nutrition education

Pangamic acid (‘ ‘vitamin B15’ 8)1

Victor Herbert,2 M.D., J.D.

A cover story in the March 13, 1978 issue tions, and even cell proliferation . . . eczema
of New York Magazine (1) lauded B15 “as a . . . arthritis, neuritis .. .“Not a sliver of data
possible cure for everything short of a transit is present in the patent application (3) to
strike.” The article, according to a note on support any of these snake-oil panacea claims
the masthead page of New York Magazine it suggests.
on April 3 “made it impossible to find the Two decades ago, pangamic acid was pro-
vitamin on any dealer’s shelf in the metro- moted for horses (1, 6), but it has been heavily
politan area for a full week.” promoted for humans since publication of a
“Vitamin B15” is the latest rage in health review by the stepson of Ernst Krebs, Jr. in
food stores in the United States (1). Numer- World Review of Nutrition and Dietetics (7).
ous articles have appeared in lay publications Without citing supporting evidence from any
and on radio and television extolling this country’s national nutrition policy body, the
substance. Yet, according to the Food and review alleged that “pangamic acid has been
Drug Administration (2), vitamin B15 is “not widely studied and accepted in many coun-
an identifiable substance . . . not a vitamin tries as a necessary food factor with important
nor a provitamin . . . no accepted scientific physiological actions.” It dated the history of
evidence establishing any nutritional proper- pangamic acid from 195 1 and did not men-
ties of the substance or any deficiency . . . in tion the earlier work by Krebs, Sr. or the
man or animal . . . no medical, nutritional, or pangamic acid patent sought in 1943 by
other usefulness for these substances has been Krebs, Sr. and Jr. (3), in which they claimed
established.” pangamate had the property of providing
relief for everything from eczema to cancer.
Background The review also failed to note the back-
In 1943, Ernst Krebs, Sr. and Jr., applied grounds of the American creators and pro-
for a patent for material similar to that pre- moters of pangamate or their difficulties with
viously discovered by Krebs, Sr., and isolated the health authorities and the law in connec-
from apricot kernels, which they named tion with it, and in connection with their
“pangamic acid” (3). Krebs, Sr. and Jr., then concurrent promotion of laetrile (4, 8). The
trade-named such material vitamin B15, just review acknowledged that “this work was
as Krebs, Jr. trade-named amygdalin, another funded in part by a grant from the Mc-
chemical also isolated (in 1830) from apricot Naughton Foundation.” The author was for-
kernels (4, 5), first as “laetrile” and subse- merly a Research Associate at the Mc-
quently as “vitamin B17.” The B15 patent Naughton Foundation3 in Mill Valley, Cali-
claimed pangamate is “a preparation for the
1 Supported in part by the Veterans Administration
immunization of toxic products present in the
Medical Research Program and in part by United States
human or animal system” which has “the Public Health Service Research Grant AM 20526.
property ofdetoxifying toxic products formed 2 Director, Hematology and Nutrition Laboratory,
in the human system” . . . “This invention Bronx Veterans Administration Hospital and Professor
of Medicine, SUNY Downstate Medical Center, Brook-
relates to a preparation for relief and immu-
lyn, New York. Author reserves the right to republish.
nity to persons afflicted with asthma and .1 As indicated elsewhere (4, 8), Andrew McNaughton
allied diseases . . . affections of the skin, res- appears to be a laetrile factory owner with two criminal
piratory tract, painful nerve and joint affec- convictions, and Krebs appears to be a medical school

1534 The American Journal ofClinical Nutrition 32: JULY 1979, pp. 1534-1540. Printed in U.S.A.

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 PANGAMIC ACID (VITAMIN B5) 1535

