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Opioid Epidemic

Purdue Pharma Taps a Gilded Age History of Pharmaceutical Fraud

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Classified advertisement for Leslie Keeley’s Gold Cure. Courtesy: ProQuest Historical Newspapers: Chicago Tribune, July 21, 1884

Newly unsealed documents from a lawsuit by the state of Massachusetts allege that Purdue Pharma, maker of OxyContin and other addictive opioids, actively sniffed out new, sinister ways to cash in on the opioid crisis.

Despite years of negative press coverage, unwanted attention from regulators, multi-million dollar fines and several major lawsuits, Purdue staff and owners sought to expand the company’s sights beyond its usual array of opioid painkillers. Purdue planned to become an “end-to-end pain provider,” by branching into the market for opioid addiction and overdose medicines, looking to peddle these medicines even while the company continued to aggressively market its addictive opioids. Internal research materials coldly explained the rationale behind this plan: “Pain treatment and addiction are naturally linked.”

As thousands of Americans continue to overdose on opioids annually, Purdue’s secret marketing research predicted that sales of naloxone, the overdose reversal drug, and buprenorphine, a medicine used to treat opioid addiction, would increase exponentially. Addiction to Purdue’s opioids would thus drive the sale of the company’s opioid addiction and overdose medicines. Purdue even planned to target as customers patients already taking the company’s opioids and doctors who prescribed opioids excessively, according to the Massachusetts lawsuit filing. To keep the plan quiet, Purdue staff dubbed the scheme “Project Tango.”

According to the Massachusetts lawsuit, Purdue used this graphic in its internal strategy materials to illustrate Project Tango. Photo: State of Massachusetts, CC BY-SA

The audacity of Project Tango enraged many observers. But considered in historical context, the news that Purdue sought to peddle opioid addiction medicines while continuing to sell opioids seems less surprising. In fact, there is clear historical precedent for Purdue’s business plan. Over a century ago, “patent medicine” sellers pioneered this strategy during the U.S.’s Gilded Age opiate addiction epidemic.

Opiate addiction in the Gilded Age

Opiates were some of the most commonly prescribed medicines in American history until the 20th century. Pills containing opium, hypodermic morphine injections and laudanum, a drinkable liquid concoction of opium and alcohol, constituted half or more of all medicines prescribed in American hospitals during most of the 19th century, according to research by the historian John Harley Warner. Opiates were also present in countless “patent medicines,” over-the-counter panaceas made of secret ingredients, often sold under catchy brand names like Mrs. Winslow’s Soothing Syrup. Americans could choose from 5,000 brands of patent medicines marketed for all manner of ailments by the 1880s. In 1904, just before federal oversight began, patent medicines had matured into an astonishingly profitable industry, with estimated sales at US$74 million dollars annually – equivalent to about $2.1 billion dollars today.

Opiate-laced prescriptions and patent medicines often caused addiction. The historian David T. Courtwright estimates that opiate addiction rates in the U.S. skyrocketed to 4.59 per thousand Americans by the 1890s – a high rate, although lower than the rate of fatal opioid overdoses in recent years. Most individuals developed addictions through medicines, rather than the infamous smoking variety of opium. Victims of “the habit” cut across demographic lines, encompassing middle-class housewives suffering from menstrual pain, Civil War veterans reeling from amputations and many others in between.

Yet even for those who became addicted to prescription opiates, the condition was socially stigmatized and physically dangerous. Like today, addiction to opiates often led to fatal overdose, condemnation and sometimes even involuntary commitment to mental asylums. As one doctor reported to the Iowa Board of Health in 1885, addicted people lived “truly in a veritable hell.”

To avoid these frightful outcomes, desperate, opiate-addicted Americans frequently sought out medical treatment for their condition.

Gilded Age Americans could choose from a range of therapies for opiate addiction. Wealthy patients frequented plush private clinics, where they could receive inpatient treatment for opiate addiction. The most popular were the Keeley Institutes, which offered patients injections of the “Bichloride of Gold” remedy, invented by the doctor Leslie Keeley.

Scores of Keeley Institutes sprang up around the country in the late 19th century, a testament to the popularity of Keeley’s “Gold Cure,” which he marketed for alcoholism and drug addiction. No up-and-coming Gilded Age city was complete without a Keeley Institute. At the height of the Gold Cure craze, there were 118 institutes serving 500,000 Americans between 1880 and 1920. Even the federal government had a contract with Keeley to provide the Gold Cure to addicted veterans. Although injections of the Gold Cure had little intrinsic medical value, historians believe that socializing with other like-minded patients in the Keeley Institutes may have helped some patients recover from addiction.

Advertisement for the main Keeley Center, in Dwight, Illinois, 1908.

Keeley faced stiff competition, however. Other popular therapies for opiate addiction included patent medicine “cures” and “antidotes,” which were cheaper than inpatient care. These could be ordered by mail without a prescription, and consumed in the privacy of one’s home, away from prying eyes.

Fueled by high demand, during its heyday at the turn of the 20th century, addiction cures bloomed into a multimillion-dollar sector of the patent medicine industry. Dozens of pharmaceutical companies peddled their “cures” to willing, opiate-addicted customers, which they marketed through pamphlets, postcards, and newspaper and magazine classifieds.

Ironically, these “cures” for opiate addiction almost universally contained opiates, unbeknownst to hopeful customers, who received little therapeutic benefit by today’s standards. But in an era before federal regulation of medicines and narcotics, there were no effective safeguards to protect addiction patients from medical fraud.

Pharmaceutical fraud

Much like Purdue Pharma, which famously marketed Oxycontin as non-addictive precipitating the opioid crisis, Gilded Age patent medicine companies also fraudulently marketed their addiction treatments as non-addictive, targeting and intentionally deceiving addicted customers. For their part, Gilded Age doctors were deeply skeptical of such products, and they often accused proprietors of fraud in medical journals and newspapers.

Samuel B. Collins of La Porte, Indiana, inventor of the “Painless Opium Antidote,” one of the era’s most popular brands, insisted that his product was not addictive. Collins was proven a fraud, however, by a skeptical Maine doctor, who in 1876 sent off a sample of Collins’ product to several chemists for analysis. Their tests indicated that the Painless Opium Antidote contained enough morphine to perpetuate opiate addiction, actually fueling demand for Collins’s product, rather than curing the underlying addiction.

Despite the overwhelming evidence, however, without any effective medical regulation or oversight, Collins maintained his fraud for decades. His business strategy presaged Purdue’s Project Tango by targeting vulnerable opiate-addicted individuals.

Advertisement for Theriaki, a painless cure for the opium habit. Exterior view of Dr. Collins’ Opium Antidote Laboratory, LaPorte, Indiana. National Library of Medicine

After decades of exposés by doctors and journalists, however, the opiate addiction cure trade collapsed during the Progressive Era under mounting public pressure and new federal legislation. One famous “muckraking” exposé, The Great American Fraud by the journalist Samuel Hopkins Adams, pulled back the curtain on the industry of opiate addiction cures for millions of appalled readers.

Collier’s ad, Dec., 1905, after the publication of articles on patent medicine fraud. Wikimedia Commons

Hopkins painted such a scathing portrait of opiate addiction cures, whose proprietors the writer dismissed as “scavengers,” that the American Medical Association paid to disseminate Adams’s reporting as part of a lobbying campaign for the regulation of patent medicines. This strategy paid off. Although far from perfect solutions, the Pure Food and Drug Act of 1906 and the Harrison Narcotics Tax Act of 1914 regulated the ingredients and sale of patent medicines and narcotics, including opiate addiction medicines. These measures ultimately ensured that Collins, Keeley and other patent medicine sellers could no longer prey upon opiate-addicted customers.

Like its Gilded Age predecessors, today’s Big Pharma actively schemes to profit off of vulnerable, addicted customers, even while taking steps to ensure that opioid addiction persists. I believe that only sustained, vigilant oversight can prevent the reemergence of a medical Gilded Age, one in which companies like Purdue Pharma can manufacture an addiction crisis and charge customers for “curing” it.

Jonathan S. Jones, PhD Candidate in History, Binghamton University, State University of New York

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Opioid Epidemic

Fentanyl-related Deaths Are the Highest in W.Va. This Is What They’re Doing about It.

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An addict injects heroin, even as a fentanyl test strip registered a positive result for contamination, Wednesday Aug. 22, 2018. Photo: Bebeto Matthews/ AP Photo

West Virginia has the highest per-capita drug-overdose death rate in the country. And while the Centers for Disease Control and Prevention has reported a recent decline in overall drug overdose deaths nationwide, deaths involving fentanyl, a synthetic opioid, are on the rise. West Virginia leads the nation in that rate as well.

