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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,
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
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