Biotech: the Revolution Is Already Underway

These are the unlikely avatars of biology’s new age--a set of test tube twins in London, a cotton boll in Alabama, a spider mite in Florida, a bull named Hermann, a boy named Andrew, and a white-faced sheep named Dolly.

As milestones in the evolving technology of life, they are tokens of a scientific upheaval that is transforming society as rapidly as it is reshaping medicine, agriculture and the pursuit of science itself.

Each is a creation born of a revolution in biology.

A lab technician screened the twins--Hannah and Danielle--for genetic defects when they were laboratory embryos outside their mother’s womb. Farmers cultivated the cotton from seeds created by combining plant and bacteria genes, while the bug has a new gene to help researchers track it in the wild. Los Angeles doctors performed gene therapy on Andrew to strengthen his immune system. Dutch researchers engineered the bull so it would sire cows whose cream contains an important medicinal compound normally found in human breast milk.

In creating Dolly from a single adult ewe cell, researchers at Scotland’s Roslin Institute crafted the latest living invention to mark the crossroads of science and human values.

These experimental creations are more than laboratory curiosities. Indeed, the seeds of the new biology are being sown across millions of farm acres this year, and its fruits are appearing on supermarket shelves and in medicine cabinets in hundreds of thousands of homes. The biological revolution is altering--in ways that we have yet to recognize--our image of ourselves.

Researchers now are poised to push the technology of life into even more challenging areas, some of them long forbidden by federal regulation or by ethical and religious constraints.

For many scientists, cloning offers an unprecedented opportunity to engineer new life forms more efficiently, to revive endangered species and to explore treatments for a host of human diseases. However, critics in the United States and around the world have argued that cloning oversteps the bounds of morality, offering humanity too much power to manipulate living things. And the prospect of cloning human beings, they say, is repugnant.

While most scientists publicly reject the idea of cloning complete human beings, many molecular biologists are eager to clone human cells using the techniques developed by the team behind Dolly.

To carry out those experiments, geneticists will be creating for research purposes what many will consider human embryos. Such endeavors have been forbidden to federally funded researchers for almost 25 years, primarily because many people consider it wrong to create a human life only to destroy it.

Indeed, some respected medical experts have begun to quietly debate whether they should attempt to cure hereditary diseases by making genetic changes in human embryos that can be inherited by succeeding generations. Many biomedical ethics experts, religious leaders and researchers have long contended that such “germ-line” genetic changes are too technically uncertain and morally perilous to be allowed.

At the same time, researchers at the New York Hospital-Cornell Medical Center are preparing to conduct the first genetic engineering experiment on healthy human volunteers. Scientists investigating treatments for cancer and other diseases want to inject harmless engineered genes into normal people to see how their immune systems respond.

Some experts worry that the research--touted as a way to better understand gene therapy--may pave the way for other experiments in healthy people seeking to enhance themselves genetically.

“I am wondering if it is not time to set some limits on science,” said Lori Andrews of Chicago-Kent College of Law at the Illinois Institute of Technology, an authority on genetic engineering and reproductive technologies.

A Pervasive Force in Agriculture

The international furor provoked by cloning comes at a time when the medical and agricultural products of genetic engineering are becoming pervasive.

This spring, millions of acres of U.S. farmland are being sown with seeds of genetically altered cotton, corn and soybeans. For the first time, genetically engineered crops comprise a significant portion of American agriculture, experts say.

More than three-quarters of the cotton in Alabama last year was genetically engineered to kill insects.

Now researchers are experimenting with cotton plants that contain polyester.

Farmers are planting 8 million acres in genetically engineered soybeans, 3.5 million acres in modified corn and 10,000 acres of altered potatoes, Monsanto Co. officials said. The company is selling genetically engineered seed as fast as it can make it.

“People’s heads are still spinning at how quickly this is being adopted,” said Margaret Mellon, a biotechnology analyst at the Union of Concerned Scientists in Washington.

Last spring, the first genetically engineered bug--a predatory mite designed to eat insects that plague strawberries and other crops--was released in Alachula County, Fla. The first transgenic nematode worms, a laboratory variant of a garden pest, are being field-tested in Salem County, N.J., with the hope that they eventually can be rendered harmless.

