On his website, www.apricotseeds.org (which was shut down by the FDA and the domain name seized to keep it from being reactivated by Vale when his legal troubles with the government first began), Vale claimed that the rare cancer he developed had a 100% mortality rate. While any form of Ewing’s Sarcoma is a nasty, aggressive cancer, the mortality rate of all forms of Ewing's, including Askin’s Tumor, is 50%--which is deadly enough. Twenty percent of all medically treated cases of Ewing’s Sarcoma are kept in remission with pharmaceuticals after surgery has removed the cancerous tumors, or the affected limb has been amputated. The remaining 30% of Ewing’s Sarcoma cases are treated with a combination of drugs and chemotherapy.
Vale, in promoting his cancer cure on www.apricotseeds.org, wanted to make it appear that amygdalin--vitamin B-17--or its serum extract, Laetrile, was solely responsible for his continued life since he began eating apricot seeds in 1994. By declaring that his condition was 100% fatal when in fact it was not, Vale implied (without saying so) that there was no medical treatment that would have prolonged his life and, for that reason, he was alive only because his parents discovered the healing power of apricot seeds.
With that lie and a Christian testimony that he believed God would heal him, Vale began to market his product, apricot seeds, and later the serum extract of amygdalin, Laetrile, over the Internet on www.apricotseeds.org.
The sale of amygdalin-based apricot seeds was very profitable for Vale and for a variety of other herbalists and naturopathic doctors who offered it to cancer victims who were frantically searching for the magic bullet that would prolong their lives. Cancer is the most frightening word in the human universe--and www.apricotseeds.org offered cancer victims not just hope for a prolonged life, but a productive, normal life thanks to the bitter seed within the pits of apricots, peaches, plums, and several other fruits. And, Jason Vale, a three times U.S. arm wrestling champion, was a perfect testimonial that Laetrile not only worked, but worked phenomenally well.
Jason David Vale was a walking sales pitch for the picture of good health. Tall, handsome, muscular--and successful. He had everything he needed, including the spiel, to become a motivational speaker. Instead, he became the US arm wrestling champion three times and an international champion once. What he did not look like was a man wasting away from very rare neuroectiderna tumors. He attributed his good health to amygdalin (vitamin B-17) extract.
In 1986, after he was diagnosed with what his website described as terminal cancer, Vale underwent surgery to remove a cancerous tumor in his chest wall, chemotherapy and radiation treatments. Since he endured several medical procedures to treat his rare cancer over a period of eight years, Vale’s claims that he was cured by apricot seeds cannot be construed as wholly accurate. Based on the known attributes of Laetrile, it is reasonable to say (providing Vale was taking no prescription medications during the period when he was taking apricot seeds) that amygdalin was holding his neuromuscular cancer at bay. Thousands of people believed his claims and went to www.apricotseeds.org and bought the bitter tasting elixir of life that “healed” Vale of his cancer. Vale watched his business grow from the sale of a few bags of apricot seeds per month into a behemoth business enterprise that ultimately escalated far beyond the sale of a few fruit pits into an operation that synthesized amygdalin pulp into a serum form of B-17 called Laetrile--a process developed in 1920 by Dr. Ernest T. Krebs. When Vale took that entrepreneurial step, he crossed the invisible line from selling a natural vitamin to a synthesized one. That same year, labeling amygdalin as a dangerous toxin, the FDA banned the interstate trafficking of vitamin B-17 even though only its serum form (because it had to be injected rather than ingested) legally belonged under the purview of the FDA.
Unknown to Vale at the time was the fact that the American and Canadian pharmaceutical industries were already doing trials with artificial forms of Laetrile like Sarcarinase™, Nitriloside™ and Koch’s Synthetic Anitoxin™ (which was a blend of malonide, glyoxylide and parabenzoquinone that supposedly had the curative affects as amygdalin on cancer cells without the toxic side affects). In the United States, a clinical study is currently being done on a new artificial form of amygdalin.
For some time, Jason Vale stayed off the radar screen of the FDA, and www.apricotseeds.org flourished. But, as Vale’s entrepreneurial venture grew, it was inevitable that www.apricotseeds.org would be noticed--and his claims of miraculous cures, examined by the FDA. It is unclear whether or not Vale’s FDA problems would have become severe enough to merit criminal contempt charges if he had confined his entrepreneurial activities exclusively to selling a natural supplement, apricot seeds, and his book, “Slim For Life,” rather than adding the serum form of Laetrile to his inventory.
On October 28,1998 the FDA sent Vale a letter informing the anticancer entrepreneur that the United States government considered Laetrile to be a “drug” and not a natural vitamin supplement. The letter (shown on left) began: “This letter is in reference to your promotion and distribution of the unapproved drug Laetrile in the form of your products: ‘Apricot seeds’, ‘Vitamin B-17’, and ‘Amygdalin’ ampules. Labeling for these products make therapeutic claims which cause the products to be drugs as defined in Section 201(g) of the Federal Food, Drug and Cosmetic Act. Labeling is not limited to the immediate product containers but includes all promotional material including video tapes which you distribute with your products...”
Vale hired an Illinois law firm, Dilling & Dilling, to argue his position to the FDA. On December 6, 1998, Kirkpatrick W. Dilling responded to the FDA’s contention that Vale’s food supplements were drugs by virtue of the way in which they were marketed. In the text of his rely, Dilling observed that “...With respect to the Amygdalin products we have suggested a new label (copy enclosed) which should more accurately reflect the nature of product, also conforming to certain regulatory strictures...”
The proposed label would not warn those buying it that amygdalin converted to cyanide when mixed with the enzyme beta-glucosidase, or that the FDA believed that Laetrile was toxic and, for that reason, had been banned from interstate sales since 1971. Instead, the new label, which would not satisfy the FDA in any way, said: “Excess consumption may cause temporary nausea. Can be used as nutritional adjunct in conjunction with chemotherapy or radiation or solely as a dietary supplement.”
Dilling concluded by telling the FDA “...This product is per se a food for special dietary use by virtue of its ingredients. As such it is subject to the provisions of Part 105.3.21, Code of Federal Regulations...”
If Vale thought, even for a minute, that Dilling & Dilling had solved his legal problems, he was sadly mistaken. His problems were just beginning. And, most of them were of his own making.
The FDA failed to buy the argument advanced by Dilling and Dilling. Dilling argued that amygdalin--even in its serum form--was a food supplement. The government’s injunction specifically targeted the selling of amygdalin in its serum form, but it had the affect of shutting down Vale’s entire operation--which is precisely what the FDA intended to do. Then, to make sure Vale could not change his corporate name, slap a new name on his website (while maintaining the numeral address) and continue his business uninterrupted, the FDA seized Vale’s website domain address and apricotseeds.org was out of business.
But not for long.
Dr. Ernest T. Krebs, Sr. developed the first synthetic Laetrile in 1920. It was marketed by the Christian Medical Research League. Kreb’s son, Dr. Ernest T. Krebs, Jr. began using Laetrile to treat cancer patients in California in the 1950s. (Laetrile has been used successfully in Russia as a cancer-fighting drug since 1948. Amygdalin has been used, either in a solid or liquid form, to treat cancer in most of the nations of the world since the mid-19th century. It is banned only in the United States.) In 1971 the FDA banned Laetrile from interstate commerce. However, several States, bowing to pressure from Laetrile users, legalized the intrastate sale of the apricot seed extract. In 1977, the US District Court for the Eastern District of Wisconsin ruled that amygdalin “...is a drug within the Food, Drug and Cosmetic Act, and that injectable amygdalin is a prescription drug...”
When the FDA issued its preliminary injunction and shut down his website, Vale scrambled to find another suitable name under which he could continue selling apricot seed extract even though he had just been banned from doing so. He chose the name Christian Brothers Contracting Corporation. Quite likely Vale’s logic in picking that name was a mental association with the old Krebs’ Christian Medical Research League name that very likely would have been recognized by many of the cancer victims seeking the magic elixir of life, with amygdalin.
Setting up a new dummy corporation, Vale rented the new company’s post office box with his own credit card and purchased the packaging supplies, etc. with the same card, leaving a trail from the new company to his own hip pocket that even a blind FDA investigator could follow. And follow it they did.
When Vale’s old customers called apricotseeds.org to reorder their anticancer supplies, Vale told them he was no longer selling amygdalin. He then recommended Christian Brothers. Vale would then hang up his apricotseeds.org telephone and wait for his Christian Brothers phone to ring.
Many of his former customers called that number.
But, just as many did not.
According to the FDA, both phones were on the same desk in Vale’s home. Even though the federal government shut down www.apricotseeds.org, it took Vale less than month to begin filling reorders for his old customers under the new corporate name. But Vale still had a major marketing dilemma. Far too many of his former customers didn’t want to do business with what they perceived to be a brand new company. Not knowing that Vale was Christian Brothers Contracting Corporation, many of his customers opted to shop around before making a buying decision.
