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The Rise and Fall of Laetrile
Benjamin Wilson, M.D.
Laetrile is the trade name for laevo-mandelonitrile-beta-glucuronoside,
a substance allegedly synthesized by Ernst T. Krebs, Jr., and
registered with the U.S. Patent Office for the treatment of "disorders
of intestinal fermentation." This compound is chemically
related to amygdalin, a substance found naturally in the pits
of apricots and various other fruits. Most proponents of Laetrile
for the treatment of cancer use the terms "Laetrile"
and amygdalin interchangeably.
Amygdalin was originally isolated in 1830 by two French chemists.
In the presence of certain enzymes, amygdalin breaks down into
glucose, benzaldehyde, and hydrogen cyanide (which is poisonous).
It was tried as an anticancer agent in Germany in 1892, but was
discarded as ineffective and too toxic for that purpose. During
the early 1950s, Ernst T. Krebs, Sr., M.D., and his son Ernst,
Jr., began using a "purified" form of amygdalin to
treat cancer patients. Since that time scientists have tested
substances called "Laetrile" in more than 20 animal
tumor models as well as in humans and found no benefit either
alone or together with other substances. Along the way its proponents
have varied their claims about Laetrile's origin, chemical structure,
mechanism of action, and therapeutic effects [1,2]. Its place
in history is assured, however, as a focus of political activities
intended to abolish the laws protecting Americans from quackery.
Krebs, Sr.—Laetrile's "grandfather"—worked
as a pharmacist before attending the San Francisco College of
Physicians and Surgeons, from which he received his medical degree
in 1903. During the influenza pandemic of 1918, he apparently
became convinced that an old Indian remedy made from parsley
was effective against the flu. He set up the Balsamea Company
in San Francisco to market the remedy as Syrup Leptinol, which
he claimed was effective against asthma, whooping cough, tuberculosis
and pneumonia as well. During the early 1920s, supplies of Syrup
Leptinol were seized by the FDA on charges that these claims
were false and fraudulent. During the 1940s, Krebs, Sr., promoted
Mutagen, an enzyme mixture containing chymotrypsin, which he
claimed was effective against cancer. He and his son also patented
and promoted "pangamic acid" (later called "vitamin
B15"), which they claimed was effective against heart disease,
cancer, and several other serious ailments. Krebs, Sr., died
in 1970 at the age of 94.
Ernst T. Krebs, Jr.—Laetrile's "father"—has
often been referred to as "Dr. Krebs" although he has
no accredited doctoral degree. He attended Hahnemann Medical
College in Philadelphia from 1938 to 1941, but was expelled after
repeating his freshman year and failing his sophomore year [3].
After taking courses in five different colleges and achieving
low or failing grades in his science courses, he finally received
a bachelor of arts degree from the University of Illinois in
1942 [3]. In 1973, after giving a 1-hour lecture on Laetrile,
he obtained a "Doctor of Science" degree from American
Christian College, a small, now-defunct Bible college in Tulsa,
Oklahoma. The school, founded by evangelist Billy James Hargis,
had no science department and lacked authority from Oklahoma
to grant any doctoral degrees.
Laetrile's Origin
Several versions of Laetrile's development have been published.
In a 1962 book, Krebs, Sr., said that he had theorized that "cancer
proteins" could be broken down by an enzyme he had prepared
when he was a pharmacy student. When the substance proved too
toxic in animal experiments, he boiled it and obtained better
results. However, according to Michael Culbert, another prominent
Laetrile promoter, Krebs ran a lucrative business analyzing smuggled
whiskey for wood alcohol and developed Laetrile while working
on a bourbon flavoring extract. During experiments with a mold
growing on the barrels in which the whiskey was aged, he isolated
an enzyme that he thought might have anti-tumor activity. When
his supply of barrel mold was exhausted, he switched to apricot
pits and used extracts (which he called Sarcarcinase) for various
tests on animals and humans during the next two decades. In 1949,
Krebs, Jr., modified his father's extraction process and named
the result Laetrile.
Historian James Harvey Young has noted that Krebs, Sr., presented
yet another version to FDA officials during an interview in 1962.
Then he dated Laetrile's birth to 1951 and said he had tested
it on patients but kept no records [1]. Noting that this version
was made public much earlier than the others, Dr. Young suspects
that Laetrile's origin was backdated to try to evade new drug
provisions of 1938 and 1962 FDA laws. In 1977, after thorough
investigation, FDA Commissioner Donald Kennedy concluded:
While it appears that Dr. Krebs, Sr., was utilizing some substance,
which apparently had the trademark Sarcarcinase, before 1938,
there is no evidence that the substance is identical . . . to
the present-day Laetrile [4].
Proponents' Rationales
In 1902, a Scottish embryologist named John Beard theorized
that cancer cells and cells produced during pregnancy called
trophoblasts are one and the same. According to Beard, trophoblasts
invade the uterine wall to form the placenta and umbilical cord.
The pancreas then produces chymotrypsin, which destroys the trophoblasts.
