Addiction is NOT a disease — and we’re treating addicts incorrectly
We all know addiction is a disease(no way). It has been so classified by all the authoritative sources. The American Medical Association labeled alcoholism an “illness” back in 1967.
The Centers for Disease Control, the Diagnostic and Statistical Manual of Mental Disorders and Alcoholics Anonymous urge us to think of alcohol and drug addiction as diseases.
Great minds such as Oprah Winfrey, Russell Brand and Joe Biden agree: the then-senator even introduced a bill in 2007 called the “Recognizing Addiction as a Disease Act.” (It never came up for a vote.)
The disease theory has powerful forces behind it, has money behind it. Perhaps most important, it has a comforting thought behind it. Hey, it could happen to anyone. You’re not a morally flawed individual if you catch the flu, are you? We don’t think of people with autism, “They could beat it if they tried.”
“To reject the disease label is not to demote addiction, nor is it to diminish sympathy for the addict’s plight.”
Addiction-as-disease is in some ways a thoroughly American idea. It ties together how we approach medicine (with a precisely defined target and a definitive program to fight it) and our proudly tolerant spirit in which being judgmental is seen as a kind of vice. Plus it opens up profit opportunities from sea to shining sea.
If addiction is a disease, though, why do most addictions end spontaneously, without treatment? Why did some 75% of heroin-addicted Vietnam vets kick the drug when they returned home?
It’s hard to picture a brain disease such as schizophrenia simply going away because someone decided not be schizophrenic anymore.
Addiction is not a disease. It’s simply a nasty habit, says neuroscientist Dr. Marc Lewis, himself a longtime addict and professor of developmental psychology, in his new book, “The Biology of Desire.”
‘Exercise of the will’
Framing addiction as a disease seems like a concept perfectly suited to our times, and yet it reaches back to Aristotle. In 1913, during an era of heavy use of opiates, a book on narcotics urged doctors not to use the word “habit” because “habit implies something that can be corrected by exercise of the will…This is not true of narcotic disease, therefore it is not a mere habit and should not be spoken of as such.
“The man who is addicted to a narcotic drug is as truly a diseased man as one who has typhoid fever or pneumonia.”
In the 1950s, Alcoholics Anonymous and Narcotics Anonymous helped advance this line of thinking by calling addiction a “malady” and physical sensitivity to alcohol an “allergy.” Twelve-step groups who are rigid about the disease theory require members to adhere equally rigidly to the prescribed treatment at the risk of expulsion from the group. At times this means intolerance for individual difference and turning a blind eye to epidemiological data.
For instance, AA teaches that any use of alcohol is likely to lead to a relapse into problem drinking, but in fact there are many recovered alcoholics who return to controlled, moderate social drinking. AA’s approach isn’t right for everyone, Lewis points out.
Even worse, AA is especially fervent about instilling in members the idea that they are powerless over alcohol. This is the opposite of teaching addicts to seize control of the future. “Most former addicts,” notes Lewis, “claim that empowerment, not powerlessness, was essential to them, especially in the latter stages of their recovery.”
He adds that people with excellent reasons to feel generally powerless in life, including minorities, women, the poor and those with especially dismal family histories, are the ones most in need of reconceiving themselves as empowered individuals.
“It’s an open question,” Lewis says, “whether the disease nomenclature, partially absorbed into the AA mainstream, has alienated more members than it’s helped.”
It may be that “exercise of the will” sounds unsatisfying simple, a too-easy solution to what can be a monstrous problem. It also causes friction with a culture that extols technical knowledge — the expert-ocracy.
Reliance on experts is supported by both supply and demand sides: As customers, we love to think that if we have a particularly nasty problem, there is someone out there who knows exactly what to do. And the $35 billion addiction-treatment industry is happy to take your money to help.
Very bad habits
Proponents of the disease theory have one talking point that they love to repeat before they hurry to change the subject: Addiction changes the structure of the brain.
This may be enough to convince non-specialists, but to experts in the field the claim that altered brain structure proves the presence of disease sounds ludicrous. The brain is a plastic organ. It changes when you age. It changes when you learn a new language or a musical instrument. It changes when you fall in love. It changes when you have children. It even changes the third time you hear your boss make a dismissive comment and you start to conclude, “This guy’s a jerk.”
The brain is continuously reshaping its neural networks. It’s like the Manhattan streetscape: Some are always under construction.
“To say that addiction changes the brain is really just saying that some powerful experience, probably occurring over and over, forges new synaptic configurations that settle into habits,” writes Lewis, who was a drug addict through most of his 20s. “Addiction may be a frightful, devastating and insidious process of change in our habits and our synaptic patterning. But that doesn’t make it a disease.”
Are we quibbling over mere word choice, though — synaptic semantics?
No, because how we see addiction is critical to how we treat it. Lewis isn’t suggesting telling addicts, “It’s all in your head. Get over it.” But he views the mushrooming of rehab centers with unease: If these businesses actually succeeded in “curing” everybody, they’d have to shut down. Calling addiction a disease is meant in part to emphasize the seriousness of being in thrall to drugs or alcohol, to elevate it to the level of a noble battle with cancer.
To reject the disease label is not to demote addiction, nor is it to diminish sympathy for the addict’s plight.
“The severe consequences of addiction,” writes Lewis, “don’t make it a disease, any more than the severe consequences of violence make violence a disease, or the severe consequences of racism make racism a disease, or the folly of loving thy neighbor’s wife makes infidelity a disease. What they make it is a very bad habit.”
Rewriting your brain
Lewis delves into case studies of addicts to illustrate different strategies people use to free themselves. “Natalie,” for instance, was a nice, middle-class student at a liberal-arts college who gradually sank into a swamp of heroin.
She started on typical college drugs — pot, magic mushrooms, ecstasy. But she found opiates like OxyContin to be a big step up in satisfaction: “They didn’t pitch you into a colorful fairyland, the way mushrooms and acid did. Instead they wrapped you in a stocking of inner peace, utter relaxation. Not the kind of sedation you’d get from a tranquilizer, but something subtler and yet more potent . . . Some misty layer of anxiety was always floating above the surface of things. Until opiates took it away.”
“Natalie” turned to heroin because it was cheaper than pills, first snorting and smoking the drug. But when she saw someone shoot up, she was transfixed. She wanted to join in that ritual herself — the heating of the brown powder in the spoon, the tourniquet, the needle.
Natalie was rerouting her brain with a feedback loop, creating more and more associations with the heroin craving. Soon it became difficult to focus on anything else — job, school, family. Her connections with people outside her drug circle frayed and disintegrated. After a mishap involving a borrowed car and a failed stint in rehab, she found herself spending nine months in a maximum-security prison.
So she taught herself to meditate. It was not as simple as “deciding to get clean.” Rewiring her thinking was work. She was building new neural paths for herself and breaking up the old ones. “They didn’t pitch you into a colorful fairyland, the way mushrooms and acid did. Instead they wrapped you in a stocking of inner peace, utter relaxation. Not the kind of sedation you’d get from a tranquilizer, but something subtler and yet more potent . . . Some misty layer of anxiety was always floating above the surface of things. Until opiates took it away.”
“We could say that Natalie chose to stop using drugs, but it’s not that simple either,” Lewis writes. “Instead, desire was rerouted. It was now in league with other goals: self-preservation, self-control, a respite from her weariness.” Natalie was educating herself as surely as someone who learns Japanese is doing so.
Natalie had to learn to overcome what Lewis calls “now appeal” — putting short-term gratification ahead of long-term thriving. When we crave something, our brains are awash in dopamine, which brings pleasure in itself. Addiction is less about enjoyment than it is about anticipation, about desire. But resisting temptation requires a lot of brain energy. At some point fatigue sets in and it becomes too exhausting not to give in.
Addicts are told again and again to resist, by counselors, therapists, friends and relatives. Just say no!
“Yet the research tells us unambiguously,” writes Lewis, “that suppression is the wrong way to go, because it accelerates ego fatigue.’
Achieving mastery over yourself requires instead a shift of perspective and a reinterpretation of your emotional state. “Instead of tying yourself to the mast in order to resist the Sirens’ song, you must recognize the Sirens as harbingers of death and reframe their songs as background noise,” Lewis says.
The ability to resist “now appeal” is thought to be centered in the left dorsolateral prefrontal cortex, which is more developed in mature adults. That’s why addiction is so often associated with youth. There is some evidence that people who learn to beat addiction are developing that area of the brain, as you might work on building up your triceps.
Embracing a future
Drugs can help by suppressing cravings or easing withdrawal symptoms, but getting free of addiction is fundamentally a process of internal development, Lewis argues. In case studies he presents in the book, he explains how honest personal reflection, reconnecting how past behavior led to current predicaments and imagining a different and better future were instrumental to successful outcomes for addicts.
“[The brain]… is like the Manhattan streetscape: Some are always under construction.”
Addiction isn’t a direct result of a stress-filled childhood, but there is close correlation between the two, and a survey that explored high youth suicide rates in some Native American areas of Western Canada found that in such communities young people were “incapable of talking about their lives in any coherent, organized way,” Lewis says. “They had no clear sense of their past, their childhood, and the generations preceding them. And their attempts to outlines possible futures were empty of form and meaning. They simply could not consider their lives as narratives, or stories.”
To Lewis, there’s a clear lesson here.
“Humans need to be able to see their own lives progressing, moving from a meaningful past to a viable future. They need to see themselves as going somewhere, as characters in a narrative.”
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Never allow your doctor to tell you that addictive drugs are okay. They are NOT okay. They will cause other disorders and diseases as they kill you slowly. These include: opioids, benzodiazepines, antidepressants, hypnotics, stimulants, and antipsychotics. There is no reason on earth to be given these unless you have to be in the safety of a psychiatric institution. Right now, here in the US, one person is dying from an accidental opioid overdose every 12.5 minutes. I don’t want you to be part of that statistic.
INSYS THERAPEUTICS PAID MILLIONS OF DOLLARS TO DOCTORS. THE COMPANY CALLED IT A “SPEAKER PROGRAM,” BUT PROSECUTORS NOW CALL IT SOMETHING ELSE: A KICKBACK SCHEME.
