By: Daniël P. Melters, PhD.
Cattle trial cuts human sleeping sickness
In addition to HIV and malaria, sleeping sickness is another serious infectious disease causing major health problems in sub-Saharan Africa, resulting in many thousands of infections each year. In total over 65 million people are at risk of infection. The disease is caused by the protozoan parasite from the genus Trypanosoma, where Trypanosoma brucei gambiense accounts for more than 98% of all reported cases. The parasite is transmitted via tsetse flies. The people most affected by this parasite live in rural areas, where they are in close contact with life-stock. These life-stock hold an important step in the life-cycle of Trypanosoma. To make matters worse, diagnosis and treatment require specifically skilled staff, resulting in only about 30% of all infected individuals receiving treatment following a diagnosis.
A collaboration between the University of Edinburgh (UK), Makerere University (Uganda), and the Ugandan government has tried to tackle the problem by injecting 500,000 cows with a parasite killing agent in addition to regular fumigation with insecticide to qualm the number of tsetse flies. The number of people diagnosed with sleeping sickness went down by 90%. Following this successful trial the program will be expanded to cover the whole of Uganda, including the treatment of 2.7 million cattle. (SciDev.Net)
Precision Medicine Initiative
Privacy Risks from Genomic Data-Sharing Beacons
One of the corner stones of President Obama’s Precision Medicine Initiative is the broad sharing of medical data between many scientists, albeit in a responsible manner. In their recent report, the NIH Precision Medicine Initiative Cohort Program (PMI-CP) workgroup advised the creation of a “hub-and-spoke” model that has a Coordinating Center to provide safeguards to facilitate data access, data normalization, and participant engagement. Part of this dataset is genomic data from patients. One major concern about genomic and genetic data is that this can be used to identify the donor, even when the genomic data is made anonymous early on. A recent article by Shringarpure and Bustamante in the American Journal of Human Genetics provides evidence that it is not only possible to re-identify to whom an anonymous genetic ‘beacon’ belongs to, but also identifies their relatives with just 1000 single-nucleotide polymorphisms (SNP)s. A beacon is a web server that answer allele-presence queries in a binary manner. This might pose a serious privacy-concern for potential participants in the PMI-CP. This concern is not limited to the PMI-CP either. Recently the American Association for Cancer Research (AACR) rolled out their Project GENIE where US and European research institutes will share their cancer genomes to catalyze the development of more precise cancer treatments. Nevertheless, Shringarpure and Bustamante do make several suggestions to continue to safeguard patient privacy. (American Journal of Human Genetics)
Another Genetic Testing Company in Hot Water with the FDA
In November 2013, the US Food and Drug Administration (FDA) warned the direct-to-consumers health testing company 23andMe that they needed to comply with federal regulations with respect to approval for medical devices (section 201(h) of the Federal Food Drug and Cosmetics Act). 23andMe offered a saliva-based genetics test that provided participants with an ancestry-based analysis of some of genetic markers, in addition to various health-related genetic variations (SNPs). The FDA is of the opinion that the latter one required approval by them as a medical device. Seven months after their warning, the FDA received an application from 23andMe. Recently, they obtained the federal seal of approval for a few of their health-related genetic tests.
23andMe is maybe the most well known of these direct-to-consumers genetic testing companies, but they are certainly not the only ones. On November 2nd, the Louisiana-based DNA4Life Company received a similar notification from the FDA. Just like 23andMe, DNA4Life has held the position that they do not need FDA approval to sell their genetic test kit. However, the FDA maintains that the genetic test, which predicts how patients will respond to 120 of the most common medication, meets the definition of a “medical device” and requires that the company either provide evidence of FDA approval or present why they do not need approval. DNA4Life has not yet publicly responded to the FDA notification.
Have an interesting science policy link? Share it in the comments!