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.