A Real-World Dr. Evil: Big Pharma's Conspiracy to Game Medical Literature

A never-surfaced litigation exhibit shows an opiate producer used the "Dr. Evil" character to describe plans to popularize addictive drug use. Part II in a series by E.R. doctor Matt Bivens

USING THESE “STUDIES”…: Opiate maker Cephalon was forced to disclose their internal Dr. Evil-themed spoof in litigation. “Using these ‘studies’… We [will] show…Fentora® ‘works for all breakthrough pain.’” Full video below

Editor’s Note: This is the second essay by former Moscow Times co-worker and current E.R. doctor Matt Bivens, about the genesis of the Opioid Crisis. The first is here. The full series is also unspooling at his Substack, The 100 Days.

“Do more reading,” I’d been told as a medical student when I worried aloud about overly liberal use of morphine (see Part I). Had I obediently done so, a thorough review of the medical literature could have turned up many studies demonstrating that a casually-written opioid prescription can wreck a person’s life.

But to find them I would have had to sift through many hundreds of peer-reviewed publications arguing the opposite: that addiction with opioid prescriptions never really happens. My medical school years (2005-2009) saw a blizzard of such academic papers, all claiming that we could relax and start slinging product. Hundreds of those papers — 439, to be exact— cited for their evidence one mysterious paper, published in the New England Journal of Medicine. 

Once upon a time we’d killed babies with morphine syrups, and destroyed lives by treating laryngitis with heroin. Eventually we wised up. Yet now, a single publication was being cited, over and over again, to contradict everything we’d learned through a century of tragic experience. This publication, called “Porter & Jick” after its authors, was receiving hugely respectful attention from hundreds of other doctors and scientists, writing in hundreds of other medical journals.

Porter & Jick was even enjoying glowing write-ups in mainstream media. TIME magazine called it a “landmark study,” one that showed fears of opioid addiction had been “exaggerated,” and were “basically unwarranted.” Scientific American said Porter & Jick’s “extensive study” was evidence for a new modern understanding that “morphine taken for pain is not addictive.”

Journalism from 30 years ago, helping lay the groundwork for a catastrophe.

So, what was this landmark, game-changing, extensive study?

Brace yourself: It was a letter to the editor, and just five sentences. 

Five sentences! 

The letter’s authors were Jane Porter, a grad student, and Hershel Jick, a physician. Porter and Jick reported reviewing 11,000 patients in “our current files” at a Boston hospital who were treated with an opioid and finding only four cases of “reasonably well-documented addiction,” whatever any of that means. As evidence goes, it’s so low-quality for decision-making purposes that it borders on useless. And that’s okay, by the way: When your research findings are too weak to merit a full publication, eking a letter to the editor out of them is a common tactic in publish-or-perish academia. Everyone understood this at the time; upon publication the Porter & Jick letter was thus promptly and appropriately ignored; and that should have been the end of it.

The original Porter-Jick letter.

But, no. Many years later, unscrupulous pharmaceutical companies dusted off this five-sentence letter. Their marketing departments had come up with a clever use for it. They would claim that addiction happens far less than 1% of the time (four cases out of 11,000 would be 0.036%). They would cite The New England Journal of Medicine. Then they would grin slyly, because no one ever reads the footnotes.

And if some skeptic did read the footnotes? At the dawn of the Opioid Crisis, the New England Journal’s archives weren’t even available on-line; they were only uploaded and made accessible around 2010. Before then, doubters who wondered what this Porter & Jick citation was about would have had to go to a brick-and-mortar library for a physical copy of the journal, if they wanted to be let in on the joke.

As that should suggest, the Porter & Jick letter was ancient: Like, pre-computer ancient. It was published in 1980. (When Porter and Jick described reviewing “our current files,” they meant actual paper files.) When the letter was rediscovered some 20 years later, the explosion of new academic citations stunned and distressed the letter’s authors. Dr. Jick came to wish he’d never published it. “Only years and years later, that letter was used to advertise by new companies that were pushing out new pain drugs,” Dr. Jick later told NPR. “I was sort of amazed. None of the companies came to me to talk to me about the letter.” (Dr. Jick passed away in October at age 91).

Eventually, this five-sentence letter would be cited more than 600 times, a situation so ridiculous that the New England Journal felt compelled to go into its archives and affix a warning label atop it. “For reasons of public health,” the warning said, anyone looking at this letter should know it has been “heavily and uncritically cited.” That label was recently removed, but here’s a screen shot of how it used to look:

“Heavily and uncritically cited” was a polite way of saying “used as part of a conspiracy.” This was no accident. The deceptive use of Porter & Jick — that “landmark study” and “extensive study” from the New England Journal of Medicine supposedly proving that “morphine taken solely to control pain is not addictive” — was one small cog of an elaborate machine, one built to tell dangerous lies to doctors and their patients. 

Deception ‘Tainted Nearly Ever Source’ a Doctor Might Consult

Many have now described aspects of that conspiracy. Few have done so more clearly than a 2015 lawsuit by the state of Mississippi against 16 of the nation’s largest opioid manufacturers.

The Mississippi attorney general said:

During the 1990s… In order to expand the market for opioids and realize blockbuster profits, Defendants needed to create a profound transformation in medical and public perception that would permit the use of opioids … to treat more common aches and pains, like lower back pain, arthritis, and headaches… Defendants, through a common, sophisticated, and highly deceptive marketing campaign that began in the late 1990s, deepened around 2006, and continues to the present, set out to, and did, reverse the popular and medical understanding of opioids. …

[The pharmaceutical companies created] a body of false, misleading, and unsupported medical and popular literature about opioids that … appeared to be the result of independent, objective research ...

Defendants coordinated the timing and publication of manuscripts … The plans for these materials did not originate in the departments … that were responsible for research, development or any other area that would have specialized knowledge about the drugs and their effects on patients, but in Defendants’ marketing departments … their deceptive messages tainted virtually every source on which doctors could rely for information …

Here’s just one of many similar documents out there confirming it, courtesy of all of those lawsuits. This is a spread sheet from a team at Johnson & Johnson working on marketing for the opioid medication tapentadol. In it, the marketing reps document sending article outlines and first drafts (!) of proposed peer-reviewed, academic publications to the author for approval — complete with reminders under Next Steps to “create reprints for sales rep distribution.” 

From the 2017 Oklahoma lawsuit against Johnson & Johnson. Accessed at the UCSF’s Library of Opioid Industry Documents. 

If a spread sheet is too dry for you, check out this Austin Powers-themed motivational video. It was made by the opioid manufacturer Cephalon, Inc. for its sales staff, and discusses how they will market their new dissolve-in-the-mouth fentanyl tablet. Cephalon was able to patent generic fentanyl as Fentora® by adding in Alka Seltzer®-style “plop plop fizz fizz” effervescence. It was also able to patent generic fentanyl as Actiq® by making it into a lollypop. Feel free to eye-roll in disgust, but that’s how you make a cheap drug expensive: Tweak how the medication gets delivered into the body, and claim it’s now a completely new substance, worthy of a new patent. (Remember this. It will come up again and again.)

The 2006 Fentora® motivational video, shown to a New York jury in 2021 over the strenuous objections of the Cephalon legal team, edits new audio into scenes from the cult classic movie Austin Powers: International Man of Mystery. “Gentlemen! I have a plan. It’s quite brilliant,” says Dr. Evil. “We are going to roll out a blockbuster marketing campaign, focusing on ‘effervescent speed’ — a concept so nebulous, so indecipherable, it will absolutely help drive prescriptions … to Fentora®!” View for yourself: