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THE ALTERNATIVE FIX

Written, Produced and Directed by Raney Aronson

 

ANNOUNCER: Each year, Americans spend $48 billion on alternative medicine, more than a third of that on herbs, vitamins and other potions claiming to treat a variety of ills.

HESTER YOUNG: I feel better than I've ever felt. So obviously, something's working.

ANNOUNCER: But as alternative treatments become a mainstream industry, some are beginning to ask whether this is good medicine--

DAVID EISENBERG, MD, Dir, Osher Institute, Harvard Med School: The notion of doing no harm has to trump the notion of "Try it, you may like it."

ANNOUNCER: --or just good business.

ROBERT PARK, PhD, Physicist, Author, "Voodoo Science": What's driving this, of course, is what drives everything, and that's money.

 

NARRATOR: On this winter afternoon at New York City's Beth Israel Medical Center, a group of hospital staff is confronted by a difficult new case, a 12-year-old girl suffering from debilitating nausea and fatigue.

RESIDENT: And then Mom said on December 30th of last year, she basically woke up vomiting and--

NARRATOR: At first glance, this may seem like a typical doctors' meeting.

SENIOR PHYSICIAN: She was tested for mono, obviously, I'm sure, repeatedly, because--

RESIDENT: I'm sure she--

NARRATOR: But in this group, in addition to the young medical fellow and her supervising doctor, there is also a mind-body specialist and an acupuncturist.

ACUPUNCTURIST: I would work with that. And I'd actually be more aggressive with herbs and things that will actually help the digestion, so then she can eat more and be interested in other foods.

NARRATOR: They all talk on an equal basis about the best way to proceed with this patient's care.

MIND-BODY THERAPIST: What is her experience of her whole condition? Because any time you formulate treatment, you want to know where the person is and, you know, how they want to address it.

NARRATOR: For decades, most Western doctors ridiculed alternative medicine, condemning everything from acupuncture to aromatherapy. But now many of them work alongside the very therapies they used to shun, and their hospitals are in the business of selling them.

MATT FINK, MD, Fmr President & CEO, Beth Israel Med Ctr: This is the advancing edge of health care. You can either lead or you can follow.

NARRATOR: Welcome to the new frontier of alternative medicine--

MIND-BODY THERAPIST: Feel a cool or warm breeze.

NARRATOR: --where therapies long considered voodoo remedies are now being integrated into our country's finest hospitals.

This is the story of how we got here, and it begins in our nation's capital with an influential senator and his own personal journey. Tom Harkin, a powerful senator who's been in office nearly 20 years, had a close friend named Berkeley Bedell. Bedell was a former congressman from Harkin's home state of Iowa and had recently turned to alternative medicine as a treatment for his prostate cancer. He believed the therapy had saved his life and had become a strong advocate for these new approaches to medicine.

Sen. TOM HARKIN, (D-Iowa): Berkeley told me he had taken this alternative treatment for his prostate cancer. My initial reaction was just, you know, "How did you find out about this? What's this all about?" I'd never heard about it, and it just-- it got me very curious just about what was happening out there.

NARRATOR: Not long after his friend's miraculous recovery, Harkin had his own personal experience with an unlikely remedy.

Sen. TOM HARKIN: Shortly after Berkeley got well, I was complaining to him about my allergies. And he said that he had a friend of his that said he can cure allergies with bee pollen and asked if I would try it. I said, "Well, why not? Can't hurt me."

So I went on this very tough regimen of taking a lot of bee pollen, sometimes as high as 60 pills a day. And literally, on about the 10th day, all of a sudden, my allergies just left. Well, that's when I began to think we've got to have somebody looking at these different approaches.

NARRATOR: Harkin was the one senator who could make this happen. The Senate committee he headed controlled the purse strings to the government's research arm, the National Institutes of Health. The senator decided to ask Congress to allocate money to have the NIH begin to study alternative medicine. The scientists at the NIH were appalled.

Sen. TOM HARKIN: From the howls and the cries of the medical community, you'd think that I was single-handedly destroying medical research in America-- $2 million to NIH. And NIH's budget at that time, I think, was around $10 billion or $11 billion.

NARRATOR: Although the money was insignificant, to scientists within the NIH, it was a watershed moment. The very idea of studying alternative medicine at the NIH, one medical anthropologist noted, was like setting up an office of deviltry inside the Catholic Church.

JAMES WHORTON, PhD, Medical Historian, U of Washington: There was this reaction that witchcraft and sorcery and alchemy and voodoo were being introduced into the National Institutes of Health, and it had no place there, and that this was purely a political play.

NARRATOR: But the politicians controlled the money, and the scientists' protests went unheeded. In October of 1991, Congress agreed to Harkin's request and passed a bill allocating $2 million to establish the Office of Alternative Medicine inside the NIH. For the first time, alternative therapies had a place in the mainstream of American medicine.

While Senator Harkin was getting his office through the NIH establishment, inside one of the nation's most prestigious medical schools, a young doctor was working on a project that would further stun the medical mainstream.

DAVID EISENBERG, MD, Dir, Osher Institute, Harvard Med School: I had begun to ask my patients, were they using herbs or acupuncture or meditation or chiropractic therapies. And even in my primary care clinic in a university hospital, if I asked 10 patients were they using or thinking about using all these complimentary alternative, unproven techniques, three or four or five would say yes.