Beard postulated that if the pancreas fails to produce enough
chymotrypsin, trophoblasts circulate through the body of both
mother and infant, making them vulnerable throughout life to
cancer.
In 1945, Krebs, Jr., founded the John Beard Memorial Foundation
to "develop and apply" Beard's theories. In 1950, the
Krebs published a version of Beard's thesis and stated that amygdalin
kills trophoblast cells where trypsin has failed. They claimed
that cancer tissues are rich in an enzyme that causes amygdalin
to release cyanide which destroys the cancer cells. According
to this theory, noncancerous tissues are protected from this
fate by another enzyme which renders the cyanide harmless. After
enforcement agencies began trying to ban Laetrile as a drug,
the Krebs claimed that amygdalin is a vitamin ("B17")
and that cancer is caused by a defficiency of this vitamin. None
of these theories is valid.
Claims for Laetrile effectiveness have also shifted. At first
it was claimed to cure cancer. Later it was claimed to "control"
cancer. When the "vitamin" theory was developed, it
was touted as a cancer preventive. It has also been claimed to
be effective in relieving pain associated with cancer and in
facilitating treatment with chemotherapy.
Scientific Review
One of the first practitioners to use Laetrile was Arthur
T. Harris, M.D., who had trained in Scotland and reportedly studied
embryology under John Beard. Harris, who had been doing family
practice in Southern California, renamed his office the Harris
Cancer Clinic. Within a year he submitted a report to Coronet
Magazine which claimed that he was "working on something
out here that is going to be the answer to cancer if there will
ever be one," but the magazine did not report what he was
doing.
By that time, the California Medical Association was receiving
inquiries about Laetrile. When members of its Cancer Commission
approached Krebs, Sr., he claimed that "limited" trials
of toxicity in animals had been performed with satisfactory results,
but that the records had been destroyed. No human trials involving
Laetrile had been undertaken, but the Commission was offered
case reports of patients in which spectacular results had supposedly
been observed. However, the details claimed by the Krebs team
could not be confirmed by other sources. The Commission was able
to obtain a small supply of Laetrile for animal tests at three
medical centers—all of which produced negative results.
At one point, the Krebs' agreed to supply Laetrile for a controlled
clinical investigation at Los Angeles County Hospital. But later
they said they would do so only if a Laetrile advocate were put
in charge—which was not acceptable to hospital authorities.
The Commission then evaluated the records of 44 patients treated
according to the Krebs' recommendations. Two years had elapsed
since the first of these patients had been treated with Laetrile.
Nineteen had already died and there was no evidence that Laetrile
had helped any of the others.
Marketing Increased
In 1956 Ernst T. Krebs, Jr., was introduced to Andrew R.L.
McNaughton, who has been dubbed Laetrile's "godfather"
by its supporters. McNaughton is the son of the late General
A.G.L. McNaughton, commander of the Canadian Armed Forces during
World War II. General McNaughton also served as president of
the United Nations Security Council and the National Research
Council of Canada.
Andrew McNaughton was educated at a Jesuit College and subsequently
received training in electrical engineering, geology, mining,
and business administration. During the war he was the chief
test pilot for the Royal Canadian Air Force. Subsequently, he
made a fortune by converting cheaply obtained war surplus items
into useful products for other nations. He provided arms for
the emerging nation of Israel and was also a double agent for
Fidel Castro, ostensibly working for the Batista government in
Cuba but often arranging for purchases to be hijacked by Castro
supporters. For his efforts, Castro made him an "honorary
citizen of Cuba."
McNaughton met Krebs shortly after he had incorporated the
McNaughton Foundation, which was seeking projects "on the
outer limits of scientific knowledge." Intrigued by Krebs'
account of the "Laetrile Wars," McNaughton began promoting
and distributing Laetrile. In 1961, to facilitate distribution
in Canada, he founded International Biozymes Ltd. (later renamed
Bioenzymes International Ltd), located in the same building as
the McNaughton Foundation. Eventually, he built factories in
seven countries.
It has been alleged that a major Biozymes stockholder (under
someone else's name) was a New Jersey mobster who was convicted
of conspiring to bribe public officials in connection with gambling.
In 1977, McNaughton told American Medical News that he had treated
the man's sister with Laetrile and that the man was a "wonderful
guy" who had given $130,000 to the McNaughton Foundation.
During the 1970s, McNaughton experienced considerable difficulty
in his financial dealings. In 1972, he was permanently enjoined
from selling Biozymes stock in the United States as a result
of a suit brought by the Securities and Exchange Commission.
In 1973, he was charged by Italian police with having taken part
in a $17 million swindle involving purchasers of Biozymes stock
who were under the impression that they were investing in an
Italian Laetrile factory. In 1974, in a Canadian courtroom, McNaughton
was found guilty of stock fraud involving a company named Pan
American Mines. It appears that $5 million had mysteriously disappeared.
McNaughton was fined $10,000 and sentenced to serve one day in
jail. A warrant for his arrest was issued after he refused to
pay the fine and left Canada without serving his sentence.
