GENET archive

[Index][Thread]

[genet-news] RISK ASSESSMENT & APPROVAL: GM mosquito in Malaysia: Too many questions and no answers



                                  PART 1


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

TITLE:   GM MOSQUITO: TOO MANY QUESTIONS AND NO ANSWERS

SOURCE:  Malaysia Kini, Malaysia

AUTHOR:  Ex vector control staff

URL:     http://www.malaysiakini.com/letters/148492

DATE:    18.11.2010

SUMMARY: "The development of a GM mosquito is certainly a scientific and technological tour-de-force and the accomplishment needs to be appropriately recognised as such. However, what is most disturbing about the present planned release of GM aedes aegypti mosquitoes is the lack of information and further approvals associated with the proposed release as outlined below. [...] 2. What commercial entity is undertaking this endeavour and who are the individuals involved? [...] Who is going to produce the GM mosquitoes, who will release them, who will account for them and who will assume responsibility for any untoward events that occur? When it comes to larger scale release, billions of male mosquitoes will be required to be released ? who will produce them and be accountable?"

----- archive: http://www.genet-info.org/information-services.html -----


GM MOSQUITO: TOO MANY QUESTIONS AND NO ANSWERS

In the letter ?GM Mosquito: Stringent protocols in Place? of Nov 9, 2010, Madam Yamuna Perimalu, writing on behalf of the corporate communications unit of the Ministry of Natural Resources and Environment, describes the lengthy (5-year) process that has occurred to develop the present proposal to release Living Genetically Modified (GM) aedes aegypti mosquitoes in Pahang (Bentong district) and Malacca (Alor Gajah and Malacca districts) and attempts to assure us that all issues raised have been thoroughly addressed.

It should be pointed out that the Malaysia Biosafety Act was only approved in 2007 and only came into force in 2009. What safeguards were in place during the unregulated years?

The development of a GM mosquito is certainly a scientific and technological tour-de-force and the accomplishment needs to be appropriately recognised as such. However, what is most disturbing about the present planned release of GM aedes aegypti mosquitoes is the lack of information and further approvals associated with the proposed release as outlined below.

1. Why is the Ministry of Natural Resources and Environment spearheading this undertaking? Doesn't mosquito and mosquito vectored disease control fall under the purview of the Ministry of Health? Why is the Ministry of Health silent in this entire matter?

2. What commercial entity is undertaking this endeavour and who are the individuals involved? There has been no disclosure of what and who is supporting the GM mosquito and its release (other than the Institute for Medical Research, IMR).

Who is going to produce the GM mosquitoes, who will release them, who will account for them and who will assume responsibility for any untoward events that occur? When it comes to larger scale release, billions of male mosquitoes will be required to be released ? who will produce them and be accountable?

3. In the United States, any release of a genetically modified organism that involves humans requires an Institutional Review Board review of the proposed release and signed informed consent of all individuals exposed to the genetically modified organism.

How will informed consent be obtained from all individuals potentially exposed ? not just from a few isolated individuals ? or are Malaysian lives not nearly so dear to our government? And shouldn't the review committee include Institute of Medical Research and the University that has an entomology department such as Universiti Putra Malaysia and the vector division, Ministry of Health to offer the opinions and advice?

4. The GM mosquito is designed to control wild mosquitoes that are classified as a ?pest?. All materials engaged for the control of mosquitoes are consequently classified as ?pesticides? and require registration and approval from the Malaysia Pesticide Board. There is no mention that such registration and approval has been requested or obtained.

5. Mdm Yamuna states that the USDA has approved the release of the GM pink bollworm and the GM fruit fly. This is true. However, these are agricultural pests and are not a threat to human health. To imply that the same level of criteria should be applied to GM mosquitoes, a known human blood feeder and human disease vector vastly oversimplifies the safeguards that need to be considered.

6. Mdm Yamuna further cites other countries, including India, as evaluating the GM mosquito. India has recently rejected the Genetically Modified eggplant ? does the Ministry of Natural Resources and Environment really believe that India will then accept the GM mosquito?

7. It is stated that this is only the first step in a multi-step process of approval and is for only the proposed ?limited? field trial. How long will the overall process require and how will dengue be controlled in the interim ? how many Malaysians will become sick and how many deaths will occur?

8. Under Malaysian law, it is illegal to harbour, rear or propagate mosquitoes. With the GM mosquito, these activities are clearly occurring. Has the concerned business and people obtained an exemption from this law?

