SAFeAGE: SA Freeze Alliance on Genetic Engineering

rBST
The use of genetically engineered bovine growth hormone in the South African Dairy industry.

Milk is a symbol of purity, our collective first food. But what about the daily variety on our supermarket shelves? The answer is: About as pure as pus and cancer.

South Africa is one of a very few nations that permits the use of a genetically engineered hormone known as recombinant bovine growth hormone (rBGH), commonly called rBST or recombinant bovine somatotrophin in South Africa. It is sold here under the trade names Lactotrophin (sold by Eli Lily subsidiary Elanco) and Hi-Lac (by MD Animal Health), presumably under licence Monsanto Corporation, the originators of this product. rBST is injected into dairy cattle to increase milk yields and has been called “crack for cows,” as it accelerates their metabolic rate, increases food intake and improves milk production by up to 15%.

Scientists found in the 1930s that injected extracts of cow pituitary glands increased lactation. But it was only through the application of genetic engineering technology that it became financially viable to produce rBST in economically viable quantities. Artificially inserting the relevant gene into E. coli bacteria effectively turns the E.coli into microscopic factories.

US authorities granted permission for rBST to be used in research herds from the 1985, and it got an official green light in 1994. We have officially been using it in South Africa since 1994. The milk of Freedom!

Using this hormone on cows creates unpleasant side-effects. It notably increases the incidence of mastitis, a painful inflammation of the udder and milk ducts, resulting in increased somatic cell counts (pus) in milk. It has also been shown to reduce livestock fertility and cause lameness and weight loss in treated cattle. An anonymous interviewee from one of the suppliers of rBGH in South Africa said off the record, of the opposition product, that “you can milk them till they drop dead. You use that stuff if you don’t care too much about your cows.”

Not only does the pus ratio increase; the veterinary treatment for mastitis is antibiotic drugs. A wide range of antibiotic drugs are available to livestock farmers and allegations have been made that significant illegal use of our few remaining “front line” antibiotics exists. This directly threatens the fragile health of citizens of this frontline region of the HIV, AIDS and TB pandemic through increasing antibiotic resistance. When the new generation antibiotics cease to be effective we have no backup. Medically speaking we simply return to the 1930s; once routinely treatable infections can become potentially life threatening.

This alone should be cause enough for withdrawing rBST from use. But there is more. Much, much more.

The developers of the hormone, Monsanto Corporation, also control over 90% of the genetically modified crops planted around the world. They prefer not to call their hormone Recombinant bovine growth hormone as the terms ‘recombinant’ and ‘hormone’ evidently create unease amongst consumers. Consequently it was euphemistically renamed bovine somatotrophin or BST, sold here as ‘Lactotrophin’.

rBST was the first genetically engineered agricultural product to be presented for regulatory review and approval. A lot was riding on its approval during the nascent biotech boom of the late 1980’s and early ‘90s. Even as a veterinary medicine, stringent criteria and a transparent regulatory process should have been a prerequisite for such a controversial drug, but this failed to occur. In the US, the lead nation for its use and regulation, the regulatory process was farcical.

Despite having to analyse a mass of data, the US Food and Drug Administration (FDA) experts found that it was not the quantity but the quality of the submission that was problematic. For instance cows with udder infection were dropped from the study - over 9, 500 cows from 500 farms were infected - certainly not the handful claimed by the FDA and Monsanto. Already pregnant cows were included in fertility studies. Statistical analysis was problematic. Key documents were refused release by Monsanto and others, citing commercial confidentiality on spurious issues such as organ weights and pathology of test animals!

The FDA took an unusual step of publishing a paper on the safety of rBST in the journal ‘Science’. In this study, instead of the usual two-year study on two different mammals to establish carcinogenicity, a twenty-eight and a ninety-day study on rats were submitted. This has been compared to submitting a high school project for a degree. The animals were both injected and fed rBST. Those injected showed significant changes while those fed showed none. But this paper ignores other critical data; for instance, 20-30% of the rats fed the hormone showed an antibody response and some also displayed evidence of thyroid and prostate dysfunction that should have triggered further investigation, but did not. Why?

FDA official John Scheid commented that the FDA had never examined the raw data but instead relied on Monsanto’s summary as a basis for decision. Informed sources claimed that this reliance on Monsanto’s analysis is a direct violation of FDA procedure.

Attempts by US regulators to raise their concerns were overridden by political appointees. Remember, the biotech bandwagon had just started rolling; rBST had to pass muster. The regulatory system actively conspired against those who raised concerns with the product and several critics were effectively silenced, according to subsequent investigations into this matter.

For instance FDA deputy commissioner for policy, Michael Taylor was given the post of the first GM regulatory tsar. He was previously a lawyer for Monsanto, having advised them on food, labelling and regulatory issues. As regulator he wrote Monsanto’s’ legal guidelines to indict dairies which attempted to label milk rBST free and then advised on FDA guidelines that make it difficult for producers to label their milk rBST free. Other similar conflicts of interest within the regulatory framework were clearly present.

A US congressional hearing into the matter wrote: “The entire FDA review of rBST seemingly has been characterised by misinformation and questionable actions on the part of both FDA and Monsanto Company officials.” They also noted how attempts by the General Accounting Office to investigate the process had to be abandoned because Monsanto refused to hand over “pertinent and related data.”

