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Date:

July 7, 2000

Subject:

Paul Ebert's response regarding labeling GM products

 

AgBioView - http://www.agbioworld.org, http://agbioview.listbot.com

Professor McHughen, and the many others that responded,

Regarding the patients' unconcern for the use of Betaseron or biotech meds
generally. I agree patients often simply trust their physician's judgment.
This has nothing to do with my point that those who do wish to be informed
have that option.

Pharmaceuticals are not labeled simply to distinguish one from another.
Prescription medications are labeled so that conscientious health care
professionals can make an informed decision on the risk/benefit ratio of
prescribing a specific product based on the extensive information required
by the FDA about the results of clinical testing. To say the purpose of
labeling is to tell the difference between Betaseron and insulin is
ridiculous. They are completely different drugs. I was referring to the
difference between recombinant insulin and insulin derived from other
methods. Factor VIII is a better example since the Factor VIII molecule is
the same in both blood isolated products and recombinant products. Patients
do care very much about these products, because many hemophiliacs were
infected with HIV from the blood isolated products. Therefore I feel very
comfortable recommending the biotech version due to the favorable
risk/benefit ratio. I am not anti-biotechnology. I am skeptical about how
biotechnology is used.

It is one thing too use biotech to create a specific molecule that a person
is unable to make on their own in order to save a patient's life. The host
organism that is used in making the drug is not allowed out into the global
environment. The biotech drug is not a non-human molecule in fact it is the
same molecule healthy people produce naturally. It is a completely
different thing to use biotech to insert genes into an organism and then let
that genetically modified organism out into the global environment. If you
want a fair comparison you would have to diagnose a plant with a genetic
disease, then if you feel it necessary to save the plant replace the missing
protein without changing the genetic make up of the plant.

I hope the biotech agriculture folks will spare me the rhetoric about how
biotech agriculture is needed to feed our over populated planet or reduce
the use of pesticides and fertilizers. Reasonable people and organizations
have been warning of the problem of environmentally (I refer to an
environment in which humans evolved and that I think is necessary for a
quality life. Yes it has already been drastically modified, but we know
this, let's not continue the drastic rate of change humans are capable of
causing.) unsustainable population growth for decades, even longer, I think
Mendel mentioned it. The impact on the environment of biotech agriculture
will only be known many years from now just as the impact of pesticides were
only recognized years after there wide spread use. Unlike pesticides and
even pharmaceuticals biotech, agricultural products won't simply be able to
be recalled, therefore biotech agricultural products need to be held to a
very high standard of testing and public scrutiny of whether the risks are
worth the benefits. Please see my other AgBioView letter of 7/3/00
(attached since Professor Prakash did not provide it to the AgBioView list
index).

Gene therapy in humans when and if it becomes available is extremely
controversial, as it should be. The ethical dilemma has been debated for
quite a while, and the technology will require the support of the public
before it is unleashed - hopefully.

The improper use of antibiotic and antivirals and there contribution to the
creation of resistant bacteria and viruses is an important problem with the
use of non-biotech drugs. As a responsible person in the field I will
scrutinize the potential problem of as yet undeveloped biotech answers to
human infections and there potential to create new strains of organisms with
resistance and even other unconsidered problems. Fortunately in the US, the
drug approval process is stricter than the food approval process.

Regarding Bishop Grewell's point that mandated labeling is too expensive.
This is a weak excuse, with all the money the biotech agricultural products
save the industry, they can probably fit it into the budget. As to the
content of the label, "Contains Artificially Genetically Modified
Agricultural Products" would be a good start. You are right regulation is
not simple. People will either ignore the label and just buy based on
price, marketing, taste, ect. But at least those that care will be informed
and if they care they will look into the risk/benefit ratio of consuming and
supporting the product.

Jamie Bishop explains an important economic point: separating GM & non-GM
products would require vast infrastructure expenses. My answer to this
point is don't build a parallel infrastructure. Let the owners of the
infrastructure choose to allow GM products to mix with non-GM. When the
corn or what ever is packaged for the consumer if it contains any GM
products it gets the label. The consumer then buys it or not. Eventually
the market place will speak. He believes that the responsibility should be
to label non-GM products. I disagree non-GM products pre-existed GM
products they are not the new technology that may or may not be good over
the long-term. The industry must convince the public of the long-term
safety of GM products. It appears the GM industry does not think it can
convince the public, so it opposes labeling.

Mr. Bishop says:
"Like you say, it's a free country. ACGA, which purports to be a farmer
group, would appear to be on the take from front-line environmental activist
groups. Their arguments are misleading. The potential cost is very high.
And at this point, with biotech in an embryo state but so full of promise to
improve lives, nutrition, health and economies, it's an early grave for a
very vulnerable new industry. So it's no wonder that a few folks get worked
up over the issue."

Labeling may hurt the industry in the short-term, but that does not excuse
it from doing what it should have done in the first place: let the public
make an informed choice about GM products.

I stand by my statement: If the science is sound what are you afraid of?
Industry only looses in the court of public opinion when the science is not
in their favor. In fact, industry usually wins despite the facts.


To Allan Cisar who says:
"Why should the burden, and the costs, of labeling fall on the majority
of farmers, processors and consumers that find biotechnology completely
acceptable?"

I doubt your assertion that the majority of consumers find biotechnology
completely acceptable. I doubt they understand the key difference between
agricultural techniques involving transferring genetic material into an
organism in order to produce "desirable" traits and pharmaceutical
techniques that produce proteins (granted host organisms are used for
recombinant production of some protein drugs, but the organisms are
contained and not spread into the global environment). The medical
profession understands this is an important difference. That is why gene
therapy is being debated publicly before it is brought into medicine. In
fact it has been a major area of debate amongst society.

It is unfortunate that tinkering with other species genes has gone forward
with so little input from society. I hope there are no adverse effects on
the environment from what has already occurred. It is not completely
acceptable! There are already enough problems dealing with naturally
evolved organisms that have been transplanted from the local ecosystem in
which they evolved. Non-native species are wrecking havoc in ecosystems all
over the world.

Biotechnology is a large field. I have mentioned areas where it is valuable
and safe. Agriculture has been far to quick to enter the area that amounts
to gene therapy in agricultural products. The industry could get away with
it because society is less concerned about tampering with the genetic make
up of non-human species.

Mr. Loyd-Evans says:
"Open and fair-minded discussion is vital. What is unforgivable is the
close-minded propaganda that demonises all GM developments and the people
who carry out the R&D and also farmers and food providers who have accepted
the use of GM."

I agree completely. Why is the GM industry afraid of letting the general
public find out what they are consuming. The general public needs to know
what they are eating and the implications of this. They will only learn
when there is labeling of the products they consume. Then they will be
interested in having an open fair minded discussion.

Environmental activists are not the only ones guilty of misleading
statements. Scientists that know better and have a professional/ethical
requirement to not mislead through use of their prestige to promote their
selfish interests. It is far to easy to promote the positive side of their
work while neglecting the negative side.

Ultimately the public should be allowed to make the final decision on a new
technology in a free society. I promote informing the public about
important issues related to biotechnology in my profession. I believe you
should be held to at least the same level of openness with the general
public.

Sincerely,

Paul Ebert RPh.
Non-affiliated independent thinker
Durango, CO
USA

Attachment:

To all interested in Biotechnology,

As we all know, history is filled with poorly thought through attempts to
improve upon the natural environment. Most in an attempt to improve the
planet for humankind. Although, from the earliest times humans have
manipulated the environment with disastrous results. Scientist from fields
as diverse as Archeology, Biology, Physics, Chemistry and there many
subcategories can name many instances. The question is will we use our
intellect to restrain ourselves from the many things we can develop. Do we
learn from history or do we again rush to implement our technical
achievements to improve the human condition? Or perhaps our own financial
condition.

I am not a Luddite. I am not an environmentalist that believes stopping new
technologies is the answer to making Earth a beautiful place of natural
balance. I am a pharmacist. My profession has learned many hard lessons
about trying to improve the human condition through technology. I would like
to make a few humble suggestions to the agricultural biotechnologists.

The US FDA does not treat foods in the same manner as drugs. The testing
required is far less rigorous for non-drugs. If many drugs can make it
through clinical trials and then can be found to be harmful, then I think we
should be even more careful with agricultural product testing. The
consequence of a harmful drug slipping through is often injury or death.
Once discovered the drug's risk benefit ratio is reexamined and often the
drug is pulled from the market.
In the case of a bioengeniered food the pre-marketing testing is much less
rigorous, therefore the opportunity for a harmful food reaching market is
much greater. If a food were to be pulled from the market it would be much
more difficult. The people eating the BioAg product would not be being
monitored by a medical professional, so it would be much more difficult to
diagnose a problem. The person may not even be aware that they are ingesting
the product if it is an ingredient in a more complex food. Any unanticipated
effects to the environment could take years to come to light. Pulling the
BioAg product may be impossible. It may reproduce on its own, cross with
another plant or irrevocably change the environment in any number of ways.

I am not defending the pharmaceutical industry. In fact I am very critical
of it. The creation of drug resistant bacteria and viruses, for example. My
mission is to point out the need for all scientists to be concerned about
the unattended consequences of their actions.

Maybe society is making a mistake to think genetic manipulation is all right
for other species, but not for humans. I believe that the consequences of
genetic manipulation are important in all species, not just humans. One idea
that deserves investigation in BioAg is one the pharmaceutical scientists
have considered. It is a reversible way to manipulate genes. In humans it
would entail introducing a gene that included a sequence or protein that
would allow the gene to be turned on or off. If the gene had negative
affects it could theoretically be turned off by denying or giving the "drug"
molecule that served as agonist or antagonist. A minimum requirement should
be a non-replication "killer" gene that would not allow a bioengineered
species to reproduce. This should be a requirement until significant post
marketing follow up has been completed to insure that long-term safety
studies are completed.

We have done enough harm to humankind and those species that share this time
and space with us. Please do your best, history will be your judge.