Selling drugs is a relationship business. It’s best to do it in person. That is why, on a summer evening in 2012, Alec Burlakoff was out for dinner with Steven Chun, the owner of Sarasota Pain Associates. Burlakoff was a sales manager for Insys Therapeutics, an Arizona-based pharmaceutical company with only one branded product, a new and highly potent opioid painkiller called Subsys. Chun was a doctor who prescribed a lot of opioids.
The location was a moderately expensive seafood restaurant in Sarasota, Fla., with linen tablecloths and large windows overlooking the bay. The sun was still high in the sky. Gleaming powerboats lined the docks outside, and a warm breeze rippled the water. On one side of the table were Burlakoff and Tracy Krane, an Insys sales representative. Krane was a newcomer to the industry, tall with dark brown hair in a bob. Burlakoff, then 38, with a slight frame and a boyish restlessness, was her new boss. He had years of experience in the opioid market. Colleagues marveled over his shameless push to make the sale, but he had a charisma that was hard to resist. Even people who didn’t trust him couldn’t help liking him.
Krane was there to learn the business, and the meeting made a vivid impression. Chun, then 49 and stout, had impeccable credentials: He was trained at the University of Washington, Cornell Medical College and the Memorial Sloan Kettering Cancer Center. He had been married at the Fifth Avenue Presbyterian Church in Manhattan, to a Juilliard-trained violinist who is the daughter of a former chief executive of Korean Air, but had since divorced. At Burlakoff’s invitation, he had brought his girlfriend at the time, a woman in her mid-20s, to dinner.
For Insys, Chun was just the right kind of doctor to pursue. In the late 1990s, sales of prescription opioids began a steep climb. But by the time Subsys came to market in 2012, mounting regulatory scrutiny and changing medical opinion were thinning the ranks of prolific opioid prescribers. Chun was one of the holdouts, a true believer in treating pain with narcotics. He operated a busy practice, and 95 percent of the Medicare patients he saw in 2015 had at least one opioid script filled. Chun was also a top prescriber of a small class of painkillers whose active ingredient is fentanyl, which is 50 to 100 times as powerful as morphine. Burlakoff’s product was a new entry to that class. On a “target list” derived from industry data that circulated internally at Insys, Chun was placed at No. 3. The word inside the company for a doctor like Chun was a “whale.”
In the few months since Subsys was introduced, demand was not meeting expectations. Some of the sales staff had already been fired. If Burlakoff and Krane could persuade Chun to become a Subsys loyalist, it would be a coup for them and for the entire company. The drug was so expensive that a single clinic, led by a motivated doctor, could generate millions of dollars in revenue.
Over dinner, Burlakoff grew expansive, Krane recalled. She marveled at the way he drew on a wealth of information about the doctor — intelligence gathered over the course of years — without letting on just how much he knew. Before he worked for Insys, Burlakoff worked for Cephalon, Insys’s chief competitor, and he knew a bit about Chun’s romantic history, Krane said. He also knew that Chun liked to visit the casinos up in Tampa, so Burlakoff made a point of talking about his own penchant for gambling, according to Krane. She had no idea if he was telling the truth.
It is unclear whether Burlakoff knew that Chun was also, at that moment, in the middle of an expensive legal battle. The previous year, two nurses who formerly worked for him secretly filed a whistle-blower suit charging “widespread billing schemes” intended to defraud the government, and federal agents executed a search warrant on his clinic. (Chun would later pay $750,000 to the Department of Justice to resolve the claims. He was never charged with a crime and denies all wrongdoing.)
What is clear is that Burlakoff thought that Chun was a tremendous prize. After briefly extolling the virtues of Subsys, Krane recalled, Burlakoff finally arrived at the true purpose of the dinner. He had a proposition to make. Insys wanted to sign Chun up, he said, for the company’s speaker program, which was just getting underway.
Speaker programs are a widely used marketing tool in the pharmaceutical business. Drug makers enlist doctors to give paid talks about the benefits of a product to other potential prescribers, at a clinic or over dinner in a private room at a restaurant. But Krane and some fellow rookie reps were already getting a clear message from Burlakoff, she said, that his idea of a speaker program was something else, and they were concerned: It sounded a lot like a bribery scheme.
Burlakoff left the dinner in a great mood, Krane said, confident that Chun would come on board. The doctor did become an Insys speaker later that year, and sales did improve, not only in Chun’s Florida office but also around the country, as more doctors signed on. By the next year, according to the company, net revenue from Subsys sales would increase by more than 1,000 percent, to $95.7 million.
But the new reps were right to be worried. The Insys speaker program was central to Insys’ rapid rise as a Wall Street darling, and it was also central to the onslaught of legal troubles that now surround the company. Most notable, seven former top executives, including Burlakoff and the billionaire founder of Insys, John Kapoor, now await trial on racketeering charges in federal court in Boston. The company itself, remarkably, is still operating.
The reporting for this article involved interviews with, among other sources, seven former Insys employees, among them sales managers, sales reps and an insurance-authorization employee, some of whom have testified before a grand jury about what they witnessed. This account also draws on filings from a galaxy of Insys-related litigation: civil suits filed by state attorneys general, whistle-blower and shareholder suits and federal criminal cases. Some are pending, while others have led to settlements, plea deals and guilty verdicts.
In the Insys case, prosecutors are looking to break new ground in holding the pharmaceutical and medical industry accountable in connection with the current opioid crisis. They’re attacking both ends of the pharma sales transaction; 11 prescribers face charges or have been convicted over their ties to Insys, and Chun has recently been subpoenaed for medical records related to Subsys. In looking into Insys’s relationship to providers like him, investigators are revealing just how opioids are sold at the point they first enter the national bloodstream — in the doctor’s office.
THE OPIOID CRISIS, now the deadliest drug epidemic in American history, has evolved significantly over the course of the last two decades. What began as a sharp rise in prescription-drug overdoses has been eclipsed by a terrifying spike in deaths driven primarily by illicitly manufactured synthetic opioids and heroin, with overall opioid deaths climbing to 42,249 in 2016 from 33,091 in 2015. But prescription drugs and the marketing programs that fuel their sales remain an important contributor to the larger crisis. Heroin accounted for roughly 15,000 of the opioid deaths in 2016, for instance, but as many as four out of five heroin users started out by misusing prescription opioids.
By the time Subsys arrived in 2012, the pharmaceutical industry had been battling authorities for years over its role in promoting the spread of addictive painkillers. The authorities were trying to confine opioids to a select population of pain patients who desperately needed them, but manufacturers were pushing legal boundaries — sometimes to the breaking point — to get their products out to a wider market.
Even as legal penalties accrued, the industry thrived. In 2007, three senior executives of Purdue Pharma pleaded guilty in connection with a marketing effort that relied on misrepresenting the dangers of OxyContin, and the company agreed to pay a $600 million settlement. But Purdue continued booking more than $1 billion in annual sales on the drug. In 2008, Cephalon likewise entered a criminal plea and agreed to pay $425 million for promoting an opioid called Actiq and two other drugs “off-label” — that is, for unapproved uses. That did not stop Cephalon from being acquired three years later, for $6.8 billion.
Subsys and Actiq belong to a class of fentanyl products called TIRF drugs. They are approved exclusively for the treatment of “breakthrough” cancer pain — flares of pain that break through the effects of the longer-acting opioids the cancer patient is already taking around the clock. TIRFs are niche products, but the niche can be lucrative because the drugs command such a high price. A single patient can produce six figures of revenue.
Fentanyl is extremely powerful — illicitly manufactured variations, often spiked into heroin or pressed into counterfeit pills, have become the leading killers in the opioid crisis — and regulators have made special efforts to restrict prescription fentanyl products. In 2008, for instance, the F.D.A. rebuffed Cephalon’s application to expand the approved use for a TIRF called Fentora; in the company’s clinical trials, the subjects who did not have cancer demonstrated much more addictive behavior and propensity to substance abuse, which are “rarely seen in clinical trials,” F.D.A. officials concluded. An F.D.A. advisory committee reported that, during the trials, some of the Fentora was stolen. The agency later developed a special protocol for all TIRF drugs that required practitioners to undergo online training and certify that they understood the narrow approved use and the risks.
Despite these government efforts, TIRF drugs were being widely prescribed to patients without cancer. Pain doctors, not oncologists, were the dominant players. This was common knowledge in the industry. Although it is illegal for a manufacturer to promote drugs for off-label use, it is perfectly legal for doctors to prescribe any drug off-label, on their own judgment. This allows drug makers like Insys to use a narrow F.D.A. approval as a “crowbar,” as a former employee put it, to reach a much broader group of people.
That points to a major vulnerability in policing the opioid crisis: Doctors have a great deal of power. The F.D.A. regulates drug makers but not practitioners, who enjoy a wide latitude in prescribing that pharmaceutical companies can easily exploit. A respected doctor who advocates eloquently for wider prescribing can quickly become a “key opinion leader”; invited out on the lucrative lecture circuit. And any doctor who exercises a free hand with opioids can attract a flood of pain patients and income. Fellow doctors rarely blow the whistle, and some state medical boards exercise timid oversight, allowing unethical doctors to continue to operate. An assistant district attorney coping with opioids in upstate New York told me that it’s easy to identify a pill-mill doctor, but “it can take five years to get to that guy.” In the meantime, drug manufacturers are still seeing revenue, and that doctor is still seeing patients, one after another, day after day.
JOHN KAPOOR, the founder of Insys, has flirted with legal trouble throughout his long career as a pharmaceutical entrepreneur. Raised in India, where he was the first in his family to go to college, he immigrated to the United States to pursue a doctorate, he has said, with five dollars in his pocket. He amassed a fortune with a series of pharmaceutical ventures, mostly in the unglamorous arena of generic drugs. One of his companies, Lyphomed, drew sanctions from the F.D.A. related to manufacturing problems, leading to recalls and a consent decree. After he sold Lyphomed to a Japanese firm in 1990, personally reaping more than $100 million, the buyer sued him, claiming that he had been deceptive about the company’s regulatory difficulties. He settled out of court. Another of Kapoor’s big investments, Akorn, was delisted from Nasdaq during his tenure as chief executive for filing unaudited financial statements, but his stake, held in trust, is now worth hundreds of millions, despite new controversy over possible breaches of F.D.A. requirements at the company.
