Ex-Employee of FDA, Congress' GAO Fault Review of Monsanto's Posilac

posted in: March 1999 | 0

At the beginning of the 1990s, Monsanto Corporation’s recombinant bovine growth hormone (also known as BST, for bovine somatotropin and by its brand-name Posilac) was on its way to becoming the first bioengineered food product to be mass marketed. But the path to approval was anything but straightfoward. No fewer than two reports from the General Accounting Office of Congress addressed the subject of its approval, while questions continue to be raised about the level of scrutiny the Food and Drug Administration gave to the drug before approving it for commercial use.

Back to Basics

To help members of Congress understand the issue, an August 1992 GAO report recites the fundamentals about rBGH: “In its naturally occurring state, rBGH is a protein produced in the pituitary gland of all cattle. It is a somatotropin, or growth hormone, that helps to coordinate how energy from feed is normally allocated within a cow’s body to meet its physical needs and to produce milk. rBGH can be produced synthetically using recombinant DNA technology.”

Just how rBGH is grown is described in the March 24, 1994, issue of Rachel’s Hazardous Waste News: “Drug companies have learned to snip out a fraction of cow DNA that codes for this hormone, insert it into the DNA of E. coli bacteria, grow the bacteria in vats, and extract large quantities of rBGH from the vats.”

The genetically modified hormone was declared safe for commercial use on milk cows by the FDA on November 5, 1993, and final approval was granted on February 5, 1994.

A Controversial Firing

Nearly a decade earlier, in 1985, the FDA’s review of rBGH was headed by veterinarian Richard Burroughs. Burroughs reviewed animal drug applications at the FDA’s Center for Veterinary Sciences from 1979 until his firing in 1989.

An article in the British magazine The Ecologist of September/October 1998 (“Revolving Doors: Monsanto and the Regulators”) describes Burroughs’ departure:

During Burroughs’ time, the FDA went from a setting where there was independent scientific review to an atmosphere of “approve, approve, approve,” Burroughs said. This came, The Ecologist article says, despite the fact that the FDA “was totally unprepared to review rBGH, the first bioengineered animal product to go through the FDA’s approval process; rBGH was out of the scope of most FDA employees’ knowledge. But rather than admit incompetence, the FDA decided to cover up inappropriate studies and decisions, and agency officials suppressed and manipulated data to cover up their own ignorance and incompetence.”

Burroughs also witnessed the elimination of sick cows from rBGH test trials and the manipulation of data by corporations to establish the drug’s safety, the article continues.

“According to Burroughs, the raw, untouched data stashed away behind the agency’s doors and protected as trade secrets would show otherwise,” the article reads.

While still with the FDA, Burroughs provided statements critical of the FDA’s handling of the rBGH issue to congressional investigators, to state legislatures, and to the press. He also “rejected a number of corporate-sponsored safety studies as insufficient and was prevented by his superiors from investigating data submitted by industry revealing possible health problems caused by rBGH,” the article states.

The FDA was suddenly no longer pleased with his work: “Though Burroughs had a record at the FDA showing eight straight years of good performance, he began receiving poor performance reports, for which he claims he was set up. Finally, in November 1989, he was fired for ‘incompetence’,” the article states.

Conflicting Reports

Another kink in the approval process of rBGH occurred in 1991 at the University of Vermont, where Monsanto was funding test trials of rBGH. A researcher leaked information about increased mastitis and birth defects among rBGH-treated cows after the project’s head scientist had made public statements to state lawmakers and the press and released a preliminary report that rBGH-treated cows were as healthy as untreated cows, The Ecologist reports.

A report in the March 24, 1994 edition of Rachel’s Hazardous Waste News expands on this: “Normally, for about 12 weeks after a cow calves, she produces milk at the expense of her own tissues. She loses weight, she is infertile, and she is more susceptible to diseases such as mastitis (inflammation of the udder). Eventually, her milk output diminishes, her food intake catches up, and she begins to rebuild her body. By injecting rBGH, a farmer can postpone for another eight to 12 weeks the time when the cow begins rebuilding her body. This means that the cow is stressed for another eight to 12 weeks and is more susceptible to infection during that period.”

