Ken Fischman, Ph.D.

“Everything has both intended & unintended consequences, & the intended

consequences may or may not happen, but the unintended consequences always do.”

Dee Hock, former CEO of VISA International

In 1988, Showa Denko, a Japanese pharmaceutical company, shipped the first batch of genetically engineered L-Tryptophan to the United States. L-Tryptophan is an amino acid, normally contained in all of our cells. Naturally-derived L-Tryptophan had been sold over the counter for decades to thousands, perhaps millions, of people to relieve symptoms of insomnia or depression. There had never been reports of any ill effects.

The genetically engineered L-Tryptophan killed 37 Americans, more than 5,000 others came down with a hitherto unheard of disease called Eosinophilia Myalgia Syndrome, and many were permanently injured.

Showa Denko’s attorney admitted in federal court that it was most likely that the genetic engineering had caused the calamity. Just prior to the trial, Showa Denko destroyed the original batches of bacteria from which the L-Tryptophan had been extracted.  Showa Denko was clearly at fault, but because the bacteria were no longer available for analysis, it could never be definitively proven that it was specifically the genetic engineering that did it. The Food and Drug Administration (FDA) declared that it was not the genetic engineering that was at fault, and the deaths and injuries were probably due to some manufacturing error. Instead of banning only the genetically engineered variety, they banned all over-the-counter sales of L-Tryptophan.

When Watson and Crick unlocked the secret of DNA in 1956, they fundamentally changed our world. They enabled scientists to understand many of the basic properties of inheritance. This was followed by the introduction of techniques enabling scientists to manipulate those processes in order to alter living organisms in ways that had never before been possible. In rapid succession, scientists deciphered the code found in the sequence of molecules along the long DNA chain, and discovered that DNA produced a similar molecule called RNA, which in turn produced proteins. Some kinds of proteins make up most of our cell structures, while others function as enzymes, controlling essential bodily processes. This new field of science is called Genetic Engineering (GE) and the new forms of life produced by it are termed Genetically Modified Organisms (GMOs). They are brought to you by modern wizards called Molecular Biologists.

Molecular Biologists have been able to decipher the genetic code laid out in the linear sequence of genes and identify many of their functions.  They can snip them out of the chains of DNA and insert them in the cells of other organisms. Farmers, animal husbandmen, and scientists have been breeding animals and plants for thousands of years in order to produce new combinations of characteristics. However, up until now, these characteristics had always been ones that had preexisted in some members of the same species. Through eons of evolution, living organisms accumulated combinations and sequences of genes that for the most part work together harmoniously. However, the techniques of Molecular Biology shorten the time dimension and leapfrog the species barrier. For example, it is now possible to take the “antifreeze” gene from Flounders, a cold-water species of fish, and insert it into the genome (total array of genes in an organism) of a potato! This enables GE potatoes to survive periods of frost, and to extend their growing seasons. Thus, scientists can now combine genes that had never before been in the same organism.

The wonderful potentialities of this science have been emphasized for years by molecular biologists, the medical establishment, agribusiness, and government itself. They tell us that they will be able to cure humanity’s illnesses, produce wonder drugs grown in genetically-altered animals, grow made-to-order organs for transplantation, feed the starving millions of mankind, etc. However, none of these institutions talk about the dark side. This article explores the dark side.

In 1992 the FDA issued a ruling, stating that genetically engineered foods are “substantially” like natural foods, and therefore do not need to be regulated.  This has come to be known as the “Substantial Equivalence” rule.  The significance of this ruling was that the food industry would not have to perform safety studies and clinical tests on GMOs, such as are required before new drugs come onto the market. The ruling also removed much of the oversight that the FDA would exercise on drugs after they reached the market. The Federal Government could thus argue, and subsequently did, that because these GE foods are just like regular foods, there is of course no need to label them in order to distinguish them from other, non-GE foods.

European countries, on the contrary, have adopted a different approach  to the marketing of GMOs.  They have put the onus of proving the safety of these foods on the manufacturers, by invoking what is called the “Precautionary Principle”.  This states, in part, that “When an activity raises threats of harm to human health, or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.  In this context, the proponent of an activity, rather than the public, should bear the burden of proof.”

Due mostly to these fundamentally different approaches, the United States and the European Union are locked in a struggle.  The Bush administration appealed to the World Trade Organization to issue substantial fines on European countries which do not allow importation and sale of GMO food from the US.

It has been repeatedly stated by both government and food industry spokesmen that there have been no documented cases of someone being harmed by GE food.

In light of these claims, an interesting incident occurred in 1996. Pioneer Hybrid, then the largest seed company in the world, wanted to make an improved soybean. Soybeans lack some of the 21 Essential Amino Acids (EAA) that human beings and most other animals need for life, but cannot produce on their own. Most of us get our EAAs from meat. Vegans, however, must carefully balance the types of plants they eat in order to make sure that they get all 21 EAAs in their diet. Pioneer extracted a gene from Brazil nuts in order to increase the soybean’s production of another amino acid, Methionine. They then gene-spliced it into their soybeans in an effort to improve their nutritional value, and hopefully the company’s profitability.

Just before this GE soybean was scheduled to go on the market, it came to the attention of some University of Nebraska scientists. By a stroke of good luck, they just happened to have some blood sera from people who were allergic to Brazil Nuts, and they decided to test these beans on it. They got a strong allergic reaction. Quite a few people are allergic to Brazil nuts, and eating these soybeans might have killed many of them. Obviously, something else besides the gene for the amino acid had been transferred into the soybeans.

