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Working the Gold Mine
Wilcox Still Finding Nuggets After 20 Years

By Colleen Chandler

It's not your typical gold mine, but it's a gold mine nonetheless. And NIEHS' Dr. Allen Wilcox has been discovering gold nuggets in this mine since he began collecting data some 20 years ago.

The gold found here, though, is liquid — 30,000 little jars containing urine samples from 221 women who in the early 1980s hoped to become pregnant. The institute had to build a walk-in freezer to hold all the samples.

The Early Pregnancy Study entailed collecting urine samples from women going off birth control to get pregnant. Researchers collected samples and other data from November 1982 until July 1986, going to the women's homes every week to swap full jars with empty ones, and replace completed survey forms with blank ones. The data collected has become fodder for 40 papers and book chapters over the last two decades.

It took 3 years to finish the first batch of urine assays. A second batch has since been completed, and a third one is planned.

The study utilized local women, located through posters and ads in local newspapers. The best response, Wilcox said, came from the Village Advocate, a Chapel Hill, N.C., shopper popular for its garage-sale ads.

The sample jars were distributed to participants in small boxes. Since seven jars — one for each day of the week — did not fit snugly into the boxes, researchers came up with the idea of adding an extra jar, with two jars for every Monday. Lo and behold, the beginnings of the gold mine.

Affectionately dubbed "The King of Pee" during the Early Pregnancy Study that included the collection of 30,000 urine samples from women who went off birth control to get pregnant in the early 1980s, Dr. Allen Wilcox has published more than 40 papers and book chapters based on data from the samples. The women who participated in the study contributed photos of children they conceived during the study and presented Wilcox with a collage of those photos. Also visible is the July 1988 issue of Newsweek magazine featuring a cover story on Wilcox's research.

Since researchers wanted to be able to measure pregnancies that were lost very early after conception, the trick was to begin collecting samples from women before they even became pregnant. To see how hard it was to be consistent in providing the samples, Wilcox subjected himself to the same daily regimen for 3 months.

"I missed 5 days out of about 100...The average woman in our study missed only 2," Wilcox said.

Clarice Weinberg collaborated with Wilcox and Donna Baird on the Early Pregnancy Study, which she said was and is "a marvel of synergistic interaction.

"He was able to keep track of the details of the enormous EPS undertaking, to prove that such a study can be done, to keep the staff committed and enthusiastic and at the same time not lose sight of the big-picture science issues we needed to think about. Somehow we also had a lot of fun doing it."

Weinberg said Wilcox has a terrific sense of humor and recalls that during the study, he was affectionately dubbed "The King of Pee" — a designation that came with a crown of little vials of yellowish liquid.

In July 1988, Wilcox' research made the cover of Newsweek magazine. Among their findings, researchers were able to show that the specific hormone that indicates pregnancy could be detected just 9 days after conception. They found that 22 percent of the pregnancies ended before women even knew they were pregnant, while another 11 percent ended in miscarriage a little later. In all, these data miners discovered, one third of pregnancies were lost before birth.

Most recently, an article from this team published in the Journal of the American Medical Association in October 2001 showed that home pregnancy tests may not be able to detect pregnancy as early as their advertisers claim. With more than $200 million of these kits sold annually in the U.S. alone, the researchers' latest findings have been widely cited.

But that is not the only research in the pipeline for Wilcox. A 6-year study of cleft lip and palate is concluding in Norway, which has one of the highest cleft rates in the world. Researchers are looking at agricultural and other sources of pollution as possible environmental causes that may interact with genetic factors. Questionnaires and biological samples were collected for the 600 babies with clefts and their parents, as well as for 800 healthy control babies and their parents.

Wilcox came to NIEHS in 1979, right after the pollution of the Love Canal became common knowledge. This was a time when reproductive effects of pollution had become a hot topic for the American public. One of the first noticeable effects of Love Canal was increased miscarriage in women who lived near the toxic dumpsite in New York.

NIEHS, with its mission of studying environmental agents and disease, was the perfect place for the young researcher who already had an interest in reproductive issues. He describes NIEHS as a land of "freedom and opportunity" for a young investigator.

"It was a place where I could do what I wanted and still fit with the needs of the institute," Wilcox said. NIEHS provided the stability to focus and build a research program without having to worry about funding. "And, I'm glad to say, it's still a great work environment today."

Weinberg described Wilcox as a "an incredibly talented person — both a brilliant and thoughtful epidemiologist and a warm, funny and compassionate person" who has touched the lives of many people in so many ways.

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