The Cutting Edge: COMPUTING / TECHNOLOGY / INNOVATION : Genetic Backlash : Biotech Industry, Critics Clash in the Ethics Arena
When a powerful group of religious leaders last week called for a ban on the patenting of life forms, it was not merely asking for a change in obscure intellectual property laws. It was, more broadly, calling for a public debate on a range of ethical questions raised by contemporary biotechnology research.
Judging by the reactions of scientists and executives gathered here this week for the annual Biotechnology Industry Organization conference, the industry remains determined to avoid any such discussion. There were bitter attacks on Jeremy Rifkin, the activist credited with putting together the religious coalition, and an acknowledgment of the need “to educate the public about our industry,” in the words of G. Kirk Raab, chief executive of Genentech.
But there appeared to be little recognition of the potential for public backlash against an industry whose underlying technology clearly raises real ethical questions. In addition, expectations about what the technology can deliver have been raised so high that disappointment is almost inevitable. While there may be plenty of fear mongering among biotech opponents--particularly in regard to agricultural biotechnology--even people who are sympathetic to biotech worry that the industry is asking for trouble.
“Individual researchers or companies can’t make the call about when it’s appropriate to use technology or whether it’s appropriate that naturally occurring genetic information can be patented,” says Cynthia Robbins-Roth, editor of BioVenture View, an industry newsletter. As society did with nuclear power, she notes, people can move suddenly against something they fear and don’t understand.
“If something is scary, the public can shut down an industry,” Robbins-Roth says. “Industry should promote discussion instead of hoping nobody takes notice.”
The 200-plus religious leaders, including Catholic priests, Protestant ministers, Jewish rabbis and others, have specifically attacked current policies that enable scientists to patent organisms created though genetic alteration or isolated in the course of genetic research. They say such patents violate the sanctity of life by allowing man to play God. But industry researchers say such patent protection is essential if they are to raise the money needed for development of bioengineered drugs.
This is just one of the thorny, here-and-now ethical issues resulting from profit-driven genetic engineering. As the biotech industry has come up with a few important--and, not incidentally, highly lucrative--drugs, it has also created some difficult societal problems.
Genetic testing is one example. Tests that can predict whether someone is likely to develop a disease based on inherited genes have only recently become available, but the Council for Responsible Genetics, a Cambridge, Mass.-based group representing scientists and academics critical of industry practices, has already documented dozens of cases of discrimination.
Some states, including California, have passed laws against discriminating in the workplace on the basis of such tests. But the issue becomes more complicated when it comes to insurance companies that are aggressively fighting for the right to use genetic tests to determine whether or not to sell an individual insurance. Thousands of people could one day find themselves unable to get insurance because of a genetic trait.
Insurance companies have long used medical “predictors” of health such as blood pressure, and there is no compelling reason to deny the use of genetic tests, says Arno Motulsky, professor of medicine and genetics at the University of Washington and chairman of a National Academy of Science committee that published an extensive report on the issue last year.
And if only patients have access to the results of genetic tests, high-risk patients could choose to take out disability insurance in large numbers. “The only answer is some kind of universal health insurance,” Motulsky says.
There is also increasing revulsion against experiments that involve putting human genes in pigs, either to produce leaner meat or so their organs can be more easily transplanted into humans.
The federal government announced this month that it will regulate experiments involving transplants of baboon organs into humans. But the decision came only after wide publicity, including a best-selling book, about the danger of viruses from primates crossing over into human populations--as AIDS is suspected of having done.
Perhaps the greatest fear is that technology advances will enable scientists to spawn a generation of people with genes that would make them somehow “better,” reminding some of work done by scientists in Nazi Germany.
Industry executives dismiss such fears as nonsense.
“We know how to work on the germ line, but we won’t do it. We are holding the line,” says George Rathmann, chief executive of Bothell, Wash., biotech start-up ICOS, referring to work on human ovaries that might one day permit genetic changes in humans that could be passed on from generation to generation.
“If you tried to change the human germ line, it would change the human species,” says Rathmann. “We don’t want people horsing around in that.”
But industry executives’ eschewing of the research is partly due to the fact that the technology is still decades from being commercially viable. In the world of basic research, the line is already being blurred. Scientists are doing extensive germ line research on mice that has applications for humans. And at the National Institutes of Health, scientists suggest that altering genes might be acceptable, for example, if the goal was to eliminate hereditary disease.
In a 1993 article in Science, Nelson Wivel of the NIH argued that each technology moves from threshold to open conflict to extended debate and adaptation, and that germ line research is now at the threshold stage.
Once a line is crossed and technology becomes available, it is difficult to prevent its use for purposes that might be medically more questionable.
That’s what happened with the human growth hormone Somatrem. Eli Lilly and Genentech received permission in 1985 to sell human growth hormones to cure the medical condition that results in dwarfism.
Today the treatment, which costs $20,000 a year and requires three shots weekly, is being prescribed by doctors, with industry backing, to thousands of normal children whose parents worry their youngsters will grow up too short. Rather than call an end to the practice, the NIH is financing an extensive study to see whether the treatment is effective on normal children.
Many people believe medicine has “no right to be mucking about with people who are normal,” says Ernest Prentice, an ethicist at the University of Nebraska’s Omaha Medical Center. The center, along with many others in the nation, decided it was unethical to participate in the NIH study.
Gene therapy is another area of concern. In this technology, a gene is inserted into a human to replace a disease-causing gene. Such therapy has saved three babies with Bubble Baby Syndrome, a condition in which a newborn’s defective immune system requires it to be kept isolated to protect it from germs. Critics fear that as gene therapy becomes more common, some practitioners could promote its use for non-medical reasons such as changing skin or eye color.
Critics say that if restrictions on the use of such technology are to be developed, they must be designed before the technology becomes widely available and segments of the population can argue that they have a right to the technology.
For this reason, the campaign against gene patents may well be too late. It is difficult to overturn a decade of legal practice: Hundreds of patents have already been issued.
“It’s like saying, ‘We survived when we had just horses and carriages, why not get rid of airplanes,’ ” says Gladys Monroy, an attorney for Morrison & Foerster, a San Francisco-based law firm. “You can’t go back.”
Industry executives say any effort to regulate the industry or hold back research could set the world back on huge opportunities to cure cancer and even end hunger.
But such claims are dangerously exaggerated, says Sol Katz, professor of anthropology at the University of Pennsylvania.
“Don’t promise what you can’t deliver,” Katz warned executives at the conference, noting that no amount of new miracle plants would make much of a dent in famine, which has far more complex sociological and economic causes.
Other executives warn that regulation stemming from ethical concerns could push badly needed jobs overseas--though that claim also looks questionable.
Regulations are far more cumbersome in the rest of the world. The European Union recently voted against allowing patents on genes and other life forms, meaning approval must be sought in each country individually.
German pharmaceutical companies, America’s greatest competitor in the world market, are conducting their biotech research in the United States in cooperation with smaller biotech firms, in part because of harsh local opposition to the research at home.
Biotechnology has an important contribution to make to medicine, but it is only one tool. As the technology leader, say critics, the United States has both the luxury and the responsibility of making sure the tool is used safely and in ways that take account of social concerns.
(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)
The Ethics of Biotech
Modern biotechnology makes it possible to do things that are ethically questionable. So far the industry has largely avoided addressing those issues. Some of the following questions already demand answers, and other will soon:
* Should life forms, including but not limited to animals and plants that are genetically altered, be patentable?
* Should a person who has a genetic defect be allowed to undergo a procedure to remove the defect? Should the person be allowed to undergo a procedure to ensure that the defect will not be passed on?
* Should scientists be allowed to conduct research that might result in altering or improving characteristics of the human species?
* Should scientists be allowed to conduct research that would enable parents to create “designer children” by specifying genetic characteristics?
* Should insurance companies and employers have access to information on a person’s genetic makeup to help determine the risk of medical problems?
* Should the United States pressure developing countries to adopt U.S.-style property rights so seeds and drugs developed through genetic engineering are protected--even if widespread use of those products would vastly reduce hunger and disease?
FORUM
Let us know what you think. Send e-mail to edge@news.latimes.com, faxes to (213) 237-7837, or mail to the Cutting Edge, Business Section, the Los Angeles Times, Times Mirror Square, Los Angeles, CA 90053. A selection of responses will be published in The Cutting Edge. Please include full name and telephone number.