Monsanto’s rBGH, Posilac, comes with an insert sheet containing information about the drug. It says that cows injected with Posilac are at an increased risk for clinical mastitis (visibly abnormal milk) and subclinical mastitis (milk not visibly abnormal), and has been associated with increases in somatic cell counts — pus in milk — and indigestion, bloat, and diarrhea. Other reports have linked rBGH to birth defects and other reproductive problems in cows.

After the conflicting accounts of rBGH safety from the University of Vermont researchers, the U.S. General Accounting Office investigated. As reported in The Ecologist, “During the investigation, the FDA stalled in providing the GAO with original Monsanto test data, and the GAO was unable to obtain critical data from [the University of Vermont] and Monsanto. The GAO terminated its investigation, concerned that Monsanto has had time to manipulate the questionable data and that further investigation would be fruitless.”

The GAO report released on August 6, 1992, was titled “FDA Approval Should Be Withheld Until the Mastitis Issue Is Resolved.” Yet the analysis was hardly the tongue-lashing the title suggests. The GAO had concluded that the FDA was evaluating rBGH just as it should and was following all “critical research guidelines.”

“Where some guidelines were not addressed, these were not threats to the validity of the pivotal study conclusions,” it stated. Some areas where there were information gaps included reproductive issues such as teratogenic and embryotoxic effects as well as fertility rates of offspring.

Antibiotic Concerns

The GAO also faulted the FDA’s failure to determine the possible indirect health effects of rBGH use, specifically, increased use of antibiotics to cure increased mastitis caused by rBGH.

“In comparing the treatment and control groups, the number of cows experiencing mastitis was approximately 33 percent higher in the treatment group (28 percent versus 21.2 percent), while the incidence of mastitis was also greater in the treatment group (0.415 cases per cow versus 0.361 cases per cow),” the report states.

“The problem here is that the increased incidence of mastitis on cows treated with rBGH could possibly lead to the increased use of antibiotics, which, in turn, might raise the level of antibiotics found in milk and beef [retired milk cows become beef].”

In another GAO report, large gaps were found between the number of drugs used to treat dairy cows and the number of drugs in milk that are screened for in tests made by the FDA and state health agencies. “States are routinely testing, under the Milk Ordinance, for only 4 drugs, while up to 82 drugs that may leave residues in milk may be in use,” the report states. Also, the GAO noted, FDA data indicates that 35 of the 64 drugs that are commonly administered to dairy cows are not approved for that use, and “still others are not approved for use in any food animals.”

Because of a lack of actual testing, the GAO conceded that the nation’s milk supply could already be excessively contaminated by antibiotics. Yet, in the case of rBGH, “there has been no effort by either the drug sponsors or FDA to determine whether there may be higher antibiotic levels in milk associated with rBGH treatment and whether they would be acceptable from a human food safety viewpoint.”

The GAO urged the FDA to examine the degree to which antibiotics must be used to treat the increased mastitis from rBGH, and that the FDA discontinue marketing products from rBGH-tested animals until potential antibiotic risks have been evaluated. (At the time of the GAO report, rBGH had not received final FDA approval. The commercial sale of products treated with yet-to-be-approved drugs is not uncommon.) On March 2, 1993, the GAO sent a letter to Donna Shalala, Secretary of Health and Human Services (of which FDA is part) saying that in interviews FDA officials “did acknowledge the possibility that there was an antibiotic human food safety concern that they should investigate.” But, the GAO said, subsequent communications from FDA “did not address our concern: does rBGH use result in higher concentrations of antibiotics in milk or not, and if so, is the higher level acceptable from a food safety standpoint?”

The GAO went on to note that FDA has said its review of human food safety issues has been completed. GAO asked, “But how can a food safety determination be made when the rBGH-mastitis-antibiotic issue has not been addressed, much less resolved?”

Within months of the GAO’s expression of ongoing concern, the FDA approved the drug for commercial use.

Volume 9, Number 9 March 1999

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