Judy Foreman

Nationally Sindicated Fitness, Health, and Medicine Columnist

Four new drugs promise major relief for arthritis

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For years, millions of Americans with arthritis have been caught in a troublesome trap.

If they don’t take medication, they often suffer severe pain and life-wrecking disability. Yet if they do, they risk worrisome side effects. Some drugs, like methotrexate and high dose prednisone, can suppress the immune system. Others — notably painkillers like aspirin, Anacin, Advil, Motrin IB and others — can cause stomach ulcers and bleeding.

Every year, in fact, more than 60,000 Americans are hospitalized with complications from prescription and over-the-counter painkillers known as NSAIDS (pronounced EN-SAIDS), or non-steroidal anti-inflammatory drugs; thousands die.

But this grim picture could soon change dramatically, thanks to four drugs that are expected to be in drugstores soon: Arava, Enbrel, Celebra and Vioxx.

“In the last two decades, there hasn’t been any time like this, with four new drugs that appear to be very effective and very safe,” says Dr. Arthur Weaver, director of clinical research at the Arthritis Center of Nebraska and past president of the American College of Rheumatology.

These are “very exciting times,” adds Dr. Michael Schiff, medical director of clinical research at the Denver Arthritis Clinic, who calls two of the drugs “breakthrough medications.”

“Breakthrough” is a word researchers don’t use lightly, but it may be justified — though longterm side effects are still unknown.

Take Enbrel, the first arthritis drug in a relatively new class of compounds called biological response modifiers, which rev up or damp down specific components of the immune system.

Less than two weeks ago, an FDA advisory panel unanimously recommended approval of Enbrel for people with rheumatoid arthritis who have not improved on other treatments. The Food and Drug Administration usually follows the recommendations of its panels, and a decision is expected soon.

In rheumatoid arthritis, which affects 2 million Americans, an unknown factor — perhaps a virus — causes the immune system in genetically susceptible people to attack the synovium, a layer of cells that lines the joints. The result is chronic inflammation, pain, stiffness and joint destruction.

An additional 20 million Americans suffer from osteoarthritis, caused by wear and tear on joints.

A major culprit in many cases of arthritis is a natural substance called TNF-alpha, or tumor necrosis factor, that enters cells through a special receptor and helps promote inflammation. Enbrel, an injectable drug made by Immunex Corp. that has been studied in more than 1,000 patients, acts as a decoy receptor, mopping up TNF before it can enter cells, says Dr. Lee S. Simon, a rheumatologist at Beth Israel Deaconess Medical Center in Boston.

(Another drug that blocks TNF, Remicade, has already been approved by the FDA — for Crohn’s disease. But that means doctors can prescribe it for other problems, and evidence suggests it can help people with rheumatoid arthritis.)

Even more exciting, says Dr. Michael Weinblatt, director of clinical rheumatology at Brigham and Women’s Hospital, is Arava, made by Hoechst Marion Roussel. Following studies in 2,200 patients, it was approved by the FDA on Sept. 11.

Like the drug methotrexate, Arava actually modifies disease progression in rheumatoid arthritis. Taken orally, it inhibits pyrimidine, a building block of DNA. This affects immune cells called T cells, reducing inflammation in the synovium.

Promising though they are, nobody knows yet what the longterm side effects of Enbrel and Arava might be, warns Dr. Doyt Conn, medical director of the Atlanta-based Arthritis Foundation.

And then there are the new “super aspirin” drugs called Cox-2 inhibitors: Celebra, by Searle, and Vioxx, by Merck, as well as others in the pipeline. In late August, the FDA agreed to a fast-track review of Celebra, which means it could be approved in early 1999; Merck plans to file for approval late this year.

Unlike Enbrel and Arava, the Cox-2 inhibitors are aimed primarily at people with osteoarthritis, though they may be used, with other drugs, for rheumatoid arthritis, too.

In arthritis, it’s not just TNF that drives inflammation, but often other natural chemicals as well, notably the prostaglandins, which trigger those all-too-familiar symptoms: pain, swelling, redness and heat.

Prostaglandins are made in cells under the direction of an enzyme called Cox, or cyclooxygenase, and many painkillers work by blocking this enzyme. But it turns out that there is not just one Cox enzyme, as scientists used to think, but at least two. Cox-1 releases “good” prostaglandins that protect the stomach and kidneys. Cox-2, made primarily by cells at the site of an inflammation, releases “bad” prostaglandins that further drive inflammation.

The reason NSAIDs are a mixed blessing is that they work against both Cox enzymes, blocking both the bad and the good prostaglandins.

The new Cox-2 drugs block only the bad prostaglandins, which means they “hold the promise of being as effective as the old NSAIDs in managing pain and inflammation without the same side effects,” says Conn of the Arthritis Foundation.

So far, Celebra has been studied in trials of nearly 13,000 people. One of them was Rich Dillon, a 53-year old firefighter from Lincoln, Neb. who gave up long games of raquetball because of osteoarthritis in his knees. Celebra, he says, “makes a great difference,” and he can play short games again.

It appears to be living up to its billing as a stomach-friendly painkiller. In one study, notes Simon of Beth Israel, no one taking Celebra (a twice-a-day pill) developed an ulcer, but 19 percent of those taking a prescription form of naproxen, an NSAID, did.

Vioxx, a once-a-day pill tested so far in studies involving 9,000 people worldwide, appears to be even more potent than Celebra at blocking Cox-2, though it may also increase edema, or swelling.

In addition to these drugs, the FDA next month is expected to consider expanded use of a blood-filtering device called Prosorba that removes antibodies that contribute to inflammation.

Financially, the combined impact of the new arthritis drugs is expected to be “huge,” says Maryann Quinn, an industry analyst at BT Alex. Brown, Inc. in New York. Celebra alone could do $500 million in sales in 1999, she says.

The drugs will be expensive — an estimated $3,000 to $4,000 a year for Arava, $6,000 to $8,000 a year for Enbrel, for instance.

And the Cox-2 drugs in particular will help treat symptoms, but probably won’t alter the underlying course of disease.

Still, this slew of new drugs could finally bring safe relief to millions. It’s been years, says Weinblatt of the Brigham, “since we’ve had such promising therapies.”

SIDEBAR:

Help for Alzheimer’s?

It’s not just arthritis sufferers who may benefit from the new Cox-2 inhibitor drugs, but people with cancer and Alzheimer’s disease as well.

In recent years, 14 studies have shown that NSAIDs — drugs like Anacin, Advil, Nuprin, and others — can slow progression of Alzheimer’s disease by 30 to 50 percent, says Dr. Clifford Saper, chief of neurology at Beth Israel Deaconess Medical Center in Boston.

That’s probably because inflammation, well-known as a culprit in arthritis, plays a role in Alzheimer’s, too. As parts of the brain become clogged with deposits of a protein called beta-amyloid, inflammation often develops around these sites.

The NSAIDs probably slow progression of Alzheimer’s by blocking so-called Cox enzymes, which promote inflammation. But the NSAIDs have a major drawback: They often cause ulcers by causing changes in the stomach lining. By contrast, the new Cox-2 drugs block inflammation just as well as the old NSAIDs, but are far gentler on the stomach.

With colleagues at other centers, Saper is testing several hundred people with mild Alzheimer’s, giving some Celebra, a new Cox-2 inhibitor, and others a dummy pill. After six months, researchers will re-test all participants to see whether Celebra slows progression of the dementia.

The Cox-2 inhibitors may also lower the incidence of colon cancer, says Dr. Jerome Groopman, chief of experimental medicine at Beth Israel. Several studies in the last decade have shown that NSAIDs can reduce the risk of colon cancer by 50 percent.

Colon cancer often arises after a two-step process. In the first step, a gene mutation leads to high levels of the Cox-2 enxyme, which results in growths called polyps. Another mutation then causes the polyps to become cancerous.

In mice, Celebra seems to block formation of polyps, thus stopping cancer before it starts. Studies are underway to see if the drug can prevent colon cancer in people at high risk. Someday, “we may be able to exploit this for people with already-established tumors,” Groopman says.