Even more dramatic are the inroads biotechnology has made into medicine.

Tens of millions of people have used genetically engineered medicine to control heart disease and diabetes, treat cancer or offset the effects of stroke, according to the Biotechnology Industry Assn.

Tens of thousands more routinely undergo genetic testing--either to judge the health of their unborn children or to tell if they themselves are susceptible to chronic diseases or cancer. Thousands of children owe their existence to the innovations of assisted reproduction technology such as in vitro fertilization.

But sociologists and anthropologists who study the impact of the new biotechnology say its most far-reaching effects may be on how people think of themselves and their ideas of law, family, insurance, property and animals. Fundamental concepts of what it means to be human have been colored by the notion that the blueprints of all living things are drawn from the same genetic code.

“These ideas are a major consequence of the last 20 years, entering people’s consciousness piece by piece,” said Alexander Capron, an authority on biomedical ethics at the University of Southern California and a member of the federal bioethics commission asked by President Clinton to consider the implications of cloning.

“The advances in biology have made a huge difference [in how we think] and it is only going to get more so,” he said. “You can avoid genetically engineered produce if it bothers you, but that is very hard to do with an idea.”

In some instances, critics say, society has gone overboard in its rush to embrace insights arising from the new biology. Henry Greely, co-director of Stanford University’s Program in Genomics, Ethics and Society, said the scientific emphasis on genes is unintentionally buttressing political beliefs that biology is the root of human character and of social ills ranging from racial inequality to violent crime.

“Our society has been jumping in recent years toward . . . scientifically unjustified and culturally dangerous ideas of genetic determinism. [This] . . . is a gross overestimate of how important genes are to how humans behave,” he said.

To complicate matters even further, the technology of test-tube conception has divorced parenting from conventional reproduction and made family formation less a matter of biology than of personal preference and contract law.

Prenatal testing also is creating a new generation of parental obligations and strengthening the idea that the fetus has a legal identity separate from the woman who bears it.

“Biological innovations are often regarded as perversions when they first come along. Then they often become widely practiced,” said Caltech science historian Daniel Kevles.

Then he paused and added: “I think there is something different about the prospect of human cloning.”

Cloning Brings New Possibilities

As a breakthrough in cell biology, cloning joins the new technology of reproduction to genetic engineering.

The techniques discovered by Ian Wilmut at the Roslin Institute offer the unprecedented opportunity to reawaken all of the genes inside an adult cell, rewind the clock that governs cell development and, perhaps, unlock the secrets of aging, experts say.

Cloning holds the promise of bypassing conventional breeding techniques to allow creation of thousands of precise duplicates of genetically engineered mammals in a single generation, Wilmut explained.

Breeders could create a viable embryo by the cloning technique of nuclear transfer, which Wilmut employed. In that process, the nucleus from any cell of a genetically altered animal is transferred into a specially prepared, unfertilized egg, then grows a perfect genetic copy.

“I am not actually sure it is such an incredible breakthrough,” Wilmut said. But “there is this aura about it that makes people jump.”

Until the advent of cloning, the ability to create new species of transgenic animals--by inserting new genes into an embryo--was hit or miss. Less than one-tenth of 1% of genetically engineered embryos properly incorporated a new gene, researchers said.

“The technique of nuclear transfer offers us . . . a way to target genes,” said Alan Colman, research director of PPL Therapeutics Ltd. in Edinburgh, which collaborated with Wilmut on the controversial experiment.

“Cloning is a bonus,” he said. “We can make a cell into an instant flock or an instant herd.”

Those who are wary of the new technique warn that equally controversial advances in the technology of animal husbandry have virtually always presaged similar developments in human reproduction--from artificial insemination, in vitro fertilization and the use of fertility drugs to frozen embryos and the micro-manipulation of human eggs, embryos and sperm. Such a progression seems inevitable for cloning as well.

But even those who object to the idea of human cloning can see its potential usefulness in certain situations, such as cases of infertility.

Barely a week after National Institutes of Health Director Harold Varmus declared human cloning “repugnant,” he testified to Congress that he could imagine a scenario in which an infertile couple used a cloning procedure for family planning.

