switching gears a bit

The American Heart Journal has reported that more than half of randomized clinical trials are not reporting information about the race/ethnicity of the study populations. This is startling to me because almost every clinical trial collects this information at the initial screening visit, so one would assume the data on race/ethnicity is of some usefulness to the sponsor or else it wouldn't be captured (on the other hand, maybe my impressions are totally abstract). With all the news and findings suggesting differences in the risk factors of cardiovascular disease depending on race or ethnicity, it would seem obvious that clinical trial sponsors would be reporting this information with the trial results and discussion. It would seem to me that a trial sponsor would be searching for any benefit of using a product, even if that benefit was only for one race or ethnic group versus a ubiquitous effect. For more information, see the link in Medical News Today or check out the link to the article itself in the American Heart Journal


The other day I wrote about Acorda's bid for FDA approval of its oral therapy to improve walking function in patients with MS. Well, today seemed like the day of reckoning as an FDA advisory panel reviewed the product. Results were not available to me at this time, but apparently someone had enough of the speculation as Nasdaq halted trading of shares of Acorda during the day. I would hope that if you were planning on moving on Acorda you would have done so by now (although I wouldn't touch it in the first place). My question is that if a favorable opinion is not handed down by the advisory committee, what will Acorda do next? Additional data manipulation can only go so far, and we can only speculate until the results of the FDA vote are available....

see more here from Acorda itself


Finally, here's some good news for those with insulin dependent diabetes and bad for insulin manufacturers: generic biosimilars could be on the way to drastically cut the cost of insulin, according to Decision Resources. Read more here