Since he was a dot.com company (or, more aptly, a dot.org company), Vale felt he needed to do some cyber advertising to pull back his old clients and add some new ones. Utilizing the services of a computer hacks and spammers, Vale managed to assemble a mailing list that contained thousands of AOL email addresses. He flooded thousands upon literal hundreds of thousands of consumers with amygdalin scare mail. At times, according to AOL’s complaint, Vale was sending hundreds of thousands of spam emails per hour. The unsolicited emails, sent with an AOL return address, provided links to a website that offered Vale’s apricot seeds and ampules of serum for sale.
Enter Steve Case, then CEO of America OnLine. AOL, like most of the dot.coms before the collapse of the dot.com industry, was desperately in search of revenue since most of the dot.coms were so overvalued that Wall Street had begun to ask some real hard questions about the basis upon which value of the dot.coms were established. In 1998 when Christian Brothers Contracting Corporation was desperately seeking apricotseeds.org’s client base, AOL was desperately seeking advertising revenue from any source.
When consumers subscribe to AOL, they are obligated to “sign” a membership agreement that prohibits them [a] from sending unsolicited commercial bulk email messages, and [b] from collecting and/or harvesting user names, email addresses or other information about other AOL members.
In the evidence offered to the court by AOL, in February, 1998--after receiving thousands of complaints from members--AOL demanded that Christian Brothers Contracting Corporation stop misusing its network.
On December 18, 1998 AOL filed a complaint against Christian Brothers and Jason Vale. The summons was served on Vale on Sunday, December 20.
That would become Vale’s “no-defense” defense when AOL won a default judgment against Christian Brothers Contracting and Jason Vale. Vale, who apparently chose not to consult his attorneys, decided that summons that are served on Sunday are invalid and could be ignored.
So, he ignored it.
In fact, when AOL’s process server delivered the summons, Vale threw the papers at him, and slammed his door in the man’s face.
Vale was now making one tragic legal mistake on top of another. He was no longer on top of the world--the world was now on top of him and the weight was going to become unbearable. The US District Court granted AOL summary judgment against Christian Brothers and Jason Vale on June 5, 1999 and scheduled a hearing to establish damages.
At that point, Vale began to pay attention, but it was too late. The case was transferred from Federal Magistrate Pitman to US District Court Judge Deborah Batts for final disposition. In his order, Pitman ruled that any requests for extensions for filing objections had to be done within 10 days. “Failure to object within ten (10) days,” Pitman said, “will result in a waiver of objections and will preclude appellate review.”
On January 4, 2000, seven months after his 10-day objection period expired, Vale filed a petition asking the court to vacate the summary judgment against “defendant” Jason Vale in his individual capacity and also as a representative of Christian Brothers. By this time, Vale was suffering financially. And, although he initially retained Dilling & Dilling to represent him in the AOL matter, Vale had literally run out of money and decided to defend the action himself.
That proved to be the most costly mistake Vale had made to date.
According to Rowland v. California Men’s Colony, 506 US 194, 202 (1993), legal corporations, partnerships and associations may not appear in federal court except through a licensed attorney. In other words, they may not represent themselves.
Using a legal technicality to keep from dismissing the entire judgment, Judge Batt dismissed the default only insofar as it applied to Vale personally. She refused to dismiss the judgment against Christian Brothers Contracting because of Vale’s willful negligence. Further, in the view of the court, while the action was pending before the court, Vale continued to spam email account holders while ignoring the judicial process that threatened to consume him. In Batt’s mind, Vale showed absolute contempt for the court and the judicial process.
In his defense, Vale argued that under New York General Business Law §11 the summons was invalid because it was served on Sunday--particularly since he was a born-again Christian (Vale, Decl. at ¶¶ 3, 5-6.) However, the service did not violate Rule 4 of the Federal Rules of Civil Procedure. Under federal guidelines, process servers are not prohibited from serving subpoenas or summons on Sundays or other holidays. Nor is there a requirement that service in a federal action must comply with State law to be valid.
Batt, who felt Vale was attempting to manipulate the court by continuing his unlawful practices as he attempted to stall justice, was an “obstructionist adversary”--and, for that reason, she was determined to punish him. Batts awarded AOL $17,940.00 for hardware processing costs, treble damages of $389,020.00 for “lost advertising revenue,” $24,625.00 in attorney fees, and $200,000.00 in punitive damages, for a total judgment of $631,585.00. The damages were levied against Christian Brothers Contracting and not Jason Vale. But, since Christian Brothers was Jason Vale, it was pretty much the same thing.
On January 27, 2000 when US, District Court Judge Deborah Batts refused to vacate the $631,585.00 default judgment against Jason Vale, he was suddenly very, very broke. On top of that, AOL now had a legal claim against every asset owned by Christian Brothers Contracting Corporation, and thus, Jason Vale. When the FDA proceeded, first with its civil action and later, with its criminal case against Vale, the anticancer entrepreneur lacked the financial wherewithal to launch a meaningful defense.
