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Q&A (Pt 1): Opioid Activist Andrew Kolodny Outlines the Origins of the Epidemic
By ROGER PARLOFF|March 5, 2018
Slide Prepared by Physicians for Responsible Opioid Prescribing
Quick Takeaway
  • Kolodny describes hate mail, death threats by angry pain patients.
  • Epidemic started in 1996, with unprecedented marketing campaign for OxyContin.
  • False "unbranded marketing," minimizing risks of opioid painkillers, boosted sales of all prescription opioids.

About two years ago someone mailed a bag of nails to the home of Andrew Kolodny, 49, the psychiatrist and public health advocate leading the charge to rein in opioid prescribing. An attached note said: “Imagine what it would feel like if all these nails were stuck in your body.”

A wiry man with close-cropped black hair, Kolodny is comfortable in the arena, mixing it up, giving offense, and taking heat—including, lately, death threats. At Brandeis he has been co-director of the Heller School’s Opioid Policy Research Collaborative since November 2016, but it is his role as co-founder and executive director of the advocacy group Physicians for Responsible Opioid Prescribing (PROP) that stirs white-hot emotion—among pain patients who fear being cut off from their legal supply of opioids. (Kolodny says he has always opposed cutting patients off their medication, and that these patients have been misled.) He has also served as Chief Medical Officer at Phoenix House, chair of psychiatry at Maimonides Medical Center in Brooklyn, and an official with the New York City Department of Health and Mental Hygiene.

Screen Shot 2018-02-19 at 3.19.07 PM
Andrew Kolodny, M.D. (Courtesy of Brandeis University)

During this interview, conducted in mid-February, Kolodny explains how he became “obsessed” with opioids and gives his analysis of how the epidemic developed. His views are important, because they closely track the theory now underpinning hundreds of lawsuits that have been filed on behalf of municipalities against opioids manufacturers in courts across the country. (Kolodny made a presentation at a settlement conference before U.S. District Judge Dan Aaron Polster in January, according to a publicly filed agenda, although the subject of the presentation is confidential.) The following is Part I of an edited transcript.)

TORI: How did you get involved in the opioid epidemic? 

Kolodny: In July 2003, after I finished my psychiatry residency at Mt. Sinai, I got a job in public health working for the New York City health department. Tom Frieden had just become the city’s health commissioner, and Mike Bloomberg had just become the mayor. Frieden [who later became President Barack Obama’s director of the Centers for Disease Control and Prevention] was especially interested in improving health outcomes in the city’s poorest communities. So on my first day on the job, I was given the assignment of reducing death from drug overdose in New York City. I have basically been working on that assignment ever since.

Nora Volkow on MAT, naloxone, new drugs, and why opioids are unique

At that time, drug overdose deaths were almost entirely in the poorest neighborhoods, which had been hit hard by heroin in the ‘70s and by crack cocaine in the late ‘80s, early ‘90s.

Most deaths were heroin overdoses. We wanted to make buprenorphine treatment more available. It was very difficult. You had to take special training to prescribe this medication and doctors felt that if they took that training they’d have addicts in their offices. And why would they want those people there?

I figured I ought to practice what I preach. I started my own clinical private practice, got certification to prescribe this medicine, and thought I would be treating people from New York City’s poorest neighborhoods.

That’s not who was coming to my office. It was mainly white people from Staten Island, Long Island, New Jersey, Westchester. They were in their 20s through 70s, and they’d all become addicted through prescription opioids.

This was around 2003-2005. During that same window, I was seeing reports coming out from the federal Drug Abuse Warning Network from other parts of the country. At first I didn’t even believe it. I remember looking at one report and I seriously thought a decimal point had been put in the wrong place.

But it was real. We were at the beginning of the opioid crisis.

In 2006 I started a new job at Maimonides Medical Center in Brooklyn. That year a paper comes out by Leonard J. Paulozzi, the then-medical director at the injury prevention center of the U.S. Centers for Disease Control and Prevention (CDC). [By 2002 overdose deaths from prescription opioids analgesics had overtaken deaths from heroin or cocaine overdose, Paulozzi reported.] He charted out deaths from prescription opioids and sales of prescription opioids and saw that they were going up together.

[Kolodny show me the following slide, which summarizes data similar to what Paulozzi showed.]

Screen Shot 2018-03-17 at 7.32.38 AM
Slide prepared by Physicians for Responsible Opioid Prescribing

[In his article, Paulozzi concluded: “Prescriptions for opioid analgesics … may have inadvertently contributed to the increases in drug poisoning deaths.”]

For me, it was like, “Ah ha, this is it. This is what’s going on.”

I was thinking, we’ve got to get the message out to the medical community to be more cautious. But what I saw happen was that in the same journal where Paulozzi published his paper, he gets attacked by two opposing commentaries. One was by Scott Fishman [then president of the American Academy of Pain Medicine (AAPM) and, later, American Pain Foundation (APF)] and one was from the Pain & Policy Study Group at the University of Wisconsin. [Kolodny eventually learned that AAPM, APF, and the Wisconsin group had all accepted substantial funding from opioid manufacturers.] That begins to bug me. There’s a serious problem, deaths are soaring, and we know what’s causing this. And groups getting money from industry are attacking a CDC researcher. [PPSG declined comment and a spokesman for UC Davis Health, where Fishman is now chief of pain medicine, said Fishman is unable to respond due to pending litigation. Fishman has been named as a codefendant in scores of lawsuits municipalities have filed against opioid manufacturers.]

