The search for safe and effective drugs is as old as mankind. Nothing is more important to doctors and patients than to have drugs they can rely on. And there are now a host of such drugs. Yet “unproven” drugs still have a fatal fascination. especially drugs for cancer. Laetrile is the latest of literally thousands of supposed remedies for cancer, generally so outlandish that it seems incredible that people once believed in them. In its 70-year history, the FDA has put hundreds of such “cures” out of business. Every decade or so. however. there is one which is promoted so effectively that it attracts a large following and becomes a national issue. It is highly revealing to take a look at some of these controversial cancer drugs of the past.
Few people today know, for example, that it was a cancer treatment which led Congress to enact the first Federal law against false claims for drugs.
This 1908 advertisement offered a 125-page book of patient testimonials as proof of the value of “Dr. Johnson’s Mild Combination Treatment for Cancer.” Testimonials—genuine or fabricated—often are the most effective sales ammunition for quack products, and the easiest to obtain. Drugs that work are supported by scientific evidence obtained from carefulIy controlled tests.
In 1910, the Bureau of Chemistry (now FDA) attempted to prosecute this product’s promoter. At the time, everyone thought the new Food and Drugs Act of 1906 would do away with the thousands of worthless and dangerous “patent medicines” then on the market. Millions of people were being harmed as well as swindled, but the Supreme Court ruled in the Johnson case that the law did not prohibit false “therapeutic” claims on drug labels but only false statements about the identity or composition of drugs.
President Taft at once called on Congress to close this dangerous gap in the law. What he said applies just as much today as then:
There are none so credulous as sufferers from disease. The need is urgent for legislation which will prevent the raising of false hopes of speedy cures of serious ailments by misstatement of facts as to worthless mixtures on which the sick will rely while their disease progresses unchecked.
Congress responded with the Sherley Amendment of 1912. which made it a crime to label drugs with false and fraudulent claims of therapeutic effectiveness. Unfortunately. the words “and fraudulent” made it difficult for the Government to prosecute in many cases because it was necessary to prove the defendant intended to swindle the purchaser. Twenty-six years later, in 1938, Congress passed a new law which required scientific proof of safety before a new drug could be sold. And in 1962 the Congress passed even stronger drug controls which required effectiveness as well as safety to be established before a drug goes on the market.
It was unproven cancer treatments that demonstrated most strikingly the need to establish effectiveness of drugs before allowing them on the market. One of these was the treatment promoted in the 1940’s by Dr. William F. Koch of Detroit, who did business as the Christian Medical Research League. Koch’s treatment was one of the greatest medical hoaxes of all time. Analysis showed it to be distilled water of extraordinary purity. but Koch claimed his medicine contained I part of a chemical called glyoxylide per 1 trillion parts of water. A Federal prosecutor said this dilution was like dumping a cocktail into the Detroit River and expecting to get a kick from the water flowing over Niagara Falls. Moreover, there was no evidence that glyoxylide in any amount had any therapeutic effect. But over 3,000 health practitioners of various kinds across the Nation paid $25 per ampule for Koch’s treatment and charged patients as much as $300 for a single injection.
In 1943, the FDA prosecuted Koch. The trial lasted 18 weeks. Forty-three expert witnesses testified that Koch’s products were misbranded and not effective in the treatment of cancer or any other disease. The defense had 104 witnesses who said the products were effective for 69 different disease,. with special emphasis on can,er. tuberculosis. and coronary thrombosis.
After 9.000 pages of testimony the case went to the jury, which deliberated eight days without reaching a verdict, and was dismissed. A poll of the jurors showed three who had insisted on acquittal from the outset. Human credulity had again been shown to be a major factor in the success of quackery.
Koch was tried again in 1946, but after five months a juror became ill and a mistrial was declared. In 1948, after an FDA inspection of Koch’s laboratories, he announced he was retiring and went to live in Brazil. But a product known as the Koch treatment continued to be sold in Mexico long after it disappeared in the United States.
The biggest health hoax of the 1950’s was the Hoxsey Treatment for internal cancer. There were two products: the “pink medicine” composed chiefly of lactated pepsin and potassium iodide. and the “black medicine” composed of a common laxative (cascara) in an extract of prickly ash bark. buckthorn bark. red clover blossoms. barberry roots. burdock root, licorice root, pokeweed, and alfalfa. Harry Hoxsey attributed this 1840 formula to his great grandfather whose horse had been cured of a leg cancer while grazing in a pasture where such plants were growing. Apart from cascara and potassium iodide, which have no value for treatment of cancer, all of these ingredients had long been discarded for medical use.