The government’s civil case against Jason Vale and his company began on April 20, 2000 when US District Court Judge John Gleeson issued a preliminary injunction ordering Vale and his company not to directly or indirectly sell, distribute, package, label or promote Laetrile. During that hearing, the FDA argued that Laetrile, also known as amygdalin or vitamin B-17 or apricot pits, had no known effect on cancer and that it was, in fact, a toxic element because when it broke down in the digestive system of the user, amygdalin was converted into hydrogen cyanide that could be lethal to humans if consumed in large enough doses.
On November 16, 2000 Gleeson’s preliminary injunction was made permanent, and Vale was permanently enjoined from engaging in any commerce where amygdalin was involved. The case against Jason Vale, apricotseeds.org and Christian Brothers Contracting Corporation should have ended on January 27, 2000 and would have if Vale been willing to give up the business he created from apricot seeds and the income it generated.
Vale decided, early on, to make his legal woes a public issue and to try his “case” in the court of public opinion over the Internet, making his legal problems a case of big business and big government against the little guy suffering from cancer. And, because he did, Jason Vale very likely damaged the ability of thousands of cancer patients in the United States to receive naturopathic amygdalin treatments in the future.
Based on the evidence that has accumulated since the original injunction, it appears Vale’s defiance of the November 16, 2000 court order was motivated more by profits and self-interest than it was from a personal defense based on selfless principles.
Beginning with the first warning letter from the FDA, Vale posted the communiqués from the government and from his own lawyers on the Internet, believing that the sympathy he would generate as a martyr would turn the tide and he would somehow prevail. Vale’s public relations campaign was directed at convincing those who suffered from cancer and relied on amygdalin or Laetrile that Vale was an unflinching, selfless provider of the elixir of life who was more interested in their well-being than his own.
Vale did a good job of convincing those who ascribe to the use of alternative medicines that he was the latest government scapegoat. Eliezer Ben-Joseph, a naturopathic physician and the host of the radio talk show, Natural Solutions, in El Paso, Texas took up Vale’s defense on his radio program. He considered Vale’s case to be a freedom issue, and denounced the government’s prosecution of the anticancer entrepreneur as an inappropriate use of judicial power. “It’s vindictive prosecution,” Ben-Joseph declared on his program. “We’re talking about apricots here...and yet the government is so drastically opposed to having this information out.” Ben-Joseph declared the government’s interest in Vale “ludicrous,” noting the government had run clinical tests on Laetrile and concluded that it had no medicinal value. Ben-Joseph poophahed the credibility of the trials observing that “...concerns have been expressed about the way the study was conducted,” adding that some recently developed cancer treatments utilized an artificial cyanide which, he pointed out, was very similar to the organic cyanide that is emitted from amygdalin when it comes into contact with the enzyme beta-glucosidase. Laetrile, Ben-Joseph admitted, does not provide a cure. “There is no cure for cancer,” he said. “But there are a lot of things we can do that augment how metabolism works. These are chemicals the body would use to detoxify or get rid of cancer.... To make a law,” he concluded, “that says that the public cannot eat an apricot pit because they think it might keep people from going to regular cancer therapy, I think, is a ludicrous jump in jurisdiction.”
Amygdalin message boards suddenly sprang up on the Internet. Interest in the amygdalin case swelled as Jason Vale’s day in court loomed near. Several testimonials to the effect amygdalin or the serum form of B-17, Laetrile, had on the author of the message or on some family member were posted on the message board sites, reflecting the attention the Vale case was receiving in the naturopathic community.
Throughout this period, even though he had been ordered by the US District Court to cease and desist from engaging in any commerce or in the promotion of any commerce that involved amygdalin, vitamin B-17, or its serum extract, Laetrile, Vale secretly started a new company in which he was the sole secret operator, to market and sell apricot seeds and serum Laetrile. When the US Attorney discovered that Vale was the owner of Christian Brothers Contracting Corporation, they conducted an undercover investigation of Vale. The investigation culminated with a raid of his home. Investigators found over 100,000 packaged apricot seeds in his basement. (Vale insisted to investigators that these seeds were for his own personal use and not for resale. If Vale’s statement was true, then he had enough amygdalin in his possession to last him 242 years.)
The investigation by the US Attorney’s office led to the criminal contempt charges for which Vale was found guilty on July 21, 2003. Sentencing is scheduled for October 24.
