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On July 19, 1996, an advisory committee to the U.S. Food
& Drug Administration did exactly what it was appointed
to do. It recommended the approval of marketing of the
French abortion pill, RU 486, in the United States.
It recommended that this pill be used with another pill,
Cytotec, an oral prostaglandin, and that the two of
them be approved as chemical abortifacients.
Sadly, this
was an entirely predictable, political event and bore
little relationship to the usual scientific evaluation
that we expect from the Food & Drug Administration.
You may recall
that right after President Clinton was inaugurated,
he announced that one of his goals would be to have
this pill approved for marketing - and quickly. His
appointee as commissioner of the Food & Drug Administration
was Dr. David Kessler. We use a term to describe him
that I don't recall that we've really used for anyone
else...He is a political prostitute. He announced, contrary
to everything that's ever come out of the FDA, that,
when the drug application was submitted, he would see
that it would be approved within six months.
Understand,
now, that the minimum time any life-saving drug has
been approved in recent years was 19 months, and, typically,
other drugs take three to five years. This is not a
life-saving drug - it is a life-taking drug -
but all rules are out the window when the pro-abortion
Clinton administration wants something. And this drug-approval
process has been politicized in an outrageous fashion.
The advisory
committee was stacked with abortion-supporters. It seemed
obvious that they never intended to really analyze the
safety and efficacy of this abortion pill in any objective
sense. Their votes approved it, and this was guaranteed
from the beginning. They did hold a daylong event, but
this was window dressing. It just gave to the pro-abortion
media a platform that gave a veneer of scientific approval
to this.
The panel
reviewed data from two French clinical trials that reported
on a total of 2,500 women. It also accepted preliminary
results from more recent American trials involving 2,100
women. The American data were preliminary, have not
been thoroughly reviewed nor verified. And one of the
members of the panel, Dr. Mary Jo O'Sullivan, Professor
and Director of Obstetrics at the University of Miami
School of Medicine, publicly stated, "I don't know
why this meeting is being held at this time when the
data are not finalized." She pointed to the fact
that this has never happened before - that the final
data were not due for at least another six months, and
that to accept preliminary data on such a controversial
drug was unheard of. But hers was a lonely voice.
The final
approval by the FDA does not have to follow the advisory
panel's recommendations. But in this case, take it as
a given that it will follow it, for that is exactly
why this stacked panel was appointed and this meeting
set up.
A group of
major pro-life organizations, reviewing the committee
members, was appalled at the bias of those appointed.
Reacting to this, on July 10 leaders from Life Issues
Institute, Concerned Women for America, Focus on the
Family, Christian Coalition, National Right to Life,
and the Christian Life Commission of the South Baptist
Convention officially wrote to Food & Drug Administration
Commissioner David Kessler requesting that six of the
people on the panel be removed. We gave in-depth documentation
of their demonstrated active bias in favor of abortion.
In an unusually
rapid reply one week later the FDA denied that there
was any conflict of interest and stated that these peoples'
previous activities would have no bearing on their judgment.
As it broke out, however, three of the six did not participate,
and, I'm sure, because of our letter. The other three
did, and they were all bad news. One was the committee
chairman, Dr. Ezra Davidson. He had signed on to a full-page
ad in the Washington Post, which defended unrestricted
abortion and opposed any legislation that would restrict
it. He was a member of the steering committee of Physicians
for Choice of Planned Parenthood.
Dr. Diana
Petitti, who also had a public pro-abortion track record,
went ahead to join him in voting to approve this drug.
Perhaps the
most upsetting one was Dr. Philip Corfman, executive
secretary of the committee. He was responsible for overseeing
the planning and conduct of the hearing. He has been
an employee of Planned Parenthood and was a founding
member of a leading pro-RU 486 lobbying organization,
the Reproductive Health Technology Project. He was the
guiding brains that put this committee together and
saw to it that approval would be granted. He was not
removed.
Of the eight
members of the panel, the final vote was seven in favor,
with one abstention. An earlier vote had been six to
two to affirm that the French studies had established
the efficacy of using RU 486, and to use this, then,
was approved as a basis for approving the drug in the
U.S. A third vote, six to two, stated that the benefits
outweighed the risks.
During this
discussion, Dr. O'Sullivan, the one member in opposition
to these votes, when discussing the risk/benefit ratio
here, pointedly asked, "Benefit to whom? If you're
talking about the woman, it may be beneficial
to her, but it's of no benefit to the baby whatsoever."
To our great surprise, the strongly pro-abortion Washington
Post actually printed this comment of hers.
However, the
final result was no surprise to anyone. The pro-abortion
juggernaut moved smoothly ahead.
Newspaper
columnist, Cal Thomas, said, "Those who want the
FDA to approve the drug have so politicized the debate
that sound medical treatment and moral reasoning have
become casualties. FDA Commissioner David Kessler admonished
the panel to consider `only science' in making its decision.
But," Cal says, "it was only science that
led to some of modern history's most outrageous and
immoral acts." Clearly, he was referring to the
Nazi experiments, which were only science and did not
take into consideration any value judgments.
One of the
things that speakers on both sides of this issue at
the hearing agreed on was that marketing RU 486 would
encourage more physicians to perform abortions. From
the pro-abortion side, this would reverse the progressive
decline in the number of physicians who now do abortions.
From the pro-life
side, our speakers stressed again and again how the
history of abortion in the U.S. shows that when the
number of abortionists goes up, the number of abortions
also goes up. We have over a million-and-a half abortions
a year now -- an appalling number -- almost every third
baby conceived in America. And this from the President
who said that he wants to make abortion "safe,
legal and rare".
This only
confirms what I've been saying - and that is that every
action he has taken has been to make it not rare, but
everywhere.
