Laetrile and the FDA: a case of reverse regulation.

Journal of Health Politics, Policy and Law

Laetrile and the FDA: A Case of Reverse Regulation John F. Cannizzaro, and Madelon M Rosenfeld, Capital University Law School

Abstract. After presenting a historical background, this paper examines several legal facets of the Laetrile controversy: the “new drug” designation and grandfather clause exemption; the notion of harm and its relationship to freedom of choice; the “informed consent” concept; the reliance on “expertise”; and issues involved in the burden of proof and the determination of jurisdiction over litigation. The authors conclude generally that Congress should act on the Laetrile question and they propose specific guidelines for such legislation, as well as for the appropriate role of the Food and Drug Administration.

Introduction

Laetrile, or amygdalin,’ has been heralded as a cure for cancer and criticized as a potentially tragic hoax. The opponents of Laetrile contend not only that it is worthless against malignant cells, but that its sale is in direct violation of the Food and Drug Administration’s (FDA) regulations pertaining to the status of new drugs. Acquiring amygdalin through interstate commerce for its use in cancer treatment is currently illegal under federal law.3 As of this writing, however, nineteen states have legalized Laetril for use by cancer patients. In determining whether a substance which has neither been proven scientifically beneficial nor harmful in cancer therapy should be denied to patients, one must go beyond the question of whether the substance is effective. The regulations pertaining to the status of new drugs appear to be in direct confrontation with fundamental principles of constitutional law, as evidenced by a close reading of the pertinent cases and provisions of the 1962 amendment to the federal Food, Drug and Cosmetic I . Historical perspective

A . Case IQw status. Although Laetrile has been tested and used since 1949,6 only recently has it gained national recognition. Previously, the drug and the controversial issues accompanying it were well-contained by the administrative agency which controlled its legal life. The current atmosphere of distrust for those in authority, combined with increased 181

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right of privacy demands,’ however, are factors which have made Laetrile a divisive legal issue. The line of cases initiated by Glen Rutherford illustrates the background of litigation surrounding Laetrile. Briefly, these cases concern the struggle of one man, on behalf of cancer patients nationally, to import the drug for personal use in cancer therapy. Glen Rutherford, a resident of Witchita, Kansas, was diagnosed as having cancer of the colon in November, 1971. He was advised that surgery was the traditional therapeutic course. Rutherford refused to follow his physician’s advice and instead proceeded with Laetrile treatments in Tijuana, Mexico. Upon bringing Laetrile back into the United States for his own use, consistent with the therapeutic regime prescribed in Mexico, Rutherford’s Laetrile was seized by the FDA.8 He subsequently brought suit to enjoin the FDA from interfering with importation of Laetrile. The district court in Rutherford v. United States held that Rutherford’s Fifth Amendment due process rights were violated by the New Drug Application requirements of the federal Food, Drug and Cosmetic Actlo and by the FDA’s failure to make a proper determination of Laetrile as an effective method of cancer treatment. ’ On appeal, the Tenth Circuit Court of Appeals never addressed the Fifth Amendment question, but remanded the case with instructions to the FDA to produce an adequate record.12 On remand, the district court upheld its initial grant of an injunction against the FDA and reaffirmed the court of appeals’ instruction for a compilation of the administrative record.13 The fourth Rutherford case certified the cause as a class action and specifically restricted the class capable of importing Laetrile for personal use. The class was to consist of all terminally ill cancer patients. l4

B. Statutory status. The legal issues affecting Laetrile pertain to the drug’s classification, both presently and historically. The Food and Drug Administration views Laetrile as a “drug,” specifically a “new drug,” whereas the proponents of the compound disagree and claim that Laetrile should be viewed as a good supplement.1s The federal Food, Drug and Cosmetic Act (hereinafter cited as the Act) indicates that even a food supplement may be considered a drug if its intended use is the diagnosis, cure, mitigation, treatment or prevention of disease in man or animal. l 6 Therefore, measured against this standard and in view of the product’s therapeutic claims, there is no doubt that Laetrile fits into the “drug” classification. II. The grandfather clause exemption One aspect of the controversy is whether Laetrile should be classified as a “new drug.” The Act provides that a “new drug” is any drug which Published by Duke University Press


