1 Thomas, A Statement Concerning Laetrile, in Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Sen., 95th Cong. 1st Session, Banning of the Drug Laetrile from Interstate Commerce By FDA 57 (July 12, 1977) [hereinafter Kennedy Hearings].

2 G. Newell, Kennedy Hearings, supra note 1, at 11.

3 Each year, approximately one million people become ill with some form of cancer. One-third will be alive and free from clinical signs of cancer five years after the cancer is diagnosed. For certain types of cancer, such as Hodgkins Disease and childhood leukemia, the rate of remission is much higher. American Cancer Society, 1977 Cancer Facts And Figures (1977). Cancer treatment rates appear to be leveling off for most forms of cancer. Knox, Cancer Death Rates Reported Leveling Off, Boston Globe, March 24, 1980, at 3, col. 3. See also Robb, , Cancer: Truth and Myth, Boston Globe Magazine, July 27, 1980, at 11Google Scholar.

4 Unproven cancer remedies have included “Chinese Stones” in colonial times and the “Mild Combination Treatment For Cancer” in the nineteenth century. In the 1940s, Dr. William F. Koch’s “cure” contained malonide and glyoxylide in a concentration of one part for every trillion parts of water. This “remedy” was never shown to have any positive effect in the treatment of cancer. In the 1950s, Harry Hoxsey sold “Hoxsey’s Remedy” until he was put out of business by a federal court injunction. United States v. Hoxsey Cancer Clinic, 198 F. Supp. 273 (5th Cir. 1952). It should be noted that several clinics in Mexico still offer Hoxsey’s remedy. Cancer Control Society, List of Clinics (1978) (mimeographed sheet).

In recent times, the “miracle” cures have become more sophisticated. In the 1950s, Dr. Andrew C. Ivy, former Vice-President of Chicago Professional Colleges and Professor of Physiology and Chairman of the Department of Clinical Sciences, University of Illinois, promoted Krebiozen as a cancer cure. Krebiozen turned out to be mostly mineral oil. Despite some public support, there were never any demonstrated cases of success for Krebiozen. See Rutherford v. American Medical Ass’n, 397 F.2d 641 (7th Cir. 1967), cert, denied, 389 U.S. 1043 (1968).

5 The basic theory behind laetrile therapy is quite simple. According to Ernest Krebs, Jr., one of its leading proponents, normal body cells produce two enzymes, rhodanese and beta-glucosidase, whereas cancer cells produce little or no rhodanese but accumulate large quantities of beta-glucosidase. When laetrile (amygdalin) approaches a cancer cell, it is hydrolyzed by the beta-glucosidase to form the poison hydrogen cyanide. This in turn destroys the cancer cells. On the other hand, the rhodanese that is present in normal cells converts the cyanide to sodium thiocyanate. This substance is relatively nontoxic and is excreted from the body in the urine. Rhodanese supposedly protects the normal cells while cancer cells (lacking rhodanese) may be destroyed.

Each statement about how laetrile is supposed to work is false. First, sodium thiocyanate is toxic and is well known for producing goiter. Reidorf, Noxious gases and vapors: Cyanide, in Drill’s Textbook of Pharmacology (J. DiPalma ed. 1971), at 1189-94; Committee on Food Protection, Food and Nutrition Board, National Research Council, Toxicants Occurring Naturally in Foods (2d ed. 1973), at 303 [hereinafter Toxicants]; Guilt, , The Odour of Potassium Cyanide, 24 Med. Leg. J. 98 (1961)Google Scholar. Second, and more importantly, there is no credible evidence that cyanide selectively kills cancer cells. Furthermore, both normal, and cancer cells have the same distribution of rhodanese. Don, and Paxinos, , The Current Status of Laetrile, 89 Ann. Int. Med. 389, 391 (1978)Google Scholar. Finally, even one of laetrile’s strongest supporters, Dr. Harold W. Manner, has stated that normal cells also contain amounts of beta-glucosidase, contrary to the theory of how laetrile is supposed to work. Manner, H., The Death of Cancer 46 (1978)Google Scholar. Dr. Manner testified on this point at the Chad Green trial. Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Apr. 23, 1979), at 9, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979). There has been some dispute as to what laetrile is. Originally, proponents claimed it was a variation of the chemical component amygdalin, a compound that occurs naturally in many fruit pits. See Food And Drug Administration, Laetrile, 42 Fed. Reg. 39,767, 39,771 (Aug. 5, 1977) [hereinafter FDA Report]. However, most laetrile proponents now admit that amygdalin and laetrile are the same. See Kennedy Hearings, supra note 1, at 249; Manner, H., Death of Cancer 152 (1978)Google Scholar. See also testimony of Harold Manner and Bruce Halstead, Custody of a Minor, No. 78-6816, transcript of proceedings of Jan. 8, 1979, at 104, and Jan. 9, 1979, at 210 (Plymouth, Mass. Super. Ct. Apr. 23, 1979). Amygdalin is composed of two parts glucose, one part benzaldehyde, and one part cyanide. M. Windholz, The Merck Index, entry no. 630 (9th ed. 1976)

Some laetrile proponents have argued that laetrile is a vitamin that they call vitamin B-17. Burk, Vitamin B-17 (Amygdalin-Nitriloside-Laetrile), Vitamin B-15 ﹛Pangamic Acid- Pangamate), Vitamin B-13 (Orotates): A Brief on Foods and Vitamins (1974). There is no evidence, however, supporting the conclusion that laetrile is a true vitamin—an organic nutrient that facilitates an essential biochemical reaction, the lack of which produces a specific deficiency disease that is corrected by ingestion of the vitamin. Greenberg, , The Vitamin Fraud in Cancer Quackery, 122 West J. Med. 345 (1975)Google Scholar. Although laetrile has received the most publicity, there are other unapproved cancer “treatments“ being sold. See, e.g., Breitmeyer v. Califano, 463 F. Supp. 254 (E.D. Mich. 1978) (upholding ban on essiac, an Indian herb).

