Ultimate Fitness
one
LESS IS MORE, OR IS IT?
My friend Cynthia, just back from a week in Italy, calls me, wanting to know if I can go for a walk. She needs one, she says. She spent the day before cooped up in an airplane for endless hours and she has to have her exercise.
I am at her house in five minutes, wearing my running shorts and a T-shirt, ringing her bell, waiting while she drinks a glass of water and searches for her sneakers and puts on some sunblock. We set out, on our usual mile-and-a-half-long path. We stroll down the small hill to the end of the street, turn right, up the long hill on Edgerstoune Road. We turn left at the top, making our way into Russell Estates, an enclave of huge and showy brick houses with neatly landscaped lawns and dogs hemmed in by invisible fences. We stride around a cul-de-sac and start back, going behind Edgerstoune, on the other side of the block.
A half-hour later, we are done. Ours is a well-traveled path, one that neighbor after walking neighbor traverses daily. I see them from my kitchen window--the pairs of women, the couples, going out walking in the morning or after work. One woman even has a personal trainer who walks with her, supervising her exercise.
I live in the realm of the walking converts. Like Cynthia, they believe that walking will make them thin and fit. And if they never seem to look any different? Then, like Cynthia, they blame themselves. She tells me she has just not gotten out enough forwalks. If she really kept up the program, walking daily, the exercise would do its magic, she says.
Everywhere I look, I see the walking message.
I turn on the television and the first channel that appears is showing an infomercial promoting a walking video. Smiling women give their testimonials: I was so fat I did not want them to take my picture when I went on a cruise, one says. When I heard "walking," I thought, "I can do that," she adds. Now thin and proud, she goes on another cruise, and seeks out the photographer. A former Olympic swimmer, Janet Evans, appears, wearing long black pants, slender and smiling. She, too, walks, she announces.
I pick up Self magazine. There it is again. Walking. Why are Americans so fat and people in other countries so slim, a story asks. It's because everyone else walks so much more. To prove it, the magazine put pedometers on a few Americans and people from a variety of places like Athens, Aibaci (in Niger), and Paris. Of course, there were some glaring economic disparities that played a role, but, sure enough, the Americans were not taking as many steps. Pauline Chu-Collins from Tustin, California, walked 4,776 steps in a day, the magazine reported. She had breakfast in bed, drove to lunch and the market, and shopped for forty-five minutes, she said. But Maria Kostaki in Athens, a bartender, put in 28,879 steps, and Ramatu Ahmad Mohammad in Aibaci, who walked for two hours to visit a friend and then walked another two hours gathering palm leaves, took 14,099 steps. Even Florence Labedays of Paris put in 13,522 steps. "I don't own a car so I do most of my shopping, errands and nights out on foot," she said, adding "I also walk to and from the train each day for work."
Walking, the article claimed, not only is "a great cardio workout" but also will "tone all your leg muscles." The source? John Reich, described as "a walking coach in Houston."
Not long after my walk with Cynthia, I am in Nantucket, a trendy island off the coast of Massachusetts where you can stillfind wide white beaches with no lifeguards to whistle you out of the water and sand dunes where beach grass undulates in the wind. Quaintness is the motif. Houses must be made of wooden shingles that turn a soft gray in the salty air. The town's streets are cobblestone. There are no traffic lights. There are no fast-food restaurants. No camping allowed.
But there is a gym, Nantucket Health Club, and some of us go there religiously, keeping up our workout schedule, lifting weights, using the StairMasters and elliptical trainers, and even walking on treadmills on sunny afternoons when the sky is a brilliant blue and the surf beckons, endlessly walking in place while watching television sets tuned to CNN.
I am intimately familiar with this gym since exercise is my obsession.
I believe in exercise to keep my weight down and also because I discovered that if I work out really hard and for at least forty minutes, I can sometimes reach an almost indescribable state of sheer exhilaration. I don't want to call it a runner's high--I'm not sure what that is supposed to be, though many describe it as sort of a trancelike state. That is nothing like the feeling I crave.
I often wonder what my life would have been like if I had been born to be thin, naturally thin, like my neighbor Barbara, who is tall and slim, has no intention of exercising, and never gains weight. But that is not my fate and so I have taken up exercise. Vigorous exercise. Heart-pounding, sweaty exercise. I've been doing it for years, running before they invented special running shoes or sports bras. Riding a road bike before they sold bicycling helmets. I carry my running shoes with me on every business trip, always prepared to exercise. And I seek out what I call serious gyms, places where the lifting is in earnest and the equipment well maintained.
My first gym was Spa Lady, an all-female affair with pink machines and low weights. I bought a lifetime membership. "Your lifetime or theirs?" my sister asked. One evening a month the women could invite their boyfriends or husbands to join them. When the men arrived, they would lift the stacks--putting on asmuch weight as the machines could hold, making sure we women saw just how tame those machines were.
I've long since moved on to a serious gym, Gold's Gym, where the color motif is black and white, and where the carpeted area for exercise machines quickly gives way to a black nonslip rubber floor. This is where free weights and the benches are kept and where men and women grunt and groan as they hoist bars loaded with heavy plates, those metal disks with a hole in the middle that you stack on the ends of metal bars. Posters on the walls for a new lifting class, called Body Pump, give the heavy-metal message to women. One shows the back of a woman lifting a barbell. "Doctors Say Women Need More Iron," it says. Another depicts a woman doing a lunge, holding a barbell on her shoulders. "Macho Is Not a Gender Thing," it says. You can see real bodybuilders at Gold's Gym, and you can hear men and women making their lifting arrangements. "See you on Saturday at eleven," one man says to his friend. "One hour. Triceps."
And I've gone through the historical sequence of exercise classes--high--impact aerobics and low-impact aerobics, advanced aerobics classes where you need the instructor's permission to attend and step classes with all their variations--before settling, for the moment, on Spinning. For a few years I went every Saturday morning to a studio that offered nothing but exercise classes and a boutique selling the then-trendy thong leotards and tights and leg warmers, a sort of Flash Dance look. The aerobics room had a special floor, wood covered by carpet, that was slightly raised to reduce the stress on our legs as we leapt and jumped. It had a great sound system, and the mirror-lined room fairly pulsated to the rapid beat of the tapes the instructors played. That studio is gone now, a victim, perhaps, of changing times.
I also tried, and fell in love with, each exercise machine as it was invented over the past twenty years. LifeCycles. StairMasters. Elliptical trainers. I listen to CDs of fast music when I'm on the machines--I buy them from a company that sells them to exercise instructors. I am a member of the company's frequent buyer program,getting CDs with the highest beats per minute mailed to me automatically whenever they make a new one.
But for now, my aerobic passion at the gym is Spinning. It is an industry unto itself--with its own special training programs for instructors and trademark protection so stringent that only an official forty-minute class that is conducted according to the company's specifications is entitled to be called Spinning. It also is an intense workout on a stationary bike that attracts a greater proportion of the people who are serious about exercise than most group sessions.
This morning, the Nantucket Health Club has a special event--a Spinning class, but in this case called a Spinning "event" since it is not really an official trademarked class. It costs $25, payable in advance, and the word is that it is going to be an insane workout.
I sign up and appear with my water bottle and heart-rate monitor, ready to go at nine a.m. I spot my assigned bike, number eight out of the ten stationary bikes in the room. Each bike has a small white towel draped over its handlebars.
The class is sold out, I notice. The exercisers start coming into the small Spinning room about ten minutes before the class starts, at which time the door will be closed, barring any late arrivals. We set up our bikes, arrange the seats and handlebars, put our water bottles in the special cages, strap the special watches that display our heart rates to the handlebars.
At a minute to nine, our instructor makes his entrance. Gregg D'Andrea. He looks promising. He is short, deeply tanned, and intensely muscular. His legs are shaved like those of a real bicyclist, who rid their legs of hair, they say, to make it easier to clean up scrapes when they fall. Gregg wears skintight black shorts that barely cover his crotch. He tugs on them constantly as they bunch up around his bulging glutes. His cropped, sleeveless black shirt says "Groovy" on the front and "Sex on Wheels" on the back. On his right wrist are two bracelets made of heavy links of silver. On his head, an orange bandanna.
This is the realm of the exercise aficionados. This sort of special class, with its aggressively fit instructor, is the place where you are most likely to find people who never got the message that it is okay to go slow, that you don't have to sweat to get in shape, that walking isn't just for wimps. We want to be pushed harder than we could ever push ourselves. We want to watch our heart rates climb as high as they can go, and stay there. We want Gregg to play fast techno music to set a pace, and we want him to force us to ride our stationary bicycles for forty minutes while he perches on a bike on a small platform at the front of the room, tossing his head from side to side and pedaling furiously, glistening with sweat. We don't want the usual Spinning instructor's reassurances: It's your ride. Take a break if you need one. Slow down if your heart rate gets too high.