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is not generally recognized by experts as both safe and effective for its intended use. l 7 Several laboratory studies conducted with Laetrile indicate that the drug has no therapeutic effect in the treatment of cancer.18 The Laetrile proponents are attempting to circumvent the impact of this type of scientific data by claiming that Laetrile should not be considered a new drug. Their claim for exemption is based on the “grandfather clause exemption”lg which provides that a substance will not be regarded as a new drug if at any time prior to 1962 it was subject to the federalFood, Drug and Cosmetic Act of 1906, as amended.20The effect of this provision is to create a twolfold exemption capable of removing Laetrile from the new drug category. The first part of the exemption deals primarily with the pre-1%2 standard which only required the proponent of a new drug to introduce evidence as to its safety.21The 1962 amendments incorporated this aspect of the law into the transitional provisions. These provisions allow a drug to escape classification as a “new drug” if on the day immediately preceding the enactment of the Act, the drug was commercially sold or used in the United States, was not a “new drug” as defined by the act then in force (which only required proof of safety)22and was not covered by an effective new drug a p p l i ~ a t i o n . ~ ~ The second part of the two-fold exemption provides that a drug will not be classified as a “new drug” if at any time between 1906 and 1938 the drug was recognized or used with the same labeling and representations as currently p r e ~ c r i b e dThis . ~ ~ provision of the exemption would not apply in the case of Laetrile, since Laetrile was not made safe for human use until 1949.25In view of the labeling and representation requirements, it would be difficult for the proponents to show that the requirements of the pre-1949 form are the same as those of the present substance. The first part of the exemption, however, provides a possibility for removing Laetrile from the “new drug” status. This part requires that the proponents prove their product’s safety for its intended use prior to 1%2. Little evidence exists to show that Laetrile was ever used on a commercial scale in this country or that it ever gained general recognition as being safe.26 Apparently, Laetrile only fulfills the third requirement which states that no new drug application need be effective with respect to the drug. Therefore, the grandfather clause exemption provides little hope for removing Laetrile from the ambit of the statute. The discussion thus far has been limited to the statutory view of the problem. However, another aspect of the Laetrile controversy deals with the extra-statutory dispute over whether Congress ever had the power to impose efficacy requirements. The 1962 efficacy amendment undoubtedly was intended to insure consumers that the product being purchased produced the effect claimed. A difficulty arises when no claim of efficacy is made for a product other than that it is safe. Whether a product can Published by Duke University Press


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make no claim and still be made available appears to depend upon the level of consumer protection that the people desire. When dealing with chemical compounds the view has justifiably been one of caution. The question then becomes whether Congress may properly correlate ineffectiveness with lack of safety. In 1962 the feeling apparently was that such a correlation was proper, at least when drugs were involved. Today, the correlation may still be justifiable, however, consideration must be given to the nature of the harm being proscribed. III. Concept of harm and freedom of choice

A discussion of the safety and efficacy requirement prior to the 1962 amendment and the encompassing concept of efficacy as safety (where an ineffective drug is deemed unsafe) following the addition to the Act, would be incomplete without a companion discourse on the inclusive concept of harm. According to Dr. Jay Katz, a physician and faculty member of the Yale University Law School, “our concept of harm is much too narrow” and excludes the more important issues of selfdetermination, privacy, and psychological integrity.27Thus, harm cannot be limited to the traditional concept of physical intrusion. Although Dr. Katz’s specialty lies in the field of human experimentation, his comments on harm are enlightening. Glen Rutherford aptly characterized this view of harm when he sought relief under the Fifth Amendment from the provisions of the Act. Submitting that the FDA’s regulations made it impossible for the common man to obtain a new drug application due to the cost involved, and that he was not free to purchase Laetrile in the United States or have the substance shipped to him, Rutherford argued in his first case that he was being denied his freedom of choice by the FDA, and that as a result he was harmed.28 When the Supreme Court was confronted by a similar problem in Abbot Laboratories v. Gardner,29 comments were made in reference to the type of action a citizen could bring against the Secretary of the FDA if such citizen was aggrieved (harmed) by any order of the Agency. In that case the petitioners sought a pre-enforcement judicial review of an act of the FDA. The Supreme Court, citing the Congressional Record,30 said that “any citizen aggrieved by an order of the secretary, who contends that the order is invalid, may test the legality of the order by bringing an injunction suit against the secretary, or the head of the Bureau, under the general equity powers of the The Supreme Court has also found a correlation between harm and the violation of the right of Where a person’s rights to privacy and self-determination were violated, as in the case of the denial of a pregnant woman’s right to demand an abortion, such a person was undeniably harmed.33 In Doe v. Commonwealth’s Attorney for City of Richmond,34 Published by Duke University Press