Over the last five or six thousand years, man has experimented with every imaginable herb, seed, root, blade of grass, tree leaf and bark in search of balms, elixirs, and poultices that could be used to heal everything and anything from a simple headache to festering gout. Man has consumed ground-up bone and cartilage, fetal tissue, glandular oils and animal organs in the erroneous belief that these primitive remedies will heal the most exotic diseases known to man, or that they will increase male potency or even reverse aging. Most of these homeopathic remedies have no more healing qualities than a placebo.
But every now and then man stumbles across a herb, a seed, a gnarled root, or common bread mold with true medicinal qualities, and one more secret of nature’s organic remedies in the order of life is revealed for the benefit of mankind. Such was the case with the cancer-killing characteristics of apricot seeds, peach pits, plum pits, almonds, and apple seeds. But, is amygdalin a curse or a cure?
Apricot seeds were used as a remedy as early as 500 A.D when they were used by the Chinese to treat respiratory ailments such as asthma, bronchitis, emphysema and temporary ailments that triggered spasms of wheezing or coughing. Apricot pits were also used as a laxative. References to the use of the pharmaceutical use of the pulp of apricot and peach seeds has been found in the writings of Pier Andres Mattiott (Matthiolus) in his principle work, Commentari in Sex Libros Pedacii Dioscorides, which was published in 1544. Mattiott’s work was the most widely read book on botany in the world at that time. Thirty-two thousand copies of this book were in circulation. Mattiott described the use of apricot seed pulp as a poultice to heal tumors.
Botanist Jonathan Hartwell worked as a research scientist at the Natural Products Division of the National Cancer Institute from 1938 until his retirement in 1975. He devoted a life of research to one subject: botanical sources for cancer treatment.
After his retirement, Hartwell wrote the book Plants Used Against Cancer. The book was published by Quarterman Publications in Lawrence, Massachusetts in 1981. Hartwell died shortly after the publication of his book, and within a year or two after that Quarterman Publications went out of business. A few copies of the book remain in private collections. On October 2, 1981, not long after Hartwell’s book was published, the Board of Scientific Counselors at the NCI voted to abolish the NCI research grant which funded all natural product research dealing with the development of anticancer agents from plants or seeds.
Jim Duke, who promoted Hartwell’s work after the death of the botanist, noted somberly at the time that “...I fear this signals the end of significant government sponsored research in the United States on medicinal plants, leaving research to the pharmaceutical firms who have shown relative disinterest in plant products.” One of the plants Duke was referring to was cassava (and other geographic variations of the manihot esculenta plant that grow in Africa, South America, Central America and as far north as the southwestern United States).
Cassava, like apricot seeds, produce hydrogen cyanide which, when it comes into contact with active cancer cells, kills them. In the bush country of Africa, and in Central and South America, the cassava plant is used to promote the healing of snakebites, boils, flu, hernia, inflammations of the joints, and a variety of sores. The stems of the cassava plant are boiled or fried and eaten as a food. In the case of cassava, it contains the enzyme linamarase which releases hydrogen cyanide if it is not harvested and prepared properly. Many people in the third world countries which use cassava as a dietary supplement suffer from cyanide side effects such as vertigo, headaches, confusion, convulsions, and sometimes, comas.
Nevertheless, the artificial amygdalin that is currently being tested in clinical studies as a cancer treatment was reportedly synthesized from cassava and not either apricots or peaches.
In his book, Plants Used Against Cancer, Hartwell observed: “The National Cancer Institute has screened about 45,000 higher plant species of activity against cancer. As of 1977, about 3,000 of these had demonstrated reproducible activity. A small fraction were appropriate for screening [and] should perhaps be accelerated....Although no exciting new leads developed during my association with the program, some plant species with anticancer activity will suffer extinction before they are ever studied. Some natural drugs that could save thousands of lives and alleviate much suffering will disappear from the face of the Earth, irretrievable, without ever being used...”
The question that still begs an answer is: is amygdalin a deadly toxin? Does amygdalin break down in the digestive system and create a form of deadly cyanide gas that can kill or seriously injure the unsuspecting consumer who believes that apricot seeds, apple seeds, or peach or plum pits will kill any cancer within their bodies, or otherwise keep them healthier than they would be if they did not consume them?
After almost a hundred years, the jury is still out.
The cancer victims who have been consuming apricot seeds, peach seeds, apple seeds or the serum form of amygdalin, Laetrile, are convinced that not only is amygdalin safe, it is an effective organic cure for cancer. Because they have been consuming as few as 5 or 6 apricot seeds or as many as 10 or more a day and are still alive, they poophah claims made by the FDA that amygdalin, vitamin B-17, apricot seeds, or Laetrile secrete a sufficiently high enough dose of cyanide that it could either prove to be fatal, or at least cause serious damage to the person who is consuming it.
