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THE RABBIT RETURNS (Part II of "On the Trail of the White Rabbit")

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I had intended in this, the second installment of a series, to follow the pale hare to the testing labs and trial centers for a disease we designate a "national epidemic" in the U.S.: diabetes. However, since my earlier posting on the question of animal testing, I have received many responses from those on other side(s) of this controversial and emotionally-charged issue. (Earlier I presented arguments against testing put forward by Dr. John Pippin, head of Physicians for Responsible Medicine).

In the interest of fairness, I present here a different well-informed view of animal testing, a case for "responsible and humane" research, from Dr. Wise Young, with whom I have been in regular correspondence since publication of the first White Rabbit installment. (BTW, the time seems to be right for increasing public awareness about animal research testing -- CNN has been running reports on the "dark side" of animal testing. If the news has gotten to CNN, a conventional yet self-styled "cutting edge" news channel, then perhaps a more open and widespread public debate may not be far behind?)

Dr. Young, M.D., PhD, is a world-renowned expert on spinal cord injury, and a leader in its research and treatment. He is Professor of Cell Biology and Neuroscience at Rutgers and Director of the W.M. Keck Center for Collaborative Neuroscience. I decided to simply quote him at length (with his permission) on the subject of animal testing.

Let me state from the outset that I support "humane" animal research, where the animals are well-cared for and every effort is made to prevent their suffering. I differ from my colleagues on two issues. First, I do not support the requirement to do large animal safety studies for all drugs. I think that it should depend on the drug and the disease. Second, I think monkey studies are justified only if the experiments cannot be done on other lower species and the experiment will yield important information that would be of great benefit to animals and humans.

There are some experiments that should be done in people directly. For example, if something is reasonably safe, I would much rather that it be tried first in humans. That is why I am doing clinical trials. I am also really torn when it comes to animal models of pain. Many people that I know are in terrible pain. The difficulty and paucity of studies that cause and assess therapies of pain in animals is one of the reasons why we don't have better analgesic therapies. On the other hand, I find it difficult to justify inflicting pain or discomfort on research animals. Therefore, I think that we should be testing analgesics directly in people, as long as the evidence suggests that the treatment is reasonably safe.

I believe that scientists have an obligation to minimize animal use, particularly experiments with more intelligent animals. So, for example, every animal protocol that I submit to the Institutional Animal Care and Use Committee must justify the experiments by doing a literature search to show that there is a suitable alternative lower animal, cell culture, or computer model. It must justify the number of animals that will be used. Finally, if animals are dying or not doing well, the investigators must have a plausible plan to stop the dying and any suffering.

Animal experiments are necessary because some phenomena simply cannot be studied in humans and must be studied in animal models. For most of human history, the mammalian spinal cord was thought to be incapable of regeneration. The overturning of this dogma required detailed microscopic examination of animal spinal cords after various treatments. We cannot kill a human to look for regeneration in the spinal cord. The best MRI technologies, e.g. diffusion tensor imaging with 3T magnets, have relatively low resolution...cannot detect regenerating axons.

Many of the most important advances in surgery and medicine would not have come about without animal research. I have no doubt that if scientists had not developed the techniques of harvesting and growing animal stem cells, we would not have discovered... and developed ways to isolate and grow embryonic, fetal, neonatal or adult stem cells. Similarly, I believe that most of the advances in surgery (i.e. coronary bypass surgery, stent, etc.), medicine, cancer, and rehabilitation would not have occurred, if not for animal research.

The main argument for animal research is that animals can be used, enslaved, and killed for human benefit. If people disagree with this argument and believe that there is no justification for animal use, further discussion will not resolve the disagreement. I respect people who believe this. But, I think that it is hypocritical for people to say that using animals for research is unacceptable while they condone the use of animals for food and skin(s), and (or) to make animals work or perform.