For more information, you may call the Arthritis Foundation at 1-800-283-7800, or contact them on the Net at www.arthritis.org.

The other ways the sexes differ

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Women, at least in America, outlive men by six years.

So how, then, do you account for this:

Women are five times as likely as men to get migraines and osteoporosis, two to three times as likely to get seriously depressed, and much more likely to get diseases like lupus, rheumatoid arthritis and scleroderma, in which the immune system attacks the body’s own organs.

Women are also more susceptible to damage from tobacco and alcohol. In men and women of equal size who consume equal amounts of alcohol, blood levels are higher in women because they metabolize alcohol differently.

Certain biological basics differ, too. Women’s hearts beat faster. And food travels more slowly through women’s intestines, which may explain why they have more constipation and slightly more colon cancer. Women also respond differently to pain and to some anesthetics.

Granted, men fall prey to heart disease earlier in life than women, and they suffer more than their share of cluster headaches and violent deaths, especially when they’re young. But the enigma remains.

How can females — and for that matter, female mammals in general — outlive males, yet have such a disproportionate share of some diseases? Beyond the obvious Adam and Eve stuff, in other words, how do women’s and men’s bodies differ, and how important are these differences to health and medicine?

That’s exactly what researchers in a new field, gender-specific medicine, are trying to find out — a quest with potentially life-saving consequences, because women and men not only get certain diseases at different rates but often have different symptoms for the same disease.

Heart disease, for instance, is the number one killer of both men and women, though women on average get it 10 years later in life because they are protected until menopause, in part by the hormone estrogen.

But unlike men, women often don’t experience the “classic” heart attack symptoms: feeling as if there’s “an elephant on their chest,” or pain radiating down their arms, says Dr. Marianne J. Legato, director of the Partnership for Women’s Health at Columbia University College of Physicians and Surgeons.

Instead, many women, perhaps 15 to 20 percent, feel pain in the upper abdomen and have nausea, sweating and shortness of breath, says Legato, a pioneer in gender-specific medicine. Unless doctors are alert, women’s heart attacks may be dismissed as stomach aches and their breathlessness, as anxiety.

Sex hormones, and the ways they influence immune reactions, metabolism, and other functions, are one major factor in gender differences.

Osteoporosis, for instance, is clearly tied to low levels of estrogen, which is produced by the ovaries and keeps bones strong. The risk of osteoporosis rises steeply at menopause as estrogen levels decline.

Men have less osteoporosis largely because they continue to produce testosterone (which the body converts to estrogen) at a comparatively steady rate throughout life, notes Dr. Andrea Dunaif, chief of the Division of Women’s Health at Brigham and Women’s Hospital.

And it’s not just bones that respond. Receptors for estrogen, androgens and other hormones are scattered throughout the body, and researchers are just beginning to understand why, says Dr. JoAnn Manson, an endocrinologist at Brigham and Women’s and a principal investigator of the Women’s Health Initiative, an ongoing nationwide study of older women.

Perhaps the most puzzling gender differences are those in the immune system, most notably in auto-immune diseases that occur when immune cells and antibodies attack the body’s own tissues. Here, too, some researchers suspect a hormone connection.

“About 90 percent of auto-immune diseases occur more often in women than men,” says Dr. Robert Lahita, chief of rheumatology at St. Luke’s-Roosevelt Hospital in New York.

Women are nine times more likely to get systemic lupus erythematosus, three to four times more likely to get rheumatoid arthritis, four times more likely to get scleroderma, and two to three times more likely to get multiple sclerosis.

Both men and women make so-called TH1 cytokines, which promote inflammation and production of immune cells, as well TH2 cytokines, which stimulate antibodies. Estrogen may trigger extra production of some TH2 cytokines and may also inhibit cells that suppress inflammation, which would contribute to auto-immune disease, Lahita says.

But precisely how hormones influence cytokine production is a matter of debate — and intense research, much of it focused on pregnancy, a time when both hormones and the immune system play out a fascinating and perplexing script.

During pregnancy, levels of estrogen and another hormone, progesterone, are high. But if high estrogen were the sole reason women get more auto-immune diseases than men, you’d think that all that pregnancy would make auto-immune diseases worse. And that isn’t so.

In fact, some auto-immune diseases, like rheumatoid arthritis, actually go into remission, while others, like lupus, do not, notes Dr. J. Lee Nelson, a rheumatologist at Fred Hutchinson Cancer Center in Seattle.

Multiple sclerosis also gets better in some women during pregnancy, but often gets worse again after delivery.

What is clear is that evolution has deemed it important to make these immune shifts in pregnancy — probably for the survival of both mother and fetus.

That’s because some cells from the fetus inevitably cross the placenta and wind up in the mother’s bloodstream. If the mother’s immune system reacted too strongly to these fetal cells, which are half “foreign” because of the father’s DNA, she would reject the fetus, Nelson notes. This means her immune system must become “tolerant” of this foreign tissue. Yet the mother’s immune system can’t become too quiescent or she would come down with endless infections.

Teasing apart the intricate hormonal and immunological shifts during pregnancy has implications not just for women with auto-immune diseases, but for a basic understanding of how gender influences biology.

“Research on women, and the changes in sex hormones at menopause and during pregnancy, has already resulted in a whole new understanding of the importance of these hormones to the functioning of all systems in the body, from brain to skin,” says Legato.

But many questions remain. The big one is why, given the burden of so many gender-specific diseases, do women still live longer than men?

That’s “the great puzzle,” says Wanda Jones, deputy assistant secretary for women’s health at the Department of Health and Human Services.

“And if we understood that better, maybe we could help men live longer.'”

SIDEBAR:

Reconciling differences

Confronting gender-specific medicine:

  • If you’re a woman, ask your doctor if that means you should take a different dose of drugs than the package label says and whether you should expect different side effects.
  • Remember that alcohol has a more potent effect on women than on men and, cigarette for cigarette, tobacco is more deadly for women, too, not to mention more addictive.
  • When you read results from a study done on men, ask your doctor if the results apply to women as well. And vice versa.
  • If you’re a woman at risk for heart attack, remember that your symptoms may not be exactly like men’s chest pain, but may be pain in the upper abdomen, nausea, and shortness of breath.
  • The need for vitamins and minerals — including supplements — varies by gender, too. In general, adults need 1,000 milligrams a day of calcium, but postmenopausal women need 1,500 a day unless they’re taking estrogen. Men rarely need iron supplements, but menstruating women may. Women of childbearing age may also need 400 micrograms a day of folic acid.
  • Migraine headaches, acne, panic attacks, and seizures often get worse just before menstruation. A diabetic woman’s need for insulin may increase at this time, too.
  • If you’re a man with heart disease, make sure you’re not being given overly aggressive treatment. Women sometimes get treatment that’s not aggressive enough, but men are sometimes treated too aggressively — with clot-busting drugs, bypass surgery, and other interventions. So ask your doctor.

For more information on the subject, you might want to read “Gender-Specific Aspects of Human Biology for the Practising Physician,” by Dr. Marianne J. Legato, Futura Publishing Co., Armonk, N.Y.

New therapy for trauma is doubted

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Eleven years ago, Francine Shapiro, was strolling through a park in Los Gatos, Calif., thinking dark thoughts.

Suddenly, her eyes started darting back and forth, a spontaneous burst of what scientists call saccadic movement, much like the rapid eye movements that occur during dreams.

Weirder yet, Shapiro noticed that as her eyes moved, her thoughts lightened. She played with the phenomenon — calling up disturbing thoughts, then flicking her eyes back and forth. Soon, bad thoughts no longer “had the same charge,” she says.

She was intrigued and began waggling her fingers in front of friends to trigger rapid eye movements, and they, too, reported mood changes.

Perhaps, Shapiro reasoned, the eye movements were somehow mimicking dream sleep, allowing better processing of traumas that might otherwise cause nightmares. Or maybe the eye movements triggered some useful shift in brain processing.