In a way, Gregg's Spinning session is a throwback to the early days of the fitness movement. The days of no pain no gain. Of going for the burn. Now, the movement seems kinder and gentler. Walking. Yoga. Signs on aerobic machines at gyms informing exercisers of the maximum number of minutes they can stay on: "Twenty Is Plenty." Machines that measure your heart rate and warn you if the number of beats per minute goes higher than a formula allows. "Fat burning" exercises that are done at a very low level of intensity, the theory being that working harder makes you lose, if anything, less weight.
Gregg, explains the pale and solemn young man behind the desk at the health club, "is a breed unto himself." Every other Spinning instructor, he tells me, is tamer. The instructors have been taught not to push so hard. Gregg "is not for everyone," the young man warns.
An e-mail arrives at my computer at the New York Times that seems to confirm the walkers' philosophy. If what the publicist is saying is true, then maybe science is telling us that the less-is-more movement is on the right track. I may love pushing myselfuntil my heart is pounding and my face is red with blood and my body is soaked with sweat; but that does not mean that there is any scientific evidence that this extreme notion of exercise is best. It might be that Gregg and his class--and the fact that Gregg actually told us to go for the burn--are as anachronistic as the "Groovy" on Gregg's shirt.
The press release gets right to the point: "Less is more when it comes to health and exercise, according to a new study's findings, which are going to be unveiled later this month at a prestigious exercise physiology conference in Finland," the publicist wrote.
"The effectiveness of traditional exercise programs, which usually consist of long periods of aerobic activity, aimed at achieving and sustaining a narrow target heart range, followed by a single 'cool down period,' [is] being questioned by a group of researchers from Harvard University Medical School, Columbia University College of Physicians and Surgeons, and the U.S.-based Dardik Institute." I have never heard of the Dardik Institute, but the medical schools named in the press release are, of course, among the best in the world.
The study involved healthy women ages thirty-two through fifty-eight, who exercised in very short bursts by running in place on a trampoline or pedaling on a stationary bicycle. Following one minute of exertion, they recovered for seven minutes.
"In one month, the women only did 40 minutes of actual exercise (all of it low impact)," the e-mailed press release says. And the results? "The women exhibited dramatic increases in their cardiovascular fitness and the strength of their immune systems while experiencing significant decreases in stress and anxiety."
The study, the publicist informs me, "calls into question the entire 'Aerobics Industry.'" Do I want more information? Of course, I tell him.
Okay. Why deny it? I'm a skeptic, conditioned by long years of science reporting. Why believe this report when its conclusions seem contrary to the position of the American College of Sports Medicine? The College says that aerobic endurance training forfewer than two days a week at less than 40 to 50 percent of maximum effort and for less than ten minutes "is generally not a sufficient stimulus for developing and maintaining fitness in healthy adults."
Of course, the College could be mistaken, but since it based its conclusions on a body of evidence, and since its statement was written by the country's leading experts, I had a feeling that the new study, not the college, was the more likely to be wrong. I'm also a skeptic because, like every other science reporter I know, and like many of the nation's most renowned scientists, I've been burned. I've written stories only to learn that the studies I'd based them on, often published in the world's best medical journals, contained fatal flaws and that their conclusions were wrong. And I've had scientists tell me of their own realization that they had fallen in love with hypotheses that were later disproved by more rigorous studies.
"This was the biggest disappointment of my career," said Charles Hennenkens, a Harvard researcher who had invested nearly two decades of his life in a theory that beta carotene could prevent cancer and heart disease, only to find that it didn't.
"We deceived ourselves and we deceived our patients," said Dr. Gabriel Hortobagyi, a cancer specialist at the M. D. Anderson Cancer Center in Houston, who spent years convinced that the way to fight advanced breast cancer was to give the highest possible doses of powerful chemotherapy drugs.
So as I scan the press release for this new less-is-more exercise study, I am looking for reasons why I should not believe it. My first thought is that something has to be wrong.
When you work at a place like the New York Times, you can count on getting hundreds of press releases every week, zinging at you by fax, e-mail, Federal Express, and regular mail. Then you get repeated phone calls. Did you receive the press release? The invitation to the press conference? The information for dialing into the teleconference? You get the tip sheets from medical and scientific journals that come out every month, some every week,in which the editors summarize in the most enticing way the conclusions of the papers they are publishing. If you are to survive, you have to learn to skim over these appeals and pick out the one in a hundred, or fewer, that actually look promising.
I have another reason, as well, for being suspicious. From what little I have seen of the exercise field, the tiny pearls of good science are buried in mountains of junk--hucksters who promote programs with not even a pretense of objective evidence that their methods work; studies that involve a handful of people and have no valid data but draw grandiose conclusions; exercise theories that are akin to urban legends.
I expect that this new study will likely fall into one of two categories. Either it will be a reasonable piece of research that will show that fitness does not require much effort. Or its data will be inadequate to show anything at all. In either case, I am definitely interested. I am aware that even if the study fails to show that less is more when it comes to exercise, that would not be evidence that more is more, that my maximum-sweat, maximum-effort regimens are the right way to go. So why not take a look at this new study, I decide. No matter how it turns out, it promises to be a case in point.
The material arrives on a Saturday, sent via Federal Express to my home. I tear open the box, pull out a video and press kit. The sixteen-minute video, a cover letter informs me, was used to explain the study to its participants. I turn on my television set and slip the cassette into the VCR.
The video begins by establishing the credentials of the researchers. The announcer says that the study will be conducted at "the world-renowned Columbia Presbyterian Medical Center in New York City and Hunterdon Medical Center in Flemington, New Jersey." Then, he says, "let's meet our outstanding study researchers."
They are introduced in turn, dressed in business suits, showngiving scientific lectures, looking nothing if not professional. There also is something a bit intimidating about them. Who are we, the lay audience, to question such authority figures? Their credentials are impressive.
There is Dr. Ary Goldberger, who "heads the research team," the video says. He is an associate professor at Harvard University and also directs the Margret and H. A. Rey Laboratory for Nonlinear Dynamics in Medicine at Beth Israel Deaconess Medical Center. Then there is Dr. Irving Dardik, dressed in a black suit with a white shirt and striped tie, a middle-aged man who gestures with his hands while his eyes look straight into the camera. Dr. Dardik, the video announcer explains, is a vascular surgeon who has "served as chairman of the U.S. Olympic Sports Medicine Council, where he was responsible for the science behind world-class athletic performance." Dr. Dardik, it turns out, was the inspiration behind the study. "The clinical trial will be testing his Heart Waves concept, which describes how the interaction of the human body with a novel exercise protocol with computerized feedback may impact health and possibly prevent or even reverse certain chronic diseases."
The others on the team have equally stellar credentials: Dr. Herbert Benson, also a Harvard professor, who runs the Mind/Body Medical Institute at Harvard Medical School ("Over four million of his books on mind-body medicine are printed," the announcer claims); Dr. George Stefano, who is a distinguished teaching professor at the State University of New York in Old Westbury and has written more than 240 papers published in peer reviewed journals; and, finally, Dr. Rochelle Goldsmith of the Division of Circulatory Physiology at Columbia University's College of Physicians and Surgeons.
The study will involve healthy people and also people with chronic fatigue syndrome and those with congestive heart failure, a serious, usually fatal disease in which the heart is increasingly unable to pump hard enough to supply the body with blood.
Dardik explains the theory behind the research: "In natureyou see the rhythms of nature throughout," he says. "Heart Waves recognize that the heartbeat actually climbs up and down by behavioral cycles, anxiety and relaxation, exercise and recovery. It speeds up and slows down, like coming up and down a mountain on a bicycle. Up and down. Like a roller coaster of your heart." It is, he says, "the way it works in nature. You see the rhythms of nature throughout. Everything is spiraling and cycling in the universe."
Goldberger appears on the screen: "The Heart Waves clinical trial is an exciting new adventure and it is an attempt to try out an exciting hypothesis about exercise," he enthuses.
But what do people actually do in this exercise study? The video soon shows us. A plump woman wearing gray surgical scrubs gets on a mini-trampoline. Dr. Dardik instructs her to jog slowly for about a minute, then to sit down and relax for about five minutes while her heart rate returns to normal. That, repeated several times, is the experimental program.
Dardik then explains his Heart Waves concept again.
