FLASHBACK: FDA approves GMO tomato despite studies showing it caused stomach lesions and death in rats
Friday, May 13, 2016 by: Julie Wilson staff writer
Tags: FDA approval, GMO tomato, Monsanto
(NaturalNews) The following excerpt is from the book Seeds of Deception: Exposing Industry and Government Lies About the Safety of the Genetically Engineered Foods You're Eating.
While the FDA was busily crafting their industry-friendly GMO policy in the early 1990s, Calgene [acquired by Monsanto in 1996] was preparing to introduce the world's first genetically modified food crop: the FlavrSavr Tomato. Gifted with mythical endurance, this GM wonder could remain looking fresh for weeks after being picked.
Although the FDA did not require it, Calgene voluntarily did three feeding studies with rats and sent the results to the FDA for its blessing. Internal FDA documents show that the agency scientists were concerned about the presence of stomach lesions. Among the female rats in one study, seven of the forty rats that ate the FlavrSavr had lesions; none were found in the controls that ate natural tomatoes.
FDA reviewers repeatedly asked Calgene to provide additional data in order to resolve what they regarded as outstanding safety questions. The director of the FDA's Office of Special Research Skills, wrote: ". . . the data fall short of 'a demonstration of safety' or of a 'demonstration of reasonable certainty of no harm' which is the standard we typically apply to food additives.
FlavrSavr Tomato was first ever GM crop to hit the market
To do that we would need, in my opinion, a study that resolves the safety question raised by the current data. The Additives Evaluation Branch agreed that "unresolved questions still remain," and the staff pathologist stated, "In the absence of adequate explanations by Calgene, the issues raised by the Pathology Branch . . . remain and leave doubts as to the validity of any scientific conclusion(s) which may be drawn from the studies' findings."Pusztai, who looked at the study years later, disagreed with the Calgene's conclusions that the lesions "were considered to be of no importance," since, he said, "in humans they could lead to life-endangering hemorrhage, particularly in the elderly who use aspirin to prevent thrombosis."
He was similarly amazed that no follow-up examination of the intestines was conducted to see if they were similarly affected. On top of this, Pusztai pointed out that there was no explanation provided as to why another seven of the forty GM-fed rats died within two weeks.
While one group of FDA scientists was assessing the FlavrSavr rat study, another group was asked to evaluate Calgene's proposed use of an Antibiotic Resistant Marker (ARM) gene.
As you may recall from Chapter 2, after the cells are inserted with foreign genes they are doused with antibiotics. If the cells survive, it means that the foreign gene made it into the cells' DNA. Calgene wanted to use an ARM gene that would cause its tomato cells to survive the antibiotic kanamycin.
'The tomatoes that will eat Akron'
On December 3, 1992, the Division of Anti-Infective Drug Products submitted to the FDA Biotechnology Coordinator their response to Calgene's proposal with the key sentence of their conclusion emphasized in all capital letters:"IT WOULD BE A SERIOUS HEALTH HAZARD TO INTRODUCE A GENE THAT CODES FOR ANTI-BIOTIC RESISTANCE INTO THE NORMAL FLORA OF THE GENERAL POPULATION."
No ambiguity there.
To further emphasize his concern, the division's director sent the document two weeks later to another FDA official with a cover letter entitled, "The tomatoes that will eat Akron."
He added, "You really need to read this consult. The Division comes down fairly squarely against the [kanamycin] gene marker in the genetically engineered tomatoes. I know this could have serious ramifications."
These FDA scientists were aware of the very serious threat posed by infections that resist antibiotics. According to the FDA website, such infections "increase risk of death, and are often associated with prolonged hospital stays, and sometimes complications. These might necessitate removing part of a ravaged lung, or replacing a damaged heart valve."
Antibiotic resistant infections
The number of sicknesses and deaths due to resistant infections continues to rise, due in part to the over prescription of antibiotics. According to BBC Online, "pessimistic experts believe it is only a matter of time at current rates until virtually every weapon in the pharmaceutical arsenal is nullified."No wonder the FDA division director referred to the FlavrSavr as "The tomatoes that will eat Akron." In spite of the concerns about antibiotic resistance and the unresolved questions about the feeding trial, the FDA approved the FlavrSavr tomato on May 18, 1994.
According to Druker, the FDA "claimed that all relevant safety issues had been satisfactorily resolved and said that because the FlavrSavr had performed so well, it would be unnecessary for any subsequent bioengineered food to be subjected to the same rigorous standard of testing. To date, there is no reliable evidence showing that any has successfully met the standard the FlavrSavr failed to meet."
Sources:
SeedsOfDeception.com
Science.NaturalNews.com
Smith, Jeffrey M. (2003) Seeds of Deception (Fairfield, IA)
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