Public Health and the Law
Laetrile: Is It Really
a
Matter of Free Choice?
FAY A. SABER, JD, MPH In recent weeks, the news media has given extensive coverage to the so-called "laetrile controversy." Newspapers, magazines, and television programs have reported that laetrile has been legalized by the legislatures in Alaska, Arizona, Florida, and Indiana. One news account reported that a California physician was convicted by a federal jury on charges of conspiracy to smuggle the drug across the Mexican border for distribution in the United States.' In view of this increased awareness about laetrile, it is important to recognize what is at the center of the controversy surrounding this drug. A recent opinion of the United States District for the Western District of Oklahoma highlights the main issues in the laetrile dispute. A terminally ill patient brought a class action suit contending that he, as a cancer victim, could adequately represent the interests of other similarly situated cancer patients. In the suit, the patient sought to enjoin the Food and Drug Administration from prohibiting the importation and interstate distribution of laetrile for use by members of the class action.2 Judge Luther Bohanon found merit in the patient's argument and issued an injunction. The Food and Drug Administration had contended that it was unlawful to place a new drug in interstate commerce without that agency's prior approval of a new drug application (NDA) establishing the drug as safe and effective for its proposed use. The FDA argued that laetrile was a new drug for purposes of the Federal Food, Drug and Cosmetic Act, and that since it had neither received nor approved an NDA, the FDA could ban the importation and interstate transportation of the drug. The court was also urged to find that the FDA had no duty to approve a new drug in the absence of an NDA and that a court could only exercise jurisdiction over a "new drug" after the applicable administrative remedies had been exhausted by a litigant. While the court recognized that FDA had the authority to determine whether a drug required an approved NDA beAddress repnnt requests to Fay A. Saber, JD, MPH, Teaching and Research Assistant, Department of Health Services, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115. This contribution was invited by Professor William J. Curran, who edits and/or writes this column for the Journal. AJPH September, 1977, Vol. 67, No. 9
fore it was sold to the public, it indicated that FDA's power was not without limits. The court stated that where FDA classifies a product as a "'new drug", absent the submission or existence of an NDA, such decision is reviewable by a United States District Court under the Federal Administrative Procedures Act. In an earlier opinion in the case,3 the United States Court of Appeals had held that the FDA was required to produce "substantial evidence" to document its claim that laetrile was a "new drug" and not already generally regarded by qualified experts as a safe and effective drug. The Circuit Court had also found that if laetrile were either placed on the market as a cancer drug between 1938 and 1962 and perceived as safe, or if utilized as a cancer drug between 1906 and 1938 under the same circumstances as currently found, it was exempt from being denoted as a "new drug" under applicable definitions in the Food, Drug and Cosmetic Act. In the lower court, the FDA tried to pursuade Justice Bohanon that even as to drugs marketed before 1962, "effectiveness" as well as "safety" must be demonstrated before a drug could be marketed for the treatment of life-threatening disease. The judge, however, rejected the additional requirement of supplying evidence of a drug's efficacy before it could be approved by FDA. In the instant case, plaintiffs were all terminally ill with cancer and no generally recognized effective form of treatment was available to deal with their life-threatening disease. Thus, to say laetrile could not be marketed until it was proven to be effective, according to Judge Bohanon, left the plaintiffs with no legally permissible form of treatment. What is the impact of Justice Bohanon's decision? By interpreting the 1962 Amendments to the Food, Drug and Cosmetic Act as requiring only evidence of a drug's safety for pre-1938 drugs, the court has greatly diminished the ability of the FDA to keep from the public medications of very doubtful benefit. While the court took care to distinguish the present case on its facts-that all the plaintiffs were terminally ill with cancer-it established a dangerous precedent, and opened the door for other courts to take the further step of permitting the use of ineffective drugs in non-terminal situations where proven therapies, such as radiation or chemotherapy, could arrest or destroy the disease. 871
PUBLIC HEALTH AND THE LAW
One may question as well whether the patient's decision to use laetrile is really a matter of freedom of choice. Is it not, for example, appropriate to envisage this decision as the erosion of authority vested in a governmental agency charged with promoting and protecting the public health? Hopefully, other federal courts will be given the opportunity to review the effects of this decision.
REFERENCES 1. "Laetrile-the man behind the movement." American Medical News, 9-14 April 18, 1977. 2. Rutherford v. United States, Civ. No. 75-0215-B (United States District Court, Western District of Oklahoma, April 15, 1977). 3. Rutherford v. United States, 542 F.2d. 1137 (1Oth Cir. 1976).
Revised Statement Issued-'Prevention of Rheumatic Fever' The Committee on Prevention of Rheumatic Fever and Bacterial Endocarditis of the American Heart Association has recently issued a revised statement entitled "Prevention of Rheumatic Fever" (Circulation 55:1, 1977). This statement covers not only treatment of acute streptococcal infections ("primary" prevention) but also makes recommendations for continuous antibiotic therapy to prevent recurrences of rheumatic fever ("secondary" prevention). Copies of this revised statement are available from the American Heart Association, 7320 Greenville Avenue, Dallas, TX 75231 or from local American Heart Association affiliates.
