Dr. Catalona's patients often ask, "What is the status of my tissue and blood samples that I donated for your research projects?"

This article is to update Dr. Catalona's patients, research participants, and other interested readers on the status of the dispute over the collection of samples begun by Dr. Catalona twenty years ago.

Last year, Dr. Catalona moved his clinical practice to Northwestern University where he is the Director of the Clinical Prostate Cancer Program of the Robert H. Lurie Comprehensive Cancer Center.

Prior to that move, Dr. Catalona wrote to his patients and research participants to tell them of the move and his plans to continue the research projects he had conceived years before.

Through the years, patients and participants have signed their consents for him to perform research on their tissue and blood samples. Dr Catalona's preliminary studies had identified regions in the human genome that are linked to prostate cancer, but the samples are still needed to further pinpoint those regions, identify the genes, and identify the mutations in these genes that are responsible for susceptibility to prostate cancer and the aggressiveness of the cancer.

Delays in finding this information will impact progress in important prostate cancer research.

When Dr. Catalona initiated a dialogue with Washington University for the transfer of samples based upon some 6,000 written consents and authorizations received to that point, Washington University lawyers requested to see the forms, and Dr. Catalona's attorney made them available for review.

Instead of sending the samples to Dr. Catalona or discussing the matter with his attorney, Washington University filed a lawsuit, claiming it owned all of the samples, that the patients' and participants' wishes did not have to be honored, and that Dr. Catalona should not have written a letter to his patients or research participants.

Dr. Catalona filed his formal response to the lawsuit on October 21, 2003, asserting that the patients and research participants have rights that must be protected, including the right to say who they want to perform research on their samples.

Dr. Catalona believes that it is appropriate for him to communicate with his patients and research participants. His response has asked the Court to honor their requests.

When called upon for an opinion, Dr. Lance Liotta, Head of Pathology of the National Institutes of Health (NIH) stated that the patients should control where their samples go. (St. Louis Post-Dispatch, August 7, 2003)

Dr. Catalona must now await the course of the litigation to see whether the samples collected under his research protocols will be considered property owned by Washington University, or whether the wishes of the patients and participants will be honored.

(QUEST readers may be interested in a website dedicated to information on patient rights: www.healthprivacy.org)

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