fornia (9), and had previously published re- heed the humorous but valid scientific dic-
lated material in that capacity (9). The tum, “Garbage in, garbage out.” The poorly
McNaughton Foundation publishes lay designed studies with conclusions not derived
booklets which promote pangamate (B15) and from the data, studies lacking adequate con-
laetrile (B17) as if they were vitamins. Among trols, could not produce meaningful positive
their booklets sold to the public at health information.
food conventions are the “Physician’s Hand-
book of Vitamin B17 Therapy,” published 18 Chemistry
October 1973 ($2.00), and “Vitamin B17, Vi-
tamin B15 and Vitamin B13,” published 12 Krebs et al. (10) and a number of Russian
June 1975 ($ 1 .50). The latter booklet states workers cited by Stacpoole (7), used the term
on page 17, “A review, ‘Pangamic Acid (Vi- pangamic acid to describe a product, claimed
tamin B15)’ will shortly be published by Dr. isolated from various plant sources, and also
Peter Stacpoole in The American Journal of obtained by laboratory synthesis, which had
Clinical Nutrition and lists over 125 references the empiric formula C10H1908N, d-glucono-
to studies on pangamic acid, most of them dimethyl aminoacetic acid (an ester of d-glu-
clinical.” In fact, The American Journal of conic acid and dimethylglycine (glycine is
Clinical Nutrition rejected the review as in- aminoacetic acid)), molecular weight 28 1 dal-
adequately scientific for the following rca- tons, has an unstable ester bond, and does
sons: not crystallize (1 1). The synthetic Russian
The title of the review declared pangamate preparation of calcium pangamate crystal-
a vitamin (with no qualifying quotation lizes with a water molecule and has a molec-
marks). The review did not cite the position ular weight of 618.7 and four methyl groups
of either the Canadian or United States food (from its two pangamate monomers) (1 1). It
and drug authorities that not only was there is described as a mixture consisting of no less
no evidence pangamate was a vitamin, but than 70% of the calcium salt of gluconic acid
also no acceptable scientific proof it had any ester and dimethylglycine, no more than 25%
therapeutic benefit or was safe for human use calcium gluconate, and no more than 6%
(2, 6, 7). In the review, none of the biochem- calcium chloride (1 1), (which can be a poison
ical data gave any description of biochemical ( 15)). It is slightly hygroscopic and must be
or chemical reactions that take place physio- stored dry and sealed to retain stability (1 1).
logically. Data on absorption, blood levels, It is a white powder, soluble 1 : 1 in water,
urine levels, excretion, degradation, etc., of relatively stable in acid, and resists heat to
pangamic acid were not provided. The usual 100 C when dry (1 1). It has a characteristic
toxicological studies were not described. No weak amine odor and a slightly bitterish taste
dose response data were provided. The cmi- (1 1). The Merck Index, 8th edition, 1968 (5),
cal data were not obtained under controlled notes pangamic acid as a mixture of sodium
conditions. There was not a critical evalua- gluconate, glycine, and diisopropylamine
tion of the literature, which might help the dichioroacetate. The 9th edition of the Merck
reader assess the various claims of different Index (12) gives the structure as D-gluconic
investigators. It was not convincing that the acid 6-bis (1-methylethyl) amino acetate. The
claims had any foundation in fact. Most of editor of the Merck Index indicated to this
the claims were conclusory statements cx- reviewer that “pangamic acid” and “vitamin
tracted from uncontrolled anecdotal obser- B15” will be deleted from the 10th edition,
vations published in Russia. What was pro- since they were deceived into listing it. Prod-
vided were general statements with no con- ucts marketed as B15 or pangamic acid, or
trolled data. No negative or contradicting calcium pangamate could contain any or all
data were cited. Although no amount of un- of the above materials, plus other materials,
controlled or anecdotal studies nor the num- since there is no standard of identity for the
ber of papers published determine whether product. The term pangamic acid appears to
or not a substance is a vitamin or whether it be used indiscriminately regardless of which
has physiological functions, the author took of various adducts are on the ester linkage.
all of these deficient studies and attempted to
derive meaningful positive information from flunk-out with at least one criminal conviction. They
quantity instead of quality, appearing not to appear to interact closely in promoting B,5 and B17.

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 1536 HERBERT

Those B15 products containing the chloride cyanosis and respiratory failure (13). The ma-
ion may be synthetic, and for them the des- terial is nutritionally worthless and may be
ignation “derived from natural sources” is one of the “toxicants occurring naturally in
meaningless. The Russian preparation is also foods,” others of which are described in the
synthetic, as appear to be the American book of that name published by the National
equivalents of it. Academy of Sciences, Washington, D.C.,
The Food and Drug Administration has 1973 (15). It is pertinent that the term “pan-
repeatedly seized i tablets that include mix- gamic acid” (Gr. pan = universal; gamic =

tures of calcium gluconate and dimethyl gly- seed) was coined to describe the claim that
cine marketed under various names such as the substance is frequently found in seeds,
calcium pangamate, Aangamik and Caldia- which is also the case for cyanide (15). Stac-
mate, and default decrees have ordered their poole et al. (14) reported on certain acute
destruction. The chemical composition varies metabolic effects ofdichloroacetate, and state
from product to product4 and its various pro- “the efficacy and safety of chronic dichlo-
moters and vendors designate its chemistry roacetate administration are unknown.”
differently from year to year and from article Their findings made a case for its use in the
to article, hence the FDA statement that it is short-term treatment of acute life-threatening
“not an identifiable substance” (2, 5-7). lactic acidosis, hitherto often fatal. One can,
Krebs appears to have been selling a product of course, legitimately use poisons to save
containing calcium gluconate, because testi- lives in acute emergencies (such as the use of
mony in his probation revocation case (4) nitroprusside in acute hypertensive emergen-
included that “. . . there were three probation- cies). However, question has been raised as
ary searches . . . on each occasion there were to whether dichloroacetate offers anything
empty barrels of calcium gluconate . . . these over bicarbonate in treatment of lactic aci-
were all 200 pound drums . . . sales rec- dosis (16). Additionally, the substance has
ords . . . 1975 . . . $10,310 passed from Mr. been shown to inhibit the pyruvate trans-
Bradford to Mr. Krebs for the B15.” porter in rat liver mitochondria in vitro,
Because oflack ofany proofthat pangamic which would be an undesirable effect if re-
acid is either a definite chemical entity, safe producible in humans (16, 17). Adverse ef-
for human use, or of any therapeutic benefit, fects noted by Stacpoole et al. (14) included
its distribution in Canada is prohibited by mild sedation and increased serum uric acid
that country’s Food and Drug Directorate levels in diabetic patients. Crabb and Harris
(6). The pangamic acid (vitamin B15) sold by suggest that dichioroacetate (DCA) may pro-
one corporation for chemical and investiga- duce oxalic acid stone formation and renal
tional use proved to be a mixture of diisopro- dysfunction, because DCA converts to gly-
pylammonium dichloroacetate, sodium glu- oxylate which is a precursor of oxalate (17a).
conate, and glycine (6). Correspondence in Aliphatic halogenated hydrocarbons have
1978 with their successor organization has recently begun to cause concern regarding
not revealed what is packed under the pan-
4 Claimant’s Answer to Government’s Written Inter-
gamic acid (vitamin B15) label of the material rogatories (Interrogatory No. 2) in U.S. v. Aangamik 15
purchased in 1978 from them. In the course Calcium Pangamate, etc. (Consolidated Cases Nos. 77C
of our correspondence with them, they at- 662, etc., U.S. Dist. Ct., N. Dist. Ill., E. Div.) states the
seized calcium pangamate was a blended mixture of N,
tempted unsuccessfully to get additional spec-
N-dimethylglycine hydrochloride, calcium gluconate, di-
ifications or analysis from their European calcium phosphate, stearic acid, and avicel. Claimant’s
supplier, and then discontinued sales. Answer to Interrogatory no. 9 stated there are about 20
mg of dimethyhglycine in 100 g of meat eaten by man,
Pharmacology but did not state whether any of it was free (as in
claimant’s product) rather than bound, or whether any
The gluconic acid,glycine, and acetate in
of it was dimethylglycine hydrochloride (as in claimant’s
some of the formulations are essentially inert. product). In his order of December 5, 1978 denying
One pharmacologically active agent is diiso- defense motion for rehearing in U.S.A. v. . . “B7 (so-
propylamine, which has been studied by dium pangamate) 50 mg . . .“, Civil Action no. 76-1860,
Kraushaar and others (12, 13). This amine U.S. Dist. Ct., Dist. of N.J., Judge Curtis Meanor stated:
“the chemical composition of the articles under seizure
acts on smooth muscle to lower blood pres-
is 64% calcium gluconate, 16% glycine, and 20% of the
sure and decrease body temperature (13). salt formed from di-isopropylamine and dichloroacetic
Acute toxic doses cause death in rodents by acid.”

