The VA screwed up the protocol, used an incomplete IC form, and showed no concern for the subjects in the trial–their own soldiers.

So let’s attack Pfizer!

These discussions are becoming borderline pointless.

Your quote does not contradict my statement.

Also, I think you have misread the news report on the VA. They said the study, whihc is on smoking cessation in PTSD patients, was started two years ago. They didn’t say that Chantix was part of the study from the beginning; Given that it was only used in a small percetage of patients in the study, it is entirely possible that Chantix was not used until it received FDA approval. If it was used prior to approval, Pfizer would have been involved; both the VA and Pfizer have indicated that the company was not involved in this study.

Atlex

http://www.ismp.org/docs/vareniclineStudy.asp

Thanks Pfizer for the early warning(s).Lol!

Atlex, you do realize that the military was giving Chantix to these vets 2 years earlier than the release date from the FDA? That would constitute an experiment, not a study.

Go back and read my note. I didn’t say that the ISMP report did not contain a look at AEs since the drugs launch. I said that it concentrated on (or focused on) AEs since September 2007. The key, though, as the FDA and Pfizer says, these AEs were taken into account with the label changes that occurred 3 times (I think) since the Fall and 4 times (I think) overall since the launch of the drug. In this instance, it looks as though the FDA and the manufacturer are diligently monitoring the AEs and making relatively rapid changes to the label. It seems to me that this is what should happen as a new drug enters the market.

I agree that Congress won’t let this go because it makes good politics. Of course, it’s terrible public policy, but why should that matter. The Washington Times and ABC made it sound as though the VA is performing Tuskegee-like experiments, when in reality they are comparing the effects of FDA approved drugs that are being prescribed within labeled indications. Semantics are important here–this is a “study” and not an “experiment.”

Atlex

I do agree with you on the point of the military conducting studies that are focused on our vets. Normally this goes on without much ado from the general public. One study comes to mind is that of the of the MiniPress TTS. It was being studied for hypertension of course, but a weird thing happened, it caused smoking cessation. The military loved this one.

Come to think of it, I believe the studies were far more comparative than Chantix for smoking cessation. This should be taken back to HQ!

Congress will never let this one go. The ball has already started rolling. Pfizer is looking bleak.

No, I’m looking at both sides. No benefit in children, directly from GSK’s clinical trials,a dear doctor letter from GSK telling doctors NOT to prescribe to under 18 and increased risk of suicide in that age group.
This information is from the “gold standard” placebo controlled clinical trial.

Pretty cut and dried.

Chantix ANHC (anti-national health care) drug

sarcasm, of course… kinda.

You’ve missed part of the point. Pfizer, as has been discussed, has nothing to do with the VA study. The incident involves the VA and its effort to communicate risks to its own patient population. The VA acknowledges that it was aware of FDA and Pfizer communications regarding label changes and admits that it might have been able to do a better job of communicating. Other than that, it strongly defends the study.

Importantly, if you believe the press reports, the study’s focus is not Chantix, but smoking cessation in general in PTSD patients. Only a small portion of the study’s enrollees were using Chantix. The VA also reports that a smaller percentage of patients on Chantix experienced suicide ideation than of those patients using other forms of smoking cessation treatment (although the numbers don’t reach a level of significance).

Bottom line…while you are trying to blame the pharma industry on this one, there’s no evidence to support your case.

Atlex