l> Mining the Genome: Big Science as Big Company -- A one-of-a-kind report.;PROFITS AND ETHICS CLASH IN RESEARCH ON GENETIC CODING

Profits and Ethics Clash in Research on Genetic Coding


he Person Genome Project, an worldwide quest to spell out the specific sequence of the 3 billion letters in the humale genetic code, is still even more than a decade from completion. But in a rapid blurring of big science and substantial company, the effort has actually already developed its first millionaires.

One is J. Craig Venter, that as a Federal employee at the National Institutes of Health occurred crucial technology for spelling out -- or "sequencing" -- long strands of hereditary code. Then, a little even more than a year earlier, he left to sign up with a undertaking to commercialize the modern technology. Now, also before they have actually a product, Dr. Venter and also his backers have raised millions of dollars by selling public shares of stock in their endeavor, Human Genome Sciences Inc., of Bethesda, Md. Differing Perspectives

Depfinishing on one's perspective, Dr. Venter and also his firm typify the ideal connect in between Government-supported fundamental science and the entrepreneurial verve vital for seeing that the fruits of the Human Genome Project make their way right into the medical marketplace. But some researchers are unbasic -- ethically and professionally -- via the idea of their colleagues profiting from the research study for which the Government has actually passist.

The Human Genome Project is an initiative to sequence the DNA in all 100,000 genes in the huguy body, which physicians hope will sooner or later allow them to treat genetically-based diseases much the method software application designers settle faulty computer system programs: by isolating flaws in the code.

"I will be extremely surprised if we don't view products from some of these companies within four or five years," sassist Dr. Francis S. Collins, that heads the country's genome effort at the National Institutes of Health in Bethesda. He said he had no difficulties through the entrepreneurial efforts of Federal alumni like Dr. Venter.

But values aside, some scientists say they are hesitant of the commercial prospects for the endeavors spinning from the five-year-old Human Genome Project. And the commercial recruitment of leading researchers from publicly sustained colleges and also Federally backed genome centers has stirred expert resentment among some geneticists, that argue that the rush to commercialize or patent pieces of the genome job will certainly hinder the higher breakthroughs that have the right to come when the scientific area openly shares its discoveries.

"This is a quick and also dirty grab -- prefer the wild West, wright here everyone was trying to stake a case," complained one geneticist, who spoke on the condition of anonymity bereason he shelp he had numerous friends connected in genome carriers. "It's basically civilization via many human genome money trying to cash in."

The issue is by no indicates unique to the Person Genome Project. When Herbert Boyer, a biology professor, left the College of California at San Francisco in 1976 to help found Genentech Inc., currently a leading bioinnovation company, he was harshly and also publicly criticized by his fellow faculty members. But the sheer dimension of the Human being Genome Project, meant to expense the Government $3 billion before it is finished, assures also better scrutiny.

"There is a particularly warm light shining on the Genome Project because it is influential," sassist Dr. Collins, the director of the job, "and also because the level of funding in some instances is so much greater than any single investigator has actually got in the previous."

As for Dr. Venter, whose 766,612 shares of Human being Genome Sciences were worth $9.2 million when the stock started trading in late November, and also on Friday were worth $13.4 million, based on the stock's price of $17.50 in Nasdaq trading, he shelp he observed no must protect his scientific or organization values. All the work-related he created at the National Institutes of Health was publimelted in scientific journals that were available to the public, he shelp, and also he has had little bit to perform through the financing he has received considering that leaving the Government.

The financing "all had to carry out with my principles, and a technique I emerged -- a whole brand-new strategy to doing the humale genome," Dr. Venter sassist. "The actual question is: while at the N.I.H., I found 10 percent of the human genes; what happens to these genes if nobody proceeds through them?"

RAISING HOPES A Federal Mandate To Find New Cures

he prospect of mapping the whole huguy genome had long been the collective pipe dream of the world's geneticists.

But it was not till Congress approved the initial financing for the job in 1988, through the National Institutes of Health and the Department of Energy's national laboratories, that researchers can seriously contheme assembling the groups of researchers, the laboratory equipment and the supercomputers that the initiative would require. And from the start, the big numbers surrounding the job lent to it the very same aura of celebrity -- and controversy -- as scientific extravaganzas choose the $14 billion space station and also the $8 billion superconducting supercollider task, which Congress voted last year to speak sustaining.

A genome is the amount complete of hereditary information in a living species, whether the simple genome of a virus or the complicated genome of a humale being. The goal of the Human Genome Project is to find the precise places of all the genes on one or another of the 46 human chromosomes -- the packets of hereditary indevelopment that specify a person's physical features. This genetic information is encoded in the chemical DNA, brief for deoxyribonucleic acid.

