Scared Straight
Review and OutlookBy
Copyright 2000 Wall Street Journal
May 15, 2000
Last Thursday, we woke up to read that people described as "activists"
were up in arms because the government was about to list a chemical as a
dangerous carcinogen. Pinch us if we're dreaming. Since when did the
advocacy community get upset about government waving any chemical into its
restrictive embrace? The answer is, since the chemical involved is one that
benefits them directly. Welcome to the real world.
The controversy is over tamoxifen, the drug that has become the first
line of defense against the recurrence of breast cancer as well as a
preventative measure for women at high risk. Tamoxifen is considered by
many doctors to be among the greatest advances in cancer therapy in 50
years. Today, the government is expected to add it to its official list of
carcinogenic chemicals, alongside the likes of mustard gas.
Tamoxifen's risks have been amply documented. Women who take it have an
elevated risk of uterine cancer. The question here isn't whether tamoxifen
has side-effects but whether reasonable people can make informed choices in
difficult moments.
Doctors have been discussing the risk of endometrial malignancies with
women taking tamoxifen for years. Its carcinogenic qualities were discussed
when it was first being tested as a preventative measure, with some
questioning whether it was an appropriate risk for healthy women to take.
Today's treatment regimens are based on a balancing of risks and benefits
that emerged from this process.
Tamoxifen is hardly the first cancer-fighting agent to be associated
with causing another cancer. The use of standard chemotherapy in lymphoma
patients has long been associated with an increased chance of developing
leukemia. These are calculated risks. In the case of tamoxifen, uterine
cancer is the lesser of two evils -- easily treatable when found early, and
significantly more survivable than breast cancer.
The Report on Carcinogens, created by an act of Congress in 1978, has
always been vulnerable to political uses. Environmental groups have used
the list to stir up public fright over pesticides, using dubious methods to
get them classified as "probable human carcinogens," then leaving them on
the list for years without further efforts to validate their concerns.
Substances such as saccharine have languished there despite weak evidence.
In many cases, a chemical's supposed carcinogenicity in humans was
extrapolated from feeding staggering doses to animals. The fact is that
virtually anything can become toxic in sufficiently large amounts.
Since tamoxifen was introduced over 20 years ago, breast cancer care has
improved enormously. Tamoxifen itself is known to cut the rate of
recurrence in breast cancer patients by 40% to 50%. The effect of lists
like the Report on Carcinogens shouldn't be underestimated. While they stop
short of outright regulation, they give an official taint to a drug that
would otherwise be rationally weighed against its potential side-effects
under a doctor's supervision.
Since the World Health Organization added tamoxifen to its list of
cancer-causing agents, many women have backed away in fear. Cancer centers
and women's groups are quite reasonably worried that if the scary
classification shows up on the hopelessly underreported evening TV news
show, it will deter women from taking a potentially life-saving drug. And
any such government classification becomes fodder for bottom-feeding
class-action lawsuits.
The crudeness of the carcinogens list makes little sense in an
information age whose consumers are clicks away from the kind of
information once available only to the experts. Last year, Bernard Schwetz,
one of the FDA's own top scientists, told a Toxicology Forum that the
Report on Carcinogens does nothing but confuse consumers and waste FDA
resources. He singled out tamoxifen as a potential casualty of the
system.
Of course no matter how much effort science makes to reach rational
conclusions about a tamoxifen, a drug such as this will never shake free of
one big problem -- it's made by a publicly traded company. Ergo, Naderite
groups like Public Citizen have been agitating to get tamoxifen on the
FDA's carcinogen list. The arguments against always come wrapped in the
language of science, but as Dr. Gilbert Ross of the American Council on
Science and Health puts it, these groups are driven by "an ideological
contempt for corporations."
Unlike other malignancies -- like skin or lung -- risk factors for
breast cancer are not easily controlled. Tamoxifen is the first drug to tip
the game back in women's favor. We're glad to see some activist groups
opening their eyes to the real life repercussions of political
fear-mongering that result from trying to put a good product on a bad
list.
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