Human Chorionic Gonadotropin (hCG) was a fascinating hormone to study in 1970, partly because not much was known about its behavior or makeup. Scientists did know that the human body secretes hCG only during pregnancy or during certain kinds of cancers. If they could find a way to precisely measure the hormone, they would have a reliable tumor marker, as well as a way to identify problems with a pregnancy. NCI’s Roy Hertz was studying a cancer called choriocarcinoma at the time. In this disease, patients exhibited tumors that secreted hCG. The clinicians wanted a way to test blood samples reliably for the presence of hCG so that they could track the tumor during treatment.

JV: We knew that the bioassay that was used for monitoring the amount of hormone they were measuring was very crude, very insensitive, but it was better than anything else we had at that time. So we needed another way of measuring the hCG in the presence of a finite amount of LH [luteinizing hormone].

At NIH, scientists at intramural institutes in Bethesda have the opportunity both to work at the laboratory bench and follow patients at the Clinical Center. Though the Reproductive Research Branch had moved to NICHD, the scientists collaborated with cancer researchers at NCI. Vaitukaitis and her colleagues examined patients with choriocarcinoma, a type of cancer in which patients showed elevated levels of hCG. While simultaneously working on purifying and developing tests for identifying hCG in human serum, they could study both current Clinical Center patients and blood samples previously collected by the NCI and frozen for research.

JV: In  In screening some of these patients, we routinely took blood and measured hCG in them. We started turning up hCG levels in some of these patients. This was brand-new territory. But here we were working in a laboratory—it really underscores why you need physicians to be involved with clinical research. If you can make the diagnosis, you had a way of treating the disease.

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.