Pusztai responds to ACNFP over Ermakova (19/1/2006)

Below is Dr Arpad Pusztai's response to a statement by the UK's Advisory Committee on Novel Foods and Processes (ACNFP) on a study carried out by Dr Erina Ermakova from the Russian Academy of Sciences. Dr Ermakova found that where female rats were fed on genetically modified soya their progeny were five times more likely to die within three weeks of birth than those of mothers fed on normal soya. Also, many of the baby rats born to mothers fed the GM soya diet were seriously underweight. ACNFP, who as Dr Pusztai notes advise the UK's Department of Environment Food and Rural Affairs, the Food Standards Agency and the Government, are a committee that's notorious for having been stacked with GM supporters, as well as for lacking expertise in nutrition. Despite this, Dr Pusztai accepts that it is perfectly reasonable for ACNFP to point to the lack of detail that currently exists about Dr Ermakova's study. What has proven more controversial in the ACNFP statement is the critical comparison ACNFP make with a study by Brake and Everson. Dr Pusztai argues that this comparison is completely invalid, as is the implication that Brake and Everson's research is of a better quality. We will be posting further comments from Dr Pusztai on these points. Dr Pusztai also points to the way in which the issue of lack of peer reviewed publication is being used by the ACNFP against Dr Ermakova, when in fact the head of the ACNFP and others, including a former head of the ACNFP (Derek Burke) and the Royal Society, have in the past sought to fudge the issue of peer review when they have found it useful as a means of contradicting research in the peer reviewed literature that raised questions about GM. Here are ACNFPs closing remarks in full and a link to their full statement: "In conclusion, there are a number of possible explanations for the results obtained in this preliminary study, apart from the GM and non-GM origin of the test materials. Without information on a range of important factors conclusions cannot be drawn from this work. The Committee Secretariat is contacting Dr Ermakova to obtain further information on this study and the Committee will consider any further information that can be obtained and review the position if a full report of the study is published in the peer-reviewed literature. The Committee also notes that Dr Ermakova's findings are not consistent with those described in a peer-reviewed paper published in 2004.1 In a well controlled study no adverse effects were found in mice fed on diets containing 21% GM herbicide-resistant soya beans and followed through up to 4 generations." Statement on the effect of GM soya on newborn rats. Advisory Committee on Novel Foods and Processes (5.12.05). http://food.gov.uk/multimedia/pdfs/acnfpgmsoya.pdf --- Pusztai on the ACNFP's response to the Ermakova study: I have to say in advance that some of the points raised by ACNFP are quite valid and until and unless all the details of her experiments are known it is very difficult to give a balanced opinion on her work. Although I in fact have the advantage of having personally met her in Frankfurt last year at the Epigenetics meeting and of having been able to question her, I am still not clear about some of these vital details. I think that she was somewhat unwise to make a submission or report to ACNFP before properly publishing the study because this committe cannot be regarded as an impartial arbiter, let alone as having sufficient nutritional expertise and know-how to judge the value of Ermakova's work (that must be obvious from their reference to the Brake and Evenson paper, see later!). One more point, she gave a paper at this Frankfurt meeting in front of scientists who did question her and, as I understand, there will be a printed version of her paper in the meeting's proceedings. The reason why I mention this is because the Royal Society and others (including a review published in Nature Biotechnology and authored by Gasson [head of the ACNFP] and Burke) repeatedly referred to how before the Chinese paper on GM sweet peppers was published in the sense that its author, Professsor Chen, gave it at a conference in front of scientists and therefore this could be regarded as equivalent to publication. It appears, however, that this only applies to pro-GM scientists and not to those who are sceptical about the merits of this new technology. Incidentally, our GM potato work was also described to other scientists at meetings before and after the 15O sec TV interview but of course that also did not qualify as publication! Now to the Brake and Evenson paper: I shall have to draw the attention of the ACNFP experts to the fact that Brake and Evenson actually studied testicular development in male mice and, that, unless these animals had a sex change, the results can have limited value and relevance to the pregnant female rats in Ermakova's study. The ACNFP's nutritional expertise comes as bit of a surprise to me. Although it is quite true that we know very little about the GM and the non-GM soybean samples Ermakova used in her study, at least she tried to keep the animals on a feeding regime that is better described than in the Brake and Evenson paper which is being held up as the "gold standard". I know that two poorly described experiments do not make a good one but the ACNFP's experts should not have referred to a paper that was not even as good as Ermakova's description of her experiment. Some time ago I was asked to give my comments on the Brake and Evenson paper I shall now copy this to you together with the Abstract of their paper and then make some final comments: --- I have read the paper. The study uses a very sophisticated method for testing for any potential harmful effects of GM soybeans on male mice. Unfortunately, the authors should have consulted someone with a firm grasp of nutritional principles and design because their flawed design of feeding (as described in the paper) from the start has made it impossible for them to draw any meaningful conclusions. I have to say that this is a common mistake committed by pro- or anti-GM scientists alike when they start up such studies. Most of these people think nutrition is the poor man's science and therefore that what you need is a bunch of animals that will be thrown some rubbish as their diet and then you make your meaasurements. Just because we all eat, we are not nutritional experts. --- Abstract A Generational Study of Glyphosate-Tolerant Soybeans on Mouse Fetal, Postnatal, Pubertal and Adult Testicular Development* Brake, D.G., and D.P. Evenson. 2004. /Food Chemistry and Toxicology/42:29-36 The health safety of transgenic soybeans (glyphosate-tolerant or Roundup Ready) was studied using the mammalian testis (mouse model) as a sensitive biomonitor of potential toxic effects. Pregnant mice were fed a transgenic soybean or a non-transgenic (conventional) diet through gestation and lactation. After weaning, the young male mice were maintained on the respective diets. At 8, 16, 26, 32, 63 and 87 days after birth, three male mice and an adult reference mouse were killed, the testes surgically removed, and the cell populations measured by flow cytometry. Multi-generational studies were conducted in the same manner. The results showed that the transgenic foodstuffs had no effect on macromolecular synthesis or cell growth and differentiation as evidenced by no differences in the percentages of testicular cell populations (haploid, diploid, and tetraploid) between the transgenic soybean-fed mice and those fed the conventional diet. Additionally, there were no differences in litter sizes and body weights of the two groups. It was concluded that the transgenic soybean diet had no negative effect on fetal, postnatal, pubertal or adult testicular development. --- My final comment: It is possible that the Ermakova study is flawed but possibly it is not. We, or even the ACNFP, do not know for certain either way. However, I understand the ACNFP's role in GM-regulation is to advise the Department of Environment Food and Rural Affairs, the Food Standards Agency and the Government on what may or may not present dangers to consumers in any new product or process, whether GM or not, in this country. In the light of this, if her study has even 1% chance of being true it would be the duty of this advisory committee and the scientists in it to urge, nay demand, the appropriate authorities to repeat the study and see if her findings are true or not or perhaps even do the work themselves. But, of course, they have no laboratory of their own because rubber-stamping of GM submissions does not require one. We have been demanding in all of our publications that reproduction performance studies must be done with all GM crops used for food before they are released into the human (or animal) food chain. If it was useful for nothing else, the Ermakova study might have opened the way to serious reproduction risk assessment studies. But from past experience it appears that the carpet is already lifted and the brush is ready!

http://www.gmwatch.org/archive2.asp?arcid=6149