Taylor went on to become V-P of public policy at Monsanto and was instrumental in gaining approval for GM crops. Nice job if you can get it.

rBST also increases the risk of cancer. This is not a maybe; it’s a fact. When used, rBST markedly increases levels of a hormone, insulin like growth factor one, or IGF-1, that naturally occurs in milk. Research shows increases in IGF-1 levels to range from ‘significant’ to 360 percent. To add insult to injury, IGF-1 is more easily absorbed when consumed with casein, the main milk protein. Further research provides a substantiative body of published peer-reviewed papers linking increased levels of IGF-1 in humans to increased risk of cancers of the breast, prostate, lung, colon, smooth muscle and other cells. Even small differences in IGF-1 levels significantly alter risk.

The UN international food safety body, ‘Codex Alimentarius’ has supported the right of nations to forbid the use of this hormone, due to the clearly enumerated potential human health effects, by failing to include it in the Generally Recognised as Safe (GRAS) categorisation. Canadian legislators and scientists closely interrogated US data and found it seriously lacking and banned the use of rBST. So too in most major dairy producing nations such as the EU and New Zealand but it has somehow been permitted here.

rBST was evidently used here experimentally from around 1992, peaked at around 6 million doses in 1998/9 and has since dropped to between approximately one and two million doses per annum. Given what we know, even this degree of usage is unacceptable.

Initially the hormone was only available through vets, but its re-registration by Monsanto under ‘Act 36’ means that it is now freely available with no meaningful controls whatsoever. The change offers practical benefits for sellers, as animal health problems can no longer be blamed on veterinarian malpractice. One vet remarked, “it is out of control.”

It is fascinating that the drug is used at all in South Africa. In interviews with every single major and many minor dairies in South Africa, not one admits using the hormone. Most are opposed. A number have promised they are hormone-free have failed to label their products, citing legal concerns. Woolworths halted the use of rBST in their Ayrshire milk in 2000 and have engaged in comprehensive labelling. Other suppliers and retailers have followed suit but labelling remains the exception rather than the rule.

Most of the big dairy customers such as Clover, Parmalat and Nestle all state their policy not to accept use of this hormone. While inspections do take place, no independent tests are undertaken, nor is the product readily detectable. No single producer was against withdrawing rBST; most supported this stance. The South African Milk Producers Organisation (SAMPRO), whose members deliver around 70% of our dairy produce, is “not in favour” of its use.

So why are we still using this stuff? Quite simply, because our regulatory authorities continue to permit its use.

The product is imported, so it is of no benefit to our balance of payments. The costs and pressure on our already struggling health services could be significant, with increased cancer rates and other possible hormonal and metabolic effects. It is questionable whether this product enhances profitability; it is expensive and more feed must be provided to treated cows.

rBST also directly threatens our dairy exports. We now export at least 5000 tonnes of cheese a year to the EU, and if rBST use is suspected or detected in any SA exports, there will be immediate negative impacts on our dairy industry.

Under the present unregulated system it is impossible to ascertain just who is using rBST. The bulk is probably used by dairy farmers whose hand is being forced by tight margins in a tough industry. One rBST supplier estimated that around 50% of farmers might be using it; this is probably on the high side, with around 20 - 30% being a more likely figure.

It is clearly inadvisable to continue the use of this product, given what we know about its impact on humans and animals. If we wish to restore the reputation of our dairy products, a good start would be for the Department of Agriculture and the Medicines Control Council to immediately withdraw the permission for rBST to be used in South Africa.

Seeds of Deception; Exposing Industry and government lies about the safety of the genetically engineered foods you’re eating, by Jeffrey Smith, 2003. Yes! Books, Fairfield, Iowa. Available from Amazon and elsewhere. www.seedsofdeception.com

This is what reputable journals say about IGF-1, which, if you refer to the Canadian hearings, it is clear that there is a risk from raised levels of the type of IGF-1 that is produced by rBGH.

"Insulin-like growth factor (IGF)-I, a mitogenic and antiapoptotic peptide, can affect the proliferation of breast epithelial cells, and is thought to have a role in breast cancer."

"Insulin-like growth factors (IGFs), in particular IGF-I and IGF-II, strongly stimulate the proliferation of a variety of cancer cells, including those from lung cancer. High plasma levels of IGF-I were associated with an increased risk of lung cancer. Plasma levels of IGF-I are higher...in patients with lung cancer than in control subjects."

"Insulin-like growth factor-1 (IGF-1) is expressed in many tumour cell lines and has a role in both normal cell proliferation and in the growth of cancers.

"The insulin-like growth factor (IGF) system is widely involved in human carcinogenesis. A significant association between high circulating IGF-I concentrations and an increased risk of lung, colon, prostate and pre-menopausal breast cancer has recently been reported. Lowering plasma

"...serum IGF-I levels increased significantly in the milk drinking group, an increase of about 10% above baseline-but was unchanged in the control group."

"Human Insulin-like growth factor (IGF-I) and bovine IGF-I are identical. Both contain 70 amino acids in the identical sequence."

"IGF-I is critically involved in the aberrant growth of human breast cancer cells."

"Estrogen regulation of IGF-I in breast cancer cells would support the hypothesis that IGF-I has a regulatory function in breast cancer."

"IGF-I is a potent growth factor for cellular proliferation in the human breast carcinoma cell line."

"IGF-I produces a 10-fold increase in RNA levels of cancer cells. IGF-I appears to be a critical component in cellular proliferation."

"Serum IGF-I levels increased significantly in milk drinkers, an increase of about 10% above baseline but was unchanged in the control group."

Robert P. Heaney, Journal of the American Dietetic Association, vol. 99, no. 10. October 1999.

M. Lippman Science, Vol. 259, January 29, 1993

“Dietary correlates of plasma insulin-like growth factor I and insulin-like growth factor binding protein 3 concentrations.” M. Holmes et al. Cancer Epidemiology, Biomarkers & Prevention. 2002 Sep;11(9):852-61.