Kapoor, now 74, bankrolled Insys almost entirely on his own for over a decade, shepherding Subsys on the long road to approval by the Food and Drug Administration. What motivated him, he has often said, was seeing his wife, Editha, suffering from metastatic breast cancer, before her death in 2005 at 54.
Often called Dr. Kapoor, he more closely resembles an academic than a business titan, with glasses and a signature mop of graying hair. But employees found that Kapoor could be aggressive and unyielding. At Insys he was known to pound the table; he dressed down a manager in front of colleagues. People who worked for him speak of the need to “survive” him.
Kapoor believed that he had the best product in its class. All the TIRF drugs — for transmucosal immediate-release fentanyl — deliver fentanyl through the mucous membranes lining the mouth or nose, but the specific method differs from product to product. Actiq, the first TIRF drug, is a lozenge on a stick. Cephalon’s follow-up, Fentora — the branded market leader when Subsys arrived — is a tablet meant to be held in the cheek as it dissolves. Subsys is a spray that the patient applies under the tongue. Spraying a fine mist at the permeable mouth floor makes for a rapid onset of action, trials showed.
Once the F.D.A. gave final approval to Subsys in early 2012, the fate of Insys Therapeutics rested on selling it in the field. The industry still relies heavily on the old-fashioned way of making sales; drug manufacturers blanket the country with representatives who call on prescribers face to face, often coming to develop personal relationships with them over time.
To carry out a delicate sales campaign, Insys made some unusual choices. Overseeing the launch under Kapoor, then the executive chairman, would be his 36-year-old protégé, Michael Babich, who had been named the Insys chief executive. A tall Chicagoan, Babich had worked for Kapoor in various roles since he was in his 20s, when Kapoor recruited him from an asset-management firm. Kapoor introduced Babich to the staff as a rising talent, but he had never led a sales effort for an F.D.A.-approved drug. According to former Insys managers, Babich tended to defer to Kapoor, who was, after all, putting up his own money.
To build the sales force, Insys hired a number of notably attractive people in their 20s and 30s, mostly women — not an uncommon tactic in the industry. But Insys reps tended to be particularly inexperienced, often with no background in pharmaceutical sales. “They were hiring people straight out of college,” said Jim Coffman, who worked as a regional sales trainer at Insys in 2012. “So there was a certain naïveté, which played into their objectives and goals.” The company was offering salaries well below market rates — typically paying a rep $40,000 when other companies would offer twice that amount — but dangling the lure of stock options and unusually large commissions.
Examining detailed TIRF sales data purchased from third parties, Insys executives zeroed in on an important fact: The entire market was anchored by a relatively small pool of prescribers. Winning the business of a handful of carefully selected practitioners per state could be enough to make Insys the market leader. The names at the top of the chart were well known in the field.
Insys managers divided the existing base of TIRF prescribers into deciles, according to how many scripts they wrote. The “high decile” practitioners tended not to specialize in treating cancer pain, according to the Boston indictment, but Insys went right after them. Sales reps were instructed to call on them multiple times a week, to the point of sitting in their waiting rooms for hours, angling for a moment with the doctor. As one manager told me, “You fish where the fish are.”
A SPEAKER PROGRAM was in the works at Insys from the start, but in the first months after Subsys hit the market, it had not gotten underway. During that period, Kapoor was disappointed by the sales of the drug, according to former employees. Managers thought the expectations were unrealistic, given that the company had beginner reps and entrenched competitors, but Kapoor didn’t want to hear it. He and Babich would soon meet with each regional sales manager one on one at the home office, and some meetings would be contentious. Turnover in the sales staff was running high.
It was then that Alec Burlakoff arrived, asking about a job. Burlakoff had a history that might have put off some potential employers. In 2002, Eli Lilly fired him as a sales rep amid an investigation by the Florida attorney general’s office into a supposed scheme to send unsolicited pills — a slow-release form of Prozac — to patients through the mail. When Burlakoff and two other fired employees sued Lilly in return, claiming the plan was approved by management, they gained media attention nationwide. Burlakoff said in a court filing that his reputation in the industry was permanently scarred. (The case was settled.) When Burlakoff later sold Actiq and Fentora at Cephalon, he was based in the Southeast region, a hot spot in the investigations into the promotion of both those drugs.
Former Insys employees consistently describe Burlakoff’s arrival as a turning point. Insys initially hired him to head the Southeast region, but within three months, he was promoted to run the entire sales force. The speaker program swiftly became the centerpiece of the sales effort, and Burlakoff made it clear how he wanted it to work.
He explained it all to Tracy Krane on the first day they met, she told me, while they were sitting in her white Cadillac CTS. It was a conversation she later recounted, she said, in a grand-jury proceeding in connection with the Boston criminal case. Burlakoff had traveled to her territory to join her on a “ride along,” coaching her through sales calls on an oppressively sunny day, and they had just left Chun’s office. The ostensible purpose of a pharma-speaker program, as Krane understood it, was to spread the word about the drug through peer-to-peer marketing. With “honorariums” changing hands, the potential for a subtle corruption is clear, but Burlakoff was not subtle. He told Krane, she said, that the real target was not the audience but the speaker himself, who would keep getting paid to do programs if and only if he showed loyalty to Subsys. It was a quid pro quo or, as the Department of Justice later called it, a kickback. “He boiled it right down,” Krane recalled: We pay doctors to write scripts. That’s what the speaker program is.
Krane didn’t know all the rules, she told me, but this didn’t sound right. She turned to Burlakoff and asked, “Isn’t that illegal?”
He brushed off the question, Krane said, with a tone she likened to patting a child on the head and telling her not to worry — the worst that could happen was the company would have to pay a settlement. If Burlakoff in fact said this, he had some reason. It was during his time at Cephalon that the company handily survived its penalty for engaging in illegal promotional schemes.
Emails that have surfaced in court and public-records requests give the flavor of the sales messages that top executives were sending. One week after Burlakoff was hired, Babich, the chief executive, wrote an email to his sales managers, directing them to make sure that reps understood “the important nature of having one of their top targets as a speaker. It can pay big dividends for them.” Burlakoff urged on his sales staff, peppering them with emails and texts that alternated between the tropes of motivational speaking (“we are all starting a new opportunity to be our very best when we get out of bed tomorrow!”) and arm-twisting reminiscent of “Glengarry Glen Ross.” “PROGRAMS ARE THE ONLY THING THAT MATTERS,” he wrote. “WHY DO SOME OF YOU REFUSE TO ACKNOWLEDGE THIS PROVEN FACT?”
The speaker events themselves were often a sham, as top prescribers and reps have admitted in court. Frequently, they consisted of a nice dinner with the sales rep and perhaps the doctor’s support staff and friends, but no other licensed prescriber in attendance to learn about the drug. One doctor did cocaine in the bathroom of a New York City restaurant at his own event, according to a federal indictment. Some prescribers were paid four figures to “speak” to an audience of zero.
Burlakoff appears at first to have tried to shield Kapoor from the details of the Insys speaker programs, or I.S.P.s, as they were sometimes called in-house. “I need your guidance on how to present to Dr. Kapoor I.S.P.’s in a way — where he won’t get involved,” he wrote to Babich in an email obtained through a public-records request. Babich replied, “You got it.” Top executives, however, soon prepared documents for Kapoor, according to the Boston indictment, that explicitly calculated the I.S.P. “return on investment” for each speaker and indicated that underperformers could be culled from the program. Prosecutors have not yet presented evidence that Kapoor in fact saw the documents.
But Kapoor also had a direct contact out in the field, a New Jersey rep at the bottom of the hierarchy named Susan Beisler, who left a paper trail that could present legal difficulties for Kapoor. Beisler, then in her late 30s, seems to have had a close relationship with Kapoor, signing one email “many hugs and kisses,” according to a pending lawsuit filed by the New Jersey attorney general. Beisler complained to Kapoor that the speaker money “being thrown” at certain doctors was giving an unfair edge to their reps, particularly Burlakoff’s “friends,” according to the suit. Burlakoff had hired a number of Cephalon alumni he knew, reps who had pre-existing relationships with key doctors. As early as the summer of 2013, according to a federal indictment, an Insys rep — possibly Beisler — wrote to Kapoor that it was “so not right” that one high-prescribing doctor was “getting $2,500 a pop to eat at fancy steakhouses in NYC often,” adding, “I don’t think anyone even goes to his ‘programs.” The following year, according to the Boston indictment, Insys quadrupled the budget devoted to the speaker program to $10 million. In the end, the Top 10 speakers each made more than $200,000.
INSYS WASN’T JUST winning over top TIRF prescribers from the competition. It was creating new ones. One star rep in Florida, later promoted to upper management, told another rep that when she went in search of potential speakers, she didn’t restrict herself to the top names, because, after all, any doctor can write scripts, and “the company does not give a [expletive] where they come from.” (Some dentists and podiatrists prescribed Subsys.) She looked for people, she said, “that are just going through divorce, or doctors opening up a new clinic, doctors who are procedure-heavy. All those guys are money hungry.” If you float the idea of becoming a paid speaker “and there is a light in their eyes that goes off, you know that’s your guy,” she said. (These remarks, recorded by the rep on the other end of the line, emerged in a later investigation.)
Unsurprisingly, tactics like these attracted some questionable figures to the program. In an email that surfaced in a lawsuit brought by the Illinois attorney general, a sales rep in the state reported directly to Babich about a pain-management doctor named Paul Madison: “Dr. Madison runs a very shady pill mill that only accepts cash,” the rep wrote. “He is extremely moody, lazy and inattentive. He basically just shows up to write his name on the prescription pad, if he shows up at all.” Insys was not deterred, it appears. According to the Boston indictment, Babich and Burlakoff hired a former exotic dancer named Sunrise Lee as a sales manager, and she helped court Madison as an Insys speaker. The company paid Madison tens of thousands dollars even after he was indicted on insurance-fraud charges that are still pending. (He pleaded not guilty.) According to the Illinois suit, which Insys later settled, he single-handedly accounted for 58 percent of the Subsys prescribed in Illinois over a three-year period.
