Comments on: Why Study a Drug? Image Enhancement, Of Course

By: pharmagossip

pharmagossip — Wed, 21 Oct 2009 06:26:25 +0000

Psychiatry is to medicine as astrology is to astronomy!

By: Doc

Doc — Wed, 21 Oct 2009 01:42:55 +0000

The marketing departments of big pharma are the ones who devise the medical study strategies for their drugs.

Medical/R&D just do their bidding.

It’s so reassuring to know some MBA marketer is deciding what studies to do, really helps me see where the future of science/pharma is headed.

By: atlex

atlex — Tue, 20 Oct 2009 17:02:44 +0000

Harpy, there shouldn’t be a check box for safety if the check boxes in question are about the rationale for conducting the study rather than the study objectives. Here are the categories (the four that are identified) mentioned above:

labeling enhancement
claim extension
line extension
image enhancement

None of these are appropriate study objectives, but all could be acceptable reasons for conducting a study, at least through the lens of a pharma company. The outside research, working with an internal medical person (or internal investigator) would then develop a study design, including study objectives.

By: harpy

harpy — Tue, 20 Oct 2009 15:45:09 +0000

I almost like your argument, Atlex, except they point out there is no checkbox for safety on the form. And, one would assume, that even if the lawyer would confuse the way “study” and “objective” are to be interpreted, Dr. Healy would not. What I can’t believe is GSK’s in-house lawyers allowed such a box to exist on such a form. Aren’t they supposed to see everything from the point of view of the courtroom?

By: atlex

atlex — Tue, 20 Oct 2009 14:53:45 +0000

I think this lawyer is intentionally mixing up the “objective for conducting the study” and the “study objectives.” For instance, if I was a medical person working on a brand and I was aware of that prescribers had misperceptions regarding a drugs safety profile, I might characterize the rationale (or objective) for conducting the study as “image enhancement” for the drug. In other words, the medical person recognizes that a new study demonstrating a positive safety profile would enhance prescribers’ perception of the drug. That would be the “objective for conducting the study.” The “study objective” would be to demonstrate the safety profile of the drug. It would be the value of the the “study objective” that would make it worthwhile (or not) for publication.

By: CV Doc

CV Doc — Tue, 20 Oct 2009 14:53:28 +0000

Didn’t a couple of companies recently fail to ENHANCE a drug’s image when doing an ENHANCE study?

By: mole gerbil

mole gerbil — Tue, 20 Oct 2009 14:49:36 +0000

I would bet that most drug studies conducted and then submitted in the majority of NDAs somehow have “marketing objectives” … isn’t that another name for image enhancement?

By: Thom

Thom — Tue, 20 Oct 2009 13:17:16 +0000

This should do wonder for image enhancement of Stowe’s professional reputation.

By: Lisa Van Syckel

Lisa Van Syckel — Tue, 20 Oct 2009 13:11:41 +0000

Ed,
Arent all psychiatrists controversial,… they are individuals who practice subjective medicine,.. yes?

By: Christopher

Christopher — Tue, 20 Oct 2009 13:01:48 +0000

Even in the age of increased transparency it seems naive to state ‘image enhancement’ as a study goal. Presmably that is implied. Of course capturing safety is implied too so that shouldn’t be as much of an issue as the attorney made it.