Publicity Mounts
Besides overseeing production, McNaughton also sought publicity
for Laetrile. He was able to convince a Jersey City surgeon,
John A. Morrone, to attend a presentation that Krebs, Jr., gave
in Montreal. After having lunch with Krebs, Jr., Morrone reportedly
went back to New Jersey a "convinced laetrilist," and
began using Laetrile on his patients.
At McNaughton's request, Morrone wrote a report on ten patients
he had treated with Laetrile, which was published in 1962 in
Experimental Medicine and Surgery, a journal no longer being
published. McNaughton also arranged for a freelance writer named
Glenn Kittler to write two magazine articles and a book on Laetrile.
Kittler, who had studied to become a priest before becoming a
journalist, had been an associate editor of Coronet magazine
in 1952. The articles were published in March 1963 in American
Weekly, a Sunday supplement to the Hearst newspapers. Immediately
afterward, Kittler's book, Laetrile: Control for Cancer, was
rushed into print with an initial press run of 500,000 copies.
The book carried a foreword by McNaughton—with his Foundation's
Montreal address. According to Kittler, the book's publisher
was so confident that publicity from the articles would boost
sales that he didn't send prepublication advertising to book
distributors. When sales lagged, Kittler claimed that pressures
from the AMA and FDA were partially responsible.
Support Groups
The efforts of McNaughton and Kittler were not fruitless,
however. Cecile Hoffman was a San Diego schoolteacher who had
undergone a radical mastectomy in 1959. After reading Kittler's
book, she visited the McNaughton Foundation in Montreal and received
Laetrile. Although she was unable to find an American physician
who would administer her intravenous Laetrile injections, she
did find Ernesto Contreras, M.D., just across the Mexican border
in Tijuana. This was perhaps the most fortunate thing that ever
happened to Dr. Contreras.
Contreras was a former Mexican Army pathologist who was in
private practice in Tijuana. After he administered the Laetrile,
Mrs. Hoffman became convinced that it controlled her cancer and
saved her life. She remained a fervent Laetrile supporter until
she died of metastatic breast cancer in 1969. Hoffman's convictions
led her to form the International Association of Cancer Victims
and Friends (IACVF) in 1963. (The word Victims was later changed
to Victors.) IACVF's purpose was "to educate the general
public to the options available to cancer patients, especially
terminal cancer patients." Joining forces with health food
industry promoters, the association began holding annual conventions
in Los Angeles that drew thousands of people. These meetings
provided a forum for virtually anyone who either promised or
sold a cancer remedy that was not recognized as effective by
the scientific community. The Krebs spoke often at these conferences.
IACVF also founded the Cancer Book House, which sold literature
promoting unorthodox cancer treatments. In addition, it arranged
for room, board and transportation to Contreras' clinic from
a California motel near the border.
Contreras, meanwhile, expanded his clinic and added translators
to his staff to accommodate the influx of American patients.
Business was so brisk that in 1970 he constructed a new clinic-the
Del Mar Medical Center and Hospital—which he promoted as "an
oasis of hope." (His facility is now called Oasis
Hospital.)
In 1973, several leaders left IACVF to found the Cancer Control
Society, whose activities are similar to those of IACVF. Another
group promoting dubious cancer therapies is the National Health
Federation (NHF), which supports a broad spectrum of questionable
health methods. This group was founded in 1955 by Fred J. Hart,
president of the Electronic Medical Foundation, a company that
marketed quack devices. NHF sponsors meetings, generates massive
letter-writing campaigns, and helps defend questionable methods
in court cases. Four people who have served on its board of governors
and the husband of its current president have been convicted
of laetrile-related crimes.
Legal Problems
The first seizure of Laetrile in the United States occurred
in 1960 at the former Hoxsey Cancer Clinic, which was then being
operated by osteopathic physician Harry Taylor, a former Hoxsey
employee. Two months before the seizure, a federal court judge
had ordered Taylor to stop distributing the various Hoxsey concoctions.
The seizure was not contested by Taylor.
In 1961, Krebs, Jr., and the John Beard Memorial Foundation
were indicted for interstate shipment of an unapproved drug-not
Laetrile but pangamic acid. After pleading guilty, Krebs was
fined $3,750 and sentenced to prison. However, the sentence was
suspended when Krebs and the Foundation agreed to terms of a
3-year probation in which neither would manufacture or distribute
Laetrile unless the FDA approved its use for testing as a new
drug.
In 1959, the California legislature had passed a law similar
to the Federal Food, Drug, and Cosmetic Act, banning commerce
of hazardous foods, drugs and cosmetics within California. The
California Department of Public Health then formed a Cancer Advisory
Council which studied Laetrile and other dubious cancer treatments.
The ten physicians and five research scientists carried out their
investigation from 1960 to 1962 and issued their report in May
1963.
During 1962 and 1963, the Cancer Advisory Council examined
more than 100 case histories submitted by various proponents
and concluded that none provided any evidence that Laetrile was
effective against cancer. The Council also reviewed the California
Medical Association's 1953 report on Laetrile, as well as a "new
synthetic" Laetrile purportedly developed by Krebs, Jr.
