Following is a transcript from Nightline that was broadcast
this Tuesday, September 27, 2005. The Vincent's Dr. Michael Greene was interviewed
for a program dedicated to discussion of the emergency contraceptive
Plan B. His comments are highlighted below in red.
ABC News Transcripts
SHOW: NIGHTLINE (11:35 PM ET) - ABC
September 27, 2005 Tuesday
LENGTH: 3670 words
HEADLINE: NIGHTLINE THE MORNING AFTER
BODY:
TED KOPPEL, ABC NEWS
September 27th, 2005. I'm Ted Koppel and this is "Nightline."
Tonight, a small pill sets off a big debate.
MICHAEL GREENE, MD
There's no doubt, there's no question about the safety of
Plan-B.
DOCTOR DAVID HAGER, FDA ADVISORY PANEL
My concern is for the women and unborn children in this country.
TED KOPPEL
In the battle over emergency contraception, did politics
trump science?
MICHAEL GREENE, MD
This is an example of political influence that's hijacked
the FDA.
TED KOPPEL
At least one FDA official agrees. That's why she quit.
DOCTOR SUSAN WOOD,
FORMER FDA DIRECTOR OF WOMEN'S HEALTH OFFICE
This is contraception. It is not abortion. The only connection
it has with abortion is that it can prevent them.
TED KOPPEL
Tonight, "the morning after," fighting over birth
control.
graphics: the morning after
TED KOPPEL
(Off Camera) Perhaps because it's been called the morning-after
pill, there's some genuine confusion as to what it does and
does not do. So, let's begin by explaining what Plan-B, the
other name by which the pill is known, let's begin by explaining
what it is not. It is not the same thing at all as RU-486.
I can see some of your eyes glazing over already. But a few
years back, RU-486, which was developed in Europe and ultimately
approved only by prescription here in the United States, was
a raging political debate. It was, quite simply, a chemical
abortion pill. Plan-B is not. In reality, it works just like
a high-test birth control pill. But if taken as soon as possible,
within 72 hours after intercourse, it prevents pregnancy by
stopping the release of an egg from the ovary, or -and this
is the controversial part, by preventing the implantation
of a fertilized egg in the uterus. Plan-B has actually been
available by prescription since 1999. Controversy arose four
years later in 2003, when the drug's distributor tried to
get the Food and Drug Administration to approve Plan-B for
sale over the counter. A few weeks ago, and the event got
lost in the Hurricane Katrina story, back at the end of August,
the director of the FDA's office of women's health, resigned
over the agency's decision to keep Plan-B from being sold
over the counter. Susan Wood will be giving her first television
interview tonight. But first, some more background from ABC
News correspondent Lisa Stark.
LISA STARK, ABC NEWS
(Voice Over) In December 2003, two FDA advisory committees
met to decide whether Plan-B, the morning-after pill, should
be sold without a prescription. The vote was overwhelmingly
in favor. 23-4.
LISA STARK
(Voice Over) The pill must be taken within 72 hours after
intercourse to be effective. That's why advocates say it's
important it be made over the counter, so a woman doesn't
have to wait for her doctor to prescribe it.
DOCTOR DAVID HAGER
I am opposed, vote no.
LISA STARK
(Voice Over) Dr. David Hager is one of the four on the advisory
panel who voted against Plan-B. An OB/GYN from Kentucky, Dr.
Hager describes himself as pro-life.
DOCTOR DAVID HAGER
I did not feel comfortable at the time indicating that I
favored over- the-counter sale with no age limitation whatsoever.
A nine, 10-year- old could purchase the medication as easily
as a 25-year-old.
LISA STARK
(Voice Over) After the vote, Dr. Hager said he was asked,
he won't say by whom, to write a letter to the head of the
FDA.
DOCTOR DAVID HAGER
I wrote a letter to the commissioner, just explaining my
-my concerns to make sure that those had been conveyed to
the commissioner's office.