NARRATOR: David Eisenberg, a doctor at Harvard Medical School, was one of the first medical students to travel to China in the early '80s to study Chinese medicine. In an effort to get Harvard to allow him to study the effectiveness of these Eastern remedies, in 1991, Eisenberg commissioned a national survey to document the extent to which Americans were already using alternative medicine.

Dr. DAVID EISENBERG: We all predicted that the prevalence of use of complimentary therapies -- acupuncture, chiropractic, meditation -- would be about 10 percent or 15 percent. And we powered the survey to prove that. But we were shocked by the time we got the data, and I remember going home to my wife almost shaking and saying, "Honey, the numbers are huge."

NARRATOR: Eisenberg had uncovered what he called "the hidden mainstream of American medicine." One in three American adults were using some sort of alternative therapy. They were spending $10 billion out of pocket. And only 28 percent of those surveyed said they had ever discussed their alternative practices with their primary care doctors. The publication of Eisenberg's survey was a pivotal moment. Doctors across the country were shocked and humbled to learn the extent to which their own patients were going elsewhere for their health care needs.

TOM DELBANCO, MD, Professor, Harvard Medical School: It was a big hullabaloo, and people took terrific notice.

NARRATOR: Tom Delbanco was a senior author of the survey and is a primary care doctor at Beth Israel-Deaconess Medical Center in Boston and a professor at Harvard Medical School.

Dr. TOM DELBANCO: What was very important was how we showed that people don't talk about it with their doctors and how it's almost as if there are two separate systems going on and they don't interact. That seems kind of silly. I think, in that sense, it was good. It opened Pandora's box, which is always a mixed blessing.

NARRATOR: The results of the Harvard survey were of no surprise to Dr. Andrew Weil. By the early '90s, the Americans counted by Eisenberg had made Weil into a media star.

[Promotional video: "Spontaneous Healing"]

ANDREW WEIL, M.D., Dir, Integrative Med, U of Arizona: Thank you. Hello. I'm going to be talking to you about spontaneous healing, the body's--

NARRATOR: His books and videos are consistent best-sellers. They tap into America's fascination with natural approaches to healing.

Dr. ANDREW WEIL: Your body can do these things.

The interest in alternative therapies waxes and wanes in long historical cycles. That depends primarily on how well conventional medicine is seen as doing its job.

NARRATOR: According to Weil, who has degrees in both medicine and botany from Harvard, conventional medicine gets low marks for delivering the kind of medical care Americans want.

Dr. ANDREW WEIL: People are very fed up with being passive recipients of authoritarian, paternalistic medicine. And many of these other systems make people feel that they are more autonomous, more in charge of their own destiny. I think that's a great longing of people today.

Conventional medicine is now seen as being reckless, dangerous, forcing on people things that are toxic. It's become out of balance in its enthusiasm for external technological solutions to problems.

NARRATOR: And this, Weil believes, is one of the reasons that so many Americans are seeking so many alternatives. In Los Angeles, California, Gil and Christie Goren are waiting to be seen by a group of traditional healers, the Maoris from New Zealand. These healers use a form of deep tissue massage that they say clears out stored-up bad energy that prevents the body from healing itself. If it looks painful, that's the point. The Maoris believe that's one way to heal.

The Gorens are here today hoping the Maoris can help Christie get patient. They have already spent three years and $45,000 on five unsuccessful rounds of in vitro fertilization.

GIL GOREN: In vitro is-- it's a business. You know, she would walk into an examination room, and a doctor would walk right in and wouldn't say a word, and then put her legs up in stirrups and put on a glove and examine her right there, with never even saying, "Hi. How are you?"

NARRATOR: Disheartened by their experience with in vitro, the Gorens are looking for a new approach from this group of Maori healers and their leader, Papa Joe. They are just one of 100 couples who the Maoris will treat for infertility during their two-week stay in Los Angeles.

PAPA JOE, Maori Healer: Hey, hey, hey, hey. How you be?

CHRISTIE GOREN: I'm good. How are you?

PAPA JOE: Bloody marvelous.

With Christie, she was full of anxiety, which allowed a lot of emotional blockage, which then transferred into physical blockages that wouldn't allow pregnancy to happen. The body's got to cleanse itself before anything can happen.

NARRATOR: Alternative therapists like Papa Joe believe that the mind wields power over the body. And to many of the millions who turn to alternative therapies, this attention to the mind-body connection is the essential ingredient missing from the care they receive from mainstream medicine.

Dr. ANDREW WEIL: We know all sorts of machinery that connects the mind to the body. When I approach a patient, you know, my first-- my thought is always, "Why is healing not happening in this person?" You know, "What's blocking it?" Conventional medicine has become very narrow in its focus on the physical body. People are spiritual entities. They're mental/emotional beings.

[www.pbs.org: Read Weil's interview]

CHRISTIE GOREN: We feel like we have a lot of good partners now, rather than when we were working with the medical profession, we felt like we were really alone in that. And I feel that we're really close, and I feel that we're-- we're going to be successful.

PAPA JOE: Give yourselves a bit of space, a bit of time. It will happen within three weeks. Don't go hard at it. You're both so tense. But if you let it happen from here-- sweet. Yeah? It'll happen within three weeks.

