The world owes Rob Robinson a huge debt. His campaigning has no doubt saved thousands of lives and his courage for standing up against a huge corporation will ensure that fellow advocates, such as myself, will have the strength to pursue the truth and stand up for what we believe in.
Rob Robinson deserves an award. His name will forever haunt those responsible for the Seroxat debacle.
This blog salutes you Rob.
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The following series of exchanges are verbatim excerpts from a transcript of a video deposition taken of Dr. David Wheadon, Vice President Regulatory Affairs and Product Professional Services, GlaxoSmithKline, in Philadelphia, PA on Thursday, October 19, 2000 prior to a civil suit involving a Paxil triple homicide/ suicide (which GSK lost.) Nothing appearing on this page can be claimed (by GSK) as "quoted out of context." Questioning Dr. Wheadon are California attorney Donald J. Farber and Texas attorney Andy Vickery.
During this deposition Dr. Wheadon committed perjury on at least one occasion:
see "Exchange #1" below.
This was a two part deposition; part one can be found by clicking on this link.
Man is the only kind of varmint that sets his own trap, baits it, then steps in it.
John Steinbeck
Sweet Thursday
Wheadon Exchange #1
"There Have Been a Number of Systematic Studies"
Paxil Victim's Attorney: I'm asking you to kind of elevate yourself above this particular paper and go to your general knowledge now on Paxil. You have been now with the company eight years, and you have studied and are aware, I presume, of Paxil's traits in either causing or unrelated to addiction and withdrawal, and based on that general knowledge I think you probably have, do you consider as a labeling instruction today that this paragraph, physical and psychological dependence, is a good labeling instruction?
GlaxoSmithKline's Dr. Wheadon: Well, quite frankly, it is an outdated labeling instruction, because there have been a number of systematic studies in humans looking at the potential for Paxil for abuse, tolerance and physical dependence. So actually, there is data to date to negate the statement that it has not been systematically studied, because, in fact, it has been.
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The June, 2005 Paxil prescribing information (excerpted below) provides readers an opportunity to contrast what today's Paxil prescribing information states in stark contrast to Dr. Wheadon's year 2000 (perjured) testimony.
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class: Paxil is not a controlled substance. Physical and Psychologic Dependence: Paxil has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of PAXIL CR (e.g., development of tolerance, incrementations of dose, drug-seeking behavior). — Paxil June, 2005 Prescribing Information
Wheadon Exchange #2
"Let's Just Wrap This Up and Move On to Something Else, Please."
GlaxoSmithKline's Attorney: Mr. Farber, I'd like you to wrap this area up, because dependence and withdrawal is not the subject matter of the 30(b)(6).
Paxil Victim's Attorney: I understand your concern.
GlaxoSmithKline's Attorney: And I thought we made that clear at the start.
Paxil Victim's Attorney: Well, I connect it. Basically, we are talking now — you know, I have a fraud count in my Complaint. You are aware of that?
GlaxoSmithKline's Attorney: You have told me that, yes.
Paxil Victim's Attorney: Okay, and as part of fraud, allegedly misleading statements on any facet of Paxil to get Paxil approved by the FDA in 1992 is certainly an element of fraud, and it is certainly discoverable information. Whether or not it is a suicide or violence issue is not the issue. The issue is misleading information of any type to get Paxil approved.
GlaxoSmithKline's Attorney: Let's just wrap this up and move on to something else, please.
Paxil Victim's Attorney: Well, I'm going as fast as I can. If your client (Dr. Wheadon) would be just a little more specific — and I'm not saying he shouldn't be evasive, but the more evasive he is, the longer it takes.
Wheadon Exchange #3
"I Do Not Know." "I Have No Idea."
Paxil Victim's Attorney: Do you recall a study — the number is P-A-R, Par — by the way, does that mean Paroxetine?
GlaxoSmithKline's Dr. Wheadon: Yes.
