Month: December 2017

U.S. FAILS TO PROSECUTE PRESCRIPTION OPIOID DISTRIBUTOR

After years of work by U.S. Drug Enforcement Agency (DEA) investigators building a case against a major drug distributor for fraudulently shipping millions of prescription opioid pills, high-ranking lawyers at the DEA and the US Department of Justice (DOJ) recently decided to settle the case and not pursue criminal charges. Instead, the lawyers settled for a $150 million fine (from a corporation with roughly $200 billion per year in revenue) and a temporary suspension of shipments of narcotics from four of its 30 distribution centers. The lenient settlement was agreed to despite the corporation having promised in a 2008 settlement to be diligent in preventing fraudulent shipments of controlled substances. However, rather than improving its oversight of narcotics shipments, its fraudulent shipments increased. [1]

The DEA team had compelling evidence that McKesson Corporation, the fifth largest public company in the U.S., had fulfilled and failed to report suspicious orders for millions of highly addictive painkillers from pharmacies, including Internet pharmacies. The nationwide DEA team, working with U.S. attorney’s offices in 11 states, wanted to fine the corporation over $1 billion and pursue criminal charges against the corporation and perhaps some of its executives. A senior DEA official stated that the corporation could have been put out of business through an indictment or a very large fine.

But when the team turned over the evidence to top lawyers at DEA and DOJ, the lawyers negotiated a settlement with the corporation and never even discussed possible criminal charges. They even allowed McKesson to keep its $31 billion federal government contract to supply drugs to the Veterans’ Administration, federal prisons, and the Indian Health Service.

Meanwhile, a pharmacy owner in a small town in Colorado that McKesson supplied was found guilty of drug trafficking and was sentenced to 15 years in prison. From 2008 (when McKesson had settled the first set of charges) to 2011, McKesson’s shipments of oxycodone (the narcotic drug that is OxyContin) to this small-town pharmacy had increased 15-fold.

The DEA team had convincing evidence that McKesson’s activities had fueled the nationwide opioid drug crisis. The $150 million fine was a slap on the wrist for a $200 billion corporation that paid its top executive $100 million last year, has 76,000 employees, and makes $100 million a week in profits. The DEA team felt insulted, undermined, and was demoralized.

This is another example of a powerful corporation, as well as its senior executives, getting off with a slap on the wrist for significant criminal activity that harmed hundreds of thousands of Americans. Purdue Pharma, the major player in the prescription opioid drug scandal, also has (so far) gotten off with a slap or two on the wrist, despite the deaths of over 200,000 Americans. (See my previous posts on Purdue Pharma here and here.) The Wall St. financial corporations and their executives have also gotten off with slaps on the wrist despite a long trail of criminal activity across many years and many business lines.

One must ask why this is happening today when in the late 1980s, during the savings and loan (S&L) bank scandal, 750 S&Ls were forced into bankruptcy and out-of-business and over 1,000 of their executives went to jail.

Since the 1980s, corporations have grown in size and power, while government regulation and oversight have been weakened. As corporations have grown, they have gained power in the economy and in the halls of government. In the economy, their size has led to monopolistic power, a lack of competition, and, therefore, the power to control prices and make huge profits.

In the halls of government, the deregulation of campaign financing now allows wealthy corporations and individuals (often business executives) to spend hundreds of millions of dollars on candidates’ campaigns for legislative, executive, and judicial branch offices. As a result, elected officials – legislators, governors, presidents, and judges – are indebted to wealthy donors. These wealthy special interests further influence government decision making by spending millions of dollars on lobbying and by having individuals move back and forth between government roles and private sector jobs, in what is referred to as the revolving door. An example of this is that one of McKesson’s lawyers negotiating the settlement with the DEA and DOJ was a former top DEA official.

Therefore, government decisions tend to favor the interests of wealthy corporations and individuals. Examples include the lack of meaningful punishment for serious wrong doing, favorable tax policies, a failure to protect the public from rip offs in the market place, and weak regulation of the safety of consumer products and our air and water.

In this environment of market place power and weak regulation, the greed of large corporations and their executives is unconstrained and ethics, morality, and often legality get pushed aside. The public interest is overwhelmed by the power of wealthy special interests. This power imbalance is exacerbated by the growing inequality of income and wealth.

We need to elect officials who will represent the public interest and not wealthy corporations and individuals. We also need to let our elected officials know that we are watching and that we know when they are doing the bidding of the wealthy interests, such as in the recent tax bill. And we need to hold them accountable by being informed and voting. That alone could create dramatic change in our country if more people did so.

Only 53% of eligible voters voted in the last presidential election. Many of them were understandably voting against the tilt in favor of the wealthy in Washington. However, they were hoodwinked by the promises of a con man who, now that he is in office, is tilting the scales even further in favor of the wealthy.

Hopefully, this election woke people up to the fact that democracy is NOT a spectator sport. We need a broad, informed, and engaged electorate for our democracy to deliver on its promise of government of, by, and for the people.

[1]      Bernstein, L., & Higham, S., 12/17/17, “‘We feel like our system was hijacked’: DEA agents say a huge opioid case ended in a whimper,” The Washington Post

PURDUE PHARMA AND OXYCONTIN CAUSED THE OPIOID EPIDEMIC Part 2

Purdue Pharma, a privately-owned corporation, and its narcotic pain-killer, OxyContin, caused the current opioid epidemic. My previous posts gave an overview of Purdue’s development and marketing of OxyContin, as well as of the complicity of Congress and the Executive Branch in allowing OxyContin to cause the national opioid epidemic.