In a March 2013 email to the sales force, Burlakoff singled out five reps at the top of the company leader board and noted that they “literally have their entire business being driven by basically one customer.” These “customers” were the top five Subsys prescribers in the nation, according to a pending lawsuit brought by the state of Arizona, and all were well-compensated Insys speakers. Three have been convicted of felonies; one has not been charged but had his license revoked. Only one remains in practice.
As a result of Insys’s approach to targeting doctors, its potent opioid was prescribed to patients it was never approved to treat — not occasionally, but tens of thousands of times. It is impossible to determine how many Subsys patients, under Kapoor, actually suffered from breakthrough cancer pain, but most estimates in court filings have put the number at roughly 20 percent. According to Iqvia data through September 2016, only 4 percent of all Subsys prescriptions were written by oncologists.
Jeff Buchalter, 34, a decorated Iraq war veteran, was one off-label Subsys patient. His doctor, William Tham, a paid Insys speaker, prescribed the drug to treat pain stemming from Buchalter’s wartime injuries, eventually raising the dose well beyond the maximum amount indicated by the F.D.A. Buchalter was taking it 12 times a day, not four to six, and alternating between the two highest doses, a medical chart from Tham’s clinic shows. Eventually, he had to be put under sedation in intensive care at Fort Belvoir, Va., while he went through withdrawal from Subsys and other prescription drugs. “I am frankly astonished at the amount of opioids the patient has been prescribed,” a hospital specialist noted in his records. Buchalter is suing Insys and Tham. (Tham’s lawyer, Andrew Vernick, told me, “He has done nothing wrong in this case, and he is not involved in any of the allegations that have been raised against Insys throughout the country.”)
Buchalter said Subsys gave him relief from pain, but it changed him into someone he did not recognize. He had always defined himself as a hard worker with integrity. With his eyes darting around the room as he spoke, he told me he became an addict, his day revolving around the next dose: He slept under his desk at the office, where boxes of Subsys filled the drawers, and his house went into foreclosure. Buchalter looked troubled and tired when we met. His hands were visibly dirty. “I’ve been absent from my life for years,” he told me. “What I remember is who I was when my daughter was born, and when I was a soldier.”
THE PREVALENCE OF off-label prescribing, while legal, did initially present Insys with a challenge. Owing to the risk and expense of Subsys, nearly all health insurers required prior authorization and would pay for the drug only for its sole approved use: breakthrough cancer pain. Only about one-third of Subsys prescriptions were being approved for reimbursement in late 2012. So Insys created an internal division dedicated to improving that number.
According to a former employee and multiple court filings, including a manager’s guilty plea, the company offered to relieve doctors’ offices of insurance hassles and take on the task of getting prescriptions covered. Insys’ “prior authorization specialists” — workers who the company motivated with bonuses — would contact insurers or their contractors, giving the impression they were calling from the prescribing doctor’s office. They used what managers called “the spiel,” which led insurers to believe that patients had cancer when they did not. Sometimes they would falsify medical charts and outright lie, former staff members have acknowledged. Babich, the chief executive, was involved in arranging for this unit’s phone system to block Caller ID to disguise the fact that calls were not coming from the doctor’s office, according to the Boston indictment.
The initiative worked. By the following spring, a company estimate pegged the approval rate for commercial insurers at 87 percent.
With insurance approval now catching up with prescriptions, Insys revenue and market share were climbing sharply, but a serious threat was brewing within. Within six months of the Subsys launch, one rep based in Texas, Ray Furchak, started to consider reporting Insys to government authorities. The speaker program, he felt, amounted to a thinly disguised kickback scheme, and he was also concerned that management was pushing an overly high dose of Subsys to first-time patients, despite boldface F.D.A. warnings of the dangers. Furchak began to collect emails and texts as evidence.
He soon filed a whistle-blower complaint against the company, as well as John Kapoor. But the defendants did not know they had been sued for months — the case proceeded under seal.
While Insys’s fortunes were on the rise, Furchak’s suit was under review at the Justice Department. In cases like his, called qui tams, a whistle-blower sues on behalf of the government, claiming fraud, and stands to share in any recovered funds. Justice Department lawyers quietly conducted interviews, weighing whether to intervene and join the plaintiff in the suit. It was one of hundreds of decisions like it that qui tam investigators face at any given time. An investigator at the Department of Health and Human Services, Michael Cohen, told me the federal government faces an overwhelming amount of health care fraud: “We call it a tsunami.”
Fortunately for Insys, the Justice Department declined to intervene in Furchak’s case. A lawyer familiar with the decision cited the difficulty of proving significant damages; Insys was not a big fish yet. Furchak did what most people do in this situation: He dropped the suit. The judge ordered his complaint unsealed, but the media took no notice at the time. Insys was free to go on doing what it was doing. It would be a long time before the law caught up to it.
In May 2013, two months after the Justice Department decision, the company went public. At an event at the Nasdaq MarketSite in Times Square, Kapoor and Babich stood smiling, surrounded by a group of cheering Insys executives.
By the end of 2013, Subsys would become the most widely prescribed branded TIRF, according to a company S.E.C. filing. In an ebullient “State of the Union” message to the sales force that October, Babich joked about hiring midget wrestlers to perform at the next national sales meeting. Now the competition was going to come after Insys, he said. “One problem they have … they don’t have a chance in hell!”
Insys became the year’s best-performing initial public offering, on a gain of over 400 percent. That December, the company disclosed that it had received a subpoena from the Office of the Inspector General at Health and Human Services, an ominous sign. But a CNBC interviewer made no mention of it when he interviewed Babich a few weeks later. Instead he said, “Tell us what it is about Insys that has investors so excited.”
BY THEN, THOUGH, Insys management had identified a potential worry in the Southeast region. Xiulu Ruan and John Patrick Couch, each a well-compensated Insys speaker, jointly owned and operated a pain clinic in Mobile, Ala., that served thousands of clients. Their main location occupied a one-story brown building on a commercial strip on the western outskirts of the city, adjacent to a Shell station.
Ruan was able to successfully recommend an Insys rep for their territory, a 27-year-old named Natalie Perhacs. Ruan had been asking her out to dinner for several months, to no avail; now she would be in his clinic several times a week. In her previous job, Perhacs’s salary was just over $30,000, but in two years selling Subsys almost exclusively to Ruan and Couch, she made $700,000. (Perhacs later pleaded guilty to conspiracy to violate a federal anti-kickback statute.)
Ruan and Couch had many patients legitimately in need of pain treatment. But it would be difficult to miss, from regularly visiting the clinic or from prescribing data alone, that something was awry. “Oh, everybody knew it,” a nurse at a different Mobile practice told me.
In 2014, the doctors each averaged one prescription for a controlled substance roughly every four minutes, figuring on a 40-hour week. A typical pill mill makes its money from patients paying in cash for their appointments, but Ruan and Couch had a different model: A majority of their scripts were filled at a pharmacy adjacent to their clinic called C&R — for Couch and Ruan — where they took home most of the profits. The pharmacy sold more than $570,000 of Subsys in a single month, according to Perhacs’s criminal plea. Together the two men amassed a collection of 23 luxury cars.
Two former patients told me that people approached them to buy or sell prescription drugs in the clinic’s parking lot. “There was always one or two out there,” Alice Byrd Jordan said.
One patient, Keith Bumpers, told me that he had thought his doctor at the clinic was “Dr. Justin.” Justin Palmer was a nurse practitioner who testified that he routinely forged Couch’s name on prescriptions. He was one of three medical staff members at the clinic who were personally misusing painkillers at work. One of them died by suicide; the other two admitted seeing patients while impaired. A patient named Tamisan Witherspoon, who was prescribed Subsys off-label and became addicted, testified that a nurse practitioner at the clinic, Bridgette Parker, spoke incoherently and collapsed asleep in an exam room in front of her. Witherspoon recognized the state Parker was in, because she had been there herself, she said, from taking Subsys. “I started to cry,” Witherspoon said on the witness stand, “because I realized that she was in trouble and so was I.”
In court testimony, Perhacs acknowledged that in late 2013, there was a “sense of panic” at Insys regarding the situation at the clinic in Mobile. The problem was that the clinic wasn’t generating enough money for the company.
“Dr. Ruan and Dr. Couch are way down,” Burlakoff wrote to Perhacs. “Can you assist please. … This was the topic of conversation today with Dr. Kapoor and Mike.”
In fact, Couch and Ruan were still writing a lot of Subsys scripts. But they had started prolifically prescribing a Subsys competitor too: Abstral, then made by Galena Biopharma. One reason Insys was losing out on potential sales, according to the Boston indictment, was that C&R Pharmacy was having trouble getting enough Subsys from distributors to keep it in stock — because of measures designed to combat the opioid crisis.
The flow of controlled substances through distributors, which are the middlemen between drug companies and pharmacies, is strictly regulated, and distributors have paid hefty settlements for failing to notify the Drug Enforcement Administration of “suspicious orders” of controlled substances from particular pharmacies. Couch and Ruan’s pharmacy was hitting caps with their distributor, according to Perhacs’s testimony — an “enormous barrier,” a manager wrote to her. In internal emails cited in the Boston indictment, leadership scrambled to find a way to beat the competition and get around the caps at the same time. One executive wrote that “certain parties would be at risk” if they were not careful. Sales reps in the region felt they needed assistance. A manager wrote to Perhacs, “Hopefully with a little help from above we can land this.”
On Feb. 13, 2014, the help arrived. Two men flew to Alabama to have dinner at a steakhouse with Couch and Ruan and their pharmacists, booking rooms for the night at the Renaissance Hotel by the Mobile River. The two men who flew to Mobile for this meeting were the chief executive, Michael Babich, and the billionaire founder of Insys Therapeutics, John Kapoor.
Over dinner, according to the Boston indictment, Kapoor and Babich struck a remarkable agreement with the pharmacists and the doctors, who were operating a clinic rife with opioid addiction among the staff: Insys would ship Subsys directly to C&R Pharmacy. An arrangement like this is “highly unusual” and a “red flag,” according to testimony from a D.E.A. investigator in a related trial. As part of the terms of the deal, the pharmacy would make more money on selling the drug, with no distributor in the loop. And there would be another anticipated benefit for all involved: Everyone could sell more Subsys without triggering an alert to the D.E.A.