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 PANGAMIC ACID (VITAMIN B5) 1537

their carcinogenic potential because of the pool, as do similar oxidation products of

ease with which they can form free radicals many substances. The Krebs patent “N-sub-
(18). The potential of dichloroacetate for car- stituted glycine esters of gluconic acid” (22)
cinogenesis therefore requires evaluation. We states “a particular object is to provide syn-
recently found it mutagenic by Ames test thetic compounds . . . which are more effec-
(19). It should be noted that toxic cataracts tive methyl donors than known methyl do-
frequently appear months or years after nors such as methionine and choline,” but no
chemical or drug exposure (20), and the con- data are presented to support the claim that
nection to prior drug or chemical exposure any of the “pangamates” in the patent is
may not be made in the absence of adequate labile. Indeed, the diisopropylamino product
alertness. A year ago this reviewer requested cannot be a methyl donor because its methyl
information from Stacpoole on possible mu- groups are on C, and only methyl groups on
tagenicity and cataract production by DCA. an N or an S can serve as methylating agents,
Subsequent to our preliminary report on and then only when there is no need for an
DCA mutagenicity (19), Stacpoole et al an- added energy source. This is not the case for
nounced the suspension of chronic oral ad- dimethylglycine, a product of choline catab-
ministration to patients on the basis of serious olism, which is synthetically attached in an
toxicity to animals and at least one human ester linkage to gluconic acid in some pan-
(20a). There was dose-related hind limb pa- gamate formulations. Its methyl groups, like
ralysis, germinal epithelial degeneration of those of sarcosine, are not labile, and so must
the testis and vacuolation of the myelinated be removed by oxidation and only then can
tracts of the cerebrum in rats and dogs. Dogs enter the one-carbon unit pool (23, 24). It was
also showed severe ocular lesions including established in 1946 that dimethylglycine was
irreversible lenticular opacities. A man de- not lipotropic (24). It enters one-carbon me-
veloped polyneuropathy. DCA may be more tabolism at the oxidation level of formalde-
toxic orally than parenterally (20a), as is the hyde, and worsens methyl depletion of rats
case for laetrile (4). on diets creating methyl deficiency who are
The d-gluconodimethyl aminoacetate for- given nicotinamide supplements, resulting in
mulation has been reported to have neuro- renal cortical necrosis in mature females and
muscular blocking activity in rabbits and damaged growth and development of fetal
chickens and to produce hypotension in dogs rats (24a). Alkali-metal (Na, K, NH4) salts of
(21). Russian calcium pangamate of this for- dimethylglycine are claimed to chelate alka-
mulation is contaminated with up to 6% cal- line earth metals (Mg, Ca), thereby rendering
cium chloride (I 1), and all calcium panga- absorbable certain sulfated polysaccharides
mate ofsimilar formulation should be consid- claimed to be lipemia-clearing (24b). The
ered contaminated with calcium chloride un- safety and efficacy of such claimed effect
til proved otherwise. It is possible that con- requires evaluation before use (see Adden-
tamination with dichloroacetate may also oc- dum).
cur, and this possibility should be evaluated Dimethylglycine (N-methylsarcosine), a
in each preparation. tertiary amine, reacts with nitrites (which are
Some formulations of pangamic acid con- formed de novo in the intestine) (25) to form
tam methyl groups, but these are not labile. both the potent carcinogen, dimethylnitrosa-
Furthermore, there is no published data that mine, and the weaker carcinogen, nitrososar-
the large promoted doses of such formula- cosine (26). Nitrites that effect this reaction
tions normally are found in the diet,4 concen- occur in human saliva (27), and nitrososar-
trate in human tissues, or play a salutary cosine induces cancer of the oral pharyngeal
physiologic role not due to folate or choline cavity and esophagus in the rat (27). Thus,
present in the diet (and not carried out with dimethylglycine ingested in concentrated free
less energy loss by choline and methionine). form in a tablet appears much more likely
None of the formulations of pangamate ap- carcinogenic than the same amount bound in
pear from available data to be lipotropic, or 100 g of meat4, since only the former is pre-
to be methylating or transmethylating agents. sented to the oral cavity and esophagus in
One-carbon compounds can be oxidation high concentration, and the dimethylglycine
products of some of the formulations, and in human muscle as a catabolic product of
those products can then enter the one-carbon choline is not presented at all to the oral