6 This was a finding in the Chad Green trial, Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Apr. 23, 1979), at 31, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d836 (1979).

7 There are many persons who claim that laetrile treatments cured them of cancer. Nearly all, however, had been treated with other forms of therapy as well; therefore, the claims of cure by laetrile are impossible to substantiate. Further, cancer is a general term for a wide variety of diseases. Many types of cancer run an irregular course, so that the fact that persons survive for an extended period of time does not necessarily indicate that the medication is responsible. The normal process through which medication is tested by the National Cancer Institute (NCI) for safety and effectiveness in treating cancer is, first, by performing animal studies, second, by obtaining a New Drug Application, and, third, by obtaining approval for marketing from the FDA. 21 U.S.C. § 201 (p)(l).

8 21 U.S.C. 321 (p)(l). See generally FDA Report, supra note 5; Note, Laetrile: Statutory and Constitutional Limitations on the Regulation of Ineffective Drugs, 127 U. Pa. L. Rev. 233 (1978).

9 FDA Report, supra note 5, at 39,181.

10 Id. at 39,786. But see note 25 infra.

11 Id. at 39,787. The report was prepared at the direction of the federal court in Rutherford v. United States, 399 F. Supp. 1208 (W.D. Okla. 1975).

12 FDA Report, supra note 5, at 39,777.

13 Id.

14 United States v. Spectro Foods, 544 F.2d 1175, 1179-80 (3d Cir. 1976); Gadler v. United States, 425 F. Supp. 244, 247 (D. Minn. 1979); United States v. Articles of Food and Drug, 444 F. Supp. 266, 271-73 (E.D. Wis.), aff’d sub nom. United States v. Mosinee Research Corp., 583 F.2d 930 (7th Cir. 1978); Hanson v. United States, 417 F. Supp. 30, 36 (D. Minn.), aff’d, 540 F.2d 947 (8th Cir. 1976). See Note, Laetrile: Statutory and Constitutional Limitations on the Regulation of Ineffective Drugs, supra note 8.

15 One proponent of laetrile. Dr. Harold W. Manner, has claimed that his experiments prove that laetrile used with megadoses of vitamins and proteolytic enzymes regresses tumors. H. Manner, The Death of Cancer 176-90 (1978). His “research,” which consists of injecting the enzymes into breast cancer tumors in mice and feeding the mice laetrile and vitamins, merely demonstrates, however, that protein-destroying enzymes will make a tumor smaller, but does not establish that laetrile in combination with enzymes and vitamins has antineoplastic capabilities. Where no enzymes were injected into the mice tumors, Manner’s research shows that laetrile or laetrile and vitamins had no effect on the tumors. Although he argues that the combination of substances works best, Manner did not examine whether the cancers were stopped from spreading by injection of the enzymes or whether lifespan was increased.

Another scientist, Dr. Dean Burk, thoroughly impeached Manner’s research when he testified, at the Chad Green trial, that good animal studies of potential anticancer drugs must examine whether the drug inhibits metastasis (spread) of the cancer and whether lifespan is increased (or decreased) by the use of the substance. Custody of a Minor, No. 73-6816, transcript of proceedings of Jan. 10, 1979, at 422 (Plymouth, Mass. Super. Ct. Apr. 23, 1979).

16 The allegations of a cover-up concern the Memorial Sloan-Kettering Cancer Center in New York. There, some preliminary research with mice indicated that laetrile had positive results in controlling certain forms of breast cancer. Although subsequent repetition of the tests has failed to duplicate the original results, the laetrile forces continue to refer to the studies, by. Dr. Kurumatsu Sugiura, as having demonstrated the benefits of laetrile and to allege that all subsequent published results are merely an effort by the medical establishment to prevent the truth from becoming known. The final report, published in 1978, concludes that laetrile does not demonstrate any disease-killing ability. Dr. Sugiura, like his coauthors of the report, concludes that laetrile does not kill cancer cells; his conclusions differ from those of his colleagues only in that he believes that laetrile has analgesic (pain-killing) benefits. Stock, Martin, Sugiura, Fugmann, Mountain, Stockert, Schmid & Tarnowski, , Anti-Tumor Tests of Amygdalin in Spontaneous Animal Tumors, 10 J. Surg. Oncology 89 (1978)Google Scholar.