9. Are there other competing technologies that can also be considered, that are effective at controlling dengue-carrying mosquitoes?

The above are only specific questions regarding the release of GM aedes aegypti mosquitoes.

Communities involved must give consent

There are further more general questions (as described in the UNDP/World Bank/WHO Special Program for Research and Training in Tropical Diseases (TDR) publication 'Ethical, Legal and Social Issues of Genetically Modified Disease Vectors in Public Health' by Darrel Marcer).

Before field release of transgenic organisms, researchers must assess all the scientific and social issues associated with GM vectors and develop safety precautions to address potential risks.

2. The scientific and social risks should be minimised through careful design of the vector system, relevant laboratory experience, and careful choice of site including consideration of appropriate social and cultural factors.

3. Even if there are no perceived realistic risks, a procedure for their evaluation should be set up so that new information can be gathered and interpreted. This procedure may involve establishing a specialised ethical review committee to offer advice to researchers seeking guidance on the ethics of projects.

4. There should be prior environmental, medical and social studies for site selection, and the most appropriate site should be chosen based on the data obtained.

5. Information should be openly exchanged as broadly as possible to relevant community leaders, members of the community, and mass media. This needs to be done with international collaboration.

6. Consent should be obtained from the communities involved. Specific mechanisms for this need to be developed and will be useful for other areas of public health interventions.

7. A contingency plan for aborting field trials needs to be developed. One approach is to engineer a lethal gene for the vectors that can be induced by a non-toxic chemical to ensure total elimination of those that have acquired the genetic construct.

8. Commitment to the local communities involved in field trials should be made that they will be the first beneficiaries of more permanent use of a GM vector should the results indicate that its use is appropriate.

9. Intellectual property concerns should not be barriers to implementation of public health measures using GM vectors or their symbionts and/or pathogens. Prior negotiation, including possible involvement to allow access to the latest technology, is preferable to confrontation.

10. To avoid any suspicion by the public that could result in their rejection of this approach, governments should not involve partners from military research establishments in the projects.

11. The data should be open to all in order to benefit from global expertise and develop international consensus.

12. Whatever guidelines are developed, they should be revised as experience with genetic engineering technology grows, as knowledge of ecology and communities grows, and with societal trends.

Dr Marcer further emphasises that an international approach is required since vectors do not honor national borders, nor is their behavior always predictable.

Has the Ministry of Natural Resources and Environment fully followed all of these suggested guidelines?

Simulations not sufficient

No consideration of mosquito mating behavior and dengue virus transmission is reported by Madam Yamuna or the Ministry of Natural Resources and Environment. Mosquitoes have a complex mating behaviour which requires the male and female mosquito to come within 1 inch (2.54 cm) of each other before their wing beats harmonise in their mating ritual.

How will the laboratory-reared GM mosquito find its wild female partner? In the wild, the adult male mosquito emerges before the female and remains nearby so that when the females emerge, they can go and obtain a sugar (nectar) meal before host-seeking and mating. The GM mosquito has no clue where the wild females are. How will they find them ? by sheer chance?

Madam Yamuna reports that simulated, contained field trials have successfully been carried out. At best, this is an artificial situation that bears no relation to the real world. When mosquitoes are contained in a closed environment, they have no choice and will eventually find each other and produce the expected result. In the wild, there is no containment and the likelihood of the GM male mosquito finding a wild female partner is dramatically reduced.

The dengue virus not only infects the salivary glands of the adult female aedes aegypti mosquito, but also the ovaries and eggs. When the eggs are laid, they are infected with dengue, which persists through the larval and pupae stages. Consequently, when the adult females emerge, they are already dengue positive and transmit the virus on their first (human) bite.

Even if they mated with the GM male Aedes aegypti mosquito, the wild female mosquitoes will still be positive for dengue and transmit the disease throughout their adult life cycle. Further, the wild male mosquitoes from the dengue infected eggs will also transmit the virus to any uninfected wild female mosquito that they mate with, thereby propagating the dengue virus to subsequent generations.

The GM adult male mosquito will soon die ? usually within 3 days. How many mosquitoes, at what frequency of release and for what period of time will be necessary to control dengue with the GM mosquito?

What if it transmits HIV?

There is a famous quotation from the late Professor Andrew Spielman then at the Harvard School of Public Health:

?No animal on Earth has touched so directly and profoundly the lives of so many human beings. For all of history, and all over the globe, she has been a nuisance, a pain, and an angel of death. The mosquito has killed great leaders, decimated armies, and decided the fate of nations. All this, and she is roughly the size and weight of a grape seed? ? from the Preface to Mosquito by Andrew Spielman and Michael D'Antonio (Harvard).

