by Colin Todhunter

May 22, 2015
from GlobalResearch Website


In a challenge delivered to Monsanto's headquarters on May 20, 2015, U.S. public interest attorney Steven Druker calls on that corporation to find any inaccurate statements of fact in his new book:



The thoroughly documented and referenced book exposes the substantial risks of genetically engineered foods and the multiple misrepresentations that have enabled them to permeate world markets.

Druker asserts that if Monsanto cannot prove that his book is essentially erroneous, the world will have a right to regard these controversial foods as unacceptably risky - and to promptly ban them.

'Altered Genes - Twisted Truth' was released in March 2015 and is the result of more than 15 years of intensive research and investigation by Druker, who initiated a lawsuit against the U.S. Food and Drug Administration (FDA) that forced it to divulge its files on GM foods.

The book indicates that the commercialization of GM food in the U.S. was based on a massive fraud.


The FDA files revealed that GM foods first achieved commercialization in 1992 but only because the FDA covered up the extensive warnings of its own scientists about their dangers, lied about the facts and then violated federal food safety law by permitting these foods to be marketed without having been proven safe through standard testing.

If the FDA had heeded its own experts' advice and publicly acknowledged their warnings that GM foods entailed higher risks than their conventional counterparts, Druker says that the GM food venture would have imploded and never gained traction anywhere.

He also argues that that many well-placed scientists have repeatedly issued misleading statements about GM foods, and so have leading scientific institutions such as,

  • the U.S. National Academy of Sciences

  • the American Association for the Advancement of Science

  • the UK's Royal Society

Druker states that contrary to the claims of biotech advocates, humans have indeed been harmed by consuming the output of genetic engineering.


He also explains that laboratory animals have also suffered from eating products of genetic engineering, and well-conducted tests with GM crops have yielded many troubling results, including intestinal abnormalities, liver disturbances, and impaired immune systems.

Druker says:

"Contrary to the assertions of its proponents, the massive enterprise to reconfigure the genetic core of the world's food supply is not based on sound science but on the systematic subversion of science - and it would collapse if subjected to an open airing of the facts."

Now, in his open letter 'Challenge to Monsanto' dated 19 May, Druker challenges Monsanto's Chief Technology Officer to "Face Up to the Extensive Evidence Demonstrating that Genetically Engineered Foods Entail Unacceptable Risks and Should Be Promptly Removed from the Market."


Druker finishes his letter by saying:

"If by July 20th you and your allies have not been able to refute the essential factual accuracy of Altered Genes, Twisted Truth according to the terms set forth above, the world will have a right to assume that it is as sound as the experts who reviewed it have affirmed - and to conclude that GE foods are unacceptably risky and must be banned."













Altered Genes, Twisted Truth

-   How GMOs Took Over the Food Supply   -
by Joseph M. Mercola
March 2015

from Mercola Website






Part 1
March 08, 2015


Genetically manipulated foods may be one of the most serious threats not only to our environment but to the health and very survival of future generations. Typically, the blame for the promulgation of genetic engineering of our food is placed on chemical companies.

But there's actually a hidden back story to how genetically engineered foods were able to reach millions of dinner tables.

Steven Druker, who you may not be aware of, is the attorney who filed a lawsuit in the late '90s challenging the most important action the U.S. Food and Drug Administration (FDA) has taken in this area: its presumption that genetically engineered (GE) foods are Generally Recognized as Safe (GRAS) and can enter the market without a shred of safety testing.

However, the evidence clearly reveals that the FDA's GRAS presumption was fraudulent when first announced in 1992 and that it remains fraudulent today.


Nonetheless, it has played the central role in allowing inadequately tested GE foods to permeate the American market. There are many components to this story, and Steven is just the man to set the story straight.

He's written a landmark and historic book Altered Genes - Twisted Truth, with the revealing subtitle: How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public.

If you have even the remotest interest in this topic, I would strongly encourage you to get a copy of this book. It is, without a doubt, the best book on the topic and provides a treasure trove of facts that will help you decimate anyone who believes that GMOs are "safe."

Steven was aware of this issue 10 years before I was, and he's really a pioneer and a champion in warning the public and protecting us from the negligence and irresponsible action of the U.S. Food and Drug Administration (FDA).



Genetically Engineered Food Blindsided Everyone

Most people are only superficially aware - if at all - of the background that led up to the FDA's landmark policy statement of 1992 that granted genetically engineered foods GRAS status.

I myself was unaware of the academic and scientific discussion that was going on some 15 to 20 years prior to the historic and crucial FDA 1992 action that made the commercialization of GE foods possible.

Steven's book goes into that in great depth, and provides an accurate historical record of the irresponsible behavior of many eminent scientists and scientific institutions in the earlier decades of the genetic engineering revolution, long before Monsanto's lackey Michael Taylor and the hordes of revolving door cronies came into the picture.

"It was probably not until about late '94 or '95 that I became aware of genetic engineering, and that it was being used by that point to reconfigure the genetic core of many of our foods.

The goal is, ultimately, to reconfigure the genetic core of almost every edible fruit, vegetable, and grain. That's the grand vision.

I became very concerned as I learned about this. I've had a long-term interest in eating healthy nutritious food myself, and in protecting the purity of the food. I was involved back in the late 1980s in the campaign to better regulate food irradiation.

