And What About The Science?

DANUTA OTFINOWSKI FOR TIME

If President Bush hoped that his decision last week to permit limited federal funding of embryonic stem-cell research would quiet the ferocious debate surrounding the issue, it was a hope that was quickly dashed. Since his announcement, advocates on both sides have continued to find plenty to argue about--whether there are really 60 existing cell lines on which the President would allow research; whether those lines would be sufficient to yield real results; whether the restrictive rules will simply drive U.S. stem-cell researchers to other countries where they can do their work with less government interference.

But nearly everyone agrees on one thing: stem cells, the unspecialized cells the body uses as raw material for tissues and organs, have the potential to treat an astonishing range of ills, including Parkinson's disease, diabetes, Alzheimer's and spinal-cord injuries. After Bush's decision, the question becomes whether they'll ever get a fair chance.

To most people, the idea of researchers dipping freely into an eternally regenerating, federally bankrolled pool of 60 stem-cell lines sounds pretty good, and that's just the way the President wanted it. "Research on these 60 lines could...lead to breakthrough therapies," Bush said. Maybe--provided scientists can get hold of them.

It was the National Institutes of Health that arrived at the 60 figure, conducting a worldwide survey of labs to determine which ones had viable cell lines already in inventory. As recently as last month, the nih put the figure at just 30, but after what a senior Administration official described as an "arduous process" of searching, the number doubled.

The day after Bush's speech, the Administration had boosted the figure even higher, to 65. And though the White House originally reported that only half a dozen of them were derived in U.S. labs, that number too was revised upward--to 30. Whatever the actual figure, no one denies that many of the cell lines were developed by private companies that protect creations of this kind with a seawall of patents. "It is very possible that they will either not be available or available at exorbitant prices with all sorts of legal clauses attached," says Yale cell biologist Dr. Diane Krause. Says Dalton Dietrich, scientific director of the Miami Project to Cure Paralysis: "That's what all the scientists are asking this morning--how am I going to get my hands on these cells?"

The White House insists that procedures are in place to deal with just this concern--in the form of so-called material transfer agreements, under which the NIH will negotiate with patent holders for access to their cell lines. "Obviously, in any area of medical or scientific research," says the Administration official, "there are companies that get out in front of the technology, and they get the patents."

In other areas of research, however, the door hasn't been closed to latecomers the way it has with stem cells, and that has the scientific community worried. In order to maximize the medical payoff from stem-cell research, researchers prefer to work with the most robust population of cell lines possible. No one knows, after all, if some lines are more viable than others and if some lend themselves to many uses while others to only a few. If too many of the lines dead-end or die off, research could stagnate. "Some stem-cell uses," says Krause, "will require diversity greater than 60 cell lines."

Here, too, the Administration is sanguine, pointing out that the wide range of countries from which the available cell lines hail--including India, Israel, Singapore and Australia--helps ensure that they will be as diverse as possible. Some researchers even insist that the precise number of cell lines isn't important at all because none of them will actually wind up in the body. At this early stage, investigators aren't so much developing cures as creating research and manufacturing techniques. For that, the specific cell lines aren't important. "This will enable the biomedical community to iron out the molecular biology of these cells," says Dr. Thomas Okarma, CEO of the biotech firm Geron, which finances stem-cell pioneer James Thomson as well as John Gearhart, "and that doesn't turn on one cell line vs. another."

Other people are troubled not by what the Bush ruling may do to the science but by what it may do to America's standing in the world. The U.S. was embarrassed once this summer when stem-cell researcher Roger Pederson of the University of California, San Francisco--fed up with all the hand-wringing and rulemaking--was seduced overseas by Cambridge University in England. This, of course, may be just an isolated defection rather than the start of a national brain drain. "I'm not packing," quips Thomson, who pronounced himself pleased that the feds would finally make some money available. But in the wake of Bush's decision, other countries may certainly be tempted to bid for more of America's best and brightest. "Overall," says Chris Higgins, director of the Medical Research Council Clinical Sciences Centre in London, "[the decision] adds to a general uncertainty as to where research can go in the U.S."