FDA publishes bovine growth hormone data

Article Abstract:

Safety data regarding recombinant bovine growth hormone (bovine somatotropin, rbGH) have been published by the Food and Drug Administration (FDA) before the drug has been formally approved, a highly unusual order of events for that agency. The report, published in the August 24, 1990 issue of Science magazine, presents the FDA's view that the drug, used to make cows produce more milk, is safe. During the past few decades, rbGH has been subjected to scientific and consumer scrutiny. The FDA has come under sharp criticism for publishing before it has approved the drug, since it thereby appears to be promoting an unapproved agent. Effects the drug may cause, says Samuel S. Epstein, a physician and professor of occupational and environmental medicine, include breast cancer in women and stimulation of premature growth in infants. Epstein wants large-scale testing of rbGH in cows to be sure no adverse effects can be noted. He also claims the FDA has hidden data that show rbGH causes lesions and increases the incidence of infectious disease in cows. The FDA's position, however, is that no definitive health effects have been found, and the review in Science magazine argues against the biological activity of rbGH in humans. Even in rats, it apparently produces no effects. The cows in FDA studies that developed mastitis (udder inflammation) after rbGH received extremely high doses, says a spokesman for Monsanto, one of four companies that manufacture rbGH. Some grocery stores and food-processing companies, however, have refused milk from herds treated with rbGH during the review process. Epstein's efforts have also occasioned a review of the FDA's regulatory process by the General Accounting Office and the Inspector General of the Department of Health and Human Services. Agency spokespersons, though, feel confident that their process will withstand criticism. (Consumer Summary produced by Reliance Medical Information, Inc.)

Reports, Milk production

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Venture capitalists push designer drug start-ups

Article Abstract:

Venture capitalists now seem to feel that the time is right for the second generation of biotechnology firms. As the saying goes, they are putting their money where their mouth is. In 1989, about $469 million was raised to start 198 medical or health care companies. Some of these companies will attempt to create a new set of "designer drugs". Existing biotechnology companies are exploiting the use of molecular biology to produce natural substances, such as growth hormone, insulin, and erythropoietin (which stimulates the production of red blood cells). The new start-up companies hope to combine computer technology and biochemistry to literally design new molecules from scratch and imbue them with the desired biological properties. Companies such as the Arris Pharmaceutical Corporation hope to utilize advanced computer technology and artificial intelligence to shorten the development time for creating new drugs; high on their list are substances that modulate the responses of immune cells by enhancing or blocking their function. Other entrepreneurs look forward to developing agents which specifically block receptors which play a role in atherosclerosis. While the rewards for the successful will no doubt be high, it is also clear that attracting start-up money is generally easier than managing the costs of continued operation. The road leading to financial success will no doubt be littered with the wrecks of the also-rans. (Consumer Summary produced by Reliance Medical Information, Inc.)

Product development, Economic aspects, Biotechnology industry, Biotechnology industries, Technological innovations, Pharmaceutical research, editorial, Pharmaceutical technology

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Bovine growth hormone: human food safety evaluation

Article Abstract:

Bovine growth hormone (bGH) is the bovine (cow) form of a hormone made in the pituitary glands of all animals that is necessary for normal growth and milk production. The proposed marketing of large quantities of a recombinant form of the hormone (rbGH, recombinant bovine growth hormone) for administration to dairy cows has triggered public safety concerns. The rbGH would be given to cows to increase their milk production. Although the Food and Drug Administration (FDA) believes rbGH is safe, it has not yet approved it. Critics have alleged that the FDA's regulatory process has been faulty. To answer these and related questions, a report on the FDA review process and the scientific information concerning rbGH is presented. Review procedures for new animal drugs are explained. In essence, the FDA makes its decision to reject or approve a drug based on data supplied by pharmaceutical companies. Protein drugs, such as rbGH, that would be orally ingested by humans receive special scrutiny. The route through the gastrointestinal tract of such a substance is described. Bovine growth hormone is not biologically active in humans, and rbGH taken orally is also inactive. Human GH and bGH differ from each other in amino acid sequence by approximately 33 percent. Overall, the FDA has concluded that rbGH given to dairy cattle poses no health hazard to consumers. (Consumer Summary produced by Reliance Medical Information, Inc.)

Safety and security measures

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