17 Alaska Stat. § 08.64.367 (Mitchie 1979); Ariz. Rev. Stat. § 32-1962 (West Supp. 1979-80); Del. Code Ann. tit. 16 §§ 4901-4905 (Mitchie Supp. 1978); Fla. Stat. Ann. § 458.333 (West Supp. 1980); Idaho Code § 18-7301A (Bobbs-Merrill 1979); Ill. Ann. Stat. ch. 561/2 §§ 1801-1802.1 (Smith-Hurd Supp. 1980-81); Ind. Stat. Ann. §§ 16-8-8-1-16-8-8-7 (Burns Supp. 1979); Kans. Stat. Ann. §§ 65-6b01-65-6bl2 (Cum. Supp. 1979); K.Y. Rev. Stat. §§ 311.950-311.962, added by 1980 Ky. Stat. ch. 354; La. Rev. Stat. Ann. § 40:676 (West 1977); Md. Code Ann. art. 43 § 133 (Mitchie 1980); Mont. Code Ann. §§ 50-41-101- 50-41-107: (1979); Nev. Rev. Stat. § 585.495 (manufacturing), § 630.303 (prescription) (1979); N.H. Rev. Stat. Ann. § 329:30 (Supp. 1979); N.J. Stat. Ann. tit. 24 §§ 6F-1-6F-5 (West Supp. 1980); N.D. Cent. Code Ann. §§ 23-23.1-01-23-23.1-03 (Smith Supp. 1979); Okla. Stat. Ann. tit. 63 §§ 2-313.1-2-313.4 (West 1980); Ore. Rev. Stat. § 689.535 (1979); S.D. Codified Laws §§ 34-14A-1-34-14A-8 (Supp. 1979); Tex Civ. Code Ann. § 4476-5a (Vernon Supp. 1980); Wash. Rev. Code Ann. §§ 70.54.130-70.54.150 (West Supp. 1980-81).

The impact of these statutes is to permit the manufacture and prescription of laetrile within the boundaries of a state. Op. Att’y Gen. (Ariz.) 77-66, 1976-77 Opinions, at 159; Op. Att’y Gen. (Neb.) 222, Food Drug Cos. L. Rep. (CCH) ¶ 38,024 (1980).

Legalization efforts have been unsuccessful in 13 other states: Alabama, Georgia, Hawaii, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, New York, Rhode Island, Vermont, West Virginia, and Wisconsin. Food Drug Cos. L. Rep. (CCH) ¶ 42,292 (1978) (a list of states defeating laetrile legalization proposals through 1978); Meislifl, Carey Signs Measure Continuing Controls on Car Insurance Costs, N.Y. Times, July 17, 1979, at B2, col. 5 (New York Governor Hugh Carey vetoes laetrile legalization proposal). See also In re Hofbauer, 47 N.Y.2d 648, 657 n.5, 419 N.Y.S.2d 936, 941 n.5, 393 N.E.2d 1009, 1015 n.5 (1979) (description of the bill that passed the New York legislature but was subsequently vetoed; Gray, , Laetrile: Canada’s Legal Position Firm but Pressure in the South Grows, 117 Can. Med. Ass’n J. (1977)Google Scholar; Laetrile Legalization a Coup for Small, Rightist Group, N.Y. Times, May 15, 1977, at 1, col. 1 (description of legalization efforts in Indiana); Stang, , Laetrile: Freedom of Choice in Cancer Therapy, Am. Op. 5 (Jan. 1974)Google Scholar (John Birch Society newsletter suports legalization of laetrile).

18 United States v. Richardson, 588 F.2d 1235 (9th Cir. 1978), cert, denied, 442 U.S. 940 (1979) (upholding convictions of conspirators in laetrile smuggling case). Cancer Control Society, List of Clinics (1978) (mimeographed sheet) (includes listing of physicians in several states who prescribe laetrile treatments).

19 Laetrile Earns U.S. Test, Boston Globe, June 28, 1980, at 1, col. 1.

20 Ingelfinger, , Laetrilomania, 296 New Enc. J. Med. 1167 (1977)Google Scholar.

21 The Federal Food, Drug and Cosmetic Act prohibits distribution of any “new drug” (that is, unapproved drug), as defined in 21 U.S.C. § 201 (p)(l) unless the Secretary of Health and Human Services has approved a “New Drug Application,” or unless the drug falls within one of the Act’s exemptions. 21 U.S.C. § 355(b)(19) (1976).

22 Commentary, Laetrile Evaluation Under Way at NCI, 239 J.A.M.A. 19 (1978)Google Scholar.

23 Although it requested data from thousands of persons, NCI received only 93 cases for study. Of these, only 22 included sufficient information for a panel examination. All of the patients were cancer victims who had been treated with laetrile after receiving other forms of therapy. The panel determined that of the 22 cases, 6 showed improvement, 7 remained in the same condition, and 9 deteriorated after the administration of laetrile. Ellison, , Byar, & Newell, , Special Report on Laetrile: The NCI Laetrile Report, 299 New Enc J. Med. 549 (1978)Google Scholar.

24 FDA Ok’s Testing Laetrile on Humans, Boston Globe, Jan. 4, 1980, at 3, col. 5; U.S. Test of Laetrile on Humans Backed, N.Y. Times, Jan. 4, 1980, at 11, col. 1. See Pendergast, , Judicial Dilemmas of Laetrile and a Possible Solution, 30 Mercer L. Rev. 573 (1979)Google Scholar.

Despite the plan for clinical trials with humans, there is increasing evidence that laetrile taken orally is toxic to both humans and animals. There have been a number of documented cases of acute cyanide poisoning from laetrile taken orally, including reports of two cases of death caused by ingestion of laetrile tablets. Braico, , Humbert, , Terplan, & Lehotay, , Laetrile Intoxication: Report of a Fatal Case, 300 New Eng. J. Med. 238 (1979)Google Scholar (11-month-old baby accidentally ate 1-5 500 mg. laetrile tablets and died of acute cyanide poisoning); Death Blamed on Cyanide-Laetrile Link, S.F. Chronicle, Feb. 6, 1979, at 15, col. 1 (a Mrs. Pye died of acute cyanide poisoning after massive ingestion of laetrile tablets). See also Laetrile Poisoning Takes Third Life, Threatens Fourth, 20 Med. W. News 5 (March 5, 1979); Morse, , Boros, & Findley, , Letter to the Editor, 301 New Eng. J. Med. 892 (1979)Google Scholar; Sadoff, , Fuchs, & Hollander, , Rapid Death Associated with Laetrile Ingestion, 239 J.A.M.A. 1532 (1972)Google Scholar; Humbert, , Tress, & Braico, , Fatal Cyanide Poisoning: Accidental Ingestion of Laetrile, 238 J.A.M.A. 482 (1977)Google Scholar.