In addition, medical records of 144 patients treated with Laetrile
were reviewed from physicians in both the United States and Canada.
After the Council determined that the drug was "of no
value in the diagnosis, treatment, alleviation or cure of cancer,"
it recommended that regulations be issued to ban the use of Laetrile
and "substantially similar" agents for the treatment
of cancer. Despite considerable opposition from Laetrile promoters,
the regulation was issued under provisions of California's Cancer
Law and became effective November 1, 1963.
The Krebs family returned to court several more times. In
1965, Krebs, Sr., was charged with disobeying a regulatory order
forbidding interstate shipment of Laetrile and pleaded "no
contest." The following year he pleaded guilty to a contempt
charge for shipping Laetrile in violation of injunctions and
failing to register as a drug manufacturer. He received a suspended
1-year sentence. In 1974 Ernst, Jr., and his brother Byron pleaded
guilty to violating the California state health and safety laws.
Each was fined $500, given a suspended sentence of six months,
and placed on probation. Byron had his osteopathic license revoked
the same year for "mental incompetence", and died shortly
thereafter. In 1977, Ernst, Jr., was found guilty of violating
his probation by continuing to advocate Laetrile and was sentenced
to 6 months in the county jail. He was jailed during 1983 after
the appeals process ended.
Meanwhile, Howard H. Beard (not a relative of John Beard),
who had worked with Krebs and Dr. Harris, suffered an unfavorable
ruling from the California Cancer Advisory Council. For many
years he had promoted various urine tests purported to measure
the level of human chorionic gonadotropin (HCG). Both Krebs and
Beard had claimed that all cases of cancer could be diagnosed
on the basis of an elevated HCG test. In 1963 Krebs, Jr., stated
that the "scientific implementation" of Laetrile relied
upon Beard's test.
Beard had further claimed that an elevated HCG level was sufficient
indication for treatment with Laetrile, even in the absence of
clinical findings or a positive biopsy for cancer. A true believer
in his test, he reportedly began taking Laetrile himself after
noting that his urine test was not quite normal. Beard maintained
a laboratory offering mail-order service, including measurement
of the urinary HCG levels.
Beard developed at least three alleged cancer tests, the most
notable of which was his Anthrone Color Test. He claimed nearly
100% accuracy if patients who were pregnant, had liver disease
or diabetes, or were taking sex hormones were excluded. He also
claimed that the test was so sensitive that it was able to detect
the development of cancer within 2-3 weeks after malignant transformation
took place.
During the early 1960s, the California Cancer Advisory Council
had provided Beard with 24-hour urine specimens from 198 patients,
as well as two "urine" specimens which consisted of
lactose dissolved in water. Simultaneous tests were performed
at the California State Public Health Laboratories. Beard was
unable to identify which urine came from patients with cancer
and which came from patients with other conditions. The investigation
also demonstrated that Beard's test results had nothing to do
with cancer but depended mainly on the amount of lactose in the
urine. Consequently, the test was banned in California as of
August 1965. In 1967, Beard was indicted by a federal grand jury
in Texas on nine counts of mail fraud related to the marketing
of his test. After pleading no contest, he was given a 6-month
suspended jail sentence and 1-year probation.
Further Efforts toward Respectability
The McNaughton Foundation persisted in trying to make Laetrile
respectable. They commissioned the SCIND Laboratories in San
Francisco to conduct animal studies involving a transplanted
tumor system in rats. Although the Foundation had reported that
weekly doses of 1 or 2 grams of Laetrile had produced "a
brilliant response" in cancer patients and the rats received
human equivalents of 30-40 grams, the results were negative.
Undaunted by the negative report, the McNaughton Foundation
filed an Investigational New Drug application with the FDA. The
FDA responded with a routine form letter giving permission—subject to further review—for investigational clinical trials
involving Laetrile. However, eight days later, when the review
was completed, the agency requested additional information from
the McNaughton Foundation to correct "serious deficiencies"
in the application. When this was not produced, the authorization
for clinical trials was withdrawn.
While the McNaughton Foundation was attempting to have Laetrile
recognized as a drug, Krebs, Jr., began claiming that it was
a vitamin, which he called B17. (It only took him about 20 years
to come to this conclusion.) Krebs apparently hoped that as a
"vitamin" Laetrile would not be subject to the "safety
and efficacy" requirements for new drugs. He may have also
hoped to capitalize on the popularity of vitamins.
By 1974, Dr. Contreras stated that he was seeing 100-120 new
patients per month, with many more patients returning to obtain
additional Laetrile. Patients typically were charged $150 for
a month's supply. Contreras acknowledged that few of his cancer
patients were "controlled" with Laetrile. While admitting
that 40% of the patients displayed no response, he claimed that
30% showed "most definite responses" to the drug. However,
these statistics may not be reliable. In 1979, he claimed to
have treated 26,000 cancer cases in 16 years. Yet when asked
by the FDA to provide his most dramatic examples of success,
Contreras submitted only 12 case histories. Six of the patients
had died of cancer, one had used conventional cancer therapy,
one had died of another disease after the cancer had been removed
surgically, one still had cancer, and the other three could not
be located [5].