Since the mosquitoes are genetically modified, there is a high probability of it causing a new borne disease in the future and it is advisable not to disturb the natural eco system. Malaysia had its first dengue outbreak in Jinjang, Kuala Lumpur in 1972. Before that, it was unheard of and basically, the aedes mosquito had developed the new strain of disease.

There are many unknowns and unanswered questions concerning the GM mosquito. Science is very good at obtaining answers to posed questions. How do we know that we are asking the correct questions? In science, it is the questions that are not recognised and unasked that lead to the greatest problems.

For thousands of years, mosquitoes have been very clever at devising ways to overcome whatever mankind has thrown at them. What assurance can be provided that that is not the case with the GM mosquito? What would happen, for example, if the GM mosquito were to acquire the ability to transmit the Human Immunodeficiency Virus (HIV/AIDS)?

What assurances can the unidentified business and people provide that this will not occur? What would happen to the Malaysia tourist industry if some unanticipated consequence resulted from release of the GM mosquito ? would other countries ban travel to Malaysia ? would Malaysian's be banned from traveling to other countries? What would the economic consequences be ? both for tourism and industry if that scenario arose?

The mosquito is quite literally the Most Dangerous Animal on the Planet! What is being proposed is the release of mankind's most mortal enemy. Can Malaysia afford to take that risk?



                                  PART 2

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

TITLE:   GM MOSQUITOES: WE HAVE ASSURANCE DON'T WE?

SOURCE:  Malaysia Kini, Malaysia

AUTHOR:  Param

URL:     http://www.malaysiakini.com/letters/148391

DATE:    16.11.2010

SUMMARY: "It is heartening to note that the National Biosafety Committee after several months of deliberations has finally approved the Health Ministry's application to undertake the field trial using genetically modified mosquitoes to suppress the dengue vector population. I am sure members of the National Biosafety Committee comprising of eminent scientists and experts from various science based disciplines in the country, would have meticulously and cautiously scrutinised the application from the IMR-Oxford scientists before approving the limited trial."

----- archive: http://www.genet-info.org/information-services.html -----


GM MOSQUITOES: WE HAVE ASSURANCE DON'T WE?

It is heartening to note that the National Biosafety Committee after several months of deliberations has finally approved the Health Ministry's application to undertake the field trial using genetically modified mosquitoes to suppress the dengue vector population.

I am sure members of the National Biosafety Committee comprising of eminent scientists and experts from various science based disciplines in the country, would have meticulously and cautiously scrutinised the application from the IMR-Oxford scientists before approving the limited trial.

The assurance by the director general of health Ismail Merican recently in the media, that the trial is safe and will be conducted in accordance to the NBC guidelines and supervision should alleviate any unwanted fears among certain quarters.

Furthermore the Academy of Sciences and the World Health Organisation is looking at the trial positively and are hoping that it will bring about a breakthrough in the control of the deadly disease.

According to MHO statistics for the end of October this year alone we have recorded more than 118 people dead (more than 60 percent increase compared to last year) and about 50,000 people have been sickened by the mosquito borne virus in the country (MOH Website).

All the efforts and money spent to control the Aedes population over the years by the authorities unfortunately have not been very successful.

We cannot sit back and watch dengue rampaging through the population without any sign of retreating. Dengue is not only a major health threat to the public but it is now a global threat to humanity.

In this context its timely and appropriate for the government to approve the field trail. The trial is reported to be safely designed to suppress the Aedes mosquito population thus there is no need to fear of any negative implications to the environment or the public.

I hope the government will stand firm on its decision and not backtrack due to the pressure of certain NGOs call to stop the trial.

Those who are against this novel trial should first pay a visit to families of those who have lost their loved ones due to dengue and the hundreds of thousands who have miraculously survived the infection.

Perhaps they should also talk to the clinicians who have been treating dengue patients to understand what a devastating and debilitating disease we are facing.

Ask the doctors who have attended to some of these dengue patients of their frustration and despair for not been able to save dengue patients despite their best efforts, with all the modern medical knowledge and facilities available.

The research mission of the Health Ministry is a noble one - that is to find a solution and a cure to the scourge of dengue and save hundreds of lives.

If the government were to stop this trial due to the pressure of certain anti-GMO groups it will be indeed a sad development.

