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 This is true.  Because of FDA's strict guidelines, Thalidamide(sp?)
had not been approved in the USA so parents were the heartbreak of
deformed babies. Unfortunately, in European countries, England for
one, I think, were not spared because the drug was already in use
there.

It must be difficult waiting for new drug approval but all the data
must be carefully analyzed.  After a potential drug is submitted to
FDA for approval, it will take, I think, about a year for the FDA to
reach their decision.  The FDA can deny the drug, or okay the drug to
go to market, or request more studies if an area of data is unclear.
The amount of data to look through is tremendous. Often they are
looking at data from 3oo-500 patients over a three to five year
period.  A lot of patients do get sick, naturally, with other
illnesses while in studies.  Patients in studies also die from things
such as cancer and heart attacks and all the other health problems.
Someone has to make sure the experimental drug was not somehow
related.  That's one reason for control groups in studies.

The problem is the media who prematurely raise the hopes of everyone
before all the studies are even finalized and before the answers are
clear.

Let's hope the check and cross check systems will go as fast as
possible without sacriface to health.

IYQ all!
Lyn Coles,RN  --Newcomer to list.
 ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

---Heather Elizabeth Baird <[log in to unmask]> wrote:
>
> After the episode of letting pregnant women take a drug that
> caused their babies to be born deformed, it is better to be safe,
> and test the drug well before it is allowed to enter the market
> place.  I am just thankful that I was not born earlier, when
> there was no treatment for Parkinsons symptoms.  I do not want to
> take any drugs or treatment that has not been tested well
> enough.  Any woman with a deformed child will, I am sure, agree.
> Billy Baird ([log in to unmask])
>

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