“Purdue is very pleased to have reached an agreement with Oklahoma that will help those who are battling addiction now and in the future.”~ Dr. Craig Landau, Chief Executive, Purdue PharmaIn March 2019, Purdue Pharma, the maker of Oxycontin, reached a huge settlement, ending the opioid lawsuit brought by the State of Oklahoma. Purdue agreed to pay $270 million deal, a decision motivated by a corporate desire to avoid a public trial and what was sure to be an enormous amount of unflattering revelations and negative press. The $270 million is easily the largest payout so far in Purdue’s ongoing legal fight. Currently, Purdue Pharma and its owners are facing over 1600 lawsuits regarding their corporate and personal roles in creating and propagating the opioid epidemic that continues to drive the drug crisis in America.
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A Sign of Things to Come?
“Purdue appears to have concluded that it was less risky to settle the Oklahoma case than have the allegations publicly aired against it during a televised trial and face exposure to what could have been an astronomical jury verdict.”~ Professor Abbe R. Gluck, Yale Law SchoolIn this particular case, Purdue made the smart business decision to negotiate a settlement, rather than risk what could have happened if they lost a public trial.More importantly, however, this settlement in Oklahoma may significantly affect the outcome of other still-pending litigation, not just against Purdue, but also those involving otherBig Pharma companies, pharmacies, and distributors.Because as impressive and as seemingly-punitive as $270 million may seem, it is just a drop in the proverbial bucket as to what these thousands of lawsuits could eventually cost the pharmaceutical industry. For example, Mike Hunter, Oklahoma’s State Attorney General, had sought a total of $20 billion in damages from Purdue and the other defendants, including Teva Pharmaceuticals and Johnson & Johnson.Already, Purdue Pharma is said to be looking into bankruptcy protection. If this were to happen, all lawsuits would immediately be halted. Purdue would then negotiate settlements with each plaintiff, under the supervision of the bankruptcy judge.This would be quite the fall from grace for Purdue, which realized $3 billion in revenue in 2017 alone. In other words, this may be apropos karma for Big Pharma.
What You Need to Know about Purdue Pharma
“Purdue Pharma has a moral, if not legal obligation to take effective steps and address addiction and abuse even as it works to reformulate the drug.”~ Richard Blumenthal, former Attorney General and current Senator for ConnecticutFounded in 1892 by two medical doctors, Purdue Pharma is one of the oldest and largest drug manufacturers in America. Since 1991, the company has focused on pain management drugs. In fact, Purdue calls itself “a pioneer in developing medications for reducing pain, a principal cause of human suffering.”Among the pain meds, Purdue manufactures are codeine, fentanyl, hydrocodone/Vicodin, hydromorphone/Dilaudid, and most especially,oxycodone/OxyContin. More than any other medication, OxyContin is the drug considered to have caused the US opioid epidemic.For nearly 20 years, the opioid painkillers manufactured by Purdue have generated considerable controversy. Although Purdue aggressively marketed their drugs as completely “safe and effective”, in reality, they are extremely habit-forming and therefore carry the high potential for dependence, misuse, and addiction. As early as 2001, Connecticut Attorney General Blumenthal issued an official statement admonishing Purdue to take stronger action in regard to the abuse of its flagship product, Oxycontin.Damningly, Blumenthal called the measures that Purdue had up to that point taken little more than “cosmetic and symbolic steps”.
What Purdue Knew and When They Knew It
“We have in fact picked up references to abuse of our opioid products on the Internet.”~ Howard R. Udell, General counsel for Purdue, in internal communication in 1999Most of the damaging information about Purdue Pharma’s unscrupulous business practices comes from the company’s internal memos and emails. For example, despite the 1999 email, Udell later testified before Congress that Purdue did not learn about the abuse of Oxycontin until 2000.Discrepancies such as this are why an investigation by the Justice Department concluded that Purdue knew about “significant” abuse of OxyContin and MS Contin within a short time after these products were approved by the FDA and hit the market:
- 1996: Just five months after Oxycontin was approved by the FDA, Udell and Richard Sackler, then the President of Purdue Pharma, were sent an article from an older medical journal describing how addicts could extract morphine from MS Contin and then inject the drug.
- A Purdue scientist researched that article. He sent his findings to, among others, Drs. Mortimer and Raymond Sackler, the brothers who bought Purdue in 1952. He wrote, “I found MS Contin mentioned a couple of times on the Internet underground drug culture scene. Most of it was mentioned in the context of MS Contin as a morphine source.”
