By Kim Coghill
WASHINGTON ¿ If some lawmakers have their way, the type of breakthrough science that made headlines over the weekend will be illegal.
The news broke Sunday that Worchester, Mass.-based Advanced Cell Technology Inc. (ACT) published a paper in the Journal of Regenerative Medicine saying it has created the world¿s first human embryos through therapeutic cloning, or somatic cell nuclear transfer. The controversial research led the news, briefly replacing the two-month-old talk of terrorism and war.
And that¿s not necessarily good news.
¿Before Sept. 11, we expected the cloning issue to come up in this session of Congress. After Sept. 11, we thought it would probably arise after the first of the year,¿ Carl Feldbaum, president of Washington-based Biotechnology Industry Organization (BIO), told BioWorld Today. ¿Now, after [Sunday¿s] announcement, it has accelerated consideration of cloning. The timing is unfortunate because it is the very end of a Congressional session and there is no time for due deliberation.¿
The debate ¿ or pending debate ¿ surrounds therapeutic cloning, not reproductive cloning, a procedure that BIO describes as ¿repugnant.¿
Already, the House has approved legislation (HR 2505) authored by Rep. Dave Weldon (R-Fla.) that bans both therapeutic and reproductive cloning. President George Bush, who opposes all forms of cloning, reportedly supports the Weldon legislation. (See BioWorld Today, Aug. 6, 2001.)
Meanwhile in the Senate, Sam Brownback (R-Kan.) has introduced an amendment to the Labor, Health and Human Services Appropriations Bill (HR 3061) that would criminalize therapeutic cloning.
The focus on cloning and stem cell research peaked Aug. 9 when Bush said the U.S. government would pay for research on 64 (now 72) existing stem cell lines located within 10 labs across the world.
While numerous human embryonic stem cell lines are in existence, ACT¿s prepared statement Sunday said those lines are of little value in human transplantation because they would be rejected by a patient as foreign. Human therapeutic cloning, the company says, has the potential to solve this problem by providing cells that are an exact genetic match for the patient.
In a television interview Monday morning, Michael West, CEO of ACT, called his research the first step in regenerative medicine.
ACT¿s paper reports preliminary studies on parthenogenesis, or activating the egg cell without fertilizing it with a sperm cell, and somatic cell nuclear transfer to form preimplantation embryos. In this research, human egg cells were prepared by removing their DNA and adding the DNA from a human somatic cell, according to the company.
When asked by a television reporter whether scientists should proceed in this area with caution since the same type of science could be misused to clone humans, West responded that it would be absurd to allow people to continue suffering from diseases because of potential abuse.
Feldbaum said BIO is doing an effective job of teaching lawmakers the distinction between those types of cloning. ¿Each time this issue has arisen, as it did in 1998 and again earlier this year, we¿ve had stronger support. For example, in 1998 [former Florida Senator] Connie Mack came over to our side and this summer Nancy Reagan wrote a letter to the president supporting therapeutic cloning for Alzheimer¿s,¿ Feldbaum said. ¿But I¿m not complacent at all because this is a very difficult moment to raise this issue. What concerns me most is that the issue will be brought up in a superheated environment where the administration and many members of Congress ¿ rightfully so ¿ are paying much more attention to the war and terrorism than they are to this technical issue.¿
ACT, a private company, contends that its goal in applying cloning to human medicine is to create stem cells capable of differentiating into a variety of cells, such as heart cells, neurons, blood cells or islets for transplant therapies.
Many scientists believe that therapeutic cloning is central to the production of breakthrough medicines, diagnostics and vaccines to treat Alzheimer¿s disease, diabetes, Parkinson¿s disease, heart attack, various cancers and many other genetic diseases.