But I too was behind the curve on understanding what was going on with genetically engineered foods, which I think puts things in perspective. So you can see why people still, up to a few years ago, didn't even know that they had been eating genetically engineered food for all these years, and feeding them unknowingly to their kids. It really has blindsided many of us."


Blatant Misrepresentation of U.S. Food Law

Steven began researching the matter around 1996, and quickly realized that there is a great gap - both then and now - between the claims made by the proponents of GE foods and the actual facts.

One major concern was the fact that while the U.S. had the strictest and the most rigorous food safety laws in the world in regard to new additives, the FDA had not enforced those laws when it comes to GMOs. Instead, the FDA gave GE foods a free ticket to circumvent the law.

In May 1992, the FDA made a blanket presumption that GE foods qualified to be categorized "Generally Recognized as Safe" (GRAS). They then said that this meant these foods could be marketed without any safety testing at all.

"That actually is a blatant misrepresentation of U.S. food law, but that was the FDA claim," Steven says.


"[They claim] there's an overwhelming 'scientific consensus' they're safe, and so safe that they don't need to be tested. Therefore, the FDA let these foods into our market without the requirement of a smidgen of testing.

Moreover, they didn't even require these foods be labeled, so the consumers at least would be informed about the major genetic reconfiguration that had occurred. This struck me as not only being unscientific but irresponsible and unethical. At the time, I had a hunch it was also illegal."

As he continued researching the matter, that hunch was confirmed.


Not only is the policy governing GMOs at odds with the science, it violates U.S. law. At first, Steven did not think he was sufficiently qualified to launch a lawsuit to contest the FDA's ruling.


But as time went on, it became clear that no one else was willing to stick their neck out to do it.



FDA Scientists Warned of Grave Risks

Steven decided to launch a lawsuit on his own, and founded a non-profit organization called the Alliance for Bio-Integrity.


Fortunately, as word got around, he was contacted by a public interest group in Washington D.C., the International Center for Technology Assessment (ICTA).

"They had a very good legal team and they were very interested in taking this on," he says.


"The lawsuit was filed in May 1998, and it quickly accomplished something very major... It forced the FDA, through the discovery process, to hand over more than 44,000 pages of its internal files relevant to the policy that it made on genetically engineered foods."

It turned out to be a real treasure trove of hidden "gems" the FDA had undoubtedly hoped would remain hidden for all time.


For starters, there were damning memos from FDA scientists assigned to the biotechnology task force, whose job it was to actually analyze and assess genetically engineered foods in terms of both the law and the science, and to do a risk assessment.

"This is probably one of the first scientific risk assessments performed by independent scientists," he notes.


"The memos that I was reading were astounding, because... they recognized that there were unusual risks in these foods. I already knew that genetic engineering had the potential to create unexpected and unpredictable new toxins and allergens in these foods.

These toxins would be very difficult to detect unless each food was subjected to very rigorous long-term toxicological testing, the likes of which the biotech industry has routinely avoided performing and has been given a pass on by various governments.


The surprising thing was not just that they understood these risks, but that they were warning about them in no uncertain terms to their superiors."


FDA Supports Biotechnology Industry as Matter of Policy

According to the FDA's own admission, the agency has been operating for years under a policy to promote the U.S. biotechnology industry.


They decided it was more important to promote the industry and uphold the fragile image of GE foods rather than tell the truth and acknowledge the scientist warnings. So they covered up these warnings.


Had Steven not sued, the warnings of the FDA's own scientists still would be unknown to this day.

"We wouldn't know the extent to which the FDA has been lying all these years. But fortunately, we do know now," he says.


"And what we know is that although the FDA scientists overwhelmingly concluded and warned their superiors that these foods entail unique risks, that they cannot be presumed safe, and that each one of them should be subjected to long-term rigorous toxicological testing, what the public heard from the FDA was that,

'The agency is not aware of any information showing that foods developed by these methods differ from other foods in any meaningful or uniform way.'

Now, it's impossible, I think, for any rational man or woman to read just the sampling of memos from the FDA scientists that are posted on the website of the Alliance for Bio-Integrity... and feel that the FDA's assertion is anything other than a blatant fraud meant to mislead the public, mislead the world, and allow genetically engineered food a free pass to enter the market. It's just an astounding fraud."

For close to 20 years, the American public has been exposed to these largely experimental, untested foods, which its own scientists said entail unique risks and could not be presumed safe.


The FDA claimed GMO's could be presumed safe, and that there was an overwhelming scientific consensus backing up their decision, yet the evidence shows that is a bold-faced lie. One document (document #8), is a letter from the FDA's biotechnology coordinator to an official of Health Canada, written in the fall of 1991, just six months before the FDA's ruling on GE foods.

Dr. James Maryanski's letter acknowledges that there is no consensus about the safety of these foods within the scientific community.


That admission is in the FDA's own files.

"Even if we didn't have the memos from the scientists, we would have that admission, and yet, what happened? The FDA basically just buries that and lies about it all," Steven says.

What's worse, because the FDA is so widely respected, and because the U.S. - which is known to have strong food safety laws - said GMO's were GRAS, it paved the way for easy approval in Canada as well.


Europe also relaxed their stance on GMO's as a result of the FDA's lie.



How and Why the Scientific Discussion Was Shifted from Cautious to Confident in Favor of GMO's Safety

Steven delved into the early history of genetic engineering that took place long before the technology was capable of producing a genetically engineered plant that could be eaten.


