including buprenorphine for opioid use disorder,” said Barnes. “Why in the world would the federal government, in the midst of a worsening drug-poisoning epidemic, discourage the prescribing of a medication to treat opioid use disorder and prevent opioid poisonings?”

The DEA deadline for receiving proposals from software contractors was October 20. No contract awards have been announced. The surveillance program could begin as early as December 1, 2020 and continue for a minimum of one year, with an option for up to four years. The potential cost of the program has not been disclosed.

I Deserve To Have My Chronic Pain Managed

By Marguerite Morgan, Guest Columnist

I have lived with chronic pain the majority of my 53 years of life. It’s hard to make the people that cross my path understand that I cannot do things I used to take for granted. Things like attending concerts and other venues, or keeping my home up and my appearance up are the things that I miss and bother me the most. 

Those I love have seen my decline and know that I am truly suffering. The only reason I am suffering is because of the lies told by the CDC. They admitted that their statistics were off regarding overdoses because they combined deaths caused by illegal drugs with those that were prescribed.

These so-called experts turned on those of us who take our opioid medication responsibly and have blamed us for the addiction issues in this country. Laws were made and bills were passed on this false information and now there are millions suffering. 

It's not right that our government continues to uphold the CDC opioid guideline, knowing that we are suffering and medications that will help are denied to us. We are treated like garbage for illnesses, diseases and injuries that doctors can't treat without fear of being raided by the DEA. Their medical licenses are way more important than our quality of life.

Nothing seems to be changing either and it probably won't in my lifetime. But I will continue to fight for those who need advocacy because there are a few good doctors willing to take a chance. 

MARGUERITE MORGAN

We are dying every day either by suicide or from being cut off from pain medication. Our hearts quit because they just can't take the pain that causes.

I just want to know why those that die from abusing drugs intentionally are more important than those of us who take our prescribed medication as directed. It seems life has truly turned upside down and nothing seems right anymore.

I suffer from intractable pain caused by an injury to my spine. I also have inflammatory rheumatoid arthritis, osteoarthritis, Addison’s disease, fibromyalgia and degenerative disc disease, to name just a few of my painful conditions.

I deserve to have this pain managed. I deserve to enjoy and take part in life, instead of just seeing it pass me by through my living room window. 

Marguerite Morgan lives in Washington state.

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

Study Launched to Look at Suicides of Chronic Pain Patients

By Pat Anson, PNN Editor

One of the more unrecognized and under-reported aspects of the opioid crisis is what happened to millions of chronic pain patients in the U.S. who were tapered or cut off from opioid medication in the name of preventing addiction and overdoses.

We know a lot about opioid prescribing. The number of prescriptions has fallen by about a third since their peak. And the supply of opioid pain relievers, according to the DEA, is at its lowest level since 2006.  We can literally count them down to the last pill.

But we don’t know what happened to the patients. How many were abandoned by their doctors? How many became disabled or lost their jobs? How many died from strokes or heart attacks? How many surrendered to despair by taking their own lives? We simply don’t know.

Critics say pain patients have fallen through the wide cracks of a cruel and willfully blind public health experiment.

“I’ve seen patients destabilized and nearly die by suicide after prescription opioids were stopped. I’ve been receiving notice of these for several years now. And I’ve never really been in a situation where a large number of patients were dying and health systems do not systematically study it and try to stop it,” says Stefan Kertesz, MD, a professor of medicine at University of Alabama at Birmingham (UAB).

“We have setup systems that insist on measuring prescription opioid doses and incentivizing reduction, but which are not measuring the outcomes of that change in care. Hospitals and clinics are not even asked to check what happened to the patient.”

In one of the first efforts to find out, Kertesz and co-investigator Allyson Varley, PhD, are recruiting family members and close friends of pain patients who died by suicide for a study to see what happened to their loved ones after changes were made in their opioid medication.

“What we’re trying to do is marry what patients are telling us is needed with scientific rigor, so that the appropriate people will listen to us when we say there is a problem,” said Varley, who works in the UAB Center for Addiction and Pain Prevention and Intervention.

“We are very committed to this. As long as people are having unsuccessful tapers, we’re interested in studying what’s happening and how to make it better, by increasing access to the care that you need when you have chronic pain, whether that’s opioids or not.”

Reaching Out to Survivors

The dead can no longer speak for themselves, which is why the survey is focused on reaching surviving loved ones who witnessed the pain and despair of their deceased spouse, child, parent, partner or friend.  

“We have to reach survivors who believe that is what they saw, and who can provide some preliminary information to hint that is really what happened,” Kertesz explained.

No one knows with any certainty how many pain patients have died by suicide in recent years, but it probably runs in the thousands. We’ve shared some of their stories on PNN, including that of Meredith Lawrence, who witnessed the suicide of her husband, Jay.

“I lost my husband in 2017 by suicide after his medications were taken away,” Lawrence said. “At that point, I wrote about our experience for the public, and it drew attention nationally. To see Dr. Kertesz and his colleagues take this seriously matters to me because nobody should lose a loved one over something treatable.”  

Much of the groundwork for the UAB survey was laid by patient advocate Anne Fuqua, who began compiling information about patient suicides several years ago. Her list has grown to over 100 well-documented suicides.

“This is truly a dream come true that these deaths are being taken seriously. When a dear friend died of a heart attack in 2014, the only way I could cope was finding and memorializing these deaths,” said Fuqua. “I could never have imagined this would come to fruition.”