IT WAS NOT long after that dinner in Alabama that the troubles at Insys came more clearly into public view. Early in 2014, according to a former employee at Insys headquarters cited in a shareholder suit, top executives learned that a major Subsys “whale” based in Michigan, Gavin Awerbuch, was under investigation. Awerbuch was a well-paid speaker and, by a large margin, the top prescriber of Subsys to Medicare patients. Further details have emerged in the Boston indictment and other court filings. Burlakoff had personally cultivated Awerbuch, flying to Michigan to take him out to dinner and then writing an email to colleagues: “Expect a nice ‘bump’ fellas.”
As it turned out, unfortunately for Insys, Awerbuch was under the eye of authorities even before Subsys went on the market. He was submitting insurance claims for bogus tests and liberally writing opioid scripts. As investigators closed in on him, his fondness for a new drug called Subsys caught their eye. He prescribed it to one patient complaining of mild to moderate back pain. That patient was an undercover agent.
Awerbuch was arrested in May 2014 and charged with illegally prescribing Subsys and insurance fraud. Insys’s stock took an immediate hit, on heavy trading volume.
In an email the previous September, Burlakoff had written to Babich and others, “Let’s make some money,” adding that it was the Awerbuchs “of the world that keep us in business, let’s get a few more.” Now Insys executives scrambled to distance themselves from the doctor. Subsys was not sold directly to doctors, who make their own decisions, they explained in a news release: “Insys only sells Subsys through D.E.A. approved wholesalers who monitor and track prescribing activity.”
With news of Awerbuch’s arrest, the New Jersey sales rep Susan Beisler wrote to a friend: “Yup. [Expletive].” When the friend responded that it was bad for the doctor but not for Insys, Beisler replied: “The thing is they bribed the [expletive] out of that guy to write. The complaint shows ten other docs they also bribed.”
It was a telling remark: In fact, the Awerbuch criminal complaint merely presented a chart of the Top 10 Subsys prescribers to Medicare patients. Names were withheld, but other details were provided. An executive at Galena, then the maker of Abstral, sent a screenshot of the list to Ruan, who was easily identifiable. The next day, Ruan began redirecting his Insys speaker fees to philanthropic purposes. “He runs away from that Insys money as fast as he can,” the assistant United States attorney Christopher Bodnar later told a jury.
With Awerbuch’s fall, Beisler apparently thought that Insys was done, but for her bosses, and for their investors, this wasn’t over. After a dip, revenues recovered and the stock resumed its climb. Insys kept paying speaker fees to physicians with disciplinary histories — and doing so out in the open, because a newly implemented provision of the Affordable Care Act meant that drug makers’ payments to doctors were now publicly posted. Burlakoff continued on the job for more than a year. Investors shrugged over the Awerbuch news and the bad press surrounding the speaker program. The subpoena Insys had received about its sales practices was “not particularly unusual,” one bullish Wall Street analysis noted later that year, adding, “we’re pretty sure that the worst-case outcome for Insys is some sort of fine.” The first hard-hitting reportof several by Roddy Boyd of the Southern Investigative Reporting Foundation, in April 2015, jolted the stock, but again it recovered and moved higher, with sales still climbing.
Insys sustained another blow when federal agents descended on Ruan and Couch’s clinic in Mobile in May 2015. They were there to seize evidence and arrest the doctors, Kapoor and Babich’s dinner companions the previous year.
The local medical community felt the impact of the raid. Because refills are generally not allowed on controlled substances, patients typically visited the clinic every month. For days, dozens of them lined up outside in the morning, fruitlessly trying to get prescriptions from the remaining staff or at least retrieve their medical records to take elsewhere. But other providers were either booked up or would not take these patients. “Nobody was willing to give the amount of drugs they were on,” a nurse in the city said. Melissa Costello, who heads the emergency room at Mobile Infirmary, said her staff saw a surge of patients from the clinic in the ensuing weeks, at least a hundred, who were going through agonizing withdrawal.
Two months after the raid in Mobile, Insys’ stock reached an all-time high.
AT DAWN ONE MORNING LAST OCTOBER, several S.U.V.s entered a gated community in Phoenix and drove up a mountainside road. Federal agents climbed out and entered a sprawling house with their weapons drawn. They took John Kapoor into custody at 7 a.m. When he appeared eight hours later in federal court, surrounded by indigent defendants being arraigned at the same time, he was wearing untied running shoes and gym shorts that appeared to be on backward.
Prosecutors had advanced from targeting lower-level employees toward the heart of the company, securing some guilty pleas along the way, including one from Michael Babich’s wife, Natalie Levine, a former Insys rep, on bribery charges. Babich, Burlakoff, Sunrise Lee and three other former senior Insys executives were indicted simultaneously on bribery and fraud charges, and months passed while Insys insiders wondered whether Kapoor would go untouched. Now they had their answer.
Kapoor and the six other executives charged in Boston have pleaded not guilty and await trial, scheduled for January. For prosecutors at the Department of Justice, this is uncharted territory. When pharmaceutical companies have been heavily penalized over marketing schemes and fraud, their leaders have typically settled the cases — or, more rarely, pleaded to misdemeanors — and walked away. The Insys defendants not only face criminal prosecution but stand accused of racketeering under the RICO Act, a law more commonly invoked against organized-crime families and drug gangs. The industry will be paying attention.
Kapoor’s lawyer, Beth Wilkinson, declined to comment in detail on the case, but did say, “We will vigorously defend Dr. Kapoor in court.” Lawyers for Burlakoff, Babich, Lee, Levine and Madison either declined or did not respond to detailed requests for comment. A lawyer for Beisler, who has not been charged with a crime, also declined to comment. Awerbuch pleaded guilty to accepting bribes and health care fraud and has been sentenced to jail time. Ruan and Couch were convicted on multiple felony counts and are in prison. They have appealed. Krane was fired by Insys in November 2012; the company cited poor sales performance. She no longer works in the drug industry.
Insys itself is still producing Subsys, though sales have fallen considerably. (Overall demand for TIRFs has declined industrywide.) The company is now marketing what it calls the “first and only F.D.A.-approved liquid dronabinol,” a synthetic cannabinoid, and is developing several other new drugs. Some analysts like the look of the company’s pipeline of new drugs and rate the stock a “buy.” In a statement, the company said its new management team consists of “responsible and ethical business leaders” committed to effective compliance. Most of its more than 300 employees are new to the company since 2015, and its sales force is focused on physicians “whose prescribing patterns support our products’ approved indications,” the company said. Insys has ended its speaker program for Subsys.
In Florida, Dr. Steven Chun is still seeing patients. The indictment against the Insys executives details the company’s relationship to 10 unnamed Subsys prescribers. Having worked to identify all of them, I was virtually certain that Chun is “Practitioner #9.” Three others have already been sentenced to prison time; Chun has not been charged with any crime. In February, after multiple attempts to contact him, I visited his Florida clinic unannounced.
Chun works out of the third floor of a two-tone stucco building flanked by palm trees, in prosperous Lakewood Ranch, a master-planned community. Adjacent to the medical complex housing his clinic is a tidy outdoor retail and entertainment area called Main Street at Lakewood Ranch. In Chun’s orderly waiting room, when I visited, an elderly man with a walker and a plaid shirt sat silently under the fluorescent lights. The clinic looked nothing like the pill mill that I had stopped by a few days earlier. It looked like a doctor’s office.
I did not expect Chun to agree to see me, but I was led down a long hallway into his personal office. Wearing dark blue scrubs with his name embroidered at the breast, he shook my hand and motioned for me to sit on a red leather sofa while he sat back in his chair, taking a sip from a thermos. A framed diploma hung on the wall behind him.
The practice of pain management has changed since Chun was in training in the 1990s, he said. There are so many regulations. People in pain have fewer and fewer places to go. And now, he said, he’s caught up in this Insys case.
Chun said that his prescribing of Subsys had nothing to do with the money that Insys paid him (more than $275,000, according to the Boston indictment). He believed in the product and he enjoyed doing the speaker programs. It suited his ego to take a teaching role, he said, smiling.
Asked for comment at press time, Chun defended his practice, saying he has never been accused of malpractice or disciplined by the state of Florida. He has complied with subpoenas related to Subsys, he said, and he has not been contacted directly by investigators in connection with Insys. He said a vast majority of his TIRF prescriptions are on-label, for patients with cancer or a history of cancer. He said he always tells patients, “Unless you have cancer, I’m not going to prescribe this for you.”
Chun said Subsys prescriptions went up 10 percent at most after he joined the speaker program. (The Boston indictment contradicts this account.) He said he only heard about the Insys “scam” after he left the program and saw no reason he was being associated with doctors who participated. He concluded, “I follow the rules.”
While Chun and I were speaking, staff members knocked on the door and entered every 30 minutes or so, carrying pieces of paper for Chun to sign. Chun explained that the nurse practitioner he worked with is not licensed to prescribe Schedule II controlled substances, the most tightly regulated category of legal drugs. The sheets of paper were prescriptions, and he signed them two to four at a time without pausing to read them over. As soon as the knock came on the door, without looking down, he would make a swift motion with his hand to retrieve his pen from his breast pocket and click the button on the top.
Down the hall, patients were presumably making the trip, in that cycle familiar to us all, from the waiting room to the exam room and finally home. Naturally the patient in the next room had no idea what Chun and I were discussing. He probably did not see that a sales rep stopped by and brought lunch for the clinic staff, getting a wave from Chun through the open door. It’s very likely that a pharmacy rang up a prescription for that patient on his way home, but the real sale had already happened, out of his sight.