- Between 1997 and 1999: 117 internal sales memos and emails had representatives using the words “snort” “street value”, or “crush ”.
- 1998: Udell sent seven Sackler family members a memo entitled “MS Contin Abuse”, contained articles from newspapers in the Vancouver area, including reports of abuse and the current black market prices.
- 1998: Purdue officials learned of a study published in the Journal of the Canadian Medical Association showing how drug abusers “coveted” long-acting opioids.
- In an editorial that accompanied the study, Dr. Brian Goldman, who was at that time a paid speaker for Purdue, wrote, “This should ring alarm bells.”
- Significantly, Purdue did not let the FDA know about the Canadian study, nor did they inform their sales representatives.
- 1999: The above-quoted Udell email
- 1999: Company execs were aware that OxyContin abusers referred to it as, “…the hottest thing on the street – forget Vicodin.”
- 1999: Richard Sackler was informed of discussions in Internet chat rooms about how abusers would snort OxyContin.
- 2000: Mark Alfonso, Purdue’s Vice-President of Marketing sent an email to Michael Friedman, the company’s Chief Executive Officer, that read, “Some pharmacies would not even stock MS Contin for fear they would be robbed. In Wisconsin, Minnesota, and Oklahoma, we had physicians indicted for prescribing too much MS Contin.”
- Friedman’s response demonstrated just how aware he was of the need to keep such information secret. He replied, “You want all this chat on email?”
It is obvious that for years, the owners and executives of Purdue Pharma deliberately misled doctors and the public by concealing these facts. Federal investigators determined that Purdue continued to aggressively promote their products as having a lesser potential for misuse than other pain medications, even “in the face of this knowledge”.Revelations like these are why Purdue has settled numerous lawsuits and why in 2007, the company’s top three executives pled guilty to felony criminal charges.
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What You Need to Know about the Sackler Family
“They hired hundreds of workers to carry out their wishes, and they fired those who didn’t sell enough drugs. They got more patients on opioids, at higher doses, for longer, than ever before. They paid themselves billions of dollars.”~ Lawsuit against Purdue Pharma filed by the State of MassachusettsIn 1952, two brothers, the medical doctors Mortimer and Raymond Sackler purchased the Purdue Frederick Company, incorporated as Purdue Pharma, LP, in 1991. The company is still 100% owned and operated by the Sackler family.The success of Purdue Pharma is directly related to the rise of direct pharmaceutical marketing. In an article for the New Yorker entitled, “The Family That Built an Empire of Pain”, Patrick Radden Keefe suggests that the Sacklers should bear a large measure of moral responsibility for the US opioid epidemic.Lawmakers seem to agree. For example, Massachusetts Attorney General Mayra Healy alleged in a 2018 lawsuit that eight members of the Sacklers “micromanaged” the company’s “deceptive sales campaign”, making them “personally responsible” for Purdue’s corporate actions.It has also been alleged that members of the Sackler family “studied unlawful tactics to keep patients on opioids longer and then order staff to use them”.In 2019, the New York Times reported that in 2008, Richard Sackler directed company officials in an email to “measure our performance by Rx’s by strength, giving higher measures to higher strengths.” By this time, according to the lawsuit, Sackler knew that higher doses for longer periods of time increased the risk of addiction and other serious side effects. But Sackler also knew that the strongest pain pills brought him the most profit. In the just-settled Oklahoma lawsuit, the Sacklers were not specifically named as defendants. Nevertheless, the family pledged to donate $75 million over the next five years to the Oklahoma State University in Tulsa. The money has to be used as funding for a opioid treatment center and research center.The Sackler Family calls the promised donation a “voluntary pledge” that does not mean that they admit any culpability. Today, the Sacklers are one of the richest families in the United States, possessing a collective net worth of nearly $14 billion.The deluge of lawsuits, the expensive settlements, and the shadow of impending bankruptcy has resulted in a startling change for Purdue Pharma. In 2017, eight members of the Sackler family served on Purdue’s board. Today, there are none. The last of the Sacklers stepped down earlier this year.
Looking to Profit Both Ways?