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District Judge Merhige’s dissenting opinion espoused the rights of individuals to make personal choices “unfettered by arbitrary and purposeless restraint^.''^^ Judge Merhige found these rights in the due process clause of the Fourteenth Amendment. In commenting on both the issues of abortion and birth control in reference to the right of privacy, Judge Merhige went on to state that “Roe and Eisenstadt . . . cogently demonstrate that intimate personal decisions on private mutters of substantial importance to the well-being of the individuals involved are protected by the Due Process Clause.”36 Nothing states this view quite as succinctly as Glen Rutherford’s vociferous statement, that “nobody has the right to tell me what therapies I have the right to die by.”37 A California Court of Appeals also dealt with the Laetrile issue on a right to privacy basis in People v. Privitera.38 The court found that the patient had a right to receive medical treatment prescribed by his physician. The court further held that California had failed to show a compelling state interest supporting its statute prohibiting the sale, prescription or administration of any drug not approved by the FDA or a state board. Such a compelling state interest would have to be shown in order to justify an infringment on a patient’s fundamental right to privacy.39 The court thus upheld the patient’s right to control his own body.40 In so holding, the court determined that this right encompasses the right to choose unorthodox treatment. This decision provides a powerful supporting argument to Laetrile proponents and their physicians. The court, however, fell short of allowing unregulated Laetrile distribution by suggesting that the compelling state interest burden might be met by an express legislative finding that “ineffective cancer remedies are more hazardous to the patient than the state-sanctioned alternatives. ”41 Contrary to the Laetrile proponents, however, the American Medical Association (AMA) and the FDA vigorously contend that when dealing with a life threatening disease such as cancer, an ineffective drug cannot be deemed a safe drug because its use would result in considerable “harm” to the patient.42In December 1976 the House of Delegates of the AMA adopted a resolution which stated in part, “the use of amygdalin . . . exploits the victims of malignancies and their families by preying upon the emotions of the hopelessly ill. . . .”43 In reference to the freedom of choice argument, the opponents of Laetrile argue that the mental state at the time the choice is made must not be overlooked. The concept “of posing to a patient the idea of accepting cutting, burning, and poisoning versus a bland, natural, harmless substance with the underlying thought . . . that this will cure him would be no choice for most people in this situation. . . .”44 Therefore, it is speculative whether the entire freedom of choice argument is viable when juxtaposed with the finality of a terminal diagnosis. Published by Duke University Press


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Journal of Health Politics,Policy and Law

N.Informed consent The idea of “informed consent’’ proposed to relieve physicians of liability for the prescription or administration of amygdalin in lieu of, or in addition to, customary modes of therapy also presents several problems. Although the informed consent criterion has been included in both the Indiana l e g i s l a t i ~ nlegalizing ~~ Laetrile and the proposed Ohio bill,46 neither makes provisions for minors nor those unable to give an intelligent informed consent. The difficulty with the consent issue has recently surfaced in the Florida courts.47There, a trial court judge removed a four year old leukemic girl from her parents’ custody when they had decided to take her off chemotherapy and initiate Laetrile treatments instead. Although Florida has legalized Laetrile ,48 the minor’s physician was able to transfer the girl to the custody of the child protection service and there reinstate chemotherapy, by proceeding on a child abuse This theory is premised on the concept that removal of a child from an accepted and apparently successful mode of medical treatment to an untested mode constitutes child abuse. Since the United States Supreme Court has never ruled on whether there is a constitutional right to medical treatment,50 it would appear that the Florida court obtained precedent for its action from the controversial Jehovah’s Witnesses cases. In these cases, the courts have authorized the traditional medical practices despite the parents’ personal preferences where the life of a child is at Although the parents have not pursued the matter further judicially, the Florida court’s ruling could be viewed as a violation of the fundamental rights of parents to raise their children,52 as well as a sanctioning of one particular mode of medical treatment over another. 53 V. Concept of expertise The concept of expert judgement also appears in the 1962 amendment and its grandfather clause e ~ e r n p t i o nand , ~ ~is as elusive as the notion of harm. Those drugs are exempted which on the effective date of the amendments have achieved general recognition among the experts as safe for intended purposes. In an article illuminating the problems of scientific expertise and its associated value judgments, attention is drawn to the problem of the generalization of expertise as one of “confusing expertise in technical knowledge of a given scientific area with knowledge of what is morally required in that area.”55 This conflict is clear in the Laetrile controversy. The cases dealing with Laetrile specifically point out the problems which have arisen pertaining to the regulation of new drugs. These controversies are intertwined with the public’s demand for freedom of choice in medical prescriptions and therapies. Resolution of the moral issues which continue to be debated is sought from the community of



