Mathanzua
JF-Expert Member
- Jan 4, 2017
- 17,450
- 23,124
Developing countries depend on the US- FDA to certify whether GMOs,are safe for human use.But do you know that the FDA does not test whether GMOs,
Agrichemicals or Pharmaceuticals are safe for human use?
Please follow me to see what really happens in the Pharmaceutical and Agrichemical Industry.There is so much deception and collusion. This discussion will show you clearly that our lives are in danger with regards to Pharmaceuticals and Agri-chemicals and that something needs to be done and quickly!
In a recent testimony before Congress, the FDA stated that it is “confident that the The Genetically Engineered (GE) or modified(GM) foods in the U.S. market place today are as safe as their conventional counterparts!”
However, FDA does not itself test whether genetically engineered foods are safe. The FDA has repeatedly made this clear. As a policy analyst for FDA has explained, “It’s the manufacturer’s responsibility to insure that the product is safe.” Or, as FDA spokesperson, has said, “it is the manufacturer’s responsibility to ensure that the [GMO] food products it offers for sale are safe.
Nor does the FDA require independent pre-market safety testing for genetically engineered food. As a matter of practice, the agrichemical companies submit their own studies to the FDA as part of a voluntary “consultation.” Moreover, the FDA does not require the companies to submit full and complete information about these studies. Rather, as the FDA has testified, “After the studies are completed, a summary of the data and information on the safety and nutritional assessment are provided to the FDA for review.”
That the FDA does not see the complete data and studies is a problem, according to a Biotechnology and Genetic Engineering Reviews article.
The FDA never sees the methodological details, but rather only limited data and the conclusions the company has drawn from its own research,the FDA does not require the submission of data. And, in fact, companies have failed to comply with FDA requests for data beyond that which they submitted initially. Without test protocols or other important data, the FDA is unable to identify unintentional mistakes, errors in data interpretation, or intentional deception.
At the end of the consultation, the FDA issues a letter ending the consultation. Here is a typical response from FDA, in its letter to Monsanto about its MON 810 Bt corn:
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[emphasis mine], and in compliance with all applicable legal and regulatory requirements.
This testing regime is insufficient for several other reasons.
Most of the animal safety testing prepared for the FDA is merely short-term. A study in the International Journal of Biological Sciences summarizes the typical testing regime: “The most detailed regulatory tests on the GMOs are three-month long feeding trials of laboratory rats, which are biochemically assessed.” Such tests may well be too brief in duration to uncover pathologies that develop more slowly, such as many types of organ damage, endocrine disturbances and cancer.
There are too few peer-reviewed studies on the health risks of genetically engineered food. In their 2004 article in Biotechnology and Genetic Engineering Reviews,it is stated that, “Published, peer-reviewed studies, particularly in the area of potential human health impacts, are rare. For instance, the EPA’s human health assessment of Bt crops cites 22 unpublished corporate studies, with initially only one ancillary literature citation.” Similarly, a 2014 review in Environment International of 21 studies of the effects of genetically engineered foods on the digestive tracts of rats found an “incomplete picture” regarding “the toxicity (and safety) of GM products consumed by humans and animals.” In other words, it concludes that there is not enough evidence to say that genetically engineered foods are safe to eat.
The FDA permits companies to submit their own safety studies, but does not require independent ones. However, the evidence regarding pharmaceutical studies strongly suggests that industry-funded studies are more likely than independent ones to be favorable to industry. Here’s Ben Goldacre’s review of this evidence:
In 2010, three researchers from Harvard and Toronto Universities found all the trials looking at five major classes of drugs:antidepressants, ulcer drugs and so on,then measured two key features: were they positive, and were they funded by industry? They found over five hundred trials in total: 85 per cent of the industry-funded studies were positive, but only 50 per cent of the government funded trials were. That’s a very significant difference.
In 2007, researchers looked at every published trial that set out to explore the benefit of a StatinThis study found 192 trials in total, either comparing Statin one against another, or comparing a Statin against a different kind of treatment. Once the researchers controlled for other factors,they found that industry funded trials were twenty times more likely to give results favoring the test drug. Again, that’s a very big difference.
