- 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.
As the Republican presidential candidates propose to dismantle President Obama’s 2010 healthcare reform package, we speak to Dr. Steven Nissen, one of the nation’s leading cardiologists. His research into Vioxx and Avandia led to severe restrictions by the Food and Drug Administration, reducing the use of both drugs. Nissen is profiled in the documentary, "Escape Fire: The Fight to Rescue American Healthcare," which is being featured this year at the Sundance Film Festival. The film tackles the powerful forces behind the battle over heathcare costs and access. "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," said Dr. Nissen, who chairs the Department of Cardiovascular Medicine at the Cleveland Clinic. "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." [includes rush transcript]
AMY GOODMAN: We’re broadcasting from Park City, Utah, home of the Sundance Film Festival, the nation’s largest festival for independent cinema. And we thank our host, Park City Television.
One of the issues raised over and over in the Republican presidential primary is the cost of healthcare. Since President Obama fought to pass his healthcare reform agenda, the issue has been the center of intense political debate. During the Republican presidential debate last Thursday, Newt Gingrich slammed Obama’s healthcare plan.
NEWT GINGRICH: The American people are frightened of bureaucratic, centralized medicine. They deeply distrust Washington. And the pressure will be to repeal it. And a lot of what Governor Romney just said, I think, is actually pretty good, sound stuff for part of the replacement. I would always repeal all of it, because I so deeply distrust the congressional staffs that I would not want them to be able to pick and choose which things they kept. But let me make one observation. You raised a good example. Why is President Obama for young people being allowed to stay on their parents’ insurance until 26? Because he can’t get any jobs for them to go out and buy their own insurance. I mean, I have an—I have an offer—I have an offer to the parents of America: elect us, and your kids will be able to move out, because they’ll have work.
AMY GOODMAN: That’s Newt Gingrich, who won the South Carolina primary. Many say Obamacare is very similar to Romneycare. That’s the healthcare bill that Mitt Romney signed off on when he was governor of Massachusetts. Still, Romney is equally fierce in his criticism of President Obama’s plan.
MITT ROMNEY: We have to go after a complete repeal. And that’s going to have to happen—that’s going to have to happen with the House and the Senate, hopefully the Republican. If we don’t have a Republican majority, I think we’re going to be able to convince some Democrats that when the American people stand up loud and clear and say, "We do not want Obamacare, we do not want the higher taxes, we do not want a $500 billion cut in Medicare to pay for Obamacare" — I think you’re going to see the American people stand with our president and say, "Let’s get rid of Obamacare." But we’ll replace it.
And I’ve laid out what I’ll replace it with. First, it’s a bill that does care for people that have pre-existing conditions. If they’ve got a pre-existing condition and they’ve been previously insured, they won’t be denied insurance going forward. Secondly, I’ll allow people to own their own insurance, rather than just be able to get it from their employer. I want people to be able to take their insurance with them if they go from job to job. So, we’ll make it work, in the way that’s designed to have healthcare act like a market, a consumer market, as opposed to have it run like Amtrak and the post office. That’s what’s at risk here—at stake here. Do we—we go back to this. Ours is the party of free enterprise, freedom, markets, consumer choice. Theirs is the party of government knowledge, government domination, where Barack Obama believes that he knows better for the American people.
AMY GOODMAN: That was presidential candidate Mitt Romney.
Well, we turn now to one of the most talked-about documentaries at the Sundance Film Festival. The film tackles the powerful forces behind the battle over healthcare cost and access. It’s called Escape Fire: The Fight to Rescue American Healthcare.
To talk more about the question of healthcare reform, we’re joined now by Dr. Steven Nissen, whose work is featured in the film. He’s chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, one of the nation’s leading clinics, and served as president of the American College of Cardiology. Dr. Nissen’s research into Vioxx and Avandia led to severe restrictions by the Food and Drug Administration reducing the use of both drugs. He features prominently in Escape Fire.
We welcome you, Dr. Nissen, to Democracy Now!, here in Park City. It’s great to have you with us.
DR. STEVEN NISSEN: It’s great to be with you.
AMY GOODMAN: I mean, I know you’re a star in the field of cardiology, but now you’re a star in a film here that has just premiered. We’re coming out of the South Carolina primary. A major focus of attack against the Democrats is what the Republicans call "Obamacare." Can you talk about the criticism and talk about what we need today, especially in light of one of the headlines we just brought out, the Citizens United decision? Why would that weigh in? Why would you care about that as a doctor in this country?
DR. STEVEN NISSEN: Well, many things to talk about here, but first of all, let me say that 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.
AMY GOODMAN: How—talk about the forces at play. You’re a fierce critic of the pharmaceutical industry.
DR. STEVEN NISSEN: Well, let me, first of all, say that the 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.
AMY GOODMAN: Let’s talk about the drugs that you investigated yourself. Start with Avandia.
DR. STEVEN NISSEN: Well, 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.
AMY GOODMAN: Avandia hid this.
DR. STEVEN NISSEN: They knew—
AMY GOODMAN: I mean, the company.
DR. STEVEN NISSEN: The company knew, yes. The company knew.
AMY GOODMAN: You found it by googling—
DR. STEVEN NISSEN: Yes.
AMY GOODMAN: —and finding a report from what? London?
DR. STEVEN NISSEN: Well, 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.
AMY GOODMAN: What is the criminal liability of [GlaxoSmithKline]?
DR. STEVEN NISSEN: Well, 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.
