been successful in duplicating these results." From 1991 to 1995, the NCI initiated multiple phase II trials of antineoplastons. In 1995, after over $1 million had been spent on these trials, they were stopped due to fundamental conflicts between NCI investigators and Burzynski and his employees, notably around Burzynski's insistence on approving all protocols in the NCI trial. Since the mid-1990s, Burzynski registered some sixty clinical trials of antineoplastons and, in December 2010, a Phase III trial which did not open for patient recruitment. Burzynski has not published full results for any of these. The aim of registering so many trials, according to the 2008 book of long-time Burzynski lawyer Richard Jaffe, was to allow for treating any cancer Burzynski might want to treat. The largest trial Burzynski registered was called CAN-1 and aimed to cover all clinic patients at that time. Jaffe wrote that CAN-1 was "a joke" of a clinical trial and explained the legal maneuvering: All trials were paused (no new patients allowed) following a 2013 FDA inspections which found (for the third consecutive time) significant issues with his Institutional Review Board, and, according to papers published in November 2013, substantial issues with the conduct of both the clinic and Burzynski as principal investigator. Efficacy Although Burzynski and his associates claim success in the use of antineoplaston combinations for the treatment of various diseases, and some of the clinic's patients say they have been helped, there is no clinical evidence of the efficacy of these methods. The consensus among the professional community, as represented by the American Cancer Society and Cancer Research UK is that antineoplaston therapy is unproven and the overall probability of the treatment turning out to be as claimed is low due to lack of credible mechanisms and the poor state of research after more than 35 years of investigation. Antineoplaston treatments have significant known side effects including severe neurotoxicity. Independent scientists have been unable to reproduce the positive results reported in Burzynski's studies: NCI observed that researchers other than Burzynski and his associates have not been successful in duplicating his results, and Cancer Research UK states that "available scientific evidence does not support claims that antineoplaston therapy is effective in treating or preventing cancer." There is no convincing evidence from randomized controlled trials in the scientific literature that antineoplastons are useful treatments of cancer, and the U.S. Food and Drug Administration (FDA) has