"It's the way we actually behave, and the way we should behave and work within the context of nature's rhythm. It's natural. It makes common sense. And it's simple. But the most important thing is when you put those three together and realize how it works. It's useful. It's practical."
As he speaks, the video shows drops of water striking a blue pool, one by one, with ripples spreading outward.
But what will this exercise program accomplish? Dardik tells us.
"As you get older, your max heart rate drops. Well, suppose we have a way over time to reverse that," he postulates. "Physiologically, you'll get younger; and, also physiologically, a younger physiology can prevent disease as well. That's healthy." He describes how the wavelength of the heart's rhythm is increased. "Instead of this," he says, moving his hands up to describe a gentle slope, "you go there." His hands move again, describing a steeper slope.
It makes no sense to me. If you ask me what Heart Waves is, I still could not tell you. I have no idea what Dardik is saying. All I know after watching that video is that the study participants are going to exercise very briefly and then rest for a long time.
So I turn to the paper. It is an unpublished manuscript, written in the traditional format for a medical journal. "Implementation of a Novel Cyclic Exercise Protocol: Short-Term Impact on Healthy Adult Women," it is called. It includes an abstract, it lists key words for indexing, it has an introduction, a methods section, and a section called "Study Design" that describes in detail how the research was conducted. A section called "Results" follows that. Then comes a discussion section, the acknowledgments, the references, and tables and graphs of the data.
The discussion section indicates that the results were promising: "We find that a short (eight-week) course of this protocol in healthy adult women was associated with evidence of improved cardiorespiratory fitness and autonomic function, as well as subjective assessment of quality of life."
The problem is that while it has all the trappings of a scientific paper, I strongly suspect that there is almost no science there. I ask a statistician for an expert opinion. David Freedman is a professor at the University of California at Berkeley and he has written papers and books on the design and evaluation of clinical studies. He agrees to take a look at the manuscript.
I fax it to him. Two days later, he calls me, decidedly unimpressed by the study. "It is quite unconvincing," he says.
Almost everything that can be wrong with a study seems to be wrong with this one. First of all, there were only eleven women, ten of whom completed the study. From the data on these ten, the investigators managed to build a complicated, and almost impenetrable, statistical analysis, one that is "almost impossible to reconstruct from this paper," Freedman says. And from that analysis they reach their conclusion that their program was making a difference.
In preparing their analysis, the investigators apparently lookedat quite a few outcomes but chose only those that seemed to point in the right direction. And there was no control group--no group of observed subjects who did not participate in the program. Without such a group, there is no way of knowing whether the changes the researchers claim they found would have occurred anyway.
Even if you take their conclusion at face value, Freedman tells me, all they have found is that the women's maximum oxygen consumption increased slightly. Was that due to the exercise? The relaxation? The alternating exercise and relaxation? The time of day? "It's impossible to say," Freedman asserts.
To be fair, I decide to show the paper to a second statistician. And I know just the person: Howard Wainer, who worked at that time at the Educational Testing Service. Not only is he well versed in the design and analysis of clinical trials, but he has a particular interest in exercise. He swims every day at lunchtime and has swum marathon distances, including the English Channel. Send the paper on, Wainer tells me.
It does not take him long to reach his conclusions. The paper, Wainer says, is impossible to interpret. There is no control group that did not have the exercise program, there is no random assignment of subjects to have the exercise program or not, and so, he says, there is no way to decide whether there was an effect, and if so, how large it was.
The investigators, Wainer adds in an e-mail to me, compared the women's fitness at the beginning of the study to their fitness at the end to argue that they saw an effect. "This is only sometimes okay," he says. "Consider using this methodology to study the efficacy of eating Cheerios for breakfast as a treatment for shortness, and using a bunch of six-year-olds as a control group: 'The study lasted a year and we found an average height gain of four inches.'" Such an analysis, he says "is okay if the (unobserved) assumption of 'no change otherwise' is true. This assumption is what the control group is for."
Finally, Wainer tells me, the investigators did twenty-three statisticaltests looking for something that would turn up positive to serve as an indication that the treatment had an effect. The likelihood that, by chance alone, one of those tests would be positive is 66 percent. But that does not mean that it is a real effect; positive results showing up in this fashion are likely to be a statistical fluke. The investigators should apply statistical methods to correct this problem, Wainer maintains. But if they had made such a correction, he calculates, they would have ended up with no effect at all.
By now, I am becoming fascinated with this paper. I have to unpeel this onion. Why did anyone do this study? Why are they announcing it with such fanfare and hiring a publicist to offer it to me on an exclusive basis--a well-honed publicist's trick to try to get a journalist's attention. Is there a marketing connection in here somewhere?
The first clue comes when I notice that the paper's second author, Irving Dardik, M.D., is listed as being with LifeWaves International of New Jersey. The next clue is the video. It is produced by VHA, described in the publicist's cover letter as "the nationwide network of community-owned health care organizations and their affiliated physicians." VHA also is mentioned in the paper, as helping to pay for the Heart Waves research.
I check the VHA Web site and learn that it is a for-profit organization whose doctors and medical centers sell various products. It is a publicly traded company, I learn by checking the Securities and Exchange Commission's Web site.
Is VHA selling the Heart Waves program? Is it actually promoting this cyclic exercise as a commercial product, based on only one preliminary study of eleven women--one of whom dropped out? A study that two leading statisticians say is ludicrous?
I e-mail the publicist. I tell him that although, as he knows, I have decided not to write about the Heart Waves study for theNew York Times, I am looking into it for a book I am writing. And so, I say, I have a few questions about the groups that are participating in it: What is the relationship between VHA and LifeWaves International? Is VHA selling Dardik's Heart Waves treatment?
He replies the next day. VHA, he tells me, has invested in LifeWaves and has contributed more than half a million dollars to the research on cyclic exercise. In addition, he says, LifeWaves is about to open LifeWaves centers in three VHA hospitals in New Jersey, where people can get the Dardik program, for a fee.
But this is just the beginning of LifeWaves' plans, the publicist tells me. It expects to be opening more LifeWaves centers in VHA hospitals around the country. And, he writes, "the company will be offering individuals the opportunity of doing it themselves via a 'smart' heart rate recorder (called the LifeWaves Personal Coach) and the Internet." He makes me a special offer, to be part of the beta test of the LifeWaves Personal Coach. "It was my recommendation that they invite a very select number of media to try it and experience the results for themselves," the publicist writes.
My suspicions more than confirmed, I probe further. Page four of the study says, "This protocol was adapted from the LifeWaves Program (LifeWaves International, Califon, N.J.; U.S. Patents 5752521 and 5810737)."
Now that is interesting.
I speak to David Saloff, the president of LifeWaves International, who tells me that the company began in 1999, when Dardik's wife, Alison Godfrey Dardik, called him and asked for his help in setting it up. Saloff had known the Dardiks for about six years and had been impressed with the Heart Waves concept. Saloff tells me that he expects that most of LifeWaves' business will be with individuals and families who buy the special heart-rate monitor and the program instructions and a personalized Web page that will store the data from their workouts. People who prefer not to use the Internet can pay to get the same training at a hospital's wellness center.
But, I ask him, doesn't he want to wait for something more conclusive than the preliminary study with ten women, a study that really does not show much, if anything, about the program's beneficial effects? No, he replies. "We're talking about exercise here. I feel perfectly comfortable with it," Saloff says. All sorts of people have used the program, including elderly people with Parkinson's disease, he tells me. "There's never been an adverse event. And this, in fact, may be a safer way to exercise."
My next impulse is to check the Patent Office's Web site to see what the LifeWaves patents say. What is this new invention, and what does Dardik, in his patent application, think it does?
The first, number 5752521, is for a "therapeutic exercise program," and it was issued on May 19, 1998, at about the same time that LifeWaves International was formed. It describes the program being tested in the study but has some sections that seem, to put it mildly, a bit odd. To take just one of many examples, the patent states that "The theory underlying my invention is that the interactions which take place in the human organism and involve the biochemistry of the organism and the behavior of its organs is based upon wave communication, and not on the complexity of the organism itself." Then it gives "examples of wave activity." They include this one:
"The hunting of animals in the wild is cyclic in nature, reflecting the spike to which I have referred. Animals in the wild rarely have chronic diseases. However, when placed in zoos or domesticated, the wave patterns are flattened and become less responsive, and the incidences of chronic diseases then rival those of humans. It is also now generally recognized that chronic diseases and behavioral disorders, such as asthma, suicide, depression, criminal behavior, and cancer are dramatically on the rise."