The First "Metabolic"
Doctor
John Richardson was a general practitioner who began practice
in the San Francisco Bay area in 1954. In 1971, after discussions
with Krebs, Jr., he decided to become a cancer specialist. He
had not encountered overwhelming success as a general practitioner.
His 1972 income tax return revealed that he had grossed $88,000
in his medical practice, leaving a net of only $10,400 taxable
income.
Richardson's practice boomed as a result of his newly found
status as a cancer "expert." He states that "Our
office soon was filled with faces we had never seen before—hopeful faces of men and women who had been abandoned by orthodox
medicine as hopeless or "terminal" cases." In
1974, he reported that his medical practice had grossed $783,000,
with a net income of $172,981. By charging patients $2,000 for
a course of Laetrile, Richardson managed to increase his net
income 17-fold in just two years. According to his income tax
returns, Richardson grossed $2.8 million dollars from his Laetrile
practice between January 1973 and March 1976. The actual amount
of money he received may have even been higher. In Laetrile Case
Histories, he claimed to have treated 4,000 patients, with an
average charge of $2,500 per patient. Culbert states that by
1976 Richardson had treated 6,000 patients. If these figures
are correct, Richardson would have grossed between $10 and $15
million dollars during this time.
Richardson's practice changed significantly after he began
treating cancer patients with Laetrile. He also began treating
what he termed "pre-clinical syndrome" patients with
Laetrile. These were patients with no identifiable tumor or lesion
who complained of feelings of "impending doom, malaise,
unexplained or vague pains, headaches, bowel changes, loss of
appetite, loss of energy, and depression." According to
Richardson, cancer patients reported a reduction in pain, an
improved appetite, return of strength, and an improved mental
outlook. In addition, high blood pressure returned to normal.
In spite of these "dramatic improvements," Richardson
admitted that most of his cancer patients died. In an attempt
to overcome this, he increased the Laetrile dosage to nine grams,
six days a week, and placed patients on a vegetarian diet and
"massive" doses of regular vitamins. Richardson coined
the phrase "metabolic therapy" to refer to this combination
of diet manipulation, vitamins and Laetrile.
In June 1972, Richardson's office was raided and he was arrested
for violating California's Cancer Law. He was convicted of this
charge, but the conviction was overturned on a technicality and
a new trial ordered. Two more trials followed which resulted
in hung juries. Hearings before the California Board of Medical
Quality Assurance in 1976 resulted in the revocation of his California
medical license. He then worked at a Mexican cancer clinic. During
the 1980s, he practiced under a homeopathic license in Nevada
until he had open heart surgery and entered an irreversible coma.
The Political Explosion
Dr. Richardson's arrest triggered the formation of the Committee
for Freedom of Choice in Cancer Therapy (now called the Committee
for Freedom of Choice in Medicine). The group's founder and
President was Robert Bradford, a former laboratory technician
at Stanford University. Michael Culbert, who at the time of Richardson's
arrest was an editor at the Berkeley Daily Gazette, became a
major spokesman for the Committee, editing their newsletter,
The Choice, and writing two books promoting Laetrile:
Vitamin B-17: Forbidden Weapon Against Cancer (1974) and
Freedom From Cancer (1976).
Culbert was assisted in editing The Choice by Maureen
Salaman, wife of Committee vice-chairman Frank Salaman. The Committee's
legislative advisor was Georgia Congressman Larry McDonald, a
urologist who used Laetrile. CFCCT's activities were closely
allied with the John Birch Society, to which Richardson, Bradford,
Culbert, the Salamans and McDonald all belonged. Soon after its
formation, CFCCT established local chapters throughout the United
States and used bookshops associated with the John Birch Society
to hold meetings and distribute literature.
In May 1976 Richardson was indicted, along with his office
manager, Ralph Bowman, and fellow CFCCT members Robert Bradford
and Frank Salaman, for conspiring to smuggle Laetrile. A year
later all were convicted of the charges. Bradford was fined $40,000,
Richardson $20,000, and Salaman and Bowman $10,000 each. During
the trial it was disclosed that Bradford had paid $1.2 million
dollars for 700 shipments of Laetrile and that Richardson had
banked more than $2.5 million during a 27-month period.
The NCI Scientist
Although facing problems on some fronts, the Laetrile movement
gained adherents. Dr. Dean Burk was a biochemist with a Ph.D.
from Cornell Medical College who had joined the National Cancer
Institute (NCI) in 1939 as a research fellow. After ten years
he was appointed as Head of NCI's Cytochemistry Section, which
had a staff of four persons at the time of his retirement 25
years later.
At McNaughton's request, Burk did an experiment in which Laetrile
was used to kill a tissue culture of cancer cells. He reported
to McNaughton that he could "see the cancer cells dying
off like flies." Eventually Burk concluded that Laetrile
was the most effective treatment available for cancer, that it
relieved the pain of terminal cancer victims, and that it might
be useful in preventing cancer. He also claimed in Congressional
testimony that Laetrile was less toxic than sugar. Burk became
fast friends with Krebs, Jr., and was given a permanent room
in Krebs' San Francisco mansion. He was soon on the "Laetrile
circuit" and was given the Cancer Control Society's "Humanitarian
Award" in 1973.
