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POLITICS: Bush's decision will set course of U.S. research

Stem cells have become the Aladdin's lamp of biology, potentially granting wishes of curing Alzheimer's disease, heart failure, diabetes and other common killer disorders that affect 128 million Americans.

Whether the lamp gets rubbed sufficiently to produce its wonders is now at the center of an acrimonious debate over federal funding for human embryonic stem cell research.

The battle lines appear to be drawn between abortion foes, who oppose federal support on the grounds that obtaining embryonic cells requires destroying an embryo, and those who believe no area of research should be shut off, even if it raises ethical concerns, and especially if it promises so much help to so many people.

But often overlooked in the debate is the tremendous ripple effect that either a ban on embryonic research or its approval will have on whether biology will ever be able to solve the mystery of reproduction, which could lead to the prevention of birth defects and cures for infertility, and whether we will be able to enter the new era of curative medicine, and whether the U.S. can retain its pre-eminent role as the world's biotech powerhouse.

The uncertainty over federal funding, which fuels academic research, has raised concerns about a brain drain from the United States to England, France, Japan, Australia and other countries as bright young scientists see the most exciting field in biology stalled or even drying up in the U.S.

At the core of this dilemma are two of the greatest biological discoveries of all time, human embryonic and adult stem cells.

The mightiest of these--those that can make all of the more than 250 different cell lines of the human body--have the potential to make replacement body parts. The vast majority of scientists and the public are hoping that the Bush administration grants their wish for federal funding for human embryonic stem cell research.

But opponents say destroying an embryo to retrieve embryonic stem cells is tantamount to taking a life, and the wish should not be granted.

Instead, their wish is to have the federal government support research only on adult stem cells, which they say have the same potential for medical cures as embryonic cells. Each individual organ system seems to have its own adult stem cells to make replacement tissue.

However, since no one really knows which stem cell line will provide the most benefits, or whether adult stem cells can obviate the need for embryonic cells, the American Academy of Pediatrics, the American Medical Association, the National Institutes of Health, in fact almost the entire scientific community, are making a third wish--federal funding for both embryonic and adult stem cell research.

Federal funding is key because it can unleash a huge army of university researchers who could greatly speed up important discoveries. Without federal money, embryonic research would proceed at a snail's pace in privately funded labs.

This remarkable controversy illustrates how rapidly science is advancing and how, more than ever before, people need to keep abreast of these developments to make decisions about their use.

It also shows that biology, once a slow-motion science, is now moving ahead at lightning speed and is placing in the hands of researchers the genes and chemicals that can be used to manipulate life processes in vastly different ways.

The discovery of genes and the ability to engineer them have dramatically changed the face of biology. They have raised great expectations for discovering the cause and cure of disease. They have also raised ethical and religious concerns about the sanctity of life. These changes have elevated biology to big business.

Twenty-five years ago, biology was still a bench-top science, and scientists went into it for the glory of making a discovery that advanced knowledge. James Watson and Francis Crick didn't make a nickel commercially from their 1950s discovery of DNA, the genetic code of life.

But their Nobel Prize-winning discovery paved the way for today's molecular biologists, who can become millionaires overnight. All it takes is the discovery of a gene or a protein, or a way to manipulate a cell, such as human embryonic stem cells, that can be used to make a new drug or therapy.

Most top researchers, for instance, are affiliated with a biotech company, which was unthinkable only 10 years ago. University of Wisconsin and Johns Hopkins scientists, for instance, made the discovery of human embryonic stem cells using money from Geron, the Menlo Park, Calif., biotech company that now has the exclusive licenses to the embryonic patents.

Most of the rest of the world does not seem to have the same trouble as the U.S. in dealing with embryonic research. England earlier this year passed a law approving embryonic research under strict guidelines that apply to public and private researchers. The House of Lords, a conservative body, cited the potential for developing new treatments for disease.

The European Group on Ethics in Science and Technology, which advises the European Commission, said that in countries where research on human embryos is already legal, there are no additional ethical barriers to the use of embryos for stem cell research.

Roadblocks in private realm

If the Bush administration decides to ban federal support for human embryonic research, such research would continue in this country under private auspices, but at a vastly decreased rate. A further roadblock is private companies' insistence on patenting their discoveries, a practice that could stop other researchers from entering the field.

"It would delay the discoveries that could lead to changes in human lives," said Dr. Irving Weissman of Stanford University. Although he has spent his career researching adult stem cells, Weissman said that embryonic research is essential for understanding human biology and opening the door to new cures.

"You always hear from the other side that `you're killing an embryo' or `you're killing a human being' when you don't allow a fertilized egg to go all the way. . . . If you ban it you are also killing human beings very directly by what you do because you're preventing the kinds of research development that would potentially work in people who are already born, who are already alive, already thinking, already have hopes and dreams."

And just as genetic engineering led to the development of America's prized biotech industry in the 1980s, embryonic research could lead to a new round of biotech companies, but not in this country, Weissman said.

Scientists faced a similar threat to research in the '80s when abortion foes wanted the federal government to ban funding for research using aborted human fetal tissue. Proponents said the aborted tissue was only going to be discarded and that transplanting some of the cells into patients with incurable disorders might help them.

