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RISK ASSESSMENT & APPROVAL: GM mosquito release in Malaysia surprises opponents and scientists - again



                                  PART 1


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TITLE:   GM MOSQUITO RELEASE IN MALAYSIA SURPRISES OPPONENTS AND SCIENTISTS - AGAIN

SOURCE:  Science, USA

AUTHOR:  Martin Enserink

URL:     http://news.sciencemag.org/scienceinsider/2011/01/gm-mosquito-release-in-malaysia.html?ref=ra

DATE:    27.01.2011

SUMMARY: "Some 6000 transgenic mosquitoes developed to help fight dengue were released in Malaysia on 21 December, according to a statement issued by the country?s Institute for Medical Research in Kuala Lumpur yesterday. Just like the first releases ever of the mosquitoes, on the Caribbean island of Grand Cayman in 2009 and 2010, the news came as a surprise both to opponents of the insects and to scientists who support them."

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GM MOSQUITO RELEASE IN MALAYSIA SURPRISES OPPONENTS AND SCIENTISTS - AGAIN

Some 6000 transgenic mosquitoes developed to help fight dengue were released in Malaysia on 21 December, according to a statement issued by the country?s Institute for Medical Research (IMR) in Kuala Lumpur yesterday. Just like the first releases ever of the mosquitoes, on the Caribbean island of Grand Cayman in 2009 and 2010, the news came as a surprise both to opponents of the insects and to scientists who support them.

The mosquitoes were developed by Oxitec, a U.K. biotech firm that aims to fight dengue by releasing massive numbers of ?genetically sterile? male Aedes aegypti mosquitoes. When wild females mate with these transgenic males, there are no viable offspring; the hope is that, as a result, the mosquito populations will collapse.

The news appears to have caught the Malaysian media and public by surprise; many recent news stories reported that the study had been postponed after intense protests. As recently as 17 January, the Consumers? Association of Penang and Sahabat Alam Malaysia, two groups opposing the use of GM insects, called on the National Biosafety Board to revoke its approval for the study. Scientists, too, were under the impression that the work had yet to begin, says medical entomologist Bart Knols of the University of Amsterdam. A 24 January blog post by Mark Benedict, a consultant at the Centers for Disease Control and Prevention in Atlanta who monitors the field closely, mentioned that the Malaysian study was ?planned.?

Knols worries that surprises such as the releases in Grand Cayman and Malaysia may erode public trust and provide anti-GM groups with ammunition. The two Malaysian groups, for instance, issued a statement yesterday saying they were ?shocked ... we condemn the apparently secretive manner in which the trials have been conducted.? Helen Wallace of the advocacy group GeneWatch UK says the lack of communication does little to instill confidence in Oxitec.

Oxitec?s chief scientific officer, Luke Alphey, confirms that Malaysian media had it wrong. But Alphey says ?nobody should have been terribly surprised? by the release. Once all the regulatory hurdles had been overcome, ?it seems predictable that the next step would be the actual release,? he says. Oxitec did not announce the news itself because that wasn?t the company?s role, says Alphey: ?This was a study by the Malaysian government done in Malaysia. It was up to them to announce it.?

Carried out in a remote area of Bentong, a district in the central state of Pahang, the study was designed to test transgenic males? survival and mobility, Alphey says. Some 6000 wild-type males, as well as controls, were released. The study ended on 5 January, after which insecticides were sprayed to kill any remaining mosquitoes, says IMR.

Wallace believes Oxitec is rushing ahead with field trials because it needs to start making money. In a recently posted analysis (pdf), GeneWatch UK claimed that the company is losing some £1.7 million ($2.7 million) per year and needs to pay back a £2.25 million ($3.6 million) loan by 2013. But Alphey says that?s not the reason. ?We are a for-profit company and finance is not irrelevant,? he says. ?But anyone who realizes that there are 50 to 100 million cases of dengue every year would feel a sense of urgency.?

The study carried out in Grand Cayman last summer was much bigger. There, some 3 million mosquitoes were released to test whether they could actually help bring down the local population. A paper describing the results?an 80% decrease in mosquito numbers?has been submitted to Science, Alphey says.



                                  PART 2

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TITLE:   CAP AND SAM DEPLORE LACK OF TRANSPARENCY ON RELEASE OF GM MOSQUITOES

SOURCE:  Consumers Organisation of Penang, Malaysia

AUTHOR:  Press Release

URL:     http://www.consumer.org.my/development/environment/569-cap-and-sam-deplore-lack-of-transparency-on-release-of-gm-mosquitoes

DATE:    26.01.2011

SUMMARY: "CAP and Sahabat Alam Malaysia are very shocked to learn from press reports today that GM Aedes mosquitoes were released on 21 Dec 2010 in Bentong, Pahang. This despite statements in the press in January 2011 by senior Biosafety Department officials saying that the trials had been postponed due to bad weather. We deplore the lack of transparency on the issue, in particular the way in which the Institute for Medical Research released its press statement more than one month after the trials began."

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CAP AND SAM DEPLORE LACK OF TRANSPARENCY ON RELEASE OF GM MOSQUITOES

CAP and Sahabat Alam Malaysia (SAM) are very shocked to learn from press reports today that GM Aedes mosquitoes were released on 21 Dec 2010 in Bentong, Pahang. This despite statements in the press in January 2011 by senior Biosafety Department officials saying that the trials had been postponed due to bad weather. We deplore the lack of transparency on the issue, in particular the way in which the Institute for Medical Research (IMR) released its press statement more than one month after the trials began. Given that the release of GM mosquitoes has attracted criticism, we condemn the apparently secretive manner in which the trials have been conducted. Such behavior does not do anything to allay the public?s fears and concerns. We are deeply disappointed that the trials have gone ahead in spite of the widespread national and international concern over GM mosquitoes. We hold the concerned agencies fully responsible for the consequences of the release of the GM mosquitoes.



                                  PART 3

------------------------------- GENET-news -------------------------------

TITLE:   PAHANG PAS SLAMS BENTONG MOSQUITO RELEASE

SOURCE:  Free Malaysia Today, Malaysia

AUTHOR:  K. Pragalath & G. Vinod

URL:     http://www.freemalaysiatoday.com/2011/01/28/pahang-pas-slams-bentong-mosquito-release/

DATE:    28.01.2011

SUMMARY: "The release of laboratory mosquitoes in Bentong last month continues to draw condemnation from groups concerned about uncertainties in the experiment. [...] PAS today became the first political party to condemn the field test, saying the news was ?shocking?. Pahang PAS commissioner Tuan Ibrahim Tuan Man, in a statement carried on Harakahdaily, said his office had received ?many complaints? since the release was reported."

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PAHANG PAS SLAMS BENTONG MOSQUITO RELEASE

The opposition party joins green groups in condemning the secrecy of the field test.

PETALING JAYA: The release of laboratory mosquitoes in Bentong last month continues to draw condemnation from groups concerned about uncertainties in the experiment.

They are especially critical of the secrecy of the exercise.

The Institute of Medical Research (IMR) said on Wednesday that 6,000 genetically modified (GM) mosquitoes designed to combat dengue fever were released in an uninhabited forest outside Bentong on Dec 31 and that ?the experiment was successfully concluded? on Jan 5.

PAS today became the first political party to condemn the field test, saying the news was ?shocking?.

Pahang PAS commissioner Tuan Ibrahim Tuan Man, in a statement carried on Harakahdaily, said his office had received ?many complaints? since the release was reported.

?The people have been caught by surprise,? he said.

Tuan Man is also a vice president of his party.

Opponents of the IMR test are dismayed because they which were under the impression that the government had postponed the release to an unspecified date in deference to the negative public sentiment that has been apparent since last October, when the National Biosafety Board anonunced its approval.

NGOs concerned

Sahabat Alam Malaysia (SAM) described the surreptitious nature of the test as ?outrageous?.

?We hold the concerned agencies fully responsible for the consequences of the release of the GM mosquitoes,? SAM said in a press statement signed by its president, SM Mohamed Idris, who said he was speaking as well for the Penang Consumers? Association, which he also leads.

According to authorities, the 6,000 insects were all male Aedes aegypti mosquitoes. But the Centre for Environment, Technology and Development of Malaysia (CETDEM) expressed concern that female mosquitoes might have been accidentally released.

?The available information provided does not indicate whether the reliability and efficiency of the sex selection process can be guaranteed,? a CETDEM press statement said.

?The accidental release of a percentage of GE female mosquitoes will raise further concerns, as females act as vectors for diseases such as dengue and chikungunya.?

The GM mosquito carries a DNA fragment designed to curb its fertility. It was developed by Oxitec, an Oxford-based biotechnology company.

Last year, Oxitec carried out a field trial in the Cayman Islands involving the release of about three million GM male mosquitoes. The company said the local population of the Aedes aegypti fell by 80 per cent.



                                  PART 4

------------------------------- GENET-news -------------------------------

TITLE:   LIOW: GM AEDES MOZZIE TRIAL NOT DONE NEAR ANY COMMUNITY

SOURCE:  The Star, Malaysia

AUTHOR:  

URL:     http://thestar.com.my/news/story.asp?file=/2011/1/28/nation/7880836&sec=nation

DATE:    28.01.2011

SUMMARY: "The trial for genetically-modified Aedes mosquitoes did not need the agreement of any local community because it was carried out in an uninhabited area, said Health Minister Datuk Seri Liow Tiong Lai. [...] Liow said the ministry would call for a public forum when the findings were completed, where details of the findings would be explained.

?For now, no more release of the mosquitoes,? he said."

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LIOW: GM AEDES MOZZIE TRIAL NOT DONE NEAR ANY COMMUNITY

PETALING JAYA: The trial for genetically-modified Aedes mosquitoes did not need the agreement of any local community because it was carried out in an uninhabited area, said Health Minister Datuk Seri Liow Tiong Lai.

The trial carried out recently was in a forested area away from human dwellings, he said.

?We did not carry out the trial in (human) inhabited areas,? he said.

Liow was responding to non-governmental organisations, which had voiced their disappointment over what they claimed was a lack of transparency over the trial.

