Dr. Catalona’s patients and research participants in his studies conducted when he was at Washington University in St. Louis continue to ask about the status of the litigation in the dispute between Washington University (WU) and Dr. Catalona over the samples that the patients and participants entrusted to Dr. Catalona for use in his collaborative research program.

The background of this dispute is set out in past issues [Winter 2004, Spring 2004, Fall 2004, and Fall 2003,] of QUEST and can be accessed on www.drcatalona.com.

To date, WU has not honored the requests of approximately 6,000 men to transfer tissue and blood samples for Dr. Catalona’s research at Northwestern University.

Eight of Dr. Catalona’s patients and research participants have joined the existing lawsuit brought by WU against Dr. Catalona, as intervenors, stating that they, the patients and participants, own their samples, and federal regulations grant them the right to control the use of them. The Judge joined them as necessary parties.

The matter on the issue of ownership and/or control, and Dr. Catalona’s request for a permanent injunction against WU was tried before the Court at a formal hearing on April 11-13, 2005.

WU’s position at the hearing was that it owns the samples, and if the participants want to withdraw, then WU has sole discretion either to destroy their samples, strip their samples of the identifiers (names, demographic information), or “anonymize” them so they could never again be linked to the patient who provided the samples or to his family.

In the latter two cases, this would allow WU to continue to use the samples for any purpose WU wanted after the participants had withdrawn. Such use could include research on matters other than that to which the participants originally agreed upon in their informed consents.

The individual patients and Dr. Catalona requested that the samples be transferred to Dr. Catalona at Northwestern University upon the request of the patients. Briefs are to be submitted on June 1st for the Court’s consideration.

QUEST will continue to provide status reports on this issue.

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