Dec 01 2011
Burzynski Tries to Distract and Intimidate
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Anarchic Teapot has raised some questions about the financial goings-on at the Burzynski Clinic, as well, over at his blog. I’m also very curious to see any of the FDA authorizations he has received allowing him to charge subjects to be in his clinical trials. They must exist, otherwise, he’d be breaking the law. Similarly, I’d really like to get a look at some of the consent forms for his trials to see if subjects are being adequately informed of everything, especially since the IRB for the Burzynski Research Institute received a warning letter from FDA in 2009 that still has not been closed, indicating that no corrective actions have been implemented by the IRB.
“That is how he is able to use a non-FDA approved drug to treat cancer – he claims he is conducting clinical trials. Of course, he still charges his “subjects” up to hundreds of thousands of dollars for the privilege of being in his study.”
After following this story for a while now, a thought has just occurred to me. However unethical it is to charge people for participating in trials (essentially a backdoor to charging for an unapproved drug), those “trials” obviously can’t be randomized, placebo controlled studies, or it would be beyond unethical to charge people for participating.
Rhetorical question: What value can those “trials” claim to have in regards to determining the efficacy and safety of the treatment?
@Karl:
Hmmmm, and an awful lot of ‘self-selection’ going on by both the ‘investigators’ and the patient-participants.
-r.c.
@Karl Withakay
Good point! Wish I’d thought of it. So, no randomization, which decreases the scientific validity of the trial. If he does randomize and charges the control group the same amount, then he is violating FDA regulations, since the regs only allow billing for the cost to manufacture/acquire the drug (i.e., direct costs), nothing else.
Everyday, I work with people who labor over every detail of clinical trials to make sure that informed consent, clinical equipoise and data integrity regulations are met. It’s literally hard to believe that the FDA tolerates such flagrant violations of these norms at this “clinic”.
Are their hands are tied by some onerous legal technicality?
All the trials Dr B is running are phase 2 – these are not necessarily required to be randomised.
CancerHelp UK says;
Not all treatments tested in a phase 1 trial make it to a phase 2 trial. Phase 2 is sometimes written as phase II. These trials may be for people who all have the same type of cancer, or who have several different types of cancer. Phase 2 trials aim to find out
* If the new treatment works well enough to test in a larger phase 3 trial
* Which types of cancer the treatment works for
* More about side effects and how to manage them
* More about the best dose to use
Although these treatments have been tested in phase 1 trials, you may still have side effects that the doctors don’t know about. Drugs can affect people in different ways.
Phase 2 trials are often larger than phase 1. There may be up to 100 or so people taking part. Sometimes in a phase 2 trial, a new treatment is compared with another treatment already in use, or with a dummy drug (placebo). If the results of phase 2 trials show that a new treatment may be as good as existing treatment, or better, it then moves into phase 3.
>>>>
So you’re looking for dosage, toxicity and any inklings of efficacy. The trials aren’t actually designed to show true efficacy – you need phase 3 for that. After 2,000 patients treated in the past 10 years (according to the clinic website) you have to ask why he doesn’t have enough data to show that he is ready for phase 3.
There is one phase 3 trial meant to be starting this year. But the paucity of convincing data after so many years of trials is rather suspicious. If there was significant evidence of efficacy (assuming his methodology is capable of showing it, which is highly doubtful based on previous criticisms of his trials http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page5) then he could licence it to a pharma company (or even set up his own) and make $$$$$$$$$.
As he hasn’t, one can only ask questions as to why. And at the prices that his clinic is charging to take part in the trials (although he doesn’t charge for the actual drug, he charges for pretty much everything else around it), there is a fairly obvious answer.
Incidentally, I wonder how many of his success stories are actually down to chemotherapy? http://www.burzynskiclinic.com/treatment-options.html
I just read Rhys Morgan’s blog and the posts about this topic. I was very impressed with his tenacity and his responses to Marc Stephens – I would imagine that he will make a big name for himself as a sceptic in the future. It’s good to see him stand up to the bullying.
