Here is a link to the letter on the FDA website [PDF] which says:
[...] some of the above-referenced claims suggest that the drugs are “well tolerated,” “work without causing side effects,” and have demonstrated “remarkable” results. The totality of these claims suggest that Antineoplastons, investigational new drugs, are safe and/or effective for the treatment of the various types of brain tumors indicated above, when they have not been approved for these uses.
Since Antineoplastons are investigational new drugs, the products’ indication(s), warnings, precautions, adverse reactions, and dosage and administration have not been established and are unknown at this time. Promoting Antineoplastons as safe and effective for the purposes for which they are under investigation, by making representations such as those noted above, is in violation of 21 CFR 312.7(a).
I think the FDA is actually being too easy on him. As I’ve pointed out as recently as last week, a credulously clueless filmmaker named Eric Merola made a “documentary” that was, in effect, a 90 minute commercial for the Burzynski Clinic and Stanislaw Burzynski that only contributed to his cult of personality, all with the obvious complete cooperation of Stanislaw Burzynski and his clinic. In addition, Burzynski advertises antineoplastons as part of his “personalized gene targeted cancer therapy,” which I tend to refer to as “making it up as you go along.” It’s rather odd, of course (well, no, it isn’t, actually), that somehow every single one of the “personalized gene targeted cancer therapy” regimens that Burzynski ever comes up with always seems to include antineoplastons (or, sodium phenylbutyrate, which is the same thing as one of the antineoplastons that Burzynski sells). Regardless of what Burzynski calls them, however, he promotes antineoplastons with glowing terms.
If Burzynski really believed in his therapy the way he says he does, he could manage to do clinical trials the way they’re supposed to be done, with no expenses related to the experimental treatment paid for by the patient enrolling in the trial.
So he’s making claims about drugs he is supposed to be testing regarding these claims. I’m mentioning that again to let it sink in. What does this say about his objectivity and about his science? What does it say to his patients? They are being promised more than has been established this treatment can deliver. Dr. Burzynski has been ordered to cease distribution of these materials. Meanwhile, he continues to get paid a lot for each of the patients that come for treatment, he has not published any thing showing that the treatment works, and he is lauded as some maverick miracle doctor in the alt med world. Just thought you should know how this guy does his business.