The Showa Denko Tryptophan disaster

New evidence indicates that genetic engineering
was the most probable cause

Published January 6, 2007. Last updated June 1, 2009.

Brief summary

An extremely poisonous substance in a food supplement killed 37 persons and 1500 contracted a chronic severely painful and incapacitating disease. This disaster started in the late 1989 and ceased when the cause was discovered. At that time, the biotech industry maintained that some change in the production of the supplement caused the accident, but our conclusion, based on recently discovered evidence, is that, with great certainty, a metabolic disturbance, caused by genetic engineering, was the reason for the appearance of the deadly and powerful poison that made the food supplement very harmful, although tests showed it was 99.6% pure.

As this disaster demonstrates that genetic engineering may give rise to very dangerous unexpected substances, difficult to detect, the present method used for assessing the safety of all genetically engineered foods must be abandoned and all foods on the market must be withdrawn.

This is because the present GE food safety testing procedures are far too insensitive to detect such unexpected dangerous poisons that may appear through genetic engineering. Therefore, it is only a matter of time before another posioning disaster occurs.


Executive summary

In 1989, a disastrous epidemic broke out in the US that caused 37 deaths and disabled 1.500 permanently in a disease called the "Eosinophilia-Myalgia-Syndrome" (EMS). It was caused by some extremely poisonous substance in the food supplement tryptophan, which had been produced by genetically engineered bacteria at the Japanese company Showa Denko.

The biotech industry maintained that the disaster was not caused by genetic engineering but by an "impurity" due to reduced filtering of the product. But recently it has been discovered that hundreds of cases contracted EMS before the filtering was decreased.

We have made a careful analysis of the facts to find out if there was any plausible other reason for the appearance of the deadly poison than genetic engineering.

Bacterial fermentation, the method used for producing tryptophan, had an excellent safety record since over 60 years before genetically manipulated bacteria were used. Therefore it is extremely unlikely that the fermentation process produced the poisonous by-product.

On the other hand, molecular biologists predicted decades ago that genetic engineering may cause changes that induce the appearance of unexpected and potentially harmful substances. This prediction has been confirmed in a number of cases. Moreover, not one gene had been inserted, as commonly is the case, but four different genes. Increasing the number of inserted genes increases the risk for unpredictable consequences.

Our conclusion is that genetic engineering caused the disaster with great certainty.

If the generally used method for safety assessment of genetically engineered foods had been used, this deadly tryptophan would have passed as a safe product. This safety assessment is clearly insufficient because is not designed to reveal unexpected poisons. All genetically engineered foods on the market have been tested with this method and are therefore unsafe. They must consequently all be withdrawn.

If not withdrawn, it is no doubt a matter of time only before another GE food disaster occurs.

Showa Denko was the Harrisburg of gene technology. Must we have a Chernobyl before the use of GM foods is stopped?




The disaster

37 persons died and 1.500 were permanently disabled in a disease called Eosinophilia-Myalgia-syndrome (EMS) caused by some extremely poisonous substance present in a tryptophan food supplement, which was produced by genetically engineered bacteria at the Japanese firm Showa Denko (1).

The american attorney William Crist has recently made a very thorough investigation which has helped bring increased clarity to the question whether genetic engineering was the cause of the appearance of this deadly toxin (2).


Our analysis, based on the new evidence

1. Was the poison created by the bacteria?

  • The insufficient filtration hypothesis disproven

    The biotech corporations maintained that EMS appeared after Showa Denko reduced the effectiveness of a carbon filter (reduced carbon content) in december 1988. They maintained that this probably had reduced the protection against chemical impurities appearing in the production process (without any explanation how they could appear). The filter story was distributed to the press worldwide as the cause of the epidemic.

    This argument is totally untenable, because it has been discovered that hundreds of cases of EMS occurred before reduced filtration was introduced (2). This discovery was the result of a careful investigation of all known cases by the attorney William Crist.


  • Tryptophan fermentation using normal bacteria never created any poison

    Tryptophan has been produced in very large quantities for many years by a several other producers through the same bacterial fermentation method as Showa Denko, using bacteria that are not genetically engineered. No similar complication has occurred in any case. Bacterial fermentation is the standard method for this kind of production.


  • Bacterial fermentation of many other substances without any problem

    Large numbers of bacterial fermentation units have been producing huge amounts of various medical substances, including other amino acids, enzymes, nucleotides, vitamins, antibiotics (including very large amounts of penicillin, tetracyclin and erytromycin).

