Transcript - June 8, 2007
BRANCACCIO: Welcome to NOW.
Nobody lives forever, but that doesn't mean we won't want to try to. To that point, here are a couple facts you need to know. According to the Wall Street Journal, American's spent at least 14 billion dollars last year on coronary stent procedures. Stents are those little tubes that open clogged arteries to the heart.
We spent all that money despite the fact that, according to the FDA, there is no evidence that stents significantly reduce the risk of future heart attacks.
Now a new study is raising questions about whether many of those procedures are really necessary.
Bryan Myers produces our report.
HINOJOSA: Shirley Davis is a 70-year-old homemaker from Buffalo, New York. A few weeks ago, Shirley began having chest pains. Worried she might be having a serious heart attack she quickly called her doctor.
DAVIS: Well, It was like a heaviness, and it was hard to breath, and when I laid on the couch, it felt like somebody put something heavy on my chest.
HINOJOSA: As it turns out, it wasn't an emergency. Still, the pain was making life difficult. So Shirley is about to undergo a common procedure known as "angioplasty."
More than a million angioplasties are performed in America each year. But a new study has found that in patients like Shirley, whose problem is chest pain, angioplasty won't help them live any longer. That study has sparked a debate over whether too many of these procedures are being done to treat routine heart disease.
Doctor William Boden is the Chief of Cardiology at Buffalo General Hospital and a professor at the University of Buffalo. Boden oversaw that new study.
BODEN: I think most patient have an expectation that, gosh, if I'm undergoing this procedure to put stents in my arteries, that that's going to make me live longer or reduce my likelihood of having a heart attack.
HINOJOSA: And, in fact, your study showed?
BODEN: Yeah, our study showed that was not the case.
HINOJOSA: Here's how angioplasty works. As we get older, blockages can form in the blood vessels around the heart, causing chest pain. With angioplasty, a tiny inflatable balloon is snaked into the artery to removes blockage. Then, a little metal tube called a "stent" is left behind to keep the artery open.
HINOJOSA: This is not the first time Shirley's had an angioplasty. Sixteen years ago, she had one. She believes it added years to her life.
DAVIS: It did wonders for me. I probably wouldn't have had the sixteen years if I didn't have it done.
HINOJOSA: But in the eleven hundred or so people studied by Dr. Boden, angioplasty did not increase life expectancy. To be clear, if you are actually having a heart attack, angioplasty and stents can save your life. But if you are having moderate chest pain that won't go away, Dr. Boden says there's a non-invasive alternative.
BODEN: You cannot treat this disease by putting a stent here or there.
HINOJOSA: In his study, Boden compared people who got stents to people who took medicine, changed their diets, and got more exercise. Boden says those kind of lifestyle changes can be hard work, but he says they can also pay off.
HINOJOSA: You said in the Wall Street Journal that medical therapy has gotten a bad rap.
HINOJOSA: Doctors who treat with diet, exercise, pharmaceutical products, you all are being told what?
BODEN: I don't think that most cardiologists have felt or believed that medical therapy could possibly be the equal of angioplasty and stenting.
HINOJOSA: Boden called his study "Courage." And earlier this year, he unveiled it at a major medical conference in New Orleans.
BODEN: "...but medical therapy was also remarkably effective..."
HINOJOSA: Boden told of his success with his approach of drugs and lifestyle changes - a combination he calls "optimal medical therapy."
BODEN: "Courage" tells us a very important message that we need to get out to physicians and patients. That optimal medical therapy works. It's effective. It's cost effective.
HINOJOSA: Reaction to the study was swift. Many in the health care profession praised the study, calling it a "blockbuster." But others, mostly doctors who perform angioplasties, quickly cried foul. One even called it "rigged."
YUSUF: They almost felt threatened. In fact, they are threatened by the results.
HINOJOSA: Doctor Salim Yusuf was there in New Orleans. He was invited by the organizers of the conference to be part of the study's presentation. Yusuf has long-advocated shifting the focus of medicine back to preventive care.