The application goes on to provide "examples of treatment." It turns out that Dardik has much more in mind than simply helping people get physically fit. The examples he cites are of sick people made well, he claims, by his therapeutic exercise program:A fifty-nine-year-old leukemia patient, whose elevated white blood cell count--a manifestation of the cancer--fell precipitously. A thirty-year-old woman with multiple sclerosis whose symptoms disappeared. A twenty-eight-year-old woman with AIDS who had been suffering from symptoms of severe immune deficiency for a year and a half. Within a few months of starting the Heart Waves program, "all symptoms disappeared," the patent says. An eighteen-year-old with brain cancer who, after surgery to remove the tumor, was, the patent application states, "disoriented, sleeping 18 hours a day, short term memory deficit, etc." He followed the Heart Waves program for three years, the patent application says, and "there has been no evidence of tumor recurrence."
The second patent, number 5810737, issued on September 22, 1998, is more of the same, a continuation, in fact, of the previous patent. It has many of the same sections, including the one about the animals in nature and the non sequitur about increased rates of chronic diseases and behavioral disorders. It even has the exact same descriptions of the patients who were treated with the program. This time, however, the Heart Waves program is to be synchronized with "an internal wave produced by a biological clock."
Who, I wondered, is this Irving Dardik, inventor of this unusual program?
He says he is the founding chairman of the United States Olympic Sports Medicine Council. He says he is a vascular surgeon. I search for the United States Olympic Sports Medicine Council but can find no mention of it on the Internet or in Nexis, an electronic database of published newspaper and magazine articles. Except, of course, a few stories that mention Dardik and state that he founded it.
I look on the Web site of the United States Olympic Committee. It's not there, either. So I send the Olympic Committee an e-mail asking if they ever heard of the Sports Medicine Council. A few days later they reply.
It turns out that the Sports Medicine Council really did exist,but it is now called the Sports Medicine Advisory Committee and it advises the Olympic Committee on sports medicine. Dardik was a doctor for the Olympics and was active with the U.S. Olympic Committee for about a decade, starting around 1974. So maybe my skepticism is unfounded.
But then I discover that Dardik has a very interesting history.
The story emerged in documents from a hearing before the State of New York Department of Health State Board for Professional Medical Conduct. Five patients who had multiple sclerosis testified that Dardik had told them that his "wavenergy" program would cure them. They were impressed by his credentials as founding chairman of the United States Olympic Sports Medicine Council and by an article published in New York magazine that lavishly praised his wave theory. When they went to Dardik, he treated them with cycles of exercise and rest, just like the subjects in his fitness study. And he charged them prices ranging from $30,000 to $100,000.
On March 22, 1995, the New York board issued its conclusions about the Dardik case. The board's Hearing Committee actually questioned Dardik's sanity, writing: "The path taken by Respondent in trying to gain acceptance for his theory as well as his deviations from proper patient care led this Hearing Committee to wonder about Respondent's mental health. Yet despite extensive use of made-up words, such as wavenergy, superlooping, matterspacetime, and frequent loose associations and expansive digressions in response to questions, the Respondent could always return to the subject when prompted and he retained the capacity to understand the questioner (usually a member of the panel) in an objective manner."
The committee added, however, that its task is to decide whether, as a doctor, Dardik "followed standards of patient care he was well familiar with from his practice of vascular surgery." He did not, the group concluded, and it revoked his medical license in New York. The board found him guilty of fraud, exercising undue influence, guaranteeing satisfaction or a cure, andfailing to maintain adequate records. Dardik appealed, citing among other things the committee's allusions to his mental state as evidence it was biased against him.
The Appeals Board saw otherwise. "The Hearing Committee has the authority to assess all witnesses for their credibility. A review of a witness's behavior on the stand would properly be included in such an assessment," it wrote, adding that the committee also has the authority to direct a respondent to submit to an examination to determine mental impairment. "In this case, the Committee mentioned they had a question over the Respondent's mental state, but after review found no reason for concern."
In the end, the Appeals Board agreed with everything the hearing committee had decided. Dardik would have to surrender his medical license, it determined. The Appeals Board also imposed a forty-thousand-dollar fine, "because we feel such a penalty is the appropriate penalty for a physician who exploits several patients." It added that Dardik's conduct demonstrates "a pattern of improper and intentional mistreatment of his Patients that deserves the most severe sanctions possible."
And even though Dardik's LifeWaves International has its headquarters in New Jersey, when I check the New Jersey Medical Examiner's Web site for his name, I find his medical license has also been revoked in New Jersey.
I have to admit that I am stunned. I thought that the study that was being pitched to me was likely to be inadequate. I thought it was probably being promoted to market a product. But I never expected to uncover such an intriguing story. I had this idea that I would just deconstruct a marginal piece of research and show how hard it can be for the uninitiated to distinguish between good science and bad. I thought that I would just try to make the point that having a group of scientists from stellar institutions like Harvard Medical School and Columbia University's College of Physicians and Surgeons is no guarantee that their conclusions are to be believed.
Publicists who are trying to get reporters to write about their clients usually succeed in getting something published, I've found. So I do a quick search for the less-is-more exercise study. Sure enough, I find it, a story put out by Business Wire, available on the Internet through Yahoo! Finance. "Only Sixty Minutes of Cyclic Exercise Per Month Shown to Profoundly Affect Health," it is titled. Not only does it quote Dardik going on about his theory, but it quotes Goldberger, the Harvard researcher, about the promising results.
"This study is exciting to us," he says, "because it presents the first evidence that a novel cyclic protocol designed to train both the activation and recovery phases of exercise may increase cardiovascular fitness, increase heart rate variability, and enhance mood in healthy subjects."
On the LifeWaves Web site, Lifewaves.com, I find detailed discussions of Dardik's ideas about waves and cycles, but there also is a disclaimer. The company states: "The Life Waves Program is based on the work of Dr. Irving Dardik* on understanding how rhythms or waves work in the natural world." The asterisk refers to a footnote that states: "LifeWaves International, LLC, does not endorse any claims by Dr. Dardik or others on any therapeutic benefits from this or any other exercise program. Dr. Dardik has no ownership interest in LifeWaves International, LLC. He is the spouse of the CEO of LifeWaves International, LLC, Alison Godfrey." Yet, elsewhere on the Web site, the company touts its study of the ten women, claiming that LifeWaves improved their health, and it cites ongoing studies on Parkinson's disease, AIDS, and insomnia, hinting that the LifeWaves program is improving the condition of Parkinson's patients and is being tested by leading medical centers for other medical conditions, including AIDS and insomnia.
I call Goldberger. Why, I wonder, did he get involved with this research? He explains that he has long been interested in heartrate patterns and had found that the more variable a person's heart rate, the healthier the heart. Dardik thought that Goldberger'swork fit well with his own and so, Goldberger tells me, in May of 1990, Dardik paid him a visit.
Goldberger liked Dardik's notion that humans have evolved to exercise in brief spurts and was drawn to much of what Dardik was saying. "He told me about his ideas about exercise and the idea that I thought was intuitively very very appealing, that exercise has two components, activity and recovery," Goldberger says. "The traditional exercise protocols focused on the former, but in trying to make a system more flexible you want to get the system to expand and relax. What he described made a lot of sense."
A decade later, when Dardik wanted to do a study, Goldberger was still interested. He is extremely guarded in telling me what he found, explaining that it was just a study to see if the program was feasible. "It at least showed the protocol was well-accepted," says Goldberger. "And there was a positive response in terms of the physiology, and they felt better. It said that at least the protocol has some objective validity and raises the need for further study. But I would be very cautious. It's a small group of subjects."
What about the commercialization? Goldberger tells me he has nothing to do with that and has no comment. Well, does he know about Dardik's history? He does, he says, although he did not know about it in 1990. But he does not want to discuss Dardik's past.
"My role and the role of the people I work with is in testing out ideas," Goldberger tells me. "I think Dardik poses a question to the conventional wisdom. If someone has a testable hypothesis, that's where it becomes interesting."
Cynthia calls me again, just back this time from two weeks in Chautauqua, New York, where her family vacations each August. Do I want to go for a walk?
As we head out, strolling along Edgerstoune Road, I tell her the story of Heart Waves. She is taken aback.
"I can't believe it," she says, horrified by the tale I relate.
What strikes me, though, is that the only reason I uncovered this story is because I did a sort of due diligence on a press release that I probably would have rejected out of hand had that strange video not aroused my curiosity. But now, I wonder, what else is out there in the exercise arena? What can you believe, and how do you know that what you believe is true?