Haunting Images show the inside of Prince’s Paisley Park compound including the elevator where he overdosed on Fentanyl – with bundles of cash, drugs and a bag labelled ‘opium’ inside his vault. A chilling video taken inside Prince’s Paisley Park compound moments after his body was found has been released by cops alongside multiple photos which show (Steve Quayle’s book on Giants), bottles of drugs, wads of cash and personal belongings piled up in the compound where he spent his last days holed up. The footage reveals a home festooned in the singer’s achievements, yet strangely lacking of many personal touches, such as photos of friends or family. Sadly, it also revealed Prince’s battle with drugs, with pills bottles found scattered throughout the multi-million-dollar home, where he had lived for almost all of his adult life, along with a vault full of files, drugs and cash.
Tom Horn emailed Steve Quayle and asked if he would comment on his book being found in Prince’s suitcase with personal belongings. Here is Steve’s reply:
TOM, MY PRAYER IS THAT SOMETHING MAY HAVE STRUCK A CHORD IN PRINCE’S HEART FOR JESUS, IN THE CLOSING MOMENTS OF HIS LIFE. SHARING THE LOVE OF CHRIST WITH THOSE WHO ARE DECEIVED BY THE DEVIL IS A WONDERFUL EXAMPLE OF GOD’S GRACE EVEN THOUGH WE WILL NEVER KNOW WHOSE LIVES THE LORD LET US TOUCH FOR HIM UNTIL ETERNITY. THE FACT THAT PRINCE WOULD BE INTERESTED IN THE GENESIS 6 STORY OF FALLEN ANGELS SEX WITH HUMAN WOMEN THAT PRODUCED THE LEGENDARY GIANTS, ALONG WITH THE MEN AND WOMEN OF ANCIENT MYTHS AND LEGENDS INCLUDING THEIR TECHNOLOGY AND ARCHITECTURE SHOWS HIS INTEREST IN THE ULTIMATE SOURCE OF EMPIRICAL HISTORY—THE BIBLE AND IT’S ANSWERS FOR OUR ORIGIN, DESTINY AND THE CONFLICT BETWEEN GOOD AND EVIL.
MAINSTREAM CHURCHES, IN HAVING FAILED TO DEAL WITH AND TEACH THE GENESIS 6 NARRATIVE, HAVE ABANDONED BIBLICAL REVELATIONS, WHICH CAN PROVIDE ANSWERS TO THOSE HEARTS DESPERATELY SEARCHING FOR MEANING AND PURPOSE IN LIFE BEYOND SEX, DRUGS, AND ROCK AND ROLL, ANSWERING THE QUESTION OF WHAT HAPPENS WHEN WE DIE WITH THOUGHTS OF ETERNITY, BEYOND THE LIES AND DECEPTION NOW BEING OFFERED. THE GENESIS 6 NARRATIVE PROVIDES THE BACKGROUND AND DOCUMENTATION FOR WHAT PEOPLE HAVE BEEN SEEKING ANSWERS FOR. WHEN YOU UNDERSTAND THE CIRCUMSTANCES OF THE SPIRITUAL CONFLICTS THAT RAGE AGAINST US, AND FROM WITHIN US, AT THE TOP OF THE LIST IS THE EVOLUTIONARY LIE THAT WILL LEAD THE WORLD INTO THE GREAT END-TIME DECEPTION THAT YOU TOM, MYSELF AND OTHERS HAVE WRITTEN AND SPOKEN ABOUT FOR DECADES. THE LIE THAT IS BEING SET UP AND DRILLED INTO MANKIND’S CONSCIOUSNESS IS THAT “EXTRATERRESTRIAL ALIENS” CREATED US AND ARE COMING BACK TO SAVE US FROM OURSELVES, WHICH THE WHOLE WORLD WILL RUN AFTER AS “THE APOSTATE CHURCHES” EMBRACE THE DEVILS INVITE. JESUS IS THE SAVIOR OF A BROKEN, HURTING WORLD, WHICH FINDS ITSELF LANGUISHING IN THE SHACKLES OF EMPTINESS, ALIENATION AND MASSIVE MENTAL AND PHYSICAL PAIN. ALL THE MONEY, FAME, FORTUNE, AND PERKS OFFERED BY THE “DEVIL’S DELICATESSEN” CAN NEVER FILL A HUNGRY HEART SEARCHING FOR PURPOSE AND MEANING ESPECIALLY WHEN CONFRONTED WITH THE END OF LIFE! JESUS STATED THAT HE IS THE RESURRECTION AND THE LIFE AND IN ROMANS 10:13 IT SAYS: “For whosoever shall call upon the name of the Lord shall be saved.”I PRAY THAT PRINCE CALLED OUT TO JESUS IN THE CLOSING MOMENTS.
Scientists have shown that CBD actually blocks the opioid receptor in the brain, leaving no more doubt that cannabis should be a primary treatment for addiction.
As the opioid epidemic rages on, those professing to seek “solutions” are willfully ignoring one of the most promising treatments – medical cannabis. When the Comprehensive Addiction & Recovery Act (CARA) was being debated in 2016, amendments to study medical cannabis were stripped out.
This happened despite studies showing that medical cannabis eases neuropathic pain, and the government’s own National Institutes of Health stating, “Medical marijuana products may have a role in reducing the use of opioids needed to control pain.”
In January 2017, the National Academies of Science published an exhaustive review of the scientific literature and found that one of the most promising areas in medical cannabis is for the treatment of chronic pain.
But all of this falls on deaf ears to those in the pockets of Big Pharma, which is largely to blame for getting America hooked on opioids, as described in a Harvard analysis.
Now, a new experimental study has shown exactly how cannabis works to treat opioid addiction – by actually blocking the opioid reward in the brain.
“This study sought to determine whether the cannabis constituent cannabidiol attenuates the development of morphine reward in the conditioned place preference paradigm. Separate groups of mice received either saline or morphine in combination with one of four doses of cannabidiol using three sets of drug/no-drug conditioning trials. After drug-place conditioning, morphine mice displayed robust place preference that was attenuated by 10 mg/kg cannabidiol. Further, when administered alone, this dose of cannabidiol was void of rewarding and aversive properties. The finding that cannabidiol blocks opioid reward suggests that this compound may be useful in addiction treatment settings.”
The use of cannabidiol (CBD), one of two major active ingredients in cannabis, is even more promising for legalization effiorts because it does not produce the high that THC does. So prohibitionists who demonize cannabis’ intoxicating effect have no ammo when it comes to CBD. CBD can even be extracted from hemp, which is grown for its fiber used in thousands of manufacturing applications.
Because it can’t get anyone high, CBD extracts are even being permitted for medical use in staunchly prohibitionist states such as Oklahoma and Utah, to treat children with intractable epilepsy.
States have been reluctant to approve opioid addiction as a valid condition for prescribing medical cannabis. Big Pharma, having already secured their grip on federal government, has undoubtedly been working over state governments to prevent cannabis from threatening their profits. They had a measure of success in Arizona, which failed vote for legalization after pharma companies donated heavily to anti-pot propaganda campaigns.
The new study showing how CBD blocks the opioid reward will certainly prompt more research. This, coupled with statistical evidence from medical cannabis states, should finally prove fatal to the irrationality of blocking cannabis for opioid addiction treatment.
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More than 200,000 Americans have died from prescription opioid overdoses since 1999 and as the epidemic continues, it raises serious questions about why the United States government has failed to stop it in the last 20 years. According to a recent report, many influential politicians are receiving incentives from drug manufacturers to, in essence, look the other way.
Purdue Pharmaceuticals, the maker of OxyContin, has contributed millions of dollars directly and countless more dollars indirectly to lawmakers to keep its drugs flying off pharmacy shelves. Rightly considered “blood money” by critics, the contributions are made in an effort to buy off state and federal legislators.
The Sackler family, the private owners of Purdue, have made billions off of a drug that has killed citizens both young and old alike—the sum total of whose deaths amount to the population size of a small metropolitan city. Yet nothing has been done to even slow the death rate attributed to opioids, and Attorney General Jeff Sessions’ response has been to push for more federal involvement in states that have attempted to allow solutions such as cannabis.
An investigative report from the Daily Caller revealed that Purdue has given $2.3 million to politicians to ensure that the drug pipeline for the “drug cartel” stays open, further enriching the Sackler family—and that is just what is traceable.
Purdue and the Sacklers have disbursed $2.3 million to nearly 300 U.S. candidates and political organizations since 1996, and Congress, until recently, has done very little to combat the opioid epidemic, TheDCNF’s investigation found. The OxyContin-backed politicians often held leadership positions, chairmanships, or served on committees that have oversight of the pharmaceutical industry. Conversely, the Sacklers have never publicly donated to addiction rehabilitation centers, a previous DCNF investigation found.
For those holding out hope that the federal government will do anything about the burgeoning crisis in opioid overdose deaths, the future does not look promising. While President Trump has claimed that he wants to “Make America Great Again” and he plans to “Drain the Swamp” of corrupt politicians, his administration has moved in the opposite direction, and appears to be solidifying the pharmaceutical industry’s hold on Washington.
“It’s blood money, literally,” Public Citizen’s Health Research Group founder and senior adviser Sidney Wolfe told TheDCNF. “It’s money earned off people’s lives being spent. This is dirty, bloody money.”
As The Free Thought Project has reported, the appointment of pharmaceutical insider and one-time drug executive Alex Azar to the role of Health and Human Services Secretary was a figurative slap in the face to any family who has lost a loved one to opioid overdose.
Not only has Azar mocked the usefulness of the only natural alternative to opiates (cannabis), but in a recent speech to the American Federation of Hospitals, Azar made no mention of the overdose epidemic. Instead, he focused his attention on making sure the prices of drugs were transparent.
It is not the price of drugs that are killing Americans. It is the fact that opioids continue to be prescribed at record levels, inflating the profits of killer companies such as Purdue and other opioid manufacturers, which include Insys Pharmaceuticals.
Both Purdue and Insys have been investigated by the federal government, and the investigations resulted in Purdue paying out millions of dollars in damages and Insys’ CEO facing numerous felony charges. Yet nothing seems to be able to stop the spread of opioids and no one in the federal government seems to be making a legitimate attempt to end the kryptonite effect opioids are having on our society.
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Whistleblower Joe Rannazzisi says drug distributors pumped opioids into U.S. communities — knowing that people were dying — and says industry lobbyists and Congress derailed the DEA’s efforts to stop it.
