DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Public Health Service Food and Drug Admin istration Rockville, Maryland 20857

Official Business

Postage and Fees Paid U.S. Department of H.E.W. HEW 393

FIRST CLASS

Volume 7 Number 1

bulletin January-Apri I 1977

Information of importance to physicians _ _ _ ___ cl.~_rJ ~th~~ '1~~-lth p~Qf~ssion~_I$ _____ --: ----c.

Update on Laetrile

Gonad Shielding in Diagnostic Radiology

January-Apri I 1977 Sherwin Gardner, Acting Co111111issio11cr William V. Whitehorn, MD, Assistant Commissioner for Professional and Consumer Programs, Editor-in-Chief Eric W. Martin, PhD, Director of Profe-'f.§iona/ Communications, Editor

UPDATE ON LAETRILE

This is an update for health professionals on Laetrile, the latest in the long history of alleged cancer remedies. This drug is now derived from pulverized apricot pits and has been widely pro­moted for prevention, treatment, and cure of can­cer. Its major component is amygdalin and it is also known as "vitamin B-17."

The extent of current Laetrile promotion and the continuing manipulation of the therapeutic claims made for it are of concern to the Food and Drug Administration, and should be of concern to all health professionals. 1 -3

History of Laetrile and FDA Actions

Despite the fact that it has been known, tested, and used for more than a quarter of a century, no valid scientific evidence which indicates that Lae­trile has any potential value in cancer management has ever been found.

Despite confused and misleading reports from Laetrile promoters, FDA has found no study which provides conclusive evidence that Laetrile is active against any cancer.

No reputable organization has found any evi­dence to support the use of Laetrile in the treat ­ment or prevention of cancer.

FDA has repeatedly requested the McNaughton Foundation of California, the most recent sponsor of Laetrile, to submit whatever scientific data it might have to correct the serious deficiencies in its animal tests and plans for clinical investigations. To date, the Government has not received any scien­tific data which would justify clinical trial under proposed conditions of use as an anticancer drug .

In addition to investigations conducted by the California Department of Public Health and by Canadian authorities, the National Cancer Institute has tested Laetrile in animals on five occasions be-

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tween 1957 and 1975. Four independent cancer research centers undertook additional studies in 19 7 5 and the Sloan Kettering Cancer Center is now conducting a "double blind" test in animals.

In June 197 5, a cancer patient, Glen Rutherford, sought to obtain Laetrile for personal use . As part of this case, FDA was ordered on January 4, 1977, to compile an administrative record on the issues set forth.

The record to be compiled must deal with two basic issues : (1) whether Laetrile is exempt from the premarket approval (New Drug Application) re­quirements for new drugs (by virtue of "grand ­father" status) and (2) whether Laetrile is generally recognized as a safe and effective cancer drug (by experts qualified by scientific training and experi ­ence to evaluate these issues). Oral arguments con­cerning testimony will be presented on May 2, 1977, at Kansas City, MO.

The rulemaking procedure will be important for FDA because this will uphold its right to act as it has under the law and should discourage the mar ­keting and attempted distribution of other un ­proven remedies . Interested and knowledgeable professionals are invited to submit information and evidence in response to the rulemaking not ice . 5

The FDA Position on Laetrile

FDA's position on Laetrile remains clear and un­changed:

• FDA has considered Laetrile a "new drug" within the mearung of Section 201 (p) of the Federal Food, Drug, and Cosmetic Act, in that it 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 in the cure, rrutigation, treat ­ment, or prevention of cancer in man.

• Federal law prohibits the interstate distribution of a "new drug" unless FDA has approved a New Drug Application (NDA) subrrutted by the sponsor and containing full reports of clinical investigations establish ing the safety and effectiveness of sud\ drug.

• While laetrile has been marketed and promoted as a vitamin (BEE 17 or B-17), FDA has no basis for accepting the claim that laetrile is a vitamin and not a drug. It is of no value as a factor in human nutrition .

This view has been supported by th~ courts. It is, therefore, illegal to market Laetrile as a vitamin or as a nutritional supplement and all attempts to market the product as such are thin ly veiled efforts to avoid the drug labeling provisions of the Food, Drug, and Cosmetic Act.

In those few cases where a court has permitted Laetrile to be used, relief has been limited solely for the personal use of an individual cancer patient. No court has authorized commercial sale or distri ­bution of Laetrile.