When Vale used the Internet to drum up public support for his cause against the FDA, several cancer victims who used apricot seeds and were afraid that if Vale lost that their supply would of apricot seeds would dry up and they would die from the cancer that amygdalin held in abeyance, came to his defense. Most of the postings were directed at US District Court Judge John Gleeson, as though they were “testifying” as character witnesses for Vale.
• Davis642@****.com wrote: “...I had a basal cell on my face which was confirmed by my physician. I ate apricot seeds for several weeks and when I went to the dermatologist to have the basal cell removed, it was gone. My father died of cancer, my grandmother died of cancer, and I eat seven seeds a day for preventative measure...”
• Robert Mathew P******s wrote: “A little over three years ago I noticed a growth on my back above my right kidney area. It was just a bump and at the time I didn’t think much of it until it began to grow uncommonly fast...[After watching the video, World Without Cancer, I began to take [apricot seeds]. Within two weeks the growth on my back began to shrink. I started eating more and more of them, and the growth got smaller and smaller...After it looked like my problem was taken care of, I stopped eating the seeds. I stopped because I hate the way they taste. For awhile...I was fine. But after a few months, I realized that same growth on my back was returning...”
• Timothy B****n wrote: “My own personal healing of skin cancer in 1997 is due to the ingestion of apricot seed. Two quarter-sized blotches on the back of my left hand, and another on my left elbow, both diagnosed as early stage skin cancer, disappeared after three to four weeks and have never reappeared. I continue to consume 6-8 seeds daily as a maintenance dose...[C]onsider that anyone is free to purchase apricots, peaches, nectarines, and other ‘stone fruits.’ I do so freely and eat the raw seed from the pit of any of them. Christian Brothers simply makes it easier to obtain the seed that I want to buy as a finished product in bulk...”
• Thomas Elliott J••••s wrote: “In December I discovered a tumor on my left testicle...I ordered Vitamin B-17 and Apricot Seeds from Christian Brothers and after two weeks, the tumor was completely gone...”
The testimonials continued in an almost endless stream. Vale’s customers, as well as those who offered an opinion because they think the government intrudes too much in the lives and affairs of the American people, were loyal to the end. Vale succeeded in winning the public relations battle for the minds of his customers; but his customers weren’t on the jury. And, none of the consumers who offered their testimonials to Judge Gleeson via the Internet died from toxic shock due to dangerous levels of hydrogen cyanide in their bloodstream--at least, not at that time they offered their support. The government argues, and rightfully so, that unless an autopsy is done to determine if recently deceased cancer patients had toxic levels of cyanide in their bodies. However, when the family physician lists the cause of death on the death certificate as cancer, few jurisdictions require an autopsy.
The British Columbia Cancer Agency reported several serious cases of cyanide poisoning as a result of people eating fruit pit seeds. Two reported deaths resulted from swallowing amygdalin preparations intended for treatment of cancer have been published in Canada: one of a child, the other of a 17-year old girl. The Vancouver Province reported on October 15, 1979 that a three year old boy suffering from leukemia died in Mexico where he was undergoing Laetrile treatments. The Los Angeles Times reported on February 8, 1979 that a 42-year old woman suffering from breast cancer died of cyanide poisoning after taking massive doses of Laetrile. Around the same time, research scientists for the British Columbia Cancer Agency in Vancouver conducted a test on cancerous lab rats. After receiving doses of Laetrile, all of the test rats died from cyanide poisoning.
In the 1980s the Mayo Clinic and three other prominent cancer centers participated in a clinical trial for Laetrile. The National Cancer Institute funded the study. In charge of the test was Dr. Charles Moertel who headed the Mayo Clininc’s North Central Cancer Treatment Group study. (Moertel was probably not the best choice the NCI could have made to head up such a study since he was the most anti-alternative medicine physician in the country. Although he didn’t know it at the time, Moertel was himself dying from cancer when he headed up the study. Dr. Moertel also led the Mayo Clinic’s attack against Nobel prize winner Dr. Linus Pauling’s unconventional vitamin/amino acid treatment of cancer. Within a year of the NCCTG clinical tests, Moertel succumbed to his cancer.)
Moertel insisted his study was unbiased by noting that the routes, dosage and schedule of administration of Laetrile where chosen to be representative of current Laetrile practices. Patients were also placed on diets identical to the one recommended by most Laetrile practitioners.