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experts. The issue is whether the evaluation of safety and eficacy for drugs in general and Laetrile specifically should reside solely with the health care professions and their correlative agencies or whether the eventual beneficiaries of the drug in question should be allowed to participate in the decision making process that determines a drug’s legal status. This determination appears inseparable from the problems involved with the concepts of harm and freedom of choice. A recent editorial in reference to Laetrile admonished physicians to “resist the naive advocacy of some laymen and two or three journalists because their proposals would lead to a complete breakdown in faith in the labeling of drugs.”56 Another editorial referred to the potential of destroying science and the confidence placed in scientific medicine*by permitting the clinical use of Laetrile through state legislation.5 7 The writer stressed the evils of allowing “emotion to overrule common sense” and spoke of “a dangerous course to be avoided of which only physicians can tell the public what it is.”58 The exclusive role of the expert, however, in molding public policy appears to be undergoing a change. Franz J. Ingelfinger, M.D.,editor of the New England Journal of Medicine and himself a cancer patient who has unequivocally stated that he would not take Laetrile under any circumstances nor recommend it to his patients, recently wrote that perhaps “an evaluation should be made by a lay-professional group” broadly representative of society and “not by committees appointed by the FDA or AMA.”59 Lewis Thomas, M.D.,president of the Memorial-Sloan Kettering Cancer Center, also voiced strong support for testing amygdalin. He recently told reporters, “I think proper clinical trials have to be undertaken and a special committee should be established to review the results of these programs and that this committee should be comprised of both professional and laymen.”60 Dr. Thomas went on to state that Memorial-Sloan Kettering was prepared to undertake clinical trials of Laetrile if asked to do so by the National Cancer Institute or the FDA. The National Cancer Institute, however, has plans to undertake its own clinical test. This test will be under the scrutiny of both lay and scientific citizens and will be conducted under appropriate “blind” conditions.? It thus would appear that the structure of scientific decision making is evolving to include both the lay person and the expert. Although the opponents of Laetrile argue that amygdalin is not generally recognized among experts as safe and effective for its intended use, its proponents cite a study conducted at Memorial-Sloan Kettering Institute.62This study, which has never been duplicated, recognized the eficacy of amygdalin in reducing metastasis to the lungs in mice induced with malignant breast cancer cells. The question then arises as to which



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“experts” are to be relied upon. The FDA may refuse approval of a new drug application if there is no “substantial evidence” that the drug is effective for its intended use.63 It is clear that congressional intent in requiring substantial evidence of eflicacy for the drug’s intended use before a new drug application can be issued would place the burden of proof on the applicant. VI. Burden of proof and jurisdiction Nonetheless, the proponents of Laetrile have recently been successful in enjoining the FDA from seizing the controversial substance when it is a part of interstate commerce. In Ruthe$ord v. United a district court judge ruled that until the FDA had compiled an adequate record to support its classification of Laetrile as a “new drug,” the plaintiff could not be prohibited from importing it for his own personal use. In affrrming the district court’s decision, the court of appeals added that the FDA would have to present “substantial evidence” to support its determination that Laetrile is not generally recognized as “safe and e f f e ~ t i v e . ” ~ ~ The administrative record requirement espoused by the court provides no surprises for the FDA. As a government agency, the FDA was already subject to statutory guidelines which proscribe capricious or arbitrary action. The Judicial Review Act requires that an agency compile an administrative record that can be used as a basis for determination by a court of review.66 Although the FDA may make a declaratory order determining a drug to be a “new drug,”67 a district court responding to a plaintiff‘s request for the equitable remedy of injunction may review the order and require a strict accounting by the a g e n c y F Therefore, the request by the district court for an administrative record was totally consistent with accepted agency procedures and statutory provisions. The court of appeals decision, however, which shifted to the FDA the burden of proving by “substantial evidence” a drug’s safety and efficacy, finds no support in the Food and Drug Act. The provisions of this Act specifically require that the proponent of a drug should be the party to introduce evidence which substantiates the product’s claims. This evidence is to consist of adequate and well-controlled investigations. 6 9 There is nothing in the statute to suggest that the FDA must prove by substantial evidence that a drug is not safe and effective. This aspect of the court’s ruling essentially ties the FDA’s hands. The court’s decision in effect converts the FDA from a consumer protection agency to a drug research group, and that is definitely contrary to congressional intent. The FDA is a consumer protection agency, not a testing, or primary research agency.7oThe Agency was selected by Congress to administer the Food, Drug and Cosmetic The 1%2 amendments to the Act




