Comments on: The zoster vaccine http://www.journalclub.org/2005/06/03/n61 Comments on the medical literature Wed, 13 Jul 2005 13:30:08 +0000 hourly 1 http://wordpress.org/?v=3.0.1 By: paul kerr http://www.journalclub.org/2005/06/03/n61/comment-page-1#comment-2933 paul kerr Wed, 13 Jul 2005 13:30:08 +0000 http://www.journalclub.org/?p=61#comment-2933 Thanks for the review - I've drawn on it for my journal club next week! What do you think of Gilden's comment that a drug cost of $500 would give a cost of $2000 per quality life year saved? Is my maths wrong - doesn't that mean that for every four patient vaccinated one will gain a full QALY? My own calculation shows the number needed to treat to prevent one case of Zoster is about 60 (642 - 315 = 327 less cases for 19,000 vaccinations - 19000/315 = 60) but to prevent one case of post herpetic neuralgia is about 360 vaccinations(80 - 27 = 53 less cases from 19000 vaccinations) - so preventing one case of post herpetic neuralgia would cost about $180000 - but this includes pain scores above 3, ie includes very mild cases, most of which were over within one to two months. Also the majority of the benefit was seen in the older age group. IE to prevent one case of moderate to severe post herpetic neuralgia in a patient in their sixties may take up to a 1000 vaccinations and may cost half a million dollars, and may cause one death from toxicity. Best wishes, Paul Thanks for the review – I’ve drawn on it for my journal club next week! What do you think of Gilden’s comment that a drug cost of $500 would give a cost of $2000 per quality life year saved? Is my maths wrong – doesn’t that mean that for every four patient vaccinated one will gain a full QALY? My own calculation shows the number needed to treat to prevent one case of Zoster is about 60 (642 – 315 = 327 less cases for 19,000 vaccinations – 19000/315 = 60) but to prevent one case of post herpetic neuralgia is about 360 vaccinations(80 – 27 = 53 less cases from 19000 vaccinations) – so preventing one case of post herpetic neuralgia would cost about $180000 – but this includes pain scores above 3, ie includes very mild cases, most of which were over within one to two months. Also the majority of the benefit was seen in the older age group. IE to prevent one case of moderate to severe post herpetic neuralgia in a patient in their sixties may take up to a 1000 vaccinations and may cost half a million dollars, and may cause one death from toxicity.

Best wishes,

Paul

]]> By: Niels Olson http://www.journalclub.org/2005/06/03/n61/comment-page-1#comment-2743 Niels Olson Sun, 03 Jul 2005 03:13:49 +0000 http://www.journalclub.org/?p=61#comment-2743 "It would have been nice"?! From Merck's perspective justifying the NDA application is the whole point of the study. They can't submit that study to the FDA and have the words "the current vaccine is also effective" in there. I mean, they can, but it certainly doesn't improve their odds of approval. Supporting the old, off-patent vaccine doesn't add to Merck's bottom line. Supporting a new, on-patent vaccine does add to Merck's bottom line, and, from Merck's perspective, getting a new vaccine past the FDA is a statistical issue so it pays to suppress any information that doesn't actively support the new preparation. “It would have been nice”?! From Merck’s perspective justifying the NDA application is the whole point of the study. They can’t submit that study to the FDA and have the words “the current vaccine is also effective” in there. I mean, they can, but it certainly doesn’t improve their odds of approval. Supporting the old, off-patent vaccine doesn’t add to Merck’s bottom line. Supporting a new, on-patent vaccine does add to Merck’s bottom line, and, from Merck’s perspective, getting a new vaccine past the FDA is a statistical issue so it pays to suppress any information that doesn’t actively support the new preparation.

]]> By: charles http://www.journalclub.org/2005/06/03/n61/comment-page-1#comment-2594 charles Wed, 15 Jun 2005 18:52:14 +0000 http://www.journalclub.org/?p=61#comment-2594 a very good review, thanks! i've seen two cases just this week of zoster, so timely as well. a very good review, thanks! i’ve seen two cases just this week of zoster, so timely as well.

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