Brazilian GMO regulators' irresponsibility produces dengue "super mosquito". Report: Claire Robinson and Jonathan Matthews
Amidst all the news and furore about the new study showing how the release of GM mosquitoes in Brazil has badly backfired, an article in the Brazilian newspaper Rede Brasil Atual – in Portuguese, but see our summary/translation below – stands out.
That’s not just because of the amount of local detail it contains that is missing from other reports but because the reporter, Cida de Oliveira, managed to interview, among others, a regulator who was not just directly involved in the regulatory decision making about the project, but wrote a detailed report on the biosafety and other concerns the project raised.
Dr José Maria Gusman Ferraz was asked by fellow members of Brazil’s biosafety commission (CTNBio), which approved the GM mosquito project, to visit the city of Juazeiro where Oxitec’s GM mosquitoes were being released. His technical visit involved checking out biosafety conditions at the lab where the GM mosquitoes were being produced, and checking how they were being released into the local environment and how the people living there were responding to the project.
What he discovered so shocked him that in his report he called on his fellow regulators to suspend the release of the GM mosquitoes until further health and environmental impact studies were done. In particular, he highlighted the contempt that he felt Oxitec was displaying towards the safety of the local population, who he says were being reduced to mere guinea pigs.
Among the many significant concerns he raised was the fact that local people had not been meaningfully consulted – in fact, had not been told anything at all about the risks involved, and had not even been asked to sign informed consent forms, as would normally be required for all participants in a scientific experiment. He also found no evidence that Oxitec had provided evidence of the approval of their experiments by institutional ethics committees.
Dr Ferraz also noted Oxitec's failure to make clear the survival rate of the GM mosquitoes, and the lack of studies on their mating with local mosquito populations. He told the reporter, de Oliveira, “The commission was warned about the possibility of this mosquito establishing itself permanently in the environment, as well as about crossbreeding between the GM and wild mosquitoes, but most members of the commission completely dismissed these concerns.”
As a consequence, the release of the GM mosquitoes went ahead with the result that, just as Dr Ferraz had warned could happen, the GM mosquitoes successfully reproduced and the resulting hybrid population is now spreading out of control.
Dr Ferraz says we should not be surprised that a commercial company that wants to profit from selling its products may be willing to mislead people or omit unfavourable data. But “What we cannot accept,” he says, is “the lack of scientific ethics” on the part of regulators and their willingness to ignore biosafety concerns and turn local people into guinea pigs, “vulnerable to the negative effects of a technology that has generated hybrids that are possibly resistant to insecticides”.
None of the risks that arise from this failed experiment, Dr Ferraz says, have been properly evaluated.
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Reporter Cida de Oliveira writes, "Without being consulted or even informed about the risks to which they could be exposed, the population of the Pedra Branca district in Jacobina, Brazil was subjected to an experiment conducted between 2013 and 2015" – with the authorization of CTNBio.
During this period, de Oliveira notes, its 1,144 residents were deliberately exposed to thousands of GM mosquitoes (Aedes aegypti) by the biotech company Oxitec. Moscamed, an organization that seeks to combat the disease-carrying Aedes mosquito, and the local health authority, the Municipal Secretariat of Health, collaborated in the experiment. Apparently harmless, the GM mosquitoes had the mission of copulating with females of the wild Aedes variety and transmitting to their offspring a protein capable of killing them before reaching reproductive age. According to Oxitec’s advertising claims, GM insects would not reproduce with other species, much less perpetuate themselves in the environment.
The goal, as de Oliveira describes it, was to reduce the population of wild Aedes mosquitoes, responsible for the transmission of the virus that caused more than 1,800 cases of dengue fever in the municipality in 2012. Although Oxitec claimed that by the end of the project it had reduced the population of dengue mosquitoes by 92%, on 19 August 2014, the mayor of Jacobina, Rui Rei Matos Macedo, decreed an emergency situation in the municipality precisely because of the disease.
