Monday, Oct. 09, 1978

Apricot Power

Washington to test Laetrile

At a briefing for National Cancer Institute staffers in Washington last week, Director Arthur Upton reviewed the NCI's progress and goals, and then quietly dropped a bombshell: the institute plans a $250,000 test on humans of the controversial cancer drug Laetrile.

While the decision spread joy through the ranks of the highly vocal Laetrile supporters, who for 15 years have been urging the NCI to test the drug, Upton's decision was apparently due more to political pressure than to scientific evidence. Laetrile promoters claim that some 70,000 cancer victims are using the apricot-pit-based substance in the U.S., despite a federal ban on interstate shipments, and have succeeded in recent years in getting 17 states to legalize its use. They scored another success recently when the U.S. Court of Appeals ruled that terminally ill cancer patients could procure the injectable form of Laetrile for personal use. Nevertheless, scientific proof that the drug works is lacking.

As pressure continued to mount, the NCI last January asked the nation's doctors for any data on patients who seemed to have had a beneficial effect from Laetrile. The response was hardly overwhelming. Out of thousands of cancer victims treated with the substance, data were submitted for a total of 93 cases. Only 22 of these cases were submitted with sufficient information and involved patients who had been treated solely with Laetrile during the time of evaluation. Of these, nine stayed the same, seven got worse, and only six showed improvement. In four of the six, tumors shrank more than 50%. Two had complete remissions; their cancer disappeared.

Under ordinary circumstances such scanty evidence would have made little impact upon the NCI. Even in cancer victims who have had no treatment, tumors occasionally shrink and even disappear--possibly because the victims' immune systems become reinvigorated. Thus, in the two submitted cases, Upton says, "there was no way we could conclude confidently that remission resulted from Laetrile." Furthermore, in most laboratory tests, Laetrile has had no effect on animals with cancer--the reason that the NCI has given in the past for refusing to begin testing of humans. Still, the increasing political pressure apparently had its effect on an NCI advisory panel of doctors and scientists, who earlier in the week voted 14 to 11 to recommend clinical testing. Upton's announcement endorsed that recommendation. Said he: "I think, by virtue of the fact there are thousands now using Laetrile and we have this evidence--as inconclusive as it may be--that we are justified. If the trial can settle the issue, I don't think it would represent a misallocation of resources."

The six-month trial, to begin in January, will involve at least 300 patients with advanced cancer that has not responded to other treatment. Each patient will sign a consent form. Says Upton: "We would not foist Laetrile on any unknowing patient." Still to be worked out is whether Laetrile will be given alone or, as some proponents advise, in combination with other metabolic therapies such as high-dose vitamins, minerals and diet changes. Since preparations of the drug are known to vary, NCI will formulate and distribute the Laetrile to be used.

But before the trial begins, the experimental plan must be filed for approval with the Food and Drug Administration, whose commissioner, Donald Kennedy, has in the past called Laetrile a "fraud" and "useless." Nevertheless Kennedy too would doubtless like the Laetrile monkey off his back, and he is expected to approve the plan.

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