Indeed, cloning theoretically could simplify the complex equation of human reproduction. Technology already has introduced so many variables that one child can have up to five parents: a sperm donor, an egg donor, a surrogate mother and two adoptive parents.

Cloning could reduce that to the biological prime number of one: a woman who, through cloning, gives birth to a genetic duplicate.

Science of Life a Major Industry

A generation ago, scientists worried that tinkering with the genes of even the simplest organisms was too dangerous--so much so that they convened an unprecedented conference at the Asilomar Conference Center in Monterey, Calif., to establish universal ground rules for gene research.

But as the specter of extreme danger has faded in the past decade, biotechnology companies have conducted more than 2,500 field tests of genetically engineered organisms and plants in the United States, without a serious accident, federal agriculture and food safety officials said.

The science of life has created a major industry, with more than 1,300 companies, nearly $13 billion in annual revenues and more than 100,000 people on its payroll--a significant percentage of them in California. Instead of spawning rogue microbes or ecological disasters, that industry has sharply changed ideas about the ownership of living organisms while researchers have raced to patent the creatures they create and the genes they find.

At the same time, changes in federal technology transfer regulations have fostered more intimate relationships between publicly financed laboratories and commercial biology ventures. And federal researchers now are encouraged to patent the fruits of their research.

For example, scientists at Case Western Reserve University who recently discovered how to create human chromosomes conducted most of their research with public funding from the National Institutes of Health. They patented the technique and acquired a corporate partner to exploit it before the research ever became public.

Such a thorough mingling of public research and private enterprise, although troubling to some, is now the rule.

Wilmut and his colleagues also patented their cloning technique before making their experiment public. The stock price of PPL Therapeutics, their corporate collaborator, jumped 16% on the announcement.

“The tens and tens of billions of dollars [from biotechnology companies] have fundamentally changed the way science is done in the United States,” said Stanford anthropologist Paul Rabinow, who studies the business of molecular biology and genetics.

In 1995 alone, medical researchers patented 500 genetic engineering products. And the pace of development is accelerating. More than 284 new genetically engineered medicines for diseases ranging from the common cold to AIDS were tested in 1995--up almost 20% from the year before, industry surveys show.

Some of the 44 biotech drugs already approved have, in fact, replaced other drugs from more conventional sources.

Genetically engineered human insulin has almost completely supplanted insulin from cows and pigs. As many as 3.4 million Americans are now taking genetically engineered insulin, according to the American Diabetes Assn.

Recombinant human growth hormone has greatly expanded the supply of the rare substance, allowing physicians to treat not only insufficient growth, but also to heal wounds or to retard the effects of aging. It has even gotten into the black market among athletes who believe it will enhance their bodybuilding efforts and boost performance.

Amgen Inc.’s erythropoietin is given to all but a few of the 200,000 people who are on kidney dialysis each year. By stimulating the growth of red blood cells, it frees them from the risks of blood transfusions and alleviates the fatigue of most dialysis patients who have been suffering from anemia.

“I think . . . genetics, immunology and so on [are] really paying off tremendously” in new treatments and a better understanding of medicine, said French Anderson, a USC molecular biologist who pioneered the concept of human gene therapy to treat inherited diseases.

Before Genentech introduced tissue plasminogen activator (tPA), there was nothing to dissolve clots. Erythropoietin also had no predecessor. There was no hepatitis B vaccine. Avonex and Betaseron, the beta-interferons, represent the first useful therapies for multiple sclerosis. Pulmozyme (DNase) is the first effective product for treating lung congestion in cystic fibrosis patients.

Doctors hope to identify more medical treatments as new genes are identified. There is no shortage of raw material.

So far, researchers have identified more than 16,000 of the roughly 100,000 genes that make up the molecular blueprint for human growth and development. Federal medical authorities are confident that they will have decoded all human genes by 2005.

The number of human genes mapped has tripled in less than two years and that number is expected to double this year, according to Dr. Frances Collins, director of the National Center for Human Genome Research. Last year, researchers identified 21 genes responsible for inherited diseases--twice as many as the year before.

