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or at least not yet
FDA on new Alzheimer test: No, or at least not yet
A new test to detect or rule out Alzheimer's is not quite ready for prime time, an FDA advisory panel said Thursday afternoon. The test, a type of PET scan developed by Avid Radiopharmaceuticals, is designed to detect the telltale buildups of amyloid plaque in the brain that signify Alzheimer's disease. While PET scans aren't new, this one uses a special radioactive marker known as florbetapir F 18 and developed under the brand name Amyvid. It's hermes kelly black cheap meant to be used when a doctor suspects Alzheimer a negative test meaning no detectable plaque would tell the doctor to consider a different diagnosis.
While the test is considered safe, members of the FDA Peripheral and Central Nervous System Drugs Advisory Committee said Avid needs to do more work training the medical professionals who would administer it. Panel members also voiced hermes kelly crocodile fake concern that there would be too many tests in other words, too many patients told they have Alzheimer when in fact they don Dr. James Tatum of the Hunter Holmes McGuire VA Hospital in Richmond cited data suggesting that in patients older than 80, as many as a third of test results would be wrong.
Tatum ended up voting in support of Amyvid, but by a vote of 16 3 his fellow panelists disagreed.
However, in a followup vote, by 16 0 (with three abstentions) the panel said the test should be approved if Avid can ensure proper training and labeling so that test results are consistent, as well as analyzed and interpreted accurately.
Maria Carrillo, senior director of medical and scientific relations at the Alzheimer Association, said she expects the training concerns to be addressed and the test to be approved later this year. Carrillo said the test could could be a boon to research, as well as patient care.
now we don have evidence of what amyloid [plaque] in the brain means when it starts, and when does it tip over into actual cognitive deficits, Carrillo said. need to follow people over time, and this could hermes kelly crocodile cheap be the tool we use. The FDA has become so gun shy because of the Celebrex fiasco that they require mountains of paperwork, regulation, etc to get things like this approved.
What this type of test will do, while not curing or treating people with Alzheimer is hopefully identify people at the very early stages and allow patients and their families to make the necessary preparations for long term care well in advance. Right now, it is still virtually impossible to treat AD once the plaques start to form.
January 21, 2011 at 14:27
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The problem, as mentioned, is there are people that will have a positive test that don necessarily have Alzheimer disease. It has nothing to do with any drug company holding off to make more money. If anything all the false positive tests will result in more meds being used that may not be needed and that may be Hermes Kelly Depeche Briefcase replica a waste of money
It is a huge step forward in Alzheimer testing, but interpretation is not as straightforward as the mainstream media is making it out to be.
January 21, 2011 at 10:50
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While this concept is great, and we do need a way to detect AD in it early stages, I can see one major flaw. The presence of amyloid plaques does not necessarily mean a patient has AD. Everyone even those who are health produce amyloid within the brain. On top of that, if the presence of amyloid is found within the brain, there is no point to it. Once a patient begins to have plaque build up, it is too late to try to do anything. Presence of amyloid can only help to diagnose, but by looking for amyloid, you will not catch it early, rather amyloid is a late appearing plaque in the time course for AD.
January 21, 2011 at 11:29
Report abuse Reply
When it get approved, look for health insurance premiums to go up. The test will probably cost over $1000. Then, whatever is discovered, people will want treatment for. Additionally, a diagnosis of early Alzheimers will cause some to become depressed and others to take their lives. For some, it will be a positive thing, and they will get their lives in order. But, I fear, that for the vast majority, who discover they have Alzheimers, it going to cause tremendous grief and family suffering. Some things are better not known until they manifest themselves.
January 21, 2011 at 12:05
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Just thought I would bring this to your attention. The application is not seeking to have the scan used to confirm Alzheimer's or dementia. It is to indicate that there is no abeta plaque , which would indicate that the person DOES NOT have Alzheimer's. This scan will have nothing to do with trying to get early screening for the disease, which is what the medical world is asking for. Here is the excerpt from the application.
A closer examination of the application reveals a point that receives almost no mention elsewhere: that Avid application actually does not seek approval to use the test to diagnose Alzheimer disease. Rather, it seeks approval to use it to rule out the presence of amyloid plaques. If FDA eventually grants approval, presumably some doctors would use it for purposes, such as testing people they already suspect have Alzheimer or screening people with mild memory impairments.
Amyvid is an imaging tool indicated for Positron Emission Tomography (PET) imaging of beta amyloid plaque in the brain. It being investigated for the potential use in ruling out Alzheimer disease. The FDA Committee stated that a negative scan would be clinically useful in indicating that Alzheimer pathology is unlikely to be the cause of a patient cognitive decline.