FDA contends that it would be contrary to the public interest to exempt Laetrile, as some pro­pose, from the efficacy requirements of Federal

law (the Kefauver-Harris Amendments). Such an exemption would set an unacceptable precedent for other unproven drugs.

FDA believes there are serious faults in the "freedom of choice" argument. No worthless drug is without harm; a patient's choice of Laetrile to the extent that such choice delays or interferes with swift diagnosis and prompt effective treat­ment is potentially fatal.

The "evidence" of efficacy presented by Laetrile promoters consists entirely of hearsay arguments and patients' testimonials. FDA and the National Cancer Institute have reviewed "success stories" submitted by the most prominent promoter of Laetrile, a Mexican physician, and failed to find evidence of therapeutic effect.

Promotion Shifts to "Prevention"

When Laetrile was first promoted, it was offered as a "cure for cancer". Today the preparation is more heavily promoted than ever before but the statements now being featured do not refer to "cure" as often as to "prevention," "relief of pain," "slows the cancer," "stops its spread," and other unproven claims.

Laetrile's promoters are more vocal and better organized today than in the past. They are sponsor­ing seminars and conventions for cancer victims and their families. They are encouraging publica­tion of articles in the press and appearances on radio and television talk shows to promote the drug, as well as lobbying and organizing write-in . campaigns to influence State legislatures and Con­gress.

FDA asks all health professionals to be alert to the kinds of claims now being made by Laetrile promoters. Examples include the following ex­cerpts from the televised film "World Without Cancer":

" .. . vitamin B-17 does control cancer in human beings with an effectiveness approaching 100 percent ."

"Unfortunately, most cancer victims start taking Laetrile only after the disease is so far advanced that they've been given up as hopeless by routine medical channels."

" ... a patient can.have his cancer destroyed by vitamin B-17 and still die from the irreversible damage already done to his vital organs.,,

"Of those with early diagnosed cancer, at least eighty percent will be saved by vitamin therapy. And, of those who presently are healthy with no clinical cancer to begin with, close to one hundred percent can expect to be free from cancer as long as they routinely obtain adequate amounts of vitamin B-1 7."

"Once vitamin B-1 7 is as wide ly understood and available as other vitamins, cancer then will be as rare as is scurvy or pellagra today."

Most of these promotional efforts are being or­chestrated by four groups promoting Laetrile use:

1. The National Health Federation, a champion

FDA Drug Bulletin

of so-called health foods and unorthodox medical treatments.

2. The International Association of Cancer Vic­tims and Friends, which publishes the Cancer News Journal.

3. The Cancer Control Society, which publishes the Cancer Control Journal.

4. The Committee for Freedom of Choice in Cancer Therapy, an organization which treats ef­forts to regulate Laetrile and similar unproven sub­stances as an invasion of personal privacy. Commit­tee leaders recently were indicted on charges of conspiracy to smuggle Laetrile into the United States. This Committee is now widely publicizing the previously mentioned film which makes false and misleading claims for Laetrile.

Promotional Impact

The impact of these groups on public opm10n and on legislators is apparent:

• In 1976, Alaska passed a law prohib iting hospitals and health facilities from barring the use of Laetrile when prescribed or admin­istered by a physician and requested by a patient.

• Bills to legalize Laetrile have been introduced or are being con­sidered in at least 10 other State legislatures.

• At least one prominent conservative journalist has condemned "know it all doctors" and argues against the Goverm:nent forbidding individuals the "freedom" to use Laetrile "merel y because experts regard it as ~orthless ."

• Newspapers such as The New York Times and Detroit Free Press editorially question why Laetrile should not be made available to those who want it.

• A number of lawsuits are active in many areas of the United States in which individual citizens are seeking legal access to Lae­trile .

• FDA is receiving 50 inquiries or more each month from Con ­gressmen on behalf of constituents interested in Laetrile.

• A Federal judge in Oklahoma recently ruled that any American victim of terminal cancer wishing to import Laetrile for his own use should be allowed to do so without Government intervention.

Laetrile and the Health Professions

In December 1976, the House of Delegates of the American Medical Association adopted the re­solutions shown in the box on page 4.

On December 16, 1976, the National Nutrition Consortium, Inc, with its reputable member socie­ties, including the American Dietetic Association, American Institute of Nutrition, American Society of Clinical Nutrition, Institute of Food Techno ­logists, Society for Nutrition Education, American Academy of Pediatrics, and Food and Nutrition Board of the National Academy of Sciences ­National Research Council, issued a formal state­ment which said, in part: " .. . there is no recog ­nized Vitamin Bl 7 or any possible need for the substance so named."