Suicides Rising

The suicide rate in the U.S. has risen by about a third since the turn of the century, but there is no easy explanation for the increase. Suicides usually involve multiple factors, such as inadequate healthcare, mental health issues, drug and alcohol abuse, social isolation and economic inequality – what has been called “deaths of despair.” Throw in poorly treated or untreated pain and you have a recipe for suicidal thoughts.

Kertesz and Varley are hoping to get at least 200 family members and friends to participate in their survey. More would be better, because it could lead to larger studies that will help them document what is happening in the pain community.

“If we can convince people that this is a tragedy that needs to stop and we are passionately committed to it, and some people come forward, maybe we can get external funding to allow us to do the research that’s really needed,” says Kertesz. “It’s very hard to make the case when you don’t have pilot data to show that these families are willing to come forward.

“If one outcome of starting the study is that policymakers begin to realize that there is a serious risk to having physicians flee their patients, that would be a helpful outcome. It might change the dialogue a bit.”  

To participate in the online survey, click here. Or call 1-866-283-7223. The survey will take about 25 minutes. Respondents will be asked a series of questions about the loved one who died, their healthcare and life situation at the time of death.

New Screening Tool Identifies 80% of Patients at High Risk of Rx Opioid Abuse

By Pat Anson, PNN Editor

A new opioid screening tool is being introduced that claims to predict – with 80% accuracy – which patients receiving an opioid prescription are likely to have an overdose or get an opioid abuse diagnosis within the next six months.

Geneia, a healthcare data firm based in Pennsylvania, is integrating the opioid screening tool into its analytics platform, which is used by hospitals, insurers, employers and physician groups providing healthcare to over 7 million patients.

Contrary to popular belief, abuse is relatively rare in patients prescribed opioids, so it’s a bit like finding a needle in a haystack. Less than one percent (0.7%) of patients on opioids suffer an overdose or abuse their medication, according to Geneia.

But the consequences of opioid abuse are so serious medically, legally and financially to both patients and providers that healthcare organizations are eager to identify patients who are most at risk.

"An ounce of prevention is worth a pound of cure," said Fred Rahmanian, Geneia’s chief analytics and technology officer. "Knowing in advance who is at high-risk for an opioid abuse diagnosis or overdose enables physicians to choose alternative pain management strategies."

For example, a hospital using Geneia’s screening tool might give a surgery patient deemed to be “high-risk” a non-opioid pain reliever like acetaminophen for post-operative pain.

‘It’s All Data Driven’

Opioid screening tools have been used for years to help providers identify high-risk patients. Usually they involve questionnaires in which a patient’s medical history is assessed, along with their personal and family history of alcohol and drug use. The risk assessment might also include genetic testing or asking if a patient suffered sexual abuse as a minor.   

Geneia’s screening tool is different. It only looks at the diagnostic codes used in a patient’s medical and pharmacy claims – known as ICD-10 codes – without getting any direct input from providers about patient history. The company’s algorithms search the diagnostic codes for 22 different variables that may indicate a patient may be prone to opioid abuse.

“It’s all data driven,” says Geneia CEO Heather Lavoie, who downplays the importance of questionnaires about patient history.

“Oftentimes you don’t get accurate information. Even about family history of substance use and abuse,” she told PNN. “People are not good historians. There’s often a lot of misinformation, so you’re not always getting an accurate response to questionnaires. Obviously, sometimes you do, but not universally. And so, the benefit is that we can, with very little information, be highly predictive.”

“Glad to see there are efforts to help identify people at increased risks of abuse.  We need accurate and easy to use predictive criteria for those at increased risk of abuse and overdose,” says PNN columnist Dr. Lynn Webster, a pain management expert who developed the first “opioid risk tool” about 15 years ago.  

“Much of the accuracy of tools depends on definitions.  Unfortunately, there are multiple definitions of abuse, misuse and addiction. This makes it difficult to understand what is actually being assessed and predicted with any tool, including this one.” 

Webster is puzzled why Geneia’s screening tool omits a patient’s personal history and genetic testing, and says it may rely too heavily on diagnostic codes.    

“Unfortunately, few physicians know how to diagnose abuse from misuse and addiction. For example, many providers still believe that if someone experiences withdrawal they are addicted, which is not necessarily true,” said Webster. “The bottom line is that if the tool is based on ICD-10 diagnoses it relies on the clinician’s ability to make accurate diagnoses, most of whom have never been trained to make such diagnoses.  

“I am surprised that genetic evaluation is not considered in their tool since the vulnerability of opioid addiction is mostly genetic. The balance of the vulnerability to addiction comes from environmental factors like social-economic despair and mental health disorders.”  

Another thing that makes Geneia’s screening tool unique is that it can be used with children and adolescents. Opioid risk tools are typically only used for patients 18 years of age or older.

High False Positive Rate

Geneia tested its screening tool against a database of several million insurance claims, and says it accurately identified 80 to 88 percent of patients who are likely to have an opioid abuse diagnosis or an overdose.

But analytics are not foolproof. Geneia’s screening tool has a false positive rate of nine percent – meaning about one in every ten patients will be flagged inappropriately as high-risk.

“The false positive rate, depending on the data-set, is pretty high because it’s a very rare event rate. It’s really hard to pick the needle out of the haystack,” explained Jasmine McCammon, a data scientist who designed Geneia’s screening tool.  

