Masters of Health Magazine January 2023 - Page 27

The Scientific Method and How Science Advances

The scientific method involves making a hypothesis and designing a study to test, support, or contradict the hypothesis. For example, if a substance is given to test animals in a long-term feeding trial, and we find that their organs such as the liver and kidneys have normal weight and appearance by the end of the study period, all we can say is that under the conditions of this experiment, there was no evidence of an adverse or toxic impact on these vital organs.

However, a study that delves more carefully into liver and kidney function, and not just the appearance, may reach a conflicting conclusion.

Therefore, the first step in any quality study is to carefully review research protocols, records, and analytical and statistical methods in order to identify why the study results differ. It usually takes additional studies to further comprehend what happened and why. In some cases, questions linger even after dozens of studies, investments, and time spent in specialized studies. More questions may be raised than answered.In the case of the rat feeding trial prior to the launch of GMOs, Monsanto studied rats for a 3 month period, fed a GMO diet. A confounding factor not identified was the quality and sourcing of their diet. Abnormalities were found, for example, in blood chemistries. Rather than performing the recommendations noted above, the conclusion in their study was that the findings were “not of clinical significance”. Both scientists and non-scientists would agree that this is faulty logic. Despite this concerning finding, GMOs were released.

The consequence of any study that demonstrates unintended consequences should have been further studies to analyze the problems found and/or to have withdrawn the product completely.

Are Regulators Regulating?

The challenge for policy makers is to specify the rules that govern what happens in the face of uncertain science and potential risks of severity, reach, and longevity.

With advances in analytical technologies and risk assessment tools, we can look at entirely different aspects and interactions between genetics and lifestyles, and between biology and health. These advances should be welcomed and are needed, and will allow public health scientists and regulators to do their jobs and avoid any uninvited surprised following the present rapid approval and release of GE crop and animal technology.

The Nuts and Bolts of Sound Risk Assessment

The top-shelf type of an experiment is a double-blind, placebo-controlled study in a well-characterized human population. For example, if RHI wanted to assess the safety of a GE corn trait to be introduced into the market, the collective team would need to do the following:

•Assess a large number of people which gives the study “power”

•The people would be separated randomly into two groups

•A specific strain of GE corn grown under typical conditions would be studied

•One group of individuals in the study would consume a defined amount of the GE corn over a specified time period

•The other group would consume the same amount of corn, but from ears harvested from a field planted with the GE corn’s isoline, meaning the same background genetics, but without GE traits

•The control group would be comprised of corn uncontaminated with pesticides

•The two groups would be blinded as to which group they were enrolled and what they were consuming

•The teams conducting the trials would also be blinded as to which individuals were in the two assigned groups