Do You Think That This Stuff Just Happens?

31 May 2018

You think that bad stuff just happens?

In 2016, 42,000 Americans died because of opioids. 40 percent of those deaths were due to prescription opioids.

That is a lot. A lot of dead Americans. But that’s just one year. “Over the past two decades, more than 200,000 people have died in the United States from overdoses involving prescription opioids.”

You think that this just happened?

You think that no one knew?

Purdue Pharma knew. Or to be somewhat more precise, the New York Times is reporting that “federal prosecutors investigating the company found that Purdue Pharma knew about ‘significant’ abuse of OxyContin in the first years after the drug’s introduction in 1996 and concealed that information.” Meier, B., “Origins of an Epidemic: Purdue Pharma Knew Its Opioids Were Widely Abused,” NY Times, May 29, 2018.

And that’s important for two reasons:

First, because Purdue Pharma “has long claimed it was unaware of the powerful opioid painkiller’s growing abuse until years after it went on the market.”

That, it turns out, was not true.

Second, because the drug maker “continued ‘in the face of this knowledge’ to market OxyContin as less prone to abuse and addiction than other prescription opioids.”

And that, too, was not true.

The New York Times article reveals a shocking story of reprehensible – and purposeful – behavior. Below are excerpts from that expose:

When the Food and Drug Administration approved OxyContin in late 1995, the agency permitted Purdue Pharma to make a unique claim for it — that its long-acting formulation was “believed to reduce” its appeal to drug abusers compared with shorter-acting painkillers like Percocet and Vicodin.

Purdue Pharma viewed the agency’s decision as “so valuable” that it could serve as OxyContin’s “principal selling tool,” an internal 1995 company report shows. The drugmaker admitted in 2007, when confronted with evidence gathered by prosecutors, that it trained sales representative to tell doctors that OxyContin was less addictive and prone to abuse than competing opioids, claims beyond the one approved by the F.D.A.

Company officials had received reports that the pills were being crushed and snorted; stolen from pharmacies; and that some doctors were being charged with selling prescriptions, according to dozens of previously undisclosed documents that offer a detailed look inside Purdue Pharma.

Prosecutors found that the company’s sales representatives used the words “street value,” “crush,” or “snort” in 117 internal notes recording their visits to doctors or other medical professionals from 1997 through 1999.

[Emails showed] that Purdue Pharma’s owners, members of the wealthy Sackler family, were sent reports about abuse of OxyContin and another company opioid, MS Contin.

Based on their findings after a four-year investigation, the [federal] prosecutors recommended that three top Purdue Pharma executives be indicted on felony charges, including conspiracy to defraud the United States, that could have sent the men to prison if convicted.

But top Justice Department officials in the George W. Bush administration did not support the move, said four lawyers who took part in those discussions or were briefed about them. Instead, the government settled the case in 2007.

In 2007, Purdue Pharma pleaded guilty to a felony charge of “misbranding” OxyContin while marketing the drug by misrepresenting, among other things, its risk of addiction and potential to be abused. Three executives — the company’s chief executive, Michael Friedman; its top medical officer, Dr. Paul D. Goldenheim; and Mr. Udell, who died in 2013 — each pleaded guilty to a misdemeanor “misbranding” charge that solely held them liable as Purdue Pharma’s “responsible” executives and did not accuse them of wrongdoing. The company and the executives paid a combined $634.5 million in fines and the men were required to perform community service.

That decision followed meetings with a Purdue Pharma defense team whose advisers included Rudolph W. Giuliani, a onetime United States attorney and former New York mayor. Mr. Giuliani, who was then regarded as a potential Republican presidential candidate, is now a legal adviser to Mr. Trump.

The Justice Department hailed the settlement as a victory. But several former government officials said the decision not to bring more serious charges and air the evidence prosecutors had gathered meant that a critical chance to slow the trajectory of the opioid epidemic was lost.

“It would have been a turning point,” said Terrance Woodworth, a former Drug Enforcement Administration official who investigated Purdue Pharma in the early 2000s. “It would have sent a message to the entire drug industry.”

It is a shocking, and sad history. The entire article is worth reading.

Here’s the question of the day: If and when governmental regulatory agencies fall short, what recourse is left for citizens to hold powerful corporate wrongdoers accountable? (Hint: It has something to do with tort law).