Copyright © 2003 by Gina Kolata
Ultimate Fitness
one
LESS IS MORE, OR IS IT?
My friend Cynthia, just back from a week in Italy, calls me, wanting to know if I can go for a walk. She needs one, she says. She spent the day before cooped up in an airplane for endless hours and she has to have her exercise.
I am at her house in five minutes, wearing my running shorts and a T-shirt, ringing her bell, waiting while she drinks a glass of water and searches for her sneakers and puts on some sunblock. We set out, on our usual mile-and-a-half-long path. We stroll down the small hill to the end of the street, turn right, up the long hill on Edgerstoune Road. We turn left at the top, making our way into Russell Estates, an enclave of huge and showy brick houses with neatly landscaped lawns and dogs hemmed in by invisible fences. We stride around a cul-de-sac and start back, going behind Edgerstoune, on the other side of the block.
A half-hour later, we are done. Ours is a well-traveled path, one that neighbor after walking neighbor traverses daily. I see them from my kitchen window--the pairs of women, the couples, going out walking in the morning or after work. One woman even has a personal trainer who walks with her, supervising her exercise.
I live in the realm of the walking converts. Like Cynthia, they believe that walking will make them thin and fit. And if they never seem to look any different? Then, like Cynthia, they blame themselves. She tells me she has just not gotten out enough forwalks. If she really kept up the program, walking daily, the exercise would do its magic, she says.
Everywhere I look, I see the walking message.
I turn on the television and the first channel that appears is showing an infomercial promoting a walking video. Smiling women give their testimonials: I was so fat I did not want them to take my picture when I went on a cruise, one says. When I heard "walking," I thought, "I can do that," she adds. Now thin and proud, she goes on another cruise, and seeks out the photographer. A former Olympic swimmer, Janet Evans, appears, wearing long black pants, slender and smiling. She, too, walks, she announces.
I pick up Self magazine. There it is again. Walking. Why are Americans so fat and people in other countries so slim, a story asks. It's because everyone else walks so much more. To prove it, the magazine put pedometers on a few Americans and people from a variety of places like Athens, Aibaci (in Niger), and Paris. Of course, there were some glaring economic disparities that played a role, but, sure enough, the Americans were not taking as many steps. Pauline Chu-Collins from Tustin, California, walked 4,776 steps in a day, the magazine reported. She had breakfast in bed, drove to lunch and the market, and shopped for forty-five minutes, she said. But Maria Kostaki in Athens, a bartender, put in 28,879 steps, and Ramatu Ahmad Mohammad in Aibaci, who walked for two hours to visit a friend and then walked another two hours gathering palm leaves, took 14,099 steps. Even Florence Labedays of Paris put in 13,522 steps. "I don't own a car so I do most of my shopping, errands and nights out on foot," she said, adding "I also walk to and from the train each day for work."
Walking, the article claimed, not only is "a great cardio workout" but also will "tone all your leg muscles." The source? John Reich, described as "a walking coach in Houston."
Not long after my walk with Cynthia, I am in Nantucket, a trendy island off the coast of Massachusetts where you can stillfind wide white beaches with no lifeguards to whistle you out of the water and sand dunes where beach grass undulates in the wind. Quaintness is the motif. Houses must be made of wooden shingles that turn a soft gray in the salty air. The town's streets are cobblestone. There are no traffic lights. There are no fast-food restaurants. No camping allowed.
But there is a gym, Nantucket Health Club, and some of us go there religiously, keeping up our workout schedule, lifting weights, using the StairMasters and elliptical trainers, and even walking on treadmills on sunny afternoons when the sky is a brilliant blue and the surf beckons, endlessly walking in place while watching television sets tuned to CNN.
I am intimately familiar with this gym since exercise is my obsession.
I believe in exercise to keep my weight down and also because I discovered that if I work out really hard and for at least forty minutes, I can sometimes reach an almost indescribable state of sheer exhilaration. I don't want to call it a runner's high--I'm not sure what that is supposed to be, though many describe it as sort of a trancelike state. That is nothing like the feeling I crave.
I often wonder what my life would have been like if I had been born to be thin, naturally thin, like my neighbor Barbara, who is tall and slim, has no intention of exercising, and never gains weight. But that is not my fate and so I have taken up exercise. Vigorous exercise. Heart-pounding, sweaty exercise. I've been doing it for years, running before they invented special running shoes or sports bras. Riding a road bike before they sold bicycling helmets. I carry my running shoes with me on every business trip, always prepared to exercise. And I seek out what I call serious gyms, places where the lifting is in earnest and the equipment well maintained.
My first gym was Spa Lady, an all-female affair with pink machines and low weights. I bought a lifetime membership. "Your lifetime or theirs?" my sister asked. One evening a month the women could invite their boyfriends or husbands to join them. When the men arrived, they would lift the stacks--putting on asmuch weight as the machines could hold, making sure we women saw just how tame those machines were.
I've long since moved on to a serious gym, Gold's Gym, where the color motif is black and white, and where the carpeted area for exercise machines quickly gives way to a black nonslip rubber floor. This is where free weights and the benches are kept and where men and women grunt and groan as they hoist bars loaded with heavy plates, those metal disks with a hole in the middle that you stack on the ends of metal bars. Posters on the walls for a new lifting class, called Body Pump, give the heavy-metal message to women. One shows the back of a woman lifting a barbell. "Doctors Say Women Need More Iron," it says. Another depicts a woman doing a lunge, holding a barbell on her shoulders. "Macho Is Not a Gender Thing," it says. You can see real bodybuilders at Gold's Gym, and you can hear men and women making their lifting arrangements. "See you on Saturday at eleven," one man says to his friend. "One hour. Triceps."
And I've gone through the historical sequence of exercise classes--high--impact aerobics and low-impact aerobics, advanced aerobics classes where you need the instructor's permission to attend and step classes with all their variations--before settling, for the moment, on Spinning. For a few years I went every Saturday morning to a studio that offered nothing but exercise classes and a boutique selling the then-trendy thong leotards and tights and leg warmers, a sort of Flash Dance look. The aerobics room had a special floor, wood covered by carpet, that was slightly raised to reduce the stress on our legs as we leapt and jumped. It had a great sound system, and the mirror-lined room fairly pulsated to the rapid beat of the tapes the instructors played. That studio is gone now, a victim, perhaps, of changing times.
I also tried, and fell in love with, each exercise machine as it was invented over the past twenty years. LifeCycles. StairMasters. Elliptical trainers. I listen to CDs of fast music when I'm on the machines--I buy them from a company that sells them to exercise instructors. I am a member of the company's frequent buyer program,getting CDs with the highest beats per minute mailed to me automatically whenever they make a new one.
But for now, my aerobic passion at the gym is Spinning. It is an industry unto itself--with its own special training programs for instructors and trademark protection so stringent that only an official forty-minute class that is conducted according to the company's specifications is entitled to be called Spinning. It also is an intense workout on a stationary bike that attracts a greater proportion of the people who are serious about exercise than most group sessions.
This morning, the Nantucket Health Club has a special event--a Spinning class, but in this case called a Spinning "event" since it is not really an official trademarked class. It costs $25, payable in advance, and the word is that it is going to be an insane workout.
I sign up and appear with my water bottle and heart-rate monitor, ready to go at nine a.m. I spot my assigned bike, number eight out of the ten stationary bikes in the room. Each bike has a small white towel draped over its handlebars.
The class is sold out, I notice. The exercisers start coming into the small Spinning room about ten minutes before the class starts, at which time the door will be closed, barring any late arrivals. We set up our bikes, arrange the seats and handlebars, put our water bottles in the special cages, strap the special watches that display our heart rates to the handlebars.
At a minute to nine, our instructor makes his entrance. Gregg D'Andrea. He looks promising. He is short, deeply tanned, and intensely muscular. His legs are shaved like those of a real bicyclist, who rid their legs of hair, they say, to make it easier to clean up scrapes when they fall. Gregg wears skintight black shorts that barely cover his crotch. He tugs on them constantly as they bunch up around his bulging glutes. His cropped, sleeveless black shirt says "Groovy" on the front and "Sex on Wheels" on the back. On his right wrist are two bracelets made of heavy links of silver. On his head, an orange bandanna.
This is the realm of the exercise aficionados. This sort of special class, with its aggressively fit instructor, is the place where you are most likely to find people who never got the message that it is okay to go slow, that you don't have to sweat to get in shape, that walking isn't just for wimps. We want to be pushed harder than we could ever push ourselves. We want to watch our heart rates climb as high as they can go, and stay there. We want Gregg to play fast techno music to set a pace, and we want him to force us to ride our stationary bicycles for forty minutes while he perches on a bike on a small platform at the front of the room, tossing his head from side to side and pedaling furiously, glistening with sweat. We don't want the usual Spinning instructor's reassurances: It's your ride. Take a break if you need one. Slow down if your heart rate gets too high.
