Reluctance to Prescribe POC Pain Management [Part B]
Rare Instance of Racism Having Unintended "Benefits"
Here is a general timeline and list of major players in the Opioid Epidemic
- Building on the findings of a Hungarian scientist in the 1920s, Stephen King, an agricultural scientist for what was then the Glaxo Group, looked to commercialize a labor-efficient process to extract opium from poppies — by using machinery to grind up dried pods instead of making tiny incisions by hand to drain pods that were still green. The modern poppy industry can be traced to the early 1950s, King discovered that poppies grown in Britain had too little opium because of frequent rain, and he began searching for a better climate in a secure location. He wanted to start production on the southern coast of Australia, near Melbourne. With concerns increasing over heroin, Australian officials rebuffed Mr. King’s plan to grow poppies on the mainland. Instead, they sent him to start poppy farms on an island that the rest of the world barely remembered: Tasmania (27).
- As heroin poured into Europe and the United States, world leaders struggled to respond. International pacts in 1961 and 1972 called for limiting production to heavily regulated areas, notably Australia, France, Hungary, India, Spain and Turkey (27).
- Purdue Pharma owned by the Sackler family said its biggest barrier to success was getting enough supply of oxycodone (25).
- In 1990, Johnson & Johnson’s outside lawyer met with Congress to get more relaxed rules for importing Johnson & Johnson’s opioids into the United States from Tasmania, an island 150 miles south of mainland Australia—where Johnson & Johnson would later plant its crops of the mutant poppy (25).
- Johnson & Johnson altered the genetics of thousands of plants to engineer a mutant strain of a “super poppy” that was particularly rich in opiates in 1994 that allowed it to manufacture and supply massive amounts of opioids (26).
- In 1998, scientists at Johnson & Johnson commercialized “Norman,” a variety that produced a much higher concentration of thebaine (27).
- Johnson & Johnson created this strain specifically in anticipation of potential future demand for oxycodone (25).
- Tasmania, which is about the size of West Virginia, is the start of a global supply chain that encompasses the biggest drug companies and produces $12 billion a year of opiate painkillers. It grows about 85 percent of the world’s thebaine, an opium poppy extract used to make OxyContin and a family of similarly powerful prescription drugs that have transformed pain management over the last two decades (27).
- Tasmanian farmers can sell their poppy harvests for at least $1,600 an acre, significantly more than other crops. Poppies have become Tasmania’s third-largest farm sector by revenue, after dairy and beef (27).
- Tasmanian farmers grew the novel plants, enticed by flashy incentive prizes — a Mercedes, a Jaguar, a BMW — that a Johnson & Johnson subsidiary awarded for growing the best crop (26).
- Tasmanian farmers want to hold on to the poppy business, which accounts for nearly one-tenth of the farm revenue in Tasmania, or roughly $80 million a year (27).
- The bulk of the opium poppy extract produced in Tasmania is shipped to pharmaceutical factories in the Northeastern United States. With its wealth and a largely private health care system willing to pay up for drugs, the United States accounts for three-quarters of global opiate painkiller sales by tonnage and five-sixths by value (27).
- The worldwide sales boom for OxyContin and its siblings has resulted in a tripling of Tasmania’s poppy acreage since the late 1990s, to nearly 30,000 hectares, or 74,000 acres. Poppies tailored for thebaine production now are about two-thirds of Tasmania’s crop (27).
- For years, Johnson & Johnson supplied more than 60 percent of all active ingredients for opioids manufactured and sold in the United States (25).
- OxyContin, which is made by Purdue Pharma and produces $2 billion a year in retail sales, is derived mainly from Tasmania-grown thebaine.
- Johnson & Johnson then went on a decade and a half long campaign to market all opioids—not just their named brands—as safe for everyday pain and having a low risk of addiction. Since they were the No. 1 supplier of narcotic, opioid active ingredients in the United States, Johnson & Johnson had every incentive to boost the opioid market as a whole (25).
- Johnson and Johnson engaged with and funded dozens of industry “front groups” to spread these false statements and promote broad and unfettered use of opioids for everyday pain (25).
- Purdue promoted OxyContin, and opioids generally, with the understanding and expectation that health care providers would prescribe it to their chronic pain patients over periods of months and years, but “From the first OxyContin label in 1996 and up to today, in 2018, the only clinical study Purdue has relied upon for OxyContin’s efficacy in adults is a two-week study of 133 patients,” the complaint states. “No clinical trials on efficacy have extended past 12 weeks. Yet, Purdue sold OxyContin as the cure for chronic pain.” (30).