On the flip side of opioid abuse, the screening tool also identifies patients who are at not high risk, giving reassurance to doctors who are uncertain about whether a patient should be given opioids.

Regardless of what the screening tool finds, CEO Lavoie says the company’s analytics should never be used as a diagnostic device.

“Predictive models shouldn’t be used in place of strong medical practice. They really are to help advise and to provide contextual information, so they (doctors) can work with the patient more directly. It’s in no way a surrogate for good care, but it does help provide additional caution,” Lavoie said.

Walmart Sues Feds Over Prescribing Regulations

By Pat Anson, PNN Editor

In an unusual move, Walmart has filed a lawsuit against the Department of Justice and Drug Enforcement Administration, asking a federal court to clarify the “roles and legal responsibilities of pharmacists and pharmacies” in filling opioid prescriptions.

“We are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding, and in fact expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs,” the company said in a statement.

Walmart and other pharmacy chains are defendants in multiple class action lawsuits alleging the companies helped fuel the opioid crisis by dispensing opioids irresponsibly. They have also been fined tens of millions of dollars by the DEA for lax controls on opioid prescriptions. According to ProPublica, federal prosecutors in Texas even sought criminal charges against Walmart, but were overruled by top officials at the Department of Justice.

Walmart is the largest retailer in the world and operates over 5,000 in-store pharmacies in the United States. The company said it filed suit against the DOJ and DEA because it was caught “between a rock and a hard place” over opioid prescribing.    

“Unfortunately, certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis. They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions,” Walmart said.

“At the same time that DOJ is threatening to sue Walmart for not going even further in second-guessing doctors, state health regulators are threatening Walmart and our pharmacists for going too far and interfering in the doctor-patient relationship. Doctors and patients also bring lawsuits when their opioid prescriptions are not filled.”

‘Corresponding Responsibility’

Under current law, pharmacists have a “corresponding responsibility” when filling prescriptions – a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but Walmart and other pharmacies have gone even further by blacklisting doctors deemed to have questionable prescribing practices.  

That’s what happened to a nurse practitioner at an Arizona pain clinic, who received a letter from Walmart in 2018 saying it would no longer fill her prescriptions – even though there was no indication any of her patients had been harmed by opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states.

“It was very humiliating. I was upset about it,” said nurse practitioner Carolyn Eastin. “We’ve already had patients who can’t get prescriptions there.”

A former Walmart pharmacist told PNN the company closely monitors opioid prescriptions and the doctors who write them.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," the pharmacist explained.

In its statement, Walmart said its pharmacists “refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic” and had “blocked thousands of questionable doctors from having their opioid prescriptions filled.” The company also said it frequently assisted law enforcement agencies in “bringing bad doctors to justice.”

Caught in the middle of this are pain patients with legitimate prescriptions that are not getting filled. In August, two patients filed class action complaints against Walgreens, Costco and CVS alleging they were discriminated against by the pharmacies.

As PNN has reported, Sen. Elizabeth Warren (D-MA) and other members of Congress are urging the DEA to update a regulation that would allow pharmacists to only partially fill an opioid prescription. Patients would have to return a second time to get the rest of their medication.

The Devil Effect on Patients with Pain

By Dr. Lynn Webster, PNN Columnist

Society's response to pain management has shifted over the years. While pain treatment today often generates controversy, in the past it was viewed differently.

During the U.S. Civil War, a wounded soldier who was in agony was often given enough chloroform “to render him insensible to pain." Afterwards, soldiers may not have recalled the pain they felt, even if they remembered having surgery. We were concerned enough for our soldiers to ease their suffering with the most effective medication that was available.

At other periods in our history, society worried more about the risks of treating pain than the debilitating and sometimes lethal effects of the pain itself. At times, we even questioned whether pain was real and whether people were just inventing symptoms to receive attention or drugs.

People with pain have often been stigmatized. They have been expected to just tough it out, and those who couldn't were accused of being weak.

The Pendulum Swings Toward Empathy

In the 1990s, most people dying of cancer experienced excruciating pain, despite the fact that doctors had the means to help them. Opioids could ease their suffering. And a consensus began to grow in the medical profession that prescribing opioids for cancer-related pain was the right thing to do. Soon after, doctors began prescribing opioids for non-cancer pain, such as arthritis. The number of prescriptions increased.

Treating pain with opioids became acceptable -- even expected -- when the alternative was to let people suffer. It seemed reasonable at the time. There was little evidence then that opioids would cause serious harm if people used the pain medication as directed.

We always acknowledged that a subset of the patient population was at risk for abuse or addiction. Pain doctors like me did the best we could for patients with the research that was available to us at the time. Perhaps, in some cases, we would do things differently now.

Casting Blame for the Opioid Crisis

Ultimately, “overprescribing” was recognized as one of the contributors to America’s drug crisis. Looking back, it is easy to cast blame. We now have better information about the risks of using opioids. But there were few effective tools at the time to control pain, so prescribing opioids seemed like a valid alternative to letting patients suffer unnecessarily.

As more opioids were prescribed, there was a corresponding increase in all drug overdoses. That set off alarms, even though the causes of overdoses are myriad and complicated, and there is no simple correlation between rising opioid prescriptions and increased overdose deaths.

Societal attitudes began to shift again in the first decade of the 21st century. Families who lost loved ones to overdoses were looking for someone to blame. There were public and private demands to hold someone accountable for their deaths. The initial target was the pharmaceutical industry.

