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Micheal Berens Conducts
Failed Brian Tumor Research
on Female Dogs and Their Puppies

TITLE OF THIS PROJECT:
Allogenic Glioma in Immune Competent Dogs:

Michael Berens is a Ph. D. who is a member of the Neuro-oncology Department at Barrow Neurological Institute of St. Joseph's Hospital and Health Center in Phoenix, Arizona. Since 1997, Dr. Berens has been funded by a grant awarded to him from the National Institute of Neurological Disorders and Stroke. Michael Berens has established a canine glioma laboratory and breeding project to create in dogs and puppies high grade malignant brain tumors. Dr. Berens plans to use the puppies and dogs for toxicity testing in cancer treatments. He also plans to market the dogs and puppies for toxicity testing and to provide the dogs and puppies as canine glioma models to other laboratories wishing to use them in cancer research.

Michael Berens' Subjects:

Pregnant female beagles and their unborn and maturing puppies. Earlier in this project, Dr. Berens' also used greyhound dogs.

Method:

Glial cells are small cells that surround the neurons in the brain. Neurons do the work of conducting information and controlling our bodies. Glia protect and nourish the neurons. Sometimes the genetic coding goes wrong in glial cells and a brain tumor develops. This tumor is called a glioma. The most malignant and deadly glioma is an astrocytoma. Astrocytomas are highly malignant brain tumors in humans and in other animals that grow rapidly destroying cells in the brain. Michael Berens harvests astrocytoma cells from dogs with spontaneously arising brain tumors to implant in developing fetal puppies. Dr. Berens also obtains glioma cells from a laboratory in the United Kingdom.

Female beagles are bred. After becoming pregnant, the females are subjected to uterine laporoscopic surgery when the fetal puppies are thirty-seven days old. These surgeries can take from four to fourteen hours. The developing puppies are injected, under the skin, with glioma cells. Thirty-seven days in gestation is a point in development when a puppy's immune system will not reject the cells. Dr. Berens predicts that the cells will cause the development of small tumors under the skin of the puppies. Puppies who develop the subcutaneous tumors are subjected to a second surgery. At four to six months of age, the tumors are excised from under the skin of the puppies. The puppies are put into a stereotaxic instrument, a hole is bored into the skull, the membrane covering the brain is punctured, and the excised tumor is implanted in the frontal or parietal lobe of the puppy's brain.

The implanted tumors develop into large, highly malignant brain tumors in the puppies. Michael Berens justifies these procedures because he says that the course of these brain tumors and treatments will be followed in order to assess tumor growth and treatment for humans. Puppies who reach the final stage of this experiment in which tumors are implanted into the brain will be assigned to one of the following conditions:

Group 1: The brain tumors simply are allowed to grow. Two papers published by Dr. Berens include pictures of the brains of two dogs in which the tumor has destroyed half of the brain.
Group 2: The brain tumors are allowed to grow and the tumors are irradiated.
Group 3: The brain tumor is allowed to grow and the tumor is irradiated and treated with experimental chemotherapy.
Group 4: The brain tumor is allowed to grow and the tumor is surgically excised, irradiated, and treated with experimental chemotherapy.

At between nine and twelve months of age, these puppies are destroyed, their bodies drained of blood and perfused, and histologies are performed. These dogs live for about a year; a year of illness and painful and invasive experimental treatment. They spend their short painful lives as little more than a living petri dish for growing malignant brain tumors.

Objectives of research:

  1. To perfect the procedure for injecting cancer cells (glioma cells) into unborn puppies at a time when their undeveloped immune systems will not reject the cells.
  2. To use this procedure for developing an animal model of malignant brain tumors.
  3. To study the course of these brain tumors.
  4. To study different courses of experimental therapy.
  5. To market the patented procedure for injecting the cancer cells into fetal puppies and "tricking" their immune systems into accepting the cancer cells.
  6. To market the dogs and puppies with brain tumors for toxicity testing of cancer treatments.
  7. To distribute the dogs and puppies with brain tumors to other laboratories for use as subjects in research.
  8. To establish a full breeding program to maintain a supply of puppies and dogs with malignant tumors for research and toxicology testing.

What is the value of this research? Over the last ten years, extending from 1990 to 2000, Dr. Berens has worked with approximately four hundred and seventy one female dogs and their unborn and developing puppies. He has performed hundreds of fetal implants on unborn puppies at thirty-seven days in the gestation period. Initially, surgeries on the mothers took as long as fourteen hours. Now surgeries take approximately four hours. Complications for the mothers include the effects of prolonged surgery, anesthesia, and spontaneous abortions.

The fetal puppies that receive cell transplants fair very poorly. At least 75% of the puppies are aborted or stillborn. The remaining puppies that survive frequently suffer from birth defects including hydrocephalus, missing limbs, and other congenital problems induced by the fetal surgery. Only 2% to 5% of the puppies, born alive, ever develop any tumor. The few remaining healthy puppies, although tumor-free, face a life of permanent confinement in a laboratory or euthanasia. From the hundreds of puppies subjected to this procedure, only a small number ever receive a cranial implant. For those unfortunate few, there are multiple surgeries to debrade and reduce the size of the quickly growing tumor, radiation and chemotherapy until, in Dr. Berens' words, "They cannot take anymore." In a ten-year period in which an estimate 471 dogs and puppies have been used and killed, two successful fetal surgeries and tumor implants have been published and documented. The failure rate of this project is 95% and perhaps, as high as 98%.

