Big Pharma's Dirtiest Dealer

Sarah Fuller first got her hands on Subsys in January 2015, when FedEx delivered a box containing a twenty-day supply of the fentanyl-based mouth spray. During the fifteen months from her first dose of Subsys, Insys Therapeutics's flagship opioid pain medication, until her death at 32 from a fatal overdose, Medicare shelled out $250,544 to cover the drug, STAT News reported.

According to Fuller's family and transcripts of their lawsuit against Insys, she had previously struggled with opioid dependency following two car accidents that left her with painful fibromyalgia. But after experiencing kidney problems related to prescription painkillers, she'd subsequently gone cold turkey and was off all pharmaceuticals the first time she visited with Dr. Vivienne Matalon (whose license was subsequently suspended) in her office in Cherry Hill, New Jersey.

That's where Fuller reportedly encountered an Insys sales rep, who was present during one of her doctor's appointments to helpfully explain how spraying Subsys under her tongue every four hours would work wonders on that pesky pain. Never mind her history of abuse, or that Subsys had only ever been approved for cancer patients with breakthrough pain.

"As far as I'm concerned they killed her," Sarah's mother told STAT in a video interview, referring to both Dr. Matalon and the Insys sales rep.

In my fifteen years of reporting on the War on Drugs—the disproportionate government crackdown on certain communities using narcotics—I've never seen a case that pulled back the curtain and tied the whole room together quite like Insys Therapeutics.

First, you've got a publicly-traded pharmaceutical company pushing fentanyl, a drug that's 50 times stronger than heroin. And then you've got the same company donating half-a-million dollars to a smear campaign against cannabis legalization in Arizona, where Insys is based, while simultaneously developing its own synthetic THC (tetrahydrocannabinol, the main psychoactive component of cannabis) drug with full state and federal government approval. What a magnificent intersection of irony, hypocrisy, and corruption.

Meanwhile, given the way the War on Drugs is generally conducted in America, the only truly surprising event in this whole sordid affair is that the Federal Bureau of Investigation actually stepped in last year and arrested six former Insys executives, including the company's one-time CEO, for allegedly "leading a nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud healthcare insurers."

Not to mention the countless people who got seriously hooked on Subsys. Throw in multiple lawsuits and a looming Congressional investigation, and it's all taken a sizable toll on the company's bottom line. On April 4, Insys reported a 41.6 percent decline in quarterly revenue, presumably the only negative outcome the company really cares about.

But it's not all bad news for Insys. Just last month the company won approval from the Drug Enforcement Administration to start selling Syndros, a wholly lab-produced 100 percent THC liquid. Meaning, as far as the federal government is concerned, a cancer patient smoking a joint in California is a criminal in possession of a Schedule 1 narcotic with no proven medical value and a high risk of abuse. But Insys can produce and sell marijuana's most psychoactive component in its purest possible form.

How is this okay with the DEA? According to a Washington Post investigation, since 2005, at least 42 officials from the agency have gone on to work for Big Pharma, including 31 directly from a division tasked with regulating the industry.

Congress, however, is about to step in. In a March 28 letter to Insys interim CEO Santosh Vetticaden, Sen. Claire McCaskill (D-Mo.) called the company representative of "an industry apparently focused not on preventing abuse but on fostering addiction as a central component of its business model."

McCaskill, as part of a wide-ranging investigation into the pharmaceutical industry's role in the opioid crisis, formally requested from Insys a variety of internal company documents related to the marketing of Subsys—the only brand name drug Insys has ever brought to market. The senator gave Insys until April 25 to respond.

In the meantime, here's a few things we know already:

According to data collected by the Centers for Medicare & Medicaid Services, Insys paid doctors $6.3 million in 2015 alone, with at least four doctors collecting over $100,000 each.

In June 2015, a nurse practitioner at a pain and headache center in Connecticut plead guilty to federal anti-kickback charges. According to the prosecution, she'd prescribed $1.6 million worth of Subsys while pocketing payments of $83,000 from Insys for speaking engagements that frequently consisted of nothing more than going out to dinner.

In Illinois, Insys paid $84,400 in speaking fees to a doctor the company knew had been indicted on federal false claims charges. When one of its sales teams informed company superiors that "the doctor runs a very shady pill mill and only accepts cash"—and then followed up with a claim that the doctor's office was under DEA surveillance—a supervisor called the doctor a "go-to physician" and advised: "Stick with him"

So far, that's all just a particularly egregious example of business-as-usual for the opioid-industrial-complex. But if THC is the primary psychoactive and medicinal compound in cannabis, why would Insys fight legal pot with one hand while whipping up synthetic batches of pure THC with the other?

Because the company doesn't want to compete with whole-plant cannabis, according to Amanda Reiman, former manager of marijuana law and policy at the Drug Policy Alliance.

"There's this misconception that illicit markets are run by dangerous criminals, while prescription markets are run by responsible business people, when the truth is that these are not mutually exclusive classifications," Reiman told me. "Insys has made their money off peddling an extremely dangerous drug, so the idea that they somehow now have this benevolent motivation to provide cannabinoid medication to the public is just a horse and pony show meant to usher in the pharmaceuticalization of cannabis."

In a prescient 2001 essay in the International Journal of Drug Policy, Dr. Lester Grinspoon, Associate Professor Emeritus of Psychiatry at Harvard Medical School, author of Marijuana Reconsidered, elder statesman of the medical marijuana movement, and one-time pot smoking buddy of Carl Sagan, described the dangers lying ahead when Big Pharma—no longer capable of suppressing the benefits of cannabis, and thus protecting themselves from its competition—inevitably pivots to cashing in.

Whole plant cannabis, Grinspoon argued, with its complex blend of cannabinoids and terpenes, is a superior medicine in both price and medical efficacy to single compound derivatives like Insys's lab-created THC. So for a synthetic product to succeed in the market, the public's safe and legal access to the cannabis plant must be limited.

"The 'pharmaceuticalization' of marijuana will only succeed if pharmaceutical products displace marijuana as a medicine," Grinspoon wrote. "This seems unlikely [absent marijuana prohibition] due to the plant's limited toxicity, easy availability, low cost relative to pharmaceuticals, ease with which it can be self-titrated, and remarkable medical versatility."

While it's hard to imagine Insys worrying about the supposed dangers to the public of legalizing weed, it's easy to think Insys would fear the competition. Especially when multiple studies show marijuana legalization significantly lowers opioid use and abuse, the company's core profit driver. Insys did not respond to multiple requests for comment.

Within Arizona's homegrown cannabis community, the smoke and mirrors obscuring Insys's true intentions has hardly gone unnoticed. Kathy Inman is a tireless advocate for medical cannabis in Arizona who specializes in reaching out to conservative groups like seniors, religious organizations and law enforcement. After experimenting with weed a few times in her youth, she never touched the stuff again until her grown daughter inspired her to give it another chance. Quickly convinced of the plant's therapeutic benefits, Inman started her own group of volunteers called MomForceAZ and began working to educate her local community.

She also volunteered on the 2016 campaign to legalize adult use cannabis in Arizona, an effort which fell short by less than 70,000 votes, in part, she believes, because of Insys's $500,000 contribution to the "No" on 502 campaign.

"Why on Earth would a supposed anti-drug organization take money from an outfit like Insys that's making and selling drugs that are killing people, in order to pay for a campaign of lies against a drug that's never killed anyone?" she asks. "They certainly were on TV a lot more than we were before the election. I honestly wouldn't mind if what they said was truthful, but they put out so much misinformation that lawmakers from Colorado actually contacted them and asked them to stop lying."

And if you think the new administration's rhetoric about tackling the opioid epidemic portends positive change, just know that Dr. Scott Gottlieb, President Trump's pick to head the Food and Drug Administration, has taken speaking fees from several opioid manufacturers, and in 2012 penned an essay calling out the DEA for being too tough on Big Pharma and pill mills. Neither the FDA nor DEA replied to request for comment.

Meanwhile, Attorney General Jeff "good people don't smoke marijuana" Sessions claims pot is "only slightly less awful" than heroin. And Tom Marino, Trump's apparent pick for Drug Czar, was an author and key supporter of the 2016 Ensuring Patient Access and Effective Drug Enforcement Act, which the pharmaceutical industry lobbied for heavily, and critics claim will make it even harder for the DEA to go after corporations engaged in criminal activity.

Back in 2014, those critics included then DEA Office of Diversion Control head Joseph Rannazzisi.

"What you're doing is filing a bill that will protect defendants in our cases [against pharmaceutical companies]," Rannazzisi recalls telling a conference call of congressional staffers.

Tom Marino, America's future Drug Czar, in turn demanded that the Justice Department Office of the Inspector General investigate Rannazzisi for "intimidating" members of Congress. He was subsequently replaced in that job, and retired in October 2015.

The War on Drugs goes on without him. Too late to save Sarah Fuller.

David Bienenstock is the author of How to Smoke Pot (Properly). Follow him on Twitter @pot_handbook.

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