LISA STARK
(Off Camera) In May 2004, the FDA, in essence, sided with
Hager. In a rare move, it rejected the advice of both its
panel and senior staff, citing concerns about usage among
younger girls. The FDA told the manufacturer, Barr Pharmaceuticals,
to reapply. Barr did that, asking the drug be made available
over the counter for females 16 or over. Those younger would
still need a doctor's prescription.
LISA STARK
(Voice Over) Five months later, speaking at a Christian college,
Dr. Hager took some credit for that.
DOCTOR DAVID HAGER
I argued it from a scientific perspective. And God took that
information and he used it through this minority report to
influence a decision. You don't have to wave your bible to
have an effect as a Christian in the public arena.
WENDY WRIGHT, CONCERNED WOMEN FOR AMERICA
I'm Wendy Wright with Concerned Women for America. And we're
very disturbed by Plan-B's promoters emphasis on access, but
not on women's safety.
LISA STARK
(Voice Over) Wendy Wright is with Concerned Women for America.
Its mission is to bring "biblical principles into all
levels of public policy." Her organization played a lead
role in fighting to keep the drug prescription-only.
WENDY WRIGHT
This will end up making particularly minor girls more vulnerable
to statutory rapists. A 40-year-old man can go in and buy
this drug, give it to a 13-year-old girl in order to cover
up and continue his sexual abuse of that girl.
LISA STARK
(Voice Over) The FDA promised it would make a decision by
January 2005. The deadline passed. At that point, Senators
Hillary Rodham Clinton and Patty Murray decided to play hard-ball
politics.
SENATOR PATTY MURRAY, DEMOCRAT, WASHINGTON
We said, the Senate will not approve Lester Crawford as FDA
commissioner until he gives us a timeline for an answer on
whether Plan-B will be approved as an over-the-counter drug.
SENATOR, MALE
The FDA has a very broad and critical mission in protecting
the public health.
LISA STARK
(Voice Over) A deal was struck. Crawford was confirmed as
FDA commissioner in July, after the FDA promised a decision
on Plan-B by September 1st, more than two years after the
original application was submitted. Meantime, Wendy Wright
and her group kept up the pressure on the FDA.
WENDY WRIGHT
The FDA staff and the advisory committee did not look at
the overall effect that making this drug easily available
can end up having.
LISA STARK
(Off Camera) Is that their job? Or is their job to determine
if a drug is safe and effective?
WENDY WRIGHT
When we are at an epidemic rate in the United States of STDs,
we as a society need to be taking a more serious look at it.
DOCTOR DAVID HAGER
If a young woman chose to use emergency contraception, then
would she not come in to see her physician for regular contraception
prescription, to be screened for sexually transmitted infections,
to have her pap smear?
LISA STARK
(Voice Over) On the last Friday in August, at 4:00 PM, the
FDA made its announcement. It decided not to decide.
LESTER CRAWFORD, FDA COMMISSIONER
The agency is unable at this time to reach a decision on
the approvability of the application because of these unresolved
regulatory and policy issues that relate to the application
we were asked to evaluate.
LISA STARK
(Voice Over) The FDA asked for another 60 days for public
comment. Senator Murray was furious.
SENATOR PATTY MURRAY
Rather, it's been delayed and delayed and delayed. We are
only left to wonder why. And the only answer I can come up
with is politics.
WENDY WRIGHT
The FDA has shown that it's sensitive to the concerns of
our society. And they have rightly looked beyond some ideologues
within the medical community to see, how the public will be
affected by this decision.
LISA STARK
(Off Camera) The final decision on Plan-B will be in the
hands of a new FDA commissioner. Just last week, Lester Crawford
resigned as head of the FDA. This is Lisa Stark for "Nightline,"
in Washington.
TED KOPPEL
(Off Camera) When we come back, I'll talk with Dr. Susan
Wood, who headed the FDA's office of women's health, and who
resigned from that post in protest.
graphics: abc news: nightline
ANNOUNCER
This is ABC News "Nightline." Brought to you by
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commercial break
TED KOPPEL
(Off Camera) Susan Wood headed the office of women's health
at the Food and Drug Administration for five years, until
her resignation just about a month ago. She previously worked
as a biochemist at Johns Hopkins University. And just to be
sure that there's no confusion, why did you quit?
