Masters of Health Magazine January 2023 - Page 28

•The team would designate which types of impacts from the ingestion of the corn that warrant tracking and perform comparisons between the groups

•Sample parameters might include changes in weight, metabolism, blood pressure, issues in the gastrointestinal tract, etc.

•Different tests could be utilized to look at organ function, changes in physiology and biopsies, or special tests (I.e., to assess the microbiome)

•When including laboratory tests, before and after studies are desirable for comparison

One of the most important aspects of a study is to avoid bias. Researchers on the teams examining any data or lab samples need to be unaware of which group the samples came from, and this is the second blinded aspect of a double-blind, placebo-controlled study.

The team would then analyze the data and perform the following:

•Compare impacts in the two study groups

•Assess treatment-oriented differences

•Record all findings which may or may not go against what they originally thought the results might reveal.

Human feeding studies are difficult, but are the gold standard. Straying from diet protocols dilutes what is called the statistical power of the study (i.e., the ability to detect differences in outcomes, if they indeed exist). For the best quality outcome, if one is doing a GE corn consumption study, the following would be need to be done:

•The setting is controlled, meaning in this case, the food is provided

•Intake is controlled and carefully measured  

•Blinded researchers would be responsible for data collection during the study

•Study supervisors would require technical training

It is obvious the inherent difficulties and expenses one would encounter in trying to create this type of study needed to assess GE products. While the above type of study is desired as outlined-above, such studies have not been conducted on GE crop traits because who will be willing to pay for them?

Without this evidence, assertions that foods derived from GE crops are safe are premature and inherently faulty. We have relied on rodent studies with many study shenanigans at play that manipulate data, such as using only a certain healthy population (i.e., juveniles), shortening the course of a feeding study, using contaminated feed in both groups which would diminish the impact of the findings and dismissing abnormal results, and the conflagration of absolute and relative risks. Sound familiar?

What Does Top-Tier Journalism Look Like?

Debate and re-examination of assumptions and accepted conclusions should be ongoing and active. Critical analysis of research methods is essential.

However, even study types that appear powerful or invincible can have drawbacks, such as studies called meta-analyses which employ a statistical technique for aggregating data from multiple studies on a topic of interest.

These types of studies are very important in healthcare settings because of their ability to weigh in on various degrees of evidence supporting different health strategies.

Conflicts of Interest

The more comprehensive the research the more expenses incurred. Bias can find its way into studies through many avenues, both inadvertently and intentionally. That is why all reputable, high-impact journals utilize rigorous peer review and have conflict-of-interest as well as funding disclosure requirements. These mechanisms can serve to promote transparency and alert both study reviewers and readers to be on the lookout for the “devil in the details”.

While journals make efforts to combat bias and to disclose conflicts of interests, this does not make up for the lack of sufficient quality studies presently on GE crops. Often, the companies promoting the engineered foods are in charge of their own studies, injecting immediate bias. Neither the EPA nor FDA independently carry out risk assessment studies.

Teams of independent technology developers are necessary and industry-sponsored studies should be eliminated. The quality of studies conducted by GE technology developers has been uneven, with evidence of inappropriate methods, problematic data collection and fraud.

A study is 2 to 5 times more likely to be favorable to a funder with a vested interest in a particular outcome, compared to a similar study on the same subject funded by a neutral source. Over time, the steady pressure of conflicts of interest has done much to skew the focus and quality of science supporting regulatory and public health decision-making, but this is far from what is should be for novel food products. Once they are released into the environment, recall is impossible.

RHI recognized that the restoration of integrity in the assessment and regulation of agricultural biotechnology is a complex and difficult mission, but vital if we are to prevent unintended consequences. Understanding study basics is a key part of this recognition. Our intention is to promote solutions-based platforms to regenerate health.

First, Do No Harm – Primum Non Nocere

An endeared principle to physicians is, “First, do no harm”. Thus, when doctors read scientific studies, they look hard for evidence of potential harm.

If a study does point to possible harm, obvious next questions include:

•Was there a follow up study that looked at the issues

•Did that study resolve or reinforce concerns over risk

•Is there any biological plausibility to a link between certain health problems and the consumption of GE foods and/or their pesticide components

•Can doctors extract from the published literature insights regarding who might be at risk (population cohorts) or who might be most responsive to an intervention

In order to be recommended by a physician, a substance must demonstrate evidence of benefit that clearly outweighs its potential for harm.

While we are presently referring to an invented GE study, one can extrapolate how this type of analysis is relevant to any population threat.

When less harmful alternatives with similar benefits exist, the choice is simple. This should be the basis of all FDA new drug approvals, but is rarely discussed in the context of GE crops and its oversight agency, the EPA. Whether the regulatory agencies are adhering to their own protocols is questionable.