WASHINGTON _ A molecular biologist from an obscureMidwestern university said on Thursday that he will return a$614,000 federal research grant to protest the dangers of unbridledgenetic engineering.

The researcher, 46-year old John Fagan, of Maharishi InternationalUniversity (MIU) in Fairfield, Iowa, has been working on identifyingcancer susceptibility genes since 1980. He heads a 27-memberresearch team at MIU's Molecular Biology Lab. The lab has receivedNational Institutes of Health (NIH) research grants totaling $2.5million since 1986.

Though MIU is clearly a fringe institution (it was founded by theguru who launched the Transcendental Meditation movement),Fagan himself has had some success in a competitive field. "Thenumber and size of grants he has received indicate he was doinggood science," Jerome Green, director of the NIH's Division ofResearch Grants, told BioWorld. "We are very careful with our grantmoney and it is rigorously peer-reviewed." Only 25 percent of allresearchers who apply for NIH funding win research grants, saidGreen.

In addition to grants, Fagan received an NIH Research CareerDevelopment award from the National Cancer Institute (NCI) threeyears ago. The five-year grant, worth more than $250,000, wasdesigned as a stipend to boost the careers of promising juniorinvestigators, according to Green. Before he joined MIU in 1985,Fagan spent seven years working in various labs at the NCI andreceived his Ph.D. in biochemistry from Cornell University.

However, Francis Collins, director of the NIH's Human GenomeProject, told BioWorld that Fagan's views are "pretty far out of themainstream. We've had two decades of intense, open discussionabout this technology and a strongly held consensus has developedamong scientists that the types of technologies we are pursuing at thepresent time are safe," said Collins. "There's nothing new here toreopen that debate."

Multiple Safety Mechanisms Exist

Collins said that multiple layers to safeguard against inappropriategenetic engineering are built into the medical and scientific researchsystem, starting with biosafety committees at all universities andextending up to the national level in NIH's Recombinant DNAAdvisory Committee.

Fagan said on Thursday that he was returning a three-year $614,000research grant awarded in September and withdrawing pendingresearch grant applications for another $1.25 million in NIH support.He called for a 50-year moratorium on germ-line geneticmanipulation (the introduction of genes into the DNA of sperm, eggsor embryos). Although germ-line manipulation on human beings isnot sanctioned in the U.S. and is banned in at least five Europeancountries, Fagan said that germ-line manipulations of plants andanimals is gathering a dangerous momentum.

"The trend is now toward increasingly rapid application of genetherapies and genetic engineering methods without properconsideration of their impact," said Fagan. "It is not possible for anyresearcher to predict the consequences of a change _ no matter howminor it seems at the present _ in the genetic makeup of anyspecies. We don't have sufficient information to make thesedecisions responsibly."

Fagan cited several biotechnology products, including virus-resistantsquash, herbicide-resistant cotton and other crops, bovine growthhormone, a Klebsiella bacteria strain modified to help convert woodchips into ethanol and salmon with an extra growth hormone gene asexamples of "germ-line genetic engineering horror stories."

Fagan's own research on two genes that are blueprints for enzymes(called cytochromes P450) involved in carcinogen and toxinmetabolism led him to the realization that genetic engineering was apotentially dangerous solution to complex health problems. Heargued that the discovery of more and more cancer susceptibilitygenes will not lead to treatments or cures, but rather to dangerousgenetic manipulations that attempt to prevent development of cancer.

"You can't genetically engineer reversal of a cancer, so you're leftwith either somatic or germ-line prevention approaches," said Fagan.He added that somatic manipulation is not feasible in humans, exceptfor monogenic diseases (caused by mutation in a single gene), whilemost of the major illnesses facing Western society today arepolygenic.

"You're left with germ-line manipulation as a prevention strategy,"he concluded. "We think of surgery as invasive, but altering thephysiological blueprint through genetic manipulation is much moreinvasive." Fagan said he does not oppose genetic research but thatthe over-optimism of scientists, the desire of companies to profit from thetechnology and a weak regulatory structure have created an "unholyalliance" that drives genetic research without proper checks andbalances. The public does not understand or help decide what isbeing done, he asserted.

French Anderson, a pioneer of gene therapy who spent 27 years atthe NIH and is now a professor at the University of SouthernCalifornia, disputed the view that gene therapy is not publiclydiscussed. "No other protocols in the history of medicine have beenas openly and publicly discussed as gene therapy protocols," he said."Every single protocol and every single adverse event is aired inpublic in front of the press."

Nonetheless, Anderson told BioWorld that he was "sympathetic" toFagan's basic concern that potential dangers of genetic engineeringaren't fully understood (that's assuming Fagan, who Anderson hasnever heard of, is making "a sincere protest" and is not just "wacky,"he adds).

"As gene therapy gets to be more and more of a bandwagon, somepeople are talking about inappropriate enhancement engineering ofhumans instead of just trying to make people [well]. Going into thegerm-line at this point is dangerous and inappropriate." In fact,Anderson opposes germ-line gene therapy in humans, even forstrictly therapeutic purposes, "for at least 10 to 15 years, even if itbecomes possible before that."

"He [Fagan] probably thinks people like me want to do that [germ-line manipulation]," said Anderson. "But I've written for years aboutthe absolute need for safeguards in genetic engineering. At present,those safeguards are good." n

-- Lisa Piercey Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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