It took a long time from developing genetically engineered bacteria before scientists could actually genetically engineer any viable edible crops.

Genetic engineering first became a reality back in the early 1970s, and at the time, it was a radical breakthrough. According to Nobel-laureate biologist George Wald, it was the biggest and most radical human intervention into the natural order that had ever occurred.


Even the scientists who were doing it were mindful of how radical it was and how important it was to be careful. Initially, the scientists themselves warned of the dangers of this new technology and how it had to be used with extreme prudence and caution.

"But they then realized there was negative feedback from the public...


So over time they began to change their story. It became clear that they had to project a united front of confidence about this [technology]. What we began to see was a progressive misrepresentation campaign... to convince the public and the government that genetic engineering is something that is essentially not very different from processes that have been occurring in nature all along anyway...


They got away with that."

The scientific establishment mounted a huge lobbying campaign in the summer of 1977, orchestrated to convince the congressmen in Washington that there was no need for legislation.


At that time, several bills to regulate genetic engineering had already been introduced in Congress. This concerted effort also relied on misinformation, which Steven details in his book, including making claims of having evidence that in reality did not exist.



Shifting the Burden of Proof

These lobbying efforts were not backed by the biotechnology industry, mind you.


There was no biotechnology industry at that time. This is a key theme of Steven's book, because it's easy to forget that there was a time before the biotechnology industry, and very few know who the leaders of the genetic engineering establishment were, or why the technology was invented in the first place.


As much as most of us despise Monsanto for their reprehensible behavior, they could never have implemented their strategy if it weren't for the prior misbehavior of the molecular biologists.

"The biotechnology industry - as irresponsible as they have been by and large - the main guilt lays at the feet of the mainstream molecular biology establishment; the scientists who were doing the research, getting the grants, and wanting to develop this technology. Most of them had altruistic goals.


They thought this was going to be used to cure so many ills in the field of medicine... I think they eventually developed an 'end justifies the means' psychology...

But when you have so many highly influential, powerful scientists who are working together to convince the world that genetic engineering is inherently safe, and that the research they're pursuing is safe, that can be somewhat dangerous.


And it turned out being very dangerous for the world, I think.

One of the points made in the book very clearly, is that the burden of proof that was placed on new technologies and new products, which ordinarily requires the developer to substantiate the safety of the new technology and its products, got shifted.


It got shifted because of the subterfuge and the fraud, and it was put on the shoulders of the critics, the people who had concerns.


There were many good scientists who had concerns, but they were all of a sudden put into the position of, You've got to prove they're dangerous," and the burden of proving safety was removed."


Molecular Biologists Pushed for Genetic Engineering Without Safeguards

The forerunners of the biotechnology industry were the molecular biology establishment.


James Watson, the co-discoverer of the DNA structure, was a member of that establishment and, for obvious reasons, one of the big proponents of genetic engineering. He was one of the scientists who became very vocal, claiming that genetic engineering was safe and that earlier concerns had been exaggerated.


And the molecular biologists who were strongly in favor of pushing ahead with genetic engineering without adequate safeguards wielded a great amount of power within the National Academy of Sciences (NAS), which is one of the premier scientific organizations in the U.S..

"My book goes into the behind-the-scene story showing that the National Academy of Sciences - because their agenda was so strongly influenced by powerful molecular biologists - were afraid of allowing a full and fair review of the possible ecological problems of releasing genetically engineered organisms," Steven says.

In contrast, one of the scientists who strove to uphold the integrity of science was Dr. Philip Regal, an eminent white hat biologist, who became the point man for attempting to get the genetic engineering venture aligned with sound science during the first 15 to 20 years of its existence.


He was also a great resource for Steven's book, giving him the set of personal recollections he had written that described what he had experienced in pursuing this endeavor.

"It was a gold mine.


It allowed me to interweave his fascinating story with the story I was telling and make it a much more exciting and compelling narrative. He made a major contribution... Not too many people know about him yet.


Hopefully through my book, he will get all of the respect and gratitude from the public and the world that he deserves."




Fraudulent Groundwork Set the Framework for Massive GMO Fraud

Dr. Regal and some of his collaborators managed to put together two major conferences, and were shocked to learn just how many high-risk projects the genetic engineers had in the pipeline, slated for imminent release.


Many of these high-risk projects were stopped because of Dr. Regal's efforts.


Still, his voice was eventually outweighed by all the others, which resulted in the technological elite we're dealing with today.

"The media tended to present all of the statements about how good these foods were and how safe they were in the mouths of the scientific experts.


Anytime concerns were raised, they would put that in the mouth of non-scientists; activists who were presented as not knowing very much about science but were just concerned."

That same tactic is used today, to great effect. Rarely if ever does a concerned scientist get any kind of airtime in the conventional media.


Scientists are also crippled by the threat of losing grant money, or their career.

"It's really kind of the comedy of the absurd.


The elite who had the power and ability to manipulate the press prevailed. They were successful in promulgating the impression that there were no real problems with genetic engineering; that there was an overwhelming scientific consensus this was so; and that regulation wasn't really needed.


They imparted the impression that they could be trusted - that they were regulating it very well and regulation was unnecessary. They essentially kept regulation at a bare minimum."


The Spin-Doctors of the '70s

It's important to understand this, because the fact that regulations on genetic engineering were kept to a bare minimum from the very start is the foundation that set up the framework for the FDA's 1992 ruling.


