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2001-08-28-wsj-nih-stem-cell.pdf
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NIH's Naming of Stem-Cell Developers Sparks Questions on Potential Advances
NIH's Naming of Stem-Cell Developers Sparks Questions on Potential Advances
By Antonio Regalado and Jill CarrollStaff Reporters of The Wall Street Journal
Aug. 28, 2001 at 12:01 am ET
Gift unlocked article
The National Institutes of Health's naming of the developers of 64 embryonic-stem-cell lines eligible for study using government funds sparked a new round of questioning among scientists and others on how quickly stem-cell science can advance under President Bush's new policy.
Researchers representing groups that created the cell lines said that many of the cells are in an extremely early stage of scientific assessment, and may not ultimately prove useful. They also indicated the NIH located as many as half of the stem-cell lines just days before President Bush gave his limited go-ahead for research of stem cells derived from human embryos.
It also remains unclear whether U.S. scientists will have easy access to the cells, about one-third of which were created by private companies. Universities that derived cells in the U.S. and abroad also have already entered into commercial agreements with biotechnology firms, which could further complicate access.
The NIH said Monday that it could begin issuing research grants as early as this October.
Resources to Move Forward
Resources to Move Forward
Despite these worries, some scientists and politicians agreed that in the short term, researchers now have both the resources and the funds to move forward. In a statement, Department of Health and Human Services Secretary Tommy Thompson said, "The knowledge that these 64 embryonic-stem-cell lines exist and will be available for research should inspire our nation's best scientific minds."
Michael Ross, chief executive officer of closely held CyThera Inc., San Diego, which derived nine of the lines cited by the NIH, said: "In the short run, this will absolutely be enough. There is a huge amount of research that can be done with what is out there." He said when it came time to begin testing medical treatments derived from the cells, something that might occur in three or four years, the cells used would probably be developed by private companies such as his.
Sen. Ted Kennedy (D., Mass.), who had requested that the NIH release the list, said Monday that it was "a first step in understanding the president's stem-cell policy." But he added that problems remain. "Not only must NIH-supported scientists work with limited cell lines, but they also face significant legal obstacles at every turn."
Developed by 10 Entities
Developed by 10 Entities
The 64 separate populations of stem cells were developed by 10 companies and academic institutions on four continents, according to the NIH, which said all the lines meet the president's criteria to qualify for federally funded research. That means they were derived before Mr. Bush's Aug. 9 televised speech from leftover embryos originally created for fertility procedures, that the patients involved had consented to the research, and that there had been no payment. Each line is a growing population of stem cells taken from a single embryo.
But those criteria don't include a guarantee that the lines will be viable and useful in research. "Without conducting basic research using these cells it would be inappropriate and not scientifically sound to judge their capabilities," said Ruth Kirschstein, acting director of the NIH in a letter to Mr. Kennedy.
Nevertheless, Tuesday's announcement confirmed what some scientists had suspected: that the administration's math on the precise number of lines has been optimistic. Lars Hamberger, who leads a group at Goteborg University in Goteborg, Sweden, cited by the NIH as responsible for 19 stem-cell lines -- nearly a third of those available under Mr. Bush's plan -- said only three have been shown to be true embryonic stem cells, which are capable of growing indefinitely in the laboratory and have certain characteristic chemical markers. Four are partially characterized, while the remaining dozen are cells taken from embryos and frozen almost immediately. Based on past experience, Dr. Hamberger said of those 12, "If we get three good cell lines we would be satisfied."
The NIH first got in touch with Goteborg officials in July, shortly after Secretary Thompson directed the agency to complete a second, more comprehensive survey of available stem-cell lines. The NIH had initially identified about 30 such lines as of June.
Dr. Hamberger said he received another call from the NIH the day after the Bush announcement seeking further information on his cells. In particular, the NIH wanted to confirm that the cells met the president's ethical criteria. "We did not realize it was so urgent," he said. When he suggested they work together to organize a stem-cell conference where he could present his findings, he says the NIH made clear the situation was "very, very pressing." He agreed to travel to Bethesda, Md., and attended a three-hour meeting last Wednesday in which he presented his results to HHS policy staffers and also to Secretary Thompson.
Start-Up Has Commercial Rights
Start-Up Has Commercial Rights
Dr. Hamberger said the Goteborg group would be willing to share its cells with U.S. researchers in scientific collaborations. However, such efforts would have to take into account commercial rights held by a start-up company recently formed by Dr. Hamberger and his colleagues, Cell Therapeutics AB. Anders Vedin, chairman of the new company, said he was unwilling to discuss the company's business model or intellectual-property positions until it had completed its first round of financing, now being collected from Swedish venture-capital firms including Innovations Capital.
Dr. Hamberger said he couldn't criticize the Bush plan because "of a personal connection" to the president. On his July trip through Europe, Mr. Bush stopped to eat in Dr. Hamberger's family restaurant.
