The AquaBounty Salmon: Will the World’s First Commercial GE Animal Be an Albatross?
Jonathan Latham and Allison Wilson
The Bioscience Resource Project
(Photo Credit: Yodod)
Is it unrealistic to expect the scientific approval process for the world’s first commercial genetically engineered (GE) animal, the AquAdvantage salmon, to be rigorous and complete? Or for the applicant to present experiments that fully meet regulatory expectations? If you expect these things, it seems, you expect too much. Despite the biotech industry’s “dedication to rigorous science-based risk assessment”, the science of the AquAdvantage salmon is full of holes. Its maker, AquaBounty Technologies, has failed to provide key data on which the safety assessment process depends.
The US Food and Drug Administration (FDA) is currently considering whether to approve this salmon for sale to US consumers. If it becomes the world’s first commercial GE animal, the approval of the AquAdvantage salmon, which contains a modified growth hormone gene, will be a technological and cultural milestone. In perhaps as few as 18 months, if AquaBounty has its way, unlabeled GE salmon will be landing on the plates of consumers. So it is a fish that needs to be safe, for the public, as well as for the environment.
Congress has determined that GE animals will require FDA approval and that approval should be based solely on science. Science-based regulation is a narrow ground on which to base societal acceptability but its advantage is that, in principle, it allows the approval process to be orderly, data-based, and transparent, with requirements set out in advance. (In this case, industry guidance can be found here.). There is, therefore, no good reason for an applicant to come to the table with shoddy science or missing data. However, that is what AquaBounty has done. This is a problem, in particular for the FDA, if it wishes to ensure that the approval process for the world’s first GE animal does not set an embarrassing precedent.
Key publication errors
The only peer reviewed publicly available data for assessing the science behind the AquAdvantage salmon is a single paper: Characterization and multigenerational stability of the growth hormone transgene (EO-1alpha) responsible for enhanced growth rates in Atlantic salmon (Yaskowiak et al. 2006). This article, researched and written by AquaBounty scientists, appeared in the scientific journal Transgenic Research in 2006. As it is AquaBounty’s sole publication on the AquAdvantage salmon, one might imagine, given its importance, that AquaBounty would have taken particular care to ensure its credibility and accuracy. It is surprising, therefore, to discover that the paper contains basic errors that prevent the reader from checking the author’s conclusions.
These mistakes can be summarised as follows: the legend for figure 1 (a Southern blot) wrongly identifies two lanes, and the transgene construct itself is mislabeled. In figure 5, the data showing the DNA sequence of the inserted transgene is entirely mangled. In this figure, two separate errors omit sequence stretches adding up to thousands of base pairs. A third error results in a long stretch of sequence being copied multiple times. In addition, the figure legend includes a typo. These errors are described in more detail in a footnote 1.
These mistakes mean that the data presented in the paper contradict its written conclusions regarding the nature of the integrated transgene (Yaskowiak et al. 2006). The errors in figure 5 were later corrected in an erratum, but readers are still left to decipher figure 1 for themselves (Yaskowiak et al. 2007).
Has AquaBounty identified the right transgene?
The primary purpose of a scientific paper (assuming the data have been presented accurately) is to allow the reader to verify that the data support the conclusions that are drawn. Yaskowiak et al. claim to have reached two fundamental conclusions:
Read full post at The Bioscience Resource Project