According to the CDC, fentanyl can be up to 100 times more potent than morphine, many times stronger than heroin, but drug users are often unaware that the heroin they’ve purchased has been laced with the drug.

Health care professionals are understandably alarmed at the rising prevalence of fentanyl, and in West Virginia they’re acting on several fronts.

In a recently released paper, researchers at the West Virginia University School of Public Health report on a joint effort of the WVU schools of public health and pharmacy and the state’s chief medical examiner to monitor drug-related deaths in order to more accurately pinpoint life-saving initiatives.

They’re mining a forensic drug database maintained at the WVU Health Sciences Center that includes every drug-related death in the state. It documents cause of death and demographic information and other medical conditions, with the objective of detecting trends in drug-related deaths.

The researchers also advocate for wider distribution of naloxone, a drug that reverses the effects of opioid overdose, an effort in which the school of public health has taken an active role.

“Naloxone really is the miracle drug,” said Gordon Smith, an epidemiologist in the School of Public Health. “We have this very, very effective reversal agent that can keep people alive.”

“While in the long-term, effective treatment and getting people off drugs is the answer,” Smith said, “you have to be alive to be able to get you off the drugs and get you into long-term treatment.”

The School of Public Health is also actively involved in addressing that longer-term objective, with a model program that uses peer recovery specialists to engage overdose victims and others with opioid-use disorder and helps get them into treatment and recovery.

Leveraging Data

With his WVU colleagues Marie Abate and Zheng Dai, Smith coauthored “Fentanyl and fentanyl-analog involvement in drug-related deaths,” funded by the National Institutes of Health and just published in the journal Drug and Alcohol Dependence.

The research team found that deaths from fentanyl in West Virginia continue to rise, with 368 in 2016 and 553 in 2017. One factor, they write, is a surge in illegal fentanyl imports from China.

The CDC reports that of the more than 70,200 drug overdose deaths estimated in the country in 2017, the sharpest increase was in deaths related to fentanyl and fentanyl analogs, with more than 28,400 deaths.

Smith believes detailed data can help curb this trend.

“We’ve been working for a while now here at WVU in collaboration with the medical examiner’s office to develop what’s really a very unique database,” he said. It’s aimed to provide health care providers and law-enforcement officers with insight into trends as they unfold.

The data can, for example, help decipher the chemical makeup of a fentanyl analog that just hit the streets or the combination of drugs involved in an overdose.

“West Virginia is one of a very limited number of states that has a very complete death investigation system,” Smith said, “and as a result, we have very, very good statistics.”

Statistics from the National Center for Health Statistics, Smith said, generally simply state that someone died of a drug overdose, “and it’s often very difficult to know the multiple drugs that are involved.”

This research was launched, he said, when medical examiners began noticing an increase in the number overdoses in which the level of each individual drug wasn’t sufficiently high enough that you would expect a person to die. It was, rather, a mixture of drugs.

“One of our significant findings is that it’s not just fentanyl,” Smith said. “It’s a whole mixture of different drugs that people are taking.”

“What we think is the most important part of our research is the ability that we have to monitor the changes in drug use over time,” he said.

What “really frightens us,” Smith said, are the fentanyl analogs. “There’s a particular drug called carfentanil that’s 100 times stronger than fentanyl. This was never used in humans; it was developed for anesthetizing elephants.”

“We’re absolutely terrified,” he stressed, of not only this drug but others that have never been tested. “An important part of our program of research is to be able to monitor, ‘What are the current drugs that people are dying from? And how do we need to modify our strategy?’”

Breaking the Cycle

The Health Sciences Center database can also suggest where greater access to naloxone is most urgently needed. Naloxone, Smith asserted, is “an important part of this multifaceted prevention program to stop people from dying of drug overdoses.”

Herb Linn, the WVU Health Research Center’s program director for collaboration and communication, helped launch the West Virginia Rapid Response Program when he was with the WVU Injury Control Research Center and has continued this work at the research center.

The Rapid Response Program was a partnership of the state Department of Health and Human Resources and the Injury Control Research Center that received funding from the federal Substance Abuse and Mental Health Services Administration to purchase and distribute naloxone kits throughout the state.

Linn believes hundreds of West Virginians have been saved through the administration of naloxone. But, he added, “we’ve got to think more systematically about how to … take these opportunities to engage people to try to help them break out of the cycle of addiction.”