FDA is aware of State medical board disciplinary actions in California, Ohio, and elsewhere involving _

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physicians who deal in Laetrile . We are assisting those medical boards in any way possible in con­nection with these actions.

FDA will attempt to honor every official request from State legislatures to provide expert witnesses and medical testimony in any hearings held on pro­Laetrile legislation and its status under the Federal Food, Drug, and Cosmetic Act .

FDA has prepared a brochure on Laetrile 4 which sets forth, for the layman, the history of this sub­stance. This brochure may be helpful to physicians who treat cancer patients and whose patients ask about Laetrile . Physicians can obtain "rnultiple cop­ies of the brochure, called "Laetrile : The Making of a Myth," by writing to Professional Communica­tions, Food and Drug Administration, HFG -25, 5600 Fishers Lane, Rockville, Maryland 20857 .

References . l. Editori al: Laetrile: quacks and freedom. Brzt Med J 1 :3-4 (Jan

1) 1977.

Gonad Shielding In Diagnostic Radiology

FDA recommends th at specific area gonad shielding be used on patients during diagnostic x-ray procedures. To enable all individuals respon ­sible for performing x-ray examinations, to make informed decisions on when to employ the shield­ing, the Agency has published criteria .1 Gonad shielding should be used when:

1. The gonads lie within the primary x-ray field, or within close proximity ( about 5 cm).

2. The clinical objectives of the examination will not be compromised.

3. The patient has a reasonable .reproductive po­tential.

The recommendation covers shielding for both males and females. But it states: "The use of spe­cific area ovarian shielding is frequently impractical at present because the exact location of the ovaries is difficult to estimate, and the shield may obscure visualization of portions of adjacent structures . '.' ..

Shielding is accomplished without adversely af­fecting radiological diagnoses by placing a suitable thickness of lead or lead -impregnated material be­tween the radiation source and the gonads. This is desirab le during x-ray examinations to minimize

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AMA RESOLUTIONS

RESOLVED That the American Meclical Association continue to inform the public of the danger of de lay in the cliagnosis and treatment of malignancies by methods not generally recognized by the medica l profession as beneficia l and effective; and be it further

RESOLVED, That the American Medical Association inform the public that the safety and efficacy of amygdalin for the treat­ment or palliation of malignancies is unproven and that the use of amygdalin in such cases exploits the victims of malignancies and their families by preying upon the emotions of the hope­lessly ill, in some cases for the profit of the unscrup ulous.

House of Delegates December 1976

2. Holden C: Laetrile : "quack" cancer remedy still brings hope to sufferers. Science 193: 982-985 (Sep 10) 1976.

3.Jukes TH: Laetrile for cancer. JAMA 236: 1284-1286 (Sep 23} 1976.

4. Laetrile: the making of a myth. FDA Consumer 10: 5-9 (Dec­Jan) 1977.

5. Laetrile. Administrative rul e making hearing . Fed Reg 42 : 10066-10069 {Feb 18} 1977.

exposure of germinal tissue to radiation that could produce adverse effects in future generations .

Unfortunately, gonad shielding has not been routinely used in diagnostic radiology . This situa­tion has persisted even though the mutagenicity of ionizing radiation is widely recognized . Inadequate use of shielding may be due to lack of emphasis on its importance during training of physicians and technologists as well as lack of commercially -avail­able, clinically-effective shields. Now, however, several types are available and practical guidance on selecting and using them is available in a Gov­ernment publication. 2

.FDA expects to publish additional recommenda­tions concerning voluntary protection of the public health from electronic product radiation . In formu­lating these recommendations, the advice of physi­cians and radiologists will be actively solicited.

References 1. Amendment, Subpart C (Racliation protection recommenda ­

tions), Part 1000, Subchapter J, Chapter 1, Title 21, Code of Fed­eral Regulations: Specific area gonad shielding. Fed Reg 41: 30327-30329 (July 23) 1976 .

2. DHEW Publication (FDA) 75-8024: Gonad Shielding in Diag­nostic Radiology. Single copies available free from the Bureau of Radiological Health (HFX-28), 5600 Fishers Lane, Rockville, MD 20857.

