My Skepticon talk: Skeptical Genetics »« A look at the Burzynski clinic’s publications

More damning revelations about Burzynski’s “research”

Yesterday I picked apart the Burzynski clinic’s list of “scientific studies supporting antineoplason research since 2006.” Unsurprisingly, a majority of these citations were just abstracts of conference presentations lacking peer review, and a couple studies published in terrible (and even sketchy) journals. I wasn’t able to comment on specifics about the papers since I didn’t have access through my university.

A reader sent me a pdf of the first paper from Pediatric Drugs, which is even more incriminating. For one, it’s a review paper. Review papers summarize the current state of scientific knowledge about a certain topic. Sometimes they perform meta analysis on multiple papers, but they don’t always add any new information. Burzynski’s review falls into the latter – that is, it does not have any new peer reviewed data. And the studies about antineoplastons that the paper cites are from multiple conference abstracts, a patent from 1995, his report to the FDA, and an entry in a book by Nova Science Publishers (aka, also all not peer reviewed).

The only peer reviewed research paper the review cites was on the previous list – it was the one published in the crappy alternative medicine journal. I haven’t gotten hold of the paper, but commenter joshtriska summarized it thusly:

[2] A report on 18 patients with “High-Grade, Recurrent, and Progressive Brainstem Glioma” picked from 4 of his clinical trials. The conclusion states that typically less than 10% of patients with this condition survive 2 years, but in his group 22% (or four whole people) survived past 5 years. The conclusion also states that “Because a small number of patients have been evaluated, a larger study is required to confirm these results”. No kidding!

And that final paper – the one published in the sketchy as hell “Cancer Therapy” journal, was also a review:

[3] A review paper, not a study. Antineoplastons are mentioned and a line of data from one of Burzynski’s trials is included in a table. The discussion states that the data concerning antineoplastons was from from conference abstracts, and not peer-reviewed.

The Burzynski clinic is claiming that it’s libelous to say “There are no scientific studies supporting antineoplaston treatment since 2006.” But it’s not libelous because it is true. Results that lack peer review cannot be said to support something. Abstracts at conferences are not peer reviewed. Review papers do not include new, peer-reviewed data. The only published paper he has itself states that it is inconclusive without a larger study to confirm the results.

Plus, they don’t even understand what the phrase “since 2006″ means. It means published starting in 2007. From that alone we throw out the first two papers. You’re left with a review paper that cites conference abstracts, and conference abstracts.

So no, Burzynski clinic. There aren’t any scientific studies supporting antineoplaston treatment since 2006. But there are plenty falsifying it.

Comments

  1. PeteUK says

    Great stuff Jen, good to see a heavy weight scientist ripping Burzynski to bits, this helps bloggers like Rhys fight off threats of libel, and as another blogger stated ‘they can’t fight the Spartacus effect if lots more bloggers join in.

    You and Rhys now have something in common, you’ve both been published In the Guardian.

  2. GaryU says

    I’m not an expert, but if I remember Smith’s argument, he says that open access should replace peer review. We don’t yet have open access, so the argument would have to change into one about the benefits / problems with peer review and how to effectively put in place an open access policy that is able to filter out all the chaff from the wheat. Doesn’t apply to Burzynski, who has neither published research in peer reviewed journals (since 2006), nor made research data available openly.

  3. Brian says

    So no, Burzynski clinic. There aren’t any scientific studies supporting antineoplason treatment since 2006. But there are plenty falsifying it.

    I am shocked, shocked to find gambling in this establishment!

  4. Investigator says

    Doesn’t apply to Burzynski, who has neither published research in peer reviewed journals (since 2006), nor made research data available openly.

    Well, yeah. That’s why I said I wasn’t defending the dangerous quack.

  5. HappyHead says

    in his group 22% (or four whole people) survived past 5 years

    Um… how do you manage that? Did the one person who survived only “mostly” survive? Did that lost three percent account for them losing a hand or a foot or something?

  6. says

    in his group 22% (or four whole people) survived past 5 years

    Um… how do you manage that? Did the one person who survived only “mostly” survive?

    From the post:

    A report on 18 patients… in his group 22% (or four whole people) survived past 5 years

    4/18 = 0.22222…

  7. Chris Lawson says

    GaryU,

    Open access is not the same as no peer review.

    Also, while I agree with Richard Smith that peer review does not deliver on its promise, I am not yet convinced that abandoning it altogether is the way forward. The obvious alternative is for papers to be selected from the submission pile directly by the editors of the journal, but there is no reason to think that it will improve on peer review on any of Smith’s criticisms (“slow, expensive, largely a lottery, poor at spotting error, biased, anti-innovatory…, prone to abuse, and unable to detect fraud”) except speed and cost. As Smith says, the problem with peer review is that it has not been demonstrated to work. My preferred solution would be to start studying it with controlled trials to figure out what works and what doesn’t.

  8. Matt says

    Jen,
    Surprisingly, my University actually did give me access to the second paper from Integrative Cancer Therapies that you mentioned still not having. I gave it a quick read. Short answer is that it isn’t very good as you’ve already mentioned. Anyways, I sent a copy to your email.

  9. Chris Lawson says

    Jen,

    This is another great post on the Burzynski fracas, but I would like to pick a bone with your contention that review articles add no new data. A good review (note the qualification), especially a systematic review with meta-analysis of data, most definitely adds useful information to our knowledge base. You’re correct in the sense that a review collects no new clinical data from trial subjects, but it does create new information that can be of high importance.

    I’m something of a meta-analysis skeptic myself, and I have seen an example of a meta-analysis being used to launder significance by combining collected data from one trial with that of a previous trial (that is, the authors turned one positive and one negative finding into two positive findings) — and this appeared in a well-known medical journal with a strong philosophy of evidence-based medicine. But I wouldn’t dismiss review articles in toto.

  10. says

    Good point, you’re completely correct that I overlooked that. HIs particular reviews don’t do that, however. I’ll correct what I said.

  11. Dianne says

    Abstracts at conferences are not peer reviewed.

    This is not universally true. ASH and ASCO, for example, both peer review abstracts. However, there is not a lot of information in an abstract and so a lot must be taken on faith, no matter how good the peer review is.

  12. says

    I just sent you the article, too, before realizing that Matt already had. Good job on your reviews. They were dense enough that I wasn’t able to watch The Colbert Report at the same time that I was reading them, which is my usual blog-reading practice. Now I’m back to Colbert!

  13. Dianne says

    My response is that Dr. Smith’s analysis is essentially worthless. I’m pretty cynical about the whole peer review process, having experienced it from both ends. But letting the “market” decide…sure, that’ll work great. The libertarian approach is so effective in other areas. Also the only “evidence” that Dr. Smith links to is an editorial by…Richard Smith. It’s about as impressive as Burzynski overall.

  14. says

    Oh my, Jen’s not going to be lacking in article copies. I sent one earlier as well. Still, the fact that people are actually reading and criticizing these articles is probably the worst possible outcome after issuing their press release.

  15. toby says

    my sister in laws glioblastoma multiform a grade 4 tumor.. is being treated by dr b. and in 6 weeks it has shrunk by 36% that means its half the size. some quack.. i think if you guys had terminal cancer (god forbid) you might be thinking slightly differently about the effectivness of chemo and radiation therapy. maybe you’d even consider trying antineoplastens??? how much is a life worth? sure dr. b’s drugs cost alot but so do conventional drugs.

  16. Chris Lawson says

    Toby,

    I’m sorry to hear about your sister-in-law, but if Burzynski can generate good clinical outcomes why won’t he publish his data?

  17. Chris Lawson says

    Diane,

    With due respect, you have misread Richard Smith. He is not a free-market libertarian; he is a fierce proponent of evidence-based medicine, has championed open access journals (even converting the BMJ to open access when he was editor), and wrote an entire book criticising medical journals for being too cozy with pharmaceutical companies — in other words, the exact the opposite of what a free-market libertarian would do.

    Also, you are complaining about the referencing for a blog post, but a blog post has a lower standard of referencing than a published paper. Having said that, of the three references provided at the end of the post, one is the paper that prompted Smith’s editorial, one is a major report on the cost of publishing research, and one is a published paper on the topic that is very well-referenced and where Smith’s arguments are given the full weight of supporting evidence. In other words, Smith’s blog post is a brief narrative argument with links to more extensive evidence if the reader is interested in learning more — which is exactly what a good medical science blog should do.

    Please don’t confuse blog posts with published papers — they have different purposes and different standards of evidentiary depth; please don’t assume that because one blog post is not fully referenced that therefore there is no evidence behind it; and please don’t paint people with political tar brushes just because they disagree with you on a given subject.

  18. Zombie says

    So, I looked up Burzynski on clinicaltrials.gov. It seems with the exception of his single stage III trial, all of his active or recruiting trials are scheduled to finish Dec 2011, that is to say, some time in the next month.

    It looks as though a lot of these stage II trials are related to each other, testing the same thing in different types of cancers. Is that typical? Also, there’s seems to be a lot of “unknown” status trials, is that also typical?

    I’m curious what the experts think of the timing of Burzynski popping in the news just as all these trials are ending. Is that significant?

    I see only one completed stage II trial in the list, finished in 2005. Where would one expect to find results reported?

  19. PJLandis says

    Yeah, and the cost is not in itself the problem. He’s charging outrageous prices for a treatment he acknowledges has not been proven to be effective and is therefore not covered by insurance. Why not lower the cost, enroll more patients in studies, and prove its effectiveness? He could charge ten times as much, paid in full by insurance, for a proven cancer treatment.

    Every patient he treats MUST be enrolled in a clinical trial, otherwise its illegal to treat patients. More disturbing are the number of trials (61 right now on clin trials . gov) he is currently or has completed without letting anyone know the results; he has the patents, so he doesn’t have any reason to hide the data unless it is not effective. Anyone can read the stories of supporters, but only Burzynski can tell us how many people didn’t respond to the treatment.

    A handful of cancer survivors is impressive, unless there are thousands who died and the media cases are outliers. If 10 people before you died or otherwise received no benefit, doesn’t the patient deserve to know? There is no good reason to hide this information.

  20. Yep says

    The medical world will not publish his data. Why is it the the national Cancer Institute confirms the data, the FDA confirms the data, everyone except the general medical public confirms the data. This is similar to people that think Obama is a Muslim or isn’t an American citizen, it’s like the climate change deniers – it’s truly a magnificent cultural phenomenon – where the government establishment verifies the cures of Antineoplastons (not miracle cure, but some cures nonetheless) yet the “medical establishment” denies the government’s own data!

    It’s like we are living in a time where we just discovered the earth is round, and everyone is freaking out because now they have to replace all their “flat earth” photos.

  21. Yep says

    It seems scientists do not care about science any more – it’s only what the bloggers say. I sure hope this blogger can cure my cancer! Who cares if Antineopalstons have been given permission to open Phase 3 randomized trials – who cares if you must first pass Phase 2 in order to gain Phase 3 – why should scientists care what the FDA has allowed to occur? Since when have scientists cared about the FDA?

    “What? The FDA has approved Phase 2 trials, and given him permission to stat Phase 3!”

    If you hate this so much perhaps you need to take it up with the FDA – silly bitches.

  22. Yep says

    The medical world will not publish his data. Why is it the the national Cancer Institute confirms the data, the FDA confirms the data, everyone except the general medical public confirms the data. This is similar to people that think Obama is a Muslim or isn’t an American citizen, it’s like the climate change deniers – it’s truly a magnificent cultural phenomenon – where the government establishment verifies the cures of Antineoplastons (not miracle cure, but some cures nonetheless) yet the “medical establishment” denies the government’s own data!

    It’s like we are living in a time where we just discovered the earth is round, and everyone is freaking out because now they have to replace all their “flat earth” photos.

  23. Yep says

    Perhaps this post should be called “More Damning Revelations About the FDA’s Ability to Approve a Cancer therapy they know works—while the scientific establishment pretends that is doesn’t work”

  24. Yep says

    Everyone also fails to notice how the NCI used taxpayer money to intentionally kill 8 people hoping to be treated by Antineoplastons, only to have it be proven that they intentionally diluted the medicines to discredit the therapy.

    Everyone also fails to notice how Dr. Dvorit Samid was given a front cover page report on “oncology News” while working for Dr. Burzynski using Antineoplastons, then she left Burzynski with his medicines,partnered with Elan Pharm, the NCI and the FDA to file duplicate patents of Antineopalstons while they were also all trying to have him thrown in prison — whoops! I guess all you “scientists” missed that one eh?

  25. Yep says

    What is more amazing – even when she is cured of her GMB – everyone here will say “well, she must have never had cancer” – or “she had a spontaneous remission” – or “my cell phone is dying I can’t hear you anymore” – these people will never except reality, because they live in a fantasy world where chemo and radiation cures cancer—instead of making it spread and causing more cancer, which is scientifically verifiable. Oh, and don’t forget phenomena, paralysis, brain damage, infertility, you know… the usual stuff.

    If you are having a 36% reduction, you will have a complete remission within 6 months – ;)

    Remember, these people hosting this blog are the real quacks – they aren’t here to tell the truth, or recognize reality – keep it up – you will prevail, and always know as you live the rest of your life cancer-free and keeping your fertility possibly expanding your family, you know how you were cured.

    Half these quacks on this blog will likely die of a chemo-induced death. Remember that on your 80th birthday :)

  26. HFM says

    Ex-cancer researcher here. (I’m a yeast person now, but never mind.)

    As people have pointed out, many of these are review articles. For the non-scientists, if you think “grown-up book report”, you’re not far off. Nothing wrong with this, but as the saying goes, you write reviews when you have tenure or have nothing else worth writing about. They don’t imply a journal’s endorsement of the authors or their work, especially not in the sort of journals that struggle to make their page quotas.

    The rest are small clinical trials with unimpressive results. The one trial not affiliated with the clinic had 4 metrics: 1 looked better, 2 looked worse, 1 was the same, and I’m assuming all of this was within statistical noise, because if it was even vaguely significant they’d have said so. The rest isn’t great either. It wouldn’t surprise me if these were their best data, too – there’s always the drawer full of negative findings that get published “someday”, but if they had better, again they’d be waving it from the rooftops.

    At least it appears that these clinical trials are being done in conjunction with actual drugs. That’s a point in their favor. Still, it smells like placebo to me – and an expensive one at that.

    I’m not terribly opposed to the FDA letting this thing into III (it doesn’t appear to be toxic, at least). But if I had non-resectable glioma, and I had 369(!) active clinical trials to offer my services to, this one would be somewhere around #369 on my list.

  27. Silus says

    Yep- You have posited many different things, but provide no evidence or proof of any of them. If you have ANY evidence of any of these claims, present it.

    Your assertions that these things are true does not make them so.
    Additionally, a cure for cancer (any kind of cancer) is something that would be worth billions of dollars, and fame that goes along with this discovery. If he had real proof, I can think of no reason not to show the world.

    Sadly, his method has not been shown to work. No one else has replicated his results for earlier tests either.

    Though some of his patients have survived, this is not even necessarily due to his treatment. Although it is rare, cancer can go into remission without medical treatment.

    Finally, no one here is starting a ‘smear campaign’. We are pointing out actual, real flaws in how Burzynski has conducted himself.