I would file this FDA case under Bed, Bath, and the Great Beyond. While the patient is getting ready for the hospital bed, the Doctor of Metaphysics takes a bath in the patient’s money, whilst the patient moves to the Great Beyond.
A quick look at clinical trials (ongoing and concluded) with the search term “antineoplaston” will pull up Burzynski’s stuff. Over 60 trials, apparently. The phase III trial is not currently open, but it is scheduled to begin this month (Dec 2011).
Link here:
http://www.clinicaltrials.gov/ct2/show/NCT01260103?term=antineoplastons&rank=1
You can see what arms are included in the trials. For the phase III study, at least, temozolomide treatment is used as the comparator. This is pretty standard for gliomas. They don’t publish the protocol for these things, so I’m not sure if the 70 people this trial is aiming for are going to be receiving the standard of care in addition to Burzynski’s “combination antineoplaston therapy” (as is the case for most new anti-cancer agent potentials). The trial summary does state all enrolled patients will have gone through standard chemo (cisplatin).
I’m confused, though. Do antineoplastons have a previously established safety profile? Cancer therapeutics do have several special cases applied to them when it comes to FDA new drug applications and clinical trial approval, but I don’t see how studies like this have been approved in the absence of good pre-clinical evidence. Any insight into how this has progressed to Phase III?
For the record, the trial information has “No publications provided ” for additional information (to be fair, though, this isn’t uncommon) and Burzynski is listed as the principle contact as “Stanislaw R Burzynski, MD PhD”
The distraction of the nitpicking is a nice lesson in being specific, rather than vague when you are exposing someone like this.
He finds it easy to choose items that can marked as “false” in technicality and that is all that someone who is inclined to believe him needs to see.
They now have confirmation that those who made these statements are wrong.
His supporters will now look no further and people on the fence will feel less inclined to trust your side. From now on, both sides will be preaching to the choir as they battle it out.
You either make the point specifically right the first time or you lose your advantage in converting those who support him or are on the fence.
Interestingly, this account (http://kassidysroadtorecovery.blogspot.com/2011/06/june-28-2011.html) seems to say that dr B is giving someone “targeted treatments” (ie cancer drugs – usually-abs or -ibs – see the FDA list linked to from Burzynski’s own website http://www.burzynskiclinic.com/treatment-options.html).
But all his open trial protocols bar one say that no other immunotherapy treatment or anti-cancer drugs should be used (http://clinicaltrials.gov/ct2/results?term=%22Burzynski+research+institute%22&recr=Open). So how the hell can you tell if the antineoplastons are working, if you’re giving someone chemo (which is what these targeted drugs are) as well? They may not be traditional cytotoxics, but they’re still very potent drugs with a significant side-effect risk.
There is something extremely fishy going on here.
Oh my god, you mean they aren’t “natural”?!?
Never thought i’d see a quack pulling that reverse.
Also this account here – patient getting $$$ chemo that her own “evil” oncologist won’t recommend, and antineoplastons on top:
http://adventureandhope.blogspot.com/2011/11/doctors-or-as-our-oncologist-at-kaiser.html
Sara – you are correct, but with any complex issue it is very difficult to be ironclad. If someone is not playing fair and is dedicated to finding something to nitpick, and is willing to distort what you say, it is almost impossible to shield yourself against it. But you do certainly want to make it more difficult to do so.
Interesting post here from a UK family going through treatment at the clinic – paying $$$$ in hidden and unexpecetd costs. Uttrely shocking:
http://supatrascancerfight.blogspot.com/2011/10/info-for-new-burzynski-patients.html
Steve,
I hope you realized that I was not referring you specifically, but the “universal” you of all of us. I could have worded that better.
You’re probably right, it would be nearly impossible to avoid the professional nitpicker, no matter how hard one tried. Particularly, since ethics is not impeding their efforts and it would be impeding the skeptic (at least I hope it would).