A recent joint investigation conducted by the CBS news program 60 Minutes and The Washington Post has made a bombshell claim about the relationship between Congress and the cabal of huge pharmaceutical companies known as Big Pharma.
If the contained claims are accurate, then this report sheds new light on the factors behind the continuing and worsening opioid epidemic that is plaguing nearly every community in the United States.
Identifying the Architects of the Opioid Epidemic
“This is an industry that’s out of control. What they wanna do, is do what they wanna do, and not worry about what the law is. And if they don’t follow the law in drug supply, people die. That’s just it. People die.”
~ Joe Rannazzisi, former Director of the Drug Enforcement Agency’s Office of Diversion Control
When looking at the entities that help create and sustain the opioid epidemic, there is plenty of blame to go around:
- Drug manufacturers – Misleading product claims and overly-aggressive marketing.
- Problem prescribers – Doctors who set up “pill mill” practices to push pain medications , with little concern for patient safety.
- Complicit pharmacies –Druggists ignoring the red flags of problem prescribing.
- Drug distributors –Companies that, in violation of federal law, fail to report suspicious orders.
The DEA Takes Aim at a Strategic Target
Originally, the DEA focused on individual offenders, such as over-prescribing doctors or pharmacies that knowingly filled fraudulent prescriptions. But when those measures did little to slow the rising tide of opioid overdose deaths, officials decided to ship their attention had about the supply chain – the drug distributors.
Because drug distribution companies know exactly how many pills are ordered by and shipped to every pharmacy day supply, they have a legal responsibility. Under the Controlled Substances Act, distributors are required to report, and even suspend suspicious orders. This would include orders that were unusually large or too frequent.
But in the interests of profit, many distributors ignored that responsibility. Jim Geldhof, who conducted pharmaceutical investigations from the DEA office in Detroit, says, “They had a business plan. Their plan was to sell a lotta pills and make a lot of money. And they did both of those very well. All we were looking for is a good-faith effort by these companies to do the right thing. And there was no good-faith effort. Greed always trumped compliance. It did every time.”
How bad was the noncompliance?
Kermit, West Virginia, is a small town with a population of just 392 people. Yet, over a two-year period, a local pharmacy ordered 9 MILLION hydrocodone pills. Elsewhere in the state, Mingo County, population 25,000, received 11 million pain pills within a five-year period.
Yet no reports or suspensions were made by the drug distributors.
Cracking Down on Distributors
“We weren’t seeing just some security violations, and a few bad orders. We were seeing hundreds of bad orders that involved millions and millions of tablets.”
~ Joe Rannazzasi
Up until recently, the DEA was able to go after drug distribution companies that shipped excessive amounts of opioid painkillers to one particular supply location. Companies that were in violation could be subject to a hefty fine.
- 2008 – McKesson, the largest drug distributor in the United States, was penalized for filling suspicious orders and fined $13.2 million.
- Also in 2008 – Cardinal Health was hit with a $34 million fine the same reason.
Between 2008 and 2016, huge drug distributors paid more than $341 million in DEA files.
If fines weren’t deterrent enough, the worst-offending drug distributors could have their ability to ship narcotics frozen by the DEA.
The Drug Industry Fights Back
Rannazzasi was gaining a well-deserved reputation for aggressively pursuing drug companies that crossed the line and knowingly helped contribute to the holocaust of overdose, abuse, addiction, and deaths impacting communities around the country.
In 2011, the drug companies started to push back.
Attorneys for working for the top drug distributors contacted higher-ups at the Justice Department to have Rannazzasi’s questioned. In other words, these companies began to use their considerable money and influence to change the way the DEA handled cases.
According to Rannazzasi, his once-successful strategy began to hit unexpected roadblocks. Supervisors and prosecutors wanted more—often superfluous—evidence in addition to everything his teams were already provided. And even when the additional requirements were met, it still wasn’t enough.
Geldhof says he experienced the same thing, recalling, “I spent a year working on this case. I sent it down there and it’s never good enough. Every time I talked to this guy he wants something else. And I get it for ’em and that’s still not good enough. You know? And this goes on and on and on. When this– these roadblocks keep– get thrown up in your face, at that point you know they just don’t want the case.”
Switching Sides as a Successful Strategy
The drug companies seem to have found another effective way to fight DEA investigations – by hiring the very lawyers that they once faced. Jonathan Novak, who served as a DEA attorney, called it a “revolving door” when former colleagues would leave the DEA to accept high-paying jobs within the pharmaceutical industry.
“Some of the best and the brightest former DEA attorneys are now on the other side and know all of the weak points. Their fingerprints are on memos and policy and emails going out where you see this concoction of what they might argue in the future,” says Novak.
Since 2011, 46 former investigators, supervisors, and attorneys from the DEA have been hired by big pharmaceutical companies and the law firms that represent them. 32 of those hires came directly from the DEA division responsible for regulating the drug industry.
This practice has two effects.
First, now that they have changed sides, these former DEA lawyers can parlay their insider knowledge into successfully bogging down any investigations into their new employers’ business practices. In some instances, they would argue against DEA policies that they themselves had had a hand in implementing.
But more importantly, they could use their established relationships to lobby their former colleagues still within the DEA and Justice Department.
For example, Linden Barber was once an Associate Chief Counsel for the DEA. When he left the DEA in search of greener and richer pastures, he advertised how much he had to offer any clients subject to DEA investigations. From his actual ad:
“If you have a DEA compliance issue, or you’re facing a government investigation, or you’re having administrative or civil litigation involving the Controlled Substances Act, I’d be happy to hear from you.”
Once hired, he also lobbied Congress on behalf of drug companies and helped introduce legislation favorable to his clients.
Now, Barber is a Senior Vice President at Cardinal Health.
Making the DEA “Toothless”
“… the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market.”
~ The Washington Post
In 2016, Congressman Tom Marino of Pennsylvania and Congresswoman Marsha Blackburn of Tennessee proposed a bill, subsequently made into law, that greatly raised the standard of proof necessary for the DEA to act on noncompliant drug distributors.
Not only did this new law make it harder for the DEA to impose fines on those companies, Novak says that it also stripped the DEA of its most potent weapon – the ability to immediately freeze any suspicious drug shipments.
John J. Mulrooney, Chief Administrative Law Judge for the DEA, wrote that this law makes it “all but… impossible to prosecute unscrupulous distributors.”
Undue Influence from Drug Distributors?
According to The Washington Post, lobbying groups representing drug distributors, pharmacy chains, and drug manufacturers spent over $102 million to support the bill.
From an internal Justice Department email obtained by The Washington Post and 60 minutes via the Freedom of Information Act, it was revealed that ex-DEA Associate Chief Counsel and current Cardinal Health Senior Vice President Linden Barber was the author of what is popularly known as the “Marino bill”.
The Aftermath of the Drug Distributors’ “Victory”
Perhaps not coincidentally, Congressman Marino led the investigation against Rannazzasi, even accusing him of trying to intimidate the U.S. Congress when Rannazzasi vehemently expressed his opposition to the introduced bill.
Although the investigation didn’t find Rannazzasi guilty of any wrongdoings, he was nonetheless stripped of most of his authority, going from supervising 600 people to supervising zero. Eventually, he resigned from the DEA.
He now works as a consultant for State Attorneys Generals have chosen to file lawsuits against Big Pharma.
Mike Gill, the former Chief of Staff for the DEA’s Administrator, now works for HDJN, a large law firm that specializes in health care law.
Former senior DEA attorney Jason Hadges, who oversaw enforcement cases, is now employed by Hohan Lovells, a Washington DC-based law firm, in their pharmaceutical and regulatory division.
Bill Tighe, who served as Congressman Marino’s Chief of Staff, is now a highly-paid lobbyist for the National Association of Chain Drug Stores.
As for Congressman Marino, he was nominated by President Donald Trump to be the country’s next drug czar. However, after the damaging 60 Minutes report said that his bill “helped pump more painkillers into parts of the country that were already in the middle of the opioid crisis”, Marino withdrew his name from consideration just days later.