Paxil Victim's Attorney: Okay. Dr. Yamada, are you involved at all with the question of whether and when to put warnings on the labels of drugs made by your company?

GlaxoSmithKline's Dr. Yamada: You know, I am not an expert on regulatory affairs. I don't know the exact procedure and probably better asked — you're better off asking David Reed about that.

Paxil Victim's Attorney: I'm not at all concerned about regulatory affairs. What I'm concern about is the business decision made by your company. We're going to put a warning on; we're not going to put a warning on. Is that something that you're involved in at all?

GlaxoSmithKline's Dr. Yamada: It's never a business decision. I think you should know that. I'm a clinician. For me it's a clinical decision.

Paxil Victim's Attorney: Whether the doctor needs that information or not?

GlaxoSmithKline's Dr. Yamada: No. It's a matter of what is clinically important, what is clinically valid, what is clinically relevant to the use and abuse of a medication. That's really what it comes down to, and, you know, it is not regulatory at all. You're right in the sense that if I felt or the people around me felt that there was a significant problem, whether or not the agency felt — the agency meaning the FDA felt it was a problem that we needed to have a warning on, I personally would feel that — feel compel to put it on our label.

Paxil Victim's Attorney: Whether they thought you needed one or not?

GlaxoSmithKline's Dr. Yamada: If I felt as a physician it was an issue with a patient, I would absolutely insist on it.

Paxil Victim's Attorney: And your company has the authority to implement warnings without having to be told by the FDA to do it; don't you?

GlaxoSmithKline's Dr. Yamada: I presume so, although we have not tested that.

GlaxoSmithKline's Dr. Yamada: ....We also have the pressure to understand that our drugs aren't safe and that every drug — although every drug — every drug has potential complications but the benefits outweigh the risks.

Paxil Victim's Attorney: And in that context, what is the importance of proper labeling as a means to accommodate these two competing interests? We need to get this drug out there on the one hand to people but the drug might hurt some people. Can that be ameliorated in some degree by proper labeling?

GlaxoSmithKline's Dr. Yamada: That is the hope. That is the hope. It's not — It's not always been borne out, and so the FDA is rethinking about what they want to do, how they actually control the physician. I mean one of the problems is that — Maybe I'm saying too much here, Chuck. (Note: "Chuck" is GlaxoSmithKline's counsel.)

Paxil Victim's Attorney: I can't ask you what he said yesterday, but I bet one of them was just answer his questions. But I appreciate your helpfulness.

GlaxoSmithKline's Dr. Yamada: It's like a pack of cigarettes. You see on there Surgeon General's warning.

Paxil Victim's Attorney: Right.

GlaxoSmithKline's Dr. Yamada: Nobody pays any attention to it.

Paxil Victim's Attorney: Right.

Paxil Victim's Attorney: Dr. Yamada, as a physician, clinician, academician who not only practiced medicine but taught other doctors how to practice medicine for many years, would you agree that as a general proposition that if language appears in the warnings section in boldface that it is more likely that doctors will take heed of that information than if it's put back in the post-marketing surveillance section and it's not in boldface?

GlaxoSmithKline's Dr. Yamada: Well, my experience would be that doctors just don't look at the label, period. Now, it could be because I was in an academic institution and that's what we did. Maybe we felt that we were more up-to-date and therefore we didn't need no label. I don't know, but my experience is that most physicians don't look at the label very carefully. And I'm not certain — I personally am not certain whether it would make a difference whether something was in a black box or in a warning section or in a precaution section, and if you would ask 20 young physicians, I'm not sure they could tell you the difference between those three.

Paxil Victim's Attorney: Do you know that in the information disseminating process one of the truly important ways that your company communicates both the indications and the side effects of your medications to doctors is through the — I forget what title we were using about the detail men, as I call them, the people that call on doctors?

GlaxoSmithKline's Dr. Yamada: Yes.

Paxil Victim's Attorney: That's a very important conduit for information; isn't it?

GlaxoSmithKline's Dr. Yamada: I believe it is, yes.

Paxil Victim's Attorney: And do you know that your people are trained, your salespeople that call on doctors are trained to emphasize and reemphasize information that is in the warning section of the labels to doctors for the very reasons that you talk about?

GlaxoSmithKline's Dr. Yamada: I believe so, but I don't know for a fact.

Paxil Victim's Attorney: Okay, sir. How are you doing comfort wise?

GlaxoSmithKline's Dr. Yamada: I'm fine. I'm fine.

Paxil Victim's Attorney: Any time you want to take a break —

Paxil Victim's Attorney: Would it be fair to say, Dr. Yamada, that if we're looking at an adverse health event that manifests itself in a purely physical or biological way, that like the liver example you used, that it's probably easier to determine a cause and effect relationship between the drug and that adverse health event than say if we're looking at something like human behavior?

GlaxoSmithKline's Dr. Yamada: I think that's fair. Human behavior is — we know so little about it, and therefore, to try to speculate on a mechanism for human behavior is very difficult.

Paxil Victim's Attorney: And yet, your company makes drugs that are designed to alter brain chemistry with a specific ultimate goal on being a modification of human behavior; isn't that true?