By Keir Liddle
One of the things that supporters of Burzynski cling to in their defence of his methods and ANP treatment is his approved clinical trials. However there is much to suggest that these trials are not, and have never been, what they seem to be.
The clinical trial registry of the US national institutes of health lists a total of 61 studies registered to one Stalislaw Burzynski or his clinic. One of these trials is registered as not currently recruiting, the much hyped phase 3 trial that is not all it seems to be, The status of 2 of these have been terminated 7 withdrawn and the status of a further 36 is “unknown” (which means the clinic has not updated their records with the clinical trial registry for over two years) and only one has been completed.
The singular study that Dr Burzynski has reported as completed was reportedly a phase 2 trial exploring the impact of antineoplastons A10 and AS2-1 on progressive or recurrent stage IV melanoma. This study was completed in February of 2005 (the final date given for data collection) however their remains no peer reviewed publication or results associated with it. Now it can take a long time to write a paper to report clinical results and get in published but over seven years seems somewhat slack on the good doctors part. The inability to locate the results from Burzynskis various studies is not a new problem as a 1990 OTA report noted:
Burzynski’s list of publications (124) includes a number of “phase I clinical studies,” along with several other types of study that also include clinical outcome data, such as ‘‘initial clinical studies,” and “toxicology studies.” Many of these studies are listed as presentations made at conferences outside the United States; these reports are not readily available in the open literature. Many of the published studies appear in the Drugs Under Experimental and Clinical Research supplements, one appears in a journal or a book cited as Advances in Experimental and Clinical Chemotherapy (which is not listed at the National Library of Medicine), and one appears in a book, which presents the same data as a paper in one of the supplements.
The report also criticises how these studies results are reported. In mainstream medical research it would be expected that they would report mainly on the toxicology of the drug being tested and not comment on efficacy. But the Burzynski “papers” reports report on “partial and complete remissions” which are used by the Doctor and the clinic to trumpet ANPs as safe and effective. Problematically the Burzynski definitions of partial and complete remission is not the same as that of mainstream medical science. In the 1987 paper published in Drugs Under Experimental and Clinical Research supplement ’‘Initial clinical study with Antineoplaston A2 injections in cancer patients with five years’ followup” Burzynski describes 15 patients as having “advanced neoplastic disease” of which six had “complete remission”. Three of these six patients were reported to have non-metastatic transitional cell carcinoma of the bladder, grade II, which would not be described as ‘‘advanced” by mainstream definitions and two of them reportedly had no measurable malignant disease when they began Antineoplaston treatment. Both these patients had no malignant disease when they began treatment and had a recurrence of cancer after ANP treatment which were then treated with surgery or chemotherapy. In another paper ‘Phase I clinical studies of Antineoplaston A3 injections” ” published in the same journal another patientin‘‘complete remission’ is described as having “adenocarcinoma of the colon, status post resection,’ meaning that the tumor had been removed surgically before the patient started treatment with Antineoplastons.
The OTA report also raises another significant concern about the outcome measures used in these studies:
Another unusual feature of these studies is the section describing increases in platelet and white blood cell counts as “desirable side-effects.” In each case, the post-treatment levels are not just increased, but are abnormally high. In the case of platelet counts, levels are high enough (ranging from about 500,000 to 3.4 million) to lead to possible blood clotting. The authors do not explain why these effects should be considered desirable; physicians would usually consider these levels as indicators of underlying disease or as risks for serious medical complications
In November 1982, consultants to the Ontario (Canada) Ministry of Health, Martin Blackstein and Daniel Bergsagel, visited Burzynski’s clinical and research facilities in Houston because some Ontario residents had sought reimbursement under the Ontario Health Insurance Plan. After reviewing Burzynski’s published papers and viewing the clinicand laboratories, the consultants, , asked Burzynski to select examples of patients who he believed had had a good response to Antineoplaston treatment. They were presented with 12 cases of which the original x-rays were only available for one and for two others, selected CT scans were available. The consultants concluded that there was no documentable change in the X-rays provided and the CT scans that were available showed no definite response to Antineoplaston treatment. They concluded that the scans were not of the same brain area or resolution making direct comparison impossible.
In other cases, the consultants reported that Burzynski’s patients had had effective treatment for treatable cancers before starting Antineoplaston treatment. On the basis of the cases they reviewed, Blackstein and Bersagel reported that they found no examples of objective response to Antineoplastons.
So we can see from the limited, and hard to source, literature that there are a number of issues with Burzynskis research:
- He appears to redefine terms so it makes ANP treatment seem effective when it is not.
- Many of the successes Burzynski reports are in fact due to prior treatment.
- The evidence Burzynski has used to support his successes is not directly comparable
The 1990 report also suggests that Dr B may have been even more slack than his scatter-gun approach to trial registration and seemingly ambivalent reaction to publishing his clinical results. It raises a question about whether these studies were actually planned prospectively, with protocols including patient selection criteria, specific recordkeeping requirements, etc. (a “clinical trial”), or whether they represent groups of patients studied retrospectively. Details concerning a protocol, which would be expected in reporting a clinical trial, are generally lacking. In addition, there is little systematic information about patients’ treatment prior to Antineoplastons, except in specific cases.
So the trials conducted by Burzynski may not even be trials but simply post-hoc recording of patients after they have undergone treatment. Which is seriously problematic in terms of research ethics and in terms of determining whether ANPs are safe and effective. Back in 1990 there was little evidence available, from Burzynski or within the published literature, that ANP treatment was in any way effective. Nothing in the behaviour of the Burzynski clinic in the years since suggests that anything has changed.
There remains no reliable published evidence that suggests ANPs are safe and effective. Yet Doctor Burzynski continues to provide the therapy in ill designed trials to vulnerable patients and their families who pay through the nose. When will someone stop him?