Judy Foreman

Nationally Sindicated Fitness, Health, and Medicine Columnist

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Medical needs, politics collide

December 21, 1998 by Judy Foreman

Sixteen years ago, Doris Laird, a humanities professor at Florida Agricultural and Mechanical University in Tallahassee, developed a benign brain tumor the size of an orange.

She had surgery — an operation that took 22 1/2 hours. It worked, or so she thought. But four years later, the tumor, a meningioma, was back. She had more surgery; 12 hours this time. Six years ago, it came back again, growing so much it threatened her vision — and her life. She had another 12-hour operation.

In 1994, Laird began taking RU486, the French abortion pill that is not approved for use in this country, on a “compassionate use” basis. There is preliminary evidence that the drug, which blocks the hormone progesterone, also slows the growth of meningioma. In Laird’s case, she says, it “stopped my tumor completely from growing.”

There’s also evidence that RU486 may be useful for a number of other medical problems, including fibroid tumors of the uterus; endometriosis (benign growths of tissue from the lining of the uterus; and Cushing’s Syndrome, a disorder of the pituitary gland.

To get RU486 on a compassionate use basis, Laird, like other patients in the same predicament, had to get an American doctor to prove to the US Food and Drug Administration that she had a serious disease that might respond to the drug. The doctor then arranged with the small French company that sells RU486 in Europe to send it free to her here.

Though cumbersome, this arrangement worked well enough for a while. But in a troubling example of the way politics can sometimes get in the way of legitimate medical needs, it all fell apart this summer when Exelgyn, the French company that in 1997 was given rights to RU486 by the original manufacturer, Roussel Uclaf, balked.

“We are ready to sell the tablets at cost, $5 a tablet,” says the company spokeswoman, Catherine Euvrard. “We are trying to find a US-based organization which is responsible enough to understand that it is up to a US organization to take care of US citizens, not to a tiny French company. I cannot tell you more.”

Laird would have been willing to pay, but like an estimated 25 to 30 other patients in similar straits, she has been caught in a web of red tape and abortion politics.

In 1996, RU486 was deemed “approvable” by the FDA as an abortion pill, but it has not been finally approved and cannot yet be marketed here. (Once approved, RU486, also known as mifepristone, could legally be used “off-label” for other medical purposes such as brain tumors.)

The New York-based Population Council, a nonprofit research group, has had the US rights to RU486 since 1994, but the company it licensed to actually produce and market the drug in the United States, the Danco Group in New York, is still in the process of arranging for manufacturing and distribution.

Danco, says spokeswoman Heather O’Neill, expects to make it available in the US “sometime next year.”

Jennifer Jackman, director of policy and research for the Feminist Majority Foundation, a Virginia-based national women’s rights group trying to bring RU486 to this country, says the “whole compassionate use thing has been a casualty of anti-abortion politics.” She adds that “plans are being worked out to provide it. I can’t be more specific.”

The National Right to Life Committee, prominent in the fight against abortion and RU486, did not return repeated calls.

Sandra Waldman, spokeswoman for the Population Council, echoes that. For two years, the council provided RU486 on a compassionate use basis to 24 patients from a supply it had obtained for research purposes, but that supply has been exhausted.

Waldman adds that the council is “very aware” of the supply problem. “Plans are being worked out for a strategy to handle current and new cases of compassionate use,” she says. “I can’t say more. An announcement will be made soon by the people involved. It isn’t all worked out.”

It certainly isn’t. In theory, patients like Laird could try to buy RU486 from doctors in Europe, where it is sold legally. But even in Europe, the drug is tightly controlled and is generally available only for abortions.

Even if they succeeded in buying RU486 in Europe, patients fear it would be confiscated if they tried to bring it into this country. The FDA allows importation of limited quantities of unapproved drugs for personal use in life-threatening situations. Recently, after consulting with its lawyer, the agency said it would “consider” allowing patients with meningioma to import a three-month supply. But patients worry because an “import alert” the FDA imposed in 1990 forbidding the import of RU486 for abortion purposes is still in effect.

For patients in whom RU486 does seem to slow brain tumor growth, there is great frustration that politics limits their options — even among those who once called themselves opposed to abortion.

Laird, who says her husband “lives on the Internet trying to solve this for me,” says she is “generally against” abortion. But she adds, “I can’t be against its being made legal. We’re talking about my sight and my life. It’s become very personal.”

It’s personal, too, for Anne McGinnis Breen, a Tucson woman who is 51 and had her first meningioma surgery at 39. She is a “practicing Catholic, married for 30 years, with three children. I don’t consider myself a feminist.”

But six years ago, her tumor recurred. “I am convinced,” she says, “that if I could have had this medication after that first craniotomy, I would not have had this recurrence.”

She has been on RU486 for two years — she has a small supply left — and according to the brain scans she gets every four months, her tumor has stopped growing. “Believe me,” she says, “I’m a radical now.”

Lyle R. Groshel of Virginia Beach, Va., echoes that. He won’t state his position on abortion.His wife’s meningioma has been treated with radiation, but if it grows back, “her only option is to find a drug that may stop the growth,” he wrote in an impassioned e-mail.

“I find it reprehensible that our government can prevent the importation or production of RU486 for use by people with meningioma.”

 

SIDEBAR

How RU486 does its job

 

RU486 works by blocking progesterone, a hormone needed for pregnancy. In combination with another drug, misoprostol, RU486 induces miscarriage. Taken alone within 72 hours of unprotected sex, it works as an emergency contraceptive.

The reason it may work on meningiomas — rare, noncancerous brain tumors that strike about 4,000 people a year — is that many of these tumors are also driven by progesterone, and blocking progesterone may slow the tumor. Surgery often works, but the tumors can regrow.

Because of its progesterone-blocking action, RU486 may also help control endometriosis (abnormal growth of uterine tissue outside the uterus) and fibroids, benign uterine tumors.

Through another mechanism, blocking of the hormone cortisol, RU486 may help treat Cushing’s syndrome, a hormonal abnormality.

So far, the data supporting the use of RU486 for brain tumors are preliminary. In 1991, California researchers reported in the Journal of Neurosurgery that they tried RU486 in 14 people with inoperable meningiomas, and five responded well.

That may sound unimpressive, but it’s “very encouraging,” says Dr. Daniel Karp, director of cancer clinical research at Beth Israel Deaconess Medical Center in Boston.

So encouraging, in fact, that the National Cancer Institute set up a placebo-controlled, multicenter study involving 200 meningioma patients. That study ended in July and results are not yet ready, says Karp, who was one of the investigators.

Even if RU486 is not a magic bullet for meningioma, “the results of the study need to be looked at — these patients are not surgically treatable,” adds Dr. John Erban, chief of hematology and oncology at New England Medical Center in Boston and another investigator in the meningioma study.

For some, it’s sneezing all the way

December 14, 1998 by Judy Foreman

You’re running around getting ready for Christmas or Hanukkah or Kwanzaa or Ramadan – or just a generic holiday party.

You shop. You cook. You get the candles from the bottom drawer, the decorations from the basement. If Christmas is your tradition, you probably get a tree, too, all fragrant and piney.You certainly don’t need something else to worry about – like holiday allergies.

Sorry about that.

While people typically associate allergies with the pollen that causes wheezing and sneezing in spring and summer, many of America’s 50 million allergy sufferers are actually miserable all year long because of allergies to mold, dust mites, pet dander, and in some places cockroaches and their droppings.

On top of those perennial miseries, some poor souls find their allergies or asthma get worse during the holidays.

For instance:

  • The sap of Christmas trees contains terpenes (compounds that are also found in turpentine), which contribute to the lovely scent but can also be strong irritants to the nasal passages of susceptible people, says Dr. Ira Finegold, director of the allergy section at Roosevelt-St. Luke’s Medical Center in New York and past president of the American College of Allergy, Asthma and Immunology. Some trees may also carry mold.

  • If you have food allergies – the big culprits are peanuts, tree nuts like walnuts and pecans, shellfish, fish, eggs, milk, wheat, and soy – you have to be careful year-round.

The trouble is, says Anne Munoz-Furlong, founder of the Food Allergy Network in Fairfax, Va., food is central to most holiday gatherings and cooks get extra-creative at the holidays.

This means you have to be extra-vigilant about piecrusts that may contain hidden nuts. Ditto for imported chocolates (with uninformative labels) and eggnog fluffed up with raw egg white, which is even more allergenic than cooked egg white.

  • Smoke, from Hanukkah candles, cozy fireplaces, and after-dinner cigars or cigarettes, can also be an irritant to people with asthma and other respiratory problems.

  • So can dust and mold on ornaments, especially if you store them in dusty, moldy places like a basement.

  • And of course, perfume or after-shave may seem the perfect gift, until the recipient runs gasping from the room.

While some allergies have such a dramatic onset they’re impossible to miss, others can be difficult to diagnose, especially in the winter when you’re more likely to attribute sneezing and runny noses to colds.

But if your “cold” lasts more than a week or so – especially if your nasal discharge is clear and you have no fever – you may have allergies.

Dust mites are a major culprit. Even if you keep your own home scrupulously clean, when you visit other people over the holidays who aren’t as vigilant you may get an allergy flareup.

The mites reside in bedding, pillow cases, bedclothes, and feed off tiny particles of human skin that have been shed, says Dr. Robert K. Bush, chairman of the indoor allergen committee of the American Academy of Allergy, Asthma and Immunology. Dust mites also thrive in carpets, says Bush, a professor of medicine at the University of Wisconsin in Madison.

Animal dander – shed from a pet’s skin, saliva, and urine – is another problem you may have under control in your own pet-free home, but not when you go visiting.

HEPA (or high-efficiency particulate arrestor) machines may help clean the air of some allergens, but they’re not cheap ($200) and you shouldn’t expect the host or hostess to buy one when you visit. They are also “of limited utility,” because some allergens like dust mites settle to the ground and don’t circulate much in the air, says Bush of Wisconsin.

What can help, if perennial or holiday allergies get to you, is to see an allergist – now, before the holidays arrive. At the very least, he or she may be able to help identify the problem and prescribe medications that can help. Claritin, Allegra or Zyrtec are a few of the many available. Over-the-counter medications such as Nasalcrom may help, too. And if you start soon enough, you may also get a series of desensitization injections.

For severe allergies, ask your doctor about a prescription for an EpiPen (pre-measured epinephrine) and carry it with you, especially to holiday parties.

Remember: Allergies are no joke. Airborne allergens and irritants can lead to serious inflammation of the bronchial tubes and sinuses (the cavities around the eyes and nose). Once the sinuses are blocked, mucus can’t drain properly and drips into the lower respiratory tract, causing bronchitis and asthma. Asthma kills 5,000 people a year.

Food allergies are no joke either. About 5 million Americans have them and an estimated 100 to 125 die every year, typically from a reaction called anaphylactic shock, in which blood pressure falls, you lose consciousness, and may develop hives, wheezing, vomiting and diarrhea, and severe shortness of breath. The flip side of all this is that there’s lots you can do to minimize allergies. And at least so far, there’s no evidence that anybody is allergic to reindeer. Or mistletoe.

Avoiding holiday allergies

  • Christmas trees, wreaths, boughs – keep your distance if they’re a problem. Consider getting an artificial tree instead.

  • Wash off dusty, moldy ornaments, too.

  • If you have food allergies and get invited to parties and potluck dinners, take a dish you know is safe and be first in the buffet line. Take a hearty portion, then don’t go back – by then, the serving utensil may have been used on another dish that could trigger your allergies. Or eat before you go.

  • Don’t cave in to pressure to sample a tiny bite unless you’re sure it contains no allergy-triggering ingredients.

  • Keep an EpiPen with you.

  • Use smokeless and unscented candles if regular candles are irritating. Don’t insist on a fire if anyone in the room has asthma, emphysema or other respiratory problems.

  • See an allergist if over-the-counter remedies don’t help.

For more information, contact:

  • 1-800-842-7777 begin_of_the_skype_highlighting              1-800-842-7777      end_of_the_skype_highlighting, the American College of Allergy, Asthma and Immunology. Ask for a new brochure called “You can have a life without allergies.” On the web, it’s http://allergy.mcg.edu

  • 1-877-9-ACHOOO begin_of_the_skype_highlighting              1-877-9-ACHOOO      end_of_the_skype_highlighting (1-877-922-4666 begin_of_the_skype_highlighting              1-877-922-4666      end_of_the_skype_highlighting), the National Allergy Bureau, run by the American Academy of Allergy, Asthma and Immunology. Ask for a brochure called “Because Allergies Last All Year Long.” On the web, www.aaaai.org/nab

Freezing, balsting, peeling away scars

December 7, 1998 by Judy Foreman

Ken Glasser, a 39-year-old Billerica man who works as a buyer of components for aircraft instruments, has been through hell trying to get rid of the stubborn scars on his chest.

He tried laser treatments, which reduced the thick, ropy scars, called keloids, for a while. But when the treatments ended, the scars – which often occur after injury, vaccinations, or even an infected hair follicle – got itchy again and started growing again.

He tried freezing, including one memorable session in which, he says, the doctor “took the safety nozzle off the liquid nitrogen gun and blasted the scars big time.”

His physician, Dr. Kenneth Arndt, chairman of the dermatology department at Beth Israel Medical Center, puts it more delicately. There’s no safety nozzle, he says, but he did switch attachments to get a thick spray – “more like a fire hose” – in order to penetrate the scars more deeply.

That hurt – more than either Glasser or Arndt expected – but helped enough that Glasser was game for more. In later visits, Arndt anesthetized the area, froze the scars with liquid nitrogen, waited until they turned spongy, then injected them with steroids to cause atrophy. That worked, but not enough to make the scars go away.

So Glasser’s at it again, this time with the addition of a cancer chemotherapy drug called 5-FU that’s injected into his scars in hopes of preventing excessive division of skin cells.

Glasser’s battle with scars is unusually dramatic, but we’ve all got them to some degree – “ice pick” marks from acne, craters from chicken pox, old badges of courage from sports. And while many scars become invisible with time, others – depending on where and how bad they are – can be a source of embarrassment.

But in recent years, doctors have been finding better ways to attack scars, even old, stubborn ones. Usually, they can’t banish them totally, but they can often make them look better.

Scars are “nature’s repair” system, says Dr. David Alkek, clinical professor of dermatology at the University of Texas Southwestern Medical Center in Dallas.

If you injure just the outermost layer of skin, the epidermis, you won’t get a scar, notes Dr. Brett Coldiron, a dermatologist at the University of Cincinnati. But when the injury extends into the dermis, you form a scar. It’s the job of fibroblast cells in that layer to do just that – pump out collagen, the glue-like tissue that helps hold wounds – and other parts of the body – together.

Sometimes, collagen does its work, then stops. But if the body makes too much, the result is a big, “hypertrophic” scar that may take a year or more to diminish. In 1 percent of people, scarring is abnormal and results in keloids, like Glasser’s, that well spread beyond the initial injury.

Scars form differently on different parts of the body because the skin varies so much, with the worst scarring usually on the chest, shoulders and upper back. You can get a scar from “the least little cut on the hand,” notes Alkek, but the same injury on the face won’t cause one.

In fact, the face is the “most forgiving area,” says Dr. Robert Stern, a Beth Israel dermatologist. “Healing times are very different. On the face, we leave stitches in for five to seven days; on the trunk, 10 to 14.”

So what can you do to help prevent scars in the first place and to minimize those that do form? Plenty, as it turns out.

With a new scar, the key is to keep the area moist and free of infections, with unguents like Aquaphor Healing Ointment. If the injury is deep, you should see a doctor for stitches or a new product called “skin glue,” a high-potency adhesive that holds the edges of the wound together as it heals.

Pressure bandages can also help prevent bad scars, by forcing collagen to be “laid down” properly; compression of the area can even help rearrange collagen in some old scars.

Over-the-counter strips of Silastic or silicone also help make scars – even some old ones – become flatter and turn white faster. No one knows why, but the strips may keep moisture in.

With immature scars – six to eight weeks old – dermabrasion can make a potentially bad scar less unsightly. The skin is “sanded,” under local anesthesia, with a diamond wheel or rapidly-rotating wire brushes, to grind the epidermis down to the level of the scar. The epidermis then regrows, hopefully hiding the scar.

Dermabrasion is often used on acne scars, and works best on faces. But the procedure sprays blood around – not a good idea in the age of AIDS – and it takes a trained eye to gauge depth. Chemical peels do much the same thing, but again, it takes a trained hand to avoiding burning or otherwise damaging the skin.

An increasingly popular alternative is laser skin resurfacing, which, like dermabrasion, works best on faces, not torsos. Usually, CO2 lasers are used for deeper skin problems and Erbium:YAG lasers, for more superficial problems. For scars that are red or purple from blood vessels, pulsed dye lasers can decrease color and flatten the scar.

Lasers convert light energy to heat that strips away thin layers of skin cells bloodlessly and with great precision. The disadvantage of laser resurfacing is that skin can stay red for weeks, longer than with old-fashioned dermabrasion.

To get rid of deep pits from acne, doctors often “punch” into the scar with a surgical instrument, take out old scar tissue, then bring the edges of the hole together with stitches. Another option is to dig under the pit with a sharp instrument to loosen it and make it shallower. The cosmetic result from this process can then be improved by skin resurfacing.

For some scars, especially long ones, the problem is partly perceptual. The human eye fixes on unbroken scars, but may barely notice one that zig-zags. For that reason, dermatologic or plastic surgeons cut open a long scar, then stitch the skin together again in stair-step fashion to make it less visible.

The direction in which a scar lies is also key, says Dr. Paul R. Weiss, a New York plastic surgeon. On the forehead, “it’s hard to do anything” for a vertical scar. But if a scar is horizontal or oblique, a surgeon can re-position it so that it is hidden by natural creases in the forehead.

The most difficult scars are keloids like Glasser’s. Though these scars can get huge, the cause is sometimes elusive. Often it’s surgery or an injury, but it can be something as minor as an infected hair follicle that the patient doesn’t even remember.

Weiss says he’s had “wonderful successes with surgery” for keloids, provided surgery is followed by steroid injections into the scars and radiation therapy to stop cell division.

But many dermatologists disagree, arguing that cutting out keloids may create worse keloids afterward. The exception to the no-cutting rule are keloids on earlobes – often from ear piercing – which can often be trimmed away successfully.

Many people, of course, simply live with their scars, figuring that beauty is more than skin deep. But some, like Glasser, keep seeking treatment in hopes of getting the skin back to normal.

Glasser says his keloids itch and are “a tremendous nuisance.” And they’re sensitive, especially when he wrestles with his two “little guys,” aged 1 and 3. “My one- year-old sits there and it hurts,” he says. Besides, he adds, he just doesn’t “want to drag this ball and chain around.”

Some home remedies

There are numerous over-the-counter products to improve the appearance of scars, though data to back the claims are scarce.

Silicone sheets – such as ReJuveness, Sil-K, Silastic Gel Sheeting and Cica-Care – often work, dermatologists say, though nobody knows why. One theory is that they may prevent water loss through the skin. Another is that they may change the skin in a way that nudges collagen – the fibrous protein that scars are made of – to re-align in a more orderly fashion. Or perhaps the slight pressure from wearing a silicone bandage may itself help a scar remodel.

These products can be expensive – $40 for a small sheet.

Other products, such as Mederma or Kelocote, are gels that are spread on scars. Mederma, made from onion extracts, may decrease the thickness of some scars, but again, the evidence is sketchy and nobody knows why it would work. Kelocote is a silicone gel that presumably acts somewhat like silicone sheets.

Many people swear by vitamin E for scars, but dermatologists say there’s little evidence for this. There’s even less for another popular remedy – emu oil.

If your scar is recent and healing well, these do-it-yourself remedies may help. If you have a thick, old scar that you want to treat, you should probably see a dermatologist.

 

At last, help for the fungus amoung us

November 30, 1998 by Judy Foreman

So you think toenail fungus is a joke. Not even a blip on the radar screen. Of interest only to your pedicurist, if that.

Well, try telling that to Gertrude Patenaude, a 57-year-old teacher-librarian from Portsmouth, R.I. who had the fungus on every toe. “It was brutal,” she says. “I couldn’t put my feet in shoes because of the pain.”

Okay, so toenail fungus, or onychomycosis, isn’t exactly the biggest threat to public health since The Plague. But it affects, by some estimates, more than 10 million Americans, including about 20 percent of older people.

It’s ugly – it makes toenails (and, to a lesser extent, fingernails) thick and discolored. It can be painful, because the thickened nails press into the delicate nail bed, especially in tight shoes.

And if you have diabetes, or poor circulation for other reasons, it can lead to ulceration underneath the nail and, ultimately, bacterial infections of the skin and bones, potentially necessitating amputation.

Got your attention? Great, because contrary to the reality a just a few years ago, there are now some pretty good remedies for toenail fungus.

The problem is caused by microorganisms called dermatyophytes – little critters that live on dead skin tissue and cause athlete’s foot. The whole process gets a toehold, as it were, when you contract athlete’s foot, which often happens when people who have a genetic predisposition to it walk barefoot in moist, germy places like locker rooms.

Athlete’s foot is treatable with over-the-counter topical creams, says Harvey Lemont, head of podiatric medicine at Temple University School of Podiatric Medicine in Philadelphia. The creams contain ingredients such as clotrimazole, tolnaftate and miconazole.

But if you don’t treat it, the fungi can creep deep into the nail matrix from where the nail grows, says Michael Hass, immediate past president of the Massachusetts Podiatric Society.

They love it there, because, unlike your fingernails, your toenails are swathed in (sweaty) socks and shoes, where it’s warm, dark and moist – in other words, perfect for fungi. And the food supply – keratin, the protein that nails are made of – is plentiful.

As the fungi grow, the nail gets thicker and may become foul smelling, according to the American Podiatric Medical Association. Debris – which can be white, green, yellow or black – can build up under the nail, discoloring the bed and giving the nail above a ghastly cast, adds the American Academy of Dermatology.

Once you’ve progressed from athlete’s foot to fungal nail infection, over-the-counter topical creams don’t help much because they can’t penetrate deeply enough, says James Chrzan, a podiatrist at Beth Israel Deaconess Medical Center. Even prescription creams may help only about 20 percent of people.

But two years ago, the outlook brightened for those with serious nail fungal infections – the arrival on the market of two oral prescriptions drugs, Lamisil and Sporanox. Both remedies must be taken for about three months, and it often takes another few months – and sometimes, repeated treatment – before the infection truly clears up, says Lemont of Philadelphia.

Both treatments work about 50 to 60 percent of the time, podiatrists say. Lamisil is typically taken every day for up to 12 weeks, while Sporanox is taken for a week, then skipped for three weeks, with this pattern repeated for three months.

The drugs are “far more efficacious and safer than the prior agents we had,” notes Dr. Robert Stern, a Beth Israel dermatologist, though they can cost $500 for a full course and may not be appropriate for people with minor problems. After all, he asks, “Does everyone really need to have beautiful toenails?”

In a small percent of people, both drugs can also elevate liver enzymes, although this rarely translates into liver disease. Still, many specialists advise blood tests of liver function before, during and after treatment. The drugs can also interfere with the metabolism of other medications in the liver, so it pays to tell your doctor about all medications you take.

In addition to the pills, some specialists recommend reducing the thickness of the nails with electric burring, a procedure normally done by podiatrists. This helps decrease the pressure on the nail bed, which can reduce the risk of ulceration. Once ulcers develop, bacteria can invade the skin and underlying tissue, potentially causing wider infection in people who have weakened immune systems because of disease or advancing age.

In healthy, young people, the pain caused by thickening nails often prompts a visit to the doctor – and treatment. But in many older people, particularly those with diabetes who lose sensation in the feet due to neuropathy, the pain of fungal nail infections can go unnoticed until the problem is severe, notes Lemont.

For Gertrude Patenaude, relief finally came with Lamisil – and throwing out all her old shoes. It took 12 weeks of treatment, and a year for healthy, new nails to grow.

But she’s fine now, and says, “I would never want to get it again.”

 

That second concussion could be a deadly one

November 23, 1998 by Judy Foreman

It was five years ago, a classic football afternoon. With his mom and stepfather cheering from the stands, Brandon Schultz, a lineman for Anacortes High School in Washington state, took what his mother, Lane Phelan, recalls as a “hard tackle.”

