Safety in numbers: how three parents can beat genetic diseases
More on the technology and feasibility of the science behind how three parents can circumvent genetic disease – and there are pictures.
The Conversation: 6 February 2012
Who is regulating the release of the GM mosquito?
By Jason Major
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
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were a lack of transparency in the regulatory system, a lack of data to support their decisions and an over reliance on unpublished data, as suggested by the following:
“The selective use of unpublished or non-peer reviewed evidence to support contentious conclusions has been repeatedly questioned”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 Gene Technology Regulator who comes with the Arnie-inspired nickname, The Regulator. He (Joe Smith) gets support and advice from the Australian Office of the Gene Technology Regulator (OGTR). The legislation for regulating gene technology is comprised of the Commonwealth Gene Technology Act 2000, the Gene Technology Regulations 2001 and corresponding State and Territory legislation.
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.”
Nanotechnology and the fight against cancer
From diagnostics to drug delivery, clinicians want to take selective aim at tumour cells
The Guardian: 31 January 2012
Stem cells to brain cells to treat range of diseases
Europe and US research groups have separately turned skin cells into sem cells then brain cells to provide disease models for Alzhiemers, multiple sclerosis, schizophrenia and others
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
UK sets sights on gene therapy in eggs
Public consultation and safety assessment would pave the way for embryo manipulation to treat genetic diseases.
Nature, 24 January 2012
Gene silencing to help treat Huntington’s Disease
Researchers have successfully delivered inhibitory RNA sequences from stem cells directly into neurons, significantly decreasing the synthesis of the abnormal huntingtin protein.
University California Davis: 19 January 2012
Breast cancer cells targeted, then burned, by gold-filled silicon wafers
Infrared light shone on nano-sized, gold-filled silicon wafers will target and burn breast cancer cells providing a potential non-invasive alternative to surgery.
Nanowerk: 18 January 2012
One mistake away from a worldwide flu pandemic
Two labs have made lethal, highly transmissible versions of bird flu virus – do the risks of it escaping outweigh the benefits of the research?
New Scientist: 12 January 2012
And a previous story from Nature News December 2011
Researchers Develop “Smart” Nanotherapeutics that Deliver Drugs Directly to Pancreas
New technology could potentially lead to new therapeutics for Type I diabetes with improved efficacy and reduced side effects
Wyss Institute, 12 January 2012
Epigenetics: A turning point in our understanding of heredity
Experiments that caused genetically-identical nematodes to have different lifespans have opened the door to new understanding of heredity.