Judy Foreman

Nationally Sindicated Fitness, Health, and Medicine Columnist

Expensive Arthritis Pills Have Not Lived Up to the Hype

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Seduced by hundreds of millions of dollars in advertising, Americans spend $6 billion a year for the arthritis pain-killers Vioxx and Celebrex, said to be as good as over-the-counter drugs — and easier on the stomach.

But the two have not lived up to their hype, according to published research and interviews with arthritis doctors and drug specialists. Vioxx, which may be better for the stomach, appears to have a far worse side effect than over-the-counter drugs: an increased risk of heart attacks.

For reasons doctors don’t yet understand, Celebrex does not seem to be linked to heart problems, but there’s conflicting evidence whether it has any benefit for the stomach.

There’s also no evidence that these drugs are any better at fighting pain than comparable doses of older medications like ibuprofen — though they cost six times as much. At CVS, a month’s supply of ibuprofen at the doses people with arthritis normally take costs $17.55; a comparable supply of Celebrex costs $107.99, and Vioxx, $110.99. Depending on copays, the consumer may actually end up paying the same amount or even more for over-the-counter drugs, though, because insurance doesn’t defray costs for non-prescription medications.

Vioxx and Celebrex, like their lesser-known cousins Bextra and Mobic, are in a relatively new class of drugs called Cox-2 inhibitors.

Despite the saturation advertising aimed at the 22 million Americans who suffer from arthritis, “there is no proof that these Cox-2 drugs are better for arthritis pain than traditional ibuprofen, and there is also no proof, except for a certain subset of patients, that these drugs are safer,” said Dr. Neil Minkoff, medical director of pharmacy at Harvard Pilgrim Health Care, which insures 800,000 people in Massachusetts, New Hampshire and Maine.

Some insurers, including Harvard Pilgrim, now insist that doctors get “prior approval” before writing prescriptions for them.

Back in the late 1990s, when the hype over Vioxx and Celebrex began, the excitement seemed well-founded. Researchers had long known that prostaglandins, natural chemicals that are made in cells under the direction of enzymes called cyclooxygenases, were the root cause of pain and inflammation.

But it turned out there were actually two types of cyclooxygenases, dubbed Cox-1 and Cox-2. Cox-1 releases “good” prostaglandins that protect the stomach. Cox-2 releases “bad” prostaglandins that further drive inflammation. The new drugs were hailed for their ability to block only Cox-2 and leave the good prostaglandins intact, something that traditional over-the-counter anti-inflammatory drugs like ibuprofen could not do.Eager to get the pain-killing benefits without stomach-killing side effects like bleeding ulcers, doctors and patients flocked to the new drugs to help dampen the pain of arthritis, as well as migraines, acute pain and menstrual cramps.

Then the bad news began trickling out.

The Cox-2 inhibitors actually “don’t eliminate gastrointestinal side effects, they just reduce them somewhat, and even that is more problematic than first thought,” said Dr. Jerry Avorn, chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital, and author of the forthcoming book, “Powerful Medicines” on the subject.

In September, 2000, a study on 8,000 patients showed that people taking Celebrex had fewer ulcer complications than those taking over-the-counter medications. But the study, published in the Journal of the American Medical Association, focused only on figures from six months of drug use, “the most appropriate” time-frame, according to Dr. Gail Cawkwell, worldwide medical team leader for Pfizer, which sells Celebrex.

When a later analysis by the US Food and Drug Administration looked at 12 months’ worth of data, this apparent advantage disappeared, said Dr. Michael Wolfe, chief of gastroenterology at Boston Medical Center.

In November, 2000, a study called VIGOR showed that 50 milligrams a day of Vioxx — a relatively high dose –reduced the risk of serious stomach problems by half, compared to prescription strength naproxen (Aleve). But the study, published in the New England Journal of Medicine also showed, to researchers’ surprise, that the risk of heart attack was two to four times higher for patients on Vioxx.

Since then, the data have been conflicting, with most — but not all — studies showing a link between Vioxx and heart disease. This spring, researchers from Brigham and Women’s Hospital, writing in the journal Circulation concluded that compared to high doses of Celebrex, high doses of Vioxx were linked to a 70 percent increase in heart attack risk in the first 90 days of use.

Dr. Lee Simon, a rheumatologist at Beth Israel Deaconess Medical Center, said that people should realize that it’s not wise to take 50 milligram doses of Vioxx for more than a week, but 12.5 and 25 milligrams a day are safer.

Consumers, shareholders and regulators, not surprisingly, have not been thrilled about these studies.In 2001, the US Food and Drug Administration issued a “warning letter” about Merck & Co., Inc.’s promotional activities for Vioxx, which the agency said was minimizing the potential heart attack link. The FDA also issued a warning letter in 2001 about misleading promotion of Celebrex, particularly its potentially harmful interactions with Coumadin, a commonly prescribed blood thinner.

Pfizer would not comment on the warning letter, or discuss possible litigation over Celebrex, but Merck is clearly on the defensive. Merck officials say they have corrected the problem. Since 2002, Merck has also included heart risk data from three studies on its package labeling, said company spokeswoman Mary Elizabeth Blake.

But in New Orleans, the Kahn Gauthier Law Group, is leading a shareholders’ proposed class action suit against Merck alleging that the company artificially inflated its stock prices based upon false and misleading statements about the safety of Vioxx. In New Jersey and California, lawyers (Seeger Weiss in Newark and Girardi & Keese in Los Angeles) are handling more than 200 personal injury lawsuits claiming that Merck failed to warn consumers about Vioxx’ potential risks. No similar cases have been filed in federal or appeals courts in Massachusetts. 

So where does this leave us? Use over-the-counter medications if they work for you. If they don’t work or if they cause stomach problems, talk to your doctor.

Pelvic Exams Done Without Permission

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At teaching hospitals around the country, medical students routinely practice doing pelvic exams on unconscious, anesthetized female patients — often without the patients’ knowledge or consent.

Some of the nation’s 126 medical schools have forbidden the practice, but Dr. Ari Silver-Isenstadt, a Baltimore pediatrician and co-author of a 2003 paper on the topic, said the practice continues to be widespread.

According to his research, 90 percent of medical students surveyed said they had done pelvic exams on anesthetized women. He did not track how many of the patients had given permission for those exams.