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 1538 HERBERT

cavity and esophagus. Additionally, what patients afterinforming them that it is not a
purveyors of pangamate” and B15 appear to vitamin, hasno known nutrient value, no
be selling is not dimethylglycine, but di- known value in the long-term treatment of
methylglycine hydrochloride, of different any diseases, its safety has not been estab-
composition and reactivity. lished, and it may be mutagenic. The claim
Hundreds of compounds found in seeds that “B15” supplies calories is deceptive and
and plants have chemical and pharmacolog- misleading. Carbohydrates and proteins sup-
ical effects. This does not make them nutri- ply 4 cal/g and fats supply 9 calories per g,
ents or physiological. Many are poisons (15), so the most a 50 mg tablet of “B15” could
as is DCA (20a), described by Krebs in the supply, regardless of its ingredients, is less
June 1978 issue of the laetrile industry mag- than half a calorie.
azine “Choice” as a “sister compound” of B15 As noted elsewhere (4, 29), there are four
(19). basic scientific canons for evaluating medical
information:
Clinical use
1) Does it go beyond “personal observa-
The allegations of long-term medicinal tion” to stand the test ofscrutiny and criticism
value for pangamic acid in cancer, alcohol- by other scientists, i.e., is it a study or a story?
ism, hepatitis, heart disease, allergies, diabe- Is it science or anecdote?
tes, schizophrenia, glaucoma, retarding aging,
2) Was it compared for effectiveness in
purifying air, and increasing respiratory abil- double blind controlled studies to other treat-
ity by providing “instant oxygen” are anec- ments and to suggestibility or to the “doing
dotal and testimonial stories rather than stud- of nothing,” i.e., to a placebo? What is the
ies, and lack comparison for effectiveness in natural history of the disorder in the absence
controlled studies to other treatments or to of therapy? Was the observed result of cause
“the doing of nothing” (6, 28, 29). A number and effect, placebo effect or coincidence due
of these stories, either totally uncontrolled or to the natural history of the disorder?
lacking the crucial choline control, originate 3) Has it been proved safe? Safe compared
in Russia. The authors often claim spectacu- to what? Is the nskjustified? What is the risk:
lar results from pangamic acid or vitamin B15 benefit ratio? (Note that if there is no benefit,
without identifying which of the many chem- the risk:benefit ratio is infinity, which is not
icals and chemical combinations which go by tolerable.)
that name they are using, without distinguish- 4) The burden of proof is on those who
ing drug effect from placebo effect, and with- propose doing or giving something, especially
out reporting any evaluation of patients for if it involves a remedy or procedure not well
short-term or long-term toxic effects. The established in medical practice.
Food and Drug Administration regards the Valid weapons against disease are forged
products as illegal whether used as a food or in the crucible of these canons. After three
as a drug, and has made a number of seizures decades, B15 has yet to successfully meet any
ofthem (2, 30). On June 12, 1978, in the New of these basic scientific challenges.
Jersey seizure case, Newark District Court
Judge Curtis Meanor upheld the Food and Conclusion
Drug Administration contention that B15 is
essentially an untested “food additive” that Pangamic acid, pangamate, and B15 are
is not generally recognized by scientific cx- synonyms for alleged
an entity that in fact is
perts as safe for human consumption and a number of different products of variable
cannot be sold legally on the market (30). composition which do not constitute a defi-
Pangamate has been prohibited in Canada nite chemical entity. The label originally de-
for more than a decade (6). Because of these scribed what may have been partly Na or Ca
facts, any physician who prescribes it should d-gluconodimethyl aminoacetate. However,
first secure an Investigational New Drug the label more often describes a product
number for it, describing which of the many which is one part sodium (or calcium) glu-
different chemical mixtures called “panga- conate, one part glycine (or dimethyl glycine);
mate” is the one to be used, should submit often also one part diisopropylamine dichlo-
his proposal to a Human Studies Committee, roacetate. Often still other synthetic mixtures
and should get informed consent from his are sold as B15 and calcium pangamate. Pan-