- Purdue Pharma officials knew that their claims about the long-term risks and benefits of opioid use “lacked scientific support” and downplayed the dangers associated with taking opioids at higher doses, including a heightened risk of addiction, overdose and death (30).
- The lone FDA examiner charged with overseeing the approval process for OxyContin, Curtis Wright, became a serious roadblock for Purdue. But Wright would soon sign off on a drug application stating that “delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of the drug.” The false claim, anchored by those two words—“is believed”—would quell the anxieties of doctors and patients around the country. And a year after OxyContin was approved, Wright left the FDA. He eventually went to work for Purdue (28).
- Johnson & Johnson had a detailed “Influence Map” that it used to target and influence every level of our state’s government with its marketing lies to try to make sure that their opioids were on our approved lists. Company representatives told state leaders these drugs were safe and effective. Internal emails show Johnson & Johnson employees bragging about persuading Oklahoma officials not to place restrictions on Johnson & Johnson opioids
- In 1996, when Purdue Pharma began marketing OxyContin, the company had a sales force of around 300 representatives assigned to its prescription sales division, according to a 2004 report by the U.S. Government Accountability Office. By 2000, the company had more than doubled its sales force to 671 representatives (30).
- Sales managers were badgered on nights, weekends, and holidays, according to the filing. The marketing campaigns focused on high-volume doctors, who were visited repeatedly by salespeople, and pushed doctors to prescribe high doses. The demands on sales managers created such a stressful environment that, in 2012, they threatened to fire all sales representatives in the Boston area because of lackluster numbers (31).
- From 2010 to 2018, Purdue Pharma’s sales force in Indiana included at least 123 sales representatives, who made more than 207,460 visits to 5,502 prescribers in Indiana to promote OxyContin and other opioids, according to the complaint, which cites the company’s internal documents (30).
- Sales of OxyContin were incentivized: In just the first quarter of 2012, this Fort Wayne sales representative sold $2,031,666 of OxyContin in her district,” the complaint states. “Purdue rewarded her and other “winners” who secured the highest volume of Purdue opioid prescriptions with generous bonuses. The Fort Wayne sales representative received a first quarter bonus of $36,600 in 2012, plus a trip to Aruba.” (30).
- Between 2000 and 2011, Johnson & Johnson sales representatives targeted Oklahoma doctors nearly 150,000 times and marketed their own synthetic opioids—such as fentanyl, tapentadol and tramadol—for use as broadly as possible (25).
- In 1999, the Sacklers gave money to help start the Tufts Masters of Science in Pain Research, Education, and Policy. Through the program, “Purdue got to control research on the treatment of pain coming out of a prominent and respected institution of learning,” the filing states. Purdue employees even taught a Tufts seminar about opioids, and Tufts and its teaching hospital collaborated with Purdue on a publication for patients called “Taking Control of Your Pain.” (31).
- The new filing also reveals how Purdue aggressively pursued tight relationships with Tufts University’s Health Sciences Campus and Massachusetts General Hospital — two of the state’s premier academic medical centers — to expand prescribing by physicians, generate goodwill toward opioid painkillers among medical students and doctors in training, and combat negative reports about opioid addiction (31).
- Under an agreement with Mass. General, Purdue has paid the hospital $3 million since 2009 and was allowed to propose “areas where education in the field of pain is needed” and “curriculum which might meet such needs,” the court document shows. Tufts made a Purdue employee an adjunct associate professor in 2011, Purdue-written materials were approved for teaching to Tufts students in 2014, and the company sent staff to Tufts as recently as 2017, the complaint says (31).
- Johnson & Johnson specifically targeted high prescribers of opioids and reinforced their misrepresentations that opioids were safe and effective for everyday pain. They sent sales representatives into pill mills dozens of times to try to get doctors to write more and more prescriptions (25).
- The complaint also accuses Purdue of rarely reporting allegedly illegal activity, such as improper prescribing, to government officials when it learned about it. In one 2009 case, a Purdue sales manager wrote to a company official that Purdue was promoting opioids to an illegal pill mill. “I feel very certain this is an organized drug ring,” the employee wrote, adding “Shouldn’t the DEA be contacted about this?” Purdue did nothing for two years, according to the complaint (31).
- One recent study by researchers at Indiana University and the University of Georgia found that direct-to-physician promotional activities by opioid manufacturers was associated with an increase in opioid prescribing. The researchers looked at 865,347 physicians in the United States with prescriptions filled under Medicare Part D in 2014 to 2016 — 63,062 of whom received opioid-related promotional visits or materials. “We found that the U.S. doctors who received payments from pharmaceutical manufacturers prescribed, on average, over 13,070 daily doses of opioids per year more than their unpaid colleagues from 2014 to 2016,” Thuy Nguyen, the study’s lead author, told The Republic. “Among recipients of opioid‐specific payments (63,062 physicians), a 1% increase in amount of payments was associated with 50 daily doses of opioid prescription,” the authors of the study state (30).
