The 90-Day Rat Study - Monsanto, IGF-1, and FDA Denial

Brandon Turbeville

I wrote a series of articles recently dealing with rBGH, the health risks that result from its usage, and the effects on the animals treated with it. I have written not only about the animal cruelty issue, but about the increased levels of cancer and the potential for the creation of antibiotic resistant bacteria associated with milk (and meat) produced with rBGH.

Yet the FDA, in the face of all the evidence available to themselves and the public, still has refused to admit that there were any health risks to humans from the use of the hormone, IGF-1, or the use of antibiotics.

For example, when responding to a study that demonstrated a possible between IGF-1 and prostate cancer, the FDA, while offering no supporting evidence, simply claims that “Although the mechanism responsible for the induction of cancer has not been characterized fully, it is clear that IGF-1 is not the causative agent.”[1]

Likewise, when addressing the concern over whether or not IGF-1 levels are related to breast cancer, the FDA responds that it has found no definitive evidence of any direct link between the two and, “Furthermore, FDA has been advised that there is no substantive evidence that IGF-1 causes normal breast cells to become cancerous.”[2] This advice was apparently extracted from a letter from Dr. Dennis M. Bier to David Kessler, then Commissioner of the FDA. However, beyond this letter, no evidence is referenced. This is business as usual when it comes to the FDA and its version of scientific documentation.

Yet, another issue related to the FDA’s questionable approval of rBGH is that of the 90-day rat study that has been a central focus of much debate.

This 1989 study was conducted by Monsanto itself, the producer of rBGH, and consisted of orally feeding rats rBGH and was submitted to the FDA in order to fulfill FDA requirements that all relevant safety information be included in the “sponsor’s” application. [3]

It should be mentioned that the FDA actually stated that rBGH posed no adverse health risks in 1985, yet it did not complete the official human health study until 1989. The genetically modified hormone was not approved for commercial sale and usage until 1993.

However, the FDA allowed for it to be sold and consumed in milk while the “commercial investigation” took place.[4]

So, the FDA had already claimed that rBGH posed no health risks to humans three years before their official study was concluded. Apparently the agency’s mind was made up before the study ever began. Likewise, if the FDA were living up to its stated goals, it makes no sense to allow a product to be sold and consumed while there is an ongoing investigation into that product’s safety. However, the FDA has become so compromised in so many different ways that this should come as no surprise.

The FDA effectively kept silent about the red flags popping up in the 90-day rat study mentioned above. After an investigation conducted by Health Canada (the Canadian version of the FDA), it was discovered that the FDA and Monsanto mislead the public on the results of the study.

Health Canada determined that the results of the study showed that 20 to 30 percent of the rats in the high dose test group produced antibody responses to rBGH as well as the development of cysts on the thyroid in some of the males. This was the same study made available to the FDA and all the while the agency maintained that there were “no toxicologically significant changes.”[5] This was not the view of Health Canada and many others who became aware of this information.

The development of thyroid cysts is significant. However, the antibody response to rBGH is even more serious as it suggests that the hormone is being absorbed into the bloodstream.

These findings, when first presented to the FDA should have launched a complete review of the effects on human health, particularly on the immune system and carcinogenic effects.[6] Of course, more thorough and unbiased science should have also occurred long before this study but, true to form, it didn’t.

Yet even if the science were to show that there were no real correlation between rBGH and antibody response or thyroid cyst development, there are still very real concerns regarding it. As was demonstrated earlier, IGF-1 is one of the main factors in adverse health effects related to rBGH.

The FDA continues to reject the idea that IGF-1 survives digestion and is absorbed into the blood stream causing any health problems. Much of this position comes from open denial. For the most part, the agency simply states that they have reviewed the science and have come to the conclusion that there is no legitimate basis for concern.

But it must be pointed out that many of the studies that the FDA uses to back itself up, on the rare occasion that it decides to do so, are studies conducted by the company sponsoring the drug in question. Indeed, there were two studies conducted by Monsanto and Elanco that concluded that IGF-1 does not survive digestion. However, as some scientists have pointed out, there are problems with that assessment.

As the scientific team for Consumers’ Union states:

Those studies are not definitive because rats were given free IGF-1, without casein or other protective proteins. Thus one would not expect the IGF-1 to survive digestion in these studies. Even so, a careful review of the Monsanto study suggested that some small amount of the IGF-1 administered in this study survived digestion and affected the rats’ growth rate.[7]

Although not for lack of trying, the FDA would be hard pressed to be further from the mark when the agency suggests that rBGH or IGF-1 poses no significant risks of adverse health effects in humans. Indeed, the science says something much different as even free IGF-1, in small amounts, did survive digestion.

When consumers learned that rBGH was being included in their dairy products and subsequently learned of the dangers, there was a backlash of the most effective kind. The public simply began to change where they spent their money and avoided products that contained rBGH.

As a result, many companies began to label their products as rBGH free and consequently saw higher consumption than those who used the hormone. This created a snowball effect and even major companies like Hood, Dannon, Yoplait, Kroger, and even Wal-Mart abandoned the use of rBGH milk in most of their dairy products.

Logically, the removal of rBGH most likely did not stem from the direction of any moral compass but from the motivation of profit. Consumers refused to buy rBGH so these businesses had little choice but to remove it. [8]

This is a powerful lesson to us all. If we, as consumers, don’t want High Fructose Corn Syrup, Aspartame®, or rBGH in our food, then we should simply stop buying products that contain these toxic chemicals. Sooner or later, the industries that added them will be forced to take them out through sheer financial necessity.

Indeed, the corporate system survives in part because we enable it by spending our money with the various corporations that make it up. For a moment, ask yourself what would happen if we stopped?

Sources:

[1] “Report on the Food and Drug Administration’s Review of the Safety of Recombinant Bovine Somatropin.” Food and Drug Administration. April 23, 2009. http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm130321.htm Accessed May 24, 2010.
[2] Ibid.
[3] Ibid.
[4] “rBGH:How Artificial Hormones Damage the Dairy Industry and And Endanger Public Health.” Foodandwaterwatch.org. June, 2009. http://www.foodandwaterwatch.org/tools-and-resources/rbgh-how-artificial-hormones-damage-the-dairy-industry-and-endanger-public-health/ Accessed May 24, 2010.
[5] “Statement of Michael Hansen, Ph.D., Research Associate Consumer Policy Insititue, Consumers Union On FDA’s Safety Assessment of Recombinant Bovine Growth Hormone December 15, 1998.” http://www.consumersunion.org/pub/core_food_safety/002269.html
[6] Ibid.
[7] Hansen, Michael Ph.D., Halloran, Jean M., Groth, Edward III, Ph.D., Lefferts, Lisa Y. “Potential Public Health Impacts Of The Use Of Recombinant Bovine Somatropin In Dairy Production.” September 1997.
[8] “rBGH:How Artificial Hormones Damage the Dairy Industry and And Endanger Public Health.” Foodandwaterwatch.org. June, 2009. http://www.foodandwaterwatch.org/tools-and-resources/rbgh-how-artificial-hormones-damage-the-dairy-industry-and-endanger-public-health/ Accessed May 24, 2010.

Brandon Turbeville is an author out of Mullins, South Carolina. He has a Bachelor’s Degree from Francis Marion University where he earned the Pee Dee Electric Scholar’s Award as an undergraduate. He has had numerous articles published dealing with a wide variety of subjects including health, economics, and civil liberties. He also the author of Codex Alimentarius – The End of Health Freedom and 7 Real Conspiracies.