Ten Years of Agbiotech Commercialisation Mistakes.

Ten years of biotech gaffes
March 1, 2006
Nature Biotechnology Commentary
John Hodgson
Excerpt below, Full text (subscription) at http://www.nature.com/news/2006/060306/full/nbt0306-270.html
via AgBioView at www.agbioworld.org

'Much of biotech's success has been built on lessons learned from mistakes. But the past ten years has also witnessed mistakes many in biotech would prefer to forget.'
On the occasion of Nature Biotechnology's 10th anniversary, it would seem right and proper to celebrate some of biotech's greatest achievements. But I shall leave the plaudits to others, elsewhere in the journal.

This article is about biotech's memorable gaffes, the deeds or events that their doers would rather forget. In a field of human endeavor where so much is about transforming something that is hardly known into plausible products for unserved markets, it would be surprising if no mistakes were made along that tricky way. From the appointment of the wrong executives to the misworded legal document, most biotech companies are replete with everyday errors, the kind of mistakes that could happen to anyone and which are readily and rapidly correctable, almost before anyone finds out. I will be leaving such trifles unconsidered.
What I deal with here are the 'bio-bloopers' that mattered, the events that had, or still have, repercussions for the life science industry or for those who depend on it.
This is not a definitive list of the errors and idiocy prevalent in this industry and the gaffes are presented in no particular order. Other goofs should doubtless have been included, and I encourage readers to send feedback on major omissions to the journal.

Gaffe 3: Muddled messages in agbiotech
Gaffes in the agbiotech area could probably fill an entire article on their own; last year's cockup in which Syngenta (Basel, Switzerland) admitted that it has been selling an unapproved transgenic corn seed, Bt10, to US farmers between 2001 and 2004, being a recent example. But industry is not wholly culpable for lukewarm public acceptance and stigmatization of transgenic crop technology.

In November 2001, Nature published a paper by David Quist and Ignacio Chapela of the University of Berkeley, California, that purported to show that transgenic DNA constructs had been found in farmers' landrace maize varieties cultivated in remote parts of Mexico, the center of genetic diversity of the crop. This work caused consternation in environmental circles, with renewed calls from activist organizations such as Greenpeace and Friends of the Earth for moratoria and outright bans on transgenic crops. The Mexican government reacted to the paper by amending its genetic modification regulations, making bench researchers liable for breaches of the rules and by banning the export or import of any form of recombinant DNA.

It subsequently transpired that the Quist and Chapela paper was technically flawed. The method of inverse PCR used to detect the transgenes was suspect, and Quist and Chapela were unable to provide samples to enable other researchers to analyze their findings. By April 4, 2002, Nature itself had disavowed the paper (although the authors still stand by their findings) with an editorial note that indicated it would not have published the paper had the criticisms that arose after publication arisen during the review process. A subsequent study of 150,000 samples from Mexican maize failed to find a single sample in which transgenes were detected, this despite the analysis having been carried out by Genetic ID (Fairfield, IA, USA), the favorite DNA diagnostics company of Yogic flyers.

The fallout. With so many of the groups ideologically opposed to transgenic crops able to exploit the media, scare the public and perpetuate myths and conspiracy theories about genetic engineering over the Internet, prestigious journals should be aware of the long-lasting damage resulting from their willingness to widely publicize results that may be contentious or equivocal. Reviewers and editors at journals also have a responsibility to ensure that peer-reviewed data are reliable. Scientific gaffes such as this one, and media distortion of the results of a laboratory study of the effects of Bacillus thuringiensis (Bt) toxin on Monarch butterfly larvae published before it, certainly contributed to the decline of European agbiotech (from 264 field trials in 1997 to 35 field trials in 2002).

Gaffe 4: European 'novel food' regulation [Pundit Note: See rebuttal comment at the end]
After years of indecision and wrangling between European Union (EU) member state governments, the European Council agreed on regulations for 'novel foods' in May 1997. A novel food was one, the legislation said, that was not "substantially equivalent" to something already on the market. The logical thinkers in science and industry concluded that many genetically modified (GM) foods would be substantially equivalent to existing types and therefore they would escape additional and meaningless labeling. However, the EU Novel Food Regulations had not defined how equivalence or nonequivalence would be determined or indeed how big 'substantial' is.

In the event, substantial turned out to mean that if any smidgeon of protein product or recombinant DNA could be detected, then the food would fail the "substantial equivalence" test. Substantial thus meant "detectable by the most refined genetic or protein test." Improved PCR-based methods, often developed in collaboration with the European Commission's Joint Research Centers in Ispra, Italy and Geel, Belgium, meant that any food over which a GM grain or bean had breathed was no longer substantially equivalent, not withstanding the fact that the genetic modification in question had no material impact on the product. Consequently, all food containing any amount of GM flour or GM rapeseed oil had to be labeled "contains GM ingredients" or "may contain GM ingredients."

The fallout. The opponents of genetic modification were quick to act within the logical void. They tested unlabeled food products and publicized the results. They promulgated boycotts of supermarket chains and retailers throughout Europe and the United States until each of the companies signed up to a GM-free policy. One-by-one these giant corporate pussycats not only bowed to this unreasoned pressure but made marketing capital from it. 'GM-free' labels now shout out emptily from every supermarket floor in Europe.

The take-home lesson: don't expect political fights to be clean and don't expect big business to support logic when markets are at risk.

Update
Ten Years of Biotech Gaffes? in Agbioview March 9 2006

- Prof J Ralph Blanchfield, MBE - jralphb#easynet.co.uk -

In his "Gaffe 4: European 'novel food' regulation" John Hodgson (Nature Biotechnology "Ten years of biotech gaffes"), quoted in Agbioview 8 March 2006, the gaffe is in fact John Hodgson's. He has got his history wrong.

He writes "After years of indecision and wrangling between European Union (EU) member state governments, the European Council agreed on regulations for 'novel foods' in May 1997. A novel food was one, the legislation said, that was not "substantially equivalent" to something already on the market.

The logical thinkers in science and industry concluded that many genetically modified (GM) foods would be substantially equivalent to existing types and therefore they would escape additional and meaningless labeling. However, the EU Novel Food Regulations had not defined how equivalence or nonequivalence would be determined or indeed how big 'substantial' is."

In fact the EU 1997 Novel Foods Regulation to which he refers did/does NOT define "novel foods" in term of "substantial equivalence" (and that term does not appear anywhere in Regulation! -- which may be seen at http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&numdoc=31997R0258&model=guichett In fact "novel food" was defined in Articles 1 of the Regulation as follows

Article 1
1. This Regulation concerns the placing on the market within the Community of novel foods or novel food ingredients.
2. This Regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories:
(a) foods and food ingredients containing or consisting of genetically modified organisms within the meaning of Directive 90/220/EEC;
(b) foods and food ingredients produced from, but not containing, genetically modified organisms;
(c) foods and food ingredients with a new or intentionally modified primary molecular structure;
(d) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
(e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;
(f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.