Brilliant Article on the Travesty of the FDA Panel's recommendation on silicone implants (cancer)
Sunday, October 19, 2003
Approval of new breast implant hinges on medical evidence
Panel allows company to experiment on women evidence shows devices cause
horrible problems
http://www.detnews.com/2003/editorial/0310/19/a15-301035.htm
By Kim Gandy
Earlier this week, a not-so-secret government-convened panel told a big
company it could make an experiment on women's health even bigger. The
initial results of this experiment were not convincing enough. Never
mind that thousands of women developed deformities and required multiple
repeat surgeries. (Well, of course, they had repeat surgeries if they
were lucky enough to afford out-of-pocket health care expenses.) The
panel wasn't absolutely convinced that women were contracting rare,
debilitating diseases on top of their other problems. It was just barely
possible that women may not, in fact, become completely disabled or die.
So, the panel concluded, women should be allowed to continue to enrich
interested industries through this experiment as long as they were
informed of certain risks.
But the panel did agonize over continuing
this experiment. Because they weren't sure what the risks were, how
could they warn women? Even though the panel had been waiting more than
10 years to see the results of this experiment to know how women might
get hurt, no one had been willing to actually count the number of women
who had suffered and what they had suffered from. So what would they
tell women about risks? The big company had only just started counting
women in the past three years of the experiment. Many of the previously
healthy women needed operations within the three years. And women
recovering from cancer who joined the experiment -- well, they got even
sicker. About half of them needed operations during the three years.
Yes, that's a lot of suffering, but then, we couldn't know, really, if
they actually would become completely disabled or die. Yet so many
women held garage sales and borrowed money and traveled from faraway to
tell their stories of anguish. And the company paid for other women to
come and tell the panel that they were happy and to let many more women
join the experiment. The panel felt sad for the sick women and was
afraid of having more sick women. It was also afraid of being "mean" to
the women who hadn't suffered from the experiment and wanted lots of
other women to be in the experiment, too. Because, one panel member
said, "It seems irresponsible to approve this product based on this
data, but it seems mean not to." And another panel member called the
frightening data "mind boggling." And another said he was
"flabbergasted."
And yet another said they were being "irresponsible."
But, of course, they couldn't be mean to the women who had survived the
experiment without illness. Some researchers said most of the terrible
problems started after seven to 10 years, but of course the happy women
didn't believe them. So the panel told the big company it could make a
whole lot more money doing the experiment by making it bigger and
bigger. And the panel told the injured women to keep going to doctors at
their own expense to fix the problems with the experiment. And the
company said oh we really, really will tell the women to go to doctors.
We will tell them to go to the doctor every year if you like -- at their
own expense. This experiment was very, very important. No, it wasn't
for a drug for rare diseases, and it wasn't something that would help
the planet or possibly bring about world peace. It was to allow the
women to put two large bags of silicone (like sand ground up and turned
into jelly) into their breasts. So, go to sleep my little girl. Because
that big company is going to give you the "freedom to choose" the
experiment.
Just don't ask about the risks. Because the panel doesn't
know, and your doctor doesn't know and the big company doesn't even want
to know. That would be mean.
Kim Gandy is president of National
Organization for Women in Washington, D.C.
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For more information on this continuing debacle, you are welcome to choose to visit:
http://www.BreastImplantAwareness.org
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