Sen. Claire McCaskill (D-MO) says it’s time for pharmaceutical companies to start worrying about their role in causing the opioid epidemic, the deadliest drug overdose crisis in US history.
“I believe we are reaching a tipping point where even pharma — which is legendary for its power on Capitol Hill — ought to begin looking over their shoulder and wondering whether or not they’ve gone too far in terms of some of their conduct,” McCaskill told me in an interview earlier this month about her investigation into the opioid epidemic.
As she described it, drug companies aggressively marketed opioids — sometimes even committing fraud — to get doctors to prescribe the drugs. She could see it in her own life as the number of opioid prescriptions rose. And that inspired her to launch a formal investigation, via the Senate Homeland Security and Governmental Affairs Committee, for which she is a ranking member, into opioid makers and distributors earlier this year.
For McCaskill, the key statistic is the disparity between how much the US prescribes opioids and other countries do. As Stanford drug policy expert Keith Humphreys noted in a recent talk, “Consider the amount of standard daily doses of opioids consumed in Japan. And then double it. And then double it again. And then double it again. And then double it again. And then double it a fifth time. That would make Japan No. 2 in the world, behind the United States.”
The statistics really do back this up. Japan is one of the lowest prescribers of opioids in the developed world (for reasons outlined in a great piece by my colleague Ella Nilsen). And the US absolutely dwarfs anyone else in terms of opioid prescriptions, with Japan not even showing up in the top 25:
McCaskill credits these kinds of numbers with animating her investigation into opioid companies.
“I looked around,” she told me, “and nobody had really done a complete and thorough investigation in Congress about the role of both the manufacturers — in terms of their sales and marketing — and the distribution of these drugs, in terms of the ability of people to divert drugs from the prescription market into the black market.”
The first report in her ongoing investigation came out last month, looking at the fentanyl producer Insys. It found that Insys misrepresented Subsys, its fentanyl product, to get insurers to pay for it, letting the company sell its product to people who didn’t need and shouldn’t have had access to such a powerful drug.
McCaskill’s team even uncovered audio in which representatives from Insys posed as staff from a doctor’s office to get an insurance company to grant prior authorization — essentially, to agree to pay for — a patient’s fentanyl prescription. “The result, in the case of Ms. Fuller, was death due to allegedly improper and excessive Subsys use,” the report concluded.
It’s unclear what will come out of McCaskill’s investigation. Some Insys executives had already been criminally charged for their conduct, and the company reportedly agreed to some reforms even before the report.
But McCaskill hopes that even if her investigation doesn’t lead to full legislation, it will help shine a light on how pharmaceutical companies contributed to the opioid crisis — and deter other drug companies from misbehaving in a similar way in the future.
“Sometimes you can even make a difference without legislation, and just shine the bright light of public attention on problems,” she said. “It makes a difference.”
What follows is my conversation with McCaskill, lightly edited for length and clarity.
What got you interested in the opioid crisis?
Well, I think, like many Americans, I’ve had family members that have been impacted by opioid addiction. My mother, near the end of her life, there’s no question in my mind that she had been prescribed opioids to the point that she was dependent. It was obvious to me as somebody who had been around drug treatment and prevention as a prosecutor many years before. I knew the signs. I could sense her dependency on the drug.
I looked around, and nobody had really done a complete and thorough investigation in Congress about the role of both the manufacturers — in terms of their sales and marketing — and the distribution of these drugs, in terms of the ability of people to divert drugs from the prescription market into the black market.
I thought it would be a good idea to take that aggressive, thorough look at how did we go from these drugs being developed to a country where we are consuming a much higher percentage of the world’s opioid supply than any other country in the world, by multiples. I wanted to try to get to the bottom of it. That’s why I began this investigation.
Why the focus on the pharmaceutical industry, the distributors, and the manufacturers? What made you think this is a good target for an investigation?
When I had my wisdom tooth pulled out, I got an aspirin and Baskin-Robbins ice cream. When my children had the work done, they were prescribing opioids. And when I’ve had surgery, I’ve had opioids prescribed.
And yes, the first few days that might be necessary, like when I had my knee replaced or when I had my breast cancer surgery. But after a few days, they’re no longer necessary. But I was prescribed 30 days and, in one instance, 30 days and a refill. So I’ve seen what appeared to me, just as a layperson watching what’s going on, that these prescriptions are increasing.
