Poking Holes in FDA’s rbGH Safety Verdict by Pete Hardin Reprinted by permission from the January, 1999 issue of The Milkweed Did the Food and Drug Administration assess the human safety aspects of Monsanto’s synthetic bovine growth hormones (rbGH) "exactly by the book", as an FDA spokesperson recently told The Milkweed? That’s a lie. FDA has repeatedly failed to protect the public health from Monsanto’s rbGH (trademarked and sold as "Posilac"). rbGH was the first genetically-engineered, food production technology review by FDA. Behind rbGH waited many intended food biotechnologies which manufacturers wanted to patent and sell. Sadly, FDA not only failed in its assessment of rbGH safety, but rbGH set precedents at FDA for review of other food biotechnologies. Let’s review the facts (and give deserved credit to persons who unearthed these unsavory details). In the mid-1980’s, FDA violated Section 512 of the 1968 Animal Drug Amendments of the 1938 Federal Food, Drug and Cosmetic Act, by failing to require that Monsanto develop a residue detection assay. FDA rules specify that before byproducts (like milk and meat) of animals in experimental drug tests may be consumed by the public, a residue detection test must be developed. FDA required no such test. Thus, Monsanto asserts milk from rbGH injected cows is "the same" as regular cow’s milk, because there is no publicly known, mandated test. (Credit Samuel S. Epstein, M.D., University of Illinois-Chicago environmental toxicologist, with this long-ago insight.) In August 1990, FDA took the unprecedented step of publishing its human safety rationale for rbGH in the journal Science. At that time, rbGH – still in the test stages – had become the biggest food safety controversy in FDA’s history. The Science article became the basis for claims "It’s safe because FDA says it’s safe." Say what? FDA published a chart showing health effects upon groups of rats fed rbGH in Science. FDA claimed he treated rats showed "no differences." But the specific chart cited shows significant differences in the growth of tibia (foreleg) bones. The tibia is the bone most sensitive to growth hormones (whether natural or synthetic). The rats leg bones grew! Other subtle changes in rodents were also evidenced - contrary to government claims. (Credit on this one to Dr. William von Meyer of Fairview Industries, Middleton, WI.) FDA’s Science article cited test by a Canadian researcher, Groenewegen, as basis for asserting that commercial pasteurization destroyed all growth hormone presence. Take a closer look! Groenewegen was an undergraduate student. His major professor wouldn’t put his own name on the research because the prof was a Monsanto academic hireling. Gronewegen cooked batches of milk for 30 minutes at the 15-second pasteurization temperature, in order to destroy the growth hormone residues. Talk about "cooking" the research! Undergraduate Groenwegen’s misguided research is a major pillar of FDA’s presumptions of rbGH’s human "safety." (Credit Robert Cohen of Oradell, NJ with this insight. Cohen is an anti-dairy activist.) (Cohen's sites are at http://www.antidairycoaliton.com and http://www.notmilk.com. To get the book "MILK: The Deadly poison" visit http://www.amazon.com/exec/obidos/ASIN/0965919609/dorwaybookshelf) The Science article cited, as one of its two cornerstone presumptions of human safety, applications of oral and injected natural cow growth hormone to human dwarfs in the 1950’s. FDA claims the dwarfs showed no effects. That’s a damn lie. [Note: FDA misreported this research citation in the Science article. The research cited should have been attributed to Jerome A. Moore, et al. In Endocrinology 122, 2920 (1988)] In fact, the abstract of the article FDA cites regarding human dwarf- feeding research from the 1950s notes that dwarfs ingesting cow hormones suffered unusually high frequencies of Creutzfeld-Jacob Disease – brain degeneration, or the human equivalent of "Mad Cow" Disease." How can FDA claim these human research subjects were unaffected by ingesting natural hormones? (Credit Cohen again.) FDA presumes that synthetic cow hormones are the same as their natural counterparts, in terms of immunogenic and allergenic factors. Yet FDA acknowledges that synthetic human growth hormones do cause certain health problems to persons injected with them. Importantly, in the early 1980’s, French youths injected with recombinant human growth hormone developed degenerative