25 The NCI Tests began July I, 1980, at four medical centers—Mayo Clinic, UCLA, University of Arizona, and Memorial-Sloan-Kettering Cancer Center. The tests will involve 200 patients, with advanced breast, lung, or colon-rectal cancer, for whom conventional . therapies have failed. Results are not expected for two years.

NCI approved clinical testing after preliminary testing on six persons at the Mayo Clinic had not demonstrated toxicity, except in the case of one patient who had consumed a large number of almonds along with the laetrile. Laetrile Earns U.S. Test, Boston Globe, June 28, 1980, at 1, col. 1.

26 Bruzelius, The Merchants of Laetrile, Boston Sunday Globe, June 17, 1979, (New England Magazine), at 6. See also American Cancer Society, Appendix to amicus brief, filed in United States v. Rutherford, 442 U.S. 544 (1979), which contains a copy of the death certificate of Mrs. Pye, supra note 23.

27 See, e.g., J. Richardson & E. Griffin, World Without Cancer 237-40 (1976); H. Manner, Death Of Cancer 164-66 (1978). But see Bruzelius, supra note 24 (some laetrile proponents discount value of metabolic therapy). For a critique of the diet by a trained nutritionist, see Herbert, , The Nutritionally and Metabolically Destructive “Nutritional and Metabolic Anti-neoplastic Diet” of Laetrile Proponents, 32 Am. J. Clin. Nutr. 69 (1979)Google Scholar.

28 B . Halstead, Amycdalin (Laetrile) Therapy 1-10 (1978).

29 Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super Ct. Apr. 23, 1979), at 25-40, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979).

30 Metabolic therapy may also have harmful consequences that are more subtle. For example, patients whose cancer is treatable with conventional therapy, but who turn to metabolic therapy, may delay seeking or using conventional therapy until their cancer has metastasized too extensively to be treated conventionally. Custody of a Minor, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979) (Although Chad Green would have had an 80% chance of total cure if chemotherapy had never been stopped, cessation of chemotherapy reduced his chance of cure. Laetrile had caused chronic cyanide poisoning, and megadoses of vitamin A had caused hypervitaminosis A). Another potential problem with metabolic therapy is the unexplored danger of reactions between orthodox therapies and metabolic therapy. FDA Report, supra note 5, at 39,803. See also Lewis, , Laetrile, 127 West. J. Med. 55, 61 (1977)Google Scholar. Finally, there is evidence that the laetrile available in this country is impure and may well be contaminated. Daivgnon, , Laetrile: A Health Hazard, 297 New Eng. J. Med. 1355, 1356 (1978)Google Scholar, Ames, , Kovach, & Flora, , Initial Pharmacologic Studies of Amygdalin (Laetrile) in Man, 22 Res. Comm. Chem. Path. Pharm. 175 (1979)Google Scholar. See also Custody of a Minor, No. 78-6816, transcript of proceedings of Jan. 9, 1979, at 250 (Plymouth, Mass. Super. Ct. Apr. 23, 1979), where Dr. Bruce Halstead testified that the laetrile available in this country is generally terrible and that he wouldn’t use kemdalin, the brand name of the amygdalin manufactured for the Contreras clinic, because it causes pyrogenic reactions.

31 Braico, , Humbert, , Terplan, & Lehotay, , Laetrile Intoxication: Report of a Fatal Case, 300 New Eng. J. Med. 238 (1979)Google Scholar; Death Blamed on Cyanide-Laetrile Link, S.F. Chronicle, Feb. 5, 1979, at 15, col. 3; Laetrile Poisoning Takes Third Life, Threatens Fourth, 20 Med. W. News 5 (March 5, 1979); Custody of a Minor, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979).

32 Bruzelius, supra note 26.

33 Brief of Appellee at 10, United States v. Rutherford, 442 U.S. 544 (1979) (argued cancer patients should have freedom to choose laetrile).

34 Lucas, The Answer; Multivitamins, Prevention, June, 1980, at 105 (FDA should not attempt to ban megavitamins because they are not unsafe).

35 The constitutional right of privacy was first recognized—in regard to contraception —in Griswold v. Connecticut, 381 U.S. 479 (1965), and was extended to abortion in Roe v. Wade, 410 U.S. 113 (1973) and Doe v. Bolton, 410 U.S. 179 (1973). The principle was extended to the medical treatment area in In re Quinlan, 70 N.J. 10, 355 A.2d 647 (1976) and in Superintendent of Belchertown State School v. Saikewicz, 373 Mass. 728, 370 N.E.2d 417 (1977). As applied to a right to take laetrile, appellate courts have been unwilling to adopt the principle. Rutherford v. United States, 616 F.2d 455 (10th Cir. 1980) and People v. Privitera, 23 Cal. 697, 153 Cal. Rptr. 431, 591’ P.2d 919 (1979).

36 See Satz v. Perlmutter, 362 So. 2d 160 (1978), aff’d, 379 So. 2d 452 (Fla. 1980).

37 Rutherford v. United States, 438 F.Supp. 1287 (W.D. Okla. 1977), aff’d as modified, 582 F.2d 1234 (10th Cir. 1978), rev’d, 442 U.S. 544 (1979) (argument that terminal cancer patients have the right to elect laetrile rejected by U.S. Supreme Court).