Hoxsey was a medicine man all his life. After being prosecuted for violating the medical practice laws of several States, he finally set up a “clinic” at Dallas. Texas.
The Hoxsey Clinic offered a package deal consisting of a perfunctory examination by an osteopath and some routine blood and urine tests. after which the patients were told they had cancer and the Hoxsey treatment was prescribed. This cost $400. and included a lifetime supply of the two medicines. At the peak of the business over 10,000 people were getting Hoxsey’s medicines.
Hoxsey had a large income from oil leases as well as the clinic and he fought the Government both in the courts and with publicity. Writers and editors were paid to publish pro-Hoxsey articles. A “crusade of prayer” launched a write-to -Congress campaign against the FDA. Nevertheless, the medicines were found worthless by two Federal Courts after lengthy trials. one before a jury.
In preparing for the trials FDA inspectors investigated some 400 cases of persons who were claimed by Hoxsey to have been cured of cancer by the treatment. This is what they found:
- One group of these victims had diagnosed themselves or had never had a biopsy showing they had cancer.
- A second group had cancer and had been treated for it by accepted and effective methods. but had later gone to the Hoxsey Clinic fearing they had not been cured.
- The remaining cases were people who had received the Hoxsey treatment and had died of cancer (the majority) or still had it. Not one case of a bona fide cure was found.
This is typical of the pattern when cases allegedly cured by untested cancer remedies are carefully investigated.
Public warnings issued by FDA saved thousands of people from being victimized by Hoxsey. In 1960, after 10 years of litigation. a Federal Court injunction finally stopped sale of the Hoxsey treatment in the United States. Announcing the conclusion of the case, FDA estimated that cancer patients had paid over $50 million for the useless drugs. How many had paid with their lives was unknown. Like the Koch treatment. Hoxsey’s “medicine” continued to be offered by practitioners in Mexico.
While FDA was battling the Hoxsey treatment another very different cancer drug was beginning to make headlines and converts. This was Krebiozen. an alleged investigational drug said to have been manufactured from the blood serum of horses inoculated with a mold that causes a disease known to veterinarians as “lumpy jaw.”
Unlike Hoxsey’s backwoods herb remedy, Krebiozen had an aura of high scientific prestige. It was sponsored by Dr. Andrew C. Ivy of the University of Chicago, who had joined forces with Stephan and Marko Durovic. Yugoslav immigrants. who said they discovered Krebiozen in Argentina. Ivy’s announcement and endorsement of the drug at a press conference in 1951 was greeted with indignation by his university colleagues. the scientific community. and the American Medical Association. But Ivy’s prestige gained widespread confidence and credibility among cancer patients. To many he became a hero battling for science against the “medical trust.”
Thousands of cancer victims eagerly sought Krebiozen, and thousands of doctors presclibed it as an investigational drug at $9 per ampule-billed as a “donation.” But the cancer experts who suspected Krebiozen from the beginning were vindicated in 1963 when a team of FDA chemists. analyzing the only sample of the substance ever obtained from the sponsors, found it to be creatine monohydrate,. an amino acid present in all animal tissue and without value in the treatment of cancer. At the same time. analysis of samples of the drug as packaged for injection into patients showed that only mineral oil was present. Krebiozen inspired an emotionally charged. organized following of people who were convinced that the scientific establishment was suppressing the use of a drug which could save lives. Nevertheless, when FDA found that the law had been violated, Ivy. the Durovics, and their Krebiozen Research Foundation were prosecuted. A special Federal grand jury indicted them on 49 counts of fraud and conspiracy. but on January 31, 1966. after a nine-month jury trial in the Federal Court at Chicago, all defendants were found not guilty. The acquittal verdict meant that the Government had failed to prove deliberate action to defraud the public. It did not mean that there was any scientific evidence to support the effectiveness of Krebiozen. The drug remained unapproved and its interstate distribution continued to be illegal.
On March 28, 1966. the first of a series of demonstrations and “sit ins” by Krebiozen supporters blocked access to the FDA Commissioner’s Office. On succeeding days the group urged the Secretary of Health, Education, and Welfare as well as members of Congress to make the FDA back down and allow the continued shipment of Krebiozen. HEW officials held a public meeting with the group to hear their protest and explain the Government’s position, but to no avail. Eleven U.S. Senators called for another start in determining whether the drug had any value for cancer.
