NIH Committee Recommends Withholding Federal Support For 47 Stem Cell Lines

Main Category: Stem Cell Research
Also Included In: Litigation / Medical Malpractice;  Genetics
Article Date: 16 Jun 2010 - 3:00 PDT

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The NIH Advisory Committee to Director Francis Collins recommended that the agency reject federal research funding for 47 embryonic stem cell lines because of a sentence of legal language in a contract signed by embryo donors, USA Today reports. RGI, "one of the world's leading performers of pre-implantation genetic diagnosis," received the stem cells from clients who donated unwanted embryos for research, USA Today reports. According to USA Today, NIH has not yet issued Collins' decision on the panel's recommendations.

Shortly after his inauguration, President Obama lifted many of President George W. Bush's restrictions on federal funding of embryonic stem cell research that had limited federal funding for research to 21 existing lines. Under Obama's policy, the number of embryonic stem cell lines eligible for federal research funds has more than tripled to 67 lines, according to the NIH Human Embryonic Stem Cell Registry.

Members of the advisory committee objected to a sentence in RGI's donation contracts that they said creates "exculpatory" language barring patients from subsequently filing lawsuits for negligence or harm -- language forbidden under federal research rules. The panel recommended approval of six lines from other institutions.

Jeffrey Botkin, who leads the committee's stem cell group, said RGI could track down donors from six or seven years ago and ask them to sign a new consent form with approved language. RGI's Oleg Verlinsky said federal patient privacy laws forbid that option because the embryos were carefully stripped of identifying information about the donors. He said that "[w]ithout federal support, no one will use [the lines] for research," adding, "They will remain frozen, or discarded, forever" (Vergano, USA Today, 6/11).

FDA Seeks Greater Regulatory Control Over Genetics Tests

Meanwhile, FDA sent letters this week to five companies that sell genetic tests directly to customers saying that the tests constitute medical devices that are subject to regulatory approval before they can be marketed, the New York Times reports. The genetic tests provide consumers with information about their DNA that can be used, in some cases, to evaluate users' risks of contracting some diseases, including breast and ovarian cancer. The companies must submit their tests for FDA approval or discuss with agency officials why some tests do not need approval, the letter states. However, the letter stops short of requiring that the tests be pulled from the marketplace since the companies had not been clearly informed that prior FDA approval was necessary (Pollack, New York Times, 6/12).

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