Dr. Steven Nissen talking:
I don’t like the use of the term Obamacare. What’s happened here is they’ve made this into some kind of a personal thing about Obama. Obamacare, or what they call Obamacare, was really a bill written by lots of people on Capitol Hill, and it happened to be supported by the President. Now, many of us think it didn’t go far enough, but it was at least an attempt to fix the system.
And my question is, if we’re not going to do—if we’re not going to do healthcare reform, what do these candidates—what do they want? We have a country where we’re spending 16 or 17 percent of every dollar on healthcare, and we’re not any healthier than our counterparts in Western Europe and other countries where they spend half that much. So, the problem is, we spend too much, we get too little, and the system isn’t working. We’ve got to fix it. Now, repealing the healthcare bill isn’t going to solve the problem. And I’d like to know is how they want to solve the problem.
pharmaceutical industry does lots of good. I mean, many new drugs that have saved lives have come from this industry. But selling pharmaceuticals is not the same as selling other kinds of products. There is a moral imperative here. And my concern is that, in several instances, drugs that their manufacturers knew were harmful, that harmed large numbers of Americans, continue to be marketed.
Now, you asked the question about the forces that are aligned against healthcare reform. And that indeed is the problem, is healthcare has become such a huge business that the forces that don’t want change—the insurance industry, the hospital industry, even physician professional societies—have so aligned to keep the system as it is that it’s very hard to overcome that. My fear in this election, because of the Citizens United ruling, is massive amounts of money from people with a huge stake in making a profit from healthcare are going to influence the electorate with just an amazing amount of money, television, every other media, and that could really turn the tide against what I thought was at least some momentum for healthcare reform.
Avandia was the most recent of these. And, of course, it was a terrible tragedy. This was a drug introduced about a decade ago. It achieved enormous market success, eventually becoming the number one selling diabetes drug in the world. What is particularly shocking is that, early on, the manufacturer of this drug had very good evidence that it increased the risk of heart disease events. And it’s important to know that heart disease is the leading cause of death in diabetics. About 70 percent of all diabetics will die of heart disease. The company knew. They successfully concealed that information. And I was fortunately able to find enough data on the studies the company had done to do an analysis, which we published on May the 1st, 2007, that showed that the drug increased the risk of heart attack by about 40 percent. When you take a drug being used by diabetics, and if it increases the risk of heart attack by 40 percent, it’s truly a medical catastrophe. Over the next three years, a public battle was waged, involving the FDA, the media, ourselves, science, and eventually this drug was removed from the market in Europe completely—you can’t buy it there—and so severely restricted in the United States that nobody gets it.
it turns out there was a website. There’s a very interesting story here. Eliot Spitzer, when he was attorney general of New York, sued GlaxoSmithKline, the maker of Avandia, for concealing evidence that their anti-depressants were increasing the risk of suicide in children and adolescents. And rather than take a monetary settlement, the settlement of that suit was that the company had to post the results of all their clinical trials for all their drugs. And they did so at a website, that was not easy to find, in the U.K. We found it. We analyzed the data. And what we saw was frightening, to say the least. And we published it.
it’s interesting, because rarely, if ever, have these sorts of problems reached the level of the criminal courts. My own view is that they should. Importantly, it would create a deterrent. It would say, look, if you conceal information that can cost the lives of our citizens, that that should be treated the same way we would treat other violent crimes. Now, I don’t think it’s going to happen. You know, the whole idea of white-collar crime being treated differently is a problem in America, but the reality is, is a lot of people were very severely harmed.
the FDA Office of Surveillance and Epidemiology, which does this kind of analysis, estimated anywhere between 50,000 and 200,000 people either died or had a heart attack as a result of the marketing of this drug when it was marketed.
Vioxx is a very similar story, yeah. In 2001, we analyzed data from a clinical trial of Vioxx. Vioxx was made by Merck. And that data was concealed from a manuscript that was published about the drug. We got access to the data through the FDA website, again, through an unusual source; published it; and there then ensued a three-year battle, public battle, that ultimately led to the withdrawal of the drug from the market completely, worldwide, in 2004. It caused heart attacks. It dramatically increased the risk of heart attack, stroke and death.
there are very good and very ethical companies in the pharmaceutical industry and companies I work with every day. But there are also forces at play, powerful economic forces, that can cause companies, if they don’t have good supervision, to do the wrong thing. And what they did in both these cases is they looked at the information, and they literally did a calculus. What would it cost if we revealed the hazard and lost the sales of the drug? What would it cost if we took our chances that somebody will find out? And they decided that it was less expensive to conceal the information than to reveal it.