In the midst of the worst drug epidemic in American history, the U.S. Drug Enforcement Administration’s ability to keep addictive opioids off U.S. streets was derailed — that according to Joe Rannazzisi, one of the most important whistleblowers ever interviewed by 60 Minutes. Rannazzisi ran the DEA’s Office of Diversion Control, the division that regulates and investigates the pharmaceutical industry. Now in a joint investigation by 60 Minutes and The Washington Post, Rannazzisi tells the inside story of how, he says, the opioid crisis was allowed to spread — aided by Congress, lobbyists, and a drug distribution industry that shipped, almost unchecked, hundreds of millions of pills to rogue pharmacies and pain clinics providing the rocket fuel for a crisis that, over the last two decades, has claimed 200,000 lives.
JOE RANNAZZISI: 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.
“This is an industry that allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices, that distributed them out to people who had no legitimate need for those drugs.”
Joe Rannazzisi is a tough, blunt former DEA deputy assistant administrator with a law degree, a pharmacy degree and a smoldering rage at the unrelenting death toll from opioids. His greatest ire is reserved for the distributors — some of them multibillion dollar, Fortune 500 companies. They are the middlemen that ship the pain pills from manufacturers, like Purdue Pharma and Johnson & Johnson to drug stores all over the country. Rannazzisi accuses the distributors of fueling the opioid epidemic by turning a blind eye to pain pills being diverted to illicit use.
JOE RANNAZZISI: This is an industry that allowed millions and millions of drugs to go into bad pharmacies and doctors’ offices, that distributed them out to people who had no legitimate need for those drugs.
BILL WHITAKER: Who are these distributors?
JOE RANNAZZISI: The three largest distributors are Cardinal Health, McKesson, and AmerisourceBergen. They control probably 85 or 90 percent of the drugs going downstream.
BILL WHITAKER: You know the implication of what you’re saying, that these big companies knew that they were pumping drugs into American communities that were killing people.
JOE RANNAZZISI: That’s not an implication, that’s a fact. That’s exactly what they did.
In the late 1990s, opioids like oxycodone and hydrocodone became a routine medical treatment for chronic pain. Drug companies assured doctors and congressional investigators — as in this 2001 hearing — that the pain medications were effective and safe.
Purdue Executive to Congress in 2001: Addiction is not common, addiction is rare in the pain patient who is properly managed.
With many doctors convinced the drugs posed few risks, prescriptions skyrocketed and so did addiction.
Many people who’d become addicted to painkillers turned to shady pill mills — pain clinics with rogue doctors to write fraudulent prescriptions and complicit pharmacists to fill them — one-stop shopping for controlled narcotics.
JOE RANNAZZISI: Pain clinics overnight popping-up – off an entrance ramp, or an exit ramp on an interstate. And all of a sudden there’s a pain clinic there.
BILL WHITAKER: Had you ever seen anything like that before?
JOE RANNAZZISI: Never. In fact– it was my opinion that this made the whole crack epidemic look like nothing.
JOE RANNAZZISI These weren’t kids slinging crack on the corner. These were professionals who were doing it. They were just drug dealers in lab coats.
BILL WHITAKER: You know what a chilling picture that paints?
JOE RANNAZZISI: I do, ’cause I watched them get arrested, and I was the one who approved the cases.
Despite arrests of unscrupulous purveyors, opioids kept flooding the black market. The death toll kept rising. This map shows the U.S. death rate from drug overdose in 1999. By 2015, the map looked like this. Most of these deaths were opioid related. Joe Rannazzisi told us prosecuting crooked doctors and pharmacists wasn’t stemming the epidemic, so he decided to move up the food chain.
JOE RANNAZZISI: There had to be a choke point. And the choke point was the distributors.
BILL WHITAKER: What took you so long to go to that choke point of the distributors?
JOE RANNAZZISI: This was all new to us. 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. That’s when we started going after the distributors.
A distributor’s representative told us the problem is not distributors but doctors who overprescribe pain medication, but the distributors know exactly how many pills go to every drug store they supply. And they are required under the Controlled Substances Act to report and stop what the DEA calls “suspicious orders” — such as unusually large or frequent shipments of opioids. But DEA investigators say many distributors ignored that requirement.
JIM GELDHOF: 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.”
Jim Geldhof, a 40-year DEA veteran, ran pharmaceutical investigations from dea’s detroit field office. Frank Younker supervised the agency’s operations in Cincinnati. Joe Rannazzisi was their supervisor. They saw distributors shipping thousands of suspicious orders. One example: a pharmacy in Kermit, West Virginia, a town of just 392 people, ordered nine million hydrocodone pills over two years.
JIM GELDHOF: 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. But don’t sit here and tell me that, “Well, we’re not sure what a suspicious order is.” Really? I mean this– this co– this pharmacy just bought 50 times an amount that a normal pharmacy purchases and they are in a town of 5,000 people. You don’t know that that’s suspicious? I mean at some point you’re just turning a blind eye to it.
BILL WHITAKER: These companies are a big reason for this epidemic?
JIM GELDHOF: Yeah, absolutely they are.
JIM GELDHOF: And I can tell you with 100 percent accuracy that we were in there on multiple occasions trying to get them to change their behavior. And they just flat out ignored us.
In 2008, the DEA slapped McKesson, the country’s largest drug distributor, with a $13.2 million dollar fine. That same year, Cardinal Health paid a $34 million fine. Both companies were penalized by the DEA for filling hundreds of suspicious orders — millions of pills.
Over the last seven years, distributors’ fines have totaled more than $341 million. The companies cried foul and complained to Congress that DEA regulations were vague and the agency was treating them like a foreign drug cartel. In a letter, the healthcare distribution alliance, which represents distributors, told us they wanted to work with the DEA. Effective enforcement, they wrote, “must be a two-way street.”
BILL WHITAKER: Frank, you said you were tough but fair. The industry says you guys were unfair. That you were taking unfair hits at them.
FRANK YOUNKER: Tell that to the people who lost their sons and daughters. See how fair theythink it is.
In 2011, more than 17,000 Americans died from opioid prescription overdoses. That same year Cardinal Health, the second largest distributor, started pushing back at Joe Rannazzisi. The companies’ attorneys went over his head and called his bosses at the Justice Department, who called in Rannazzisi to have him explain his tactics.
JOE RANNAZZISI: And it in– infuriated me that I was over there, trying to explain what my motives were or why I was going after these corporations? And when I went back to the office, and I sat down with my staff, I basically said, “You know, I just got questioned on why we’re doing– why we’re doing what we’re doing. This is– this– this is– now this is war. We’re going after these people and we’re not going to stop.
BILL WHITAKER: Do you really think you were getting this pushback because you were going after big companies, Fortune 500 companies?
JOE RANNAZZISI: I have no doubt in my mind. So the question is, why would it be any different for these companies as compared to the small mom-and-pops that we had done hundreds of times before.
BILL WHITAKER: What’s the difference?
JOE RANNAZZISI: The difference is, is they have a lot of money, and a lot of influence. And that’s the difference.
Rannazzisi says the drug industry used that money and influence to pressure top lawyers at the DEA to take a softer approach. Former DEA attorney Jonathan Novak said it divided the litigation office. He said in 2013, he noticed a sea change in the way prosecutions of big distributors were handled. Cases his supervisors once would have easily approved, now weren’t good enough.
JONATHAN NOVAK: We had been achieving incredible success in an almost unstoppable wave, and then suddenly it stopped.
Novak prosecuted cases brought to him by Joe Rannazzisi’s investigators. He said his caseload started to slow down dramatically.
JONATHAN NOVAK: These were not cases where it was black — where it was grey… These were cases where the evidence was crystal clear that there was wrongdoing going on.
He said his bosses started to bog down the system, demanding ever more evidence.
JONATHAN NOVAK: But now, three undercovers by four officers over three months, that wouldn’t be enough. Maybe we need an expert to explain how recording equipment works. Maybe we need an expert to explain– the system for prescribing. What’s a prescription? It felt honestly confusing and almost insane. Where was this coming from?
Jim Geldhof says his investigations were getting bogged down too. He was looking into one mid-sized distributor that had shipped more than 28 million pain pills to pharmacies in West Virginia over five years. About 11 million of those pills wound up in Mingo County, population 25,000. Suddenly, he said, he ran into roadblocks from one of attorney Jonathan Novak’s bosses.
JIM GELDHOF: “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.
BILL WHITAKER: But this is the DEA. That’s what you’re supposed to do.
FRANK YOUNKER: Yeah.
JIM GELDHOF: You would think.
The DEA’s toughest sanction is to freeze distributors shipments of narcotics — a step they haven’t taken in almost two years.
JONATHAN NOVAK: I mean there’s no denying the numbers. At the height of the opioid epidemic, inexplicably, they slowed down.
He said one big reason for the slowdown: DC’s notorious revolving door. Novak said he saw a parade of DEA lawyers switch sides and jump to high-paying jobs defending the drug industry. Once they’d made the leap, they lobbied their former colleagues, novak’s bosses, and argued the dea’s cases were weak and ultimately would lose in court. It had a chilling effect on dea litigators.
JONATHAN NOVAK: Some of the best and the brightest former DEA attorneys are now on the other side and know all of the — the — the weak points. Their fingerprints are on, memos and policy and — and — and emails going out where you see this concoction of what they might argue in the future.
BILL WHITAKER: You and the other attorneys had been winning these cases.
JONATHAN NOVAK: All of the time.
The Justice Department is the agency that oversees the DEA. A senior attorney at the department at the time, told us in a statement, ”Department of Justice leadership was not advised that DEA had changed enforcement strategies…Any significant policy shift should have been brought to [our] attention.”
FRANK YOUNKER: There was a lotta pills, a lotta people dyin’, and– and we had tools in our toolbox to try to use and stem that flow. But it seemed down in headquarters that that toolbox was shut off.
BILL WHITAKER: You’re watching an out of control epidemic and yet you both feel that at the height of this epidemic your– your– your hands were being tied?
FRANK YOUNKER: Yeah, if it’s a war on drugs then treat it like a war.
JOE RANNAZZISI: Addiction rate was still increasing. The amount of people seeking treatment was still increasing. It was all increasing. Still, the amount of prescriptions were increasing. And we started slowing down.
