Seeing as how the below YouTube video only had 185 views, I decided to provide it with a little Burzynski “bump”
“Professor John Crown gives his thoughts on Dr. Burzynski … ”
Nov 6, 2012 ► 6:54
“Burzynski runs slick highly lawyered operation that has attempted to intimidate a very brave Welsh boy who blew a whistle on his activities”
Perfessor, how many lawyers does Burzynski’s slick highly lawyered operation utilize?
Or does Burzynski utilize one highly slick lawyer in his operation?
I might have been under the misconception that slick highly lawyered operations represented the Oil industry, just because of the nature of the slickness of oil
“For the record I believe Burzynski treatment unproven Actually untested despite many years of opportunity to do so”
Perfessor, in your esteemed opinion, exactly what year did Burzynski first have the “opportunity to do so”?
Would you please opine as to when in the clinical trial process you believe Burzynski’s treatment would be “proven”?
Would that be phase 1, 2, or 3?
“Problem is difficult I have no problem sending Irish Pts who want USA or other Intl 2nd opinion to leading cancer centres not #Burzynski”
Perfessor, does that mean you only send Irish Patients to leading cancer centres that utilize surgery, and / or chemotherapy, and / or radiation, and / or radiotherapy?
“I must say that Dr. Burzynski has been on the eh International Alternative Medicine ah landscape for many years”
“Ahhh … Over the years I’ve had a a number of patients uhhh you know asking if I could testify to the bonifides of of unproven therapies that were being offered by Dr. Burzynski and the answer has been we can not”
“There there are no valid data data for any treatment that he’s offering”
“Very serious question marks have been raised in a number of fora
ahhh … about uh the quality of work he’s doing”
Perfessor, exactly what are those “very serious question marks”?
“And in particular why after so many years of research ahh there are as yet no uh published validated randomized trials which show uh uh any of the benefits which he claims that his take on cancer therapy should have provided”
Perfessor, when this video was posted November 6, 2012, were you aware of THIS randomized trial?
RANDOMIZED Phase II Study of Hepatic Arterial Infusion with or without ANTINEOPLASTONS as Adjuvant Therapy after Hepatectomy for liver Metastases from Colorectal Cancer
Annals of Oncology 2010;21:viii221
“The the the three important trials the ones that actually get you into business are phase 1, 2, and 3 … and uh … phase 1 trial is the er … one of the earliest trials of a new drug in in humans”
“Phase 1 trials will subject … different cohorts of patients to an increasing dose of the drug … to try and get a better handle on what the toxicity of the drug might be and to work out what is the most rational and safest dose to give eh eh in trials which are then looking at its activity in cancer”
“Phase 2 trials are the trials where you’re actually first looking to see … is there evidence that the drug has an activity in cancer”
“And in phase 2 trials all of the patients get the same drug … usually in the same dose … and at the end of it you can make a statistical statement about what percentage of patients appear to benefit”
“If you see in a phase 2 trial that a drug is producing 10 … or 20 percent of patients having major shrinkages of the cancer … you may become very excited indeed about that drug”
“But the proof of the pudding comes with phase 3 trials”
“In phase … 3 trials … patients … are randomly assigned to get what is generally, legally defined … standard treatment for their condition … versus … the speculative … new treatment”
“And these are typically quite large trials … because they may result in a license for the drug for a particular indication”
“They’re incredibly heavily policed”
“They must conform to an extraordinarily stringent set of standards”
“And and … and also that they have a realistic … endpoint”
“For instance if there is a particular kind of cancer where … the median survival is a year … it may be very significant indeed if the new treatment produces a 6 month increment a year and a half … as opposed to a year”
“So, a lot of work goes into these trials, and they’re … very expensive to conduct – most phase 3 trials are very large, involving many hundreds of patients, and then some cases, and certainly some of the trials that I’ve been involved in, involving many thousands of patients”
Perfessor, have you read THESE?
The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective
Safety and Efficacy Comparison Trial
The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors
Guidance for Clinical Trial Sponsors – Establishment and Operation of Clinical Trial Data Monitoring Committees
5/2007 – Guidance for Industry – Food and Drug Administration
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
“There are individual phase 3 trials which have cost between 500 million, and 1 billion U.S. doc … Dollars, to conduct”
Perfessor, does Burzynski have “between 500 million, and 1 billion U.S. Dollars,” to conduct an individual phase 3 trial?