The effect of the new technology is only beginning to be felt, experts say. This first wave of medical products resulted from relatively simple manipulations of life. Most of the first biotech products to reach the market were simply normal human proteins produced by genetically engineered bacteria.

Now researchers are perfecting more powerful techniques to produce the next generation of treatments.

Many of the newer drugs being studied are more complex products, such as vaccines and monoclonal antibodies as well as tools for gene therapy.

And the altered bacteria themselves used to produce the first round of medical compounds are being replaced by more complex living bioreactors.

Man-made sheep, designed to give a human protein called alpha-1 antitrypsin in their milk, graze in the hills outside Edinburgh. Their milk is being tested on people as a treatment for emphysema and cystic fibrosis. Genetically engineered cattle, which give human alpha-latalbumin in their milk, are pastured outside Blacksburg, Va.

Genetically engineered mice with human diseases are the living test tubes found in dozens of medical research laboratories.

Some Early Hopes Fail to Pan Out

But if the original fears about manipulating life have not materialized, the benefits also have not developed quite as its boosters had predicted:

* Many genetically engineered foodstuffs cleared technical and regulatory hurdles only to run afoul of consumer distaste, labeling disputes and international trade boycotts. The Flavr-Savr tomato, touted for its ability to stay fresh longer, was withdrawn for further development. Milk produced by treating cows with bovine growth hormone has been widely boycotted for fear of bacterial contamination caused by the drug.

Now evidence suggests that new genes in some crops can trigger allergies in sensitive people. Other studies indicate that by sharing pollen, some weeds can pick up new genes for herbicide resistance or other engineered traits from nearby crops. In addition, crops designed to contain their own pesticide may actually promote resistance to common organic pesticides. A mutation in a single gene in one crop pest--a moth--can confer resistance to four varieties of organic pesticide, researchers have determined.

* Scientists have created dozens of genetically engineered animals as models of human diseases, but efforts to create livestock tailored to the demands of modern factory farming--from self-shearing sheep and faster-growing pigs to featherless fowl--have resulted in creatures that were crippled by arthritis-like conditions, diabetes or ulcers, subject to heatstroke and often infertile. Attempts to use “humanized” pigs in human organ transplants have been slowed by fears that the organs may transmit animal viruses to human patients.

* Human gene therapy--which attempts to cure inherited diseases by altering the genes in human cells, as in the case of Andrew in Los Angeles--has been disappointing, experts convened by the National Institutes of Health concluded. Doctors conducted 106 clinical trials of experimental gene therapies in the past five years involving more than 597 patients, but “clinical efficacy has not been definitively demonstrated at this time in any gene therapy protocol, despite anecdotal claims of successful therapy,” the NIH group said. The panel warned proponents of gene therapy to stop promising what they cannot yet deliver.

* Some genetically engineered microbes, such as those designed to protect plants from pests, survive better in the wild than many scientists had assumed--so long, that some researchers are concerned that they might upset the ecology into which they are released, new research shows. Many molecular biologists had believed that it was safe to release man-made microbes, in part, because the genetic alterations generally leave the organism weaker than its natural competitors, and so it would quickly die off under natural conditions. But University of Georgia scientists--in the first study of its kind--determined recently that genetically engineered microbes can survive quite well in the wild. “There is probably some level of over-optimism in assuming that [genetically engineered organisms] can be magic bullets to do a certain job without ever harming the ecosystem,” said Robert Hodson, the senior scientist who conducted the study.

* Discovery of genes that predispose people to diseases, including breast, ovarian and colon cancers, generated new diagnostic tests, but some experts warn that the tests are misused or given without adequate counseling. Doctors who test patients for a gene that causes colon cancer often fail to perform the test properly and commonly give inadequate or misleading information about the results, researchers at Johns Hopkins University recently found. Although a genetic diagnosis can often be a life-or-death matter, the doctor’s interpretation of the results was wrong in nearly one-third of the cases, the researchers said.

Genetic tests for susceptibility to chronic diseases and cancer also are creating new opportunities for discrimination.

A recent Georgetown University study of people in genetic-disease support groups determined that 47% of those who mentioned the inherited condition on their insurance forms were denied coverage.