CHRISTIE GOREN: I really didn't expect to hear that. I expected maybe another five months. It just has always been another five or six months for me. Almost a little unreal, kind of like everything I've been waiting for could happen in three weeks.

Dr. TOM DELBANCO: The question is how to find that terribly important medical ingredient called hope. In alternative medicine, when they need something to be hopeful about, the messages are definitive, clear, very emphatic, as far as I can see, and from what I've read, based on incredibly little scientific evidence.

NARRATOR: What is the science behind these alternative therapies?

EXHIBITOR: [New Life Expo] Once the body is harmonically in tune or in balance with itself, it starts to assimilate and integrate medicine better.

NARRATOR: With millions of Americans spending billions of dollars on alternative medicine, we wanted to find out what the scientific research has shown. We went back to the NIH to find out what the Office of Alternative Medicine that Senator Harkin set up 10 years ago has learned. The office, it turns out, has been mired in a continuing controversy between the NIH scientists and the politicians. The scientists argue that Congress was more interested in advocating for unproven therapies than subjecting these new treatments to real evaluation. Harkin and his fellow congressmen complained of slow-moving, overly cautious scientists.

Sen. TOM HARKIN: The people at NIH just thought they could just bury it. It was new, and it wasn't invented here. And it didn't fit into the narrow kind of research confines that NIH had been used to.

NARRATOR: But Harkin was undeterred by critics of the office, as he continued to pressure Congress for more money.

Sen. TOM HARKIN: I came back the next year and the year after and the year after and kept on them to start expanding and to do more research.

NARRATOR: Finally, in 1998, Harkin won a major battle when Congress agreed to turn the small office into a full-fledged research center. With new status and real money, the NIH could no longer ignore alternative medicine. And as a sign that times were changing, the institute put one of its top research scientists in charge, Dr. Stephen Straus.

STEPHEN STRAUS, MD, National Institutes of Health: I took this job because it's about the opportunity to prove that there are new things, that we can expand opportunities for health care. But along the way, we have to accept the possibility that some will not be good, some will not be safe, some will not be better than existing therapies. The public is going to have to accept it. People who have vested interests, they're going to have to get over it.

NARRATOR: Now universities around the country vie for new-found grant money from Straus's office. At the University of Maryland, they have received a grant from the NIH for the largest American study ever on the Chinese therapy acupuncture. They have recruited 570 patients for this study. All of them suffer from osteoarthritis in their knees and have not responded to conventional anti-inflammatory drugs.

Sylvia Ankers has had arthritis for over a decade.

SYLVIA ANKERS: We don't have any health insurance, so I had gone, you know, to a couple of doctors, and they'd give me shots of silicone or something in the knees. And it would last for a little bit, but then we were back to the pain and hurting to walk, and that. So I figured I was ready for trying anything. And I'd heard, you know, acupuncture-- it's old. It's got to be good, you know? [laughs]

NARRATOR: Brian Berman is in charge of the acupuncture study.

BRIAN BERMAN, MD, U of Maryland School of Medicine: The research of acupuncture is complex. Now we're beginning to look at what works, what doesn't work, for what types of patients and what types of conditions.

NARRATOR: Though millions of Americans use acupuncture and the therapy has been used for thousands of years in China, large-scale scientific studies in this country have only been able to prove acupuncture's effectiveness for two specific ailments: controlling nausea due to chemotherapy and relieving dental pain. And even these small benefits have been questioned by skeptical scientists.

MARCIA ANGELL, MD, Harvard Medical School: Both of these conditions are subjective. You're reporting that your toothache feels better. You're reporting that you're less nauseated.

NARRATOR: Marcia Angell is a senior lecturer at Harvard Medical School and the former executive editor of The New England Journal of Medicine. She has been a persistent critic of the research done on alternative medicine.

Dr. MARCIA ANGELL: You have to ask how well were these studies controlled? I suspect, in most cases, acupuncture works through a placebo effect.

NARRATOR: Controlling for what scientists refer to as the placebo effect was the task given to Berman's team. The placebo effect is the phenomenon of a patient feeling better after a treatment even when the treatment itself has no medicinal effect. For this study, as part of the control, the patients are not allowed to watch the acupuncture needles being inserted. And to ensure the integrity of the study, neither were our cameras. Some of these patients are not receiving acupuncture at all. Instead, they are receiving a fake or sham treatment.

Dr. BRIAN BERMAN: We had people get needles through a guide tube when we were putting in the real acupuncture. And then when we were putting in the sham acupuncture, we had the guide tube slightly on its side, so you would feel a sharp edge, and then we would tap, but there was no needle going through.

NARRATOR: This is the way Berman is controlling for the placebo effect. If patients who receive only sham acupuncture report feeling better, it would suggest it was simply the placebo effect at work.

Dr. BRIAN BERMAN: We asked the patients-- we developed a credibility questionnaire, "What do you think that you got? Did you get acupuncture or did you not?" And they weren't able to tell the difference.

SYLVIA ANKERS: I believe that I got the real acupuncture. My granddaughter and I like to go shopping once in a while. We have a bus trip from church. And last time we went to the mall, she pushed me around in a wheelchair. I went-- we went again the end of May of this year. I walked the entire mall. So I know that something was working.

