News of the Week remain under controversy for some time. FDA's handling of the BGH approval process is being investigated by both the General Accounting Office and the Inspector General of the Department of Health & Human Services, for example. The European Commission has been reviewing BGH and has postponed a decision on its use until January. The U.K/s Veterinary Products Committee has decided it needs more data on animal health before approving Monsanto's application to license the drug. And both Wisconsin and Minnesota have banned sale or use of BGH until June 1991. This controversy was displayed at Panel okays disputed a highly contentious meeting earlier bovine growth hormone this month of the NIH panel, which was chaired by Mel vin M. GrumA panel convened by the National bach, chairman emeritus of pediatInstitutes of Health has given essen- rics at the University of California, tially a clean bill of health to geneti- San Francisco. Testimony of scientifcally engineered bovine growth hor- ic experts and consumer groups fomone (BGH). Also known as bovine cused on several issues. somatotropin, BGH is designed to inOne issue was that levels of increase milk output in dairy cows. sulinlike growth factor-1 (IGF-1) in So far, BGH is used only in experi- milk of treated cows is generally mental trials in the U.S., but it has higher than in milk of humans or been cleared for general use in sever- untreated cows. Even though IGF-1 al other countries. The Food & Drug is also found in human saliva, severAdministration has approved sale of al scientists at the meeting recommeat and milk for human consump- mended studying whether the extra tion from cows treated in tests. But IGF-1 in milk from treated cows FDA is still reviewing the hormone's could exert local effects on the uphealth effects on cows, and has not per gastrointestinal tract. When cleared BGH for general use on FDA approved milk from treated them. Monsanto, Eli Lilly, American cows for human consumption, it reCyanamid, and Upjohn have spent an estimated $500 million to develop the drug, and anticipate a $1 billion a year market worldwide. NIH formed the panel, at Congressional request, to consider several matters: the effect of BGH on milk production in cows, health effects on cows from its administration, health effects on humans from consuming meat or milk from treated cows, and further research needed on BGH use. The panel concluded that BGH increases average milk production and does not have adverse effects on the general health of dairy cows, or on the composition or nutritional value of milk. It also decided that "meat or milk from BGH-treated cows [is] as safe as those from untreated cows/7 However, despite this generally Grumbach: never 100% certainty positive assessment, BGH is likely to
of important photophysical properties of buckminsterfullerene. The research will appear shortly in the Journal of Physical Chemistry. Of particular note to the many chemists now embarking on fullerene research, Foote says, is that C6o is a potent generator of singlet oxygen, a species that can react with and damage biologically imnortant important molerïamaap bioloffirallv molecules (see page 2). "The possible :ules (see oaee z). Ihe Dossible physiological consequences ot of tnis this onvsioioeicai conseauences should probably not be overlooked," he notes. Rudy Baum
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December 17, 1990 C&EN
lied on research that used an assay method that gives falsely high values for the amount of IGF-1 in human milk. Another topic of intense discussion was animal health. Published data available to the panel show that cows remain reasonably healthy when treated with BGH. However, their pregnancy rates go down an average of about 16%, according to Robert J. Collier, dairy research director at Monsanto Agricultural. These pregnancy rates are comparable to the lowered rates found in cows bred to produce large quantities of milk. Mastitis, or swelling of the cow's udder, is another possible adverse effect of BGH. Some research trials show increased rates of mastitis in treated cows, while others show no change. According to Peter H. Calcott, manager of public information for Monsanto Agricultural, cows that are naturally high milk producers also suffer from mastitis somewhat more frequently. Several public interest groups expressed concern at the meeting that elevated rates of mastitis would lead to greater use of antibiotics for treatment, resulting in more problems with drug residues in milk. Critics at the meeting also contended that the panel did not have access to sufficient data to evaluate the health of treated cows. The results of trials on about 20,000 cows have been submitted to FDA. However, the panel was able to examine only the published data, which report research on about 4000 cows. Favorable research results have been given wide publicity, and adverse results suppressed by the companies developing BGH, charged David S. Kronfeld, professor of agriculture and of veterinary medicine at Virginia Polytechnic Institute & State University, Blacksburg. To resolve questions on human and animal health, the panel recommended that research be conducted on IGF-1 and on mastitis, reproduction, and stress in cows. However, the panel believes that meat and milk from BGH-treated cows are basically safe. "There will always be some unanswered questions. There is never 100% certainty/7 says Grumbach. Bette Hileman
