TechNyou

A burst of research involving modified mosquitos to control diseases such as malaria and dengue has prompted scrutiny of the research itself and the regulatory oversight attached to it.

For previous news on this research see

here and here

Even though the research has been happening in the lab for some time, there are concerns we don’t have sufficient scientific knowledge about potential effects on the environment and human health and the regulatory authorities in the respective countries haven’t the legislation to deal with this novel technology. Others of course dispute this, namely one of the companies involved in the development of a genetically-modified mosquito.

PLOS has dedicated their January 2012 edition to tropical and neglected diseases and sought the opinion of the various players in this area for their views on the science surrounding genetically modified insets and their regulation. The focus is on the US and Europe, but Australia gets a mention and generally we fair pretty well

Issues raised

The main issues were raised by Reeves et al in their article, Scientific Standards and the Regulation of Genetically Modified Insects.

Their key gripes were a lack of transparency in the regulatory system, a lack of data to support their decisions and an over reliance on unpublished data, as suggested by the following:

“The selective use of unpublished or non-peer reviewed evidence to support contentious conclusions has been repeatedly questioned”

“Additionally, the failure of US regulators to publish data (in this case their own data) prior to their inclusion in regulatory documents represents a worrying precedent for the scientific quality and transparency of future environmental impact assessments.”

“However, despite these advantages, the flow of information to the public and scientific domain over the last 9 years has been limited. In fact, it can be argued that dissemination of relevant information is so restricted that it undermines the value of public consultation exercises, as comments will almost by definition be ill-informed and readily dismissed as such.”

For the defence

The defence being the people from Oxitec who is developing genetics-based control solutions for pest insects. One of these is the GM mosquito modified to control dengue fever, which they have had limited trial releases of in the Caymans and Malaysia.

These guys actually agree that greater transparency in permit applications, reports and the science is in most, if not all, cases better. If for no other reason, one would hope it would help build confidence in the regulatory system. But the Oxitec guys defend this position only so far claiming a right to protect their intellectual property.

The question is can we achieve public accountability and still allow companies to protect their IP? This ain’t my area of expertise, but I would have thought that it was possible.

They also defend the regulators use of unpublished data calling their assumptions naive. Their following barbs pretty sum up their feelings here:

“Reeves et al. are also on weak ground when they assert that regulators should consider only information published in peer-reviewed journals. This assertion depends on three assumptions: that journal peer-review is a superior guarantee of quality than any other method, that no data from any other source can be of adequate quality to warrant consideration, and that regulators themselves are incapable of adequately assessing the quality and significance of data provided to them. Each of these assumptions is naïve at best.

…Furthermore, journals select papers for publication using criteria that are not fully congruent with the needs of regulators. In particular, it is difficult to publish negative data. Studies showing lack of difference between a transgenic strain and its unmodified wild-type counterpart may be of great interest to regulators but not to journal editors.”

Suffice to say that there is healthy debate. The difference with these opposing groups is that there is no outright rejection of the science or its potential uses simply because it involves GMOs. The debate lies with the regulatory response and how the scientific and regulatory process is communicated to society to ensure adequate oversight.

Oz regulations

One of the problems, of course, is that regulations are not consistent across countries. So how does it work in Australia if a company or research group wants to release genetically modified mosquitos, or any other insect?  Who regulates and monitors this and do we have oversight that is robust enough to minimise risk to the environment and human health? Of course, what is an appropriate risk will differ for each person, but the following is how it works in Australia. Whether it is adequate is for you to judge.

For anything to do with a genetically modified organism (GMO) the bucks starts and stops with the Australian Office of the Gene Technology Regulator (OGTR).

Although Australia has yet to release into the environment any genetically modified animal there has been considerable research on using the technology to control pest animals such as the European Carp, mouse, rabbit and fox. None of this left the laboratory.

Process to release GM animals in Australia

The following relates to groups wanting to intentionally release a GMO into the environment. This falls under the criteria called Dealings involving and Intentional Release (DIR).

They can be a limited controlled release (ie small numbers in a limited area usually a field trial), or a commercial release such as what Oxitec want to eventually do with their GM dengue mozzie. Each are treated differently under OGTR regulations

A limited release DIR has a 150 day assessment process where they assess the application, confer with the states and territories and put together a risk management plan. This is then made public (online, etc) for comment. The OGRT make any decisions regarding the granting of a licence or if there are any risk management criteria that accompany such a licence based on these consultations and any other associated scientific literature and reports available.

If the request is for a commercial release then the assessment process is 255 days and there are two rounds of public consultation allowed for assessment of the risk management strategy.

Some context

As pointed out in the last PLOS article by Mumford, billions of mass-reared insects, which are not GM, are released into the wild each week around the world. Many are non-native pest species reared, irradiated, and distributed in sterile insect release programs.

In Australia we have released loads of fertile insects and other organisms such as fungi as biological control agents. Thousands of other similar biological control agents have been released worldwide. The cane toad is the obvious example that went wrong, but today there is years of science done and intense regulatory oversight for any proposed biological control organism.

The Wolbachia example

Wolbachia-infected mosquitos have had a limited trial release in Australia in the hope they will help control dengue fever. For the story on the Wolbacia research see here

Because the Wolbachia-infected mosquito is not a genetically modified organism, the scientists involved in the research and the mosquito’s release report at a conference they struggled to find the appropriate regulatory procedures that applied to their technology to ensure responsible oversight and approval. The risk assessors in that case have called for the regulatory process to be reviewed to ensure that it is appropriate for both proponents and regulators.

From Mumford, PLOS: “Although it is not a GM release as neither of the organisms involved have foreign genes inserted, the recent Australian release of Ae. aegypti transformed with Wolbachia (which reduces the capacity of the mosquito to act as a vector of dengue) is an interesting example of the state of regulation in this general area. The authors state “Approval for the release of Aedes aegypti containing Wolbachia was provided by the Australian Pesticides and Veterinary Medicines Authority.”

Nanowerk Spotlight: 2 February 2012

RSC Chemisry World: 1 February 2012

The Guardian: 31 January 2012

New Scientist: 30 January 2012

Image: Yuji Sakai/Digital Vision/Getty

Nanowerk: 30 January 2012

The Guardian 29 Jan 2012, Cloning scientists create human brain cells

UC SanDiego 25 Jan 2012, Researchers Induce Alzheimer’s Neurons From Pluripotent Stem Cells

Guardian Science: 26 January 2012

TechNyou

In reference to the news story I posted this morning about the feeding trials of pigs with Bt corn, the kind people from Teagasc has supplied me with some proceedings and slide presentations from this research – see below.

I will appreciate anyone’s thoughts on the study, their analysis, it implications and any shortcomings in the research methodology and initial results, etc,

I mentioned that I thought the data was unpublished. It turns out that part of the research – the short-term feeding stuff – has been published in the British Journal of Nutrition and is now available for review (Walsh et al., 2011).

Links to

Proceeding paper

Pig_Conference_Proceedings2011

Slide presentation

8_GMSAFOODSlidePresentation

Further Teagasc research 

Hanging questions and caveats

The proceedings paper doesn’t explicitly say if the GM and non GM Bt corn used in the trials were exactly the same cultivars – see following extract:

The Bt maize was grown in a neighbouring plot to the non-GM maize counterpart under identical environmental conditions in Valtierra, Navarra, Spain and the only difference between the two maize types was the Bt toxin.

This is important as two cultivars of corn can have radically different nutrient profiles, and levels of other compounds such as naturally occurring allergens, toxins and anti-nutrients. They were at least grown under identical conditions – something else that can significantly change these components.

These results only apply to the short and medium-term studies because the laboratory analysis for the long-term data is still happening. There a few lines of, “further research will need to be done to find out what is happening…” in the proceedings so we will have to wait and see. It is possible the long-term feeding analysis will provide some answers and clarification.

Couple of findings

I have yet to analyse the paper in detail and will probably wait until the long-term trial analysis is completed, but here a couple of the findings that jumped out.

Results from the medium-term study found that feeding Bt maize to pigs for 110 days had no effect on body weight, their average daily weight gain or their average daily feed intake.  But average daily feed intake (ADFI) was higher in pigs fed Bt maize during days 14-31 and overall from day 0-31. However, there was no difference in body weight between the two groups of pigs on day 31. Overall, feed efficiency was not affected by feeding Bt maize even though pigs fed Bt maize were less efficient on days 14-31 which was a consequence of higher feed intake by these pigs at that time. In other words weanling pigs were eating more during days 14-31 but their weight gain was the same as the conrol pigs.

If this difference in ADFI at days 14-31 is real (ie, it would need to be repeated and probably with a larger sample) then it would be interesting to know why this is happening.

In the slide presentation they present the finding that Bt maize may offer protection against an inflammatory response observed following non-GM maize consumption. I wonder if this is because maize is notoriously affected by a fungal toxin that is prevalent in corn damaged by insects?  Has anyone got any knowledge on this and if this may be a cause?

Update (30 Jan 2012)

Peadar Lawlor the head of the Irish component of the project got back to me re: the research and plans for publication. His response, “… we will have ~12 peer review papers from this work by the middle of this year. We have published in the British Journal of Nutrition, Animal, PLoS ONE etc. We will publish all our work from the project.” All links to papers and research updates will be posted on their website see Teagasc link above

And here is the link to their PLoS One paper

Home page image: impactlab.net

Teagasc: 24 January 2012

TechNyou

Note. this research has yet to be per-reviewed as far as I can tell, so it has yet to be subjected to the scrutiny of other scientists. At the moment the reserach is to be presented at a scientific meeting in March. I am unsure if there are plans to publish it in a scientific journal. I have emailed Teagasc to find out.

Image: waterfootprint.org