“The capacity to predict diseases without being able to treat them will be a social nightmare, an employment nightmare, an insurance nightmare,” said UC Berkeley sociologist Troy Duster, who is chairman of a federal task force at the NIH and the Department of Energy investigating the social, legal and ethical implications of the new technology.

Last month, a coalition of health experts and ethicists urged Congress to enact measures protecting people against abuse of genetic information to deny jobs, promotions, insurance coverage or other benefits. Eighteen similar measures have previously been introduced without success.

The International Bar Assn., which represents 167 countries, expects to present proposed regulations guarding against the misuse of genetic data to the United Nations later this spring.

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ON THE WEB

* Graphics, photos and stories from “In Our Own Image” are available on The Times’ World Wide Web site at https://www.latimes.com/cloning/

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About This Series

The cloning of a sheep named Dolly sent shockwaves throughout the world this year. But that is only one of a host of advances in biotechnology. The revolution is touching virtually all corners existence, from conception to nutrition to disease control. The genetic engineering advances also raise basic questions about how society will deal with these newfound abilities, who should control their use and how far research should be allowed to proceed.

* Today: The biotechnology revolution--the future has arrived.

* Monday: What is the “self” and can it be cloned?

* Tuesday: The U.S. government’s reluctance to regulate reproductive technology raises some thorny issues.

* Wednesday: The quest to map the human genome leads down some unusual roads.

* Thursday: Barnyard biotech--of cows with medicinal milk and pigs with human-like organs.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Custom-Talioring Nature

Researchers use the tools of genetic engineering to transfer genes beteween different species, but conventional genetic engineering techniques can be hit or miss. Researchers hope that cloning will be more efficient. That will allow them to create transgenic animals more quickly and also to create new types of human cells to investigate potential medicial treatments.

Conventional Gene Splicing

1. Most gene transfer experiments start with a plasmid, a circular strand of bacterial DNA that lies outside the bacterium’s nucleus.

2. Scientists use special enzymes to cut the plasmid open, remove unwanted DNA and add desired genes.

In Plants

There are many ways to add plasmids to plant cells. One of the most common is to coat small gold or plastic balls with the plasmids; the balls are then fired into the cells with a special gun.

The plasmids are then taken up by the cells, giving them a new genetic characteristic.

The cells can then be induced to form seedlings that contain the new genetic trait.

In Animals

Plasmids are generally injected into fertilized embryos with a long thin needle, a process called micro-injection.

The altered embryos are then inserted into surrogate mothers, where they are grown into intact animals.

About one in 100 of the new animals produced this way will contain the desired gene. It is this basic inefficiency that makes cloning so potentially valuable.

3. The rusulting plasmid is a “vector,” a tool used for inserting DNA into another species.

The Difference Cloning Could Make

Researchers create a clone by combining a genetically engineered cell with an unfertilized donor egg. They can repeat the process for as many eggs and surrogate mothers available, allowing them to create an entire herd of genetically identical animals in a single generation.

Researchers isolate an adult cell 1, starve it so it becomes dormant 2, and then remove it nucleus 3.

They also take an egg from a second donor 4, remove its nucleus 5; and then fuse the egg cell with the adult nucleus 6 to create an embryo 7.

The new embryo is implanted in a surrogate mother 8. The end result is a genetic duplicate 9 of the ewe that provided the adult cell.

Researched by ROBERT LEE HOTZ and VICKY McCARGAR / Los Angeles Times

Biology on the Fast Track

Key developments in modern biology.

1871

* Discovery of DNA.

1884

* The first recorded instance of artificial insemination with donated sperm takes place in Philadelphia.

1943

* DNA is proved to be the genetic molecule.

1952

* American biologists develop the basis for cloning, by removing the nucleus of a cell, which contains all the genetic material of the organism, and substituting another.

1953

* James Watson and Francis Crick discover the structure of DNA.

1960

* Amniocentesis, a procedure that allows for the diagnosis of Down’s syndrome and other genetic disorders, is introduced.

1966

* The gentic code is identified.

1967

* British biologist John P. Gurdon successfully clones a frog, but the cloned frog does not mature.

1973

* Foreign DNA fragments are inserted into bacteria.

1976.

* National Institues of Health issues safety guidelines to control laboratory procedures for gene splicing. Rules later are relaxed as process proves safe.

1978

* Louise Joy Brown, the first child conceived through in vitro fertilization (IVF), is born in Great Britain.

1979

* The Ethics Advisory Board of the National Institutes of Health (NIH) concludes that federal support of IVF research and embryo transfer could be ethically acceptable.

* First IVF clinic in the United States opens in Norfolk, Va.

1980

* NIH Ethics Advisory Board is disbanded by the Carter administration before it approves any funding for IVF research, beginning an indefinite moratorium on federal funding for such research.

* U.S. Supreme Court rules that manmade lifeforms can be patented.

* Biotech firm Genentech sets Wall Street record for fastest stock increase: from $35 to $89 a share in 20 minutes.

1981

* First American IVF baby, Elizabeth Jordan Carr, is born in Norfolk, Va.

1982

* Insulin becomes the first genetically engineered drug approved by the Food and Drug Administration (FDA) for use on people.

* Presidential commission debates genetic engineering of human beings.

1983

* The first ‘donor baby’ is born in Australia, created with a donated human egg.

1984

* First embryo “twinning” with sheep is reported. Others replicate this feat in cattle, pigs, goats, rabbits and rhesus monkeys.

1985

* NIH approves experimental guidelines for treatment in which genes are transplanted to correct hereditary defects in humans.

* Monsanto attempts first deliberate release of manmade microbes into the environment.

1986

* U.S. Patent and Trademark Office issues the first patent on a plant produced through genetic engineering.

1987

* A committee of the National Academy of Sciences concludes that transferring genes between species poses no environmental hazards.

1988

* First U.S. patent on a genetically engineered higher animal is issued--a mouse used in cancer research.

* Patent office suspends the granting of patents on new life forms for five years to consider implications.

1990

* The FDA approves rennin, used in cheese, as the first genetically engineered food product.

* The first human gene therapy experiment is conducted.

1991

* Researchers create a transgenic dairy bull carrying a human gene for a lucrative medicinal compound.

1992

* A healthy baby girl is born to a British couple following the first successful application of preimplantation diagnosis to detect genetic diseases in a human mebryo.

1993

* Researchers at George Washington University in Washington announce that they have successfully “cloned” some defective human embryos by splitting eight-cell human embryos.

* A 59-year-old British woman gives birth to IVF twins, touching off a worldwide debate over the ability of new reproductive technologies to allow post-menopausal women to carry a pregnancy to term.

* Congress lifts 20-year ban of federally funded reseach on human embryos, but the ban is quickly reimposed.

* Cornell researchers announce the birth of the first U.S. babies born from embryos screened in a laboratory for genetic flaws before being transferred to their mother’s womb.

1994

* First cloning of calves grown from more advanced embryos.

* Federal panel urges funding of some human embryo research. Ban continues.

1995

* Nearly 200 religious leaders from Roman Catholic, Protestant and Jewish denominations, as well as associations of Buddhists, Hindus and Muslims, call for a halt to the patenting of human and animal life forms for profit.

1996

* Genetically engineered cotton goes on sale.

* Scottish scientists produce the first cloned mammal--a sheep named Dolly--using an udder cell from a 6-year-old adult sheep.

1997

* The birth of Dolly is made public seven months after the fact.

* President Clinton temporarily bans federally funded cloning research.

Source: Congressional Quarterly, Designs On Life

Compiled by ROBERT LEE HOTZ and SCOTT J. WILSON / Los Angeles Times

Spliced Genes on the Job

Biotechnology firms have conducted more than 2,500 field tests of genetically engineered organisms and plants in the United States. The biggest categories include:

Herbicide tolerance: 27.6%

Enhanced product quality: 26.7%

Viral resistance: 10.4%

Insect resistance: 24.3%

Fungal resistance: 3.8%

Other*: 7.2%

* Marker genes, selectable markers bacterial and nematode resistance

Source: U.S. Department of Agriculture

The Patent Picture

The U.S. patent office in 1995 issued 350 patents for genetic engineering, almost half of which were for health care. The U.S. biotech companies dominate the scene, holding more than 80% of the health care patents.

* 1995 genetic engineering / pharmaceutical health care patents: 150

The U.S. holds the bulk of the 150 patents for health car genetic engineering.

United States: 122

European Community countries: 11

Japan: 6

Others: 11

Source: Pharmaceutical Research and Manufacturers of America

The Business of Biotech

* Industry growth: U.S. pharmaceutical companies are currently testing or seeking FDA approval for more almost 300 biotech medicines. There were 113 companies involved in testing products in 1996, 11% more than in 1995.

* Product growth: Fifty new biotechnology medicines alone went into development last year, a 21% increase over the previous year.

* Top targets: Fully 40% of the products are being tested for cancer treatment. About 10% are for treating or preventing HIV and AIDS.

* Gene therapy: The fastest growing category of biotech products is gene therapy, with 28 new products in 1996 compared with 17 in 1995.

* Vaccines: The second-fastest growing segment is vaccines, up 44% in 1996 to 62 in development. Target illnesses are cancer, AIDS, rheumatoid arthritis and multiple sclerosis.

Source: Pharmaceutical Research and Manufacturers of America

Voices

“We are very concerned that in prohibiting any potential misuse of this technology, society does not lose the opportunity to develop new treatments ... [But] “it is the unanimous view of the group within the institute and within the company that we would find this sort of work with human embryos offensive.”

--Ian Wilmut, senior researcher, Roslin Institute, Scotland

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“Why are we uneasy about cloning? We might be worried about the dangers of excessive control over human reproduction, about the dangers of unbounded human pride.”

--Thomas H. Murray, member, National Biotehics Advsiory Commission

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“Cloning research must be allowed because of its contribution to understanding human disease. If an infertile couple sees cloning as an option, I see nothing wrong with that.”

--Moshe Tendler, bioethics expert, Yeshiva University

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“There is concern this is going to lead to a knee-jerk reaction.”

--Jonathan MacQuitty, chief executive, GenPharm International Inc

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“We simply cannot stand by and allow humans to be copied. That would be breaking through an ethical barrier that goes far beyond even the barrier of the atomic bomb.”

--Juergen Ruettgers, German research minister

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“There is much about cloning that we still do not know. But this much we do know Any discovery that touches upon human creation is not simply a matter of scientific inquiry, it is a matter of morality and spirituality as well.”

--Bill Clinton, U.S. president

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“My own feeling is that if that were ever to be used, it would be used incredibly sparingly.”

--Harold Varmus, director, National Institutes of Health

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“Cloning is not a threat to public saftey. It is a potential threat to public morals.”

--W. French Anderson, molecular biologist, USC

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“The cloning issue is the coming together of reproductive technology and eugenics.”

--Alexander Capron, member, U.S. National Biotehics Advisory Commission

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“Cloning adds to the notion that animals are like machine parts that can be mass produced and, for some people, reduce the sanctity of living things. There is truth to that notion. There is a point where you can mass produce living things to reduce their value and sanctity.”

--Sheldon Krimsky, science policy analyst, Tufts University.

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“We may wonder whether this is a miracle for which we should thank God, or an ominous sign that we want to play God,”

--Nancy Duff, theologian, Princeton Theological Seminary

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“We should not assume the free choice of (a clone’s potential parents) is the only choice that has large implications for society.”

--Lisa Cahill, theologian, Boston College

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“We hardly know enough now to risk cloning a human being but we should not close the door on it.”

--Daniel Kevles, science historian, California Institute of Technology

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“What we are concerned about is that there is research that could be highly beneficial that involves the cloning of certain cells...It’s a wise idea to call a time out. This has happened a bit sooner than people expected.”

--Carl Feldbaum, president, Biotechnology Industry Association

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“We mustn’t shut down other related forms of research that could unlock the secrets to diseases.”

--Ronald M. Green, director, Dartmouth College Ethics Institute

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“This aims at the heart of the mystery of the child. It breaks the connection between procreation and sexuality.”

--Gilbert Meilaender, theologian, Valparaiso University in Indiana

Compiled by ROBERT LEE HOTZ / Los Angeles Times