6 Y0 |! |; b3 QA key advisory panel to the National Institutes of Health (NIH) director has recommended that four additional human embryonic stem cell lines be added to those eligible for US funding. If agency director Francis Collins concurs in coming days with the advice offered on 9 December by his advisory committee, as is widely expected, the number of fundable lines will rise to 86 from the current 82. Two of the new lines come from the Jawaharlal Nehru Centre for Advanced Scientific Research in Bangalore, India and two from Swedish biotech company Cellartis. ! r+ T$ o" z( X; s! |8 O- I q2 q: t8 C# X. P$ m, t. G
But the committee's discussion of several other lines, some of which it rejected, revealed that the approval process that began one year ago this month can still be a tangled web. Sloppy consent procedures torpedoed three lines submitted by the Children's Memorial Hospital in Chicago. (See, for example, pages 16,18 and 22 at this link. The informed consent forms were used by the fertility clinic where couples donated the embryos -- the Midwest Fertility Center in Downer's Grove, Illinois.) * K4 }' z8 D4 m6 r* ~9 ~
6 C7 `& i" J7 W( KAnd in one case, problems with the translation of a single Chinese word -- that can be translated as both "specimen' and "embryo"-- led to the tabling, until expert native-Chinese speakers can weigh in, of a decision on six lines from Guangzhou Medical College in China. (For the full plethora of Guangzhou-related documents, see here and here.)1 R; ]" v. [9 T* j- w Y8 L: u
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And, days after key oral arguments in a lawsuit seeking to block US funding for human embryonic stem cell research, it became clear from another application that at least one US infertility clinic has pulled back from participating in a process which would allow stem cell lines derived from its leftover embryos to receive US funding. 3 V% w4 W) |4 i; |+ p* i: } 2 J; a! o7 v8 d1 o1 x) m9 n& @0 B0 `1 A# A$ C
According to an October 26 email to NIH from stem cell scientist Rick Wetsel at the University of Texas Health Science Center at Houston, which owns the relevant lines, the IVF clinic that was the source of the embryos from which the lines were derived has stopped communicating with him since a preliminary injunction was issued by a US district court in August, temporarily blocking federal funding for the research. Wetsel was seeking documentation from the clinic as part of the effort to win NIH approval for the lines. ! ?; z. {! x, a0 F 1 t, _8 x' v& z- u- PWetsel wrote:6 @' D2 T4 s2 e# i# ^
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"Before the injunction was filed, [name redacted] had said that she would retrieve the clinical consents, but that they were offsite and it would take her a couple of weeks," Wetsel writes to Ellen Gadbois, the key NIH staffer facilitating the approval process. "However, once the injunction was filed, [name redacted ]will no longer answer my emails or phone calls. I am assuming that she is afraid that the fertiliy clinics involved in the approved NIH hESC lines may be sued if the federal judges agree in the end with [the] injunction. She was always very responsive to our questions prior to the injunction....Of course, this has really upset our financial donor, who donated a considerable amount of money in the hope that someday UT would have their own early passage hESCs for federally funded research."2 ]) q% L( j% n3 r2 S8 o
1 D2 O0 t4 U' i% FThe report of the committee's working group on the Texas submission can be found here. In the end, it was voted down by the advisory committee for other reasons, including the sloppy consent procedures visibile, for instance, on pages 11, 12 and 14 here.7 f: ~3 w5 U6 y
# L' e- g) K- }7 Y4 wStory Landis, the director of NIH's National Institute of Neurological Diseases and Stroke, who is the agency's top official overseeing the approval process, noted after the committee's votes were taken that the volume of submissions coming into the committee is falling off. "I think we have caught up with the backlog," that accumulated during the George W. Bush era, Landis said. "There’s the possibility that [the committee working group assigned to stem cell line reviews] could go out of business, except for foreign donations.' * `0 A, X) R2 ~' K- g# y# m0 K6 Q: k7 a# [/ z e
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