By Kim Coghill

Washington Editor

WASHINGTON ¿ It looks like it will be at least several months before any legislation dealing with reproductive or therapeutic cloning lands on President Bush¿s desk.

But based on the way things stand today, it doesn¿t look too promising for U.S. scientists interested in therapeutic cloning. If Rep. Dave Weldon (R-Fla.) has his way, a scientist who clones an embryo for research purposes will be a criminal facing a fine and 10 years behind bars.

And unfortunately for the biotechnology industry, a majority of Weldon¿s colleagues agree with him. Last Tuesday, in a 265-162 vote, the House passed Weldon¿s bill (HR2505) banning all human cloning. On the same day, the House voted 249-178 to defeat legislation (HR2608) introduced by Reps. James Greenwood (R-Pa.) and Peter Deutsch (R-Fla.) that would prohibit reproductive cloning, but allow it for research.

And the final blow of the day occurred when President Bush issued a statement saying he supports the Weldon bill and ¿strongly opposes¿ language in the Greenwood-Deutsch legislation that permits human embryos to be created and developed solely for research purposes.

Although the Biotechnology Industry Organization (BIO) lobbied for the Greenwood-Deutsch bill, representatives from the Washington-based group don¿t see the House vote as a defeat. Instead, they view it as a temporary setback.

The issue now shifts over to the Senate.

Michael Werner, BIO¿s director of federal government relations and bioethics counsel, said the climate in the Senate is more favorable for BIO. ¿We know that powerful senators like [Ted] Kennedy have already said they oppose the Weldon bill and of course the Senate a few years ago stopped legislation that was very much like the Weldon bill,¿ Werner told BioWorld Today. ¿We can expect the supporters of Weldon, who want to criminalize all cloning, will probably try to push their agenda in the Senate, so we¿ll have to push back.¿

Sen. Sam Brownback (R-Kan.) this session introduced legislation (S-790) similar to Weldon¿s. Brownback introduced anti-cloning legislation in 1998.

Werner said if BIO-friendly legislation is introduced in the Senate, Kennedy (D-Mass.) is expected to be behind it. A spokesman for Kennedy said the senator hasn¿t decided whether he will introduce such legislation. However, he suggested Sen. Dianne Feinstein (D-Calif.) may author such a bill. Feinstein¿s office could not be reached for comment.

Many scientists believe therapeutic cloning is central to the production of breakthrough medicines, diagnostics and vaccines to treat a variety of diseases. Therapeutic cloning also could produce replacement skin, cartilage and bone tissue for burn and accident victims and help to regenerate retinal and spinal cord tissue. However, such cloning techniques cannot produce a whole human being.

Carl Feldbaum, BIO¿s president, called the House vote a step backward with the potential to reverse progress toward new medical treatments.

And while the Bush administration says it opposes human cloning, including the creation of cloned embryos for research, the White House continues discussing whether federal dollars should pay for stem cell research.

Werner expects a decision on stem cell research this month. As the law stands now, the government will pay for research on embryonic or pluripotent stem cells, so long as the private sector pays to collect them.

¿After the president makes his announcement about funding stem cell research, we can expect that the cloning and the stem cell issues will be debated, if not exactly at the same time, certainly side by side,¿ Werner said. ¿I would suspect September, October, November there will be a lot of debate about cloning and stem cell research.¿

Tom Daschle (D-S.D.), the Senate major leader, reportedly has said he will consider legislation authorizing stem cell research if Bush bans it.

Banning therapeutic cloning stifles some stem cell research, Werner said. ¿One of the obstacles to be overcome in stem cell research is figuring out a way to use that research for individual patients. Therapeutic cloning is an ideal way of solving the problem of immune response rejection, and by shutting off somatic cell nuclear transfer, you are severely undercutting the potential value of stem cell research.¿

Recently, Sen. Bill Frist (R-Tenn.), a Bush ally and avowed pro-lifer, released a proposal supporting stem cell research, provided a few conditions are approved along with it.

Frist recommends banning money for creating embryos solely for the purpose of research, and he recommends that funding be limited to blastocysts (the inner cell mass of the early embryo) that would otherwise be discarded. (See BioWorld Today, July 19, 2001.)

He also recommends restricting federally funded research to a limited number of stem cell lines.

Although Werner said BIO doesn¿t have a specific view on Frist¿s proposal, he did say there are several points within it that concern the industry. In particular, Frist wants to limit the number of stem cell lines federal funds will support.

Some scientists say restricting the number would not provide enough genetic diversity.

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