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 PANGAMIC ACID (VITAMIN B15) 1539

gamic acid is trade-named vitamin B15 but it nate and dimethyl glycine tablets and calcium pan-
gamate tablets. FDA Consumer 1 1(8): 36, 1977 (Oc-
has no known nutritional worth, has no vi-
tober); FDA Talk Paper T78-27. Pangamic Acid,
tamin properties, and no such vitamin exists. March 31, 1978. FDA Drug Bull. 8: 38, Dec. 1978-
In fact, pangamic acid can be said not to Jan. 1979.
exist, since there is no standard of chemical 3. KREBS, E. T., AND E. T. KREBS, JR. United States
identity for products sold under that label. Patent no. 2,464,240, issued 1949, applied for No-
vember20, 1943.
There is no proof that it has any therapeutic
4. HERBERT, V. Laetrile: the cult of cyanide. Am. J.
benefit or is safe for human use, and it may Clin. Nutr. 32: 1121, 1979.
be mutagenic. All of the B15 and pangamate 5. Merck Index (8th ed), 1968. Rahway, NJ: Merck
products being sold, including those in health & Co., Inc.
food stores, appear to be at least partly syn- 6. FRENCH, W. N., AND L. LEVI. Pangamic acid (vi-
tamin Bis, Pangametin, Sopangamine): Its composi-
thetic. The use of pangamate may violate the tion and determination in pharmacological dosage
primary ethical rule of medicine-above all, forms. Canad. Med. Assoc. J. 94: 1 185, 1966.
do no harm (31, 32). 7. STACPOOLE, P. W. Pangamic acid (vitamin B15).
In the Middle Ages, anecdotal claims of World Rev. Nutr. Dietet. 27: 145, 1977.
8. Subcommittee on Health and Scientific Research:
efficacy and safety of nostrums were auto-
Proceedings ofthe July 12, 1977 hearings on banning
matically accepted, and it was for science to of the drug haetrile from interstate commerce by
disprove them. This required science to prove FDA. Washington, D.C.: United States Government
a negative, often difficult or impossible to do. Printing Office, 420 pp.
The Age of Reason began with recognition 9. STACPOOLE, P. W. Review of the pharmacologic and
therapeutic effects of diisopropylammonium di.
that to protect the public health and safety
chloroacetate (DIPA). J. Chin. Pharmacol. 9: 282,
required adopting the rule that it is for the 1969.
proponent to prove his claim, rather than for 10. KREBS, E. T., SR., E. T. KREBS, JR., H. H. BEARD, R.
science to disprove it, and that nostrums MALIN, A. T. HARRIS AND C. L. BARTLETt. Pan-
gamic acid sodium: a newly isolated crystalline wa-
should be considered inefficacious and unsafe
ter-soluble factor. A preliminary report. Int. Red.
until proved efficacious and safe. With lae- Med. 163: 18, 1951.
trile and pangamic acid, we are in danger of 1 1. BUKIN, V. N. Calcium pangamate (vitamin B15). A.
returning to the age when anecdote substi- N. Bakh Institute of Biochemistry, Academy of Sci-
tuted for science. Both products appear to ences of the U.S.S.R. (45 page manuscript sent in
June 1978 by U.S.S.R. Ministry of Health to V.
meet the criteria that define a quack remedy
Herbert, in response to request to Russian ambas-
(4, 29, 33-37), and both appear to be more sador to the U.N. for Russian view of pangamate.
toxic on oral than parenteral administration Forwarded by V. Herbert to Food and Drug Admin-
(4, 20a). istration and available from the F.D.A. V. N. Bukin
Because of its usual content of dichioroac- and I. N. Garkina hold United States Patent no.
3,907,869 (Sept. 1975).), for “Method of Producing
etate or dimethylglycine hydrochloride, per- Calcium Pangamate” (“vitamin B15”), “consisting in
sons buying pangamate in the erroneous be- esterification of gluconic acid or the lactone thereof
lief they are purchasing nutrition may be with dimethylglycine hydrochloride in an aqueous
purchasing mutagenesis or other unknown medium in the presence of hydrogen chloride or
sulfuric acid at a temperature of from 30#{176} to 70#{176}C.
harms.
The esterification product is concentrated and neu-
The United States Food and Drug Admin- trahized with calcium carbonate to obtain aLmost
istration “Statement on Pangamic Acid”, non-hygroscopic calcium pangamate in a high yield
dated August 18, 1978, concludes: (up to 80%).
12. Merck Index 9th (ed), 1976. Rahway, NJ: Merck
“FDA considers ‘vitamin B15’ to be a food
& Co. Inc.
additive for which no evidence of safety has 13. KRAUSHAAR, V. A. E., R. W. SCHUNK, AND H. F.
been offered. It therefore is illegal for the THYM. Zur Pharmakologie des Diisopropylamine.
substance to be sold as a dietary supplement. Arzneimittel Forsch. 13: 109, 1963.
No new drug application for “Pangamic 14. STACPOOLE, P. W., G. W. MOORE AND D. W. K0RN-
HAUSER. Metabolic effects of dichloroacetate in pa-
Acid” has been submitted or approved by
tients with diabetes mellitus and hyperhipoproteine-
FDA and the substance legally cannot be mia. New Engl. J. Med. 298: 526, 1978.
marketed as a drug.” U 15. Committee on Food Protection: Toxicants Occurring
Naturally in Foods (2nd ed). Food and Nutrition
References Board, National Research Council. Washington,
1. NOBILE, P. Will vitamin B,5 curewhat ails you? New D.C.: National Academy of Sciences, 1973.
York Magazine 11(11): 38, 1978 (March 13). 16. COHEN, R. D., AND R. A. ILES. Dichloroacetate and
2. Notices of judgment: Pangamic 15, calcium gluco- the treatment of lactic acidosis. New EngI. J. Med.

