Using an advanced computer program and a single drop of blood from patients, researchers from the National Institutes of Health and a private firm, Correlogic Systems Inc., reported that they had accurately diagnosed 50 out of 50 women with ovarian cancer.
The results created a sensation.
Ovarian cancer is especially lethal because it tends to go undetected until it's too late. By the time symptoms appear, 80% of its victims are too ravaged by the disease to be saved. Reliable, early detection and treatment would save lives.
But nearly three years later, the diagnostic breakthrough is not close to reaching patients.
The project stalled while the government's two lead researchers -- Dr. Lance A. Liotta of the National Cancer Institute and Emanuel F. "Chip" Petricoin III of the Food and Drug Administration -- signed on as paid consultants with a rival of Correlogic named Biospect Inc.
Both companies were seeking ways to diagnose diseases, including ovarian cancer, by developing systems that could recognize patterns of proteins in the blood. In order to verify whether such systems would work, both companies were seeking samples of blood from patients.
Correlogic, which was working with the NIH on its product, complained in mid-2003 about Liotta's deal with Biospect. But senior officials at the National Cancer Institute allowed Liotta to continue as a leader of the government's ovarian cancer collaboration with Correlogic and as a paid consultant to Biospect. An administrator said that he saw no reason to believe that Liotta's consulting was overlapping with his government work. Similarly, Petricoin had received permission from the FDA to enter into the paid arrangement with Biospect.
Interviews and government and company records examined by the Los Angeles Times show that Liotta and Petricoin shared information with Biospect executives about their work with Correlogic, sometimes consulting with Biospect directly from their government offices.
Liotta and Petricoin declined through an attorney to be interviewed for this article. The attorney, Charles J. Morton Jr., said that both men had performed their government duties diligently and properly and had shared no information that was confidential. Any delay in developing an ovarian cancer test, Morton said, was not the fault of Liotta or Petricoin.
In sworn testimony this year to the House Energy and Commerce subcommittee on oversight and investigations, the scientists said that their jointly arranged and paid consulting services for Biospect were unrelated to their government work on the ovarian cancer test.
"I would never knowingly engage in any conflict of interest," Liotta, a 28-year NIH employee, testified May 18.
Petricoin, an 11-year FDA employee, testified that his consulting for Biospect was "performed to the highest ethical standards." He added that "at no time did I directly consult with Biospect about the work in our research [collaboration] with Correlogic, or provide them with any secret or nonpublic information."
Spotting a Promising Idea
The idea for using a drop of blood and a computer program to detect ovarian cancer was hatched in June 1999, when Petricoin and Peter J. Levine, Correlogic's president, had brunch with their wives in Alexandria, Va. The women had met at work, and the couples were social friends.
The two men scribbled notes on a cocktail napkin about spotting patterns of protein in blood that might indicate ovarian cancer. The idea seemed promising. Soon, the National Cancer Institute and Correlogic began collaborating in the lab, examining blood samples from women who might be at risk for ovarian cancer and from women who already had the disease.
In February 2002, the company and government scientists published the favorable results in the Lancet, the British medical journal.
At first, progress was swift. In comments posted on the cancer institute's website, Liotta estimated that clinical studies seeking to confirm the results could start in about six months. Liotta, chief of the institute's laboratory of pathology, had already said publicly that the FDA might grant marketing approval for an ovarian cancer test on a fast-track basis.
In April 2002, the government agencies licensed Correlogic to commercialize the test being developed for ovarian cancer or other diseases.