As cases nearly ground to a halt at DEA, the drug industry began lobbying Congress for legislation that would destroy DEA’s enforcement powers. That part of the story when we return.
In 2013, Joe Rannazzisi and his DEA investigators were trying to crack down on big drug distributors that ship drugs to pharmacies across the country. He accused them of turning a blind eye as millions of prescription pain pills ended up on the black market. Then, a new threat surfaced on Capitol Hill. With the help of members of Congress, the drug industry began to quietly pave the way for legislation that essentially would strip the DEA of its most potent tool in fighting the spread of dangerous narcotics.
JOE RANNAZZISI: If I was gonna write a book about how to harm the United States with pharmaceuticals, the only thing I could think of that would immediately harm is to take the authority away from the investigative agency that is trying to enforce the Controlled Substances Act and the regulations implemented under the act. And that’s what this bill did.
The bill, introduced in the House by Pennsylvania Congressman Tom Marino and Congresswoman Marsha Blackburn of Tennessee, was promoted as a way to ensure that patients had access to the pain medication they needed.
Jonathan Novak, who worked in the DEA’s legal office, says what the bill really did was strip the agency of its ability to immediately freeze suspicious shipments of prescription narcotics to keep drugs off U.S. streets — what the DEA calls diversion.
JONATHAN NOVAK: You’re not gonna be able to hold anyone higher up the food chain accountable.
BILL WHITAKER: Because of this law?
JONATHAN NOVAK: Because of this law
BILL WHITAKER: How hard does it make your job in going after the wholesale distributors?
JONATHAN NOVAK: I would say it makes it nearly impossible.
This 2015, Justice Department memo we obtained supports that. It states the bill “could actually result in increased diversion, abuse, and public health and safety consequences.”
JONATHAN NOVAK: They are toothless. I don’t know how they stop this now. It’s a very sad state of affairs.
Who drafted the legislation that would have such a dire effect? The answer came in another internal Justice Department email released to 60 Minutes and The Washington Post under the Freedom of Information Act: “Linden Barber used to work for the DEA. He wrote the Marino bill.”
Ad: Hi, My name is Linden Barber. I’m the director of the DEA litigation and compliance practice at Quarles and Brady’s Health Law Group.
Barber went through the revolving door. He left his job as associate chief counsel of the DEA and within a month joined a law firm where he lobbied Congress on behalf of drug companies and wrote legislation. He advertised what he could offer a client facing DEA scrutiny.
Ad continued: 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.
JONATHAN NOVAK: It’s not surprising that this bill, that has intimate knowledge of the way that DEA, you know, regulations are enforced, the way that those laws work, was written by someone who spent a lot of time there, charged a lot of cases there.
BILL WHITAKER: Knew the workings?
JONATHAN NOVAK: Very much so.
Eric Holder was the attorney general at the time, he warned the new law would undermine law enforcement efforts to ”prevent communities and families from falling prey to dangerous drugs.” The major drug companies — distributors, chain drug stores and pharmaceutical manufacturers — mobilized too. According to federal filings, during the two years the legislation was considered and amended, they spent $102 million lobbying Congress on the bill and other legislation, claiming the DEA was out of control, making it harder for patients to get needed medication.
A particular thorn for the drug industry and the bill’s sponsors was Joe Rannazzisi. He had been a witness before Congress more than 30 times and was called on again to testify about this bill.
JOE RANNAZZISI: 16,651 people in 2010 died of opiate overdose. OK. Opiate-associated overdose. This is not a game. We are not playing a game.
MARSHA BLACKBURN: Nobody is saying it is a game, sir. We’re just trying to craft some legislation. Let me ask you…
Rannazzisi, who admits to having a temper, felt so strongly about the damage the bill could do, he lashed out at Marino’s committee staffers.
TOM MARINO: It is my understanding that Joe Rannazzisi, a senior DEA official, has publicly accused we sponsors of the bill of –quote supporting criminals –unquote. This offends me immensely.
BILL WHITAKER: Congressman Marino from Pennsylvania said that you accused him of helping criminals.
JOE RANNAZZISI: I’ve never accused Congressman Marino of helping criminals. I said that this bill is going to protect defendants that we have under investigation. And if Congressman Marino thinks I accused him of something, I don’t know what to tell you.
But a week after the hearing on legislation that would hobble the DEA’s enforcement authority, Marino and Blackburn wrote the inspector general for the Justice Department, demanding that Rannazzisi be investigated for trying to quote “intimidate the United States Congress.”
MATT MURPHY: There were people in industry that didn’t care much for Joe Ranazzisi, wanted him silenced, or wanted him outta the way. Basically unceremoniously kick him to the curb.
After almost 30 years with the DEA, Matt Murphy, Rannazzisi’s lieutenant, became a consultant for the drug industry — an industry with which he’s now disillusioned. He said he was shocked at the animosity he witnessed toward his friend and former boss.
MATT MURPHY: My theory is that the industry through lobbying groups donated — a certain amount of money to politicians to get a law passed that favored the industry. And also maybe using those political ties to have Joe removed.
BILL WHITAKER: Congress launched an investigation of him?
MATT MURPHY: Right.
BILL WHITAKER: And he was out?
MATT MURPHY: Yeah, pressure was put on for him to be moved out. I’m pretty confident of that. There was no reason to take the guy who was the most qualified person in DEA to run the Office of Diversion Control out of the Office of Diversion Control.
The investigation requested by Congressman Marino against Rannazzisi went nowhere, but soon after, Rannazzisi was stripped of his responsibilities. He says he went from supervising 600 people to supervising none — so he resigned.
JOE RANNAZZISI: We were totally focused on all these people dying and all these drugs being diverted. And we were not really looking at our flanks, waiting for somebody to come after us. So maybe that was my fault. And I just never realized that that was something that would have occurred.
In the end, the DEA signed off on the final version of the “Marino bill.” A senior DEA representative told us the agency fought hard to stop it, but in the face of growing pressure from Congress and industry lobbyists, was forced to accept a deal it did not want. The bill was presented to the Senate in March of 2016.
Majority Leader Mitch McConnell brought the legislation to the floor and it passed the Senate through unanimous consent with no objections and no recorded votes.
It passed the House the same way, with members of Congress chatting away on the floor.
A week later, with no objections from Congress or the DEA, President Barack Obama signed it into law without ceremony or the usual bill signing photo-op. Marino issued a press release the next day claiming credit for the legislation.
The drug distributors declared victory and told us the new law would in no way limit DEA’s enforcement abilities. But DEA chief administrative law judge, John J. Mulrooney, who must adjudicate the law, wrote in a soon-to-be-published Marquette Law Review article we obtained, that the new legislation “would make it all but…impossible” to prosecute unscrupulous distributors.
JOE RANNAZZISI: I just don’t understand why Congress would pass a bill that strips us of our authority in the height of an opioid epidemic in places like Congressman Marino’s district and Congressman Blackburn’s district. Why are these people sponsoring bills, when people in their backyards are dying from drugs that are coming from the same people that these bills are protecting?
BILL WHITAKER: Why do you think that is?
JOE RANNAZZISI: Because I think that the drug industry — the manufacturers, wholesalers, distributors and chain drugstores — have an influence over Congress that has never been seen before. And these people came in with their influence and their money and got a whole statute changed because they didn’t like it.
Seven months after the bill became law, Congressman Marino’s point man on the legislation, his Chief of Staff Bill Tighe, became a lobbyist for the National Association of Chain Drug Stores.
Since the crackdown on the distributors began, the pharmaceutical industry and law firms that represent them have hired at least 46 investigators, attorneys and supervisors from the DEA, including 32 directly from the division that regulates the drug industry.
Mike Gill, chief of staff for the DEA administrator, was hired by HDJN, one of the country’s largest healthcare law firms.
And most recently, Jason Hadges, a senior DEA attorney overseeing enforcement cases during the slowdown, joined the pharmaceutical and regulatory division of DC-based law firm Hogan Lovells. He declined to speak with us.
AmerisourceBergen and McKesson declined our requests to appear on camera.
So did Cardinal Health, which three months ago hired the author of the bill, Linden Barber, as senior vice president. With Scott Higham and Lenny Bernstein of the Washington Post, we called the head of public relations of Cardinal and asked to speak with Barber.
BILL WHITAKER: This is Bill Whitaker I’m a correspondent with 60 Minutes, I was calling to see if, um, we could speak with Linden Barber.
We were told the company would not make him available.
We also tried for several months to speak to Congressman Marino. Finally, we went to his DC office.
BILL WHITAKER: Hello. I’m Bill Whitaker with, uh, 60 Minutes.
MARINO STAFFER: Yes.
BILL WHITAKER: And we’d like to speak with Congressman Marino if we could.
MARINO STAFFER: I’m going to have to refer you to our Chief of Staff.
We were told he was not available…
MARINO CHIEF OF STAFF: Can you please turn the camera off and we have to ask the camera to leave the office.
His staff then called the Capitol Hill Police on us.
CAPITOL POLICE: Just accept the uninvite and leave the area.
When Joe Rannazzisi looks back he has one regret.
Joe Rannazzisi: You know all these people that died happened under my watch. The one thing I wanted to do, the one thing that I just thought would have the most impact, is to lock up, arrest one of these corporate officers. You arrest a corporate officer. You arrest somebody that’s involved in the decision process, knowing what the law is. If you make that arrest, then everybody sits up and takes notice because three-piece-suit guys just don’t do well in prison. They don’t.
Joe Rannazzissi now consults with state attorneys general who have filed suit against distributors for their role in the opioid crisis. Tennessee Congresswoman Marsha Blackburn is running for the Senate. As for Congressman Marino, he was just nominated to be President Donald Trump’s new drug czar.
Correction: Majority Leader Mitch McConnell brought the Marino bill to the Senate floor where it passed. A previous version of this article incorrectly stated that Sen. McConnell introduced the bill.
Correction: According to federal filings, $102 million was spent by major drug companies — distributors, chain drug stores and pharmaceutical manufacturers — lobbying Congress on the Marino bill and other legislation. A previous version of this article incorrectly said that amount was $106 million.
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