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The Sydney Morning Herald Saturday, August 18, 2001 Hard cell Brave new world ... A neurosphere, which can grow into living tissue, started as a single stem cell. A cure for degenerative diseases will be worth billions, and private companies want their share, writes Gay Alcorn. News special: The next frontier Frogs, chicken and mice were all very well, but researcher Ali Hemmati-Brivanlou was ready to move on to studying human embryonic stem cells, so promising a field that normally cautious scientists were excitedly predicting revolutionary improvements in the quality of human life. Professor Brivanlou confronted unexpected obstacles. His employer, Rockefeller University in New York, opened negotiations earlier this year with Geron Corporation, the biotechnology company that claims worldwide, exclusive rights to just about everything to do with stem cells. Brivanlou was astonished at the conditions Geron wanted to put on his research into how these unique cells grow into different parts of the body such as the pancreas, the blood, or the brain. Private companies demanding a return for investing in high-risk medical research are hardly new. But normally, says Brivanlou, a deal known as a "material transfer agreement" would apply. This would give a company claiming intellectual property a period of about a month, after the work was completed, to scrutinise the results and take up options for further research or commercialisation before the researcher could publish results. Californian-based Geron wanted much more. "Not only did they have this confidentiality agreement, I wasn't supposed to talk about the work, I could never talk without permission of Geron, couldn't talk with my colleagues, we could not publish our results," says Brivanlou. "And it went beyond stem cells. I couldn't talk about cancer, anything that Geron might some day be involved with. Everything belonged to them. We are talking about the health of human beings, and Geron is just punitive." Rockefeller University declined the conditions, and Brivanlou was left a frustrated, and furious, researcher, still experimenting on frogs. Geron declined to comment. Now that President George Bush has allowed government funding for the 60 stem cell colonies, or "lines" already extracted from embryos - but no money for work on new stem cells - there is intense anxiety among scientists about what happens next. Are there 60 stem cell lines and if so, are they of good quality? Is Bush's political compromise an invaluable boost to the nascent research or entirely inadequate to move beyond animal experimentation to clinical trials and one day, cures for Alzheimer's, Parkinson's, diabetes, paraplegia and a host of other conditions? However many cells are available, how are scientists going to get at them? When the buzz subsides about the "magic" cells that can grow into any type of tissue in the body, who actually owns them and who's going to profit? "Commercial interests," Doug Melton, a Harvard University researcher, said this week, "may not coincide with the public interest." Scientists are deeply sceptical that there are 60 stem cell lines, a figure identified by America's National Institutes of Health, the leading public backer of medical research in the world, after telephone calls to international groups known to be working in the field. Robert Klupacs, the chief executive officer of ES Cell International, the company linked with renowned scientists Alan Trounson and Martin Pera of the Monash Institute of Reproduction and Development in Victoria, thought there were about 20. American scientists are dismissive. " I'm sitting here in California without the foggiest idea of what 60 stem cell lines he's referring to," Stanford University cancer researcher Paul Berg told The Wall Street Journal. The Bush Administration insists the cell lines are "diverse, robust and viable". About half are believed to be in the US. Fully 10 were harvested by Australian researchers, six by the Monash group, and four by BresaGen Ltd, an Adelaide-company that last year also set up in America. Israel and Singapore are key players, and Sweden and India are also believed to have stem cell lines, although details are sketchy in what is a highly secretive business. Bush drew a line - no public funding for embryonic stem cells harvested after his announcement on August 9 - a nod to anti- abortionists who say extracting stem cells, which destroys the embryo, is abortion (even though embryos left over at IVF clinics are routinely discarded anyway). That does not prevent private funding of stem cells, nor does it prevent the work continuing internationally, which it undoubtedly will. There is even fretting in the US about a most unusual phenomenon, a brain drain from the US to the UK, Israel and Australia. No-one doubts the importance of American public funding. The NIH's budget is $US20 billion ($37.6 billion) and last year it spent $US226 million on adult stem cell research, a related field. Scientists are hoping for at least as much for embryonic stem cell work, which they say has far greater potential. BresaGen set up in America as an acknowledgment of commercial reality. "To get all the research and development done and get products to market is going to require more capital