DOCTOR SUSAN WOOD
I quit because I felt that science was being overruled at
FDA and women's health was being damaged.
TED KOPPEL
(Off Camera) Let's start with the first part. You're saying
science was being -overruled. By whose definition?
DOCTOR SUSAN WOOD
I think by the definition of all the ways we've always done
business at FDA, where science and the scientists and medical
professionals at FDA are the ones who review the evidence
and make a decision about whether a drug should be approved
or not approved.
TED KOPPEL
(Off Camera) What's the question? What's the issue that was
resolved?
DOCTOR SUSAN WOOD
Right. Well, in that case, it was about emergency contraception.
It has been approved by prescription use for women of all
ages. And has been caught up in delay after delay, even though
there's consensus at the -amongst the scientists and health
professionals there that it should be approved. Not just for
prescription status, but more importantly for over-the-counter
the status -over-the-counter status, so that women can have
access to it when it's most effective to prevent an -unintended
pregnancy and ultimately to prevent abortions.
TED KOPPEL
(Off Camera) What would you say are the main reasons that
- and you, you call it the consensus. So, clearly, there were
some scientists who did not agree. But the preponderance of
scientists who voted on this did agree.
DOCTOR SUSAN WOOD
Well -I would actually still call it a consensus. Because
the scientists you're referring to who didn't agree were part
-were the few of the advisory committee made up of outside
experts. They voted, a preponderance, to bring it over the
counter and that it was safe and effective for women to use
over the counter. What then happened ...
TED KOPPEL
(Off Camera) Do you remember what the vote was?
DOCTOR SUSAN WOOD
It was 23-4, I believe, in favor. And unanimous that it was
safe for women to use over the counter.
TED KOPPEL
(Off Camera) And within the FDA?
DOCTOR SUSAN WOOD
Within the FDA -FDA does overturn its advisory committees
on occasion. And sometimes -and usually when they do so, it's
for good reason. In this case, the FDA staff, at every level
within the agency, multiple levels, agreed that it should
be approved for over- the-counter status. And agreed that
it was appropriate for women to have access in a timely manner,
so it would actually work more effectively.
TED KOPPEL
(Off Camera) You keep saying women. I gather that some of
the controversy has to do with girls. If I have to go or if
my daughter has to go to our physician, to her physician and
the physician has to write a prescription, there is at least
a -a barrier between her using it recklessly and using it
in the way that it should be used.
DOCTOR SUSAN WOOD
I don't -this product is very safe. There's not much concern
that it will cause -as a safety issue. The question that was
raised, by a very small part of the agency, was whether or
not they could understand the label and use it properly. But
we've never asked that question about any other product. We
don't ask it about pain medication. We don't ask it about
cold medication. We don't ask it about condoms or any other
contraceptive method that's available over the counter. This
is very, very safe. There's no question about its safety.
There's no question that it's more effective if it's used
within hours not within days.
TED KOPPEL
(Off Camera) Clearly, there is a -there is a distinction
between a normal contraceptive, I mean, a pill that can be
used as a contraceptive, which has to be taken before the
act of sex and Plan-B, which is designed to be taken after.
DOCTOR SUSAN WOOD
And that's, that's really the central difference, is the
timing. It works in a mechanism very similar to many other
birth control pills. The mechanism is very similar, it just
has to be taken after. And the sooner you take it after, the
more effective. If you need it on Saturday morning, waiting
until you get to a physician, either by phone or in person,
to get a prescription by Monday morning, it's too late and
it doesn't work. And the worst thing that can happen is that
you would have an unintended pregnancy.
TED KOPPEL
(Off Camera) You can understand that those who are concerned
about it on moral grounds would argue that by making a pill
like this available to an underage teenager, 15, 16-year-old,
you could be encouraging reckless sex. The knowledge that
even after you've had sex, it is still possible, then, to
take a pill that will prevent a pregnancy is likely to make
the sexual act more not less likely.
