By Keir Liddle
One of the oft-repeated claims made by Burzynski supporters is that Antineoplasteon (ANP) therapy is “non-toxic” and not at all like those other chemotherapy agents with their nasty side effects. This seems based solely on a well-worn logical fallacy “ANPs are a therapy derived from “natural” sources so there is no way they could be harmful” and in reality the claim that ANP therapy is non-toxic fails to stand up to scrutiny.
Data, drawn from the clinic’s first annual report issued Jan. 23, 1998, details the first treatment results released by an outside agency on ANPs. They are not favourable on either efficacy or toxicity. The data shows that while marketing materials may describe antineoplastons as “non-toxic substances” this is at odds with the FDA analysis of Burzynski’s data, the data reported by investigators from Memorial Sloan-Kettering, Mayo and NIH (the institutions that conducted the NCI-sponsored trial of the substance) and the information contained in his own research protocols.
Burzynski favours a high dose regimen for ANP therapy (the refusal of independent investigators to give such high doses is one of the reasons he gives for the NCI-sponsored trial collapsing) but on a high dose regimen of ANP a patient is exposed daily to 2.6 times the total amount of sodium normally found in the body.
Side effects from sodium overdose alone are likely to include hypernatremia, edema, and, potentially, seizures. Even a low dose of antineoplastons pumps 41.4 grams of sodium into the same patient’s veins, by comparison, the daily sodium load of phenylacetate or phenylbuterate, two drugs closely related to antineoplastons, is around 8.8 grams. Yet even with a sodium content of about one-seventeenth of high-dose antineoplastons, phenylacetate and phenylbuterate are considered high-sodium drugs.
Patients being given high sodium drugs are generally carefully monitored, advised to go on a low-sodium diet and given diuretics. Burzynski has said his patients are encouraged to drink large amounts of fluid, but sometimes neglect to do so.
“When they stay in Houston, we watch them very carefully, and we monitor fluid in and out very carefully, and we try to convince then that this is important to do, but sometimes they don’t drink as much fluid as they should, and then they may get dehydrated, and they have an elevation of sodium.”
FDA officials said that according to Burzynski’s data, 4% of his patients died while on protocol. According to FDA, hypernatremia, or an excess of sodium in the blood, was present in 65% of patients participating and may have been a factor in the deaths of 1.7% of patients enrolled in the studies in 1997. Independent investigators involved in the NCI-sponsored trial also found ANP treatment to be associated with substantial toxicity finding severe toxicity in three (of nine) patients.
Dr Burzynski maintained, in a telephone interview with the cancer letter, that:
“We Don’t See Any Significant Toxicity”
Dr B. has also stated in interviews with various “natural cancer cure” sites that ANPs are completely non-toxic:
“LE: Does the treatment affect normal cells?
Burzynski: No, this is why antineoplastons are a nontoxic treatment. They affect only abnormal cells.”
Though all medications come with side effects these can usually be offset against benefits derived from treatment in drugs that pass through the clinical trial process. Can this be said of ANP therapies?
According to the data drawn from the Burzynski clinic 1997 annual report the answer seems to be probably not.
Of 828 patients who received antineoplastons intravenously, there were 36 patients for whom Burzynski reported responses – 34 who were in FDA-approved studies and two among the group of patients who received antineoplaston by special exception because there was no conventional treatment available for them. The overall response rate, as reported by Burzynski, was just 4.3%. Eleven of the 36 patients who “responded” to treatment subsequently died and death was reported for 64 percent of all protocol patients and 61 percent of special exception patients. Forty-five percent of patients withdrew from the study at their own request and 36 percent withdrew because their tumors grew or their condition got worse while they were treated.
It is worth noting that there are questions over whether we can trust, even these unimpressive, numbers from Burzynski due to his lax research practices and I shall cover these in a future post.
But in terms of ANP it seems worth reminding supporters of Doctor B that, no matter what the substance, the difference between a cure and a poison is how large the dose is.