To this day, neither Shapiro nor anyone else can explain what, if anything, happens inside the brain with the technique she has dubbed EMDR — eye movement desensitization disorder, which, as Shapiro initially conceived it, involves inducing rapid eye movements while reliving painful memories.

But since that day 11 years ago Shapiro has been ferociously studying — and promoting — EMDR. When she first began her studies, she was enrolled in a now-defunct, never-accredited school, the Professional School of Psychological Studies in San Diego. She eventually earned a PhD in psychology there and in 1989 published a study showing EMDR seemed to help people with post-traumatic stress disorder, which is characterized by nightmares, flashbacks and anxiety.

More recent EMDR studies in people with emotional trauma, Shapiro claims, show that “84-90 percent no longer have post-traumatic stress disorder after only three treatments.”

Surely one of the strangest therapies ever aimed at tortured psyches, EMDR has become increasingly popular — and controversial. Shapiro has now trained more than 25,000 practitioners through the EMDR Institute in Pacific Grove, Calif., and estimates 2 million people have been treated.

Indeed, EMDR is “among the fastest growing interventions in the annals of psychotherapy,” says Harvard psychologist Richard McNally. But he cautions: “What is effective in EMDR is not new, and what is new is not effective.” Many others agree.

Yet EMDR has obvious appeal, especially to health insurers.

This spring, the Kaiser Permanente medical center in northern California began offering EMDR, calculating it could save $2.8 million a year if it was used for all post-traumatic stress disorder patients, says Steven Marcus, a Kaiser psychologist whose 1997 study led to the decision.

Other insurers also offer it, says Shapiro. And Blue Cross Blue Shield in Massachusetts is informally looking into it.

But two huge questions loom: Does it work, and if so, how?

Last year, a task force of the American Psychological Association headed by Dianne Chambless, a University of North Carolina psychologist, proclaimed EMDR a “probably efficacious treatment for civilian PTSD.” That means it’s not a “well-established” treatment, she says, but that at least two “scientifically sound” studies — three, by her count — showed EMDR “was more effective than no treatment.”

The so-called Wilson study of 1995, the Rothbaum study of 1997 and the Scheck study of 1998 all found that EMDR patients improved more than patients on a waiting list to begin therapy or those receiving standard talk therapy. In the Rothbaum study of 21 rape victims, in fact, 91 percent of the group treated with EMDR was deemed to have recovered from the trauma disorder after three sessions, while there was no change in the control group.

But if EMDR worked, was it due just to “imaginal exposure,” that is, to reliving in the imagination the traumatic event until it loses its power — like watching a horror movie so often you become desensitized? Or was it some almost magical effect from the therapist waggling her fingers to trigger the eye movements?

Dr. Roger Pitman, a Harvard psychiatrist and coordinator of research at the Veterans Affairs Medical Center in Manchester, N.H., decided to find out. In research published in 1996, Pitman studied 17 Vietnam veterans with PTSD. (Vets with the disorder are considered harder to treat than rape victims dealing with one assault.)

Pitman gave half the group EMDR, complete with finger-wagging and eye movements, and the other half a similar treatment without eye movements. Each group then got the other treatment. “EMDR had some benefit,” Pitman says, but “whatever it was, it wasn’t the eye movements.”

Grant Devilly, a psychologist at the University of Queensland in Australia who has two studies about to be published in scientific journals, agrees.

Starting with a group of 51 war veterans, Devilly gave some vets two sessions of EMDR, others, no special treatment, and a third group, “sham” EMDR. This group relived traumatic memories, but their eyes remained fixed on a flashing light from an “opticator,” a phony machine designed to look scientific.

Both the real and sham EMDR groups showed some improvement, but it was not statistically signficant. And there was no difference between those whose eyes moved and those whose eyes didn’t, says Devilly. Conclusion: The eye movements are not essential.

In the other study, Devilly compared EMDR to cognitive behavior therapy, in which patients relive their trauma and learn ways to deal with it. Both helped, he says, but cognitive behavior therapy was better and longer lasting, though EMDR guru Shapiro claims other new studies still give EMDR the edge.

Other critics of EMDR, like Jeffrey Lohr, a psychology professor at the University of Arkansas, remain underwhelmed.

Writing in a 1997 newsletter of the National Council Against Health Fraud, Lohr and a co-author charged that Shapiro “took existing elements from cognitive-behavior therapies, added the unnecessary ingredient of finger waving, and then took the new techique on the road before science could catch up.”

But Dr. Bessel van der Kolk, a Boston University psychiatrist and head of the medical trauma center at Arbour Health Systems, a private organization in Brookline, disagrees.

Initially skeptical, van der Kolk, a specialist in post traumatic stress disorder, says he became convinced when his patients sought EMDR elsewhere and came back saying it helped more “than five years of talking therapy.” When that happens, he says, “you start sitting up.”

So far, he has studied 12 people with PTSD and is now analyzing brain scans before and after EMDR treatment. EMDR is “pretty bizarre,” he acknowledges, but it seems to have induced “remarkable changes” in some people.

For her part, Shapiro has softened her view that eye movements are essential. Part of what changed her mind was that anecdotal evidence from blind patients for whom therapists used tones and hand-snapping instead of finger-wagging and produced results similar to standard EMDR.

She bristles at charges that she has tried to keep data that conflict with her findings from being published, arguing her critics are waging “ad hominem” attacks on her.

But the critics aren’t backing off. As Lohr puts it: “EMDR is cognitive behavior therapy with bells and whistles that won’t do anything. It’s a dog that won’t hunt.”

SIDEBAR:

Troubles on the right

Eye movements may play a role in a new treatment for anxiety developed by Dr. Fredric Schiffer, a psychiatrist at Harvard’s McLean Hospital in Belmont.

Schiffer believes people may literally be of two minds: A person may feel anxious when one side of the brain is dominant, but calm and mature when the other side holds sway — almost as if the “inner child” lived on one side and the adult self on the other. By using special goggles that feed visual input to one side of the brain at a time, Schiffer thinks, it may be possible to shift back and forth between these states.

More than 30 years ago, researchers led by 1981 Nobel laureate Roger Sperry began studying “split brain” patients, people with severe epilepsy that doctors treated by cutting the nerves that connect the left brain hemisphere to the right.

The researchers found the two halves of the brain could process information independently. In the popular imagination, this helped fuel the (wildly oversimplified) notion that logic resides in the left brain and emotions on the right.

Two years ago, Schiffer studied a split-brain patient who’d been bullied as a child, and he found that the patient denied distress when his left brain was activated, but expressed it when the right side was.

Schiffer has devised goggles that control visual input to the brain and tested them in 70 patients. About 60 percent reported some difference in anxiety depending on which side of the brain was stimulated; 30 percent report clinically significant differences.

The goal, says Schiffer, whose book, “Of Two Minds,” hit stores this month, is “to teach the troubled side of the brain that the world is less threatening that it thought.”

The debt we owe the guinea pigs

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Fifty years ago this month, a band of researchers fanned out through the neighborhoods of Framingham, urging residents to sign up for a study designed to track ordinary people to try to detect early signs of heart disease – then, as now, the No. 1 killer of Americans.

One of the 5,209 who agreed was Ida Leach, now 83.

With her late husband, Henry, Ida Leach worked at the Dennison Manufacturing Co., making labels and crepe paper. The young couple eagerly agreed to undergo two hours of free medical testing every couple of years, and years later enrolled their kids and their spouses, too – an act that would prove life-saving.

Today, thanks to the Leaches and about 10,500 other volunteers, the Framingham researchers have published more than 1,000 scientific papers on heart disease, and spent $ 43 million.

Along the way, they’ve discovered most of what we now take for granted about heart disease – that cigarettes increase the risk (1960), that high cholesterol and blood pressure do, too (1961), that exercise lowers risk while obesity raises it (1967), that homocysteine (an amino acid) in the blood raises it (1990).

Those findings, like those from major studies of cancer and other diseases, are of inestimable benefit to society. But as the Leaches discovered, the personal benefits of becoming a human guinea pig can be enormous, too.

