According to a news article published by Reuters – Medicine (see HERE), “China is fast-tracking approval for innovative drugs at home in a bid to offer more and cheaper options to patients, as many in the rapidly aging country struggle to find alternatives to costly treatments sold by multinational pharmaceutical firms for chronic diseases.
In an August overhaul to its drug administration law, Beijing said conditional approval could be granted to some still-under-research medicines of ‘predictable’ clinical value for life-threatening diseases for which effective treatment is not immediately available. Further research on Oligomannate’s pharmacological mechanism and long-term safety and effectiveness is required, according to the NMPA [China’s National Medical Products Administration] statement.”
The news was received by the scientific community with hope and caution.
A recent article in Science (Science, 11 4 2019) published some opinions on the issue. Below are some excerpts from the report that, in our view, appear to be more relevant:
“The news has elicited both hope and skepticism from researchers not connected to the company. “I think it’s fascinating, and if it’s true that [the effects are happening] through the microbiome, that’s fantastic,” says Sangram Sisodia, a neurobiologist at University of Chicago in Illinois who has studied the impact of the microbiome on Alzheimer’s disease in mice but is not associated with the research. But just like China’s regulators, he and others want to see more evidence. Some aren’t yet convinced that the subtle improvement among Alzheimer’s patients measured by a cognitive test is clinically meaningful.”
New Alzheimer’s drug
Green Valley Pharmaceutical has presented its clinical findings at one or more conferences and they’re described in releases from the company and a research institute where work on the compound originated, though not yet in a peer-reviewed paper. “We’re still cautiously optimistic,” regarding the drug’s promise, says Rebecca Edelmayer, director of scientific engagement at the Chicago-based Alzheimer’s Association. But, she adds, “I think we need to really understand for sure what kinds of changes are occurring through a medicine like this and how they actually relate to a disease process.”
Our bioethical opinion
From a bioethical point of view, official approval of a treatment for a disease of the seriousness and scope of Alzheimer’s must be supported by larger, broader and peer-reviewed scientific studies. Taking into account China’s past irregularities in the field of biotechnology (read HERE and HERE), this latest development calls for caution and warrants further studies.
From a bioethical point of view, the official approval of a treatment for a disease of seriousness and breadth, such as Alzheimer’s must be supported by larger, broader and peer-reviewed scientific studies. Taking into account China’s past irregularities in the field of biotechnology (read HERE and HERE), this latest development calls for caution and warrants further studies.