The government will be setting a precedent and there will be no stopping of these so called anti- GMO groups and other fear mongers to subject the authorities to all sorts of pressure and threats in the near future.

What is at stake here is public health and the future of good science. The government should stand firm on its decision as this will augur well for the progress and development of medical science and technology in this country.

If man had feared the unknown in the past he would not have landed on moon and returned to earth safely.

Fear and ignorance is a stumbling block to any young nation which is aspiring to be recognised as a developed nation worldwide. Let there be light.



                                  PART 3

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

TITLE:   FIGHTING DENGUE WITH ?FAMILY PLANNING? FOR MOSQUITOES

SOURCE:  Xinhua, China

AUTHOR:  Lucy-Claire Saunders

URL:     http://news.xinhuanet.com/english/2009-07/15/content_11709219.htm

DATE:    15.07.2009

SUMMARY: "In an attempt to address what is already an endemic in some parts of the world, a team of researchers at Oxitec, based in Oxford, the United Kingdom, has created a Genetically Modified (GM)A. aegypti mosquito designed to compete with wild-type mosquitoes. If all goes well, the GM version will eventually lead to a reduction in dengue-carrying mosquitoes.

Controlled testing has already begun in Malaysia and, pending regulatory approval, authorities are expected to release the organisms into the wild."

----- archive: http://www.genet-info.org/information-services.html -----


FIGHTING DENGUE WITH ?FAMILY PLANNING? FOR MOSQUITOES

UNITED NATIONS, July 14 (Xinhua) -- The scourge of dengue fever might be cut by neutering the mosquitoes that carry it. Call it family planning. Males are genetically engineered so that when they mate with females, their offspring never surpass the larval stage of development.

While the idea is nothing new, it is the first time such an approach is being used to develop male-sterile Aedes aegypti, the type of mosquito that carries yellow fever, chikungunya, and dengue fever.

The World Health Organizations (WHO) estimates that approximately two-fifths of the world's population -- 2.5 billion people -- are now at risk from the dengue virus, primarily in South Asia and Latin America.

But recent reports show that the tropical disease has increased30-fold over the past 50 years, especially as temperatures warm in typically cool regions, such as in North America.

In an attempt to address what is already an endemic in some parts of the world, a team of researchers at Oxitec, based in Oxford, the United Kingdom, has created a Genetically Modified (GM)A. aegypti mosquito designed to compete with wild-type mosquitoes. If all goes well, the GM version will eventually lead to a reduction in dengue-carrying mosquitoes.

Controlled testing has already begun in Malaysia and, pending regulatory approval, authorities are expected to release the organisms into the wild.

But not everyone is buzzing with excitement. A concerned group of citizens in the South Asian country fear they are being subjected to an experiment where all the risks are not immediately apparent.

The first open-field testing of GM mosquitoes has many fearing that Oxitec and the Malaysian government will lose control over its creation, creating a Frankenstein-mosquito.

A SELF-LIMITING TECHNOLOGY

Oxitec's head of business development Ann Kramer told Xinhua in a recent interview by phone that, unlike other GM mosquitoes being developed by academic groups, Oxitec's mosquito will be unable to spread its genetically altered traits throughout the environment.

"With our approach, they will be released, they will die, and their progeny will die so there will always be the ability to take it at a speed we control," she said from her office in Oxford. "We can decide, rather than run the risk of things going faster than we had perhaps planned."

The John Hopkins Group in Maryland, for example, is currently working on a GM Anopheles mosquito that is resistant to the malaria parasite. In theory, the genetic trait will be passed on through reproduction in an attempt to dominate the mosquito population and reduce infection rates.

The Sterile Insect Technique (SIT) that Oxitec employs has been around for decades. In the United States and Mexico, authorities used the method to eliminate the New World screw-worm by about 1985.

And in China, there could be future possibilities for the technique. Kramer said the Ministry of Agriculture has contacted Oxitec about using their approach to combat the Oriental fruit fly, which is threatening China's citrus agriculture.

But up until recently, the SIT seemed doomed to fail in A. aegypti mosquitoes because, in part, the radiation for sterilization is extremely damaging. To address the issue, Oxitec has developed a sterile male version which does not need to be irradiated and produces late-acting lethality in its larvae.

"In the past, that has not been possible," said Kramer, noting that the Indian government has also begun testing the Oxitec technology in labs in Chennai.

