DATE: Monday, July 28, 1997                 TAG: 9707280073

SECTION: FRONT                   PAGE: A1   EDITION: FINAL 

SOURCE: BY MARIE JOYCE, STAFF WRITER 

                                            LENGTH:  175 lines

WANTED: IUD USERS AN EVMS RESEARCHER IS TESTING A NEW VERSION OF THE IUD - A BIRTH CONTROL DEVICE WITH A DUBIOUS PAST.

Dr. Freedolph D. Anderson is offering women a form of birth control that's safe, effective and easier to use than even the pill. And he's offering it for free.

You'd think patients would be beating down the door of his office at Eastern Virginia Medical School. But Anderson literally can't give it away.

That's because he is offering the IUD, and the mere mention of intrauterine devices evokes memories of the infamous Dalkon Shield.

A popular IUD in the early 1970s, the Dalkon Shield caused infections in thousands of women, triggering miscarriages, rendering some infertile and killing 18. The lawsuits eventually led Richmond company A.H. Robins into bankruptcy.

The intrauterine devices offered today are different. Yet even though no one in America has died since the 1970s, even though the method is wildly popular in Europe, most American women still won't touch them.

That's a problem for Anderson, who is leading the effort to bring a new version of the IUD into the American market. To get permission from the federal Food and Drug Administration, Anderson, a gynecologist at EVMS' Jones Institute for Reproductive Medicine, must test the product on some 800 American women.

But in nine months, he's persuaded fewer than 30 to sign on.

``We had patients who said, `I wouldn't want an IUD because my gym teacher said I shouldn't have an IUD,' '' Anderson said.

The culprit in the Dalkon Shield case, doctors believe, was the tail, a thread that dangled from the IUD through the opening of the cervix to allow easy removal. The Dalkon Shield's tail was made of many filaments wrapped together.

This design apparently acted as a wick, drawing bacteria from the vagina into the uterus. Later, it was also found that the company had misrepresented the effectiveness of the product. The Dalkon Shield also was known for its distinctive, crab shape, although this apparently had nothing to do with its problems.

IUDs now are made with monofilament tails that don't have the same wicking effect.

The modern IUD has many advantages that make it a good method for some women, say experts in birth control. It is very effective, ranking with the pill, and it frees women from the regimen of getting regular shots, taking a pill daily or using a diaphragm or condom every time.

Though it initially costs more than some other forms, it is one of the cheapest methods in the long run. And it doesn't have the same side effects caused by hormonal methods like the pill.

Scientists have debunked a long-held belief that using an IUD contributes to pelvic inflammatory disease. And there is good evidence today that it does not work by dislodging a fertilized egg - a contention that has caused some to label it an abortion method.

Among those women who do choose to use it, the IUD enjoys great loyalty.

Yet the IUD is used by just 1 percent of American women who use birth control, according to The Alan Guttmacher Institute, a think tank that deals with reproductive issues. That compares with rates of 20 percent in Germany, 26 percent in Sweden, and 39 percent in Norway and Finland, Anderson said.

American doctors are reluctant to mention it to patients.

``Basic ignorance of the facts, fear of medical liability, inadequate medical training in IUD insertions, and confusion regarding the mechanisms of action of the IUD have led to a dearth of physicians recommending this method in the U.S.,'' concluded a report by the National Institute of Child Health and Human Development.

American IUD use plunged after the Dalkon Shield was taken off the market in 1974. Not long after, other pharmaceutical companies took their versions off the American market, too, even though they weren't designed the same way.

But the United States has a serious problem with lack of adequate birth control, population-control experts say. Almost 60 percent of pregnancies in the nation are unintended, and about half of those are the result of the failure or incorrect use of birth control, according to the Alan Guttmacher Institute.

Only two IUDs are available in America: the ``copper T,'' the ParaGard T 380 A made by Ortho Pharmaceutical; and another T-shaped version that contains the hormone progesterone - which helps with abnormal bleeding - but lasts only a year.

Anderson would like to add a third choice.

He first learned of the new CS-300 at a conference in Germany. Made by a German company, Prosan, it has captured a small share of the European market since it became available in 1995. Anderson, who directs clinical studies for the Jones Institute's Technology Development Center, saw an opportunity.

To satisfy the FDA, he must conduct a study with 800 women, some with the Copper T, some with the CS-300.

