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Recombinant DNA: Biotechnology Becomes Big Business

by Kathy Yih

‘Science for the People’ Vol. 12, No. 5, September-October 1980, p. 5-7

This article is adapted from an article which originally appeared in the Guardian. Kathy Yih is a graduate student in biology at the University of Michigan. She has been active in Ann Arbor Science for the People and the Farm Labor Organizing Committee for the past several years.

With the U.S. Supreme Court’s recent decision that new life forms can be patented, concern over recombinant DNA has resurfaced. Critics of genetic engineering are once again being sought by the media. But while a small minority raises important objections, recombinant DNA technology has moved into the marketplace. The potential of genetic engineering to produce highly profitable products has led to a flurry of publicity and investment; four new genetic engineering companies – Biogen, Cetus, Genentech, and Genex – have formed, some with major corporate support. Their combined paper value has risen to over $500 million. The London Economist recently observed that “biotechnology is one of the biggest industrial opportunities of the late twentieth century.” Development plans include manufacture of enzymes; inexpensive production of dyes, detergents, pesticides, and rubber; and improvement of crop yields by use of bacteria engineered to fix atmospheric nitrogen.

Recombinant DNA, a technique developed over the last 8 years, involves taking genes from plants, animals, or viruses and recombining them with material from other organisms to form an infinite variety of new life forms. Is the incredible amount of activity in the field an example of “pure” science being applied to better the lot of humankind? Not quite. Recent developments in producing interferon provide a good example of the profit motives underlying the research – as does the hype used to justify it.

The Biogen Announcement

In Jan. 1980, Charles Weissman of the scientfic advisory board of the firm Biogen and Dr. Walter Gilbert of Harvard University announced that they had succeeded in producing interferon through recombinant DNA techniques. Interferon is a virus-fighting protein naturally produced in minute amounts by human white blood cells: it may be important in the treatment of virus infections and certain types of cancer. It was discovered in 1957, but its investigation and use have been limited by the high cost of extracting it from human cells. So the possibility of producing more interferon at less cost through recombinant DNA techniques is a major development.

Biogen was incorporated in 1978 in Luxembourg and specializes in the production of vaccines by recombinant DNA methods. The company was set up by the International Nickel Company (Inco) of Toronto, which owns 23% of the company’s stock. Schering-Plough, a large pharmaceutical firm, bought a 16% share in 1979, and has been granted an exclusive license from Biogen to market interferon. The interferon announcement was carefully orchestrated for maximum effect. Weissman had barely presented the research formally to scientists at the Massachusetts Institute of Technology before facing the press. The day after the news appeared, the price of a Schering-Plough share climbed 3 5/8 and Inco rose 1 1/2.

But Biogen is not the only firm doing interferon research: others include Burroughs, Wellcome, Cetus, Dupont, Genentech, Hoffman-LaRoche, Eli Lilly, Merck, National Patent Development Corp., Syntex, Upjohn, and Warner-Lambert. As one researcher said, “If you look on the (research) log books of any major pharmaceutical company, you’ll probably find interferon there.” And, although Biogen has received much of the publicity, they are not the unequivocal leader. Genentech scientists have reported bacterial yields of interferon as high as 100,000 molecules per bacterial cell, more than 50,000 times higher than Biogen’s reported yields.

Then why was Biogen the one to make an announcement? “Because,” says Backe, an investment service company, “there is no incentive for others to announce their early success. Schering-Plough is facing a patent expiration on Garamycin, an antibiotic responsible for at least 40% of their worldwide earnings. Hence a very positive announcement was needed to counter impending negative news. Other companies with brighter near-term pictures would be imprudent to describe early laboratory success with interferon.”

Interferon and Curing Cancer

Interferon is a good publicity generator because of its possible use in cancer treatment. But existing evidence indicates that interferon is getting much more credit than it deserves. Although recent studies have shown some regression of certain types of cancer with interferon treatment, the results have been both ambiguous and unimpressive. Not enough of the substance has been available for thorough testing, and, in some cases, no one knows how interferon does what it has been reported to do. Dr. Frank J. Rauscher, vice-president of the American Cancer Society, considers interferon research very important but concedes that none of the results so far have been better than those achieved by conventional treatment. Dr. Arthur S. Levine of the National Cancer Institute (NCI) said of interferon studies in general, “Taken together I think one would have to be circumspect.”

Sheldon Krimsky of Tufts University, and the National Institute of Health (NIH) Recombinant DNA Advisory Committee said, “But one thing is clear: interferon will not combat all cancer. Cancer is a complex of different diseases with a multiplicity of causes, requiring different treatments. When discussing cancer, “cure” is not a part of the vocabulary of anyone who knows anything about cancer.” However, investment depends on sustaining interest in research, according to a Wall Street Journal analysis. This, the Journal points out, means keeping the hope of a cancer cure flickering. In a society where cancer is on the rise and fully 80% of cancers are environmentally caused, raising hopes for a chemical cure is a cruel deception.

Who Pays?

The misdirection of attention toward finding a chemical cure is accompanied by the misdirection of millions of dollars in public funds. A vast amount of taxpayers’ money goes into research grants, university salaries, and laboratory facilities for cellular-level cancer research, including interferon work. About $10 million of NCI’s 1980 budget was for interferon research with more than half of that being earmarked for buying interferon. Five companies have either signed contracts or are in final negotiations for several million dollars in NCI funds for clinical trials. And the American Cancer Society (“Help prevent cancer with a check-up – and a check.”) is spending $5.8 million for preliminary interferon studies at 10 US medical centers.

Universities – supported in part by state and federal educational funds, and through National Science Foundation (NSF) and NCI grants – carry a high proportion of the financial load of scientific research. Public money, in the form of university facilities, public salaried university scientists and federal research grants, essentially subsidizes the development of products and techniques which eventually bring profits to private companies. Of course, this is not unique to biotechnology (see, for example, Paul Barnett’s article on agricultural research, July/ August SftP).

The connections between academia and industry are not limited to funding, however. In some cases, the researchers have direct links with private genetic engineering firms. Examples include: Walter Gilbert of Harvard University, chairperson of Biogen’s scientific board and partial owner of 15% of the company’s stock with the eight other members of the scientific board; David Jackson of the University of Michigan, head of Genex’s scientific advisory board and a soon-to-be vice president: and Herbert Boyer of the University of California at San Francisco (UCSF), co-founder of Genentech and its major stockholder.

Safety Issues

In the early 1970’s biologists were generally vocal in their criticisms of recombinant DNA research. Some pointed to the need for public input in assessing the hazards, which include the possible release of diseasecausing organisms or other genetically-altered organisms that could change the environment in dramatic and unpredictable ways. The public outcry forced the government to adopt NIH guidelines for publicly funded recombinant DNA research, but since then little criticism has appeared in the media. Here also the common interest of scientists and industry have come into play. While the rivalry among the various research groups and companies rages, an increasingly unified public relations stance has developed. The possible benefits to the public of genetic engineering are trumpeted to the press, and hazards are minimized to keep regulation at bay. Both industry and “independent” researchers want to avoid regulatory intervention as much as possible.

The current NIH guidelines put an upper limit of 10 liters on the volume of recombinant-DNA-containing material that can be used in any single experiment. Several exceptions to this rule have been made, however. In addition, although private industry almost always seems to follow the NIH guidelines, no mandatory regulations exist for industry. Congress refrained from legislating private DNA research in 1978. Most recently, the NIH recombinant DNA advisory committee passed a resolution calling for publication in the Federal Register of a statement concerning its role in advising the government on proposals for large-scale industrial production of recombinant DNA products. The resolution stated that the committee’s determination of the safety of the genetic material involved was not to be construed as assurance that large-scale production procedures themselves were safe. The resolution represents a ducking of responsibility for the consequences of industrial production. Some members of the committee argue that the panel has insufficient expertise in the area of large-scale production. But meanwhile, industrial research, development, and production proceed unregulated.

Where is the Recombinant DNA Industry Headed?

Initially, Sheldon Krimsky has said, there will be great emphasis placed on developing products with a strong public appeal (such as insulin and interferon). This emphasis will serve to legitimize the field. Later, he thinks, industry will try more dangerous things such as viral pesticides, products with a greater potential for causing disease or ecological disaster.

With recombinant DNA technology in the hands of industry – aided by academic scientists – we can expect continued exposure to biological risks, and continued benefits to private interests at public expense. As David Suzuki, a geneticist, wrote three years ago, “What could be more explosive than the application in human engineering of techniques of molecular genetics … in a society in which racism, bigotry, greed, and economic inequities are apparent?”