"BREAK BONE"

In the past, the dengue virus typically spread as a result of a monsoon or tropical weather. But that appears to be changing. Countries around the world say that the virus is on the rise, from Vietnam to the United States.

Last week, a New York-based nonprofit environmental group reported that two types of mosquitoes capable of transmitting the virus -- the predominantly urban species A. aegypti and the Asian tiger mosquito -- have been found in 28 U.S. states and may travel further around the country as temperatures rise.

Climate change could push the traditionally tropical disease into the far corners of the United States, where dengue-carrying mosquitoes have typically been rare.

According to the WHO, cases of dengue have reached unusually high rates in the past four years, with 50 million infections worldwide every year.

Dengue, or "break bone," fever can be caused by any one of the four types of dengue virus. A person can be infected by at least two, if not all four types at different times during a life span, but only once by the same type.

Sometimes, dengue infections lead to hemorrhagic fever, a potentially lethal complication that has become a leading cause of hospitalization and death among children in Asia, according to the WHO.

Marked by the severe onset of a fever of 103 to 105F, or around 40C, victims suffer from pain behind the eyes, muscle and joint pains, skin rash, diarrhea and vomiting.

With no cure or vaccine in sight, the WHO has stated that the only way to prevent virus transmission is to attack the mosquitoes themselves.

THE ULTIMATE EXPERIMENT

So far, Oxitec's GM A. aegypti looks promising, said Kramer. Malaysia's medical research center has tested the sterile bugs in physically contained semi-field trials in a simulated three-room Malaysian dwelling.

Among a host of other concerns, researchers are primarily interested in whether the GM mosquito is able to compete with local males to win the female over and impregnate her with the never-to-be-born offspring.

"Our strain performed very well," said Kramer. "It competed very well with the local, wild Malaysian mosquitoes."

But before the Malaysian government can conduct open-field trials, a slew of national regulatory agencies must give their approval.

Dr. Yeya Toure, who leads vector research in the WHO Tropical Diseases Department (TDR), and a group of experts from around the world have begun creating regulatory standards in a framework designed to assist developing countries develop technical, safety and ethical review of trials involving GM insects.

"What the WHO and TDR want to do is to provide guidance to countries for addressing an issue that holds both potential for human health benefits and also some risks," Toure told Xinhua in a statement. "WHO, TDR and its partners intend to help countries getthe necessary guidance (so they can be) better prepared to make their own assessment and decision."

As with all GM testing, researchers are aware of public concerns about health and the environment. Oxitec has conducted several small focus groups in Malaysia, said Kramer, noting that the people they spoke to were receptive to the idea of a sterile mosquito that could reduce the rate of dengue infections.

But not everyone is convinced. Cheah Hooi Giam, an optometrist who lives in Malaysia, started an online petition demanding that the Malaysian government take full responsibility and make itself liable for any problems that may arise from the release of the GM mosquitoes.

Giam told Xinhua by e-mail that he is concerned his country is being taken advantage of by groups in the West looking to make a profit.

"Why should a developing country bear the brunt of being the site of a field trial for releasing genetically modified mosquitoes?" he asked. "If anything, developing countries are least able to handle an emergency if something should go wrong with the release."

Giam said he worried that the GM mosquito could mutate and become resistant to current methods of eradication like pesticides.

"A controlled environment can never be the same as the real environment," he said. "Nobody can give an assurance or know what will or will not happen in the real environment."

But Kramer said Oxitec, which was spun off from Oxford University in 2002, is developing a technology that will benefit the developing world so "it's right and proper" that they be involved in the entire process.

"There is no market to make stack loads of money," she said. "It does not exist."

Oxitec, which receives partial funding for its SIT program from the Bill and Melinda Gates Foundation, estimates governments that want the technology will have to pay roughly one to three U.S. dollars per person -- roughly the same as mosquito bed nets.

Currently, the Malaysian government spends 130 million U.S. dollars a year on trying to control mosquitoes and on tending to those infected with the dengue virus, according to Kramer, who cited a report to be released shortly.

Going after A. aegypti is the best approach to a quickly-spreading disease, said Kramer. Insecticides only kill the mosquitoes present at that very moment and many people do not want insecticide sprayed in their homes.

Despite a high awareness that trash easily becomes breeding grounds for mosquitoes, Kramer noted that "in no country are they managing to clean up the mosquitoes well enough to prevent the spread of dengue."




~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
GENET-news is a public news service from GENET.
Visit GENET website to learn more about GENET: www.genet-info.org
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~