By: Nivedita Sengupta, Ph.D.
Genetically Engineered Foods
Policy: Reboot the debate on genetic engineering
Genetic engineering (GE) is a highly controversial topic of debate in current days partially because of its increasing impact on day to day living. In recent years, a great deal of advancement has been made in the field of GE as established by the development of sophisticated modern tools like CRISPR. This has led to increasing concern among people regarding GE and food safety laws.
One of the issues with respect to food safety laws was to determine whether the focus of the regulatory policies should be the process by which GE organisms are made or the GE products themselves. Most people in favor of product-based regulation believe that GE organisms are no different compared to the conventionally bred organisms. In United States, since mid-1980s, GE products have been overseen by the Coordinated Framework for Regulation of Biotechnology (CFRB). According to the CFRB, product-based regulation is the science-based approach and hence GE organisms could be covered by existing policies without any need for formulating new laws. Thus they could be simply channeled into particular government agencies depending on whatever category they fell into.
However, in the process of regulating GE products, the agencies realized that the process of engineering is important as well. The agencies recognized that from a scientific standpoint, a product’s traits, harmful or beneficial, depend on the process by which it is made. For example, in human gene-therapy trials, new methods for delivering genes have removed the need for potentially harmful viral vectors. Thus, product and process issues are not distinct in regulation. Though regulating GE products rather than the process is accepted in many countries beyond the United States, other countries like Brazil and Australia have laws which mandates the regulation of the mechanisms by which the GE products are developed.
The inconsistency of views among GE developers and regulators in product-versus-process arguments demands a fresh start on formulating regulatory policies involving GE. It’s time to consider a mix of product and process issues to order to identify product groups which are likely to be of concern and require regulation. These efforts should be focused on keeping in mind the polarization of product-versus-process and science-versus-values framings so that the government can form a system which will be based on information provided by science as well as the concerns and values of citizens. (Jennifer Kuzma, Nature Comment)
Dengue vaccine aces trailblazing trial
Vaccine development is a long and complex process which can take decades to be available for clinical use. Scientists at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, have developed a vaccine which may be the most potent vaccine available to date for preventing dengue infections. These researchers employed a ‘human challenge’ strategy during the development and testing of this vaccine, a method which fell out of favor during the last century. ‘Human challenge’ involves deliberately infecting healthy volunteers with a weakened form of the disease causing virus. Concerns about the safety of deliberately infecting people has limited the use of human challenge studies and usually researchers test developing vaccines on people who are already at risk of contracting the disease of interest.
The dengue virus is a difficult vaccine target because of its four serotypes. Infection with one of the serotype will render a person immune against that type for life but will offer no protection against the others and may also increase the risk of acquiring hemorrhagic fever upon exposure to a different dengue serotype. The current vaccine study tested only dengue serotype 2, the most virulent serotype. 21 volunteers were injected with the experimental vaccine, and 20 volunteers with a sham vaccine. Six months later, all 41 volunteers were injected with a weakened version of the dengue virus which causes symptoms similar to a mild dengue infection, such as rash. The vaccine provided 100% protection against the challenge and only the individuals who received the sham vaccine showed mild symptoms with 80% of them developing a rash.
As all the current dengue vaccines only protect a proportion of volunteers, if these results hold up in larger populations the vaccine could be one of the most promising dengue vaccines developed. “This is a tremendous step forward, and something that has been desperately needed for 30 years,” says Duane Gubler, a disease researcher at the Duke NUS Medical School in Singapore who was not involved in this study. Moreover, he mentioned that the lack of human challenge studies is actually one of the things that made the development of dengue vaccines very difficult. Scott Halstead, a virologist and vaccinologist at the Uniformed Services University of the Health Sciences in Bethesda, Maryland stated that “this is an incredible paper that shows what is absolutely necessary to develop a vaccine against the dengue virus. It’s a really important demonstration of the kind of proof that you really need to have before you spend US$1.5 or 2 billion on a phase III [efficacy] trial.”
Meanwhile investigators have already begun a second human-challenge study to test whether the vaccine protects against dengue serotype 3, and they hope to go on to test it against serotypes 1 and 2 using human challenge strategy. Moreover, they intend to perform studies using the human-challenge strategy to develop vaccine against Zika virus, which is related to dengue. Though scientists are enthusiastic of using human challenge strategy for developing vaccines in recent future, it demands reconsideration of the policies and consideration of the past incidents on which current laws are based. (Erika Check Hayden, Nature News)
Federal Science Funding
Biological specimen troves threatened by funding pause
Collecting biological specimens is an essential part of science and conservation and collections are used to identify species, track diseases and study climate change. One such important biological specimen collection is the collection of fish samples in Burke Museum of Natural History and Culture in Seattle which serves as a repository for the US National Oceanic and Atmospheric Administration (NOAA) for the North Pacific. NOAA uses the specimens collected each year to assess fish abundance and set fishing quotas for species conservation. In another case, a collection of eggs possessed by the Field Museum in Chicago led to the famous conservation discovery that the pesticide DDT caused widespread nesting failures in birds of prey resulting in near extinction of several species.
Despite their value to science, biological specimen collections recently lost a valuable source of funding and support. The US National Science Foundation (NSF) announced that it would indefinitely suspend a program which provides funding to maintain biological specimen collections. The NSF will maintain its current grants but not accept any new proposals. Many researchers and curators have found this disheartening and are worried because the NSF is one of the only public providers of such funding and only roughly 0.06% of the agency’s $7.5-billion is allocated for maintaining biological specimen collections. According to NSF they are soliciting feedback on the program along with evaluating the currents grants in the collections grant program. Depending on the results of evaluation, decisions will be made and it remains unclear whether the funding hiatus is temporary or permanent.
This pause however has scientists dismayed given the importance of these scientific collections. As mentioned earlier, preserved specimens play an immense role in understanding historic range of species and provide information on species invasion and extinction. Biological collections also help researchers track species carrying human diseases for containment of disease outbreak. Moreover, due to advancements in technology, the specimens can be put to use in a way which has not yet been anticipated. For example, DNA sequencing of museum specimens which were collected before DNA identification was discovered has helped to identify previously unknown species. With the sudden change in funding options many museums are considering digitizing their collections, and indeed, the NSF’s program to support digitizing collections remains unchanged. But “there’s no point digitizing if we don’t take care of the collections themselves”, says Barbara Thiers, director of the William and Lynda Steere Herbarium at the New York Botanical Garden. “You certainly can’t get any DNA out of an image.” (Anna Nowogrodzki, Nature News)
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