The activities of the Burzynski Research Institute have attracted attention worldwide. For well over 20 years Dr Burzynski has been administering investigational drugs, which he calls antineoplastons, to patients with very advanced cancers. He charges extremely high fees for entering patients in what he claims are clinical trials. Hitherto none of these `trials’ has met internationally recognised standards of design. Of 61 protocols registered on www.clinicaltrials.gov, 34 are recorded as of unknown status, six have been withdrawn, and only one has been completed. There are only five publications from this investigator on PubMed indexed as clinical trials, but three appear to be reporting on the same study.

In 2009 The FDA issued a warning letter to the Burzynski Research Institute IRB, citing multiple violations. These violations implicated The Burzynski Research Institute itself in various breaches of Good Clinical Practice. The warning letter has not been closed out, the Burzynski Research Institute has not received a for-cause inspection by the FDA.

How could approvals for phase I and phase II trials could have been issued over so many years, when the protocols were so obviously of no real scientific value? For example, protocol NCT00003533 states its objectives as:

-Provide treatment with antineoplastons A10 and AS2-1 for patients with incurable, metastatic, hormone-refractory adenocarcinoma of the prostate.

-Describe response to, tolerance to, and side effects of this regimen in these patients.

The first objective has no scientific aim or predicted outcome, which is not acceptable practice. BRI claims antineoplastons to be orphan drugs, but that does not excuse abuse of the scientific method.

To illustrate the level of concern many people have for this matter, I would direct you to a digest at:

http://josephinejones.wordpress.com/2011/11/29/burzynski-blogs-my-master-list/.

In many areas, the public is being asked to contribute to fund-raising efforts to pay for the treatment of children by Dr Burzynski. Professionals in clinical research have concluded that there is no realistic prospect of success from this treatment. How does the FDA justify allowing this investigator to continue?

We are requesting that your office inspect the Burzynski Research Institute for compliance with Good Clinical Practice.