I had a feeling it might be because they were being marketed extensively. And as it turns out, I believe that’s part of the problem. We have lots of different issues with opioids that we have to look at, but no question these drugs were aggressively marketed to the medical community.
We have already issued one report on one company that went so far that they had an internal sales slogan, “Start them high and hope they don’t die.”
So we are going to continue looking at all the documents that have been produced and continue asking questions until we get to the point that we completely understand why it is that these are so heavily prescribed in America, unlike other countries.
Speaking as a reporter who’s been looking at this issue, one of the things that’s surprised me is how some of the more irresponsible companies have behaved. I’m curious if there are things that have surprised you in the course of this investigation.
Well, it is early yet. Now that we’ve expanded our investigation into the distribution of these products, we are at over a million and a half pages of documents and counting.
But I will say that the brazenness of Insys and the fraud they were committing — masquerading as people in a doctor’s office in order to create prior authorization of a fentanyl product — that surprised me, that they would be that bold, that they would actually call and pretend they were with the doctor, calling from the doctor’s office. That was shocking to me that they would go that far.
The company knew they had no internal controls related to these problems because they had looked at it and determined they didn’t have internal controls as to what was being said and how these drugs were being pushed, particularly through this internal group that was trying to up the numbers of authorizations that people who were being prescribed this drug were getting.
I’d say that was shocking — some of the evidence that came out on the report we’ve issued on Insys and their product.
Like you mentioned, it’s shocking that they thought it was okay and that they could get away with it. Why do you think they thought that? To me, it’s a question of what kind of culture are we cultivating as a country, where a drug company can feel it can do this.
Well, these are companies that are driven by quarterly analyst calls. These are companies that are driven by profit. These are companies that are trying to harness drugs through a patent process and ride that horse as long as they can possibly ride it — in terms of having a monopoly. It’s profit, just dollars and cents, and not seeing, not stopping long enough to look at the bigger picture: “Is what we’re doing ethical? Is what we’re doing good for public health? Is what we’re doing going to be an ultimately terrible reflection on this company even if we make our number for the quarter?”
And some of this is the pressure that the high costs of [research and development] impose on this country in order to make these things work.
But some of the tactics that are being used within the pharmaceutical industry to go market these products and even other drugs and [to] protect patents, I believe we are reaching a tipping point where even pharma — which is legendary for its power on Capitol Hill — ought to begin looking over their shoulder and wondering whether or not they’ve gone too far in terms of some of their conduct.
How have your colleagues in the Senate reacted to this investigation so far?
It’s interesting. It doesn’t feel like they’re reacting in any partisan way. I think that there may be some skepticism because this is an investigation that the chairman [Sen. Ron Johnson (R-WI)] has not chosen to join directly in.
Although I would tell you that the chairman has not pushed back at all on the work we’re doing. And I am cautiously optimistic that if we got to the point that a company was stonewalling us — which we’re not to that point, but if we did get to that point — I think we’d get bipartisan cooperation in trying to move forward to get the information we need to understand exactly why we’ve had this boon in the prescription of these kinds of drugs.
Have you faced any resistance then?
No, I haven’t. I think this is because this is legitimately the biggest public health crisis facing our country. We have more deaths now [from drug overdoses] than we had at the height of the AIDS crisis. This country was gripped with the public health issues surrounding AIDS, and this is surpassing that.
The thing about this particular public health crisis is it isn’t limited to any geographical area or any socioeconomic strata. It hits the suburbs, it hits farming communities, it hits the cities, and everything in between — north, south, east, west.
The nature of this problem is such that there is good bipartisan concern about what has happened in this space.
Are you concerned that the chair hasn’t officially joined the investigation?
I’m not. As I said, I’ve gotten no pushback from the chairman. He and I have worked together on other issues well.
I have done a lot of bipartisan investigations. [Sen.] Rob Portman [R-OH] and I did the Backpage investigation together. [Sen.] Susan Collins [R-ME] and I did the Valeant and the Turing investigation together.
So I have a record of working with my Republican colleagues on important investigations that sometimes take a while and are labor-intensive and are paper-heavy. But in both of those investigations, we were able to make a difference when it was all said and done. Sometimes you can even make a difference without legislation, and just shine the bright light of public attention on problems. It makes a difference.
In some instances, legislation is necessary. In others, it’s not. Too early to tell in this particular investigation whether any legislation would be appropriate.
Do you think we as a country are paying enough attention to the opioid crisis? It seems to me like it’s not getting the kind of all-consuming coverage and political attention that the crack cocaine and HIV/AIDS crises drew. Do you think that’s right? And if so, does that concern you?