38 United States v. Rutherford, 442 U.S. 544 (1979), reversing 582 F.2d 1234 (10th Cir. 1978); People v. Privitera, 23 Cal. 3d 697, 153 Cal. Rptr. 431, 591 P.2d 919 (1979), reversing 75 Cal. App. 3d 697, 141 Cal. Rptr. 764 (1977).

39 See note 31 supra.

40 Note, Laetrile: Statutory and Constitutional Limitations on the Regulation of Ineffective Drugs, 127 U. PA. L. REV. 233 (1978).

41 The clinical trials on humans will involve administration of laetrile to 200 patients with advanced cancer. The patients, all consenting adults, will receive megadoses of vitamins and a vegetarian diet along with laetrile. Laetrile Earns U.S. Test, Boston Globe, June 28, 1980, at 1, col. 1. See note 25 supra.

42 Rutherford v. United States, 399 F. Supp. 1208 (W.D. Okla. 1975).

43 Id. at 1214.

44 Rutherford v. United States, 542 F.2d 1137, 1144 (10th Cir. 1976).

45 FDA Report, supra note 5, at 39,768, 39,806. For a description of FDA authority concerning approval of drugs, see 21 U.S.C. § 201(p)(l). See also Weinberger v. Hyson, Westcott & Dunning, Inc., 412 U.S. 609, 629-34 (1973) (Supreme Court interpreted § 201(p)(l) to require an “expert consensus” on safety and effectiveness of a “new drug“).

46 Judge Luther Bohannon heard the case each time in the district court.

47 Rutherford v. United States, 438 F. Supp. 1287 (W.D. Okla. 1977). The principal basis for the court’s decision was a finding that the exemptions to the Food, Drug and Cosmetic Act applied and therefore laetrile was exempt from FDA authority. 21 U.S.C. § 321(p)(l) (1938 grandfather clause exempts drugs that are identical to drugs marketed between 1906 and 1938 and whose labeling has not changed from the labeling used in that period); 21 U.S.C. § 321 (§ 107(c)(4) of Pub. L. No. 87-781) (1962 grandfather clause exempts drugs that are identical in chemical composition and labeling to those in existence on Oct. 9, 1962, that were sold commercially in the United States on that date, and that were generally recognized as safe and were not covered by an effective New Drug Application).

48 Rutherford v. United States, 438 F. Supp. 1287, 1294-1300 (W.D. Okla. 1977), aff’d as modified, 582 F.2d 1234 (10th Cir. 1978), rev’d, 442 U.S. 544 (1979).

49 410 U.S. 113(1973).

50 410 U.S. 179(1973).

51 Cannizaro, & Rosenfeld, , Laetrile and the FDA: A Case of Reverse Regulation, 3 J. Health Pol., Pol’y & L. 181 (1978)Google Scholar.

52 Rutherford v. United States, 582 F.2d 1234, 1236 (10th Cir. 1977), rev’d, 442 U.S. 544 (1979) (court created criteria for the so-called “Rutherford affidavit,” wherein a licensed medical practitioner would certify a patient as terminally ill and the patient could then obtain injections of laetrile). The court apparently limited its decision to injections because most of the data on toxicity concerns orally administered laetrile. See Toxicity of Laetrile, 7 FDA DRUC BULL. 25 (Nov.-Dec. 1977).

53 Thus, such physicians would satisfy the requirements of the “Rutherford affidavit.“ See note 52 supra.

54 See Custody of a Minor, No. 78-6816, transcript of proceedings of Jan. 8, 1979, at 69, and Jan. 9, 1979, at 274 (Plymouth, Mass. Super. Ct. Apr. 23, 1979) (even though Chad Green was not terminally ill and was not taking injections of laetrile, Dr. Ernesto Contreras and Dr. Bruce Halstead would give him a “Rutherford affidavit” so that he could obtain laetrile).

55 442 U.S. 544 (1979) (Court concluded FDA offended right of privacy by denying person right to use a nontoxic substance).

56 Id.

57 Id. at 550. See also FDA Report, supra note 5, at 39,805 (several expert submissions to the FDA cast severe doubt on the present ability of medical knowledge to distinguish between terminal and nonterminal cancer patients).

58 Id. at 551. See generally Note, Laetrile: Statutory and Constitutional Limitations on the Regulation of Ineffective Drugs, 127 U. Pa. L. Rev. 233, 255 (1978) (court of appeals exemption for use of laetrile by terminally ill would prevent FDA from regulating any substances administered to the terminally ill).

59 Rutherford v. United States, 616 F.2d 455, 458 (10th Cir. 1980).

60 Lane v. Candura, 1978 Mass. App. Ct. Adv. Sh. 588, 376 N.E.2d 1232 (1978). See generally Superintendent of Belchertown State School v. Saikewicz, 373 Mass. 728, 370 N.E.2d 417 (1977); In re Quinlan, 70 N.J. 10, 355 A.2d 647 (1976).

61 Rogers v. Okin, 478 U.S. 1342 (D. Mass. 1979); Rennie v. Klein, 462 F. Supp. 1131 (D.N.J. 1978).

62 23 Cal. 3d 697, 153 Cal. Rptr. 431, 591 P.2d 919, cert, denied, 444 U.S. 949 (1979).

63 Cal. Health & Safety Code § 1701.1 (Supp. 1979). This was not the first time that Dr. Privitera had been accused of violating the statute. His first conviction was upheld on appeal. People v. Privitera, 55 Cal. App. 3d 39, 128 Cal. Rptr. 151 (1975).