Research kills fewer animals than the millions of pets that are killed in the pounds every week. Animal use in research is a tiny fraction of the number of chickens, sheep, pigs, cows, fish and wild animals that are killed for food. Many more wild animals are killed as pests (traps), poison(ing) and shooting -- than animals are used in laboratories.

I would submit, however, that animal research does more good for people and animals than any of the above uses of animals.

Finally, I love animals, even the rats and mice. I grew up with dogs and it is a long-held dream of mine to have a dog. When I was in college, I lived in an apartment with four cats and many kittens. So, animal experiments are not easy for me. I do the experiments because I believe that it will help people and other animals.

-- Wise Young, M.D.

Dr. Young goes on to note that the FDA is now (finally?) putting most animal safely testing results into data-bases that can be readily accessed, presumably, thus reducing unnecessary repetition of studies and experiments. He also says that there is strong motivation for businesses to reduce animal testing, as this testing is very costly. And, most intriguing, he feels that if people were willing to accept a "slightly higher risk" in the products they use, regulatory requirements could be lowered.

Changing regulatory requirements is a challenge that Dr. Young believes would save the lives of many thousands of animals. Instead, he says, animal research protesters are attacking university scientists and also companies. Most safety tests, he notes, are done by technicians in companies paid to complete the studies, "like a farmer would grow animals for slaughter." He is "all for minimizing such studies."

I selected a few examples from Dr. Young's own animal research history (as he provided it) -- which I thought might be revelatory, as I end this installment. Dr. Young finished medical school at Stanford, followed by a neurosurgery residency at Bellevue Hospital in New York in 1977. His first spinal-injured patient there was a 17-old wrestler who broke his neck in a match. Dr. Young: "I had to tell him and his parents that there was nothing that we could do." Because of this experience, he began studying treatments of spinal cord injury in cats, the only spinal cord injury model available at the time. As a "cat lover" he says, "this was not easy." However, "the two therapies that I tested were effective in cats: methylprednisolone and naloxone." Three years passed and he studied "about 70 cats" to obtain data necessary to take the two drugs to clinical trial. "I would do this again, if necessary, because (these) treatments (have) helped millions of people and animals."

In 1981, he tested the two drugs in two trials of 30 consecutive patients with acute spinal cord injury, demonstrating that the therapies were safe and beneficial. In 1985 he received an NIH grant to fund a multicenter clinical trial (the National Acute Spinal Cord Injury Study) showing both drugs were effective for human spinal cord injury. His 1990 published study showed that methylprednisolone was more effective and it is now widely used (for both human and animal spinal cord injury) around the world.

(Dr. Young included information on his studies with rats, mice, skates and monkeys -- but there is not space to reproduce them all here.)

"Since 1997, when I moved to Rutgers, I have focused on chronic spinal cell injury, particularly stem cell therapies. In my opinion, the discovery of stem cells was the most important factor in reducing the number of research animals used in laboratories. Before 1998, we had to kill animals just to grow neural cell cultures. Now we can grow them from stem cell lines derived from animals and humans and maintain the cells in culture indefinitely. I started the Stem Cell Center of New Jersey..."

Dr. Young adds, however, that "cell cultures cannot replace animal studies. "For conditions such as spinal cord injury, animal studies are essential for discovering new therapies and mechanisms, as well as (providing) data for safety and efficacy of therapies for clinical trials."

Dr. Young currently runs two clinical trial networks. In 2004, he formed the China Spinal Cord Injury Network, which includes leading centers for spinal cord injury in China, Hong Kong and Taiwan. This year, he formed the Spinal Cord Injury Network USA, with eight centers in New York, New Jersey, Philadelphia, Atlanta, Austin and Colorado. The two networks will be testing the most promising therapies for people with chronic spinal cord injury. The FDA, he says, requires significant animal data to demonstrate the safety of therapies before they will approve clinical trials.

When asked The Question -- "Can the system be changed to reduce animal use?" Dr. Young says he "believes so."

What do you think? More to come -- on the trail of the White Rabbit.

-- Carol Muske-Dukes