Purdue Pharma, the FDA, and the Sackler Family -- Players In an Evil Oxy Enterprise

“New York state Attorney General Letitia James says the family that owns Purdue Pharma, maker of the opioid OxyContin, used Swiss bank accounts to transfer $1 billion from the company to itself.

“The allegation, which came in court documents filed late Friday (September 13, 2019), indicates that the Sackler family is trying to keep its wealth free from potential liability in other court cases involving Purdue Pharma's role in

the opioid crisis.”

The death and destruction caused by Purdue and their prescription OxyContin devastate the nation. The company helped convince innocent Americans that opioid medications weren’t just for those in agony from cancer or major surgery – but that drugs like OxyContin, an opioid formula, could be used for much more manageable forms of short-term as well as chronic pain.

The corporation did this without credible research or secondary concern. Their actions of releasing and promoting the drug were reckless and criminally misleading. According to the Centers for Disease Control and Prevention, in as little as three to five days, exposure to opioids can start some people – like those genetically vulnerable – on a trajectory towards addiction. Purdue Pharma directed attempts to play down the dangers of the opioid painkiller while littering their campaign for OxyContin with biases and inaccurate characterizations.

This is a story of greed, unimaginable wealth, and corporate murder. In the face of facts, Purdue and the Sacklers … and even the Food and Drug Administration are responsible for the opioid epidemic.

Oxy Abuse

To accuse a pharmaceutical company and the government of being key players in the worst health epidemic in U.S. history may seem like a conspiracy theory; however, the reality is shockingly evil. All have played a major part, and overdose deaths have risen steadily, quadrupling in the U.S. since 1999 as prescriptions soared.

“The opioid epidemic, and addiction more broadly, have become the defining public health crisis of our generation.”

-- Nora VolkowDirector, National Institute on Drug Abuse,

National Institutes of Health

In 1996 Purdue Pharma introduced their new drug, a time-released formulation of oxycodone they called OxyContin. Incredibly, the drug was touted as having a low risk of addiction. Purdue trained its sales representatives to carry the message that the risk of addiction was “less than one percent.”

(Meier B. Pain Killer. Emmaus, PA: Rodale Press; 2003.)

Purdue backed OxyContin with an aggressive marketing campaign. Key components of this effort were pain-management and speaker-training conferences in sunshine states such as California and Florida, attended by more than 5,000 physicians, nurses and pharmacists, many of whom were recruited to serve on Purdue’s speakers' bureau.

The company also used a bonus system to incentivize its pharmaceutical representatives to increase OxyContin sales. The average bonus exceeded the representatives’ annual salaries.

In 1998, as Purdue hawked OxyContin for conditions such as arthritis and back pain, it decided to "increase communications" with patients, company records show. Their goal was stated as a strategy to "convince patients and their families to actively pursue effective pain treatment. The importance of the patient assessing their own pain and communicating the status to the health care giver will be stressed."

"Fear should not stand in the way of relief of your pain," a pivotal marketing brochure said. The OxyContin slogan in 1999 was: “The One to Start With and the One to Stay With.”

The New York Times reports that according to a court filing, Richard Sackler, the son of a company founder, said sales representatives should advise doctors to prescribe the highest dosage of the powerful drug because it was the most profitable.

In one email (2001), Richard Sackler suggested blaming addicts when the growing problem of opioid abuse became apparent in the early 2000s."We have to hammer on abusers in every way possible," he wrote when he was president of Purdue Pharma. "They are the culprits and the problem. They are reckless criminals."

Kaiser Health News (August 17, 2018) reports on Purdue and what the New York attorney general's office called operating a "public nuisance" in it sales tactics and marketing of opioids …

“Purdue's six-page pamphlet for patients, provided to the Florida attorney general, was titled 'OxyContin: A Guide to Your New Pain Medicine.' 'Your health care team is there to help, but they need your help, too,' the pamphlet says. It says OxyContin is for treating 'pain like yours that is moderate to severe and lasting for more than a few days.'

“To patients or family members worried about addiction, Purdue's pamphlet said: 'Drug addiction means using a drug to get “high” rather than to relieve pain. You are taking opioid pain medication for medical purposes. The medical purposes are clear and the effects are beneficial, not harmful.'"

Dr. G. Caleb Alexander, a physician at the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health, said the sales pitch was "simply not true" and called it "a smoking gun" for Purdue's role in the opioid epidemic.

Of course, Purdue's marketing and promotion amplified the prescription sales and availability of opioids. The extraordinary amount of money spent in promoting a sustained-release opioid was unprecedented.

During OxyContin's first 6 years on the market, Purdue spent approximately 6 to 12 times more on promoting it than the company had spent on promoting MS Contin, or than Janssen Pharmaceutical Products LP had spent on Duragesic, one of OxyContin's competitors.

(“Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem.” Washington, DC: General Accounting Office; December 2003.)

As early as 2001, pressured by Big Pharma and pain sufferers, the Food and Drug Administration made a fateful decision and, with no new science to back it up, expanded the use of Oxycontin to just about anyone with chronic ailments like arthritis and back pain. A small label change allowed the industry to sell more pills at higher doses.

"There are no studies on the safety or efficacy of opioids for long-term use."