1st PATIENT: I think I got the placebo. My knees hurt. They still hurt.

2nd PATIENT: I debated with my wife, you know, "Am I getting the real stuff or not?" And I-- you know, after a while, I said, "I'm going to suspend my judgment on that." It's working. It's-- whatever it is, whether it's a placebo effect or it's actually acupuncture, it's done something for me."

[www.pbs.org: Learn more about the placebo effect]

NARRATOR: The results of the study have not been released yet, but FRONTLINE has been told off the record that Berman's team is encouraged by their findings.

When Berman publishes his acupuncture study, it will only be the second large-scale trial completed on alternative medicine since the NIH began funding the research 10 years ago. The only completed study to date is on the popular herbal supplement St. John's Wort.

[CNN news story]

REPORTER: If you get the blues from time to time, you've probably heard of St. John's Wort.

NARRATOR: The NIH St. John's Wort study made headlines last year as the media reported widely that this popular natural anti-depressant had been proven not to work.

REPORTER: Studies show that St. John's Wort was not effective against severe depression.

NARRATOR: But the controversy surrounding this study demonstrates the pitfalls and passions that scientists face as they examine alternative therapies that are already on the market. The study measured the herb's effectiveness in treating patients with moderate to major depression. This very design, its critics say, rendered its results suspect, if not useless.

Deb Soule is an herbalist in northern Maine. For over a decade, she's treated patients with St. John's Wort and other medicinal herbs.

DEB SOULE, Herbalist: I have used St. John's Wort for a number of people who have mild depression, some people due to lack of light in the wintertime. There are many people who will use it from early to mid-October until about March, and they say that it's been very, very helpful for them in those months when the light is much less. But we're talking about mild to moderate depression. And there's a real difference from mild to moderate depression to severe depression.

NARRATOR: But testing St. John's Wort for major depression, critics like Soule believe, the NIH was setting the herbal supplement up to fail.

DEB SOULE: They knew that it was going to be ineffective, and they wanted to sort of just across the board make a public statement that, "See? St. John's Wort is just not effective." And that's just a poor design of a study.

NARRATOR: But Straus defends the NIH's work.

Dr. STEPHEN STRAUS: Surveys show that the more depressed people are, the more likely they are to use herbal products. And the research that had been published, mostly from Germany, most of the studies included individuals with major forms of depression, as opposed to milder forms of depression. So to claim that we studied St. John's Wort in the wrong population is a disingenuous claim. Very complex doing these studies in what you choose to do and what you choose not to do. And at the end of the day, somebody is still going to criticize you.

[www.pbs.org: Explore scientific evidence debate]

NARRATOR: But while experts debate the effectiveness of St. John's Wort, new evidence suggests that under certain conditions, the supplement may even be dangerous.

DAVID EISENBERG, MD, Harvard Medical School: St. John's Wort reduces the availability of the life-sustaining AIDS drug, Adenovir [sp?], in people with HIV. That could lead to a death. Or people who take drugs to protect themselves from rejecting a kidney or a heart after a heart transplant, if they take St. John's Wort, the protective drug plummets in the blood and they can have an acute rejection. That's known. That's predictable. That's hard science. I would bet my salary on it.

The problem is, there's not enough warning to the public to say you cannot take these herbs with these drugs.

Do you think the average American going to the average drug store realizes that the herb or supplement they're picking up right next to their over-the-counter drug does not have to prove that it's effective, does not have to prove that it's safe before it can be sold? I think most Americans don't realize that. That's a problem.

NARRATOR: So how is it that dietary supplements, which Americans spend billions of dollars on every year, go through so little testing before they hit the market?

SENATE PRESIDENT PRO TEM: --a bill to amend the federal Food, Drug and Cosmetic Act to establish standards with respect to dietary supplements and for other purposes.

NARRATOR: It all goes back to a bill passed by Congress in 1994, the Dietary Supplement Health and Education Act, or DSHEA, as it's known by insiders.

Sen. ORRIN HATCH (R, Utah): I send to the desk a substitute amendment on behalf of Senators Hatch and Harkin.

NARRATOR: DSHEA was a bipartisan bill championed by Senator Harkin and Senator Orrin Hatch of Utah.

Sen. ORRIN HATCH: --taken a great interest in this matter through the--

NARRATOR: Like Harkin, who believes that bee pollen cured his allergies, Hatch is convinced of the benefits of dietary supplements.

Sen. ORRIN HATCH: There are a hundred million people in this country who regularly use dietary supplements. I'm one of them. Tom Harkin's one of them. Almost every member of Congress is one of them.

Today we honor the wishes of 100 million people in a health care issue, consumers of dietary supplements, people who simply want the ability to lead healthy lifestyles without the constant intervention of one tiny agency which is possessed by a regulatory zeal equaling none.

NARRATOR: The Senate's bill was the final action in an ongoing battle between Congress and the Food and Drug Administration, the FDA, who had recently indicated they were planning to regulate dietary supplements more rigorously.

