The 21st Century Cures Act... not specific to aneurysms

07/17/15 NY Times Opinion Pages can be readily found online...

Search: The F.D.A.'s Medical Device Problem

It is well worth reading...

Can we add links?

hmm... I sense safety problems. http://www.fiercemedicaldevices.com/story/nyt-op-ed-slams-device-breakthrough-pathway-proposed-21st-century-cures-act/2015-07-17-0

yes....

Campanile said:

Can we add links?

Thank for this one...

year or so ago, we did list some recall data....also found of interest was "voluntary recall".....even tho stock #'s ran over a year...there is a lot that can b so interesting/fascinating...

And, in one issue,..I contacted a major manufacturer looking for some "scientist"...and it was the huge corporate senior counsel... and I asked if his legalese covered the scientific data...still awaiting his response since 2009...

Madere (dancermom) said:

This is disturbing on many levels. First the obvious, anecdotal evidence is not accepted in the scientific community. Second, the un-seen hand, who is it? An individual, a corporation, corporations?

Ohhh...giggling...NYT again... Sunday Review - Editorial

Why Science Needs Female Mice..

"Scientific research has a gender gap....not just among humans...In many disciplines, the animals used to study diseases and drugs are overwhelmingly male..."

It notes a study published in the journal Nature Neuroscience...suggests that research done on male animals may not hold up for women.

"failure to consider gender in research is very much the norm...per some analysis of scientific studies that were published in 2009, male animals outnumbered females 5.5 to 1 in neuroscience, 5 to 1 in pharmacology, and 3.7 to 1 in physiology...

Only 45 % of animal studies involving depression or anxiety and only 38 % involving strokes used females, even tho these conditions are more common in women"..

For all the women here...we are the majority % of brain aneurysms... And, the ref to depression and anxiety are so driven in treatment...even tho we are awaiting to hear from someone who had a neuro-doc explain the limbic system to any of us as a patient in our procedure selection and the proximity of the aneurysm(s)/arteries to which structure(s) in the limbic system...

And, gosh, all of that is for any gender...

So...can the rats be found to study the individual(s), or the corporation(s)? or the supporters/promoters of the 21st Century Cures Act?

There is another Opinion Pages.... How Not to Fix the F.D.A...

Can be readily pulled up online...

Patio,

This is amazing. Thank you, for bringing it to our attention. You are a BAF treasure. I hope everyone here reads this article, because the ramifications for every female suffering nerve pain are huge. http://www.theverge.com/2015/6/29/8861765/pain-immune-cell-sex-difference-mice



patioplans said:

Ohhh...giggling...NYT again... Sunday Review - Editorial

Why Science Needs Female Mice..

"Scientific research has a gender gap....not just among humans...In many disciplines, the animals used to study diseases and drugs are overwhelmingly male..."

It notes a study published in the journal Nature Neuroscience...suggests that research done on male animals may not hold up for women.

"failure to consider gender in research is very much the norm...per some analysis of scientific studies that were published in 2009, male animals outnumbered females 5.5 to 1 in neuroscience, 5 to 1 in pharmacology, and 3.7 to 1 in physiology...

Only 45 % of animal studies involving depression or anxiety and only 38 % involving strokes used females, even tho these conditions are more common in women"..

For all the women here...we are the majority % of brain aneurysms... And, the ref to depression and anxiety are so driven in treatment...even tho we are awaiting to hear from someone who had a neuro-doc explain the limbic system to any of us as a patient in our procedure selection and the proximity of the aneurysm(s)/arteries to which structure(s) in the limbic system...

And, gosh, all of that is for any gender...

So...can the rats be found to study the individual(s), or the corporation(s)? or the supporters/promoters of the 21st Century Cures Act?

Thank you...over and over...there is so much more than I can note here now..

TODAY is my 12TH ANNIVERSARY...of surviving the coronary care disruption of the minimally invasive procedure(s)...many of my records suggest I was likely and presumably not going to recover enough
to be here ...I was able to walk/talk into my 3rd Emergency...

What jogs my twisted humor is that the angios are marketed as the "gold standard" for the minimally invasive procedures for those "approved" platinum devices...Then, we can/may get the likely/presumably verbiage ...in our records...w/this high quality equipment/procedures/devices...

Campanile said:

Patio,

This is amazing. Thank you, for bringing it to our attention. You are a BAF treasure. I hope everyone here reads this article, because the ramifications for every female suffering nerve pain are huge. http://www.theverge.com/2015/6/29/8861765/pain-immune-cell-sex-diff...



patioplans said:

Ohhh...giggling...NYT again... Sunday Review - Editorial

Why Science Needs Female Mice..

"Scientific research has a gender gap....not just among humans...In many disciplines, the animals used to study diseases and drugs are overwhelmingly male..."

It notes a study published in the journal Nature Neuroscience...suggests that research done on male animals may not hold up for women.

"failure to consider gender in research is very much the norm...per some analysis of scientific studies that were published in 2009, male animals outnumbered females 5.5 to 1 in neuroscience, 5 to 1 in pharmacology, and 3.7 to 1 in physiology...

Only 45 % of animal studies involving depression or anxiety and only 38 % involving strokes used females, even tho these conditions are more common in women"..

For all the women here...we are the majority % of brain aneurysms... And, the ref to depression and anxiety are so driven in treatment...even tho we are awaiting to hear from someone who had a neuro-doc explain the limbic system to any of us as a patient in our procedure selection and the proximity of the aneurysm(s)/arteries to which structure(s) in the limbic system...

And, gosh, all of that is for any gender...

So...can the rats be found to study the individual(s), or the corporation(s)? or the supporters/promoters of the 21st Century Cures Act?