DEPARTMENT OF HEAL TH, EDUCATION, AND WELFARE Public Health Service Food and Drug Administration Rockville, Maryland 20857

Official Business

Postage and Fees Paid U S. Department of H E W HEW 393

FIRST CLASS

,, '•

Volume 7 Number 5

dru ·· November - December 1977

lnformati .on of importance to physicians and other .. health professionals

TOXICITY OF LAETRILE ...

FDA.ar~ai! . bUliltin

November - December 1977 Donald Kennedy, Ph D . Commissio11cr William V. Whitehorn, MD, Assistant Commiss ion er for Professional and Consumer Programs, Editor -in-Chief Eric W. Martin, PhD, Direct or of Professional Communications , Editor

TOXICITY OF LAETRILE

This update on Laetrile is int end ed to alert health professionals to new hazards associated with the product and to report on the changing status of issues discussed in the January-April 1977 issue of the Drug Bulletin.

Diversi on of cancer patients from effec tive ther­apy remains the maj or haza rd in the promotion and use of Laetrile. Tragic results of its use are seen in pati ents who co uld have been help ed had they continued or und ertaken effect ive therapy . Case re­ports on such unfortun ate pa t ients were unc overed during the court ordered FDA review and public hearing and durin g the California Board of Medical Examiners hearing which resulted in a license revo­cat ion.1 Since mor e and more of these tragic cases are surfacing as malp ract ice' cases are being filed and coming to tri al, th e FDA Consumer publish ed an art icl e on this subject. 2

Hazards in the Use of Laetrile

While a great deal of co ntrov ersy surround s the actual identit y of Laetrile,3 proponents of the drug as well as the scient ifi c co mmunity genera lly -agree that material known in the US as Laetri le is act u­ally amy gdal in. This glycos ide con lain s cyan ide, a pot ent and ra pidl y acl ing resp iral ory enzy me po i­son.

Altho ugh the fact that Laetri le co ntains cyanide has long bee n known some of the older cases of cyanide poisoning from amyg dalin and related cya­nogen et ic glycos id es have only recently been co l­lecte d and reporte d together with severa l new cases of cyanide poisoning and o th er adverse reactions from the drug . Some 3 7 po isonings and 1 7 deaths, mos tly from ingestion of apr icot or othe r fruit ker­nels , have now been recorded in the foreign and American medical literature .4 Exce llent summaries of both acute and chro ni c cya nid e toxicity produc ed by ingestion of amygda lin and related

glycos ides appear in a re cent co mpr ehensive medi­cal revi ew. 5

The precise m echanism of cya nid e release is un -clear in many situations. We do kn ow th at its re-lease from amygdalin occurs in the pres ence of hydroly z ing {3-glucosidase enzymes wh ich are present in some raw fruits and vegetables. Lett uce, mushro oms, certain fresh fruits, gree n pepp ers , ce l-ery, and sweet almonds aH co ntain th ese enzy me s. Thus ingestion of any of th ese un coo ked foods with amygdalin ca n produc e cya nide intoxi ca tion. Whether or not the bacter ial flora of the gastro in­testinal tract contain the enzymes is unkn o.vn . In­tra cellul ar hydrol ys is of amygdalin probabl y does occ ur, however, in the in test inal mucos a and within the liver, wher e the {3-glucosidases occur as lysoso mal en-z-yn,c:-s. Nork: co e1ucidace chese mec h-- -- ~

anisms is in progr ess . 6

Acute Tox icity

When released in the gastrointestinal tra ct, cya­nid e is rapidly absorbed and promptly inhibits ce l­lular respiration by reacting with cytoc hrome oxi­dase. The resulting cyto toxic hypoxia produces dizziness, nausea, vomiting, hypotension, shock, stupor, co ma, respiratory failure, and death . When given by intr avenous inj ec tion th e fate of amygda­lin is obscure but it is less toxic th an wh en in­geste d. However, some of the findings descr ibed above, may also follow paren t era l administratio n.

The first rep orted case of cya nid e poisoning from Laetr ile in the US was the death of an 11-month- old girl in Attica, New York, in Jun e 1977. 7 She accidentally inges ted up to 5 tablets ( 500 mg/ ta b) of Laet ril e. Clinic al and postmortem examinations confirmed cyanide intoxication in this case. A pr eliminar y report suggests a fat al over­dose also i11 a 1 7-year-o ld girl-in - Califo -rnia-iolf ow ­ing ingestio n of the co n tents of several ampul es (approximately 10.5 gra ms) of Laetrile for injec­tion. 8

Because he alth prof essionals have only recently beco me awa re of the potential for cya nide toxicity from amygdalin, testing for cya nide levels in ca ncer patie n ts receiving La etr ile or at post mort em has be en rare. Indeed, some deaths ascribed to cancer, particularly in debilitat ed patie nts , may have been either due to or acce lera ted by cyanide from the dru g. Further studies should be und erta ken to de­termine whether this is tru e or not. Meanwhile, clini cians should be alert t o the signs and symp ­toms of cya nide intoxic at ion.

