Posted by: Khepera | Saturday, 24 April 2010

REVISED: The Fallacies of Big Pharmaceuticals & FDA Policies

There are several debates — dealing with the FDA and their policies in approving drugs & the use of herbs and other natural remedies — which are sweeping this country like brush fires.  You may find it of interest to discern the overlap between the FDA & USDA.  One of the keys in maintaining authority in power is in how that power is exercised — constraint/unfettered @ special interest for instance.  Despite the naysayers, in some of these instances, we must consider collusion in the least, if not conspiracy to deceive/misrepresent.

One of cornerstones of the scientific community is peer review, and associated procedural policies — aren’t there supposed to be research reviews along the line?  Recently, Dr. Scott Reuben has pleaded guilty to several counts relating to his falsification of research connected with the FDA approval of Bextra, Celebrex & Vioxx, in association with Pfizer, who paid Dr. Reuben nearly half a million dollars(see also more coverage).

This coverage also points out this is not Dr. Reuben’s first time around with these problems. This begs the question @ who is in charge, where is the vigilance, and at what point is profit more important than health &/or nutrition.  Consider how intertwined this is in the supposed research to support or condemn certain products, or types of products.  This factor is significant when one examines the posture taken towards organic foods, herbal and natural health products(see Codex Alimentarius, also Codex Alimentarius home site) in contrast to obvious supports to agribusiness concerns.  The focus has shifted primarily to plant durability, yield and resistance to disease, while allowing nutritional value to be sacrificed.  Wheat is a good example.  Check out the Kansas Wheat Quality Laboratory, consider their stated goals:

The objectives of this project are:

  1. To provide timely evaluation of important physical kernel, protein, milling, and flour properties, which determine bread baking and oriental noodle quality of promising lines developed by wheat breeders and geneticists. This includes identifying protein and hardness properties of early-generation winter wheat lines and germplasm, which were contained in the proposal titled “Protein/Hardness Screening of Early Progeny Wheat”.

  2. To cooperate with faculty, research staff, and graduate students in Grain Science, Agronomy, Plant Pathology, and Entomology in studies designed to determine influence of genetics, diseases, insects, soil and environmental factors, storage and processing on milling and baking quality, and qualities needed in oriental noodles and ethnic breads.

  3. To provide technical assistance to Kansas wheat marketing efforts by the Wheat Commission, U.S. Wheat Associates, Wheat Quality Council, and K-State Cooperative Extension.

Further, what were once considered attempts at assisting Nature are now held as copyrightable intellectual property, for which a market has been created, and controlled.   A shift has been brewing for over a decade, in the direction of personal food production, even in urban areas. Now, there is an awakening by urban gardeners that many of these codes, standards, etc. are structured to constrain small family farms, and therefore impacts them as well.

There is compelling evidence that the degradation or decline of nutritional value in wheat and other cultivated grains over the last 20-30 years is a significant causal factor in the rampant obesity we see among children and adults in this country.  Add in relatively new sedentary habits like video games, etc., and is no surprise that we have the cognitive conundrum of significant progress in extending our lifespans, yet the quality of health during our lives has dropped dramatically.  Consider a 2008 press release from the Organic Center, entitled Still No Free Lunch: Nutrient levels in U.S. food supply eroded by pursuit of high yields(link to PDF). An excerpt from their press release announcing the report:

Today’s farmers raise more bushels of corn, pecks of apples, and pounds of broccoli from a given piece of land than they did decades ago. But those crops are often less nutritious, according to a new report released today from the Organic Center, “Still No Free Lunch: Nutrient levels in U.S. food supply eroded by pursuit of high yields.”

“Our crops are more abundant [i.e., per acre yields are higher], but they are also generally less nutritious,” said report author Brian Halweil, a senior researcher at the Worldwatch Institute and a member of the Organic Center’s scientific advisory board. Historical records from the U.S. Department of Agriculture show that everyday fruits and vegetables—from collard greens to tomatoes to sweet corn—often have lower levels of some vitamins and less iron, calcium, zinc, and other micronutrients than they did 50 years ago.

The most compelling data supporting the general decline in nutrient levels in crops comes from contemporary studies where researchers have grown modern plant varieties side-by-side with historic, generally lower-yielding cultivars, using similar production practices and levels of inputs, like nitrogen fertilizer. Several such studies have found that the modern-era varieties produce 10 to 25 percent lower levels of iron, zinc, protein, calcium, vitamin C, and other essential nutrients per pound of produce or grain.

For instance, looking at 63 spring wheat cultivars grown between 1842 and 2003, researchers at Washington State University found declines in the concentrations for all eight minerals studied, with an 11 percent decline for iron, 16 percent decline for copper, 25 percent decline for zinc, and 50 percent decline for selenium.

“To get our recommended daily allowance of nutrients, we have to eat many more slices of bread today than people had to eat in the past,” said Halweil. “Less nutrition per calorie consumed affects consumers in much the same way as monetary inflation. That is, we have more food, but it’s worth less in terms of nutritional value.”

Clearly, it is important to examine the big picture instead of focusing only on the regulation of food and drug/herb/vitamin supplements as separate. They did name the agency that for a reason. Thanks to Sis. Adenike(for the next 2 sections), here is a link to aid in gaining a better understanding of the statistical aspect of this issue with the wheat, and other products of industrial farming.  An excerpt:

We now have solid, scientific evidence of this troubling trend. For example:

  • In wheat and barley, protein concentrations declined by 30 to 50 percent between the years 1938 and 1990.
  • Likewise, a study of 45 corn varieties developed from 1920 to 2001, grown side by side, found that the concentrations of protein, oil and three amino acids have all declined in the newer varieties.
  • Six minerals have declined by 22 to 39 percent in 14 widely grown wheat varieties developed over the past 100 years.
  • Official U.S. Department of Agriculture (USDA) nutrient data shows that the calcium content of broccoli averaged 12.9 milligrams per gram of dry weight in 1950, but only 4.4 mg/g dry weight in 2003.