Medical students on surgical “rotations” are in the operating room primarily to learn, not to care directly for the patient. For that reason, he said, “medical students who are not central to patient care should not be doing this without explicit permission. It’s a no-brainer.”

Dr. Marcia Angell, senior lecturer in social medicine at Harvard Medical School said the reason doctors don’t ask is that women might refuse — “which makes it even worse,” she said. “They have no right to use humans as tools. It’s exploitation.”

Doctors often justify having medical students perform pelvic exams on anesthetized women by saying that asking consent would take too much time, might scare patients and that patients already know medical students will be involved in their care by the sheer fact of choosing to go to a teaching hospital.

In gynecological surgery, “the exam under anesthesia is a crucial part of the procedure, it’s not separate from the surgical procedure,” said Dr. Andrea Rapkin, a professor of obstetrics and gynecology at the University of California at Los Angeles Medical Center.

Doctors must inform patients that they will be examined under anesthesia, but “we don’t specify that it is a pelvic exam,” Rapkin said. “We have no reason to specifically state that a medical student will (perform the exam)…It’s not the whole team of medical students —
it’s usually one or two.

Silver-Isenstadt’s team also found that as medical students proceeded through their training, they became less and less concerned about seeking consent, a sign that they were becoming acculturated to a medical system that, as he put it, “assumes patients are not in control of their own bodies.” In a previous paper, Silver-Isenstadt found that if asked to give permission for medical students to do a pelvic exam in the operating room, roughly half of patients would agree.

Since publication of the 2003 paper, which ran in the American Journal of Obstetrics and Gynecology many medical organizations have condemned the practice as clearly unethical.

The American College of Obstetricians and Gynecologists says that “if a pelvic examination that is planned for an anesthetized woman undergoing surgery offers her no personal benefit and is performed solely for teaching purposes, it should be performed only with her specific informed consent obtained while she has full decision-making capacity.” The Association of American Medical Colleges calls the practice “unethical and unacceptable.” The state of California now explicitly forbids it. (A UCLA spokesman said his school’s consent process meets state guidelines)

Some argue that there is simply no need to use unconscious women as teaching tools. Judy Norsigian,executive director of the Boston-based advocacy group, Our Bodies, Ourselves, noted that paid volunteers have allowed medical students to practice pelvic exams on them for years, coaching the students on how to do the exams gently and effectively.

At Harvard, the policy was changed six or seven years ago after a group of medical students objected to performing exams without express permission, said Dr. Daniel Federman who was then dean of medical education and is now senior dean for clinical teaching. Now, “a student directly involved in that patient’s care may do a pelvic exam under anesthesia if the patient’s doctor has asked her about it in advance, has introduced the student and obtained consent,” he said.

The Medical College of Wisconsin changed its policy last year to say that physicians must discuss with the patient prior to surgery the fact that a medical student may participate in a pelvic exam, and those exams must not be performed by multiple students.

At Tufts University School of Medicine, “all women coming in for obstetrical-gynecological surgery are told that if they need a pelvic exam before surgery, a medical student may be involved in that exam,” said Dr. Steven Ralston, director of the third year clinical clerkship program in obstetrics and gynecology. “But no student will be doing that unless he or she is involved in the surgery and the exam itself is necessary for the surgery. Absolutely, patients can say no.”

At the University of Massachusetts Medical School in Worcester, “every woman who is getting a pelvic exam and any man getting a genitourinary exam from a medical student has given consent for the student to do the exam,” said spokeswoman Alison Duffy.

Dr. Linda Heffner, the new chief of obstetrics and gynecology at Boston University School of Medicine, said in a prepared statement that the school does not have a written policy on this issue but is developing one. “Personally, ” she wrote, “I believe that patients should always be asked for their permission to be examined by a medical student. We need to help patients understand the importance of these examinations in the medical education process.”

Silver-Isenstadt said he became sensitized to the issue a decade ago while a student at the University of Pennsylvania School of Medicine. In the operating room one day, the surgeon did a pelvic exam on the patient — a totally appropriate and necessary pre-operative step — and then asked Silver-Isenstadt to do likewise.

“I asked, ‘Does she know I am going to do this?’ ” The surgeon said no. “I said, ‘I am really uncomfortable doing this,” — and he didn’t, though he took some grief for it.

Scientific Support For Yoga Is Slim

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I have been standing on my head, off and on, for about 35 years now,  as well as sitting cross-legged breathing through one nostril at a time, and — my favorite — lying flat on my back, utterly relaxed, in the so-called “corpse pose.”I am, in other words, one of the 15 million Americans who, according to a Harris Interactive Service Poll done in 2003 for Yoga Journal, have fallen in love with this ancient Indian practice that’s part meditation, part exercise. To the cognoscenti — and our numbers grew by nearly 29 percent between 2002 and 2003 — yoga is a pleasant practice that seems to enhance physical and emotional strength, flexibility and balance. But does it?

Well, to the extent that yoga overlaps with what the so-called “relaxation response,” it’s no leap at all to conclude that yoga is good for you. The “relaxation response,” a term coined years ago by Dr. Herbert Benson, president of the Mind/Body Medical Institute in Boston, consists basically of quieting the mind and body through prayer, contemplation or focusing on something simple, like breathing.

The relaxation response has been shown to lower blood pressure, heart rate and respiration; to reduce anxiety, anger, hostility and mild-to-moderate depression; to help alleviate insomnia, premenstrual syndrome, hot flashes and infertility; and to relieve some types of pain, like tension headaches.

But for yoga itself, there’s not much scientific evidence that the practice confers its own specific health benefits — though that doesn’t seem to dampen anyone’s enthusiasm, including my own.

“There is not enough really good research to draw strong conclusions about anything about yoga,” said health psychologist and yoga teacher Roger Cole of Synchrony Applied Health Sciences, a health promotion consulting firm in Del Mar, Calif.

Take standing on your head. There is some data suggesting that inversion may slow heart rate and make people secrete less of a stress hormone, norepinephrine. “The question,” said Cole, “is whether that amounts to clinical benefits.”