Sen. ORRIN HATCH: We had to take on the whole FDA and the whole raft of left-wing groups that believe that everything in our lives should be regulated and that we can't-- we're so stupid as a people, we can't make our own decisions and that we're so dumb that we don't know what's good for us. It's the attitude that government should tell you everything you should do. You don't have any right to make any choices yourself. And they threw everything but the kitchen sink at us, but we had the people with us. And the reason we had the people is because a hundred million people have benefited from dietary supplements.

NARRATOR: In the months before DSHEA was proposed, the people had made their voices heard. Congress received more letters about dietary supplement regulation than they did during the entire Vietnam war.

Sen. ORRIN HATCH: They didn't want the over-regulatory groups making it impossible to be able to afford dietary supplements. The American people demanded it.

NARRATOR: But the people, Hatch's critics contend, were being influenced by an aggressive PR campaign organized by a growing nutritional supplement industry.

[1994 television ad paid for by the supplement lobby]

SWAT TEAM MEMBER: Freeze!

MEL GIBSON: Hey, guys! It's only vitamins!

[on screen: The federal government is actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors' office and health food stores. Could raids on individuals be next?

Write Congress now.

Speak with our nutrition department staff to find out how to write your letter TODAY!]

WALLACE SAMPSON, MD, Scientific Review of Alternative Medicine: The industry propaganda was that they were threatening to take all our vitamins away. This was a major, major, intentional campaign.

MEL GIBSON: Vitamin C, you know, like in oranges.

Dr. WALLACE SAMPSON: They supplied people with their envelopes and the paper to write it on and the pen to write it with. And the largest mail snowstorm in history hit Washington.

PETER JENNINGS, ABC News: Before the Senate adjourns, it is expected to give final approval to a bill on dietary supplements. The measure--

NARRATOR: DSHEA was passed unanimously by Congress and has become one of the most controversial piece of health care legislation ever enacted.

ROBERT PARK, PhD, Physicist, Author, "Voodoo Science": It would be my candidate for one of the worst pieces of legislation ever passed.

NARRATOR: Robert Park is the author of Voodoo Science, a skeptical look at the business of alternative medicine. He has been an outspoken critic of DSHEA.

ROBERT PARK: In the past, if you sold something, you had to show that it was safe, or that at least, that what you said it was, was in the bottle. Now you don't have to do that.

NARRATOR: What DSHEA did was take away the FDA's powers to regulate a supplement before it goes into stores. Now the only time the FDA can step in is if a supplement is shown to be dangerous after it's already on the market. While some supplement companies have begun to set their own standards, others have not. Under DSHEA, it is voluntarily, left entirely up to the companies themselves.

Dr. MARCIA ANGELL: Most manufacturers of dietary supplements don't test for safety because they don't have to. It may be that the large drug companies would do the same, if they didn't have to test for safety, but they have to. The government requires it. The FDA requires it. They must show safety.

Dr. TOM DELBANCO: It's wonderful right now to be someone who makes herbal drugs. I wouldn't be regulated. No one would be watching over my shoulder. The only people who'd be interested in me are my stockholders, to see how big a profit I can make.

NARRATOR: And the dietary supplement companies have made enormous gains. Since DSHEA was passed in 1994, the supplement industry has exploded, nearly doubling its sales. It is now an $18 billion-a-year business, with some 900 supplement companies nationwide. And as his critics have pointed out, the greatest number of those companies are in Hatch's home state of Utah. The senator has received more campaign money from the supplement industry than any other congressman.

ROBERT PARK: What's driving this, of course, is what drives everything, and that's money. Their argument is, "Our responsibility is to take care of our constituents, to do what our constituents want done." But by their constituents, they often mean a handful of wealthy industries.

Sen. ORRIN HATCH: You're going to get criticized no matter what you do. Actually, you are supported by people who believe that you're doing what's right. But I wouldn't support them if I thought the industry wasn't a good industry, if I didn't think it did good for mankind.

NARRATOR: In fact, for centuries, people around the world have relied on many of the ingredients that are now bottled and sold as dietary supplements. Proponents of DSHEA point to this long history of use as proof that if they were unsafe, people would have stopped using them, and therefore, stringent regulations are not necessary.

But critics of DSHEA contend that today's supplements are sold in much higher concentrations and are often taken in combination with pharmaceutical drugs. And this is where the dangers of dietary supplements are starting to surface. Since DSHEA was passed nine years ago, the FDA has received more than 7,000 adverse event reports about dietary supplements. While this number pales in comparison to the number of complaints about pharmaceutical drugs, these reports have linked some dietary supplements to increased blood pressure, heart palpitations and, in some cases, death.

AARON BROWN, CNN: Yesterday, 23-year-old Steve Bechler became the first baseball player ever to die in--

KATIE COURIC, NBC News: --indicates that ephedra, a controversial diet supplement, played a role in the death of--

STONE PHILLIPS, NBC News: --taking an over-the-counter weight-loss supplement containing a stimulant called ephedra.

NARRATOR: Last February, the dietary supplement ephedra was in the news when it was suspected in the death of a major league baseball player.

STONE PHILLIPS: The local medical examiner pointed to Bechler's ephedra use as a possible cause of his death.

NARRATOR: This was hardly the first time the supplement has come under attack. It has been linked to a death in more than 100 previous cases.

NEWSCASTER: --has called for a ban on all ephedra-containing products.

