30
Oct2015

From the progress in gene therapy for genetic retinal diseases to a survey that finds the majority of animal studies for drugs are not rigorous enough, this week’s Research Ethics Roundup examines some of the latest controversial issues occurring in research ethics.

RER 10.30 #223andMe Will Resume Giving Users Health Data: Two years after the Food and Drug Administration (FDA) ordered it to stop selling and marketing its DNA testing service, 23andMe announced a new product that has the backing of the federal agency. The service provides consumers with carrier status information related to genetic mutations, health-related information on nonmedical traits, and ancestry reports.

Can a Cancer Drug Reverse Parkinson’s Disease and Dementia?: A small Phase I study of a dozen subjects who have Parkinson’s disease with dementia or Lewy Body dementia has shown small doses of nilotinib to be effective in reducing their symptoms and demonstrating both physical and cognitive improvement. The drug, which is approved by the FDA for treating leukemia, was provided to subjects through an expanded access study led by a research team from Georgetown University Medical Center.

Blind man sitting on a benchSuccess Against Blindness Encourages Gene Therapy Researchers: A small gene therapy study for those with a genetic retinal disease has resulted in all subjects having improved sensitivity to light. However, past similar studies have shown that the effects of such treatment are not permanent. The research team plans to apply to the FDA for regulatory approval in 2016; if successful, it would the first gene therapy marketed in the United States.

Drug Research Hampered by Substandard Animal Testing Procedures: A United Kingdom survey of thousands of animal studies found that top-tier journals reported on poorly designed studies in which researchers failed to take basic steps in preventing biases in their work. The research team also found that journals were unlikely to publish on studies that demonstrated little or no effectiveness in tested compounds.

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