brain diseases. (Credit Epstein.) Fully half the text of FDA’s 1990 article in Science focuses on IGF-1 (Insulin-like Growth Factor-One). IGF-1 is the hormone which circulates in the blood of humans and cows to each cell in the body, coordinating cellular function. IGF-1 is exactly the same in cows and humans. Despite statistical flim- flams by FDA and Monsanto, milk from cows injected with rbGH in fact contain higher levels of IGF-1. IGF-1’s links to cancer development are cited in tens of thousand of medical and scientific research articles. FDA presumes that all additional IGF-1 is destroyed by digestion in the human stomach, and thus cannot enter the human blood stream. A wide array of scientific literature debunks that naïve theory. Take a single article, reported in the Journal of Endocrinology (1995): 146. Pgs. 215-225, by researchers from the Cooperative Research Centre for Tissue Growth and Repair of the Women’s and Children’s Hospital in North Adelaide, Australia, titled: "Degradation of IGF-1 in the adult rat gasterointestinal tract is limited by a specific antiserum or the dietary protein casein." To make a long story short, the presence of the milk protein, casein, impairs digestion of IGF-1, so IG-1 can enter the bloodstream. Significance? Critics argue that virtually none of the rbGH human safety tests involving IGF-1 used milk-borne IGF-1, but rather recombinant IGF- 1 in natural form. Had researchers used IGF-1 bound in milk, their conclusions might have been different about "no effects" on lab animals from IFG-I ingestion. Importantly, research citations in this 1995 Journal of Endocrinology article cite studies prior to 1990 whose title clearly state evidence that IGF-1 can survive digestion and enter the blood stream. Once in the bloodstream, IGF-1 can bind to receptors. Critics worry that IGF-1 receptors in women’s breasts are a fertile area for additional IGF-1 to bind. (Let’s credit Dr. Michael Hansen, with Consumers Union, for digging out this research.) In 1995 Monsanto researcher Bernard Voiland reported in the journal Protein Science that a previously-unnoticed, amino-acid sequence change had occurred in the company’s manufacture of rbGH, but that Monsanto overcame the quirk. The molecule presently sold by Monsanto as "Posilac" is structurally different from the molecule on which years of "safety" test were conducted for FDA! "Posilac" should be pulled from commercial sale until years of human safety tests are conducted on the product being sold. Think one little amino-acid sequence change is no big deal? Black persons who suffer from Sickle Cell anemia have a genetic variant of one amino acid. An eye affliction, Retinosa pigmentosa, also results from a single amino acid sequence change in a human gene. In 1992, FDA ruled that biotech variants of foods were "the same" as their natural counterparts and needed no special human safety testing. That policy is clearly wrong. Synthetic human and cow growth hormones are recognized as more potent than their natural counterparts. In March, 1996, the New York Times reported on a failed biotech experiment, in which Monsanto infused Brazil nut genes into soybeans (trying to make a soybean with Lysine – to complete soy’s amino-acid sequence). Unfortunately, persons allergic to Brazil nuts also suffered allergic reactions to the soybeans infused with Brazil nut genes. Obviously, biotech-derived foods are NOT the same as their natural versions. Conclusion: Years more research needed Many of the individual citations in this review would merit immediate ban on commercial sale of Monsanto’s "Posilac" – if FDA took its mandate to protect public health seriously. In aggregate, FDA’s human safety oversight failures add up to a damning indictment of the agency’s failure to safeguard the nation’s milk supply from potentially dangerous, hormonal residues (linked to cancer development in tens of thousands of scientific research articles). "Everything by the book?" Test rats were significantly affected in many ways in research FDA cites as establishing human "safety." Human dwarfs fed natural cow growth hormone in the 1950’s suffered brain degeneration. Research shows IGF-1 (particularly when bound by casein) survives digestion and enters the human bloodstream. And research wrongly attributed to a Canadian undergraduate student’s "cooking" milk for 30 minutes (at the 15-second pasteurization temperature) to "destroy" rbGH residues is purely bogus.