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Pitt, Johns Hopkins scientist sued over prostate cancer research

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Thursday, Sept. 3, 2009
 

A Johns Hopkins researcher and the University of Pittsburgh committed more than five years of research fraud, a Redmond, Wash., company said Wednesday in a lawsuit filed in federal court.

Onconome, a privately owned biotechnology company, said it spent millions of dollars funding prostate-cancer research based on a patent held by the university and Dr. Robert H. Getzenberg. The company also spent millions preparing to produce and market tests based on the patent — only to find that it was based on scientific breakthroughs that "were and are imaginary," the lawsuit states.

"Notwithstanding the spectacular (and false) results proclaimed by defendants, the Getzenberg assay was no more accurate in distinguishing cancerous tissue from normal tissue than flipping a coin," according to the lawsuit.

Pitt spokesman John Fedele said the university doesn't comment on pending litigation. Getzenberg couldn't be reached for comment.

Getzenberg claimed in 2001 to have found a biomarker — Early Prostate Cancer Antigen or EPCA-2 — that was found only in human patients with prostate cancer. Investors founded Onconome based on his claim but learned from other researchers in 2007 that Getzenberg never successfully mapped human DNA and that the only protein he correctly mapped came from a rat, the lawsuit states.

Between 2002 and 2008, Getzenberg acted as the chief scientific development and spokesman for the company. In at least 23 board meetings, he presented research updates claiming progress in developing his alleged discovery into a workable test for prostate cancer, according to the lawsuit.

The progress, though, was illusionary, the lawsuit states. Getzenberg would present the company with carefully selected lab results to show his research was working, but he left out "most of the data from his lab, which was inconsistent with his claims."

The company is suing Pitt for failing to properly supervise Getzenberg's research.

Steven Recht, a Weirton, W.Va., lawyer representing Onconome, declined to comment on the lawsuit other than to say the 68-page complaint lays out the specific claims that the company is making against Pitt and Getzenberg.

An accurate prostate-cancer test would be valuable. Prostate cancer is the most commonly diagnosed cancer and the second-leading cause of cancer deaths in American males.

The lawsuit says the test for prostate cancer is "problematic" because it often detects cancer where none exists.

Doctors commonly screen for prostate cancer by using a screening test known as PSA — for prostate-specific antigen — that measures a protein in the blood. Although some doctors have questioned its accuracy, others say the PSA is a reliable tool.

"Used in the right way, the PSA is a very good tool," said Dr. Jitendra Desai, a urologist at UPMC Passavant in McCandless. "I'm not sure of the effectiveness of these new tests."

Desai said some men should undergo a PSA in combination with a digital rectal exam — a combination that can help detect cancer in its early stages when treatment is most successful.

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