Twelve years ago, their son-in-law, Kenneth Kaczmarowski, of South Milwaukee, was in town for a regular family visit-cum-checkup, more than 15 years after he first accepted the Leaches’ suggestion that he, too, enter the study.

“I was a thick-headed Pollack,” says Kaczmarowski, now 57. “I kept saying nothing was really wrong.”

But the vigilant Framingham team, alarmed by his test results, thought otherwise and urged him to get help, fast. He did: a septuple coronary bypass that saved his life.

Over the last half-century, hundreds of thousands of people – some healthy, some deathly ill – have volunteered for studies that have changed medical treatment.

Over the last 40 years, for instance, 50,000 women with breast cancer have participated in groundbreaking trials run by Dr. Bernard Fisher of Pittsburgh, scientific director of a study of how various treatment combinations affect survival.

Among other things, Fisher’s studies showed that for most women with breast cancer, survival was the same whether a woman had a mastectomy, a lumpectomy (removal of just the cancerous lump) or a lumpectomy plus radiation, a finding that has spared countless from losing a breast. Nowadays, however, women usually have radiation plus lumpectomy because that reduces the chance for a local recurrence.

Fisher’s studies have revolutionized treatment in other ways, too. They’ve shown the efficacy of chemotherapy and the hormone tamoxifen, and demonstrated that many women with early cancer benefit from systemic (whole body) treatment with chemotherapy, tamoxifen or both, in addition to surgery and radiation.

Volunteers with heart disease have also helped change medical history, says Dr. Patrice Desvigne-Nickens, director of the heart research program at the National Heart, Lung and Blood Institute, sponsor of the Framingham study.

Over the years, she says, key studies have shown that for many people with severe heart disease, bypass surgery is more effective than drug treatment; that clot-busting drugs (TPA and streptokinase) can open arteries and save the lives of people who have just had heart attacks; that lowering cholesterol, too, can be life-saving.

In many such research projects, people volunteer out of altruism, hoping the knowledge gained from testing a new cancer drug for cancer or tracking symptoms of a disease will help other people.

But many say they reap personal benefits as well, a fact researchers hope will lure more people into trials.

Sometimes, as in the Framingham study, all you have to do is agree to undergo free, thorough checkups every few years. The risks in this kind of “observational” trial are few, chiefly a little time lost from work and perhaps babysitting costs.

There is, of course, a potential risk to confidentiality because so many researchers pore over each blood test or chest X-ray. But researchers take pains to guard the privacy of medical records.

“We do not release them to anyone for any reason under any circumstances without a signed release each time,” says Dr. Daniel Levy, director of the Framingham study.

“Usually, there isn’t a name linked to the data. There may be a number, but that’s not given to insurance companies,” adds Dr. JoAnn Manson, an endocrinologist at Brigham and Women’s Hospital. She is a principal investigator in the Women’s Health Initiative, an ongoing, nationwide study to determine the health consequences of hormone replacement therapy, low fat diet, and vitamin D and calcium supplements in older women.

Perhaps the greatest risk in joining an observational trial is actually a benefit: You may get bad news sooner than you otherwise would, because you’re watched so closely. Levy, for instance, recently discovered breast cancer in a woman who was there for a routine visit for the heart study.

With interventional, as opposed to observational, studies, the risks and benefits of volunteering are slightly different. These studies involve patients who already have a disease or are at high risk for it. Often, they’re divided into two or more groups randomly, then given different drugs or other treatments. Typically, neither the patients nor their doctors are told who is in which group.

Many people hesitate to join such a trial, fearing that they’ll be among the group that gets a placebo, or dummy drug, in place of a real treatment.

In many cancer studies, however, “this isn’t much of an issue,” says Mary McCabe, head of the office of clinical research promotion at the National Cancer Institute. That’s because patients usually get either the new treatment or the best available standard care.

And while people often assume a new treatment is better, nobody really knows, which is precisely why the study is needed.

As a volunteer, you have the right be fully informed about the study and to drop out at any time, notes McCabe of NCI, though you should discuss this with your doctor.

If you’re pregnant, of course, the pros and cons of joining an interventional study get trickier, but if your doctor suggests it, it’s worth considering.

The bottom line is that you should never feel coerced into joining a study, says Manson of the Brigham. But if you’re comfortable with it, the benefits – to you, as well as society at large – often outweigh the risks.

After 50 years in the Framingham study, Ida Leach needs no convincing: “There are no disadvantages, as far as I can see.”

Information on studies

Although some studies are not recruiting new volunteers, many others are.

The Framingham Heart Study, for instance, is still seeking minority volunteers for a waiting list. (Telephone 508-935-3438)

The National Cancer Institute has numerous ongoing studies. For more information call 1-800-4-CANCER or search the web at http://cancertrials.nci.nih.gov.

You can also check the bulletin board sections of newspapers and listen for ads recruiting volunteers on radio and TV, or call major teaching hospitals for information about participating in research studies in your area.

 

Fish oil seen cutting risk of Mental Illness

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Fish oils that are already believed to reduce the risk of heart disease may help combat a number of serious psychiatric illnesses as well, researchers said yesterday.

At an international conference sponsored by the National Institutes of Health, scientists said that though the data are preliminary, a growing body of evidence suggests that higher consumption of essential fatty acids in the oils, notably one called omega-3, appears linked to a lower risk of depression and better treatment of manic-depression and schizophrenia.

Essential fatty acids must be consumed in the diet or as supplements because the body cannot make them. A major dietary source of omega-3 is fatty fish such as mackerel, Atlantic salmon, bluefish, halibut, herring, and sockeye salmon.

The researchers did not make specific recommendations for consuming fish or omega-3 supplements. But previous research suggested that eating fish two to three times a week is healthful, says Larry Lindner, executive editor of the Tufts University Health & Nutrition Letter.

People seeking to increase their consumption of omega-3 fatty acids also can eat green leafy vegetables, nuts, flaxseed, and canola oils, which contain fatty acids that the body can make into two chemicals, called EPA and DHA, that are thought to produce the health benefits. The researchers said they had no definitive answers on whether DHA, which is found in breast milk, should be added to infant formula in America, as it is in Europe and Asia.

Consuming high quantities of omega-3 supplements, however, can suppress immune function, conceivably leaving people more vulnerable to infection. On the other hand, Lindner said, omega-3 supplements seem to help people with arthritis, an auto-immune disorder. A 3,000-milligram daily dose has been shown to reduce arthritis symptoms caused by immune system damage to joint tissue. Omega-3 also can reduce the ability of the blood to clot, which means it could be hazardous in a person with a bleeding disorder.

The research includes data suggesting that countries where large quantities of fish are eaten have lower rates of depression than countries where fish is not a major part of the diet, said Dr. Joseph R. Hibbeln, chief of the outpatient clinic at the National Institute on Alcohol Abuse and Alcoholism at the National Institutes of Health.

Major depression is 60 times more prevalent in some countries than others, Hibbeln said. Fish consumption appears to be an “important protective factor.”

Lindner called the link between fish oils and reduced incidence of depression “provocative,” but said it was “too early to make a recommendation that people suffering from a mood disorder should eat more fish or start taking omega-3 supplements.”

Hibbeln’s team found that higher blood levels of two omega-3 fatty acids (EPA and DHA) in both normal people and alcoholics correlated with higher levels of an important brain chemical, serotonin. This suggests, he said, that consuming omega-3 fatty acids may influence production of serotonin. Many scientists believe that low levels of serotonin are linked to depressive, suicidal, or violent behavior.

In one study of 18 suicidal patients, higher blood levels of EPA were linked to lower scores on tests that predict suicide, Hibbeln noted. The emerging data, taken as a whole, suggest that EPA and DHA may reduce depressive and suicidal behavior.

Dr. Andrew L. Stoll, director of psychopharmacology at Brigham and Women’s Hospital in Boston, reported what he called “very exciting” results from a study of about 50 patients with manic-depression, or bipolar disorder, which affects an estimated 2 million Americans.

About half the patients were given 10 grams a day of omega-3 (equal to several servings of fish) in a special formulation and the other half received a placebo made of olive oil. All patients continued to receive their usual medications as well.

The study was planned to last nine months, said Stoll, but after four months the rate of relapse in the omega-3 group was dramatically lower, prompting researchers to stop the study early. Although it is not totally clear how omega-3 works, Stoll said, it appears to act like lithium and valproate, two manic-depression medications that block transmission of neurochemical signals inside brain cells.

Omega-3 fatty acids also appear to help reduce symptoms of schizophrenia in people taking standard medications, said Dr. Malcolm Peet, head of psychiatry at the University of Sheffield in the United Kingdom. Schizophrenia, which affects 1 percent of the population, produces delusions, hallucinations, apathy, and withdrawal.

Peet has found that levels of fatty acids are lower in people with schizophrenia. In three small studies, he said, giving omega-3 supplements to schizophrenic patients appears to lessen the severity of symptoms.

Good for you, no matter how you slice them

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Ripening in the late-summer sun, filling garden baskets and salad bowls, reddening gazpacho in kitchen blenders, simmering in saucepans for spaghetti sauce, tomatoes might just be the best, maybe the only, reason for welcoming the end of summer.

And beyond the tempting taste – a blessed relief from the cardboard baseballs we get the rest of the year – tomatoes are actually good for you.

Very good, in fact, according to growing body of evidence.

Three years ago, Harvard epidemiologists and nutritionists led by Dr. Edward Giovannucci studied nearly 48,000 male health professionals and found that those who ate the most tomatoes, tomato sauce, tomato juice, and pizza (!) were 21 percent less likely to get prostate cancer than those who ate the least. In fact, the biggest tomato-eaters were 34 percent less likely to get the most virulent form of prostate cancer.

The magic ingredient is probably lycopene, a powerful antioxidant. Scientists think that antioxidants retard cancer, heart disease, and aging by combatting free radical damage to DNA and other cellular structures caused oxygen metabolism.

The Harvard team decided to study tomatoes because they knew that lycopene, a pigment known as a carotenoid that gives tomatoes their red color, winds up in high concentrations in the prostate, says Dr. Meir Stampfer, one of the authors. “Plus we knew about this intriguing Italian north-south gradient.”

That was a study showing that men in southern Italy, who eat lots of tomatoes, get less prostate cancer than men in the north, who eat fewer. Despite its size, the Harvard study doesn’t prove cause-and-effect, warns Stampfer: “People who eat tomatoes probably eat other good things.”

But other studies add to the growing view that tomatoes carry considerable health benefits.

Nearly a decade ago, a study by the Johns Hopkins School of Hygiene and Public Health found that high blood levels of lycopene were linked to lower risk of pancreatic and bladder cancer, notes Inke Paetau Robinson, a research nutritionist at the Agriculture Research Service, part of the US Department of Agriculture.

In 1991, another study found that consuming a lot of lycopene and having high blood levels of the stuff appeared to reduce the risk of precancerous lesions in the uterine cervix. Two Israeli test tube studies have also shown that lycopene slows the growth of breast and uterine cancer cells and may also help prevent tumors.

And in 1994, a large Italian study found that the risk of digestive tract cancers was reduced among men and women who ate seven servings or more of tomatoes and tomato products a week.

And it’s not just cancer risk that seems to fall with high consumption of the juicy red fruit. (Technically, tomatoes are fruits, not veggies, because they develop from flowers and have one or more seeds.)

Last year, a European study of about 1,300 men called EURAMIC, published in the American Journal of Epidemiology, studied fat samples from men who had had heart attacks and compared them with fat from men who had not. (Lycopene is stored in fat.)

The study found that men whose fat had high concentrations of lycopene had about half the risk of heart attack as those with lower levels.

Again, Stampfer, the Harvard epidemiologist and nutritionist, warns that this association doesn’t prove cause-and-effect. But it does make theoretical sense: Antioxidants in general are known to keep “bad” cholesterol (LDL) from being oxidized and thus building up as dangerous plaques on artery walls.

Although nutritionists often recommend eating fruits and vegetables raw to get the maximum health benefits, that doesn’t hold for tomatoes, notes Jennifer Nelson, director of clinical dietetics at the Mayo Clinic.

Tomato products – like pasta and barbeque sauces – that are made from cooked tomatoes actually provide more lycopene than raw tomatoes, because cooking helps free lycopene from its tight packaging with fiber, she says.

But tomato juice doesn’t raise lycopene levels much, unless it’s made from cooked tomatoes or is consumed with fat, which helps lycopene absorption.

Since the body can’t make lycopene, you have to eat it – not such tough duty since it also comes in watermelon, strawberries, and red grapefruit, though tomatoes are far and away the most abundant source.

The question is, how much lycopene do you need? Unfortunately, nobody knows, though the Harvard study found a beneficial effect with a few servings a week – and pizza counts. So does ketchup!

From a weight control point of view, tomatoes are a nearly-perfect food. A raw tomato weighing 4 1/3 ounces has only 26 calories, says Larry Lindner, executive editor of the Tufts University Health & Nutrition Letter. It also has less than half a gram of fat, one gram of protein, and six grams of carbohydrates, plus fiber and vitamins A and C.

So if your garden is churning out more tomatoes than you can handle, don’t panic. Make salads. Make gazpacho. Make pasta sauce. Give tomatoes to the less fortunate.

And if nature isn’t ripening tomatoes fast enough for your need, simply pick some and put them in brown paper bags. This traps ethylene, a natural gas that tomatoes emit as they ripen, and speeds things up.

But most important, enjoy the bounty. It’ll be gone long before you can say “Halloween.”

Sun-dried tomatoes

Just as raisins are made by drying grapes, sun-dried tomatoes are make by taking the water out of tomatoes, which concentrates the nutrients, including the calories. In fact, it takes 17 pounds of fresh tomatoes to make one pound of sun-drieds. For sun-dried tomatoes NOT packed in oil, here’s how it stacks up.

Tomatoes
Sun-dried
Fresh
Calories
258
 21
Fat
3 grams
0.33 grams
Calcium
110 milligrams
5 milligrams
Folate
68 micrograms
15 micrograms
 Vitamin C
39 milligrams
19 milligrams
Vitamin A
874 International Units
623 International Units
 

SOURCE: US Department of Agriculture and Tufts University Health & Nutrition Letter. Globe staff chart

Ginkgo stock is continues to rise

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Like many others at midlife or beyond, Wendy Fink, a health educator in her 50s, was appalled at the way her memory kept conking out.

“I was having trouble getting words,” says Fink, who lives in Royalston. “I was feeling very stressed about this.” So she tried ginkgo, an herbal memory-booster that’s getting new respect in mainstream medicine, albeit for genuine dementia, not run-of-the-mill “senior moments.”

“It seems simplistic,” Fink says of her four-month trial of ginkgo last winter, “but my problem went away. I feel much clearer, brighter, more myself.” She has “no idea,” she adds, why the improvement has persisted although she no longer takes the ginkgo.

The fact that she can’t explain it is hardly surprising, given that there’s little evidence that ginkgo helps healthy people like Fink with age-related memory decline.

But the lack of evidence doesn’t seem to be deterring the hopeful, who last year spent $ 270 million on ginkgo, making it the third best-selling herbal remedy, after echinecea, the cold-fighter, and ginseng, the energy-booster.

Sales “took off” last fall, among both healthy folks and those with dementia, after the Journal of the American Medical Association published a study showing it improves mental functioning in people with dementia, says Thomas Aarts, executive editor of the Nutrition Business Journal in San Diego.

Even the government is intrigued. The National Institute on Aging and the Office of Alternative Medicine are jointly sponsoring a two-year study in 42 patients with Alzheimer’s disease at Oregon Health Sciences University.

The ginkgo tree responsible for all this is a natural wonder. It’s so ancient – its ancesters appeared 300 million years ago – it’s known as a “living fossil. And it’s so resistant to environmental toxins that it thrives in smoggy cities worldwide. And therein may lie its secrets.