Among the initiatives in which Linn’s involved is a CDC-funded project through the West Virginia Bureau for Public Health to engage overdose survivors in emergency departments, connecting them with peer recovery coaches, treating them with buprenorphine for their withdrawal symptoms and helping them get into long-term treatment.

“We’ve got to keep getting [naloxone] out there,” Linn said, “and then we have to build up a systematic approach to helping people break that cycle.”

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Opioid Epidemic

HIV Cluster Found in West Virginia County with High Rate of Opioid Use

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Dr. Michael Kilkenny, physician director of the Cabell-Huntington Health Department, discusses the recent HIV cluster in Cabell County on Monday, March 4, 2019, in Huntington.Photo: Lori Wolfe/The Herald-Dispatch

An active HIV cluster of 28 known cases has been confirmed in Cabell County, West Virginia, primarily among the area’s population of intravenous drug users, according to the state’s Bureau for Public Health.

The cluster, tracked from January 2018 to the present, represents a sharp uptick from the baseline average of eight cases annually over the past five years. This is the first notable HIV cluster in West Virginia where intravenous drug use is identified as the main risk factor, said Dr. Michael Kilkenny, physician director of the Cabell-Huntington Health Department.

In Appalachia, HIV is typically a rare diagnosis compared with coastal cities. This latest cluster represents a continuing shift in how HIV is most often spread, from men having risky sexual contact with other men to intravenous drug users, Kilkenny said.

Other areas in the region are likewise experiencing HIV clusters, including the Cincinnati metro area and smaller pockets scattered around West Virginia.

More than 20 of the 28 known HIV cases are Cabell County residents, Kilkenny said, while the remainder live elsewhere but may have been diagnosed at one of the county’s medical facilities.

The West Virginia Bureau for Public Health characterizes a cluster as being confined to a certain population – in this case, IV drug users – where it may be able to be controlled with minimal risk to the general public. An outbreak would indicate the disease is spreading beyond that initial group.

Kilkenny said there is no model to predict how much Cabell County’s cluster could grow, and declined to speculate.

A true-life worst case scenario was lived out around 250 miles down the Ohio River in 2015, when rural Scott County, Indiana, suffered an HIV outbreak infecting 181 people among a close network of residents sharing needles to inject opioids.

Cabell County is estimated to have more than 1,800 active IV drug users, so introducing HIV into that population is a point of major concern, Kilkenny said.

However, he continued, Huntington is well-equipped with the systems already in place to treat substance use disorder and that at-risk population, meaning it’s better prepared to face the spread of HIV than a community starting from scratch.

“We know how many people we have and we have outreach already into that population,” Kilkenny said.

“So while on the one hand that sounds like a scary number, on the other hand I don’t think that another community, that I could name, has that information going into the intervention.

“So I think we’ll be able to intervene quicker and more effectively than a community who doesn’t know what their population is or doesn’t have programs in place that touch those people.”

The main push of the plan to treat HIV in Cabell County – which has been in the works for about six weeks between the county and state – is to identify every case and refer individuals to treatment, Kilkenny explained.

Even though HIV isn’t curable, medication can now drive down the viral load in a person’s blood to the point where it can no longer be spread.

The plan also includes an ongoing public awareness campaign to encourage those at risk to get tested, and to reduce stigma surrounding the disease in the general public.

The health department hosted a public forum on HIV on Feb. 19 to offer information on the disease. It featured state and local experts.

“It’s important for people to know that HIV is not the death sentence it was 30 years ago, and that it’s not spread by social contact like hugging or shaking hands,” Kilkenny said.

“Those people should have no concerns at all about HIV,” referencing those who don’t engage in known risky behaviors.

This article was originally published by the Herald-Dispatch.

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Injured Workers in Rural Areas More Likely to Receive Opioid Rx

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A worker cuts a tree branch lodged on a home's utility lines in Media, Pa., Monday, Feb. 25, 2019. Thousands of utility customers remain without power in Pennsylvania as high winds continue to roar through the state, knocking down trees and power lines. Photo: AP Photo/Matt Rourke

Injured miners and construction workers are in the occupations most likely to receive an opioid prescription, the study shows. Injured workers living in “rural” or “very rural” areas were up to 25% more likely than urban injured workers to receive opioid painkillers.

Injured workers in rural areas are more likely to receive prescriptions for opioids, a new study shows.   

