Comments on: Infant Deaths Disputed In Glaxo Vaccine Trial

By: KMTGCP

KMTGCP — Sat, 06 Sep 2008 20:40:08 +0000

Truthman30 (or anyone else?)

Is ther any further followup on the TeGenero story you so kindly provided the link for? Thanks.

KMTGCP

By: truthman30

truthman30 — Wed, 16 Jul 2008 19:21:16 +0000

Is there any indication at all that Glaxo was testing high doses? Of course not. Plus, toxicity studies are never done in wide-scale studies such as this. The dose would have been determined in much earlier phases of research. There is a zero percent chance that they were testing high doses for toxicity.
Atlex

Well, it was just a question Atlex?..

And thank you for refraining from engaging with me..

Just to note, the infamous tegenero - elephant man trial..

http://www.theregister.co.uk/2006/03/20/tegenero_trial_science/

I’m sure that looked innocent enough too at the time?

By: Atlex

Atlex — Wed, 16 Jul 2008 18:02:43 +0000

truthman30,

I usually refrain from even engaging with you, but at times I can’t help but fall into that trap.

Atlex

By: truthman30

truthman30 — Wed, 16 Jul 2008 17:38:13 +0000

“I have to believe that no-one at GSK or any other ethical vaccine development company, wants to see children die in a clincal study.
Lets be realistic folks”

Not unless they were testing high does for toxicity?..

By: Anne

Anne — Wed, 16 Jul 2008 13:27:11 +0000

“Since the beginning of the study, COMPAS is monitored by an Independent Data Monitoring Committee (IDMC) to oversee the safety aspects of the study and to help ensure that the highest ethical, safety and compliance standards are followed, including informed consent. ”

If that’s their highest ethical and safety standards (12 deaths), I don’t want to know about their lowest.

By: José

José — Wed, 16 Jul 2008 12:17:11 +0000

Boy - things seem to be getting out of hand here. I think the first comment by Atlex must be considered: “There is not enough information available…..”. While it may make us feel better to believe that the likes of GSK are simply out to use the poor for experimentation in the name of greed, I strongly doubt that this is the case.

Yes, there is no doubt that GSK along with all other vaccine developers and manufacturers are commercial entities with shareholders who require profits and up-lift in value [in fact most of these shareholders are probably pension funds and insurance companies that we all rely on]. But…there is also no doubt that GSK along with any other ethical vaccine developer, would place safety at the forefront of any clinical trial.

Before we condemn anyone, are there any data showing that the 12 deaths, as a percentage of the vaccinated cohort in the study, represent a statistically significant increase as compared to the normal death rate for a non-vaccinated population from the same region? Are there any data showing that these deaths are directly attributable to the vaccine?

If we truely want to stop vaccine development being in the hands of corporate profit making companies, then we must lobby our governments to go back to the old days of 50 years ago when all vaccine development was essentially state run and paid for by the taxpayer. Are we willing as taxpayers to foot the enormous costs of drug development? There are advantages to this approach, but I am also sure that there would also be disadvantages.

I have to believe that no-one at GSK or any other ethical vaccine development company, wants to see children die in a clincal study.

Lets be realistic folks

By: H. H. FD\udenbrergm M.D., DDGM IOM

H. H. FD\udenbrergm M.D., DDGM IOM — Wed, 16 Jul 2008 11:40:00 +0000

Mr. Silverman, keep up the good work.
Only adberse publicity will halt Glaxo’s inexcusablke begavior.

By: ol cranky

ol cranky — Tue, 15 Jul 2008 22:29:13 +0000

So where’s the Argentine MOH? Did they evaluate the protocol and approve it to be conducted in the country? Are they evaluating the safety data?

Also, what was the cause of death for the children? They come from very poor families with limited access to health care - isn’t it possible the deaths were completely unrelated to the study or vaccine and the only reason anyone in Argentina is paying any attention to the deaths of these children is because they happen to have been in a drug trial that tracked these events?

By: Meg

Meg — Tue, 15 Jul 2008 19:38:34 +0000

Well, we have the Nigerian kids, the Polish kids, the Argentinian kids, and even U.S. poor kids (I’m counting Rebecca Riley). But who cares in Pharma? Deaths are irrelevant: The only thing that counts is greed.

By: truthman30

truthman30 — Tue, 15 Jul 2008 16:24:03 +0000

One way or the other, I bet in the long run this turns out to be a non-story ginned up by groups looking to create their own version of the Constant Gardener.
Atlex

Dead children possibly exploited by a drug company is hardly a non story Atlex?..

It amazes me how you and the pharma brigade seem to be more concerned with public perception of the industry before ethics and good practice, surely if you concerned yourself more with these first you wouldn’t have to worry about public perception of the industry?…

As for the constant gardener..

http://archive.salon.com/books/review/2001/02/02/lecarre/index.html

John Le Caree said himself that “By comparison with the reality, my story [is] as tame as a holiday postcard.”

Having researched the industry for 6 years, I would have to agree with him…