Burk also became active in opposing fluoridation and spoke
against it in many cities throughout the United States and Europe.
An inveterate tobacco user, he claimed in Congressional testimony
that he had developed a safer cigarette.
The Professor
In 1977, Harold W. Manner, Ph.D., chairman of the biology
department at Loyola University in Chicago, achieved considerable
notoriety by claiming to have cured mammary cancers in mice with
injections of Laetrile and proteolytic enzymes and massive oral
doses of vitamin A. What he actually did was digest the tumors
by injecting digestive enzymes in amounts equivalent to injecting
a woman with a pint of salt water containing about 1 1/2 ounces
of meat tenderizer every other day for six weeks. Not surprisingly,
the mice developed abscesses where the enzymes were injected,
the tumors were liquefied, and the injected tissue fell off.
Since no microscopic examinations were conducted and the animals
were observed for only a few weeks following treatment, no legitimate
assessment of this type of therapy could have been made. But
Manner announced at a press conference sponsored by the National
Health Federation that a combination of Laetrile, vitamins and
enzymes was effective against cancer. He reported his experiments
in a chiropractic journal and wrote a book called The Death of
Cancer.
Manner also founded the Metabolic Research Foundation whose
stated purpose was research into "metabolic diseases,"
which—according to him—included arthritis, multiple sclerosis
and cancer. Sponsored by the Nutri-Dyn company he held seminars
throughout the country for chiropractors and unorthodox physicians
[6]. Nutri-Dyn manufactured processed animal glands ("glandulars"),
which Manner said would help the corresponding body parts of
cancer patients. In 1982, a reporter from WBBM-TV Chicago became
Metabolic Physician #219 by attending a seminar in Los Angeles
and donating $200 to the Metabolic Research Foundation. To indicate
his "professional" background the reporter used the
initials "D.N.," which, he later explained, stood for
"Doctor of Nothing." Manner promised to refer ten patients
a year to him.
According to Manner, Loyola University officials became upset
with his activities and asked him to either give them up or resign
from his position at the school. During the early 1980s, he left
his teaching position, became affiliated with a clinic in Tijuana
that offered "metabolic therapy." He died in 1988,
but the clinic is still operating.
The Rutherford Case
Glen Rutherford was a 55-year-old Kansas seed salesman who
was found to have a grape-sized polyp of the colon in 1971. When
a biopsy revealed that it was cancerous, he was advised to have
it removed. Fearful of surgery, he consulted Dr. Contreras, who
treated him with Laetrile, vitamins and enzymes, and cauterized
(burned off) the polyp. Although cauterization usually cures
this type of cancer when it is localized in a polyp, Rutherford
emerged from this experience claiming that Laetrile had cured
him and was necessary to keep him alive. People Magazine reported
that he also began taking 111 pills (mostly vitamins) costing
$14 per day. In 1975, he became lead plaintiff in a class action
suit to force the FDA to allow "terminal" cancer patients
to obtain Laetrile for their own use.
The case was heard before Judge Luther Bohanon in the Western
Oklahoma United States District Court. Bohanon was extremely
sympathetic to Rutherford's wishes. In 1977, Bohanon issued a
court order permitting individuals to import Laetrile for personal
use if they obtained a doctor's affidavit stating they were "terminally
ill." Two years later, the U.S. Supreme Court rejected the
argument that drugs offered to "terminal" patients
should be exempted from FDA regulation [7]. However, further efforts
by Rutherford and his supporters plus defiant rulings by Bohanon
enabled the affidavit system to remain in effect until 1987,
when it was finally dissolved.
Legislative Action
During the mid-1970s, Laetrile promoters portrayed themselves
as "little guys" struggling against "big government"
and began trying to legalize the sale of Laetrile. Eventually,
27 states passed laws permitting the sale and use of Laetrile
within their borders. Federal law still forbade interstate shipment
of Laetrile, and since it was impractical to manufacture it for
use in just one state, these state laws had little or no practical
effect. Proponents hoped, however, that if enough states legalized
its use within the states, Congress would change the federal
law as well. Although bills were introduced to exempt Laetrile
from FDA jurisdiction, they were unsuccessful and petered out
with the death of Congressman McDonald in 1983.
In 1977, a U.S. Senate subcommittee chaired by Senator Edward
Kennedy (D-MA) held hearings on Laetrile that developed interesting
testimony. Dr. Richardson claimed that the FDA, AMA, NCI, American
Cancer Society, Rockefeller family and major oil and drug companies
had all conspired against Laetrile. Robert Bradford said that
he would welcome a test of Laetrile but that "orthodox medicine
was not qualified" to do one. However, he Krebs, Jr., and
Richardson were unable to agree on the formula for Laetrile.