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extend the authority of the FDA to scrutinize and evaluate new drugs for effectiveness as well as safety.72According to the Act, the FDA does not have to “prove” that a particular substance is safe and effective, but rather the seeker of a new drug application must come forward with the “substantial evidence” as required by the amendments. 73 In his opinion, Justice Doyle of the Tenth Circuit Court of Appeals spoke of the “obligation” of the FDA to substantiate the safety and efficacy of Laetrile as a new drug.74By placing the burden of proof upon the FDA, Justice Doyle set precedent, the implications of which threaten the basic structure of the bureau as a regulatory agency. The court’s ruling, however, does point out a significant weakness in the statute. Congress structured Title 21 with the impression that drug proponents by their own initiative would move to obtain a new drug application and submit evidence capable of providing the FDA with enough information by which to render a proper d e t e r m i n a t i ~ nAs . ~ ~a result, the statute does not adequately deal with situations in which no new drug application (NDA) was ever in effect. The consequences of such a deficiency are to generate needless judicial decisions aimed at providing procedures and guidelines for the non-NDA plaintiff. The most recent decision in the Glen Rutherford cases concerning the results of the Laetrile hearings strikes a severe blow to the FDA. The opinion permanently enjoins the FDA from interfering with the importation of Laetrile by cancer patients? Although his intentions are noble, it would appear that Justice Bohanon arrived at his conclusions through circular reasoning. Quite simply, Justice Bohanon avoided the “new drug” issues by arbitrarily ruling that Laetrile was not a “new drug.” Based on unfounded evidence, the decision determined Laetrile to have beengenerally recognized by experts as safe for its intended use in cancer therapy prior to 1962, thereby avoiding the necessity of proving the drug’s effectiveness. These conclusions cannot be substantiated by a reading of the Laetrile hearings transcript. First, the testimony offered was not given by scientific “experts” qualified to determine the drug’s safety. 77 Secondly, nothing in the hearings supports Justice Bohanon’s conclusion that Laetrile was marketed and “generally” recognized as safe prior to 1962. Not even under the old standard where a proponent had to show safety by apreponderance of the evidence78could it be said that the present evidence suffices. There exists little doubt that the present ruling was predicated upon the earlier ruling of the court of appeals, which erroneously shifted the burden of proof to the FDA.79 These decisions have placed the FDA in the difficult position of having to prove by hearing that any substance which existed prior to 1962 was not marketed and generally recognized as safe. The necessity of having to prove a negative imposes an unbearable burden which neutralizes the FDA’s function as a



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drug regulatory agency. This recent ruling demonstrates even more clearly that a proper resolution of the Laetrile problem must come from Congress. The difficulties which result extend even as far as determining which court will have jurisdiction to review the claims. According to the statute, the power of review is granted to the courts of appeal in cases where the agency has made a determination based upon the data submitted.80 However, where no NDA has ever been in effect and the proponents seek injunctive relief, the district court would claim jurisdiction.81 The FDA has primary jurisdiction to determine whether a substance is a “new drug;” however, the agency does not have unbridled discretion in this matter. The state provides an administrative hearing and a court review system for reevaluating FDA’s decisions.82 Yet, despite these guidelines, the pervasiveness of the FDA’s authority remains questionable. As a federal agency whose powers have been delegated by Congress, the FDA regulates products that flow in interstate commerce. The agency has no control over goods transported and sold i n t r a ~ t a t e In . ~ ~order to circumvent the FDA’s authority, several states have recently enacted legislation legalizing the use of Laetrile within their Most of the states which have done so, however, do not possess the raw materials necessary for Laetrile’s manufacture. The necessarily resulting importation of the components would bring the entire process back under federal regulation. Drug regulation, however, has historically been an area requiring national uniform legislation. Although Congress did not specifically state that the Act would pervade the entire area of legislation, the need for such preemption is evident. 85 Conclusion Resolution of the Laetrile question alone will not prevent similar problems from arising. The difficulties lie not in the FDA heirarchy, but in the wording of the statute which outlines the agency’s authority. The extent of a regulatory agency’s powers should not be a matter left to judicial interpretation. Congress should move quickly to alleviate the diffkulties which the Laetrile controversy has so undeniably shown to exist. The area of dispute demonstrated by the Laetrile struggle has centered around a cry of freedom of choice. Such an argument has been effective because the statute fails to consider various constitutional guarantees of the eventual beneficiaries. The resolution of the Laetrile problem, as well as similar future problems, must come from Congress. The current statute should be amended to provide for those deficiencies which have arisen in the Laetrile issue.