This wasn't anything new. The American public has more hostility toward Big Pharma than any other industry. A 2019 Gallop poll found that the public felt more distrust of Big Pharma than they did of the federal government!

The news media covered the tragedies of teenagers and young adults who were dying from overdoses. Often, those deaths involved opioids. The media also covered stories of families torn apart by addiction. Then the media's narrative shifted to allegations of deceit, greed and cover-ups by the pharmaceutical industry.

At first, they focused on Purdue Pharma. The company was making billions of dollars from OxyContin, and they were accused of irresponsibly promoting its use. The federal government filed a lawsuit against Purdue Pharma and this week announced a $8.3 billion settlement with the company.  

I recall the initial complaints about OxyContin were unrelated to the increased number of opioid related overdoses. Instead, Workers Compensation groups were complaining about the skyrocketing cost of the drug. In the late 1990’s, I recall hearing the medical director of Utah’s workers’ compensation program speak to the local pain society. He angrily insisted that the cost of OxyContin was exploding and must be stopped.

A new "Opium War" had begun. But this time, it was not between the Chinese and British. Instead, it involved health insurers and opioid manufacturers.

Chasing a Pot of Gold

The need to blame someone for the overdoses and make them pay for the harm opioids caused accelerated. Opioid manufacturers and physicians were in the cross-hairs of policymakers and law enforcement agencies.

Opioid distributors and patient advocacy groups were also accused of contributing to the drug crisis. It was alleged that distributors knowingly and irresponsibly supplied communities with large amounts of pills that far exceeded the amount needed for medical purposes. Advocacy groups were accused of being front organizations for opioid manufacturers. Whether or not distributors were irresponsible depends on one’s perspective, but the accusation about patient organizations was often baseless and malicious.

Of course, the bandwagon of accusers grew as the potential pot of gold increased. Lawsuits filed by states, cities and counties could result in a golden egg if they could convince a sympathetic jury or judge that they had been wronged. The sympathies of the public turned more and more against the drugs used in pain treatment.

The Devil Effect Harms Us All

Greed and the harm it causes is a well-known story. However, what is not as well appreciated is how it leads to a cognitive bias called the "devil effect" -- in which one bad quality creates the impression that there must be only negative qualities associated with a person or entity.

The belief that Big Pharma is inherently bad makes it difficult to appreciate the good things (such as vaccines and cures) that come from the industry, and to separate it from the bad things. Today, when doctors consult with or accept any funding from the industry, particularly the companies that make opioids, it is often referred to as “being in bed with the devil.”

Society’s belief that Big Pharma is inherently evil helps explain why people in pain are struggling. The truth is, Big Pharma is not intrinsically bad -- although there are some bad actors in the industry -- and drugs used to manage pain are essential partners in healing when used appropriately.

Our tendency toward black or white blanket perceptions -- and our choice to not learn about the complexities that would allow for a more balanced approach in our reasoning -- has consequences for every aspect of society. When it comes to pain management, the devil effect has yielded the terrible unintended cost of suffering by innocent people.

The pendulum eventually may swing back toward empathy for people who are suffering, but not until more people recognize the influence the devil effect has on society's attitudes towards Big Pharma, opioids and people in pain.

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. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD. 

Fentanyl and Heroin Use Rise During Pandemic

By Pat Anson, PNN Editor

The use of illicit fentanyl and heroin rose dramatically during the first two months of the COVID-19 pandemic, according to a large new study by Quest Diagnostics. Misuse of hydrocodone, morphine and some other opioid medications also increased.

The study adds to growing signs that Americans are turning to potent illicit drugs to cope with the stress and economic disruption caused by the pandemic.

“It’s the social isolation, the depression, the anxiety, stress, job loss, the loss of health insurance and the election. All these things that add stress to our lives are driving people to increase use of alcohol at home and, in the case of this study, drug misuse,” said co-author Harvey Kaufman, MD, Senior Medical Director for Quest Diagnostics. 

Kaufman and his colleagues analyzed data from over 872,000 urine drug tests, comparing samples taken before the pandemic to those taken from March 15 to May 14, 2020. The urine samples came largely from people undergoing substance abuse treatment or were prescribed opioids and other controlled substances, and are not representative of the population at large.

Interestingly, while the rate of drug misuse remained largely the same before and during the pandemic – about 49 percent – there were notable shifts in the type of drugs being misused.

Drug positivity rates increased by 44% for heroin and 35% for non-prescribed fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine. Positivity rates for non-prescribed opiate medication (hydrocodone, hydromorphone, codeine and morphine) rose by 10 percent. There were no significant changes in the misuse of oxycodone and tramadol. 

Fentanyl was frequently found in urine samples that tested positive for amphetamines (89%), benzodiazepines (48%), cocaine (34%), and opiates (39%). The abuse of multiple substances in combination with fentanyl has been a growing problem for years, but Quest researchers were surprised by how much it has accelerated.

“It’s shocking that something could move that quickly. It’s been well underway for half a dozen years, but the pandemic supercharged it,” Kaufman told PNN.

Gabapentin Misuse

One surprising detail in the Quest study is that the nerve drug gabapentin (Neurontin) is being misused more often than any other prescription drug. Non-prescribed gabapentin was found in nearly 11% of urine samples — second only to marijuana — in the first two months of the pandemic. While that’s down from pre-pandemic levels, it adds to a growing body of evidence that gabapentin is being overprescribed and abused.