Despite the intense pressure, FDA refused to back down. Dr. James L. Goddard, thc Commissioner of Food and Drugs, cxplained the Agency’s position this way:
I know therc are several hundred people who believe in their hearts that Krebiozen will cure them. And 1 have deep sympathy for these people. But there are 198 million people whose health and safety depend in some measure on the integrity of FDA. . . . The Commissioner of Food and Drugs has neither the moral nor the legal right to disregard the laws of Congress and the evidence of science. We cannot and will not permit the introduction of Krebiozen into interstate commerce.
Like believers in the Hoxsey Treatmcnt. Krebiozen advocates demanded a “fair test” of the drug. Data from tests conducted in animals. however. was totally inadcquate to justify FDA approval to test Krebiozen in humans. Ye,. in 15 years of illegal distribution as an investigational drug, Krebiozen was tried on thousands of cancer patients without discernible effects. A National Cancer Institute committee of 24 leading cancer experts reviewed 504 case histories provided by Dr. Ivy and found unanimously that Krebiozen was ineffective as an anti-cancer agent.
After the trial, the Krebiozen boom collapsed. Stephan Durovic abruptly left the United States. winding up in Switzerland where he had banked his profits. Marko Durovic spent years in controversy with the Internal Revenue Service. He died in 1976. And Dr. Ivy continued to dispense Krebiozen from his office in Chicago, changing the name from Krebiozen to Carcalon, which he claimed to be an improved product. and which he continued to prescribe until his retirement a year ago.
The Koch, Hoxsey, and Krebiozen treatments overlapped in time. and there were numerous other cancer frauds during the 30-plus years that saw their rise and fall. Millrue, an herbal extract with iron and vitamins, was prescribed and dispensed by Roy Paxton, an Illinois healer who diagnosed all diseases by feeling the patient’s feet. After serving a three-year sentence for violating the Federal Food, Drug, and Cosmetic Act, he became a director of the National Health Federation. which now advocates quackery as “freedom of choice” in health matters.
The Rand Vaccine, a sensation in 1966, was much more effective as a stock promotion than as a cancer treatment. The manufacturer supplied it free of charge, but the stock of the company leaped from $7 to $50 a share. The “vaccine” was crudely made from the blood of animals which had been injected with material from human cancers collected indiscriminately from hospital operating rooms. Investigation disclosed toxic effects and heavy bacterial contamination, and in one study (not disclosed to FDA by the sponsor) the vaccine actually hastened the growth of cancer in test animals. On February 7, 1967, on evidence provided by the FDA, a Federal court order stopped further manufacture and distribution.
The reaction to the ban was intense. Organizations and individuals who had backed Krebiozen now backed the Rand treatment. Within a week after the ban a petition with 25,000 signatures was being circulated in Washington urging that supplies of the vaccine be continued. The tragic stories of those who had been duped were ignored. But the Rand “cure” declined almost as quickly as it had arrived.
Today’s cancer fad is Laetrile, also known as amygdalin and vitamin B-17. Laetrile, which is derived from apricot kernels, has been tested repeatedly in animals but never has been found to have any effect on cancer. Despite this lack of scientific evidence, it is heavily promoted by well-organized groups. In this respect, and others, there are striking similarities between Laetrile and the Koch, Hoxsey, Krebiozen. and other phony cancer cures of the past. None of these remedies were backed by established drug firms despite the fact that an effective cancer drug would be enormously profitable. Not that there isn’t money in cancer treatments that aren’t effective. There is. Koch, Hoxsey, and the promoters of Krebiozen proved that. And it is being proved again with Laetrile.
|These panels are from a comic hook used by the Committee for Freedom of Choice in Cancer Therapy to promote Laetrile. Condemning accepted methods is standard practice in medical quackery. This Laetrile promotion is aimed at diverting cancer victims from treatment of known value. which could save their lives. At the same time. Laetrile advocates are telling State legislatures they want only to enable terminal cancer patients to get the drug. The comic hook also illustrates the plumy scientific explanations often used by quacks to impress their victims, most of whom have no way of evaluating the ideas presented.|
In the 25 years since it was first touted as a cancer cure, Laetrile has developed into big business on an international scale. In Mexico Laetrile treatment is offered by clinics at a cost of $1,000 or more a month. In May of this year FDA seized 12 tons of apricot kernels at a plant in Wisconsin where they were being used to make Laetrile. And court records show that Dr. John A. Richardson, a California physician who was convicted of conspiring to smuggle Laetrile, charged $50 for a single injection of Laetrile and deposited more than $2.5 million in a single bank account between 1973 and 1976.