When the fuss was over, the federal government set up strict guidelines on how to harvest fetal tissue--a woman or couple could not be paid and they could not designate who would get the tissue--and is now spending about $20 million a year to support more than 100 research projects.

But the use of human fetal tissue for research goes back much further. More than 50 years ago, the polio vaccine was developed after scientists learned how to grow the paralyzing virus in human fetal cultures.

The newest use of fetal tissue is to develop cures. The lessons to be learned from this experience show that, despite the promise of a new technology, research progresses slowly, trials in humans take a long time, unexpected things can happen, and what at first looked like a breakthrough may only be a significant advance.

Parkinson's study

Yet the results from the biggest study to date of fetal tissue are guardedly encouraging. The study involves 40 Parkinson's disease patients, half of whom had brain cells from aborted fetuses implanted in their own brains in hopes they would produce a missing chemical, dopamine, that regulates movement.

It also shows that controversial research, which starts off being funded by private sources, can gain federal support to speed new discoveries.

Dr. Curt Freed began experimenting with human fetal tissue for Parkinson's disease 13 years ago using private money. In 1991, he received his first federal support after the National Institutes of Health changed its policy, based on the fact that abortions are legal and animal studies indicated that fetal tissue might be useful for some disorders.

Reporting last March in the New England Journal of Medicine, Freed and his colleagues said the fetal tissue transplants were working in 85 percent of the patients and that the fetal cells were producing dopamine.

Tests of the patients' movements, walking ability and jerkiness showed that 18 percent of those who received the transplants improved compared to patients undergoing a sham procedure. But a big improvement occurred among patients younger than 60: one-third of them showed significant recovery, and some even stopped taking Parkinson's medications.

However, the news that got picked up from the report was that five patients had complications related to the transplants. Freed said these patients had become sensitive to dopamine and could not tolerate normal amounts. For them, the dopamine caused some jerky movements.

Three of the five were successfully treated either with drugs that reduce the effectiveness of dopamine, or with electrodes implanted in their brains that quiet jerky movements, Freed said.

The other two opted not to have any further treatment because they felt better and said the jerkiness did not interfere with their lifestyle.

One of them, an electrician, was happy because he was able to walk twice as fast as in the past, cutting his time to the train station from 40 minutes to 20 minutes.

"What actually happened was what we thought would happen," Freed said. "There was a spectrum of responses, with the younger patients showing the most significant improvement."

Freed has launched a second large experiment in which transplanted fetal tissue will be placed in a different location in the brain to reduce side effects.

As some people debate stem cell research, others are taking action. The potential of embryonic and adult stem cells to revolutionize medical care is so great that it has become the driving force behind a new field called regenerative medicine.

It has long been known that the body can repair itself, stitching up wounds and beating down infections, in ways that depend on the body making new cells. Mainstream medicine depends on this natural healing process for many victories.

But, if damage is too severe or a disease becomes chronic, these natural repair processes no longer can do the job. Heart muscle cells die when a blocked artery stops delivering blood, and holes appear in the brain of Alzheimer's patients when neurons wither and die.

Instead of patching up broken bodies, regenerative medicine has the lofty goal of restoring health, function and youth.

"This whole business about regenerative medicine is really becoming quite a major field," said Ronald McKay, chief of the laboratory of molecular biology at the National Institute of Neurological Disorders and Stroke. "But how quickly it will turn into clinical benefits is hard to say."

McKay's lab is using embryonic cells from mice to make new brain cells that become incorporated into the animals' brains. His goal is to coax the new neurons into making the movement-regulating chemical dopamine that is missing in Parkinson's patients.

So far he has not succeeded, but "this is the first time that we've really thought that we can manipulate the adult brain."

Earlier this month, the University of Pittsburgh School of Medicine set up the McGowan Institute for Regenerative Medicine, the first of its kind. The institute is designed to bring together university researchers working on stem cells, artificial organs, tissue engineering and other advances to restore or replace diseased body parts.

New tools

"The tools through which you can do regenerative medicine are very new," institute director Alan J. Russell said. "It's very exciting. The field is moving so fast that literally what you can accomplish seems to change on a daily basis."

Pittsburgh scientists Michael Chancellor and Johnny Huard recently isolated muscle stem cells that they used to treat incontinence in rats. The stem cells were injected into the sphincter muscle that controls the outlet from the bladder where they produced new muscle cells and blood vessels.

One of the mysterious features of stem cells is that they seem to go where they are needed to build replacement parts. Scientists believe stem cells respond to chemical distress signals sent out by injured cells.

Dr. Margaret Goodell of the Baylor College of Medicine found that by injecting mouse bone marrow stem cells into the tails of mice that had heart attacks, the stem cells traveled through their blood to the site of damage, where they constructed new heart cells and new blood vessels to supply them.

"The basic research we are doing now will evolve into the regenerative medicine of the future and eventually into the prevention of diseases that regenerative medicine is designed to treat," David L. Stocum of Indiana University-Purdue University at Indianapolis wrote in the new publication, the Journal of Regenerative Medicine.

"Much remains to be done," he said, "but regenerative biology

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