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 1540 HERBERT

298: 1364, 1978. 33. BRUCH, H. The allure of food cults and nutrition
17. HALESTRAP, P. The mitochondrial pyruvate carrier: quackery. J. Am. Dietetic Assoc. 57: 316, 1970.
Kinetics and specificity for substrates and inhibitors. 34. HERBERT, V. The health hustlers: how to spot a food
Biochem. J. 148: 85, 1975. quack. In: The Health Robbers, edited by S. Barrett
l7a. CRABB, D. W., AND R. A. HARRIS. Metabolic effects and G. Knight. Philadelphia: Stickley, 1976, pp. 99-
ofdichloroacetate. New Engl. J. Med. 299: 255, 1978. 123.
1 8. WITHEY, J. R. Mutagenic, carcinogenic and terato- 35. BARRETF, S., AND G. KNIGHT. The Health Robbers.
genic hazards arising from human exposure to plastic Philadelphia: Stickley, 1976.
additives. In: Origins of Human Cancer. Book A. 36. HERBERT, V. The nutritionally and metabolically
Incidence of Cancer in Humans, edited by H. H. destructive “nutritional and metabolic antineoplastic
Hiatt, J. D. Watson, and J. A. Winsten. New York: diet” of laetrile proponents. Am. J. Clin. Nutr. 32:
Cold Spring Harbor Laboratory, 1977. 96, 1979.
19. HERBERT, V., A. GARDNER AND N. COLMAN. Muta- 37. JANSSEN, W. F. Cancer quackery: past and present.
genicity of dichloroacetate (DCA), an ingredient of FDA Consumer 1 1: 27, 1977.
the “cancer cure” pangamic acid (“vitamin B15”).
Addendum
Blood 52 (Suppl. I): 252, 1978; HERBERT, V., A.
GARDNER AND N. COLMAN. Evidence for possible Regarding the patent of dimethylglycine to enhance
lack of safety for human consumption of dichloroac- absorption ofheparin (24b), the Manager of Professional
etate, a “sister compound” and frequent ingredient Services of the corporation to which the patent is as-
ofthe non-vitamin “B15” (pangamate), Chin. Res. 27: signed informed this reviewer by letter dated 2 May 1979
55la, 1979. that, “We never carried out any long term animal studies
with this particular agent, and therefore I am unable to
20. HARKNESS, D. R., AND S. ROTH. Clinical evaluation
answer your question about toxicity. Also, dimethyl-
of cyanate in sickle cell anemia. Prog. Hematol. 9:
glycine was never tested in humans. We never marketed
157, 1975. any products of this type since the extent of absorption
20a. STACPOOLE, P. W., G. W. MOORE, AND D. M. (of heparin)never reached levels greater than five percent
KORNHAUSER. Toxicity of chronic dichloroacetate. of the administered dose.”
New Engl. J. Med. 300: 372, 1979. Despite the U.S. government position that pangamate
21. MARSHALL, F. N., R. H. ADAMSON AND J. P. LONG. is illegal, worthless, and possibly unsafe, in 1979 it was
still being vigorously promoted and sold in every “health
Some pharmacologic properties of pangamic acid
food” store in the United States visited by this reviewer,
(vitamin B15). Proc. Soc. Exptl. Biol. Med. 107: 420,
including those of the multimilhion-dollar General Nu-
1961. trition Center chain. Mr. Paul Sage, of the Bureau of
22. KREBS, E. T., AND E. T. KREBS, JR. N-substituted Enforcement of the FDA, informed this reviewer that
glycine esters of gluconic acid. United States Patent the FDA lacked enough personnel to seize pangamate
no. 2,710,876, patented June 14, 1955. from these thousands of stores, and was doing its best to
