By Keir Liddle
Dr Stanislaw Burzynski is in trouble with the FDA again. This time for making misleading claims to promote ANP therapy on his various websites.
On the 18th of October 2012 the FDA issued yet another warning to the seemingly ever embattled “cancer crusader”. FDA regulations state that antineoplasteons, Burzynskis controversial cancer treatment, do not have marketing authorization in the United States as they are investigational new drugs.
Promotion of an investigational new drug is prohibited under FDA regulations at 21 CFR 312.7(a), which states:
“A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.”
The FDA has ruled that the Burzynski clinic and research institute have violated this regulation by posting videos and press releases on their websites that promote Antineoplastons as safe and/or effective in the absence of any scientific evidence to support this. The full ruling can be found here.
Some of the claims ruled to have breached FDA rules include:
“The remarkable response of one of the patients who was treated on the study protocol was the subject of the second presentation. . . . She achieved complete
response in February 1999 and continues to be tumor free and lives a normal life since then.”
A previous report to the FDA from the Burzynski clinic indicated that 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.
“ANP was well tolerated, with just two cases of serious reversible toxicities.”
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. More on the toxicity of ANP can be found in this article.
Buryznskis website, and Burzynski himself in an embedded video, makes several unfounded claims about how ANP therapy supposedly works including claims that they are gene targeted. Claims which the 21st floor has previously shown to be laughable. The 21st Floor has also suggested at least one way in which patients on ANP be tragically come to believe they are getting better when their condition is in fact worsening.
The FDA has dragged it’s feet on Burzynski, possibly due to several high profile court losses, but slowly they at least seem to be taking some steps to assure that Dr B cannot promote ANP therapy without evidence and attempted to address his unethical research practices. However this does nothing to stop the media uncritically supporting Burzynski and his treatment. However, in the UK at least, journalists should be aware of the MHRA as articles they write may well fall under the remit of The Medicines (Advertising) Regulations 1994.
Particularly those claims regurgitated uncritically in newspapers in support of charitable campaigns aiming to get patients to Texas to undertake his cancer treatment. This act might be useful to quote in correspondence with newspapers running stories on the clinic and antineoplasteon therapy.
The act came into force in 1994 and section nine states:
9.—(1) Subject to regulation 11, no person shall issue an advertisement relating to any relevant medicinal product which contains any material which—
(b)suggests that the effects of taking the medicinal product are guaranteed, are unaccompanied by side effects or are better than, or equivalent to, those of another identifiable treatment or medicinal product,
(c)suggests that health can be enhanced by taking the medicinal product,
(e)is directed exclusively or principally at children,
(h)suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural,
(l)mentions that the medicinal product has been granted a product licence.
Now if it is adjudged that the websites and articles relating to the clinic and antineoplasteon therapy qualify as adverts than the above section in the act (at least) poses some difficult question for those regurgitating the clinics claims.
The media should take this as a warning not to uncritically regurgitate Burzynskis claims and to consider the legacy of Burzynskis ghosts. A legacy they are complicit in growing.