The most co mpr ehens ive clini ca l data on chronic cya nid e intoxicati on appea rin g in the medical liter -

26

ature are based on foreign cases. Such poisoning has been seen extensive ly in Nigeria and other areas where cassava root is a staple. Its tuber contains a cyanogenetic compound similar to amygdalin and, unless the food is properly processed to remove the glycoside, ingestion leads to tropical (nutritional) ataxia. 9

Chronic ingestion of cassava root has been re­ported to elevate thiocyanate blood levels thus leading to goiter and a potential increase in the incidence of thyroid cancer. Furthermore, birth de­fects may develop in the offspring of mothers who have ingested cyanogenetic substances during preg­nancy. 5

Other Adverse Reactions

Adverse reac;.tion. reports _for Laetrile include hypotension, hemoglobinuria, gastrointestinal hem­orrhage, vomiting, headache, and diarrhea. 5 Recent reports from Georgetown Univers ity include aller­gic reations. These have ranged from an acute epi ­sode of fever, rash, and gastrointestinal symptoms to proximal muscular weakness. In one case rever­s al of symptoms occurred on withdrawal of Laetrile and reappeared on resumption. 1 0 In addi­tion, FDA has received other reports of adverse reactions through its own established reporting systems ..

Potential Problems Related to the Pharmaceutical Product

FDA h as no con tr ol over the manufacture and distribution of Laetrile. There is no way to ensure quality of the drug or to take action when a harm­ful sample is found. Because lot numbers are not used regularly, quality control defects cannot be determined or the drug recalled from distribution. Therefore, it is very tltfficult - to-ptotect the con­sumer when hazards are identified.

Nevertheless, many deficiencies in the manufac­ture of Laetrile have been detected. Fungal con­tamination has been found in a sample of a Mexi­can parenteral formulation of the drul 8While no specific problems secondary to microbial con­tamination have been reported yet, the potential for severe systemic infection ( eg, endocarditis, mul­tiple abscesses, hepatitis, etc) is significant. Fur­thermore, pyrogen tests conducted on a sample at one laboratory were positive. At another labora­tory methyl and isopropyl alcohols were found as adulterants in the parenteral formulation. Still other analyses have revealed subpotency. Leakage of some ampules has been detected and can lead to entry of contaminants. Autoclaving, which causes

FDA Drug Bulletin

stereochemical inversion of the mandelonitrile portion of amygda lin, may cause the drug to have physiological properties radically different from those of the naturally occurring substance . An ad­ditional impurity of unknown toxic potential, amygdalinamide, has also been identified in the in­je ctable formulation.

Use of Laetrile - Toxicity Implications

Most heal th professionals are aware of Laetrile's potential for harm through delay or avoidance of traditional therapy. But because of the widespread use of Laetrile, health professionals must be alert also to the potential hazards of cyanide poisoning and other complicat ions associated with use of an untested drug of dubious identity and uncertain manufacture. The following are important sug­gestions for physicians who see patients on Lae­trile: • Remain alert to signs and symptoms of acute

and chronic cyanide intoxication and be pre­pared to administer emergency treatment with full knowledge of its potential complications.

• Warn patients who use Laetrile against taking the parenteral preparation by mouth, since the high concentration can be rapidly fatal.

• Observe for pyrogen reactions and septic compli­cat ions in patients who use intravenous Laetrile.

• Be alert for other adverse or unusual reactions such as those already reported in the literature.

• Report all adverse reactions including toxicity to: Division of Drug Experience

HFD-210 FDA 5600 Fishers Lane Rockville, MD 20857

Use of Laetrile - Legal Implications

FDA recom -mend~- t-hal phy~ "i-ei-;:rw,- dnd pharma­cists become fully informed of the legal impli­cations of prescribing or dispensing Laetrile for pa­tients. There is wide variability in the laws of the 12 states which have legali zed use of the drug. In one state a legal opinion declares that the Laetrile law is in direct conflict with other laws of that state. In states where Laetrile is "legal" physicians and pharmacists should seek legal counsel to ac­quaint themselves with the often conflicting Fed­eral and State laws before prescribing or dispensing the drug. • Passage of state legislation does nqt protect

sponsors, promoters, distributors, dispensers, or sellers of Laetrile from applicable civil or crimi­nal sanctions under the Federal Food, Drug, and Cosmetic Act.

