The email below is a response and summary to a phone conversation I had with Wayne Dolcefino just before Easter, on the 26th March 2013. We discussed the details of a recent inspection of by the FDA of the IRB (Institutional Review Board) who are responsible for assessing patient suitability for protocol acceptance at the Burzynski Clinic. The FDA inspection observation document is worth reading, but a good summary of their findings can be found on The Other Burzynski Patient Group website.
If you’re interested in finding out more about the Burzynski Clinic then this Q&A is a fairly good starting point. This email forms part of a now large series of emails posted on this site between Wayne Dolcefino and myself. Worth having a read for background.
Hope you and your family had a great Easter.
As I told you on the phone the observation notes referred to are not related to any FDA inspection of the Burzynski clinic. They are observations of the BRI IRB, which is a separate company which works for alot of researchers , including Dr. Burzynski and his clinic, and the research institute. I have never met, nor do I work for those folks , so it would be inappropriate for me to opine on the few observations made there.
I am sure all your self proclaimed medical expert friends out there know that FDA observation notes are not a conlusion of anything.’ They are inspectional observations, and do not represent a final agency determination.
And they are certainly no reflection on Dr. Burzynski and his clinic. The IRB has a director, and he does not work for Dr.Burzynski. I would address the bloggers by name , the ones who used this unrelated review to launch their increasingly tired attack on the Burzynski clinic again, but honestly, they are destroying their own credibility with each article and commentary, so I do not think they deserve the personal shout out.
I did get a kick out of the conspiracy theory that suggested I wrote clinical trial, instead of clinical trials in my response to hide the fact there were multiple trials over years. You got me. Even though the multiple trials are part of hundreds of government records, including dozens of articles and speeches by Dr. Burzysnski and his staff around the world, I have apparently convinced someone out there I was hoping to hoodwink you, instead of making a simple typo.. Boy you guys are good.
Just and FYI about observation notes, which I am sure your medical expert friends already know. I know from my research that often files are misplaced when they are from research done 15 years ago, and found as soon as they know there is a question, sometimes the inspector is using current FDA rules when they may not have applied at the time of the resarch, and sometimes, the inspector just makes a mistake. Sometimes reasonable people may disagree on a a technical issue that will be resolved.That is why responsible people probably would wait until the IRB or the hundreds of other recipients respond and see if the FDA is satisfied.
You asked if the clinic talked to the IRB about a warning letter five years ago. They did, and like the FDA were satisified by the responses.
As I am sure you know the FDA sends out hundreds of observation notes, a way to check their inspection work, and then warning letters. Virtually all of them are resolved as part of the normal regulatory process that comes with drug research
Some of America’s biggest hospitals get warning letters, like M.D. Anderson. It hardly means they have done something wrong. I would be curious if someone took the time to research how many FDA inspections of pharmaceutical research resulted in no observation letters, versus the ones who did. Why don’t you guys get on that and report back to me for comment.
Comon guys, I know you wish something would happen to help revive your increasingly desperate and diminishing arguments, but every time you leap to a ridiculous conclusion , you actually end up helping me, so thanks.
P.S. I do not drink Kool-Aid at the clinic. Just coffee, with a little sugar.
I’m just going to leave that email there. I’m not going to address the points he makes directly. I will add that Wayne’s observations that this was only an interim observational report are valid. It is. But it still raises valid cases and concerns. Whether these issues are resolved with satisfaction as they were in 2005 remains to be seen. All we know is that the IRB was inspected and not for the first time, concerns have been raised by the FDA in relationship to record keeping and acceptance of patients into protocols. On a personal note, I wouldn’t continue to do business with a company that had issues like this. You would hope that a good cancer clinic would want to distance themselves from these sort of issues. But hey, that’s just my opinion.
I should add that Wayne was a great pains to make me aware that there is no link between the clinic and the Institutional Review Board. Here are the some of the relevant quotes from our conversation regarding that point.
“Not only do he [Dr. Burzynski] have nothing to do with it [IRB], in fact I think it would be prohibited for him to have anything to do with it.”
“There’s a doctor… I asked the question myself, because I don’t know… some guy named Hazelwood.” (I interrupt to offer the female first name of Carole). I don’t know if its a man or a woman. I’ve never been involved in any discussions with them. Err, I called the clinic this morning because I wanted to talk to him and they can’t even… they’re not even connected phone wise with them, there’s no relationship in that way. There are other people in that building, it doesn’t to me… there isn’t a connection.”
“I’ve never met this Hazelwood person. I know he’s not an employee of Dr. Burzynski’s.”
It’s at this point that I should link to the last annual SEC (Securities and Exchange Commission) fillings for the Burzynski Research Institute, Inc. Section 10 states that Dr. Carlton Hazelwood is one of only four board members. While being a director for the Institute is not a directly paid position, nor is it compensated in the form of shares, it does show that there is a direct personal relationship.
When Dr Burzynski is in the business of trying to get approval to licence and commercially sell Antineoplastons, it strike me as dubious practice that the Chair of the Burzynski Clinic’s IRB is also a director of the clinic itself. I want to be careful not to insinuate any wrongdoing, but it does seem that you could assume a conflict of interest. You would be forgive for assuming that is would be in Dr. Hazelwood’s interest to show a favourable bias towards allowing patients to fit the clinics criteria for acceptance to protocols. But that’s not an opinion I’m willing to agree with.
All of this speaks to more issues for the clinic. This isn’t the first time the IRB for the Burzynski Institute has had concerns raised about it. I suspect this won’t be last issues raised about the Clinic in general, either.
Anyway, I thought I would share this, if a little behind the times! I feel there may be more important things coming.