23. WHITE, A., P. HANDLER AND E. L. SMITH. Principles fight the huge and lucrative pangamate industry by
of Biochemistry. New York: McGraw Hill, 1973. bringing court cases against producers. However, while
the cases grind through the courts, the producers of
24. JUKES, T. H. Pangamic acid and “vitamin B15.” Nutr.
pangamate such as Aangamik (4) continue to promote
Notes 14: 13, 1978.
and sell, and others spring up and do likewise. Where
24a. WOODARD, J. C. Effects of deficiencies in labile there is money to be made, there are those who will
methyl groups on the growth and development of make it.
fetal rats. J. Nutr. 100: 1215, 1970. With respect to the misleading health claims, the
24b. WINDSOR, E. Orally-active therapeutic composi- government has no power to stop them, unless they are
tions and process for using same. U. S. Patent stated on the labeling of the product (34), and the
3,088,863; patented May 7, 1963. Patent assigned to multibilhion dollar nutrition cultism industry (4, 33-35)
Riker Laboratories, Inc. and its pangamate arm are too legally sophisticated to
do that. The claims are made in nutrition cultism hitera-
25. TANNENBAUM, S. R., D. Fm, V. R. YOUNG, P. D. ture sold in “health food” stores and elsewhere, which is
LAND AND R. BRUCE.
W. Nitrite and nitrate are
protected “free speech” (34). Many “health food” stores
formed by endogenous synthesis in the human intes- were selling in 1979 the General Health and Nutrition
tine. Science 200: 1487, 1978. Centers, Inc. vitamins and minerals placemat which
26. FRIEDMAN, M. A. Reaction of sodium nitrite with misleadingl7 claims pangamic acid as a vitamin which
dimethyhglycine produces nitrososarcosine. Bull. En- facilitates ‘ cell oxidation and respiration, metabolism
vironm. Contamin. Toxicol. 13: 226, 1975. (protein, fat, sugar), glandular and nervous system stim-
ulation,” whose “deficiency symptoms” are “heart dis-
27. HARTMAN, P. H. Nitrates and nitrites in the human
ease, nervous and glandular disorders,” and whose “ther-
diet. Science 202: 260, 1978.
apeutic applications are “alcoholism, asthma, atheroscle-
28. Vitamin B15. Med. Lett. 20: 44, 1978. rosis, cholesterol (high), emphysema, heart disease, head-
29. How to evaluate medical information. Harvard Med. aches, insomnia, poor circulation, premature aging, rheu-
School Health Lett. 3: 6, 1978. matism, shortness of breath.”
30. HOPKINS, H. Debunking pangamic acid. FDA Con- Parenthetically, victims havejust brought the first civil
sumer 12: 15, 1978. suit against the author and publisher of a nutrition
3 1. HERBERT, V. Medical, legal, and ethical considera- cultism book sold in “health food” stores and elsewhere
which made a misleading nutrition claim which they say
tions in the use of drugs having undesirable side
led them astray and thereby caused the death of their
effects. Am. J. Clin. Nutr. 28: 550, 1975.
child (4). The misleading claim was that large doses of
32. HERBERT, V. Acquiring new information while re-
potassium can help against colic.
taming old ethics. Science 198: 690, 1977; reprinted On June 18, 1979 the United States Supreme Court
in Jurimetrics J. 18: 215, 1978 (published by the ruled 9-0 against laetrile in Rutherford v USA (4). Many
American Bar Association). of the same interests promote both laetrihe and B15 (4).

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