Some yoga teachers claim that standing on your head increases blood flow to the brain, a supposedly good thing. That’s nonsense, said Dr. Timothy McCall, a slim, Somerville physician and yogi who writes a health column for Yoga Journal. “Blood flow to the brain is tightly regulated,” he said, so going upside down probably doesn’t bathe the brain in extra blood. And standing on your head could worsen glaucoma (increased pressure within the eye) and or problems with the retina. That said, McCall is still convinced that headstands “have a profound effect on slowing the body down.”

McCall, who, perhaps more than anyone else, has tried to assess the science of yoga, has visited research institutes in India, where most of the yoga studies are being done.

Though some of the research — both in India and the West — is methodologically flawed, yoga has more than 50 documented effects, including greater strength, increased flexibility, better balance, better cholesterol levels and better mood.Of five studies on asthma since 1985, three showed statistically significant benefits. One 1998 study on carpal tunnel syndrome (pain caused by pressure on a nerve in the wrist) found yoga could reduce some symptoms and improve grip strength. A couple of small studies found that yoga can lead to both subjective and objective improvements in COPD, or chronic obstructive pulmonary disease, a disease in which the airways and air sacs in the lungs lose their elasticity, making it difficult for air to flow in and out.

Another small study found that the slow, diaphragmatic breathing of yoga helps increase oxygenation in some patients with congestive heart failure. Several studies show yoga helps improve symptoms of coronary artery disease, though the patients also made other changes — like switching to low-fat diets. One study of severe depression found that the deep breathing (pranayama) of yoga, electric shock therapy and drugs all improved scores somewhat on a standard depression test.

At Boston’s Brigham and Women’s Hospital, senior neuroscientist Sat Bir Singh Khalsa is studying yoga as a treatment for insomnia. At the University of Texas MD Anderson Cancer Center in Houston, Dr.Lorenzo Cohen, director of the integrative medicine program, hasfinished a 7-week study of 39 men and women with lymphoma that waspublished in April. Cohen randomized patients to receive instruction in Tibetan yoga or no special intervention. Those who practised yoga slept better than those who didn’t, though there were no differences in other measures such as anxiety, depression or fatigue.

Researchers at the UCLA Jonsson Cancer Center are about to start a study of yoga to combat fatigue in women with breast cancer. Put bluntly, yoga may indeed have more health benefits than have been documented so far. But the skimpiness of solid data so far means: Buyer Beware. If you’re in a class and the teacher makes absurd claims — like a certain pose will make your spleen happy — smile serenely and think of the claim as a metaphor.

And choose your teacher with care. Unlike hairdressers and manicurists, yoga teachers are not licensed. Anational organization called Yoga Alliance (www.yogaalliance.org) lists teachers who have completed various levels of training, but it provides no real evidence of competence. Some methods of yoga, like the Iyengar system, do have a rigorous, multi-tiered system of certification, says Patricia Walden, director of the BKS Iyengar Yogamala of Cambridge. But it’s still a crapshoot. So good luck. And, as they say in Sanskrit when one person puts her palms together and offers a humble greeting to another, Namaste.

Unraveling the Mysteries of MS

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Judi Bartnicki, 53, had been an artist all her life. Then MS, or multiple sclerosis, struck four years ago, doing its worst damage in her left hand, the one she needs for painting and drawing.

“I kept trying to paint and I would drop everything,” she said. Finally, her fiance David Richardson, figured out a way to tape her paintbrush to her left hand. Painting is still painful, the Georgetown resident said, “but I am so happy to be able to do it. I am doing my best work.”

MS is a nasty, chronic disease in which the immune system attacks the myelin sheath that insulates nerves. It rarely shortens lives, but it does seriously diminish the quality of life of 400,000 Americans, two-thirds of them women. Until recently, doctors had only a sketchy idea of what goes wrong in the brains and spinal cords of people with MS and few drugs to combat it.

But in the last several years, MS “has gone from a mysterious disease with no treatment to a disease we understand, have treatments for, and have a way forward to cure,” said Dr. Howard Weiner, head of the Partners MS Center at Brigham and Women’s Hospital.

For instance, researchers now think MS may be not one disease but four. They know that even in the early phase when symptoms come and go, the brain is being continuously damaged. They think hormone treatments may help, as may some new medications.

Many, if not most people who get MS have no family history of the disease, although having a parent or an identical twin with MS does raise the risk, said Dr. David Hafler, a professor of neurology at Harvard Medical School.

There appears to be no “MS virus” per se. But doctors believe that some invader, probably a virus, activates so-called TH1 immune cells, which pump out pro-inflammatory chemicals called cytokines. The TH1
cells then mistakenly attack bits of myelin that “look” like the invading virus. The result is severe, patchy inflammation throughout the brain and spinal cord, which cause temporary blindness, muscle weakness, tingling, trouble walking and double vision. TH1 cells also
get into the brain, destroying myelin in brain cells, which causes problems in thinking.

In MS, in other words, the immune system is out of whack, with the pro-inflammatory, TH1 side of the equation overactive, and the anti-inflammatory side — TH2 and TH3 cells — underactive.

In recent years, five injectable, prescription drugs have become available to restore this balance, relieve symptoms and slow the disease’s progression. Betaseron, Avonex and Rebif directly damp down TH1 cells. Copaxone calms “activated” T cells. Novantrone, reduces the activity of both T and B cells (which make antibodies). A sixth, Antegren, which is still awaiting federal approval, blocks activated TH1 cells from crossing into the brain.

Bartnicki started taking Avonex two months ago and finds it ” excellent.” “I don’t have bad, bad bouts like I used to,” she said. “I don’t have the terrible muscle spasms I used to have. I can paint for longer periods.”

The new understanding of MS is based on several studies, including one by Weiner, who recently published a book, “Curing MS : How Science Is Solving the Mysteries of Multiple Sclerosis. His team used MRIs to regularly scan the brains of 40 MS patients for a year. Even between acute attacks, he found, “the disease is actually progressing.”

Dr. Jack Burks, an MS specialist at the University of Nevada School of Medicine in Reno, said “for every attack I see in my office, there are probably 10 attacks that could be seen on an MRI…Now, the big push is to treat early, when patients feel really good.”