He said an earlier announcement by the Institute for Medical Research (IMR) referred to a trial that was meant for an inhabited area, and that had been postponed.

An announcement reported yesterday referred to a trial in an uninhabited area in Bentong, Pahang that started on Dec 21 and ended on Jan 5.

He said the trial was contained because mosquitoes did not fly beyond 200m, and the area had been fogged after the trial to ensure that all the mosquitoes were killed.

?We adhered to all the bio-safety procedures and guidelines for the trial,? he said.

Liow said the ministry would call for a public forum when the findings were completed, where details of the findings would be explained.

?For now, no more release of the mosquitoes,? he said.



                                  PART 5

------------------------------- GENET-news -------------------------------

TITLE:   LET IT SNOW: FIELD-TESTING MALARIA-REFRACTORY STRAINS BY INUNDATION

SOURCE:  Malaria World, The Netherlands

AUTHOR:  M. Q. Benedict

URL:     http://www.malariaworld.org/blog/let-it-snow-field-testing-malaria-refractory-strains-inundation

DATE:    24.01.2011

SUMMARY: "In July of 2010, the Mike Riehle lab reported that they had created a transgenic strain of Anopheles stephensi that was refractory to malaria. However, as they noted, there is no way to spread the transgene into wild populations thus making this an important laboratory finding waiting for an undeveloped drive mechanism. I?ll argue that this provides an opportunity rather than a hurdle."

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LET IT SNOW: FIELD-TESTING MALARIA-REFRACTORY STRAINS BY INUNDATION

In July of 2010, the Mike Riehle lab reported that they had created a transgenic strain of Anopheles stephensi that was refractory to malaria (first author Corby-Harris (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2904800/ and http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2919565/?tool=pubmed). However, as they noted, there is no way to spread the transgene into wild populations thus making this an important laboratory finding waiting for an undeveloped drive mechanism. I?ll argue that this provides an opportunity rather than a hurdle. How? Read on.

Alan Robinson and I (http://tinyurl.com/63n8bm7) and Luke Alphey (http://www.ncbi.nlm.nih.gov/pubmed/12225915) have argued that developing transgenic applications for mosquito control should be done incrementally, beginning with simple self-limiting approaches: transgenic mosquitoes that are sexually sterile are a safe place to start, and they offer the possibility of a positive effect on public health. This anticipated beginning has occurred as the first releases of ?sterile? Aedes aegypti that have been performed in Grand Cayman and those that are planned for Malaysia.

I don?t want to get carried away by an early small success, but if GM mosquitoes find acceptance, we will likely arrive at a time when spreading resistance genes (often called pathogen refractoriness) in wild populations is possible. First some background that shaped the current thinking.

The common assumption is that resistance effectors or the transgene insertion per se will have a negative fitness. Even if it were introduced into a wild population, selection would quickly eliminate it. So what is needed to make this strategy work is an engine; a drive mechanism which would increase the frequency of the resistance effector in spite of the fitness cost that it confers. Assuming that either the engine or the effector could break down by mutation at some frequency, it will be prudent - and essential - to field-test the two components individually in a test not confounded by the characteristics of the other. (This reasoning and the approach can equally apply to a vector of viruses such as Aedes aegypti.)

Let?s return now to the resistant strain of Corby-Harris et al. that blossomed from the mystical Arizona desert. I propose that this gene could ? even should - be tested in natural populations by inundation. The activity would consist of releasing fertile resistant males in large numbers into (semi-) isolated natural populations. ?What?s the point? This will have no lasting effect unless releases continue. The gene will simply disappear.? Thank you. That is exactly the point.

It is self-limiting, but it provides several highly informative pieces of information about the effector that would influence whether it should ever be paired with a drive mechanism. The outcomes of such as release include:

1. The increase in the frequency of the transgene in wild populations would demonstrate the practical capacity to produce and release males and the degree to which they mate competitively. (It also should prove informative regarding the population size and perhaps, mosquito dispersal capacity, but neither of these requires GM mosquitoes.)

2. If the releases continued sufficiently long, it could provide an indication of the likelihood of parasites developing resistance to the specific effector.

3. Again, depending on the duration and level of the releases, it would provide measurable, though not permanent, reductions in malaria transmission.

4. When releases ended, a definitive measure of the fitness cost of carrying the gene could be obtained by the rate of its declining frequency.

5. The first real parameterization of a transgene mutation rate in wild mosquito populations would be obtained. (Natural mutation rates could reasonably be applied to a stable transgene, but this has not been determined experimentally.)

While this sounds like an experiment of little lasting benefit to the populace that participates, it must be viewed as an essential, first step in developing more valuable, driven effectors that would in fact have a durable effect.

Perhaps readers can suggest an alternative to this general approach for determining the potential of effectors when challenged with real parasites, in wild genetic backgrounds and in the presence of humans. I cannot.

Are more laboratory studies of the Corby-Harris stock warranted before a field test is performed? Certainly. But unless red lights appear, preparation for inundation experiments could proceed.

The risks of such a trial are negligible: the benefits are great. The malaria relief and encouragement that would result from a positive trial would extend from research labs to at-risk populations that have often been assured that novel interventions were on the way.