YUSUF: My comments were that this was one of the most important studies to have been completed in recent times. Because a study like this, where you're swimming against the current, is always a challenge to do.
HINOJOSA: Yusuf says Boden's study confirms the belief that invasive procedures like angioplasty are being overused.
YUSUF: The problem is when a procedure that people feel is attractive, seductive, gets done, and there are a lot of vested interests pushing it, it starts to spread like wildfire. And that's what happened with angioplasty.
Heart disease and coronary disease is a self-inflicted disease. We're too fat. We eat the wrong food and we don't exercise. And people don't want to hear that. They want a quick fix. "Doc, fix me. I can go back and have my double burger."
HINOJOSA: Doctors who perform angioplasties are known as "interventional cardiologists." And just a few weeks ago, they held their own annual meeting in Orlando, Florida.
We decided to drop in and hear what they were saying about Boden's study. As you might imagine, most were skeptical, and even blamed the media for blowing it out of proportion. Doctor Ted Feldman heads up this annual gathering devoted to angioplasty.
FELDMAN: To say there are too many being done is a vast oversimplification.
HINOJOSA: Doctor Feldman says the notion that he and his colleagues are too eager to perform angioplasty is baloney. Feldman says medicines have always been the first choice for treating chest pain. He says he ought to know—he helped write the treatment guidelines for his profession.
FELDMAN: I can tell you in my practice, that patients are referred to me by general cardiologists who have screened patients. And there is an intermediate step and that is a discussion with the referring cardiologist about, "Is this appropriate? Is there a clinical need?" And I think that represents the most common practice pattern in the United States.
HINOJOSA: There's a lot at stake. You can't talk about this issue without talking about money. An angioplasty can cost as much as $40,000. And any study that calls for fewer of them could change the way insurance companies reimburse doctors and hospitals—not to mention, affect the bottom line of the companies that make angioplasty equipment.
Besides doctors, there's another group that's turned out in force at this meeting—the medical device companies.
MEDICAL DEVICE REP: "Can you feel it going thru the lesion? Is there a tightness there?"
HINOJOSA: Device manufactures often foot part of the bill for events like this. Many of the big names are here: Medtronic, Boston Scientific, Saint Jude Medical. For them, it's the perfect place to reach out to doctors, hoping to convince them to use their products.
SAINT JUDE REP: "It is very easy, you'll be amazed by the particulate you'll get out of there."
HINOJOSA: Doctor James Ferguson—he's the tall guy on the left—is a well-respected medical researcher. He doesn't do angioplasties, he's just here to listen in.
FERGUSON: There's no question that coronary intervention is big business. There is a lot of money involved in this. And this gets everybody very nervous. And very upset. And very passionate.
HINOJOSA: In fact, before Boden's student was even reported in a medical journal, it was the subject of an article on "Forbes.com." The headline? "Study could hurt stent sales." Doctor Boden suspects a doctor with connections to the device companies leaked his study to alert the angioplasty community.
HINOJOSA: So you were wanting to research this as a doctor, but part of the controversy had to do with, "does this mean that the market for these products is going to suffer?"
BODEN: There was a concern on the part of many, I believe, that if the study was negative that this would have a harmful effect on patient perspectives and attitudes, referring physician attitudes and perspectives, about who should or should not undergo angioplasty.
HINOJOSA: Along side the scientific controversy is another controversy—have device makers been offering perks to doctors to get them to use their products? That's illegal. Now, a federal investigation is looking into whether that's exactly what's been going on.
Congressman Henry Waxman is chairman of the house oversight committee. He's looked at the numbers regarding the use of stents, and finds them unusually high. So he's launched an investigation to find out how the two leading stent makers—Cordis, a division of Johnson and Johnson, and Boston Scientific—have been marketing and promoting their products.
One thing that concerns Waxman is the so-called "off label" use of stents. When a medical device is approved for sale by the food and drug administration, the agency requires a label describing the product's specific use. Using a device in a manner other than described is not illegal. But for device makers to promote such "off label" uses is illegal. Waxman wants to know why stents are so often used in this off-label manner.