then we have now," said Dr Allan Robins, the senior vice-president and chief scientific officer of BresaGen, which is concentrating its efforts on Parkinson's disease. "When you do have products, about half the patients will be here in the US." Australian scientists say that Bush's decision was perfect for Australian interests, because of the numbers of local stem cell lines and the quality of local scientists. Klupacs says that in the past few days, 40 to 50 American researchers have contacted him about using Monash's lines. "The trickle has turned into a bit of a flood." However, worn down by decades of underfunding and indifference to science in Australia, researchers worry that the advantages could be squandered without government funding and a national policy co-ordinating what is a fragmented industry. There have been other chances, says Klupacs, but "we soon got run over because we couldn't compete". "We've got to make sure that doesn't happen again. This is an area, because it's so young, where we could lead the world." There is palpable excitement surrounding stem cell research, which sometimes obscures the reality that moving beyond the Petri dish is years, even decades, away. There are no human trials as yet, but animal trials are encouraging and there are soaring hopes that one day healthy cells could be injected into the body, ushering in a new era of regenerative medicine. Then there is the Geron Corporation, the "800-pound gorilla", says Klupacs. Geron is an unlikely gorilla. It has just 112 employees and, last year, lost $US46 million. But years ago, before there was any prospect of government money for research, Geron backed Dr James Thomson of the University of Wisconsin, and now believes it invested well. In 1998, Thomson extracted the first human embryonic stem cells (just pipping the Monash scientists for the honour) and promptly patented them. It was a broad patent, and the university now claims it has the rights to all the 60 stem cells, no matter where they are. Wisconsin's for-profit foundation charges fees for researchers to use their stem cells, but refuses them the right to exploit any findings commercially. That right belongs to Geron, which has an exclusive deal with Wisconsin over transforming cell lines into six vital types - bone, blood, muscles, nerve, pancreas and liver. Geron was unavailable for comment, but its CEO, Thomas Okarma, has said the the licence gives his company "worldwide exclusive commercial rights" to stem cells. "People who want to follow through on commercial applications of these cells will need to visit with Geron", said the company's chief financial officer, David Greenwood. Those statements make American researchers furious, and Australian scientists nervous. BresaGen used some of Wisconsin's stem cell lines 18 months ago, but they failed to grow, and the company extracted its own earlier this year. There are doubts about what rights it has to them, and what rights Geron will have over its research if it ever bears fruit. Robert Klupacs from ES Cell International says "it's going to get tricky" and has lawyers scouring the implications of the American deal. "Were not quite sure the claim they have in their patents would cover our lines." This week, Wisconsin University fell out with Geron and, in American style, has sued the company that funded its research. Geron, already the dominant player in the field, wants not only commercial rights to cell types it already has, but also to 12 more. Wisconsin says the company's dominance has gone far enough. Both Klupacs and BresaGen's Allan Robins believe deals will be done and that the field is big enough for more than one player. Klupacs concedes that the Monash team would have "absolutely" applied for a worldwide patent if it has been the first to extract a human embryonic stem cell line, although the university has been far more generous in distributing its work. It sends its lines to scientists at no cost, with the condition that it has a 12-month chance to negotiate any licences for new technology that results from the research. There is one hitch that makes the Australian scientists more sanguine than their American colleagues. Wisconsin's commercial foundation failed to get a patent in Australia or in Israel, potentially a costly mistake. Geron has two pending patent applications in Australia, but over narrower issues of how to make the stem cell lines last longer, rather than broad patents covering stem cell research generally. Patent lawyer Arti Rai, from the University of Pennsylvania, says that "Israel and Australia may end up being really the key to all of this. It's going to be a truly international legal fight." Geron's claims to anything commercial arising from stem cell work are unusual, says Rai, particularly when the research is still so new. Scientists in America fear one company's dominance and resent the control Geron seeks over their work. Geron says it has no intention of constraining research, but is unapologetic over its apparent monopoly. "We guessed right," Thomas Okarma told The Boston Globe just before Bush's decision. "Patents are what patents are. We funded the work; we have the rights." SOURCE: The Sydney Morning Herald http://www.smh.com.au/news/0108/18/review/review7.html * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn