NOTE: Special thanks to Jann Bellamy for advising me regarding the legal aspects of this post.
There are times when I fear that I’m writing about the same topic too many times in too brief a period of time. Most commonly, I notice this concern when writing about the lunacy of the anti-vaccine movement. In fact, it’s fairly rare that I feel it for any other topic. There is, however, one topic other than antivaccinationist assaults against science and reason that will sometimes obligate me to go on a roll such that I might write multiple posts in a short period of time. I’m referring, of course, to the dubious doctor known as Stanislaw Burzynski, a man who charges desperate patients with advanced (and usually incurable) cancer tens and even hundreds of thousands of dollars to participate in his “clinical trials” of antineoplastons, compounds that he claims to have isolated from urine and that he now represents as a promising new treatment that can do much better than existing therapies with much less toxicity, even though there’s no evidence that it can. He’s even starred in his very own documentary, which his very own propagandist Eric Merola, used as a paean to the greatness that Burzynski obviously considers himself to possess. The documentary was awful, full of biased misinformation and overall just a plain bad movie. Lately, Burzynski has been claiming to use what he refers to as “personalized gene-targeted cancer therapy,” which is more appropriately described as “personalized therapy for dummies,” given how incompetently it is carried out and the manner in which Burzynski mixes and matches very expensive targeted therapy and chemotherapy in ways guaranteed to produce synergistic toxicity.
Through it all, Burzynski collects huge fees for his “services,” motivating the desperate families of dying cancer patients to hold massive fundraisers. This sort of story has become a depressingly common topic for this blog over the last year since I really started to notice Burzynski and his followers in a big way. Most recently it was Rachael Mackey and Amelia Saunders. Before that, it was a parade of children and adults that included Brynlin Sanders, Jesse Bessant, Shana Pulkinen, Billie Bainbridge, Kelli Richmond, and Olivia Bianco. There are more, so many more, but they all share two things in common. First, Stanislaw Burzynski failed them, and, second, they made the news because they held fundraisers to try to pay the tens and hundreds of thousands of dollars that Burzynski charges for his services. Meanwhile, although Burzynski somehow has a phase 3 clinical trial that was apparently approved by the FDA (although it hasn’t accrued a single patient in nearly two years), the FDA has slapped him down for serious problems with the institutional review board (IRB) that oversees his “clinical trials” and for making claims for his antineoplastons even though they are not FDA-approved.
Unfortunately, as I noted last week, although the Texas Medical Board (TMB) brought action against Burzynski to strip him of his medical license, it appears that he he will slither away yet again, given that the proceedings against him have apparently been dismissed. At the time I took note of this development, I didn’t know how Burzynski had managed to slither away from accountability for his actions and justice yet again. Certainly, the gloating by the likes of Patrick “Tim” Bolen shed no light on the question, nor did this triumphant screed by someone who calls herself Sarah the Healthy Economist:
Why has Dr. Burzynski been so relentlessly persecuted first by the United States Government and then the Texas Medical Board for so many years?
Follow the money my friends!
The multi-agent gene targeted therapy called Antineoplastons is a nothing short of a huge medical breakthrough that promises to completely shatter the cut, poison, burn Standard Of Care – surgery, chemotherapy and radiation treatment. When clinical trials are completed and Antineoplastons approved, it will be the first time in history that a single individual and not a pharmaceutical company holds the exclusive patent to manufacture and distribute these gene targeted medicines on the open market.
Uh, no. Antineoplastons don’t represent “multi-agent gene targeted therapy.” The person who wrote this bit of gloating is clearly too ignorant of what Burzynski actually does and claims to know that the “gene-targeted” therapy he claims to provide is not antineoplastons (although Burzynski somehow manages always to include antineoplastons in his concoctions). Nor is what Burzynski does anything that will “completely shatter” the current cancer treatment paradigm.
None of this stops the hyperbole, though:
Parents have particular reason to rejoice that the case against Dr. Burzynski has been dismissed. One form of childhood cancer – diffuse, intrinsic, childhood brainstem glioma for which conventional medicine has no cure has been cured by Antineoplastons (with dozens of others). [ANP – PubMed 2003] [ANP – PubMed 2006] [ANP – Cancer Therapy 2007] [Rad & other – PubMed 2008] [Chemo/Rad – PubMed 2005]
Congratulations Dr. Burzynski on this huge win against the foes that are attempting to silence you and stop your amazing work. The road ahead is still long until treatment with Antineoplastons is widely available to all Americans, but this recent victory brings a big one home for the little guy!
No, it’s not. It is, unfortunately, a victory for a man who uses the desperation of dying cancer patients to extract huge sums of money from them or, as one of his patients put it, to use them “as an ATM” and coercing her into buying her prescriptions from a Burzynski-owned pharmacy at “outrageous” prices. Meanwhile, the heart of the case brought against Burzynski brought by the TMB was his off-label use of targeted therapies in treating cancer patients. When I last reviewed this, I was astounded at the number of targeted drugs in the drug cocktails used. Not only was Burzynski using chemotherapy and a lot of it, but he was using some very expensive products of big pharma in a medically unsupportable manner. So let’s head over to the actual legal rulings. I do this, of course, with a bit of trepidation because, of course, I’m not a lawyer. However, even not being a lawyer, I think the reasons for the dismissal become fairly obvious by reading some of the motions and rulings. Plus I had input from a real lawyer.
So why was Buryznski’s case dismissed? Fortunately, some of my readers helped me out in the comments of my last post. You, too, can get these PDFs if you wish, just by going to the Texas State Office of Administrative Hearings (SOAH) and, using a guest account, searching for docket 503-11-1669. The “money filings” are ORDER NO. 12 – RULING ON RESPONDENTS MOTION FOR DISPOSITION, STAFFS SPECIAL EXCEPTIONS, AND MEMORIALIZING PARTIES STIPULATION OF FACTS and ORDER N O. 16 » GRANTING AND DENYING IN PART STAFFS MOTION FOR RECONSIDERTION OF ORDER NO. 12. Basically, the TMB had gone after Burzynski based on the doctrine of vicarious liability, which means in essence that the TMB was arguing that Burzynski was responsible for the actions of the physicians working for him who had cared for the patients at the heart of the TMB case against Burzynski. In response, Burzynski moved to dismiss and/or strike TMB allegations against him to the extent that the allegations were based on the actions of other physicians working at his clinic. His attorney’s argument was that, under administrative law, there is no vicarious liability for the actions of others. This is apparently different from tort law (for example, medical malpractice), where the physician can be held liable for the actions fo physicians working under his control or supervision in some circumstances. The bottom line is that the administrative judge ruled in Burzynski’s favor. From the RESPONDENT’S REPLY TO THE BOARD STAFF’S SUPPLEMENTAL RESPONSE ON THE CONSOLIDATE MOTION FOR DISMISSAL AND SUMMARY DISPOSITION:
Respondent’s ownership of the clinic and his self-designation as the clinic’s chief physician on some forms, his ability to hire and fire everyone, and even that the forms which state that he is in “charge of treatment” (as stated in the informed consent forms for patient A) is only evidence of responsibility under vicarious liability theory, given the fact that the medical records detail exactly what doctors provided services to these two patients and who was involved in the delivery of medical care to these patients.
The judge accepted this reasoning, which meant that the TMB faced the bad option of trying to prosecute a case based only on what the complaint alleged that Burzynski himself did. It’s not clear why the TMB voluntarily dismissed the case after this ruling, but perhaps the TMB’s lawyers concluded that there wasn’t a strong enough case based only on the allegations against only Burzynski. Basically, by throwing his fellow physicians working for him under the bus, Burzynski walks. Why do I say “throwing them under the bus”? Simple. The TMB could, if it so desired, begin actions against the individual physicians who took care of these patients, and I sincerely hope that the TMB does just that.
As for the significance of the ruling, contrary to what Burzynski’s apologists would like you to believe, this ruling says absolutely nothing about whether what Burzynski is doing is good science or not. It says exactly nothing about whether what Burzynski is doing is good medicine or not. It says even less about whether Burzynski’s clinical trials are ethical or not. All the board found was that, as a matter of law, the TMB couldn’t bring action against Burzynski on the basis of actions performed by doctors under his supervision. So when someone like Patrick “Tim” Bolen exults that Burzynski’s somehow been vindicated, Sarah the Healthy Economist says “alternative cancer treatment wins big,” or Burzynski’s lawyer Richard Jaffe says something like, “The cutting-edge, multi-agent gene targeted therapy devised by Dr. Burzynski which was at the heart of this proceeding is still being given at the clinic and is helping countless patients,” it’s a non sequitur. Just because the judge ruled on a narrow point of law regarding whether specific allegations were admissible in a case against Burzynski says nothing about the validity of Burzynski’s work, nor does it in any way vindicate him. He got off on a technicality, and that’s all.
That still leaves the claim by Jaffe that “two medical board informal settlement panels found that the use of these combination drugs on the advanced cancer patients involved was within the standard of care.” Unfortunately, we have no way of finding out what the settlement panels did or didn’t find because the proceedings of such panels are confidential, being as the name implies an attempt to see if the parties can settle the case prior to litigation. One notes that the board appears to have disagreed with Burzynski’s characterization of the settlement proceedings.
I’m not going to lie or downplay it here. The dismissal of the TMB action against Burzynski is a major setback to efforts to stop what Burzynski is doing. He’s now basically free to continue to do what he’s been doing for the last thirty years. Once burned, it’s unlikely that the TMB will take another crack at him any time soon. The last time it did was back in the 1990s. Will it be in the 2020s before a future board decides to try again, or will Burzynski retire or die before then, leaving his son Greg to carry on the family business?
859 replies on “Stanislaw Burzynski gets off on a technicality”
Thanks Orac (and Jann).
You’ve got to hand it to the sneaky old ba§tard, that’s a clever ruse isn’t it? Advertise your services as genius, persecuted medical maverick, lure
victimspatients into your clinic, and then never meet, see, or treat them. “Wasn’t me your honour, I was at home rolling in $100 bills at the time”.
I hope TMB goes for the treating physicians add goes hard at them. Burykidski will find it hard to operate a clinic sans
And he’ll also find it hard to recruit new doctors if it’s known that working at the Burzynski Clinic could be a quick way to lose their licenses.
Let’s see – “helped countless patients.” Hmmm….kind of hard to judge since Dr. B hasn’t published any of his trial results. In fact, all we hear about are the ones that seem to die.
Also, since his “drug cocktail” isn’t scrutinized, he could be giving just about anything to these patients (especially since they buy the drugs from his pharmacy).
It is extremely scary that this guy is still allowed to practice (though because of the technicality, it doesn’t seem that he is “treating” anyone).
Countless patients? Zero could be said to be countless, I suppose, in the convoluted logic that holds sway at that clinic.
IANAL, but I’m wondering if this technicality leaves Burzynski open to fraud charges. (Federal charges, since he is clearly operating across state lines.) He collects huge sums of money from patients who think he is treating them, but he is now on record in court as stating that he isn’t the one doing the treating. Does somebody with a better knowledge of criminal law want to comment?
Could someone explain why the FDA or other entity can’t, or won’t shut him down?
But he is treating them – through his subordinate physicians. That’s enough to get off the fraud issue, and also enough to buffer him from responsibility in regards to licensing. Isn’t law nice?
The more I hear, the more disgusted I get.
I’ll join you in hoping they go after his subordinates. I suspect once they tear down that shield against responsibility, Burzynski might be too greedy to stop and hopefully he’d get caught as soon as he did anything personally.
But I’d worry that he’d retire to his mansion and start writing books on how you, too, can fleece the terminally ill for profit.
@ Bronze Dog:
I think that it’s more likely that he’ll write books about how his therapy can save the terminally ill because that’s a way to channel them to his family business.
As far as I’m concerned: until Burzynski’s shut down for good, Orac can’t write often enough about him.
FDA doesn’t regulate the practice of medicine. They can go after him for how he sells/promotes his unapproved drugs or how/whether he conducts clinical trials, but they can’t do anything about his medical license or ability to practice medicine.
Once again, I suggest that folks write to PBS’s Frontline to nudge them into doing an episode on him. Let’s shine a light on the darkness, people!
The problem with Frontline is that they would most likely take the “tell both sides” approach, which would give Dr. B plenty of chance to spin. What would best fit Dr. B is a Michael Moore- style documentary that would lay out the histories of the people the clinic failed to help. Another thing worth looking into is where all the online “testimonials” are coming from. That’s clearly a huge part of how the clinic’s business is being sustained. I would wager that if (BIG “if”!) that subcultural bubble could be burst, the clinic would collapse.
Another thing that’s shaping up is that it looks more and more like it would be easier to get the clinic simply on fishy business practices than Burzynski on his medical practices. That would entail more agencies getting involved, and I’m not sure which ones.
David N. Brown
It’s my understanding that the most you can usually expect from charges such as these are a letter of admonition against the supervising license-holder. Spin value aside, this action may have throw some cold water on B’s inner workings.
@ David N. Brown:
A BIG If indeed!
Dr B’s fame ( infamy, actually) is unfortunately supported by alt media and woo-meisters far and wide who provide maintaintence of the sub-culture- simultaneously pushing worthless or dangerous woo and discrediting SBM.
@David N. Brown
Frontline generally takes the following format:
First half: present the topic in a neutral light, from the POV of those promoting the issue.
Second half: apply a no-punches-pulled reality-based critique of said POV.
I’ve been impressed by how they’ve handled other controversial topics, like Facilitated Communication (Prisoners of Silence) and vaccines (The Vaccine Wars). No one who watches those would come away with any doubt as to the reality of the subject, other than via willful ignorance. I think they could do a very good job with Burzynski, showing what he claims and what actually goes on, with the very real (and very depressing) results.
That said, there’s no reason why a multi-pronged approach could not be used.
Sorry to ask something that may be obvious here, but I really want to know: why does the government/FDA let him get away with it? I know the FDA is under-funded/staffed, but it seems like his drug and clinical trial offenses is a gigantic pile of turd that would be easily actionable by the FDA, if not other entities. Who could pressure them? (and I agree with Edith Prickly: don’t let up on Burzinski, Orac)
I’m with Edith. I’d take daily, hourly Burzynski posts until the truth is out and he’s shut down.
I’m not one to believe in simplistic beliefs like claiming that certain people are inherently evil, but with Stan the Cancer Con Man, it’s almost too easy.
I could weep, honestly.
@ Ism, the ultimate irony here (well two actually) is that the FDA has actively enabled Burzynski by allowing him to continue to “conduct” phase II and III trials without publishing results. I urge you to get your hands on Dr. Goldacre’s “Bad Pharma” when it becomes available in the U.S. as it is a stunning litany of pharma and regulatory offences that keep this circle jerk going.
The other oddity is how Burzynski can be let off on this technicality when he is the ringmaster of his scam circus. Physicians in his employ are doing his bidding so I can only hope that the Texas Medical Board do go after them.
As Orac noted in his post, FDA has come down on his IRB (several years ago…would be nice to hear a followup from the FDA on that one) and just last month (concerning his promotion of antineoplastons). It would be nice to have them do something about the clinical trials themselves, given how long they’ve been going with zero published results and no wrap-up date in sight. Honestly, not certain what the hold up is, there.
OT note from the antivax front: there’s a truly excellent op-ed piece in the Newark Star-Ledger today (along with the typical run of sane and demented comments from the peanut gallery):
The op-editorialist (co-author of a new book on vaccination) could use some additional favorable reviews on Amazon.
Link to Dangerous Bacon’s Newark Star-Ledger op-ed on vaccines. 🙂
Why does this writer continue to embarrass himself? He/she has never even there during this legal process. Go back to your vaccine drivel. Good luck with your “hourly posts” in avoiding scientific fact. FDA sanctioned clinical trials, duh. Burzynski has never once lost a legal case, because, uh, he is always found to be right. Flat Earth Society is calling you all. Ring ring.
Technicality = scientific fact. Round earth = technicality.
There is some good “news” on the Burzynski clinical trials. In January of 2011, he had five open trials and the Phase III trial was supposed to open sometime that year. In January of 2012, he only had 1 open trial, and the Phase III trial is still not open for recruitment. In fact, that may explain why Deb wasn’t able to enroll her child in his clinic – of the trials that may still be open (no updates since June 2009, primary end-date December 2011), none are open to both adults and children. We know that he recently treated an adult. So it appears that he may not be able to treat children unless he can manage to open the Phase III trial, which is restricted to children under 18.
Perhaps the FDA has finally told him “Tits or GTFO”?
The Star-Ledger could use a bit of cursory fact-checking:
Wrong newspaper, and a misleading payload anyway.
Roger, did you even read the post you’re commenting on? If so, could you explain precisely how in this case Burzynski was ‘right’ and his accusers were ‘wrong?’
Then explain why the Phase III trial has not recruited any participants.
Not specifically related. But an interesting example of the dark side of “evidence.”
@ Narad: I didn’t catch that error in the Newark Star-Ledger op-ed.
McCarthy was hired by the Chicago Sun-Times and Paul Raeburn at the Ho-Po blogged about her new *job* as a columnist-blogger…twice.
McCarthy will not be blogging about vaccines:
Actually, judging from web results, the most visible propaganda outlets are dedicated sites and social media pages that appear to be either the direct work of Burzynski’s staff or those who openly identify as his patients and/or supporters.
The wider “alt med” scene is no doubt a source of support for Burzynski, but I think there is a strong potential for the movement to turn against him. The problem for Dr. B on that front is that, while “alties” are infamously unfazed by questions about efficacy and even safety, they tend to be sensitive about overt commercialism and paranoid about any hint of “Big Pharma” influence. In those terms, it is to be expected that many of them are already getting uncomfortable with the clinic’s publicity machine and the sheer size of the cash flow. If, on top of that, it came out that Burzynski was relying on “Big Pharma” products and even funding, then there could be an open backlash.
David N. Brown
You get the “facts” arse about face in almost every conceivable way – no surprise for someone who can defend Burzynski and not piss themselves laughing whilst doing so.
Stan “the brave maverick” Burzynski avoided the legal case by dis-associating himself from the wrong doing, not by vindicating the actions taken in his name in his own clinic.
The man is not only a weasel and a fraud, but lacks any conviction whatsoever.
I read many of the files at SOAH last summer. I think in one of the recent rulings the board agreed to take some of them out of public view. My impression was that would protect the ability of the doctors working under Burzynski to defend themselves if there’s further action? (I’m not a lawyer.)
The last I remember, Burzynski said in his documents, yes, he saw some of the MRIs and advised the physicians, but that didn’t make him responsible. At about the same time, a person offering to refer terminal cancer patients on an online support forum to Burzynski promised that he treated every patient personally. And s/he claimed to have no knowledge about any lawsuits.
What has happened to the Lola Quinlan lawsuit against Burzynski? I looked for information the other day and saw that Ms. Quinlan died last May. Will her heirs pursue the case?
@Roger – If Burzynski is right, then OJ is innocent.
I don’t think it would. As I recall this fairly late tidbit, the issue was that the TMB wanted to be able to use material from the informal settlement talks, which Burzynski opposed, but Burzynski included some of the information in a response, and it was later decided that the material could be submitted under seal if things went forward, and the clerk was supposed to pull the original and replace it with a redacted version. (I believe I got this backward once before, so caveat lector; the response in question hadn’t been marked as redacted the last time as looked at it, so I’m not sure if that step was left off or if the response didn’t get replaced as it was intended to.)
Anyway, it doesn’t really impinge on the ability of the TMB to move forward in separate complaints, but that seems politically unlikely just on the basis of having blown this one.
David, I only wish the alties were sensitive about commercialization. I see them posting “information” on cancer blogs from Mercola and Robert Moss as if it were gospel.
edit-meant to say information on cancer support boards.
Naturally, “alt med” communities are far more sensitive about commercialism from outside influences than among themselves. It’s my observation that even commercially-sponsored alt-med sites (I consider AoA an example) will try to offer some kind of social and spiritual message and even downplay the commercial aspect.
Another thing I am beginning to wonder about: The reports of “cocktails” used by Burzinski sounds to me like a product of the “compounding pharmacy” interest. I looked under that rock some time ago when I did several research pieces on Lee Silsby, the sponsor of AoA. (See “Cures” page at evilpossum.weebly.com.) At that point, I speculated that it was not inconceivable that an operation like Lee Silsby might actually receive some discrete funding or other encouragement from a “Big Pharma” sponsor, as a way to investigate new uses of Big Pharm products quietly. If Burzynski and/or associates have gotten themselves into the compounding business, I believe it’s very possible they found some “mainstream” pharmaceutical backing.
David N. Brown
Lola Quinlan did die, May 2012. I located this, which indicates that Ms. Quinlan (or her estate), did prevail with the lawsuit against Burzynski and his pharmacy, when Burzynski overcharged Quinlan for chemotherapeutic drugs.
Did Burzynski then start to appeal that verdict…then make a motion to dismiss his own appeal…which was granted?
Your posts are too biased. I neither defend nor support Dr. Burzinski, but it is more than obvious that you are already too opinionated to write objectively (I actually doubt this has ever been a premise for you).
Had the ruling been different, how would you have written this phrase below?
“Just because the judge ruled on a narrow point of law regarding whether specific allegations were admissible in a case against Burzynski says nothing about the validity of Burzynski’s work, nor does it in any way vindicate him. He got off on a technicality, and that’s all.”
“Just because …” bla, bla, bla … you were a surgeon, not a judge, correct? Neither a lawyer (apparently). Finding excuses and turning everything in your favor for the sake of your argumentation is not very noble.
But we already knew surgeons are pretty biased …
By the way, don’t hold out much hope for the TMB of doing anything. PublicCitizen had a full article in the “Outrage of the Month” section in their Oct. Health Letter on the “Deficiencies of the Texas Medical Board.”
Essentially, “the report provides evidence concerning the inadequate capacity of the Texas Medical Board to protect Texas patients form preventable medical harm.”
How would any ruling on a point of administrative law said anything about whether or not Burzynski’s practices actually work as claimed?
(By the way, perhaps you missed the bit where Orac admitted that he is not a lawyer and that he got help from an actual lawyer on the points of law in this article.)
Roger: “Burzynski has never once lost a legal case, because, uh, he is always found to be right.”
Rog, could you pass along this wisdom to the folks at Wikipedia?
“Burzynski’s use and advertising of antineoplastons as an unapproved cancer therapy were deemed to be unlawful by the U.S. Food and Drug Administration (FDA) and the Texas Attorney General,] and limits on the sale and advertising of the treatment were imposed as a result…
In 1994, Burzynski was found guilty of insurance fraud for filing a claim for reimbursement by a health insurer for an illegally administered cancer treatment.”
I don’t follow the legal argument that Dr. B is not responsible because he doesn’t treat the patients. If I hire someone to kill my spouse, I am guilty of murder as I understand it. How is this different? I admit my ignorance of the law, so perhaps someone can enlighten me a bit.
Ahhhhh…….relativism. The poltically correct notion that all ideas, however nonsensical, no matter how discredited, should be given equal weight when being considered.
You are just plain WRONG. Asking how Orac would have responded were the facts different is pointless. Search out and watch Terence Mckenna’s discourse on relativism on youtube to see why you are wrong, he explains why your point of view is ridiculous far more succinctly and amusingly than i am able to do.
Burzynski himself put his ideas outside the realm of what should be given serious consideration when he refused to back up his grandiose claims with actual evidence and began his 30+ year campaign of fraud against the desperate and confused.
Difference between administrative law and tort law. TMB has authority to impose sanctions on a physician’s practice of medicine based on how they’ve practiced medicine on patients. So, if he had actually seen patients directly or otherwise been directly involved in the management of their care, they could do something to him. But, because he was not directly involved in the care of the patients, TMB can’t impose sanctions against his license to practice.
The TMB can’t sue on a tort action because they were not wronged by Burzynski. Only the patients and/or their families could bring such an action against him. In a tort action, it doesn’t really matter whether he was directly involved or not; as the employer/director of the clinic, he bears at least some measure of responsibility.
At least, that’s my understanding, but IANAL.
[sarcasm ]Yeah! Isn’t it terrible that Orac is so biased against taking tens of thousands of dollars from families who are just trying to cure their loved ones. Oh, and he just keeps asking, asking and asking for the papers for those clinical trials. Jeesh, those people were going to die anyway, so why not let Burzynski continue to let them pay for him to do his experiments. He will tell us the results when he is and ready to, he doesn’t need Orac, the FDA, and others to tell him how run his clinics. Right? [/sarcasm]
And when they’ve successfully shut this guy down, go after the likes of Benny Hinn. He does the same thing except without the medicinals. He claims to be able to cure, yet there are all manner of examples of his “clients” that are not cured. And he and his enterprise pay very little tax.
@ DFR: Orac has already blogged about Benny Hinn…and other faith healers:
IANAL. I agree with Todd W’s post about the difference between an administrative hearing conducted by the Texas Medical Board and civil tort lawsuits instituted by Burzynski’s patients, or the survivors of those patients.
Orac and other science bloggers have posted about Burzynski’s “treatment” and the indiscriminate use of traditional chemotherapeutic medications. These blogs have had an impact on potential patients and their families. Perhaps some of Burzynski’s victims and or/their families will institute lawsuits against Burzynski and his staff. Enough negligence lawsuits against them, would result in them being uninsurable against medical malpractice.
That would be an arguable restraint of religious exercise. I studied the subject of “faith healing” as a seminary student, and my evaluation of Hinn was that he at least distanced himself from egregious abusers like Peter Popoff. From a legal perspective, advocates of “faith healing” are on a solid footing as long as they present themselves primarily as religiously-based emotional support, and especially don’t advise anyone against seeking orthodox medical treatment. An additional legal consideration is that “non-profit” religious organizations would mainly fall under the jurisdiction of the IRS.
David N. Brown
I did not miss anything. I spend days to cover all Orac has written about that case.
“Burzynski’s practices and work” is too broad in scope to comment on it in a definitive manner.
You have no idea what you are talking about, and you obviously had not idea what I was talking about. Hence, dismissed.
Yes, and perhaps you think this is very different from what you are basing your sarcasm on:
Oh, I forgot – these were real companies, real researchers doing real science. It is just 4 years = 80,000 people becoming victims – nothing to compare with 30+ years and hundreds dying from something that they would … have died from anyway.
If Burzynski is wrong (and probably he is), so is almost everybody else in this “business”. Oh, did we forget that Orac is perhaps in the same or similar business? Shifting the focus is a very convenient strategy. Finding a scapegoat while doing that is even better. Throwing accusations without presenting known facts of similar cases from the “real science field” is definitely subjective. All of this combined = biased representation. A fact, regardless of whether or not you like it. I understand your feelings and ego may be hurt, but try to detached yourself from them to see the world from a logical, objective point of view.
As a matter of fact, I support more than 50% of what Orac has written about the case. But not acknowledging the obvious is simply a prejudiced behavior derived from specific personal experiences and motives.
Life is subjective, as is science. Don’t try to represent science as the only true solution to all problems – it is not. You know nothing about how exactly the human body functions at molecular level, as does Dr. Burzynski. Therefore, please don’t make huge conclusions based on superficial knowledge.
You could try to be more objective, because you can. You simply don’t want to. It’s called ego and defense of the own territory.
This news is both sick and sad. Is there any way to appeal?
You’re wrong to write “You know nothing about how exactly the human body functions at molecular level” as some out-of-hand straw-man dismissal.
Orac is a researcher as well as a surgeon – he has a decent enough knowledge of the molecular biology of cancer.
Likewise, some of us ‘@All’ commenting do in fact know molecular biology.
Regards your idea that Science is subjective: individual people might have their interpretations of data (like your own for that matter) but the data itself are the data – you can’t wave them away.
I am dismissed? You are too funny. What exactly is your point?
Burzynski is a fraud, and we can safely continue to describe him as such because a) he has already been labelled a fraud by the FDA and by the courts for fraudulent health insurance claims and b) he has NO evidence to support either the efficacy of his treatments or a contrary opinion of his character. Yes, the scientific argument is biased, but that is because all available evidence is against Burzynski, and he refuses to join the debate, refuses to provide the data that vindicates his “wonder cure”. What do we get instead? , obfuscation, evasion and now comical attempts to portray his escape from legal censure (by abandoning his subordinates and leaving them to take the blame) as a vindication of his medical expertise .
Despite opening 60 phase 2 trials over decades, he has not added one scintilla of knowledge to the cumulative fight against cancer. That in itself tells a pretty straightforward story. He has enriched himself by selling false hope to desperate families around the world.
I don’t need to know the details of how the human body functions at a cellular level to know a snake oil salesman when I see one. And if Burzynski and his supporters want to overturn that widely held opinion of him, then they know what to do – release the accumulated data from his incomplete trials and show the scientific community and the world at large that he ISNT just another money grubbing weasel.
FWIW, I emailed the following to [email protected]:
There is a doctor in Houston, Texas, who runs an eponymous “cancer clinic”. He purports to have an “all natural” cancer cure called “antineoplastons”, that is not chemotherapy, and will cure when conventional treatment has failed, even on the most rare and difficult types of cancers.
In fact, he sells chemotherapy – conventional chemotherapy drugs – marked up far beyond the prices patients would pay at regular hospitals. He treats on a cash only basis, and has attracted desperate patients from the US, Canada, Europe, and Australia.
Many of these are parents who have young children that have been treated by experts. Rather than enjoying their last days together as a family, they spend time in run-down motels, having scraped together the needed cash through friends, family, charity appeals, and others.
Google searches will yield names of some of Burczynski’s victims, as well as a couple of former patients that were mad as hell when they found out they were being swindled.
Burczynski has, in the past, threatened people. See the Respectful Insolence blog (written by breast cancer surgeon and researcher Dr David Gorski) and the Quackometer blog (written by Andy Lewis) for further details.
I believe this would be a good story for ProPublica to research and write. Exposing Burcynski would help to make a case to have his doctor’s licence revoked by the Texas Medical Board, one of the laxest medical licensing bodies in the country.
There is more, but I am sure – should ProPublica decide to look into this story – you will find out how horrible it is, and how many lives he has touched for the worse.
Given the miscellaneous oddities of tense construction in your broadcast, I would like to ask whether this is supposed to mean what it plainly reads as.
Jim, how does other pharmaceutical companies doing bad things exonerates Burzynski charging tens of thousands of dollars to desperate cancer patients okay dokay? Or makes it okay to claim he is doing clinical trials when he has never published any results?
At least the those drug companies do publish results, and are required to have the unpublished data available.
By the way, Burzynski also owns real companies: his clinic and the pharmacy where he charges exorbitant prices.
Should I waste my time and energy on Stanislaw R. Burzynski like people here? Or on:
2007 $515 Million: Bristol-Myers Squibb
2007 $634 Million: Purdue Pharma
1/2009 $1.415 Billion Fine: Eli Lilly and Company
2009 $2.3 Billion Fine: Pfizer
2010 $520 Million: AstraZeneca
2011 $950 Million: Merck
6/4/11 $327 Million Fine: Janssen Pharmaceutica
10/2011 $780 Million Fine: Amgen
4/11/12 $1.2 Billion Fine: Johnson & Johnson and subsidiary
5/10/12 $1.5 Billion Fine: Abbott Laboratories
7/2/12 $3 Billion Fine: GlaxoSmithKline
7/16/12 $13 Billion Fines: Big Pharma in 4 years
9/21/12 $11 Billion Fines: Pharmaceutical companies in last 3 years (8 out of top 10)
10/21/12 $1 Million Fine: Ft. Mill Pharmaceutical Company
10/26/12 $95 Million Fine: Boehringer Ingelheim
$760 Million (Pending): Amgen
$1.5 to $2 Billion Fine (Pending) Johnson & Johnson
There’s no reason we can’t do both; i.e., go after unethical “researchers” like Burzynski and keep an eye on pharmaceutical companies. Actually, Burzynski behaves more unethically than a pharmaceutical company in that he does things that pharmaceutical companies don’t do, such as charging patients huge sums of money to be in his “clinical trials.”
DJT – Big Pharma had me in a clinical trial for free. In fact, I was given money for parking and lunch.
Too bad the name of your hero ain’t on your list. An ol’ timey gibbeting would be more apropos but I’ll settle for stripping him of his acreage with custom wrought-iron gates.
Quickly again, cause work needs to be done. 🙂
Please read carefully my sentence again. I’m not wrong, because I know what I’m talking about. Had you known “how exactly the human body functions at molecular level”, a cure for cancer would have been found.
Molecular biology touches only the surface. I’m talking about different spatial and temporal scales – access to which will provide a complete picture of the molecular processes within the human body. Yes, you do have some knowledge, but it just remains “decent”. Similar to the $200 billions over the last 35 years the US have invested in the “fight against cancer”. Scientific result = some “decent” progress. Real result = zero.
As for the subjectivity, how many times do you carefully and methodologically look at raw data coming from work done by other people, researchers, institutions? And how often do you just read the abstracts, introductions and conclusions of their reports? Give me these two numbers per number of reports per year and then we can talk about data and interpretation. Moreover, big (raw) data introduces even bigger biases.
You are funny too. Why do you think that I care about Burzynski? No need to convince me of anything – he is not the first, won’t be the last one to generate such a controversy. My point was that if he was a bad person of 100 on some random scale, there were many other people who would fell within the range 90-100, but apparently they served special interests and hence, better not talk about them. Objective and fair?
No, it was not supposed to mean that. He also falls within the “not-knowing” category.
Grammar in comment sections in blogs is not my priority. When writing quickly, I often omit or misplace certain words/letters. Moreover, literature and language are not my strengths, so don’t claim proficiency.
Let’s not go into the money thing, because healthcare takes 17.8% of the GDP of the country, so please. Healthcare costs faced by a cancer patient elsewhere are on the same order of magnitude as what Burzynski charges patients. When exactly the money is taken, before, during or after a clinical trial, is irrelevant from a patient’s point of view. It’s simply a “technicality”.
Drug companies have been required to provide their data to the public for about a couple of years now. Burzynski is not that different – sooner or later he will show you the data, what’s the problem? I don’t really see a big difference between his way of hiding data from the way drug companies and some researchers had hiden data for many years in the past.
I disagree on two points:
1. You should go after all that do unethical things. Not “go after” Burzynski and just “keep an eye” on pharmaceutical. Bias?
2. How much does a human life cost? Let’s then talk about who behaves “more unethically”.
This is actually a small list.
I know most of you would say that “all these companies did ethical things, but were unfortunately fined on technicality”…
What a load of bollocks; you sound like a whiny homeopath who claims that “materialistic science” cannot measure homeopathic effects. The fact is Jim that much is known “at the molecular level” how cancers form. The problem is Jim is that cancers have multiple aetiologies and finding ways to kill the cancer without killing the patient are exceedingly difficult. You would know this if your understanding of molecular biology transcended everyone else’s as you imply.
A boring Tu Quoque argument. I have no love for pharmaceutical companies and their antics but the fact that they are held to a modicum of regulatory standards and fined for violations stands in stark contrast to the slimy dealings of Burzynski who has been left relatively unfettered to bilk individuals out of money and precious time.
And you know this how? Because you have chosen to paint yourself into a corner with your rigid thinking? Pharma behaves badly and should be punished is not mutally exclusive of Burzynski behaves badly and should be punished. In fact it’s more consistent than the hand-waving rubbish you’ve produced.
Jim, project much oh great and mighty OZ?
Ohhh, so we are being too nasty to Slimeball Stan and not nasty enough to other peddlers of woo? You obviously don’t read much of Orac’s output, they all come in for a bashing.
Oh wait – no, you appear to have changed tack again……. we are too mean to peddlers of woo and not mean enough to Big Pharma.
“Molecular biology touches only the surface. I’m talking about different spatial and temporal scales……..”
Oh wait, no, you are talking bollocks.
Let’s say I claimed to have a dietary cure for advanced cancers–lots of fresh green veggies, for example, and for several decades I’d been charging patients 10’s of thousands of dollars to participate in clinical trials of my diet but refused to make public the results of these trials. Further, I insist that my patients purchase their veggies at a specific grocery store where a head of lettuce goes for $2800 and tomatoes cost $395 each (and which–what a coincidence–I own.)
Now top that off with the fact that not only do I offer no evidence my diet works, but the diet has previously looked at by multiple independent researchers and found not to be an effective cancer treatment (just as phenyl butyrate–the pro-drug for the metabolites Burzynski calls antineoplastins–had been evaluated extensively without evidence of practical efficacy.)
Would you still be saying “No biggie–sooner or later he’ll show us the data so -where’s the problem?
Hey, way to focus on an aside, rather than on the actual question I asked, Jim! Wow. You sure brushed that inconvenient question out of the way. I admire your integrity and rhetorical skill. Tell me where I, too, can become as proficient as your own mighty self?
Now, then, Jim, how would any ruling on a point of administrative law said anything about whether or not Burzynski’s practices actually work as claimed?
Perhaps this time you’ll answer.
Okey-dokey. Exhibit 1:
So, let’s play a game. Call it “Bunny Feedies.” Why was the cellular dynamics of non-purse-string wound healing well reckoned by washing out precisely the details of “molecular processes” that you’re nattering on about?
Orac: Do I understand correctly that you are really seriously attempting to contend that Big Pharma was Fined $13 BILLION (That is BILLION with a “B”) over this 4 year period and GlaxoSmithKline was Fined $3 BILLION this year (the largest ever Fine on a drug co) for behaving MORE ETHICALLY than SRB?
Please provide “FACTS” that support your false allegation that SRB “behaves more unethically” than Big Pharma in that he does things that Big Pharma doesn’t do.
al kimeea: Please see below regarding Big Pharma; whom I refrain from calling your “hero” as I have no “FACTS” to substantiate such a claim in the course of this lively civil discourse.
Please provide “FACTS” that support your false allegation that SRB is my “hero.”
Please provide “FACTS” on how much SRB has been Fined so that he may be added to my list.
I will happily accept your apologies.
1. Gaming the system to jack up prices on a drug,
2. The FDA had approved a drug for adults, but not for children & adolescents, and not for geriatric patients suffering dementia. In fact, the agency explicitly warned against using it for dementia. BMS zeroed in on child psychiatrists & other pediatric specialists & created a team to exclusively call on nursing homes.
1. Fraudulently misbranding drug for suggesting it was less addictive & less abused than other drugs,
2. Sales representatives saying users could stop using the drug, without withdrawal. Sales representatives were allowed to draw “fake scientific charts,” on the drug’s safety, which they passed out to physicians as proof of their claims.
Eli Lilly and Company
1. Allegations that they pushed drug for children & for elderly dementia patients, both off-label uses. Made particular efforts to push a drug in long-term care facilities & nursing homes. Aimed to make a drug a primary care drug, despite the fact that it was only approved to treat 2 disorders–typically not handled by primary-care doctors,
2. Misdemeanor misbranding charge for promoting drug off-label,
3. Civil wrap-up for the feds & to states that agreed to settle.
1. Improperly marketing drugs (It is illegal to promote uses for a drug that have not been approved by the FDA — a practice known as off-label marketing),
2. Encouraging doctors to prescribe its drugs with free golf, massages, & junkets to posh resorts,
3. At the very same time Pfizer was negotiating & resolving the allegations of criminal conduct by its then newly acquired subsidiary, Pfizer was itself in its other operations violating those very same laws,
4. Variety of marketing infractions. Sales reps were rewarded with junkets & cash for pushing a drug as a multi-purpose pain reliever when it was only approved for arthritis pain. Sales employees explained that off-label promotion was tolerated & no big deal, even though they knew it was illegal.
1. Pursued a host of ploys to get doctors to write off-label prescriptions for its drug, like paying them fees for articles & studies ghostwritten by others.
2. Drug had been approved for treatment of a number of uses, but investigators found that AZ was trying to get physicians to write prescriptions for a long list of uses for which the drug was not approved. Targeted doctors who did not typically treat the conditions the drug was approved for, such as physicians who treat the elderly, primary care physicians, pediatric & adolescent physicians.
1. Marketing allegations (hawked drug for an unapproved use),
2. Allegations that they exaggerated the drug’s safety & downplayed its risks. They pulled the drug for safety reasons after data linked it to increased risks of heart attack & stroke,
3. Reps misled doctors about the drugs safety to boost sales & that the company lied to state Medicaid programs about the drug’s risks,
4. [Misbranding] violation. Criminal fine-for a misdemeanor misbranding violation-payment to wrap up civil claims, including those filed by 40 states attorneys general.
Allegations of kickbacks & other marketing infractions designed to boost sales of drugs.
Johnson & Johnson and subsidiary
1. Off-Label promotion (marketing practices involving 2 drugs, misbranding a drug),
2. State claims of Medicaid fraud,
3. Kickback allegations involving a nursing home pharmacy provider & several other drugs,
4. Texas settled its off-label marketing claims against J&J,
5. Arkansas, where a jury found the company guilty of fraudulently marketing a drug-and a judge ordered the company to pay a $1.2 billion penalty. (That award is under appeal.)
1. Marketing/Misbranding charge (promoted a product-a seizure drug-for off-label use in elderly dementia patients who became agitated or aggressive. A specialized, specially trained sales force pushed drug in nursing homes to help control these patients, even though it had no credible evidence that the drug was safe or effective for that use. Had to stop a clinical trial in elderly dementia patients because of adverse events. Pushed drug as a schizophrenia treatment. Though the drug was approved to treat mania in bipolar patients-and sometimes those patients display psychotic symptoms-clinical trials showed the drug added to antipsychotics didn’t help schizophrenia patients any more than the antipsychotics alone. The company didn’t tell sales reps about that data for 2 years),
2. Allegations that its marketing tactics triggered false claims to government health programs, including Medicare & Medicaid
3. Paid to wrap up consumer-protection claims at the state level.
1. Illegal promotion of some of its products for unapproved uses not cleared by the FDA (promoting [marketing] off-label, non-covered uses),
2. Employed several tactics aimed at promoting the use of a drug, including helping to publish a medical journal article that misreported data from a clinical trial,
3. Failure to report safety data to the FDA (failed to report to the FDA on safety data from certain post-marketing studies & from 2 studies of the safety of a drug – drug linked to heart risks, failed to report data from studies detailing the safety risks to the FDA, allegations that it downplayed the safety risks of a drug, withheld data from the FDA until studies raised red flags about risks to the heart, false-claims allegations-exaggerating a drug’s benefits),
4. Alleged false price reporting (pricing & rebate claims),
5. Introducing misbranded drugs (2 misbranding charges),
6. Improper marketing of drugs (allegations of mismarketing 5 drugs),
7. Tried to win over doctors by paying for trips to Jamaica & Bermuda, as well as spa treatments & hunting excursions,
8. Alledgedly paid kickbacks to doctors to prescribe drugs,
9. Allegedly overcharged the government for drugs.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the major pharma lobbying group, claims its members are “committed to following the highest ethical standards and all legal requirements,” according to PhRMA’s website. To demonstrate this, PhRMA members developed the “Code on Interactions with Healthcare Professionals,” which states that: Ethical relationships with healthcare professionals are critical to our mission of helping Patients . . . An important part of achieving this mission is ensuring that healthcare professionals have the latest, most accurate information available regarding prescription medicines.” Nearly 60 pharma companies; including Abbott, Pfizer, Eli Lilly, Glaxo, J&J and Amgen, are signatories to the code. At least 3 of them: Abbott, Pfizer & Eli Lilly – while the PhRMA code was in place they committed these billion-dollar-plus violations.
So, your argument is, Didymus Judas Thomas, that because of Big Pharma was naughty that it is okay dokay for Burzynski to charge tens of thousands of dollars to be part of his “clinical trials”, that he has conducted for thirty years but has not published are real results.
It seems things are getting interesting here. 🙂 So interesting that some egocentric people, a.k.a. the God of Science, found a way to disseminate their anger via usage of offensive language. @Mom, I’m sorry for being a “rigid”, “rubbish” “homeopath” and do not live up to your standards of holy knowledge. My deep apologies, it won’t happen again.
You are killing me. You must be a comedian, right?
Do you think I expect comedians to really understand science?
Some of your statements are not factual. Regardless, if you hold a single person so much accountable when evidences for a myriad of similar or even worse practices exist , my answer to your question would be Yes. It will be Yes until you realize how hypocritically you act by showing double standards.
Ignoring the irony, I gave an answer to your question to the extent I was able to answer. If you want an answer, I’d say “I don’t know how.” However, as far as a remember, the results of this ruling have triggered this post we are commenting on right now. And as far as I remember, many people, including the writer, inferred many things about the Burzynski’s practices regardless of the nature of the ruling. So, why not wait for a non-administrative ruling and then make your huge accusations?
But no, many of you cannot wait for this. They are the Gods and only a few (actually one unlucky) are highly “privileged” to experience their judgmental force. Others with similar sins are intentionally excluded. It looks like a modern version of ritual human sacrifice to Gods.
I don’t play games. Moreover, your games are becoming boring.
I came here to say a single thing:
“The writer shows a huge bias in this post probably derived from his opinionated nature, personal experiences and biological & social instinct for survival pushing towards finding a culprit and exposing him (as a scapegoat), which makes the writings unattractive and highly subjective. 25% more objectivity by showing other sides of the same problem would make a pleasant difference. Otherwise, it looks like the author has something personal against some individual, named Dr. Burzynski in this particular case.”
Whatever else topic you implied or tried to propagate to me remained somewhat irrelevant and I did not really feel you talked to me.
The logic is nonexistent anymore, so:
Have a good day. Positivism can help with anger and other personal physiological issues.
PS. @DJT, thanks for trying to balance the discussion by shedding some light onto the same, but real and much bigger problem than the one being described here.
Are you going to get to the question that was posed to you?
Oh, dear, “Jim” isn’t CITIZEN JIMSERAC, is it?
Yup. Classic crap artist techniques. “In actuality, all I know about Orac is that my fee-fees get hurt when he says mean things about my pwecious Stanley. But if I talk about his ‘opinionated nature,’ ‘personal experiences,’ ‘biological & social instinct for survival pushing towards finding a culprit,’ I might fool some rubes into thinking I’m doing anything more than airing out my pie-hole.”
Fact: Burzynski has been claiming for thirty years that he has vital knowledge about how to treat cancer.
Fact: Burzynski has had thirty years to actually demonstrate the truth of that claim by doing the studies. He hasn’t.
Fact: Burzynski has instead over those thirty years enriched himself by misleading desperate patients into buying standard chemotherapy drugs at highly inflated, nonstandard prices.
Fact: Nothing that anyone else on Earth does – not Big Pharma, not Pol Pot nor Idi Amin nor Jeffrey Dahmer nor Charlie Manson – make any of the above less wrong for Burzynski to do.
How come you don’t care about cannibalism and murder, Diddums? Surely you can’t criticize Big Pharma unless you first criticize everyone who’s actually gone out and committed violent murder with their own hands, especially those who then go on to eat their victims! If not, aren’t you essentially giving a free pass to murderous cannibals by focusing on Big Pharma instead?
See, that’s the kind of absurd logic you get by refusing to realize that “tu quoque” is a fallacy. The fact is that Burzynski acts unethically and nothing obligates us to delay talking about his unethical acts until we’ve gone through all the conversational detours you’d love us to go through.
Same pompous, vapid, bluster.
Chris, it is somewhat ironic that your Location is “Neither here nor there…” since “Neither here nor there” did I indicate that my argument was “that because of Big Pharma was naughty that it is okay dokay for Burzynski to charge tens of thousands of dollars to be part of his “clinical trials”, that he has conducted for thirty years but has not published are real results.”
I will be happy to accept your apology.
Chris, if I understand you correctly, you want me to do your research for you. Thank you for the opportunity to do your research for you.
Below are resources for your reading enjoyment.
You can access the link below re SRB and view the clinical trials. Please feel free to read the available information about exceptions to results being required to be submitted. Perhaps SRB’s work comes under an exception. You may contact them on their site by phone & live chat with any questions you might have.
Per-patient clinical trial costs have risen an average 70% across all development phases since 2008. Phase I per-patient costs increased an average 46%. Phase II costs increased an average 72%. The largest increases in per-patient costs came in Phase IIIa & Phase IIIb, which saw an average 88% & 86% rise, respectively.
The most significant factor for increased clinical trial costs is patient recruitment. This comes as no surprise because clinical development teams have struggled to enroll sufficient volunteers to fill trials for several years now.
Dramatic rise in cost to research & develop drugs that are eventually brought to market: In 1975, bringing a drug to market cost $100 million in 2012-adjusted dollars. By 2005, that figure had exploded to more than $1.3 billion, according to numbers from the Tufts Center for the Study of Drug Development.
The top 20 drug companies spend $30 billion on research & development, about 40% of which goes to fund clinical trials.
8 of the top 15 drug companies did not get the go-ahead for a single drug last year.
In 1980, drug companies spent some $2 billion on R&D, and 34 new drugs were approved. In 2000, they spent close to $30 billion, but only 24 drugs were approved.
Completing all the phases of clinical trials required for approval of a new drug can cost anywhere from $300 to $800 million.
Although the NIH budget has doubled in the past five years-with the implied purpose of encouraging the development of new drugs-the FDA’s budget remains inadequate to review these drugs for qualification.
Jim – Hilarious, you’re the compleat troll.
Narad, did you read the post I posted before your post? Here is more interesting reading:
Extreme tactics have also been used by other drug companies in regard to marketing psychiatric drugs for children. Drug companies allegedly paid 7 figures to 3 Harvard professors of psychiatry – who then went on to encourage diagnosing children with bipolar disorder & medicating them with antipsychotic drugs.
I am aware of that. Please keep in mind that pharma company got no free lunch here (and I also used to read 1boringoldman’s blog) but also, keep in mind if it was not for pharma company and their medication, I’d be dead today.
Diddums has just cited well known crank Peter Breggin, can Mercola, Adams and Null be far behind. Does anyone know if Breggin has been on Alex Jones’ Prison Planet?
Breggin does have his own weekly show on PRN – I assume Denice is more familiar with him. I have read part of one of his books back in my altie days and was favorably impressed at the time. However, the more I have heard of him lately, and the more I have learned about neuroscience the more convinced I am that he is a mental illness denialist. As the evidence for a biological and often genetic in various mental illness increases, he doubles down on the denialism. I would like to hear DWs take on him.
1. You should go after all that do unethical things. Not “go after” Burzynski and just “keep an eye” on pharmaceutical. Bias?
Apparently there is an Internet Law that prevents Jim and any bloggers other than Orac from criticising ethical violations in the cancer-treatment field. Otherwise Jim would be able to “go after all that do unethical things” rather than demanding that Orac do it.
Didymus Judas Thomas, okay, do my research for me:
Tell me the title, date and journal of the PubMed indexed paper where the results of those clinical are published. Then tell us why the one Phase 3 clinical trial is not allowing participants.
What planet are you living on?
Now there’s a howler that the rest of us missed. I am thinking Bo Diddly’s dimmer brother must be living on a planet where underpants are worn on the head on a regular basis.
I think we are dealing with a bull$hitter in the philosophical sense i.e. someone who does not care whether what they say is true or false.
You can access the link below re SRB and view the clinical trials. […].
Most commenters here are familiar with the clinicaltrials.gov database. It lists 62 trials under “burzynski”, most of them registered in a flurry of activity on Nov. 1 1999 which presumably corresponds to the opening of the legal loophole that Burzynski is exploiting. One of those 62 is someone else’s research on tuberculosis.
*One* study has been “completed” (in 2009; no results published); two have been “terminated” (i.e. abandoned without results due to too few subjects). Seven were “withdrawn” after seven years because Burzynski had not bothered recording any subjects at all. One (registered 2010) is not yet recording subjects.
The other 51 are all “status unknown” because Burzynski has not bothered updating the records with information about subjects.
Is this intended to convince anyone of Burzynski’s sincerity and commitment to testing the efficacy of his treatment?
Militant Agnostic: “[C]rank Peter Breggin must be a pretty good “crank” seeing as how he has been a medical expert in a number of product liability suits against drug companies & a judge made public his report as noted in the link I provided.
Chris, here are the PubMed’s:
Antineoplaston A in cancer therapy. (I).
Antineoplastons: history of the research (I).
Phase I clinical studies of antineoplaston A3 injections.
Phase I clinical studies of antineoplaston A5 injections.
Initial clinical study with antineoplaston A2 injections in cancer patients with five years’ follow-up.
Preclinical studies on antineoplaston AS2-1 and antineoplaston AS2-5.
Toxicology studies on antineoplaston AS2-5 injections in cancer patients.
Toxicology studies on antineoplaston AS2-1 injections in cancer patients.
Toxicology studies on antineoplaston A10 injections in cancer patients.
Chronic animal toxicity studies on antineoplaston A2.
Potential of antineoplastons in diseases of old age.
Efficacy of antineoplastons A10 and AS2-1.
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report.
The present state of antineoplaston research (1).
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme.
Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report.
Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1.
Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
Treatments for astrocytic tumors in children: current and emerging strategies
Stanislaw R. Burzynski, MD, PhD: novel cancer research and the fight to prove its worth.
So Jim has departed having been exposed as a troll. Did he ever put forward a real complaint other than “I don’t like Orac” ?
It is ironic in the extreme that his complaint was dressed up as “Orac holds a personal grudge against Burzynski”.
from wiki here’s what several other judges have had to say aboot Breggin’s “expertise”
Some of your statements are not factual.
Which statements are not factual? Be specific.
Would you argue we should not spend time and resources addressing domestic abuse and burglary as long as murders and armed robberies occur? A simple yes or no answer would be appreciated.
Strawman fallacy–what double standard could you be talking about? No one here, and certainly not me, is arguing pharmaceutical companies should not be held accountable if and when they act in an unethical or illegal manner.
Ooh, a link to HuffPo. Thanks, I’ll pass.
Didymus Judas Thomas, most of those are ongoing and not final reports. Did you even read the titles when you cut and pasted? The last one is just an editorial.
Now pick out one that proves Burzynski’s form of chemotherapy works better than present treatments. Just one, and quote the results.
As a comparison, tell us if it works better than Gleevec does for chronic myelogenous leukemia for the condition that the one report you choose is about.
Then go and find out what happened to the Phase 3 clinical trial. How many subjects have they recruited? Are they charging them?
It doesn’t seem to be working out too well for you.
Diddums, your Gish Gallup shows exactly what? Self-promotion of Burzynski, old and failed trials for safety and efficacy and zero replication. After 30+ years of this scam he still doesn’t have FDA approval.
Did you actually follow up on the links you provide in your post above, Didymus, or did you just copy-pasta from some pro-Burzxynski website? These citations don’t ptovide any evidence Burzynski’s antineoplastin protocols are safe or effective treatments for cancer.
They’re either review articles (e.g. “Antineoplastons: history of the research”, “Treatments for astrocytic tumors in children: current and emerging strategies”, etc.) or published abstracts from presentations or posters Burzynski ‘s given at different conferences which have not undergone perr-review ( e.g., “The present state of antineoplaston research”,“Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem glioblastoma multiforme”.,”Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report” , “Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1”, etc.)
What they are not is peer-reviewed publications providing data or analysis from any of the ‘clinical trials’ Burzynski’s supposedly been conducting for the past several decades, demonstrating that antineoplastins are either safe or effective as a treatment for advanced (or for that matter any ) cancers.
As opposed to Gleevec. It took less than five years for it to be approved for a couple types of cancer.
JGC, that is why I asked him if he had even read the titles of those papers.
It’s like when anti-SBM prevaricators quote Ben Goldacre: I wonder if they ever even read complete sentences or just fish out random phrases with which they agree.
the biggest problem advocates of the various woo’s face isn’t that they have no evidence their preferred brand of woo is effective, it’s that they have no idea what evidence it works would look like.
Antaeus Feldspar, please state “FACTS” that support your false claim that I “don’t care about cannibalism and murder.” The post in question is about SRB and that is what my writings have been directed at. Sure I can criticize Big Pharma first, because I live in The United States of America and have Freedom of Speech. I am not bound to discuss what you may want to discuss as an aside.
Alain, I am glad you are alive. I may possibly be alive for the same reason.
AdamG, I take it that you did not click on the above links that I provided and read the contents thereof. Please view the 1st link re pdpipeline. I am living on planet Earth. What solar system are you living in?
Militant Agnostic, I hope you are not using unsoiled underpants.
al kimeea, the above link I provided re Breggin; which I guess you did not read, is dated 2006 as far as the case. We all know that Wikipedia is a credible resource seeing as how under Burzynski / Legal issues, at the very bottom it cites a “review” where the “reviewer” didn’t actually “review” (watch) the movie, but that “FACT” isn’t pointed out on Wikipedia. You actually have to click on the  link to access the link to the “review” where it admits that the author “hasn’t seen the movie.”
@Didymus – so, no comment on the fact that the links you provided in PubMed don’t say what you think they say?
Oh, I read the links. That doesn’t change the fact that this statement:
Is completely, demonstrably false. If you’re willing to post such falsehoods, and then double down when caught in an obvious mistake, how am I to trust any of the sources you cite?
It’s clear you didn’t actually read my link, so here’s the actual report from Science on NIH funding:
I’m curious, DJT, have you graced us with your enlightening presence before?
The smell of socks is strong with this one.
Um, something about a review of the Merola infomerical has precisely what to do with your LOOK A SQUIRREL injection of Breggin going on in the eminently “credible resource” HuffPo?
Didymus Judas Thomas, come on! Cite and quote which one of those papers in your Gish Gallop shows that Burzynski’s treatment works as well as Gleevec for its specific kind of cancer. At least one was for leukemia.
Tell me the title, date and journal of the PubMed indexed paper where the results of those clinical are published.
Didymus Judas Thomas:
Chris, here are the PubMed’s:
I hope it is not unduly pedantic to point out that anything labeled “Preclinical studies” or “Toxicology study” is not clinical results.
Chris, do you have any “FACTS” supporting your innuendo that I did not read the titles? Please explain why I should “pick out one.” After all, I have not yet seen your apology and you have not used the “Magic Word.” You do know what the “Magic Word” is, right, Chris? The “Magic Word” is “Please.”
Science Mom, have you read my previous post & links re the difficulties, time, and expense involved in obtaining FDA approval? Did you watch the Burzynski movie as I did & note near the end where it showed that it would take $300 Million for the FDA III trial? And that amount may have risen since then.
JGC, please explain how I would have been able to provide the above links without following up on them. Have you reviewed Burzynski’s sites to determine if the links are there?
Lawrence, “links … don’t say what [I] think they say?” Please cite where I said what the links would say.
AdamG, please cite the “FACTS” which buttress your unproven inane statement that “It’s clear that [I] didn’t actually read [your] link. When viewing that site were you able to draw a conclusion as to what years the NIH statement was referring to? I think the more important part of the statement is the part re the FDA. I’m not even going to waste my time answering your last question since I answered your question about what planet I live on but you did not answer my question about what solar system you’re from.
Narad, since al kimeea brought up wiki I commented on the credibility of information on wiki re Burzynski since this post is about SRB. I brought up Breggin since his comments on HuffPo are re Big Pharma. I also construed Breggin’s comments re no requirement for drug co’s to disclose certain information, as also applying to SRB.
Chris, I actually do other things during the day other then feverishly monitor what comments are being posted here. My statement at the top of this applies.
herr doktor bimler, where does Chris’ post state “clinical results?” It states “clinical.” As far as I’m concerned that left it up to my discretion as to what to choose to post.
Perhaps by going to the list of publications on the Burzinsky clinic website (www.burzynskiclinic.com/publications.html) and then pulling up the pubmed links without looking further? OR maybe you got lucky amd simply cut and paste the list with the pubmed links intact from one of the many websites Burzynski’s marks, convinced he’s the real deal, have set up to promote his clinic.
The real question, if we accept you did actually follow up and examine the citations you’ve offered, is however did you fail to realize they offer no evidence antineoplastins are safe or effective?
Diddums, you said:
“herr doktor bimler, where does Chris’ post state “clinical results?” It states “clinical.” As far as I’m concerned that left it up to my discretion as to what to choose to post.”
Lets look at what Chris said:
“Tell me the title, date and journal of the PubMed indexed paper where the RESULTS of those clinical are published. Then tell us why the one Phase 3 clinical trial is not allowing participants.”
To make it easy I have capitalized the relevant word in Chris’s request.
Still having difficulty Diddums?
We will await the data.
As far as I’m concerned that left it up to my discretion as to what to choose to post.
*Of course* it’s up to you what information you link to, whether or not it’s relevant or persuasive. This is an internet comment thread — not a Wikipedia page where someone else will delete your contributions if they’re bullsh1t.
Given that the article was written in 2012, and that the statement refers to the past 5 years, the article is clearly claiming that the NIH budget doubled in the period from 2007-2012.
Do you believe that this is a factual claim or not? If so, please cite the “FACTS” that support this unproven inane statement.
For someone so focused on facts and proof, why won’t you acknowledge that this is an erroneous statement?
I thought the magic word was “abracadabra”.
Is it me or does this smack of a pyramid scheme? Like in the mob where there are levels of people below the boss, so that the boss is forever covered should the law ever get near prosecuting someone…
I’m betting on sonny-boy.
Forgive my ignorance, but are studies allowed to be open-ended in terms of time scales? Is there any regulation that says the study lasts X long, and after that date, you need to get an extension and/or end the study? And if extensions exist, are there any limits on how long/how many you can get?
Last Thursday-ism, love it! That’s not been used for a while…
Also (and @Jim)
Science ≠ law
Well, that’s evidence that Burzyinski’s treatments work…
Lovely, now we have the “other ways of knowing” fallacy.
Cue the word, “quantum”.
Yeah, that’s not how it works. Patients do not pay anything, before, during or after a clinical trial. Private and public donors might, but that’s not quite the same thing: and you know it.
I guess people take issue with it being ‘later’. 30 years is enough time to show evidence of some kind – why wait so long?
And now we have the “science is religion” fallacy.
And now the flounce…
I’m guessing the assumption is that each doctor (should) take it upon him/herself to treat the patient according to their own knowledge/experience/conscience, and that therefore have more individual responsibility. IANAL or doctor, but that would be my guess.
@Didymus Judas Thomas
You are hilarious – but quite outmatched. Your debate tactics seem to be ‘argue semantics’ rather than ‘argue the point’.
To my recollection, there are no such laws. However, IRBs who are doing their jobs would normally take a look at subject enrollment and expected targets, then decide that if enrollment is stagnant for some period of time, that perhaps the study should be closed, unless there is some very compelling reason to keep it open.
One way that his trials might be shut down is to target the IRB. If they persist in violating IRB regulations, they could be stripped of their approval. If that happens, then he would need to find a new IRB to oversee his studies. If he doesn’t do that, then his studies would be illegal, as they would be operating without IRB approval.
No, Peaches, you got asshurt over having pointed out that Breggin, who you invoked to persist in trying to change the subject, is a crank, pouted about his being “a medical expert in a number of product liability suits against drug companies,” then cranked up the pissiness when it was pointed out that he’s proved to be a really sh*tty expert witness and tried to impugn the source by observing that Wikipedia linked to a bad review of the Burzynski movie that you were able to find fault with. That’s a really f*cking impressive gotcha.
It was colossally stupid to invoke Breggin in the first place, as he’s completely unnecessary to the diversionary maneuver, and you just kept piling it on.
^ “having it pointed out”
No real sciency comment to make so I’ll chuck in an Ad Hom.
We really should refer to DJT as Epi. It’s the nearest to Balls as anything I’ve ever read on this fine site. (Stand Fast Dana Ullman)
Epi and dydimous. Did you see what I did there?
You are so correct.
The only period since 1980 that the claim can accurately refer to is 1998–2003, which makes one wonder why it’s being parroted right here and right now. Actually, scratch that last bit.
Didymus Judas Thomas:
The fact that you claimed that some papers were results, when the titles clearly indicated they were not. I even included one of those titles. Now here it is again with some others:
From reading the titles, I can see none of them are results of a full clinical trial. In fact, in some of the papers claiming to be “results” were actually opinion pieces. You were asked specifically before you posted that Gish Gallop:
Though I did skip the word “trials” after the word “clinical.” This is a blog, typos and dropped words happen.
Now, please cite one paper that shows the clinical results that match the efficacy of Gleevec. And do you have an answer as to why the Phase 3 clinical trial is not allowing participants?
All of a sudden, I’m getting a strong penny-stock vibe off of DJT.
DJT Dow Jones Transportation ( average)
That is not- in any shape or form- advice.
Believe it or not, I’m quite familiar with the FDA approval process and I’m not exactly feeling sorry for rich old Burzynski who has made his nut off the backs of desperate people. He has chosen to make claims of miracle cure then he had better have something to show for it; no one is keeping him from doing so.
But of course, let’s decide treatment merit based upon a self-promoted and aggrandised movie. In fact, screw peer review and regulation, let’s pass drugs onto consumers based upon YooTube vids.
Aww, and poor wittle Burzynski sitting in his gauche mansion. What do you think venture capitalists are for Diddums? If he had such a great product, he would have no trouble getting investors. Why doesn’t he?
Did you watch the Burzynski movie as I did & note near the end where it showed that it would take $300 Million for the FDA III trial?
Are we to read this as a concession that Burzynski has in fact no intention of conducting a Phase-III trial, and that his application to do so — and his claim to be recruiting subjects — are fraudulent?
Wow, you really don’t have much self-awareness, do you?
We are discussing Burzynski. You are the one coming along and trying to tell us that we are violating some principle or other if we discuss Burzynski rather than Big Pharma, and that our violation of that principle indicates that we don’t want to hold Big Pharma responsible for its misdeeds.
My mocking suggestion that, if you wanted to focus attention on Big Pharma rather than cannibalism and murder, you would be violating a similar principle and indicating you didn’t want to hold murderous cannibals responsible for their acts, is what’s called a reductio ad absurdam. It’s a way of saying “your logic is BS, because you can apply it to a valid set of premises and yet reach this completely absurd conclusion.”
I’m afraid I made a mistake in assuming you could think clearly enough to draw the obvious connection between what you were facetiously accused of and what you had just accused us of. I’ll try not to overestimate you like that in the future.
Especially since Burzynski actually charges the patients the cost of the clinical trial.
Nice catch HDB. Perhaps Diddums will be along to throw another shiny object in our paths to avoid answering this.
There’s really only two possibilities I see: either Burzynski’s decades of clinical trials have produced no evidence antineoplastins work or evidence they don’t work, inwhich case he’s s a fraud, or they’ve shown they do work but he’s withholding publication to ensure a monopoly for his clinic thereby denying millions of cancer patients access to his miracle cure
In which case of course he’s a monster.
Thanks – so it’s clear to me that if the IRB is corrupt, then the studies have very little chance of being done properly?
This is a test since I submitted a response to JGC over 4 hours ago which indicated it was under review for posting but hasn’t posted. So, I am seeing if my posting is being denied, or what.
@didymus – if you are unaware (and you mostly like are), there is a comment filter in place that activates under certain circumstances (key words for example, or too many links) to prevent the spamming of this blog.
The blog author isn’t a machine (well, mostly not a machine, lol) and gets to the held comments when he is able.
So, how about a real retort instead of whining.
JGC, did you actually access the link you provided? Because there are no links on the Publication page to PubMed. Please advise which SRB site has links to PubMed and/or matches the list I made from:
Please explain to me how & when it became my responsibility to state an opinion re the efficacy of Antineoplastons (not Antineoplastins). Don’t take my word for it, read what the National Cancer Institute at the National Institutes of Health:
and American Cancer Society says:
And we can ask why there’s been so much research and patents issued re Antineoplastons:
Non-SRB Antineoplaston 1986-1989 (in date order):
Preclinical studies on antineoplaston A10 injections. Ashraf AQ, et al. Drugs Exp Clin Res. 1986
3-Phenylacetylamino-2,6-piperidinedione, a naturally-occurring peptide analogue with apparent antineoplastic activity, may bind to DNA. Lehner AF, et al. Drugs Exp Clin Res. 1986
Altered methylation complex isozymes as selective targets for cancer chemotherapy. Liau MC, et al. Drugs Exp Clin Res. 1986
In vitro cancer growth inhibition and animal toxicity studies of antineoplaston A3. Lee SS, et al. Drugs Exp Clin Res. 1987
Tissue culture and animal toxicity studies of antineoplaston A5. Lee SS, et al. Drugs Exp Clin Res. 1987
Pharmacokinetic study of radioactive antineoplaston A10 following oral administration in rats. Ashraf AQ, et al. Drugs Exp Clin Res. 1987
Chemoprevention by antineoplaston A10 of benzo(a)pyrene-induced pulmonary neoplasia. Kampalath BN, et al. Drugs Exp Clin Res. 1987
N,N’-disubstituted L-isoglutamines as novel cancer chemotherapeutic agents. Khalid M, et al. Drugs Exp Clin Res. 1987
Quantitative assay of plasma and urinary peptides as an aid for the evaluation of cancer patients undergoing antineoplaston therapy. Liau MC, et al. Drugs Exp Clin Res. 1987
Chemo-surveillance: a novel concept of the natural defence mechanism against cancer. Liau MC, et al. Drugs Exp Clin Res. 1987
Stereochemical modelling studies of the interaction of antineoplaston A10 with DNA. Hendry LB, et al. Drugs Exp Clin Res. 1987
Inhibition of spontaneous mouse mammary tumour development by antineoplaston A10. Muldoon TG, et al. Drugs Exp Clin Res. 1987
Actions of an endogenous antitumorigenic agent on mammary tumor development and modeling analysis of its capacity for interacting with DNA. Hendry LB, et al. J Steroid Biochem. 1988
Chemopreventive effect of antineoplaston A-10 on urethane-induced pulmonary neoplasm in mice. Eriguchi N, et al. Nihon Gan Chiryo Gakkai Shi. 1988
Non-SRB Antineoplaston 1990-1999 (in date order)
Theoretical investigations on the structure and potential binding sites of antineoplaston A10 and experimental findings. Michalska D, et al. Drugs Exp Clin Res. 1990
Pharmacokinetic study of radioactive antineoplaston A10 in rats and mice. Xu W, et al. Drugs Exp Clin Res. 1990
Studies of the release rate and bioavailability of antineoplaston A10 capsule. Wang H, et al. Drugs Exp Clin Res. 1990
The anticancer effect of antineoplaston A-10 on human breast cancer serially transplanted to athymic mice. Hashimoto K, et al. Nihon Gan Chiryo Gakkai Shi. 1990
Inhibitory effect of antineoplaston A-10 on breast cancer transplanted to athymic mice and human hepatocellular carcinoma cell lines. The members of Antineoplaston Study Group. Tsuda H, et al. Kurume Med J. 1990
3-phenylacetylamino-2,6-piperidinedione inhibition of rat Nb2 lymphoma cell mitogenesis. Wood JC, et al. Proc Soc Exp Biol Med. 1991
[Antineoplastons–structure, chemical properties and mechanism of activity]. Kochman A, et al. Postepy Hig Med Dosw. 1992. Article in Polish.
The inhibitory effect of the combination of antineoplaston A-10 injection with a small dose of cis-diamminedichloroplatinum on cell and tumor growth of human hepatocellular carcinoma. Tsuda H, et al. Jpn J Cancer Res. 1992
‘Antineoplastons’. An unproved cancer therapy. Green S, et al. JAMA. 1992
Inhibition of estrogen stimulated mitogenesis by 3-phenylacetylamino-2,6-piperidinedione and its para-hydroxy analog. Copland JA, et al. J Steroid Biochem Mol Biol. 1993
The influence of antineoplaston A5 on the central dopaminergic structures. Juszkiewicz M, et al. Drugs Exp Clin Res. 1994
Antiestrogenic piperidinediones designed prospectively using computer graphics and energy calculations of DNA-ligand complexes. Hendry LB, et al. J Steroid Biochem Mol Biol. 1994
Synthesis of Mannich bases of antineoplaston A10 and their antitumor activity. Choi BG, et al. Arch Pharm Res. 1994
The effect of Antineoplaston, a new antitumor agent on malignant brain tumors. Sugita Y, et al. Kurume Med J. 1995
Cellular accumulation of antineoplaston AS21 in human hepatoma cells. Sołtysiak-Pawłuczuk D, et al. Cancer Lett. 1995
The influence of antineoplaston A5 on particular subtypes of central dopaminergic receptors. Juszkiewicz M, et al. Drugs Exp Clin Res. 1995
Toxicological study on antineoplastons A-10 and AS2-1 in cancer patients. Tsuda H, et al. Kurume Med J. 1995
Inhibitory effect of antineoplaston A10 and AS2-1 on human hepatocellular carcinoma. Tsuda H, et al. Kurume Med J. 1996
3-[(Phenylacetyl)amino]-2,6-piperidinedione hydrolysis studies with improved synthesis and characterization of hydrolysates. Revelle LK, et al. J Pharm Sci. 1996
Enantioseparation of 3-phenylacetylamino-2,6-piperidinedione and related chiral compounds. Tang Y, et al. J Chromatogr A. 1996
Lessons from antineoplaston. No authors listed. Lancet. 1997
Lessons from antineoplaston. Silver H, et al. Lancet. 1997
Lessons from antineoplaston. Baldwin of Bewdley, et al. Lancet. 1997
Lessons from antineoplaston. Fahner JB, et al. Lancet. 1997
Lessons from antineoplaston. Tweddle S, et al. Lancet. 1997
Antineoplaston AS2-1 for maintenance therapy in liver cancer. Tsuda H, et al. Oncol Rep. 1997
Quick response of advanced cancer to chemoradiation therapy with antineoplastons. Tsuda H, et al. Oncol Rep. 1998
[Assessment of early treatment results with antineoplaston AS2-1 in subacute sclerosing panencephalitis]. Sobczyk W, et al. Neurol Neurochir Pol. 1997. Article in Polish.
Antineoplaston treatment for advanced hepatocellular carcinoma. Kumabe T, et al. Oncol Rep. 1998
Synthesis of antineoplaston A10 analogs as potential antitumor agents. Choi BG, et al. Arch Pharm Res. 1998
Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma. Buckner JC, et al. Mayo Clin Proc. 1999
[The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitis]. Sobczyk W, et al. Neurol Neurochir Pol. 1999. Article in Polish.
Non-SRB Antineoplaston 2000-2009 (in date order)
Potential utility of antineoplaston A-10 levels in breast cancer. Badria F, et al. Cancer Lett. 2000
Immune modulatory potentials of antineoplaston A-10 in breast cancer patients. Badria F, et al. Cancer Lett. 2000
Pharmacologic and biologic therapies in cancer care. Decker GM, et al. Clin J Oncol Nurs. 2000
Novel piperidinedione analogs as inhibitors of breast cancer cell growth. Abou-Zeid LA, et al. Arch Pharm (Weinheim). 2000
Synthesis, spectroscopic characterization, stability assessment and DNA-binding of new 2,6-piperidinedione derivatives. Abou-Zeid L, et al. Farmaco. 2001
A novel strategy for remission induction and maintenance in cancer therapy. Tsuda H, et al. Oncol Rep. 2002
The preventive effect of antineoplaston AS2-1 on HCC recurrence. Tsuda H, et al. Oncol Rep. 2003
Long-term survival following treatment with antineoplastons for colon cancer with unresectable multiple liver metastases: report of a case. Ogata Y, et al. Surg Today. 2003
[Anti-proliferative effects of biochemical defense modifier antineoplaston in colorectal carcinoma]. Ogata Y, et al. Nihon Rinsho. 2003. Article in Japanese.
Managing social conflict in complementary and alternative medicine research: the case of antineoplastons. Hammer MR, et al. Integr Cancer Ther. 2004
Effects of antineoplaston AS2-1 against post-operative lung metastasis in orthotopically implanted colon cancer in nude rat. Matono K, et al. Oncol Rep. 2005
[The regulatory action of dipeptide “Deglutam” on the glutamine metabolized enzymes in the carcinosarcoma SM-1 cells]. No authors listed. Biomed Khim. 2005. Article in Russian.
Antineoplaston induces G(1) arrest by PKCalpha and MAPK pathway in SKBR-3 breast cancer cells. Fujii T, et al. Oncol Rep. 2005
Induction of apoptosis in human hepatocellular carcinoma cells by synthetic antineoplaston A10. Qu XJ, et al. Anticancer Res. 2007
Preclinical studies of molecular-targeting diagnostic and therapeutic strategies against breast cancer. Fujii T, et al. Breast Cancer. 2008
Precise engineering of targeted nanoparticles by using self-assembled biointegrated block copolymers. Gu F, et al. Proc Natl Acad Sci U S A. 2008
Novel aminopeptidase N inhibitors derived from antineoplaston AS2-5 (Part I). Li X, et al. Bioorg Med Chem. 2009
Novel aminopeptidase N inhibitors derived from antineoplaston AS2-5 (Part II). Li X, et al. Bioorg Med Chem. 2009
It’s not a surety, but it definitely ups the likelihood. Remember, the IRB is there to ensure that subjects are protected. They have the authority to shut down a study if the investigator and/or anyone else on the study is screwing up. If the IRB is not doing their job properly, then the risk to subjects goes up as the potential for PI shenanigans goes unchallenged.
In Burzynski’s case, the IRB overseeing his research was cited on quite a number of violations:
1) They did not ensure that risks were minimized and reasonable compared to anticipated benefits/knowledge to be gained.
2) They did not have written procedures for initial/continuing review of research involving a medical device. (Apparently, at least one study involved medical devices.)
3) They did not ensure that informed consent would be sought or documented.
4) They had voting IRB members who were directly involved in the research being reviewed (Carlton F. Hazlewood, the IRB’s chair, is an investigator on one study and advisor on the DSMB. Another IRB member was a coinvestigator of another study.)
5) They did not conduct continuing reviews for a couple studies, instead having only verbal conversations with the PI.
6) They did not keep complete copies of all study-related documents (protocols, consent forms, etc.).
7) They did not keep minutes of their meetings, recording who attended, who voted, basis for changes/disapproval, or discussion summaries of controverted issues and how they were resolved.
8) They allowed non-IRB members to vote in place of individuals who had conflicts of interest.
These violations were all documented in a letter to the IRB dated October 5, 2009. No close-out letter is recorded, meaning that either FDA just didn’t post it, or the deficiencies listed in the warning letter have not yet been corrected or any corrective actions have not yet been verified by FDA inspectors.
You said, emphasis added:
You do realize that a patent being issued has absolutely nothing to do with whether or not something actually works, right? All it means is that someone really wanted to protect the invention or method from other people trying to do something with it without first getting permission. That’s all a patent does.
@DJT: Until you can prove to us ONE of those many copy/pasta links shows that antineoplastins are: 1)nontoxic (the only real study I know about them closed early due to toxicity) 2)effective at safe levels (not found) 3)safer and more effective than current treatments (not proven) then all you are doing is spamming.
Chris asked you many comments ago for ONE clinical study that showed antineoplastins were as or more effective than the fast-tracked chemotherapy drug. You haven’t answered that. Why not? And no, it’s NOT our job to find the study. You made the claim, you provide the proof. That’s how it goes (AKA: CITATION NEEDED).
Otherwise, we’ll just assume you are trolling. We aren’t as vicious to chew toys as they are on Pharyngula, but we do have fun with them.
Oh, and I should have added – please show you also know the difference between in-vitro and in-vivo studies….
Oh holy hell Batman, no wonder your comments ended up being delayed… Try fewer links next time.
Of course – with lax oversight there’s more opportunity to screw up, with more oversight there’s more opportunity to fix the screw ups.
But if the IRB in this case isn’t paying attention to the ‘no results for 30 years’ thing, then shutting down the study isn’t very likely is it?
And in this case, it’s not doing much of anything to protect them from fee-gouging or from paying to be in clinical trials.
So basically if the IRB isn’t doing their job properly, all they get is a letter? (Presumably law cases come after numerous letters) So the FDA/etc are really quite toothless in this whole case…
[…] Most regular readers of this blog know who Stanislaw Burzynski is, but, even if I’ve just written about him a few days ago (this time in the context of his apparently having managed to slither away from justice again, […]
Yes, I did go the the clinic’s website and noted taht it didn’t include the pubmed links; as you recall I suggested puled up the links from pubmed and appended them to the titles before posting them here, without actually investigating the articles further. That’s the only way I can imagine you’d offer these articles, which represent review articles, poster abstracts and opinion pieces and don’t present any clinical study results, in response to Chris’ question “Tell me the title, date and journal of the PubMed indexed paper where the results of those clinical are published.”
You’ve voluntarily expressed an opinion regarding antineoplastons, by arguing we should cese criticizing Burzynski’s clinic and simply wait and see. Surely that isn’t what you’d advise if you did not beleive they were potentially a safe and efficacious treatment for the advanced cancers his patients present?
By the way, which do you think he is– fraud, who is witholding publishing the results of his clinical trials because they provide evidence of antineoplastons efficacy, or a monster who’s witholding publication to maintain a very lucrative monopoly, thereby denying thousands of cancer victims access to the cure?
Not sure what action has been taken to follow-up on that letter. I’d need to file a FOIA request. If the deficiencies are not resolved, the IRB’s registration or assurance could be revoked, meaning that they would not be able to review/approve any research that falls under the Common Rule. That would mean that any research he conducts that is approved by that IRB would not be able to be used for approval by FDA, nor would he be able to get any funding support from any agency that falls under the Common Rule.
Minor correction to my last comment. FDA has its own set of IRB requirements separate from the Common Rule. Some differences are noted here.
The FDA can disqualify an IRB for failure to comply with regulations. If that happens, then:
I was unable to find his IRB listed as registered, which may partially explain why he’s not pursuing FDA approval. Again, though, some info may not be available online, in which case a FOIA request to find out the details would be a better way to go.
Didymus Judas Thomas. how come you did not provide the one paper showing the clinical trial results that show Burzynski’s treatment is as effective as Gleevec, with direct quotes from the paper about the effectiveness?
Seriously how does a paper with a title like (going up to check the Gallop Gish) “Synthesis, spectroscopic characterization, stability assessment and DNA-binding of new 2,6-piperidinedione derivatives” in any the results of any clinical trial? How is one case report as in “Long-term survival following treatment with antineoplastons for colon cancer with unresectable multiple liver metastases: report of a case.” about a full clinical trial?
Come on, just one paper with a direct quote showing effectiveness equivalent to Gleevec for its particular type of cancer. If you do not answer as the question is asked, then we know that there are none.
Sir Didddimus? I gotta warn you, flooding the arena doesn’t work with this group.
Also, Didymus Judas Thomas, you have failed to answer why the Phase 3 clinical trial has no participants.
Don’t take my word for it, read what the National Cancer Institute at the National Institutes of Health:
and American Cancer Society says:
I guess Didy didn’t bother to read those information sheets either, as they both conclude that there is no evidence that Stan’s antineoplastons have any postive effect. Just because these two cancer organizations provide an information page about ANP on their websites does not mean they endorse, recommend or support this form of unproven, untested “treatment.” The information sheets are merely provided for the benefit of anyone doing research into all the cancer treatments being offered, the good, the bad, and the useless. They appear to me to be more of a warning AGAINST Stan’s little shop of horrors than an endorsement.
Given that you plainly didn’t understand the papers you posted the first time around and apparently don’t grasp why that’s important, I suppose it would have been a bit much to expect the ability to extract information from journal titles or author lists, either.
Here’s a hint: When you see three identically titled Lancet articles in a row, they’re not original work. Moreover, “Baldwin of Bewdley” as author should really be a flag. However, I think it’s equally hilarious that you disgorged this one as an example of extramural antineoplaston “research.”
Marc Stephens Is Insane:
Which is precisely why I want him to provide direct quotes from the one paper that shows clinical trial results are as effective as Gleevec for the cancer the paper is about.
He seems to have trouble understanding the question, and understanding that the titles on the Gish Gallop he posted are not results of full clinical trials.
He never checked them, they are comments on an article, most likely not in support of Burzynski. Actually, he is having trouble with vocabulary, especially the concept of the “one.” One, as in a number between zero and two.
Internet search of Antineoplaston Patent US6013278 displays SRB’s patent. Patent search of US Patent & Trademark Office site re 6013278 displays SRB’s patent, patent search on “Antineoplastons” displayed 33 patents, on “Antineoplaston” displayed 573 patents, & trademark search on “Antineoplaston” displays SRB’s trademark.
Antineoplaston (Dr Samid): ralphmoss . com / html / burz9 . shtml
Internet search of “ResearchproposalfromDrSamid.pdf” will display link for [PDF] “uniformed services university of the health sciences” Samid’s letter re Antineoplaston.
Internet search of patent “0725635” displays patent re Antineoplaston (Samid-GOVT OF USA as represented by the SCTY OF DEPT OF HHS), the 11 patents SRB contends the US issued to duplicate his patent.
Orac writes: “[D]espite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy…” What’s your point? Internet search on “Antineoplastons” “a form of chemotherapy” displays a google 2006 books link re “Get Healthy Now” (pg. 575) where SRB indicates that Antineoplastons are a form of chemotherapy.
Now to respond to comments! 🙂
Read our lips: patents mean nothing. Anyone can patent anything, if they thought of it first (except for a perpetual motion machine–they are “unpatentable.”) The patent office doesn’t give a crap if anything works or not.
And a Ralph Moss reference? Sheesh. What’s next? Whale.to? Mike Adams? Mercola?
What’s your motivation behind all this effort to prove something that is unproveable? Do you really think any of us will change our minds based on the links you copy-paste?
Do you work for Burzynski? How much is he paying you to post your comments?
(I love the “reverse Pharma-shill gambit”…)
Perhaps you’d like to take a look at the posts of Mr. Saunders, the parent of a Burzynski patient, who was clearly misled into believing that antineoplastins are not chemotherapy. That’s the point.
One of the hallmarks of everything pro-Burzynski is that “he doesn’t use chemotherapy.” I’ve seen that mantra repeated dozens of times from supporters. It’s the single biggest selling point he uses to recruit customers. And he misleads people into thinking there will be no side effects either, while the side effects themselves are often life threatening.
Perusing DJT’s citation gishgallop I notice that the number of citations about antineoplastons has been steadily declining, suggesting a steady decrease in interest.
1986-1989 13 citations = 4.3 per year
1990-1999 32 citations = 3.2 per year
2000-2009 18 citations = 1.8 per year
A further check myself also reveals:
2010-2012 1 citation = 0.3 per year
A close examination also reveals there is literally nothing of any substance in there. These are nearly all preclinical, in vitro, or animal studies with a few case reports, a few small uncontrolled studies of patients often also receiving standard treatment, some of unknown status (in Polish for example) and (as Narad noted) one social science study on how one of Burzynski’s trials ended up a complete shambles. Smoke and mirrors.
Do we need to go back to the promo copy for the movie?
BTW, how’re you coming along on that doubling-of-the-NIH-budget bit?
@Didymus – #1 – the point is Dr. B & his supporters are specifically telling people that his treatment is not Chemo – which is a lie.
#2 – Where are the “PUBLISHED” clinical results that show that Dr. B’s treatment is effective vs. conventional cancer treatments?
@Narad – yeah, because I know a lot of researchers that would be very interested to find out that their budgets had, instead of being steadily reduced, were in fact doubled…..
Direct question, DJT: to the best of your knowledge has Burzynski ever published results from a completed Phase II trial of antineoplastons which demonstrates their safety and eficacy at treating advanced cancers?
If so, where?
Hey, who am I?
Don’t forget the magic word, Peaches.
There are some (typical) unbelievable fan comments about Burzynski on the Healthy Home Economist link Orac provided above. In addition to plugs for Simoncini and Cantron, most comments are a response to this first comment from an unhappy former Burzynski patient:
I have experienced this treatment and this case is not the “persecution” you claim. This treatment is NOT harmless! It can be deadly itself. They don’t mention that when you show up. It was $20,000 upfront for the first few days of treatment. How is this not monopolizing?? Like chemo, it makes the patient sick and unable to function normally. It requires a complete overhaul of your life(and diet) and the lives of those around you. Not to mention the antineoplastons WREAK!! I cannot even describe the awful smell that you are subjected to all day, every day. It permeates the house, everything, and everyone it touches. While I’m sure the treatment works for some, so does just a dietary change, so does doing nothing, so does a placebo. The FDA approval doesn’t mean anything. If there’s enough money, the FDA has approved many drugs that are then found to be deadly. In our experience, every patient that we met while there was dead within 2 months of returning home.
I do agree that every patient should have the right to choose their treatment. However, there is a lot of info missing about this particular case and this clinic. The government may not be as unfounded in their case as you are leading people to believe.
There is a follow-up comment about how they never even got to meet Burzynski, etc.
The website is full of other Mike-Adams-style panic stories about ther perils of wireless baby monitors, Pop-Tarts, and other woo.
Didymus Judas Thomas:
Since you changed to Gish Galloping with patents, I can assume there are no papers showing results from clinical trials that Burzynski’s methods are as effective as Gleevec for any cancer.
You can now apologize for wasting our time.
No need to follow up – I had just meant to explore the issue of IRB loopholes and oversight. It’s a side topic that I’m not informed about. Thanks for the links. I can set myself a little light reading when I have more time.
Actually, it makes me wonder about something else. Some years ago I remember havoc in the press due to a UK doctor who had been struck off there, working here in Aus. It concerns me that if Dr B gets royally trounced in the US, he’ll simply pack up and move somewhere else. I can guess that different countries might not care (ie. Mexico), but if he say, went to the UK, would he have problems developing research and/or setting up an IRB? As an example, Wakefield is not likely to attract any private or public funding anymore, but do IRBs ever decide to avoid a particular researcher? Can you shop around for IRBs? (Again, showing my ignorance of how this all works…)
Well sure, because books and patents are exactly the same as results from double blind placebo trials in a peer-reviewed journal. *rolls eyes
That worries me – they went to him, presumably to treat life threatening cancer, but dietary changes fixed it? Something doesn’t smell right. (And it’s not the antineoplastons)
Short answer, yes, but you’re supposed to be open.
Most research centers will have an IRB of their own. However, there are some for-profit IRBs, which carry with them a host of niggly little ethics issues. Sponsors/investigators are supposed to record all IRB interactions, which would include one IRB saying “No way”. This info is supposed to be shared with FDA (if going for approval of a new product or indication) or, if they then shop for another IRB, the new IRB.
Even with not-for-profit IRBs, there are two varieties: institutional IRBs (e.g., large universities or academic hospitals will have their own local IRB) and independent IRBs. Both have their potential problems: independent IRBs open the potential for “IRB shopping”. You can find a number of articles online about this concern, such as when one IRB disapproves a study and the PI or sponsor looks for one that will approve it. Institutional IRBs remove that risk, but they can create a sort of monopoly on what research gets approved and what doesn’t.
Oh, I wasn’t kidding. There was what seemed to be an active “let’s try to put on a pump-and-dump” scene centered around BZYR for a while. I just happened to note that some of DJT’s poorly demarcated quote-barfs also (indeed, exclusively) appeared a while ago in association with PPHM. The former apparently no longer has a market maker and is off the OTCBB.
Who knew that Byrzinski Research Institute was a publicly traded company (though I might have known this and forgotten it) with current stocks at $0.10 a share. Interesting find! Wonder what the SEC filings would reveal…
Oh, you know, the usual.
This 8-K is a good one, though.
Ok, thanks. So if shutting down Burzyinski is also about going after the IRB, then the regulatory bodies need also to make sure he doesn’t just grab his 5 next closest buddies and offer them positions on a new one….
But without an IRB at all, he can’t do much of anything in terms of marketing the clinic/treatments. …?
Do I recall a 21st Floor post about that? I can’t get the search to work there and I don’t have it bookmarked.
Carigen, the Cayman Islands entity, incidentally, is wholly owned and controlled by Burzynski.
He could try to set up another IRB under a different name, but he may have trouble with that. Might get more scrutiny due to past concerns about how he’s operating.
But, yes, without an IRB, he would not be able to get his antineoplastons approved for marketing, which means he could not advertise it for the treatment of any disease or condition. Also, all use of it would have to be within the confines of a clinical trial.
So can we assume that the brave maverick has seen the writing on the wall for his particular brand of thievery and is preparing to bolt for countries more amenable to con-men and fraudsters?
I do hope he gets nailed before he flees.
Looks more like a Colonel Sanders–type of setup that they’re after. The target countries (Bahrain, Dubai, South Korea, Indonesia, Malaysia, Qatar, Singapore, and Thailand) are something of a mixed bag.
Am I correct in guessing that Worldwide Medical Consultants, Inc — the other entity mentioned in that licensing deal between Burzynski’s various fronts — is itself another Burzynski money-laundering front? It appears to have existed since 1998, without ever dealing with anything other than Burzynski Research Institute and the Carigen tax-avoidance entity.
This is difficult to say, given New Jersey’s system of providing public records. What it’s been doing for the past 14 years is certainly interesting. Still, if one entertains notions of Al Capone (I’ve really gotten the “bang bang” line in a taxi in Spain), I think one would really like to see how much revenue flux there is in a four-doctor clinic that seems to specialize in paternity testing.
Let’s not forget how easy it was for the Geiers to pull this off with their own hand-picked IRB and no clinical trial registration. This went on for years and I don’t recall their completely unethical IRB even being a point of charges against them. Although their malfeasance is so vast that I could be wrong on that.
MarkL, why should I try to find the RESULTS?
herr doktor bimler, “bullsh1t?” Wow! I wonder how many people will now follow your lead & use profanity because “the doktor did it!” I am so glad you used the “1” in it so as not to offend as much. :-O
AdamG, you have not yet advised me what solar system you are living in. So, you think it’s from 2012 but the link has 2011 in it. My research shows that that link was linked to another site as far back as 11/5/06, which as Narad pointed out, means that it likely applies to 1998-2003.
Todd W., No, “abracadabra” is Steve Miller’s “magic word” when he sings “Abra Abra Cadabra, I want to reach out & grab ya.”
flip, what’s your point? You write that “[p]atients do not pay anything, before, during or after a clinical trial.” Below are some sources which do not agree with you:
Narad, I am amazed at your mastery of the English language! “[A]sshurt,” “sh*tty,” & “f*cking!!” The “*” sign really differentiates you from petulant “yoots.” However, I will not stoop to your level & ASSUME what your mental or emotional state is, because the “FACT” is that I do not know yours & you do not know mine, but I do know that you make an ASS out of U & ME when you ASSUME.
Peebs, nice try, but DJT refers to “Doubting Thomas.”
I think we should call Peebs “Peeps.” Do you “see” what I did there?
Denice Walter, you are so politically incorrect.
Narad, Dead Wood.
Chris, please point out where I stated that the PubMeds were “results” & cite which law or regulation requires the information you are requesting. Feel free to look up the contact for the Phase 3 clinical trial & e-mail or call them since you have so much time on your hands.
Science Mom, if you want to decide treatment based on a movie, that’s fine with me! Venture Capitalists are great if you want to turn over some of your decision-making power to the people with the money. Just think, instead of wasting $60+ million trying to go after SRB the gub-ment could have given the $ to NIH to fund clinical trials! You did know that earlier this year it was reported that some NIH funded trials were not being published up to more than 2 1/2 years after completion, right?
herr doktor bimler, read it as whatever you want to read it as, or you can go on the clinical trials site & look up the e-mail & phone # & use one of those resources to contact SRB & ask, or go on one of the SRB sites & look up the Public Relations/Media contact & contact them, or you can take the below video comments at face value that a new documentary is to be released re SRB in 2012, and watch it when it comes out to see if it answers your questions:
Antaeus Feldspar, your absurd conclusion is that you would rather spend more time & energy re SRB who you have not provided any information as to how much he has been fined, rather than Big Pharma who has been fined $13 BILLION in the past 4 years. The difference is that Big Pharma has violated laws significantly more than SRB.
Science Mom, see above for your “shiny object!” 😉
Lawrence, when Orac whined that SRB “got off on a technicallity,” did you ask him to offer a “real retort” like SRB did not “get off on a technicallity,” but he got off because the law is the law?
Todd W., yes, this is why the HHS filed 11 patents based on Antineoplastons.
M. Dawn, I am under no requirement to prove or not prove anything to you. I made what claim? As far as I’m concerned, based on your theory of thinking, your post is spam & trolling since it proves nothing.
Oh, and I should have added that I am under no requirement to show you anything.
A response to the father of a Burzynski patient – Respectful Insolence, SRB did not “slither away from justice again,” but like Orac, he did have good legal advice.
JGC, please cite where I argued that you “should cese (sic) criticizing Burzynski’s clinic and simply wait and see.” Should we assign any blame to NIH which was running a clinical trial re Antineoplaston & didn’t complete the trial but published the results of the incomplete trial?
Chris, why have you not apologized for misstating my argument?
Shay, from what I can tell, alot of this lot doesn’t question the “FACTS.”
Also, Chris, you have failed to say “Please.”
Marc Stephens Is Insane, you’re insane in the membrane because you have no verifiable “FACTS” that I did NOT read both articles.
Narad, you really are clueless, aren’t you? How would I have been able to provide the links if I did not actually access the actual page(s) with the information I linked to? Here’s a hint: you can search “Baldwin of Bewdley” on the internet like I did & see that this is the actual Title of a person. To me, “this one” is research
Marc Stephens Is Insane, did you access the link(s) & information & actually read what it’s about? What’s your motivation for not giving any indication that you’ve read the information available re the last 4 points of the post? What am I trying to prove that’s unproveable? What was Orac’s motivation for writing his comments on:
12/5/11 “[D]espite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy…” &
12/12/11 “Why do his supporters (and, let’s be honest, Dr. Burzynski himself) portray his therapy as “nontoxic” and “not chemotherapy…” &
1/20/12 “…contrary to Dr. Burzynski’s claim that he doesn’t use chemotherapy…”
though my post indicates this is not the case since at least the book 11/1/2006. If SRB indicates one thing in a book, something else in a movie, and something else elsewhere, then people should fact-check it. Maybe some people should post less & fact-check more.
My motivation is that if I am expected to believe that the information on this blog is “FACTUAL,” then the people on this blog shouldn’t take everything Orac posts as “FACT” without fact checking it. Orac should be held to the same standard he is holding SRB to. If Orac wants to be believable then he needs to be less vitrolic & more factual. I can not force anyone to believe anything if they are not open-minded enough to believe. No I do not work for SRB. I am not being paid to post comments. Those are rediculous questions unless you have asked Orac if he works for Big Pharma & is being paid by them to post comments.
AdamG, I didn’t see you raise that issue on that blog, but I did. That’s my point.
Marc Stephens Is Insane, if SRB is indeed making claims that are not backed up by “FACTS,” then his feet need to be held to the fire like anyone else’s.
Kreblozen, it would be interesting to find out what the final result are of the research re the trial that ended up in complete shambles.
Narad, they can’t have it both ways. See my above previous reply to you re NIH. With all the fact-checking of people’s posts it takes time for me to reply because some people are making comments that are questionable when it comes to their “FACTS.” :-O
Lawrence: #1 – question the conflicting information. #2 – Why are you asking me? Find the law or regulation that requires it, contact their Public Relations/Media contacts like Orac has done, and post the results. Everyone on here should have the ability to find information on the internet.
JGC, I have not had time to address this since I’m too busy replying to everyone’s posts.
Chris, see above reply to you. How many people have posed questions to you today compared to me? Thank you for your impatience.
flip, I can see you don’t give a flip. Question conflicting information. It is the responsibility of the consumer to ask questions. That is the advice of the organizations I have posted links to today re cancer.
Am I correct in guessing that Worldwide Medical Consultants, Inc
This other document —
— inclines me to accept that Worldwide Medical Consultants, Inc are separate from Burzynski.
I have no idea whether the Delaware-incorporated Worldwide Medical Consultants is connected to the Florida-based Worldwide Medical Consultants that existed previously to 1998. There is some back-story.
Evidently WMC have convinced Burzynski that they can offer “substantial contacts, knowledge and experience in educating medical and health professionals and the public in the Covered Territories” (i.e. they know whose palms to grease), for the purpose of setting up the chain of Burzynski Clinics catering to the needs of a newly-affluent middle class. There is no doubt some reason why the deal calls for WMC to receive payments for their consultancy from the Cayman Island company and then pay %10 of that into Burzynski’s home account.
And we can ask why there’s been so much research and patents issued re Antineoplastons:
It’s an article of faith within the Burzynski support network that the US Gubblement has been using its dictatorial powers to deny the brave embattled researcher of his patents and of the recognition he deserves, so DJT has done everyone a favour by exposing this story as a load of cobblers.
I strongly recommend the latest Oh No Ross and Carrie podcast on these subjects.
Thank you both. That helps clarify things for me, and put into context the problems of regulation.
Cookie please. Damn this is annoying…
Didymus Judas Thomas:
Simple, you are making a claim, therefore you must provide the evidence. So if you wish to prove that Burzynski is not profited from desperate cancer patients with false hope, you must prove his methods work as well as another treatment that does, Gleevec.
MSII, you should see how annoying it is when your computer flies to the future.
Ugh, curses. There was no preview and I missed closing a tag. Try again:
Again, if you wish to show Burzynski is not a quack, you must prove it.
Actually I did, to both.
Now you must either answer the questions that show Burzynski is legit, or apologize for wasting our time.
Unlike you, when I make a statement I already have the evidence at hand, which I provide for as I make the statement. And as of last night, I answered many questions. Mostly from my daughter on how best to make an outfit she is designing. I also answered why my laptop was acting weird (cookies not being recognized, being told security certificates were expired): after it crashed it reset its time and date to be 2083 and everything was 70 years out of date.
Now, be a good boy and stop whining, just answer our questions.
Shay, from what I can tell, a lot of this lot doesn’t question the “FACTS”
Many of this lot are scientists, researchers and medical professionals, and hey’re doing a fair job of shredding whatever you’ve managed to produce. You’ve demonstrated that you’re doing a quick copy/paste without bothering to check the articles you’re citing to see if they support your claims. I am not a researcher or medical professional, but even I can spot the “throw it at the wall and see if any of it sticks” tactics, just by actually, you know, READING a couple of your links.
But carry on. It’s fun to watch.
No I do not work for SRB. I am not being paid to post comments. Those are rediculous questions unless you have asked Orac if he works for Big Pharma & is being paid by them to post comments.
Ahh, but Burzynski fans ask Orac and other science bloggers that very same question every single day. It’s called the Pharma-shill gambit. I’m glad you are admitting it is “rediculous”.
So why ARE you spending so much time defending Stan?
Do you defend other quacks like Simoncini, Gerson, John of God and Nick Gonzalez too?
Also, the little whiny boy could not even be bothered to read the titles to his cut and pasta links! That has provided more than a few laughs.
@MSII – another Burzynski “patient” story on the same thread:
“I, too, have first-hand experience with Dr. Burzynski’s treatments. In 1996 my mom was diagnosed with two dominant cancers, ovarian and colon. She was given less than a year to live, I was her primary caretaker. My grandparents took my mom to Burzynski’s clinic in Houston after she decided to forego traditional medical treatments. Burzynski’s initially did no accept my mom as a patient but after my grandfather donated $1M dollars to Burzynski’s research program (Google Budwine & Burzynski and you’ll read about the donation and Burzynski introducing my grandfather to the president of Poland as a thank you) mom was quickly accepted into his program. She was hooked up to a 24/7 I.V. drip of the antineosplatons on her first visit as a patient. Lynn is right. The concoction is noxious. It wreaks of animal urine and the syrupy substance will eat through anything. Skin, fabric, wood. Mom lost her hair, her appetite, her memory, her personality, and she shed her skin and nails. Her skin blistered and the itching was enough to leave her begging for mercy in a cool bathtub every night. To honor her parents she persevered. After three months of treatment Burzynski declared her cancer free and mom died approximately one month later. Mom said taking the treatment was the worst decision she’s ever made. Buzynski lost all credibility with me for accepting her when he likely knew there was nothing he could do for her, treating her with such a toxic brew knowing how sick it would make her in vain, and for ever telling my mom she was cancer free. She was riddled with metastatic tumors when she died. In my humble opinion, it is a shame you have written this article without any first hand experience or reviews from patients or patient’s families. I respectfully request your update your article if possible with tales from both sides of the Buzynski story.”
Funny how $1M changed Stans mind.
jergen, and that makes it all more despicable that a whiny little boy, Didymus Judas Thomas, spends so much time trying to defend Burzynski without providing any real evidence.
Didymus Judas Thomas:
“MarkL, why should I try to find the RESULTS?”
Eh? I am puzzled, you claimed that you were not asked for results. You were. Now your answer is “Why should I?”.
Is that how you hope to “win” the debate ? By just being an obnoxious, intellectually and logically challenged halfwit?
You are out of your depth here by ANY reasonable measure, I advise you to get a responsible adult to make your decisions for you in future……. you know, like what to wear, what to eat for breakfast etc.
You are a buffoon.
As I do not care to waste the time of our host with releasing comments from moderation for simple cursing, that’s the way it goes, pillock.
Thanks for the profound schoolmarmishness. There’s nothing to assume. You plainly don’t understand why what you’re coughing up ranges from unimpressive to laughable.
I’m already able to recognize the style of a title in the peerage, you prat. As for accessing the “actual page(s),” no, I don’t think you went and dug up an actual article from, say, Биомедицинская химия (moreover, there’s a punchline if one does go after this one). Perhaps by “actual page(s)” you mean “PubMed entries.” However, in this case, you would have noted, for example, that the entry from Lord Baldwin doesn’t have any content there. It’s a comment on an editorial. It is this, you imbecile. And this you cite in a linksplosion of “research” that is supposed to stun people who have already observed that you can’t even make inferences about content from article titles with your towering mobile-device-based intellect?
Hammer & Jonas? Sure. But it’s not the sort of research that has any bearing on the point that you thought you had made. The fact of the matter is that you were too goddamned stupid to figure out that you embarrassed yourself the first time and therefore tripled down with the same routine.
Puff Didy wrote:
flip, what’s your point? You write that “[p]atients do not pay anything, before, during or after a clinical trial.” Below are some sources which do not agree with you
Of the three links Didy then provides, one makes no reference at all to payments, one mentions the patient may be expected to pay for some incidental costs and routine lab work (but not the entire cost of the trial), and one link says this:
Will you have to pay to participate in a clinical trial?
The clinical trial sponsor (whether it is the U.S. government or a company) pays for the experimental treatment, and most pay for other parts of the treatment process, such as any special testing or extra doctor visits. Some sponsors pay for travel time or travel expenses. For Medicare patients, Medicare covers the costs of procedures that patients would have even if they were not in a clinical trial (routine costs) in all government-sponsored Phase II and Phase III clinical trials. Some health insurance companies also will cover routine costs in clinical trials. You will be responsible for any costs not covered by the clinical trial sponsor or your health insurance company. Therefore, be sure to ask questions about cost before making your decision to take part in a clinical trial, especially to confirm what costs your health insurance company will cover.
Once again Didy provides links that don’t say what he thinks they say.
It’s a comment on an editorial.
I was amused by Earl Baldwin’s turn of phrase in that comment, where he worries about “peer pressure”.
That reminds me:
I glazed over at this pidgin English the first time around, but that’s not a U.S. patent number. One might wonder just how much puffery is involved in the “11 patents” routine that is trotted out but seemingly never documented. Do look those up for everyone’s edification, DJT.
Well, let’s ignore for the time being the idiocy of your still pursuing the tu quoque “you can’t say anything bad about my guru Stanwey until you’ve criticized everyone worse than he is.” Let’s also ignore the idiocy of thinking that fines are automatically proportional to wrongdoing and not being fined is therefore a sign of innocence.
Big Pharma is the term you’re using to refer collectively to, let’s see, how many multinational corporations? At least ten multinational corporations? And you’re seriously suggesting that SRB can’t come in for his fair share of criticism until he does more wrong (as measured by amount fined) than ten-plus multinational corporations?
Tell you what, Diddums: why don’t you go out and find us any one individual who was fined $13 BILLION dollars? If you can’t find one, you have two choices: you can either assert that obviously, no individual on earth can be criticized for wrongdoing because no individual matches the infamy of ten multinational corporations, or you can acknowledge what the rest of us already know, that trying to absolve one individual by comparing them to a plethora of multinational corporations is pretty damn stupid.
Nuh-uh Diddums; you made the claims, you provide the relevant citations instead of copypasta you found somewhere.
Dumb or dishonest? You’re the one who trotted the movie out as some kind of proof. If Burzynski is so hard pressed for cash then he’s got to turn over some autonomy. There are also other sources of venture capitalism that don’t require that though. A little harder to come by and one has to have a solid proposal so I guess that leaves Burzynski out.
He’s making money without approval; he has no intention of getting approval so enough with the boo-hoo poor Burzynski can’t fund regulatory hurdles.
Did you watch the Burzynski movie as I did & note near the end where it showed that it would take $300 Million for the FDA III trial?
Are we to read this as a concession that Burzynski has in fact no intention of conducting a Phase-III trial
herr doktor bimler, read it as whatever you want to read it as, or you can go on the clinical trials site & look up the e-mail & phone # & use one of those resources to contact SRB & ask, or go on one of the SRB sites & look up the Public Relations/Media contact & contact them…
Dude, I am asking you for a clarification of your comment. How in the name of $DEITY is any advice from Burzynski going to help me understand what you meant when you cited the high cost of a Phase-III trial as a justification for not performing one?
Worldwide Medical Consultants, Inc., does not appear to be a Delaware corporation, the SEC form notwithstanding. The New Jersey one was NJ entity 0100732390, but that name has been revoked and they owe $1015.
I can help you there. It (PMID:10069350) only accrued 9 patients because of disagreements between Burzynski and the NCI and only 9 were eligible for the study. Here’s what Vickers had to say (PDF) about this study:
I meant “only 6 were eligible…”
And I can see you like sentences that are too all over the place to make any sense, Gish gallop and preference for assertions over evidence. Oh, and that sentence above also suggests you enjoy strawmen.
Here’s what I said to you last:
If you missed my point, let me spell it out for you. Anyone can get a patent on anything. You don’t need to actually make something in order to get a patent. In fact, many items haven’t been made. Getting a patent only means you had the time, energy and money to fill out a form.
Books aren’t peer-reviewed. Here’s why they are useless as evidence.
Feel free to question conflicting information. But you might want to try raising your standards a little as to what you accept as information. For example, plenty of books and patents exist on blood letting. It doesn’t mean that that old pre-scientific technique worked though. (Most of the patents I saw on the US Patent website were for legitimate blood letting stuff – from what I could tell, things like blood collection, etc. Still my point holds true)
But why do I waste my breath? It’s clear you don’t care about that stuff, you just want us to pat you on the head and say “you’re right”. Shifting the goal posts (float like a butterfly, sting like a bee seems to be an apt way of describing your antics) and making distracting arguments is nice and all, but you still haven’t provided us with any reason why we should accept Burzyinski’s methods work: since he hasn’t even done that himself.
Also, see Marc’s reply to you about the clinical trial payments. The links you supply suggest, at best, that a patient may have to pay some side costs – ie. what you’d pay to see a doctor as part of your illness anyway – but none state that you have to pay for the research costs themselves. In other words, you wouldn’t normally be paying $300k or more for participation. The others are right, you’re not reading what you’re posting links to.
More to the point, if he can afford a multi-million dollar home, he can afford to put it up for sale to pay for a proper trial.
flip, let’s not exaggerate (or post without understanding):
If you missed my point, let me spell it out for you. Anyone can get a patent on anything. You don’t need to actually make something in order to get a patent. In fact, many items haven’t been made. Getting a patent only means you had the time, energy and money to fill out a form.
2nd sentence – semi-true. 3rd sentence – true. 4th sentence – true. 5th sentence – very untrue.
I don’t feel the need to clarify. It’s obvious (for those of us who have patented stuff).
Btw, I don’t feel most of you are able to carry a civilized and respectful discussion without personally insulting your opposition, so please don’t try to involve me in anything. Just couldn’t resist this time after seeing over and over how people try to make their points by using fake arguments..
Please, let’s not sully Ali here. DJT is more along the lines of Reggie Strickland.
$60 million? Whose ass did you pull that number out of?
Politics at casa securivm: http://www.securivm.ca/2012/12/why-are-we-glutton-for-punishment.html
Let me know, on the blog, if it’s inappropriate to post here.
Oh, that a-hole – didn’t he show up in the comments here a while ago?
I think “float like bee, sting like a butterfly” for doesn’t know diddly.
Forgive me, sports is not in my vein of interest. It was the first thing that popped into my mind. DJT’s writing style has a feel of hopping from one foot to another trying not to get caught.
Very confused as to what exactly DJT is trying to prove, since everything he’s posted has been proven incorrect….
Posted on the response to Saunders, but will repeat here:
People should check out the excellent and heavily resourced post on Josephine Jones that recaps a lot of the info about Burzyinski. It’s a bit of an encyclopedia of newspaper articles, blogs, papers, and a historical account of various issues:
Get ready Burzynski “FANS!!!”
Burzynski: Cancer Is Serious Business Part II
Coming Early 2013 (Trailer time: 5:09)
Statement by David Kessler, FDA Commissioner, The White House, C-SPAN, re Antineoplastons.
Statements from SRB, individuals, medical professionals,
FOX 26 News, Dr. Masakazu Sawanobori, Tokyo, Japan.
Book by Sawanobori including information about him:
Thats it DJT?
Your position of last resort is to just to be a blatant troll? I knew you were thick, but I hadn’t guessed quite how thick!
@DJT – so if Dr. B ready to reveal the results of his 30 years of “clinical trials?”
Ah, I see now. DJT is just a promoter for a new ‘movie’.
Nice to see that he’s really not interested in answering my questions.
Shouldn’t the new movie be Cancer is a Lucrative Business? It certainly is for Burzynski and his henchmen.
So, now you’re down to appealing to the authority of a Japanese proponent of intravenous vitamin C quackery? Well done.
Marc Stephens Is Insane, please provide FACTUAL proof to prop up your deluded statement that “I guess Didy didn’t bother to read those information sheets either.”
Chris, what claim am I making? Please cite the claim & date of the post. Why do you mistakenly think it’s my responsibility to “show Burzynski is not a quack?” Please cite where I have indicated that SRB is or isn’t a quack & the date of the post. Why do you mistakenly believe it’s my responsibility to “show Burzynski is legit?” Please cite where I have indicated that SRB is or isn’t legit & the date of the post. Why should I apologize when you have not apologized for misstating my argument 11/28 as pointed out in my 11/28, 11/29 & 12/1/12 posts? I asked you “[h]ow MANY people have posed questions to you” & you were not able to provide a # but just “MANY.” (Emphasis added for ease of reading.) Actually, are you having trouble with numbers, especially the concept of the “one?” One, as in a number between zero & infinity. Now, stop whining, just answer my questions. In my 12/1 post I asked you to “[P]lease point out where I stated that the PubMeds were “results” & cite which law or regulation requires the information you are requesting,” & you did not, though you posted my question to you; one right after the other, in 2 of your 12/1/12 posts.
Narad, good question. Who are you?
Shay, please cite any post(s) & their dates which “shredded whatever” I’ve “managed to produce” where I have not responded to their alleged “FACTS.” Please cite any post(s) & their dates which support your allegation that I’ve “demonstrated that” I’m “doing a quick copy/paste without bothering to check the articles” I’m “citing to see if they support” my “claims.” Maybe you’d like to take a crack at my above post to Chris where I point out that my question has still not been answered, just by actually, you know, READING.”
Marc Stephens Is Insane. please cite any post(s) & their date which support your misguided allegation that I am “spending so much time defending Stan.” And No, I am not defending quacks.
Chris, please cite any post(s) & their date which support your misguided attempt at trying to prove that I “could not even be bothered to read the titles to” my “cut and pasta links!” Exactly what are “PASTA links?” 😐
jergen, another Burzynski “patient” story:
Chris, and that makes it all more despicable that you misguidedly claim that I spend “so much time trying to defend Burzynski without providing any real evidence.”
MarkL, please cite any post(s) & their dates that buttress your misguided belief that I “claimed that” I was “not asked for results.” At least I am an Adult who does not need to stoop down to your level of adolescent name-calling.
Narad, how old are you? 9? Because that’s what your choice of coarse language suggests. And if you are “already able to recognize the style of a title in the peerage,” why did you write on 11/30/12 that “Baldwin of Bewdley” as author should really be a flag,” but not state why it should be a flag? Way to ASSUME that i somehow attempted anything “that is supposed to stun people.” Since you obviously have the miraculous power to read my mind, what is the “point that” I” thought “I” had made”?
Marc Stephens Is Insane, you quote my post:
“flip, what’s your point? You write that:
“[p]atients do not pay anything, before, during or after a clinical trial.”
Below are some sources which do not agree with you.”
1. You write that: “one makes no reference at all to payments,” yet the 1st link states: Questions to Ask: Anyone interested in participating in a clinical study should … feel comfortable asking the research team questions about … any expenses.
2. The 2nd link: Paying for Clinical Trials: As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of care. Even if you have health insurance, your plan may not cover all costs related to receiving treatment in a clinical trial. There are 2 types of costs associated with a clinical trial: patient care costs & research costs. Patient care costs are those costs related to treating your cancer. These costs are often covered by health insurance. They include: Doctor visits,
Hospital stays, Lab tests, X-rays & other imaging tests. Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Examples include: The study drug, Lab tests performed purely for research purposes, Additional x-rays & imaging tests performed solely for the trial. When you take part in a trial, you may have extra doctor visits that you would not have with standard treatment. These extra visits can add costs for transportation & child care.
3. The 3rd link:”Who is responsible for the costs of the clinical trial (tests, doctor’s visits, etc.). Who is responsible for the costs if a patient needs additional care as a result of the clinical trial. The trial sponsor may pay for some of your medical care or tests. Be sure to ask your doctor or the research nurse about who is responsible for these costs before agreeing to participate. Your medical care may be more expensive. Your health insurance company may not pay for your clinical trial care or tests. Be sure to ask your doctor or the research nurse about who is responsible for these costs before agreeing to participate. Where you live may require more money for travel. You will be responsible for any costs not covered by the clinical trial sponsor or your health insurance company. Be sure to ask questions about cost before making your decision to take part in a clinical trial, especially to confirm what costs your health insurance company will cover. Would I be responsible for additional costs of tests or travel?
Once again Marc Stephens Is Insane misrepresents links that don’t say what he thinks they say.
When was the last time that a nine-year-old called you a prat, Fanny? Have some salad creme and relax.
Well, I was mocking you on the grounds of general ignorance, so I don’t know that I’m really responsible for providing an exercise key.
Oh, look, it’s the magic teaching puzzle again.
Precisely that which you stated at the outset of your humiliating and comically inept self-immolation: that these offererings represented support for the assertion that “there’s been so much research.”
Didymus Judas Thomas, you are pathetic. As a acolyte of Burzynski you are adept at using the Gish Gallop, but completely unable to find one paper that shows his methods are as effective as Gleevec for the treatment of any cancer. It is truly sad that you spend so much time defending a fraud without any evidence.
I think enough is enough .
Diddums clearly has no intention of answering any of the questions put to him, and is more intent on frustrating the debate than in joining it.
Time to move on, remembering this sage advice:
“Please do not feed the Troll”
Do you understand the meaning of the word ‘prove’ or ‘evidence’? You’re like those people who insist it’s up to everyone else to disprove god.
Your word salad Gish gallop is almost incomprehensible. Can you perhaps slow down and take small bites?
The rest of your comment about who pays for what in a trial either shows you can’t/won’t read, or you have trouble understanding English. Is it not your native language?
In none of the above have you even come close to proving that Burzyinski has published evidence, that you have provided it, or that we should stop asking for it for any reason.
@flip – I was going to say incomprehensible, because I have no idea what he’s trying to say…
The reason why Earl Baldwin of Bewdley is a red flag when discussing alternative medicine is that the same reason Kent Hovind would be a red flag if we were discussing evolution: Baldwin is a known and prominent promoter of woo, who as a member of House of Lords Science and Technology Sub-Group for Alternative and Complementary Medicine wrote a report in support of homeopathy.
I think he’s trying to say that he’s neutral, and that we should supply proof that he isn’t. Or something. ‘Almost’ incomprehensible is probably an understatement.
I’m willing to believe that perhaps he’s just misunderstanding what he’s reading, due to language barriers. (There’s a huge difference to his style as compared to Marg or Judtih)
Narad, www . radaris . com/p/Dvorit/Samid
Antaeus Feldspar, if you don’t watch out you’ll have a brain aneurysm trying to prove that False Positive! 😮
Please cite the post(s) & their date which you misguidededly think exists, proving that my guru is Stanwey. I’m seriously suggesting that you & others are expending more energy on SRB than on executives from GlaxoSmithKline; which was fined the biggest drug co fine to date of $3 BILLION, yet no executives were fined.
“What we’re learning is that money doesn’t deter corporate malfeasance,” said Eliot Spitzer, who, as New York’s attorney general, sued GlaxoSmithKline in 2004 over similar accusations. “The only thing that will work in my view is C.E.O.’s and officials being forced to resign and individual culpability being enforced.”
Others have said that to institute real change, executives must be prosecuted criminally or barred from participating in the Medicare & Medicaid programs, an action known as “exclusion.”
This has occurred in only a handful of cases, and rarely in a case involving a major pharmaceutical company. In 2011, 4 executives were sentenced to less than a year in prison for conducting clinical trials that were not authorized by the FDA.
That same year, the former chief executive of a drug co was sentenced to 30 days in jail & fined $1 million for selling misbranded drugs.The previous year, HHS excluded him from doing business with the federal government.
www . nytimes . com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all
Yet Glaxo earned $27.9 BILLION on 3 drugs during the time-period covered.
New York Attorney General Eliot Spitzer sued GSK in 2004; which earned $3 BILLION in 2003 on the drug in question, alleging they misled doctors by concealing it’s adverse effects & released only 1 out of at least 5 studies on the drug:
www . ecommercetimes . com/story/36159.html
That an internal memo said that in light of the poor study results, the company’s “target” was to “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact”. It says that the company also gave its salespeople a memo stating that the drug “demonstrates remarkable efficacy and safety…” Attached to the memo, the suit says, was the 1 published study that showed some positive results:
www . nature . com/drugdisc/news/articles/429589a.html
Estimated that the drug was prescribed to 2.1 million people & earned $55 million that year:
www . ag . ny . gov/sites/default/files/pdfs/bureaus/health_care/newsletters/hcnews_junjul04.pdf.
“Because so much drug company data submitted is considered proprietary, it is up to the F.D.A. to decide when to disclose possible safety concerns.”
www . nytimes . com/2004/06/03/business/spitzer-sues-a-drug-maker-saying-it-hid-negative-data.html?pagewanted=all&src=pm
Former New York Governor Eliot Spitzer, who’d sued GlaxoSmithKline previously while serving as New York’s attorney general – argued that seeking monetary damages isn’t going to change most problematic practices of the pharmaceutical industry. Instead, they say, we should seek criminal charges against specific executives, the risk of jail time being the only way to actually change behavior. In the last 3 decades, the FDA has become increasingly dependent for its continued functioning upon user fees paid by the very drug makers it’s meant to regulate.
www . ideas . time . com/2012/07/06/glaxo-fine-what-will-stop-big-pharma-fraud
Science Mom, so you still refuse to cite which post(s) & their date applies to this “claim” you keep referring to but for some reason can’t cite. See my above post re Part II of the Burzynski movie.
Maybe NIH should fund it because of this:
Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
Authors: Burzynski SR, Janicki TJ, Weaver RA, Burzynski B.
Journal Integr Cancer Ther. 2006 Mar;5(1):40-7.
Affiliation: Department of Internal Medicine, Burzynski Clinic, Houston, Texas 77055, USA. [email protected]
Abstract: BACKGROUND: Brainstem glioma carries the worst prognosis of all malignancies of the brain. Most patients with brainstem glioma fail standard radiation therapy and chemotherapy and do not survive longer than 2 years. Treatment is even more challenging when an inoperable tumor is of high-grade pathology (HBSG). The objective of this report is to summarize the outcome of patients with HBSG treated with antineoplastons in 4 phase 2 trials. Patients: The following group of 18 patients was evaluable: 4 patients with glioblastomas and 14 patients with anaplastic HBSG. Fourteen patients had diffuse intrinsic tumors. Twelve patients suffered from recurrence, and 6 patients did not have radiation therapy or chemotherapy.
METHODS: Antineoplastons, which consist of antineoplaston A10 (A10I) and AS2-1 injections, were given in escalating doses by intravenous injections. The median duration of antineoplaston administration was 5 months, and the average dosage of A10I was 9.22 g/kg/d and of AS2-1 was 0.31 g/kg/d. Responses were assessed by gadolinium-enhanced magnetic resonance imaging and positron emission tomography.
RESULTS: The overall survival at 2 and 5 years was 39% and 22%, respectively, and maximum survival was more than 17 years for a patient with anaplastic astrocytoma and more than 5 years for a patient with glioblastoma. Progression-free survival at 6 months was 39%. Complete response was achieved in 11%, partial response in 11%, stable disease in 39%, and progressive disease in 39% of patients. Antineoplastons were tolerated very well with 1 case of grade 4 toxicity (reversible anemia).
CONCLUSION: Antineoplastons contributed to more than a 5-year survival in recurrent diffuse intrinsic glioblastomas and anaplastic astrocytomas of the brainstem in a small group of patients.
PMID 16484713 [PubMed – indexed for MEDLINE]
Full text: HighWire Press. Related Citations (304)
www . ncbi . nlm . nih . gov/m/pubmed/16484713
Y’all are the ones whining about reports not being published, yet you cite no law or regulation that requires the publishing.
http: // highwire . stanford . edu/cgi/searchresults?RESULTFORMAT=1&hits=150&sortspec=match&sendit=Update+display&tyear=2013&resourcetype=1&tmonth=Dec&fulltext=Antineoplastons&andorexacttitleabs=and&src=ml&author1=Burzynski&fmonth=Jan&y=0&fyear=1753&x=0&fdatedef=1+January+1753&andorexacttitle=and&searchsubmit=redo&andorexactfulltext=and&tdatedef=3+Dec+2012
herr doktor bimler, refer to my above post re Part II of the Burzynski movie.
Dude, only SRB knows if he has the $.
flip, you “talk” a lot but I guess you don’t know how to do a search on the Internet, but then again, it was the strawman in the Wizard of Oz that didn’t have a brain.
I’m not the one who made the over-broad generalization that: “Patients do not pay anything, before, during or after a clinical trial.” That was flippant.
Narad, and I guess you’re more along the lines of George Bush … pick 1.
W. Kevin Vicklund, look behind you.
www . thenhf . com/article.php?id=3326
www . healthlifee . com/disease/cancer/12754-the-many-trials-of-dr-burzynski.html
https: // docs.google.com/viewer?a=v&q=cache:ElTW2l484TUJ:www.clintonlibrary.gov/assets/storage/Research%2520-%2520Digital%2520Library/jennings-hsa/Box%2520038/647904-correspondence-buryznski-stanislaw-2.pdf+&hl=en&gl=us&pid=bl&srcid=ADGEESgTZjL8ZaHuyFVVZ0jgSthZTEd8IBSj7m6E5EMiBgMAUm_HuXZAcTRaEKxJRaspiDlO_AOwyTAe4aNl162ddc5prFMX69WVZrUQGDICVkfKRmYzm2JZElyyYWeh07F6ejJ4Rc2j&sig=AHIEtbS2iobO2tOSfDKA6P9-zBxSvBnaSw
https: // docs.google.com/viewer?a=v&q=cache:Q5CJZ7wMlm8J:dash.harvard.edu/bitstream/handle/1/9453691/mstennes.pdf%3Fsequence%3D1+&hl=en&gl=us&pid=bl&srcid=ADGEESgpwuCsrSXG4QtI80dh0bj5gapqSiOCt–5MZHN1yPkemicxoBErvoU4OS9_rjKlHo7KR7afzi_YKNmo-0nyWUR7kOYuv8nNR7jy1s3MKTlBdeDCxBqURMWNOCvcB2JxOlowbaG&sig=AHIEtbQ-32lniQlIAduG2ZMSTX1gbT-Qgg
https: // docs.google.com/viewer?a=v&q=cache:gU3fCI4uOhoJ:www.clintonlibrary.gov/assets/storage/Research%2520-%2520Digital%2520Library/jennings-hsa/Box%2520038/647904-correspondence-buryznski-stanislaw-1.pdf+&hl=en&gl=us&pid=bl&srcid=ADGEESg507sz38woNzSvUboFoihXr6CgDyiY6p66MlI25LflJhDbA3QtD9YQrRfF495cxXLGlxNwiAYKKTgMZ5GS92TRs5iVU8WnRKh5FmM2HDcuLOTYwuW5Y7Sbd5YKqMEH1FL45fxT&sig=AHIEtbRe80fGTp17jpbBUtVjafDB-3O0MA
Lawrence, please enlighten me on how my 2 11/28 posts
were proven incorrect, for example.
MarkL, let me guess, you suffer from insecurity? You perhaps posit that people are not interested in the Trailer or anything else which might answer some of the questions they have posted on this blog.
Lawrence, did you view the trailer?
flip, I think we know who’s getting more questions from other posters on here, and it’s not you!
Narad, I haven’t been to Limey Blimey Pea Soup Country. Have some tater salad & relax. And I am mocking you on the grounds of feigned ignorance. You should learn how to use that “matching teaching puzzle.” Have you ever solved a Rubix Cube? Research like those in the above last link to Science Mom?
Chris, you are more pathetic because of your “stick-my-head-in-the-sand” ostrich-like standing that you are so physically & mentally inept that you keep positing theory along the lines that ignorance of the law is an excuse.
Yes, and I can even spell it correctly. It’s trivial if one can remember so much as two transformations in the group.
Um, one cannot legitimately arrive at this conclusion, given the “design.” Did you get this from Moss again? Do you understand why ICT is not exactly an impressive source?
You still don’t understand what the tu quoque fallacy is, or what a controlled clinical trial is, apparently. You swamp this blog with references to articles about Burzynski, none of which are good evidence of anything, and then claim you are not supporting him. What was the point of posting all those links? If you are trying to destroy any small amount of remaining credibility you have left, don’t bother, you lost it all some time ago.
By the way, many of Burzynski’s longest surviving patients had conventional treatment. You linked to a story about Laura Jo Hofsess who had Tarceva, Herceptin and radiotherapy as well as antineoplastons. As MSII mentioned, sadly she didn’t survive. We don’t know what contribution to survival any of Burzynski’s treatments have made because he has never published (or carried out as far as I can see) any controlled studies.
DJT is a true blue Burzynski fanboy who has graduated into a full troll. Time to ignore him.
Sorry, can’t keep track of your incoherent word salads. Don’t know what I’m refusing to do.
Bwahahaha!!! Sure the NIH is going to fund crap based upon personal testimonies. It’s bad enough they fund homeopathy Tell your mate Burzynski to apply for an NCCAM grant, he’d have better luck since they fund quackery. Or ya know, he could actually publish the results of his decades-long “clinical trials”.
Not at all Diddums, I just think it pointless to argue with a Burzynski fanboy who ignores any request for even the smallest sliver of evidence that the object of his perverse support is anything other than a con man, yet continues to post advertorials and puff pieces from dubious sources as “proof” that the maverick doctor deserves other than ridicule and condemnation.
Everything you have posted in this thread adds up to a big fat zero, you have achieved nothing other than to make yourself look ridiculous.
Falsely claiming that I was the person who claimed that Burzynski cost taxpayers $60 million in lawsuit(s) is not getting off to a good start. Or are you admitting to assault?
Written in 2012, no source other than Burzynski, author not involved in the trial in any capacity. Not a reliable source.
Written in 2010, no source other than “documentary” paid for by Burzynski, author not involved in the trial in any capacity. Not a reliable source.
Proof that you are serving up plenty of copy-pasta rather than something you read: none of these three sources make a claim that the trial(s) cost taxpayers $60 million. Also, these documents are available direct, without having to resort to a Google docs archive.
Care to try again? Whose ass are you reaching into?
I love the sources Didy provided written by Dr. Julian Whittaker, a very special kind of quack who has been discussed here by Orac (and debated with Orac!) in depth.
A master of the graph.
He’s in Burzynski’s back pocket because of that anti-aging project they’ve been working on and he is the only doctor who will speak out in support of Burzynski (not counting the two anonymous doctors in the new movie trailer). What else do you expect? They’re partners.
By the way, I strongly suspect the Asian Burzunski clinics he’s looking to open will heavily promote the anti-aging angle of his business. Just a hunch.
And he’s also a scientology doctor who endorses their lethal Narconon program.
Hey guys and gals, sometime I just love that you are able to quote relevant quotes from Didysquat’s post because I have a really, really hard time reading his post.
@ Didysquat, would you please ventilate your post, I understand absolutely nothing of what you write.
Sorry, I put an extra “t” in Whitaker’s name.
Here’s part of his entry on Wikipedia (I know, I know, but the sources are good…):
Whitaker opposes the use of pharmaceuticals in the treatment of mental illness and believes that psychiatry is fraudulent. In a CNN interview with Anderson Cooper, Whitaker states that psychiatric diagnoses have “no basis” and are fabricated or voted into existence by powerful groups of doctors with financial interests. The combination of medication and talk therapy endorsed by psychiatry is a “script”, says Whitaker, who claims in the interview that his golden retriever can provide talk therapy just as well as a psychiatrist. According to Whitaker, vitamins, such as those promoted on his website, can cure psychiatric disorders by improving general health.
Whitaker has been a controversial figure, and has been criticized for his self-promotional approach to medicine, potential conflicts of interest, and his embrace of scientifically unsound practices.
The National Council Against Health Fraud (NCAHF) criticises Whitaker for promoting himself as “America’s #1 health advocate,” “America’s #1 health champion,” and “the physician America trusts.” According to the NCAHF, Whitaker advocates potentially dangerous therapies involving growth hormones, chelation and megavitamins, and intervenes on behalf of other “maverick” doctors in legal trouble.
The Los Angeles Times notes that Whitaker serves as a consultant to vitamin companies advertised on his website, a practice criticised by other doctors who prefer to promote only evidence-based products. In the article, Whitaker is classified as a doctor “mixing celebrity and cyberspace”.
Whitaker claims to be a leading expert in “anti-aging medicine.
You’re not the only one. DJT seems to really not grasp the concept of “context.” It’s like the whole thing has to be reconstructed from scratch, including what’s taken from elsewehere with no indication, with every word-blob.
Furthermore, does he think we’re not aware of all the puff pieces, vanity articles, insignificant studies published in non-credible journals, etc.? Or support editorials by other quacks? Several of those pieces have provided fodder for Orac and other science bloggers in recent times, to be explained, debunked or ridiculed.
I’m suprised he hasn’t posted the Dr. Oz/Eric Merola TV interview yet.
@ Marc Stephens Is Insane:
Whitaker, like Gary Null, claims special knowledge in the arcane ‘science’ of anti-aging medicine which includes such as ideas as:
you live much longer if you severely restrict calories**,
guzzle gallons of green juices.
take handfuls of supplements,
eat mostly raw for ‘enzymes’, cook at 116 degrees F or less,
use organic and unprocessed foods, sans additives,
avoid acidic foods ( Young),
exercise every day and maintain an extremely low weight and BMI.
They also scoff about environmental pollution, radiation*** and EMFand about a THOUSAND OTHER THINGS.
I think you get the general idea that they believe that aging comes from external sources; damaged DNA can be repaired with the right nutrition etc.
I guess there’s nothing natural about aging- at least in their fevered imaginations.
** works in rats, so why not in woo-meisters?
*** but not the sun.
Whitaker is “board certified” in anti-aging, except there’s no such thing.
From a Houston Times story on Burzynski back in 2008. I posted this on the other Burzynski thread a few days ago:
Which leads to one of the most troubling aspects of the Burzynski saga: Why have no credible oncologists stood up for him? Why don’t oncologists regularly refer their patients to his clinic? Why aren’t the greatest minds in medicine calling for the swift approval of antineoplastons?
If they are out there, the Press needs to hear from them. Burzynski obliges as best he can, throwing out the name of perhaps his biggest ally in medicine (using that term loosely). That is Julian Whitaker, an alternative medicine practitioner who claims to be “board-certified in antiaging medicine.” That could be true — it’s just a question of which board he’s talking about. One thing is for sure: It’s not the American Board of Medical Specialties, which is what most doctors are talking about when they say “board-certified.” The ABMS does not recognize “anti-aging” as a medical specialty. When asked for the names of supporting doctors who don’t have Web sites featuring “Rollback Savings!” on their lines of nutritional supplements, Burzynski eventually comes up with Bruce Cohen, a brain tumor specialist at the Cleveland Clinic. Cohen did not return calls.
By the way, someone named “Leah” posted a comment triumphing the Burzynski dismissal and championing other brave mavericks like Budwig. The comment seems to have been lost in the shuffle as there are no replies, and it’s a few comments up from the end, so I thought I’d bring it to your attention in case anyone feels like doling out some respectful insolence.
Darn, I really am losing my mind in my old age. The “Leah” comment is on the “response to a Burzynski father” thread. It looks to be copy-pasted from some Stan fan site. It’s really quite amusing.
I will only bother in reposting what Krebiozen said:
and Science Mom and I are in agreement:
I have no idea what you were trying to say to me.
@Marc Stephens is Insane,
I was amused that “Leah” prominently mentioned Wilhelm Reich, a very good candidate for the most notorious crazy crank of the twentieth century. Still, it’s hard to deny that Reich’s story still gives a certain charm, which I find completely lacking in Dr. B.
David N. Brown
It seems her entire post, lock stock and barrel was lifted right off a Burzynski site, or Facebook posting.
I have to agree wholeheartedly with Leah’s post. Burzynski definitely belongs in the same category as Gerson, Rife, Hoxsey and Budwig. Just not the way she means.
Leah’s post actually made me aware of some other quacks I’d never heard of, and have been merrily Googling them too. Some serious fruitcakes and nutbars in that list. I love the people who believe shining coloured lights on different parts of your body can heal.
From Leah’s post:
The bottom line is this; if it’s owned or patented by a private individual, or can’t be patented at all, and can be used to cure cancer especially, you are not going to be allowed to practice your craft or use the technique or substance as a treatment and especially call it a “cure,” as long as the medical establishment can help it, thus far at all costs.
But it seems as if the medical establishment has so far been unable to stop Burzynski from “practicing his craft” so the entire paragraph is meaningless.
And I had no idea it was Reich behind the whole orgone thing. I thought that was more modern nuttery, from the whale.to era, like chemtrails.
I came across this earlier tonight: the blog of another Burzynski patient who died this past summer, six-year-old Supatra Adler. There’s a chart of all the treatments the parents were forcing this little girl to undergo beside the antineoplastons. They had her on Thai herbal medicine, mushroom extract from Taiwan, grapeseed extract, algae (to “detox” from radiation), several large glasses of juice a day (Gerson?), AND a Budwig diet. They complain that the little girl didn’t take to the cottage cheese and flax seed: what six-year-old eats that?
Take a look at this chart:
@Marc Stephens Is Insane,
Reich and orgone are well-covered by historians of science. To my recollection, one of the first places I read about him would have been the “Big Book of” comic/ encyclopedia series. He was also covered in Martin Gardner’s “Fads and Fallacies”. As I indicated, many accounts almost put him in a sympathetic light. I think it’s especially telling that for better or worse, Reich really did live up to the image of the independent, non-conformist “maverick”. With Burzynski, on the other hand, it looks increasingly like he doesn’t (and maybe CAN’T) do much of anything without the approval of his lawyers and PR men. It’s as if big business has strip mined the romance even out of the crazies and charlatans.
David N. Brown
I will always have a soft spot for Reich, for inspiring Trevor Constable to become one of the great lunatics of our time.
Reich undoubtedly started off sane, as a student of Freud with some valuable (IMHO) ideas about sexual repression, and undoubtedly ended up totally bonkers, believing he could zap invading alien spaceships with his cloudbusters. It’s hard to say just where in his career he completely lost the plot. There are some interesting parallels between Reich and Rife BTW, both believing they had discovered a cancer bacillus, for example. Reich is yet another example of an expert wandering out of his area of expertise and into trouble.
flip, I knew in your rigorous search for the truth that you would want to know any new information on SRB that comes to light. 🙂
$1.58 BILLION: Drug co’s & healthcare marketeers projected to spend on online advertising in 2012:
www . pharmalot . com/2012/06/pharma-will-spend-how-much-advertising-online
19 times more: Amount drug co’s spend on self-promotion compared to basic research.
$200 BILLION: Amount drug co revenues rose between 1995-2010
www . huffingtonpost . com/mobileweb/2012/08/09/pharmaceutical-companies-marketing_n_1760380.html
$6+ BILLION: Amount of revenue earned by top 5 drugs 3rd Quarter 2012:
www . fiercepharma . com/press-releases/drugscom-releases-q3-sales-top-100-us-drugs-singulair-drops-nexium-and-abil
$307+ BILLION: Amount spent on prescription drugs in USA 2010
http:// mobile . pharmacytimes . com/publications/issue/2011/May2011/Top-200-Drugs-of-2010
Marc Stephens Is Insane, yep, unfortunately people die.
Narad, I expected no less from you. Bring up Vitamin C & ignore his other research, publications, and education. Well done!
Chris, you are apathetic. Like a misguided chicken little dissumulator. It is truly sad that you spend so much time trying to prove a False Positive by claiming that I am defending a fraud without any evidence, because you’re unable to cite said evidence, because it doesn’t exist!
MarkL, who famously has no FACTS to support his position: “MarkL, please cite any post(s) & their dates that buttress your misguided belief that I “claimed that” I was “not asked for results.” At least I am an Adult who does not need to stoop down to your level of adolescent name-calling.”
Or do you clearly have no intention of answering any of the questions put to you, and are more intent on frustrating the debate than in joining it”?
Please do not feed MarkL “London Broil.”
flip, do you understand the meaning of False Positive? Can you prove the devil? Do you have a Gish Gallop Poll (or Pole) where you live? Do you have trouble understanding American English? Is it not your American native language? Have you ever opened Black’s Law Dictionary? It’s not my responsibility to “even come close to proving that Burzyinski has published evidence.” You as a Human Being; if you are indeed one instead of a Bot or Pet Rock, should be inquisitive enough to research things yourself instead of asking people to spoon feed it to you. Is the above post which has at its end, the HighWire Stanford University edu site, the “Research” you want?
Lawrence, read between the lines.
JGC, OH MY Goodness! Homeopathy!! Why that must be like sacrilegious!!! It reminds me of the story of the FDA vs. John S. Najarian:
http:// dash . harvard . edu/bitstream/handle/1/9453691/mstennes.pdf?sequence=1
www . ncbi . nlm. nih . gov/m/pubmed/7575112
www . mndaily . com/1996/02/22/najarian-acquitted-all-counts
http:// minnesota . publicradio . org/display/web/2006/02/28/uofmhospital
www . surg . umn . edu/Faculty_Alpha/najarian_john_s/home.html
www . surg . umn . edu/Faculty_Alpha/najarian_john_s/najarian_cv/home.html
flip, i see the idea lightbulb appeared above your head! Yes, I am saying I’m neutral as indicated in my 12/1 post.
Ever heard of the American Language?
Narad, do you need glasses? I’m concerned about your eyesight. Have you considered LASIK? Did you see the NCBI NLM NIH gov site link? I didn’t get this from Randy Moss. People can whine about ITC all they want.
Krebiozen, I really don’t give a “flip” about tu quoque. Do you know what law & regulations are? Black’s Law Dictionary? How to file a lawsuit? So your fallacy is that to neutrally post things so people can draw their own conclusions about the credibility of the information … oh wait! I think this is one of the reasons that the American Revolution against the British happened! Here’s my suggestion. Take your issues to the FDA.
Chris is a true blue Gleevec fanatic. Side Effects Associated With GLEEVEC: Some of these side effects may be minor, others could be very serious. Severity of some side effects may be reduced with the help of other medicines, others may require stopping therapy for a while or changing the dose. In some cases, therapy may need to be discontinued. Serious side effects: Severe fluid retention (holding water) & swelling, Cytopenias (reduction of certain elements in blood circulation), Severe congestive heart failure (impaired ability of the heart to pump blood) & left ventricular dysfunction (impaired functioning of the left side of the heart), Severe liver problems (hepatotoxicity), Hemorrhage (abnormal bleeding), GI perforation (holes in the stomach or intestine), Hypereosinophilic (a condition with increased eosinophils, which are a type of white blood cell) heart disease, Skin reactions (such as fluid-filled blisters), Hypothyroidism (reduction in thyroid hormones), Potential toxicities from long-term use, specifically liver, kidney, and/or heart toxicities, Potential harm to an unborn child, Growth retardation (slowing of growth), Tumor lysis syndrome (electrolyte disturbance), Dizziness, blurred vision, & somnolence. Common side effects: Almost all patients experience side effects at some time. Most side effects are mild to moderate in severity. Some common side effects that you may experience include: Fluid retention (holding water), Muscle cramps, pain, or bone pain, Abdominal pain, Anorexia (loss of appetite), Vomiting, Diarrhea, Decreased hemoglobin (decrease in blood cells which carry oxygen), Hemorrhage (abnormal bleeding), Nausea, Fatigue, Rash. It is especially important to tell your doctor about any fever, shortness of breath, blood in your stools, jaundice (yellowing of the skin and/or eyes), sudden weight gain, symptoms of heart failure, or if you have a history of heart disease or risk factors for heart disease.
www . gleevec . com/patient/kit-gist/gleevec-therapy/side-effects.jsp?usertrack.filter_applied=true&NovaId=4029462064338618122
Sounds like fun!
Science Mom, you disappoint me greatly, but I guess there is a lot of science involved in using the “Search” function for this blog. So … you made the claim but can’t remember your claim. But this’s the same NIH which funded him 1974-1976! 😮
http:// books . google . com/books?id=ImIJAAAAIAAJ&q=Burzynski&dq=Burzynski&lr=&as_drrb_is=q&as_minm_is=0&as_miny_is=&as_maxm_is=0&as_maxy_is=&num=100&as_brr=0&output=html_text&cd=52
MUAH !! (Multiple Unsuccessful Attempts at Humor) Please cite any “FACTS” that substantiate your hallucinatory fantasy that Burzynski is my mate. NCCAM funds Ducks? The “clinical trials” in the above post to Science Mom where I provide a link for HighWire Stanford edu?
MarkL, I just think it pointless to argue with a LIAR who has no reply for “MarkL, please cite any post(s) & their dates that buttress your misguided belief that I “claimed that” I was “not asked for results.” At least I am an Adult who does not need to stoop down to your level of adolescent name-calling.” You LIE when you write that I am “a Burzynski fanboy” as you have not onw iota of evidence in support of that: because i dont live in the same State as him, have never met him, have never communicated with him, don’t personally know anyone who has met him, and have never received anything from him. Who LIES when he writes that I am one “who ignores any request for even the smallest sliver of evidence that the object of his perverse support is anything other than a con man” since you don’t have a scintilla of evidence that I support SRB or in the least exhibit perverse support for him or “yet continues to post advertorials and puff pieces” which is another LIE as I was the one who pointed out on 11/30/12 the Internet search on “Antineoplastons” “a form of chemotherapy” displays a google 2006 books link re “Get Healthy Now” (pg. 575) where SRB indicates that Antineoplastons are a form of chemotherapy…’ & pointed out “Orac writes: “[D]espite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy…” and you LIE when you post that my information is “from dubious sources as “proof” that the maverick doctor deserves other than ridicule and condemnation.” You cite not 1 dubious source & you also conveniently do not point out that I’m the one who pointed out on 11/30/12 the National Cancer Institute at the National Institutes of Health & American Caner Society had information re Antineoplatons & SRB, thusly proving the last sentence of your post to also be a LIE.
W. Kevin Vicklund, you’re the one who asked: “Whose ass did you pull that number out of?” Didn’t you feel it come out of you right after you realized what a stupid question that was to posit in that manner? So you blithely ignore the author of the article & write her off as: “Not a reliable source.” However, you write “no source other than Burzynski” as if you were in the room with writer of the article, and state no FACTS to support your claim. You also write “author not involved in the trial in any capacity.” However, this proves nothing as the information could have been obtained from Attorney Rick Jaffe or through a Fredom of Information Act (FOIA) request or by other means. Would you care to try & pull a rabbit out of a hat?
Marc Stephens Is Insane, are you a curmudgeon? Because there is a Search function on the blog which allows you to search for “Whitaker,” and come up with nothing. Please cite the post(s) & date which contain Whitaker as the source.
Alain, I think there are quite a few “characters” trying to “ventilate” my posts without much success.
Narad, if you can’t remember what you wrote that I’m replying to, then maybe you’re just writing superfluous material.
flip, why am I not surprised you need someone else to reply for you? Don’t worry, people who have a lollipop as their picture generally have no idea what someone is trying to say to them.
FWIW I was wondering about those two, even to the extent of taking screen caps and zooming in on their name badges. The first one seems to be called “Ali B” something, and is a hematologist/oncologist. The second one is Dr. Eric Carlson MD who is described as the head of Oncology at the University of Tennessee Medical Center on multiple websites (10,500 host the identical story, to be precise) but is in fact part of the oral and maxillofacial surgical team there. He is also “Chief, Oral and Maxillofacial Surgery, University of Tennessee Memorial Hospital and University of Tennessee Cancer Institute” and “Professor and Chairman, Director of Residency Program, Department of Oral and Maxillofacial Surgery, University of Tennessee Graduate School of Medicine”.
Dr. Carlson was, according to the aforementioned multiple websites, treating Betty Whyte for Merkle [sic] cell cancer before she was treated by Burzynski though he refers, confusingly, to “Mrs Wright” in the clip. I think she may be one of the patients seen in the clip (2:37). I can’t find any more information about her case anywhere, and I can’t even be sure that this is the patient Dr. Carlson is discussing.
DJT< regarding Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma.
This paperdoes not give results from a double-blind, randomised clinical trial. Instead it includes subjects from four different trials, without stating what trials they were part of. Burzynski has cherry picked subjects from separate trials to make a false case for antineoplastin efficacy.
Note that subject numbers, even across four trials, is low (18 patients)
Further teh subjects aren’t matched with respect to cancer stage, etc.: while the paper states that 14 patients had diffuse intrinsic tumors it does not state what the remaining four patients had.
Even with the cherry picked best cases antineoplastons were at best marginally effective–12 of 18 patients suffered recurrence.
The paper states 12 patients had radiation therapy or chemotherapy simultaneously or prior to receiving antineoplastons but does not match outcomes to treatment, so there’s no way to tell if the marginal success he’s claiming for his tehrapy can be attributed to to antineoplastins or to standard chemo/radiation.
In short, this paper is a massive fail as far as providing evidence antioneoplastions effectively treat paper. I know that Journal Integr Cancer Ther is a low impact journal, but I’m still surprised they’d accept an submission this flawed for publication.
In answer to your pathetic evasion:
Diddums, you said:
“herr doktor bimler, where does Chris’ post state “clinical results?” It states “clinical.” As far as I’m concerned that left it up to my discretion as to what to choose to post.”
Lets look at what Chris said:
“Tell me the title, date and journal of the PubMed indexed paper where the RESULTS of those clinical are published. Then tell us why the one Phase 3 clinical trial is not allowing participants.”
To make it easy I have capitalized the relevant word in Chris’s request.
Still having difficulty Diddums?
We will await the data.
As for my having no facts to support my position that Burzynski is a con-man………….. What more do I need? It isnt my job to show that his medicine doesnt work, it is up to him to get FDA approval.
Burzynski has failed to provide ANY evidence that his treatment works. After closing on 4 decades of experimentation, he cannot put together ANY results that support the efficacy of Antineoplaston therapy. Nothing. Zip. Nada.
Yet still he relies on fanboys like you to fight for his reputation. Why has he not sued people for calling him a money grubbing worm? Why does he answer almost universal condemnation and ridicule with advertorials and puff pieces in woo-friendly journals.
So what of your contribution here? What have you actually achieved but put forward the same tired arguments supported by the same evidence free bullsh1t that the brave maverick’s supporters always produce? Arguments and articles that have been dissected and repudiated a dozen times or more here and in many other blogs & journals.
Burzynski is a fraud, a description that applies equally to you and your tired word salad of copy/pasta bull.
Are you a complete and total moron? Do you read or even look at any of the links you provide?
No mention of Julain Whitaker? Look at the very first document here, in the LINK YOU PROVIDED. A newsletter from Dr. Julian Whitaker titled “The FDA’s Unholy War Against Dr. Burzynski”.
I didn’t make up a Whitaker refernce out of thin air. You gave it to us. Do you have the class to admit you were wrong and say “oh yeah, there was a document from Julian Whitaker in there, I am sorry I made a mistake”? Those words will never issue forth from your keyboard. Are you ever wrong about anything?
And yes, of course people die, but you presented two newspaper articles about Mary Jo Hofness from last year as proof that Burznyski is not a fraud. I am merely pointing out, if you want to use the same patient as an example, that she died several months ago. Don’ty you understand when you post newspaper articles we can do the same?
The last thing I will ever write to you, Didy, is a huge question. You keep denying you are shilling for Bursynski and claim you are not here to support him. Please then, tell us in one or two sentences, why exactly are you here, posting lengthy comments attrempting to “show us” the other side?
Sorry, forgot to include the VERY SAME LINK Didy sent us with the Whitaker newsletter as the first document:
Oh, and Didy, take a look at this link YOU SENT US: another Julian Whitaker newsletter, titled “The FDA’s Latest Abuse of Power” from 1996 (it’s not the first document here, you have to scroll down a bit…that means use your mouse to move the words up on your screen so you can see the rest of the documents.
Yeah, I invented the Julian Whitaker references. I await your apology.
And Didy, since you love newspaper articles so much, why don’t you read this, a recent profile piece from 2008 from the doctor’s own hometown newspaper. I know it’s long, but maybe you can read it in chunks and take a nice lie-down in between if your brain starts to hurt.
Tell me this is a man you would trust with your life, or a loved one’s life. Who talks like this to reporter when they know they’re on the record? Calling a reporter a shit with a little brain? The man is deranged, and this brilliant reporter didn’t try to hide his contempt for Burzynski.
Pretty rich coming from someone with the communication skills of a doorknob.
Hey, there are some pretty intelligent electronic doorknobs out there now. Computer chips, memory, etc. Don’t insult the hardware industry!
And for the record, I speak Canadian English, eh? Et francais aussi. But not American English. Unless I take a trip to Burlington Vt. and I drop the “u” in words like colour and neighbour.
So you are using a book (with an invalid link) to prove something? What is the grant number? You have produced so much drek here I really don’t even know what claim you are responding to. That’s why we use quoting, you should try it and provide any statements you are responding to. You seem to be the one with unlimited time on your hands, not me.
Your defence of Burzynski is so charming but I could be wrong and you are either paid to do so or are so enamoured with him in a rather unhealthy way that you don’t mind making a complete arse of yourself.
Burzynski really needs a better class of fanbois; I actually made a helpful suggestion but you are too dim to grasp that. So what about clinical trials. He’s been allegedly running them for over 30 years with nothing really to show from them. And as I stated earlier, he has no intention because he is bilking a good living out of desperate people and has insulated himself rather well.
On the Burzynski Clinic website, there’s a relatively new link to an interview with Stan published this summer in some rag called “Alternative Therapies”. In his own words, he says he was receiving a substantial salary in Poland and got a research job at Baylor as soon as he arrived in the US (he says at that point he still could barely speak any English.) So what’s all this BS about coming to this country with $15 in his pocket and not being able to pay for staff or research protocols? He only struck out on his own after he had being employed here for some time. He didn’t set up his clinic the second he stepped off the boat, so what does that “$15 in his poecket” even mean?
More seriously, in this interview he addresses everything: the clinical trials, the adversaries trying to stop him, the cost of his treatments, “targetted” gene therapy, the new era of antineoplastons, everything. All paranoia and lies, of course, like this. (Sorry for the formatting, it’s cut-and-paste from a pdf:)
Dr Burzynski: When patients come to us, most of them are treated
in our oncology practice. We try to help obtain payments from the
insurance companies for them—they have insurance policies and
for most of them, insurance covers the treatment which is done
here. If you are talking about antineoplastons clinical trials, we
provide medication free of charge, which costs us a lot of money.
Annually, we spend $5 to $6 million for this purpose. If you have
support from the government, then this money probably would
come from the government. But instead we have to generate the
money through our business activities and use this money for the
approval process. It can be done. In medical history, it was always
done this way. Only recently have the doctors become the slaves of
organizations like the NCI or pharmaceutical companies. We are
independent and can do whatever we would like to do without being
manipulated by the other agencies…
I almost spit coffee when I read this nonsense:
ATHM: Do you think that understanding in the medical community
about your research is improving with time or evolving?
Dr Burzynski: Absolutely. Some of the brightest oncologists are
working together with us. We have a group of about 100 top oncologists.
We are treating patients together with oncologists from
all over the world. We are talking about the brightest guys. The rest
of the club does not understand what we do at all and hate us. They
would like to get rid of us. They hate to see our good results. But
this crowd also will change if the breakthrough comes. So at this
moment, we have to convert oncologists one by one. Of course,
I am giving lectures at the oncology congresses, but only a few of
these doctors will pay attention to what I have to say because I am
not from a big medical institution. They don’t believe something
can come from a small clinic, a small research center. They all assume
research must come from a big pharmaceutical company or
big institutions. Unfortunately, not much good came from these
institutions within the last decade. But a number of doctors are beginning
to understand what we do, and the number of those who
would like to be trained in our strategy is increasing all the time.
We have oncologists coming to us from various countries almost
all the time to learn how to use our approach.
Please read the entire thing. I’m sure you’ll find things to pick apart in every single sentence.
It’s a valid link, but Didy puts in all these annoying spaces in order to carpet bomb us with mutiple links in a single comment. Here it is without the spaces, but there’s nothing earth-shattering there:
Regarding Reich, it’s beyond serious dispute that he had some kind of mental health issue, but it’s problematic to treat it as an issue in appraising his work. From all we know of mental illness, it’s VERY unlikely that he ever had a problem that was not with him all along. It is plausible, however, that his symptoms and overall condition worsened over time. The period from the late 1930s onward, when he evidently went through significant turmoil in his personal life, could be especially significant.
David N. Brown,
I was using the terms “sane” and “bonkers” in an informal layman’s sense, not necessarily referring to mental health issues, rather to extremely unusual belief systems.
However, when you consider how Reich was treated I don’t think it is very surprising that he had some sort of mental breakdown. His ideas may have been wrong, but destroying research and burning books is no way to deal with that, in my view.
When I was younger I spent a lot of time reading Reich’s works, and what others wrote about him. I have a book of his letters and journals that cover the period when he asked Einstein to take a look at one of his orgone accumulators. The repeated refrain, “Still no word from Einstein” is very sad.
Thanks MSII; I thought I had gotten all of the spaces (cripes you don’t need that many to slip through the filters). Yea, looks like Burzynski is in good company with Gerson and Hoxsey. Diddums shouldn’t be drawing attention to that hot mess.
PhRMA takes credit for Antineoplaston Brain Cancer Cure …
Jodi Fenton – Anaplastic Astrocytoma Grade III
The bite-sized posts are a great improvement. A statement of what you are asserting, followed by evidence to support it, would improve them even more.
I’m sure you are not suggesting in any way that Jodi Fenton’s case is evidence that Burzynski’s treatment is effective, but you still might be interested in what jli, an experienced histopathologist, has to say about it (Testimonial 1).
You can see the medical records that jli refers to here.
I also notice that the tumor measured 2.2 cm x 1.8 cm x 1.5 cm on her MRI, which is 5.94 cm³. After surgery the size of the tumor was 0.17³ which means that 97% of the tumor was removed during surgery, possibly more if you allow for post-operative inflammation as jli mentions. Not bad for an “inoperable” tumor.
Typo – that should read “the size of the tumor was 0.17 cm³ “.
That headline should really read, “Burzynski takes credit for Surgical Brain Cancer Cure”.
Perhaps your response made sense to you, but it doesn’t match up with what I last wrote. In fact, it just shows you to be sidestepping anything and everything that we say.
And you wrote back:
So how in the world does one lead into the other? (Added, after reading the full comment: I see now that he’s replying to various comments but there’s no way to tell what sentences reply to what comments. I can’t be bothered scrolling up to figure it out, so here it remains…)
My question required a yes/no. I do not see such a sentence above. And no, American English is not my native tongue. I do however, speak Australian English, which is hardly different. And I use proper grammar and sentences that flow on from each other from one thought to the next in a manner that can be followed easily.
Perhaps you need to step out of your geocentric sphere for 2 seconds and recognise that the internet is international and that those international people can understand how to write English far better than you can. And by the way, I was attempting to defend a possible non-English speaker. I was giving you the benefit of the doubt, and for that, I guess I’m sorry. You’re not struggling with ESL, you’re apparently just an idiot who doesn’t know how to write well.
— By the way, is this even grammatically correct? “Is it not your American native language?” Sounds like you transposed your words.
I’m also not sure you actually know or understand the references we made and you ‘satirised’.
As for requiring you to post evidence, maybe you need to clarify why you’re here and why you’re posting. We’re talking about one person who is supposed to be curing cancer. WTF are you talking about?
And I have yes, been looking at files and publications and reading various things here and there. I don’t have a lot of time to read everything; but the world and internet is large and you can’t just ‘research’ something based on doing a google. You and Jenny Mcarthy would get on fine I’m sure.
That isn’t exactly clear from your ranting. If you’d like to make it clearer, start writing in a way people can understand you. I’d recommend replying to one person at a time, and using shorter comments, and perhaps some decent paragraph styling.
By the way, I don’t understand this need to remain neutral. Science doesn’t give a flying f* about being nice to everyone, it picks sides. You’re either wrong or you’re not. Big Pharma can be wrong in certain instances; it can be right in others. The bold mavericks are hardly ever right; but can be in rare occasions. Like the others have been trying to say to you: we do not need to criticise everything to criticise Burzyinski. If you don’t understand, here’s a link:
Or you dimbulb, I didn’t want to reinvent the wheel as I was in the middle of five other things and they had said what I had wanted to in a perfectly eloquent manner. Feel free to use all the ad hominems you like, it won’t make you any more legible or my re-use of their comments any less apt.
Feel free to continue blathering to yourself, I am not going to bother reading your replies as they’re so unintelligible, evasive, and full of ranting.
(To regulars, I get the feeling this crank is a libertarian – ‘balance’ and ‘freedom’ seem to be what he’s aiming for, and the right for customers to get screwed because it serves them right)
Je ne suis pas Francais, ou Canadien. Mais j’ai appris un peu a l’ecole.
Unfortunately I have also taught myself American spellings due to its commonality for overseas clients. It can be quite frustrating to remember and tough when your spellchecker doesn’t do its job. Canadian English – don’t you just put an ‘eh’ on everything at the end? 😉
I pointed that out already in one of my comments about the files on Josephine Jones’ site.
Diddums, you may wish to remain ignorant of tu quoque, but unfortunately I can explain it so simply that it will be apparent to everyone that you know you’re not arguing in good faith.
A tu quoque argument is one in the following form:
1) You shouldn’t talk about A doing wrong if B did something worse.
2) B did something worse.
3) Therefore you shouldn’t talk about A doing wrong.
Sadly for you, premise 1 is bullshit and that makes the whole argument bullshit. You may try – you’ve already tried – to pretend that you aren’t trying to disrupt and shut down discussion of Burzynski’s wrongdoing; that too is bullshit. There’s no point in dignifying it with any other name.
Comments re 12/4 –
JGC, you remind me of:
Under “Pharmacologic and Biologic Treatments”
” [P]reliminary data recently were criticized by respected mainstream scientists as uninterpretable, and the therapy as useless and toxic.” (And it cites):
“Anonymous Experts say interpretable results unlikely in Burzynski’s antineoplastons studies. Cancer Lett. 1998;24:1–16. [PubMed]”
But the link to this cite doesn’t bring this “Anonymous” up & a search doesn’t either. Seriously? Anonymous?
MarkL, WoW! You successfully posted basically the same thing on 11/29 & 12/4!! Have you been following along with the rest of us? Because since my 2nd post on 11/28 & Chris’ immediate missrepresention of what I wrote, and my request on my subsequent post “I will be happy to accept your apology,” and Chris’ follow-up 11/29 post sans apology, herr doktor bimler’s “piling on,” Chris’ ensuing excuse for an apology, my post that Chris use the “Magic Word,” Chris’ concomitant non-apologetic post sans “Magic Word,” Science Mom’s jumping on the bandwagon, JGC’s open season, Chris’ unapologetic “Magic Word” unaided post, Denice’s joining the circus, JGC’s blathering epiphany, Lawrence’s claim jumping, Chris’ impenitent absent “Magic Word” slurry, herr doktor bimler’s supplanting post, JGC’s off-shoot, MarkL’s usurping, herr doktor bimler’s aside, Todd W’s oppugn, flip’s flippant addition, Peebs’ elucidation, Denice’s hiccup, Chris’ unrepentant “Magic Word” using rehash, Narad’s penny pinching post, Denice’s insider comment, Chris’ unremorseful aside, Lawrence’s 11/30 whiny repository, MI Dawn’s hijacking, JGC’s goulash, Chris’ remorseless plea, Chris’ implacable uncontrite potpourri, Chris’ rehash, Lawrence’s linguine, Chris Goes GLEEVEC: “I don’t know what ‘apology’ means” time-wasting unapologetic post, Narad discovers Wall Street & Gordon Gekko:
12/1 – I post “Chris, why have you not apologized for misstating my argument?” Chris’ whines “Actually I did,” without any reference, twice, then whines again, and again, MarkL again interjects nothingness, Science Mom searches for a UFO, 12/2 Narad goes “George Bush,” flip flips out, Lawrence is confused, flip flip flops, 12/3 Chris chrysalises, Chris frantically searching for more ways to keep from apologizing, MarkL searches for pork pie in the sky, flip shows how to post posts posthaste, 12/4 MarkL re-posts basically what he reposted 11/29, then lies down but doesn’t play dead, Marc Stephens Is Insane goes Insane, then after posting: “The last thing I will ever write to you,” writes more, and MORE, AND MORE, Science Mom admits: “I could be wrong.”
Marc Stephens Is Insane, are you Insane? Egad! HIS name is on 1 document out of 49!! I can understand why you are morally outraged!!! Do you think that I have a photographic memory so that I remember every name I read when reviewing all the information I go through in a day? Since you didn’t back up your post with “FACTS,” I just instinctively thought you were in denial. You actually got that one right! Unlike Chris, I will actually apologize for not consuming enough “Brain-Food,” or is that considered Homeopathic? I don’t use a keyboard, I project my thoughts like Dragon.
Please provide the “FACTS” that shore up your solecism that by posting 2 newspaper articles, I was attempting to provide “proof that Burznyski is not a fraud.” Who’s just “attrempting (sic) to “show”” you “the other side?” I’m presenting both sides. I don’t use a mouse. That would be cruelty to animals, which wouldn’t make PETA happy. Oh My! HIS name is on 1 document out of 42!! How could I not remember THAT!!!
THAT man could be a little man. Do you know how tall he is? I couldn’t tell from on-line pictures. But what a fabulous piece. Just look at how many people commented on the story on that site! O!! This is the guy cited on Wikipedia under SRB’s Clinic/Documentary pg. where he comments on it while admitting he didn’t watch it. What kinda “Hack” does that kind of Yellow Journalism?
What ever should I think about this Congressional testimony?:
And my below links for Science Mom?
Narad, pretty rich coming from someone who has no response to my three 12/4″The Land of the Brave post.”
Science Mom, as someone pointed out later in the blog, there was a reason why I was adding spaces to links, but the reason is I got tired of Orac’s “Spam Bot” link-blocking. Who’s doing the most research around here to respond to people’s posts? You? Yes … you are wrong; maybe in more ways than 1. Read this:
12/6/12 Texas Medical Board Dismisses Case Against Cancer Doctor Burzynski:
FDA requiring Radiation in Phase 3 trial:
Petition to White House:
Antineoplastons clinical trials:
Marc Stephens Is Insane, no, it’s to bypass the Orac Spam Bot Link Block.
Still no evidence?
Just more copy/pasta?
I appreciate your post being more ventilated but haven’t read all your previous post, I lost the context but fear not, I’ll try to read some of your evidence (found in this latest post) and report back.
What in holy hell was that from Diddums?! Trying to read his post is what I would imagine being on an acid trip is like.
More like Ritalin with a chaser of Nyquil. But, hey, it’s discovered the horizontal line, so there’s that.
Well, at least he seems to be learning. But he could try harder at making sentences shorter and allowing one thought for each. Perhaps somewhere in that mess is an actual point….
When someone thinks Black’s Law Dictionary is some sort of really impressive mention, I’m not encouraged.
Anyone besides me notice that some of Orac’s comments show up on:
www. sciencebasedmedicine. org
www. sciencebasedpharmacy. wordpress. com
www. skepticalhumanities. com
www. skeptico. blogs. com
www. skepdic. com
www. anaximperator. wordpress. com
www. beforeitsnews. com
www. doubtfulnews. com
www. hepinfo. net
Orac has commented twice on this thread and I cannot see any sign of those comments being recycled elsewhere. So the answer is “No, it’s just you”.
hdb, it seems interesting that we are taking different meanings of DJT’s word “comments” and come up with different but correct answers to DJT’s question.
You read “comments” as referring to blog comments, such as these. You correctly answer that you’ve not seen Orac’s words repeated from comments here to comments elsewhere.
In line with DJT’s looseness of thought and expression, I read his word “comments” as referring to Orac’s thoughts, and expression thereof, literal and paraphrased, in his articles as well as in the comments section here. My answer reflects the general applicability and insight of Orac’s thoughts and expressions — such that most blogs frequented by people who think are likely to contain many of the thoughts, expressed literally or paraphrased. This is not even taking into account that Orac’s work is quoted by his friend, and others, because of his perspicuity in the matters he writes on.
What DJT actually meant may never be known, even to DJT — he hasn’t exhibited much in the way of clarity.
Science Mom, I’ve been on several excursions via LSD and they made a lot more sense.
If I were looking for info on Burzynski because I was considering utilizing his services and found these addled prattlings of DiddyMau5 JT, I’d drop the idea like a bad habit.
I’m disappointed you haven’t responded to my comment above, pointing out that at least 97% of Jodi Fenton’s tumor was surgically removed before she started antineoplastons. Yet the YouTube video you linked to claims that, “Jodi Fenton was cured of a Grade 3 Anaplastic Astrocytoma after being treated only with Antineoplastons”. Do you anything to say about that? Doesn’t that make you wonder just a little bit about the honesty of the rest of Burzynski’s propaganda?
No, but I comment on most of those blogs from time to time, since they all cover subjects I am interested in. So what?
Oh, thanks, I needed a laugh. 🙂
But seriously, maybe DJT is just a shill for Big Skeptics, promoting those evil websites that tell us we should be using science in our medical decisions. *claps* Very good, DJT, Lord Draconis will be along shortly to give you your prize…
Don’t know why I’d remind you of this letter, as neither I nor anyone else is criticizing Burzynski because anonymous scientists question whether his studies could produce interpretable data. I’m quite willing to stipulate that they may be wrong and –who knows?–maybe Burzynski’s studies could provide interpretable data. The real problem is that there’s nothing to attempt to interpret: Burzynski has never published data from the clinical trials he’s supposedly been conducting for a couple of decades.
Meanwhile, studies have been published which found antineoplastins ineffective. Like those found at the link you provided, which you conveniently ignored to focus on the whole anonymity red herring (Green S. Antineoplastons: an unproved cancer therapy. JAMA. 1992;267:2924–8; Buckner JC, Malkin MG, Reed E. et al. Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc. 1999;74:137–45.)
Krebiozen, so, what do histopathologists do? Hysteria-of-Pathological-Liar-ists?
The Microscopic examination of tissue on glass slides.
So, what’s this person’s motivation?
“Blogging against alternative cancer treatments.”
Well, THAT answers THAT question!
jli’s “theory” re Jodi Gold Fenton “becomes problematic” (I use jli’s own words) when the reader is advised not to just look at the highlighted yellow portion but where “it tells us that the lesion could also be a lymphoma or an inflammatory process…”
jli does not point out that pg. 5 of the Medical Records indicates: “Other MR spectroscopy features. in particular the decreased lactate, make the diagnosis of lymphoma or abscess or other infectious process less likely.”
jli wrote:”At the start of the testimonial we were told that the astrocytoma was inoperable. Well – it was accessible for biopsy, so how then could it have been inaccessible to surgery?”
Well, JGF says that it was “inoperable,” so who told her that? Was she given inaccurate information by a medical professional?
pg. 9 indicates the Biopsy was a “Stereotactic Biopsy”
which is supposedly a “minimally invasive procedure.”
jli keeps suggesting that surgery was performed after the biopsy but does not cite any supporting evidence.
Pg. 2: 2 cm. approximately – 5/11/2000
Pg. 3: 2.2 cm superior/inferior by 1.8 cm anterior/posterior by 1.5 cm mediclateral – 5/11/2000
Pg. 5: 2.67 X 2.02 X 2.55 cm. approximately – 5/11/2000
Pg. 6: 2.2 cm superior/inferior by 1.8 cm anterior/posterior by 1.5 cm – 5/11/2000
Pg. 8: 1.0 cm in length x 1.0 to 2.0 mm in thickness Labeled “biopsy left parietal mass”: The specimen consists of a core of gray tissue 5/15/2000
Pg. 10: 6/1/2000
0.2 x 0.1 = 0.02
0.5 x 0.3 = 0.15
Pg. 13: 6/1/2000
0.3 / 0.2 / 0.06
0.5 / 0.3 / 0.15
The truth is out there somewhere.
flip, what did you say?
See my 12/4 response to: “Lawrence, read between the lines.”
Have you ever considered that maybe you’re posting too much garbage if you need to scroll up to remember what you posted?
I post replies in the same order as the posts I’m replying to.
12/2 my post re Part II of the SRB documentary was commented on 3 posts later by you on the same day where you whined that i didn’t respond to your Dingo Didgeridoo Kangaroo questions, and then the 4th post on 12/3 you again posted away about SRB & later posted: “I have no idea what you were trying to say to me.” So the 8th post of 12/4 was my: “flip, I knew in your rigorous search for the truth that you would want to know any new information on SRB that comes to light,” because I knew you would want to watch Part II of the Documentary to learn if any of your questions are answered.
For someone who “can’t be bothered scrolling up,” you sure had time to post a lot.
Really? We all know from History that except for the aboriginal people, everyone else from Down Under are decendants of criminals, Right? 🙂
How’s your Geosphere? And the Vegamite sandwiches?
I like transposing words to make people think.
I think I’ve made it clear why I’m here:
12/4 to MarkL: ” you also conveniently do not point out that I’m the one who pointed out on 11/30/12 the National Cancer Institute at the National Institutes of Health & American Caner Society had information re Antineoplatons & SRB.”
Need some more? Check out my above post with links to SRB’s SEC filings.
I know how to research off-line.
What did you say? I couldn’t understand you by cricky!
I’m not going to reply to 1 person at a time. Too time consuming. Consider how much time I spent researching for Krebiozen, above.
Yep, we know Science picks sides from:
Galileo – the Earth is round.
Ignaz Semmelweis – wash your hands between the time you deliver a baby & do an autopsy & deliver a baby, unless you like sending people “Down Under.”
Your Hyperbole is impressive!!
If you don’t understand why SRB is in the position he is in today because you refuse to look at the factors that contribute to the problem … then I can’t help you. Seen any ostriches lately with their heads in the ground?
So, if you are going to criticize SRB then you should criticize tu-quack.
It’s like criticizing the prison guard but not Lenin, Stalin, Hitler, or Mussolini
As usual, I guess blood has rushed to your head, being from Aussie Land, because as our former Republican American President Ronald Reagan used to say in Presidential Debates: “Well, there you go again.” Libertarian? Really? You don’t see my trying to state that your Political affiliation is x or y. Y? Because it’s irrelevant!
flip, is that where they play ‘”ock-eh?
Antaeus Feldspar, Really? If Lenin, Stalin, Hitler, or Mussolini were around, I guess you’d go after the prison guard.
Sadly for you, you resort to using a curse word as if that will somehow legitimize what you post, and you may try – you’ve already tried – to pretend that I’m trying to disrupt and shut down discussion of Burzynski’s wrongdoing. There’s no point in dignifying it with any other name.
You conveniently tu-quack.
See my above post to flipper.
MarkL, still no apology from Chris for misrepresenting what I posted?
I feel no compelling need to do what Chris requested when Chris can’t apologize for misrepresenting what I posted. So, when people pile on after Chris, and want me to do what Chris wants, well, there’s your answer!
Science Mom, I guess being a Science Mom you would know what an acid trip is like.
flip, sure, the point is in the above post to MarkL.
Narad, Black’s Law Dictionary is impressive because the Gub-ment has gone after SRB numerous times, and if their lawyers knew how to practice law, then SRB wouldn’t be where he is today if they knew how to do legal research, discovery, depositions, and present a compelling case.
ClinicalTrialsFeeds. org., Burzynski:
http:// clinicaltrialsfeeds. org/clinical-trials/results/spons=%22Burzynski+Research+Institute%22
8/20/1994 Before the Texas State Medical Board of Medical Examiners, Stanislaw R. Burzynski, M.D., Ph.D., Docket No. 503_-_92_-_529:
www. bioethicswatch. org/pd/burzynski_txorder19940831.pdf
4/18/1995 Burzynski appears before grand jury, Houston Chronical, Ruth Sorelle, Deborah Tedford, Medical Writer Staff:
www. chron. com/CDA/archives/archive.mpl/1995_1268882/burzynski-appears-before-grand-jury.html
1997 The Dividing Line Between the Role of the FDA and the Practice of Medicine: A Historical Review and Current Analysis, Citing Burzynski:
http:// dash.harvard. edu/bitstream/handle/1/8846812/cberry.pdf?sequence=1
6/7/2001 Inspection of clinic, Dal-DO/San Antonio Resident Post, HFD-47, Good Clinical Practice Branch II, Division of Scientific Investigations, CDER (FACTS #213702):
www. circare. org/info/bri/burzynski_fda-eir_20010810.pdf
12/20/2001 inspection of institutional review board (IRB), Dal-DO/San Antonio Resident Post, HFD-47, Good Clinical Practice Branch II, Division of Scientific Investigations, CDER:
www. circare. org/info/bri/briirb_fdaeir_20020215.pdf
1/13/2009 Burzynski Research Institute Gets SPA Clearance from the FDA to Initiate Pivotal Phase III Trial of Combination Antineoplaston Therapy and Radiation Therapy, Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma:
www. sec. gov/Archives/edgar/data/724445/000110465909002283/a09-2965_1ex99d1.htm
10/5/2009 Warning Letter, Department of Health and Human Services, Public Health Service, Food and Drug Administration:
www. fda. gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm
2/29/2012 Form 10-K, fiscal year ended:
www. sec. gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm
10/18/2012 Department of Health and Human Services, Public Health Service, Food and Drug Administration, Antineoplastons A10 and AS2-1 Injections MA #1:
www. ratbags. com/rsoles/history/2012/1110fda_burzynski_2012.pdf
Cell Biology and Signaling
http:// m.neuro-oncology.oxfordjournals. org/content/14/suppl_3/iii1.abstract?sid=e29ac3b0-44dc-4450-bad2-2ec944af1d24
Search results citing Burzynski (3):
http:// m.neuro-oncology.oxfordjournals. org/search/keywords/advanced?options[q]=search&options[author1]=S.%20Burzynski&options[sortspec]=date&options[submit]=Submit&options[numresults]=10&options[sortmethod]=0
11/2010 Cell Biology and Signaling:
http:// m.neuro-oncology.oxfordjournals. org/content/12/suppl_4/iv7.abstract?sid=95079a14-178f-4a13-b6dc-3fab4e9485da
11/2010 Ongoing Clinical Trials:
http:// m.neuro-oncology.oxfordjournals. org/content/12/suppl_4/iv69.abstract?sid=49e4f4d6-eaba-4841-9e7c-c156ddc51a80
http:// m.neuro-oncology.oxfordjournals. org/content/14/suppl_3/iii1.abstract?sid=95079a14-178f-4a13-b6dc-3fab4e9485da
And it’s not likely anyone will find it hidden in your screeds.
Cutting through your flim-flam, the only really important fact is that the great majority of the tumor was removed before Jodi started Bursynski’s treatment.
Look again at the medical reports here. You appear to have seriously misunderstood what they say, so allow me to explain.
On page 2 it gives the approximate length of the tumor as seen on a CT scan as 2.2 cm.
On page 3 it gives the approximate measurements of the tumor as seen on MRI, stating that “it may have a small ring of edema”, as 2.2 cm superior/inferior by 1.8 cm anterior/posterior by 1.5 cm making the volume of this tumor approximately 6 cm³.
On page 5 it gives the results of proton magnetic resonance spectroscopy and approximate measurements of the tumor as 2.67 cm x 2.02 cm x 2.55 cm which I make approximately 14 cm³.
There are 3 sets of measurements from 3 different imaging techniques which broadly agree with each other.
On page 6 it refers again to the size of the tumor estimated from the MRI, which is better at estimating size than proton magnetic resonance spectroscopy which is mainly used to establish the structure and composition of tumors, not their size.
All the above diagnostic procedures appear to have been carried out on or around 05/11/00.
On page 8 it refers to the size of the biopsy sample sent to the lab on 05/15/00. Part of this was used for a frozen section which was examined during the operation, notice it refers to “intraoperative frozen section consultation”. This means that part of the biopsy was frozen, sectioned and examined to provide the surgeon with information on what further action needed to be taken, during surgery while the patient is still on the table. Frozen sections are only done when further surgery may be necessary depending on the results.
Since the intraoperative consultation reports “high grade glioma” it is highly likely that further surgery was carried out and more of the tumor was removed. This is supported by the following information in Jodi’s records.
On page 10 it gives the result of an MRI performed on 06/01/00 which found the volume of the tumor was 0.17 cm³.
On page 12, in a letter to Burzynski we are told that Jodi, “began antineoplaston therapy on June 6 2000”. The letter also mentions a brain FDG PET scan done on June 8 2000 that was “consistent with no residual neoplasm”.
To summarize the relevant information:
Pre-op tumor size by MRI on May 11 approximately 6 cm³.
Post-op tumor size by MRI on June 1 approximately 0.17 cm³.
Antineoplastons started June 6.
Tumor undetectable by PET scan on June 8.
So almost all the tumor had disappeared several days before the patient even started Burzynski’s treatment, and all of it had gone two days after treatment was started. The most likely explanation is that the tumor was removed during surgery, and the residual 0.17 cm³ seen on MRI was post-op inflammation. Burzynski’s treatment cannot possibly have had anything to do with this.
Chris merely requested that you fulfill the basic minimum requirement for arguing in support of the brave maverick – that you provide real evidence to support your argument.
Not journalistic puff-pieces, not advertising, not anecdote, REAL DATA. Strawmen, tu quoque arguments, Onus probandi, Gish gallops, Appeals to accomplishment and other logical fallacies are not going to get you any traction here either.
Burzynski is a fraud, and unless you have some hard evidence to the contrary (you don’t, even Burzynski himself doesn’t have that), you are a fraud too for insisting that the “brave maverick” Doctor is anything other than a snake-oil salesman.
Looking again at Jodi Fenton’s medical records as presented, the only thing that makes sense is that there’s a histopathology report missing. Somewhere there must be a histopathology report on the tumor that was removed after the surgeon was given the frozen section results. That report would include information on whether the tumor had clean margins or not.
Tumors don’t just disappear after being biopsied, and the only reason the surgeon ordered a frozen section was to find out if the mass he or she had biopsied was malignant. As it was malignant and the surgeon was informed of this intraoperatively, he or she would surely have done his/her best to remove the tumor. Anyone with more specialized knowledge than I care to comment on this?
Also, the letter from an unnamed person at OncoImaging P.A. refers to “the series of brain MRI examinations”, but also to “each of the MRI examinations” as if there were only sent two. They then refer to “the initial study in June” (my emphasis) […] “showed two foci of enhancement. These lesions subsequently resolved, a finding consistent with a complete response to therapy”.
Clearly this person was not sent the initial MRI taken on May 11 at all. They were asked to evaluate the post-op MRI taken on June 1 that showed some residual post-op inflammation, a PET scan from June 8, and a subsequent MRI that showed no mass at all. From the letter it is clear that they were not fully aware of what they were looking at, and were not shown the initial MRI that showed a 6 cm³ tumor at all. Isn’t that more than a little dishonest?
It’s obvious that it’s not an either-or situation, where either you go after the dictator who’s killed millions or you go after the individual perpetrator whose crimes may have shown depraved indifference to the welfare of others but whose crimes didn’t affect as numerically large a group of people.
Which means it just comes right back to your premise “You shouldn’t talk about A doing wrong if B did something worse.” That premise is crap, it’s always been crap, and the fact that you keep trying to push that crap shows your true nature.
Actually, I’m just keeping in mind what an old friend of mine once said. He said the most devastating insult is actually “You’re stupid,” because the minute you start crafting a wittier, more intellectually elegant response, you’re implicitly saying that the other person’s nonsense requires some sort of sophisticated intellectual counter.
“A shouldn’t be criticized because B is worse” does not need a sophisticated intellectual counter. It was countered millenia ago. It’s bullshit plain and simple. End of story. It may be the only move you have available to you, but that’s what happens when you defend a creep like Burzynski.
I think it’s time for an ultimatum question; it’s often the only way to deal with Gish gallopers like you.
Here’s how it works: we ask you a question. If you post three comments, on this thread or any other, without giving an answer to the question, you will be treated as having answered it, in a way you probably won’t like.
The question is this: Burzynski claims to be conducting clinical trials, testing out a treatment that has clinical equipoise (that is, it may or may not work or might even potentially make things worse; not knowing which it is is why we are doing trials.) If he was truly doing clinical trials, then the people who agree to be his subjects in the trials are doing him a great service, putting their precious remaining years or months of life at risk so that his treatment can be tested; they should certainly be receiving some compensation for the risk they are taking to test out his putative treatment. But as we all know, Burzynski actually charges his patients five and six figures to be in his trials; hell, you have to pay him just to get him to consider whether you’d be a suitable subject for his trials.
What possible justification can there be for Burzynski to be charging such exorbitant sums when a) the patient is the one providing something of value, b) the very fact of charging such huge amounts actually taints any data that theoretically might come out of the trials, since it excludes people who aren’t rich and can’t do effective fundraising from the study population?
If you don’t give us your answer within your next three comments, it will be taken as you answering: “Burzynski’s trials are just a ruse so that he can sell his ‘treatment’ without having to ever prove it works, and that’s okay because Burzynski shouldn’t have to follow the same rules that restrict everyone else.”
Is he still going on about me? I haven’t noticed because part of ignoring the troll is to just scroll past his screeds.
I can just assume he has not posted the one Burzynski paper that shows clinical trial results that are as good as a conventional cancer treatment like Gleevec, with direct quotes clearly explaining the results. The latter being proof he actually read the paper he is citing.
I find it hilarious that the NG ad server is posting all kinds of ads for medical malpractice lawyers on this page! The ad server picks up the context of the discussion and serves up the ads it deems germane to the subject. (Like the MMS banner ads that popped up on the MMS thread, or the alkaline water machine ads I see here all the time.) Except it’s ironic in this case.
I wonder how much Stan pays for malpractice insurance. Oh, right, probably nothing, as he doesn’t treat or see patients based on this TMB ruling.
He will throw his own staff under the bus if push comes to shove, though. They all must carry huge coverage.
I wonder if anyone has ever tried the medical malpractice route with Stan or do his waivers protect him from liability?
Burzynski is a fraud,
MarkL left out the word “convicted”.
No, sorry. The invocation merely indicates that you are completely unable to summon a single thoughtful comment on the subject of law and probably wouldn’t be able to recognize one even if it dropped out of the sky scrawled on a 16-ton weight. (Actually, given that you did it twice in one text-evacuation, “incantation” might be a better choice of words.)
I guess his ‘thoughtful’ comment about the law was reserved for me, and his insightful insistence that all non-native Australians are descended from criminals.
I have a comment with an ultimatum question for Diddums; however, because I used a bad word, the comment is being held for moderation.
Just to clarify, I don’t think any comments DJT may post before my comment is actually released should count towards his three. It may be hard, however, to work out exactly when the comment came out of moderation and which of DJT’s fewmets came afterward.
What factors would distinguish between between a physician using what they might call ‘off-label medications as treatments’ and a physician conducting studies and trials with the same medications on their patients? If they are using the drugs off-label, and no studies have been done to evidence their effectiveness in a given condition, what’s the difference? If the physician calls them “studies”, would that be relevant?
Nah, he tossed the same laughable posturing at Krebiozen in the same bowl of wilted word salad.
I like transposing words to make people think.
Yes, it certainly brings certain thoughts to the minds of onlookers. So does sticking pencils up one’s nostrils and saying “wibble”.
I would note that DJT abruptly switched away from Katherine Lee Bates to the Field Artillery March just as he arrived at the fruited plain.
Didymus Judas Thomas
Why did you skip the line about Brotherhood?
Orac blogs near the top:
“The documentary was awful, full of biased misinformation and overall just a plain bad movie.”
Let’s examine Orac’s statement, shall we?
1:44:44 – 1:44:52 of the Ducumentary displays:
“None of the oncologists who originally diagnosed each patient presented in this film would agree to go on-camera, or submit a written statement.”
Garden State Film Festival, New Jersey
Newport Beach Film Festival, California
Humanitarian Vision Award 2010
http:// newportbeachfilmfest. blogspot. com/2010/04/update-burzynski-2nd-screening-added_25.html?m=1
http:// blog. bigmoviezone. com/docs/awards2010.pdf
Palm Beach Film Festival
Winner! Audience Award Best Documentary! documentary channel, 2011
http:// blog. documentarychannel. com/post/15572363380/space-tourists-and-burzynski-cancer-is-serious
Winner! National Audience Award, HumanDoc Festival, Warsaw, Poland, 2011
Winner! Warsaw Audience Award, HumanDoc Festival, Warsaw, Poland, 2011
Moondance International Film Festival
Feature Documentary Film Semi-Finalist 2011
San Luis Obispo International Film Festival, California
ALIVE Documentary Award, New York
https:// docs. google. com/viewer?a=v&q=cache:4TdKU8yqn4oJ:www.alivenewyork.org/uploads/1/0/3/3/10338129/aliveawardsfinal.pdf+&hl=en&gl=us&pid=bl&srcid=ADGEESi5cq6TtHVuyWQzVSbig8CHTiQAkAuTEiU-p2jYGOChV6hKmG3YuHSQgLAakM-Eli9RmDuDX0nQ22Nkz2lzT9bG-CIJTj5p52AMKwzmvAwqluSr6fpgziQzhXNERoIq6YkF6wtO&sig=AHIEtbSBvfjNFC9q281gTaotgApRk1WEwQ
Seriously, do you really think that winning awards at *film festivals* is a measure of what is accurate? It has more to do with technical achievements and- possibly- audience appeal, i.e. it sells its message well. The people who judge these things are in the field: they create and work on films ( like my cousin who creates ‘movie magic’), and for some awards ( audience choice), are the general public who viewed the film. It has nothing to do with science or medicine.
For example, Gary Null, who never met a pseudo-science hypothesis that he didn’t like- or try to promote- has won a plethora of awards at various festivals around the world ( see his websites for a list: Gary Null.com/ Progressiveradionetwork) for his films that:
discuss the link between vaccines and autism,
deny the realtionship between hiv and aids,
promote nutrition-based cures for cancer,
frighten people away from psychiatric meds for learning disabilities and mental illness in children,
state that SBM is the cause of death in hundreds of thousands each year,
as well as other social and environmental issues, including using the difficulties of veterans, poverty and AGW as avenues for self-promotion.
NONE of his so-called scientific essays hold any water in the real world.
I forget: is DJT being *neutral* towards Burzyinski, or not? Because he does seem to be going out of his way to defend him…
Hey, it works for Anne Dachel.
Right. And as we all know, she is a paragon… of something.
It has more to do with technical achievements and- possibly- audience appeal, i.e. it sells its message well. The people who judge these things are in the field: they create and work on films
One wonders if DJT believes in the accuracy of every advertisement that won a Lion Award from the marketing industry.
herr doktor bimler, Bill Price has noticed as be pointed out to you, above.
al kimeea, did you drop LSD like a bad habit?
Krebiozen, I’m disappointed you hadn’t figured out that I’m responding in order by date & even listing the date since 12/6!
Bill Price has noticed Orac’s comments on other sites.
Well, it’s either Orac posting elsewhere or people quoting him.
flip, as Comedian Bill Engvall says: “Here’s Your Sign!”
JGC, because your 12/3 (6th post of that day) post & my 12/4 (8th post of that day) response to you which you had no comment for, which makes me think that you are Anonymous, since if you replied it most have been Anonymously.
I notice all these posts that say SRB does not publish, but who reads between the lines & pays attention to my post mentioned above to MarkL (right after the post to you), the 1st link re the SRB 10-K, which under:
“Table of Contents, FORWARD LOOKING STATEMENTS,” mentions:
“ITEM 1, BUSINESS, General” mentions:
“currently conducting Phase II clinical trials,” and further down is a section re:
Phase II Clinical Trials,” “The Company began Phase II clinical studies in 1994 with 4 studies.
“At that time, a number of patients were also receiving Antineoplastons … outside these clinical trials.”
“On February 23, 1996, the FDA requested that all then-current patients of the Burzynski Clinic desiring to continue Antineoplaston treatment be admitted to a Phase II Study, according to Protocol CAN-1.”
This action resulted in the formation of 6 cohorts of patients in the CAN-1 study, with the largest group suffering from primary brain tumors.
New patients either were admitted to the CAN-1 study or have been admitted to 1 of the other studies sponsored by the Company, as appropriate.
The Company currently sponsors 1 ongoing Phase II clinical trial that is open for enrollment, which is conducted pursuant to investigational new drug applications (“INDs”) filed with the FDA & approved by an Institutional Review Board (“IRB”) designated according to federal regulations.
“All clinical trials are for the treatment of a wide variety of cancers using only a combination of Antineoplastons A10 & AS2-1.”
“Most of the trials involve the use of intravenous formulations of Antineoplastons; however, a few trials use oral formulations.”
“Dr. Burzynski acts as principal investigator for all clinical trials …”
“All of the clinical trials are conducted at the Burzynski Clinic.”
Each trial provides for the admission of up to 40 patients, except the CAN-1 study, in which 133 patients were enrolled.
“Please see “—Active Phase II Clinical Trials” for a list of all of these clinical trials.”
Prior to approving a New Drug Application (“NDA”), the FDA requires that a drug’s safety & efficacy be demonstrated in “well-controlled” clinical trials.
Several types of controls are acceptable to the FDA. 1 of these is a “Historic Control.”
“Under a Historic Control if the course of a disease is well-known, the response of patients taking a drug can be compared to a historic group of patients with that disease who have not had medical intervention.”
“For example, it is known that the tumors of patients suffering from primary malignant brain tumors (“PMBT”) will continue to grow, eventually causing the patient’s death.”
If a drug is administered to a patient with PMBT & the tumors of the patient disappear or shrink significantly, an assumption is made that there has been a response to the drug.
All of the Company’s clinical trials, except 1, involve the use of Historic Controls.
“Further, all trials except the CAN-1 study are “prospective clinical trials” (“PCT”).”
A PCT is a clinical trial wherein patients are accrued into & follow the clinical trial protocol from the very beginning of the trial.
“A retrospective trial is a trial in which data from patients treated prior to the start of a clinical trial is considered. Results of retrospective trials are, in most instances, not acceptable to the FDA. ”
In addition, there are no clinical trials being conducted that involve “double blind” studies & all but 1 clinical trial involve no randomization into multiple treatment groups.
“The ultimate goal of any treatment for cancer is patient survival.”
“However, the FDA has determined that requiring exhaustive data showing improved patient survival may unnecessarily delay the approval of new cancer drugs.”
For that reason, the FDA may grant marketing approval for a new drug product on the basis of adequate & well-controlled clinical trials establishing that the drug has an effect on a surrogate endpoint (“Milestone”) that is reasonably likely to predict clinical benefit.
“Each of the Company’s Phase II trials describes such Milestones which are used to determine success or failure of the treatment employed.”
“In most of the trials, the Milestones are radiographic evidence of tumor shrinkage by X-ray, computer aided tomography or magnetic resonance imaging.”
“Where appropriate, tumor markers such as Prostate Specific Antigen, blood counts, or bone marrow biopsy are used in order to assess a tumor’s growth.”
Where tumor size is used as the Milestone, each clinical trial protocol that is open for enrollment describes a “complete response” as a complete disappearance of all tumors with no reoccurrence of tumors for at least 4 weeks.
A “partial response” is described as at least a 50% reduction in total tumor size, with such reduction lasting at least 4 weeks.
“An “objective response” is described as either a complete or partial response for protocols BT-06, BT-08, BT-09, BT-10, BT-11, BT-12, BT-13, BT-15, BT-18, BT-21, BT-22 & BT-23.”
Stable disease” is described as less than 50% reduction in size but no more than 50% increase in size of the tumor mass, lasting for at least 12 weeks.
The protocols of the Company’s clinical trials involve a 2-stage design, wherein the 1st stage proceeds until the Company admits 20 patients into the trial.
After a specified time period, if there are 0 responses by the 1st 20 patients, the trial will be discontinued & the drug declared to have less than desired activity.
If there is at least 1 response, the trial will be continued until 40 patients have been accrued. If the study continues, the following conclusions ac