Re: Avandia, Pharma, Docs, and Us


"Freckles" <Freckles1507@xxxxxxxxx> wrote in message
news:4669547d$0$30614$4c368faf@xxxxxxxxxxxxxxxxx

"Judy G." <VA_Lady2007@xxxxxxxxx> wrote in message
news:diaai.28766$3L1.17441@xxxxxxxxxxxxxxx
There was an interesting squib from the Washington Post, reporting on a
Congressional grilling of some FDA reps. FDA pointed out (correctly)
that there already was a warning on Avandia. One of the questioners
asked him or her to "show me" and as the FDA was desperately fumbling
thru the insert, kept asking "Did you find it yet?" Well, they did, in
dinky tiny print. Which was all that was required. Clearly, it wasn't
adequate labeling even BEFORE the more recent tests, and was WAY less
than adequate for at least a year.

Pharma and the FDA deserve major criticism on this one, the former for
failing to conduct the so called "mandatory" follow up testing, and the
latter for letting them get away with it and not using whatever teeth
they have to make them do what the law requires. This is no more than we
should expect: Pharma is in this for the profits, the bottom line is
what matters, and their actuaries and accountants (save us from bean
counters) probably figure that it's cheaper to fight lawsuits and pay off
the occasional claim than to put appropriate labeling on the products. I
suspect we'll find out that the manufacturer knew darned well that this
stuff was killing people, and used every tool in the legal box to keep
the information out of public view. They they don't get paid to care
about anything except their profit margins. They are starting to care
because the very bad publicity (and likely soon, a rash of multi million
dollar lawsuits) is affecting stock prices.

FDA on the other hand DOES get paid to care. Their attitude seems to be
that there should be bigger labels so we, the patients, can read this
stuff. All well and good, but there are millions of people on the planet
who can't read at all, either because they never learned or can't SEE the
small print. Full disclosure: I use a magnifying glass.

Question: No where in the stories I've read so far, and I admit I
haven't read many, do I see any "blame" being put where it probable at
least partially belongs: on the door steps of the doctors who prescribe
this stuff to people with pre existing heart conditions. I never took
it, so I never read the label, but even if I had, if the FDA
commissioners can't find the "warning" I doubt I would have. Shouldn't
the doctors know?


--
Judy G
DX T2 12/2001; DX LADA 09/2004
Humalog 3 3xday; N 9 am and pm
"Still working on the blend!"


The excerpt shown below was taken from a recent data *** which is
included with each
subscription of Avandia.


Before using
Some medicines or medical conditions may interact with this medicine. INFORM
YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine
that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be
needed if you are taking other medicine for diabetes. Inform your doctor of
any other medical conditions, allergies, pregnancy, or breast-feeding. USE
OF THIS MEDICINE IS NOT RECOMMENDED if you have newly diagnosed or
worsening
heart failure (acute congestive heart failure) or type 1 diabetes.
ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you have
heart disease (e.g., chronic congestive heart failure) or liver disease.
Contact your doctor or pharmacist if you have any questions or concerns
about taking this medicine.

Two years ago in July I was rushed to the hospital with congestive heart
failure.

While being treated for that condition, I was diagnosed with type 2 diabetes
and the hospital's endo prescribed Avandia for me along with amaryl and
insulin on a sliding scale.

Shortly after I got out of the hospital, a home nurse was going over my
medicines with me. She read the insert *** which came with the Avandia and
said, "My God, you should not be taking this." She phoned my GP who
immediately took Avandia off of my medicine list and instructed her to tell
me to stop taking it, NOW.

As I said that was almost 2 years ago and the warning about heart patients
was on the inserts then.



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