One, two, three, four, five,
Once I caught a fish alive,
Six, seven, eight, nine, ten,
Then I let it go again.
Why did you let it go?
Because it bit my finger so.
Which finger did it bite?
This little finger on my right.
Following on from Part I, today I am trying to decipher, along with Sally K. Laden, what the term 'emotional lability' means, more to the point whether or not Sally K. Laden knew as far back as 1998 if 'emotional lability' meant suicide attempts.
Before I move on I'd like to list Laden's qualifications again.
Laden graduated in 1981 from the University of Connecticut with a Bachelors degree in Pharmacy and in 1983 from the Kansas University with a Masters degree in Hospital Pharmacy.
In 1985 Laden became the Associate Editorial Director - Scientific Therapeutics Information [STI]
She has been self employed since 2003, working from home for the business she founded, MSE Communications LLC where she is a Freelance Medical Writer. According to her LinkedIn profile she is also a Developmental Editor for Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, and has been since January 2013.
Laden is also a member of the American Medical Writers Association.
So, a Bachelors degree and a Masters degree. Quite safe to assume then that Laden is quite well educated, in other words she's not stupid, the definition of which is; lacking intelligence or common sense.
In part I it was established (If Laden was telling the whole truth, that is) that GlaxoSmithKline handed over approx 200 pages of a clinical trial they had carried out using paroxetine [Paxil] to treat depression in children and adolescents. By Laden's own admission, "I believe it's considered a synopsis of the report rather than each individual patient's data".
In fact the entire clinical study report was over 1400 pages long yet Laden only saw 200 of these. Hardly the basis of drawing up such an important draft, particularly when it involved medicating children and adolescents. Here, I do question Laden's lack of intelligence or common sense. It's okay to question, right?
Nonetheless, Laden came to the conclusion [based upon the 200 pages] that Paroxetine is a safe and effective treatment of depression in the adolescent patient."
Maybe her conclusion was correct on the basis that Glaxo only gave her 200 pages. Maybe Glaxo omitted the other 1200 pages because Laden may have arrived at a different conclusion?
Key:
Q = George Murgatroyd (Baum Hedlund)
A = Sally K. Laden
Q: So you relied upon GSK in providing you with accurate information, correct?
A: Yes
Q: And to the degree that that information is inaccurate that's not your fault right?
A: It's not my fault?
Q: Yes. If you wrote something in the manuscript that's inaccurate, that was based upon information that was provided to you by GSK, it would not be your fault if you wrote something inaccurate, correct?
A: I guess, correct.
Q: Okay. Now I mean do medical writers have the responsibility to go back and look at the raw data to see if the interpretation of that data is correct?
A: I don't believe so
...
Q: Okay. You know GSK coded the suicide events in Study 329 as Emotional Lability. Are you aware of that?
A: Yes
Q: Were you aware of that fact at the time you prepared the first draft of the manuscript?
A: I don't know
Q: How did you become aware that that term was being used to cover suicide attempts?
A: It must have been in a document. In whatever document I was given.
Q: Okay. So when you prepared the first draft you knew that Emotional Lability was included?
A: Again, I don t know if I had this at the time of the first draft. I don't know. I cannot say that I had this document that is sitting in front of me at the time I wrote the first draft and I would have to look and see what is in here.
Q: Okay. Well let me maybe back up for a second. When you prepared the first draft of the manuscript were you aware of the number of adolescents who experienced events involving suicidality? Just suicidality events, suicide events?
A: Completed suicide?
Q: No just events involving suicidality?
A: I don t recall
At this point Murgatroyed tells Laden to look at her draft.
Q: Did you find something in the first draft that talks about suicidality?
A: There is the Emotional Lability
Q: Okay. How about suicidality?
A: No
Q: Okay. My question is do you know what the term Emotional Lability means?
A: Emotional means you have emotions. Lability means you re waxing and waning.
Q: Okay. And when you wrote the manuscript did you know that that was the topic that GSK stuck the suicide events under?
A: I don't know. I don't remember.
Murgatroyed then asks Laden if she was aware that the FDA analysed Study 329 with regard to adverse events. Laden replied, "I am aware of that."
Murgatroyed then showed the results of the FDA to Laden.