NARRATOR: With mounting evidence that ephedra may case death, the FDA has recently stepped up efforts to pull it off the shelves. Ephedra makers are fighting this effort, saying that it's impossible to prove that the herb was the direct cause of death. Under DSHEA, the burden of proof lies with the FDA, and until they make their case successfully, the supplement remains on the market.

NEWSCASTER: --about whether a product millions of people take is really safe.

DAVID EISENBERG, MD, Harvard Med School: What kind of a society do we want to live in? Do we want to risk the possibility that some people will be hurt, or do we want to regulate so that we are sure that things that are sold to people, particularly vulnerable elderly, children, people on multiple drugs, that they are safe? I would vote for a society that says let's at least regulate to insist on safety.

[www.pbs.org: Explore dietary supplement safety]

NARRATOR: Regulating for safety before supplements go on the market would require a revamping of DSHEA, and even with the ephedra scare, Congress has made no move to do so. In the meantime, states are starting to take action on their own. So far, three have banned the retail sale of ephedra.

While most people use dietary supplements and other alternative therapies for mild ailments, some now turn to them when the stakes are much higher and conventional medicine has little to offer. Leslie Wagschal and his wife, Marny, are arriving from Toronto, Canada, to New York City. They are in New York because Leslie is hoping to find a new therapy that will keep him alive. He has been diagnosed with pancreatic cancer. The average lifespan with patients for this deadly disease is only five months.

To Leslie, any alternative is better than the standard treatment of chemotherapy and radiation.

LESLIE WAGSCHAL: I would like quality of life. And therefore, I decided totally against chemotherapy because chemotherapy will destroy everything. There is no magic bullet. There is no magic bullet. But tomorrow, maybe there is. But I can only benefit of this magic bullet if I'm around. Therefore, my decision was to investigate this alternative possibilities.

NARRATOR: Leslie has turned to one of the most radical alternative cancer doctors in the United States, Nicholas Gonzalez.

NICHOLAS J. GONZALEZ, MD: I got two copies of your supplement program. We're going to go over it together in a couple minutes. A few introductory remarks--

NARRATOR: The Gonzalez therapy is based around an intensive regimen of nutritional supplements. The doctor often prescribes upwards of 150 pills a day.

Dr. NICHOLAS J. GONZALEZ: Now, in addition to the pancreatic enzymes as the top of the page, to attack cancer, I want you to take four with each meal to help digestion. The ones with--

NARRATOR: Along with the supplements, Gonzalez also designs a strict, individualized diet for each of his patients to follow. But it is the final part of his regimen that is the most surprising.

Dr. NICHOLAS J. GONZALEZ: Coffee enemas. Probably nothing generates more controversy about our program than coffee enemas, even though they come right out of the orthodox literature. They were used for decades--

NARRATOR: Gonzalez's patients are required to give themselves four enemas a day using home-brewed organic coffee.

Dr. NICHOLAS J. GONZALEZ: Nothing in my experience helps deliver clean-out faster, more efficiently, more effectively than coffee enemas. They are critically important to the success of the program, and I myself have done them daily for 21 years.

NARRATOR: Gonzalez is a conventionally trained immunologist. But four years ago, he became a major player in the alternative medicine movement when he published a small pilot study claiming that with his unconventional therapy, he had been able to prolong the life of pancreatic cancer patients like Leslie by more than a year. The NIH took notice and has decided that the Gonzalez therapy is worth studying.

With the NIH grant has come a blitz of publicity for Gonzalez. Suddenly, this outlaw doctor, as a New Yorker article dubbed him, is seen as a crusader. The high hopes that new patients like Leslie hold out for his therapy rest on stories of current Gonzalez patients, like Hester Young, seen her standing beside the doctor who she believes has saved her life.

Like Leslie, Hester turned to Dr. Gonzalez in desperation. She had already undergone radiation and chemotherapy twice to fight bouts of both breast cancer and rectal cancer, when six years ago, her doctor told her he had bad news.

HESTER YOUNG: In '97, when I went through my regular routine work, my primary physician just walked out and said to me, "Hester, it's in your lungs. It's in both lungs, and it's small, too small for me to go into." And he just-- I mean, there was nothing-- what could he say?

My comment was, "I'm going to go see Dr. Gonzalez." I could not take the chemo again. I just couldn't. I know other people could, but I couldn't.

NARRATOR: Instead, Hester has followed the Gonzalez regimen rigorously. For six years, every day she's taken 150 pills and done her four coffee enemas. And according to Hester, she's experienced the results.

HESTER YOUNG: I feel good. I feel better than I've ever felt. So obviously, something's working.

NARRATOR: Stories like Hester's are what drive the popularity of alternative therapies. But we wondered what the scientific proof was for Gonzalez's treatment of Hester. The proof for Hester's case, it turns out, is not simple. The only definitive test for cancer is a biopsy, something Hester never had. Without a biopsy, it is impossible to prove Hester had a recurrence of cancer when she came to Gonzalez.

HESTER YOUNG: I think it's getting better. I really do.

NARRATOR: But Gonzalez says he has had success treating a number of other patients with documented cancer. And in Hester's case, based on her X-rays and other tests, he has no doubts.

Dr. NICHOLAS J. GONZALEZ: As far as I'm concerned, she had cancer. As far as I'm concerned, she's doing great. As far as I'm concerned, there's no evidence of visible cancer and she'll probably live another 15 or 20 years, hopefully.

