On September 22, 1976, President Ford sent a memorandum to the heads of all major federal departments and agencies. Although it received no attention at the time, the President's memo may be remembered years from now as the keynote to one of the most significant developments of the 20th century.
The memo concerned the formation of a new Interagency Committee of the federal government. Its mission: "To review federal policy o the conduct of research involving the creation of new forms of life."
That Interagency Committee has since convened at the National Institutes of Health (NIH) in Bethesda, Maryland, on November 4 and November 23, for a total of five hours and 30 minutes. There were no TV crews present, no photographer to shoot pictures of the proceedings for the record book. UPI and AP didn't even list the meeting on their daily calendars of important events to cover in Washington. Both sessions were conducted behind closed doors.
With these meetings, just three years after molecular biologists had succeeded in separating and recombining the DNA molecules that carry the genetic code for all living beings, unlocking for the first time the secret of creating life itself, the United States officially entered the Organic Age.
Up to now, human beings have been engaged in a constant battle against the elements. We have used our wits to harness the resources of the external world for our own survival. Ours was a finite reality. At best, we could manipulate and exploit parts of our universe for our own ends; at worst, we could destroy those parts of the outside environment that threatened our well-being.
In short, our limits were established by what already existed. Within the past 30 years we have approached the outer limits of that finite world of matter and energy with the splitting of the atom, our entry into the Nuclear Age.
Yet now, even as we still grapple with the nuclear demon, a new phenomenon has emerged, having to do with the world of life itself. With the unlocking of the secrets of DNA, we will eventually be able to change the cellular structure of living beings and to create entirely new species. Biologists are already doing it with microorganisms. The Nuclear Age was the age of the physicist; the Organic Age is the age of the biologist.
At this moment, microbiologists are at work in more than 180 separate laboratories across the country, busily spending more than 20 million dollars in government grants in pursuit of the creation of new forms of life. They are experimenting with so-called recombinant DNA.
By now most newspaper readers have heard of the controversy surrounding DNA research at universities. But, sheltered from the glare of publicity that bathes every new debate at Harvard or Stanford, something much more ominous is happening.
Today seven major drug companies are engaged in, or about to begin, recombinant-DNA research. The companies will soon apply for patents on the new forms of life they are developing. In time this research will translate into an unparalleled commercial bonanza for the pharmaceutical, chemical and agricultural companies as they introduce literally dozens of new-life-form products into the market place.
General Electric is already out in front with the announcement that it has applied for a patent on a tiny microorganism that can eat up oil spills.
While the commercial prospects for this new technology have whetted corporate appetites, the potential dangers in its further development and application-although some of them are still years off-pose perhaps the single greatest challenge to life that humankind has ever faced.
That challenge is made more awesome by the fact that virtually any amateur biologist can obtain the enzymes necessary to experiment with new life forms. Miles Laboratory, which markets the enzymes, admits that most of its enzymes sales are done through the mail, and that there are no "guarantees of what the customer will do" once that person receives the biological materials.
How does one even begin to look at a technology that could eventually lead to the creation of new plants, animals and even the alteration of the human species?
And then there is a more immediate question before us as we enter the Organic Age: should our present corporate system be used as the developing and marketing process when life itself is the product?
Recombinant DNA is a recently developed technique that recombines DNA segments (the basic material determining the hereditary characteristics of all life) from two different organisms.
Scientists became able to do this when they found that DNA segments had "sticky" ends that, under proper laboratory conditions, could be fastened to another organism's DNA segments. Thus is formed the genetic basis for new living and multiplying organisms that do not exist in the natural evolutionary order.
Although most scientists agree that recombinant DNA is one of the most important scientific breakthroughs of modern history, they violently disagree as to whether the potential benefits of even the most restricted experimentation outweigh the grave potential dangers to human life and the environment.