Paxil Victim's Attorney: That's what I thought it meant. On study Par 08-03 conducted in Yugoslavia from late '89 to early '91, do you remember reviewing that study in general?
GlaxoSmithKline's Dr. Wheadon: I think the actual study is Par 08-3, which was a long term depression study done in Yugoslavia.
Paxil Victim's Attorney: By the way, maybe you don't know, but who was the principal investigator in Yugoslavia on that study?
GlaxoSmithKline's Dr. Wheadon: I do not know.
Paxil Victim's Attorney: I'm sure that fact is in the records somewhere at SmithKline, no doubt; correct?
GlaxoSmithKline's Dr. Wheadon: I have no idea.
Paxil Victim's Attorney: You don't have any idea whether you keep records of who principal investigators are?
GlaxoSmithKline's Dr. Wheadon: I said, Mr. Farber, that I have no idea who the investigator in Par 08-3 is or was.
Paxil Victim's Attorney: That wasn't my question. My question was whether the records would reflect that, and you said you had no idea.
GlaxoSmithKline's Dr. Wheadon: I would imagine that records would reflect that, yes.
Paxil Victim's Attorney: That's what I'm talking about. I don't want to be contentious here, but the more evasion we get, the longer it takes.
GlaxoSmithKline's Attorney: He is answering your questions, Mr. Farber, to the best of his ability.
Paxil Victim's Attorney: Well, he didn't. I had to spend an extra two minutes to get an admission here, which I thought was fairly obvious. And just for the record, that's why these things take so long. And I'm going to take as long as I have to, no matter how many days, to get the information. End of speech.
Wheadon Exchange #4
"Regarding a Certain 'Exhibit #14'"
Paxil Victim's Attorney: But I'm going back to the word discontinuation. If you said to the board, on their voting day, that you had an attempt in Par 08-3 to systematically assess a discontinuance syndrome, why would your instructions issued two months later state to the contrary, that there was no attempt to systematically observe the discontinuation syndrome?
GlaxoSmithKline's Dr. Wheadon: I can only speak to the document that you have put in front of me, which I can identify, and the statement is that this was our attempt to systematically assess a discontinuation syndrome, meaning using the Par 08-3 data. I cannot speak to what you keep going back to, that being Exhibit 14, which I have no ability to identify or to verify.
Paxil Victim's Attorney: Well, I will take the time. Maybe we can get this later at some point, but I do want the contradiction explained at some point. I understand what you are saying now. But if what I put before you is true, on Exhibit 14, if that's true, can you explain the obvious discrepancy between the systematic and the nonsystematic words in these two documents?
GlaxoSmithKline's Dr. Wheadon: I cannot at this time, no.
Wheadon Exchange #5
"It Has To Do With Fraud Getting This Approved."
Paxil Victim's Attorney: Now, on the issue of relapse, unquote, versus withdrawal or discontinuation syndrome, do you recall, at the October 5th meeting, that the issue of relapse criteria that had been established for Par 08-3 back in '88 or when the protocol was written, do you recall what the relapse — in general, I'm not asking you to quote it, but do you recall what the relapse criteria was?
GlaxoSmithKline's Dr. Wheadon: I do not recall exactly what that criteria was.
Paxil Victim's Attorney: Do you remember the subject, though, of the relapse criteria, whether it was too stringent or about right? Do you recall the criteria standard being discussed at the committee meeting during discussions?
GlaxoSmithKline's Dr. Wheadon: Quite frankly, I do not recall.
Paxil Victim's Attorney: Now, I'm going to ask you a more general question based on your professional background. On the general issue of relapse and withdrawal, I don't know if this is true. Would you tell me if it is true that if a person, a patient, who has been taking Paxil — and can we define basically the withdrawal conditions as either being — and I think I have quoted this from your publications — either being a taper, a gradual tapering down of Paxil use or an abrupt quitting of Paxil altogether, so a reduction of Paxil use by a patient. When that occurs, and two days later, let's assume, the patient was taking Paxil regularly for three months under my hypo. Two days later, after abruptly quitting, the patient then suffers symptoms. Now, my question is concerning symptoms. Would you agree that the symptoms upon review by the physician, that it might be an open question whether the patient were then suffering withdrawal or was suffering a relapse into his prior depressive state? In other words, is that a difficult situation or is it an important situation to assess correctly from the physician's point of view?