At the Mayo Clinic in Rochester, MN, Dr. Claudia Lucchinetti, a neurologist, has looked at samples of brain tissue taken from MS patients who were undergoing brain biopsies to exclude other diseases, and at tissue obtained at autopsy from MS patients. She found that the lesions — damaged spots in the myelin sheath — are different in different patients, suggesting MS has at least four major subtypes. In one, the damage comes from TH1 cells and macrophages, another type of immune cell. In another, the damage is done by antibodies made by B cells. A third type resembles a viral infection or stroke; the fourth type is characterized by damage in the cells that make myelin. If doctors can find a less invasive way to sort out the types, they might be able to tailor drugs better to each patient.
Hormones also play a role. It’s long been known that MS gets better during pregnancy. That’s because the fetus consists partly of foreign tissue (from the father), so a woman’s immune system must be quieted during pregnancy so that it does not attack the fetus.

In a pilot study, Dr. Rhonda Voskuhl, head of the MS Center at the David Geffen School of Medicine at UCLA, set out to mimic pregnancy by giving estriol, a type of estrogen, to women with MS. She saw a reduction in brain lesions on MRI scans and a favorable shift in the immune balance. When she took the women off the hormone, they got worse.

When she put them back on, they got better again, she said.
Other researchers have been trying, so far with mixed results, to create individualized vaccines to restore immune balance, said Dr. Henry McFarland, chief of the neuroimmunology branch at the National Institute of Neurological Diseases and Stroke, part of the National Institutes of Health.

For symptom relief, injections of Botox, made from the botulinum bacteria, may help relax stiff muscles, allowing some patients to move more easily, said Dr. Michael O’Dell, professor of clinical rehabilitation medicine at Weill Medical College of Cornell University in New York.

The growing understanding of MS clearly provides new hope. But in the meantime, it’s important not to “sit around waiting for a miracle,” said Dr. Lisa Iezzoni, 49, who has had MS for 27 years and zips around Beth Israel Deaconess Medical Center, where she is a researcher, in a scooter
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The key, said Iezzoni, who is not taking any MS drugs now, is to “find a doctor who feels comfortable working with you on your terms.”

Does Eating Soy Make you Healthier, or Not?

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Health food advocates have long claimed that soy, he little legume found in everything from tofu burgers to smoothies, can protect against heart disease, ward off   cancer and combat hot flashes.

But those claims are coming under scrutiny, now that a soy food manufacturer, the Solae Co. of St. Louis, Mo., is seeking government approval to tout on its labels soy’s supposed cancer-fighting abilities.

The company’s petition to the US Food and Drug Administration for a new health claim has the support of some soy researchers, but has angered others who say the science simply isn’t there to support it.

Some controversial research in mice even suggests that soy could promote breast cancer. The FDA, which has loosened its rules on what products do and don’t deserve to be sold with health claims, is accepting public comment on the issue until mid-June. (www.fda.gov.)

The company wants its labels to say, in part, that “scientific evidence suggests that consumption of soy protein may reduce the risk of certain cancers,” and in other materials, names cancers of the breast, colon and prostate. The company cites 58 studies in support of its position, but also asks that the labels carry the caveat: “However, this evidence is not conclusive.”

Indeed the evidence is not conclusive.

Most of the evidence comes from epidemiological studies, which look at groups of people to find associations between their habits, such as soy consumption, and their risks of getting diseases. Such studies, however, are not designed to prove that certain behaviors cause or protect against diseases.

Dr. David Heber, director of the Center for Human Nutrition at UCLA, who is sympathetic to Solae’s claim, said, “Soy is an important tool in helping women achieve their personal best body weight and shape, and obesity is a major contributor to breast cancer risk.”

But leaping from that to the idea that eating soy can actually help prevent cancer and other diseases is dangerous business, according to David Schardt, a senior nutritionist at the Center for Science in the Public Interest, a nutrition advocacy group in Washington, D.C. “It doesn’t make sense to urge people to consume these products when we don’t know whether they prevent cancer or make matters worse.”

The notion that soy could make matters worse makes some theoretical sense. Soybeans are rich in weak plant estrogens, specifically genistein  and daidzein, which are called isoflavones. Like the estrogens that humans make in their bodies and buy by prescription, these estrogens could theoretically spur the growth of estrogen-dependent breast cancer cells.

Some hints come from the laboratory of Bill  Helferich, a professor of Food Science and Human Nutrition at the University of Illinois. He has found that genistein from soy can promote the growth of human breast tumors implanted into mice.

In Asia, he said, soy is consumed in minimally-processed forms like tofu, and Asians do have a lower incidence of breast cancer than Americans. The whole soybean contains 30 to 40 percent protein. But many soy products in the US are highly concentrated, and contain up to 90 percent protein. The oncentrated products still contain isoflavones but may be missing potentially beneficial but unidentified compounds, he said.

But Heber of UCLA argues that Helferich’s mouse model is flawed because mice are missing an enzyme in human fat cells that controls estrogen metabolism.In truth, soy has been losing its luster for several years. Nearly five years ago, the FDA became so convinced of soy’s capacity to lower cholesterol that it began allowing manufacturers to put health claims on soy products indicating that it may lower heart disease risk.But since then, the emerging data “has not upheld that health claim,” said Alice Lichtenstein, a professor at the Friedman School of Nutrition Science and Policy at Tufts University. It turns out, she said, that soy has “very little effect” on lowering “bad” or LDL cholesterol. Others note that soy can reduce heart disease risk to the extent that it is substituted for greasy meat.Nor has soy lived up to its promise for combatting hot flashes, said Dr. Sherwood Gorbach, professor of community health and medicine at Tufts University School of Medicine, who only a few years ago was developing a soy supplement for hot flashes and has now abandoned that effort. “We have a patent,” said Gorbach, “but the evidence was not compelling.” Other researchers say soy is somewhat better than placebo, but doesn’t get rid of hot flashes entirely.

But the real battle now is over soy’s alleged anti-cancer properties, and how that goes depends on new thinking at the FDA — which recently weakened its rules on health claims for food and dietary supplements.

In 1990, Congress passed a statute, the Nutrition Labeling and Education Act, which required that FDA-approved health claims for food be based on “significant scientific agreement,” said Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest, a nutrition advocacy group based in Washington, D.C. The food industry objected, arguing that this requirement violated their first amendment rights to free speech. The FDA ignored the industry’s argument until 2002, when it said it would “permit health claims for foods even if there is no significant scientific agreement” on the benefits, said Silverglade.Last July, the FDA announced it would begin allowing some food companies to make “qualified” health claims, the weaker claim Solae is seeking. In September, Silverglade’s group joined with another Washington-based advocacy group, Public Citizen, and sued the FDA, over this change in policy. A ruling on this suit is still pending.

