Washington Editor

WASHINGTON - If public opinion carries any weight in the legislative process, then a recent poll of America's view on therapeutic and reproductive cloning should assure scientists that Congress would vote on their side.

In a Senate Judiciary Committee hearing Wednesday, Sen. Dianne Feinstein shared a poll conducted by the Coalition for the Advancement of Medical Research (CAMR) showing that two-thirds of Americans support therapeutic cloning research to produce stem cells for treating life-threatening diseases and conditions, and that they want the government to allow it to proceed.

On March 6, CAMR surveyed 1,012 adults and found that 67 percent supported therapeutic cloning and 30 percent wanted to outlaw it.

Feinstein, a California democrat, is lobbying for support of bipartisan legislation allowing such research co-sponsored by Sens. Orrin Hatch (R-Utah), Arlen Specter (R-Pa.), Edward Kennedy (D-Mass.) and Tom Harkin (D-Iowa). (The legislation is referred to as S 303 or "The Human Cloning Ban and Stem Cell Research Protection Act of 2003.")

"Just this past December, we were told that the Raelians had cloned a human being," Feinstein said. "This is very likely a hoax. However, it underscores the point that we must ban human reproductive cloning now - before some unethical scientist is successful in creating a human clone."

Indeed, whether to clone a human is not the issue. If anyone in Washington supports that type of science, they aren't admitting it publicly.

The issue at hand is therapeutic cloning, or somatic cell nuclear transfer (SCNT). Much of the science community supports nuclear transfer, believing such research would provide new ways of deriving genetically matched embryonic stem cells that can be used to create cell and tissue transplants to treat diseases and injuries that afflict more than 100 million Americans - diseases like diabetes, neurodegenerative disorders, autoimmune diseases and certain cancers.

But there's a growing, vocal population of scientists, politicians and handicapped Americans who believe researchers can achieve the same results by studying adult, rather than embryonic, stem cells.

Illustrating that view, James Kelly, a wheelchair-bound patient advocate, told the committee, "I will not allow a baby to be killed to get out of this wheelchair."

He added, "Two years ago, while closely researching my own condition, I blindly accepted media reports claiming embryonic stem cells were our best hope to cure other conditions. When I realized the push for cloning was supported by companies that claimed they had no interest in pursing the field, I wondered why."

Based on his research, Kelly concluded that embryonic stem cells derived from cloning do not perfectly match the patient, contain known and unknown genetic defects, are expected to require immune suppression for immune-sensitive conditions, retain the genetic age of the donor, are not considered desirable for transferal and may be too expensive for patients to afford.

Kelly, who said he has a blue-collar background, presented the committee with eight pages of testimony, complete with two pages of references including publications such as Nature, Journal of Clinical Investigation, Science Daily and Journal of the American College of Cardiology.

He asked senators to consider legislation to ban all cloning (S 245) introduced earlier this year by Sens. Sam Brownback (R-Kan.) and Mary Landrieu (D-La.). (See BioWorld Today, Jan. 9, 2003.)

Brownback, who believes cures can be found in adult stem cells, told the committee, "[Nuclear transfer] is a procedure that results in a clone.

"We have to address the issue of when human life begins and do we treat [embryos under 14 days] as property or a person," he said. "We've been unwilling to decide whether it is a human life."

For Hatch, life begins in the womb. "I am proud to hold a right-to-life philosophy. I believe that human life beings in the womb, not the Petri dish," he said.

Legislation To Support Therapeutic Cloning

Feinstein's bill allowing therapeutic cloning imposes regulations on scientists conducting nuclear transfer research. Key points of the legislation show it would:

• impose a sentence of up to 10 years in federal prison for anyone attempting to clone a human being, and establish a minimum civil penalty of $1 million or three times the gross profits resulting from the violation, whichever is greater

• mandate that eggs used in this research be unfertilized

• prohibit the purchase or sale of unfertilized eggs, including eggs that have undergone nuclear transfer, to prevent "embryo farms" or the possible exploitation of women

• impose strong ethics rules on scientists mandating informed consent by egg donors; review of any nuclear transfer research by an ethics board; and safety and privacy protections

• prohibit any research on an egg cell after 14 days - when that cell begins to divide and when cell differentiation begins.

In the House

The Republican-held House passed legislation that not only bans all cloning, but also prohibits the U.S. from importing medical therapies created from cloned human embryos. (See BioWorld Today, March 3, 2003.)

Introduced by Reps. Dave Weldon (R-Fla.) and Bart Stupak (D-Mich.), the Human Cloning Prohibition Act of 2003 (HR 534) passed in a 241-155 vote.

The Washington-based Biotechnology Industry Organization was particularly offended by the legislation, referring to it as overkill.

Michael Werner, BIO's vice president for bioethics, said it was "draconian legislation" that could potentially have serious consequences on medical research.