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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."
"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."