Doctors aren't sure why an IUD works. Conventional wisdom used to say that the device interfered with a fertilized egg's implanting in the uterus. Doctors can't dismiss that theory, but many studies have shown that the eggs of IUD users don't get fertilized.

It may work because of copper wrapped around it. Copper ions, which fight infection, may also kill sperm. Also, by stimulating the lining of the uterus, the IUD may switch the body's immune system into attack mode, causing it to destroy the invaders.

The new CS-300 seems to work with less copper, which can cause bleeding and spotting between periods, a side effect that makes some women switch to another method, Anderson said.

The new device is smaller than the copper T, so it fits more women who have not had children, and it's easier to insert, he said.

The CS-300 also likely would be less expensive. The copper T costs about $300 and lasts about 10 years. Though it's cheap in the long run, the initial investment is hard for some women.

If and when Anderson stops the tests and the CS-300 goes on the market, it'll probably cost about $60 and will last three to five years, he said.

For now, women who participate in the study through the Jones Institute will get the device for free, along with a free gynecological exam. They won't be charged for the insertion, either.

Several Hampton Roads gynecologists also are participating in the study. Women who go through those offices are not charged for the device, though they may pay their regular fee for the doctors' services.

Kim Moreira is one of the women who has signed on. She's been very satisfied with the device.

``I know that for at least five years I will be OK. I won't get pregnant,'' she said. The only disadvantage so far is the extra bleeding she gets during her menstrual cycle, she said.

After she and her husband had their first child 16 months ago, Moreira, 25, looked for a way to delay a second child while she completed her nursing studies.

She had used the pill since she was about 18 but had never been very happy with it. She often forgot to take it, then would double up the dosage. The hormones caused depression and mood swings.

``I didn't want to have to deal with that again, for my poor husband's sake,'' she said.

She saw a flier about the IUD study in the snack room at Ghent Family Practice, where she works. Her doctor had never mentioned the device as a possibility.

The insertion procedure was quick - she went at lunch and was able to return to work that afternoon. Like many women, she felt some pain, similar to very bad menstrual cramps, when the staff used a clamp to grab the outside of the cervix to steady it. The actual insertion is painless, Anderson says.

``We try really hard to make it as painless as possible, because we want them to tell their friends,'' he said. The procedure sometimes is more painful for a woman who hasn't had children, because her cervix is firmer.

Moreira is too young to remember the Dalkon Shield deaths, but she had heard about it, and her mother-in-law was worried. Moreira had her doubts when she first inquired about the study.

``I had heard . . . about the shield one - you know: `Don't get them,' '' she said. She's talked to women the age of her mother-in-law who say, ``Oh, it's terrible.''

But after talking to people at the Jones Institute, she decided the risks were small.

Population-control experts think younger women like Moreira are more likely to be open to the IUD than those who remember the Dalkon Shield days.

But Dr. Felicia Stewart, an expert in birth control who generally approves of the IUD, cautions young women who have not had a child yet about using a method that doesn't protect against sexually transmitted diseases.

``This is not a fabulous choice because it certainly doesn't do anything to protect fertility,'' said Stewart, director of reproductive health programs for the Henry J. Kaiser Family Foundation in California.

She's seen patients who have picked up diseases from partners they believed were faithful. ``It's very common. That's all there is to it.''

The best protection against infection is consistent use of barrier methods - latex or plastic male or female condoms, Stewart said.

Even the pill provides some protection - possibly because the hormones thicken the layer of mucus on the cervix or marshal the immune system.

Anderson will allow in the study only women who are in monogamous relationships, though he acknowledges he has no control over how women or their partners behave outside his office.

Anderson must finish his study in about four years, he said. He is trying to interest population-control groups in the effort, with the hope of attracting more funding and expanding the study to other areas.

But many of those groups, he said, want to spend their time and money on devices that also prevent the spread of sexually transmitted diseases.

If the FDA approves the CS-300 and the device takes off, EVMS stands to gain a lot of money because the school owns some of the rights to the product.

If the study fails because of a lack of participants, ``Well, we'll write a paper - this is an academic institution - but that's not what we want,'' he said. ``What we want is to get this thing on the market so that EVMS can benefit from it.'' ILLUSTRATION: Color Photo

BILL TIERNAN/The Virginian-Pilot

Dr. Freedolph D. Anderson is having trouble finding women willing to

test the new CS-300 IUD, even though they get the device for free

and it lasts three to five years. KEYWORDS: BIRTH CONTROL IUD EASTERN VIRGINIA MEDICAL SCHOOL

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