Washington Editor

WASHINGTON - Nearly a month after President Bush signed a bill related to the use of cord blood-derived stem cells - a relatively non-controversial measure - more charged policy debates continue over the longstanding tumult surrounding embryonic stem cells.

Pro and con arguments played out last week at the Woodrow Wilson Center, which hosted a discussion, simply titled "The Stem Cell Controversy." The debate - labeled in the discussion as "divisive," and "a difficult morass" - has at its core differing opinions on the beginning of life, of course.

"A blastocyst is not a person," asserted Michael West, an embryonic stem cell proponent who heads the Alameda, Calif.-based company Advanced Cell Technology Inc. Blastocysts used at that stage provide a blank canvas of sorts - cells from them can be genetically modified in any way, he said, and are "nearly magical to a cell biologist."

West, also a professor at the University of California at Berkeley, based his argument on the reasoning that an embryo's existence for the first 14 days features no development, as it "has not yet committed to individualization." It does not make sense, he said, to argue that an embryo at this stage is a person. Therefore, therapeutic cloning (or somatic cell transfer) should receive federal funding.

William Hurlbut, a member of the president's Council on Bioethics, had a contrasting view. "The act of fertilization is a leap from zero to anything," he said, arguing that because the gametes cease to exist individually, "they effect a transition to a new organism, a human life."

A professor at Stanford University in Palo Alto, Calif., he favors alternative sources of the pluripotent cells and has advocated altered nuclear transfer. That involves using somatic cell nuclear transfer techniques, but intentionally alters the nucleus before transfer to create a biological entity that lacks the attributes and capacities of a human embryo.

West conceded that such an alternative "could be implemented," but maintained that it wouldn't be in patients' best interests. However, Hurlbut countered that policy ought to reflect a resolution on which all Americans could agree. "A purely political solution will leave our society bitterly divided," he concluded.

The matter is highly politicized already, with party lines often obscuring the scientific and ethical questions. Such divisions had to be overcome in order to secure passage of the Stem Cell Therapeutic and Research Act of 2005, said Sen. Orrin Hatch (R-Utah).

Those seeking federal funding for embryonic stem cell research had stymied the uncontroversial cord blood bill, claiming that it was developed as an alternative to progressing the more controversial research. Getting it through "was no small thing," Hatch said of the measure, which he co-sponsored with Sen. Chris Dodd (D-Conn.) in the Senate. It was guided through the House under the direction of Rep. Chris Smith (R-N.J.).

Labeled H.R. 2520, it is "a real step in the right direction," Hatch said, later noting that all stem cell technologies represent "the most promising health care and medical research, in my opinion, in the history of the world."

The pro-life senator has long had an interest in the area, and in the past has proposed a bill to ban reproductive cloning and prohibit research on any embryo created through somatic cell nuclear transfer beyond 14 days, while allowing federal funding for stem cells derived prior to that point. "I do want to make sure that life is protected," Hatch said last week, a belief held on par with a statement he has made on multiple occasions: that human life does not begin in a petri dish.

Still on the table, in addition to Hatch's proposal for an outright ban on reproductive cloning, is the Stem Cell Research Enhancement Act (H.R. 810), a measure that would allow federal funding for embryonic stem cell research. It passed in the House last summer and also has enough votes for Senate passage, including the backing of Senate Majority Leader Bill Frist (R-Tenn.), but it is likely to be vetoed by the president and lacks enough votes for an override.

In the wake of the scientific scam perpetrated in South Korea, West reminded Hatch and others in attendance that the U.S. has "another historic opportunity to lead the world in this area." Whether that resonates elsewhere in Washington remains to be seen.

FDA Makes Drug Labeling Changes

As part of its safety oversight upgrades, the agency is revising package inserts to improve prescriptions. Final guidance issued last week prioritizes warning information, which the FDA said could curtail many of the 300,000 adverse events that occur annually in U.S. hospitals.

The requirements include a new area called "Highlights" to provide quick access to important benefit and risk information. The inserts also will incorporate initial approval dates, and toll-free numbers and internet information for suspected adverse events are included to improve side effect reporting.

Acting FDA Commissioner Andrew von Eschenbach called the redesigned labels part of the agency's commitment to provide practitioners the "tools and information" needed to "optimize their clinical practice" while allowing them to make "more personalized prescribing decisions for their patients."

The FDA also has developed an online health information database, DailyMed, to provide free, up-to-date medication information to consumers, health care professionals and health care information providers.

Part D Drug Plan Having Difficulties

The Department of Health and Human Services has acknowledged prescription problems with the new Medicare drug coverage program, which went into effect at the start of the year and left many overcharged. Others claims couldn't be processed because of errors in enrollment lists.

Under the new system, the U.S. government is expected to buy nearly half of all prescriptions in the country, according to some estimates. Many states have taken action to cover seniors' drug costs until the problem is fixed.

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