AMY GOODMAN: How many people do you think needlessly died?
DR. STEVEN NISSEN: Well, 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.
AMY GOODMAN: Vioxx?
DR. STEVEN NISSEN: And Vioxx is a very similar story, yeah. In 2001, we analyzed data from a clinical trial of Vioxx, data that had not—
AMY GOODMAN: Who makes Vioxx?
DR. STEVEN NISSEN: 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.
AMY GOODMAN: Because it did what?
DR. STEVEN NISSEN: It caused heart attacks. It dramatically increased the risk of heart attack, stroke and death.
AMY GOODMAN: So talk about the calculation that a company that Glaxo—well, the official name of the company?
DR. STEVEN NISSEN: GlaxoSmithKline.
AMY GOODMAN: GlaxoSmithKline. So often they merge that I get confused.
DR. STEVEN NISSEN: Absolutely.
AMY GOODMAN: GlaxoSmithKline, GSK.
DR. STEVEN NISSEN: Yes.
AMY GOODMAN: And Merck. What are the calculations they make, in terms of what would it cost to reveal the information, what would it cost not to reveal and just pay out lawsuits when people die and some family members sue?
DR. STEVEN NISSEN: Yeah. Again, I want to say, make sure that everybody understands, that these are our outliers. I mean, 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.
AMY GOODMAN: This was, in the case of—in the case of Avandia, an actual memo that you saw.
DR. STEVEN NISSEN: There is. 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.
AMY GOODMAN: And yet, does the new legislation, the new healthcare bill, do anything about this, regulate this in any way? Would it change the situation?
DR. STEVEN NISSEN: No, it doesn’t. And again, 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.
AMY GOODMAN: And that is? What do we need?
DR. STEVEN NISSEN: Well, 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.
AMY GOODMAN: Talk about your own clinic. Cleveland Clinic is known throughout the world, and it’s a very interesting model. It’s similar, Dr. Steve Nissen, to Mayo Clinic.
DR. STEVEN NISSEN: Yeah. 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.
AMY GOODMAN: Let me ask you an example, the stent.
DR. STEVEN NISSEN: Yes.
AMY GOODMAN: Why would a doctor in a different situation maybe deal with things differently?
DR. STEVEN NISSEN: Well, there’s been a lot of criticism—and I’ve been one of those that have criticized—the overuse of coronary stents. We now know that in patients that have chronic chest pain, that stents do not prevent heart attack or extend life.
AMY GOODMAN: Why do doctors put them in? And what are they exactly?
DR. STEVEN NISSEN: 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.
AMY GOODMAN: Where does the American Medical Association stand on that issue?
DR. STEVEN NISSEN: Well, the AMA 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.
AMY GOODMAN: Dr. Steven Nissen, as we wrap up, what you feel people should understand, take from the problems with medicine, about the issues we must deal with in this country, like regulation? I dare say that everyone from Mitt Romney to Newt Gingrich would be deeply concerned if the medical devices and drugs that they themselves or their family members were given were not highly regulated. And yet, we are talking about a political discussion now that has to do with targeting regulation as the problem, the jobs killer in America today.
DR. STEVEN NISSEN: Well, it’s a terrible, terrible way to approach this problem. You know, regulation—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.
AMY GOODMAN: How does diet fit into this picture?
DR. STEVEN NISSEN: It’s a huge issue. I mean, look, 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.
AMY GOODMAN: Well, we’re going to take that on in our next subject. Raj Patel will join us. Among his books, Stuffed and Starved. Dr. Steven Nissen, I want to thank you for being with us, but ask a final question. We are here at the Sundance Film Festival. You’re here because you’re one of the subjects of this film called Escape Fire, dealing with America’s healthcare system. Explain why the film was called Escape Fire, what that means.
DR. STEVEN NISSEN: Well, there was a fire a number of years ago, where an individual, in order to actually escape the fire—
AMY GOODMAN: The firefighter.
DR. STEVEN NISSEN: The firefighter, built a fire around himself.
AMY GOODMAN: So the flames were coming at all these firefighters that were going in to fight the fire.
DR. STEVEN NISSEN: That’s right. And he fought fire with fire. And—
AMY GOODMAN: He actually lit a match—
DR. STEVEN NISSEN: And formed a fire—
AMY GOODMAN: —in front of himself.
DR. STEVEN NISSEN: Exactly. And that—
AMY GOODMAN: Horrifying the other firefighters.
DR. STEVEN NISSEN: Exactly. He did, indeed. And, you know, 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.
AMY GOODMAN: And just to say, with this firefighter, he encouraged the other fighters—firefighters to join him in the circle. He lit a flame. The fire would burn the area around him, and then the fierce fire that was coming at them would not scorch them, because the land would already be scorched. The firefighters thought he was crazy, ran away, and they were all enveloped in the flame and killed.
DR. STEVEN NISSEN: And unfortunately, the best solutions for the healthcare problem, people are running away from them, not running toward them.
AMY GOODMAN: Dr. Steven Nissen, one of the country’s leading cardiologists, featured in the new film Escape Fire: The Fight to Rescue American Healthcare. Dr. Nissen is chair of the Department of Cardiovascular Medicine at the Cleveland Clinic, one of the nation’s leading clinics.
This is Democracy Now! We’re broadcasting from Park City, Utah, from Park City Television. We’ll be back looking at another film that takes on an issue that is central to the debates that are taking place in this election year. It’s the issue of poverty and hunger. Stay with us.