Another disturbing
issue was - who should not take the pill. Basically,
two sets of studies were given - finalized studies from
France and preliminary results on studies from the U.S.
In the French tests women who had the following health
problems were excluded: those who smoked 10 or more
cigarettes a day, had heart and circulation problems,
asthma, glaucoma, diabetes, high blood pressure, kidney,
liver or adrenal problems, anemia, and if they were
over age 35. No recommendation was voted on by this
panel as to whether women with such health problems
would be excluded in the United States if this drug
were licensed.
Another disturbing
fact was that the U.S. tests did not examine women 18
and under. The recommended approval does not exclude
its use for women 18 and under. And this is further
evidence of the completely unscientific approach that
is being taken in licensing this drug.
It seems rather
evident that the concern here is not whether or not
women with such health problems are adversely affected,
or that the possibility exists that teenage women would
have a different reaction than more mature women. One
doesn't know these things, you know, unless you test
for them. All we have here is a headlong political rush
to approve a "politically correct" drug and
to do so within Mr. Clinton's first term.
One of the
few good things that came out of the hearing, if you
can call it good, is that the pro-abortion people wanted
approval for use up to nine weeks, or 63 days, after
the first day of her last normal menstrual period. The
committee, however, recommended that it only be used
from 5 to 7 weeks. This means that if she comes in when
she is one week overdue for her missed period, the pill
can only be used in those next two weeks.
And who would
use it? The panel merely stated that the abortionist
who uses the RU 486/Cytotec combination must be able
to diagnose and date pregnancy, identify a tubal pregnancy,
have ultra-sound available and be able to do
an emergency D&C to stop hemorrhage or to complete
the abortion. Nothing was said about enforcing these,
and, let me tell you, any doctor with a license to practice
medicine could qualify under these recommendations.
Very disturbing
was their recommendation that RU 486 must be administered
"under the supervision of a physician". It
did not say "given by a physician".
This means that a nurse or physician assistant, rather
than a doctor, may be the only person the aborted woman
sees.
This will
take three visits to the doctor. On the first visit,
she is to take 600 mgs. of RU 486 by mouth. Two days
later she is to return to the abortion facility. At
that time only 3% of the women will have aborted. And
so the remaining 97% will be given 400 mgs. of Cytotec,
a prostaglandin drug. She then is to wait at the office
for four hours. During the trials, about half of the
women had aborted during those four hours. The remaining
went home and awaited the abortion. Whatever passes
from her she is to collect in a jar and bring back to
the office. Needless to say, she's going to get a look
at some very tiny fingers and toes.
All of the
women are supposed to return for a third visit to confirm
that the abortion has been completed or that further
attention is needed.
Now, in France,
if that woman did not come back, they went out, got
her and brought her back. But that kind of control simply
doesn't exist in the United States. We'll have a lot
of women who simply won't return. Some of these women
will have complications. A small percentage will not
abort at all and they'll carry their babies to term.
The most immediate
risk from the pill is bleeding. The average woman in
the test bled for nine days. The longest, 69 days. One
who testified against licensing was a doctor who provided
emergency room treatment to one of the women who participated
in the Planned Parenthood trial in Iowa. His patient
almost died from hemorrhage and was saved only with
multiple transfusions.
And other
problems? In the French trials, half of the women were
nauseated; one-fourth of them vomited; four-fifths had
painful contractions, with one-third reporting these
contractions to be very severe; and many of them needed
narcotics.
One of the
members on the panel who voted to approve the drug stated
that the term "safe" should not be misinterpreted
"as free of adverse events and serious adverse
events".
In summary,
in a complete disregard for the normal scientific processes
that have always been a fact of life at the Food &
Drug Administration, this drug's approval has been totally
politicized. Dr. David Kessler, head of the FDA, promised
that he would have it approved within six months - a
startling statement, since urgently needed, life-saving
drugs have never gone through the approval process in
less than 19 months, and a more typical approval process
has been 3 to 5 years.
The panel
appointed by Clinton was stacked with strongly biased,
pro-abortion members. With one exception, they voted
to approve this.
The hearings
provided a platform for the pro-abortion press to frame
the issue so that it looked as if this had been a scientific
appraisal. Nothing could be further from the truth.
The American
tests are finished, but we only have preliminary results
- no final results until next year. No drug has ever
been approved before the final results of the testing
were in, but this one will be. And why? Because our
pro-abortion President has exerted great pressure to
have it approved.
No tests have
been done on women 18 years and younger, and yet this
panel approved its use for teenagers. In France it is
not approved for use on women with at least 12 common
medical problems. None of these restrictions were recommended
by this panel.
In France
this can only be used in clinics that have emergency
medical facilities such as blood transfusion availability,
defibrillators, electrocardiograms, and more. None of
these requirements were recommended by this panel.
In short,
this panel relied upon the experience of France, which
has a far more rigid and controlled patient population
than here. Our doctor-patient relationship is far looser,
more voluntary and contains no requirements to have
a woman return if she doesn't want to. In France, if
she doesn't come back, they'll go get her - they'll
bring her in, and she has little choice in the matter.
In short, the testing that they relied on from France
is not comparable to the medical practice in the U.S.
Further, what
of the effect of this pill on future breast cancer?
What impact will it have on future pregnancies? What
of its effect on other organs? The panel did not ask
these and other important questions.
Let me predict
-- women are going to again be guinea pigs. This could
be another Thalidomide tragedy, another Dalcon shield
tragedy. Some women will die. Some babies will be born
deformed. But Mr. Clinton wants this. Dr. Kessler is
doing what he has been asked to do. And the pro-abortion
juggernaut rolls on.
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