We’ll do one more. In 2006, researchers looked into every trial of psychiatric drugs in four academic journals over a ten-year period, finding 542 trial outcomes in total. Industry sponsors got favorable outcomes for their own drug 78 per cent of the time, while independently funded trials only gave a positive result in 48 per cent of cases.
These results present a compelling argument for FDA to require independent pre-market safety testing for genetically engineered food, but the FDA fails to do so.
Perhaps more importantly, the agrichemical industry is under no obligation to report the results of all their studies. How do we know that they are not suppressing evidence of health risks of genetically engineered food? It is well-known that in other industries “publication bias” and the suppression of studies is common place. That is certainly true in the pharmaceutical industry. Here, for example, is Ben Goldacre’s description of missing evidence in trials on antidepressants:
researchers found seventy-four studies in total, representing 12,500 patients’ worth of data. Thirty-eight of these trials had positive results, and found that the new drug worked; thirty-six were negative. The results were therefore an even split between success and failure for the drugs, in reality. Then the researchers set about looking for these trials in the published academic literature, the material available to doctors and patients. This provided a very different picture. Thirty-seven of the positive trials,all but one,were published in full, often with much fanfare. But the trials with negative results had a very different fate: only three were published. Twenty-two were simply lost to history, never appearing anywhere other than in those dusty, disorganized, thin FDA files. The remaining eleven which had negative results in the FDA summaries did appear in the academic literature, but were written up as if the drug was a success!
This was a remarkable piece of work, spread over twelve drugs from all the major manufacturers, with no stand-out bad guy. It very clearly exposed a broken system: in reality we have thirty-eight positive trials and thirty seven negative ones; in the academic literature we have forty-eight positive trials and three negative ones.
Why shouldn’t we expect the agrichemical industry to follow the pharmaceutical industry’s pattern of suppressing negative results? This question seems especially relevant, given the agrichemical industry’s history of suppressing evidence of health risks of their other products and operations. It makes no sense for the FDA to trust an industry with such a record.
It is also worth remembering that in the U.S. there is a history of fraud in toxicological testing. As Dan Fagin and Marianne Lavelle explain in their book "Toxic Deception, “The U.S. regulatory system for chemical products is tailor-made for fraud. The subjects are arcane, the results subjective, the regulators overmatched, and the real work conducted by or for the manufacturers themselves.”
Regarding Monsanto’s role in such frauds, they write that:
Paul Wright had been a research chemist at Monsanto before he went to work for IBT [then the nation’s largest toxicology lab] in 1971 as its chief rat toxicologist. Wright stayed at the lab for only 18 months before he returned to Monsanto.But it was long enough, the [federal] government investigators concluded, for him to be in the middle of a series of apparently fraudulent studies that benefitted Monsanto products.In all three cases [regarding n herbicide and a chlorinator], the [federal government] investigators wrote in an internal memo, there was evidence that Monsanto executives knew that the studies were faked but sent them to the FDA and the EPA anyway.
Finally, how can we assess the health risks of genetically engineered foods that are currently on the market or at WEMA? At this time, we can’t. The TBS or TFDA does not require any post-market studies of health risks of genetically engineered food. As a 2010 study in the International Journal of Biological Sciences points out, “although some stakeholders claim that a history of safe use of GMOs can be upheld, mammalian studies are already available which show that GMOs are harmful.Substantive evidence could be difficult to find in the absensce of intensive and conclusive human or animal epidemiological studies to support such a claim as yet, in particular because of the lack of labeling and traceability in GMO producing countries.” Infact Monsanto tries as much as possible to do just that,because they know the risks involved.It the present circumstances,it would be unwise to accept GMO companies to make us guinea pigs.
Perhaps not coincidentally, there is a similar problem with testing of the harmful effects pesticide,fertilizers on crops, fruits and vegetables eaten by Tanzanians.
