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A call to rein in genetic research


FRESH from Yale Law School in 1978, Lori Andrews took the bar exam the same day that Louise Brown, the first test-tube baby, was born.

Since then, Ms. Andrews' legal career has been intertwined with the stormy development of reproductive and genetic technologies.

Her expertise, tempered by compassion and wit, has made her a respected voice of reason in clamorous disputes -- about genetic testing, surrogate arrangements, the disposition of frozen embryos, cloning -- that were never forecast by the pioneering scientists who made them possible.

Ms. Andrews has served as chairman of the federal commission on the legal, ethical and social implications of the Human Genome Project and last year was appointed director of the Institute for Science, Law and Technology at the Illinois Institute of Technology.

A professor at Chicago-Kent College of Law since 1993, she has written six books, including her latest: "The Clone Age: Adventures in the New World of Reproductive Technology."

Q: The revolution in genetics was presented to the world as a boon. What is really happening?

A: For many people, genetic tests have created more problems than benefits. Biomedical companies and physicians have a financial incentive to heavily market these tests, and healthy people interested in learning whether they are at risk for future diseases may agree to be tested before considering the psychological, social, and financial impact of learning genetic information about themselves. There also is the problem of the therapeutic gap. Many diseases can be diagnosed through genetic testing, but few can be treated successfully. This has enormous implications. For example, health insurers may refuse to insure healthy people whose genes indicate they might get cancer or some other disease 10 to 20 years hence.

Q: Insurance companies say genetic discrimination is not a problem. But you continue to collect cases, don't you?

A: Yes, increasingly people are being judged based on their genes. Courts are even getting into the act now. In the case of a divorcing couple, the husband persuaded a South Carolina court to order Huntington's Disease testing on the wife. (Huntington's destroys mind and body and is incurable).

So in the future in the contested custody cases, we might see the mandatory testing of both spouses, where the woman says, "Test him for prostate cancer susceptibility" and he says, "Test her for breast cancer susceptibility." Suddenly, the child is not going with the best parent but the one who statistically has the longest life span. That's something that troubles me.

Fewer than 15 percent of those at risk for Huntington's seek the test because they want to live with hope.

Q: With so much going on, what do you see as the most dangerous problem?

A: The poor quality in genetic testing now and the lack of training. In a survey of physicians about genetics, the average score was 74 percent. Imagine if you've got the disorder that's in the other 26 percent! In another study in the New England Journal of Medicine, one-third of physicians incorrectly misinterpreted the results of genetic testing for cancer.

I was on a committee of the National Academy of Sciences and we found that hospitals didn't even know which of their personnel were doing genetic testing. Every oncologist, every neurologist sees it as a panacea.

I think there's another issue. A lot of these things are done with a simple blood test. Or even now in classrooms in three states, where there's genetic testing for "Fragile X," an indication of mental retardation, on a saliva sample. Kids swish some Gatorade and spit it in a cup. It's not very physically risky so we don't scrutinize it. Even though the social and psychological risks -- and some of the medical risks -- can be very high.

For example, people who learn they have a gene associated with a late-onset disorder have a higher level of depression and anxiety. They should have help dealing with the psychological impact and the knowledge that insurers and employers might discriminate against you based on this genetic information.

Q: And now the $3 billion Genome Project paid for by public funds is in a race to be privatized? Isn't the idea of our genes as commercial property ridiculous?

A: Patents have gone amok. First of all, I think the patent office has it wrong legally. You're not supposed to be able to patent a product of nature or a formula like E=MC2 and a human gene seems to be both.

Another reason genes shouldn't be patented is that they are discovered by doctor-researchers using tissue from their patients. That goes against our idea of the fiduciary duty of physicians to put their patients first.

Q: There's a sense of everybody trying to get a slice of the profits, isn't there?

A: Sure. Under traditional patent law, an inventor would be able to patent a genetic test and collect a royalty from doctors who use it in patients. In the current genetic gold rush, though, patents are issued to the person who discovered a particular gene (like the breast cancer gene) and to each person who discovers a mutation in that gene. There may be hundreds of gene mutations in a particular gene and proper testing will need to look for at least several dozen of them. The cost of genetic tests is going through the roof because of these multiple licensing fees.

Q: Biotech companies are commercializing genes, but we allow university and government scientists to do so as well. They're getting rich at our expense, correct?

A: Yes, and consequently the fundamental nature of science is changing. Scientists used to share information and genes with colleagues. Not any more. Even researchers at the National Institutes of Health, funded by taxpayer dollars, are getting rich selling publicly funded research to biotech companies.

Q: Is there a move afoot to regain some control?

A: The United States and Britain have plans to block the patenting of human genes by private corporations. This would be a reversal of the current Patent Office position, which not only allows the patenting of whole genes, but also of partial gene sequences (small parts of genes).

Q: You were head of the watchdog group of ethicists and lawyers appointed to monitor the human and societal implications of the genome project, yet you quit. Why?

A: Congress and the public were looking to us to protect against the misuse of genetics. But we didn't have sufficient independence to do so. The committee's staff and budget were controlled by the very scientists running the Human Genome Project. It was like the fox guarding the chicken coop.

Q: What types of laws do we need?

A: We need four types. First, we should allow people to have control of what information is generated about them. So I wouldn't let courts in divorce mandate genetic testing on people. And I wouldn't let insurers require any kind of genetic testing. Then, if people choose to have testing, we should control who has access to results.

Beyond that, we should have protections against discrimination. But that last layer is not helpful without the previous two because it's often very hard for someone who was denied a job based on his genes to prove it.

Finally, I'd do away with gene patenting to try to stem the commercial push for inappropriate use of genetic tests and treatments.

This is an edited excerpt of an interview that was conducted by Peter Gorner, a science writer for the Chicago Tribune.

Pub Date: 10/10/99

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