"It is outrageous that it took an independent lab to find the contamination."
Note that the lab was using a new technology that had not been developed before.
"It is outrageous that it took GSK more than a month to contact the FDA."
GSK used that time to verify the findings of the original lab. You know, to make sure that what the lab said they found was actually real. Once they confirmed the findings, they took the appropriate step and notified FDA.
Think about that. GSK, a vaccine manufacturer, actually took the time to investigate their product for this safety issue and then reported it to FDA, knowing full well that it would likely impact their profits. This runs contrary to the AoA meme of corporations caring more for profits than for safety.
@Jim
"Where are the well paid watchdogs in our government?"
Well paid? When's the last time you took a look at the FDA's budget? They are one of the least-funded agencies in government with one of the largest tasks: regulating hundreds of thousands of food, drug and cosmetic products. Due to poor funding, they do not have nearly the human resources necessary to do an ideal job. So, before you go playing the blame game, start lobbying your congressional reps to give the FDA the financial resources it needs to fulfill its mandate.
This comment is being cross-posted to Silenced by Age of Autism.
After reading some more of the comments, a few things need to be pointed out.
First, rotavirus vaccine (whether Rotarix or Rotateq) are oral. They are not injected.
Second, the discovery was of fragments of viral DNA, not full, intact viruses.
Third, the discovery was made using new technology previously unavailable. Blaming GSK for not catching the contamination is like blaming Middle-Ages people for not catching lead in their drinking water.
Fourth, as I mentioned before, the manufacturer informed FDA. They did not cover it up. They acted in a responsible manner, rather than thinking "only of profits" as many would like to accuse them.
Fifth, the FDA acted quickly once they became aware of the issue. Further, they actually do randomly test drug products. However, before castigating them for not doing enough, please investigate just how much the FDA is funded. Again, as I mentioned before, the agency is sorely underfunded. If you feel that they are doing an inadequate job of policing the industry, then write to your congressional representatives!
We've discovered how to detect these new contaminants. Going forward, vaccine makers are likely to use this technology to maker safer vaccines, which is what everyone wants. We will probably continue to come up with new ways to detect even more things that we don't currently know about.
Just as a side thought, how much testing is done of the food you eat? What kinds of contaminants may be lingering in our food supply that we don't know about because we do not currently have the technology? Are you going to stop eating and argue against food in the same way you refuse to vaccinate and argue against vaccines?
This post is being cross-posted to Silenced by Age of Autism.
@Anne McElroy Dachel
ReplyDelete"It is outrageous that it took an independent lab to find the contamination."
Note that the lab was using a new technology that had not been developed before.
"It is outrageous that it took GSK more than a month to contact the FDA."
GSK used that time to verify the findings of the original lab. You know, to make sure that what the lab said they found was actually real. Once they confirmed the findings, they took the appropriate step and notified FDA.
Think about that. GSK, a vaccine manufacturer, actually took the time to investigate their product for this safety issue and then reported it to FDA, knowing full well that it would likely impact their profits. This runs contrary to the AoA meme of corporations caring more for profits than for safety.
@Jim
"Where are the well paid watchdogs in our government?"
Well paid? When's the last time you took a look at the FDA's budget? They are one of the least-funded agencies in government with one of the largest tasks: regulating hundreds of thousands of food, drug and cosmetic products. Due to poor funding, they do not have nearly the human resources necessary to do an ideal job. So, before you go playing the blame game, start lobbying your congressional reps to give the FDA the financial resources it needs to fulfill its mandate.
This comment is being cross-posted to Silenced by Age of Autism.
Posted at AoA on April 14, 2010 at 1:49pm(EDT)
ReplyDeleteAfter reading some more of the comments, a few things need to be pointed out.
First, rotavirus vaccine (whether Rotarix or Rotateq) are oral. They are not injected.
Second, the discovery was of fragments of viral DNA, not full, intact viruses.
Third, the discovery was made using new technology previously unavailable. Blaming GSK for not catching the contamination is like blaming Middle-Ages people for not catching lead in their drinking water.
Fourth, as I mentioned before, the manufacturer informed FDA. They did not cover it up. They acted in a responsible manner, rather than thinking "only of profits" as many would like to accuse them.
Fifth, the FDA acted quickly once they became aware of the issue. Further, they actually do randomly test drug products. However, before castigating them for not doing enough, please investigate just how much the FDA is funded. Again, as I mentioned before, the agency is sorely underfunded. If you feel that they are doing an inadequate job of policing the industry, then write to your congressional representatives!
We've discovered how to detect these new contaminants. Going forward, vaccine makers are likely to use this technology to maker safer vaccines, which is what everyone wants. We will probably continue to come up with new ways to detect even more things that we don't currently know about.
Just as a side thought, how much testing is done of the food you eat? What kinds of contaminants may be lingering in our food supply that we don't know about because we do not currently have the technology? Are you going to stop eating and argue against food in the same way you refuse to vaccinate and argue against vaccines?
This post is being cross-posted to Silenced by Age of Autism.