Krebiozen (aka Carcalon, creatine, substance X, or drug X) is a disproven cancer treatment that is made available as an alternative cancer treatment. While the substance has been marketed as a cure for cancer, originally sold for thousands of dollars per dose in the 1950s and early 1960s, Krebiozen is not known to possess any therapeutic value. Attempts to analyze its composition have shown that Krebiozen consists only of the amino acid creatine dissolved in mineral oil, and some samples sold as Krebiozen consist solely of mineral oil with no other discernible ingredients.
Amino acids are organic compounds containing amine (-NH2) and carboxyl (-COOH) functional groups, along with a side chain (R group) specific to each amino acid. The key elements of an amino acid are carbon (C), hydrogen (H), oxygen (O), and nitrogen (N), although other elements are found in the side chains of certain amino acids. About 500 naturally occurring amino acids are known (though only 20 appear in the genetic code) and can be classified in many ways. They can be classified according to the core structural functional groups' locations as alpha- (α-), beta- (β-), gamma- (γ-) or delta- (δ-) amino acids; other categories relate to polarity, pH level, and side chain group type (aliphatic, acyclic, aromatic, containing hydroxyl or sulfur, etc.). In the form of proteins, amino acid residues form the second-largest component (water is the largest) of human muscles and other tissues. Beyond their role as residues in proteins, amino acids participate in a number of processes such as neurotransmitter transport and biosynthesis.
Creatine ( or ) is an organic compound with the nominal formula (H2N)(HN)CN(CH3)CH2CO2H. This species exists in various modifications (tautomers) in solution. Creatine is found in vertebrates where it facilitates recycling of adenosine triphosphate (ATP), the energy currency of the cell, primarily in muscle and brain tissue. Recycling is achieved by converting adenosine diphosphate (ADP) back to ATP via donation of phosphate groups. Creatine also acts as a buffer.
Mineral oil is any of various colorless, odorless, light mixtures of higher alkanes from a mineral source, particularly a distillate of petroleum.
The American Cancer Society states: "Available scientific evidence does not support claims that Krebiozen is effective in treating cancer or any other disease." According to the U.S. Food and Drug Administration (FDA), creatine has been linked to several dangerous side effects.
The American Cancer Society (ACS) is a nationwide voluntary health organization dedicated to eliminating cancer. Established in 1913, the society is organized into eleven geographical divisions of both medical and lay volunteers operating in more than 900 offices throughout the United States. Its home office is located in the American Cancer Society Center in Atlanta, Georgia. The ACS publishes the journals Cancer, CA: A Cancer Journal for Clinicians and Cancer Cytopathology.
Krebiozen was initially promoted by Stevan Durovic, a Yugoslavian physician who claimed that the substance came from horse serum inoculated with Actinomyces bovis .Durovic claimed that Krebiozen had been useful in the treatment of cancer, mainly in cats and dogs. His claims were backed by Andrew Conway Ivy, a prominent physiologist, and by several politicians including Senator Paul Douglas (D-IL). Ivy became convinced that Krebiozen possessed anti-cancer properties, administered the substance to himself and colleagues, then to a dog, and eventually started testing Krebiozen on patients.
Yugoslavia was a country in Southeastern and Central Europe for most of the 20th century. It came into existence after World War I in 1918 under the name of the Kingdom of Serbs, Croats and Slovenes by the merger of the provisional State of Slovenes, Croats and Serbs with the Kingdom of Serbia, and constituted the first union of the South Slavic people as a sovereign state, following centuries in which the region had been part of the Ottoman Empire and Austria-Hungary. Peter I of Serbia was its first sovereign. The kingdom gained international recognition on 13 July 1922 at the Conference of Ambassadors in Paris. The official name of the state was changed to Kingdom of Yugoslavia on 3 October 1929.
Actinomyces bovis is a gram-positive, rod-shaped bacterium of the genus Actinomyces. It is the causative agent of Lumpy jaw in cattle, and occasionally causes infections in humans
Andrew Conway Ivy was appointed by the American Medical Association as its representative at the 1946 Nuremberg Medical Trial for Nazi doctors.