“In their internal documents, Kathe and staff wrote down what Purdue publicly denied for decades: that addictive opioids and opioid addiction are ‘naturally linked. They determined that Purdue should expand across ‘the pain and addiction spectrum,’ to become ‘an end-to-end pain provider.’~ Lawsuit against Purdue Pharma filed by the State of MassachusettsAccording to the Massachusetts lawsuit, in 2014, Purdue attempted to launch a new program called Project Tango. This was Purdue’s secret attempt to capitalize on the treatment of opioid addiction. Specifically, while Oxycontin sales were significantly declining, the company’s team decided to look into the expanding addiction treatment market.To Attorney General Healy, this is just another example of Purdue’s corporate greed and their refusal to take any responsibility for the US drug crisis. She says the Sacklers don’t “want to accept blame for this. They blame doctors, they blame prescribers, and worst of all, they blame patients.”Support for this comes from Richard Sackler’s own words, taken from a 2001 email, which read, “We have to hammer on the abusers in every way possible. They are the culprits and the problem. They are reckless criminals.”
Statistics about the Opioid Crisis
“These are essential medicines for easing suffering at the end of life and when used for a couple of days after major surgery or a serious accident. If you are taking them around the clock every day, quickly, you become tolerant to the pain-relieving effects. In order to continue getting pain relief, you’ll need higher and higher doses. As the doses get higher, the treatment becomes more dangerous and the risk of death toll goes up.”~ Dr. Andrew Kolodny, Co-Director of Opioid Policy Research, Heller School for Social Policy and ResearchFor 2016, the most recent year that nuanced data is available, the U.S. Department of Health and Human Services reports that:
- 11.5 million people in America misused prescription pain medications.
- For 2.1 million people, that misuse was so bad as to meet the criteria for a diagnosis of an opioid use disorder.
- On average, opioid overdoses killed 116 people a day.
- But by 2017, that average had jumped to 134 lives lost every day.
Between 2000 and 2016, approximately 200,000 Americans fatally overdosed on prescription opioid pain medications. And according to some predictions, it’s going to get worse between 2015 and 2025.
- The number of opioid-related deaths will climb sharply, from just over 33,000 to almost 82,000.
- That is a 10-year increase of nearly 150%.
- Overall, opioids will kill around 700,000 people.
- 4 out of every 5 opioid fatalities will involveheroin and/or fentanyl.
- Illicit opioid drugs will take more lives prescription painkillers, jumping from “only” 19,000 annual deathsto 68,000.
- That is a 260% increase.
Affecting Every Part of the Country
“In terms of the overall number of overdose deaths, the epidemic is unprecedented and has wide-ranging negative effects, not only on individuals, but on their families and communities.” ~ Dr. Nora Volkow, Director of the National Institute on Drug Abuse According to the Centers for Disease Control and Prevention’s Vital Signs report, every region of the country experienced an increase in opioid poisonings between 2016 and 2017. Taken as a whole, the number of emergency department visits in America involving opioid overdoses went up by at 30%. From July 2016 to September 2017, opioid-related overdoses increased in 52 areas in 45 states:
- Midwestern region: +70%
- Large cities: +54% in 16 states
- Large “fringe” cities: +21%
- Medium-sized cities: +43%
- Small cities: +37%
- Micropolitan areas: +24%
- Non-core cities: +21%
- Males: +30%
- Females: +24%
- 25 to 34-year-old age demographic: +31%
- 35 to 54-year-old age group: +36%
- 55 and older: +32%
OxyContin: Developing a Blockbuster
“In terms of narcotic firepower, OxyContin was a nuclear weapon.” ~ Barry Meier, Pain Killer: A ‘Wonder’ Drug’s Trail of Addiction and Death The story of Oxycontin begins a few years before when Purdue’s patent for MS Contin was about to expire. Up to that point, MS Contin—a controlled-release morphine pill— was the company’s biggest seller. Executives were worried, saying that their product “could face such serious generic competition that other controlled-release opioids must be considered.” Purdue decided to focus on a controlled-release formulation of oxycodone, the powerful opioid that had been developed in Germany in 1916. Oxycodone was both inexpensive to produce and familiar to prescribers and patients. It was already used in Percocet (Oxycodone/Tylenol) and Percodan (Oxycodone/Aspirin). Purdue succeeded in developing Oxycontin, a medication of pure oxycodone with a time-release formulation similar to that of MS Contin. Significantly, while dosages started out at a low 10 mg, the “jumbo” pills were as high as 80 mg or even 160 mg. This meant that OxyContin was far more potent than any other painkiller then on the market. But before Purdue release of Oxycontin, they employed focus groups to determine any barriers or biases that might prevent its widespread use. The biggest perceived negative was opioids’ potential for abuse. Luckily for Purdue, however, right about this time, respected doctors began talking about the serious problem of undertreated chronic pain and how opioids might be an ideal solution. For example, in 1993, Dr. Russell Portenoy, a highly-regarded pain specialist, told the New York Times, “There is growing literature showing that these drugs can be used for a long time, with few side effects.” Portenoy even went so far as to describe opioids as “a gift from nature”. Then, in 1997, the American Pain Society and the American Academy of Pain Medicine published in a statement suggesting that opioids should be used to treat chronic pain. But maybe it wasn’t luck, after all. Dr. Portenoy was funded by Purdue Pharma. And the person who wrote the joint statement for the two pain management organizations was a paid speaker for Purdue, Dr. J. David Haddox.