Unproved cancer treatments cash in on pseudoscience. Theories of their action are dressed up in high-sounding terminology which seems plausible and convincing to the cancer victim. who in any case is eager to believe. Koch claimed to have discovered the “cancer” germ, and an antitoxin to kill it. Hoxsey said his medicine ”corrects the abnormal blood chemistry and normalizes cell metabolism,” jargon like that once used by medicine peddlers at county fairs. The Laetrile theory and claims have been changed repeatedly to get out of shaky scientific or legal positions. Originally it was claimed that Laetrile worked by seeking out cancer cells and then releasing hydrocyanic acid to kill them. Laetrile advocates now claim that cancer is caused by a deficiency of “Vitamin B-17” and that Laetrile is “Vitamin B-I7” so it can prevent, control, or cure cancer. Nutritional scientists do not recognize Laetrile as a vitamin.
|Ads like these were common and fleeced thousands of desperate cancer victims until the 1930s when stronger laws and rigorous enforcement put an end to them. C.R. Chamlee claimed that a “Pacific island shrub” produced his “cures” but chemical analysis showed that “Chamlee’s Cancer Specific” contained only alcohol and water, with small amounts of iron, strychnine, and saccharin. Joint efforts by the Bureau of Chemistry (now FDA) and the U.S. Post Office finally stopped Chamlee’s mail-order business, hut he was able for several years to continue an office practice in Chicago and Los Angeles.|
Cancer treatments that cannot be supported by scientific evidence traditional]y have been promoted by testimonials –stories by people supposedly cured. Many who have given cancer cure testimonials are now dead—from cancer. Others did not have cancer at a]1. Many more had previous treatment by proven methods.
One of the more outspoken advocates of Laetrile is Glen Rutherford. who says he would be dead because of a cancerous rectal polyp were it not for Laetrile. The polyp was discovered in 1971. Rutherford refused surgery in the United States and instead went to Mexico for Laetrile treatments. These treatments, Rutherford said at an FDA hearing on Laetrile last May, have been successful.
But what Rutherford did not point out at the hearing—according to Medical World News magazine—was that shortly after he began taking Laetrile his polyp was cauterized by Mexican surgeons. Cauterization is a standard surgical treatment and can cure a localized cancer in the overwhelming majority of instances.
Laetrile, as has been the case with other unproved treatments, is credited by its supporters with being ablc to cure all types of cancer. To experts on the disease, this itself is a giveaway. Cancer is not a single disease but a common name given to more than 100 different and distinct clinical entities. No single substance is likely to be effective against all forms of cancer.
What has been learned from the long fight against ineffective cancer treatments?
First and most important. no matter how harmless their ingredients, all such products are death traps for those whose cancers are curable by effective methods. The lesson learned long ago, and translated into law. is simple-the only practical way to protect the public from medical frauds is to keep them off the market. The “freedom of choice” argument is a phony one; what it really means is freedom to swindle the sick.
All the cancer “cures” in this article were alike in their appeal to thousands of frightened. desperate cancer victims, Harry Hoxsey put it clearly when he wrote: “Cancer victims come to us because they’re unwilling to accept as final a death sentence handed them by their own doctors.”
Quackery sells vain hope. Scientific mcdicine provides reasonable hope, having much better means to do so. Morale is an important element in the treatment of cancer. Aware of this, the medical profession is working to develop methods of cancer management that make patient morale a meaningful factor in treatment.
The need for massive health education in the area of cancer “cures” is obvious. The seven danger signals of cancer. bedrock of anti-cancer education. are well known. Experience with cancer treatment fads now suggests the need for another list—a guide to real freedom of choice in cancer treatment:
- Don’t bet your life on any method that has not been approved for marketing or research. The odds against any unproven treatment having any value are overwhelming.
- Go after the best possible treatment by known cancer experts.
- Avoid any “fad” treatment. promoted by some crusading group of laymen. Effective or truly promising treatments do not need crusades to gain acceptance.
- Don’t trust testimonials from lay persons who think they have been cured by unrecognized treatments. Such people may mean well but they are qualified neither to diagnose cases, including their own, nor to determine what was responsible, if anything, for a cure.
- Stick with the prescribed treatment. even if results are not immediately apparent. Don’t panic and go on wild goose chases that waste your precious time, energy, and money.
- Have faith in the experts who are devoting their careers to cancer research and treatment. Remember, doctors have as much reason as anyone to want an effective treatment-they too die of cancer.
- If your specialist “gives up,” look for another. A good doctor does not abandon his patient to hopelessness.
Wallace F. Janssen was the FDA’s public information director many years and later served as an FDA Historian. He was responsible for the public warning that saved thousands of people from being victimized by the Hoxsey cancer treatment, and was an originator of several National Congresses on Quackery.
This article was posted on November 5, 2005.