A November 2014 report by the U.S. Government Accountability Office found that the FDA only tests the pesticide levels of less than one per thousand imported fruits and vegetables, and one per hundred of those grown domestically. I doubt if the TBS and TFDA even does that.
Agrichemicals or Pharmaceuticals are safe for human use?
Please follow me to see what really happens in the Pharmaceutical and Agrichemical Industry.There is so much deception and collusion. This discussion will show you clearly that our lives are in danger with regards to Pharmaceuticals and Agri-chemicals and that something needs to be done and quickly!
In a recent testimony before Congress, the FDA stated that it is “confident that the The Genetically Engineered (GE) or modified(GM) foods in the U.S. market place today are as safe as their conventional counterparts!”
However, FDA does not itself test whether genetically engineered foods are safe. The FDA has repeatedly made this clear. As a policy analyst for FDA has explained, “It’s the manufacturer’s responsibility to insure that the product is safe.” Or, as FDA spokesperson, has said, “it is the manufacturer’s responsibility to ensure that the [GMO] food products it offers for sale are safe.
Nor does the FDA require independent pre-market safety testing for genetically engineered food. As a matter of practice, the agrichemical companies submit their own studies to the FDA as part of a voluntary “consultation.” Moreover, the FDA does not require the companies to submit full and complete information about these studies. Rather, as the FDA has testified, “After the studies are completed, a summary of the data and information on the safety and nutritional assessment are provided to the FDA for review.”
That the FDA does not see the complete data and studies is a problem, according to a Biotechnology and Genetic Engineering Reviews article.
The FDA never sees the methodological details, but rather only limited data and the conclusions the company has drawn from its own research,the FDA does not require the submission of data. And, in fact, companies have failed to comply with FDA requests for data beyond that which they submitted initially. Without test protocols or other important data, the FDA is unable to identify unintentional mistakes, errors in data interpretation, or intentional deception.
At the end of the consultation, the FDA issues a letter ending the consultation. Here is a typical response from FDA, in its letter to Monsanto about its MON 810 Bt corn:
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[emphasis mine], and in compliance with all applicable legal and regulatory requirements.
This testing regime is insufficient for several other reasons.
Most of the animal safety testing prepared for the FDA is merely short-term. A study in the International Journal of Biological Sciences summarizes the typical testing regime: “The most detailed regulatory tests on the GMOs are three-month long feeding trials of laboratory rats, which are biochemically assessed.” Such tests may well be too brief in duration to uncover pathologies that develop more slowly, such as many types of organ damage, endocrine disturbances and cancer.
There are too few peer-reviewed studies on the health risks of genetically engineered food. In their 2004 article in Biotechnology and Genetic Engineering Reviews,it is stated that, “Published, peer-reviewed studies, particularly in the area of potential human health impacts, are rare. For instance, the EPA’s human health assessment of Bt crops cites 22 unpublished corporate studies, with initially only one ancillary literature citation.” Similarly, a 2014 review in Environment International of 21 studies of the effects of genetically engineered foods on the digestive tracts of rats found an “incomplete picture” regarding “the toxicity (and safety) of GM products consumed by humans and animals.” In other words, it concludes that there is not enough evidence to say that genetically engineered foods are safe to eat.
The FDA permits companies to submit their own safety studies, but does not require independent ones. However, the evidence regarding pharmaceutical studies strongly suggests that industry-funded studies are more likely than independent ones to be favorable to industry. Here’s Ben Goldacre’s review of this evidence:
In 2010, three researchers from Harvard and Toronto Universities found all the trials looking at five major classes of drugs:antidepressants, ulcer drugs and so on,then measured two key features: were they positive, and were they funded by industry? They found over five hundred trials in total: 85 per cent of the industry-funded studies were positive, but only 50 per cent of the government funded trials were. That’s a very significant difference.
In 2007, researchers looked at every published trial that set out to explore the benefit of a StatinThis study found 192 trials in total, either comparing Statin one against another, or comparing a Statin against a different kind of treatment. Once the researchers controlled for other factors,they found that industry funded trials were twenty times more likely to give results favoring the test drug. Again, that’s a very big difference.