GlaxoSmithKline's Attorney: Mr. Farber, what does this have to do with the Lacuzong case?
Paxil Victim's Attorney: It goes back to the issue of approval. If we could — I want to go off the record.
GlaxoSmithKline's Attorney: I don't want to go off the record.
Paxil Victim's Attorney: Okay. It has to do with fraud getting this approved.
GlaxoSmithKline's Attorney: Mr. Farber, the subject matter of today's deposition was defined in the 30(b)(6), which, for whatever reason, you apparently have not read, and you are entitled to ask any questions you want within that subject matter as it relates to the Lacuzong case, which has nothing to do with withdrawal at all. So I think you are going to have an opportunity to deal with that in another context. The witness hasn't been prepared on this. And I want to use the time fruitfully for you inasmuch as the 30(b)(6) defines the scope of this deposition, and we are going to argue that you get no more questioning in any of the areas in the 30(b)(6), so I would like to make the best use of this time in covering that, because you will have ample time to deal with your withdrawal case, which has nothing to do with Lacuzong.
Paxil Victim's Attorney: I appreciate that, counsel. I agree with what you just said, but I'm talking now about Doctor Wheadon's own presentation before this committee in October of 1992 to get this drug approved.
GlaxoSmithKline's Attorney: But that wasn't your last question.
Paxil Victim's Attorney: That is the general line of query here. I'm only dealing with his representations and why he said what he said at that committee hearing to get this drug approved. That's very important. Now, if you want to go on the record now and say we will discuss that entire subject at a later deposition in San Jose or anywhere, that's fine with me. I will take your commitment there. But whether it is Doctor Wheadon or not, I'm discussing his testimony now before this committee.
GlaxoSmithKline's Attorney: Ask your question as it relates to his appearance at the hearing then.
Paxil Victim's Attorney: On the issue of relapse, was the standard of relapse discussed at that hearing in your exchanges with committee hearing? Do you remember that?
GlaxoSmithKline's Dr. Wheadon: As I stated earlier, Mr. Farber, I do not recall a discussion concerning the definition of relapse in the Par 08-3 data.
Paxil Victim's Attorney: Okay, I'm done with that subject. Now, let's get into suicide.
Wheadon Exchange #6
"70 Percent of the Scripts are Written by Non-Psychiatrists"
Paxil Victim's Attorney: Now, I take it that one of the things that made you attractive to SmithKline Beecham, when you were recruited in '92, was that you had considerable experience at Lilly in working on Prozac, and particularly, at the time of the launch; is that true?
GlaxoSmithKline's Dr. Wheadon: I have no idea what made me attractive to SmithKline Beecham.
Paxil Victim's Attorney: You mean, in the interview process, they didn't seem excited about the fact that you had that experience?
GlaxoSmithKline's Dr. Wheadon: Well, certainly, they were interested in my experience as a psychiatrist, and certainly, my experience at Lilly was a part of that. But again, I can't say what made me particularly attractive to them.
Paxil Victim's Attorney: Well, your experience as a psychiatrist in terms of practicing was as a psychiatrist in the context of working for a big pharmaceutical company, rather than a psychiatrist in a private clinical practice; isn't that true?
GlaxoSmithKline's Dr. Wheadon: Additionally having been trained as a psychiatrist, yes.
Paxil Victim's Attorney: Incidentally, having been trained as a psychiatrist, what do you think about the fact that 70 percent of your company's market for Paxil is people who did not have that kind of training?
GlaxoSmithKline's Dr. Wheadon: I'm not sure what you are asking.
