DEPOSED: Risperdal, Prolactin & Gynecomastia: The Gorksy Transcript Pt III

IF you haven't availed yourself of J&J CEO Alex "Risperdal" Gorsky's deposition yet, what's keeping you?

A 15 year old boy was poisoned with Risperdal, grew male breasts from it, and later had to have them surgically removed. 

Here's the transcript.

'Mental Health' at its, well, ...... butt covering non-disclosing to the consumer, usual self.

Let's start with a J&J Ideation or two of how J&J views the definition of "Off Label Marketing"

Deposition: starting on pg 158 (pg 41 of the pdf)

We're finding the hair splitting here between Marketing Plans and Selling Plans for the pediatric market (in 2001/2002 pre FDA pediatric approval) fascinating.

“11 Q. Turn to the top of the next page, please, page
12 261. See where it says “RISPERDAL use in the
13 child/adolescent population is exploding”? Is that
14 correct?
15 A. That’s what it says, yes.
16 Q. Then down below it says, “Key Base Business
17 Goals — well, strike that. I’m sorry.
18 “RISPERDAL use in the child/adolescent
19 population is exploding,” but in this time frame,
20 2001/2002, Risperdal is not indicated by the FDA for
21 any pediatric use, is it?
22 A. Again, we did not have the specific
23 indication, as we discussed earlier, until 2006. I
24 don’t remember exactly what the labeling said regarding
Page 158
1 use in children, but as I discussed earlier, there was
2 a significant — there appeared to be a significant
3 increase in the recognition of this condition in
4 children and adolescents during this time, which was
5 substantiated by data and its occurrence.
6 And physicians have an opportunity to use a
7 treatment that they perceive to be appropriate and
8 effective in a particular patient population, and
9 that’s clearly what we were seeing happening in this
10 area.
11 Q. Look down at the heading that says “Key Base
12 Business Goals and Objectives.” Do you see that?
13 A. Yes.
14 Q. And the fifth of the Key Base Business Goals
15 says “Grow and protect share in child/adolescents.” Is
16 that right?
17 A. Yes, that’s correct.
18 Q. My question is, how can Johnson & Johnson grow
19 a share in a child and adolescent market when the drug
20 isn’t even indicated for use in the child and
21 adolescent market?

22 A. Well, my interpretation of that is, this is in

23 fact a marketing plan, (1) not a selling plan. As a

24 marketing plan, its intent is to cover a wide range of

1 activities regarding the development as well as the

2 promotion of Risperdal.

3 That being said, all of our actual promotion
4 to the physicians would follow what was outlined in our
5 package insert and all of our materials went through a
6 significant review process, and that’s the way our
7 representatives were trained. And in an area such as
8 this, this is a marketer versus a sales representative,
9 their language.
10 And when in fact physicians took it upon
11 themselves and their patients to prescribe the product,
12 their statement would in fact be correct: To ensure
13 that when a physician made that choice, that it was in
14 fact Risperdal.
15 Q. You were the vice-president of sales and
16 marketing at this time frame, 2000/2001, correct?

J&J Guilty Says Arkansas Jury In $1.25 Billion Marketing Case

And according to now CEO, and then VP of Marketing and Selling Gorsky, there's a Difference between Marketing plans and Selling plans. Apparently it's only illegal if it leaves the J&J premises themselves as Marketing rather than Selling, but In House Off Label Marketing is a different Ideation.

UPDATES:
March 20, 2014
Arkansas Supreme Court Reverses Billion Dollar Risperdal Case

June 1st, 2015
Janssen To Pay $7.5 Million In Risperdal Settlement

Back to the deposition:

On pg 21 of the pdf:

8 Q. And then one of the safety areas that’s
9 discussed there is prolactin. Is that right?
10 A. It says, “Safety areas include prolactin (in
11 publication), cardiovascular” and a number of other
12 items.

pg 38

18 Q. The date is May 17th, 2002 in the top
19 left-hand corner?
20 A. Yes.
21 Q. If we turn to page two at the topline results
22 summary, it has two numbers there I want to talk about.
23 The first one in the second paragraph: What was the
24 rate of EPS-related adverse events and risperidone, if
1 you can find that for me?
2 A. It was noted as 47.8 percent.
3 Q. And what was it for haloperidol?
4 A. 57.8 percent.
5 Q. And then next under that they say there was a
6 statistically significant difference between the
7 treatment groups and the number of patients with
8 prolactin-related adverse events, too. Is that
9 correct?
10 A. That’s correct.
11 Q. And what was the percentage of
12 prolactin-related adverse events for Risperdal?
13 A. It says five percent.
14 Q. And what was it for haloperidol?
15 A. 0.4 percent.
16 Q. So, let’s turn back to page 8779, please. Do
17 you see in the middle there 3.1.3, it has
18 “Prolactin-related adverse events”?
19 A. Yes, I do.
20 Q. And then it has the same percentages down
21 there in the third or fourth row, the total number of
22 patients with prolactin-related AEs? It has five
23 percent for risperidone and 0.4 for Haloperidol?
24 A. Yes, it does.
Page 148
1 Q. And that’s fourteen patients out of 278 had
2 prolactin-related adverse events in this clinical
3 trial. Is that right?
4 A. That’s correct.

11 Q. And what was the percentage of
12 prolactin-related adverse events for Risperdal?
13 A. It says five percent.
14 Q. And what was it for haloperidol?
15 A. 0.4 percent.

Prolactin/Gynecomastia, a 12.5 fold Increase over Haldol.

And as we All know, Haldol, Another J&J Wonder Drug, is Also a Dr. Paul Janssen developed product.

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