If safety regulations for the industry had been stricter, it's unlikely that they would have been able to pull it off.

"If that fraudulent groundwork hadn't been laid by the mainstream scientific establishment, especially the molecular biology establishment, the FDA could not have done what it did.


It wouldn't have had the aura of scientific respectability, nor could Monsanto and the biotech industry have later been able to do what they've done."

The primary blame, the primary guilt goes back to the early 1970s, to the molecular biologists who were, little by little, fudging things, fudging facts, and spin-doctoring.


As my book says, eventually, spin-doctoring will cross the line to downright misrepresentation...


As Dr. Philip Regal mentioned:

"Within the scientific community, gossip became as good as truth; as good as fact."

And people just parroted what they heard other people saying.



Major GMO Disaster Used as Leverage to Attack Natural Supplements

While there's no proof that a whole food developed through GE has killed anyone after just a few meals, we do know that a genetically engineered food supplement was acutely toxic - and did take lives.


In the 1980's, a supplement of the essential amino acid L-tryptophan, which was produced through genetic engineering, was the first major GMO catastrophe, killing dozens of people who took it. Thousands were seriously sickened, many of whom were permanently disabled.


The novel disorder that afflicted these unfortunate people was named eosinophilia-myalgia syndrome (EMS). I was witness to this outbreak while I was a practicing physician.

In the 1980s, I used to prescribe L-tryptophan for my patients as a sleeping aid and for the treatment of depression. So did numerous other doctors. However, the supplements we prescribed were manufactured conventionally.


But when one of the manufacturers started to use genetic engineering, a deadly epidemic ensued and the FDA took all the brands of L-tryptophan off the market.


Thus, the agency used this disaster as a tool and leverage to attack natural supplements with a pristine safety record.


Prior to the release of the GE version of L-tryptophan, that supplement had never created a problem in anyone.

"The scientific evidence is very clear: tryptophan supplements were not a problem.


To our knowledge, the only tryptophan supplement that ever created a problem was the one that was created through genetically engineered bacteria.


As my book demonstrates, when one gathers all of the evidence that we have and puts it all together, then the finger gets pointed pretty strongly at the genetic engineering technology itself as having been the cause for the toxic contamination that caused the major epidemic in 1989 and 1990."

People died because they consumed a product of genetic engineering.


And it's important to understand how this tragic event was spun to serve the industry's agenda even further. Rather than raise questions about genetic engineering of supplements, the tragedy was used to raise questions about the safety of natural supplements.


Undoubtedly, a lethal mishap like this is bound to occur again, and when it does, the industry will use the L-tryptophan incident as a template for how to address and divert attention again, seeing how it worked so well the first time.

"If we don't get the knowledge out there, they will be able to continue the same game plan. It's very important to get the truth out there, so that it cannot continue into the future and so that changes are made. Dramatic changes have to be made."


The GMO Supplement That Killed Dozens and Injured Thousands

How was L-tryptophan re-engineered?


In the mid-1980s, one of the main developers of L-tryptophan supplements, Showa Denko Corporation in Japan, decided they could turn out more L-tryptophan in the same amount of time if they endowed the bacteria they were using with extra genes.


The bacteria naturally have the genetic components to synthesize L-tryptophan. By giving the bacteria an extra copy of those genes, they reasoned that more L-tryptophan would be produced more quickly.

Alas, they discovered that in order to achieve maximum production rates, they also had to boost one of those genes with a promoter from a virus. This created a very unnatural situation.


As Steven notes,

"They were messing around in very radical, unprecedented ways with the metabolism of bacteria that have been safely used for many, many years."

There were early reports of the supplement giving people trouble, and as production was increased, the product appears to have become increasingly toxic.

"The final version [of this genetically engineered bacteria], which was the most souped-up of them all and the most disruptive to their metabolism, cranked out not only a lot of L-tryptophan but some unusual contaminants.


The profile of that toxic tryptophan was highly unusual. It contained many more contaminants than most products do. They were very low level though. It was still pure according to pharmacological standards. It tested pure.


Generally, most chemicals are not dangerous at that extremely low concentration, but at least one of those [contaminants] was, and it created a major epidemic.

Now, one of the points, which is very sobering, is that this epidemic... was only determined because the symptoms were highly unusual and unique...


It was fortuitous in a sense that it was such a strange disease, otherwise, it would not have been even recognized, and those tryptophan supplements would still be marketed and still be killing and maiming people.


It's a very important thing to know."


'Disappearing a GMO Disaster'

Powerful, persistent, and successful misinformation was dispensed to disassociate genetic engineering from the toxic contamination of this L-tryptophan supplement.


Consequently, most people - including many scientists - do not know that this lethal epidemic was caused by a genetically engineered food supplement.

According to Steven, claims that the toxic contamination was caused by some defect in the manufacturing process, independent of genetic engineering, simply are not true.


In his book, Steven details the scientific evidence that strongly suggests the toxin was most likely produced by bacterial enzymes, probably within the bacteria themselves, or in the broth before it was put through the purification system, which would place the blame squarely on the genetic tampering itself; not on some flawed manufacturing process.

"It's just so gross that you will hear from both governments around the world who are promoting this and from scientists a claim that no genetic engineered food has ever been associated with a human health problem.


One government official has stated that not so much as a sneeze or a sniffle has ever been associated with the product of genetic engineering.