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When reviewing the statute for possible alterations, Congress should consider the following suggestions: (1) Congress should eliminate the grandfather clause exemption. (2) All drugs which the FDA considers consistent with the statute should be published and the list should be revised periodically to reflect current research developments. (3) Special provisions should be made to allow terminal patients access to drugs which are consistent with their therapeutic regimes, regardless of whether they have been proven effective. Since a terminal patient is by definition one for whom science has been unable to find a suitable cure, no drug could possibly be both safe and effective. Therefore, no justification appears reasonable for denying these patients access to yet unproven ineffective drugs. All developments resulting from the use of these drugs should be documented and the results made available to the general public. If there are indications of potential success regarding effectiveness, then consideration should be given for making the drug generally available. (4) The FDA should have greater access to research institutions, universities and hospital research centers who will substantiate the test results received from organizations seeking distribution permits for new products. The FDA should not be required to depend upon the reliability and integrity of organizations which it is designed to regulate. Should Congress choose not to revise its statutory scheme, the final determination would have to be made by the United States Supreme Court. In doing so, the Court will inevitably be required to balance the ever emerging right of privacy with Congress’ power to legislate for safety and efficacy. A potential resolution of this dilemma would be to allow Congress the power to legislate safety, labeling and the representations made with respect to effectiveness, rather than regulating effectiveness itself. Although many resolutions are possible, this suggestion appears to provide an equitable result. Implementation of these suggestions would return the FDA to its former status as a vital and potent consumer protection agency. Federal statutes to protect the American public should be drafted with the constitutional rights of the people in mind. Overregulation is not the proper resolution to any problem; however , regulation which balances Congress’ protective intekests with the public’s constitutional rights should become the goal of every legislator. When an issue such as Laetrile invades the social, legal and political arenas, the eventual outcome, as predicted by the British Medical Journal, will be that “the Lawyers will become richer, the patients poorer, and the law an ass.’’86




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Notes 1. T. H. Jukes, “Laetrile for Cancer,*’Journalof the American Medical Association 236 (September 1976): 1284. The chemical amygdalin is hydrolyzed by a beta-glycoside and the hydrolysis yields dextrose (a sugar), benzaldehyde (a mild anaesthetic) and hydrogen cyanide (a poison). Originally, the promoters of Laetrile claimed that the hydrolyzing enzyme was only present in the cancerous cells. Supposedly, when the amygdalin was carried into the carcinogenic cells, the enzyme was to react with the arnygdalin to release hydrogen cyanide, which eventually was supposed to destroy the cell. This theory was soon abandoned, however, when investigations indicated that little, if any, cyanide releasing enzyme was present in the cancerous cells. J. R. DiPalma, ‘‘Laetrile: When Is A Drug Not A Drug?,’’ American Family Physican 15 (January 1977): 1867. 2. The FDA regulations pertaining to the status of new drugs are promulgated under 21 U.S.C. § 321(p) (1970), which provides: The term “new drug’’ means(1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is 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, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a “new drug” if at any time prior to the enactment of this chapter [June 25, 19383 it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or (2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations,been used to a material extent or for a material time under such conditions. 3. 21 U.S.C. § 355(a)(z)(1970)which provides: No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) is effective with respect to such drug. 4. Alaska, Arizona, Delaware, Florida, Illinois, Indiana, Louisiana, Nevada, New Hampshire, New Jersey, Oklahoma, Oregon, Texas and Washington. 5 . 21 U.S.C. $5 1-392 (1970). 6. American Medical News, April 18, 1977, p. 9. 7. People v. Privitera, 141 Cal. Rptr. 764 (Cal. App. 1977). 8. Rutherford’s importation of Laetrile was alleged to be in violation of 21 U.S.C. 5 355(a) (1970).

9. 399 F. Supp. 1208 (W.D. Okla. 1975). 10. 21 U.S.C. § 355(b) (1970), which provides: Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such person shall submit to the Secretary as a part of the application (1) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (2) a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (5) such samples of such drug and of the articles used as components thereof as the Secretary may require; and (6) specimens of the labeling proposed to be used for such drug. 11. The court erroneously stated that the FDA failed to make a determination regarding Laetrile’s status, The federal Food, Drug and Cosmetic Act, 21 U.S.C. 9 355(c) (1970), however, does not require the FDA to make any determination until a new drug application has been submitted. 12. Rutherford v . United States, 542 F. 2d 1137 (10th Cir. 1976). 13. Rutherford v. United Stares, 424 F. Supp. 105 (W.D. OWa. 1977).



