.
Monsanto participates in a voluntary consultation process with the FDA that is derided by critics as a meaningless exercise.
.
Monsanto submits whatever information it chooses, and the FDA does not conduct or commission any studies of its own.
.
Former EPA scientist Doug Gurian-Sherman, who analyzed FDA review records obtained through the Freedom of Information Act, says the FDA consultation process "misses obvious errors in company-submitted data summaries, provides insufficient testing guidance, and does not require sufficiently detailed data to enable the FDA to assure that GE crops are safe to eat.
.
But that is not the point of the exercise.
.
The FDA doesn't actually approve the crops or declare them safe.
.
That is Monsanto's job!
.
At the end of the consultation, the FDA issues a letter stating:
.
Based on the safety and nutritional assessment you have conducted, it is our understanding that Monsanto has concluded that corn products derived from this new variety are not materially different in composition, safety, and other relevant parameters from corn currently on the market, and that the genetically modified corn does not raise issues that would require premarket review or approval by FDA. . . .
.
As you are aware, it is Monsanto's responsibility to ensure that foods marketed by the firm are safe, wholesome and in compliance with all applicable legal and regulatory requirements.
.
The National Academy of Sciences and even the pro-GM Royal Society of London describe the US system as inadequate and flawed.
.
The editor of the prestigious journal Lancet said, It is astounding that the US Food and Drug Administration has not changed their stance on genetically modified food adopted in 1992. . . .
.
Governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health.
.
One obvious reason for the inflexibility of the FDA is that they are officially charged with both regulating biotech products and promoting them -- a clear conflict.
.
That is also why the FDA does not require mandatory labeling of GM foods.
.
They ignore the desires of 90 percent of American citizens in order to support the economic interests of Monsanto and the four other GM food companies.
.
Monsanto's studies are secret, inadequate, and flawed
.
The unpublished industry studies submitted to regulators are typically kept secret based on the claim that it is "confidential business information."
.
The Royal Society of Canada is one of many organizations that condemn this practice.
.
Their Expert Panel called for "completely transparent" submissions, "open to full review by scientific peers"
.
They wrote, "Peer review and independent corroboration of research findings are axioms of the scientific method, and part of the very meaning of the objectivity and neutrality of science"
.
Whenever Monsanto's private submissions are made public through lawsuits or Freedom of Information Act Requests, it becomes clear why they benefit from secrecy.
.
The quality of their research is often miserable, and would never stand up to peer-review.
.
In December 2009, for example, a team of independent researchers published a study analysing the raw data from three Monsanto rat studies.
.
When they used proper statistical methods, they found that the three varieties of GM corn caused toxicity in the liver and kidneys, as well as significant changes in other organs.
.
Monsanto's studies, of course, had claimed that the research showed no problems.
.
The regulators had believed Monsanto, and the corn is already in our food supply
.
Monsanto rigs research to miss dangers
.
Monsanto has plenty of experience cooking the books of their research and hiding the hazards.
.
They manufactured the infamous Agent Orange, for example, the cancer and birth-defect causing defoliant sprayed over Vietnam.
.
It contaminated more than three million civilians and servicemen.
.
But according to William Sanjour, who led the Toxic Waste Division of the Environmental Protection Agency, "thousands of veterans were disallowed benefits " because Monsanto studies showed that dioxin [the main ingredient in Agent Orange] was not a human carcinogen.
.
But his EPA colleague discovered that Monsanto had allegedly falsified the data in their studies. Sanjour says, "If they were done correctly, [the studies] would have reached just the opposite result."
.
Here are examples of tinkering with the truth about Monsanto's GM products:
.
When dairy farmers inject cows with genetically modified bovine growth hormone (rbGH), more bovine growth hormone ends up in the milk.
.
To allay fears, the FDA claimed that pasteurization destroys 90 percent of the hormone.
.
In reality, the researchers of this drug (then owned by Monsanto) pasteurized the milk 120 times longer than normal.
.
But they only destroyed 19 percent.
.
So they spiked the milk with a huge amount of extra growth hormone and then repeated the long pasteurization.
.
Only under these artificial conditions were they able to destroy 90 percent.
.
To demonstrate that rbGH injections didn't interfere with cows' fertility, Monsanto appears to have secretly added cows to their study that were pregnant before injection.
.
FDA Veterinarian Richard Burroughs said that Monsanto researchers dropped sick cows from studies, to make the drug appear safer.
.
Richard Burroughs ordered more tests on rbGH than the industry wanted and was told by superiors he was slowing down the approval.
.
He was fired and his tests canceled.
.
The remaining whistle-blowers in the FDA had to write an anonymous letter to Congress, complaining of fraud and conflict of interest in the agency.
.
They complained of one FDA scientist who arbitrarily increased the allowable levels of antibiotics in milk 100-fold, in order to facilitate the approval of rbGH.
.
She had just become the head of an FDA department that was evaluating the research that she had recently done while an employee of Monsanto.
.
Another former Monsanto scientist said that after company scientists conducted safety studies on bovine growth hormone, all three refused to drink any more milk, unless it was organic and therefore not treated with the drug.
.
They feared the substantial increase of insulin-like growth factor 1 (IGF-1) in the drugged milk. IGF-1 is a significant risk factor for cancer.
.
When independent researchers published a study in July 1999 showing that Monsanto's GM soy contains 12-14 percent less cancer-fighting phytoestrogens.
.
Monsanto responded with its own study, concluding that soy's phytoestrogen levels vary too much to even carry out a statistical analysis.
.
Researchers failed to disclose, however, that they had instructed the laboratory to use an obsolete method of detection -- one that had been prone to highly variable results.
.
To prove that GM protein breaks down quickly during simulated digestion, Monsanto uses thousands of times the amount of digestive enzymes and a much stronger acid than what the World Health Organization recommends.
.
Monsanto told government regulators that the GM protein produced in their high-lysine GM corn was safe for humans, because it is also found in soil.
.
They claimed that since people consume small residues of soil on fruits and vegetables, the protein has a safe history as part of the human diet.
.
The actual amount of the GM corn protein an average US citizen would consume, however, if all their corn were Monsanto's variety, would be "about 30 billion to four trillion times" the amount normally consumed in soil residues.
.
For equivalent exposure, people would have to eat as much as 22,000 pounds of soil every second of every day.
.
Monsanto's high-lysine corn also had unusual levels of several nutritional components, such as protein and fibre.
.
Instead of comparing it to normal corn, which would have revealed this significant disparity, Monsanto compared their GM corn to obscure corn varieties that were also far outside the normal range on precisely these values.
.
On this basis, Monsanto could claim that there were no statistically significant differences in their GM corn content.
.
Methods used by Monsanto to hide problems are varied and plentiful. For example, researchers:
.
Use animals with varied starting weights, to hinder the detection of food-related changes;
.
Keep feeding studies short, to miss long-term impacts;
.
Test Roundup Ready soybeans that have never been sprayed with Roundup -- as they always are in real world conditions;
.
Avoid feeding animals the GM crop, but instead give them a single dose of GM protein produced from GM bacteria.
.
Use too few subjects to obtain statistical significance;
.
Use poor or inappropriate statistical methods, or fail to even mention statistical methods, or include essential data; and
.
Employ insensitive detection techniques -- doomed to fail.
.
Monsanto's 1996Journal of Nutrition study, which was their cornerstone article for "proving" that GM soy was safe, provides plenty of examples of masterfully rigged methods.
.
Researchers tested GM soy on mature animals, not the more sensitive young ones.
.
GMO safety expert Arpad Pusztai says the older animals "would have to be emaciated or poisoned to show anything."
.
Organs were never weighed.
.
The GM soy was diluted up to 12 times which, according to an expert review, "would probably ensure that any possible undesirable GM effects did not occur."
.
The amount of protein in the feed was "artificially too high," which would mask negative impacts of the soy.
.
Samples were pooled from different locations and conditions, making it nearly impossible for compositional differences to be statistically significant.
.
Data from the only side-by-side comparison was removed from the study and never published.
.
When it was later recovered, it revealed that Monsanto's GM soy had significantly lower levels of important constituents (e.g. protein, a fatty acid, and phenylalanine, an essential amino acid) and that toasted GM soy meal had nearly twice the amount of a lectin -- which interferes with the body's ability to assimilate nutrients.
.
Moreover, the amount of trypsin inhibitor, a known soy allergen, was as much as seven times higher in cooked GM soy compared to a cooked non-GM control.
.
Monsanto named their study, "The composition of glyphosate-tolerant soybean seeds is equivalent to that of conventional soybeans."
.
A paper published in Nutrition and Health analysed all peer-reviewed feeding studies on GM foods as of 2003.
.
It came as no surprise that Monsanto's Journal of Nutrition study, along with the other four peer-reviewed animal feeding studies that were "performed more or less in collaboration with private companies," reported no negative effects of the GM diet.
.
On the other hand," they wrote, "adverse effects were reported (but not explained) in [the five] independent studies."
.
They added, "It is remarkable that these effects have all been observed after feeding for only 10 to 14 days.
.
A former Monsanto scientist recalls how colleagues were trying to rewrite a GM animal feeding study, to hide the ill-effects.
.
But sometimes when study results are unmistakably damaging, Monsanto just plain lies.
.
Monsanto's study on Roundup, for example, showed that 28 days after application, only 2 percent of their herbicide had broken down.
.
They nonetheless advertised the weed killer as "biodegradable," "leaves the soil clean," and "respects the environment"
.
These statements were declared false and illegal by judges in both the US and France.
.
The company was forced to remove "biodegradable" from the label and pay a fine.
.
Natural News
No comments:
Post a Comment