Brandon looked “shook up” and sat out the rest of the game. Later, he told his parents he’d blacked out. For the next few days, he had bad headaches, took Tylenol, and skipped practice.

Nobody thought it was anything serious like a concussion or brain injury. He had just gotten “dinged,” that’s all.

A week later, he played again, his mom capturing every heartbreaking moment on video. He was “slow to get up from a tackle,” she remembers. Moments later, as his teammates huddled, he stood apart, holding his head. Then he collapsed – and didn’t regain consciousness for five days.

Today, Brandon can talk and walk, with a brace, but has trouble organizing information. He lives in a rehabilitation facility, refilling ball washers at a golf course and dreaming, he says, of living “like any other 21-year old man.”

Brandon Schultz has what researchers are beginning to call “second impact syndrome,” a rare but devastating problem in which people, usually young athletes, suffer a mild head injury, return to play too soon and get clobbered again before the brain has fully healed.

If the second injury occurs while the individual still has symptoms such as headache, dizziness and memory problems from the first – whether that’s days or weeks later – the result can be brain swelling and a rapid, massive increase in intracranial pressure.

And that can be “catastrophic or fatal,” according to a 1997 report from the Centers for Disease Control and Prevention.

It’s not just a macho thing, either. It’s cheerleaders toppling off human pyramids, gymnasts faltering on flips, pole vaulters bouncing onto a hard surface.

Overall, there are 300,000 sports-related brain injuries a year, the CDC says, mostly concussions – temporary, trauma-induced alterations in mental status.

Four studies from 1984 to 1994 suggest that 10 percent of college football players and 20 percent of high school football players get brain injuries in a given season. A 1997 study found that 5 percent of kids who play soccer suffer brain injuries.

And professional boxing, which one specialist describes as “premeditated brain injury,” is truly horrific: A 1997 study showed 87 percent of boxers sustain brain injuries.

The effects can be long-lasting. A Johns Hopkins University study of 95 kids with head injuries showed that, a year later, they were more likely than other kids to have behavior problems and be in special education programs.

The fact that many concussions occur without loss of consciousness makes things especially tricky with kids, says Ronald Savage, a psychologist at the May Institute, a private, Randolph-based nonprofit program for people with brain injuries.

If the first injury is missed, he says, “putting kids back in the game too soon can put them at risk for death. Kids don’t just get another serious concussion – they die.”

Neuropsychologist Murdo Dowd of the Spaulding Rehabilitation Hospital in Boston agrees. Asked if he sees a lot of these injuries, he says bluntly: “No. They’re dead.”

Statistically, the incidence of second impact syndrome is unknown, partly because many times the first injury is never formally diagnosed. By the CDC’s count, there were 17 cases of second impact syndrome between 1992 and 1995 alone, and sports medicine specialists think the true number is far higher.

Since 1982, the National Center for Catastrophic Sports Injury Research in Chapel Hill, N.C., has kept track of the injuries that lead to death or paralysis. In some sports, like cheerleading, things have gotten worse as stunts get more dangerous, says Frederick Mueller, director of the center.

In football, they’ve improved. Fatalities at all levels of football peaked at 36 in 1968, he says, when coaches still taught players to block and tackle by crashing head first into opponents. That left 25 to 30 players paralyzed every year.

In 1976, this was outlawed, and better helmets came along, too. By 1997, the numbers were down: Seven high school players and one college player were paralyzed.

Still, many athletes and their parents don’t understand the risks of playing “while still symptomatic from an initial head injury,” says Dr. Robert C. Cantu, chief of neurosurgery at Emerson Hospital in Concord. And there is “no certification of coaches, and therefore individuals coaching the highest-risk sports may not fully understand the risk.”

In theory, the team physician has the final say about when an injured player can go back in the game. But many teams, especially in high school, have physicians at games, but not at daily practices.

Parents can be just as competitive as kids, says Dr. David Burke, director of the traumatic brain injury unit at Spaulding, a martial artist and a team physician at many martial arts events. “I have been happy I am a martial artist when I disqualify [ someone] ,” he says. “That’s the only thing assuring my continued health” when parents and kids protest.

So how can you tell if someone has a concussion and when it’s safe to play again? Doctors aren’t unanimous, but last year, the American Academy of Neurology and the Brain Injury Association issued recommendations now endorsed by many other groups.

With mild concussions – no loss of consciousness, transient confusion, and a return to normal within 15 minutes – you can return to play that day. With moderate concussions – the same symptoms last more than 15 minutes – you should not return until you’ve been symptom-free for a week.

With more serious concussions – including any loss of consciousness – you shouldn’t return to sports until you’ve gone a week without symptoms if the loss of consciousness was brief – longer if it was longer.

“If there is any loss of consciousness, you absolutely, positively, should not return to play that day,” warns Dr. Stephen Rice, director of the Primary Care Sports Medicine Fellowship at the Jersey Shore Medical Center in Neptune, N.J., a consultant to the Schultz case.

“You only get one brain,” he says. “Head injury is serious business.”

As Brandon Schultz discovered. His family sued the school system, arguing it should have had better-trained coaches. Last month, that suit was settled for an undisclosed sum.

The money certainly helps. But Brandon is still washing golfballs and learning to balance a mock checkbook. Does he wish somebody had done something differently?

“Yeah,” he says. “I wish that every day.”

1: Concussion types

A concussion is an alteration in mental status induced by head trauma that may or may not involve losing consciousness. There are three categories:

  • Grade 1 – transient confusion; no loss of consciousness; mental status abnormalities last less than 15 minutes.  – Management: The athlete can play again that day if symptoms resolve within 15 minutes.
  • Grade 2 – transient confusion; no loss of consciousness; mental status abnormalities last more than 15 minutes.  – Management: The athlete can play again only after he or she has been asymptomatic for a full week.
  • Grade 3 – loss of consciousness, either brief (seconds) or prolonged (minutes or longer).  – Management: An athlete who is unconscious for only a few seconds can play again after a full week of no symptoms. If the loss of consciousness lasts several minutes or more, the waiting period is at least two weeks.

Source: American Academy of Neurology

2: Football leads to far more head and neck injuries than any other sport. These numbers are for 1982-97.

Sport

Permanent

Serious

Sport Level Deaths disabilities injuries

Gymnastics  High School

1

7

4

Gymnastics  College

0

5

1

Ice hockey High School

2

4

5

Ice hockey College

0

4

3

Track and Field High School *

16

10

13

Track and Field College *

2

2

3

Football High school

61

147

166

Football College

5

21

62

Cheerleading High School

1

7

10

Cheerleading College

1

5

10

Wrestling High School

2

20

11

Wrestling College

0

1

2

 “(pole vault, discus, javelin, shot put)

SOURCE: National Center for Catastrophic Sports Injury Research Globe staff chart

 

Finding a combination to fight hepatitis C

November 19, 1998 by Judy Foreman

Until now, there has been no truly effective treatment for hepatitis C, the blood-borne virus that is spread in the same ways as AIDS, and that is believed to infect about 4 million Americans.

A drug called interferon helps in 40 percent of cases, but the benefits are short-lived. Only 10 to 15 percent of patients remain in remission, six months after treatment is stopped.

But two studies published in today’s New England Journal of Medicine offer new hope. One, led by researchers at the Scripps Clinic and Research Foundation in La Jolla, Calif., found that six months after treatment, a combination of interferon and a drug called ribavirin was 31 to 38 percent effective among patients being treated for the first time. That’s 3 to 5 times the response rate for people getting interferon alone.

The other study, led by researchers at the University of Florida College of Medicine in Gainesville, found that six months after treatment, the same combination was 49 percent effective in patients who had relapsed after previous treatment. This is 10 times higher than treatment with interferon alone.

Together, the studies represent an “important advance,” says Dr. T. Jake Liang, chief of the liver diseases section at the National Institute of Diabetes, Digestive, and Kidney Diseases, part of the National Institutes of Health.

It is still not clear how long treatment should last. In the California study, there was little difference in outcome whether people were treated for six months or 12. But the studies are “a big step forward,” Liang said in a telephone interview.

The way not to panic: Another Prozac role

It’s official: Prozac, like the antidepressants Zoloft and Paxil, has now been shown to work against panic disorder, a debilitating illness that affects 3 million Americans.

In a study led by Dr. David Michelson of Eli Lilly, the maker of Prozac, the popular antidepressant proved safe and effective in reducing panic attacks and symptoms of phobia, anxiety, and depression in people with panic disorder, a syndrome in which a person suffers repeated attacks of panic. The study is in this month’s American Journal of Psychiatry.

In a separate study published in this week’s Journal of the American Medical Association, Brown University researchers showed that Zoloft, already used for acute depression, is also effective as an ongoing treatment for chronic depression.

Major lung surgery is small operation

Minimally invasive surgery, in which doctors operate through one or more small incisions, often aided by tiny TV cameras in fiber optic cables, is clearly an idea whose time has come.

But is it really possible to remove an entire, intact lung this way and send the patient home the same day?

Yes, says Dr. Eduardo R. Tovar, a thoracic surgeon at St. Jude Medical Center in Fullerton, Calif., who describes his technique in this month’s issue of Chest, a journal of the American College of Chest Physicians.

Traditionally, surgeons have used one long incision – from the shoulder blade, under the arm, around to the front – to remove a cancerous lung. In the last five years, they’ve also used minimally invasive surgery, which involves four or five small incisions between the ribs for viewing plus a 4-inch incision under the arm through which the lung is removed.

Now, Tovaro says he can remove a lung using only one small – 3-inch – incision on the patient’s side.

In the five patients reported on – he has also done four others – Tovar occasionally uses a miniature TV camera inserted through the same incision to see ligaments that he needs to cut. He anesthetizes nerves in the area by freezing.

One patient went home the same day. Four others went home the next morning. With standard minimally invasive surgery, patients stay in the hospital five to seven days.

“This is an eye-opening article,” said Dr. Joseph LoCicero, chief of general thoracic surgery at Beth Israel Deaconess Medical Center, although it is unclear how many patients can benefit.

It “boggled my mind,” added Dr. A. Jay Block, editor in chief of the journal. But, he said, “I doubt there are a whole lot of surgeons who could do this at the moment.”

 

Meditating helps, but how is a mystery

November 16, 1998 by Judy Foreman

The idea of standing stark naked in a little booth soaking up UV light three times a week doesn’t seem all that bad as medical treatments go, especially since it can help ameliorate psoriasis, an itchy, scaly, disfiguring skin disease.

But many people do find the experience stressful, which is why meditation guru Jon Kabat-Zinn wanted to see if calming the mind during treatments might speed healing of the body.

In a randomized study of 37 psoriasis patients published last month, Kabat-Zinn, a molecular biologist who heads the Center for Mindfulness in Medicine, Health Care and Society at UMass Memorial Health Care, found that patients who listened to relaxation tapes healed 3.8 times faster than those who didn’t.

The tapes taught patients breathing and “mindfulness,” the Buddhist practice of moment-to-moment, non-judgmental awareness. The UMass study is part of an emerging body of research that could provide new evidence for the idea that meditation has real – and beneficial – effects on mind and body.

But just how real and beneficial? That remains to be seen.

There’s no question that many people swear by meditation, defined as a mental technique that focuses attention on a word, sound, image, or repetitive process like breathing, and that the notion of the mind healing the body has huge intuitive appeal.

There’s also no question that a number of studies show people report that meditation “leads to a reduction in anxiety and unhappiness,” says psychologist Richard Davidson, who directs the Brain Imaging and Behavior Laboratory at the University of Wisconsin.

What’s not known, he says, is to what extent these changes in mood “are associated with changes in brain function that have consequences for health and disease.”

In fact, there are many “leaps of logic” from saying that a mental technique can reduce stress to documenting long-term physical changes, says medical sociologist Barrie Cassileth, who teaches at Harvard Medical School, Duke University, and the University of North Carolina.

For instance, some studies suggest meditation can change scores on some tests of immune function. But many of these changes “are so trivial and so transient they could not possibly have the benefits people ascribe to them,” she says.

Still, there’s a growing push by brain researchers, who once focused primarily on intellectual processes, to understand the underlying biology of emotions, specifically the patterns of brain activity in various emotional states.

In Wisconsin, Davidson and Dr. Ned Kalin, a psychiatrist, have been trying to link the positive emotional states associated with meditation – calmness and optimism – to brain wave patterns, using EEGs (electroencephalographs) and imaging techniques called PET and functional MRI.

In Rhesus monkeys, they have found that fearful monkeys show more activity in the right pre-frontal cortex of the brain than calmer monkeys, which show more activity in the left. The calm monkeys with more left pre-frontal activity also exhibit another measure of decreased stress: lower levels of two stress hormones, cortisol and CRH, or corticotropin-releasing hormone.

In humans, they’ve found that people who are calm, happy, and tend to recover from stress quickly also, like the monkeys, show more activity in the left pre-frontal cortex, while those who report more negative emotions show more activity on the right.

And these patterns are stable – if you show one pattern today, you’ll probably show the same pattern a month from now.

So the big question is, if you have the “bad” pattern, can you change it? And if so, how? With drugs? With meditation?

In monkey studies, the Wisconsin group has shown that the sedative Valium shifts brain waves from the more agitated to the calmer pattern. Studies from other labs suggest that medications, including Prozac-like anti-depressants (which also work against anxiety) can also trigger increases in left pre-frontal brain activity.

There’s also evidence from other labs that brainwave biofeedback (a nondrug technique that uses monitoring devices to teach people to control their brainwaves) can shift the pattern from the right to the left side.

To see if meditation can also shift brain patterns in a favorable direction, the Wisconsin team studied employees from a high-tech firm, measuring brain waves, cardiovascular and immune function, then giving the volunteers an 8-week course that includes meditation taught by Kabat-Zinn.

The volunteers were then retested and compared to people who were on a waiting list for the training. The study, still being finished, isn’t perfect: Even if there are changes, researchers won’t know if they’re due to meditation, to the group discussions or something else.

But if it turns out that the first volunteers do show changes that the waiting-list group does not, the study could provide the most tantalizing evidence yet that meditation works.

And that would fit with what Dr. Herbert Benson, president of the Mind/Body Medical Institute at Beth Israel Deaconess Medical Center, has been saying for years about the “relaxation response,” which he defines as meditation, yoga, prayer, even repetitive exercise like jogging.

Though Benson’s research has drawn fire from some other scientists over the years, he remains convinced that, “regardless of the technique involved,” the relaxation response leads to decreases in breathing and heart rates, blood pressure, and responsivity to norepinephrine, a stress hormone.

And two years ago, in a published study of 20 first-time meditators, Benson and a colleague, research psychologist Gregg Jacobs, asked some of the same questions the Wisconsin team had asked.

In that study, the Boston team showed that brain waves recorded via computerized EEGs change in specific ways – toward less arousal and greater calm – when people listen to relaxation tapes, but not when they listen to “sham” relaxation tapes that do not teach people how to meditate but just extoll meditation’s virtues. This is strong evidence, says Jacobs, that the changes are not due to the placebo effect (expectations of benefit) but to the relaxation response specifically.

Other researchers are also trying to pin down specific effects of meditation, among them psychologist Zindel Segal at the University of Toronto.

In a still-unpublished study of 140 patients, he’s found that an 8-week course of meditation along with cognitive behavior therapy – learning to re-interpret stressful thoughts – can reduce the rate of relapse among people who have been treated for depression. (Other studies have already shown that cognitive behavior therapy alone can help with anxiety and depression.)

Tantalizing as all this is, there is still no proof that meditation acts on the brain to influence health in measurable ways. That means you can’t assume that “if you meditate and calm your mind, you can promote the body’s ability to heal itself,” says Cassileth. “We don’t know if this is true.”

But as long as you don’t eschew medical care for a serious health problem, there’s probably little harm in trying meditation. And if you’re stressed and unhappy, it can help.

Just don’t expect miracles. As Cassileth puts it: “This sense that we can conquer everything with our minds is, unfortunately, just not true.”

Some tips to get you started

There are many approaches to meditation, so if you’re interested it pays to read books and sample meditation tapes to learn what appeals to you. Some other tips:

  • To find organizations that offer courses, look under “meditation instruction” in the Yellow Pages.

  • If you want to learn meditation outside a religious or spiritual context, call a major hospital. Many offer meditation or relaxation courses.

  • If a course seems too cult-like, trust your instincts and go elsewhere. You do not have to do or believe anything that doesn’t fit with your value system.

  • If you have serious mental health or medical problems, see your doctor. Don’t expect meditation to be a cure-all.

  • Remember that there are many ways to achieve relaxation, from meditation to jogging to doing crossword puzzles or going to the movies. Meditation is far from the only way.

There are numerous books on meditation. Among them:

  • “The Relaxation Response,” by Dr. Herbert Benson. (William Morris & Co.)

  • “The Wellness Book,” by Dr. Herbert Benson, Eileen Stuart and others. (Simon & Schuster.)

  • “It’s Easier Than You Think,” by Sylvia Boorstein (Harper Collins).

  • “Minding the Body, Mending the Mind,” by Joan Borysenko. (Addison Wesley.)

  • “The Miracle of Meditation: A Manual on Meditation,” by T.N. Hanh. (Beacon Press.)

  • “Full Catastrophe Living,” by Jon Kabat-Zinn. (Dell Publishing.)

  • “Wherever You Go There You Are,” by Jon Kabat-Zinn (Hyperion.)

  • “A Path With a Heart,” by Jack Kornfield (Bantam.)

  • “How to Meditate,” by Larry Leshan. (Bantam.)

‘Deep pockets’ that nobody wants

November 9, 1998 by Judy Foreman

It was the “Floss or Die” poster that got to 54-year-old Jack Kelsch of Wareham.

Kelsch works as a grants administrator at the Harvard School of Dental Medicine, where the perils of periodontal disease are standard water cooler fare and “deep pockets” means gum disease, not money.But as Kelsch discovered, that poster was no joke.

Most people know gum disease can lead to tooth loss, or, as some put it, “Ignore your teeth and they’ll go away.” But can it also lead to heart disease? Stroke? Death from all causes?

Yes, according to a growing body of evidence showing that infections in the mouth – notably periodontal disease in the “pockets” where the teeth meet the gums – can indeed have a major impact on health.

Luckily, this gloomy picture is offset by more upbeat news: A number of new treatments for periodontal disease have been approved by the US Food and Drug Administration in recent months.

Periodontal disease is a serious problem for 29.6 million Americans, according to the American Academy of Periodontology. (Others say as many as 67 million Americans – one in three adults – have it to some degree.)

It all starts when bacteria – a strain different from those that cause tooth decay – take up residence in the gums. White blood cells from the blood then flock to the area to fight the infection, triggering inflammation.

At first, this just results in gingivitis – swelling and redness of the gums, says Dr. Nadeem Karimbux a periodontist at the Harvard Dental Center. But when chronic inflammation destroys gums and bone around teeth, it’s periodontitis.

Periodontal infection is troublesome enough in the mouth. But it can be even more serious if it spreads.

Several years ago North Carolina researchers showed that periodontal disease in pregnant women was associated with an increased risk of low birth weight babies.

In 1993, a study of 7,610 Americans published in the British Medical Journal showed that men and women with periodontal disease had a 25 percent higher risk of coronary heart disease and a 46 percent higher risk of death from all causes than those without gum disease.

Last summer, newly-published data on more than 1,000 Boston men showed that those with the worst periodontal disease were twice as likely as those with the least to die of heart disease, and three times as likely to suffer stroke, even when other factors such as smoking and cholesterol were accounted for.

In fact, the deeper the pockets of infection, the greater the risk of death from all causes, says the author of that study, Dr. Raul Garcia, director of the Veterans Affairs Dental Longitudinal Study at the Boston VA Outpatient Clinic and a health policy professor at Boston University School of Dental Medicine.

These findings fit, somewhat, with those from a 1996 Harvard study of more than 44,000 male health professionals. That study didn’t find a link between periodontal disease per se and heart disease, but did find a link between heart disease and the main consequence of gum disease: tooth loss. Another Harvard study of 22,037 doctors, on the other hand, found no such link.

The apparent link between periodontal disease and other health problems may be explained by recent studies showing that oral bacteria can indeed become travelling troublemakers.

When bacteria from the periodontal pockets enter the bloodstream, notes Garcia, they may contribute to the formation of plaque on artery walls. This leads to blood clots that can cause heart attacks and strokes. In fact, several recent studies have found bacteria from the mouth in parts of the brain damaged by strokes and in diseased coronary arteries.

Bacteria from the mouth can also directly cause infections in other parts of the body. That’s why the American Heart Association has long recommended that certain heart patients undergoing dental procedures take antibiotics to prevent a heart infection called bacterial endocarditis.

If your dentist or hygienist discovers, by poking around with a probe, that your pockets are deeper than four or five millimeters and you’re starting to lose bone around the teeth, you’re probably a candidate for scaling and root planing. This is a deeper cleaning process than the one we’re all supposed to have every six months. It involves scraping bacteria off tooth roots, under local anesthesia, and can take up to an hour for just one quadrant of the mouth.

If that doesn’t do the trick, surgery is often required – opening the gums, cleaning tooth roots and the jawbone of bacteria, then stitching the gums together tightly to reduce the pockets.

Oral antibiotics might seem a logical solution for periodontal disease, but they’re not. They cause side effects and can create resistant strains of bacteria.

But new ways of delivering antibiotics and other germ-killing drugs just to the gums, not the whole body, and a new understanding of how some antibiotics work, hold promise.

In recent years, periodontists have been using Actisite, a plastic fiber impregnated with antibiotics that is placed in the gums. So far, though, there’s no proof that five years after treatment, it’s better than scaling and root planing alone, says Karimbux of Harvard.

A newer approach to local control of disease is PerioChip, developed in Israel and marketed in this country by Astra Pharmaceuticals, Inc. It was approved in May by the FDA.

The chip, which Jack Kelsch had implanted last month, is about the size of a baby’s fingernail. Inserted into pockets after scaling and root planing, it releases a bacteria-killing chemical, chlorhexidine, over a week.

Yet another new local treatment is Atridox, made by Atrix Laboratories, Inc. Approved by the FDA in September, this gel is injected into the pocket, where it solidifies and releases an antibiotic, doxycycline, also over about a week.

The latest remedy, Periostat, approved just last month, is also based on doxycycline. It acts not by killing bacteria, as the antibiotic usually does, but by attacking an enzyme called collagenase, a tissue-destroying substance pumped out by white blood cells, including those that flock to the gums.

A decade ago, researchers showed that low doses of doxycycline can reduce levels of collagenase, says Brian Gallagher, CEO of CollaGenex Pharmaceuticals, Inc., which makes Periostat.

Studies show that Periostat, a twice-a-day pill, increases the attachment of gums to teeth, when used with scaling and root planing. This makes it a useful adjunct to current treatment “but not a magic bullet,” says Dr. Robert S. Schoor, president of the American Academy of Periodontology.

If you have a deep pocket and scaling reduces it by one millimeter and Periostat by a half-millimeter, “that’s a 50 percent improvement” over scaling alone, he says. “But you still have a deep pocket and you haven’t cleaned the roots of poison.”

Other researchers are investigating ways to use bone grafts – either synthetic or from cadavers – to combat the bone loss that leads to tooth loss in severe periodontal disease.

Used alone, none of these treatments is likely to reverse periodontal disease, but used with existing treatments they should help.

Prevention, of course, is also key – brushing, flossing, and professional cleaning.

Remember the poster: “Floss or die.”

Signs to watch for

The American Dental Association and the American Academy of Periodontology recommend that you see your dentist if you have any of the following symptoms. It is also possible to have periodontal disease without these signs:

  • Gums that bleed easily, or are red, swollen or tender.

  • Gums that have pulled away from the teeth.

  • Pus between the teeth and gums when the gums are pressed.

  • Persistent bad breath or bad taste.

  • Permanent teeth that are loose or separating.

  • Any change in the way your teeth meet when you bite.

  • Any changes in the fit of partial dentures.

To keep teeth and gums healthy, you should brush twice a day and floss once. And have regular dental checkups.

The midwives’ time has come – – again

November 2, 1998 by Judy Foreman

Carol Rose, a Harvard-trained lawyer from Melrose, was pregnant with her first child two years ago when her health plan pulled a switch.