64 410 U.S. 179 (1973) (government could not interfere with physician and patient making abortion decision in first trimester of pregnancy). The decision came down shortly after the New Jersey Supreme Court’s decision in In re Quinlan, 70 N.J. 10, 355 A.2d 647 (1976), upholding on privacy grounds a right to withhold medical treatment from an incompetent patient. The majority opinion in Privitera cites Quinlan extensively.

65 Cal. Const, art. 1, § 1. “All people are by nature free and have inalienable rights. Among these are enjoying and defending life and liberty, acquiring, possessing, and protecting property, and pursuing and obtaining safety, happiness, and privacy.” See White v. Davis, 13 Cal. 3d 757. 120 Cal. Rptr. 94, 533 P.2d 222 (1976).

66 Rutherford v. United States, 399 F. Supp. 1208 (W.D. Okla. 1975).

67 People v. Privitera, 74 Cal. App. 3d 936, 141 Cal. Rptr. 764 (1977), rev’d, 23 Cal. 3d 697, 153 Cal. Rptr. 431, 591 P.2d 919, cert, denied, 444 U.S. 949 (1979) (the harmlessness of laetrile was assumed).

68 People v. Privitera, 23 Cal. 3d 697, 153 Cal. Rptr. 431, 591 P.2d 919, cert, denied, 444 U.S. 949 (1979). After certiorari was denied, Dr. Privitera began serving his six-month jail sentence. Kilpatrick, Human Freedom and Dr. Privitera, Nation’s Business, Apr. 1980, at 11.

69 Id. at 702, 153 Cal. Rptr. at 441, 591 P.2d at 922 (quoting Whalen v. Roe, 429 U.S. 589, 599-600 (1977)).

70 “it is of course well settled that the state has broad police powers in regulating the administration of drugs by the health professions.” Id. at 705, 153 Cal. Rptr. at 441, 591 P.2d at 922 (quoting Whalen v. Roe, 429 U.S. at 603 n.30 (1977)).

Chief Justice Bird dissented. Most of her dissent consisted of reprinting the majority opinion from the court of appeal. In her short introduction, she noted that “so long as there is no clear evidence that laetrile is unsafe to the user, I believe that each individual patient has a right to obtain the substance from a licensed physician who feels it appropriate to prescribe it to him.” Justice Newman also dissented in a brief opinion, in which he stated that he would have upheld the court of appeal on the basis of the California constitution’s right to privacy provision.

71 Cal. Health & Safety Code § 1701.1 (West Supp. 1979) (no drug can be sold in California unless approved by the FDA or the California Department of Health).

72 The government’s interest in regulating drugs was recognized in Whalen v. Roe, 429 U.S. 57 (1977).

73 Acute lymphocytic leukemia, the most common form of blood cancer in children, is a cancer of the white blood cells and of the bone marrow. The disease is considered very treatable with conventional chemotherapy. George, , Aur, , Mauer, & Simone, , A Reappraisal of the Results of Stopping Therapy in Childhood Leukemia, 300 New Eng. J. Med. 269 (1979)Google Scholar.

74 Counsel for the hospital went to the probate court because of the decision of the Massachusetts Supreme Judicial Court in Superintendent of Belchertown State School v. Saikewicz, 373 Mass. 728, 370 N.E.2d 417 (1977), which, he believed, placed exclusive jurisdiction over questions of medical decision making in the probate court. It should be noted that, in Massachusetts, a physician is under a legal obligation to report suspected cases of child abuse or neglect. Mass. Gen. Laws Ann. ch. 119, §§ 51A-51F (West Supp. 1980).

75 Mass. Gen. Laws Ann. ch. 119, §§ 21-24 (West Supp. 1980).

76 Custody of a Minor, 1978 Mass. Adv. Sh. 2002, 379 N.E.2d 1053 (1978).

77 Jehovah’s Witnesses in State of Wash. v. King County Hosp., 278 F. Supp. 488, 501 (W.D. Wash. 1967), aff’d, 390 U.S. 598 (1968); John F. Kennedy Memorial Hosp. v. Heston, 58 N.J. 576, 279 A.2d 670 (1971); People ex rel. Wallace v. Labrenz, 411 III. 618, 104 N.E.2d 769, cert denied, 344 U.S. 824 (1952). See Custody of a Minor, 1978 Mass. Adv. I Sh. 2002, 2033 n.8, 379 N.E.2d 1053, 1062 n.8 (1978).

78 Jehovah’s Witnesses in State of Wash. v. King County Hosp., 278 F. Supp. 488, 504 (W.D. Wash. 1967), aff’d, 390 U.S. 598 (1968); People ex rel. Wallace v. Labrenz, 411 Ill. 618, 626, 104 N.E.2d 769, 774, cert, denied, 344 U.S. 824 (1952). But see John F. Kennedy Memorial Hosp. v. Heston, 58 N.J. 576, 580, 279 A.2d 670, 672 (1971) (there is no constitutional right to die).

79 The U.S. Supreme Court once stated that “parents may have the right to make martyrs of themselves, but they do not have the right to make martyrs of their children … .” Prince v. Massachusetts, 321 U.S. 158 (1944). See also John F. Kennedy Memorial Hosp. v. Heston, 58 N.J. 576, 279 A.2d 670 (1971) (parents cannot withhold consent to transfusion for their 23-year-old daughter).

80 Custody of a Minor, 1978 Mass. Adv. Sh. 2002, 2005 n.l, 379 N.E.2d 1053, 1056 n.l (1978).

81 Id. at 2005, 379 N.E.2d at 1056. The Greens also filed an action in federal court alleging a constitutional right to elect laetrile treatments for Chad, but the case was dismissed. Green v. Truman, 459 F. Supp. 342 (D. Mass. 1978).