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14. Rutherford v . United States, 429 F. Supp. 506 (W.D. Okla. 1977). 15. See Hanson v . United States, 417 F. Supp. 30 (D. Minn. 1976). 16. Gadler v . United States, 425 F. Supp. 244 (D. Minn. 1977); 21 U.S.C. § 321(g)(l)(B) (I 970). 17. 21 U.S.C. § 321(p) (1970). 18. G. J. Hill, et al., “Failure of Amygdalin to Arrest B16 Melanoma and BW5147 AKR Leukemia,” Cancer Research 36 (June 1976): 2102-7; see note 1, DiPalma 186-7; American Medical News, April 1 1 , 1977, p. 15. 19. 21 U.S.C. § 321(p) (1970) provides: (1) . . . except that such a drug not so recognized shall not be deemed to be a “new drug” if at any time prior to the enactment of this Act [June 25, 19381it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use. . . . 20. See note 12. 21. Act of 10 October 1962, Pub. L. 87-781, § 102(a)(l), which includes the requirement of efficacy as well as safety. 22. See note 17. 23. An effective “New Drug Application” is the permission obtained from the FDA to market a new drug after the promoter has submitted substantial evidence as to the drug’s safety and efficacy. 24. 21 U.S.C. P 321(p)(l) (1970). 25. See note 6. 26. Editor Interview, “Laetrile: Focus on the Facts,’’ CA-A Cancer Journal for Clinicians 26 (January 1976): 50. 27. R. Restak, “Premeditated Man,’’ Bioethics and the Control of Future Human Life 138 (1975). 28. See note 9. 29. 387 U.S. 136 (1%7). 30. 83 Congressional Record 7892 (1938). 31. 387U.S. 143. 32. Griswold v . Connecticut, 381 U.S. 479 (1%5). 33. Roe v. Wade, 410 U.S. 113 (1973). 34. 403 F. Supp. 1199 (E.D. Va. 1975). 35. 403 F. Supp. 1203. 36. 403 F. Supp. 1204 (emphasis added). 37. Laetrile Administrative Rule Making Oral Argument, FDA Docket No. 77N-0048 (1977). 38. See note 7. 39. 381 U.S. 479 (1965). 40. See Schloendorffv. Society of New York Hosp., 211 N.Y. 125, 129, 105 N.E. 92, 93 (1914), in which Judge Cardozo made his statement, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body . . . .” 41. 141 Cal. Rptr. 783 [citing People v . Privitera, 55 Cal. App. 3d 39, 52, 128 Cal. Rptr. 151, 159 (1976) (emphasis deleted)]. 42. See note 12, 1142 n.5. 43. “Resolution of the AMA: If Your Patients Ask About Laetrile,” Resident and Staff Physician 23 (June 1977): 111. 44. See note 37 (discussion of B. Morrison). 45. Indiana House Enrolled Act 1405, 100th Indiana General Assembly, First Regular Sess. (1977-78). 46. H.B. 650, 112 Ohio General Assembly, Regular Sess. (1977-78). 47. The name of the case dealing with this issue has been withheld by the Florida courts since the matter deals with the rights of a juvenile. 48. Florida House Enrolled Act No. 786, Fifth Leg. of the 1968 Revis., First Regular Sess. (1977). 49. Jehovah’s Witnesses of Washington v . King County Hosp. 278 F. Supp. 488 (W.D. Wash. 1%7); New Jersey v . Perricone, 37 N.J. 463, 181 A.2d 751 (1%2).



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50. The Court’s avoidance of this issue is demonstrated by the ruling in O’Connor v. Donaldson, 422 U S . 563 (1975). 51. See note 49. 52, People ex re1 Kropp v . Shepsky, 305 N.Y.S. 465, 113 N.E.2d 801 (1953). However, a recent unreported New York case which deals with a parents’ preference for Laetrile for their child has seen the court accept supervision over the child’s Laetrile therapeutic regime. This is significant in that New York has not legalized Laetrile. Columbus Dispatch, December 11, 1977 p. 15. 53. The state’s action in this case may be viewed as an extension of the “parens patriae” theory espoused by the United States Supreme Court in O’Connor v. Donaldson, 422 U.S. 563 (1975). 54. See note 17. 55. R. M. Veatch, Generalization of Expertise, 2 Hustings Center Stud. 29 (1973). 56. Editorial, “ ‘Worthless but Harmless’ Drugs Can Be Deadly,” Chest 69 (March 196): 331. 57. American Medical N e w , April 2 5 . 1977, p. 6. 58. See note 57, p. 4. 59. F. J. Ingelfinger, “Laetrilomania,” New England Journal of Medicine 2% (May 1977): 1168. 60.American Medical News, May 30, 1977, p. 10. 61. 27 C A - A Cancer Journal for Clinicians (1977): 301. 62. See note 6, p. 13. 63. 21 U.S.C. § 355(d) (1970) states: “[slubstantial evidence” means evidence consisting of adequate and well-controlled investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibily be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. 64. See note 9. 65. See note 12. 66. 5 U.S.C. § 706 (1976). 67. Weinberger v . Hynson, Westcott & Dunning, Inc. 412 U.S. 609 (1973). 68. See note 66. 69. 21 U.S.C. Q 355(d)(5) (3970). In 1%2. the McNaughton Foundation obtained an NDA, but because of irregularities in the tests the FDA revoked the authorization to market Laetrile. The statute provides that upon receiving notice of the revocation, the proponent may request a hearing to determine the basis of the FDA’s decision. The McNaughton Foundation, after receiving notice of revocation, never requested a hearing, therefore the application was allowed to self terminate. The FDA is employing the Foundation’s previous failure to follow up on their application as a reason for classifying Laetrile as a “new drug.” 42 Fed. Reg. 39768 (1977). 70. At least this is how the FDA describes itself. See HEW Publication No. (FDA) 76-1017. 71. See note 5. 72. 21 U.S.C. Q 355(b) (1970). 73. 21 U.S.C. § 355(d)(6) (1970). The process for obtaining approval to distribute a new drug begins when a company identifies a potentially beneficial compound. Animal tests are conducted with the drug and the results are employed to provide a basis for preparing human tests. The company is next required to obtain a NOTICE OF CLAIMED INVESTIGATIONAL EXEMPTION FOR A NEW DRUG or INVESTIGATIONAL NEW DRUG APPLICATION (IND). The IND allows the company to perform tests on humans. Approval for the application is based upon the results obtained in the preliminary animal tests. After submitting the application, the company is required to wait 30 days before initiating testing. During this time, the FDA performs comprehensive examination of the compound in order to determine the validity of the company’s claims. If no objections are made during this period, the company may proceed on humans. Finally. all the data collected is incorporated and submitted to support the