FDA on new Alzheimer test: No, or at least not yet
A new test to detect or rule out Alzheimer's is not quite ready for prime time, an FDA advisory panel said Thursday afternoon. The test, a type of PET scan developed by Avid Radiopharmaceuticals, is designed to detect the telltale buildups of amyloid plaque in the brain that signify Alzheimer's disease. While PET scans aren't new, this one uses a special radioactive marker known as florbetapir F 18 and developed under the brand name Amyvid. It's hermes kelly black cheap meant to be used when a doctor suspects Alzheimer a negative test meaning no detectable plaque would tell the doctor to consider a different diagnosis.
While the test is considered safe, members of the FDA Peripheral and Central Nervous System Drugs Advisory Committee said Avid needs to do more work training the medical professionals who would administer it. Panel members also voiced hermes kelly crocodile fake concern that there would be too many tests in other words, too many patients told they have Alzheimer when in fact they don Dr. James Tatum of the Hunter Holmes McGuire VA Hospital in Richmond cited data suggesting that in patients older than 80, as many as a third of test results would be wrong.
Tatum ended up voting in support of Amyvid, but by a vote of 16 3 his fellow panelists disagreed.
However, in a followup vote, by 16 0 (with three abstentions) the panel said the test should be approved if Avid can ensure proper training and labeling so that test results are consistent, as well as analyzed and interpreted accurately.
Maria Carrillo, senior director of medical and scientific relations at the Alzheimer Association, said she expects the training concerns to be addressed and the test to be approved later this year. Carrillo said the test could could be a boon to research, as well as patient care.
now we don have evidence of what amyloid [plaque] in the brain means when it starts, and when does it tip over into actual cognitive deficits, Carrillo said. need to follow people over time, and this could hermes kelly crocodile cheap be the tool we use. The FDA has become so gun shy because of the Celebrex fiasco that they require mountains of paperwork, regulation, etc to get things like this approved.
What this type of test will do, while not curing or treating people with Alzheimer is hopefully identify people at the very early stages and allow patients and their families to make the necessary preparations for long term care well in advance. Right now, it is still virtually impossible to treat AD once the plaques start to form.
January 21, 2011 at 14:27
Report abuse
The problem, as mentioned, is there are people that will have a positive test that don necessarily have Alzheimer disease. It has nothing to do with any drug company holding off to make more money. If anything all the false positive tests will result in more meds being used that may not be needed and that may be Hermes Kelly Depeche Briefcase replica a waste of money
It is a huge step forward in Alzheimer testing, but interpretation is not as straightforward as the mainstream media is making it out to be.
January 21, 2011 at 10:50
Report abuse Reply
While this concept is great, and we do need a way to detect AD in it early stages, I can see one major flaw. The presence of amyloid plaques does not necessarily mean a patient has AD. Everyone even those who are health produce amyloid within the brain. On top of that, if the presence of amyloid is found within the brain, there is no point to it. Once a patient begins to have plaque build up, it is too late to try to do anything. Presence of amyloid can only help to diagnose, but by looking for amyloid, you will not catch it early, rather amyloid is a late appearing plaque in the time course for AD.
January 21, 2011 at 11:29
Report abuse Reply
When it get approved, look for health insurance premiums to go up. The test will probably cost over $1000. Then, whatever is discovered, people will want treatment for. Additionally, a diagnosis of early Alzheimers will cause some to become depressed and others to take their lives. For some, it will be a positive thing, and they will get their lives in order. But, I fear, that for the vast majority, who discover they have Alzheimers, it going to cause tremendous grief and family suffering. Some things are better not known until they manifest themselves.
January 21, 2011 at 12:05
Report abuse Reply
Just thought I would bring this to your attention. The application is not seeking to have the scan used to confirm Alzheimer's or dementia. It is to indicate that there is no abeta plaque , which would indicate that the person DOES NOT have Alzheimer's. This scan will have nothing to do with trying to get early screening for the disease, which is what the medical world is asking for. Here is the excerpt from the application.
A closer examination of the application reveals a point that receives almost no mention elsewhere: that Avid application actually does not seek approval to use the test to diagnose Alzheimer disease. Rather, it seeks approval to use it to rule out the presence of amyloid plaques. If FDA eventually grants approval, presumably some doctors would use it for purposes, such as testing people they already suspect have Alzheimer or screening people with mild memory impairments.
Amyvid is an imaging tool indicated for Positron Emission Tomography (PET) imaging of beta amyloid plaque in the brain. It being investigated for the potential use in ruling out Alzheimer disease. The FDA Committee stated that a negative scan would be clinically useful in indicating that Alzheimer pathology is unlikely to be the cause of a patient cognitive decline.
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