And if so, why? Last night is had a phone call with Elisabeth Lee, Regulatory Counsel, Division of Information Disclosure Policy at the Center for Drug Evaluation and Research. This was in relation to my request under the US Freedom of Information Act, which I submitted on 7th February. Here is the text of my request:
Please provide the reference(s) for the following publication(s):
All studies demonstrating efficacy of antineoplaston treatment, submitted by The Burzynski Research Institute, and/or Dr Stanislaw Burzynski, and/or The Burzynski Clinic, in support of the application to proceed to phase III clinical trials.
Please note that, as approval for phase III has been granted by the FDA, and there is now an obligation to publish hypothesis-testing research, it is to be expected that the information I have requested will have either been published, or is pending publication. If the latter is the case, please state where publication will take place.
I received an acknowledgement via snail mail dated 9th February, and nothing after that until I started chasing last week. The US FOI Act has the same 20-day response benchmark as ours does, so this was a long way over. The request was passed from pillar to post until it arrived on the desk of Ms Lee, who emailed me and asked me to phone her. Here are some highlights of the conversation.
EL: This is a complex request. Have you made previous FOI requests to the FDA?
Me: No, not previously.
EL: Well complex requests normally take 18-24 months for a response.
Me: Excuse me, but what is complex about it?
EL: A simple request is something that is already available, that we would pull from our databases, in a short amount of time. The FDA is not able to confirm or deny the existence of any information on new drug applications, or to confirm the status of new drug applications.
Me: What puzzles me is how the FDA has allowed at least 61 `trials’ to be conducted, without showing any evidence of efficacy. My understanding is that in order to get into phase III one would have to show some efficacy from earlier phase studies. Is this information you can’t give me?
EL: (Long pause): Erm – we can’t discuss drug research prior to approval of the drug.
Me: You do realise of course that this drug has been investigational for over three decades?
EL: I understand…..
Me: So this could go on indefinitely?
EL: I can’t speak to that unfortunately.
Well you get the drift. The conversation went on like this for several minutes more, with every question stonewalled. So let’s summarise:
- The FDA has been approving clinical trials which don’t meet the most basic of scientific standards (that the FDA would demand of drug companies).
- The FDA does not consider that charging desperate people huge sums for an unproven treatment is unethical.
- The FDA is not worried about non-compliance by the Burzynski Research Institute’s institutional review board (ethics committee) and the Institute itself, because it has not closed out the warning letter. Note that I regularly get notified by the FDA of regulatory action being taken against other IRBs and investigators.
- The FDA has given approval for a phase III trial but refuses to justify that approval.
The FDA has used the `complex request’ option to block this request. In fact it is not complex at all. The FDA has given phase III approval, and will have issued that in writing to the applicant. The document is readily available. It is curious that the FDA is trying to use two ways of blocking this request. One is that it’s a `complex request’, which it isn’t, and the other is that all information prior to drug approval for marketing is confidential. My guess is that they are using the first in order to defend their failure to reply within 20 days, and the second as `belt and braces’.
But I am of course not sufficiently familiar with US law, and would value contributions from American friends. There is something very odd going on here.