POSITIVITY RATES FOR NON-PRESCRIBED DRUGS (MARCH-MAY 2020)

SOURCE: QUEST DIAGNOSTICS

Gabapentin was originally developed as an anti-convulsant, but it has been repurposed to treat chronic pain and is often prescribed off-label as an alternative to opioids. When taken as prescribed, there is little potential for gabapentin to be misused. However, when taken with muscle relaxants, opioids or anxiety medications, gabapentin can produce a feeling of euphoria or high.

A likely factor in the decline in gabapentin misuse during the pandemic is a drop in physician visits. Fewer visits mean fewer prescriptions, and gabapentin may have become less available for diversion.

Just as stay-at-home orders forced many patients to cancel or postpone healthcare appointments, it also led a significant decline in drug testing. Orders for lab tests by Quest dropped by as much as 70% in the first few weeks of the pandemic. They have since rebounded, but are still well below pre-pandemic levels.

“COVID-19 interrupted non-essential patient care, but it hasn’t stopped drug misuse,” co-author Jeffrey Gudin, MD, Senior Medical Advisor to Quest, said in a statement. “Given the psychological, social, and financial impacts of the COVID-19 crisis, more efforts are needed to ensure that patients are taking medications as prescribed. While the nation focuses on the pandemic, we must not lose sight of the ongoing drug misuse epidemic, which continues to kill upwards of 70,000 Americans each year.” 

After briefly declining in 2018, drug overdoses began rising again in 2019. According to one preliminary study, drug overdoses are up about 17 percent so far this year.

Study Finds Most Drugs Ineffective for Neuropathic Pain

By Pat Anson, PNN Editor

A first of its kind study that compared four medications widely used to treat neuropathy found that all four were usually ineffective in treating pain and many patients stopped taking them due to side effects.    

Over 20 million people in the U.S. suffer from neuropathic pain, a tingling, burning or stinging sensation in the hands and feet caused by nerve damage. Neuropathy is often caused by diabetes, chemotherapy or trauma, but in about 25% of cases the cause is unknown and classified as cryptogenic sensory polyneuropathy (CSPN).

There is little guidance for physicians and patients on what drugs to take for CSPN, so researchers at the University of Missouri School of Medicine conducted a “real world” study in which 402 patients with CSPN took one of the four neuropathy medications.

The four drugs studied were nortriptyline (Aventyl), a tricyclic antidepressant; duloxetine (Cymbalta), a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant; pregabalin (Lyrica), an anti-seizure drug; and mexiletine (Mexitil), an anti-arrhythmic medication used to treat irregular heartbeats.

Nortriptyline, duloxetine and pregabalin are approved by the FDA for treating neuropathy, while mexiletine is used off-label. None of the drugs were originally developed to treat neuropathic pain.

"As the first study of its kind, we compared these four drugs in a real-life setting to provide physicians with a body of evidence to support the effective management of peripheral neuropathy and to support the need for newer and more effective drugs for neuropathic pain," said lead researcher Richard Barohn, MD, executive vice chancellor for health affairs at the University of Missouri.

After 12 weeks of use, any drug that reduced pain for a patient by at least a 50% was considered effective, a recognized industry standard to define therapy success.. Researchers also kept track of patients who stopped taking a drug and dropped out of the study due to adverse effects.

The study findings, published in JAMA Neurology, can best be described as underwhelming. Patients were far more likely to stop taking a drug than they were to stay on a medication that was helping them.    

Of the four drugs, only nortriptyline was an effective pain reliever for at least 25% of patients. It also had the second-lowest drop-out rate (38%), giving it the highest level of overall utility. Duloxetine had the second-highest efficacy rate (23%) and the lowest drop-out rate (37%).

Pregbalin had the lowest efficacy rate (15%) and the second highest drop-out rate (42%), while mexiletine had the highest drop-out rate (58%) and an efficacy rate of 20 percent.

EFFICACY RATE OF NEUROPATHY DRUGS

SOURCE: JAMA NEUROLOGY

"There was no clearly superior performing drug in the study," Barohn said. "However, of the four medications, nortriptyline and duloxetine performed better when efficacy and dropouts were both considered. Therefore, we recommend that either nortriptyline or duloxetine be considered before the other medications we tested."

While nortriptyline had the highest efficacy rate, it also had the highest rate of adverse events, with over half of patients (56%) reporting side effects such as dry mouth, drowsiness, fatigue and bloating.  

Previous studies have found that duloxetine and pregabalin had higher efficacy rates for neuropathic pain, but Barohn and his colleagues say their research more accurately reflects what patients experience in real life and what physicians encounter in their practice.

“Our findings could affect how these 4 drugs are used by all physicians who treat patients with neuropathy. Findings support duloxetine and nortriptyline as better-performing drug choices in this population with neuropathic pain, suggesting that they should be prescribed before pregabalin or mexiletine are considered. However, this study also supports a finding that all 4 drugs helped improve pain in at least some patients, so each could be tried if others failed,” they concluded.     

There are several other drugs used to treat neuropathy, including gabapentin, venlafaxine and sodium channel inhibitors. Barohn says additional comparative studies should be performed on those drugs. His goal is to build effectiveness data on nearly a dozen drugs for CSPN.