Selling a Wonder Drug
“What Purdue did really well was target physicians, like general practitioners, who were not pain specialists.” ~ Steven May, former sales representative for Purdue Oxycontin was released in 1996 with the benefit of perhaps the biggest marketing campaign in the history of the pharmaceutical industry. A thousand sales representatives were trained in the persuasive techniques originally pioneered by Arthur Sackler. Oxycontin was aggressively promoted as a pain medication with almost unlimited applications—not just short-term pain such as for cancer, surgery, or injuries, but also long-term chronic pain such as fibromyalgia, back pain, or arthritis. In the case of most medications, the goal is to prescribe the drug to the smallest number of patients possible, at the lowest effective dose possible. But this normal therapeutic goal was contrary to the highly-competitive mindset of a trained Purdue salesperson. The impetus was always to sell more and more, and to always push for the highest dose. Through some unfortunate misunderstanding, many doctors mistakenly believed that oxycodone was less potent than more-familiar morphine. Purdue sales reps exploited that misconception. Salespeople were also taught how to bypass any questions or objections. For example, if a doctor asked if Oxycontin was habit-forming, reps were taught to answer that the drug was “virtually non-addictive”, a term that has no real meaning. Ex-salesperson May was trained to specifically say, “The delivery system is believed to reduce the abuse liability of the drug.” While that statement might sound promising, is not a definite answer, nor is it is based in fact. Of special relevance, Purdue Pharma had not conducted any clinical trials to determine the abuse or addiction potential of Oxycontin. In its first full year, Purdue saw $49 million in OxyContin sales. But by 2002, sales had skyrocketed to $1.6 billion, and by 2010, they had exploded to over $3 billion. In fact, OxyContin controlled one-third of all pain medications sales in 2010. By 2016, 20 years after it was released OxyContin had generated $31 billion in sales for Purdue Pharma.
The “Letter to the Editor”
“We conclude that despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”~ Dr. Hershel Jick, New England Journal of MedicineIn 1980, a Boston University Medical Center researcher wrote a brief letter and mailed it to the Editor of the New England Journal of Medicine. Dr. Jick had conducted a small study and had come to the conclusion that patients given opioid painkillers were unlikely to subsequently become addicted.But the so-called “Jick letter” was NOT based on any peer-reviewed, official scientific research. Pointedly, the research that Dr. Jick cited only included patients who were given small, controlled doses, and did not include patients receiving opioid painkillers on an outpatient basis.
Modern-Day Snake Oil
“Most of the questionable practices that propelled the pharmaceutical industry into the scourge it is today can be attributed to Arthur Sackler.”~ Allen J. Frances, Chairman of the Department of Psychiatry, Duke University School of MedicineEven though the conclusions did not apply to Oxycontin, representatives for Purdue Pharma referred to the Jick letter thousands oftimes as indisputable proof that opioid products were completely safe and carried virtually no potential for abuse. Unfortunately, those claims were not at all true.
- Reps were taught to continuously quote the Jick letter’s conclusion that the risk of OxyContin addiction was “less than 1%.”
- On the contrary, research shows that the rate of abuse, addiction, or addictive behaviors is greater than 1 in 4.
- Purdue reps strongly pushed OxyContin as the best treatment for chronic neck and back pain.
- However, recent studies have concluded that opioids do little to improve function or lessen disability.
- More importantly, opioids appear to be less effective for chronic pain relief than over-the-counter remedies such as ibuprofen, aspirin, or Tylenol.
- A recent study found that the long-term use of opioid painkillers can instead make chronic pain worse.
- Purdue seriously mislead doctors and patients by exaggerating OxyContin’s duration. Sales reps boasted of 12 hours of continuous pain relief. In fact, that is what “contin” stands for.
- But in reality, the pain relief provided by Oxycontin wears off in only 8 hours.
