Medical Whistleblower

[Guest guest]

Democracy Now!

As GOP candidates challenge Obama’s healthcare reform, we speak to Dr. Nissen, a top cardiologists who is featured in a film “Escape Fire.†“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," says Nissen. What will be the fate of healthcare reform in 2012 and why?

Medical Whistleblower Dr. Nissen on "Escape Fire: The Fight to Rescue American Healthcare" www.democracynow.org Dr. Nissen is profiled in the documentary, “Escape Fire: The Fight to Rescue American Health Care,†featured this year at the Sundance Film Festival. Democracy Now! speaks with Dr. Nissen about the efforts to dismantle healthcare reform by leading Republican presidential candidates.

[Guest guest]

This is the whole interview. It is well worth the

read.

January 23, 2012

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Medical Whistleblower Dr. Nissen on " Escape

Fire: The Fight to Rescue American Healthcare "

As

the Republican presidential candidates propose to dismantle President

Obama’s 2010 healthcare reform package, we speak to Dr. 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]

Dr.

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.

Related stories

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. 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 GlaxoKline, 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 [GlaxoKline]?

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:

GlaxoKline.

AMY GOODMAN:

GlaxoKline. So often they merge that I get confused.

DR. STEVEN NISSEN:

Absolutely.

AMY GOODMAN:

GlaxoKline, 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. 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. 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. 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.