DOCTOR SUSAN WOOD
Actually there's no evidence to that effect. And in fact,
there's evidence to the contrary. That it doesn't change your
contraceptive behavior. It doesn't change sexual behavior,
even in teens.
TED KOPPEL
(Off Camera) How -how do we know?
DOCTOR SUSAN WOOD
There are studies that have been reviewed not just by me
but by, again, all of the outside experts on the advisory
committee and all of the staff within FDA. And they examined
that issue very carefully and came to the conclusion that
there is no good evidence to be concerned about that. And
in fact, what you want to do is prevent an unintended pregnancy
and prevent the abortions, which is, again, common ground.
I think the issue around teens and sexual behavior, we have
to look at what's already available. There are other contraceptive
methods on the market. We know that increased access to contraception
doesn't change behavior. What it does change is the risk of
an unintended pregnancy.
TED KOPPEL
(Off Camera) All right. There are political consequences
to making this drug available over the counter. And I get
the sense that political pressure may have been behind what
happened or at least that you perceive it that way. Let's
take a short break. When we come back, we'll talk about that.
Back with Dr. Wood in a moment.
commercial break
TED KOPPEL
(Off Camera) And I'm back again with Dr. Susan Wood. Would
it be fair to say that you felt that the decision the FDA
made was not on the basis of science, but made on the basis
of political pressure?
DOCTOR SUSAN WOOD
I have to agree with the first half of your sentence. I can
only tell you what I observed. And that was, it was not made
on the basis of the scientific and medical evidence. And not
just me but all of the scientific and professional staff who
normally are the part of the decision-making at the agency,
because they're the ones who review the evidence and evaluate
it and make the recommendations, they also were cut out of
the decision. People who should have known and should have
been part of the decision-making, were not in the room and
were not aware of what the decision was until very late in
the process.
TED KOPPEL
(Off Camera) Forgive me, I think you're being a little coy.
If it - if it wasn't made on the basis of scientific evidence,
other than political pressure, what can you think of as having
been a reason that would have caused the FDA to make the decision
it made?
DOCTOR SUSAN WOOD
And I'm -I'm really trying not to be coy. But my problem
is, is I don't really understand why we couldn't see this
as common ground. I honestly was very hopeful that this would
get approved in one fashion or another. Either through having
prescription status for younger women and nonprescription
for older. But some way it would be approved because the science
was so compelling and the evidence is so clear. And it's common
ground. This is contraception. It is not abortion. The only
connection it has with abortion is that it can prevent them.
So, honestly, and perhaps I'm na<ve, but honestly, I was
hopeful that the science would win out and the health of women
and families would win out. And so, when it didn't, I can
only say what I saw, which we were out of it. And I'm - and
I'm still surprised.
TED KOPPEL
(Off Camera) No, I get that. I understand that. What other
possible reason can there have been then that someone brought
pressure to bear, which I describe as political. But if you
have some other description, tell me what it is.
DOCTOR SUSAN WOOD
Well, I won't disagree with you on that point. 'Cause I honestly
don't know where it came from, either. And so, it must have
come from somewhere. But because I'm a scientist, I tend to
try to say, what do I know? And I honestly don't know but
I won't disagree with you that it must have come from somewhere
else.
TED KOPPEL
(Off Camera) Wasn't there nearly -or indeed, I think that
Senator Kennedy - I mean, Senator Clinton, in particular,
believed that there was a deal, that a deal had been made?
What was the nature of that deal? And do you have any, any
understanding as to why that deal collapsed?
DOCTOR SUSAN WOOD
Well, it sounded like semantics to me. I mean, I know as
much about the deal as -from what I read in the newspapers.
Was that Secretary Leavitt and Commissioner Crawford had agreed
to take an action. And they did take an action. So, technically,
they were correct. They took an action, which was a delay.
TED KOPPEL
(Off Camera) Clearly not the action that Senator Clinton
suspected.
