On January 16, 2012 I learned that GlaxoSmithKline, manufacturer of a
flu vaccine, has a pregnancy registery line. That day I called their
pregnancy registry line to ask some questions. Though my blood was
boiling the longer the conversation went on… though I wanted to
scream, “How can you do this to pregnant women without their
consent?!?”, I did not… I kept my calm and continued to ask
non-hostile questions. The following is the conversation that I had
with the representative:
Angie: Hi, I am a midwife and I saw that you have a pregnancy registry
for pregnant women who receive your vaccine. I was wondering… what is
the purpose of the pregnancy registry?
Representative (from the GlaxoSmithKine‘s pregnancy registry line): To
determine if there are any problems with pregnant women and their
Angie: How does the pregnancy registry work?
Representative: Before we go any further is it ok if I ask for your
name and contact information?
Angie: Sure…. *and I gave my name and the contact info she asked for*.
Representative: Well, you know, we can’t do testing on pregnant women,
so… Pregnant women can register themselves or their OB can register
them. If the pregnant women registered themselves they are asked for
their care providers contact information.
Angie: Why are they asked for their doctors contact information?
Representative: So that they can be followed since we can’t do drug
testing on pregnant women.
Angie: So the mom’s and babies followed?
Representative: Yes, they are, but we can’t do drug testing on pregnant women.
Angie: Right, so… are they followed after birth or just to the time of birth?
Representative: They are not followed after birth they are only to the
time of delivery.
Angie: Why are they followed to the time of birth?
Representative: To look and see if there are any problems.
Angie: And they are not followed after the time of birth to see if
there are any long term effects?
Representative: No, they are just followed until the birth.
Angie: How are the moms and babies followed… who is responsible for
Representative: It is the Drug Safety Department that follows them.
After the mom is registered, the Drug Safety Department send the Care
Provider a form to fill out asking if there were any problems at time
Angie: So by “problems” do you mean birth defects?
Representative: Yes, birth defects.
Angie: What do they do then with this information?
Representative: Well, they want to see the safety of the vaccine, then
of course, down the road, our policy would change.
At this point I could not continue asking questions… I was so very
angry. I thanked her for her time and hung up.
The following is part of the label from the flu vaccine manufactured
by GlaxoSmithKline. I encourage you to call them yourself and ask your
———————– USE IN SPECIFIC POPULATIONS —————-
• Safety and effectiveness have not been established in pregnant women
or nursing mothers. (8.1, 8.3)
• Register women who receive FLUARIX while pregnant in the pregnancy
registry by calling 1-888-452-9622. (8.1)”
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