She was in the exam room, waiting for her female doctor when a male doctor walked in. She’s not anti-men, or anti-doctor, but this guy was a bad match. “I had a bunch of questions,” she says. “He said, `I have limited time.’ I felt so dehumanized and medicalized that I left.”

When she turned to Leslie Ludka, a nurse-midwife who heads the midwifery program at Brigham and Women’s Hospital, she discovered “the best of both worlds” — someone with time to answer questions, yet backed by doctors at a major hospital.

When the big day came, says Rose, Ludka was great. “When the pain was at its peak, I said, `I’m not sure I can do this.’ She said, `The pain will not get worse than it is right now.’ ” It didn’t. Rose had a drug-free delivery, just as she had hoped.

Midwifery — the art of helping a woman through childbirth — is as low-tech as mother’s milk, as ancient as womankind. But until recently, it had been squeezed out of the birthing room by doctors and their gadgets, much as death has been hustled out of homes and into hospitals.

That is changing — 6.5 percent of American babies are now delivered by midwives, usually in hospitals, compared to 1 percent in 1975. And this could be good news for babies.

A study published in May by the National Center for Health Statistics found babies delivered by certified nurse-midwives were less likely to die than those delivered by doctors.

The study, by researchers Marian MacDorman and Gopal Singh, looked at all singleton babies delivered vaginally in the United States in 1991 at 35 to 43 weeks of gestation — roughly full term. (The study did not look at multiple births or Caesareans, which account for about one quarter of all births.)

Of the 2.8 million births studied, the team focused on about 1 million: a sampling of doctor-attended births (850,000) and all 153,194 births at-tended by certified nurse-midwives.

The results were striking:

– After controlling for socioeconomic and medical risk factors, the infant mortality rate — death during the first year — was 19 percent lower for certified nurse-midwives than for physicians.

– The death rate in the first 28 days — was 33 percent lower. – And the risk of low birthweight infants was 31 percent lower.

Some doctors, among them Dr. Michael Greene, director of maternal-fetal medicine at Massachusetts General Hospital, suspect that the midwives’ better track record may be due to their having patients who were “healthier to begin with.”

Dr. Fredric Frigoletto, chief of obstetrics at MGH and a past president of the American College of Obstetricians and Gynecologists, agrees. This study has “significant limitations,” he says, because it’s not clear “how patients found themselves in the midwife or doctor cohort.”

Statistician MacDorman agrees that any study like hers based on data from birth certificates can’t control for all factors, but she notes that since her study deliberately left out multiple births, preterm births and Caesarean deliveries, the women were comparable in that they all had normal deliveries.

Furthermore, her study showed that midwives were more likely than doctors to care for women at higher socioeconomic risk — black women, American Indians, teenagers, women with three or more previous births, unmarried women, those with less than a high school education and those with late or no prenatal care.

The doctors were somewhat more likely to have medically difficult cases, she says, but “the differences were small.”

So if there’s magic in midwifery, what is it? Midwives say it’s time and support — during prenatal visits and labor.

One study cited by MacDorman found certified nurse-midwives spent an average of 49.3 minutes on the first visit — versus 29.8 minutes for doctors. Subsequent visits averaged 29.3 minutes for midwives, against 14.6 minutes for doctors.

Frigoletto counters that if you add up the time the doctor, the nurse and the nurse’s assistant spend with each patient, “the total visit might be just as long.”

Unlike doctors, most midwives stay with the woman — not just nearby — for the duration. This allows quick action if the baby’s heart rate soars or plummets. If low-tech remedies such as having the woman change position or drink fluids don’t help, the midwife can then call in the doctor.

Often, the combination of massage, position changes, breathing exercises and moral support do the trick, though Frigoletto warns there’s little data linking these interventions with birth outcomes.

Midwives believe they have economics on their side, too. A 1996 study of 1,000 patients showed that hospital charges for midwife births were 21 percent lower than those for doctors, perhaps because they’re less likely to use interventions such as electronic fetal monitors and to do procedures such as episiotomies (surgical cuts to enlarge the vaginal opening).

Though midwives, like doctors, can use painkilling medications and drugs such as oxytocin (Pitocin) to induce or speed up labor, they do so sparingly lest they trigger a vicious circle: Painkillers may slow labor, which means a woman may need oxytocin, which causes more pain, which may necessitate more painkillers.

“There’s some truth to that” scenario, says Frigoletto. But usually, the need for drugs depends on the individual and how many previous births she’s had. He adds that doctors, like midwives, are cautious about using drugs too early in labor.

And midwives have some time-honored tricks up their sleeves. Instead of using forceps, midwives often ask a woman to stand and rock her hips or squat to free a stuck baby. They also may use nipple stimulation, which can help a woman’s body release its own natural oxytocin.

“What was nice,” Rose says of her son’s birth two years ago, was having “all the advantages of a midwife, yet if something went wrong, there was a doctor on call and a neonatal intensive care unit 30 seconds away.”

So nice, in fact, that Rose and her husband asked Ludka to deliver their second child, who arrived last month — with the help of another midwife at the Brigham. Ludka was fast asleep — she’d been delivering a baby the whole night before.

SIDEBAR 1:

Some nations cite lower death rates

Long a staple of medical care in other countries, midwifery is growing steadily in the United States.

In 1975, only 1 percent of American babies were delivered by midwives, according to government statistics. By 1991, it was up to 4.4 percent; by 1996, 6.5 percent.

Worldwide, the use of midwives is often associated with lower infant mortality, says Lisa Paine, head of maternal and child health at the Boston University School of Public Health.

In most countries that are “ahead of us in infant mortality rates, there is greater reliance on care provided by midwives,” she says.

But interpreting such data can be tricky, warns Dr. Fredric Frigoletto, chief of obstetrics at Massachusetts General Hospital. Neonatal mortality (deaths in the first month of life) are a big contributor toward infant mortality (deaths in the first year). The United States counts deaths of premature and low birthweight infants as neonatal deaths, but some countries might not count them at all, which skews the statistics, he says.

Still, the apparent link between reliance on midwives and low infant mortality is intriguing. In Britain, about 70 percent of births are attended by midwives and the infant mortality rate is 6.1 per 1,000 — versus 7.8 per 1,000 in the United States, says Paine. In the Netherlands, where nearly half of all births are attended by midwives, the rate is 5.2.

In Canada, midwifery is less common than in the United States, but the infant mortality rate is lower (6.0), for unclear reasons.

Japan, whose infant mortality rate is the world’s lowest (3.8 per 1,000), is facing a potential midwife shortage. Many of Japan’s midwives are over 65, and it’s not clear there will be enough younger midwives to take their place.

In the United States, there are now an estimated 5,500 certified nurse-midwives, according to the American College of Nurse-Midwives, an advocacy and lobbying group in Washington, D.C.

Certified nurse-midwives — nurses who have taken accredited midwifery training and have passed a national certification exam — are licensed in all 50 states. In addition, there are several thousand lay midwives. They are not licensed in Massachusetts and many other states. But in some cases, they have passed a different exam and may be certified by the National Association for the Registry of Midwives, in which case they’re called CPMs: certified professional midwives.

In some states, CPMs are allowed to deliver babies in hospitals, but in most states, they’re not; they deliver babies at home and in birth centers.

Despite the growth in midwifery, there are “not enough midwives to meet the demand,” says Judy Norsigian, program director of the Boston Women’s Health Book Collective, the women’s health group that wrote self-help book “Our Bodies, Ourselves.”

SIDEBAR 2:

To learn more

For more information, try:

  • American College of Nurse-Midwives, 202-728-9860 or 888-643-9433 to find a midwife near you. On the web, it’s www.midwife.org

  • Midwives Alliance of North America, 888-923-6262

  • Massachusetts Midwives Alliance, 508-376-8201

  • Massachusetts Friends of Midwives, 1 800-WITH-YOU (1 800 948 4968).

SIDEBAR 3:

A GROWING PHENOMENON

PLEASE SEE MICROFILM FOR CHART DATA

GLOBE STAFF CHART

Herbal hazards taken alone or with prescription drugs, some of these innocent-sounding `natural’ remedies can be dangerous

October 26, 1998 by Judy Foreman

If your doctor suggested that you take two different sleeping pills that have never been tested in combination, would you do it?

