Comments on: Life After Andy: Searching For FDA Leadership http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/ News, Comment and Conversation Fri, 10 Feb 2012 21:11:44 +0000 http://wordpress.org/?v=2.6.2 By: An FDA Reviewer http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380718 An FDA Reviewer Fri, 07 Nov 2008 15:37:33 +0000 http://www.pharmalot.com/?p=17339#comment-380718 Nathan, If I could quit my job and speak I would. However even if I quit my job I still couldn't speak legally. As for suggestions. There are those in Congress that know what needs to be done. They need the politicaly clout from the public that writes them so they can actually do something. I'm not going to get into specifics of what pressures and rewards FDA management can bring. The more I reveal the more likely FDA management will be able to find something I say so they can use it against me. An FDA Reviewer Nathan,

If I could quit my job and speak I would. However even if I quit my job I still couldn’t speak legally.

As for suggestions. There are those in Congress that know what needs to be done. They need the politicaly clout from the public that writes them so they can actually do something.

I’m not going to get into specifics of what pressures and rewards FDA management can bring. The more I reveal the more likely FDA management will be able to find something I say so they can use it against me.

An FDA Reviewer

]]> By: Nathan http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380714 Nathan Fri, 07 Nov 2008 14:57:13 +0000 http://www.pharmalot.com/?p=17339#comment-380714 Reviewer, 1) If someone was working on the plans for Auschwitz I hope that they would quit their job and testify to what they saw/heard. 2) In your postings, you seem to forget that we ALL want safe drugs to be approved - even those of us in pharma and (almost certainly) those in the management of the FDA. There are differences of opinions about how to achieve that goal. I hear complaints from you frequently, but I seldom (if ever) have heard a viable suggestion on how the present system could be FIXED. (short of firing all your bosses) Do you genuinely believe that those in the management of the FDA wish harm upon people just to pad their pocketbooks? It’s not even clear to me why they would have any pressure to approve drugs at all. What kind of pressure can pharma really apply to the FDA? It’s not as if the FDA (or its managment) gets a cut of drug profits. Yet that’s the impression you constantly give. Reviewer,
1) If someone was working on the plans for Auschwitz I hope that they would quit their job and testify to what they saw/heard.
2) In your postings, you seem to forget that we ALL want safe drugs to be approved - even those of us in pharma and (almost certainly) those in the management of the FDA. There are differences of opinions about how to achieve that goal. I hear complaints from you frequently, but I seldom (if ever) have heard a viable suggestion on how the present system could be FIXED. (short of firing all your bosses)

Do you genuinely believe that those in the management of the FDA wish harm upon people just to pad their pocketbooks? It’s not even clear to me why they would have any pressure to approve drugs at all. What kind of pressure can pharma really apply to the FDA? It’s not as if the FDA (or its managment) gets a cut of drug profits. Yet that’s the impression you constantly give.

]]> By: David http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380713 David Fri, 07 Nov 2008 14:46:49 +0000 http://www.pharmalot.com/?p=17339#comment-380713 Nathan - What would you suggest FDA Reviewer do? I am certain he would be interested in any ideas you might have. Nathan -
What would you suggest FDA Reviewer do? I am certain he would be interested in any ideas you might have.

]]> By: An FDA Reviewer http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380711 An FDA Reviewer Fri, 07 Nov 2008 14:28:36 +0000 http://www.pharmalot.com/?p=17339#comment-380711 Thank you David. Nathan, I love my work and do it ethically. Would your say the same thing to someone who worked on the plans for Auschwitz, realized what was really going on, and tried to warn the Jews? From what I have seen I believe that I am in a similar position. However information on drugs are trade secrets and besides the press isn't going to listen. Unfortunately our government has virtually killed free speech and unless a Congressman or Senator releases information those of us who work in government will be fired, go to jail, and even face the possibility of having ourselves or our family members killed as retaliation for actually speaking out and warning people. Why do you say anything now when I simply make a statement about what other reviewers have said to me? Personally I agree with them. I have seen Janet Woodcock do something that I believe actually is criminal. The problem comes down to proving it. I could testify as to what I observed but I simply don't trust that others who observed the same thing to speak the truth. I don't hate. Instead I have hope. I have hope that maybe, just maybe, that I can help not prevent but minimize another tragedy like Vioxx that is actually occurring right now as I write this. Thank you David.