    Such manufacture has been going on at a large scale since more than 60 years without the appearance of any unexpected highly poisonous chemical impurity (fermentation of the first substance produced at a large scale, penicillin, started in 1945).

    EMS was caused by extremely small amounts of a very poisonous substance that was able to pass the filters even when the filtration was at the standard level used in industrial fermentation (that is, before filtration was reduced by Showa Denko).

    This leads to an important conclusion:

    If a very dangerous poison could appear due to some fundamental weakness in bacterial fermentation, it would have been discovered in other cases, using the standard filtration procedure.

Conclusion

  • It has been established that reduced filtration was not the cause of EMS.
  • Non-GE tryptophan bacteria have never generated any dangerous toxin. This is especially convincing as such production has occurred at several sites since decades and the amounts produced have been large.
  • The method of production, bacterial fermentation has an impeccable safety record having been used for many organic substances since over six decades at a large scale without any similar complication
  • No plausible explanation has been presented how an extremely toxic substance could appear in the production process except for in the bacteria.

Therefore, as all other elements in the production method have been cleared beyond reasonable doubt, we can conclude with great certainty that the bacteria themselves caused the emergence of the poison and not some fancied other source in the production process as implied by the biotech corporations.



2. What caused the appearance of the poison in the bacteria?

  • A Non-GE cause is extremely unlikely. The excellent completely poisonfree safety record from over six decades of bacterial fermentation at a very large scale, makes it extremely improbable that the bacterial strain spontaneously started to produce an extremely poisonous and unusual substance.
  • The diametrically opposite situation is the case with genetic engineering, as unexpected appearance of poisons due to genetic engineering has been predicted by molecular biologists because of the way gene manipulation can disturb cellular functioning.
  • Moreover, this prediction has been experimentally confirmed. That is, unexpected appearance of poisons has occurred in reality due to genetic engineering (3).
  • In the case of the Showa Denko bacteria, they had undergone an unusual extent of genetic manipulation as not one, as usually is the case in GE, but four different foreign genes had been introduced.
  • The risk for unexpected complications is greater, the larger number of genes are inserted because it brings about a greater instability in the genetic control of metabolic processes.
  • The risk was especially great for a disturbance of the metabolic processes involved in generating tryptophan, because all the artificially inserted genes were specifically directed at increasing the production of this substance. This means that the natural metabolic pathway was disturbed in four different ways, which means a great interference with the normal metabolic processes.
  • The most suspect impurity, "EBT" was closely similar to tryptophan. It is the kind of substance that could appear due to disturbed regulation of the metabolism.

Conclusion

Considering the above points, including especially the impeccable safety record of bacterial fermentation and the theoretically predicted and experimentally confirmed risk for GE-induced metabolic disturbances generating unpredictable poisons, in this case enhanced by multiple gene insertions, it can be concluded with very great certainty that it was genetic engineering and nothing else that caused the appearance of the poison.


Coverup by the biotech corporations supported by FDA

When the kind of poison was found in the investigation of the disaster, that could be expected to be produced due to disturbed metabolic control, scientists began to express great concerns about genetic engineering.

Soon after the report saying that the poison in the tryptophan pills was similar to the amino acid tryptophan, a very confusing report appeared. This new report indicated, that even tryptophan itself could produce EMS-like symptoms. There are strong reasons to suspect that this report was "fabricated evidence".

This is because no other study has reported that tryptophan is harmful. Tryptophan is a natural substance, an amino acid that is part of the normal biochemistry of the body and such. Therefore, if tryptophan itself had been poisonous, EMS would have been a major disease of mankind. Actually, the US food and drug agency, FDA, now allows tryptophan to be used even in baby food.

Still, at that time, the "toxic tryptopan" report was taken by FDA as a reason to consider other reasons than GE for the toxicity.

The Biotech corporations had every reason to suppress and distort the evidence

Just at the time of the accident, the Biotech corporations were about to launch GE foods. If EBT were proven to be the cause of EMS, it would be probable that GE was the reason for the disaster. They realized that this would make it psychologically impossible to sell GE foods on the market without very expensive (billion dollar) safety testing which would wreck the whole GE food project that just was about to be launched.

Facing this threat, it is very likely that the corporations "encouraged" the fabrication of "advocacy" research reports that confused the issue (this would not have been the first time science was misused to promote corporate interests, see "Dysfunctional science"). The report that natural tryptophan caused EMS-like symptoms in rats was an ideal and effective confusing factor that contributed to the conclusion that the issue could not be settled.

FDA heavily biassed

As FDA is the authority responsible for food safety, they should have done everything possible to find out if GE caused the accident, considering that GE foods were about to be launched for commercial production. They should have initated a careful investigation of the suspect itself, the Showa Denko bacteria. This would have made it possible to find out for sure whether the poison was made by the bacteria and whether genetic engineering was the cause. But this was not done. The bacteria were avaialable and Showa Denko offered to send them to FDA for investigation, but FDA showed no interest, according to a message to us from an American lawyer who assisted Showa Denko. Later they were destroyed by Showa Denko.

In stead, the absurd report about natural tryptophan causing EMS-like symptoms was taken very seriously by FDA as an important reason for concluding that it was not clear that genetic engineering was the cause.

This may sound amazing, but it is a well established fact that FDA was heavily biassed in favor of GE foods, to the extent that, when the GE foods were about to be launched, it ignored severe warnings from its own scientists about using GE foods, and suppressed evidence indicating harmful effects of genetically engineered food. This was found out in an investigation of FDA protocols made by the lawyer Steve Druker in a lawsuit against FDA (4).

This explains why FDA, in spite of compelling reasons to suspect that genetic engineering caused the disaster, apparently was completely uninterested in finding out the real truth, and accepted very weak and unlikely evidence as an excuse to drop the case.


Summary

No other scientifically tenable reason for the appearance of the deadly poison has been found, and the probability for a metabolic disturbance to occur due to genetic engineering was considerable, considering that four different genes had been inserted, causing an especially great degree of instability in the cellular regulation of the production of tryptophan.

This is furthermore supported by the fact that unexpected poisonous substances have been reported also in some other cases of genetic engineering. On the other hand, when natural bacteria have been used for producing tryptophan and many other substances at a massive scale, no harmful substance has appeared.

Therefore, we can conclude with great certainty that a metabolic disturbance, caused by genetic engineering, was the reason for the appearance of the deadly poison in the tryptophan-producing bacteria of Showa Denko.



Usage of GE organisms, recipe for another disaster

  • This disaster shows that genetic engineering can generate unexpected substances that are so poisonous that even extremely small quantities can kill or cause severe disease.
  • This is not a unique accident, as unexpeted poisonous substances have been generated also in other organisms, including at least one genetically engineered plant. Unfortunately, genetic engineering is almost entirely sponsored by commercial interests that earn billions from genetic engineering. Therefore, it is highly probable that, if poisons have been generated and detected in the experimentation with GE, they have been kept strictly secret. In general, the biotech industry consider their laboratory data as business secrets, other than what is required for the approval procedures. We find this unacceptable, and demand full openness and honesty by the biotech corporations regarding their experimentation with GMOs. As long as this is not the case, we find it justified to posit that poisonous substances have appeared also in other GMO cases, buried as "business secrets" in the case they were discovered. However, because of the insensitive test methods used, poisons may have passed unrevealed in the experiments.
  • The established method for safety assessment of GE foods, based on "substantial equivalence", is not capable of reliably detecting unexpected hazardous substances. This is especially so in cases where they cause genetic disturbances or are carcinogenic. For an explanation for laymen, see our article "Inadequate safety assessment of GE foods". For a scientific explanation, see the article by professor John Fagan "Testing the Safety of Genetically Engineered Foods".
  • Therefore, it is only a matter of time before another unexpected toxin appears in GE food, which in the worst case might harm millions of people before the connection is discovered, especially if, as is the case in the US and Canada, the GE foods are not labeled.

Consequently, all GE foods must be withdrawn from the market before another disaster occurs.

If, for some ethically unacceptable reason, this is not immediately done, at least the GE-foods must be immediately labelled so people have a chance to avoid them. Presently the only way to do so in countries, including the US, where they are not labeled, is to eat only certified organically grown food.

GE can never be safe because of its inherent nature

It will take several decades to develop sufficent knowledge about genetic engineering so as to know how it works (see "Incomplete knowledge about DNA"). Already now there exists enough knowledge about the effects of GE to be able to conclude that GE is not safe enough for developing any kind of organism and that its inherent nature is such that it can never be safe. Therefore the only reasonable and sound scientific conclusion is that it is a dangerous method, not to be used, if at all, other than under strictly contained laboratory conditions.

It is no doubt a matter of time only before genetic engineering will be forbidden, and mankind will be amazed how governments and international organs, including the FAO and Codex Alimentarius, could allow such a potentially disastrous method to be deployed in spite of very incomplete knowledge of DNA and the effects of gene manipulation on the cell as well as its health and environmental consequences.

The reckless dissemination of genetically engineered foods and other GMOs is nothing less than a great scandal made possible by political suppression of serious warning signals and disinformation from corrupt or incompetent scientists sponsored by irresponsible multinational corporations.

It is not a question whether, but when the next disaster occurs. considering the serious incompleteness of knowledge and the highly insufficient safety assessment metods.

Showa Denko was the "Harrisburg" of Genetic Engineering. We should not need a "Chernobyl" before it is banned, especially as no GE food and no other GE product provides any such benefit that it is justified to take any risk at all by using it.



Concerned? What You can do.


References and additional info

1. For more about the catastrophe, see "Tryptophan summary"

2. The report of William Crist regarding the Showa Denko catastrophe as presented in the book "Seeds of deception" by Jeffrey Smith. It is an excellent presenation of the GE food issue reveailing the governmental corruption and the deceptive behavior of biotch corporations in the process of establishing commercial approval of GE foods.

3. a)Tobacco plants were genetically engineered to produce the Gamma-linoleic acid, a popular food supplement. In stead the plant unexpectedly mainly produced the toxic octadecatetraenic acid. This substance does not exist in the natural tobacco plant. (Reddy SA, Thomas TL. Nature Biotechnology, vol 14, sid 639-642, May 1996)
b) When a yeast was manipulated for increased fermentation there was an unexpected production of a metabolite (methyl-glyoxal) in toxic and mutagenic concentrations. (Inose, T. Murata, K. Int. J. Food Science Tech. 30: 141-146, 1995).

4. FDA lawsuit

5. Excerpt from our Open Letter: "We, the undersigned scientists and physicians, demand that all genetically engineered (GE) foods be withdrawn from the market unless they have undergone rigorous safety assessment including long term testing on animals and humans." No GE food sold as human food has presently undergone such testing.

6. Inadequate safety assessment of GE foods.

7. An example of fatal substantial equivalence. Applying the Showa Denko case, we demonstrate how useless and insufficient the present safety assessment procedure is.

8. Professor Gilles-Eric Seralini pointed out serious weaknesses in the safety analysis of a GE Maize variety that was approved as harmless on the basis of substantial equivalence. More.


Harrisburg - another accident whose significance was ignored for fostering dubious technology

As long as politics and corporate interets are allowed to suppress scientific safety concerns, the world is in great danger

The "Harrisburg accident" occurred 1979 in a nuclear reactor in Harrisburg, PA, US, that came close to meltdown (also called the "Three mile Island accident"). It sparked the discussion of the safety of nuclear energy. But not until the Chernobyl catastrophe occured in 1986, the further usage of nuclear energy in the US and other countries was either stopped or plans were made to replace it with other solutions as soon as possible.

Before Harrisburg, experts sponsored by the US and other governments, fervently denied that the technology was unsafe. Still several independent experts had warned that nuclear energy reactors are unsafe. This situation is very similar to the denial today of GE risks by biotech sponsored scientists and the refusal of governements to listen to the well underpinned warnings of impartial experts including PSRAST.

This shows that it is unacceptable and dangerous that governmental bodies interfere with, and override technology assessments made by impartial scientists. They evidently don't have the competence, foresight, intelligence and sense of responsibility to be able to handle complex technological issues. Unfortunately corruption of government officials and politicians has contributed to suppression of truth.

This danger is especially great now that science has reached a level where it is capable of generating very powerful technologies that can destroy the Earth.

We have suggested the establishment of national and international councils of truly independent experts that have the ultimate, unrestricted power to decide for the country, or for the world, in issues regarding responsible and safe application of new technologies, see "A suggested procedure...". History has very clearly shown that there are very strong reasons to create such bodies whose decisions are imperative and cannot be overrun by any political or corporate influence.


Physicians and Scientists for Responsible
Application of Science and Technology
- A Global Network -


"Genetically Engineered Food - Safety Problems"
Published by PSRAST

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