Gene-engineered bovine product banned - C&EN Global Enterprise

May 7, 1990 - For the first time, a product of genetic engineering has been banned in the U.S. Fearing impact on the state's dairy industry, on April ...
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News of the Week The discharges will have to meet state water-quality-based regulations or technology-based limits of TCDD that EPA is developing now for both mill effluent and pulp and paper sludge. States were required to have TCDD standards by Feb. 4,1990, but only 21 states have met this require­ ment. EPA currently recommends an ambient water-quality level of 0.014 parts per quadrillion for TCDD. FDA has been given the task of managing risks from TCDDcontaminated food-contact papers. David Hanson

Academic research funding called inflexible Big changes are inevitably in the offing for the university research system, under threat from a growing monster known as "proposal pres­ sure/' according to a paper just is­ sued by Congress' Office of Tech­ nology Assessment. The study is part of an ambitious top-to-bottom assessment of basic research's eco­ nomic and social environment. Its project director is sociologist Daryl Chubin. Proposal pressure is the number of research proposals submitted to an agency compared with the num­ ber actually funded. Everyone doing or funding academic research knows about it and its causes, in agonizing detail: young, promising researchers not getting funded, funds chan­ neled according to geography rather than talent, Congress meddling with the peer review system, eco­ nomic competitiveness stresses dis­ torting the goals of basic research, and research dollars being wasted away by overhead costs. As OTA documents, the proposal pressure ratio is going up and up. OTA surveyed several agencies and reports that in the case of National Science Foundation, the number of proposals reviewed increased from 14,499 to 36,802 between 1977 and 1988. But the proportion actually funded declined from about 46% to 28%. More or less the same decline held for the Veterans Administra­ tion, National Institutes of Health, and the Air Force. 'The system that appeared flexi­ β

May 7, 1990 C&EN

which then produce the hormone. Monsanto, Eli Lilly, American Cyanamid, and Upjohn have spent an es­ timated $500 million to develop the drug, and industry analysts expect it to have a worldwide market as large as $1 billion annually. Though critics of bovine soma­ totropin focus their opposition on a number of issues, by far the most frequently mentioned criticism is the financial viability of small and mid-size dairy farms. Opponents say by inflating milk production, the drug will lower the cost of dairy products and force even more dairy farmers out of business. Historically, as agricultural prices have fallen, small farms have been the first to go bankrupt. In contrast, Peter H. Calcott, man­ ager of public information for Mon­ santo Agricultural, expects that if the drug is offered for sale through­ out the U.S., it will increase overall milk production in the U.S. only about 3%. Even if the drug were found at high levels in milk, it would be safe for humans because it is totally digested in the stomach and is not active as a human growth hormone, he adds. Some critics, such as fired former FDA veterinarian Richard J. Bur­ For the first time, a product of genet­ roughs, claim the drug has detri­ ic engineering has been banned in mental effects on animal health, in­ the U.S. Fearing impact on the state's creasing liver, heart, thyroid, and dairy industry, on April 27, Gov. ovary size. Also, opponents allege Tommy G. Thompson of Wisconsin that higher levels of bovine growth approved legislation temporarily hormone are found in milk shortly stopping the sale or use of bovine after the cows are injected and the growth hormone until June 1, 1991. hormone's effects on human health The day before, Gov. Rudy Perpich have not been adequately investi­ of Minnesota approved a measure gated. Researchers agree, however, that sustained levels of a peptide banning the drug for one year. Bovine growth hormone increases hormone called insulinlike growth milk output in individual cows an factor-1 are higher in milk when the average of about 15%. First devel­ drug is used, but not so high as exist oped in the early 1980s, it has been in human milk. They also agree that tested extensively in cattle since that reproduction rates in cows treated time. The Food & Drug Administra­ with bovine growth hormone are tion has not yet approved the drug lowered. for sale, but has registered it for use Because of allegations concerning in limited research trials. animal and human health, Sen. The genetically engineered bo­ Patrick J. Leahy (D.-Vt.) in one re­ vine growth hormone, bovine soma­ quest and Rep. John Conyers Jr. (Dtotropin, is a nearly identical copy of Mich.) and Rep. Ted Weiss (D-N.Y.) the natural growth hormone that in a separate request have asked for helps regulate milk production in a General Accounting Office investi­ cattle. It is made by inserting the gation of FDA's approval process for gene that codes for the growth hor­ bovine growth hormone. mone into Escherichia coli bacteria, Bette Hileman ble and diverse is now being test­ ed," says OTA. "Scarce resources re­ quire choices. And choices attenuate the flexibility and diversity that have undergirded the unparalleled creativity of U.S. science. This study finds evidence of an overburdened research system. How to cope in the 1990s may be as much an organiza­ tional as a fiscal challenge to the federal government." The paper ends up suggesting that the university "management mechanisms and models" of the soaring 1960s may no longer be "sufficient or appropriate" for the 1990s. It says that if competition for research funds continues to grow, "creative energies will flow into proposal writing, rewriting, and re­ view rather than in the conduct of research. Many scientists argue that this is already the case. . . . A frame­ work for weighing alternatives, making research choices, and plug­ ging them into the political process [is] lacking." Wil Lepkowski

Gene-engineered bovine product banned