- Johnson & Johnson used sales “hooks” to specifically target women and returning war veterans (25).
- Purdue Pharma knew where their best chances of success were, and they were in these kinds of towns that had high rates of disability. Oxycontin was marketed to doctors who were already prescribing larger numbers of opioids. The instance of opioid prescriptions was higher in places where there had been people with legitimate pains because of work injuries, logging, mining, fishing in Maine, coal, furniture factories. These were primarily white, rural communities with blue-collar employment that produces an above-average number of injuries (32).
It is well noted that the non-white minorities are more likely to be undertreated in a variety of medical settings and specifically receive inadequate treatment for pain conditions [1,12-13]. Interestingly, this may not be only a medical system bias as a recent study assessing the opinions of white laypersons, medical students, and medical residents identified a continued belief that the black body is biologically “different” from the whites and actually “stronger” [14]. These beliefs may stem from the days of slavery in the United States where scientists and physicians used pseudo-scientific studies on slaves to justify the need for slavery, often citing biological differences between white and non-white persons [14]. On an individual level, these biases may be difficult to consciously identify; however, the continued application of these beliefs can be detrimental to the current and future clinical and therapeutic interventions of the medical practitioner [15] (34).
- Since 2007, Purdue has sold more than 70 million doses of opioids in Massachusetts for more than $500 million (31).
- A 2021 investigation by the US House Oversight Committee indicated that members of the family, "who have owned a controlling share of Purdue Pharma since 1952, are collectively worth a total of $11bn" (33).
- The early spread of Oxyontin abuse was from Southwest Virginia up the Shenandoah Valley. Later there was a rise in heroin addiction and trafficking along the I-85 corridor. Scholars say that increase in heroin use was fueled in part by addiction caused by prescription medications like Oxycontin. Unlike most drug epidemics, prescription opioid abuse began in rural areas and spread to cities and suburbs. Part of the pattern stemmed from marketing strategy (32).
the 1986 Anti-Drug Abuse Act signed by the President Ronal Reagan, which imposed a minimum sentencing law for the distribution of crack cocaine and powder cocaine. This law included a 100:1 ratio between crack cocaine versus powder cocaine distribution, where crack cocaine distributors were more harshly penalized [19]. In 1988, the Omnibus Anti-Drug Abuse Act expanded the law to allow for harsher criminalization of the crack cocaine users. A possession of 5 g would result in a five-year minimum sentence, while powder cocaine possession for the same amount would only result in a one-year maximum sentence [20] (34).
- More than 300,000 people are estimated to have died over the past two decades from overdoses involving prescription painkillers like OxyContin (28).
- More than 2,000 lawsuits have been filed against the Connecticut-based pharmaceutical company [Purdue Pharma, owned by the Sacklers] by U.S. cities and states, including Indiana, accusing the firm of fueling the nation’s opioid crisis [30].
- In 2021, there were more than 100,000 overdose deaths in the US, with opioids involved in 75% of those according to the US Centres for Disease Control and Prevention (33).
- On Tuesday, an appeals court ruled that its owners, the Sackler family, would receive full immunity from civil suits. In exchange, they will pay $6bn [Leaving the family 5 BILLION remaining dollars to wipe their tears with] to help address opioid addiction (33).
- “After over a month of testimony, we have shown why we believe that Johnson & Johnson is the Kingpin behind the opioid crisis that has caused the deaths of thousands of Oklahomans and created a generation of people addicted to opioids in our state,” Attorney General Hunter said (25).
- Department of Mental Health and Substance Abuse Commissioner Terri White testified that it will cost the State over $17 billion to clean up the mess Johnson & Johnson made—money that must be spent to abate this crisis by the company that was a primary cause of it, not the taxpayers of this state (25).
Sources:
28] https://time.com/6303583/painkiller-netflix-true-story/
30] https://www.therepublic.com/2019/09/15/opioid_sales_reps_visited_columbus_doctors_frequently/
31] https://www.statnews.com/2019/01/15/massachusetts-purdue-lawsuit-new-details/
32] https://dailyyonder.com/opioid-marketing-unintentionally-protected-rural-black-region/2018/11/06/
33] https://www.bbc.com/news/world-us-canada-65764307
34] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6384031/