Nathan,

I love my work and do it ethically.

Would your say the same thing to someone who worked on the plans for Auschwitz, realized what was really going on, and tried to warn the Jews?

From what I have seen I believe that I am in a similar position. However information on drugs are trade secrets and besides the press isn’t going to listen.

Unfortunately our government has virtually killed free speech and unless a Congressman or Senator releases information those of us who work in government will be fired, go to jail, and even face the possibility of having ourselves or our family members killed as retaliation for actually speaking out and warning people.

Why do you say anything now when I simply make a statement about what other reviewers have said to me?

Personally I agree with them. I have seen Janet Woodcock do something that I believe actually is criminal. The problem comes down to proving it. I could testify as to what I observed but I simply don’t trust that others who observed the same thing to speak the truth.

I don’t hate. Instead I have hope. I have hope that maybe, just maybe, that I can help not prevent but minimize another tragedy like Vioxx that is actually occurring right now as I write this.

]]> By: Nathan http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380710 Nathan Fri, 07 Nov 2008 14:09:41 +0000 http://www.pharmalot.com/?p=17339#comment-380710 Dan, no - it's perfectly appropriate. However, the AMOUNT of dirty laundry is what is strange to me. I don't see any "hope it might precipitiate some change" -- I only see complaints - not constructive critisism or suggestions - only complaints. Maybe I'm totally off-base, but this seems to be a voice of a disgruntled long-time employee frustrated with his/her job but afraid to do something contructive about it. Dan, no - it’s perfectly appropriate. However, the AMOUNT of dirty laundry is what is strange to me. I don’t see any “hope it might precipitiate some change” — I only see complaints - not constructive critisism or suggestions - only complaints.

Maybe I’m totally off-base, but this seems to be a voice of a disgruntled long-time employee frustrated with his/her job but afraid to do something contructive about it.

]]> By: David http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380705 David Fri, 07 Nov 2008 13:28:54 +0000 http://www.pharmalot.com/?p=17339#comment-380705 Nathan - So airing dirty laundry with the hope it might precipitate some change is inappropriate in your eyes? IMO that is why this industry is in the shape it is - because too many people have been willing to look the other way for too long. Nathan -
So airing dirty laundry with the hope it might precipitate some change is inappropriate in your eyes?
IMO that is why this industry is in the shape it is - because too many people have been willing to look the other way for too long.

]]> By: Nathan http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380677 Nathan Fri, 07 Nov 2008 02:59:09 +0000 http://www.pharmalot.com/?p=17339#comment-380677 An FDA Reviewer, Do you ever have anything positive to say about your work? It seems that you just like to air your dirty laudry out here in the open where people are happy to read about it. But it's seeming more and more likely to me that you are just a disgruntled employee who hates what you do for a living. An FDA Reviewer,
Do you ever have anything positive to say about your work? It seems that you just like to air your dirty laudry out here in the open where people are happy to read about it. But it’s seeming more and more likely to me that you are just a disgruntled employee who hates what you do for a living.

]]> By: Josh http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380673 Josh Fri, 07 Nov 2008 01:56:03 +0000 http://www.pharmalot.com/?p=17339#comment-380673 We will hasten the approval of drugs as more companies use newer technologies available to minmize cost and time to market. J We will hasten the approval of drugs as more companies use newer technologies available to minmize cost and time to market.

J

]]> By: Josh http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380672 Josh Fri, 07 Nov 2008 01:47:48 +0000 http://www.pharmalot.com/?p=17339#comment-380672 Reviewer - no, I didn't know that. Why do you think that may be? J Reviewer - no, I didn’t know that. Why do you think that may be?

J

]]> By: An FDA Reviewer http://www.pharmalot.com/2008/11/life-after-andy-searching-for-fda-leadership-at-the-fda/#comment-380671 An FDA Reviewer Fri, 07 Nov 2008 01:32:55 +0000 http://www.pharmalot.com/?p=17339#comment-380671 The WSJ blog indicated Janet Woodcock the current CDER Director would really make Pharma happy. A number of FDA reviewers I've know have said that they believe she deserves to be put in jail. The WSJ blog indicated Janet Woodcock the current CDER Director would really make Pharma happy.

A number of FDA reviewers I’ve know have said that they believe she deserves to be put in jail.

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