<B>Stem Cell Research @ Reliance </B> <P>Silence and lack of transparency has often been the bane of India - govt. or companies. In Agra we had MEA that would refuse to tell journos anything about anything while TSP were having a field day. In the following article (wsj has subscription), Reliance's refusal to cooperate w/ Journalists puts a black mark on Indian advancements. Anybody who's anybody in NY/DC reads the WSJ, so this story is sure to get a lot of publicity. How do we improve our standards? Please read on & comment...<P><I>Mystery Surrounds Fertility Clinic<BR>Tied to a Stem-Cell Lab in India </I><P>By DANIEL PEARL, ANTONIO REGALADO and JESSE PESTA <BR>Staff Reporters of THE WALL STREET JOURNAL<P>BOMBAY, India -- This city has two dozen fertility clinics, but none more mysterious than the one on the fourth floor of an office tower under construction at Hurkisondas Nurrotumdas Hospital, in the heart of India's economic capital.<P>Reliance Industries Ltd., an Indian petrochemicals giant with budding technology interests, says it was here that a new Reliance biotech company harvested donated embryos and produced seven of the 64 populations of stem cells that U.S. officials last month declared could be available for research purposes. But some of the city's most prominent gynecologists -- including five associated with the hospital itself -- say they weren't aware the clinic existed.<P>"Funnily, though I'm head of gynecology, it has not been brought to my notice," says Shirish Sheth, a doctor with Hurkisondas Nurrotumdas.<P>Reliable Source?<P>Facts about Reliance Industries' stem-cell research:<P>Began: April 2001<P>Total investments:<BR>$5 million<P>Investment plans:<BR>$25 million over five years<P>Embryo stem-cell lines: Seven (three in early stage, four in medium stage)<P>Other activities: Research involving umbilical cord stem cells, skin cells, tissue engineering<P>Source: the company<BR> <BR>"I'm not aware of the services, what is being provided from there," says the hospital administrator, Vikram Anand, from his office a stone's throw from the 21-story tower.<P>The Reliance Life Sciences clinic is something new in the history of test-tube fertilization: a fertility clinic set up as part of a commercial stem-cell laboratory. The company has kept it shrouded in secrecy, and the confusion surrounding it offers further evidence that the coveted cells lines on the Bush list are not completely understood.<P>Stem-cells derived from embryos are believed to be capable of forming human tissues that could help fight a variety of diseases. But because obtaining them involves destroying human embryos, such research has set off an emotional debate in the U.S. The Bush administration's new policy was intended to mollify some ethical concerns by allowing taxpayer money to fund research only on stem-cell lines already created when he announced the policy on Aug. 9. Furthermore, to make sure the embryos hadn't been made for research, the president approved funding only of research involving stem cells from embryos donated by fertility patients who no longer wanted them.<P>Reliance, a novice in biotechnology, says it followed even stricter ethical guidelines set by the U.S. National Institutes of Health last year in creating the cell lines: It used only excess embryos after in-vitro fertilizations performed at its Bombay clinic, obtained signed consent forms from the patients, and didn't give donors financial compensation.<P>The company says the NIH contacted it in late July and had conferences by telephone and videophone before putting Reliance on a list of 10 laboratories world-wide that met President Bush's eligibility guidelines for becoming a source of stem cells.<P>NIH officials say that by the middle of June, the agency had identified at least four of the Reliance cell lines. They say they have on file a faxed copy of Reliance's patient consent forms dated July 27 but that the name of the clinic is missing from the documents. Thursday, the NIH said it is moving to seek additional legal assurances from Reliance and the nine other groups with approved cell lines that their cells meet President Bush's criteria for federal funding. It has sent a legal document to each lab, asking it to certify that their cells do, in fact, meet rules laid out in the president's televised address last month.<P>To appear on the Bush list of allowable cell lines, laboratories had to have the stem cells extracted from embryos by Aug. 9. But the opening date of Reliance's fertility clinic is a matter of some confusion and calls into question whether the company could have met that deadline. In an interview last week, K.V. Subramaniam, Reliance Industries' senior executive vice president, said Reliance's fertilization clinic "started last month" and would produce cells for future use. But a few days after the first interview, Mr. Subramaniam said the clinic started running early this year.