NARRATOR: While a scientific evaluation of Hester is not possible, the NIH hopes their study can give new patients more scientific proof to hang their hopes on. And in doing so, the Gonzalez therapy is beginning to move away from the fringe of medicine, where it has been for decades. Just 10 years ago, Gonzalez's therapy led to a fight with the New York State medical board. The board found instances of incompetence and negligence in his evaluation of several patients. They placed him on probation and ordered retraining. But Gonzalez maintains the case was really an attack on his unconventional cancer regimen.

Wallace Sampson is a retired oncologist and the editor of The Scientific Review of Alternative Medicine. He and his magazine have been long-time critics of alternative therapies like the Gonzalez regimen, and he is concerned about how patients might see the NIH study.

WALLACE SAMPSON, MD, Scientific Review of Alternative Med: We have to present it as, "Well, it's just science. It's just a research project," you know? "There must be something to it. if they're researching it, there may be something to it." How do you handle a patient with that sort of thing? The best way to handle it would be to say, "No," that "there's no evidence for it. We think that's pseudo-science. We think people are taking advantage of you. We don't like that."

Dr. NICHOLAS J. GONZALEZ: OK. Good luck. And let me know how you're doing. Even if everything goes fine, call me. But certainly, I expect to hear from you--

My enemy are not my critics. My enemy is cancer. And to the day I die, that's going to be my enemy. I had a friend of mine who's a very bright scientist, said nothing's more frightening than a new idea. I guess that's part of it.

NARRATOR: The Gonzalez therapy is not covered by insurance. Today's visit cost the Wagschals $2,800. But for Leslie, meeting Gonzalez and beginning his program has offered a new outlook on his disease.

LESLIE WAGSCHAL: I'm leaving here with new hope, with a stronger feeling of having a much, much better chance of survival. And if he's half as good as he says he is, I look forward to--

MARNY WAGSCHAL: Meeting you again in six months' time.

TED KAPTCHUK, Researcher, Harvard Medical School: It's important to be open to the fact that we don't know everything about illness and health. It's important for both sides of this equation of alternate versus mainstream to engage.

One of the questions in medicine is the art of medicine, and one of the things about patients using alternative medicine--

NARRATOR: Ted Kaptchuk teaches at Harvard Medical School and has written extensively about the relationship between mainstream health care and alternative medicine.

TED KAPTCHUK: Until very recently, alternate medicine would be best characterized as antagonistic medicine. It was a war between the outs and the people who ran the elite institutions in our country. What's happened in the last 10, 15 years is that the strategy of war has ceased.

NARRATOR: And that ceasefire has meant that many of our nation's finest hospitals have opened the door to alternative medicine.

RECEPTIONIST: The Continuum Center for Health and Healing. This is Paul. How can I help you?

NARRATOR: At Beth Israel Medical Center in New York City, their Continuum Center for Health and Healing offers a wide range of these therapies.

RECEPTIONIST: --chiropractic, acupuncture. They do mind-body work, Reiki healing--

NARRATOR: It was founded three years ago under the leadership of Matt Fink, who was the president of Beth Israel at the time.

MATT FINK, MD, Fmr President & CEO, Beth Israel Med Ctr: If hospitals don't get involved in these kinds of programs, they will lose patients because patients will go elsewhere. At the same time, it gives hospitals and other practitioners an opportunity, I think, to be in the advancing edge of health care.

NARRATOR: New York's Beth Israel Medical Center is on the vanguard of a new trend in medical care. Over a fifth of our nation's hospitals now offer some type of alternative therapy.

Dr. MARCIA ANGELL: This is the cart before the horse. This is upside-down. This is Alice in Wonderland. You do the evidence first, and then you do the treatment. And that's the problem with this.

NARRATOR: Dr. Edward Shalts offers one of the most contentious alternative therapies at Beth Israel, homeopathy. Shalts has a medical degree from Russia and has been practicing homeopathy for over 20 years. Today Shalts is having a follow-up visit with Adrienne Cerniglia and her 5-year-old son, Dylan.

When Dylan was only 4, a child psychiatrist recommended he be put on both Prozac and Ritalin in order to stabilize his emotions and erratic behavior. His mother decided to try homeopathy instead and says she has already seen the results.

ADRIENNE CERNIGLIA: Since the last time we spoke and we gave him the remedy--

EDWARD SHALTS, MD, Beth Israel Ctr for Health & Healing: Yes.

ADRIENNE CERNIGLIA: --he's-- his behavior has been-- his listening better. His behavior's been more controllable. He's not doing the kind of bizarre things that he was doing before.

NARRATOR: With experiences like the Cerniglias', homeopathy is gaining acceptance in America. The therapy is already used widely throughout Europe, and there have been some studies that have shown it works. But it still remains one of the most controversial alternative therapies.

ADRIENNE CERNIGLIA: And then all of a sudden, it just stopped. And--

Dr. EDWARD SHALTS: And we gave him this remedy, what, 10M or 1M?

NARRATOR: The remedies that homeopaths prescribe are surprising.

Dr. EDWARD SHALTS: The next remedy I gave him was Tarantula Hispanica?

ADRIENNE CERNIGLIA: That's correct.