In a way, Gregg's Spinning session is a throwback to the early days of the fitness movement. The days of no pain no gain. Of going for the burn. Now, the movement seems kinder and gentler. Walking. Yoga. Signs on aerobic machines at gyms informing exercisers of the maximum number of minutes they can stay on: "Twenty Is Plenty." Machines that measure your heart rate and warn you if the number of beats per minute goes higher than a formula allows. "Fat burning" exercises that are done at a very low level of intensity, the theory being that working harder makes you lose, if anything, less weight.
Gregg, explains the pale and solemn young man behind the desk at the health club, "is a breed unto himself." Every other Spinning instructor, he tells me, is tamer. The instructors have been taught not to push so hard. Gregg "is not for everyone," the young man warns.
An e-mail arrives at my computer at the New York Times that seems to confirm the walkers' philosophy. If what the publicist is saying is true, then maybe science is telling us that the less-is-more movement is on the right track. I may love pushing myselfuntil my heart is pounding and my face is red with blood and my body is soaked with sweat; but that does not mean that there is any scientific evidence that this extreme notion of exercise is best. It might be that Gregg and his class--and the fact that Gregg actually told us to go for the burn--are as anachronistic as the "Groovy" on Gregg's shirt.
The press release gets right to the point: "Less is more when it comes to health and exercise, according to a new study's findings, which are going to be unveiled later this month at a prestigious exercise physiology conference in Finland," the publicist wrote.
"The effectiveness of traditional exercise programs, which usually consist of long periods of aerobic activity, aimed at achieving and sustaining a narrow target heart range, followed by a single 'cool down period,' [is] being questioned by a group of researchers from Harvard University Medical School, Columbia University College of Physicians and Surgeons, and the U.S.-based Dardik Institute." I have never heard of the Dardik Institute, but the medical schools named in the press release are, of course, among the best in the world.
The study involved healthy women ages thirty-two through fifty-eight, who exercised in very short bursts by running in place on a trampoline or pedaling on a stationary bicycle. Following one minute of exertion, they recovered for seven minutes.
"In one month, the women only did 40 minutes of actual exercise (all of it low impact)," the e-mailed press release says. And the results? "The women exhibited dramatic increases in their cardiovascular fitness and the strength of their immune systems while experiencing significant decreases in stress and anxiety."
The study, the publicist informs me, "calls into question the entire 'Aerobics Industry.'" Do I want more information? Of course, I tell him.
Okay. Why deny it? I'm a skeptic, conditioned by long years of science reporting. Why believe this report when its conclusions seem contrary to the position of the American College of Sports Medicine? The College says that aerobic endurance training forfewer than two days a week at less than 40 to 50 percent of maximum effort and for less than ten minutes "is generally not a sufficient stimulus for developing and maintaining fitness in healthy adults."
Of course, the College could be mistaken, but since it based its conclusions on a body of evidence, and since its statement was written by the country's leading experts, I had a feeling that the new study, not the college, was the more likely to be wrong. I'm also a skeptic because, like every other science reporter I know, and like many of the nation's most renowned scientists, I've been burned. I've written stories only to learn that the studies I'd based them on, often published in the world's best medical journals, contained fatal flaws and that their conclusions were wrong. And I've had scientists tell me of their own realization that they had fallen in love with hypotheses that were later disproved by more rigorous studies.
"This was the biggest disappointment of my career," said Charles Hennenkens, a Harvard researcher who had invested nearly two decades of his life in a theory that beta carotene could prevent cancer and heart disease, only to find that it didn't.
"We deceived ourselves and we deceived our patients," said Dr. Gabriel Hortobagyi, a cancer specialist at the M. D. Anderson Cancer Center in Houston, who spent years convinced that the way to fight advanced breast cancer was to give the highest possible doses of powerful chemotherapy drugs.
So as I scan the press release for this new less-is-more exercise study, I am looking for reasons why I should not believe it. My first thought is that something has to be wrong.
When you work at a place like the New York Times, you can count on getting hundreds of press releases every week, zinging at you by fax, e-mail, Federal Express, and regular mail. Then you get repeated phone calls. Did you receive the press release? The invitation to the press conference? The information for dialing into the teleconference? You get the tip sheets from medical and scientific journals that come out every month, some every week,in which the editors summarize in the most enticing way the conclusions of the papers they are publishing. If you are to survive, you have to learn to skim over these appeals and pick out the one in a hundred, or fewer, that actually look promising.
I have another reason, as well, for being suspicious. From what little I have seen of the exercise field, the tiny pearls of good science are buried in mountains of junk--hucksters who promote programs with not even a pretense of objective evidence that their methods work; studies that involve a handful of people and have no valid data but draw grandiose conclusions; exercise theories that are akin to urban legends.
I expect that this new study will likely fall into one of two categories. Either it will be a reasonable piece of research that will show that fitness does not require much effort. Or its data will be inadequate to show anything at all. In either case, I am definitely interested. I am aware that even if the study fails to show that less is more when it comes to exercise, that would not be evidence that more is more, that my maximum-sweat, maximum-effort regimens are the right way to go. So why not take a look at this new study, I decide. No matter how it turns out, it promises to be a case in point.
The material arrives on a Saturday, sent via Federal Express to my home. I tear open the box, pull out a video and press kit. The sixteen-minute video, a cover letter informs me, was used to explain the study to its participants. I turn on my television set and slip the cassette into the VCR.
The video begins by establishing the credentials of the researchers. The announcer says that the study will be conducted at "the world-renowned Columbia Presbyterian Medical Center in New York City and Hunterdon Medical Center in Flemington, New Jersey." Then, he says, "let's meet our outstanding study researchers."
They are introduced in turn, dressed in business suits, showngiving scientific lectures, looking nothing if not professional. There also is something a bit intimidating about them. Who are we, the lay audience, to question such authority figures? Their credentials are impressive.
There is Dr. Ary Goldberger, who "heads the research team," the video says. He is an associate professor at Harvard University and also directs the Margret and H. A. Rey Laboratory for Nonlinear Dynamics in Medicine at Beth Israel Deaconess Medical Center. Then there is Dr. Irving Dardik, dressed in a black suit with a white shirt and striped tie, a middle-aged man who gestures with his hands while his eyes look straight into the camera. Dr. Dardik, the video announcer explains, is a vascular surgeon who has "served as chairman of the U.S. Olympic Sports Medicine Council, where he was responsible for the science behind world-class athletic performance." Dr. Dardik, it turns out, was the inspiration behind the study. "The clinical trial will be testing his Heart Waves concept, which describes how the interaction of the human body with a novel exercise protocol with computerized feedback may impact health and possibly prevent or even reverse certain chronic diseases."
The others on the team have equally stellar credentials: Dr. Herbert Benson, also a Harvard professor, who runs the Mind/Body Medical Institute at Harvard Medical School ("Over four million of his books on mind-body medicine are printed," the announcer claims); Dr. George Stefano, who is a distinguished teaching professor at the State University of New York in Old Westbury and has written more than 240 papers published in peer reviewed journals; and, finally, Dr. Rochelle Goldsmith of the Division of Circulatory Physiology at Columbia University's College of Physicians and Surgeons.
The study will involve healthy people and also people with chronic fatigue syndrome and those with congestive heart failure, a serious, usually fatal disease in which the heart is increasingly unable to pump hard enough to supply the body with blood.
Dardik explains the theory behind the research: "In natureyou see the rhythms of nature throughout," he says. "Heart Waves recognize that the heartbeat actually climbs up and down by behavioral cycles, anxiety and relaxation, exercise and recovery. It speeds up and slows down, like coming up and down a mountain on a bicycle. Up and down. Like a roller coaster of your heart." It is, he says, "the way it works in nature. You see the rhythms of nature throughout. Everything is spiraling and cycling in the universe."
Goldberger appears on the screen: "The Heart Waves clinical trial is an exciting new adventure and it is an attempt to try out an exciting hypothesis about exercise," he enthuses.
But what do people actually do in this exercise study? The video soon shows us. A plump woman wearing gray surgical scrubs gets on a mini-trampoline. Dr. Dardik instructs her to jog slowly for about a minute, then to sit down and relax for about five minutes while her heart rate returns to normal. That, repeated several times, is the experimental program.
Dardik then explains his Heart Waves concept again.
"It's the way we actually behave, and the way we should behave and work within the context of nature's rhythm. It's natural. It makes common sense. And it's simple. But the most important thing is when you put those three together and realize how it works. It's useful. It's practical."
As he speaks, the video shows drops of water striking a blue pool, one by one, with ripples spreading outward.
But what will this exercise program accomplish? Dardik tells us.
"As you get older, your max heart rate drops. Well, suppose we have a way over time to reverse that," he postulates. "Physiologically, you'll get younger; and, also physiologically, a younger physiology can prevent disease as well. That's healthy." He describes how the wavelength of the heart's rhythm is increased. "Instead of this," he says, moving his hands up to describe a gentle slope, "you go there." His hands move again, describing a steeper slope.
It makes no sense to me. If you ask me what Heart Waves is, I still could not tell you. I have no idea what Dardik is saying. All I know after watching that video is that the study participants are going to exercise very briefly and then rest for a long time.
So I turn to the paper. It is an unpublished manuscript, written in the traditional format for a medical journal. "Implementation of a Novel Cyclic Exercise Protocol: Short-Term Impact on Healthy Adult Women," it is called. It includes an abstract, it lists key words for indexing, it has an introduction, a methods section, and a section called "Study Design" that describes in detail how the research was conducted. A section called "Results" follows that. Then comes a discussion section, the acknowledgments, the references, and tables and graphs of the data.
The discussion section indicates that the results were promising: "We find that a short (eight-week) course of this protocol in healthy adult women was associated with evidence of improved cardiorespiratory fitness and autonomic function, as well as subjective assessment of quality of life."
The problem is that while it has all the trappings of a scientific paper, I strongly suspect that there is almost no science there. I ask a statistician for an expert opinion. David Freedman is a professor at the University of California at Berkeley and he has written papers and books on the design and evaluation of clinical studies. He agrees to take a look at the manuscript.
I fax it to him. Two days later, he calls me, decidedly unimpressed by the study. "It is quite unconvincing," he says.
Almost everything that can be wrong with a study seems to be wrong with this one. First of all, there were only eleven women, ten of whom completed the study. From the data on these ten, the investigators managed to build a complicated, and almost impenetrable, statistical analysis, one that is "almost impossible to reconstruct from this paper," Freedman says. And from that analysis they reach their conclusion that their program was making a difference.
In preparing their analysis, the investigators apparently lookedat quite a few outcomes but chose only those that seemed to point in the right direction. And there was no control group--no group of observed subjects who did not participate in the program. Without such a group, there is no way of knowing whether the changes the researchers claim they found would have occurred anyway.
Even if you take their conclusion at face value, Freedman tells me, all they have found is that the women's maximum oxygen consumption increased slightly. Was that due to the exercise? The relaxation? The alternating exercise and relaxation? The time of day? "It's impossible to say," Freedman asserts.
To be fair, I decide to show the paper to a second statistician. And I know just the person: Howard Wainer, who worked at that time at the Educational Testing Service. Not only is he well versed in the design and analysis of clinical trials, but he has a particular interest in exercise. He swims every day at lunchtime and has swum marathon distances, including the English Channel. Send the paper on, Wainer tells me.
It does not take him long to reach his conclusions. The paper, Wainer says, is impossible to interpret. There is no control group that did not have the exercise program, there is no random assignment of subjects to have the exercise program or not, and so, he says, there is no way to decide whether there was an effect, and if so, how large it was.
The investigators, Wainer adds in an e-mail to me, compared the women's fitness at the beginning of the study to their fitness at the end to argue that they saw an effect. "This is only sometimes okay," he says. "Consider using this methodology to study the efficacy of eating Cheerios for breakfast as a treatment for shortness, and using a bunch of six-year-olds as a control group: 'The study lasted a year and we found an average height gain of four inches.'" Such an analysis, he says "is okay if the (unobserved) assumption of 'no change otherwise' is true. This assumption is what the control group is for."
Finally, Wainer tells me, the investigators did twenty-three statisticaltests looking for something that would turn up positive to serve as an indication that the treatment had an effect. The likelihood that, by chance alone, one of those tests would be positive is 66 percent. But that does not mean that it is a real effect; positive results showing up in this fashion are likely to be a statistical fluke. The investigators should apply statistical methods to correct this problem, Wainer maintains. But if they had made such a correction, he calculates, they would have ended up with no effect at all.
By now, I am becoming fascinated with this paper. I have to unpeel this onion. Why did anyone do this study? Why are they announcing it with such fanfare and hiring a publicist to offer it to me on an exclusive basis--a well-honed publicist's trick to try to get a journalist's attention. Is there a marketing connection in here somewhere?
The first clue comes when I notice that the paper's second author, Irving Dardik, M.D., is listed as being with LifeWaves International of New Jersey. The next clue is the video. It is produced by VHA, described in the publicist's cover letter as "the nationwide network of community-owned health care organizations and their affiliated physicians." VHA also is mentioned in the paper, as helping to pay for the Heart Waves research.
I check the VHA Web site and learn that it is a for-profit organization whose doctors and medical centers sell various products. It is a publicly traded company, I learn by checking the Securities and Exchange Commission's Web site.
Is VHA selling the Heart Waves program? Is it actually promoting this cyclic exercise as a commercial product, based on only one preliminary study of eleven women--one of whom dropped out? A study that two leading statisticians say is ludicrous?
I e-mail the publicist. I tell him that although, as he knows, I have decided not to write about the Heart Waves study for theNew York Times, I am looking into it for a book I am writing. And so, I say, I have a few questions about the groups that are participating in it: What is the relationship between VHA and LifeWaves International? Is VHA selling Dardik's Heart Waves treatment?
He replies the next day. VHA, he tells me, has invested in LifeWaves and has contributed more than half a million dollars to the research on cyclic exercise. In addition, he says, LifeWaves is about to open LifeWaves centers in three VHA hospitals in New Jersey, where people can get the Dardik program, for a fee.
But this is just the beginning of LifeWaves' plans, the publicist tells me. It expects to be opening more LifeWaves centers in VHA hospitals around the country. And, he writes, "the company will be offering individuals the opportunity of doing it themselves via a 'smart' heart rate recorder (called the LifeWaves Personal Coach) and the Internet." He makes me a special offer, to be part of the beta test of the LifeWaves Personal Coach. "It was my recommendation that they invite a very select number of media to try it and experience the results for themselves," the publicist writes.
My suspicions more than confirmed, I probe further. Page four of the study says, "This protocol was adapted from the LifeWaves Program (LifeWaves International, Califon, N.J.; U.S. Patents 5752521 and 5810737)."
Now that is interesting.
I speak to David Saloff, the president of LifeWaves International, who tells me that the company began in 1999, when Dardik's wife, Alison Godfrey Dardik, called him and asked for his help in setting it up. Saloff had known the Dardiks for about six years and had been impressed with the Heart Waves concept. Saloff tells me that he expects that most of LifeWaves' business will be with individuals and families who buy the special heart-rate monitor and the program instructions and a personalized Web page that will store the data from their workouts. People who prefer not to use the Internet can pay to get the same training at a hospital's wellness center.
But, I ask him, doesn't he want to wait for something more conclusive than the preliminary study with ten women, a study that really does not show much, if anything, about the program's beneficial effects? No, he replies. "We're talking about exercise here. I feel perfectly comfortable with it," Saloff says. All sorts of people have used the program, including elderly people with Parkinson's disease, he tells me. "There's never been an adverse event. And this, in fact, may be a safer way to exercise."
My next impulse is to check the Patent Office's Web site to see what the LifeWaves patents say. What is this new invention, and what does Dardik, in his patent application, think it does?
The first, number 5752521, is for a "therapeutic exercise program," and it was issued on May 19, 1998, at about the same time that LifeWaves International was formed. It describes the program being tested in the study but has some sections that seem, to put it mildly, a bit odd. To take just one of many examples, the patent states that "The theory underlying my invention is that the interactions which take place in the human organism and involve the biochemistry of the organism and the behavior of its organs is based upon wave communication, and not on the complexity of the organism itself." Then it gives "examples of wave activity." They include this one:
"The hunting of animals in the wild is cyclic in nature, reflecting the spike to which I have referred. Animals in the wild rarely have chronic diseases. However, when placed in zoos or domesticated, the wave patterns are flattened and become less responsive, and the incidences of chronic diseases then rival those of humans. It is also now generally recognized that chronic diseases and behavioral disorders, such as asthma, suicide, depression, criminal behavior, and cancer are dramatically on the rise."