There is a document that surfaced in court cases that literally makes a calculation of how much it would cost if this came to light and how much it would cost if it didn’t. And the ultimate calculation was it was better to keep this under wraps.
what we ended up with healthcare reform bill was a bill that just kind of moves the needle a little bit in one direction. Now look, I think it was a step forward. At least it goes forward towards making certain that the 50 million Americans—it’s just scandalous that in a country with our wealth, 50 million of our citizens don’t have any health insurance. And they’re one illness away from bankruptcy, from the kind of catastrophes that can befall famillies. So this bill did help to close that gap, but it really was more about insurance reform than it was about healthcare reform. It is still light years away from what we need to solve the problem of healthcare in America.
I think we need to contain costs with a system that doesn’t reward doing the wrong things. We have what I like to call “perverse incentives.” And this is talked about in Escape Fire extensively by myself and by Don Berwick, the former administrator of Medicare, that these incentives basically pay physicians to do procedures, to do things to patients. We aren’t being paid for quality, we’re being paid for quantity. And as a consequence, we drive more and more utilization, more and more procedures, and that’s why we spend so much and we get so little.
Cleveland Clinic
It is actually a little different, the Mayo Clinic. And I’ll tell you one thing that I am proud of in our institution, is we are not reimbursed on a fee-for-service basis. Every physician that works at the clinic gets a salary. So when you see a patient, there is no incentive to do procedures that may be not needed. There is a simple formula that says you get paid for coming to work every day and taking care of patients. You do your job. Now, we’re well paid. The physicians are well paid. And they all know they could make more money in private practice, not in an institution like that, but people feel very proud of the fact that we are not incentivized to do things to people.
Stents are these little metal mesh devices that prop open the coronary. The coronary is narrowed. And they’re used very widely in millions of Americans. And in the right setting, they’re very useful. The problem is, we’re twice as likely to use a stent in patients in the United States as they are in other developed countries. And part of the reason is that every time you put a stent in, a bill is generated, and that represents revenue. Now, look, well-meaning people do respond to economic incentives. It’s the way our system is built. And so, I believe you have to take some of that incentive, some of that profit incentive, out of the system. And that’s what you do when you move toward a system that basically is a salary-based system, rather than a fee-for-service-based system. We’re a long way from having that in America.
American Medical Association has not been on the forefront of healthcare reform. You know, you may—many people don’t realize that when Medicare was first proposed, the AMA was vehemently opposed to Medicare. They said it was socialized medicine to pay for healthcare in senior citizens. And now, they’ve come a long way since then, but they haven’t come far enough.
under-regulation of the financial industry led to a catastrophe. And under-regulation of the medical industry has led to similar catastrophes. But believe it or not, there are people, on the right, who believe that the FDA should be abolished. And I’ve actually been interviewed on some channels, like Fox, where people have said, “Well, why do we need the FDA, Dr. Nissen? Why can’t the market regulate this? I mean, if drugs aren’t safe or effective, people won’t use them, right?” And the very idea is chilling, and should be chilling, to Americans. We need regulation. We need thoughtful regulation. Regulation is not a four-letter word. And we need regulation, and we need a government that looks out for the interests of its people, rather than the interests of business. And right now, most of the efforts of the federal government, many of these agencies, are so closely aligned with the business community that they’ve lost sight of what their real mission is: to represent the American people.
we could prevent a lot of the diseases that we now treat, if we could deal with the problem of obesity. But, you know, obesity is also a problem of poverty. You know, you ask, why is obesity so problematic? Is because the most fattening foods are the cheapest and most easily obtainable. And that’s why, in low-income populations, obesity is on the rise. We need to do better. And that’s why, I think, when I hear comments like Obama is “the food stamp president,” thank God for food stamps. Without food stamps, we’d have a lot of people starving in the streets.
An escape fire is a fire lit to clear an area of vegetation in the face of an approaching wildfire when no escape exists. I think that the analogy here, among others, is that we need to now fight fire with fire. And so, one of the things I loved about working on this film, with this wonderful crew, is that Escape Fire, they—it was done by people who share our passion for improving healthcare. And I think the film really speaks to the problem and talks about some of the solutions.
Discussion with Dr. Steven Nissen.
Dr. Steven Nissen, one of the country’s leading cardiologists and an outspoken critic of the pharmaceutical industry. His research into Vioxx and Avandia led to severe FDA restrictions, reducing the use of both drugs. Time magazine named him one of the 100 Most Influential People in the World in 2007. He is the chair of the Department of Cardiovascular Medicine at the Cleveland Clinic.
– from democracynow.org