I certainly think it’s in the top tier of issues that is talked about in Washington. I will admit that in these times, a lot of the oxygen in the room is consumed by some of the partisan battles and the unusual nature of some of the things — I mean, we’ve never had a president using his Twitter handle as a method to mold public opinion. It’s a different time, where there are a lot of distractions in terms of the public attention.
But there is a unifying thread around opioids in Washington. I feel it being here. I think most members feel it — that they know we have a responsibility to act and do more than just wring our hands and say, “What are we going to do?” We’ve passed legislation that’s comprehensive as it relates to the addiction of opioids. We are working every day to make sure treatment beds are available and make sure we’re getting a grasp of the problem of black-market fentanyl coming in through the mail, our ports.
There are a lot of different parts of this problem that many different members of Congress have worked on. So I do feel that it is in the top tier of issues that is on everyone’s mind here. And I don’t think it’s getting kicked to the curb at all at this point.
But when I talk to addiction treatment facilities, they point to this statistic: Only 10 percent of people who have a drug use disorder get specialty treatment for it. And one of the major complaints in this crisis is that there’s still weeks- or months-long waiting periods.
So do you think Congress has done enough to expand treatment to this point?
No, I don’t.
I think that people are familiar with substance abuse treatment know the moment of crisis is the key moment. It does make a difference if you can capture someone into a good treatment bed at the moment of crisis; it increases the likelihood of avoiding a relapse. And unfortunately, too many of the treatment beds in this country are dependent on having money or insurance that covers those treatments.
There are way too many people who have burned every bridge in their family, are completely out of money, are completely dependent on the public health system for any treatment help they’re going to get. Which means that we’ve got to, under the category of worrying about opioid addiction in this country, continue worrying about Medicaid funding.
The way the provisions, the budgets that have been proposed in order to pass the tax cuts that Republicans are talking about is proposing a trillion-dollar cut to Medicaid. Well, that’s a knife in the heart of addiction treatment in this country for a vast number of people who are hooked on opioids. So we’ve got to remember it’s not just talking a good game about, oh, we’ve got to do something about opioids; we’ve got to back it up with the public money that’s necessary to treat the addictions that are out there if we really want to save lives.
I’m trying to get an idea of what the endgame to this investigation is. You’ve already looked at Insys and found some pretty alarming things. What do you hope to achieve with this?
It’s a bit like the Turing [and] Valeant investigations [which looked at drug pricing abuses].
If there’s another pharmaceutical company that thinks it would be a good idea to put a unit inside the manufacturer of the drug to try to pose as if they are a doctor’s office getting prior authorization, I’m hoping that our investigation has already prevented that kind of behavior from happening.
And there may be other behaviors that we uncover in this investigation that we can bring forward in a very public way. And that would be a cautionary moment for other pharmaceutical companies to engage in that same kind of behavior.
How are you following up on the findings on Insys in particular?
They had a complete change in management. There are people that are being criminally prosecuted.
But we’re continuing to follow both what the company is doing both in terms of the reforms they’ve instituted. Also, we’re following these criminal prosecutions, making sure we’re paying close attention so somehow those don’t go away, whatever pressures might be brought to bear on the people who might bring up those charges.
Do you think the regulatory structure has failed? There are all these stories about the overprescription of opioid painkillers for years and years and years. It seems the DEA, FDA, and so on should have caught some of these problems and stopped them before they got this out of hand.
I wouldn’t shy away from that kind of criticism. It’s hard to imagine that we could have such an outsize level of prescriptions to this kind of drug in our country compared to other countries, and that people in leadership positions and regulatory positions didn’t see that and begin to ask themselves why. Why is everyone getting a bottle of opioids?
I will say, too, that one of the things in the long list of things we need to look at in this phase is that we took a step in this epidemic that most countries have not — and that is making pain a vital [sign]. Most vitals in the hospital have to do with a numerical assessment. What is your blood pressure? What is your temperature?
When they made pain a vital, all of a sudden we’re being asked constantly in the hospital, “Tell me what your pain level is from 1 to 10.” And doctors and medical personnel are evaluated by how well they manage their patients’ vitals. So it allowed the patient on a subjective basis to begin to weigh in on whether or not they had pain. I think that also has contributed to the overprescription of opioids. And I think it’s something we have to look at, along with all the other things we have to work on.