While failing to combat the "evil" Aedes mosquito, Oxitec’s "friendly" technology may have caused unknown ecological changes in Jacobina. That's because the millions of OX513 transgenic mosquitoes released in this small southwestern city in the Brazilian state of Bahia transferred their lab-modified genes to the natural population of Aedes aegypti. In other words, the transgenic mosquitoes reproduced and perpetuated themselves in the environment. The data, which gives the lie to Oxitec’s claims, were revealed on September 10 in an article in the journal Scientific Reports, published by Nature Research.
The study was authored by researchers at Yale University in the United States, the University of São Paulo (USP), the National Institute of Science and Technology in Molecular Entomology and Moscamed Brazil. According to the sampling and the criteria used to define this genetic exchange – technically called introgression – it is possible to say that from 10% to 60% of mosquitoes carry at least one OX513A gene.
Further, according to the study, wild mosquito gene samples collected at periods of six, 12 and 27–30 months after the release of the GM mosquitoes provide clear evidence that portions of the GM genome were incorporated by the natural insect population that was supposed to be significantly reduced. The scientists wrote, "Evidently, rare viable hybrid offspring between the release strain and the Jacobina population are sufficiently robust to be able to reproduce in nature." That is why they recommend a genetic monitoring programme during the release of transgenic organisms to detect “unanticipated outcomes”.
Gene exchange
Biologist José Maria Gusman Ferraz, a researcher at Ecological Engineering Laboratory of Unicamp (the University of Campinas, a public research university in the state of São Paulo, Brazil) and a postdoctoral professor at the University Center of Hermínio Ometto Foundation (UniAraras), commented, “The study shows that there was a gene exchange, and that in this exchange the wild mosquitoes incorporated genes from another [transgenic] variety, resulting in hybrid insects, which usually have greater vigour and are more potent – yet there are no studies on these hybrids. Even less is known about the hybrid’s efficiency in virus transmission, which may even be higher. What we have now is a 'super mosquito' that can grow in environments where others might not grow."
Ferraz praises the fact that these results emerged out of a study that involved specialists who are very familiar with the experiments in the cities of Bahia, such as Margareth de Lara Capurro, professor at the Parasitology Department of the Institute of Biomedical Sciences at USP, and the geneticist Aldo Malavasi, who was a professor in the Department of Genetics at USP and is the current director of Moscamed Brasil.
De Oliveira describes how in 2013 Ferraz, as a member of CTNBio, visited the city of Juazeiro in Bahia. Since 2011, Juazeiro has been deliberately infested with the Oxitec mosquitoes. The purpose of his technical visit was to check the conditions in the laboratory where the insects were being produced that were released in Juazeiro and Jacobina. For example, Ferraz wanted to check if larvae were leaking down the drain or other similar undesirable outcomes, as well as to check how releases were being made into the environment and how the native population was responding to the intervention.
In his report, Ferraz asked CTNBio to suspend the release of GMOs in both cities until further health and environmental impact studies were done. And he highlighted the contempt for the safety of the population, who had been reduced to guinea pigs.
First, because CTNBio itself, which was supposed to fulfil the role for which it was created (to protect biosafety), placed the GM insect in risk class 1 (low risk to the individual and low risk for the community) when it should be in class 2 (moderate risk to the individual and low risk to the community), according to sources who spoke to Rede Brasil Atual.
Second, because the affected residents only received information about the mosquito that transmits dengue viruses and the disease itself, and were told nothing about the risks posed by the transgenic insects to their health and the environment. On top of that, they did not sign an informed consent form, as is usual in cases of participation in a scientific experiment. Nor did Oxitec provide – and nor did CTNBio demand – the judgements of the human and animal ethics committees of the responsible institutions, in spite of the fact that people would be bitten and that their blood would come into contact with the insects, leaving them vulnerable to infections, among other possible outcomes.