<P>Firuza Parikh, a pioneer of in-vitro fertilization in India, who is director of both Reliance Life Sciences and the fertility clinic, echoed that, saying the clinic opened in March, as did a Reliance spokesman. But one of Reliance Life Sciences' equipment suppliers said the Reliance clinic couldn't have started accepting patients before mid-May, because equipment hadn't arrived until then.<P>Even opening in March, the new Reliance fertility clinic would have had to work unusually fast to produce excess embryos that quickly. Normally, a fertility clinic sees its first patients several months after opening and fertilizes eggs a month or more after a patient's first appearance. It takes four weeks to stimulate a patient's ovaries to get the eggs and one week to grow the embryo before implanting it in the mother's uterus. Once that process is completed, fertility doctors usually keep spare embryos frozen for years, until there is no chance the patients would want to use them for another pregnancy. Only then are they deemed "excess."<P>On Tuesday, a receptionist at Reliance Life Sciences said the clinic doesn't yet have any brochure or written information. Dr. Parikh, who also runs a fertility clinic at another hospital in Bombay, said she doesn't need to "advertise" the clinic because she is so well known. She won't allow journalists to enter the facility, citing concerns about contamination.<P>Reliance wouldn't make available copies of individual patient-consent forms, citing patient confidentiality. Asked how many in-vitro fertilizations the Reliance clinic has performed, Dr. Parikh said, "I don't see why I should answer." Fees, she said are more than $1,000 -- comparable with other clinics.<P>The difference is that one floor above the fertility clinic, Satish M. Totey leads a team trying to develop cells from the embryos into different life forms. Reliance last week released photographs and a brief video of a laboratory assistant blowing through a tube into a solution that the company said contained embryos. Dr. Totey, hired six months ago from a government biotechnology lab, says establishing cell lines will take another two to three months, and further "characterization" will take another six months.<P>Dr. Parikh, says she maintains a "Chinese wall" between the clinic and the research lab, and Reliance has set up its own ethics committee, dominated by outsiders.<P>Reliance, which says it decided one year ago to enter biotechnology, says it always keeps its new ventures quiet as long as possible to avoid alerting competition. Indeed, in an interview in March, the company's managing director, Anil Ambani, denied having major biotechnology ambitions.<P>Reliance says it hopes to concentrate its stem-cell research on diabetes and cardiovascular diseases, and is in discussions with unnamed American companies to perform joint research that would lead to commercial patents. "We are not interested in selling the cell lines. We are interested in collaborative research," a Reliance spokesman says. "As of now, we are not talking about grants."<P>Reliance Industries, which began as a textile-trading firm and moved into polyester, petrochemicals and oil refining, is by some measures India's largest company, and also one of its most controversial. The company faced allegations in the mid-'90s of improprieties in the handling of share certificates -- it characterized the incidents as innocent mistakes -- and it has a long reputation for using strong political connections to help dominate businesses, even when it is late entering. Reliance downplays that reputation, says it has a strong five-year old ethics policy, and has circulated a recent survey of business executives naming Reliance as "most admired business house" in India.<P>The Indian government has been drafting guidelines that would likely require projects like Reliance's to get approval from a government ethics committee, but the guidelines are still waiting government approval, according to the chairman of bio-ethics committee, Sankar Valiathan.<P>India has no movement akin to the pro-life movement that made embryo-based research controversial in the U.S., and some biotech advocates have said India needn't put American-style restrictions on labs. Still, India is sensitive to any hint that developing countries are taking advantage of its poverty and huge population. Critics of clinical trials in India, for instance, claim that many fail to inform patients of their rights and risks. V.K. Vinayak, an advisor to India's Department of Biotechnology, says India's ethics rules will probably govern laboratories' procedures for getting patient consent and the "respect they are showing to the embryos."<P>Write to Daniel Pearl at
daniel.pearl@wsj.com, Antonio Regalado at
antonio.regaldao@wsj.com and Jesse Pesta at
jesse.pesta@wsj.com