Q: And it says drug, meaning Paxil 6.5%, Placebo 1.1%, Risk ratio equals 5.9%, do you see that?
A: I see that
Q: Do you know what a risk ratio is?
A: My understanding is that it's statistical language comparing one thing with another of the probability of an event happening.
Q: Okay. In this instance an adolescent taking Paxil is almost six times at the risk of experiencing possible suicide related event compared to an adolescent taking placebo, correct?
At this point the attorney representing Laden, Stuart Margohs (Berdon Young & Margohs), interrupts...
"That is one question. The other question is whether or not you can tell if that is a depressed adolescent or not."Murgatroyed points out that Study 329 was a study involving depressed adolescents.
Back to the questioning of Laden
Q: Do you think it s appropriate to promote Paxil as safe when over 5 percent of the adolescents taking Paxil during clinical trials of 329 attempted suicide?
A: I can't answer that question. I am not an expert to know whether 5 percent is a dangerous risk in a dangerous disease or 50 percent is a dangerous risk in a dangerous disease. An expert would know that. I'm not an expert.
Is it safe to assume that Laden is not answering the question put to her by Murgatroyed because she actually knows that over 5% of kids taking Paxil who attempted suicide is really an appallingly high figure?
Let's just take a look at Sally Laden's education once more.
Laden graduated in 1981 from the University of Connecticut with a Bachelors degree in Pharmacy and in 1983 from the Kansas University with a Masters degree in Hospital Pharmacy.
And yet Laden cannot seem to answer a simple question about whether or not she thinks over 5 percent of the adolescents taking Paxil during clinical trials of 329 who attempted suicide is appropriate.
One does not need to be an expert. All Laden needed to do here was hold up both hands, keeping one closed in a fist and the other fully open showing her five digits. Her closed fist representing placebo, her open hand showing her fingers and thumb representing the percentage of kids attempting suicide whilst on Paxil.
If this question was not answerable because Laden is 'not an expert' then her degrees in Pharmacy (a four-year course) really mean nothing. The course would have given Laden a broad understanding of the pharmacy-related aspects of chemistry and biology. The course would have also covered the science behind the preparation, supply and monitoring of medicines.
Are we expected to believe that she could not answer the above question because she wasn't an expert or was there some other reason?
Laden knows how to read a prescription, she knows exactly how many pills she should put in a bottle but she cannot answer a question on whether it was appropriate that more kids attempted suicide on Paxil then they did placebo?
C'mon!
As I mentioned in Part I, Laden is married. What I failed to mention is that Laden has a son.
Here's my question to Laden. Her son is believed to be in his 20's. He would have been a small child around the time Laden prepared her first draft. If, during his teen years, let's say 13-18, he would have been dignosed with depression, would Laden have allowed a prescribing physician to give him Paxil to treat his depression?
I can only assume that the answer would be 'no' given that 5 percent of kids attempted suicide on the very same study that she wrote, "Paroxetine is a safe and effective treatment of depression in the adolescent patient."
Does she not feel that every parent has a right to know this information, if so, at what point did they need to know? 1998, 99, 2000?
Another way of looking at it is this.
Laden takes her son to see a child psychiatrist. The child psychiatrist tells her that her son is depressed. He informs her that he wants to try Paxil to help alleviate his symptoms of depression. He also tells her the results of the Paxil 329 study. "Mrs Laden, I have to inform you that five percent of kids attempted suicide during the clinical trials of Paxil, all of them were on Paxil at the time. I also have to tell you that none of the kids on placebo attempted suicide." Would Laden shrug her shoulders and say, "Ah well, I'm not really an expert, go ahead and write the prescription for my son."
I think not.
It's a luxury that many parents have never had. They were told it was safe. Doctor's prescribing it were told it was safe. Psychiatrists reading her ghost-written article have been told it was safe. The study has never been retracted from the Journal of the American Academy of Child and Adolescent Psychiatry. One would think, as a mother, Laden would be calling for its removal. Morally it would be the right thing to do. Her silence is, in my opinion, embarrassing.
Here's just one victim who died by suicide after being prescribed Paxil. Sadly, the young girl in this video never made it to her 20's. Glaxo denied that Paxil had anything to do with her death. Laden can bury her head in the sand and believe the same if she wants.
Bob Fiddaman
Part III HERE
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