All of this evidence has been assembled and rigorously reviewed by Dr. Donald R. Davis, a now (mostly) retired chemist from the University of Texas.

So what’s causing these declines? The evidence indicates there are at least two forces at work. The first is what agriculture researchers call the environmental “dilution effect.” Davis notes that researchers have known since the 1940s that yield increases produced by fertilization, irrigation and other environmental means used in industrial farming tend to decrease the concentrations of minerals in those plants. These techniques give growers higher yields, and consumers get less expensive food. But now it appears there’s a hidden long-term cost — lowered food quality.

Another good source for this sort of info is from a 2005 study “Changes in USDA Food Composition Data for 43 Garden Crops, 1950 to 1999” (use this link to access the PDF file of the study).  Note this info is also from Dr. Donald Davis’ research. For the full text of the following discussion of that study’s results use this link. An excerpt:

Research study shows only heirloom organic breeds nutritionally complete.

One look at a big, red tomato and one can almost taste its’ juicy freshness…unless, that tomato was part of a group of 43 fruit and vegetable crops analyzed by Dr. Donald Davis, research associate at the Biochemical Institute at the University of Texas, Austin. For two decades, Davis and two colleagues Melvin Epp, and Hugh Riordan analyzed nutritional data taken from selectively bred high yield conventionally grown produce. In 2005, their study titled “Changes in USDA Food Composition Data for 43 Garden Crops, 1950 to 1999” showed the results.

According to Davis, “We tracked 50 years in U.S. Department of Agriculture food composition data for 13 nutrients in 43 garden crops, vegetables, strawberries and three melons. Low and high yield varieties were grown and analyzed side by side eliminating key uncertainties that apply to historical data. The data was then analyzed. “

The following information is taken from that paper with editorial changes made to increase its understanding for readers. What the researchers found were declines in average concentrations of six nutrients. The subtraction sign representing the negative symbol, indicates decline. The results of 20 years showed declines in: protein of – 6%, calcium: –16%, phosphorus: – 9%, iron: –15%, riboflavin: – 38%, and vitamin C: – 20%.

In the article, Davis cited direct evidence of genetic trade-offs between yield and mineral concentration in broccoli, between calcium and magnesium, and for wheat, in iron between zinc, copper, selenium, phosphorus, and sulfur. Correlation coefficients between yield and nutrient concentrations were negative for 14 hard red winter wheats. For 27 commercial broccoli hybrids, correlation coefficients between yield and calcium and magnesium ranged from – 0.46 to -0.69.

“There seems little doubt that sizable genetic trade-offs exist, but we do not yet know their breadth,” Davis stated in his conclusions.

An explanation of exactly what happens in genetically engineered dilution effects may be helpful. Over many years of using yield potential as the dominant criterion in developing improved varieties, while average yields have risen, plant root systems have not been able to keep pace in drawing more needed micronutrients from the soil. When breeders selectively breed for one resource, using a selected trait like yield, fewer resources remain for other plant functions as the study explains.

“There may be trade-offs between the number of seeds and their size or between yield and growth rate and pest resistance. In tomatoes, there are trade-offs between yield which is the harvest weight and the dry weight, or between yield or fruit size and vitamin C, and between lycopene which gives tomatoes their the primary color and beta-carotene which is the precursor to vitamin A.”

This information on nutritional decline and selective breeding is nothing new to agricultural researchers and scientists. Science journals began publishing writings on nutritional decline over 20 years ago. A 1981 review in “Advances in Agronomy” discussed the widely cited “dilution effect,” in which yield-enhancing methods like fertilization and irrigation may decrease nutrient concentrations, an environmental dilution effect. Recently, evidence has emerged that genetically based increases in yield may have the same result, a genetic dilution effect. An explanation of exactly what happens in genetically engineered dilution effects may be helpful. Over many years of using yield potential as the dominant criterion in developing improved varieties, while average yields have risen, plant root systems have not been able to keep pace in drawing more needed micronutrients from the soil. When breeders selectively breed for one resource, using a selected trait like yield, fewer resources remain for other plant functions as the study explains.

One of the key reasons for concern is the clear corporate/agribusiness-driven attack by the FDA on organic foods, farmers & supplements.  At the behest of the FDA, “organic” has become a ‘label’ for use in marketing rather than a qualification of how food is grown. Further, when you examine the science of agriculture, you will come to realize that an organic farm, even a few, in close proximity to ‘standard’ farms — using pesticides, chemical fertilizers, etc. — are inevitably exposed to the spread of these elements via wind, dust, and sometimes even water drainage, not to mention the unavoidable influx of pollen from the farms by way of bees.

When you combine the prominence of corporate interests/agendas in the policy-making & regulations of the FDA with their clear animosity towards organic and natural supplements — and the exposed pattern of deceitful research/qualification processes used by the FDA — one is left with the inescapable actuality that health, in its true meaning, is not now, nor has it perhaps ever been the mission of the FDA.  Unfortunately, this appears to be equivalently true of the USDA — United States  Dept. of Agriculture.

Remember to come back and check, as this post is evolving, growing with new info, links etc., as readers make contributions  Your comments are welcome.


  1. […] other animals.  The same goes for the ingestion of GMO’s, as addressed in earlier posts(and here also). We have forgotten that the old name for farming is “husbandry“, as in animal […]

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