The time-consuming job is gene "sequencing," the procedure of defining the genes chemically, which for the genome task will certainly suppose finding out the correct identification and order of all three billion DNA subunits that consist of the 100,000 genes in the human body. By sequencing all the huguy DNA, and researching families for aberrations in the genetic code associated through diseases, geneticists hope to allude the method to even more accurate diagnostic tests and more potent drugs through fewer side effects.

In 1988, $3 billion seemed choose an excellent estimate of the ultimate cost of the 15-year job. The effort is presently receiving about $165 million a year from the Federal Government.

In the United States, the genome project is separated among nine various genome centers at assorted national laboratories and colleges. France, the various other known human being leader in genomics, focused its nationwide initiative in the Centre d'Etude du Polymorphisme Humain in Paris, typically recognized as CEPH. Dr. Daniel Cohen, the director of CEPH, recently announced the initially finish, albeit sketchy, map of the humale genome. Geneticists in other countries, whether via colleges or study institutes, are also at work-related independently on pieces of the job.

RAISING MONEY Hurry, Don't Miss The 'Disease Genes'

evin J. Kinsella, a undertaking capitalist through Avalon Ventures, evinces a strike-it-affluent giddiness once talking about genomics, as the field is known.

"This is my last biotech deal; this is the crvery own jewels," he shelp of the genome agency he has actually helped set up, Sequana Therapeutics Inc. in La Jolla, Calif. He is serving as chairmale and chief executive till a full-time management team deserve to be set up.

Sequana, which has actually already elevated $12 million, is negotiating through six large pharmaceutical suppliers that might be interested in licensing its modern technologies, he said, and also in each situation his sales pitch is this: "Can you be competitive in the year 2000 without the illness genes in hand? Unequivocally, no."

With the prospects of interesting brand-new drugs and medical methods spinning out of the genome job, venture capitalists -- investors who put together pools of money to finance new businesses -- have actually been busily seeking places to put their dollars. As a result, investments in genome suppliers by endeavor capitalists, and also corporations and stock-market investors, are exceeding the $165 million a year in Federal backing for the genome job.

"This is groundbreaking, not only because of the Government involvement and investment, but bereason of exactly how easily and how richly it's been augmented by exclusive investors," sassist Mark Edwards, president of Recombinant Capital, a study company that tracks biotechology investments.

It was a venture fund called the Healthtreatment Investment Corporation that staked Dr. Venter $70 million in 1992 to produce the Institute for Genomic Research, a nonprofit lab. Separately, Healthcare Investment founded Human being Genome Sciences to commercialize the institute's findings, and gave Dr. Venter stock in the firm. Although the company is the initially of its form to start selling shares of its stock to the public, it is just among a dozen human genome carriers that have actually been put up with venture-capital or private capital, consisting of Sequana and also Millennium Pharmaceuticals Inc. of Cambridge, Mass.

With a much less aggressive undertaking funding community abroad, various other countries have actually been slower to commercialize genome research. And so some significant overseas researchers have actually allied through American service providers. Dr. Cohen of CEPH in France, for instance, is a scientific adviser to Millennium.

Regardless of all the investments, skeptics abound in the bioinnovation and pharmaceutical markets, and in academia. They note that hundreds of gene sequences are currently known, and that in addition to the dozen brand-new genome service providers, numerous various other types of biomedical carriers have actually been working on potential drug compounds to make use of that expertise, yet through little bit to display for it. The whole genome of the virus that causes AIDS has been fully determined, for instance, without a cure so far.

While knowing the hereditary indevelopment underlying an illness is unquestionably much better than not knowing it, the doubters question whether genomics justifies the production of a dozen new carriers, or if it is just the latest high-modern technology fad to wow undertaking capitalists.

Questions From Skeptics

"As an investor it's a way to make a buck," said David Martin, a former chief scientist at Genentech who is now senior vice president for the Chiron Corporation, a biomodern technology firm in Emeryville, Calif., that has no straight involvement in genomics.

"I've looked at the organization plans of a number of these suppliers, and also I don't understand exactly how they are going to rotate it right into a actual business that sells commodities," Dr. Martin sassist. "We're not at a point wright here we deserve to take a DNA sequence and produce a drug."

But the genome companies complete that they perform not must wait for the project to be completed to start pursuing drugs or diagnostic steps. If they deserve to sequence one vital humale gene -- the gene implicated in hereditary breast cancer, for instance -- they say they may be on their means to arising a screening test or treatment.