The researcher also noted Oxitec's failure to make clear the survival rate of the mosquitoes developed in its laboratories, since the technique does not guarantee 100% sterility in the males produced. He also questioned the minimum levels of water contamination by the antibiotic tetracycline that enables the survival of Oxitec’s insects [tetracycline suppresses the transgene that inhibits survival and reproduction]. These data directly relate to the probability of the GM mosquito population increasing and the consequent environmental imbalances.
Scorned by CTNBio, Ferraz's report also questioned the lack of studies on the performance of transgenic males in mating with wild Aedes females. “The commission was warned about the possibility of this mosquito establishing itself permanently in the environment, as well as about crossbreeding between the GM and wild mosquitoes, but most members of the commission completely dismissed these concerns. So they went straight to the field and dumped the mosquitoes into the environment where people live," said the researcher.
Oxitec omitted information
By de Oliveira's account, the experiment in Jacobina was authorized by CTNBio in December 2012. In the extract of opinion 3,541/2012, published in the Federal Official Diary, the then President Flávio Finardi Filho stated that “The process (01200.002408/2012-74) describes the proposed biosafety conditions for the release, the general conditions for conducting the experiment, and the qualifications of the research team involved in the project”. And that “the Commission considered that the experimental protocols and other proposed biosafety measures comply with CTNBio standards and the relevant legislation aimed at ensuring biosafety of the environment, agriculture, and human and animal health”.
But Oxitec, as Ferraz well recalls, omitted a number of pieces of information. They even pulled pages out of the dossier, claiming confidentiality, and the biosafety commission turned a blind eye. He recalled that the company denied the possibility of any ecological implications from crossing between surviving transgenic mosquitoes and wild Aedes females, even without having done any studies on it. And Oxitec dismissed the potential for the OX513A line of GM mosquitoes to interbreed with Aedes albopictus, a species that competes with aegypti and also transmits several viruses.
In April 2014 a majority of CTNBio members approved the request for the commercial release of GM Aedes mosquitoes. So far there had been no technical evaluation of the experiment in Jacobina, which only happened in 2018. The report presented to the commission, according to Rede Brasil Atual's sources, was full of defects and inaccuracies, reflecting the lack of concern for safety and the irresponsibility of exposing the population to unknown and unnecessary risks. Yet again, commercial and reductionist science prevailed within the commission (with few exceptions), which dismissed the risks posed by genetically modified organisms directly associated with viruses that cause serious diseases in humans.
The favourable CTNBio opinion on the release expresses the majority of the members' view that a single study by Oxitec's own researcher - Renaud Lacroix - plus the dossier submitted by the firm's lawyer – was a “considerable set” of information. The opinion, signed by the then-president of CTNBio, Edivaldo Domingues Velini, argues that "Although there is no experience with the commercial release of this GMO yet, there is a considerable body of pertinent information coming from the planned release of this mosquito in other countries." And the opinion quotes Lacroix et al., 2012 – as if his research was not totally in tune with the interests of Oxitec, the company he works for.
Business
De Oliveira describes how in the midst of the 2015 dengue outbreak, Oxitec took advantage of its marketing authorization and sought to leverage its business. It started selling its GM Aedes mosquito to the Municipal Health Department of Piracicaba, a city in the Brazilian state of Sao Paulo. As in Jacobina and Juazeiro, the local population in São Paulo state was the target of an advertising campaign to convince them of the effectiveness of a technology that had not been adequately evaluated for environmental and health risks. Without consultation, the residents of 12 neighbourhoods were bombarded with thousands of transgenic insects. Without proper monitoring or transparency, the case ended up with the Office of the Public Prosecutor, which signed with the company and the Municipality a Term of Adjustment of Conduct (TAC) that, according to activists, was never honoured.