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marketing of the drug. The FDA then evaluates the validity of the data submitted and is statutorily required to render a final determinationon the NDA within 180 days. “Inside the FDA-The Long Road to Drug Approval,” American Medical News,October 24, 1977, Impact 12. 74. See note 12. 75. The problem evidenced by the FDA’s reliance on reputable pharmaceutical companies, has recently been articulated by New York Magazine. In an investigatory article, the magazine indicated that Searle, a leading national pharmaceutical manufacturer, has been under investigation for falsifying research data and conducting tests under unsanitary and uncontrolled conditions. The impact of such discoveries, in a highly respected producer of drugs, serves to indicate the tragic flaw in the statute’s reasoning. T. van der Haar and M.Miller, “Warning: Your Prescriptions May Be Dangerous To Your Health,” New York Magazine, 10 (May 1977): 46. 76. Ruthetjiord v. United States, NO. 75-0218-B (W.D. Okla. Dec. 5, 1977). 77. The United States Supreme Court has stated that testimonials by physicians do not provide the requisite expertise required by the Act. 412 U.S. 609 (1973). 78. See note 77. 79. See note 12. 80. 21 U.S.C. § 355(h) (1970). 81. See note 14; 5 U.S.C. §§ 701-4 (1976). 82. See note 80. 83. 21 U.S.C. § 355(a) (1970). 84. Alaska, Arizona, Delaware, Florida, Illinois, Indiana, Louisiana, Nevada, New Harnpshire, Oklahoma, Oregon, Texas and Washington. 85. Recently, the State of Washington has taken a novel approach in hope of finally resolving the Laetrile controversy. The Washington State Board of Pharmacy has approved making Laetrile an over-the-counter drug. American Medical News,October 13, 1977, p. 14. The effect of such a move would be to eliminate the physician from the awkward position of having to prescribe a “drug” which the physician does not believe to be effective, while simultaneously making Laetrile available legally at low costs, rather than at current black market rates. Evidently the underlying hope of the state officials sponsoring the legalization is that the ready availability of the drug will remove some of the luring mystique which has made the substance so attractive and perhaps eventually help discard the compound as a worthless hoax. The Washington approach could be effective, except that other considerations come into play. The expectations proffered by the Washington State legislature may eventually prove successful in Washington, but for the majority of other states that still consider the drug “illegal,” the Washington approach could only lead to more problems. With the developing new Washington market, the people in unapproved sale states need only contact someone in Washington to obtain the drug, and the likely result will be a type of “legal” black market that would develop via the Washington connection. The cost would probably be just as prohibitive as the present black market price and the end result would only be the successful relocation of Laetrile distribution headquarters from Mexico to Washington. Although the Washington attempt to resolve the problem is commendable, the Laetrile problem pervades state boundaries. The controversy and difficulties arising from Laetrile and similar drugs is of national proportion and must be handled at a national level. 86. Editorial, “Laetrile: Quacks and Freedom,” British Medical Journal 1 (January 1977): 4.


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