“Each patient,” Moertel indicated in his report, “had either a tumor area which could be measured in two dimensions or malignant hepatomegaly with a clearly defined liver edge extending at least 5 cm on below the costal margin. Lesions visible by radioisotope liver scan or by computerized tomographic scan were accepted if they measured 5 cm in diameter.” According to Moertel, only patients in good general condition, who were ambulatory and who were able to maintain good nutrition were selected to participate. Patients who were bedridden or otherwise disabled were ineligible. Naturopathic physicians who have studied the medical pathology of the patients included in the study, and manner in which Dr. Moertel conducted the study, believe Moertel was biased and deliberately selected patients with very aggressive cancers who had been diagnosed as terminal even though they were ambulatory at the time--patients who most likely would not respond to alternative methods of treatment.
The NCI admits that the patients selected for the NCCTG study were all terminal, and that none of them had ever received chemotherapy or had endured any surgery to remove tumors. Further, Dr. Moertel admitted that he selected only those where the doctors knew that conventional cancer drugs would not work due to the types of cancers the patients had. Dr. Moertel did not want to “waste” people who could be saved with conventional treatment. The deck was stacked against the naturopathic physicians. The study was extremely biased since the only patients included were people with aggressive, nontreatable cancers that not even conventional cancer drugs could help. An honest, unbiased study would have included patients with a great variety of cancers at varying stages of development. To include only those written off as dead by the medical community shows a clear bias on the part of the study coordinator.
One hundred seventy-eight patients were included in the clinical test. Fifty-four percent showed measurable cancer progression after 21 days of intravenous treatment of Laetrile. After 3 months, 91% showed disease progression. After 7 months, 100% of the patients had markedly larger tumors. Fifty percent of the patients died within 5 months. Within 8 months, 85% of the patients were dead.
During the test period, according to the NCI, none of the four centers involved in the study found any anticancer effect. All of them reported significant blood levels of cyanide in some, but not all, of the patients. The NCI said: “...[L]aetrile failed on four counts. It did not make cancer regress. It did not extend the lifespan of cancer patients. It did not improve cancer patients’ symptoms; and it did not help cancer patients to gain weight or otherwise become more physically active. Laetrile and natural products containing it...were thus found to be ineffective as a treatment for cancer.”
In the minds of the naturopaths, the debate over Laetrile and the attempt of the federal government to label amygdalin as a regulated drug instead of a vitamin supplement, is one of money and the issue of whether or not the medical community really wants to find a cure for cancer.
In the view of some alternative health practitioners the medical community wants to ban the use of organic amygdalin (Vitamin B-17) since it represents “the cheap cure” for cancer. However, with non-FDA approved Laetrile shots ranging up to $300 per injection, that doesn’t sound like a cheap cure to me--nor does using a medical procedure (injection) to assimilate amygdalin without a practitioner’s license strike me as either legally or medically prudent. When you want a Vitamin B-12 shot, you go to your doctor. B-12 is an organic vitamin, but in its serum form, it is regulated by the FDA and administered by a licensed physician (even though the shot is given by a Physician’s Assistant or a registered nurse). On the other hand, the naturopath can rightfully argue that diabetics regularly give themselves injections of insulin. The insulin, however, is regulated by the FDA and dispensed through a licensed pharmacist.
Is there any merit to the cost argument? When you compare the price of a $16.95 hundred-count bag of apricot seeds that lasts 15 to 20 days, to a prescription of 30 to 60 Laetrile tablets at $5 to $20 per pill--or whatever the market will bear--it is easy to see that an FDA-approved, pharmaceutical company produced cancer fighting drug could be extremely expensive for Americans without prescription coverage.
Then there is the argument that cancer treatment centers like the Mayo Clinic and others do not want to find a cure for cancer since that would literally put them out of business. That is an unsupported argument since the same logic could have been advanced about the doctors who operated the polio treatment and research centers in the early half of the century. The medical community did everything humanly possible to put themselves out of business--and did. Polio was pretty much eradicated in the industrialized world. The same can also be said about small pox (even though new strains of that disease are now appearing in AIDS victims) or muscular dystrophy, or any other horrible disease. The doctors and research scientists in each of these fields are trying hard to put themselves out of business.
That said, we return to the question: is there medical merit to Laetrile? And, the NCCTG clinical study notwithstanding, does amygdalin have a curative effect against cancer? And, is it likely that the medical community will create a prescription drug from amygdalin that will be used to fight cancer?
Dr. Philip Binzel, Jr., M.D., a former physician with the FDA has been arguing for years that Laetrile is the answer to fighting, and curing, cancer. His book, Alive and Well, details his investigation--and his conclusions.