“And at the end of a phase 3 trial if you have … clear evidence that you have met, the statistically, predetermined endpoint, that your study has done what you asked it to do, you can then go, to the relevant regulatory agency such as the FDA, ah or in Europe the EMEA, ah and ask for approval of the drug, for … licensing and sale”
“Burzynski does no data for phase 3 trials”
Perfessor, has Burzynski done any phase 3 trials so that he would not “does no data for phase 3 trials?”
“He’s got sketchy data from phase 2 trials”
Perfessor, what is the “sketchy data from phase 2 trials” that Burzynski has got?
“Phase 2 trials are not … enough, in general with the rarest exceptions, to prove that something actually works”
Perfessor, would that be in the “rarest exceptions” like these?
“Dr. Burzynski in common with uh many of the … uh denizens of the Alternative Medicine in particular ah alternative cancer medicine world, ah asks people to understand a few … facts, which they, repeatedly tout”
“First one is that … uh there are good treatments for cancer but they’re being suppressed”
“One frequently hears the allegation that the drug companies … ehhh in conspiracy with the doctors … ah are deliberately ah … ah hiding ah simple anti cancer therapies which are highly effective, ah for financial self interest – ah this is unbelievably offensive but it is also stupid … beyond belief”
“I I I personally have treated … far too many ah leading drug company executives and or their family members, and, ahhh who obviously were not in on the conspiracy either, ah to begin to believe that, and I’ve seen far too many, ah fine cancer specialists, who have themselves died or lost family members to cancer to think that they took part in any such conspiracy”
“Uh the second uh argument which is fre frequently advanced, is that, and you know, by definition new treatments are considered radical at the time that they are introduced”
“Uh they’re often rejected by the medical and scientific consensus, and subsequently proven to be correct”
“I I I think that formerly that often was the case when medicine and and cancer medicine in particular, was a less evidence based and fact based … discipline … than it is now”
Perfessor, what is your opinion on these Burzynski documents?
“Dr. … Burzynski has a very ah active track record of pursuing people legally … ah who he claims … defame him, including an extraordinary case recently where somebody apparently acting on his behalf … uh chased after a uh … secondary school student in in Wales eh uh a very brave and clever young man called Rhys Morgan … ah who, when he noticed that several ah you know ve very many people in his locality were running fundraisers, ah to send different cancer patients t to see Dr. Burzynski – did a bit of homework on him, and came to the conclusion as many of us have come to, that his methods are wholly unproven, and and certainly are not an acceptable alternative to mainstream cancer therapy … eh suddenly found himself in receipt of … substantial … threats”
“Strange threats not only legal threats but they sent him … a Google earth … photograph, of his own family home”
“Ah they also said they would report him to his school for his illegal activities”
“Now, no none of this would be considered kosher behavior by a lawyer … and but Burzynski is pretty active in in chasing people who, who disagree with him”
Perfessor, would that be THIS “very brave and clever young” “Fact-Challenged” “man called Rhys Morgan”?
TheSkeptiCritic (@TheSkeptiCritic) tweeted at 8:12pm – 16 Apr 13:
“I I I personally believe that his, his trials are going nowhere – I believe it’s mainly a money making operation, which has the effect of exploiting (?) that the desperation of patients who have had very bad news about cancer, and deflecting them away from … treatments that might actually offer them help”
Perfessor, would that be THIS “money making operation”?
“I have always strongly advised my patients not to go anywhere near Dr. Burzynski because I don’t … believe that his operation is validated – I don’t believe he has subjected himself … to the kind of rigor and standards that a mainstream ah mainstream cancer facility will do”
“I don’t believe that the claims of his treatment are validated”
“I think it is, extremely unfair for him, to claim that he has proof that these treatments work, when he has not yet presented that, uh those data, in the fora where they’re, you know subject to the appropriate level of scrutiny”
“So I always tell people, don’t do it”
“Beware … the person who directly advertises and says … come to me because I’ve got something which mainstream medicine doesn’t know about, which mainstream medicine is … suppressing”
“And the other thing you should realize is that in general, you will not be asked to pay for an experimental treatment”
Perfessor, if people do not participate in clinical trials, how will we know if an experimental treatment will work?
“That is something else that people really need to know”
“If someone is asking you to pay for an experimental treatment, your alarm bells should instantly ring, that that there is something odd about that”
Perfessor, where did the funding come from for the trials that you have been “involved in, involving many thousands of patients”?
Hopefully we can get to the bottom of this Blarney because of the Burzynski “bump”