What? There was a major epidemic!"


GMOs Infiltrate Agriculture

In the early 1980s, some large corporations started to become interested in the potential applications of genetic engineering to agriculture.


Remember, if that preliminary groundwork by the molecular biologists (discussed earlier) had not been laid and the burden of proof had not already been shifted, Monsanto, Dow, and others would not have gone ahead to invest in genetically engineered seeds as they would have never been able to get these dangerous products presumed to be GRAS by the FDA.

But the groundwork was laid and the path forward was opened wide.


That's why it's so important to understand that early history. Then, enter Michael Taylor, a partner at a major Washington, D.C. law firm that represented Monsanto.


After serving as Monsanto's legal counsel, Taylor was then installed as Deputy Commissioner on Food Policy at the FDA - a position that didn't even exist before Taylor got the job.

"It was because, I think, as I looked through the records, there were FDA scientists who were objecting to the drafts of the policy statement, saying,

'Wait, what's happening to all the scientific elements in this?' ...

I believe, this is my belief, that Michael Taylor was brought in at that critical junction to start getting things moving in the direction that the Bush White House and the people directing the FDA wanted.


But certainly, we can see within the memos... where the clout was. It was coming from the White House and the Office of Management and Budget. The economic and political considerations were trumping the scientific considerations.


And the poor FDA scientists were spending their time trying to do their job as scientists, and it turned out it didn't come to anything."

Steven's book also shows how former President Ronald Reagan's deregulation agenda dovetailed with that of the molecular biology establishment, giving the industry a major breakthrough.


There's a 1958 law requiring that novel additives to food must be demonstrated safe. They cannot be presumed safe ahead of time. Each and every one should, by law, have to undergo stringent safety testing.


This is the law the FDA broke, pretending as if it did not even exist, when it claimed that genetically engineered foods don't need to be tested.

When Vice President Dan Quayle announced the FDA's policy, he announced it as regulatory relief for the industry, saying,

"We're freeing the industry from any new burdens and regulations."

What he didn't know was that the industry was also being freed from a law that, ever since 1958, had been one of the major consumer protection laws in this country.


It was now being illegally circumvented in the name of deregulation. This illegal activity has allowed the biotech industry to perpetuate and increase their penetration into the market, without ever having to actually prove the safety of any of their products.


Remember, the safety of GE foods is merely presumed. It's not proven.



GMO FDA Lawsuit Derailed

So, whatever happened to Steven's lawsuit against the FDA, you might ask? In short, it was stymied.


And here's why:

As Steven explains, the judge concluded that there was no need for a trial because trials are only necessary when there's a dispute about material facts.


Trials are done to clarify the facts. In this case, the critical facts were the very records that the FDA had in its possession as of May 1992, when it released its policy.


Since those were the key facts, there was no need for a trial, as everyone agreed on what the records said.

After submitting briefs and answers, the judge will ordinarily call for oral arguments, to tease out more information.

"We fully expected that she would, but surprisingly she didn't. When she finally issued her opinion, it was a bit of a stunner. What she stated was that, essentially, in May of 1992 the FDA administrators had some rational basis to presume that genetically engineered foods are generally recognized as safe."

That was the key legal issue.


Did the FDA's presumption about GMO's being generally recognized as safe have a rational basis?


Steven's team had to demonstrate that there had been,

"arbitrary and capricious breech of administrative discretion".

But as long as the FDA could show some rational basis for their decision, they could be upheld. In this case, Steven's team demonstrated there was no rational basis.

According to the FDA's own regulations, in order to qualify as generally recognized as safe, an additive or supplement must have solid, technical evidence of safety that has been generally known and accepted within the scientific community. That ordinarily means that evidence should have been published in a peer-reviewed scientific journal, so its solidity can be certified.


There has to be an overwhelming consensus that the product is safe, and that consensus has to be based on solid technical evidence.

"The FDA's own files show that in the case of genetically engineered foods, neither of those conditions applied. In fact, their files show just the opposite.


There was certainly a major dispute about the safety of these foods even within the FDA. Most of their scientific staff said you can't presume they're safe. That right there is a scientific fact. It's a material fact.


Also, there was that letter from the FDA's own biotechnology coordinator, admitting that there was no scientific consensus."


"By the way, we didn't even have to base it on what was in the record because nine well-credential life scientists took the unprecedented step of signing the complaint as plaintiffs.


It was unprecedented for a group of scientists to be suing a federal regulatory agency on the basis that one of its policies being scientifically unsound.


Right there, by doing that, we demonstrated there was not a general recognition of safety within the scientific community."



Theatre of the Absurd

In earlier years, the FDA had taken a supplement off the market claiming it was not GRAS on the basis of testimony of only two experts.


Here, the judge acknowledged the plaintiffs had shown that significant disagreement existed within the scientific community by bringing in nine scientists. But then she got tricky.

She claimed that the critical issue was not whether these foods could be reasonably presumed safe in 1998 (the year the suit was filed).


Most people would think that is a critical issue, because if these products cannot legitimately be presumed safe - and are thus being marketed illegally even though millions of people are eating them - that's clearly a major problem.


But, as Steven explains, the judge wasn't interested in determining whether GE foods were truly GRAS in 1998 and were actually being sold legally at that time. She instead focused solely on whether the FDA administrators had some rational grounds for presuming they were GRAS as of May 1992.

