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Re: [IPk] Second hand pump - what to do??

>I remember someone telling me--back when Humalog wasn't approved for pumps
>(is it now? I think not yet)--that a few insulins hadn't been approved for
>use by pregnant women...though they were routinely prescribed for
>gestational diabetes patients and type 1s certainly can't just stop taking
>insulin for 9 months.
>Tells us something about the US FDA's priorities, as well as those of the
>analogous authorities around the world, no?

Hi Melissa -

Who'd be a doctor eh? :-)

My limited understanding of this area is that when a foetus is growing in
the mother's womb, organs are being created. When we are adults, organs are
simply maintained. They are quite different biological processes. Many of
these new genetically modified insulins (Humalog, NovoRapid, Lantus etc)
were abandonned quite late in the development phase when they were found to
be carcinogenic - they create cancers, tumours etc. (Did Humalog cause my
brain tumour? I have absolutely no idea. But the tumour was diagnosed about
5 years after I started on Humalog.) So the regulatory authorities apply
very different standards when exposing new drugs to foetuses and young
children. They have to prove that it does good, rather than proving it does
no harm. We don't want another Thalidamide on the market (which itself was
never approved for use by pregant women, but they took it nonetheless as it
helped with morning sickness - and is now used again I believe but under
strict hospital supervision). When Julia was pregnant with our first son
Christopher, at the 6 month scan, a cyst was spotted in the foetus, so she
was whacked on the emergency list at the hospital, and was in every 2 weeks
for detailed check ups. 6 hours after the birth, Christopher was examined
by the doctors again, and the cyst had vanished into thin air! They later
explained that modern scanning machines show them things that 5 years ago
they wouldn't have even seen - and the 'cyst' was probably just a bubble of
water. And in her 2nd pregancy, she had a horrendous chest infection
towards the end, but doctors were forbidden to give her antibiotics, as
they weren't certified for use in pregnant women. Julia got thoroughly
narked off with it all when she realised they weren't treating her - they
were treating her baby, and she was just the child-bearing-unit. So went
into labour instead ;-)

So that's why they apply different standards to pregnant women and young
children. Doctors can override the restrictions at their discretion, but I
believe they (or their insurers) then take professional responsibility to
the outcome - rather than the drug manufacturers.


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