When genes are to be introduced into host cells, they do not come alone. After the donor DNA has been cut into many pieces, it is then inserted into bacterial plasmids (circular bacterial DNA), and in this form, the genes can be duplicated to any number necessary. Then, they must overcome the host cell’s defenses against invasion of foreign DNA. This is usually accomplished by attaching a “ferry,” – an infectious virus or bacterium – to that gene. The virus or bacterium can penetrate into the cell and insert the gene into the native DNA. A way also has to be found to identify and select those cells in which the new gene has been inserted and to dispose of all cells that do not contain this gene. This is usually done by attaching a so-called Antibiotic Resistance Marker (ARM) gene. This ARM confers antibiotic resistance, usually to Streptomycin. Treating the cells with Streptomycin then kills all cells which do not possess the desired inserted gene.

Genes do not function all by themselves. Most of them are active during only part of the life of the cell.  They may need the assistance of other genes, called Promoters, which “turn on” or activate them. Therefore, a promoter gene, derived from a virus,  is also attached. These genes may also bring with them uninvited guests. When genes are snipped out of their original DNA chain, the process is not exact. The chain is cut in various places by enzymes, leaving pieces of, or entire neighboring genes, attached to the gene to be inserted. The properties of these DNA Fragments may not be known and their presence may not even be detected.

From this and other evidence, a reasonable person could draw the conclusion that contrary to what the FDA and food industry say, GMOs used as foods are definitely different from regular foods, and need to be tested and labeled to safeguard the health of both ourselves and the rest of the planet.

There are several good arguments why GE foods should be labeled. For one, people should have the right to know what is in the food they feed to their families. But even more importantly, if GE foods are not labeled, and something goes wrong, and people get sick and/or die, what could be done to trace the source of the problem? Epidemiologists, those public health officials whose job it is to track down the causes of diseases and other health hazards, would have no way to trace the problem back to the GE foods.

One more important point. Agribusiness companies such as Monsanto consistently claim that their GE seeds will increase crop yields with these techniques, thus being able to feed the world’s ever-increasing human population and avoid famine and starvation. Unfortunately most of the evidence so far demonstrates that on the contrary, most of them either marginally increase or even decrease yields. One theory of why this occurs is that much of the plant’s energy has been diverted from normal growth into perpetually producing the inserted gene’s product.

A holy grail of molecular biology has been the hope that GE will one day be able to cure inherited diseases by substituting normal genes for the abnormal ones. For the first government-sanctioned attempt at Gene Therapy, children with a hitherto consistently lethal disease were selected. These so-called bubble babies have non-functioning immune systems, and need to be physically isolated from the environment  in artificial enclosures. They usually die in early childhood from infections against which they have no defense. A number of clinical trials were begun around the world, in which ostensibly normal genes were inserted into such children.  Eleven children were selected for one trial in France. Their physicians were optimistic due to the preliminary results. Most of the children showed improved immune functioning. Then one boy came down with Childhood Leukemia. They assumed that this was an unfortunate coincidence. A few months later a second child developed Childhood Leukemia.

Analysis of their DNA showed what had happened. In the first child the Promoter gene accompanying the therapeutic gene had landed square in the middle of an Oncogene called LMO-2, and turned it permanently on. An Oncogene is a gene, probably needed for normal development, which if switched on permanently, causes cancer. Analysis of the other child’s DNA provoked  much more concern. The same Promoter gene landed near the same Oncogene, but not on it. Promoter genes show a gradation of effects, depending how close they are to the gene in question. The closer, the stronger the effect.  All gene therapy trials were immediately stopped.

The results of this trial are exceptionally chilling. It showed that it matters very much where in the host genome the foreign gene is inserted. The fact is that the scientists have no idea of where the gene is going to land; where, if any, there is a “good” place to land; and no way exists at this time to direct it to such a place.  There has been much talk about “targeted gene repair” , but so far scientists have been unsuccessful in directing foreign genes to specific sites, and may never be able to do so.

Perhaps even more importantly, the question arises as to whether the insertion of the Promoter gene in the Oncogene in one case and near the Oncogene in the other, was a coincidence. Considering the vast amounts of DNA in a cell, and that a human cell is estimated to contain 10 – 30,000 genes, it is very unlikely that this was an accident. Therefore, we are left with the possibility that when foreign genes are inserted into a human cell, their destination may not be random, but directed, but not by us. In these cases, it was directed to an Oncogene, with tragic results.

There has lately been some good news in the field of gene therapy. The latest trials of this technique have met with better results.

The prospect of worldwide distribution of GMO’s is particularly troubling because they differ in several crucial respects from pollution by petrochemicals and radioactive substances.  Unlike chemicals, GMOs can replicate themselves, thus producing potentially immense amounts.  They can mutate(change) their genetic constitutions, and therefore, their properties.  Furthermore they can disperse to other environments, either on their own, or by piggybacking on other organisms by becoming integrated into their DNA.  It is quite likely that if  some of them prove to have deleterious effects, it will be impossible to correct the situation, and put them back in Pandora’s box.

In this new world of GE, which we are entering so rapidly, the term caveat emptor (let the buyer beware) takes on a new and ominous meaning.

The Dark Side of GE, 10/29/03