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WBB: Unapproved drugs

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Posted: 2/8/2012 12:00:00 PM
Edited: 4/30/2022 10:19:46 AM (3)
 

Sourced from: Infinite Health Blog, by Dr. Davis, originally posted on the Wheat Belly Blog: 2012-02-08


Unapproved drugs

Imagine a world in which the pharmaceutical industry were permitted to develop drugs, then bring them directly to market, no regulatory process required. They develop a drug to treat a specific condition, like toe fungus or depression, then introduce it to market for pharmacies to sell and physicians to promote (since that is now the new de facto role of physicians: drug marketers). No FDA application required. The developer might have performed the usual phase 1, 2, and 3 clinical trials, they might have not. They can just bring it to market, no questions asked about safety, efficacy, or suitability for human consumption.

Imagine the mess that would result. It would be pure profiteering and marketing.

While the FDA process is far from perfect, it does introduce a level of scrutiny, a requirement to test for safety and, to some degree, efficacy. Anyone who has contributed to these sorts of trials or seen the incredible reams of paperwork filed for an FDA New Drug Applications knows how demanding these requirements can be.

There is no such requirement for food crops widely consumed by humans. This comment from two agricultural geneticists in the business of generating new wheat breeds sums it up well:

The growing world-wide demand for wheat is placing pressure on breeding programs to produce elite cultivars that can adapt to a range of environments without compromising agronomic performance, grain quality or disease resistance. Wheat-breeding efforts focus on developing new varieties with improved disease resistance (to nematode, fungal and/or viral infection), tolerance to abiotic stresses (such as heavy-metal toxicity, drought and cold tolerance) and numerous grain quality attributes that affect baking and other uses of the final product. The combination of existing knowledge and resources with modern biotechnology and functional genomics is providing the opportunity to study the genetic, biochemical and physiological basis of these complex traits. Current efforts aim to address the major challenge of capturing the information from both wheat and model organisms, such as rice and Arabidopsis, in order to define genes that underpin the unique attributes of wheat. The resources being developed using biotechnology include comprehensive mapping initiatives and genome-wide expression studies; these need to be implemented together with wheat-breeding programs, in conjunction with high-throughput screening, to efficiently develop new, improved wheat varieties.

Agricultural geneticists are concerned about issues like yield, disease resistance, drought tolerance, and aesthetic qualities of the final product (e.g., bread texture) . . . but not effects on humans who consume these crops. You could read on, but nowhere will you find a comment like this:

Given the extensive genetic changes we introduce into unique strains of plants, both anticipated and unanticipated, it is important to bear in mind that such changes frequently result in biochemical differences in the eventual end-product. Insertion of a simple stop codon, for instance, to prevent the translation/transcription of a specific polypeptide may result in ‘downstream’ expression of (or failure to express) other plant components. Unique amino acid sequences in plant proteins have potential to generate allergenicity and immunogenicity to humans in ways not previously seen. Such changes must be assessed biochemically and, in selected cases, in clinical studies to assess safety for consumers prior to distribution.

In effect, 50 years of plant hybridization, crossbreeding, backcrossing, chemical and radiation mutagenesis (induction of mutations) and now gene splicing (“genetic modification”) have allowed the appearance of new compounds in food crops, most of which have not been studied but are widely consumed by humans. Agricultural genetics has, in effect, permitted the appearance of multiple new “drugs” on the market without any regulatory scrutiny or safety testing in animals or humans. The result: Commercial foods that have poorly-understood effects on humans.

So, yes, modern food mistakes are about such issues as overconsumption of sucrose, overexposure to fructose, food colorings and preservatives, and relative macronutrient intake (e.g., excessive carbohydrate intake). But it’s also about the substantial changes introduced into food crops like wheat, corn, and soy, that have not been examined–because the questions were never asked.


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Posted: 2/6/2022 2:22:05 PM
Edited: 2/6/2022 2:47:12 PM (1)
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