[Andrew Kolodny is co-director of the Opioid Policy Research Collaborative of the Heller School for Social Policy and Management at Brandeis University. He is also the co-founder and executive director of Physicians for Responsible Opioid Prescribing (PROP). This is Part II of an interview. Part I, in which Kolodny discusses the origins of the opioid epidemic, was posted here. This is an edited transcript of a conversation that took place in February.]
Who is addicted today, and how did they become addicted?
We basically have three groups of Americans who are opioid addicted right now. First, we have the the survivors of the heroin epidemic of the 1970s. That epidemic disproportionately hit low-income, inner-city folks. AIDS killed many of them, and many died of overdoses, but there’s this small, shrinking cohort which have managed to survive. In that group, over the last couple years, deaths are going up rapidly. Because the heroin supply has never been so dangerous. Now they’re dying because of fentanyl [laced in the heroin].
The other two groups became opioid addicted after 1995, after the introduction of OxyContin. There’s basically a younger group and an older group. Both become addicted through the use of prescription opioids. Both are almost entirely white. A little bit Native American in some parts of the country.
The younger group—20s to early 40s—could become addicted in three ways. Some were taking prescription opioids for medical purposes. It could be a young person with Crohn’s disease or a very serious injury, who was put on longterm opioids and became hooked.
A second way young people get addicted is through pure recreational use.
Then the third way is almost a combination of the first two: They have brief medical exposure with, say, wisdom teeth or a minor sports injury. They don’t get addicted, but they basically got their first taste of the drug. And at some point after that they use it recreationally, and get hooked.
This younger group has a hard time maintaining their supply of opioids from doctors. Doctors don’t like to give healthy-looking 30-year-olds a large quantity on a monthly basis. But once you’re addicted, you have to keep doing it to avoid feeling really sick. It’s not just flu-like sick. It feels like you’re going to die. There’s really this panic attack. This sense of impending doom. They wind up on the black market, and the pills are very expensive. So where heroin is available, they switch.
So in the past three or four years, among these young whites deaths are soaring because of the fentanyl. Fentanyl has really been a game changer.
The third group—the older white group—is becoming opioid addicted almost entirely through medical treatment. But they don’t have to switch to heroin, because they don’t have a hard time finding doctors who will give them opioids on a monthly basis for chronic pain.
When and why did you found Physicians for Responsible Opioid Prescribing (PROP)?
In 2009 U.S. Food and Drug Administration announces that it’s [considering imposing new strictures on] opioid prescribing. Some of these make a lot of sense, like mandatory training for prescribers of opioids and setting up registries, so you can make sure patients receiving these medications are not visiting lots of different doctors.
But the groups getting money from manufacturers very effectively lobbied FDA, and FDA thought they were hearing from diverse stakeholders that their ideas were really bad. They basically watered down the whole program, and what they adopted in 2010 was useless.
Those lobbying the FDA kept saying that we have two problems in America: a problem with drug abusers, and a problem with millions of people who are suffering from chronic pain. It was framed as if any kind of reduction in prescribing in an effort to stop drug abusers would be bad for the millions with chronic pain. And that was just totally false.
One of the first papers on this came out from Jane Ballantyne, then at Harvard Medical School, in the New England Journal of Medicine in 2003. She’s the president of PROP right now. The paper shows that these medicines are not just dangerous, because patients could get addicted and die of an overdose, but they’re also ineffective. They can make pain worse. These are lousy drugs for chronic pain.
So PROP forms in 2010 really with this message that we don’t have these two distinct groups.
We put out new educational material and we start meeting with FDA. We say, look, you guys got it wrong. It’s not just that there are abusers taking it to get high. These are highly addictive drugs and pain patients taking them as directed are being harmed. Ultimately our relationship with FDA got a bit more adversarial.
We would file a document called a citizen petition [in 2012]. It’s a way to make an administrative request for label changes. We wanted there to be narrow indications on opioid labels, to prohibit marketing for chronic pain.
We didn’t want to see patients forced off medications, but didn’t want to see any more people getting started on opioids who shouldn’t be, and we wanted the drug companies to be prohibited from claiming that opioids were safe and effective for conditions for which they’re not safe and effective. [PROP’s first petition, was largely denied, although the FDA did order manufacturers to perform new studies, which are ongoing. PROP’s second petition, filed jointly in August with the Association of State and Territorial Health Officials, the FED UP! Coalition, the National Safety Council, and Shatterproof, seeks a ban on very high dosage opioids, like OxyContin 80 mg pills.]
That put us head-to-head with the opioid lobby and organizations that get funding from them, and with pain patients as well, who’ve been very manipulated into believing all sorts of conspiracy theories about us.
I get a lot of hate mail and threats. It used to be just threats of physical assault, so that I’ll know what their pain feels like and I won’t want to get rid of opioids. (Not that I want to get rid of opioids.) But now in the past few months it’s become more than just threats of assault. Like: Somebody needs to put a bullet through Kolodny’s head. That kind of thing.
How are those communicated to you?
Email. Twitter. Voice messages at work. I had a bag of nails mailed to my home, with a note: Imagine what this would feel like if all these nails were stuck in your body.
Most of these people are people who are on opioids. Some believe the opioids are helping them, because if they go without a dose they feel agonizing pain. So they think the opioid is treating an underlying pain problem as opposed to treating the withdrawal pain. Which you really can’t tell the difference between. Because when you’re going into withdrawal there’s increased pain sensitivity.
And some of them know that opioids aren’t really helping them, but they’re afraid of losing access to a legal supply. And if their doctor won’t give it to them anymore, what will that mean? Am I going to have to line up at a methadone clinic? Am I going to have to buy heroin?
And the truth is we don’t have adequate resources for this population. I don’t want to see these people cut off. But they really are being led to believe that PROP and I am pushing to have opioids banned.
What is the solution for those people?
For some of those people who are at very high doses, the doses have to come down whether they agree or not. Because they are at very high risk for death.
Is there some other medication you can give?
For people who can’t come down in dose, you can switch them to buprenorphine. If you can get them on safer doses and they’re using it in a controlled way you can kind of leave them alone. You try to help them come off if they’re motivated to do that.
If you can help these people come off, often their pain improves significantly. And quality of life improves.
How do we attack the epidemic?
What you need to do is what you would do for any epidemic. You prevent new cases of the disease, and you see that people who have the disease get effective treatment.
Preventing opioid addiction more than anything else means much more cautious prescribing, so we don’t addict new patients.
And the substitute medications are what?
For most patients with pain they can be effectively treated with NSAIDs [nonsteroidal anti-inflammatory drugs, like Advil or Alleve] plus Tylenol. There are times you have to use opioids. But when you do need to expose them, it can be brief.
When should opioids simply never be prescribed?
Low back pain with a normal spine. Fibromyalgia. Chronic headaches.
What about sickle cell disease?
Sickle cell is tricky. Opioids are good for acute pain. Even for some people with chronic pain, opioids may be good if taken intermittently. So for somebody with osteoarthritis, gout, rheumatoid arthritis, or sickle cell, where they’re prone to painful flareups, you can use opioids effectively—though it’s risky.
The problem with opioids is when you take them every day. Within a few days you’re going to need more. Then dependence sets in, which means that when you try to come off, you’re going to feel sick, including a worsening of pain.
When else might we need opioids?
Opioids certainly play an important role for end-of-life care. And for addiction treatment. Methadone maintenance and buprenorphine are the first-line treatments.
Unfortunately we can’t ban opioids. And for eight to ten million Americans who have been put on chronic opioids treatment and may never be able to come off, we don’t want to force them off either.