Embryos, Dickeys, WARFs, and “rat poison.”

Maybe I should have called this column “I smell a rat.”

All this fuss and bother that Sam Berger is making in today’s blog.bioethics.net “Guest Column” over the lack of federal funding of embryonic stem cells had me following links and searching Google half the night in an effort to decide whether or not Berger’s political bias as a research assistant for the Progressive Bioethics Initiative at the Center for American Progress, who seems to base his essays on his objection to the Bush Administration, had anything to with his spin. The more I read,the more convinced I became that Berger is bound to know better than to claim that the only thing holding American “progress” back is the lack of our federal tax money.

For one thing, in vitro fertilization has done just fine and dandy without Federal funds or regulations for 30 years. How else do you explain the big business of assisted reproduction and those 400,000 “spare” human embryos that Berger wants to tear into?

George Q. Daley, MD, PhD, who (when he’s not trying to clone human embryos) makes his living creating and disassembling human embryos at Harvard, absolutely contradicted Berger’s assertion in his 2003 article for The New England Journal of Medicine. Three years ago, Daley outlined his conviction that the limit on federal funds wasn’t really the biggest problem facing researchers (sorry, the NEJM is subscription only):

An even more restrictive element of government policy prohibits the use of funds for “the creation of a human embryo or embryos for research purposes; or . . . research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.” Proposed in 1996 by Representative Jay Dickey (R-Ark.) as a rider on the appropriations bill for the Department of Health and Human Services and renewed every year since, the Dickey Amendment prohibits federal engagement in a field of research pertaining to the nature of the human embryo, its disorders of development, and the derivation of new human embryonic stem-cell lines.(elipses in original, bold is mine.)

(Daley failed to mention who was the President in 1996 and indulged a little political bias by mentioning that the challenger in the 2004 Presidential election had promised to over turn the Bush policy.)

The biggest hurdle for researchers may not even be law and the limits of federal funding:

In 1998, University of Wisconsin researcher James A. Thomson received the first embryonic stem cell patent in the United States, after claiming he had a recipe for extracting the cells from primate embryos.Thomson received additional stem cell patents on the process in 2001 and last April.

Under the patents, a researcher in the United States who uses embryonic stem cells in any way must pay a licensing fee to WARF, the university’s licensing arm.

“Outside of the (U.S.) government, the No. 1 hindrance to stem cell research is the WARF patents because of how they try to enforce their licenses,” said Mahendra Rao, the former head of the National Institutes of Health’s stem cell efforts.(emphasis is mine)

“WARF,” the Wisconsin Alumni Research Foundation and its subsidiary, Wicell, hold and manage the patents and licenses on embyronic stem cells, pretty much however, whenever and whereever they’re derived or used. WARF and WiCell constitute the monopoly that controls embryonic stem cell research in the US and much of the world, through an agreement with the NIH to distribute cell lines, by selling near-mandatory stem-cell-how-to-courses at the University of Wisconsin and by collecting royalties and license fees on their patents. Some of those licensing rights have been assigned to a WiCell start-up, Geron. (The interconnection of the most visible US bioethicists with each other and with WiCell, Geron, and the generator of press releases for “ethical” embryonic stem cells, ACT, was the subject of my “Ethicists for Hire?” last week.)

Not everyone is happy about the monopoly.:

Rights held by Geron, a San Francisco Bay Area biotech company, represent another expensive hurdle. WARF gave it exclusive commercial rights for the use of embryonic stem cells in treating cardiac, nervous system and pancreatic diseases.

If a company wants to develop therapies in these areas, it must negotiate a licensing fee and royalties with Geron.

and,

Recently, the California institute’s board decided that if a grant-receiving organization made a discovery with Proposition 71 dollars that could be patented and sold, a portion of the profits would be returned to the taxpayers.

The board debated this policy at length, because it was looking for a balance between getting a return on the investment of taxpayers and not hindering scientific development.

WARF has decided it is entitled to a cut of the state’s royalties.

“They are building a program using our patent. You can’t build a program on our patents and pay us nothing,” Donley said. “Who has dollar signs in their eyes now?”

Which reminded me that “WARF” also owns the rights to “warfarin,” the blood thinner that was originally developed in the late 1940’s as the main ingredient in rat poison.