Subject: We see wonderful ads of people demonstrating their health, whether they're skating across the ice or doing their Tai chi.

From: "Wang" <[email-masked]>
Date: Thu, 7 Jun 2007 11:37:23 -0300

Tell us a little bit about that.
I was faced with this dilemma.
This is the first time that my job was actually in jeopardy and where the FDA actually intended to fire me. MANETTE:  Has anyone tried to silence you and stop you from becoming a whistleblower? So whose interest was being served there?
That I have a job and I'll be able to support my family, that I'm protected from retaliation, that maybe some good will come out of that. Another one comes along and the FDA feels its obligation to approve it.
You have to go through the chain of command and if somebody up above you says that they want things done in a particular way well, they want it done in a particular way. What I'm hoping is that Congress will respond.
It's the same with the ads that appear in magazines. That's very difficult and it is a little bit discouraging. It's all part of the same person. This is another way that the FDA has betrayed the American public and has betrayed the public health. Can you explain what you meant by that?
You have to change the culture of the organization, and you have to change the incentives in the organization. But, if there is any way that they can approve the drug, they will. Now with management it's been another story. I can't change the FDA, but Congress can.
You need to weed the garden patch of drugs that aren't doing what they're supposed to do. But a lawsuit for multiple millions of dollars has more of an impact. I knew that was not a sustainable argument. I can say this with certainty. If a drug is so bad that they can't find a reason to approve it, they won't.
It creates needs or desires where there really isn't a need or a desire. You take ten drugs off the market well, no good deed goes unpunished at the FDA. Third, all of these drugs appear to have the ability to increase the risk of suicidal behavior. Companies are required to put some of the labeling in the ad. So it's a captured agency and America is not well served when industry is calling all the shots.
The company that has that second drug markets it like it's this breakthrough medicine. There is a problem and the evidence is overwhelming, but we'll just have to wait and see. If I don't tell them the truth, then I'm now responsible, in part, for future deaths. At least it's giving them something.
It's not a wonderful system.