Paul Berg, a prominent recombinant-DNA researcher at the Stanford University School of Medicine, believes experimentation in recombinants could result in the creation of major new food crops that can obtain nitrogen from the atmosphere rather than from fertilizer; a new form of medicine, gene therapy, to treat crippling genetic diseases; and such things as cheap and efficient production of vitamins, antibiotics and hormones.
On the other hand, scientists like Liebe Cavalieri of the Sloan-Kettering Institute for Cancer Research argue for a complete moratorium on recombinant-DNA research until the long-range implications are fully discussed.
Cavalieri points out that such research "involves many unknown factors beyond the control of the scientist." According to Cavalieri, "it is necessary to create vast numbers of cells with unknown genetic alterations in order to obtain a cell containing a specific recombinant DNA."
He continues: "The probability of creating a dangerous genetic agent in the process is real, and there is no way to test for the danger. The scientist does not know what he has done until he has analyzed the newly created cell-at which point it may be too late."
At that point, science fiction's most horrible scenarios become fact.
Cavalieri and his colleagues are deeply concerned over the possibility that a new Andromeda-type virus, for which there is no known immunization, might accidentally be developed in a laboratory somewhere and spread a deadly epidemic across the planet, killing hundreds of millions of people.
They also fear that a new, highly resistant plant might be developed that could wipe out all other vegetation and animal life in its path. Dr. Robert Sinsheimer, who chairs the Biology Division of the California Institute of Technology, warns that "the invention and introduction of new self-reproducing living forms may well be irreversible." Sinsheimer asks: "How do we prevent grievous missteps, inherently untraceable?"
Sinsheimer got the first tentative answer to his question last summer when the City Council of Cambridge, Massachusetts, voted to prohibit work on recombinant DNA at Harvard and MIT pending further public investigation. This unparalleled public restriction of scientific research focused, for the first time, the attention of the national media on the question of the creation of new life forms.
But even as scientists, public-interest groups, social commentators and the media continue to rehash the implications of the Cambridge incident, another development, almost totally ignored in the press, may be far more significant than any event that has taken place in academia: the entry into the field of DNA research of the private corporation.
On September 23, 1976, a little-noticed Washington Post story reported: "US health officials acknowledged that the government does not know what companies are trying to create revolutionary new forms of life or the whereabouts of their laboratories."
Dr. Bernard Talbot of the Office of the Director of NIH told us that "as of now, there is no federal agency that is looking at research being done by private industry in recombinant DNA.... We have no registry [of companies involved in this field]."
It is probably true that NIH and other federal agencies are unaware of the specific nature of the research going on in private industry. However, governmental authorities do know what companies are involved in this research and where their plants are located, but they have not been willing to make this information public.
At present, seven major pharmaceutical companies are now engaged in or about to be engaged in secret recombinant-DNA research. Nine other corporations involved in drugs, chemicals and agricultural products are now looking into the potential application of recombinant DNA.
They are: Cetus Corporation, CIBA-Geigy Corporation, DuPont, Dow, W.R. Grace & Company, Monsanto, French Laboratories, Wyeth Laboratories and Searle Laboratories.
Corporations in DNA Research
Location of Laboratory
State of Research
Miles Laboratories(Dr. Robert Erickson, Dept. of Science Information and Communication Services)
Rochester, NY, and South Bend, IN (Research under contract to universities)
Eli Lilly & Company(Dr. Cornelius W. Pettinga, Executive Vice President)
Hoffman-LaRoche(Dr. Sidney Udenfriend, Director, Roche Institute)
The Upjohn Company(Dr. Joe Grady, Section Head, Infectious Diseases)
Merck, Sharpe & Dohme Research Laboratories(Dr. Jerome Birnbaum, Executive Director, Basic Biological Sciences)
Pfizer, Inc.(Dr. John DeZeeuew, Research Scientist)
Abbott Laboratories(Dr. Lacy Overby, Director, Experimental Biology)
North Chicago, IL
The almost airtight secrecy surrounding this particular research, says Medical World News, is "reminiscent of the atmosphere surrounding biological-warfare research a few years ago."
Tom Craig, the public-relations representative for Abbott, said that his firm has no intention of informing the general public about Abbott's activities, "because it's often difficult to obtain an understanding of what is being done. It creates more alarm than is justified.
At Upjohn, public relations chief Joe Haywood even tried, at first, to deny that the firm had any role in recombinant-DNA research. Only when confronted with hard evidence did he finally admit to Upjohn's involvement.
At Roche Institute, an assistant to the director who identified himself as Dr. Bartle refused any comment when asked when the new maximum-control facilities would be operational and how many researchers would be involved. Similar responses were invoked right down the line in interview after interview with various company officials across the country.
It's not surprising, then, that a check with public officials in Rochester, Kalamazoo, South Bend, and Nutley revealed that none were aware of secret research into recombinant DNA going on in laboratories in their communities.
In Kalamazoo, Michigan, Mayor Francis Hamilton pointed out that, while the Upjohn laboratory was "within three blocks of where I'm sitting," he had not been informed by the company that it was involved in recombinant-DNA research.
In New Jersey, Dennis Helms, in the Attorney General's office (who is already in charge of an investigation into recombinant DNA in his state), was asked if he knew of any firms doing any P-4 level recombinant-DNA research. ("P-4" refers to maximum-risk research controls.)
Helms said it was his understanding from people in the industry that NIH, in Bethesda, Maryland, has the only P-4 facility in the country. Helms was then asked if the Hoffman-LaRoche Company had informed the Attorney General's office that they were constructing a P-4 facility in Nutley, New Jersey. The answer was no.
Even though NIH (the agency responsible for overseeing the Interagency Committee) continues to assert that it has no "official" knowledge of research going on in the private sector, its director, Dr. Donald Frederickson, initiated a meeting nine months ago (on June 2, 1976) with representatives of 20 US corporations to ascertain their interests and needs regarding research into recombinant DNA.
At a meeting held at NIH headquarters on December 3, 1976, Frederickson himself said:
"It is essential there be a way the industrial technology of this country can take advantage of this."
This cozy behind-the-scenes relationship between industry and government officials isn't hard to understand once one looks into the backgrounds of the officials involved.
A number of the consultants to or members of the NIH group that drew up the government's regulatory guidelines on DNA research have industry ties-among them Dr. Ernest Jaworski of the Monsanto Company and Dr. Louis G. Nickell of W.R. Grace & Company.
More important still, of the 15 members of the key Interagency Committee for whom we were able to obtain background biographies, seven had previously been employed with major US corporations. Two of these had served with major pharmaceutical companies now involved in recombinant-DNA work.
Oswald Ganley, the State Department representative to the committee, was previously employed as Assistant Director of International Relations at Merck, Sharpe and Dohme Laboratories; and Department of Transportation representative William D. Owens was at one time a director of a subsidiary of the Searle Corporation.
This industry-weighted committee on recombinant DNA was scheduled to present its recommendations on the "creation of new life forms" to the President in mid-January, although it may be weeks or months before the report's contents are made public. The report is expected to cover several major items:
How Will Dangers Be Contained?
When the federal government started doing research some years ago on infectious diseases afflicting cattle and other animals, it set up an Animal Disease Center on an uninhabited island off the easternmost tip of Long Island.
The lab is windowless. A barbed-wire fence surrounds the entire island. Under the fence, three feet of buried concrete prevent rodents and insects from burrowing through to the facility.
Every one of the Center's workers gets an elaborate security check by the FBI before being allowed access to the Center. Employees wear sterilized garments and work under air pressure lower than outside, and all are required to shower between each experiment. Security guards protect the premises from unauthorized trespassers.
Researchers and government officials are taking every precaution possible to make sure no germs that could infect American farm animals escape the island.
By contrast, NIH's own maximum-security DNA-research facility is a mobile trailer parked off a side street outside the agency's office in Bethesda, Maryland, a residential suburb of Washington. It is protected only by a simple seven-foot cyclone fence. According to NIH officials, the mobile trailer is not yet operational because they are still fixing its leaky roof.
Some secretaries and other office workers at NIH are quite frightened about the trailer parked outside their offices. One of them called the environmental organization Friends of the Earth a few weeks ago, pleading for help. "The employees are all talking about this P-4 trailer and we're scared to death," she said. "Can you do something? Anything."
The set of guidelines the government has drawn up for recombinant-DNA research, although elaborate, are nowhere near so tight as the security precautions at the Animal Disease Center. True, there are the so-called physical-containment provisions, requiring laboratory air to be kept under low pressure, researchers to take showers, and so forth. There are also a series of biological-containment requirements, which mandate that certain experiments be done with weakened strains of bacteria that theoretically could not survive outside the laboratory.
Nonetheless, these labs are usually located in populated areas, and the government does not have the staff to police them and make sure the physical- and biological-containment requirements are met.
Most recombinant-DNA experiments are done with E. coli bacteria, which exists in the intestinal tracts of all human beings. The chief danger involved here is that a research accident could produce a particularly virulent virus that causes a disease for which there is no immunization.
A lab technician who accidentally breathed or swallowed a few of its particles could then begin rapidly spreading the virus to others-perhaps eventually to a whole population.
"Only one accident is needed," biologist Cavalieri says, "to endanger the future of mankind."
Sinsheimer of Cal Tech believes that the government guidelines are insufficient. In a letter to NIH this year he says, "I cannot believe that under these proposed guidelines the organisms can be contained... The organisms will inevitably escape and they will enter into the various ecological niches known to be inhabited by E. coli." The consequences, Sinsheimer says, "are highly predictable and likely highly dangerous."
Who Will Regulate the New Life Forms?
The most astonishing thing about commercial recombinant-DNA research today is that nobody knows which government agencies have the authority to regulate it.
Perhaps the Center for Disease Control, which oversees the interstate shipments of hazardous biological agents; perhaps the Food and Drug Administration, when companies begin using recombinant-DNA techniques to create drugs or hormones for human use; perhaps the Patent Office, when companies apply for patents on these products; perhaps the Environmental Protection Agency, under the new Toxic Substances Control Act.
Then of course there's the National Institutes of Health, which has drawn up the research guidelines on the subject but which has no power to enforce them.
Industry loves this situation, of course. The confusing welter of bureaucracies makes it much easier for the corporations to go ahead and do what they want.
The gaps are huge.
When Dr. Robert Elder of the FDA was asked if his agency would be informed if, for example, test animals in a commercial lab began mysteriously dying from unknown diseases after being injected with a new recombinant-DNA-type drug, he said that there would be "no requirement that [the company] inform us," and that he knew of no other agencies that would be privy to such information.
Given vast loopholes like this, it is still more remarkable to learn, as we go to press, that a significant faction of the Interagency Committee is urging that federal guidelines on recombinant-DNA research be made voluntary and that the industry be left to police itself. In the unlikely event that the committee takes a tougher stance and recommends, for instance, the creation of a new super-agency with enough money and muscle to closely police all DNA research, look for the industry to resist.
There will be cries that the government is interfering with free scientific inquiry; the drug companies will fight back with all the lobbying power at their command. If the committee compromises and urges a distribution of regulatory authority among various agencies, government regulation may remain almost as diffuse and ineffective as it is now.
Who Will Own and Profit from New Life Forms?
Not a single person on the government's Interagency Committee we interviewed even questioned the right of commercial firms to patent processes for creating new forms of life. Dr. Delbert S. Barth, the Environmental Protection Agency representative to the Interagency Committee, summed up the prevailing sentiment of his fellow committee members on the question: "This is a moral and ethical question-and I don't have a strong opinion."
And because the members of this group either are pro-business or do not have a strong opinion on the moral or ethical questions involved, they will in all likelihood recommend that private corporations like Miles, Upjohn and Abbott be entrusted with the authority to create and market new forms of life, for profit.
The only question regarding commercial patents being addressed by the committee is a technical one: how to protect the secrecy of research going on in commercial labs so that competitors will not steal trade secrets before the firm can patent a new life-form process.
Under the existing NIH guidelines covering university DNA research, scientists must disclose all their plans in advance. (Two universities-Stanford and the University of California-have applied for patents on their DNA-recombination processes.) Industry leaders say that these provisions of the guidelines would be unacceptable because, in the words of Dr. Jerome Birnbaum, director of Merck, Sharpe and Dohme Laboratories, "if you disclose your research plans, you lose the right to a patent."
The Interagency Committee is expected to go along with the industry's demands to keep its research secret by establishing some kind of provision whereby only a select few government officials will be privy to the specific nature of the research going on in the corporate laboratories. An awesome thought, since it's only a matter of time before molecular biologists are able to create new plant and animal forms or alter the genetic characteristics of the human species.
A few researchers-despite the opposition of most scientists-are already talking about just that. One of them is Dr. James Bonner, Professor of Biology at the California Institute of Technology, who has written: "We can control the [genetic] changes to produce better individuals.
"This is even more important now that we see limitations being placed on the number of children that may be born into the world. There is a moral obligation to see that these children are free of genetic defects, and we may even have to proceed to the logical conclusion that these children should be provided with the best genetic material we can obtain. Man has done this with all of his domestic animals and plants. It seems likely that he will do it also with himself."
Dr. Bonner, whose words on the subject appear in a book published by the National Aeronautics and Space Administration, goes on to say: "The logical outcome of activities in modifying the genetic make-up of man is to reach the stage where couples will want their children to have the best possible genes.
Sexual procreation will be virtually ended.
One suggestion has been to remove genetic material from each individual immediately after birth and then promptly sterilize that individual. During the individual's lifetime, record would be kept of accomplishments and characteristics.
After the individual's death, a committee decides if the accomplishments are worthy of procreation into other individuals. If so, genetic material would be removed from the depository and stimulated to clone a new individual. If the committee decides the genetic material is unworthy of procreation it is destroyed... The question is indeed not a moral one but a temporal one-when do we start?"
Up to now, recombinant-DNA research has been seen as largely a health and safety question. With the possibility of hazardous viruses escaping from labs, it is indeed. But even this question is bound to seem secondary as the broader implications of recombinant DNA begin to be understood by the general public.
When America begins to ask itself whether individual scientists and a handful of government bureaucrats and private companies have the right to rearrange the evolutionary order and create new forms of life, the recombinant-DNA question will emerge as a focus of national attention.
Mayor Peter Memeth of South Bend, Indiana, one city in which recombinant-DNA research is going on, touches a central nerve when he says, "if they had all that trouble in Tennessee with the apes, then they haven't seen anything yet, I guess."
Considering the fury that engulfed the Scopes trial, the issue of artificially creating and controlling new life forms may well reach very deep. The controversy it raises will make the debate over abortion seem a mere brush fire by comparison.
Dr. Harry Hollis, Director of the Committee on Family and Special Moral Concerns of the Christian Life Commission of the Southern Baptist Convention, and a spokesperson for President Carter's own denomination, says:
"I feel very strongly that Huxley's warnings have a bearing for us today. After Dachau and Watergate, we shouldn't take lightly what human beings are capable of inflicting on each other. This is not just science fiction. Genetic engineering for the worst of reasons is a possibility in this world in which we live."
The issue of who has the authority to develop and produce new forms of life is perhaps the single most important question any society has ever had to grapple with.
With the dawn of the Organic Age upon us, there is no longer any question of going back. The question now is how we proceed, and how we prevent ourselves from embarking on an inexorable corporate course toward Huxley's Brave New World.
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