By Keir Liddle
In a protracted and ongoing debate on the #Burzynski twitter hashtag Skeptics and critics of Burzynski have clashed with supporters of the clinic and it’s ANP treatment. One of the central arguments in this debate is the seeming abscence of evidence supporting the efficacy of ANP in treating cancer.
Recently Burzynski supporters claimed victory over his critics when the National Cancer Institute in America amended it’s information and advice on Antineroplasteons to state that:
So have all of the critics and Skeptics been caught with their pants down? Is all this controversy over ANPs really just down to a lack of research?
Let’s look at the studies added to the NCI summary and see if they tell us anything we didn’t already know.
Table two summarises Antineoplastons Clinical Trials but this title is a little misleading as only seven of the twenty-one studies listed are labelled as phase II trials.
The rest comprise nonconsecutive and consequtive case series. A case series (also known as a clinical series) is a medical research descriptive study that tracks patients with a known exposure given similar treatment or examines their medical records for exposure and outcome. The potential problem of bias in such reports is well known within medical science. Case series may be confounded by selection bias, which limits statements on the causality of correlations observed; for example, physicians who look at patients with a certain illness and a suspected linked exposure will have a selection bias in that they have drawn their patients from a narrow selection (namely their hospital or clinic). For this reason they are far less reliable than properly conducted RCTs in assessing the efficacy of a new treatment.
It is also worth noting that Burzynskis case series have been the subject of prior scrutiny. As this page on the American Cancer Society website details:
During the 1980s, the United States Congressional Office of Technology Assessment (OTA) reviewed medical journal articles describing cases of cancer patients whom Dr. Burzynski had treated with antineoplaston therapy. Its report, published in 1990, concludes that, “Despite a substantial number of preliminary clinical studies published by Burzynski and his associates describing outcomes among the patients he treated with Antineoplastons and an attempt at a ‘best case’ review, there is still a lack of valid information to judge whether this treatment is likely to be beneficial to cancer patients.”
In 1982, consultants to the Ontario (Canada) Ministry of Health visited Burzynski’s clinic and reviewed records of twelve patients selected by Burzynski from among the thousands he had treated. According to the OTA report, the Canadian doctors “found no examples of objective response to Antineoplastons.” In 1985, the Canadian Bureau of Prescription Drugs examined the records of Canadian doctors who had treated patients at Dr. Burzynski’s clinic in Houston. Of 36 patients, 32 had died without showing signs of improvement. Of the remaining 4, one patient died after slight improvement, while one patient died after stabilizing for a year. The 2 remaining patients had widespread cancer.
So we should be wary when Doctor B presents his best cases as when experts cast a critical eye over them exaggerated reports of benefits seem to vanish a lot more readily than tumours treated with ANP do.
It is also worth noting that the OTA report criticized Burzynski’s research process and noted that his definitions of advanced cancer and of complete and partial cancer remission were not used in accordance with generally accepted definitions. One example they pointed to was a patient said to have had a complete remission after treatment with antineoplastons. The report concluded, however, that this claim was inappropriate because the cancer had been removed by surgery before the antineoplaston treatment was started.
Turning our own critical eye to the studies listed as “phase II clinical trials” on the NCI website we can see straight away that two of the seven are reports of conferences abstracts published in The Journal “Integrative Cancer Therapies“. Conference abstracts are subject to far less rigorous peer review than published journal articles.
One is the infamous Mayo Clinic trial that ended in acrimony and which could not confirm any tumour regression in patients in this study.
The remaining three report on phase II trials of (in total) 28 patients. Of these 22 are included in studies conducted by the Burzynski institute and 6 by a Japanese research group who have not followed up their results since. Needless to say 28 patients is not a number one could use to make any reliable pronouncements of treatment efficacy.
In short supporters crowing over this page editing as a victory for Burzynski are at best mistaken in their belief it vindicates him and at worst outright misleading people about the content of these supposedly peer reviewed trials.