March 08, 2015
By Dr. Mercola
By Dr. Mercola
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 US 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 US 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 US 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 US 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 GMO’s at odds with the science, it violates US 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, adding: “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 US 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 US—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 US.
“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 GMOs… 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.