Why Study a Drug? Image Enhancement, Of Course
10 CommentsBy Ed Silverman // October 20th, 2009 // 7:26 am
Why else? Well, there are other reasons to consider. Health benefits, for instance. Maybe a new indication. Or in this day and age of health reform, perhaps cost effectiveness. But that wasn’t the alleged case as revealed in testimony given during recent litigation involving birth defects associated with GlaxoSmithKline’s Paxil antidepressant (the drugmaker was ordered to pay $2.5 million).
The interesting exchange below - in which David Healy, a controversial psychiatrist and consistent critic of antidepressant clinical trial data, was questioned - yielded this nugget: one of five reasons offered by Glaxo to investigators to conduct a study of Paxil was ‘image enhancement.’ You know, make the drug appear more desirable in the eyes of health care providers, primarily physicians. And that was checked off by a Glaxo investigator.
In his opinion, Healy testifies that “the odds of (a paper) being actually published in a leading journal would be remote to nonexistent” if the reason given were image enhancement. Hmm… Just the same, that was an option for Glaxo investigators. In this case, the investigator was Emory University psychiatrist Zachary Stowe, who received payments from Glaxo at the same time he was conducting federal research about antipressant use in pregnant women, according to a US Senate probe.
Stowe, by the way, was instructed by Emory to eliminate conflicts related to current federal grants and is one of the psychiatrists cited by US Sen. Chuck Grassley in his ongoing quest to highlight undisclosed conflicts among academics who receive federal and corporate research funding (see here).
Plaintiff’s attorney: And it says, The investigator, is Stowe there, it says, the study message rationale is to characterize the PK profile of Paroxetine excretion in the breast milk, at the top under the category of women’s health?
Healy: That’s correct.
PA: This is an actual GSK internal document, though, right?
Healy: Yes.
PA: And under the objectives in performing the study, there are five possible places somebody can put a check or an X; is that correct?
Healy: It is.
PA: What is checked here?
Healy: What has been checked is image enhancement.
PA: Doctor, have you ever heard of a scientist doing a study to enhance the image of a drug?
Healy: Well, I know of how to apply to the NIH for a grant or to the comparable grant-giving bodies in the UK. They would not have a spot which says image enhancement. You would not get a grant for image — research grant for image enhancement purposes.
PA: Do you know of any article that has ever appeared in peer-reviewed literature that has been published in a reputable journal that in which the author said the purpose of his study was to enhance the image of a drug?
Healy: No, I don’t.
PA: Is that something that you would expect somebody to tell a journal that the purpose of their study was to enhance a drug’s image?
Glaxo attorney: Objection, Your Honor.
Judge: Overruled. Go ahead.
Healy: Well, if this were the purpose, then, yes, this is the kind of thing that people should be told.
PA: If they were told, in your experience as a reviewer and somebody who has published as much as you had, what are the odds of that paper getting published if you actually tell the journal the reason you’re doing the study is to enhance the image of the drug?
Healy: The odds of it being actually published in a leading journal would be remote to nonexistent.
PA: Let’s continue. By the way, on this form, under objectives in the study, is there a checkmark for safety?
Healy: No, there wasn’t.
PA: There is one for regulatory for labeling enhancement, claim extension and line extension and image enhancement?
Healy: Yes.
Judge: Who is this document prepared by, sir?
Healy: This was actually prepared within GSK after Dr. Stowe actually applies to the company for research funding. This is GSK looking at the issue and saying is this the kind of study we wish to support or not.
Judge: Isn’t this for women’s health?
PA: This is an internal GSK document.
Judge: Where does it say that?
PA: Well the PAR number on the lower right-hand corner and the confidential subject to protective order language, Your Honor.
Judge: So this is not the doctor writing to GSK saying, I want to do a study that does this, this is GSK’s document?
Healy: This is GSK’s document. He has written earlier giving the protocol of what he would hope to do.
Judge: This X is what they put down?
Healy: Yes.
PA: Yes.
Judge: Not what he put down?
PA: No, sir.
You can read more here….
Christopher
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.
Lisa Van Syckel
Ed,
Arent all psychiatrists controversial,… they are individuals who practice subjective medicine,.. yes?
Thom
This should do wonder for image enhancement of Stowe’s professional reputation.
mole gerbil
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?
CV Doc
Didn’t a couple of companies recently fail to ENHANCE a drug’s image when doing an ENHANCE study?
atlex
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.
harpy
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?
atlex
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.
Doc
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.
pharmagossip
Psychiatry is to medicine as astrology is to astronomy!