So she ruled that the evidence submitted in May 1998 was irrelevant - despite the fact it clearly demonstrated that GE foods were not GRAS at that point.


Moreover, she said that the agency's administrators had a right to overlook the opinions of their own scientific staff - essentially giving them free rein to pretend there was consensus in 1992 when there clearly was not.


Moreover, she herself overlooked that letter by the FDA's biotechnology coordinator admitting that there was not a scientific consensus about safety during that period.


Nor did she make any mention of a crucial memo by an FDA official admitting that the technical evidence required to support a GRAS presumption was entirely lacking. And she failed to take note of these two critical admissions even though the plaintiffs' briefs had clearly called them to her attention.

As a result, the FDA still clings to its unfounded and thoroughly rebutted presumption that genetically engineered foods are GRAS.


However, once you're done listening to Steven's story, or reading his book, you will know the truth of the matter the next time you hear someone talk about 'overwhelming safety' of GMO's...


This is a fascinating book and discussion and it is loaded with so much new information that it turned into the longest interview I have ever done. So we needed to break it into two parts.


We will post part two on March 15, 2015.





Video 1



Interview Transcript











Part 2
March 15, 2015


Genetically engineered (GE) foods are a serious threat to our environment and our health.

In this article, Steven Druker, author of 'Altered Genes - Twisted Truth', continues the fascinating story of how GMOs came into being and have been allowed to permeate our food supply through illegal means and without legally required safety testing.

The subtitle of his book, How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public, is quite descriptive, and Steven has done a wonderful job of exposing this extraordinary fraud.

Not only has he exposed it, but he's also taken an activist role and actually sued the Food and Drug Administration (FDA) in 1998 and challenged their 1992 policy statement that presumed genetically engineered foods are Generally Recognized as Safe (GRAS).

That '92 policy serves as the fraudulent foundation by which the biotechnology industry has been able to get away with marketing GE foods without having to first demonstrate that they're safe. There's so much information here, I strongly encourage you to get a copy of his book if you have any interest in this topic.

It will give you a clear understanding of what the problems are and how we got to the point where we are now.



Key Facts Overlooked by Federal Judge

In part one of this interview, we reviewed his lawsuit against the FDA, and how the federal judge appointed to the case failed to rule in accordance with the law.

"She actually ignored some very important evidence that was in the FDA files and that the other attorneys and I presented," Steven says.

"I cannot speculate as to the judge's motivations other than when I read the opinion, I find it difficult to understand how such an opinion came out because there are some serious facts that were overlooked."

One the main pieces of evidence that came straight from the FDA's own files was a letter written by the FDA's biotechnology coordinator, sent to a Canadian health official only seven months before the FDA announced its policy on GE foods in May 1992.

In that policy, the FDA purported there was an overwhelming consensus within the scientific community that these foods are safe - so safe in fact that they do not need to be tested.

But in the preceding letter, the FDA's biotechnology coordinator had admitted that there was not a consensus about safety of these foods in the scientific community at large...

In fact, FDA scientists had overwhelmingly concluded that GE foods present a different array of risks than their conventionally produced counterparts; that none of them can be presumed safe; and that they need to be demonstrated safe through rigorous testing, which also happens to be the law.

"Both what the law was requiring and what the FDA's own scientists, from their own analysis, were recommending was the same thing: these foods cannot be presumed safe and they need to be tested," Steven says.

"Unfortunately, the decision makers of the FDA... who were far more under the influence of political and economic considerations than scientific ones, covered that up, and lied about it.

They said they weren't aware of any information showing that these foods differ in any meaningful or uniform way from other foods. The problem is that the judge should've factored that information in.

She never mentioned that letter and that admission from the FDA's biotechnology coordinator, although we had called it to her attention several times. There's something strange when that happens."



By Law, the Requisite Scientific Consensus Cannot Be Based on Hypothesis or Speculation

Another key aspect to the GRAS requirement as per U.S. law is that not only must there be overwhelming consensus present within the scientific community, that consensus cannot be based on hypotheses or speculation; it has to be based on solid evidence.


But in the case of GE foods, there is no such evidence.

"The FDA's own files contain the admission that they didn't have any such evidence... Both of those criteria that are necessary failed abjectly.

The FDA's own files basically provide all the information the judge would have needed to have ruled that that was the case. Not only did she improperly not take account of the FDA's scientist's concerns and of that admission by the FDA biotechnology coordinator, she completely evaded the issue of whether the technical evidence was there - even though at the beginning of her opinion she acknowledged that that was one of the two prongs that had to be proven.

And then she never came back to the issue even though we certainly drilled it home several times in the various submissions we made to the court. That's why it's very difficult to understand how this could've happened."

The Food Additives Amendment of 1958 was created to protect the public from potentially harmful substances added to foods, and this law specifically places the burden of proof on the manufacturers of new additives.


This law presumes that all new additives are unsafe until proven safe.

Astoundingly, in the case of GE foods, the federal government has, over the years, slowly, surreptitiously, and illegally shifted that burden of proof - taking it off of the shoulders of the manufacturers, and placing it on consumers and critics.


We now have to prove that GMOs are unsafe, which is absurd!



Why the Appeal Was Dropped

The FDA's presumption that GMOs are GRAS is supposed to be rebuttable. (The judge even emphasized that the FDA had emphasized that fact.)


In this case, the only way you can rebut a presumption made about GMOs in 1992 is with evidence that came out after 1992. Otherwise, you cannot rebut the presumptions.


