"We inject everything that we think we can see."

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PHOENIX - In response to growing concerns regarding federally funded animal research projects, William Foley, President and CEO of Catholic Healthcare West Arizona, arranged a meeting, Thursday, November 16, 2000, between Barrow Neurological Institute and several members of the professional community. The meeting, held at Barrow Neurological Institute, was preceded by thousands of letters and telephone calls to Mr. Foley from Arizona citizens protesting the continuation of the failed cancer research project headed by Michael Berens, Ph.D. More than three hundred animals have died during several years of noncompliance with Public Health Service requirements on Barrow projects funded by the National Institutes of Health (NIH). Berens’ cancer research project, in which beagle dogs and puppies are used as subjects, has an ongoing failure rate of more than 95%. The noncompliance problems spanned the years 1986 through 1998, and included facility-wide failure to review projects involving animals properly.

Several members of the veterinary, medical and animal advocacy communities attended including: Elliot Katz, DVM, president of In Defense of Animals; Ann Chynoweth and Rick Swain, the Humane Society of the United States; and Janet Forrer, DVM, a Tucson veterinarian. Merill Chernov, MD, a prominent Valley surgeon; Ed Boks, Director of Maricopa County Animal Control; and Patricia Haight, Ph.D., an experimental psychologist participated as well. Aides to Congressman John Shadegg, Mr. Bruce Raden and Ms. Borgette Santaella were also in attendance. St. Joseph's Hospital and Medical Center was represented by Joan Rankin-Shapiro, Ph.D., Director of the Neuro-oncology Research Division at Barrow Neurological Institute.

Issues discussed included details of the failed, but continuing, Berens project and the facility-wide noncompliance problems discovered during the 1998 performance site visit by Dr. James O'Donnell, former Director of Extramural programs at NIH. Details revealed at the meeting by St. Joseph’s generated additional concerns among those attending the meeting. These concerns included:

• The canine glioma project has involved fifty fetal implant surgeries and yielded only three tumors in a ten-year period at a cost of more than $200,000.00 per year to taxpayers.
• One hundred-and thirty-eight healthy puppies not developing tumors have been euthanized and the project euthanizes every animal not developing a tumor. Apparently, twenty-two more puppies await this fate. The waste of healthy animals was one concern voiced by members of the Arizona State University Institutional Animal Care and Use Committee when it terminated the study at that institution.
• Serious problems with the fetal implant surgeries continue. These problems include difficulties in seeing whether fetal puppies are or are not injected with brain tumor cells. Dr. Shapiro said, "We inject everything that we think we can see." Problems with surgical procedures were a major point of concern for Arizona State University when it put the canine glioma project on restricted approval in 1997 and terminated the protocol in 1999.
• The project has moved to killing every puppy in the project and to genetic tissue analysis of all puppies in the project in the hope of identifying genetic predictors of tumor growth. Because of the lack of scientific control and surgical preciseness, there is a large pool of puppies in which it is not clear whether or not they were injected with cancer cells during fetal development. Therefore, any statements about the genetic make-up of these animals, with respect to cancer cells, are confounded, at best. On the other hand, The Wall Street Journal recently reported that genetic testing in human patients with glioma tumors is yielding vital information that predicts a patient's responsiveness to chemotherapy.
• Although forty-six mother dogs have been adopted out of the Berens project, at least eight mothers were destroyed because they were "unadoptable" due to behavior problems. Ed Boks, Director of Maricopa County Animal Control asked Dr. Shapiro to stop killing "unadoptable" animals and to allow him to find homes for such animals. Mr. Boks has a program to find homes for difficult-to-place animals.
• Although noncompliance problems on funded research projects, with respect to proper review, have been recently corrected, Dr. Shapiro admitted that other concerns voiced by the NIH site team in 1998 have not been addressed. [In an earlier conversation with Dr. Haight, Kathryn Bayne of the Association for the Accreditation of Laboratory Animal Care International (AAALAC) acknowledged that organization, too, had been aware of the Barrow concerns.]
• Dr. Shapiro acknowledged a conflict of interest during the meeting. Berens has a commercial patent on the surgical process of implanting the cancer cells into fetal puppies, the faulty process contributing to the large number of puppies being killed. St. Joseph’s Hospital will receive 75% of any proceeds generated by the patent. Due to the potential monetary reward, St. Joseph’s may be placing their economic interests ahead of the dogs’ welfare and even the best interests of human patients and their families hoping for a possible cure. IDA President, Elliot Katz, urged St. Joseph’s to relinquish its patent rights to eliminate any conflicting interests.

During the week of November 13, 2000, Arizona State University students and Barry Goldwater High School students and faculty signed petitions asking that Barrow Neurological Institute stop the canine glioma project; that Sheriff Joe Arpaio continue his investigation; and that NIH suspend funding for this project. Hundreds of signatures were collected on each petition. On Monday, November 20, petitions were delivered to Deputy Chief Locksa of the Maricopa County Sheriff's Department; to the office of William Foley, CEO of Catholic Healthcare West Arizona; to the Maricopa County Attorney's office; and mailed to the National Institute of Neurological Disorder and Stroke.

The Maricopa County Sheriff's Department has an ongoing investigation of the Michael Berens project. Congressman John Shadegg initiated a Congressional inquiry earlier this year.

Find out more about IDA's campaign against Dr. Berens and the Barrow Neurological Institute