On June 3, 2009, Sean Tracey cross-examined Jane Nieman, who at the time was Director, U.S. Post-Marketing Group, Worldwide Clinical Safety for GlaxoSmithKline in a deposition. Ms. Nieman testified about a spontaneous event report for an aborted male child that was assigned Manufacturer Control Number 2001014040-2109 case number 3667484. This report, received by GSK/SB on June 7, 2001, concerned a late-term therapeutic abortion performed at about 6 months gestation following diagnosis of a serious cardiac malformation called truncus arteriosus. Ms. Nieman testified that a staff of internal physicians and other personnel at GSK/SB performed an internal causality assessment to determine whether this heart defect was related to Paxil and decided that the heart defect’s relatedness to Paxil was “almost certain.”
The drama was intense. If this was fiction, people would say something like this could not happen in real life.
It needs to be read alongside the letter to June Raine on RxISK, Regular Woman or Mother, whom UK politicians appear to universally regard as not just scientifically brilliant but close to a saint. Company people are likely on average to show more humanity than bureaucrats.
Okay. Now, from a safety standpoint, from a pharmacovigilance standpoint, a mother calling in and saying she took Paxil and her baby got Truncus arteriosus, and it was so bad that she made the decision to terminate her baby, to terminate her pregnancy and end her baby’s life, that is something that should be taken very seriously by GSK; isn’t it?
That is probably understandably a heart-wrenching decision for a mother to make; isn’t it?
Speaking as a mother, I would — I would find it a heart-wrenching decision.
And so this woman understandably is calling GSK and, quite frankly, is saying she doesn’t think that — she’s not insinuating, she says, that it was the drug that caused her baby’s birth defect that ended in her baby’s life being taken. But as you told me, GSK doesn’t take that at face value. They go further than what the reporter says, right? They do their own internal investigation; don’t they?
And if GSK had found out and determined that it was their drug that resulted in this Truncus arteriosus that resulted in this mother making the decision to take her son’s life, do you think that is something that GSK should have shared with this mother?
In the years that I was with GSK, I was not aware of an instance where what you just described might have happened, to go back to a consumer and say, “We’ve made a different medical assessment of your case.” That’s not to say it doesn’t happen. But I don’t know — I’m not aware of a situation where that has happened, to my knowledge.
Do you think that this woman who made this heart-wrenching decision to end her baby’s life had a right to know if GSK decided that it was their drug that caused this defect?
If — if — if there was considered to be an association with the drug and birth defects, that would be reflected in prescribing information. And then that would be a discussion she could have with her physician based on her own personal circumstances and the prescribing information.
What question are you answering?
I’m saying she — it’s — it’s a discussion I personally feel she should be having with her physician.
What if the physician doesn’t know that the drug causes a heart defect which caused her to end her baby’s life? What if GSK hasn’t told the physicians? What if it’s not in the label? What if none of those things are possible and GSK is the only one that has concluded that it was their drug that resulted in this birth defect that resulted in her taking her baby’s life. Do you think that woman has a right to know that?
I — I just don’t — I don’t feel comfortable answering that question. It’s just not a practice that I recognize happening.
Put aside your GSK hat. As a human being, as a mother, if a drug company made a determination that their drug caused this type of horrific defect that caused you to end your son’s life, is that something that you believe as a human being you have a right to know?
If I was in that hypothetical situation, I would like to know that, yes.
Can you think of any moral or ethical reason not to tell that mother what you believe to be true if you’re a drug company?
I can’t think of any moral, ethical reason why that would not happen.
Why they wouldn’t tell her?
Why — why she wouldn’t feel it was her right to know — I think as a mother, I would want to know.
Do you believe you would have a right to know, a moral right to know that information?
It’s a hypothetical situation. I — I would want to know.
Do you think somebody should have picked up the phone and told this woman that GSK made an assessment that their drug caused her baby’s birth defect?
I don’t know who made that assessment or what they made that assessment on. So, I don’t feel comfortable speculating as to whether or not that should have happened.
All right. We’re back from lunch. Are you ready?
Yes. Thank you.
Do you have any answers you want to change that you’ve given today so far?
All right. As luck would have it, believe it or not, in the last hour, as I was asking you questions about this woman who had a baby with a Truncus arteriosus, GSK mailed a friend of mine the actual backup data for this case. So I’m going to show it to you and see if you recognize it. And I saw it for the first time about 25 minutes ago.
And there is a series of e-mails back and forth between this woman and GSK, and there are some GSK internal documents.
Okay. Let’s right now turn to the e-mails, because I think in terms of the chronology of this file, the e-mails appear to be what started everything off to me.
But do you see the one dated May 31st?
Yes, I see it. Yes.
So up at the top, it says, “www.clinicalsafetySRG.” And the subject is — “Forward: Paxil potential adverse event GM.”
If we continue down, we see the beginning of the thread, which is dated Thursday, May 31, 2001. And it says, “This e-mail was received by one of our external web sites and Glena at CRC.” And then we go down, and it says,
“My name is…” and that’s redacted.
“I was diagnosed with panic disorder about four-and-a-half years ago. Since that time I’ve been taking Paxil, which is truly a miracle drug. I’ve been panic-free with this drug and have been able to go on with a normal life.