Senator Kennedy concluded that the Laetrile leaders were "slick
salesmen who would offer a false sense of hope" to cancer
patients. The New York Times commented that the Laetrile promoters
were regarded by the Senators "with a blend of amusement
and contempt."
Victims in the News
As Laetrile became newsworthy, several cancer victims treated
with it drew widespread media scrutiny. One was Chad Green, who
developed acute lymphocytic leukemia at age 21. Although he was
rapidly brought into remission with chemotherapy, his parents
started him on "metabolic therapy" administered by
a Manner Metabolic Physician. When Chad developed signs of cyanide
toxicity, Massachusetts authorities had him declared a ward of
the court for treatment purposes only. His parents then brought
suit to reinstitute "metabolic therapy." When the court
ruled against them, they fled with Chad to Mexico, where he was
treated by Dr. Contreras. Several months later Chad died in a
manner suggestive of cyanide poisoning. Dr. Contreras stated
that the boy had died of leukemia, but was a good example of
the effectiveness of Laetrile because he had died a pleasant
death! Chad's parents stated that he had become very depressed
because he missed his grandparents, his friends and his dog.
Joseph Hofbauer was a nine-year-old with Hodgkin's disease.
Unlike Chad Green's parents, Joseph's parents never allowed him
to receive appropriate treatment but insisted that he receive
Laetrile and "metabolic therapy." When New York State
authorities attempted to place him in protective custody, his
parents filed suit and convinced family court judge Loren Brown
to rule against recognized treatment of Hodgkin's disease. Brown
stated that "This court also finds that metabolic therapy
has a place in our society, and hopefully, its proponents are
on the first rung of a ladder that will rid us of all forms of
cancer." Joseph died of his disease two years later. Acute
lymphocytic leukemia and Hodgkin's disease both have a 95% 5-year
survival rate with appropriate chemotherapy.
During 1980, movie star Steve McQueen attracted considerable
attention when he was treated with Laetrile at another Mexican
clinic under the supervision of William D. Kelley, a dentist
who had been delicensed by the State of Texas after several brushes
with state and federal law enforcement authorities. Although
McQueen gave a glowing report when he began his treatment, he
died shortly afterward.
NCI Studies
In response to political pressure, the National Cancer Institute
did two studies involving Laetrile. The first was a retrospective
analysis of patients treated with Laetrile. Letters were written
to 385,000 physicians in the United States as well as 70,000
other health professionals requesting case reports of cancer
patients who were thought to have benefited from using Laetrile.
In addition, the various pro-Laetrile groups were asked to provide
information concerning any such patients.
Although it had been estimated that at least 70,000 Americans
had used Laetrile—only 93 cases were submitted for evaluation.
Twenty-six of these reports lacked adequate documentation to
permit evaluation. The remaining 68 cases were "blinded"
and submitted to an expert panel for review, along with data
from 68 similar patients who had received chemotherapy. That
way the panel did not know what treatment patients had received.
The panel felt that two of the Laetrile-treated cases demonstrated
complete remission of disease, four displayed partial remission,
and the remaining 62 cases had exhibited no measurable response.
No attempt was made to verify that any of the patients who might
have benefited from Laetrile actually existed. The reviewers
concluded that "the results allow no definite conclusions
supporting the anti-cancer activity of Laetrile."
Although the NCI mailing had not been designed to uncover
negative case reports, 220 physicians submitted data on more
than 1,000 patients who had received Laetrile without any beneficial
response.
In July 1980, the NCI undertook clinical trials of 178 cancer
patients who received Laetrile, vitamins and enzymes at the Mayo
Clinic and three other prominent cancer centers. The study included
patients for whom no other treatment had been effective or for
whom no proven treatment was known. All patients had tumor masses
that could easily be measured, but most of the patients were
in good physical condition. Since Laetrile proponents were unable
to agree on the formula or testing protocol for Laetrile, NCI
decided to use a preparation that corresponded to the substance
distributed by the major Mexican supplier, American Biologics.
The preparation was supplied by the NCI Pharmaceutical Resources
Branch and verified by a variety of tests. The dosage of Laetrile
was based on the published recommendations of Krebs, Jr., and
the Bradford Foundation.
The results of the trial were clear-cut. Not one patient was
cured or even stabilized. The median survival rate was 4.8 months
from the start of therapy, and in those still alive after seven
months, tumor size had increased. This was the expected result
for patients receiving no treatment at all. In addition, several
patients experienced symptoms of cyanide toxicity or had blood
levels of cyanide approaching the lethal range [8]. An accompanying
editorial concluded:
Laetrile has had its day in court. The evidence, beyond reasonable
doubt, is that it doesn't benefit patients with advanced cancer,
and there is no reason to believe that it would be any more effective
in the earlier stages of the disease . . . The time has come
to close the books [9].
Bradford and American Biologics responded to the study with
three different lawsuits against the National Cancer Institute,
alleging that as a result of the study, they had sustained serious
financial damage from a drastic drop in demand for Laetrile.
All three suits were thrown out of court. Today few sources of
laetrile are available within the United States, but it still
is utilized at Mexican clinics and marketed as amygdalin
or "vitamin B17" through the Internet.
