How is it within Wise's control that the FDA is requiring animal safety data?Originally Posted by Lyerly
How is it within Wise's control that the FDA is requiring animal safety data?
This post is about the FDA, I don't mean to inject politics into this thread, but since the FDA is a government agency I wanted to mention that Ted Cruz said if he were elected president (yes, I know it's a moot point now as the primaries are over, but he is still a Senator) that any therapy, medicine, procedure, or medical equipment that has been approved, and proven safe, in foreign countries but is not available in the USA, the FDA would be given 30 days to approve it or the issue/item would be put before congress for an up/down vote.
IMO this is exactly what we need in the US to speed up the approval process at the FDA and help eliminate the redundancy of repeating studies that have already been done and proven overseas. It would greatly benefit us all.
These kind of policies need to be encouraged.
What studies have been done or illnesses been helped or cured and FDA is rejecting it? No general statements.
Yes, I should have made it more clear that this was not a jab at wise it was me not understanding and frustration with FDA requiring it. I assume to even get to Phase II in China, animal studies were already conducted. So why repeat? Was a any patients treated with only the 6/6/6 or did they all receive cells and lithium?
For the record I have lower motor neuron damage so this treatment along with others isn't anything that will benefit me anytime soon. Just the more I learn about research the more confused and frustrated I become. While I think there are some people that really want to help us, I do see a huge lack of collaboration and possibly people wanting to make sure that it is their work and their work alone that did it. Probably has to do with competing for funding as well.
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Thanks for the clarification.
You pretty much hit the nail on the head. It frustrates the hell out of me as well, it honestly makes me livid sometimes. I am in the second year of getting my PhD, and we young students hear all the time about how it's important to publish in high impact journals, to present at conferences, to get awards, to get grants...I have not once heard about how it is important to do research that makes an impact towards an ultimate goal (like curing SCI). Scientists must compete for funding as part of their jobs, and often times competing for funding undermines the integrity of the scientific work itself.
In a lot of disease populations, SCI included, a lot of researchers look at SCI as an interesting scientific problem, and are not focused on an ultimate goal of making an impact in the lives of people with SCI. This is nothing I fault them for, there are a lot of factors that go into that mentality. But you are right, there is a big lack of collaboration - sometimes this is because of egos, sometimes it is because of a lack of resources, and sometimes there is a lack of understanding about what other scientists can contribute or are trying to accomplish.
IMO, the most important yet least frequent type of collaboration there is, is collaboration between researchers and people who actually have an SCI. More people with SCI need to understand the scientific process, and more researchers need to understand the needs of the SCI population if we want a cure to come faster.
http://www.anatomicalconcepts.com/stimulette-den2x/
The Stimulette is a muscle stimulator for those who have lower motor neuron damage and can't use FES to combat muscle atrophy. Last I checked, the stimulette is not FDA approved, and cannot be prescribed by doctors in the USA.
Phase II trials are not sufficiently powered to be statistically convincing. On the other hand, they can show trends and based on those trends one can always propose to go forward with Phase III trials. It's not all that unusual for the FDA to ask for additional experiments or data at this stage because you're asking for a much larger population of people to be injected.
As I have shared before, I was able to order one and have it come in through customs but knew there was a risk involved. I did not have a scrip for it. I understand that it is not worth the manufacture going through the expensive FDA approval process due to cost and a very small market for it. It's been used for over a decade in Europe.
When you hear of animal trials, it makes you feel like it's going backwards and as long as it has taken to get to this point. It seems like it will be years and years for it to possibly ever get the point of helping people.
I see your point but the point is made that FDA is blocking so many things. I just disagree and I do not trust politicians to make such decisions. Politicians should appoint qualified people to make a judgement and congress should not vote up or down on health issues. This is not the right topic for this thread.
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