82 Mass. Gen. Laws Ann. ch. 119, § 26 (West Supp. 1980), permits parents to obtain a review and redetermination of custody orders after the passage of six months.

83 The Greens admitted publicly that Chad was receiving daily metabolic therapy, consisting of megadoses of vitamins A and E, 500 milligrams of laetrile, an enzyme enema, a folic acid tablet, a mineral supplement, and a vegetarian diet. Doherty, Chad Getting Laetrile Too, Boston Globe, Sept. 19, 1978, at 6, col. 1.

84 Custody of a Minor, No. 78-6816, transcript of proceedings of Jan. 16, 1979, at 844-49 (Plymouth, Mass. Super. Ct. Apr. 23, 1979). See also note 86 infra.

85 All four controls had serum (blood) cyanide levels of 0.0, while Chad’s was at 1.1 mg./l00 ml. Similarly, his urine thiocyanate levels were more than four times those of the controls. The Greens’ witnesses could not explain why his cyanide levels were so high, id.; the DPW witnesses described his cyanide levels as equal to persons in West Africa blinded from routine dietary ingestion of cassava, another cyanogenic glycoside, id. at 852 (testimony of Dr. Victor Herbert). See Toxicants, supra note 5, at 306. See also Bruzelius, Tests Find Chad is Poisoned, Boston Globe, Jan. 18, 1979, at 3, col. 6.

86 Custody of a Minor, No. 78-6816, transcript of proceedings of Jan. 9, 1979, at 81 (Plymouth, Mass. Super. Ct. Apr. 23, 1979). Dr. Contreras criticized the Greens for giving Chad extra folic acid when he was receiving methotrexate injections. Methotrexate injections kill leukemia cells that migrate into the spinal column by inhibiting the metabolism of folic acid, a B vitamin. Goodman, L. & Gilman, A., Pharmacological Basis of Therapeutics 738 (5th ed. 1975)Google Scholar. Furthermore, two of the Commonwealth’s witnesses described the probable effects to Chad’s colon of his regular use of a papain enema. Id., transcript of proceedings of Jan. 16, 1979, at 636-39 (Dr. John Truman), and 651-53 (Dr. Victor Herbert).

87 The court found that the Krebs theory of laetrile treatment was unsound because one of the parents’ experts, Dr. Manner, had experimentally refuted the foundation of the Krebs theory, and had determined that there is no difference between cancer cells and normal cells in the distribution of Beta-glucosidase or rhodanese. Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Apr. 23, 1979), at 9, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979). See also Jukes, , Laetrile for Cancer, 236 J.A.M.A. 1284, 1285 (1976)Google Scholar; FDA Report, supra note 5, at 39,779-81.

88 Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Apr. 23, 1979), at 13, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979). See also Ames, , Kovach, & Flora, , Initial Pharmacologic Studies of Amygdalin (Laetrile) in Man, 22 Res. Comm. Chem. Path. & Pharm. 175 (1979)Google Scholar (actual amount of laetrile only 50-70% of stated dose amount).

89 Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Apr. 23, 1979), at 14, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979). See generally Herbert, , Laetrile: The Cult of Cyanide, 32 Am. J. Clin. Nutr. 1121 (1979)Google Scholar; Berlin, , The Treatment of Cyanide Poisoning in Children, 46 Pediatrics 793 (1970)Google Scholar.

90 Custody of a Minor, No. 78-6816 (Plvmouth, Mass. Super. Ct. Apr. 23, 1979), at 39, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 8.96 (1979). See also Osuntokun, , Cassava Diet and Cyanide Metabolism in Wistar Rats, 24 Brit. J. Nutr. 797 (1970)Google Scholar.

91 Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Apr. 23, 1979), at 14, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979). See also TOXICANTS, supra note 5, at 306.

92 Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super Ct. Apr. 23, 1979), at 14- 20, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979). Testimony indicated that the enzyme enema can destroy tissue in the colon and that megadoses of vitamin A can cause hypervitaminosis A, which apparently can damage the liver. See Goodman, L. & Gilman, A., The Pharmacological Basis Of Therapeutics 958, 1574 (5lh ed. 1975)Google Scholar. See also National Academy of Sciences, Recommended Daily Allowances 152 (8th ed. 1974); Herbert, The Rationale of Massive-Dose Vitamin Therapy: (Megavitamin Therapy—Hot Fictions v. Cold Facts), in White, P. & Selvey, N., IV Proceedings, Western Hemisphere Nutrition Congress 84, 87 (1975)Google Scholar.

93 Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Apr. 23, 1979), at 39- 41, aff’d, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979). See also United States v. Articles of Food and Drug, 444 F. Supp. 266 (E.D. Wis.), aff’d sub nom. United States v. Mosinee Research Corp., 583 F.2d 930 (7th Cir. 1978) (presence of cyanide in laetrile makes it dangerous).

94 Klibinoff, Chad Green Dies After Long Leukemia Fight, Boston Globe, Oct. 14, 1979, at Al, col. 5; Child Cancer Victim in Dispute on Laetrile Dies in Mexico Home, N.Y. Times, Oct. 14, 1979, at 44, col. 3.

The parents were held in civil contempt for violation of the court order that Chad be treated with chemotherapy in Massachusetts; the court also found probable cause for criminal contempt. Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Order No. 2 Feb. 7, 1979). See Knox, Chad Green Dies in Mexico, Boston Sunday Globe, Oct. 20, 1979, at Al, col. 4.