We’ll do one more. In 2006, researchers looked into every trial of psychiatric drugs in four academic journals over a ten-year period, finding 542 trial outcomes in total. Industry sponsors got favorable outcomes for their own drug 78 per cent of the time, while independently funded trials only gave a positive result in 48 per cent of cases.
These results present a compelling argument for FDA to require independent pre-market safety testing for genetically engineered food, but the FDA fails to do so.
Perhaps more importantly, the agrichemical industry is under no obligation to report the results of all their studies. How do we know that they are not suppressing evidence of health risks of genetically engineered food? It is well-known that in other industries “publication bias” and the suppression of studies is common place. That is certainly true in the pharmaceutical industry. Here, for example, is Ben Goldacre’s description of missing evidence in trials on antidepressants:
researchers found seventy-four studies in total, representing 12,500 patients’ worth of data. Thirty-eight of these trials had positive results, and found that the new drug worked; thirty-six were negative. The results were therefore an even split between success and failure for the drugs, in reality. Then the researchers set about looking for these trials in the published academic literature, the material available to doctors and patients. This provided a very different picture. Thirty-seven of the positive trials,all but one,were published in full, often with much fanfare. But the trials with negative results had a very different fate: only three were published. Twenty-two were simply lost to history, never appearing anywhere other than in those dusty, disorganized, thin FDA files. The remaining eleven which had negative results in the FDA summaries did appear in the academic literature, but were written up as if the drug was a success!
This was a remarkable piece of work, spread over twelve drugs from all the major manufacturers, with no stand-out bad guy. It very clearly exposed a broken system: in reality we have thirty-eight positive trials and thirty seven negative ones; in the academic literature we have forty-eight positive trials and three negative ones.
Why shouldn’t we expect the agrichemical industry to follow the pharmaceutical industry’s pattern of suppressing negative results? This question seems especially relevant, given the agrichemical industry’s history of suppressing evidence of health risks of their other products and operations. It makes no sense for the FDA to trust an industry with such a record.
It is also worth remembering that in the U.S. there is a history of fraud in toxicological testing. As Dan Fagin and Marianne Lavelle explain in their book "Toxic Deception, “The U.S. regulatory system for chemical products is tailor-made for fraud. The subjects are arcane, the results subjective, the regulators overmatched, and the real work conducted by or for the manufacturers themselves.”
Regarding Monsanto’s role in such frauds, they write that:
Paul Wright had been a research chemist at Monsanto before he went to work for IBT [then the nation’s largest toxicology lab] in 1971 as its chief rat toxicologist. Wright stayed at the lab for only 18 months before he returned to Monsanto.But it was long enough, the [federal] government investigators concluded, for him to be in the middle of a series of apparently fraudulent studies that benefitted Monsanto products.In all three cases [regarding n herbicide and a chlorinator], the [federal government] investigators wrote in an internal memo, there was evidence that Monsanto executives knew that the studies were faked but sent them to the FDA and the EPA anyway.
Finally, how can we assess the health risks of genetically engineered foods that are currently on the market or at WEMA? At this time, we can’t. The TBS or TFDA does not require any post-market studies of health risks of genetically engineered food. As a 2010 study in the International Journal of Biological Sciences points out, “although some stakeholders claim that a history of safe use of GMOs can be upheld, mammalian studies are already available which show that GMOs are harmful.Substantive evidence could be difficult to find in the absensce of intensive and conclusive human or animal epidemiological studies to support such a claim as yet, in particular because of the lack of labeling and traceability in GMO producing countries.” Infact Monsanto tries as much as possible to do just that,because they know the risks involved.It the present circumstances,it would be unwise to accept GMO companies to make us guinea pigs.
Perhaps not coincidentally, there is a similar problem with testing of the harmful effects pesticide,fertilizers on crops, fruits and vegetables eaten by Tanzanians.
A November 2014 report by the U.S. Government Accountability Office found that the FDA only tests the pesticide levels of less than one per thousand imported fruits and vegetables, and one per hundred of those grown domestically. I doubt if the TBS and TFDA even does that.
