New England Journal, Conflict of Interest and Amgen

Quite a battle has broken out over the decision of the NEJM not to publish an editorial by Robert Steinbrook MD which is highly critical of the ways in which Amgen's Epoetin is prescribed in the U.S. There are no agreed upon maximum levels for hemoglobin and it appears as if Epo is being over prescribed at bigger than necessary doses by the for-profit dialysis industry. Steinbrook's editorial was published in the Lancet. Questions also have arisen about why the Journal chose to have Julie Ingelfinger write an editorial to substitute for Steinbrook's when she has close ties to the NKF--an organization that receives a significant percentage of its funding from Amgen.

It is still very clear that the management of conflicts of interest for universities, journals, academic health centers and even bioethics centers remains conflicted with no consensus on mimimal rules or about what constitutes a conflict. The academic and journal communities would be well-served in the coming year to convene a blue-ribbon panel to write a report on COI that might serve as the starting point for addressing the complex questions involved. - Arthur Caplan

New England Journal Editorial: Good Luck Dodging Stem Cell Science with the Hurlbut Trick

I've already been awfully critical of William Hurlbut's idea that the stem cell debate can be obviated by an artful dodge in embryo creation. I noted too that just a few days after Hurlbut's idea was celebrated by the superconservative religious scholars whom he had bless his idea, they turned on him. Today the circle is truly complete, as scientists put to rest the idea that Hurlbut has figured out what counts as an embryo: New England Journal of Medicine has today published an editorial entitled "Altered Nuclear Transfer in Stem-Cell Research * A Flawed Proposal" by Melton, Daley and Jennings, that reads in part:

Hurlbut's argument for the ethical superiority of altered nuclear transfer rests on a flawed scientific assumption. He argues, on the basis of supposed insights from systems biology, that it is acceptable to destroy a CDX2 mutant embryo but not a normal embryo, because the former has "no inherent principle of unity, no coherent drive in the direction of the mature human form." But these are ill-defined concepts with no clear biologic meaning, and an alternative interpretation would be that embryos lacking CDX2 develop normally until CDX2 function is required, at which point they die. Philosophers may debate these and other interpretations. We see no basis for concluding that the action of CDX2 (or indeed any other gene) represents a transition point at which a human embryo acquires moral status.

-GM

IVF Risks and Benefits

Liza Mundy chronicles this year's ASRM discussion of the recent New England Journal discussion of IVF risks. The framing of the Slate piece is ASRM's colorful bazaar atmosphere and the even more wild atmosphere of IVF (according to Mundy). But the article is a really outstanding overview of the state of the debate, complete with references to all the studies. Anybody planning to teach IVF ethics issues to undergraduates or laypeople should read this piece.