“I was married in October 2000. My husband and I found out we were pregnant at Christmastime. I was so excited. I love children. The only problem is that I carried the baby to six months gestation and then had to have” — “and then had to have a termination.” “The doctors diagnosed my son with Truncus arteriosis. They said he would not lead a normal childhood and would most likely not make it through the open heart surgery that he would need as soon as he was delivered (if he was able to make it to that time.)
“To say the least, I was absolutely distraught with this news. I thought this was something that I did, was because I stayed on the Paxil for selfish reasons.
“I wanted to know if you could direct me to any information you might have of any woman that has taken Paxil and still had healthy babies. “My husband and I are ready to try again to get pregnant in the next month or two. I am so nervous. I don’t want to stop taking my miracle pill. But, then again, if there is a chance that this might hurt or affect the baby, I want to know upfront. And I will somehow stop taking it for the time being.
“Please contact me as soon as possible. I love everything this drug has done for me. I am so thankful that your company had this available for me. I just want to continue to have a normal life and have the child that I always wanted.
“Please contact me as soon as possible…”
“Please don’t forget about me,”
The — the response we see to this is, I believe, on the next page. And what’s — what is confusing to me a little bit is, it looks like she sent two e-mails and they said they didn’t get the first e-mail. And so I want to skip that response from GSK and go to her second e-mail.
Are you with me?
Her e-mail of June the 1st 2001?
Yes. Because we’ll see in a minute that they say they didn’t get the first e-mail. Okay?
On Friday, June 1, 2001, she writes
“This response is in regards to an e-mail that I had sent you…” it says “preciously, I was asking to see if you have any or are in the process of any clinical trials for women who are currently on Paxil and pregnant. I wanted to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have healthy babies.
“I am in no way insinuating your product did this to my child. I love the product, and I don’t think I could have gotten through my panic attacks without the wonderful help of this miracle drug.
“I just want to start to try and get pregnant again soon. I do not want to put my unborn child through anything that would hurt him/her.
“Please, if you do not have this information, where is this information held? Does anyone do studies like this?
“Please, any information you may give me would be great. Thanks again for your help.”
And then her name is redacted.
And then if you turn over, just to put this in context, again, two more pages, you’ll see this page that says, “We never received.” She’s referring to the first e-mail. So I think what happened is, the response is to both of her e-mails.
But let’s talk about her e-mails, and then we’ll talk about her response. The second e-mail, she asks — she asks some pretty good questions; doesn’t she?
The e-mail related to her questions about clinical trials? I think they’re natural questions to ask in that — in that — in that situation.
Well, as someone in the industry, I know that we don’t do studies on pregnant women. But as a consumer, I could see that that would be a question that they would ask.
You don’t do studies prospectively on pregnant women, but certainly studies are done looking at women that have become pregnant and been on drugs and seen what the results were, right?
Yes. Sorry. I should have made that distinction.
Sure. And maybe that’s what she’s asking. I don’t know. But she wants to know essentially, it looks like, whether or not there are any studies showing whether or not Paxil is safe to use in pregnancy, right?
I don’t — I don’t — I don’t know what she’s asking in this situation.
What she says was, “I want to find out information to see how many women were on Paxil during pregnancy and if they were able to successfully have — successfully have healthy babies,” right?
Okay. And then she asks about, “Are there any studies that are being done?” And she asks about clinical trials before that sentence and asks about studies after that sentence, right?
Do you know whether GSK had undertaken to do any of the studies she’s asking about in June of 2001?
I’m not — I don’t know.
Do you know as you sit here today whether or not GSK ever voluntarily undertook a study to look at what Paxil was doing to pregnant women?
Retrospectively or prospectively?
No. I’m excluding the internal reviews we’ve discussed so far. I don’t — I don’t think that those are studies — right?
And let’s read GSK’s reply or response. It says,
“Thank you for your inquiry. We are attaching a copy of our current product information for Paxil. Please review the section on use during pregnancy.
“Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition.
“Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician.
“We believe that because your physician knows your medical history, he or she is best suited to answer your questions.
“Our drug information department is available to answer any questions your physician or pharmacist may have about our products. Your healthcare professional can call our drug information department…” and then there is the number.
Now, do you know, in 2001, what GSK’s policy was for telling patients or doctors or pharmacists what they would tell them about the number of congenital abnormalities associated with Paxil?
I do not.
Did you know at this time your company’s policy was to not tell doctors or patients or pharmacists how many reports of congenital abnormalities had been reported with Paxil usage?
The question is whether June Raine is capable of responding as a mother – as a mother means not just expressing sympathy to another woman who has lost a child through suicide but doing something to bring some good out of a ghastly situation and she and her agency are complicit in perpetuating.
Jane Nieman was deposed in the Kilker case. Lyam Kilker was born with heart defects after his mother took paroxetine while pregnant. The jury found GSK guilty. That verdict cost them several million dollars but the 600 cases backed up behind them likely cost the company around $1 Billion overall.
Despite 600 cases or so being settled for around $1 billion in the US, MHRA have done nothing to warn mothers about these hazards
Two years after the Kilker case, in the appropriately named Matrixx case, the Supreme Court in the United States ruled that investors in a company like Matrixx have the right to see the adverse event data that a company might have on file about their compounds.
The company argument was that these were meaningless – until RCTs had shown something happening to a statistically significant extent, then it just wasn’t happening and investors need not bother their pretty little heads about anecdotes. The Court disagreed.
We who invest our bodies and lives and our children’s lives in these drugs have no such rights.Share this: