|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
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 ca. 1971