A scientist of Stanford University has successfully inserted antibiotic-resistant genes into a potential disease germ. The experiment has raised serious new questions about the adequacy of federal guidelines forbiding experiments that combine genes in ways that might hurt anyone.
The question of whether or not the Stanford experiment reveals a gap in the guidelines is being examined by a Senate health subcommittee and by the National Institutes of Health, it has been learned.
A committee has been named by NIH Director Dr. Donald Frederickson to consider possible expansion of the year-old federal guidelines to cover this and other possibly unsafe biological reseach.
Sen. Edward M. Kennedy (D-Mass.), chairman of the Health and Scientific Research Subcommittee, said last week that the Stanford work "presents an unacceptable risk for the American population" and indeed shows "a fundamental weakness" in the NIH guidelines.
He said he expects to take up the matter this week when the health subcommittee's parent body, the Senate Human Resources Committee, meets to mark up and vote on his bill to extend the guideline - which now cover only federal grant recipients - to all researchers, including industry's.
The guidelines forbid scientists from artificially joining unrelated genes to make any disease germs resistant to antibiotics. But the guidelines over only new and revolutionary "recombinant DNA" method of linking DNA (deoxyribonucleic acid), the basic chemical of genes.
S. D. Ehrlich, a French geneticist working at the California university, used a different gene-mixing method believed to occur sometimes in nature.
He inserted several bits of genetic material from antibiotic-resistant staphylococcus bacteria into an ordinarily harmless kind of bacteria called bacillus subtills, or B. subtilis.
He did so by a familiar genetic method called transformation in which genes pick up pieces of free-floating foreign DNA.
He reported in the April issue of the Proceedings of the National Academy of Sciences that the transplanted genes successfully "replicate" (reproduce) "and express their gentic information [antibiotic resistance] in this new host."
If B. subtilis were always harmless, the Erlich report would probably have gone completely unnoticed. But Dr. L. Barth Reller of the University of Colorado Medical Center in Denver reported in 1973 that B. subtilis had seriously infected and almost killed a 28-year-old drug-using veterinary assistant.
Dr. Bernard Talbott, special assistant to NIH's deputy director for science, said that "if Ehrlich had proposed to do the same thing by recombinant methodology, we'd have told him to wait and referred it to an advisory committee to see whether or not it was within the guidelines. That would depend in part on whether or not B. subtilis was regarded as aa disease organism. I don't know the answer."
Ehrlich has left Stanford and is back the Institute of Molecular Biology of the University of Paris. Standford's Dr. Joshua Lederberg - a Nobel Prize winner in whose laboratory Ehrlich worked and the sponsor of Ehrlich's April report - strenuously defended the project.
"If B. subtills is a pathogen [a desease-causing organism], then anything's a pathogen," he said. "It is infectious only in a host with no immune defense."
In fact, he said, B. subtills was chosen for the experiment as a host that could not possibly be criticized as one that might become dangerous. Also, he said, the work was done in a laboratory meeting safety requirements for similar research under the NIH guidelines.
Ehrlich maintained in his scientific report that his results "make it likely that similar gene-mixing occurs commonly in nature."
There is a growing body of evidence that this could be true. If it is true, many scientists are beginning to argue, the present restrictions on recombinant DNA may well be meaningless and can soon be discarded, since nature seems to be doing the same sort of thing anyway and not destroying humankind.