With just one dissent and one abstention, FDA's VeterinaryMedicine advisory committee voted to recommend approval ofMonsanto's mammary supercharging hormone for cows, bovinesomatotropin (BST) --recombinant bovine growth hormone(BGH).

Although committee members agreed unanimously that BGHsignificantly increases incidence of mastitis, a bacterialinflammation of the teats that leads to abnormal secretions inmilk, this increase, they said, was "manageable," and need notcontribute to increasing the load of antibiotic residues in milk.

Moreover, such residues would in no way endanger milkdrinkers because milk monitoring is so meticulous. A parade ofdairy farmers who testified all agreed that penalties forcontaminated milk, which one said would run $12,000 a dayfor his operation, packed a fearful punch.

Nonetheless, approval is not a foregone conclusion. FDACommissioner David Kessler was present, which is highlyunusual, to "listen and learn, that's all I'm going to say," he toldBioWorld.

Following charges by Michael Hansen, representing ConsumersUnion, the publisher of Consumer Reports, and Rep. BernieSanders, I-Vt., that FDA was "skewing data and withholdingcritical information from its Veterinary Medicine AdvisoryCommittee regarding the safety of recombinant bovine growthhormone," Kessler exhorted the committee to "be as thoroughas you can. ... Make sure that anything that is relevant is on thetable and in full public view."

Moreover, Gerald Guest, head of FDA's Center for VeterinaryMedicine, who would normally make the final decision himself,told BioWorld that Kessler would be taking part "because of hisstrong personal interest."

Meanwhile, the unfavorable politics of the proceedings couldnot have been lost on Kessler, the only major Bushadministration appointee to retain his position within theClinton administration.

Jeremy Rifkin charged that Guest "has been visiting seminars,promoting the benefits of BGH," a charge that Guest denied toBioWorld, saying that he had merely been "explaining theregulatory process at seminars."

The U.S. Department of Agriculture, charged Rifkin, had put"several million dollars into promoting BGH," while it was stillunder review, only to be stopped by Rifkin's suit in FederalCourt.

Alluding to the an August 1992 report by the U.S. GeneralAccounting Office calling for approval to be withheld until themastitis issue is resolved, and the agency's March 2 letter toHealth and Human Services Secretary Donna Shelalacomplaining that FDA still had not answered GAO's questions,Rifkin warned, "We are going to go into Federal Court under theAdministrative Procedure Act and the National EnvironmentalPolicy Act."

Nor would consumers, and even many companies rally arounda product with "no redeeming social value," said Rifkin, whoadded that baby-food maker Gerber had joined his grass-rootscampaign "just yesterday."

BGH is bad for farmers (because it would throw many out ofbusiness), bad for taxpayers (because of milk price supports),bad for the cows, and may be bad for public health," Rifkinsaid.

The five farmers and some veterinarians specializing in cattle,some of whom had also worked on the Monsanto studies, allpraised BGH. The farmers said that their BGH-treated cows hadeither no more or less mastitis than controls -- anecdotalinformation that the committee did not appear to takeseriously. And the milk flowed 15 percent to 20 percent fasterfrom the treated cows, they said.

Moreover, several said that calving, which is necessaryperiodically to restimulate milk production, is the greateststress in the life of a cow, but that BGH makes possible longerintervals between calvings.

Rifkin demanded to know where the farmers who opposed BGHwere. According to Tim Atwater, director of Rural Vermont, anadvocacy organization, 90 percent of farmers in his stateoppose the use of the hormone.

The committee had recommended approval despite Kessler'sexhortations regarding critics' charges of bias because its jobwas not to "perform an audit on malicious intent," StephenSundlof, a committee member and professor in the College ofVeterinary Medicine at the University of Florida, told BioWorld.

In gaining the committee's endorsement, BGH has cleared amajor scientific hurdle. Nonetheless, if FDA grants finalapproval, the hormone is virtually guaranteed continuingpolitical trials.

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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