Paxil Victim's Attorney: Do you endorse the idea of non-mental health care professionals diagnosing depression and treating it with psychoactive drugs like Paxil?
GlaxoSmithKline's Dr. Wheadon: Yes, I do.
Paxil Victim's Attorney: And isn't that about 70 percent of Paxil's market, nonmental health care professionals?
GlaxoSmithKline's Dr. Wheadon: If I recall correctly, 70 percent of the scripts are written by non-psychiatrists.
Wheadon Exchange #7
"This Whole Suicide Issue is Just a PR Problem, Don't Worry About It."
Paxil Victim's Attorney: I got seven minutes here. I will finish one way or the other. New subject, suicide and the suicide issue in total, what Mr. Vickery was talking about and this whole issue of Prozac and so forth, is that a public relations problem for your company? Do you consider that — I know it doesn't have a precise answer. I'm just asking for your opinion. Does this present a public relations problem for SmithKline Beecham?
GlaxoSmithKline's Dr. Wheadon: Frankly, it presents a problem for the psychiatric field and for the cause of insuring that people are willing to seek mental health care. One of the issues in this country has always been that there is a closeted notion about people with psychiatric illness. And this serves a great disservice to people that really need to be willing to come forward and get care. So from that standpoint, SmithKline and I, as a psychiatrist, are very concerned about this issue.
Paxil Victim's Attorney: I agree with that. I totally agree with that. And my question is, if, therefore, it were deemed to be studied as an issue, as a valid scientific inquiry, is it not proper for the authorities, such as FDA and SmithKline, to, in fact, treat it as a clinical serious problem for studying, rather than themselves treating it as a PR problem? Do you agree with that proposition?
GlaxoSmithKline's Dr. Wheadon: I don't understand your question.
Paxil Victim's Attorney: Well, if it is a serious problem, and I agree, it is a very serious problem, and it were deemed to be important enough to be held at an FDA hearing to determine that, isn't it an important enough subject to be studied scientifically?
GlaxoSmithKline's Dr. Wheadon: And it has been studied scientifically.
Paxil Victim's Attorney: Are you aware that Doctor Brecher called SmithKline — I know this happened before your watch, and if you don't know anything about it, you can tell me, but are you aware or did somebody tell you that Doctor Brecher called SmithKline on October 3rd, 1990, and basically said, this whole suicide issue is just a PR problem, don't worry about it? That's my words.
GlaxoSmithKline's Dr. Wheadon: I'm not aware of that.
Paxil Victim's Attorney: Let's go to Exhibit 18.
Whereupon the court reporter marked document as Exhibit 18 for identification.
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GlaxoSmithKline's Attorney: Mr. Farber, whose writing is this on the margin?
Paxil Victim's Attorney: Preconceived?
GlaxoSmithKline's Attorney: Right, and PR.
Paxil Victim's Attorney: It is my writing. I will specify that for the record.
GlaxoSmithKline's Attorney: I would like a copy that goes in that is free of this for the exhibit.
Paxil Victim's Attorney: That's fine. I have no problem with that. We will get a corrected copy for the thing, okay? So the original exhibit will have this deleted. Now, this general subject reported in the summary of conversation — I know you weren't there at the time, and you may not have seen this, but are you aware of this general subject that an FDA official called SmithKline at some point before your arrival and indicated that the suicide issue was merely a PR problem?
GlaxoSmithKline's Dr. Wheadon: No, I was not aware.
Paxil Victim's Attorney: Exhibit 19, same thing, if you don't like my funny face, I will delete that. There is a funny face on this.
GlaxoSmithKline's Attorney: I think we should delete it.
Paxil Victim's Attorney: We will. I have no problem deleting it.
Whereupon the court reporter marked document as Exhibit 19 for identification.