‘Partial Fill’ Rule for Pharmacies Would Harm Pain Patients

By Pat Anson, PNN Editor

A retired Nevada pharmacist who lives with chronic back pain is warning that patients will suffer if the Drug Enforcement Administration enacts a rule that allows pharmacists to only partially fill opioid prescriptions.

The DEA is under pressure from Sen. Elizabeth Warren (D-MA) and other members of Congress to stop “foot-dragging” and finalize a regulation that would allow patients to take home only part of their opioid prescription. They would have to return a second time to get the rest.

“I think it (the DEA partial refills) would have a huge impact on patients who regularly get their pain meds filled. Can you just imagine people already in pain having to go back to their pharmacy again to get the balance? Going once a month is already problematic for many. Twice a month would be inhumane,” Rick Martin said in an email to PNN.

“Pharmacists might not like it either because it would make them have to account for their inventory more often and maybe double the amount of work to fill the same Rx again.”

Warren, along with Sen. Dianne Feinstein, Sen. Shelley Moore Capito, Rep. Kathleen Clark and Rep. Steve Stivers, sent a bipartisan letter to acting DEA Administrator Timothy Shea last week urging him to update the “partial fill” regulation, as required under the 2018 Comprehensive Addiction and Recovery Act (CARA). 

“DEA has failed to issue its proposed rule, despite assurances in recent years that ‘this proposed rule is a top priority’ for the agency,” the letter says. “Defining ‘partial fill’ and fully implementing Section 702 of CARA will reduce the number of prescription opioids in circulation, a crucial step in addressing the opioid crisis that is devastating communities across the country. DEA’s continuing foot-dragging on this issue puts Americans at risk.”

Warren and her colleagues asked the DEA to provide an update and staff-level briefing on the matter no later than October 20.

Under current rules, the DEA only allows pharmacists to do a partial fill if they don’t have enough medication on hand to completely fill a prescription – something that many patients say is already happening. In a report issued earlier this year, the DEA said the supply of prescription opioids was at its lowest level since 2006.

“Once again, the letter just shows a bunch of busy-body ignorant uneducated senators sticking their nose where it doesn't belong,” said Martin. “They (pharmacists) shouldn't be doing this unless they don't have an adequate amount to fill or unless the patient gives them permission to partial fill.”

The Warren letter claims over half of those who abuse opioid medication obtain it from a friend or family member. The DEA, however, has said less than one percent of opioids that are legally prescribed are diverted.

Illicit fentanyl, heroin and other street drugs are responsible for the vast majority of overdoses. A 2019 study of overdoses in Massachusetts – Warren’s home state – found only 1.3% of overdose victims had an active opioid prescription.  

Doctor Who Lost Medical License Leading Effort to Sue Kolodny

By Pat Anson, PNN Editor

Pain patients and their supporters are planning to rally Wednesday at Brandeis University in Massachusetts, a protest against Dr. Andrew Kolodny, a senior scientist at Brandeis who co-directs opioid research at the Heller School for Policy and Management.

Kolodny is the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group that has led efforts to reduce opioid prescribing in the U.S. Many patients blame PROP for their poorly treated or untreated pain, as well as increased suicides in the pain community. The so-called “Killer Kolodny Rally” is being organized by Claudia Merandi of the Don’t Punish Pain rally organization.

“If we in the pain community want to make changes, we have a lot of work to do. We have been damaged severely. And Kolodny’s largely responsible,” says Dr. Arnold Feldman, a retired anesthesiologist who is working with Merandi to raise money for a possible class action lawsuit against Kolodny,

As PNN first reported, Kolodny and PROP played influential roles in drafting the CDC’s controversial 2016 opioid prescribing guideline. Kolodny is also a well-paid expert witness in opioid litigation cases.

“Kolodny is enriching himself to a very large degree,” Feldman told PNN. “Every day I am finding weblike connections between Kolodny and pharmaceutical manufacturers.”

Feldman and some patient advocates have claimed — without offering any proof — that Kolodny has benefited financially from promoting addiction treatment drugs like Suboxone.

The allegation led Kolodny to ask for and receive a letter from Indivior, Suboxone’s manufacturer, stating that he does not have a financial interest in the company and has received no payments from it as a consultant, speaker or in any other capacity.    

Nevertheless, Feldman claims that he has evidence of Kolodny’s culpability and will be able to uncover more once a class action lawsuit is filed.  He and Merandi have not been able to find a law firm willing to take the case.

DR. ARNOLD FELDMAN (YOUTUBE IMAGE)

“I’ve got lots of evidence. I’m not going to put it out in public because we’re going to need this in our case,” Feldman said. “Unfortunately, I’m not a stranger to lawyers.”

Medical License Suspended

Feldman has indeed fought and lost a number of legal battles, including an unsuccessful effort to get his medical license back after it was suspended in 2016 by Louisiana’s Board of Medical Examiners. The disciplinary action came after a patient died three years earlier while getting an epidural steroid injection at Feldman’s surgery clinic in Baton Rouge.

Feldman was charged with seven counts of negligence and unprofessional conduct, such as allowing an unlicensed and unsupervised employee to insert an IV into the patient and give him medication. The patient went into cardiac arrest during the procedure and Feldman was unable to revive him. 

“I had a patient who passed away. Not from anything I did. He had a cardiomyopathy and passed away. They tried to get me for that. But they couldn’t because the autopsy said he died from natural causes,” Feldman told PNN.

