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hCG Research at NIH/Page 4
hCG Research at NIH
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hCG Research at NIH

In 1972, Vaitukaitis, Braunstein, and Ross were ready to publish their major paper on hCG research, in which they described their methodology for using antibodies to the beta subunit of hCG in a radioimmunoassay to identify and measure hCG in the presence of LH. Before publishing, they met with the NIH lawyers to discuss patenting their process. Surely none in the room that day could have predicted the multi-million dollar business that the home pregnancy test would become within the next few decades. However, the test’s usefulness as an accurate tumor marker alone might have justified the patent, since by then the team had already used the test on Clinical Center patients and proved its reliability. But NIH declined to patent the test. Since the work was done using public funds, went the argument, the results should go immediately into the public domain, with no royalties for either the government or the scientists. This policy has since been changed. NIH now submits patents listing the scientists as co-inventors, and the scientists can receive limited royalties from their discoveries. But the millionaire’s life was not to be for the NICHD researchers.

JV: One of our concerns was that we [had] developed this assay and we wanted to protect the public from getting gouged with being charged for these tests, because we knew it would be picked up by the commercial outfits. But the legal counsel [of NIH] would not at that time allow patenting.

GB: We knew this would be a fantastic pregnancy test. We went to the government lawyers and said, “This is a technique that is going to be extraordinarily useful. Why not have NIH profit from it?” But since it was developed with public funds, the lawyers said no.

In the 1970s, the researchers went on to other subjects. Vaitukaitis returned to Boston to spend a decade at the Boston University School of Medicine before returning to the NIH in 1986 to work with the division that would become the National Center for Research Resources (NCRR). She has served as Director of NCRR since 1993. Glenn Braunstein went to California, where he continues research on hCG and other reproductive hormones at Cedar-Sinai Medical Institute in Los Angeles. In his long and illustrious career at NIH, Griff Ross would attain the posts of chief of the Endocrinology and Reproduction Research Branch, clinical director of NICHD, scientific director of NICHD, and associate director of the Clinical Center.

In 2003, as NICHD celebrated its fortieth anniversary, Institute Director Dr. Duane Alexander singled out the pregnancy test research as some of the most seminal work done by the Institute over its four decades. Judith Vaitukaitis was inducted into the NICHD Hall of Honor “for discovery of the beta subunit of human chorionic gonadotropin and identifying it as the earliest marker of pregnancy, leading to its development as the standard pregnancy test and as a monitor for response to cancer treatment.”

Note: Quotations labeled “JV” are from an interview with Judith Vaitukaitis, August 18, 2003. Quotations labeled “GB” are from a telephone conversation with Glenn Braunstein, October 3, 2003.

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Judith Vaitukaitis and Griff Ross, circa 1971
Judith Vaitukaitis and Griff Ross ca. 1971
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