31

FDA Drug Bulletin Nov em ber - Decemb er 1977

• Passage of sta te legislati on does not prov id e immuni ty fr om malpract ice suits. In fac t, several are now pend ing and a m aj or in sur er in one state where legislat ion has bee n passe d is reported ly refusin g to insur e ph ys icians again st damages fro m Lae tril e use.

• Lit erat ur e regardin g th e stat u s and use of Lae­tr ile is availabl e fr om FDA.

Recen t Devel opmen ts

sumpt ion t hat sin ce Laetril e is "o bvi ously safe" th ere shou ld be "freed om of ch oi ce" to take it.

In format ion such as the FDA Commi ssione r 's report sho uld be usefu l to state legislat o rs . In addi ­t ion t o this report ma ter ials u seful fo r p ati ent s and t he pub lic in general are : La e trile : Th e Poli tical Succ ess of a Scientif ic Failur e;1 3 L aetri le : The Maki ng Of A My th; 1 9 Canc er Quack ery : Past A nd Present ;2 O Cancer Drugs That Work,2 1 and La e­trile: Th e Fatal Cure. 2 These are suit abl e for health profe ssiona ls and schoo ls as well as civic and con­sum er gro ups. Sp eaker s knowledgea ble on Lae tri le can be co ntact ed t hroug h FD A's regional and dis­tr ict offi ces.

T he prog ress of pro -Laet ril e legislatio n in state legislat ur es has bee n slowed and in some cases re­versed. As of Septem ber 1, 1977, at least thre e state legislat ur es had vote d down bi lls legalizing t he drug int rasta te. T he governors of New York and Illi nois vetoed Lae tr ile bill s du rin g August . FDA Co mm issioner Kennedy tes t ified befo re th e Cali­forn ia State Asse mbl y Health Co m mittee whic h subse qu entl y vo ted dow n the bi ll for the stat e. Other st ate legislatures with Laetr ile bi lls ad- 1

j ourne d withou t fin al act ion. Clearly, a nu mb er of st at e legislatu res h ave now paus ed to ta ke a second look at th e scient ific meri t s an d cons um er pro ­tect ion issues invo lved .

R eferences l . Admin ist rati ve Record : In Matt er of a Ru lem aking Pro cee din g

Con ce rn ing Lae tri le (d oc ket # 77N -0048) : _ R 429 Verif ied s ta tement o f Andr ew I. Cederbaum , MD R 388 Affid avit o f J ack R. Coop er , MD R 178 Aff idavit of Jo hn T .P. Cud mo re, MD R 428 Verifi ed s ta tement o f Lawr ence H . Einh orn , MD R 179 Affid avit of William J . Evans, MD R 188 Affidav it o f William A. No len , MD R 193 Veri fied st a tement o f J ac que s V. So uadji an , MD R 196 Verif ie d state ment o f Rob ert W. Tal ley, MD R 19 7 Verified stat e ment of Do nald C.S. Ta n , MD

2. Lae tr ile : T he Fat al "Cure ". FDA Consumer 11: 10-1 5 (Oct) 1977.

Art icles in the lay press have help ed expose the lac k of credib ility of maj or Laetr ile prop onent s and traff ickers and h ave prov ided the pub lic with obje ct ive info rm ati on. 11 ·l 3

Meanwhi le, furt h er report s of lac k of effi cac y in ani mal t esti ng h ave been made pu b lic.14- 16 A maj or h earing in Jul y before the US Senat e Sub­com mi tt ee on Hea lth and Scientific Research ex ­posed the lack of evidence of eff icacy as well as new con cerns abo ut Lae tr ile tox icity. At th at hear­ing, Comm issione r Kennedy det ailed h is review of an unpr ecede nted ad min istrat ive reco rd compi led du ring the previous six months at th e requ est of J ud ge Lut her Boh anon of Ok lah oma City .1 7 The Commissio ner 's exhaust ive review was pr int ed in fu ll in th e Federal R egis ter on August 5, 1977 , and a su mm ary o f the most signifi can t find ings was re ­lease d t o the press .3 The fin d ings of serious tox­icity, adverse react ions, and deat hs were of such concern that th e Sur geo n General of th e US Pub lic Hea lth Serv ice ann oun ced the hazards to the gen­era l publi c, whi ch includ es the small num ber of peop le wh o are legally receiv in g Laetr ile under a co ur t order pend ing out come of ju dicial review of t he Commi ssioner 's findin gs.1 8 This review is st ill m progress.