Dr. Ross of CyThera said his company's cells also hadn't been fully characterized. But he cautioned that scientists "still had no firm definitions for defining an embryonic-stem-cell line."
In addition to CyThera and Goteborg University, the other groups that created the cell lines, according to the NIH, are BresaGen Inc., Athens, Ga., (four stem-cell lines); Karolinska Institute, Stockholm, Sweden (five); Monash University, Melbourne, Australia (six); National Center for Biological Sciences, Bangalore, India (three); Reliance Life Sciences, Bombay (seven); Technion-Israel Institute of Technology, Haifa, Israel (four); University of California, San Francisco (two); and the Wisconsin Alumni Research Foundation, Madison (five).
sep 4 2001
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https://www.wsj.com/articles/SB999812488197411390?mod=Searchresults&pos=19&page=1
2001 (Sep 07)
2001-09-07-wsj-mystery-fertility-clinic.pdf
2001-09-07-wsj-mystery-fertility-clinic-img-1.jpg
Mystery Surrounds Fertility Clinic Tied to a Stem-Cell Lab in India
Mystery Surrounds Fertility Clinic Tied to a Stem-Cell Lab in India
By Daniel Pearl, Antonio Regalado and Jesse PestaStaff Reporters of The Wall Street Journal
Sept. 7, 2001 at 12:01 am ET
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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.
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.
"Funnily, though I'm head of gynecology, it has not been brought to my notice," says Shirish Sheth, a doctor with Hurkisondas Nurrotumdas.
"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.
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.
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.
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.
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.
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.
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.
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.
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."
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.
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.
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.
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.
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.
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."
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.
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.
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."
2001 (Sep 09)
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2006
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2007
https://www.wsj.com/articles/SB118047691793317687?mod=Searchresults&pos=3&page=1
2007-05-30-wsj-india-health-sector-lacking.pdf
2007-05-30-wsj-india-health-sector-lacking-img-1.jpg
India Health Sector Seen Lacking
India Health Sector Seen Lacking
By Brian Gormley
May 30, 2007 at 12:01 am ET
In January, a delegation from New Enterprise Associates traveled to India for a two-week trip to scout out health-care investing opportunities. Its conclusion: The hype has gotten ahead of reality.
Like many U.S. venture-capital firms, NEA is already backing Indian technology companies. But unlike some, it doesn't see the need to begin making health-care deals there right away, said general partner Chip Linehan, one of five people who made the trip.
Though the health-care market in India is less mature than the technology sector, it is expected to grow as the middle class expands and demands access to high-quality health care. That has prompted many U.S. firms to begin considering investment opportunities.
Some contend the opportunities are already ripe. In April, MPM Capital said it would invest there with the help of Indian biotechnology concern Reliance Life Sciences, one of the limited partners in its new fund. In addition to funding Indian companies, the Boston firm wants to help U.S. pharmaceutical companies in its portfolio save money by conducting clinical trials there.
Meanwhile, San Francisco-based Burrill & Co. is raising as much as $200 million for an India-focused fund, and Vivo Ventures of Palo Alto, Calif., which recently closed its $275 million sixth fund, is considering direct investments in India, said partner Chen Yu.
Mr. Linehan, who traveled to India with general partner Charles Newhall, senior associate Mohamad Makhzoumi, principal Amita Shukla and a consultant, said NEA over the next 10 years will join firms such as MPM in making health-care investments in India. But the January trip didn't convince him of the need to jump on any opportunities right away. While there, the group looked at a range of companies, including contract-research organizations, pharmaceutical companies and health-care services providers, Mr. Linehan said.
Though India is known for producing generic pharmaceuticals -- with global firms such as Ranbaxy Laboratories Ltd. -- Mr. Linehan said that sector is mature and the group didn't see much opportunity for growth-equity investment. And there is very little medical-device activity there.
The best near-term prospects, in the NEA group's eyes, are in services, such as health insurers, lab operators and hospital companies. But those with positive earnings before interest, taxes, depreciation and amortization had high valuations compared with their U.S. counterparts, Mr. Linehan said. This is driven partly by their growth potential, but also by an abundance of capital from local and some foreign investors, he said.
Still, it is hard not to be attracted to the opportunities in the health-care market. Though the infrastructure for health-care services is well behind that of the U.S., Mr. Linehan said he expects it to expand rapidly.
"If you look at a 10-20-year outlook, the prospects are very good, health care is clearly going to be a huge growth engine for the Indian economy," Mr. Linehan said. "We're definitely interested in the area, and we're spending time there."
But "we've struggled to find investment opportunities where we think the risk-reward dynamic is as favorable as we see here in the States. Valuations are ahead of the fundamentals and don't accurately reflect the risk," he said, adding that there is risk of a health-care "bubble" forming in India if investors jump in too quickly.
Yet Mr. Linehan said some would see NEA's stance as conservative, and he didn't rule out an investment near-term, putting the chances the firm will fund an Indian health-care company within the next year at 50-50. And the January trip won't be his last; he will probably go back again this year, he said.
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