Here too, the judge did something absurd.

"In 1998, we brought out solid evidence that rebutted [the presumption made in 1992], and... essentially, [the judge] said that 'you have rebutted it, but this evidence is irrelevant.'


She made a rebuttable presumption irrebuttable and irrefutable by ignoring any evidence that we introduced after May of 1992. That was just another absurdity I want to make sure has been brought to the fore," Steven says.

An appeal was filed, but after the filing, the FDA announced that it was coming out with a new regulation on GE foods.


The May 1992 policy statement was not a regulation. In fact, it didn't regulate the biotech industry one iota. It was completely nonbinding. The FDA stated it would create a new regulation requiring manufacturers to give prior notice before marketing a GE food in the U.S..


No labeling or safety testing would be required, but it was still significant because it was a new regulation that would supersede the policy statement.

"If we brought a lawsuit against that new regulation, all of the evidence we had brought in 1998 that the judge excluded would have to be relevant, because the FDA knew of it in early 2001 when they issued that preliminary regulation.


So, they issued notice of a proposed regulation and they called for comments. It looked like they were actually seriously going to enact the regulation.

On the last possible day to drop an appeal, we dropped the appeal because it appeared it would be a waste of time. The intelligent thing to do would be to wait for the new regulation and sue on it, [so that] all of the evidence the judge excluded would be relevant, and the FDA would clearly lose.


There was no way they could've won... But then, in the spring of 2003, more than two years later, the FDA announced that they were putting that [regulation] on the back burner...

That regulation never moved beyond the proposed state. They basically backtracked to the safety of the May 1992 policy statement that had already been upheld in court, and they stayed with that.


That's where we still are today."



Claim of Scientific Consensus on GMO Safety Is Patently FALSE

The 1992 FDA policy statement, which was invalid when it was made, has been repeatedly rebutted and refuted, and yet that policy statement is still the sole purported legal basis for the presence of GE foods in the U.S..


The FDA knew the legal criteria of their policy had not been fulfilled, and today there's even more evidence of conflict and disagreement within the scientific community.


In fact, on January 24, a statement signed by 300 scientists, researchers, physicians and scholars was published in the peer-reviewed journal Environmental Sciences Europe, asserting that there is no scientific consensus on the safety of GMOs.

Moreover, the paper, titled "No Scientific Consensus on GMO Safety," states that the claim of scientific consensus on GMO safety is in actuality,

"an artificial construct that has been falsely perpetuated."

The paper also notes that such a claim,

"is misleading and misrepresents or outright ignores the currently available scientific evidence and the broad diversity of scientific opinions among scientists on this issue."

In addition, the FDA still does not possess any evidence demonstrating safety because they do not even do scientific reviews.


And even if they did, a large number of scientists say there's still no evidence demonstrating that GE foods are safe, while a number of independent studies have raised serious health concerns.


Quite clearly, there is NOT a "general recognition of safety among scientists," and these foods are on the market illegally.


They were illegal when they were first introduced in 1992, and they continue to be illegal now in 2015.

"One of the nation's most important and most venerable consumer safety statutes, consumer protection laws, has been blatantly and intentionally violated by the agency that's supposed to uphold it, and they've been getting away with it all these years," Steven says.


"It's time to really pull the rug out from under the whole thing, because the evidence is overwhelming. All people have to do is just read it."



What Geneticists Could Learn from Computer Scientists

Besides analyzing genetic engineering from the standpoint of biological science, there's another important field of science that is relevant to the discussion of GMO safety, and that is information technology and computer science, especially software engineering.


The reason for this is because genetic engineers are taking huge and very complex information systems (the genomes of plants), and they are making radical revisions to them based on a very deficient knowledge base.

"There is so much about the genome of the plants that they are reconfiguring, of which they are unaware," Steven says.


"It's well-known that the genomes of plants and animals are by far the biggest, most complex, and most intricately interrelated information systems on our planet. They dwarf any manmade system...


And yet, when we look at the experience of computer science and the lessons that have been learned the hard way over many years... there's no way to safely revise them.


Or I should say, no way to revise them in a way that can be presumed to be safe."

Computer scientists have learned that they cannot assume that a revision only changes what they wanted it to change.


Even if it was very precisely done and very minor, they have to presume that it might have unintended effects. This is especially true when that program is a life-critical program - one of the programs that if it were to fail would involve more than just an annoying crash of your word processing program; it could be a crash of a jetliner, or it could be the malfunction of an X-ray machine.


In fact, Steven notes there have been fatal accidents with radiation machines in which a minor problem in the revision of the computer code led to the death of patients who received the wrong radiation dose.

"Certainly, it doesn't take much imagination to know what could go wrong if there's a bug in the airplane guidance system.


The plane can go down. That's why any revision made to such life-critical software systems has to go through rigorous testing after each revision. And put not only through the tests that were done beforehand, but a new battery of tests that weren't even done when that system was first approved.

But there's nowhere near the same parallel kind of testing in the case of genetically engineered food. Nowhere near it.


Even the most rigorous tests that have been done on genetically engineered food fall far short of the rigor with which life-critical software programs are tested after every revision...

The genetic engineers cannot control where the packet of new genetic information (the DNA) is going. It's randomly inserted. It's a radical revision in several other ways too. They have very little understanding about those informational systems, because after all, they didn't design them. We know that they're far more complex and far more intricately interrelated than any human-made software...