When did the prescription opioid epidemic begin?

It began in 1996. [That’s the year Purdue Pharma began marketing OxyContin ER, a powerful, time-released form of oxycodone.] That’s when prescribing really takes off.

[He shows me a slide.]

Here’s oxycodone.

Consumption of Oxycodone

But it’s not just oxycodone that takes off in 1996. You see the same thing with hydrocodone:

Consumption of Hydrocodone

In 1996 morphine takes off, too. And hydromorphone (like Dilaudid). For all the opioids, 1996 is the year that the prescribing really just explodes.

OxyContin hits the market in 1996. But all of them go up. Why is that?

And I think the best answer to that question comes from a [U.S. General Accounting Office (GAO)] report published in 2003 that looked at what Purdue was up to when they introduced OxyContin. This is a graph from the report showing how much they were spending compared to earlier narcotics advertising campaigns.

Marketing OxyContin

Now you could look at this and ask: This is about OxyContin [oxycodone]. So why did Vicodin [hydrocodone] and morphine and Dilaudid go up? Why wasn’t the increase limited to oxycodone?

And they answered that in this report. The bulk of what Purdue was really up to was focused on getting the medical community to feel comfortable with opioids as a class of drug.

Unbranded marketing?

Exactly. Now they got into trouble for the misbranding in 2007. That’s what they paid the big fine for. [Purdue pleaded guilty to misbranding that year and paid $634.5 million.] But they never got into trouble for the worst of what they had done, which was the non-branded stuff: getting the medical community to believe that opioids were safe and effective for longterm use, and that the risk of addiction is very low. They’re getting into trouble for that now. That’s the basis of the litigation that’s been filed by the municipalities across the country.

[Kolodny’s next slide sets out four allegedly false messages that were conveyed during that campaign: 

  • Physicians are needlessly allowing patients to suffer because of “opiophobia.”
  • Opioid addiction is rare in pain patients.
  • Opioids can easily be discontinued.
  • Opioids are safe and effective for chronic pain.]

And none of this is true. We didn’t just hear these things from sales reps. We were hearing these messages in CME programs. Purdue sponsored 20,000 CMEs in the first six years of the release of oxycontin.

And we were hearing it from our professional societies, from our state medical boards, from every different direction. If you were an enlightened doctor in the know and wanted to be different from those puritanical doctors who were letting people suffer, you’ll know that opioids are a gift from mother nature and should be used much more. And as we responded to this campaign and the prescribing took off, it led to this severe epidemic that we’re dealing with today.

Many of the lawsuits against opioid manufacturers today actually name prominent pain management physicians of the past—referred to in the complaints as “key opinion leaders”—as defendants in the lawsuits. Specifically they name Russell Portenoy, Perry Fine, Scott Fishman, and Lynn Webster, who also allegedly accepted money from manufacturers in the form of honoraria, consulting fees, and research funding. [Their attorneys declined comment on the suits.] These doctors aren’t accused of negligence, but of knowing false statements. Do you think that, at the time, they were making false statements knowingly?

I think a lot of what they were teaching they may have believed. I think they would’ve realized a lot faster that what they were saying didn’t make any sense if it wasn’t in their financial interest to keep spouting this nonsense off.

[He shows another slide.]

This is 1999, three years into the epidemic.

1999

You’re looking at data from state licensed drug treatment programs. They have to ask you when you come in for treatment, what’s the primary drug you’re addicted to? The states with the greatest number of people showing up  addicted to prescription opioids show up as red or maroon. Just a few states are showing up as red or maroon.

This is 2001:

2001

This is 2003:

2003

This is 2005:

2005

This is 2007:

2007

This is 2009:

2009

When you have a sharp increase in a disease over a short period of time, that’s the definition of an epidemic.

A spokesperson for Purdue Pharma declined to comment on the specifics of the accusations being made against the company in the litigation, including those articulated here by Kolodny. A spokesman provided this statement: “We are deeply troubled by the prescription and illicit opioid abuse crisis, and are dedicated to being part of the solution. As a company grounded in science, we must balance patient access to FDA-approved medicines, while working collaboratively to solve this public health challenge. Although our products account for approximately 2% of the total opioid prescriptions, as a company, we’ve distributed the CDC Guideline for Prescribing Opioids for Chronic Pain, developed three of the first four FDA-approved opioid medications with abuse-deterrent properties and partner with law enforcement to ensure access to naloxone. We vigorously deny these allegations and look forward to the opportunity to present our defense.”

Part II of the interview is published here. There Kolodny discusses the hate mail he has received; why he co-founded PROP; what categories of people are addicted today, and what can be done for them.

Filed under: Litigation/ Manufacturers/ Q&A