With an eye on expanding its market to other municipalities, de Oliveira writes, Oxitec became a sponsor of health policy events, such as the Congress of the Council of Municipal Health Secretaries of São Paulo (Cosems-SP), in 2015-2017. The company also sponsored the Health Solutions Fair - Zika, in August 2017, in Salvador, attracting criticism from the Brazilian Association of Collective Health (Abrasco). For Abrasco, the participation of the company was "a symptom of institutional distortion that deserves reflection and permanent vigilance on the encroachment of interests that are contrary to Brazilian public health".
In July 2017, the city of Juiz de Fora, in Minas Gerais state, signed a contract to purchase the same GM mosquito as was released in Juazeiro, Jacobina, and Piracicaba. With a term of four years and expected expansion, it cost R$ 165,000 in the first year. The insects began to be handled in a "factory" installed in the municipality, since the facilities in Piracicaba were deactivated at the same time. Oxitec, which does not admit to the failure of its first-generation GM mosquito, obtained approval from CTNBio for the planned release of a second-generation GM mosquito, the OX5034. The target this time will be the population of the municipality of Indaiatuba, in the region of Campinas, in São Paulo state.
The difference in these new GM Aedes is that they are engineered with a defective gene, fatal to females, which will die in the larval phase. The trait should be transmitted to all offspring. Again, the promise is to reduce the population of wild mosquitoes, thereby decreasing the transmission of the dengue, zika and chikungunya viruses.
Mohamed Habib, an entomologist and professor at Unicamp, voted against commercialisation of the GM mosquito at the CTNBio, but was outvoted by the majority of the other members. He told Rede Brasil Atual that from a technological standpoint, these new insects have been developed to try to correct flaws in the former, but they won't work either: “They could function in isolated areas, such as islands and enclosed valleys, but not in large open areas where mosquitoes fly freely from one point to another, reproducing as they do in these locations. Indaiatuba is not an island area, but an extensive flat area.”
Cayman Islands
De Oliveira recounts that in the same month of July, so busy for Oxitec, the British organization GeneWatch revealed that the first generation of GM mosquitoes was expensive, did not work and could put the health of the population at risk. To reach this conclusion, the organization's experts analyzed the content of emails exchanged between company managers and representatives of the health authority in the Cayman Islands, a British territory in the Caribbean.
GeneWatch compared the data reported in Oxitec's propaganda with those collected in public hearings, such as in the United States Congress, and the very few studies - which CTNBio considers abundant - with communications obtained through access to information requests.
Amidst the policy of cuts, fiscal adjustment and Constitutional Amendment (EC) 95, which mainly penalizes the municipalities with the lowest revenue, the difficulties of Oxitec tend to multiply in line with the transgenic mosquitoes dumped on the population of Jacobina. The Municipal Health Department of Piracicaba no longer bears the logo of the partnership with the "Friendly Aedes" that it exhibited for so many years. Instead, a humorous ad warns people of their responsibility to eliminate breeding sites from their homes. The Department did not respond to Rede Brasil Atual's questions.
As José Maria Gusman Ferraz points out, it is consistent with the capitalist system for a company to want to profit from selling its products, even if it produces misleading advertising and omits unfavourable data. But “What we cannot accept is the lack of scientific ethics on the part of CTNBio, the release of transgenic organisms even without sufficient information, putting the population into the role of guinea pigs, vulnerable to the negative effects of a technology that has generated hybrids that are possibly resistant to insecticides. None of this has been evaluated.”
Also unacceptable, Ferraz told de Oliveira, is the mantra repeated by CTNBio committee members that their role is to strictly analyze the gene inserted in a plant, animal or microorganism, as if it had no relationship to, or impact on, health, the environment, or life as a whole. “Transgenic organisms increase the use of pesticides, which is very harmful. But then they say that this is another problem, outside the scope of CTNBio, as if it were possible to separate everything into small boxes. That is Cartesian. It is incompetence and irresponsibility for researchers to get into approving everything without critical analysis, in unscientific decisions.”