Both Cordis and Boston Scientific are here in Orlando. Boston Scientific is the biggest stent maker in America. Almost a third of its profits have come from the manufacture and sale of stents.
BAIM: By statue, we as device manufactures are prohibited from marketing our devices for off label use...
HINOJOSA: Doctor Donald Baim is the Chief Medical Officer of Boston Scientific, and is a pioneer in the field of angioplasty. Baim denies his company offers illegal inducements to get doctors to use their stents. He says the reason stents are so popular among both doctors and patients is because they work.
BAIM: There's nothing from the FDA or any other agency that says the physician is not free to offer that patient the best treatment. So it's not a question of flying blind, or being a cowboy, or working in a dangerous area.
HINOJOSA: This group is celebrating the 30th anniversary of the world's first angioplasty, and Baim has been invited to deliver a major speech.
BAIM: "I'd like to talk about our shared professional history..."
HINOJOSA: Baim says Boden's conclusions aren't anything new. He says his colleagues never tell patients with chronic chest pain known as "stable angina" that angioplasty will prolong their life. Baim says in those kinds of cases, angioplasties are done for other reasons.
BAIM: The reason that stable angina patients choose something other than medical therapy, angioplasty or surgery, is because they are either unhappy with their lifestyle and their activity capacity, or, they're unhappy with the side effects of the medicines they're taking.
HINOJOSA: For proof of that, Baim says, just look at Boden's study. Many of the patients who started out on medicine eventually decided to get Angioplasty anyway.
BAIM: The question is really a question of what sort of lifestyle do Americans think they're able to achieve. And are we willing to use healthcare resources to help them do that. Hip replacements don't improve survival. But they let people who can't walk without incredible pain walk normally. And undergo normal activity. That's basically the same situation with angioplasty for a stable angina patient.
HINOJOSA: Dr. William Boden doesn't have anything to do with Congressman Waxman's investigation of the device makers. Nonetheless, he too acknowledges that money is always lurking in the background of this issue.
HINOJOSA: When you started this, did you think, my gosh, I'm taking on an industry that is worth billion and billions of dollars in this country?
BODEN: We did know that was something that ultimately we would be taking on...
HINOJOSA: Whatever the reasons for the controversy surrounding his study, Boden says he doesn't mind. Any debate it's sparked is a good thing, he says—at least, it's getting doctors and patients refocused on what he calls, "good old-fashioned" healthcare.
BODEN: I think society has placed a higher value on the importance of technology. And by inference, if you're not getting a procedure, somehow, you are being deprived of the latest and greatest benefits that medicine has to offer.
Many patients have had the view that, "well, if I'm given the choice to have, you know, the quick fix of getting an angioplasty procedure and a stent, compared to taking medical therapy I'd rather have the stent."
HINOJOSA: Remember Shirley Davis, the patient we saw earlier getting an angioplasty? She's out of the hospital now, recovered and playing with her grandkids.
Shirley said that for her, medicines weren't working, so angioplasty was the best way to go to relieve her chest pain. But she also believes the angioplasty will add years to her life. In fact, survey's show that over 70% of patients like Shirley are convinced angioplasty will help them live longer.
DAVIS: I don't know if you can actually get rid of it, the blockage, with drugs. I don't know, but that is the way I look at it.
HINOJOSA: But when Shirley was getting her angioplasty, even her doctor told us he never promotes it as a path to longevity. He agrees that Doctor Boden is right—it's only through aggressive medical therapy and dramatic lifestyle changes that one can expect a longer life.
BRANCACCIO: You can dig even deeper - more about what people are saying about stents can be found on our website. PBS.ORG is the place to start.
Now we still have time for a media reform story before we go. It's about a looming challenge to what had been an emerging bright spot in the media landscape: Internet radio. In contrast to all that corporate drek you often get stuck with if you listen to music on a regular radio, Internet radio presents an ear-opening alternative. But the fear is that many would go silent in a battle over royalties. Megan Thompson produced our report.