The bottom line? If you enjoy soy as a food, go for it. But don’t expect miracles, and check with your doctor before upping your soy intake if you already have breast cancer.

If I Were the Diet and Exercise Czarina (Part 2 on the Importance of Exercise)

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What this fat, out of shape country needs is a Diet and Exercise Czarina. I hereby volunteer.

First, let’s get two philosophical things straight. Eating too much and exercising too little is obviously a matter of individual responsibility. Nobody’s force-feeding us, or tying us down so we can’t exercise.

But the fact that 64% of Americans are now either overweight or obese, the fact that physical inactivity combined with bad diet is overtaking tobacco as our leading killer, and the fact one in every four adults does little or no exercise all suggest that other things are at play, too.  We live in what some call a “toxic” environment – surrounded by junk food and stressed by too much work and too little time to work out.

In other words, the forces beyond our immediate control – government, employers, the food industry, health insurers, schools, city planners – could do a lot more to supplement our individual efforts to get trim and fit.

For instance, Congress could pass and the president could sign something like the bill recently sponsored by Sen. Tom Harkin (D-IA) that would force chain restaurants – and vending machines – to display the calories, sodium, fat and transfat content of menu items. (Instead, the House recently passed the so-called “cheeseburger bill,” which bans lawsuits that blame the food industry for making us fat.)

Restaurants could offer lower-calorie kids’ meals. A recent study by the Washington-based Center for Science in the Public Interest showed that some kids’ meals have enough fat and calories to choke an adult. The group tested food from chain restaurants and found that a “Boomerang Cheese Burger with Fries” at the Outback Steakhouse contained 840 calories, more than half of what a sedentary kid aged four to eight needs a day.

Schools could add a BMI, or body mass index, score to kids’ report cards.  Arkansas schools already do this, says exercise physiologist William J. Evans, chief of the nutrition, metabolism and exercise lab at the University of Arkansas for Medical Sciences. (The BMI is a ratio of height to weight. To calculate it, take your weight in pounds and multiply by 703; then divide this number by height in inches squared. Ideally, BMI should be about 23, maybe slightly older for older folks.)

Schools could also bring back physical education. Only 8 percent of elementary schools, 6.4 percent of middle schools and 5.8 percent of high schools provide daily physical education, according to the federal Centers for Disease Control. Another no-brainer: Schools could restrict the sale of sugary drinks, as the American Academy of Pediatrics recommends.

Employers could do a lot more, too. Helen Darling is the president of the Washington, D.C.-based National Business Group on Health, which represents 207 of the country’s largest employers. Big employers are just “starting to wake up” to the impact that America’s obesity and flabbiness have on the bottom line, she said.

For years, “the view among enlightened employers was that things that have to do with one’s person – what you eat, whether you exercise or not – was none of their business. It would be considered invasive. But as of just about a year and a half ago, our organization looked at what drives health care costs and disability costs and productivity,” she said. Members were “stunned.”

Medical claims for an obese employee are typically twice as high as those of a non-obese employee, her group found. Indeed , obesity costs American business an extra $13 billion a year in health, disability and life insurance, as well as in paid sick leave. (Overall, obesity costs the country $117 billion a year.)

Even more startling, the biggest increases in both medical and disability claims are in younger employees. A recent study by the Rand Corporation, a nonprofit California think tank, found a 40 to 50 percent increase in recent years in the number of people aged 30 to 49 who are too disabled to care for themselves or do routine tasks. “The only factor researchers could identify that would explain such a large jump in disability is obesity,” the Rand researchers said in a prepared statement.

So what can businesses do? Plenty, said Darling.  “The number one way to have any kind of fitness as part of the [corporate] culture is if the CEO and the CFO and the senior VPs are fitness buffs.”  Behavior change is tough, but “the workplace is the facilitator,” she said. After all, workplace smoking bans helped many Americans quit. To encourage fitness and weight loss, employers can make stairwells well-lit and cheerful, they can provide healthy food choices in the cafeteria and offer to pay for health risk appraisals from an employee’s own doctor, and give employees who follow their doctors’ plans $100 or extra benefits.

Company gyms can help, but not if  “people are looked down on” for taking time from work to exercise, noted James Hill, director of the Center for Human Nutrition at the University of Colorado Health Sciences Center in Denver. A better approach may be “walking meetings.”  One CEO in Colorado, he said, goes for a walk every day at 3 and employees are free to join him.

City planners and civic groups could help by making streets more pedestrian-friendly. Nationally, a group called Walkable Communities, Inc. helps civic groups do just that. In Boston, a group called WalkBoston worked with city planners to make sure that some of the green space freed up by the Big Dig construction project becomes walkable, says Liz Levin, the group’s president. [Note: I have just been put on the WalkBoston board.]

Health insurers, too, are beginning to create incentives to boost the survival of the fittest. HealthCare Dimensions in Tempe, Arizona, sells a program called “Silver Sneakers” to 21 health insurers in 14 states, including Fallon Community Health Plan in Massachusetts. Companies like Fallon buy the program for their customers on Medicare, and the Silver Sneakers folks contract with private health clubs and not-for-profit fitness centers like YMCAs to offer classes – free – to enrolled seniors.

Mohit Ghose, a spokesman for America’s Health Insurance Plans (AHIP), a Washington-based industry group for the insurers who cover more than 200 million Americans, says many health plans already offer some kind of exercise benefit. About 18 percent offer exercise counseling or cardiovascular fitness programs as a basic benefit. Roughly 76 percent will help customers get access to a gym at a discount, but “people need to ask the question by calling the 800 numbers of their plans,” he said.

Starting in January, PacifiCare, a consumer health organization in Cypress, CA, has been offering a “health credits” program that offers prizes – like exercise bikes or treadmills – to members who earn credits by participating in health promotion programs, such as exercise or smoking cessation.

None of this is rocket science. But as Czarina, I have hope, and not just because I’m an idealist. As the big players figure out how badly obesity and sloth affect the bottom line, things will have to change.

Exercising Your Right to Live Longer (Part 1 on the Importance of Exercise)

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It can be rather bewildering, frankly. We all know by now — duh — that we’re supposed to exercise.But how? By lifting weights? Or running? How much? A short walk from the parking lot to the office, or miles and miles a day? How often? Once a week on Saturday mornings, if someone else can watch the kids, or every day? How hard? Til we’re a breathless, sweaty mess or just pleasantly glowy? And most of all, in our crazy, overscheduled-lives, when?

Great minds have tackled these questions, and are tackling them again, with new federal exercise guidelines due out this summer. But one of the conclusions is already known: Exercise is just about the closest thing to a magic bullet that modern medicine can recommend. It’s very, very good for you for a long list of reasons that we’ll get to in a minute.

Think evolutionarily. We are all animals, not that different from zebras, lions, dogs, etc. Animals do not lie on the couch all day eating potato chips and watching TV. (Okay, maybe your zebra does, but he probably wouldn’t if he had the choice.)

Animals are built to run around, hunt, eat, sleep, procreate and then do it all again. They probably even like the running around part. Studies suggest that rodents, when put in cages with little wheels to run on as well as toys to play with, prefer the exercise wheels. In other words, our animal souls think of exercise as fun and essential, not some unwanted burden imposed by experts.

Okay, so you’re not buying that. But you’re still determined to exercise and you can’t possibly do it all — the strength training with weights, the yoga for flexibility, the brisk walking or running or swimming for cardiovascular fitness. What’s most important? Simple: The aerobic, cardiovascular stuff, in other words, getting your heart rate up. This doesn’t mean strength training is not important — it is, for building muscle mass and stronger bones. Stretching and flexibility are important, too. But if you have to choose, do the exercise that has been shown overwhelmingly to prolong life and reduce chronic disease.

A number of epidemiological studies show that 30 minutes a day of moderate intensity physical activity is enough to significantly reduce the risk of many diseases, including heart disease, hypertension, stroke, diabetes, certain cancers and hip fractures, said Dr. I-Min Lee, an associate professor of medicine at Harvard MedicalSchool

That may not be enough to achieve and maintain weight loss, cautioned William J. Evans, chief of the nutrition, metabolism and exercise lab at the University of Arkansas for Medical Sciences. “But there is no question that 30 minutes a day is enough to make a significant difference in life expectancy and health.”

So how hard do you have to work at it? The experts waffle a bit on this. But very roughly, if you’re a 30 year old, you should exercise aerobically at a heart rate of between 155 and 165; if you’re 40, it’s 145 to 155; if you’re 50, it’s 140 to 150. If you’re 60, it’s 130 to 140. If you’re 70, it’s 125 to 135. (The actual formula is slightly complicated, but here it is. Take the number 220 and subtract your age, say, 60. That gives 160. That’s an estimate of your maximal heart rate. Now subtract your average resting heart, say 60, from this, which gives 100. Then you take 70 percent of that number (100), which gives 70. Add that number (70) to your restingheart rate (60), and you get 130, the heart rate you should be aiming for during aerobic exercise.)

The goal of 30 minutes a day comes from guidelines set in 1995, when a team of exercise physiologists and doctors from the federal Centers for Disease Control and Prevention and the American College of Sports Medicine and others tried to figure out what to recommend for average Americans, most of whom, then as now, didn’t exercise. Though they recommended 30 minutes a day, they softened this by saying people could “accumulate” 30 minutes in three bouts of 10 minutes each, a moreachievable goal for many people.

The new guidelines expected out this summer will probably recommend the same. The difference, said Dr. Bill Kraus, a cardiologist and exercise guru at Duke University Medical Center, is that “when those [1995] guidelines were written, no one had a clue.” Today, they do, especially for the question of intermittent versus continuous exercise. In one study published in 1999, exercise physiologist John Jakicic at the University of Pittsburgh found that for weight loss, body composition, improvements in blood pressure, cholesterol and blood sugar, it made no difference whether the exercise was continuous or intermittent. That makes sense, he said, because those factors “are all about energy burn.” The only place in which continuous exercise was better was in fitness measures (like one that physiologists called “VO2 max”), a measure of the efficiency with which the heart and lungs getoxygen to the muscles and the efficiency with which the muscles use oxygen.

For weight control, a report in 2002 from the Institute of Medicine, an arm of the National Academy of Sciences, concluded that 30 minutes of exercise a day is “insufficient” to maintain healthy weight. It probably takes 60 minutes, especially if you’ve been overweight Steven Blair, president of the Dallas-based Cooper Institute, a leading exercise research center, is a case in point. “I need even more than an hour of vigorous exercise. I have run nearly every day for 35 years and now, at 65, I run 25 miles a week, which is a lot for a fat, old man.” Even so, he’s gained 25 to 30 pounds.

But exercise clearly helps to some extent with weight control, even if you make no changes in diet. At Duke University, cardiologist Kraus and his team took 240 typical Americans — sedentary, overweight men and women aged 40 to 65 with mild to moderate cholesterol problems — and divided them into four groups for a 6-month study. There was no change in diet for anyone.

Over the six months of the study, the control group — typical, non-exercising Americans — gained three pounds. The other groups lost weight, with those who exercised more at a higher intensity losing more weight than the gentle exercisers.

The bottom line, says Kraus, is this: Any exercise is better than none, and more is better than less.

On the Verge of an Ovarian Cancer Test

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Judith Rubel, a former marketing specialist for a Boston-area hospital, seemed an unlikely candidate for ovarian cancer. She was healthy, fit and slim. She had no family history of the disease. Besides, ovarian cancer was pretty rare — only one woman out of 59 gets the disease over a lifetime.“It never occurred to me that it could happen to me,” Rubel, who now lives in Old Saybrook, Conn., said last week.

But 6 years ago, when Rubel was 52, she was diagnosed with the cancer — which is quite survivable when found early, but often fatal when caught after it’s spread. Because there’s no good test to catch ovarian cancer, nearly three-quarters of the 25,580 women diagnosed with the illness this year will have advanced cancer by the time it is found,, as Rubel did. One of the lucky ones, Rubel, who endured surgery, chemotherapy, and a bone marrow transplant, feels well today.

But she is still worried: Will her cancer recur, and if her 33-year-old daughter gets the disease, would it be caught any earlier? Researchers believe it will. Scientists at the National Cancer Institute and a number of private companies are racing to develop blood tests to catch these well-hidden cancers early enough to treat them more successfully.

“I am optimistic that within five years there will be a truly reliable screening test,” said Dr. Beth Y. Karlan, president-elect of the Society of Gynecologic Oncologists and director of gynecologic oncology at Cedars-Sinai Medical Center in Los Angeles. Such a test “would improve survival from ovarian cancer more than any new therapy.”

Finding ovarian cancer early is a tall order, in part because at any given moment, only one woman in 2,500 has the disease. Moreover, the ideal screening test must be both highly sensitive and highly specific, meaning it should catch virtually all cancers and nothing but cancers. An ovarian cancer test that is 99 percent sensitive is pretty good — unless you’re in the 1 percent of missed cancers.

A test that is 99 percent specific sounds pretty good, too, except that the 1 percent of mistakes means 25 women of every 2,500 screened would undergo abdominal surgery — unnecessarily — to see if they really had cancer. In other words, “Many people would have to go through a dangerous procedure to find out they didn’t have cancer,”  said Dr. Richard Penson, of Massachusetts General Hospital.

For women like Rubel’s daughter, already known to be at high risk, doctors use a blood test called CA-125, as well as a pelvic exam and transvaginal ultrasound, to detect cancer. But the CA-125 test, though good at detecting recurrences of cancer, is not good enough by itself to screen the general population. (A large British study of 200,000 postmenopausal women at normal risk is underway to see if screening with CA-125, combined with ultrasound, can reduce mortality from ovarian cancer.)

One of the most promising new approaches is called proteomics, the study of proteins in the cells, tissues and body fluids. Even before a tumor can be felt, some researchers have found, the tumor begins secreting a distinctive pattern or fingerprint of proteins.

Researchers “are very excited about the proteomics approach to cancer screening,” said Dr. Daniel William Cramer, a professor of obstetrics, gynecology and reproductive biology at Boston’s Brigham and Women’s Hospital and the principal investigator of the Boston component of a national effort called EDRN, Early Detection Research Network. In theory, proteomics testing could be used to screen for a wide range of cancers.In 2002, Dr. Lance Liotta, chief of the laboratory of pathology at the National Cancer Institute, and others published a paper in the journal Lancet showing that proteomics can identify distinctive patterns of proteins in the blood of women with ovarian cancer. The test was very percent effective at finding ovarian cancer, though it also falsely identified 5 percent of women as having cancer when they did not. Government researchers are now conducting a two-part study on proteomics, to determine its effectiveness at detecting ovarian cancer and its ability to predict recurrence.

In the commercial world, a number of private companies, including Correlogic Systems, Inc., of Bethesda, Md., Ciphergen, of Fremont, Calif., Fujirebio Diagnostics, of Malvern, Pa., LPL Technologies of Cleveland, and others, are also scrambling to develop and sell an ovarian cancer test — a huge potential market if they can convince women and insurance companies the test is truly reliable.

Correlogic is closest to market with its OvaCheck test, though the FDA has suggested it may need to review the product, and the Society of Gynecologic Oncologists has posted a statement on its website saying, “More research is needed to validate the test’s effectiveness before offering it to the public.”

A team from the Cleveland Clinic and LPL Technologies is working on a blood test for ovarian cancer. At Ciphergen, researchers are pursing a test for three “biomarkers” to be used in conjunction with CA-125 to detect ovarian cancer in high risk women.

“The ultimate test,” said Karlan of Cedars-Sinai, “may end up being not one test used alone,” but a combination. Despite intense lobbying from women desperate for a better test, she urged patience. “Every woman whose mom had this will want to be tested every month. But we don’t have the data yet on when, and who, to screen.”

New Cancer Therapy Easier on the Patient

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Eighty-two year old Marie Desilets lives in Dunstable, about an hour’s drive from Brigham and Women’s Hospital in Boston. When she discovered that she needed radiation for breast cancer a year or so ago, she faced a dilemma.

She could get regular radiation treatments, which would involve being in Boston 5 days a week for seven weeks. Or, she could opt for a new type of radiation that involves only 10 treatments — given twice a day for 5 days.

In the standard method, the whole breast is irradiated; in the new one, radiation is aimed only at the exact spot where the tumor was.Desilets chose the latter, and went shopping every day between the first and second treatments. “It was a piece of cake,” she said. “I highly recommend it. I felt great the whole time.

“More than half of women with relatively small tumors opt to skip a lumpectomy and instead have their entire breasts removed — usually to avoid radiation. Radiation, which requires regular treatments for weeks and has side effects including skin irritation, is a huge hassle for those who live a long way from a medical center or whose work schedules make it difficult to spend part of every day getting treatment.

But the new procedure that Desilets had, called “accelerated partial breast radiation,” is likely to change such thinking.  An estimated 71,000 women each year may be potential candidates for the procedure which is already available at many medical centers, thanks to growing patient demand. Many insurers already pay for it.

It’s too soon to say that whether the new technique is ready to replace the old, which is supported by decades of practice and studies.”The quandary is that the rationale for partial breast irradiation is compelling, but we are moving away from something that is tried and true with excellent long-term results to something that has at least something of a question mark,” said Dr. Jay Harris, chief of the department of radiation oncology at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute.

For that reason, he and others suggest that women considering partial breast irradiation be treated through clinical trials, a number of which are underway or about to start.

On the other hand, the risk of the new approach is probably small. Almost all the time, when a cancer grows back in the breast where it started, it does so right in the area where the initial tumor was, not in a more distant part of the breast, said Dr. Phillip Devlin, director of brachytherapy at Brigham and Women’s Hospital and the Dana-Farber Cancer Institute. That suggests tightly-targeted radiation should do the trick.Indeed, while radiation is important for reducing the risk of recurrence of cancer in the same breast, it does not affect overall survival.

Unlike chemotherapy, whose goal is to knock out cancer cells anywhere in the body, “radiation controls local recurrence,” said Dr. Oscar Streeter, associate professor of clinical radiation oncology at the Keck School of Medicine at the University of Southern California. “It does not have an effect on overall survival.”

Because of its newness, partial breast irradiation is generally recommended only for women with small tumors in only one section of the breast and no signs of cancer spread to the lymph nodes.In one of three forms of the new procedure, called catheter-based or interstitial radiation, doctors numb the breast, then insert 10 to 20 small tubes into the area where the tumor was. They then insert a radioactive “seed” containing Iridium 192 into each catheter, leave it in briefly, then take it out and put it in the next catheter.

The whole procedure takes about 10 minutes, said Dr. Frank Vicini, chief of oncology at the William Beaumont Hospital in Royal Oak, MI and principle investigator of a new trial of partial breast irradiation in 3,000 women. The radiation is given twice a day for five days — the tubes stay in the whole time — and provide the same tumor-killing effect as standard radiation, said Vicini, author of a study in 2003 of nearly 400 women, half of whom got the new radiation and the other half, whole-breast radiation.  After 5 years, the study showed, there was no significant difference in the rate of local recurrence.

A second approach is with a device called the MammoSite, which involves placing just one catheter into the cavity where the tumor was. So far, women receiving MammoSite treatment have only been followed for about two years, but the data look promising.

The third, and newest, approach involves an old-style external beam and is called 3D-conformal radiation or a similar technique called, IMRT, for intensity-modulated radiation therapy. Instead of targeting the radiation to the whole breast, the beam is aimed with exquisite precision, using CT scans, to just the area where the tumor was.

For Marie Desilets, who had the Mammosite procedure,  the new radiation was a breeze. “I didn’t feel anything. My skin didn’t get red. There were no repercussions at all.” 

The 2-hour Marathon

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Hardly anyone thought it was possible for a human being to run a mile in less than four minutes – until Roger Bannister did it in 1954. Within 3 years, nine other men had done it, too.

In the dark old days, some people thought women shouldn’t compete at all for a variety of silly reasons, including the belief that too much exercise might dislodge the uterus, rendering a woman infertile.

Once women finally did start running marathons, it was considered a given that none could run one in less than 2 hours and 20 minutes –  until Paula Radcliffe ran the (flatter-than-Boston) London Marathon exactly one year ago today (April 13th) in 2:15:25.

Athletic records are made to be broken – that’s the fun of it. But there must be some limits to human performance, right? After all, as Steven Blair, president and CEO of the Cooper Institute, an exercise research center in Dallas, put it, “A time of zero seconds will never be achieved in the Boston Marathon, to state the ridiculous.”

So what are the factors that limit performance, especially in endurance events like the marathon? There are many, though some exercise physiologists nonetheless believe someone someday just might run a marathon in under two hours.

“We still don’t completely know” what all the limits of human performance are, said Miriam Nelson, director of the John Hancock Center for Physical Activity and Nutrition at the Friedman School, Tufts University. “World records will be set for many years to come.”

But in general, human performance depends heavily on genetics, in particular the genes that govern cardiac output, and on training, the physiological adaptations the body makes to respond to the stress of intense, prolonged exercise. Nutrition, motivation, equipment (like better running shoes) all count, too. So does the ruggedness of joints.

For endurance events, “the first limit is the ability of the heart to pump enough blood and to deliver oxygen to the peripheral, skeletal muscles,” said geneticist and exercise physiologist Claude Bouchard, executive director of the Pennington Biomedical Research Center in Baton Rouge, LA. “Cardiac output is extremely important,” and good cardiac output (as well as bad) has a strong genetic component – it tends to run in families.

“The second determinant is the efficacy of the skeletal muscle machinery” to use that oxygen, to combine it with fuel (carbohydrates or fats) to make ATP, adenosine triphosphate, the energy molecule that allows muscle filaments to contract.  The production of ATP takes place inside cells in an organelle called the mitochondrion; the more mitochondria a person has, and the more efficiently they work, the better the ATP production.

In other words, the two most important factors, at least for endurance events, are getting enough oxygen into muscles and the ability of muscles to use this oxygen to make ATP. This combination is often referred to as VO2 max, or maximum volume of oxygen.

Training increases both the number and efficiency of mitochondria, Bouchard said. And like cardiac output, the ability to respond favorably to training – “how trainable you are” – also runs in families.  “You can’t be an elite athlete if you don’t have both sets of conditions – [being] highly endowed and highly trainable.”

And while two athlete wannabes might look the same on some physiological measures, “you can’t tell until you train someone how well the mitochondria will respond,” said David Costill, now partially retired but formerly the director of the Human Performance Laboratory at Ball State University in Muncie, IN. In genetically-favored people, he said,  “you see a large increase at the cellular level in mitochondrial number and all the enzymes in mitochondria.”

Training also produces an increase in capillaries – tiny blood vessels that bring oxygen to cells. And of course, an increase in muscle strength.

Fuel matters, too. For optimal endurance, athletes need to be able to burn both carbohydrate, which is stored in muscles in a form called glycogen, and fat, which is stored everywhere. “We can store a functionally infinite amount of energy in the form of fat, but we are limited in the form of energy as carbohydrate in the muscle itself,” said Russell Pate, a professor of exercise science at the University of South Carolina. That’s why marathoners spend the last two or three days before a race eating carbohydrates and letting glycogen build up in their muscles.

When marathoners “hit the wall,” it’s usually because they are running out of glycogen. The way to avoid this is to “be well-adapted for fat metabolism,” said Pate, which means teaching the body to burn fat to supplement waning carbohydrate stores, which can be done by endurance training.  (Elite runners do this by training 120 to 140 miles a week.)

Genetically gifted marathoners are also endowed with an ideal ratiosof fast-twitch to slow-twitch muscles.  The best endurance athletes have lots of slow twitch, or Type I, muscles, which look red and have a high oxidative capacity – a good ability to use oxygen efficiently. (Ducks, which, like marathoners, travel long distances, are also loaded with slow-twitch muscles, which is why duck meat is red; chickens, not exactly endurance champs, are rich in white, fast-twitch, or Type II, muscles.)  Toward the end of a marathon, when most racers are running out of glycogen in their slow-twitch muscles, the lucky ones can recruit fast-twitch muscles for a final kick.

In the long run, and a marathon is clearly that, being an elite athlete takes a combination of good genes and grueling training. Dr. Lisa Callahan, a sports medicine physician at the Hospital for Special Surgery in New York, put it this way:  “If you take two people with the same physique, the same running style, the same motivation and drive, who train exactly the same and one always beats the other, that may be the genetic edge.”

But David Costill of Ball State begged to differ: “It’s not genetics. Most winners will tell you it’s having a killer instinct, and truly believing they are the best.”