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Paxil Victim's Attorney: Exhibit 19 is a FDA conversation record, July 19th, from a conversation with Tom Laughren, M.D., at FDA, calling Thomas Donnelly, the regulatory affairs officer. And basically, I will summarize. I don't think you will have a problem with this. There is a call, where Doctor Laughren called SmithKline and wanted assistance for a ten-year data base and asked the company for a large data base, so he could go out and give a presentation on it personally, out of official business. That's what this says. That's my summary. And my question to you is this: Is it standard operating procedure at SmithKline to do personal favors for FDA officials?
GlaxoSmithKline's Dr. Wheadon: No.
Paxil Victim's Attorney: Has SmithKline under your watch, at least as far as you know, ever met socially with — let me go back. In 1992, from the time you arrived in February, up until the committee meeting in October of '92, did any SmithKline official have contact with any of the six members who sat on that committee meeting on October 5th?
GlaxoSmithKline's Dr. Wheadon: That is such a broad question, Mr. Farber, I quite frankly have no ability to answer that.
Paxil Victim's Attorney: No, if you don't know, I would understand that. But you don't know; correct?
GlaxoSmithKline's Dr. Wheadon: I have no idea.
Paxil Victim's Attorney: Would it be contrary to company policy to make personal contact with any committee member who was assigned to sit on an impending committee to consider a SmithKline product in the approval process?
GlaxoSmithKline's Dr. Wheadon: You have to be far more specific. It would not be unusual for a scientist and a member of an FDA committee to be present at the same meeting. They may have a conversation on the scientific issue that may be discussed at that meeting. So simply having contact, meaning running into one another at a meeting and having a friendly discussion is certainly not outside of company policy, no.
Paxil Victim's Attorney: I'm not talking about the day of the meeting. Let's eliminate the day of the meeting and coffee breaks and all that nature. I'm talking about the lead-up to the meeting, when the members have been identified, and a drug of your company will be under consideration by that committee. Is there a company policy preventing, call it a conflict of interest policy or whatever you want to call it, such a policy in effect to preclude social or any personal contacts with any of the committee members?
GlaxoSmithKline's Dr. Wheadon: I answered previously, and I think you may have misunderstood my answer, it is not outside the realm of possibility, and it is perfectly acceptable if a member of the company and a member of an advisory committee happened to run into one another at a scientific meeting, not the advisory committee meeting, and exchanged pleasantries and maybe have a brief discussion, that is acceptable.
Paxil Victim's Attorney: How about a concentrated attempt to contact one of these officials specifically for the purpose of discussing the issue?
GlaxoSmithKline's Dr. Wheadon: That is contrary to company policy.
Paxil Victim's Attorney: I'm not done, but I will quit here in one minute.
Whereupon the court reporter marked document as Exhibit 20 for identification.
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Paxil Victim's Attorney: I guess I'm cut off here. Just for the record, I'm not done, counsel, but for today, I will quit here in one minute. My Exhibit Number 20 is a memorandum and a fax, really, from Doctor Laughren to Tom Donnelly, and you will see it is dated August 25, 1992, after your arrival at SmithKline, and it is a twopage letter, and he talks — I'm specifically focusing on Page 2. My question concerns Page 2 in the second paragraph under discontinuation for adverse events. And you can see it is a dialogue. I will read it. It says, quote, I find that a number of events occurring at an incidence of 1 percent or greater for Paroxetine in Appendix 4-B are not in this section; e.g., vomiting, confusion, manic reaction, abdominal pain, hypertension, palpitation, paresthesia, constipation, decreased appetite, weight gain, CNS stimulation. This discovery erodes my confidence somewhat, and I would like an explanation for this fairly obvious discrepancy, unquote. Does this general subject ring a bell with you as to what Mr. Laughren was talking about, Doctor Laughren was talking about?
GlaxoSmithKline's Dr. Wheadon: I'm quite frankly not familiar with this particular item, nor this particular topic.
Paxil Victim's Attorney: So nothing that I have just read rings a bell at all?
GlaxoSmithKline's Dr. Wheadon: No.
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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