Some Final Thoughts
As long as there remain crippling and fatal diseases, there
will undoubtedly be individuals eager to offer "alternatives"
to scientific treatment and large numbers of desperate individuals
willing to purchase them. The Laetrile phenomenon started with
a pharmacist-physician who developed one concoction after another
for the treatment of serious diseases, especially cancer. It
continued with his son, a self-imagined scientist, who spent
many years in college but failed to earn any graduate degree.
A man who earned his fortune from gun-running and a catholic
newspaper columnist promoted it as a persecuted drug that cured
cancer. A cadre of John Birch Society members saw the repression
of Laetrile as a sinister plot against their basic freedoms.
After it was dubbed "vitamin B-17," an army of health
food devotees promoted Laetrile, along with vitamins and diet,
as nature's answer to cancer.
After peaking in the late 1970s, the "Laetrile Movement"
ran out of steam in the wake of the Supreme Court decision, the
NCI study, the death of Steve McQueen, and other unfavorable
publicity. But as the Laetrile fantasy faded, its prime movers
added many other "miracle cures" to their arsenal and
added AIDS, arthritis, cardiovascular disease, and multiple sclerosis
to the list of diseases they claim to treat. Although they appear
to speak with sincerity, they still fail to sponsor the type
of research which could persuade the scientific world that anything
they offer is effective.
Recent Enforcement
Actions
- On April 20, 2000, the U.S. Justice Department obtained a
preliminary injunction barring Christian Bros. Contracting Corp.,
of Whitestone, New York, and its president, Jason Vale from making
or distributing amygdalin, Laetrile, "Vitamin B-17,"
or apricot seeds [10]. Although Vale signed a consent decree,
he continued his sales activity through a network of Internet
sites, toll-free telephone numbers, and shell companies. In 2003,
a federal jury in Brooklyn found him guilty of criminal contempt
[11] for which he was sentenced to prison.
- In July 2000, Kenneth N. Michaels and his company, Holistic
Alternatives, both of Louisville, Ohio, were indicted for allegedly
conspiring to distribute Laetrile and hydrazine sulfate in interstate
commerce. The indictment also alleges that with intent to mislead
the FDA, the defendants failed to register their drug manufacturing
facility [12].
- On September 1, 2000, a United States District Court Judge
issued a preliminary injunction against World Without Cancer,
Inc., The Health World International, Inc. of Bay Harbor Island,
Health Genesis Corporation, an Arizona concern that does business
in Bay Harbor Island, Florida, and David E. Arizona, an officer
of the three corporations. The ruling enjoins the defendants
from introducing or causing the introduction into interstate
commerce of laetrile products, apricot seeds, or any other unapproved
drug product as well as manufacturing, processing, packing, labeling,
promoting, or distributing these or any other new drug. The order
also requires the defendants to modify their Internet web sites
to cease using the web sites to promote the sale of or offer
for sale their laetrile products [13].
- In February 2004, Jack Edwin Slingluff, D.O., of Canton,
Ohio, was charged with introducing an unapproved new drug into
interstate commerce. The one-count criminal information states
that he "caused thirty (30) vials of the unapproved new
drug Amigdalina B-17 (AKA Laetrile) to be shipped from West Palm
Beach, Florida, to Salem, Ohio; in violation of Title 21, Sections
331(d), 355(a) and 333(a)(1), United States Code."
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For Additional Information
References
- Young JH. Laetrile in historical perspective. In Merkle GE,
Petersen JC, editors. Politics, Science, and Cancer: The Laetrile
Phenomenon. Boulder, CO: Westview Press, 1980.
- American Cancer Society. Laetrile background information.
New York: Amerian Cancer Society, 1977.
- Bruzelius, NJ. The merchants of Laetrile. Boston Sunday Globe,
June 17, 1979.
- Kennedy D. Laetrile: The Commissioner's Decision. H.E.W. Publication
No. 77-3056.
- Laetrile: The political success of a scientific failure.
Consumer Reports 42:444-447, 1977.
- South J. The Manner clinic. Nutrition Forum 5:61-67, 1988.
- United States vs. Rutherford, 442 U.S. 544 (1979).
- Moertel C and others. A
clinical trial of amygdalin (Laetrile) in the treatment of human
cancer. New England Journal of Medicine 306:201-206, 1982.
- Relman A. Closing the books on Laetrile. New England Journal
of Medicine 306:236, 1982.
- Barrett S. Laetrile
spammers facing $631,585 penalty. Quackwatch, Sept 9, 2000.
- Lewis C. Online
laetrile vendor ordered to shut down. Quackwatch, Nov 28,
2003.
- Licking
County man and his company man and his company indicted for distributing
laetrile and hydrazine sulfate. U.S. Justice Department news
release, July 18, 2000.
- FDA
takes action against firms marketing unapproved drugs. FDA
Talk paper, T00-39, Sept 6, 2000.
- Quackwatch Home Page
||| Special Message
for Cancer Patients
This article was revised on February
17, 2004.
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