In the 1970s when the FDA banned both the import of amygdalin into the country from Mexico, and the interstate transportation of Vitamin B-17 from State to State, they claimed the reason for the ban was that amygdalin (apricot, peach and plum pits and apple seeds) contained traces of cyanide and if a consumer ate massive doses of amygdalin, it could prove to be lethal, or at least that the person consuming amygdalin risked severe toxic side affects. Clearly, the decision of the FDA to ban amygdalin was influenced by the pharmaceutical industry which has been experimenting with artificial forms of laetrile for several years since the FDA has changed its opinion too many times why Laetrile needed to be banned.
After the NCCTG study, the view of the FDA was that Laetrile was “neutral worthless.” It did nothing. It had no medicinal value as an anticancer drug, nor would it do any serious damage to the people who used it other than to discourage them from seeking cancer treatment from a medial specialist. When the FDA went after apricotseeds.org, their view was that Laetrile was a drug by definition of the Food, Drug and Cosmetic Act and therefore had to be dispensed by a licensed physician. When the FDA came back against Jason Vale the second time, their view had changed. Once again, Laetrile was worthless as an anticancer agent and Vale was a con man who profited by deceiving unfortunate Americans with cancer into believing that apricot seeds would cure them.
The FDA scientists missed what Dr. Binzel’s research uncovered.
The National Cancer Institute and the FDA knew from the NCCTG clinical tests that amygdalin created cyanide in cancer patients since they detected trace elements of the poison in all of the subjects in the NCCTG study. They just didn’t know why it was there. Nor, apparently, did they take the time, or expend the effort, to discover the answer. No one was interested--no one, that is, except Dr. Philip Binzel.
Addressing the subject on the British website, World Without Cancer, Binzel said: “A doctor from the United States FDA once said that Laetrile contains ‘free’ hydrogen cyanide and, thus, is toxic. I would like to correct that misconception. There is no ‘free’ hydrogen cyanide in Laetrile. When Laetrile comes in contact with the enzyme beta-glucosidase, the Laetrile is broken down to form two molecules of glucose, one molecule of benzaldehyde and one molecule of hydrogen cyanide [HCN]. Within the body, the cancer cell and only the cancer cell contains that enzyme. The key word here is that the HCN must be FORMED. It is not found floating around freely in the Laetrile and then released. It must be manufactured. The enzyme beta-glucosidase, and only that enzyme, is capable of manufacturing the HCN from Laetrile. If there is no beta-glucosidase, no HCN can be formed from the Laetrile.
“Laetrile does contain the cyanide radical [CN]. This same cyanide radical is contained in Vitamin B-12 and in berries such as blackberries, blueberries and strawberries. You never hear of anyone getting cyanide poisoning from B-12 or any of the above-mentioned berries, because they do not. The cyanide radical [CN] and hydrogen cyanide [HCN] are two completely different compounds, just as pure sodium [Na+]--one of the most toxic substances known to mankind--and sodium chloride [NaCl], table salt, are two completely different compounds.”
When the medical community first explored the possibility of using Laetrile as a cancer drug in the 1920s, they discovered that amygdalin secreted cyanide. They just didn’t understand what triggered it, and they were clueless why it was important. Cyanide was, after all, a poison that killed people. That was enough.
Hydrogen cyanide [HCN] is a chemical that kills cancer cells and leaves healthy cells intact. While the NCI found HCN in the patients in the NCCTG study, the FDA, a couple of years later found no evidence that Laetrile contained cyanide. Of course, the FDA tested the Laetrile extract. Cyanide, Dr. Binzel discovered, does not appear until Laetrile comes into contact with a cancer cell. At that point, cyanide is metabolized and at that time, it attacks and kills the cancer cell.
The reason the FDA flip-flops so much on whether or not Laetrile is a toxic element is that when they alleged that Laetrile was toxic in the first Jason Vale hearing, Vale’s lawyers challenged their claim and asked them to present evidence to that fact. The FDA admitted they had none. Nevertheless, they still insist that a minimum lethal dose of HCN is 100 mg per 150 lbs. In 1984 the FDA determined that an apricot seed contains 2.92 mg/g of HCN and a peach pit contains 2.50 mg/g. This is interesting since a later FDA test revealed that Laetrile, the serum form of amygdalin contains no HCN at all, and thus, is worthless as an anticancer agent.
It is clear that the Laetrile debate will continue for the foreseeable future. In the meantime, the pharmaceutical industry continues to test anticancer medicines derived from artificial amygdalin, claiming that it is much safer, and much more stable, than organic amygdalin. It’s a safe bet, however, that before the pharmaceutical industry introduces an effective cancer-fighting amygdalin drug which will cost the consumer much, much more than a bag of apricot seeds, serum and tablet forms of Vitamin B-17 will be a regulated by the FDA and Laetrile will be classified as a prescription drug.