Barrow Researcher May Have to Repay $1.5 Million in Federal Funds

Date: August 1, 2001

FOR IMMEDIATE RELEASE Contact: David Blatte, Esq., (510) 548-7382

Pat Haight Ph.D., (480) 394-0578

False Claims Suit Filed against Barrow Researcher and St. Joseph's Hospital.

Civil lawsuit could force researcher to repay $1.5 million in federal funds.

Phoenix, AZ…Barrow Neurological Institute Staff Scientist, Michael Berens, has been named as a defendant in a False Claims lawsuit filed in Federal District Court in San Francisco. The suit alleges that Berens made false statements to the federal government in his attempt to secure grant money. The suit was filed on March 23, 2001 by Berkeley attorney, David Blatte, on behalf of the U.S. government, the national animal advocacy organization, In Defense of Animals (IDA), and Arizona psychologist, Patricia Haight. It names Berens, St. Joseph's Hospital and Medical Center, Barrow Neurological Institute, Catholic Healthcare West Arizona, and Catholic Healthcare West as co-defendants.

At issue are alleged false claims made by Berens in an application for more than $500,000 to the National Institutes of Health (NIH) to conduct brain tumor experiments on beagle puppies, in subsequent progress reports, and in a 1999 published paper in Neoplasia. Among other things, the suit alleges that Berens misrepresented the success rate of his experiments and the success and accuracy of surgical procedures, which attempted to create brain tumors in puppies by injecting tumor cells into their legs in utero and transferring the tumors later to the brain. According to internal documents, the experiments had above a 95 percent failure rate, resulting in the deaths of more than 300 beagle puppies and dogs. The suit also alleges misrepresentation of the collaborative role of UK researcher, Dr. Geoffrey Pilkington.

The Federal False Claims Act, enacted in 1863 to stop misuse of Federal funds during the Civil War, allows a private citizen with knowledge of fraud to sue by filing a qui tam suit on behalf of the United States government. If found liable, Berens and his co-defendants could be required to repay as much as $1.5 million back to the Federal government.

Arizona State University (ASU) terminated any relationship with the Berens' project in 1999 because of ongoing concerns over surgical procedures, deaths of puppies who did not develop tumors, and the failure rate of the project. Two weeks after ASU put the project on modified approval in 1997, largely because of problems with the surgical procedures, Dr. Berens submitted a signed application to NIH stating that, "we have also achieved the technical and surgical skills necessary for realizing the desired outcome." Problems with the fetal implant surgery continued until the project ended in April 2001 and no significant improvement in success rate was ever achieved.

University of Arizona cancer researcher, Dr. Delon Washo-Stultz stated, "Year after year the scientific community struggles to secure funding for important research. Scientific integrity is fundamental in research. Dr. Berens' selective reporting of results and misrepresentation of the details of the Canine Glioma Project reflects poorly on the entire scientific community."

"The claims made regarding the number of tumors created and the preciseness and success of the surgical procedures do not match ASU Animal Care records for the dogs and Dr. Berens own admission of a 5% success rate" said Dr. Pat Haight, IDA Research Consultant. "We are not filing this suit because the research failed but because of claims made by Dr. Berens to obtain money from the Federal government after seven years of abysmal results. The suit is a way of holding Dr. Berens accountable for the suffering and deaths of the dogs and puppies and for recouping taxpayer money."

Attorney Blatte said "After seven years of failed experiments and hundreds of dogs needlessly killed, it was time to stop. Unfortunately, Barrow and Dr. Berens have not heard the message. Although Michael Berens is not currently doing work on dogs, some aspects of the protocol appear to continue even today."

Community business leader, Bari Mears was appalled, "The fine reputation of Barrow is not in keeping with the carelessness and lack of compassion demonstrated by Berens toward his subjects. He does not represent the standards of the hospital or of a compassionate community and should never be allowed to use animals in research again."

Update on Barrow Beagles!