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This study was requested by 40 members of Congress, concerned that alternative cancer therapies be fairly evaluated. The Congressmen requested a comprehensive evaluation, but what this 560-page report provides is, instead, a comprehensive devaluation, presenting mainly derogatory statements and innuendoes concerning the therapies, interlarded with puffery for the agencies that repress them.
A pattern of prosecution without defense which was established in the first draft is now extended to supporting studies as well, which are determinedly belittled. In most cases all independent corroborative studies are ignored and descriptions of proponent studies are faint and fragmentary.
The report is comprehensive, however, regarding negative information, and, I might add, misinformation.
One of the problems is false standards of appraisal. In the report, all favorable clinical studies are rejected as methodologically unsound because they are not randomized, controlled trials. Moreover, OTAšs ivory tower proposal for testing IAT is a 100-patient randomized trial in the U.S. which would cost millions of dollars and take years for FDA to approve. It is extremely rare, however, for spontaneous remissions to occur in verified carcinomas or for prolonged survival to occur in terminal cancer. NCI, and even FDA, now recognize this reality and no longer require randomized clinical trials for anti-cancer drugs.
To be consistent, OTA must recommend abolition of FDAšs Phase I and II trials, as these are generally uncontrolled. OTA also, for the sake of consistency, must judge surgery an unproven cancer remedy, since there is no large-scale, randomized clinical trial proving a survival benefit of surgery vs. non-treatment, the type of trial that you seek to apply to Burtonšs therapy.
Another problem is charges without rebuttal. Negative information is extensively presented with virtually no mention of proponent points in rebuttal. A false impression is thus created that the charges are unanswerable and hence conclusive.
For examble, two pages are devoted to an attack on several Burzynski cases by Blackstein and Bergsagel, whereas one line mentions that Dr. Burzynski issued a rebuttal. Though Ms. Gelband had his rebuttal, had 14 pages of exhibits, and wrote me that she would include his points, none were mentioned. Readers will not know that independent radiologists and oncologists had confirmed the remissions that Blackstein and Bergsagel dismissed.
Nor is there any mention of Dr. Paulingšs rebuttal in Nutrition Review (1986) to the Mayo Clinicšs trial of vitamin C. Pauling noted that the vitamin C was stopped after a median of only two-and-a-half months, and after that both groups received 5-FU. Of course, the results were the same.
Then there is the problem of misrepresentation of positive studies. OTA alleges that Burzynski published only four clinical studies on antineoplastons, none peer reviewed, and that he paid for publication. All of these are patent falsehoods. His current bibliography shows 14 clinical papers, ten in peer reviewed journals.
I have with me a letter from the journal in question that shows that his payment was for reprints, as is customary. The masthead of the journal states all studies are peer-reviewed.
OTA claims that Dr. Emanuael Revici never published peer-reviewed papers. But even the American Cancer Society cites Revici's papers "in peer reviewed journals" in the journal CA in 1989.
Regarding Lawrence Burtonšs 1962 abstract from his animal studies, OTA states "The treated group lived longer, no data were presented, and the study was never fully reported. " In fact, survival data were given showing that treated mice survived 15 times longer. The study was fully reported with accompanying tables in his 1962 and 1963 papers.
OTAšs own consultant, Dr. Terence Phillips of George Washington University, stated in his contract report regarding this animal study, "The data presented are rational and support the conclusions of the authors." OTA said just the opposite in the draft.
Finally, there is the question of the suppression of corroborative data. In most cases, OTA omits all mention of independent corroborative studies. Paulingšs vitamin C results, for example, were confirmed in a controlled clinical trial in Japan by Morishige in 1979. Remissions on the Kelley therapy were substantiated in a careful 50-case review by Dr. Nicholas Conzalez which Ms. Gelband has. No mention in the report.
Anti-cancer effects of antineoplastons in animals were found in Japan and at the Medical College of Georgia, all published in peer-reviewed journals. No mention in the report.
Prevention of metastases by laetrile was reported by Sugiura and Schmid at Sloan-Kettering. This is published. Laetrilešs by-product benzaldehyde regressed tumors in most patients in two Japanese clinical trials (Kochi, Cancer Treatment Reports, 1985). I have all these studies with me. By claiming comprehensiveness, however, OTA has deepened such sins of omission. Its report exemplifies, therefore, techniques of repression in medical evaluation.