The study by the Workers’ Compensation Research Institute (WCRI) looked at how a worker’s age, injury, industry and location impacted how likely they were to be given prescriptions for opioids. WCRI is an independent, non-profit research institute that looks at workers’ compensation policies and practices to provide information to the workers’ compensation industry.  

WCRI looked at 1.4 million post-injury pain medication prescriptions in 27 states from October, 2014 to September 30, 2015. All prescriptions were issued before the Centers for Disease Control issued tighter guidelines for opioid prescriptions in 2016.  

 (The states studied were Arkansas, California, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin.)  

(Source: Correlates of Opioid Use. Workers Compensation Research institute)

Injured workers in rural or very rural counties were found to be more likely to receive at least one opioid prescription. The study used the Urban-Rural Continuum Codes to determine whether or not an area was rural. According to those codes, rural areas include non-metropolitan counties adjacent to metro areas or counties where population size was greater than 20,000; and very rural areas were those where population size was less than 20,000.  

According to the study, two thirds of injured patients in rural and very rural areas received at least one opioid prescription, where one third received two or more prescriptions. But those in rural areas were only slightly more likely to stay on the prescriptions longer, with 10 percent of those injured workers on opioids having prescriptions for 60 days or more, as compared to 9 percent in rural areas.   

“In this study we tried to identify factors that were associated with higher and lower opioid dispensing rates and we observed higher opioid dispensing rates in rural counties compared to urban counties,” said Dr.  Vennela Thumula, the study’s author, said in an interview with Daily Yonder. “Similar results were reported in a CDC study looking at the general population.” 

Thumula said the study did not address causality, but that geographic differences can affect opioid prescription rates.  

“It is beyond the scope of our study to establish causality,” Thumula said. “That said, geographic differences in medical practice and health care delivery systems and differences in socioeconomic factors such as education level, socioeconomic status, labor force participation, and other quality of life indicators, may play a role… We found similar results, i.e., higher opioid dispensing rates in rural counties compared to urban counties, even in a study we published last year which focused on one state, Kentucky. It is interesting that similar direction of results was seen in this study even after controlling for local opioid dispensing rate quartiles.” 

Previous WCRI studies found that workers in some states – such as Louisiana, California, Georgia, North Carolina, Pennsylvania, South Carolina and Texas, are more likely to receive opioids and to get prescriptions for longer periods of time. Between 1 in 10 and 1 in 12 injured workers with opioid prescriptions in those states were identified as having “long-term” prescriptions, or prescriptions for more than 60 days’ supply of the drug in any 90-day period.  

The study also found that employees at small companies were more likely to be given prescriptions for opioids. Injured employees who worked for small businesses, or those having a payroll of less than $20 million, were also more likely to be prescribed opioids. The study found that 54 percent of injured employees of companies with payrolls between $1 million and $4 million were given at least one prescription for opioids, compared to 47 percent of those employed by companies with payrolls between $20 million to $80 million. Injured workers at those small companies were also more likely to have two or more opioid prescriptions, and to have long term prescriptions.  

(Source: Correlates of Opioid Use. Workers Compensation Research institute)

Injured workers in certain industries, like mining and construction, were more likely to receive opioid prescriptions, as were workers between the ages of 40 and 60, and workers who sustained fractures, carpel tunnel syndrome or neurological spine pain, were more likely to receive at least one opioid prescription.  

Thumula said the study looked at patterns WCRI had seen in previous studies.  

“WCRI has been examining opioid utilization patterns across states and over time for many years,” Thumula said. “Over these years we learned that workers in certain industries, workers sustaining certain injuries were more likely to receive opioids. This study was an attempt to quantify this variation.” 

But in general, Thumula said, opioid prescriptions are declining.  

“In previous WCRI studies, we found substantial decreases in opioids dispensed to injured workers,” she said. “Also, fewer injured workers received opioids on a longer-term basis in recent years. We haven’t specifically examined whether workers had a diagnosis of opioid use disorders but a decrease in opioid prescriptions, especially on a longer-term basis may have impacted the rate of opioid dependency.” 

While WCRI does not make any policy recommendations, the information may be of use to those who do, WCRI officials said.  

“This study can help public officials and other stakeholders better predict which injured workers are more or less likely to receive opioids,” said Dr. John Ruser, WCRI’s president and CEO. “For example, this study finds that injured workers in certain industries are more likely to receive opioids on a chronic basis. This information might be useful in setting priorities for targeting special interventions to reduce inappropriate opioid prescriptions.” 

This article was originally published by Daily Yonder.

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