Saccharin test not flexible enough?

Press, 20 July 1977, Page 19

Saccharin test not flexible enough?

The ban on saccharin by the United States food and drug administration (F.D.A.) has drawn attention to an absurdly tight provision in American law on substances that produce cancer. Under the so-called Delaney clause, any human food proved carcinogenic in animals must be banned. The F.D.A. has no discretion, unless it can question the validity of the research. Some foolproof research in Canada had shown that if rats soaked up saccharin equivalent to a human being drinking 800 saccharinsweetened drinks a day, then one in 12 of the wretched rats developed cancer. The American housewife, unimpressed by this .over-weighting- of rats’ bladders, raided the supermarkets, for all the remaining saccharin she could

find, and the F.D.A. started to tumble backwards.

How ridiculous are such tests? Virtually all chemicals found to be carcinogenic in man are carcinogenic in animals, too. But it is hard to prove that the converse also is true; partly because of the difficulty of establishing cause and effect outside a controlled laboratory experiment (to which people cannot be subjected), and because cancer in people can take 20 years to show.

A better defence of the tests is that the argument from large doses to small ones may not be as shaky as it sounds. It has been shown that even a minute exposure to asbestos, for example, can be dangerous.

But, there are two sound reasons for not banning

saccharin, both based on human “tests.” One is that long-term records of diabetics, who cannot use sugar and therefore consume unusually large amounts of artificial sweeteners, show that they are no more prone to bladder cancer than tire rest of the population. Such records cover a larger sample than a recent, unpublished study linking saccharin with people suffering from bladder cancer.

The other is that the alternative artificial sweetener, cyclamates, is already banned, because that, too, was supposed to give cancer to rats — a conclusion that is now going out of fashion. If consumers switch to sugar, some researchers say they run worse risks still.

To strike the right balance between protecting people and inconveniencing them is hard, and that is why so rigid a law as the Delaney clause is bad. More flexibility is needed also in drug regulation, where a new drug’s benefit to patients may far outweigh its risks. Several studies have related the sharp fall in the number of regulations, and foreigners visiting America are sometimes asked to smuggle in lifesaving drugs available abroad.

In 1948, an expectorant submitted to America’s drug authorities for approval was described in 73 pages. By 1972, a skeletal muscle relaxant involved 456 volumes, each two inches thick. Despite the incredible growth of such safety testing, some danger-

ous drugs still go undetected — probably they always will — and it is now common for new drugs to be tested on a second generation of animals, thus increasing the seven years and slsm it already often takes to put a new drug on the market. High standards are not to be laughed at: they saved the United States from a thalidomide disaster. But they have costs — and not just money costs — as well. Besides the F.D.A., America’s environmental protection agency is heavily involved in carcinogenic testing. Its outgoing acting chief, Mr John Quarles, recently said that Americans must learn to accept some risk of cancer. Judging by the rush there was to buy up stocks of saccharin, they have already learnt. — “Economist,” London.