The Supreme Court entered the Laetrile controversy yesterday by agreeing to decide whether a medicine intended for the dying is exempt from federal law requiring drugs to be safe and effective.
The justices will review a decision by the 10th U.S. Circuit Court of Appeals that the Food and Drug Administration must issue regulations to permit physicians throughout the country to inject Laetrile into the veins of cancer patients "certified" to be terminally ill.
An estimated 50,000 to 75,000 Americans have taken Laetrile, which is derived mainly from apricot pits. Many of them obtained treatment in Mexico, with hotly disputed results.
The substance repeatedly has been denounced as useless by leaders of key units of conventional medicine, including the FDA, the American Medical Association and the National Cancer Institute. Last January, however, the NCI announced the start of an intensive study of patients who claim to have been helped by Laetrile.
The litigation began in 1975, when two terminal cancer victims and their spouses filed a class action suit intended to stop the FDA from interfering with interstate distribution of Laetrile. Later, 17 states, including Maryland, passed laws intended to circumvent the agency. An estimated 100 Maryland residents are getting Laetrile.
As a result of the suit, a federal judge ordered an administrative hearing, which FDA Commissioner Donald Kennedy conducted and concluded in 1977.
One key issue was whether Laetrile was a "drug" under the Food, Drug and Cosmetic Act of 1938. Kennedy ruled that it was, because it was sold for the cure or prevention of disease.
A second issue was whether Laetrile, under 1962 amendments to the law, is a "new drug" -- one "not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed... in the labeling..."
Kennedy ruled that Laetrile was a "new" drug, one that neither experts nor acceptable scientific studies had found to be safe and effective.
He cited "an absence of scientifically sound data upon which experts... could base an opinion that Laetrile is safe" and an absence of any clinical studies of Laetrile's effectiveness," "published or otherwise, which are even arguably adequate or well-controlled."
One key question remained: Was Laetrile exempted by a "grandfather" clause in the 1938 law and the 1962 amendments?
Kennedy held that it wasn't because it hadn't been shown to be of the same formulation before and after enactment of the law and the amendments, because the labeling also varied, because it wasn't on sale on either grandfather date, and because experts generally didn't recognize it as safe on those dates.
In December 1977, however, U.S. District Court Judge Luther L. Bohannon in Oklahoma City ruled that the 1962 grandfather clause exempted Laetrile. He set aside Kennedy's factual findings, saying, "By denying the right to use a nontoxic substance in connection with one's own personal health care, FDA has offended the constitutional right of privacy."
Last July, the 10th Circuit affirmed -- without addressing Bohannon's holdings on the grandfather clause or on privacy.
Instead, Chief Judge Oliver Seth of Santa Fe wrote for the appeals court that "as a matter of law the 'safety' and 'effectiveness' requirements... have no application to terminally ill cancer patients who desire to take the drug intravenously."
In addition, Seth explicitly rejected Kennedy's factual finding that Laetrile has a known but not fully investigated toxicity.
In the successful petition for review, Solicitor General Wade H. McCree Jr. wrote that the decision "seriously limits the commissioner's power to protect the public from unsafe and ineffective drugs" even though confined on its face to intravenous use for terminally ill cancer patients.
The decision "would make it difficult if not impossible for the commissioner... to keep uproven drugs out of the marketplace," McCree contended. And, he said, nothing in the legislative history shows a congressional intent to exempt drugs for the terminally ill from the law's safety and effectiveness requirements.
For the plaintiffs, lawyer Kenneth Ray Coe wrote that "the entire administrative record is bereft of any bona fide evidence that Laetrile is not 'safe'... there is not a single case of an individual being harmed...."
This ran counter to Kennedy's warning that the appeals court decision, if upheld, would lead to "needless deaths" among purportedly "terminal" patients who could be helped by "legitimate" therapy.
Rejecting Seth's assertion that safety and effectiveness are meaningless for the terminally ill, McCree emphasized that to be effective a drug need only live up to the claim made for it, and to be safe it must merely be shown to have benefits, either therapeutic or palliative, that "outweigh any adverse effects of its use; that is,... it will not gratuitously harm the person taking it."