The tree’s resistance to insects and toxins may stem from its chemical makeup, says Varro Tyler, a plant medicine specialist emeritus at Purdue University and co-author of “Rational Phytotherapy, a Physicians’ Guide to Herbal Medicine.”

Its two main constituents are the flavonoids, which gobble up free radicals (harmful byproducts of oxygen metabolism), and the ginkgolides, which inhibit a natural platelet activating factor and therefore make the blood less likely to form clots that can clog arteries.

Ginkgolides are devilishly complicated molecules. In fact, Harvard chemist Elias J. Corey, who won the 1990 Nobel Prize for developing a method to synthesize complex organic molecules, including ginkgolide B, recalls that he became interested in the ginkgo molecule precisely “because it was such a challenge.”

Because ginkgo seems to boost blood flow and combat free radicals, the German Commission E, a government-appointed panel that reviews herbal therapies, recommended it in 1994 for dementia-related memory deficits, dizziness, ringing in the ears.

Ginkgo may also help alleviate impotence caused by anti-depressant drugs, according to Tyler.

So far, there have been more than 100 studies on ginkgo by plant medicine scholars, including 36 German studies in the 1980s in which patients with declining intellectual function appeared to benefit from 120 to 160 milligrams a day of ginkgo extracts. German authorities later criticized these studies for not including measurements of daily functioning as well as symptoms of disease progression.

But two recent studies did include those measures. In 1996, a Berlin study of 156 patients with Alzheimer’s disease or stroke-related dementia showed that a particular ginkgo biloba extract called EGb761 was a modestly effective and safe treatment, at a relatively high dose of 240 mg a day.

Last year, in the JAMA study of 202 dementia patients that sent American sales soaring, Dr. Pierre L. Le Bars, executive research director at the New York Institute of Medical Research in Tarrytown, also found that extract modestly effective.

About 27 percent of patients responded to ginkgo, Le Bar says, about the same response rate that occurs with a prescription drug called Cognex and less than the 40 to 50 percent response rate to another prescription drug, Aricept.

Compared to a placebo or dummy drug, a relatively low dose of ginkgo (120 mg a day) is linked to slight improvements in intellectual function, social behavior, and mood, Le Bars found.

In other words, ginkgo is promising, but not dazzling.

In fact, the effects of ginkgo are “so minuscule that. . .they may mean little from a functional point of view,” adds Dr. Thomas Perls, a geriatrician at Beth Israel Deaconess Medical Center. “Ginkgo is barking up the right tree. I just don’t know if it’s the right dog.”

Still, it’s being taken ever more seriously by researchers.

Jerry Cott, head of adult psychopharmacology research at the National Institute of Mental Health, says ginkgo has been shown in test tubes to protect neurons. And data suggest, he says, that ginkgo “is potentially more effective than vitamin E,” which in high doses can slow progression of dementia symptoms.

But there’s no evidence yet that ginkgo can actually prevent Alzheimer’s, “and that’s where we really need the answer,” adds Cott, who is helping the World Health Organization design a study to find out.

Marilyn Albert, director of gerontology research at Massachusetts General Hospital, agrees: “I’d be cautious, because the government does not oversee manufacturing of ginkgo and other products sold as dietary supplements. And this drug, like any other, might potentially interact with other medications.”

Still, barring reports of horrible side effects, the appeal of ginkgo is likely to continue to grow. So if you want to try it, start with 60 to 180 mg a day in divided doses, suggests Barry Taylor, a naturopathic doctor at the New England Family Health Center in Weston who says he’s recommended ginkgo to “hundreds” of patients.

But make sure the label says the capsules contain roughly 24 percent ginkgo flavonoids (also called flavonone glycosides) and 6 percent terpene lactones (also called ginkgolides A, B and C and bilobalide, a related compound.)

Discontinue ginkgo if you get a rash or other allergy. And because ginkgo can make blood less likely to clot, don’t take it without consulting your doctor if you have a bleeding disorder or take blood-thinning drugs, including aspirin.

A childhood with no cones or hotdogs?

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When the seventh and posthumous – edition of Dr. Benjamin Spock’s “Baby and Child Care” was published recently, the guru’s endorsement of a vegetarian diet for kids over 2 caused many nutritionists and doctors to choke on their leafy greens.

Dr. T. Berry Brazelton, professor emeritus of pediatrics at Harvard Medical School, thinks it’s “absolutely hopeless” to try to get kids to eat enough vegetables to offset the loss of nutrients they would suffer from giving up meat and milk.

Dr. Ronald Kleinman, author of the kids’ nutrition guide, “Let Them Eat Cake!” and chief of pediatric gastroenterology and nutrition at Massachusetts General Hospital, calls it a “terrible recommendation for the population as a whole.”

Even Dr. Steven Parker, the Boston Medical Center pediatrician who co-authored Spock’s last edition, can’t stomach the elderly pediatrician’s “advocacy of what amounts to a vegan diet for kids – no meat, fish, dairy or eggs.”

“This was an area upon which we didn’t agree,” says Parker, noting there’s little data – for or against – a vegan diet for kids. So how did they resolve it? “Spock trumped Parker.”

But not everybody thinks it’s nuts to feed kids a diet limited to grains, legumes, seeds, veggies, and fruits. After all, that does leave peanut butter, pasta, bagels, and cereal.

And not everyone thinks it’s impossible to do in a culture where kids are bombarded by images of burgers and ice cream.

Dr. Neal Barnard, president of the Washington-based Physicians’ Committee for Responsible Medicine, an animal rights group, contends that a vegetarian diet for kids is a valuable way to reduce diet-associated diseases in later life because “childhood is a time when adult dietary patterns are set.”

The American Dietetic Association says “appropriately planned vegan” and vegetarian diets that include dairy products and eggs “satisfy nutrient needs of infants, children, and adolescents and promote normal growth.” The American Academy of Pediatrics adds that if meal planning is adequate, vegan children grow normally.

Reed Mangels, 41, a nutritionist and registered dietician in Amherst who has been feeding her kids a vegan diet for years, says it’s “quite doable.” They’re happy with bean burritos, soy milk on cereal, lots of p-b-and-j’s, veggie burgers, and veggie hot dogs. “We’re talking quick and easy,” she says.

But are we talking enough protein, minerals, and calories?

That depends.

A good vegan diet is “perfectly compatible with good health and is probably preferable to a diet of Coca-Cola, pizza, and MacDonald’s,” says Dr. Walter Willett, professor of nutrition and epidemiology at the Harvard School of Public Health.

If parents consult a registered dietician and use fortified cereals and plan meals well, a vegetarian diet that includes milk and eggs can be “a fine option” for kids,” says Johanna Dwyer, director of the Frances Stern Nutrition Center at Tufts and one of the few nutritionists who has studied the issue. “But I take a dim view of a strict vegan diet for kids” – one that excludes eggs and dairy products.

If, however, parents are haphazard about nutrition and ignore other health measures – such as routine immunizations – a vegetarian diet can contribute to poor growth and anemia.

Without any animal products, for instance, kids may become deficient in iron, calcium, some B vitamins, vitamin D, and zinc. In Northern climates like Boston’s, vitamin D deficiency can be a particular problem because the body makes the vitamin from precursors that are activated by sunshine.

And some kids who avoid animal products may become so deficient in vitamin B-12 they are at increased risk of seizures, adds Willett, who suggests that vegan kids take a multi-vitamin supplement daily.

Milk is a particular bone of contention.

Six years ago, Spock (who went on a nondairy, low fat, meatless diet in 1991, at age 88) triggered controversy when, with Barnard of the animal rights group, he proclaimed that neither adults nor kids should drink cow’s milk, contending that it “causes intestinal blood loss, allergies, indigestion and contributes to some cases of childhood diabetes.”

Milk may be “culturally normal” to Americans, though it’s not for much of the rest of the world, but it interferes with absorption of iron, Barnard contends.

Willett disagrees: Milk doesn’t interfere with iron absorption “in any major way” and is such a rich source of calcium that if a child is on a dairy-free diet, he should take a calcium supplement – 800 to 1,000 milligrams a day.

You can get enough calcium from vegetables, adds Kleinman of MGH, but it takes four cups of broccoli to equal a cup of milk.

And while a report in 1992 in the New England Journal of Medicine did suggest that cow’s milk may increase the risk of diabetes in genetically-susceptible children – perhaps by triggering production of antibodies that attack the pancreas – research since then has debunked that notion, Kleinman adds.

And what of the anti-milk argument that the fatty liquid leads to clogged arteries, even in kids?

Both the National Cholesterol Education Program, a government-sponsored committee of nutrition specialists, and the American Academy of Pediatrics say that fats should not be restricted in kids under two, but after that they should follow the same guidelines as adults – a diet of not more than 30 percent fat. In other words, kids should eat dairy products, but the low-fat kinds.

Getting enough protein is not a serious problem for children on vegan diets, provided the sources of plant protein are varied – not just carrots, celery, and lettuce, but beans and other legumes. While nutritionists once thought it was necessary to eat “complementary” proteins such as beans and grains at the same meal to get the full range of amino acids, many now think it’s fine just to balance proteins over 24 hours.

But getting enough calories on a veggie diet can be a problem. Granted, 30 percent of American kids are obese – they eat too many calories and expend too few in exercise. But kids on veggie diets, which are low in fat and high in fiber, may not provide enough energy for a growing child.

Very high fiber diets, says Dwyer of Tufts, means some kids “just can’t eat enough, especially when they are small and are being weaned from breast milk. They eat all the time.”

For Reed Mangels, the vegan mom, the bottom line is that even if parents don’t follow all of Spock’s recommendations, at least he’s made “people think a little bit about what kids eat.”

But Parker, Spock’s co-author, thinks a diet of all veggies is silly, especially since there’s little evidence that the eating habits you form in childhood stick with you for life.

“Personally,” he says, “I think a childhood without ice cream just isn’t worth it.”

Your Health History – Up For Grabs?

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Today, the federal government is taking the first steps toward a national system that would give each of us a single number or “identifier” linked to every medical record ever kept on us. It’s a prospect that privacy advocates fear may destroy what little confidentiality remains in the era of computerized medical records.

Granted, so many people can already legally view your medical file – not just doctors or nurses but insurers, self-insured employers and even law enforcement officials under some conditions – that some nihilists figure things can’t get worse.

“Big brother has already found you. He knows where you live. He knows you go to a psychiatrist. He studies your drug behavior,” says Arthur Caplan, director of the center for bioethics at the University of Pennsylvania.

Because most medical care is paid for by third party insurers, he says, when it comes to real safeguards of privacy, “I don’t think we have any way. . . We are not at T-minus 30 seconds and holding. We are trying to grab a missile that has cleared the atmosphere and bring it back.”

But others concerned about medical privacy say things could get worse if the Department of Health and Human Services, as required by the 1996 Kennedy-Kassebaum law on health insurance portability, goes ahead with regulations on what’s become known as the “unique health identifier.” HHS says it will only proceed if there is “sufficient national consensus.”

The identifier, the subject of hearings by an HHS advisory panel that begin today in Chicago, could be a number, perhaps your Social Security number or an “enhanced” version of it, according to a white paper that the agency recently posted on the Web.

Although many health plans already use Social Security numbers to track patients, some let you pick a less-traceable number instead. But having a single, mandatory “womb to tomb” number could make it even easier for claims information and pharmacy data to be linked to other data bases – like tax records, voter registrations, motor vehicle data and credit card records, privacy advocates fear.

If your employer is self-insured, for example, the only health care information it can see is its own records. If there were a health identifer, the employer could access your entire medical history, privacy advocates say.

The unique health identifier, the HHS white paper notes, need not be a number at all. It could be a sample of your DNA, which horrifies advocates like Wendy McGoodwin at the Cambridge-based Council for Responsible Genetics. Or it could be some other unique “biometric marker” like a fingerprint, distinctive patterns on the retina or iris in the eye, or a voice pattern.

To some, streamlining the electronic processing of medical records is an overdue cost-saving reform.

In October, the Sequoia Software Corporation in Columbia, Md., won a multi-million dollar grant from the US Commerce Department to develop a national “Master Patient Index.” The goal, the company said, is to develop a “massively distributed medical records system across a national computer backbone.”

As of now, the company lamented, the electronic flow of information from patient records is hampered because “there has been no common indexing to correlate and cross-reference patient identifiers such as name, birthday and Social Security number.” The state of affairs that the company bemoans is one that grateful privacy advocates dub “security through obscurity.”

Kathleen Frawley, vice president for legislative and public policy services for the American Health Information Management Association, a Chicago-based group, says the horse is already out of the barn:

“Right now, there are 1,500 different claim forms used by insurers that require hospitals and doctors to process information differently. . . We are already in a privacy crisis. This doesn’t make it worse.

“People don’t realize their health information is already going out the door,” she adds. At least, she notes, the 1996 law that calls for a health identifier also says that Congress must enact privacy legislation by August, 1999, and that if it doesn’t, HHS must issue privacy regulations.

Advocates for some sort of health identifier system aren’t backing down. Because people now typically have than half a dozen health plans over a lifetime and see many doctors, there is a need for “different enterprises and consumers to be able to track medical history over time,” argues Elliot Stone, executive director of the Waltham-based Massachusetts Health Data Consortium, a private, nonprofit group that builds large data health care bases.

Though Stone does “not necessarily” favor a single identifer, he believes it’s possible to “blend confidentiality policy with technology.”

And there are potential benefits – at least to society at large – of making it easier to access private medical data. These include better tracking of diseases, quicker detection of fraudulent billing and better medical care if, say, you’re insured in Massachusetts and wind up in an emergency room in California.

At Brigham and Women’s Hospital, having computers analyze patient records and doctors’ orders has produced “an order of magnitude decrease in medication errors” by alerting doctors to potential drug interactions or allergic responses, says John Glaser, vice president and chief information officer at Partners HealthCare System, Inc., of which the Brigham is a part.

Even so, says Glaser, a health identifer “would be a mistake. Medical data already leaks all over kingdom come. The risk of an identifier outweighs any benefits.”

Many others agree.

Last year, a National Research Council panel concluded that while there are ways to make electronic records more secure than paper records – like “audit trails” listing everyone who accesses a record – the benefits of a health identifier must be weighed “against the potential risks to privacy.”

Peter Szolovits, a member of that panel and a professor of computer science at MIT, puts it this way: “Now, your only confidentiality comes from the fact that most people don’t want to take the trouble to find out stuff about you.

“Adopting a single, universal health identifier will make things worse because it will make it that much easier and cheaper to link up records. Encryption techniques could make it possible to let me, as a patient, control whether my medical records at MIT can be linked with my insurance records. But my fear is this is not what would be adopted as a health identifier.”

It might make sense to have national health identifier if we had a national health care system to go with it, says George Annas, professor of health law at the Boston University School of Public Health.

But “getting rid of the national health care system and keeping the identifer is crazy,” he says. “Very large HMOs, etc. like it because they can track their members. It’s more efficient. I’m sure public health people like it, too, and researchers love it.

“But anyone interested in privacy and confidentiality should be horrified. The average person gets nothing out of this.”

“It’s incredibly scary,” agrees A.G. Breitenstein, director of the Justice Resource Health Law Institute in Boston, who adds that law enforcement officials are already pressing for “total, open access” to medical records. “Right now, law enforcement personnel have to physically present a warrant or subpoena to each holder of your records. With the unique health identifier and the linkage of computerized data systems, almost anyone, including law enforcement personnel, pharmaceutical companies, biotech companies, employers can link into the whole system at the touch of a keystroke without your knowledge or consent.”

“Well-meaning intentions often have very unfortunate consequences, and that is likely to happen with a permanent individual health identifier number,” adds Richard Sobel, a fellow at the Berkman Center for the Internet and Society at Harvard Law School.