The state medical board felt otherwise and accused Feldman of a coverup, saying he gave investigators a “quite staggering” amount of false records and testimony about what happened.

“Dr. Feldman failed to adequately monitor the patient, exercised poor management or care of the patient after complications arose, and all of his resuscitation attempts were contributing factors to the patient’s death,” the board said in its ruling.

Feldman’s clinic had previously been cited in 2010, 2011 and 2013 for not following safety standards, putting patients in “immediate jeopardy” of injury and death.

Investigators also said Feldman allowed his employees to forge his signature and sign opioid prescriptions, and that he gave pre-signed prescriptions to patients without seeing them.

Feldman says he was denied due process by the medical board and appealed his suspension twice in court, but it was upheld both times.

“Dr. Feldman failed to adequately monitor the patient, exercised poor management or care of the patient after complications arose, and all of his resuscitation attempts were contributing factors to the patient’s death.”

— Louisiana Board of Medical Examiners

Because of the disciplinary action in Louisiana, Feldman’s medical licenses were also suspended in California, Alabama and Mississippi. Feldman had previously been reprimanded and put on probation by Mississippi’s medical board in 2000 after he “violated numerous laws and regulations” involving the prescribing, dispensing and administration of controlled substances.

In 2017, the Drug Enforcement Administration effectively ended Feldman’s career by revoking his DEA license to prescribe opioids and other controlled substances.   

No longer able to practice medicine, Feldman lost his home, car and clinic, and for a time lived in a motor-home, according to testimony he gave at a legislative hearing. He now lives in Florida. Feldman says he could have his medical license reinstated in Louisiana, but it would cost $460,000 that he doesn’t have.

‘I Know Pain Management Better Than Anyone’

Although he hasn’t practiced medicine in years, Feldman still considers himself an expert in pain management because he “learned skills that nobody else had.”

“I know this business, meaning pain management, better than anyone living. I’m a surgeon. I’ve done disc surgery. I’ve done pain pumps, (spinal cord) stimulators, and 100-thousand nerve blocks. I know what’s going on,” he said. “Most of these pain conditions are incurable, and I’ll tell you what, half of them are created by the medical profession.”

Since his forced retirement, Feldman has become something of a gadfly in the pain and legal communities, joining with another doctor whose medical license was revoked in filing a $28,000 trillion lawsuit against the Federation of State Medical Boards, the American Medical Association and other entities.

Feldman and Merandi have established a non-profit called The Doctor Patient Forum to advocate for doctors in legal jeopardy and pain patients who can’t get proper treatment. “He is brilliant. We work well together,” says Merandi.

The two have raised nearly $12,000 for the lawsuit against Kolodny, with most of the money coming in small donations from pain patients who know little or nothing about Feldman or how the money will be spent. 

“It’s in a bank account. I don’t touch it. I haven’t taken a dime. Nor will I ever. When we have enough money and find a law firm, that’s where the money will go,” he promised. 

“The only way to bring awareness to this is with litigation,” Merandi said in a recent radio interview. “We believe we have to bring Andrew Kolodny before a court of law. We have to bring the others before a court of law. We need an investigation done and that costs money.”

Legal experts say attorneys in class action lawsuits are typically not paid for their services and expenses unless they prevail in court. All payments have to be approved by a judge, with the money coming from the award or settlement — not the plaintiffs. Legitimate attorneys will not ask for upfront money in a class action case, according to consumer advocate Ron Burley.

Patient Advocate Who Drew Attention to Pharmacy Discrimination Dies

By Pat Anson, PNN Editor

A patient advocate in California who fought breast cancer and helped draw attention to the discrimination often faced by pain patients at pharmacies has died. April Doyle passed away last month after a 12-year battle with metastatic breast cancer. She was only 42-years old.    

In April 2019, Doyle posted a tearful video on Facebook and Twitter after a Rite Aid pharmacist refused to fill her prescription for Norco, an opioid medication she took for cancer pain. At the time, her Stage 4 breast cancer had metastasized into her lungs, spine and hip. 

“I have to take 20 pills a day just to stay alive,” Doyle said in the video, which soon went viral. “Every time I take my pain pill prescription there, they give me the runaround. They don’t have enough in stock or they need me to come back tomorrow because they can’t fill it today. Or something stupid. It’s always something and it’s always some stupid excuse.”

Doyle’s video struck a chord with pain patients around the country, who often have trouble getting their opioid prescriptions filled. The publicity also led to apologies from a Rite Aid vice-president, the store manager and the pharmacist who refused to fill her prescription.

Doyle said the pharmacist told her he was worried about being fined or even losing his job if he filled her prescription, even though cancer pain is exempt from opioid prescribing guidelines. 

“It’s astonishing the reaction it has gotten. I had no idea this was so common. It’s actually kind of sad how common it is,” Doyle told PNN at the time. “It really struck a nerve with what’s apparently a big problem.”

Doyle wrote several articles about breast cancer that were posted online and her own blog. In her final post on AdvancedBreastCancer.net, Doyle shared her feelings and worries about her young son while she was sick at home from chemotherapy.

“He’s such an amazing boy and it isn’t fair that he has to grow up with a sick mother. If I’m even around for much more of his growing up. In my heart, I know this is what I’m really mourning,” she wrote.