BRANCACCIO: There's a new kind of radio. Only it's not on your old AM/FM dial ... It's radio through your computer. With just a few clicks through the Internet you can listen to thousands of stations ... Big, corporate ones, little, cool ones, just about any kind of music you can think of.
So just who is behind this new kind of radio? To find out, we went to paradise. Paradise, California. Here, in the foothills of the Sierra Nevada Mountains, is an Internet radio station heard around the world.
GOLDSMITH: "You're listening to Radio Paradise..."
BRANCACCIO: Meet the voice of radio paradise: Bill Goldsmith. From the second floor of his house, Goldsmith rocks up to thirty thousand listeners every day, around the planet.
GOLDSMITH: We have 207 people listening in London, 5 in Oxford...
BRANCACCIO: From a library of about fifteen thousand songs, Goldsmith blends everything from Beethoven to the Beatles to Better Than Ezra. Using a computer program he wrote himself.
GOLDSMITH: I do consider radio to be an art form. It's just as much an art form as the creation of the music itself - or it can be.
BRANCACCIO: Bill is a 30-year FM radio veteran. But when the Internet came along, he realized he could run his own radio station exactly how he wanted to - with no commercials - listeners send the money, public radio style.
GOLDSMITH: I am not a salesman. I am a disc jockey. I don't love commercials, I love music.
BRANCACCIO: In the last month, 1 in 5 Americans has listened to Internet radio, which includes little indie outfits like Radio Paradise, as well as the online versions of established, regular radio stations and big webcasters like AOL. The attraction is the diversity ... If you want Flamenco Guitar, it's there on the 'net. So is Electro, Deep-House, Trip-Hop or Lounge, if that's what you're into.
But despite its popularity, Internet radio is fighting to stay on the air. A new set of fees threaten to wipe out many stations in July.
GOLDSMITH: We've put our—our lives and all of our time and resources into it for—for many years, in most cases. Seven years, in my case. If this goes into effect on July 15 we'll have to shut down.
BRANCACCIO: So what's with July? It turns out that a panel at the Library of Congress, called the Copyright Royalty Board, decided to increase the royalty payments that Internet radio stations make to musicians and record labels in order to use their songs. Goldsmith says his payments will increase ten-fold, and he'll owe more money than he makes.
GOLDSMITH: We have absolutely no problem whatsoever with paying a royalty - as long as it's a reasonable one.
BRANCACCIO: This royalty increase is a victory for John Simson, director of Sound-Exchange, the organization that collects the payments to musicians and record labels. A lawyer and musician himself, Simson has worked for years to get artists what he says is their fair share. He says this royalty is vital for musicians and record companies as folks get used to listening to music on their computers for practically free.
SIMSON: We have a dramatically changing marketplace. You know I hear people say, "Oh well you know people are discovering music this way and they buy more CDs this way." And you know interestingly what we're seeing is a dramatic decrease in the sale of CDs and we're seeing—people consuming music in new ways.
BRANCACCIO: Internet stations and thousands of their listeners came together and stormed Washington.
Congressman Jay Inslee, a Democrat from Washington Sate, says he got almost as many letters from Internet radio listeners as he did about the Iraq war. Inslee introduced a bill to make royalties more affordable.
INSLEE:We need to have a fair return to these geniuses who provide us music and songs. They need a fair return. We also can't strangle the goose that laid the—the golden radio, if you will, on the Internet.
BRANCACCIO: As the July deadline looms, behind-the-scenes negotiations between Sound-Exchange and some webcasters are ongoing, but no deal has been struck yet. And it's doubtful that Inslee's Bill will pass anytime soon. Meanwhile, the webcasters' lawyers have filed an appeal in Federal Court that they hope will buy some more time.
And Goldsmith continues broadcasting from Paradise, counting the days.
D-Day for the new royalties for Internet radio is July 15.
BRANCACCIO: And that's it from NOW. From New York, I'm David Brancaccio. We'll see you next week.