DOCTOR SUSAN WOOD
Not the action suspected, which was a decision. And there
was no decision made here, technically. But I would argue
that the decision to delay approval of this product over-the-counter
is, in fact, a denial. And this is, again, in part why I resigned.
Because by couching it as a delay and a non-decision, in fact
denied women of all ages, not just teens but women of all
ages access to timely use of this product.
TED KOPPEL
(Off Camera) If you had thought that it was a brief delay,
in other words, if you thought it was only going to be a delay
of a couple of months, you wouldn't have resigned.
DOCTOR SUSAN WOOD
Probably not.
TED KOPPEL
(Off Camera) So, you obviously think that what we're talking
about here is not really a delay but a way of shelving it
and not dealing with the issue.
DOCTOR SUSAN WOOD
Right. The mechanism is a rather bureaucratic one to potentially
open it up to rulemaking. Which, to make a long story short,
means opening up to a process that usually takes many months
to years, if in fact that's the way they go.
TED KOPPEL
(Off Camera) And you're saying that insofar as health is
concerned, insofar as the impact of this physically and psychologically
is concerned, there's no difference between this and a rubber
condom?
DOCTOR SUSAN WOOD
It's -I would have to compare it to oral contraceptives or
in terms of its availability, to a condom, or spermicides
or the today sponge.
TED KOPPEL
(Off Camera) Right. Are oral contraceptives - just help me
out, are they available over the counter?
DOCTOR SUSAN WOOD
No. And there's an ongoing debate about that. But they're
not needed on an emergency basis. They're effective on chronic
use, over long periods of time. For emergency contraception,
we're talking about single use of a product that's very, very
safe and needs to be taken very, very quickly. Within hours
to make it most effective.
TED KOPPEL
(Off Camera) Else the young lady will be pregnant?
DOCTOR SUSAN WOOD
She certainly will be at-risk of that, yes.
TED KOPPEL
(Off Camera) But you can understand how certain people who
are worried about the moral impact of this will say, look,
the next step then is going to be these same people who are
pushing Plan-B are gonna also be pushing oral contraceptives
as also being available over the counter because the same
logic that apply applies, not exactly but the same logic,
you want to prevent pregnancy, you want to prevent the consequences
of unwanted pregnancy, let's have contraception all around.
DOCTOR SUSAN WOOD
I think at this point, the focus is on emergency use. When
you need it right away and can't wait for prescription. And
there are many women and girls who don't have regular access
to a physician or place of regular health care. Look at the
uninsured, just as a start. And we have to make sure that
they are not the ones put at-risk simply because of the barrier
of getting to a physician, getting a prescription, and then
getting it filled, all within a window of time that will be
essentially closing on them, in terms of making sure it's
effective.
TED KOPPEL
(Off Camera) What are you doing now?
DOCTOR SUSAN WOOD
Well, when I left the agency, I didn't have a plan. And I
certainly didn't expect this kind of attention from national
and international media. So, what I'm doing now is, is thinking
about talking to people. Because I feel so strongly about
the importance of science being what drives our health decisions.
It's so important to people in their everyday lives. So, I'm
continuing to try and figure out a way to tell people about
that, as well as to keep working in, in health policy, to
help women and families.
TED KOPPEL
(Off Camera) Dr. Wood, good of you to come in. Enjoyed having
you here, thank you.
DOCTOR SUSAN WOOD
Thank you.
TED KOPPEL
(Off Camera) I'll be back in a moment with a word about tomorrow's
"Nightline."
graphics: nightline: abcnews.com
ANNOUNCER
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commercial break
TED KOPPEL
(Off Camera) Tomorrow on "Nightline," do you know
what your kids are eating in school these days? The naked
chef puts on some clothes, crosses the Atlantic and starts
another revolution.
CHEF, MALE
If you truly love your kid, it doesn't matter where I come
from or who I am. Because, you know, you should be trying
to do the best of your kids.
TED KOPPEL
That's "Nightline" tomorrow. And that's our report
for tonight. I'm Ted Koppel in Washington. For all of us here
at ABC News, good night.