In Mexico, the Greens took Chad off chemotherapy against the advice of the Mexican physicians. Boy’s Chemotherapy Halted by Parents, Doctor Says, N.Y. Times, Aug. 18, 1979, at 6, col. 6. Chad died from a relapse of the leukemia. Legal Issues Remain in Chad Green Case, N.Y. Times, Oct. 15, 1979, at D44, col. 1. Because the Mexican clinic arranged to have his body embalmed immediately upon his death, the extent of cyanide poisoning at the time of death could not be determined by autopsy. Boy’s Leukemia Is Confirmed in Autopsy, N.Y. Times, Oct. 22, 1979, at B5, col. 1. See generally Knox, Did Chad Have to Die Now? No One Can Know the Truth, Boston Globe, Oct. 15, 1979, at 8, col. 1; Moran, The Case Against Chad Green’s Parents, Boston Phoenix, Oct. 30, 1979, at 3, col. 2; McLaughlin & Richard, The Selling of Chad’s Story, Boston Globe, Nov. 25, 1979, at 1, col. 1.

95 Custody of a Minor, 1979 Mass. Adv. Sh. 2124, 393 N.E.2d 836 (1979).

96 Id. at 2138, 393 N.E.2d at 843.

97 Id. at 2139, 393 N.E.2d at 843. See generally Parham v. J.R., 442 U.S. 584 (1979). See also Quilloin v. Walcott, 434 U.S. 246, 255 (1978).

98 Custody of a Minor, 1979 Mass. Adv. Sh. at 2139, 393 N.E.2d at 843 (1979). Because of the clear showing of harm from laetrile, Chad Green can be distinguished from In re Hofbauer, where a parental decision to have laetrile prescribed was upheld. In re Hofbauer, 47-N.Y.2d 648, 419 N.Y.S.2d 936, 393 N.E.2d 1009 (1979) (New York Court of Appeals upheld lower court decisions permitting a family to decline conventional therapy in favor of metabolic therapy, including laetrile, for a 10-year-old boy with Hodgkins Disease). In Hofbauer, the state did not attempt to demonstrate any harm from laetrile and therefore did not meet its burden for intervening in the family relationship. See Note, Of Love and Laetrile: Medical Decision Making in a Child’s Best Interests, 5 Am. J. L. & Med, 271 (1979). Subsequently, however, the boy died of the disease. At the time of his death, he was a patient in a laetrile clinic in the Bahamas, where his parents had taken him to be treated. Boy, 10, in Laetrile Case Dies, N.Y. Times, July 18, 1980, at D13, col. 5. See also Goodman, Finding a Child’s Best Interests, Boston Globe, Oct. 18, 1979, at 15, col. 3.

99 United States v. Rutherford, 442 U.S. 544 (1979); People v. Privitera, 23 Cal. 3d 697, 153 Cal. Rptr. 431, 591 P.2d 919 (1979). See also Rutherford v. United States, 616 F.2d 455 (10th Cir. 1980).

100 When the second superior court trial of Chad Green began, the U.S. Supreme Court had not yet granted certiorari in Rutherford and the California Supreme Court had the state’s appeal of Privitera under advisement. The one other relevant case, In re Hofbauer, had just been affirmed by an intermediate appellate court. 65 App. Div. 108, 411 N.Y.S.2d 416 (1978). Thus, momentum was still very much with the proponents of legalization. Within a year, however, the constitutional and statutory bases for legalization had been discredited in subsequent proceedings of Rutherford, 442 U.S. 544 (1979), and Privitera, 23 Cal. 3d 697, 153 Cal. Rptr. 431, 591 P.2d 919, cert, denied, 444 U.S. 949 (1979). The most recent decision in Rutherford continues this trend. 616 F.2d 455 (10th Cir. 1980). See also Yates, , Laetrile v. The Law, 6 Barrister 12 (Summer 1979)Google Scholar; Note, Of Love and Laetrile: Medical Decision Making in a Child’s Best Interests, 5 Am. J. L. & Med. 271 (1979).

101 Rutherford v. United States, 438 F. Supp. 1287 (W.D. Okla. 1977), aff’d as modified, 582 F.2d 1239 (10th Cir. 1978), rev’d, 442 U.S. 544 (1979); People v. Privitera, 23 Cal. 3d 697, 153 Cal. Rptr. 431, 591 P.2d 919, cert, denied, 444 U.S. 949 (1979). As Hofbauer, 47 N.Y.2d 648, 419 N.Y.S.2d 936, 393 N.E.2d 1009 (1979), demonstrates, in the absence of evidence of toxicity, courts have been reluctant to proscribe laetrile. Even where questions of toxicity were raised, courts sometimes framed relief so as to allow at least limited legal use of laetrile. Compare United States v. Articles of Food and Drug, 444 F. Supp. 266 (E.D. Wis.), aff’d sub nom. United States v. Mosinee Research Corp., 583 F.2d 93C (7th Cir. 1978) (laetrile is a fraud on the consuming public because the presence of cyanide makes it dangerous).

102 People v. Privitera, 23 Cal. 3d 697, 153 Cal. Rptr. 431, 591 P.2d 919, cert, denied, 444 U.S. 949 (1979); United States v. Rutherford, 442 U.S. 544 (1979) and Rutherford v. United States, 616 F.2d 455 (10th Cir. 1980).

103 Custody of a Minor, No. 78-6816 (Plymouth, Mass. Super. Ct. Apr. 23, 1979); 1979 Mass. Adv. Sh. 2124, 2144, 393 N.E.2d 836, 850 (1979).