Ivy called a press conference in 1951 at which he announced to an audience of journalists, politicians, doctors and potential investors that Krebiozen was a success. At the press conference, Ivy claimed that of 22 treated patients, 14 were alive and none had died of cancer. However, in reality 10 of the treated patients had died—all of cancer—at the time of the press conference. Shortly afterward, the Krebiozen Research Foundation was established by the Durovic brothers, with Ivy as president.
Intrigued by Ivy's announcement, 10 hospitals and cancer research centers followed up on the trial and attempted to reproduce Ivy's claimed results. None of these independent researchers observed any effect of Krebiozen on cancer. A compilation of these institutions' negative data was reported in the Journal of the American Medical Association in 1951.Krebiozen's backers responded by alleging a conspiracy against the drug. In 1959, Ivy began producing his own version of the drug under the name "Carcalon".
Reproducibility is the closeness of the agreement between the results of measurements of the same measurand carried out with same methodology described in the corresponding scientific evidence. Reproducibilty can also be applied under changed conditions of measurement for the same measurand to check, that the results are not an artefact of the measurement procedures. A related concept is replicability, meaning the ability to independently achieve non-identical conclusions that are at least similar, when differences in sampling, research procedures and data analysis methods may exist. Reproducibility and replicability together are among the main beliefs of 'the scientific method'—with the concrete expressions of the ideal of such a method varying considerably across research disciplines and fields of study. The reproduced measurement may be based on the raw data and computer programs provided by researchers.
A conspiracy theory is the fear of a nonexistent or alleged conspiracy or the unnecessary assumption of conspiracy when other explanations are more probable. Evidence showing it to be false, or the absence of proof of the conspiracy, is interpreted by believers as evidence of its truth, thus insulating it from refutation.
On October 28, 1964, the Durovics, Ivy and the Krebiozen Research Foundation were indicted for introducing mislabeled drugs into interstate commerce in violation of the Food, Drug and Cosmetic Act. After a 9-month trial, the case ended with a hung jury and they were acquitted.Soon afterwards, Durovic was indicted for tax evasion and fled the United States.
A hung jury or deadlocked jury is a judicial jury that cannot agree upon a verdict after extended deliberation and is unable to reach the required unanimity or supermajority.
In order to evaluate Durovic's and Ivy's claims, the National Cancer Institute (NCI) requested samples of Krebiozen. These were provided on two occasions to the NCI and one occasion to the U.S. Food and Drug Administration (FDA). Durovic proposed to charge the NCI $170,000 per gram of Krebiozen, although ultimately the samples were provided free of charge. However, the FDA spectrophotometry team, led by Alma Levant Hayden, proved the samples consisted only of creatine monohydrate, a simple amino acid, sometimes dissolved in mineral oil.When the FDA went back to test previously acquired samples of Krebiozen, they found that many lacked even creatine, and consisted solely of mineral oil with no discernible active ingredients.
Amygdalin is a naturally occurring chemical compound, famous for falsely being promoted as a cancer cure. It is found in many plants, but most notably in the seeds (kernels) of apricot, bitter almonds, apple, peach, and plum.
The Burzynski Clinic is a controversial clinic offering an unproven cancer treatment. It was founded in 1976 and is located in Texas, United States. It is best known for the controversial "antineoplaston therapy" devised by the clinic's founder Stanislaw Burzynski in the 1970s. Antineoplaston is Burzynski's term for a group of urine-derived peptides, peptide derivatives, and mixtures that Burzynski named to use in his "cancer treatment". There is no accepted scientific evidence of benefit from antineoplaston combinations for various diseases.
Pralatrexate is an anti-cancer therapy. It is the first drug approved as a treatment for patients with relapsed or refractory peripheral T-cell lymphoma, or PTCL — a biologically diverse group of aggressive blood cancers that have a poor prognosis.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
714-X or 714X, also referred to as "trimethylbicyclonitramineoheptane chloride", is a mixture of substances manufactured by CERBE Distribution Inc and sold as an alternative medical treatment which is claimed to cure cancer, multiple sclerosis, fibromyalgia and other diseases. There is no scientific evidence that 714-X is effective in treating any kind of cancer, and its marketing is considered health fraud in the US.