- As a result, patients in need of relief ed up taking more of the medication than is prescribed.
Any of these inaccurate claims are bad enough. But when the majority of the sales pitch is one lie on top of another exaggeration on top of another misrepresentation, patients are put at real risk.Today, Dr. Jick says, “The letter wasn’t of value to health and medicine in and of itself. So, if I could take it back — if I knew then what I know now, I would never have published it. It wasn’t worth it.”
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What Happens Now with Big Pharma Opioid Lawsuits?
“(Purdue Pharma is) drowning in lawsuits. This isn’t the first settlement the company has reached during this big opioid crisis, but it comes in a crucial year, at a time when people are watching to see if this company will start cutting deals with states and local governments two limit its legal exposure. So this is a big settlement. It’ll be looked at as a potential template for future deals all over the country.”~ Brian Mann, “All Things Considered” National Public RadioPurdue Pharma withheld vital information that was important to the health of its patients. This corporate policy of deception for the sake of profit created the opioid epidemic in America. One of the most fundamental lessons in bioethics taught to medical students is the principle to “First, do no harm.” This concept is supposed to remind all doctors to soberly consider the possible harms to a patient before performing any medical intervention. The lies of Purdue and other Big Pharma companies caused thousands of doctors to violate that basic principle.Well-meaning doctors were purposefully misled. Because they had been reassured again and again that these medications were effective, safe, and appropriate, they continued to prescribe Oxycontin and other dangerous opioids. Trusting patients had faith in their doctors, but because these powerful painkillers are habit-forming even when taken as directed, entire generations of opioid addicts were created.But now that so much evidence of corporate malfeasance has come to light, there is a loud outcry for accountability and justice. At every level –state, county, city, and even tribal, communities have filed lawsuits because of the harm caused by the improper and unsafe marketing, branding, distribution, and prescription opioid painkillers.Opioid lawsuits, settlements, and criminal cases are not a new thing. Purdue Pharma:
- 2004: Paid the State of West Virginia $10 million
- 2007: Violated the False Claims Act and fined $601 million
- 2015: Paid the State of Kentucky $24 million to Kentucky
Oklahoma negotiated the largest settlement yet awarded in a non-criminal case, but $270 million may just be the tip of the iceberg. There are still 1600 pending civil lawsuits. For many of these, the Oklahoma settlement may serve as a template for future negotiations and compensation. This settlement clearly demonstrates the lengths to which big Pharma defendants may be willing to go to avoid publicity and limit the damage that could result from unfavorable court decisions.After the Oklahoma case ended, a group of class-action lawyers released a joint statement:“This settlement is another reflection of the extraordinary importance and strength of the claims against Purdue Pharma. Purdue’s wrongdoing, however, does not stand alone. There are nearly two dozen other defendants with pending allegations against them in federal court. We believe all of these defendants—opioid manufacturers, distributors, and pharmacies—must be held responsible for their role in the epidemic, and we will continue to pursue accountability for the thousands of communities we represent.”
What Does This Settlement Mean to YOU?
“To resolve the opioid problem, you’re going to need billions. Treatment alone could be fifty billion dollars or more. And you need prevention and education programs on top of that.”~ Attorney Mark Moore, who worked in a similar class-action lawsuit against Big TobaccoThere are several important points to consider about this recent development:FIRST, Purdue, other Big Pharma companies, and a number of doctors, pharmacies, and distributors acted improperly—and in some cases criminally—and directly helped cause the ongoing and worsening opioid epidemic in America.SECOND, that fact highlights the extreme importance of patient education. In other words, if you are prescribed to medication, you should try to learn everything you can about that drug before you put it in your body. Do your own research and ask your doctor questions, until you have a full understanding of any potential risks.THIRD, now that we are more aware of the dangers, there needs to be a renewed focus on non-opioid pain relief strategies. Although opioid painkillers have a legitimate use for end-of-life pain and certain short-term conditions, they are not a safe solution for chronic pain management.FOURTH, although it is overdue, the parties are most responsible for the opioid crisis are finally being held accountable. This is good news, because it may lead to policy changes that can help us reduce the rates of opioid dependence, misuse, addiction, and overdose deaths.FINALLY, opioid abuse and addiction affect us all. Statistics show that there is no part of the country that is unaffected by this extreme threat to public health.And if that includes you or someone you care about, then the best thing you can do isseek professional help. Today, there are therapies and medications that can help you safely and successfully regain your sobriety and overcome opioid dependence.