  28. says

    Speaking of the Ogata abstract, Kevin noticed something weird in their randomization protocol that I didn’t notice at first. “The patients were randomly assigned… [to group A or B] …by the number of metastases and presence of extra-hepatic metastasis at the time of or before operation”. I’m curious whether you’ve seen protocol like that before. It doesn’t seem like it could be random, if you’re using a sorting method.

  29. marty says

    “Yep” your replies should be titled “More Sockpuppets supporting unproven therapies and using the BIGPHARMA excuse”.

  30. BCPA_Lady says

    *delurks*

    toby:

    My heart goes out to you and to your sister-in-law. My brother-in-law was diagnosed with Stage 4 glioblastoma in July 2004 and died in October 2004. He was 25 years old. Our family would have done anything, paid any price, perhaps even risked the Burzynski clinic had his condition allowed for long-distance travel. He was enrolled in three different clinical trials through the NCI (the first two ending within the first week due to adverse reactions).

    sure dr. b’s drugs cost alot but so do conventional drugs.

    Here’s the thing: reputable trials of experimental treatments do NOT charge those who are enrolled. In fact, they actually PAY their patients for participating. They provide the drugs at no cost — because they are unproven.

    “Dr.” B’s drugs cost a lot despite the fact that they are completely unproven, are often combined with commonly used chemo-therapeutic agents — which are marked up at an unconscionable rate, far beyond what “Big Pharma” charges for the exact same drugs, and against all common practice for experimental cancer research.

    I think you, and your sister-in-law, need to ask yourself why virtually every other cancer trial in the United States pays those who participate and does not charge for the drugs being tested, while Burzynski charges literal fortunes from desperate patients and their families. I think you need to ask why virtually every other experimental treatment that shows even the merest “promise” in trials has been trumpeted and sent out for review by other cancer researchers in order to verify their results — while the Burzynski clinic has done none of that.

    Regardless, I extend my best wishes for your sister-in-law’s recovery.

  31. HFM says

    They don’t quite say so, but I assume they’re using a blocked study design. This would use information about the patients to help create balanced groups – for example, if they had 10 patients with extra-hepatic metastases, they’re going to assign 5 to each arm, but which 5 is random. This is pretty common, especially if you know your study will be underpowered; I don’t have a problem with it.

    Kevin also takes issue with the treatment protocol, but I think he misread it. HAI *is* chemotherapy with 5-FU. Group A gets HAI with IV and oral antineoplastons; Group B gets HAI alone.

    Hopefully I’m not giving the authors more credit than they deserve…but the study itself looked solid to me. The results aren’t very promising, but that’s another matter.

  32. says

    Thanks, I’m unfamiliar with medical study design. I learned something today :)

    The HAI/ANP treatment looked to me like a normal two-arm situation, but I was worried I missed something.

  33. says

    My brother-in-law had a very small tumor in his throat that was considered very treatable with a good prognosis.

    He also did not trust conventional medicine and opted for alternative therapies.

    Being that he’s just one individual, the result of this alternative therapy – an excruciatingly painful, drawn-out and horrific death while his four small daughters watched – must be considered purely anecdotal.

  34. Azkyroth says

    O.o

    *reaches for the marshmallows*

    I’m really glad you’re looking into this. As a parent myself, I at least FEEL like what Burzynski’s doing ought to be potentially eligible for the death penalty. >.>

  35. captainchaos says

    Wow, you’re an actual tinfoil hat wearing crackpot. I thought people like you were a myth. Cool!

  36. Yep says

    I can’t believe this Burzynski guy is able to cure cancer – doesn’t that just piss everyone off?

  37. Yep says

    Yes! It’s Yep – the blogger without proof – but then again, doesn’t that represent all bloggers?

    Since when has a blogger presented proof? Who cares if Antineoplastons, surgery, or chemo has provided proof?

    It’s all about stomping anyone that is doing anything innovative right?