872
AJPH September, 1977, Vol. 67, No. 9
Laetrile: Is It Really
a
Matter of Free Choice?
FAY A. SABER, JD, MPH In recent weeks, the news media has given extensive coverage to the so-called "laetrile controversy." Newspapers, magazines, and television programs have reported that laetrile has been legalized by the legislatures in Alaska, Arizona, Florida, and Indiana. One news account reported that a California physician was convicted by a federal jury on charges of conspiracy to smuggle the drug across the Mexican border for distribution in the United States.' In view of this increased awareness about laetrile, it is important to recognize what is at the center of the controversy surrounding this drug. A recent opinion of the United States District for the Western District of Oklahoma highlights the main issues in the laetrile dispute. A terminally ill patient brought a class action suit contending that he, as a cancer victim, could adequately represent the interests of other similarly situated cancer patients. In the suit, the patient sought to enjoin the Food and Drug Administration from prohibiting the importation and interstate distribution of laetrile for use by members of the class action.2 Judge Luther Bohanon found merit in the patient's argument and issued an injunction. The Food and Drug Administration had contended that it was unlawful to place a new drug in interstate commerce without that agency's prior approval of a new drug application (NDA) establishing the drug as safe and effective for its proposed use. The FDA argued that laetrile was a new drug for purposes of the Federal Food, Drug and Cosmetic Act, and that since it had neither received nor approved an NDA, the FDA could ban the importation and interstate transportation of the drug. The court was also urged to find that the FDA had no duty to approve a new drug in the absence of an NDA and that a court could only exercise jurisdiction over a "new drug" after the applicable administrative remedies had been exhausted by a litigant. While the court recognized that FDA had the authority to determine whether a drug required an approved NDA beAddress repnnt requests to Fay A. Saber, JD, MPH, Teaching and Research Assistant, Department of Health Services, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115. This contribution was invited by Professor William J. Curran, who edits and/or writes this column for the Journal. AJPH September, 1977, Vol. 67, No. 9
fore it was sold to the public, it indicated that FDA's power was not without limits. The court stated that where FDA classifies a product as a "'new drug", absent the submission or existence of an NDA, such decision is reviewable by a United States District Court under the Federal Administrative Procedures Act. In an earlier opinion in the case,3 the United States Court of Appeals had held that the FDA was required to produce "substantial evidence" to document its claim that laetrile was a "new drug" and not already generally regarded by qualified experts as a safe and effective drug. The Circuit Court had also found that if laetrile were either placed on the market as a cancer drug between 1938 and 1962 and perceived as safe, or if utilized as a cancer drug between 1906 and 1938 under the same circumstances as currently found, it was exempt from being denoted as a "new drug" under applicable definitions in the Food, Drug and Cosmetic Act. In the lower court, the FDA tried to pursuade Justice Bohanon that even as to drugs marketed before 1962, "effectiveness" as well as "safety" must be demonstrated before a drug could be marketed for the treatment of life-threatening disease. The judge, however, rejected the additional requirement of supplying evidence of a drug's efficacy before it could be approved by FDA. In the instant case, plaintiffs were all terminally ill with cancer and no generally recognized effective form of treatment was available to deal with their life-threatening disease. Thus, to say laetrile could not be marketed until it was proven to be effective, according to Judge Bohanon, left the plaintiffs with no legally permissible form of treatment. What is the impact of Justice Bohanon's decision? By interpreting the 1962 Amendments to the Food, Drug and Cosmetic Act as requiring only evidence of a drug's safety for pre-1938 drugs, the court has greatly diminished the ability of the FDA to keep from the public medications of very doubtful benefit. While the court took care to distinguish the present case on its facts-that all the plaintiffs were terminally ill with cancer-it established a dangerous precedent, and opened the door for other courts to take the further step of permitting the use of ineffective drugs in non-terminal situations where proven therapies, such as radiation or chemotherapy, could arrest or destroy the disease. 871
PUBLIC HEALTH AND THE LAW
One may question as well whether the patient's decision to use laetrile is really a matter of freedom of choice. Is it not, for example, appropriate to envisage this decision as the erosion of authority vested in a governmental agency charged with promoting and protecting the public health? Hopefully, other federal courts will be given the opportunity to review the effects of this decision.
REFERENCES 1. "Laetrile-the man behind the movement." American Medical News, 9-14 April 18, 1977. 2. Rutherford v. United States, Civ. No. 75-0215-B (United States District Court, Western District of Oklahoma, April 15, 1977). 3. Rutherford v. United States, 542 F.2d. 1137 (1Oth Cir. 1976).
Revised Statement Issued-'Prevention of Rheumatic Fever' The Committee on Prevention of Rheumatic Fever and Bacterial Endocarditis of the American Heart Association has recently issued a revised statement entitled "Prevention of Rheumatic Fever" (Circulation 55:1, 1977). This statement covers not only treatment of acute streptococcal infections ("primary" prevention) but also makes recommendations for continuous antibiotic therapy to prevent recurrences of rheumatic fever ("secondary" prevention). Copies of this revised statement are available from the American Heart Association, 7320 Greenville Avenue, Dallas, TX 75231 or from local American Heart Association affiliates.
872
AJPH September, 1977, Vol. 67, No. 9