Hoxsey Therapy or Hoxsey Method is an alternative medical treatment promoted as a cure for cancer. The treatment consists of a caustic herbal paste for external cancers or an herbal mixture for "internal" cancers, combined with laxatives, douches, vitamin supplements, and dietary changes. Reviews by major medical bodies, including the U.S. Food and Drug Administration (FDA), the National Cancer Institute, the American Cancer Society, M. D. Anderson Cancer Center, and Memorial Sloan-Kettering Cancer Center, have found no evidence that Hoxsey Therapy is an effective treatment for cancer. The sale or marketing of the Hoxsey Method was banned in the United States by the FDA on September 21, 1960 as a "worthless and discredited" remedy and a form of quackery.
Poly-MVA is a dietary supplement created by Merrill Garnett (1931–), a former dentist turned biochemist. Poly-MVA is an ineffective alternative cancer treatment.
Ibandronic acid or ibandronate sodium is a bisphosphonate medication used in the prevention and treatment of osteoporosis and metastasis-associated skeletal fractures in people with cancer. It may also be used to treat hypercalcemia.
Cancer Treatment Centers of America (CTCA), headquartered in Boca Raton, Florida, is a national, for-profit network of five comprehensive cancer care and research centers and three out patient care centers that serves cancer patients throughout the United States.
Reslizumab is a humanized monoclonal antibody against human interleukin-5 (IL-5). Reslizumab binds specifically to IL-5, a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils. By binding to human IL-5, it blocks its biological function; consequently survival and activity of eosinophils are reduced. The benefits with reslizumab are its ability to reduce the exacerbation rate and improve lung function and asthma-related quality of life in patients with severe eosinophilic asthma and with at least one previous asthma exacerbation in the preceding year. The most common side effects are increased blood creatine phosphokinase, myalgia and anaphylactic reactions.
Mepolizumab is a humanized monoclonal antibody used for the treatment of severe eosinophilic asthma. It recognizes and blocks interleukin-5 (IL-5), a signalling protein of the immune system.
A protein kinase inhibitor is a type of enzyme inhibitor that blocks the action of one or more protein kinases. Protein kinases are enzymes that add a phosphate (PO4) group to a protein, and can modulate its function.
Cancell, also called Protocel, Sheridan's Formula, Jim's Juice, Crocinic Acid, JS–114, JS–101, 126–F, and Entelev, is a formula that has been promoted as a treatment for a wide range of diseases, including cancer. Cancell is available in tablet and liquid form. Originally called Entelev, the formula was developed by biochemist James V. Sheridan. Sheridan sought to target the primarily anaerobic cell metabolism of cancer cells, claiming to lower cell potential leading to the destruction of cancer cells. The Cancell formula was tested by the National Cancer Institute and found to be ineffective against cancer, though Cancell continues to be marketed as a dietary supplement in the US.
A glossary of terms used in clinical research.
Lenvatinib is an anti-cancer drug for the treatment of certain kinds of thyroid cancer, and potentially for other cancers as well. It was developed by Eisai Co. and acts as a multiple kinase inhibitor against the VEGFR1, VEGFR2 and VEGFR3 kinases.
Trametinib is a cancer drug. It is a MEK inhibitor drug with anti-cancer activity.
An adaptive clinical trial is a clinical trial that evaluates a medical device or treatment by observing participant outcomes on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations. The adaptation process generally continues throughout the trial, as prescribed in the trial protocol. Modifications may include dosage, sample size, drug undergoing trial, patient selection criteria and "cocktail" mix. In some cases, trials have become an ongoing process that regularly adds and drops therapies and patient groups as more information is gained. Importantly, the trial protocol is set before the trial begins; the protocol pre-specifies the adaptation schedule and processes.
Alma Levant Hayden was an American chemist, and one of the first African-American women to gain a scientist position at a science agency in Washington, D.C. She joined the National Institutes of Health (NIH) in the 1950s. Hayden graduated from Howard University with a master's degree in chemistry, and became an expert in spectrophotometry, the measurement of how substances absorb light. She published work on infrared and other techniques for analyzing chemicals in a range of journals. Hayden was appointed Chief of the Spectrophotometer Research Branch in the Division of Pharmaceutical Chemistry at the U.S. Food and Drug Administration (FDA) in 1963, and may have been the first African-American scientist at the FDA. Hayden came to national attention in 1963 when she led the team that exposed the common substance in Krebiozen, a long-controversial alternative and expensive drug promoted as anti-cancer. Hayden was married to fellow research chemist Alonzo Hayden, and had two children. She died in 1967.