– Ed Thompson, 60 Minutes

Since then, the FDA has approved other opioids for wide prescribing even as evidence mounted that the drugs were addictive, open to abuse, and often not effective for long-term use. The administration has been accused of being complicit in the epidemic by failing to use its powers to protect the public as the death toll escalated.

Nationally, the increasing availability of OxyContin has been associated with higher rates of abuse as it became the most prevalent abused prescription opioid by 2004. Individuals of all ages abuse OxyContin – by 2013, the National Institute on Drug Abuse (NIDA) reported 6,973,000 people aged 12 and up have used OxyContin nonmedically in their lifetimes.

(Cicero T, Inciardi J, Munoz A. “Trends in abuse of OxyContin and other opioid analgesics in the United States: 2002–2004.” J Pain. 2005;6:662–67.)

Finally, in the middle of the deadly Opioid Epidemic, the FDA specified that strong painkillers like OxyContin should only be used for severe, chronic pain from conditions like arthritis and cancer. The damage had been done, and the fallout continues.

"We have learned the hard way that many patients develop opioid [addiction] when using these medicines as prescribed," says Dr. Alexander.

Yet, many critics claim the FDA has not learned from its mistakes. Just consider that the division that approves new opioid drugs receives 75% of its funding from the industry. This puts the FDA in the posture of a business partner of Big Pharma rather than a regulator.

Anesthesiologist Raeford Brown puts it like this:

“I think that the FDA has learned nothing. The modus operandi of the agency is that they talk a good game and then nothing happens. Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything. The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”

Aftermath

What remains? Today enough opioid prescriptions are written each year in the U.S. to give every adult American his or her own one-month supply. Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them. Past misuse of prescription opioids is the strongest risk factor for starting heroin use, especially among people who became dependent upon or abused prescription opioids in the past year.

(Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. “Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic reviewand data synthesis.” Pain. 2015.)

So …

Since 1999, more than 700,000 people in the US have died of drug overdoses, mostly driven by an increase in opioid-related deaths. That’s comparable to the number of people who currently live in big cities like Denver and Washington, DC.

Every day, more than 130 people in the United States die after overdosing on opioids. The misuse of and addiction to opioids – including prescription pain relievers, heroin, and synthetic opioids such as fentanyl – is a serious national crisis that affects public health as well as social and economic welfare. Some estimates predict that hundreds of thousands more could die in the next decade of opioid overdoses alone.

The Centers for Disease Control and Prevention estimates that the total "economic burden" of prescription opioid misuse in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

Holding Purdue Accountable

Payback? Nothing can bring back the innocent lives lost to the opioid crisis. Nothing can compensate for the misery. The AMA Journal of Ethics explains the damage in one year:

“In 2010, 16,651 Americans died from prescription opioid overdoses. For each death there were 15 drug-treatment center admissions, 26 prescription opioid-related emergency room visits, 115 people who met criteria for prescription opioid abuse or addiction, and 733 people who used these medications nonmedically (that is, for the feeling that the drug provided).”

(Gary M. Reisfield, MD. “OxyContin, the FDA, and Drug Control.”

AMA Journal of Ethics. April 2014.)

Still, Purdue and the Sacklers should pay and pay heavily for their greedy handiwork. As German Lopez, Senior Correspondent for Vox states:

“The rise in opioid misuse, addiction, and overdose originally began with the proliferation of prescription painkillers – which were overprescribed by doctors, allowing the drugs to flow not just to patients but to the friends and family of patients, teens rummaging through parents’ medicine cabinets, and the black market.”

Although Purdue Pharma has secured support from 23 states and thousands of local governments for a multibillion-dollar deal that could enable the drugmaker to resolve much of the opioid litigation it faces through a planned bankruptcy restructuring, 25 states and the District of Columbia oppose the deal, in part because they believe it will not yield as much as projected, and because some feel the Sackler family is not contributing enough of its personal wealth to the total.

The New York AG's office, which is among the plaintiffs opposing the deal, also alleged that Mortimer Sackler hid his ownership of an Upper Eastside townhouse in Manhattan through a shell corporation and that he failed to disclose its existence in the litigation.

If the Sacklers, with their ill-gotten billions, continue to lowball victims, hide their assets, and skirt responsible settlements, they should be forced to give until they bleed. More power to New York in their drive to get a much larger settlement.

And, not just settlements from Purdue and the Sacklers – it's time for the government to own up to its part in the carnage and pay back. Purdue must think so. The company says the Physicians for Responsible Opioid Prescribing tried to get the FDA to regulate Oxycontin in 2012 but failed. Purdue claims it “was” and “is” simply following FDA guidelines in how it markets the deadly opioid.

“The FDA rejected these proposed restrictions,” claims Purdue.

Still, the FDA – in all its so-called “wisdom” and actions like approving new and more potent opioids – says that making painkillers less likely to be abused is a “public health priority.” Have things changed?

Dr. Sidney Wolfe, a former member of the FDA’s drug safety committee and a founder of the Public Citizen Health Research Group, said the FDA had been given every opportunity to act but “can no longer be trusted” because it is heavily swayed by the drug industry which provides the bulk of the funding for the FDA’s drug approval division. And he believes the agency’s “dangerously deficient oversight” is continuing to fuel the opioid epidemic.

Without a doubt, it is clear that the greedy pharmaceutical industry has been built off the backs of helpless, “legalized” addict-patients. There is plenty of righteous blame pointed directly at agencies and industries that scratch each other's evil itch for maximum profits.