NARRATOR: For Dylan, it was ground-up tarantula, but in a mild form. Homeopathic pills are so diluted that even according to homeopaths, virtually none of the original substance remains.

Dr. EDWARD SHALTS: This homeopathic remedy was diluted 10 to -400 times. If you think about it, it would mean that I would take a drop of the tincture of tarantula, put it in a volume of water equal to the volume of earth, and it would be more than I gave to this child.

NARRATOR: To homeopathy's detractors, this is what makes the therapy scientifically impossible.

Dr. TOM DELBANCO: You grind up a spider, you bathe the spider parts in water, you dilute the parts so far that there's not one molecule of spider left, you put that water on a pill and you say, "Swallow it. It's going to make you feel better." There's no way that that potion of water plus inert pill is anything different from a placebo.

NARRATOR: Even Matt Fink, the person who decided to offer homeopathy at Beth Israel Medical Center, says he doesn't know what to make of the treatment.

Dr. MATT FINK: My personal view of homeopathy is I don't understand how it works, and I'm personally not convinced that it does work. But that doesn't mean that I would prevent a homeopathy practitioner from working here. We're not supposed to go out and just tell people what to do. They're coming to us for help, and we're supposed to respond to their needs and their requests.

[www.pbs.org: More on homeopathy]

Dr. WALLACE SAMPSON: There's been a shift in who gets the authority to determine what's done. It used to be that nothing went on with a patient in a hospital unless the physician said so. Science no longer has the authority that it did. People point to hospitals and say, "Oh, they're doing it, so therefore, there must be something to it." But that's just backwards. They're doing it because they think you want it. And you don't want it, they're not going to do it. So it's a market out there.

The bottom line is finances. The reason that these departments are going on in the United States' finest hospitals is because without them, they are afraid they'll go broke. It's a market share. And any hospital administrator knows that, and they should be honest about it.

INTERVIEWER: Is it ethical?

Dr. WALLACE SAMPSON: Of course it's not ethical.

Dr. MATT FINK: I think it is always better to be able to give patients a series of options of how to treat something, tell them what the risks and benefits are and have them participate in deciding how they should be treated. It's not scientific, but a great deal of health care is not scientific. There will always be a certain art to the practice of medicine. Part of it is science and part of it is beyond science.

Dr. DAVID EISENBERG: The issue isn't that complementary alternative and integrative medicine has been disproven, but that very little research in the last decade has been done to prove or disprove its efficacy or its cost-effectiveness. We have so few studies that have been done to a level of excellence that they can authoritatively and definitively tell us, "This does work. This doesn't." The games have just begun.

NARRATOR: In the meantime, before science can offer many answers, patients will continue to use therapies that they believe work for them.

HESTER YOUNG: I'm getting results, and I'm feeling well. It would be ridiculous for me to not trust what's happening. Nothing that anybody could say would make me feel differently.

TED KAPTCHUK, Researcher, Harvard Medical School: Patients really believe in their own belief system, believe in their own experiences. My mother is a good example. Her religious act of taking all her dietary supplements, her rituals of taking care of herself, which aren't scientific, give her a lot of support, give her a lot of sense of meaning. And those are important parts of her life that are not going to be tampered with by objective science.

NARRATOR: For Christie and Gil Goren, seeing Papa Joe and the Maoris was never about science, it was about hope. One year after their session with the Maoris, Christie is still not pregnant, but she's still certain they're on the right path.

CHRISTIE GOREN: If people were to look at this and think, "Oh, they're just hoping"-- we both feel like, "What else is there?" We've taken this into our own hands. We've done what we need to do to make ourselves happy and to feel better. So this is going to work for us. We feel very confident.

[On October 22, 2002, Leslie Wagschal died of pancreatic cancer. His pancreatic cancer was so advanced that he had been unable to begin the Gonzalez therapy.]

EPILOGUE (Nov. 29, 2005): Hester Young had a recurrence of cancer in October 2004, but is currently in remission and still a patient of Dr. Gonzalez. Three years after their session with the Maoris, Christie Goren has not gotten pregnant. In July 2004, the couple adopted a baby. Dr. Berman's acupuncture study was published in December 2004. Results show that arthritis of the knee improves faster when Chinese acupuncture is used in combination with a Western course of treatment than when Western treatment is used alone.

 

THE ALTERNATIVE FIX

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ANNOUNCER: FRONTLINE's report continues on our Web site. You'll find more about homeopathy, acupuncture and other alternative therapies, tips for evaluating what is safe, experts' views on the evidence supporting alternative treatments and the trend by medical institutions to offer both alternative and traditional medicine, and the opportunity to watch this entire report on line. Then join the discussion at pbs.org or write an email to frontline@pbs.org.

Next time on FRONTLINE: It was touted as a miracle drug.

ANNOUNCER: Victims.

Then my miracle turned into my nightmare.

ANNOUNCER: Whistleblowers.

If I spoke to the media about their drug, bad things would happen.

ANNOUNCER: Big business.

The FDA says, "We have to be nice to the industry because they are paying our bills."

ANNOUNCER: The government.

Americans need to recognize that every time they put a pill in their mouth, it's an experiment.

ANNOUNCER: Dangerous Prescription. Watch FRONTLINE.

 

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