If she recommended an energy-booster, but you couldn’t tell from the label what was in the bottle, would you take that?

What if she told you to ingest a medication normally used on the skin – would you want to know it might cause liver failure?

You’d probably answer “No,” “No way,” and “You bet your litigious soul I would.”

But now suppose you’re prowling the aisles in the health food store looking at “natural” remedies? You might grab something and figure, “Hey, this is herbal. It must be safe.”

As a nation, we’ve gone bonkers over alternative or “complementary” medicine, including “dietary supplements,” including herbs. More than one-third of American adults now use herbs and we spend more than $3.6 billion a year for them.

But like someone hopelessly in love, we’re a bit blind. Because herbs are sold – and regulated, by the Food and Drug Administration – as supplements, we don’t think of them as drugs, though we take them to fix or prevent all manner of ills.

This suits many people just fine, including Congress, which in 1994 curbed the FDA’s power to review supplements, including herbs, before they’re marketed.

But while the body politic may like things this way, the body into which we pour these products reacts the same whether something is labelled an herb or a drug. And while many herbs are apparently safe, some – and some combinations of herbs and prescription drugs – clearly are not. Consider:

In the latest of issue of FDA Consumer magazine, the FDA published a short list of herbs it considers “possible health hazards.” One is comfrey, whose leaf and root are used externally for treating bruises but which some people are ingesting for general healing. According to the FDA, which keeps track of adverse reports on herbs and supplements, comfrey can obstruct blood flow to the liver, with possibly fatal consequences.

Varro Tyler, dean emeritus of the Purdue University School of Pharmacy and Pharmacal Sciences, puts it bluntly: “Don’t drink comfrey. . . It should be taken off the market.”

Another risky herb is the stimulant ephedra (Ma huang), which can cause high blood pressure, heart attacks, stroke, and death.

Despite the 1994 law weakening its powers, the FDA still has the authority to yank supplements, including herbs, off the market if it can prove they’re dangerous. It hasn’t done so yet with any supplement, but it’s come closest with ephedra. Last year, the agency proposed dose limits on the active ingredient in ephedra, but so far has not followed up.

Other herbs the FDA lists as dangerous include chaparral, an underground “cure” for cancer that may cause irreversible liver disease; germander, an appetite suppressant that may also cause fatal liver disease; and dieter’s teas that can cause vomiting, constipation, and possibly death.

The FDA is also worried about willow bark, which is marketed as an aspirin-free product but can cause Reye’s syndrome, a potentially fatal disease associated with aspirin use by children; and lobelia, an emetic used to induce vomiting, that may cause cause breathing problems, rapid heartbeat, and possibly coma and death.

Complicating things is the fact that many people take more than one herb simultaneously and combine herbals with prescription and over-the-counter drugs. These combinations pose serious risks, says plant medicine specialist Tyler, who detailed his concerns in September’s Prevention magazine.

For instance:

  • Blood thinners. Many herbals – notably garlic, ginkgo, ginger, and feverfew – reduce the ability of the blood to clot, which can help prevent heart attacks and strokes. But if taken with over-the-counter anticlotting drugs like aspirin or prescription drugs like Coumadin, you may bleed too easily. If you’re facing surgery, you should not only stop taking mainstream anticoagulants, but the botanicals as well.

  • Diuretics and laxatives. Some herbal laxatives such as senna, cascara sagrada, and aloe make you lose a lot of water and potassium. If you take these remedies for more than a few days, you may be at risk for cardiac arrhythmias. Combining these with diuretics – prescription drugs for high blood pressure – increases this risk. In fact, combining prescription digitalis with diuretics, including the herbals, could even be fatal, warns Timothy Maher, head of the division of pharmaceutical sciences at the Massachusetts College of Pharmacy.

  • Sedatives and sleeping pills. Studies show that one herbal sedative, kava, is safe and effective for anxiety and, indirectly, for insomnia; another herb, valerian, works well for many people, too. But there is little data on combining these herbs with each other or with prescription sedatives, antidepressants or alcohol.

For that reason, Tyler says, it’s safest not to mix them. But Dr. Michael Jenike, associate chief of psychiatry at Massachusetts General Hospital, says some people do combine kava with Prozac-like antidepressants. “So far,” he says, “there are no apparent adverse effects, but there may be some risks we don’t know about.”

Combining kava with alcohol is risky, he says. You may become too sedated, as if you combined Valium and alcohol.

  • Substances that affect blood sugar. Hundreds of herbals, including bitter melon, dandelion, and prickly pear can lower blood sugar. In theory, if you combine these with insulin, you could wind up with too low blood sugar, which can lead to coma and death. This is less likely if you monitor blood sugar closely.

  • Antidepressants. Some people combine the herbal antidepressant St. John’s wort with prescription antidepressants like Prozac. Some people also use St. John’s wort with a diet drug called phentermine, an amphetamine-like stimulant. While the first combination may not be dangerous, the second, at least in theory, could be.

Like other so-called SSRI antidepressants, Prozac works by blocking reabsorption of serotonin, a neurotransmitter, by brain cells. Phentermine may increase serotonin in the blood by blocking its destruction in platelets, says Dr. Richard Wurtman, director of the MIT clinical research center and developer of Redux, a diet drug now off the market.

Last year, when the diet drug combination “fen/phen” was withdrawn from the market because of the risk of heart disease, some dieters switched to “phen-Pro,” a combination of Prozac and phentermine.

But the net effect of taking either fen-phen or phen-Pro may be the same – too much serotonin. That is believed to cause heart damage and a potentially fatal condition called primary pulmonary hypertension, says pharmacist Maher. He, with Wurtman, has shown that phentermine acts in the test tube like a class of drugs called MAO inhibitors, which boost a number of brain chemicals, including serotonin.

“If phentermine really is an MAO inhibitor, it would be potentially fatal to take with Prozac,” says MGH’s Jenike, and in theory that would hold for combining phentermine with St. John’s wort, too. So far, though, he is not convinced that phentermine is really an MAO inhibitor.

And what if St. John’s wort itself acts as both an MAO inhibitor and Prozac-like SSRI? That’s a possibility, says pharmacist Maher. If it’s true, that could make it dangerous to take with drugs like Prozac, Zoloft and Paxil and Effexor. But if St. John’s wort does act as an MAO inhibitor, “one would expect reports of adverse effects if you combined it with these prescription SSRIs,” says Jenike. So far, there have been none.

The bottom line is buyer beware. To the federal regulatory system, there’s a difference between herbs and drugs.

But to your body, there isn’t.

Supplement standards being written

Not long ago, the FDA had the power to force manufacturers of dietary supplements, including herbal remedies, to prove those products were safe.

That changed in 1994, when Congress passed the Dietary Supplement Health and Education Act.

Now a “dietary” product can remain on the market unless the FDA finds clear evidence – not mere suspicion – of harm, which means “people have to be hurt first,” says Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest, a nonprofit consumer group in Washington.

Also, the law only requires manufacturers to produce supplements in accordance with “good manufacturing practices” in the food industry. Manufacturing standards in the food industry are less stringent than those in the pharmaceutical industry. The FDA is now writing new standards for supplements.

Furthermore, before the law, all health claims on supplements – as on food – had to have FDA approval before marketing. Now, manufacturers can make “structure/function” claims without prior approval. That means they can’t say a product prevents heart disease, but they can say something vague, such as, this product “helps maintain cardiovascular function.”

The herbal industry is aware there have been quality-control problems, says Mark Blumenthal, executive director of the American Botanical Council, a nonprofit educational group based in Austin, Texas.

In fact, the council has developed a chemical analysis system to test products, he says. In one study using this system, the council found that some products that claimed to contain ginseng did not.

In August, the Los Angeles Times reported on a chemical analysis it commissioned on the herbal antidepressant, St. John’s wort: Three of 10 brands tested had no more than half the potency listed on the label, and four had less than 90 percent.

At least two companies are now beginning to analyze the ingredients listed on herbal products.

But sometimes, the problem is that herbal remedies contain adulterants that shouldn’t be there at all. In a recent issue of the New England Journal of Medicine, FDA researchers reported on two cases of serious heart problems traced to supplements contaminated with the powerful heart drug digitalis.

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