“Cancer is slowly taking things away from me. I hate, hate, that I can’t do something myself. The stubbornness in me is resisting yet it comes out a waterfall of tears. Something so mediocre or dumb to someone else, but it’s an example of what my life has become and how I no longer can dictate what I can or cannot do.”

“April was a dedicated advocate in the metastatic breast cancer community. She told her story with authenticity and inspired so many young women and men living with the disease. She had a way of bringing people together and supporting people in all stages of breast cancer,” Doyle’s obituary in the Visalia Times said.

“She never let her disease define her. She never backed down from adversity and always stood forefront. April fought the stigma and stood up for patient rights. She leaves a legacy in the breast cancer community that will inspire people forever.”

Doyle leaves behind her 9-year old son, Colin. Her family asks that donations in her honor be made to METAvivor, a non-profit that supports breast cancer research.

Most Patients Satisfied With Telehealth, But Some Exploited for Healthcare Fraud

By Pat Anson, PNN Editor

Telehealth has been a godsend for pain sufferers during the coronarvirus pandemic, with many patients discovering the ease and convenience of visiting with their doctors online or over the telephone. Some have even been able to get prescriptions written for opioid medication without an initial face-to-face meeting with their doctors – thanks to a DEA decision to relax some of the rules about prescribing controlled substances.  

Unfortunately, some providers are taking advantage of patients — and the pandemic — by filing billions of dollars in false medical claims.

Saving Time and Money

Most patients who use telehealth – also known as telemedicine – to connect with pain management specialists were highly satisfied with their experience, according to a new study presented at the annual meeting of the American Society of Anesthesiologists.

Last summer, researchers at UCLA’s Comprehensive Pain Center began giving patients the option of in-office visits or remote appointments via telehealth. Nearly 1,400 patients chose telehealth, resulting in nearly 3,000 virtual appointments before and during the pandemic, from August, 2019 to June, 2020.

“This era of contactless interactions and social distancing has really accelerated the adoption of telemedicine, but even before the pandemic, patient satisfaction was consistently high,” said lead author Laleh Jalilian, MD, an anesthesiologist at the Ronald Reagan UCLA Medical Center in Los Angeles.

“Patients who are being evaluated for new conditions may be better off having office visits initially. But once patients establish a relationship with providers, follow-up visits can occur efficiently with telemedicine, while maintaining patient rapport and quality outcomes. We believe 50 percent of our visits could be conducted via telemedicine.”

Asked about their experiences with telehealth, 92 percent of patients said they were satisfied. Many said they were happy to avoid the lengthy commutes and time spent in Los Angeles area traffic. On average, patients saved 69 minutes in traffic per visit and $22 in gas and parking fees.

For telehealth to be sustainable in a post-pandemic world, Jalilian says insurers should consider expanding reimbursement for providers to take into account the additional work and technology needed for telehealth visits. The Centers for Medicare & Medicaid Services (CMS) has waived many of the limits on telehealth visits during the pandemic and some private insurers have followed suit.

“Now that telemedicine is more widespread, it may become a valued part of care delivery in chronic pain practices,” said Jalilian. “Clearly many patients benefitted from remote consultations and follow-up appointments using telemedicine. We hope it will encourage policymakers and insurance providers to continue to support these platforms and inspire more innovation in this developing field of research and patient care.”

Telehealth Fraud Takedown

But as demand has grown for telehealth services, federal prosecutors say hundreds of healthcare providers have exploited the situation. In what’s being called the largest healthcare fraud and enforcement action in Department of Justice history, criminal charges were recently filed against 345 doctors, nurses and other providers for submitting over $6 billion in false and fraudulent claims to Medicare, Medicaid and private insurers. Some of the false claims were for COVID-19 testing.

The fraud charges involve more than $4.5 billion connected to telemedicine, $845 million involving substance abuse treatment, and $806 million connected to illegal opioid distribution.

“This nationwide enforcement operation is historic in both its size and scope, alleging billions of dollars in healthcare fraud across the country,” said Acting Assistant Attorney General Brian Rabbitt.  “These cases hold accountable those medical professionals and others who have exploited health care benefit programs and patients for personal gain.” 

Prosecutors say telemedicine executives allegedly paid kickbacks to doctors and nurse practitioners to order unnecessary medical equipment, genetic and other diagnostic testing, and pain medications, either without any interaction with patients or after a brief telephone conversation with patients they had never met or seen. Medical equipment companies, genetic testing labs and pharmacies then purchased the orders in exchange for illegal kickbacks and bribes.

In addition to those charges, CMS announced that it had taken administrative action against 256 healthcare providers, revoking their Medicare billing privileges because of their involvement in telemedicine schemes. 

“Telemedicine can foster efficient, high-quality care when practiced appropriately and lawfully.  Unfortunately, bad actors attempt to abuse telemedicine services and leverage aggressive marketing techniques to mislead beneficiaries about their health care needs and bill the government for illegitimate services,” said HHS Deputy Inspector General Gary Cantrell. 

The charges against substance abuse treatment facilities -- known as “sober homes” – mostly involve illegal payments to patient recruiters for referring scores of patients to treatment facilities. The patients were then subjected to medically unnecessary drug testing – often billing thousands of dollars for a single test – and therapy sessions that were often not provided.

Some sober homes also allegedly prescribed medically unnecessary controlled substances and other medications to patients to entice them to stay at the facility.  Prosecutors say the patients were then often discharged and admitted to other treatment facilities, or referred to other labs and clinics, in exchange for more kickbacks.