Washington Editor

WASHINGTON - Researchers around the U.S. likely are praising a Harvard University scientist not only for creating 17 new human embryonic stem cell lines, but also for making them available to others.

Indeed, Douglas Melton, a professor of natural sciences, used private funds put up by Harvard, the Juvenile Diabetes Research Foundation International in New York and the Howard Hughes Medical Institute in Chevy Chase, Md., to derive the 17 stem cell lines. Researchers described the work in an article published online Wednesday in the New England Journal of Medicine. A print version will be included in the March 25, 2004, edition of the publication.

The news out of Harvard comes on the heels of Rep. Henry Waxman's (D-Calif.) charge that only 23 of 78 stem cell lines tapped for federal funding under President Bush's policy released August 2001 will ever be viable. Furthermore, Waxman has accused the administration of dismissing two scientists from the president's handpicked Advisory Council on Bioethics as punishment for questioning the stem cell policy. Members no longer serving are cell biologist Elizabeth Blackburn and ethicist William May.

Waxman, a member of the Government Reform Committee, makes no secret of his disdain for Bush policies, particularly those related to science. In fact, Waxman's website includes a section created "to provide an ongoing record of interference with science by the current administration."

In a five-page letter to Bush, Waxman and Rep. Louise Slaughter (D-N.Y.) quote National Institutes of Health sources as saying that eight of the 23 lines OK'd for federally funded research dollars are not ready for distribution. Of the remaining 55 lines, NIH officials have determined that seven are duplicates and 17 have failed to replicate. Thirty-one lines are the property of institutions outside the U.S. that do no have NIH funding, the letter said. (Originally Bush cleared 64 lines; the outstanding 14 were added to the count some months later.)

Making the point in more detail, James Battey, chairman of the stem cell task force at the NIH, told BioWorld Today that there are 15 cell lines ready for research, plus eight derivations at organizations that have NIH grants to be developed.

"So if all eight were developed into stem cell lines, we would have 23 distribution-quality cell lines," he said.

Also, there are 31 lines on the NIH stem cell registry that are located in Korea, India or Sweden at five different institutions that have not yet applied for an NIH grant, so their status is uncertain, Battey said.

Meanwhile, with excitement over the new 17 lines at Harvard, Leonard Zon, president of the International Society for Stem Cell Research in Northbrook, Ill., and a professor of pediatrics at Harvard's Children's Hospital in Boston, said he doesn't believe the president or his advisers were looking to be deceptive in August 2001 when they agreed to fund research on 64 (now 78) stem cell lines in existence at the time. (See BioWorld Today, Aug. 13, 2001.)

Rather, he said, at the time, there was a rush to find stem cells and information about them. "I think during that process, obviously there were lines that were put down [on the list] that just didn't exist or wouldn't grow," Zon told BioWorld Today. "That is extremely unfortunate because it is much more limiting than we had previously thought."

But add in the 17 lines at Harvard, and privately funded investigators will have more to choose from. Harvard is expected to give scientists free access to the lines.

The lines are expected to be quite useful, said Zon, adding that there's a subtle advantage to them.

"They can be passaged by process of enzyme digestion," he said. "You can actually take the cells off the plate in an easier way than the lines that are federally sanctioned. I don't want to say that the federally funded lines aren't worth anything - they are definitely worth something - but this is just a subtle difference for those of us who work on these lines."

But of key importance is that the Harvard lines double what's available, giving scientists more diverse choices, Zon said.

Battey added, "I think Dr. Melton should be congratulated on generating a potentially very useful resource for the community."

Politically, the new lines raise a question about federally funded investigators who supposedly cannot work on privately funded lines.

"This is a very strange policy to have if you are working in the field where you can't use half the lines available - it doesn't make any sense," he said. "I think as people start to create genetic models with the various lines - let's say Dr. Melton can get a diabetes model with those embryonic stem cells - does that mean a federally funded researcher can't study that model?"

Zon believes problems with the Bush policy could be repaired, but the first step is to sit down with the administration and discuss progress in the field and how the current policy impacts the industry.

"It is clear to me that if there was a successful use of embryonic stems cells to fix something clinically, that all the regulations would melt away," he said. "So every step you make toward bringing stem cell research to the clinic has tremendous impact on the whether the policy makes sense or not."

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