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Sounds Like Life is going to be fun, fun, fun for the girls and boys in Afghanistan!…some “special” Viagra side effects to look forward to:

Three men rape 13-year-old girl - Girl stoned to death for adultery

The Afghan women jailed for being victims of rape

Bush, Burqas and the Oppression of Afghan Women

Afghan Woman, raped, forced to watch her child killed, and then jailed for “escaping her house” by Anti-Taliban Govt.

School Girls Acid attacks and rape: growing threat to women who oppose traditional order - Female MPs speak out as conditions worsen and Islamists gain respectability

Abused Afghan women often end up in jail
A woman fleeing domestic violence or rape often ends up guilty

Go Team USA!

It isn’t worth it on every single post. As with all news outlets there’s a lot of non-professionals and non experts. No one can monitor every comment on the web or in other media outlets. This was a pretty innocuous post and I took it as likely hyperbole and was just going to let it slide. I mean I certainly don’t agree with a lot of what people say here about psychiatry, psychiatric illness, and the drugs. Even if Blake-Tracy’s comment wasn’t meant as hyperbole I mean even you and I can’t get it right all the time either. However when I checked Blake-Tracy’s website I did find an interesting quote from a GWU researcher that if true may indicate something very significant and I would be interested in the source material for that. Plus even when I work and I know a drug company has lied to me repeatedly I need to look at each submission on its’ own merits.

As for getting it right here every time I made a comment to Steve a while back about costs of drug development then a few days after I made it I realized I could do some checking via annual reports if I wanted to and especially for biologics it may very well be higher than with small molecules although that wouldn’t help me with things that are inappropriately charged to drug development that rightly should be under marketing costs. I post as commentary here and I certainly don’t expect anyone to hold me to the same level of fact checking that I would expect of myself if I was doing a review or working and had access to better resources like a medical library.

I also haven’t pointed out some of the problems with your posts on phen-fen. For example you claim an average of $ 1 Million per person on average is way too large. Well the only place I’ve seen the $20 billion figure you quote is here on pharmalot. Other places have $5 - 13.1 billion. Plus even if it is $20 billion over 20,000 people at an average of $1 M per person. When you figure that these were typically young to middle aged women who had years decades of employment ahead of them and may no longer be able to work plus need treatment. Have a decreased quality of life with needing to take expensive treatments, oxygen and regular echo cardiography, then $1 Million for 40 - 50 years of life expectancy and loss of 30 - 40 years of work doesn’t seem outlandish to me. So I could very well make the same type of argument about your argument about preemption and that’s a much more serious issue than this.

As for claiming the FDA made a mistake and backing it up. Well I’ve been making repeated claims that it’s my opinion that FDA is extensively corrupted by the industry and approving drugs illegally yet for me to fully back it up I would have to break the law by obtaining and releasing documents that by regulation would be illegal. So no I don’t think I can agree with you. Instead we’ll have to wait for the Congressional hearings or other legal means to back up my claims.

There’s too much corruption with the pharmaceutical industry right now and until it’s corrected it’s only going to hurt the industry, the people in it, and most importantly patients. Ultimately that’s my main concern, the patients who are being harmed.

Why didn’t you make the same type of comment about the person who complained about the nearly doubled increased risk of suicide with antiepileptics.

He complained that it was due to an increased risk in prescribing for psychiatric diseases. When I checked the FDA advisory committee documents although there was an increased risk in patients with psychiatric diseases the average of a 1.8 fold increased risk overall was due to a nearly 4 fold increased risk in patients with epilepsy.

Why don’t you criticize that person for dumbing down the risk in epileptics.

Salmon

Most of what you say in the last post is fair. After I posted I did check about Blake-Tracey. I’ll grant you that in a quick search I find issues in her background. However I didn’t see her trying to use the term Dr. to imply gravitas in the present situation. As I said for all I knew based on this post she had a doctorate in English.

As for yourself, not giving specifics allowing identification with a specific company I can understand. However there are things you can reveal without endangering who you work for. For example I asked you before if Atlex signified that you are a lawyer, especially since some of your posts suggests you have a good knowledge of the law. Plus from your past posts I get the impression that you tend to focus your attacks largely on the individuals and not their arguments.

As for my own situation. You are correct about the two possibilities. I personally believe that there is sufficient written documentation to vindicate me and that should be sufficient to result in significant jail time for certain FDA officials. Just to be clear I am not talking about all of the FDA officials I have commented on here, only some of them. For some (e.g. Bob Powell) I have posted about here I am only pointing out certain facts related to what is publicly known about them and is related to their official functions and/or are my opinions related to their official work. These opinions of course are related to scientific facts regarding certain classes of drugs and/or my expertise in how drug development and FDA works and specific personal experiences.

Even if I am vindicated there is no reason that I should have had to go through what I have gone through and also will go through over the next several years trying to vindicate myself and for simply trying to do my job and protect the public. I’ve indicated that I have suffered from severe forms of mental illness. Considering that there’s a 10% chance of suicide among whistleblowers who don’t suffer from mental illness I believe that what I claim I was intentionally subjected to was simply unconscionable. Thus I hope that with the next session of Congress that I have the opportunity to meet with Congress and possibly even to testify on the importance of rapid passage of the whistleblowers protection act that would allow individuals such as myself to immediately go to a judge and get some sort of restraining order.

As for the tribal leader whether you care for him as a person or not I would suggest you should care whether he dies or not simply from prudence and what the potential consequences for our soldiers are.

You seem to have a major problem with brevity and continuously repeat your own story. Frankly, I’ve read it before and don’t need to read it over and over again. Of couese, I’ve only read your side of the story, so I don’t have enough information to develop an informed opinion. In my mind, you’re either a brave sole who has been treated unjustly or an unfortunate paranoid bureaucrat. If you are the former, I hope you get a fairing airing of your grievances and a just outcome. If you are the latter, I guess you’ve already suffered the appropriate consequences.

As for my Viagra statement…please get a sense of humor. In actuality, I couldn’t care if a tribal leader dies or not, so long as we get what we need from him.

I’m still unclear as to what about my background you don’t understand. I work in pharma and have significant years (>20) of experience primarily in areas related to marketing (not sales) both in major pharma and as a consultant. As I have also stated, I am not a medical or science professional. As Ed is aware, I am careful not to provide any specifics, because I am neither authorized to speak on behalf of my company nor interested in such a role.

As for your statement about Blake-Tracey, I think if you look at her Wikipedia listing and other sources, you’ll find that she received her PhD from an unaccredited school based purely on her experience. My intent is not a personal attack. I am careful to only attack those who attack me. As I previously stated, she calls herself “Dr. Blake-Tracey”, which to me, suggests that she is tossing her title out to imply that she has expertise in the area, thus giving greater credibility to her opinion. My intent was simply to suggest that her opinion should carry no more weight than anyone else’s since her credentials are suspect.

Atlex