T he t ox icit y co ncern s contr ast wit h Lae tril e pro ­mot ion to the American publi c as " harm less" t her ­apy . To a large exte nt, the legalizati on effort in num ero us states h as bee n spa rked by th e false as-

32

3 . Co mmi ssion er' s Decision on Status of Laet ril e , Fed R eg (Au g 5), 4 2 : 39768 -39806, 1977 , an d FDA Press Release, Au g 4 , 1977.

4 . Ross JF: Th e harm fu l e ffec ts o f La e tril e, apri co t kern e ls, and o th er cyanoge ni c fruit an d vege tab le ma terials on hum an beings; and th e ine ffec ti veness of Lae tr ile as a the rape u t ic agent in pa tient s with cance r, Stat ement Prese nt ed to Sub com mitt ee on Hea lth and Scien­t ifi c Resea rch , Commi t tee o n Hu man Reso urces, Uni ted Sta tes Sen ate, Jul y 12, 19 77.

5. Lewis JP : Lae tr ile. West ] Me d 12 7 : 55 -.E,2 \J\u g) 1977. 6 . Person al co mmun ica t io n from Eric E. Co nn and Michae l P

St one, Sept emb er 30 , 19 77. 7 . Hu mb ert JR , Tress JH , Bra ico KT : Fat a l cya n ide poi sonin g:

acc iden ta l ingestion of am yg dalir. JAMA 238 : 482 (Au g 8 ) I 977 . 8. Sadoff L, Fu chs K , and Ho lland er J : Rap id dea th assoc ia ted

with Laet ril e in gesti o n. JA MA (in pr ess) . 9 . Osunt o kun BO : At axic ne u ropat h y associa ted with hi gh

cassava die t s in Wes t Afric a . Chron ic Cassava Toxic ity (Ed s: Nes tel B, and MacInt y re R) . Int ernatio nal Deve lopm ent Researc h Ce nt er, Ot taw a , Canad a, 197 3 .

10 . Sm ith Fl', Bu tle r TP, Cohan S, Schei n PS : Lae trile tox ic it y : a report o f tw o cases.J AMA 238 : 136 1 (Sep 26 ) 1977. -

I l. New York Times, Ju ne 26, 1977. !2 . N ewswee h,Jun e 2 7, 1977; Tim e, Ju ne 20 , 19 77. 13. Edit o rial : Lae tr ile - The p olit ica l succ ess of a sc ientifi c failure .

Consu mer R eports 4 2 :444-7 (Au g) 1977 . 14. Sto ck CC, T arn owski GS , Schm id FA, e t al: Ant itum or test s

o f am yg dal in in t ran sp lant able an im al tum or sys tem s. J Surg Oneal (in pr ess ).

15 . Sto ck CC, Ma rt in DS , Sugiu ra K, et al: An ti tum or tes ts of amygdalin in spontan eo us ,m im al tu mor systems. ] Surg Onco l (in press ).

16. Ovejera AA, Houchens DP , Bark er AD, et a l: DL -Am yg dalin: ina ct ivity in the trea tm en t of hum an tum or xe no gra ft s in a thymi c nud e mice . Science (in pr ess ).

17. Kenn edy D: St ate ment on Lae tri le . Presente d to th e Sub co m­mitt ee on Health and Scien t ific Research , Co mmitt ee on Human Reso urces, Un ited St a tes Senate, Jul y 12, 19 77 .

18. St a tem ent by Su rgeon Genera l, Aug 9 , 19 77 (ava ilab le from Offi ce o f Assist an t Sec re ta ry for Hea lth ).

19. Laetri le : the making of a m y th . FDA Consum er I 0: 5-9 (Dec -J an) 1977.

20. Cance r quac kery : pas t and pr ese nt . J anssen WF: FDA Con ­sumer 11 : 27- 3 2 Ou l - Aug) l 977 .

2 1. Canc er Drugs Tha t Work. FDA Consum er 11: 18-2 1 (Oct ) 1977.