Very political science
By Kenneth Smith
Copyright 1999 Washington Times
June 24, 1999
It has become fashionable in some quarters to argue that women
ought to be able
to make such decisions on their own. If members of our society
were empowered
to make their own decisions about the entire range of products for
which the
Food and Drug Administration has responsibility, however, then the
whole
rationale for the agency would cease to exist."
So wrote then-agency head David Kessler in the New England
Journal of Medicine
in 1992. He was defending his decision that year to ban
silicone-gel-filled
breast
implants on grounds that the agency could not ensure they were
safe. Not that the
agency had proved they weren't safe.
Implants had been around
for several decades in as many as 2 million women, and despite grim
anecdotes
about ruptures of the device, the overwhelming majority of women
were pretty
happy with them. Hence the need for Mr. Kessler's warnings that
women could
not be trusted to make the decision of whether to have them.
In the ensuing panic Dow Corning Corp. went bankrupt after
being inundated
with claims from women, to say nothing of their lawyers, who
accused the
company of manufacturing breast
implants that caused major illnesses in users. Dow has agreed to
pay $3.2 billion to settle the claims. Other
manufacturers, among them Baxter International, Bristol-Myers
Squibb and
Minnesota Mining and Manufacturing, have agreed to a settlement
estimated at $3 billion combined.
Today, though, there is one less rationale for the FDA to
exist and one more
reason to avoid scaring women for political or other
reasons. Yet another group of scientists, this one under the
auspices of a
group belonging to the National Academy of Sciences, has been
unable to find
any link between the
implants and cancer, immunologic diseases, or neurological
problems. Such diseases are
the basis for much of the litigation the companies have had to
endure.
Reported the scientists:
(1) There is
no evidence to suggest that the silicones used in
implants are toxic to humans. When individual studies have pointed
to possible toxic,
immunological, or neurological effects, more extensive analysis
failed to
uncover associations with specific diseases or conditions.
(2) There is no established link between
implants and a unique disease
syndrome. Syndromes of the type ascribed to
implants generally involve symptoms that are nonspecific and common
in the general
population.
(3) There is no evidence that conclusively links silicone
to harmful effects on
the immune system. Early studies addressing the immunology of
silicones are
limited and have substantial technical problems. Follow-up
analysis have failed to uncover associations with specific
immunological
diseases or other conditions. In addition, the committee also
could find no
evidence that mothers with
implants pass silicone on to infants when breast-feeding. It turns
out there are
higher levels of silicon in cows' milk and commercially available
infant
formula than in the milk of nursing mothers with
implants.(Brace yourself for suits against cows and infant
formula.)
Not that there aren't any problems for women with
implants. They do suffer from some of these diseases but at a rate
no higher than the
rest of the population. They also have to deal with a variety of
potentially painful, local complications that can require
additional surgery.
Anyone who is contemplating getting breast
implants better keep those complications in mind. Still even those
injuries, which
industry does not necessarily dispute, are hardly sufficient to
bring down a
major corporation.
Activists and trial lawyers
who have made a good living off this long-running scare tried to
knock the new
report down, saying it showed industry bias. Well, then there must
be a lot of
bias around because almost any study on the subject that matters
has been
unable to find any major
illness related to
implants.
David Bernstein, a law professor and adviser for a tort
reform group, told the
New York Times the report might help end the ongoing litigation.
"It is a very strong statement," he said.
"It would have been nice to have had this $7 billion
ago," Mr.
Bernstein said.
Mr. Kessler's contempt for the choices of individual women
wasn't the only
problem here. The media had a big part in it too. In a famous, or
rather
infamous, episode of
"Face to Face with Connie Chung," Ms. Chung began her
program saying,
"Coming up,
some shocking information about breast
implants." Anyone watching would have expected this worse, and
Ms. Chung did not
disappoint. She interviewed several women who claimed their breast
implants had caused serious problems and left the audience
wondering why FDA had not
stepped in to ban the devices.
The impression that first-hand testimony like this has on
listeners is hard to overestimate. The Academy
of Sciences group heard much the same kind of stories from women
both directly
and indirectly. Many of the women, the scientists noted, are
"seriously ill." The experts listening to them were
"moved by their suffering." But they still couldn't find
the link
between
implants and more serious diseases. A scientific panel can sort
out life-threatening
health problems from those that cause pain and discomfort. It can
sort out
fact from emotion. Not only are the media careless in
distinguishing between
them, they can disregard the differences recklessly.
Consider one newspaper headline from 1992 that is not for the
faint-hearted:
"Under the knife: Woman Uses Razor to Remove
Implants."
While scientists try to clean up the mess that Mr. Kessler
and others have
left behind, he has moved on to bigger, more politically correct
wars against
the
tobacco industry. Apparently being a federal scaremonger means
never having to
say you're sorry for being arrogant. In the New England Journal he
wrote that
caveat emptor - let the buyer beware - would never be FDA's
philosophy. Let
Americans beware the David Kesslers of the world.
Kenneth
Smith is deputy editor of The Washington Times editorial page.
Comments on this posting?
Click here to
post a public comment on the Trash Talk
Bulletin Board.
Click here to send a private
comment to the Junkman.