One solution would be to repeal the part of the Kennedy-Kassebaum law, also known as the Health Insurance Portability and Accountability Act of 1996, that calls for the identifier, says Dr. Denise Nagel, a Lexington psychiatrist and head of the National Coalition for Patient Rights.

In fact, the HHS advisory panel whose hearings begin today (called the National Committee on Vital and Health Statistics) has already recommended that HHS not adopt a health identifier until after privacy legislation is enacted.

Currently, there are half a dozen bills dealing specifically with medical privacy in Congress, as well as others addressing patients’ rights in managed care organizations.

But privacy advocates fear that, despite slogans touting “patients’ rights,” some bills may undermine confidentiality by allowing too easy access to

“We’re at a crossroads,” says Nagel. The HMO industry wants “Congress to allow them to control and use our personal medical information without our consent. They’ll win if we don’t speak up.”

 

 To learn more

 To read the HHS “White Paper” on the unique health identifier, go to this web site:

http://aspe.os.dhhs.gov/admnsimp/nprm/noiwp1.htm

To listen live to the hearings the National Committee on Vital and Health Statistics, go to:

http://aspe.os.dhhs.gov/ncvhs

For more information on privacy concerns, go to:

http://cyber.law.harvard.edu/spaces.html

www.nationalcpr.org (This web site, run by the National Coalition for Patient Rights, will be on line by July 27.)

www.epic.org (The Electronic Privacy Information Center)

For other information, go to:

http://www.ahima.org

http://www.sequoiasw.com

Stretching your fitness routine

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Twenty years ago, the gurus at the American College of Sports Medicine told us to get off our duffs and get those lungs and hearts pumping. Eight years ago, they told us to pump iron, too.

Now, they’ve added a third cornerstone to their fitness guidelines — get flexible.

Don’t groan; it’s long overdue. And while stretching is an addition to, not a substitute for, the aerobic exercise and weight lifting we should already be doing for health and fitness, it’s arguably the easiest and most enjoyable exercise of the lot.

And if it’s just looser limbs or a better golf swing you’re after — as opposed to yoga-like inner peace — you can even do your stretches while doing something else, like watching TV.

In case you haven’t noticed, one of the less pleasant features of aging is that creakiness called decreased range of motion. If you can’t move your limbs, head, and trunk through a full range of motion, exercise physiologists say, you’re setting yourself up for orthopedic problems, including low back pain and injury.

It’s also just plain demoralizing if your shoulders get so tight that brushing your hair becomes an Olympic event or your hamstrings become so taut the mere words “bend over and touch your toes” send you back to the couch for another decade.

The solution, the sports medicine folks declared several weeks ago, is flexibility training.

For the record, there are no clinical studies proving the benefits of flexibility training. In fact, compared to the data on aerobic exercise and strength training, the data on flexibility is scant, says William Evans, director of the nutrition metabolism and exercise program at the University of Arkansas Medical School.

But studies are piling up fast enough to justify adding flexibility training to the standard fitness regimen, says Glenn A. Gaesser, an exercise physiologist at the University of Virginia and a co-author of the new guidelines.

For one thing, it’s clear that connective tissue benefits from stretching — or at least suffers from lack of it. In women who wear high heeled shoes, tendons, ligaments — and muscles — become so shortened that walking uphill may produce cramps or injuries to calf muscles.

For another, it’s been demonstrated many times in animals that stretching a muscle triggers growth factors that increase the number of tiny, contractile protein filaments inside each muscle cell.

These actin and myosin filaments slide over each other or pull apart, grabbing on to (“cross-linking”) each other at intervals. This lets the muscle cell contract or extent with controlled ratcheting action.

Muscle cells also have mechanisms called spindle receptors that sense where the muscle is in space and how much tension — or muscle tone — it has. When you stretch a muscle suddenly, or too far, these receptors send out an alarm, telling the muscle to contract immediately to protect itself against injury.

But if you stretch carefully, you can train these receptors to pause before firing, allowing the muscle to get longer — grow — without reflexively tightening.

Muscle physiologists have identified three kinds of stretches: static, ballistic, and PNF, or proprioceptive neuromuscular facilitation.

Ballistic stretches, in which you bob or bounce while trying to do something like touch your toes, are not widely recommended because they can cause muscle injury.

But static stretches are safe. It’s a static stretch if you sit on the floor with your legs extended and slowly try to touch your toes, holding the stretch 10 to 30 seconds.

PNF stretches are also safe, but are more complicated and often require a partner. For instance, as you sit on the floor with your legs extended, your partner pushes on your back while you push against him, contracting your muscles for about six seconds. Then you do a static forward stretch for 10 to 30 seconds.

The idea is that by contracting your muscles first, you re-set the firing threshold of the stretch receptors in muscle fibers so that it takes more stretch to make them fire.

Not all exercise physiologists use PNF stretches in their practice, in part because they believe static stretches are almost as effective.

Some gurus swear by yoga as the best approach to stretching, and yoga is “an excellent way to develop flexibility,” says James Graves, chairman of the exercise science department at Syracuse University.

But it’s not the only approach, and a simple 20-minute routine that stretches major muscle groups two to three days a week also works fine. It’s also best to stretch after your muscles are already warmed up.

If you want to try yoga, shop around for a teacher you like, advises Betsey Downing, a sports psychologist who runs the Health Advantage Yoga and Personal Development Center in Herndon, Va.

A good teacher, she says, is one who knows anatomy and can offer precautions and alternative stretches if you have an injury or problem doing a particular move.

There’s no universally-accepted certification program for yoga teachers, so it makes more sense to ask a teacher about his or her experience and approach — there are dozens of varieties of yoga — than about credentials per se.

And beware of teachers, and stretches, that cause pain. It’s fine to feel that your muscles are working. But sharp pain — particularly in the joints or at the points where the muscle attaches into the bone — is a sign of injury, not progress.

SIDEBAR:

What it takes to be fit:

When the federal government issued its 1995 exercise guidelines, it had the modest goal of lowering people’s risk for chronic conditions like hypertension and diabetes. The American College of Sports Medicine guidelines have a more ambitious goal: fitness.

The feds call for accumulating at least 30 minutes of moderate activity on most days. This means you can add up a 10-minute walk, 10 minutes of gardening, 10 minutes of chasing the kids around the playground.

The sports medicine guidelines are tougher — aerobic workouts of less than 20 minutes don’t even count.

And while the feds focus on mild aerobic exercise, the sports medicine group recommends aerobics plus strength training and, as of a few weeks ago, flexibility training as well. You can do the minimum level of all three in roughly three hours a week.

For overall fitness, here’s what they recommend:

  • Aerobic, or cardiovascular conditioning.
    • Frequency — 3 to 5 workouts a week. Fewer than three won’t be enough, more than five will add little.
    • Intensity. The goal is to work fairly hard, at 55 to 90 percent of your maximum heart rate. To estimate this, subtract your age from 220. If you’re 50, this yields 170. If you want to work out at 75 percent of your max, multiple 170 by 75 percent, which gives 128 beats per minute.
    • Duration. Workouts should last 20 to 60 minutes.

    If you must cut corners on aerobics, sacrifice duration first; for example, chopping a 40 minute workout to 30. If you have to cut more corners, sacrifice frequency; drop from five days a week to three or four. Don’t sacrifice intensity.

  • Strength training, or using weights or machines to build muscle mass, two to three days a week. In each session, work each muscle group eight to 10 times.

    • For instance, to work the quadriceps, the big muscles in the front of the thigh, do knee extensions (sit in a chair and lift the foot against resistance, either a weight or a machine).

    Other major muscle groups to work include the hamstrings, abdominals (that means bent-leg sit ups), chest presses (push ups or bench presses) and rowing-type exercise in which you use the upper body to pull weight toward you.

    You also need to work the back muscles, either pushing up against a machine or lying on your belly, hooking your feet under the bed, and arching up so your chest is off the floor.

    For arms, try biceps curls and triceps manoevers (hold a weight in your hand with your arm straight up over your head; bend your elbow so your hand brushes your shoulder; then extend it up.)

  • Flexibility training, or stretching the major muscles groups at least four times, two or three days a week.