How does the scientific community view Michael Berens' research? Until 1999, Michael Berens, housed his dogs and puppies at Arizona State University. In 1999, the Arizona State University Institutional Animal Care and Use Committee, refused to support the research any longer by housing Michael Berens' dogs or puppies at their facility. The withdrawal of support came because of serious concerns by IACUC members regarding the overall failure of the project, the large number of dogs and puppies already involved and killed, the prolonged and unnecessary confinement of the dogs and puppies, the large number of healthy puppies that were euthanized because they failed to develop any tumor, and the suffering of the few puppies that actually developed a malignant brain tumor. One IACUC committee member bluntly asked Dr. Berens when he would acknowledge that his project had failed.

Michael Berens responded to these concerns of his colleagues by transferring the remaining puppies to a Veteran's Administration facility in Tucson, Arizona. He continues to do the fetal implants at Barrow Neurological Institute and shows no evidence of terminating the project. The project continues to be supported by the National Institute of Neurological Disorders and Stroke.

Other serious areas of concern for animals used in research at Barrow Neurological Institute: In 1998, a member of the National Institutes of Health Office of Extramural activities made a performance site visit to Barrow Neurological Institute. What he observed at Barrow spurred the official to contact NIH and report several areas of serious noncompliance. The most glaring area of noncompliance was in the lack of IACUC reviews. Several research projects at Barrow were not reviewed according to their animal welfare assurance filed with the Office of Laboratory Welfare at NIH. One project, involving primates, had not been reviewed for twelve years. NIH requires that every research project funded by them be reviewed every three years. The NIH official reported several other areas of concern including the fact that the staff veterinarian could not obtain continuous access to surgical areas in which animals were being subjected to surgical procedures and a continuing lack of communication between Barrow and NIH.



UPDATE
Patches

Pictured left is Patches who was released
from the Michael Berens Project
in December 2000.


We are very grateful for your hard work and commitment in helping IDA bring a permanent end to Michael Berens' brain cancer research on beagle puppies and their mothers. There have been some significant victories in the effort to stop this failed brain tumor research. The victories have come because of the letter writing, telephone calls, and protests by thousands of people committed to stopping this cruel research.

On December 15 and December 16, 2000, Michael Berens released 19 of 22 beagle puppies being held at the Veteran's Administration Hospital in Tucson, Arizona. The puppies had been held at the VA facility for over a year after they were transferred from Arizona State University following that institution's termination of the Berens' protocol. In a November meeting with the Barrow Vice President for Research, Dr. Elliot Katz and others were told that the puppies would be euthanized and their tissue used for genetic studies (the studies could have been done with a blood test and were meaningless because Michael Berens could not determine if the puppies had even received cancer cells). The 22 puppies were the only living survivors of the fetal implant surgery. 135 healthy puppies had survived the surgery and, after not developing tumors, had been killed. Arizonans went into action sponsoring a candle light vigil in front of Barrow Neurological Institute and renewing their efforts to save the lives of the puppies through telephone calls and letters. Suddenly, in the middle of December, Dr. Berens quietly arranged for 19 of the puppies to be adopted to employees at the Tucson VA Hospital. The Phoenix New Times reported the adoptions in a story titled, "Who Let the Dogs Out: The Beagles are going Home"
(www.phoenixnewtimes.com/issues/2001-01-25/news2.html).
The employees were told that they were not to let anyone know about the adoptions because animal rights activists would see it as a victory and the project that the puppies had come from was just coming to an end. Recently, the 20th puppy also was adopted out.

Through each of your efforts, the lives of 20 beagle puppies have been saved. IDA continues to gather information about the two puppies that were not adopted from the project and were taken back to Barrow Neurological Institute.

On January 4, the Phoenix New Times published a break-through eight page story on the Berens' project with a fair and accurate presentation of the reasons for serious concerns about the project. The title of the story is "Screwing the Pooch". In the same edition of the New Times, another story appeared discussing the ethics of using animals as research subjects.

Michael Berens has not reapplied for funding from National Institutes of Health (NIH) and NIH currently is not funding the project.

Concerned Citizens for Animal Welfare (C.C.A.W.), a new organization made up of prominent community members and civic leaders in Arizona, has been formed to help permanently stop the Berens' research on beagle puppies and to address other issues regarding research on animals at Barrow Neurological Institute.

Members of Congressman John Shadegg's congressional office staff met with Dr. Pat Haight and other community members in April to discuss ongoing concerns regarding the Berens' research. Following that meeting, Congressman Shadegg wrote a letter of inquiry to both the USDA and NIH. Congressman Shadegg had earlier asked NIH to place a moratorium on funding for the project and to conduct a full review of the project.

As part of the World Week for Animals in Laboratories, Arizona community members protested the lack of responsiveness by Senators John McCain and Jon Kyl to letters from their constituents asking for the Senators' active involvement in the Barrow issues. At the protest in front of the Phoenix offices of Senator John McCain as community members stood in the sun in soaring 100 degree heat, a national advisor for Senator McCain came out and assured Dr. Pat Haight that the Senator would follow through on a written request to him. Following a written request by Dr. Haight, Senator McCain, too, made an inquiry at both the USDA and NIH regarding the Berens' project.


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