And yet, they're making the assumption that they can presume that what they're doing will have only introduced the one change they want and will have not disrupted anything else in a deleterious manner. That is - from the standpoint of computer science - insanity. It's certainly reckless...


I think anybody listening who knows something about software engineering should definitely dig into that chapter and start sharing it with your colleagues, because I think that can catch the imagination of the entire information technology community.

That community obviously is not anti-technology. They embrace cutting-edge technology, but they've also learned that when you're doing cutting-edge technology, you also have to be aware of the risks and you have to do testing to help minimize unintended consequences.


They've learned the lesson about unintended consequences."



The Media Has Promulgated Lies and Failed to Do Due Diligence

The reason Steven wrote the book was to get all the evidence out there, and I am currently in discussions with filmmakers to see if we can turn Steven's book into a documentary or wide-media series.


If you're listening to this interview and have connections, let me know, and we'll see if we can make something happen.


There's undoubtedly an important need for this, as the conventional media is clearly corrupted by multinational corporate interests and the persuasive molecular biologist community as discussed in part one.

When endeavoring to get the suppressed information from the FDA's files publicized, Steven would travel to all sorts of media events, interviews would be done, but the key facts would not get published.


Instead, the reports were spun to hide the crucial facts and make GE foods and the FDA's policy look good.


The media also failed to properly report on the matter back in 1998, when the lawsuit against the FDA was filed.

"There is an entire chapter devoted to the malfunction of the American media, and the subtitle is 'Pliant Accomplices in Cover-up and Deception.' Because unfortunately, the mainstream American media have behaved very badly when it comes to genetically engineered food.


Certainly, the way they've treated the lawsuit and the FDA files that it brought to light is a case study in irresponsibility.

There have been several instances in which I have given information, key memos from the FDA files, to investigative journalists... who work for mainstream journals and mainstream newspapers.


They wanted to do something with it, and it got shut down by the editors."



The U.S. Has Strong Food Safety Laws, But Those Laws Are Being Violated

Many Americans believe the reason the U.S. has so many GMOs permeating our marketplace while other nations, including the European Union (EU), do not is because those countries have stronger, more rigorous regulations ensuring safety.


While this should be a correct assumption in theory, it's not based in actual reality. Because, as Steven's book points out, the U.S. actually has stronger food safety laws in regard to GE foods than the EU, but those laws are being violated.

And they've been violated since 1992. In fact,
GMOs are on the market because our food safety laws have been illegally circumvented.


Moreover, the EU is not fully upholding its laws either. The precautionary principle is supposed to be the guiding principle in European Food Safety law. The European Commission has emphasized that several times.


But in the case of GE foods, they are not following a precautionary approach - instead they're being quite lax; and part of the problem is the general belief that the U.S. has done the necessary legwork.

The U.S. media has also played a significant role in allowing this fraud to be perpetuated without backlash.


In more recent years, the European media has become more like the media in the U.S., but in the '90s and the early 2000s, the European media was very open to reporting problems about genetically engineered foods.


Most importantly, they would quote scientists who were voicing concerns, and that had a huge effect on the consumers.

"It was the consumers that made it clear to the major grocery chains that they would not buy genetically engineered food. Several major grocery chains made it clear to the manufacturers that they would not buy them either because the consumers didn't want them.

That essentially stopped genetically engineered foods from getting directly into the human food chain in the European Union.


It was consumer understanding, not consumer ignorance, but consumers being informed by the media who reported about courageous scientists who have spoken up [that created the] public backlash.


That never happened in the U.S.... That's important to understand."



Misrepresentations by Molecular Biologists Led to the Creation of One of the Biggest Frauds in History

Ultimately, the blame for this fraud has to be put at the feet of the molecular biology establishment - the main scientific establishment in the life sciences - which Steven discussed in Part 1 above of this interview.


His book goes into this part of history in great detail, demonstrating how the aggregate misleading statements about the science behind GMOs and their purported safety were born back in the early 1970s when genetic engineering was first established.


Within the context of the history of science, the fraud related to GE foods is one of the biggest and most pernicious ever committed by scientists, and it began with molecular biologists who wanted to protect the budding science of genetic engineering by whitewashing potential concerns.

In the 12th chapter of Steven's book, "Unfounded Foundational Presumptions," he shows that even when the evidence goes against the genetic engineers of today, they always fall back on some of those initial presumptions made by the molecular biology establishment - presumptions that support the notion genetic engineering is a 'safe' enterprise - and they never really acknowledge that those presumptions have been solidly refuted.

"One of the key ones of those, which I think is important to bring out, is that somehow, no matter how unruly and unpredictable somebody can demonstrate genetic engineering to be, they will always say,

'Well, conventional breeding is worse. Nature is far more random, unruly, and risky.'

That is a very important point to bring out, because there are so many Americans who probably, just as a matter of course, believe what they're being told about this.

They don't understand that that is actually a foundational assumption - that you can't actually trust food that's been here for a long, long time; that nature is somehow being slandered and disparaged as being far more unruly, unpredictable, and dangerous.


Every act of pollination is somehow supposed to be at least as risky, if not riskier, and more unpredictable than these radical insertions of foreign genetic material into soybeans, corn, and zucchinis.


That I found to be gross slander against nature. I think more and more people need to understand that."




Video 2



Interview Transcript