This post describes Purdue’s efforts to conceal the harm that OxyContin is causing, while continuing to aggressively market – and profit – from it. The most detailed reporting of the role of Purdue and OxyContin in the opioid epidemic that I am aware of is the article that appeared in the October 30th issue of The New Yorker, “The family that built an empire of pain”. [1] This blog post is largely drawn from that article.

OxyContin is a large dose of oxycodone that can be taken all at once due to Purdue’s innovative time release formula, which means that the pain killer’s effect lasts for 12 hours (supposedly).

Purdue claimed that OxyContin’s time release formula made it virtually non-addicting and hard to abuse. However, ironically, the information sheet provided with it basically gave instructions on how to abuse it. The information sheet warned against crushing the pills and then ingesting them. Abusers quickly figured out that snorting the crushed pills gave a heroin-like high. The information sheet also warned against dissolving the OxyContin pills in liquids. Abusers quickly figured out how to dissolve the pills and inject the solution, which was just like shooting heroin.

Soon after OxyContin’s release, signs of abuse were evident in Maine and Appalachia. Purdue’s own sales data indicated that doctors were over-prescribing OxyContin and that some were engaged in writing large numbers of clearly fraudulent prescriptions. Evidence that patients were selling extra pills on the black market also surfaced.

Problems with the use of OxyContin as prescribed also quickly became evident. Some patients were displaying signs of addiction and withdrawal within the 12 hours between scheduled doses. Many patients were finding that the pain-killing effect didn’t last 12 hours, so they took the pills more often, which increased the likelihood of addiction. A 1999 study found that 13% of patients who used OxyContin for headaches became addicted.

Purdue said the concerns over addiction were overblown. It told sales reps to say that less than 1% of OxyContin patients became addicted. Purdue claimed that patients were not experiencing addiction and withdrawal symptoms, but were just feeling their underlying pain. It coined the term “pseudo addiction” to describe this supposed phenomenon. It claims there is no inherent problem with OxyContin, saying the problem is individuals who misuse it.

However, internal Purdue documents, which have emerged due to litigation, reveal that it knew, even before it got approval to market OxyContin, that not all patients achieved 12-hour pain relief and that more frequent use was a recipe for addiction. Purdue’s records show that in 1998 it was aware that taking OxyContin at 8-hour intervals was becoming more and more common. A Purdue employee called this “very scary.” It appeared that in some cases these more frequent doses were due to addiction and to keep the patient from going into withdrawal, rather than to treat pain.

In 2001, the Attorney General of Connecticut wrote to Purdue expressing his alarm over the growing abuse of OxyContin. Three years later, having received no response, he filed a lawsuit. In 2003, the Drug Enforcement Agency (DEA) found that Purdue’s aggressive marketing had “very much exacerbated OxyContin’s widespread abuse.” It concluded that Purdue had “deliberately minimized” the risks of OxyContin. The DEA sent Purdue a warning letter saying that its ads “grossly overstate the safety profile of OxyContin by not referring in the body of the advertisements to serious, potentially fatal risks”. Nonetheless, Purdue continued to aggressively market OxyContin and no government agency took steps to – or was allowed to – regulate its sale. (See my previous post for more detail on the lack of regulation.)

Purdue currently faces thousands of OxyContin-related lawsuits, including 10 from states and numerous ones from cities and counties. To-date, it has settled or pled guilty in the cases that have reached a conclusion. Many experts believe this is a strategy to avoid going to trial where it would have to disclose internal documents that would reveal very damaging information about what Purdue knew about the dangers and harm of OxyContin.

In 2006, Purdue paid $75 million to settle a case brought by 5,000 patients. In another case, it pled guilty to criminal misbranding and acknowledged marketing OxyContin “with intent to defraud or mislead.” Three senior officials pled guilty, but no one from the Sackler family that owns Purdue was punished. The 3 officials all got off with probation and fines totally $35 million. Purdue itself paid a $600 million fine.

The total of $700 million in fines and settlements to-date seems small and hardly a sufficient deterrent, let alone punishment, for Purdue’s blatantly irresponsible marketing and selling of OxyContin. It is only about 2% of the roughly $35 billion in revenue that Purdue has received from OxyContin. Furthermore, it is only about 1% of the $50 billion estimated cost of treatment for those with opioid addiction problems.

In 2010, Purdue reformulated its OxyContin pills, so they are harder to crush or dissolve and, therefore, to abuse. As a result, many of those who had become addicted to OxyContin have now turned to illegal drugs, such as heroin and fentanyl.

Many industry observers believe that an important motivation for the reformulation of OxyContin was not to make it safer, but to extend its patent, which would have run out in 2013. Purdue is now working to block sales of generic versions of the original OxyContin by claiming that they are unsafe.

Purdue continues to fight any restrictions on the prescribing of OxyContin, claiming that such steps would deny law-abiding patients needed pain medication. It has continued to spend heavily on lobbyists and campaign contributions to block enactment of restrictions by government regulators. And, taking a page from the tobacco industry, it is expanding its marketing of the original OxyContin overseas.

I urge you to contact your US Representative and Senators to ask them to support the regulation of prescriptions for opioid pain killers. The Centers for Disease Control (CDC) has introduced guidelines that would reduce the use of OxyContin and other opioid pain medicines. The guidelines state that “Opioids should not be considered first-line or routine therapy for chronic pain”. The guidelines recommend the use of non-drug pain treatment, such as physical therapy, and of non-opioid drugs as the first responses to pain.

Please urge your elected officials to support the implementation of the CDC guidelines on opioid pain killers and to fund opioid treatment, along with addiction prevention and education programs.

[1]      Keefe, P.R., 10/30/17, The family that built an empire of pain, The New Yorker (https://www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain)