In what is being called an unprecedented move, the Food and Drug Administration will release extensive details later this week of its earlier findings that a still-unapproved and controversial drug, a genetically engineered growth hormone intended to increase cows' milk production, is safe for humans.
The FDA's conclusion that bovine somatotropin--known as BST (or BGH, for bovine growth hormone)--is safe for humans was reached in 1985--a preliminary step in a long review process. But opposition to the hormone has persisted, and even increased.
While resistance to any genetically engineered product underlies much of the opposition, foes also say that use of the drug may be cruel to cows and may produce unsafe milk. Another concern is the effect of large increases in milk production on the economies of the small family farm.
Already several states have considered--and two of them have imposed--moratoriums on commercial use of BST. Makers of the drug hope the FDA report will partially defuse arguments of opponents in California who are forming action groups and drafting moratorium legislation. California is the nation's second-largest producer of milk, after Wisconsin, and its large-scale dairy farming operations are a potentially lucrative customer base for the four major companies developing BST.
FDA officials acknowledge that the report, which is expected to be released later this week in the journal Science, is in direct response to the controversy over BST. It is very rare for the FDA to publish detailed interim findings while a drug is still under review, according to FDA officials, who say they cannot recall a previous case in which similar measures were taken.
In a prelude to the FDA report, a separate article in this coming Friday's issue of the Journal of the American Medical Assn. summarizes the FDA findings, and reviews studies sponsored by Monsanto, one of the drug's makers, in which authors Drs. William H. Daughaday and David M. Barbano participated.
And a strongly worded editorial in the same issue of the Journal is highly critical of opponents who "tend to use the safety and health issues as a red herring to strengthen their economic concerns . . . confusing and frightening the non-scientific public" into what the editorial's author calls the "hysterical reaction" of the legislative bans.
Yet it seems unlikely that the articles will put the issue of human safety to rest. Already, Jeremy Rifkin, head of the Washington-based Foundation on Economic Trends, has assailed the Journal article as evidence of a "flagrant disregard for scientific impartiality" because of its authors' ties to Monsanto. Opponents also question the FDA's veracity and have triggered two investigations into charges that the agency is hiding research results of negative effects on animals.
The FDA is still reviewing BST for its effects on cows, as well as environmental and manufacturing aspects. Documents submitted by Monsanto alone would create a 67-foot-high stack, but many predict that the agency will finish wading though the review next year. Its decision on whether to approve BST for sale could come close on the heels of the June 1, 1991, expiration of the bans on BST imposed by Wisconsin and Minnesota.
Until a few years ago, BST was being cast as the product that would establish agricultural biotechnology as a multibillion-dollar business. Monsanto, Eli Lilly, American Cyanamid and Upjohn spent hundreds of millions of dollars in the race to be the first to develop BST and get it through the regulatory approval process. But opponents were also working hard--campaigning to dry up the potential market for the drug.
Many foes say BST will mean economic ruin to family dairy farmers, especially in the Midwest where such farms are typically small, if large increases in milk production drive down the price of milk and undermine the farms' profitability. BST has been shown to increase milk production by 10% to 20%.
But other opponents seem to focus primarily on the genetic engineering issue. Bovine somatotropin is a naturally occurring protein that assists cows in producing milk; it is present in its natural form in all cows and their milk. Through biotechnology techniques, scientists have been able to identify, isolate and reproduce the protein.
Researchers say neither natural nor synthetic BST has any effect on humans.
In his editorial in the AMA Journal, Dr. Charles J. Grossman of the University of Cincinnati's College of Medicine writes: "Because milk produced from cows treated with bovine somatotropin is no different from the milk of untreated cows, it is both inappropriate and wrong for special-interest groups to play on the health and safety fears of the public to further their own ends. If the issue is economic, let it be clearly stated as such and leave genetic engineering out of the controversy."
"For consumers with honest questions about (BST's effects on) human health, these articles will be very helpful," said Larry J. O'Neill of Monsanto's Animal Sciences Division. "But no amount of factual information, I believe, will deter ideological opponents. It will, however, make it impossible for them to argue with a straight face that this is harmful to consumers' health."