1.24.99
Troubling times, these....
The phrase that ended the entry previous begin this one. It's because I am really in a quandary over this one. I have devoted a lot of "brain time" to the topic at hand, and have forced some thought, and have come to one conclusion. Being how I am such a damn creative soul, I've had this song lyric running thru my feeble mind all day. It's from a 1970-something song, I think it's called "Stop:"
You might wonder why the FDA visiting my site might bring worries to me. It's because they are the "long arm of the Law." If you are really interested, visit the FDA Website and have a look at what they do for a living. The blood banking industry probably could do a very good job at regulating itself, seeing how this is a fairly high-liability thing we are looking at here, but when it comes to health, the public at large isn't interested in hearing this. after all, a blood product that is contaminated can really screw up your day, not to mention your liver.
In light of their charge at CBER, they really do a fair job at protecting the interests of the public at large. In fact, they might do too good a job. In their zeal to protect the health of the public, they tend to allow the interests of private organizations override common scientific thought. That's the reason that questions about Creutzfeldt-Jakob disease are asked. In the memo that kindly requested that we ask these questions, they acknowledge that CJD is most likely not a bloodbourne disease, and that no cases of CJD have been linked to blood transfusion. In my opinion, it is political motivation, rather than scientific, especially given the fact that one of the most important and obvious routes of CJD transmission is ignored. (corneal transplants)
A couple of months, I spouted that opinion, and I stand by it 100%, and I know that many of the great leaders in this industry will agree with me, even if they might not admit it in a public forum, as I have.
So, that's what the FDA does. They over-regulate. They're hyper-cautious. Eh, that's really not such a bad thing in retrospect. It protects people from unscrupulous folks, and from the looks of some of the consent decrees that the FDA has issued recently, they have a real mission in the protection of the interest of the nation's health. My organization has been inspected many times since I've been in their employ, and I can vouch for the fact that we really have our shit together. I don't know the exact statistics, but I am told that most of our inspections are returned with no citations. I could launch a whole Freedom of Information Act query and see the exact numbers and answers, but why should I? I know that we are doing it correctly. Our operating procedures could be easily measured by the pound, and they are painstakingly accurate.
Which comes to the greatest of the FAQ's:
"If you were faced with having an option of receiving a transfusion from your own blood centre, would you have it?"
"Yes, I would. The blood supply, thanks to sophisticated testing and careful donor screening is far safer than it has been at any other time in history. Consequently, the number of reactions to transfusion have dropped dramatically. Graft Vs. Host type reactions still occur, but their numbers have also been minimized."
And that is the word of the Shtupman. Amen.
The phrase that ended the entry previous begin this one. It's because I am really in a quandary over this one. I have devoted a lot of "brain time" to the topic at hand, and have forced some thought, and have come to one conclusion. Being how I am such a damn creative soul, I've had this song lyric running thru my feeble mind all day. It's from a 1970-something song, I think it's called "Stop:"
"Paranoia strikes deep.And that's where I am right here, right now. Paranoid. Big brother is looking over my shoulder, and it irritates me. It has been very upsetting, and I don't care for it. In fact, I bowed out of a retirement party last night because I just didn't feel in the mood to "glitter and be gay," which would have been required of me. I am positive that I have disappointed several people, but I have to think of myself here first.
Into your life it will creep.
It strikes when your always afraid
The man will come and take you away."
You might wonder why the FDA visiting my site might bring worries to me. It's because they are the "long arm of the Law." If you are really interested, visit the FDA Website and have a look at what they do for a living. The blood banking industry probably could do a very good job at regulating itself, seeing how this is a fairly high-liability thing we are looking at here, but when it comes to health, the public at large isn't interested in hearing this. after all, a blood product that is contaminated can really screw up your day, not to mention your liver.
In light of their charge at CBER, they really do a fair job at protecting the interests of the public at large. In fact, they might do too good a job. In their zeal to protect the health of the public, they tend to allow the interests of private organizations override common scientific thought. That's the reason that questions about Creutzfeldt-Jakob disease are asked. In the memo that kindly requested that we ask these questions, they acknowledge that CJD is most likely not a bloodbourne disease, and that no cases of CJD have been linked to blood transfusion. In my opinion, it is political motivation, rather than scientific, especially given the fact that one of the most important and obvious routes of CJD transmission is ignored. (corneal transplants)
A couple of months, I spouted that opinion, and I stand by it 100%, and I know that many of the great leaders in this industry will agree with me, even if they might not admit it in a public forum, as I have.
So, that's what the FDA does. They over-regulate. They're hyper-cautious. Eh, that's really not such a bad thing in retrospect. It protects people from unscrupulous folks, and from the looks of some of the consent decrees that the FDA has issued recently, they have a real mission in the protection of the interest of the nation's health. My organization has been inspected many times since I've been in their employ, and I can vouch for the fact that we really have our shit together. I don't know the exact statistics, but I am told that most of our inspections are returned with no citations. I could launch a whole Freedom of Information Act query and see the exact numbers and answers, but why should I? I know that we are doing it correctly. Our operating procedures could be easily measured by the pound, and they are painstakingly accurate.
Which comes to the greatest of the FAQ's:
"If you were faced with having an option of receiving a transfusion from your own blood centre, would you have it?"
"Yes, I would. The blood supply, thanks to sophisticated testing and careful donor screening is far safer than it has been at any other time in history. Consequently, the number of reactions to transfusion have dropped dramatically. Graft Vs. Host type reactions still occur, but their numbers have also been minimized."
And that is the word of the Shtupman. Amen.
<< Home