The application goes on to provide "examples of treatment." It turns out that Dardik has much more in mind than simply helping people get physically fit. The examples he cites are of sick people made well, he claims, by his therapeutic exercise program:A fifty-nine-year-old leukemia patient, whose elevated white blood cell count--a manifestation of the cancer--fell precipitously. A thirty-year-old woman with multiple sclerosis whose symptoms disappeared. A twenty-eight-year-old woman with AIDS who had been suffering from symptoms of severe immune deficiency for a year and a half. Within a few months of starting the Heart Waves program, "all symptoms disappeared," the patent says. An eighteen-year-old with brain cancer who, after surgery to remove the tumor, was, the patent application states, "disoriented, sleeping 18 hours a day, short term memory deficit, etc." He followed the Heart Waves program for three years, the patent application says, and "there has been no evidence of tumor recurrence."
The second patent, number 5810737, issued on September 22, 1998, is more of the same, a continuation, in fact, of the previous patent. It has many of the same sections, including the one about the animals in nature and the non sequitur about increased rates of chronic diseases and behavioral disorders. It even has the exact same descriptions of the patients who were treated with the program. This time, however, the Heart Waves program is to be synchronized with "an internal wave produced by a biological clock."
Who, I wondered, is this Irving Dardik, inventor of this unusual program?
He says he is the founding chairman of the United States Olympic Sports Medicine Council. He says he is a vascular surgeon. I search for the United States Olympic Sports Medicine Council but can find no mention of it on the Internet or in Nexis, an electronic database of published newspaper and magazine articles. Except, of course, a few stories that mention Dardik and state that he founded it.
I look on the Web site of the United States Olympic Committee. It's not there, either. So I send the Olympic Committee an e-mail asking if they ever heard of the Sports Medicine Council. A few days later they reply.
It turns out that the Sports Medicine Council really did exist,but it is now called the Sports Medicine Advisory Committee and it advises the Olympic Committee on sports medicine. Dardik was a doctor for the Olympics and was active with the U.S. Olympic Committee for about a decade, starting around 1974. So maybe my skepticism is unfounded.
But then I discover that Dardik has a very interesting history.
The story emerged in documents from a hearing before the State of New York Department of Health State Board for Professional Medical Conduct. Five patients who had multiple sclerosis testified that Dardik had told them that his "wavenergy" program would cure them. They were impressed by his credentials as founding chairman of the United States Olympic Sports Medicine Council and by an article published in New York magazine that lavishly praised his wave theory. When they went to Dardik, he treated them with cycles of exercise and rest, just like the subjects in his fitness study. And he charged them prices ranging from $30,000 to $100,000.
On March 22, 1995, the New York board issued its conclusions about the Dardik case. The board's Hearing Committee actually questioned Dardik's sanity, writing: "The path taken by Respondent in trying to gain acceptance for his theory as well as his deviations from proper patient care led this Hearing Committee to wonder about Respondent's mental health. Yet despite extensive use of made-up words, such as wavenergy, superlooping, matterspacetime, and frequent loose associations and expansive digressions in response to questions, the Respondent could always return to the subject when prompted and he retained the capacity to understand the questioner (usually a member of the panel) in an objective manner."
The committee added, however, that its task is to decide whether, as a doctor, Dardik "followed standards of patient care he was well familiar with from his practice of vascular surgery." He did not, the group concluded, and it revoked his medical license in New York. The board found him guilty of fraud, exercising undue influence, guaranteeing satisfaction or a cure, andfailing to maintain adequate records. Dardik appealed, citing among other things the committee's allusions to his mental state as evidence it was biased against him.
The Appeals Board saw otherwise. "The Hearing Committee has the authority to assess all witnesses for their credibility. A review of a witness's behavior on the stand would properly be included in such an assessment," it wrote, adding that the committee also has the authority to direct a respondent to submit to an examination to determine mental impairment. "In this case, the Committee mentioned they had a question over the Respondent's mental state, but after review found no reason for concern."
In the end, the Appeals Board agreed with everything the hearing committee had decided. Dardik would have to surrender his medical license, it determined. The Appeals Board also imposed a forty-thousand-dollar fine, "because we feel such a penalty is the appropriate penalty for a physician who exploits several patients." It added that Dardik's conduct demonstrates "a pattern of improper and intentional mistreatment of his Patients that deserves the most severe sanctions possible."
And even though Dardik's LifeWaves International has its headquarters in New Jersey, when I check the New Jersey Medical Examiner's Web site for his name, I find his medical license has also been revoked in New Jersey.
I have to admit that I am stunned. I thought that the study that was being pitched to me was likely to be inadequate. I thought it was probably being promoted to market a product. But I never expected to uncover such an intriguing story. I had this idea that I would just deconstruct a marginal piece of research and show how hard it can be for the uninitiated to distinguish between good science and bad. I thought that I would just try to make the point that having a group of scientists from stellar institutions like Harvard Medical School and Columbia University's College of Physicians and Surgeons is no guarantee that their conclusions are to be believed.
Publicists who are trying to get reporters to write about their clients usually succeed in getting something published, I've found. So I do a quick search for the less-is-more exercise study. Sure enough, I find it, a story put out by Business Wire, available on the Internet through Yahoo! Finance. "Only Sixty Minutes of Cyclic Exercise Per Month Shown to Profoundly Affect Health," it is titled. Not only does it quote Dardik going on about his theory, but it quotes Goldberger, the Harvard researcher, about the promising results.
"This study is exciting to us," he says, "because it presents the first evidence that a novel cyclic protocol designed to train both the activation and recovery phases of exercise may increase cardiovascular fitness, increase heart rate variability, and enhance mood in healthy subjects."
On the LifeWaves Web site, Lifewaves.com, I find detailed discussions of Dardik's ideas about waves and cycles, but there also is a disclaimer. The company states: "The Life Waves Program is based on the work of Dr. Irving Dardik* on understanding how rhythms or waves work in the natural world." The asterisk refers to a footnote that states: "LifeWaves International, LLC, does not endorse any claims by Dr. Dardik or others on any therapeutic benefits from this or any other exercise program. Dr. Dardik has no ownership interest in LifeWaves International, LLC. He is the spouse of the CEO of LifeWaves International, LLC, Alison Godfrey." Yet, elsewhere on the Web site, the company touts its study of the ten women, claiming that LifeWaves improved their health, and it cites ongoing studies on Parkinson's disease, AIDS, and insomnia, hinting that the LifeWaves program is improving the condition of Parkinson's patients and is being tested by leading medical centers for other medical conditions, including AIDS and insomnia.
I call Goldberger. Why, I wonder, did he get involved with this research? He explains that he has long been interested in heartrate patterns and had found that the more variable a person's heart rate, the healthier the heart. Dardik thought that Goldberger'swork fit well with his own and so, Goldberger tells me, in May of 1990, Dardik paid him a visit.
Goldberger liked Dardik's notion that humans have evolved to exercise in brief spurts and was drawn to much of what Dardik was saying. "He told me about his ideas about exercise and the idea that I thought was intuitively very very appealing, that exercise has two components, activity and recovery," Goldberger says. "The traditional exercise protocols focused on the former, but in trying to make a system more flexible you want to get the system to expand and relax. What he described made a lot of sense."
A decade later, when Dardik wanted to do a study, Goldberger was still interested. He is extremely guarded in telling me what he found, explaining that it was just a study to see if the program was feasible. "It at least showed the protocol was well-accepted," says Goldberger. "And there was a positive response in terms of the physiology, and they felt better. It said that at least the protocol has some objective validity and raises the need for further study. But I would be very cautious. It's a small group of subjects."
What about the commercialization? Goldberger tells me he has nothing to do with that and has no comment. Well, does he know about Dardik's history? He does, he says, although he did not know about it in 1990. But he does not want to discuss Dardik's past.
"My role and the role of the people I work with is in testing out ideas," Goldberger tells me. "I think Dardik poses a question to the conventional wisdom. If someone has a testable hypothesis, that's where it becomes interesting."
Cynthia calls me again, just back this time from two weeks in Chautauqua, New York, where her family vacations each August. Do I want to go for a walk?
As we head out, strolling along Edgerstoune Road, I tell her the story of Heart Waves. She is taken aback.
"I can't believe it," she says, horrified by the tale I relate.
What strikes me, though, is that the only reason I uncovered this story is because I did a sort of due diligence on a press release that I probably would have rejected out of hand had that strange video not aroused my curiosity. But now, I wonder, what else is out there in the exercise arena? What can you believe, and how do you know that what you believe is true?
Copyright © 2003 by Gina Kolata
