The Center for Public Integrity

In the spring of 1997, scientists at Scotland's Roslin Institute successfully reproduced a sheep using DNA from a single adult sheep cell. It was a spectacular breakthrough. But the birth of Dolly, the first cloned mammal in history, provoked outrage among anti-abortion activists and many bioethicists, and triggered a debate on the dangers of human cloning.

In the United States, public interest groups and religious organizations clamored for the federal government to regulate any research that would lead to human cloning. A CNN/Time magazine poll taken after the announcement of Dolly indicated that 89 percent of Americans agreed that it was "morally unacceptable to clone humans." President Clinton responded promptly by issuing an executive order on March 4, 1997, prohibiting the use of federal funds for human cloning, citing what he termed "profound ethical issues."

But the presidential action did not affect privately funded research. Meanwhile, the Scottish company owned by the Roslin Institute was bought in May 1999 by an American biotechnology firm, Geron Corp., bringing the possibility of human cloning closer to home for Americans. Subsequently, Japan, India and most European countries banned cloning or imposed laws supervising such research, while the United Nations, the World Health Organization and the G-7, seven top industrialized nations, called for an outright ban.

Yet nearly three years after Dolly, there still is no federal legislation in place in the United States to regulate or even supervise human cloning, though some states have acted.

What is perhaps the most complex scientific and moral issue ever faced by Congress has become the object of traditional inside-the-Beltway maneuverings. Campaign contributions, revolving-door politics and old-fashioned lobbying by the biotechnology industry have helped keep any sort of cloning legislation from being enacted.

Biotechnology companies specializing in stem cell research stand to reap huge financial windfalls from successful therapies developed via this science. To ensure that their research can continue and perhaps accelerate, some of the companies have teamed up with patients rights groups against certain religious and pro-life groups in the fight over federal regulation of this controversial field. As a result, what was once a debate between science and religion has become, in part, a clash between profits and ethics. New guidelines from the National Institutes of Health, released yesterday, mark the first hard-fought victory for patients rights groups and biotechnology companies interested in this issue. President Clinton took the occasion to voice his support for the guidelines, noting the "potentially staggering benefits" of this technology.

Geron Corporation and Advanced Cell Technology (ACT) are the two companies most interested in NIH funding for research involving stem cells derived from human embryos. Stem cells are indifferentiated, and can develop into brain, heart, or any number of more specific cells. They form within the first eight days of an embryo's life, and develop into almost all of the human body's various tissues and organs.

Since Geron's successful isolation of these types of cells in 1998, scientists and patients rights groups have jubilantly theorized about the extraordinary possibilities in developing treatments for a whole range of diseases and ailments. For example, depending on the future success of stem cell research, scientists might be able to grow stem cells into the neuron cells of the brain, which could provide treatments to those suffering from Parkinsons and Alzheimers disease, or heart cells for those suffering from cardiac ailments.

It was a sweet moment for J. Craig Venter, the president and chief scientific officer of Celera Genomics Inc. of Rockville, Md. On June 26, Venter and the head of the Human Genome Project, the government's genome venture, announced to a crowd assembled at the Capital Hilton Hotel in Washington, D.C., that they had finished decoding a rough draft of the human genome, which contains the entire set of human genes. Some in the audience raised questions about how much of "God's handwriting" would be controlled by a private corporation. Attempting to reassure the skeptics, Venter said, "No one is proposing to patent the genome."

But Venter was being somewhat disingenuous. While no one is proposing to tie up ownership rights to the entire genome, his company and others already are seeking 17-year patents for many of the 80,000 to 120,000 genes that are estimated to make up the genome. So far, genome-related companies have gotten a free ride, with the support of Congress and the U.S. Patent and Trademark Office behind them, in their quest to patent specific human genes. But as the gold rush to patent these genes accelerates, the companies might face a tougher challenge in convincing lawmakers and the public that patenting human genes is in the best interest of the public health, not to mention morally palatable.