One technique, called "positional cloning," makes it possible to spell out the sequence of a gene by locating it on a chromosome without knowing its specific organic task. Studying the genomes of households through well-known histories of a specific disease, and finding the disparities between their genes and those of healthy and balanced world, scientists have the right to locate genetic mutations or deficiencies. Therapies can then be designed to make the important alterations to the trouble-leading to genetic task.

Notable among the companies employing this method is Millennium, which has drawn attention for the stature of its beginning clinical advisers -- Eric S. Lander, director of the federally funded Whitehead/M.I.T. Center for Genomic Research in Cambridge, the largest genome center in the USA, and also Dr. Cohen, director of France's genome initiative. Millennium has attracted venture capitalists including the Mayfield Fund and also Kleiner Perkins Caufield & Byers, which each has actually a document of picking winners in biotechnology, choose Genentechnology and also Amgen Inc. of Thousand also Oaks, Calif.

RAISING EYEBROWS Knowledge Thirst, Profit Hunger

iven his prominent role in the Human being Genome Project, Dr. Lander's ties to Millennium have been a selling allude for investors, however a reason for some elevated eyebrows in the genetics area. Anticipating this reaction prior to he joined the company's advisory board last year, Dr. Lander shelp he had sought permission from the National Institutes of Health and received a letter in reply from Dr. Bernadine Healy, then director of the N.I.H., giving him clearance.

Perhaps more to the allude, Dr. Lander shelp all the job-related done by him and his associates at the Whitehead/M.I.T. genome facility was being made public without patents or other restrictions, and also that Millennium had actually no prior accessibility to the research study findings.

"If you desire to dial us up on the Net, you'll gain a complete dump of our information," he shelp, referring to the ability of anyone to accessibility the center's research study using an individual computer, modem and also telephone line. "We chose early that what we are building at the center is not commercial."

Other influential numbers in the genome neighborhood that have actually forged commercial allegiances encompass Ricdifficult Myers and also David Cox, that run the Federally financed genome facility in Palo Alto, Calif. With Dennis Drayna, a previous Genentech researcher, they have developed Mercator Genetics Inc. in nearby Menlo Park.

On the other hand, Mark Pearboy, a member of the Person Genome Project's nationwide advisory board, is also chief executive of the genome firm Darwin Molecular Technologies Inc. in Seattle. Leroy Hood, a significant genome researcher at the College of Washington, has also joined Darwin Molecular.

What comes to some geneticists is that the potential for split loyalties, combined via the expectations of the substantial investors financing the genome carriers, deserve to produce pressures that also the a lot of dispassionate scientist would have trouble resisting.

"The human being who are involved need to be incredibly clear about their duties, bereason you can easily discover yourself in a problem of interemainder -- absolutely in a problem of commitment," shelp Norton Zinder, professor of molecular genes at Rockefeller College, who was head of the Human Genome Project's advisory committee from 1988 to June 1991.

Dr. Zinder listed that he was receiving Federal grants in the beforehand 1980's at the very same time he was a clinical adviser to Genetics Institute Inc., a bioinnovation company in Cambridge, from which he received special founders' shares of stock. But he never thought about himself in dispute because he disclosed the commercial connection to university and also Federal officials and offered only as an adviser to the agency.

"Sometimes, complete disclocertain is all you want," Dr. Zinder sassist. "I don't mean world to be saints. I would certainly prefer a line to be drawn." He shelp he had written to Dr. Collins at the National Institutes of Health saying that clear rules be establiburned to define problems of interemainder in the genome task.

Open About Activities

r. Collins, in an interwatch, sassist he was satisfied that Dr. Lander and also other genome-facility directors had been sufficiently open up about their assorted clinical and also commercial tasks. "Many are trying to emphasis their basic science initiative in the genome facility," he said, "and also look at the companies as a area to focus on application to certain conditions."

Undoubtedly, some scientists say the profit motive, fairly than being a corrupting pressure, is the surest method to generate genuine products that can save stays.

"Tright here is no dispute in the underlying societal interemainder," sassist Wtransform Gilbert, a Harvard biochemist that won a Nobel Prize in 1980 for his work-related in genes, 2 years after he had actually co-established Biogen Inc. to commercialize his explorations. The many significant commodities of the agency, additionally based in Cambridge, encompass alpha-interferon, which it licenses to the pharmaceutical gigantic Schering-Plough as a treatment for hepatitis.

Dr. Gilbert is energetic in genomics, last year co-starting Myriad Genetics Inc. in Salt Lake City. He sassist he observed plenty of parallels between his previously mingling of scientific research and service and also the problems now swirling around the Human Genome Project.

"A technology is developed in a genome facility for the advantage of the country," he shelp. "It's out there and also easily accessible.

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If the technology is never before commercialized, the country is worse off."

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