    Who cares if people have been cured using ANTINEOPLASTONS – who cares if anyone is ever cured by cancer right? It’s all about people dying –

    nothing is better than ignoring the USA gov’t data on antineoplastons, and then saying “screw those cancer folks” – “let ‘em die!” people should only be poisoned with chemo & radiation and THEN die, the people do not deserve these “Antineoplastons” – how dare they ask for non-toxic treatment and live – fuck them!

    all who have cancer need to die like those on concentration camps like the dirty cancer-victims they are, and die from chemo, radiation and have their bodies cut apart.

    we need to tell the world that they do not deserve an “Option” – let ‘em die!

    Anyone that is cured by these urine “antineoplastons” they need to be shot! all of them!

    America is NOT free – and anyone that thinks that they deserve an option of cancer treatment—especially if they choose antineoplastons—needs to be shot on site!

    to death to all who refuse to choose chemo and radiation or surgery (except biopsies because then the burzynski clinic can analyze them) but after they do! BURN THE CANCER PATIENTS WHO RESIST!

    all cancer patients must accept their poisoned induced death!

    I LOVE THIS BLOG!

  38. F says

    At this point, you have completely stopped making any sense at all. And you’ve become a repetitive troll. I see you just become worse downthread. If you want to talk about lies and misrepresentation, have a read through your posts here.

  39. Interested says

    To get back on track and ask about the publications – has anyone figured out if the conference abtracts are for posters or talks, what calibre of conference they are, and what the abstract submission review process is? These are important questions to answer. If they are just poster abstracts, and if the conference has no abstract submission review process, then these ‘publications’ become even more worthless. This would be good to find out.

  40. Blitzgal says

    Hey, Yep, I see you’re completely ignoring Kristjan’s link that indicates that Burzynski does indeed use chemo drugs in his treatments, and have also refused to answer BCPA Lady’s question about why, when other cancer trials are performed free of charge, Burzynski insists on fleecing his patients out of hundreds of thousands of dollars?

  41. Blitzgal says

    “In 1988, Burzynski got a tremendous boost when talk-show hostess Sally Jesse Raphael featured four “miracles,” patients of Burzynski, who she said were cancer-free. The patients stated that Burzynski had cured them when conventional methods had failed. In 1992, “Inside Edition” reported that two of the four patients had died and a third was having a recurrence of her cancer. (The fourth patient had bladder cancer, which has a good prognosis.) The widow of one of Raphael’s guests stated that her husband and five others from the same city had sought treatment after learning about Burzynski from a television broadcast—and that all had died of their disease.”

    http://www.quackwatch.com/01QuackeryRelatedTopics/cancer.html

  42. Matt says

    You mentioned climate change denial as similar to skepticism of Burzynskies treatments. They’re not similar at all, but I’m glad you brought it up because it actually lets me make a point.

    There are many many many peer-reviewed stuides, published in many many many different journals, that all support climate change. People that still do not accept this data are in denial.

    There is absolutely no peet-reviewed study on Burzynskies data. Zero! Contrary to what you seem to believe, publishing good data isn’t that difficult if you did the study properly. People that still believe Burzynski, despite that there is absolutely zero evidence, are in denial.

  43. says

    I have seen some real loonies in my time, Yep, but you are definitely in the running for the Hall of Infamy.

    Rather than frantically copy-and-pasting, you might want to take the time to follow the links provided and read what people are saying. There has been no conclusive proof presented (by Burzynski, the government, or the FDA) that Burzynski’s treatments are at all efficacious. From the evidence available, he cannot cure cancer.

    But he (and his shills, like you) claims he can. That’s what pisses us off, because it means he preys on desperate individuals who are dying or have loved ones who are dying of cancer. He engages in unethical practices (charging money for what he claims are clinical trials). He engages in bullying tactics against anyone who brings these facts to light. He grows irrationally angry whenever anyone questions his genius.

    These are not hallmarks of a great scientist. They are the hallmarks of a charlatan. And if you’re not being paid by Dr. Burzynski, you have my condolences about the wasted hours, days, or years your idolatry of him has cost you.

  44. Mark Studden says

    Great to see such a vigorously scientific denouncement of such vigorously unscientific buffoonery and charlatanism (Hey, Doc B, I’m in the UK, so SUE ME!).

    Can’t wait to break out the pitchforks and lanterns and march on this snake oil salesman’s castle to torch the lot.

    If the whole story wasn’t so damn tragic for the victims and their loved ones I could contemplate mercy, but… heck, pass the gasoline, I’ve got the matches.

  45. says

    Also, the NCI doesn’t appear to confirm his data at all.

    From their site (http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/patient/page2):

    These studies reported mixed results, including some cancer remissions (signs and symptoms of cancer decreased or went away). Other investigators have not been able to obtain the same results reported by Dr. Burzynski and his team. Some of the patients in the reported studies received standard treatments in addition to the antineoplastons. In those cases, it is not known if responses and side effects were caused by antineoplaston therapy, the other treatments, or both. One additional independent report (a study from Japan) was completed but does not have the same findings as the Burzynski report.

    No randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals.

    In 1991, the National Cancer Institute (NCI) reviewed some of Dr. Burzynski’s cases and decided to conduct clinical trials on antineoplastons at cancer centers. By August 1995, only 9 patients had enrolled and the clinical trials were closed before being completed.

    So. No randomized trials have been published. The NCI does not confirm any efficacy. You were saying?

  46. Joe says

    To answer your question about why Dr B is only suing in the UK, Jen, it is almost certainly due to our stupid libel laws which mean that those who try to apply reason to those who promote ‘alternative medicine’ are all guilty as sin until proven otherwise. It is remarkably easy to sue someone for libel here, and expensive to defend against. For example, see Simon Singh, and Ben Goldacre, to name but two cases.

  47. says

    In the fields I move around in (linguistics and cognitive science), even “peer-reviewed conference abstract” means “somebody on the program comittee read the abstract and it sounded basically on-topic.” There is no endorsement of the findings, and the intent is just to bring people together in an environment that encourages discussing research and meeting people.

  48. melior says

    I also have a question about the (approved, but not started) Phase III trial. The methodology seems to be a comparison of patients divided into two subsets, one receiving Temozolomide (oral capsules) and the other “antineoplastons” pumped directly into a CV catheter.
    With such a setup, there’s no way to do double-blinding, correct?

  49. David St. Hubbins says

    Not necessarily. Each arm could receive both capsules and medication into the CV catheter; in arm A the capsules would be active medication and the catheter injection placebo, in arm B the other way around. I read too many studies already for our IRB, so I didn’t read carefully into dr. B.s study to see if that’s how it was actually set up; but it is possible to double blind a study like this.

  50. Kevin says

    For any lurkers who have *any* doubt as to Yep’s credibility, this post is a simple, succinct case in point. If you read nothing else in this reply thread, please take just a minute or two to read and revel in the sheer irrationality of the world Yep must live in.

    Yep says this:

    “I AM ORAC, AND I WISH THAT LAURA DIES!!!!!!

    http://scienceblogs.com/insolence/2011/11/the_burzynski_clinic_disavows_marc_stephens.php

    Just scroll down about 2/3 of the way into the post.”

    “Yep” clearly implies that he “caught” Dr. Gorski aka Orac of Respectful Insolence, expressing hope that Laura’s treatment does not work.

    Following Yep’s link, we find that Orac actually wrote this (my emphasis added):

    “I also find the anecdote/testimonial of Laura Hyman less than convincing. I have nothing against Laura Hyman. Indeed, I only wish her the best, as I do all cancer patients, especially those with forms of cancer as nasty as hers. Indeed, believe it or not, I hope that for her sake the antineoplastons she’s taking work. Unfortunately, looking at the evidence that exists for the efficacy of antineoplastons I find it highly unlikely that Burzynski can help her. In any case, the press release reports that Laura’s tumor is shrinking, but looking at her blog post talking about her most recent MRI results I’m less than impressed. I wish I could be more impressed, but I can’t. The reason is simple. The tumor on Ms. Hyman’s most recent MRI looks almost identical to how it looked six weeks before. the differences in measurement do not look significant within the range of error of the study to me, and the differences in enhancement could easily be due to differences in technique. Of course, that could mean that she has stable disease (disease that is not growing)–which would be a very good thing in the context of the cancer that Ms. Hyman has–but after only six weeks and such equivocal and questionable changes in the tumor I believe it’s very premature to say much of anything one way or the other. Certainly, it’s premature to point to Ms. Hyman as a success story.”

    Again, if at any point you even begin to wonder about giving “yep” the benefit of the doubt, please reread this post and consider saving yourself a lot of time by dismissing Yep’s proclomations outright. They are universally garbage.

  51. John Horstman says

    Nit-picky grammar point: “thusly” isn’t a word (well, it’s not a Standard Received English word). “Thus” is already an adverb, meaning “in this manner” or “like this” (in the sense in which you mean to be using it here; it’s other meaning is also an adverb, a synonym for “therefore”); you can’t make it any more adverbial by adding the -ly morpheme (as you would with an adjective to make it an adverb).

  52. Interested says

    I’ve posted these two comments on the other post about the papers but I think they bear repeating here. it would be great if any clinically/scientifically-minded people could actually look in depth at the other abstracts in this way too.

    >>>>Comment 1

    Here’s the text from the Japanese group’s conference abstract:
    >>>
    Randomized Phase II Study of Hepatic Arterial Infusion with or without Antineoplastons as Adjuvant Therapy after Hepatectomy for Liver Metastases from Colorectal Cancer

    Publication date: May 17, 2010
    Category: Colorectal cancer
    Publisher: ESMO
    Authors: Y. Ogata; K. Shirouzu; K. Matono; M. Ushijima; S. Uchida; H. Tsuda

    Full Text
    Description

    Background: Hepatic recurrence occurs in a high rate after hepatectomy for patients with colorectal metastasis to the liver. Therefore, hepatic arterial infusion chemotherapy (HAI) has been applied as an adjuvant therapy after hepatectomy. However, HAI is less effective against extra-hepatic recurrence. Antineoplastons (AS2-1 and A10) are naturally occurring peptides and amino acid derivatives found in human blood and urine. Sodium phenylacetate is the main component of AS2-1 and A10. The small peptides reportedly control neoplastic growth and have minimum adverse effects. It seems to be reasonable to apply systemic administration of antineoplastons in addition to HAI after hepatectomy in colorectal metastasis to the liver. This randomized phase II study compares the efficacy of hepatic arterial infusion with or without antineoplastons as postoperative adjuvant therapy for colorectal metastasis to the liver. Patients and Methods: A total of 65 patients who underwent hepatectomy, thermal ablation or their combination for liver metastases from colorectal cancer enrolled between 1998 and 2004 from Kurume University hospital. The patients were randomly assigned to receive systemic antineoplastons (infusion A10 followed by peroral AS2-1) plus HAI using 5-fluorouracil (group A) or HAI alone (group B) by the number of metastases and presence of extra-hepatic metastasis at the time of or before operation. The primary endpoint was mode and extent of recurrence, and secondary endpoints were cancer-specific survival, disease-free survival, rate of re-surgical treatment and adverse effects. Results: Thirty two patients were randomly assigned to group A and 33 to group B. The cancer-specific survival rate in the group A was higher than that in the group B. Although the disease-free survival rates were similar between the groups, the rate of single organ recurrence and re-surgical treatment was higher in the group A. In addition, the extent of recurrent tumors in the group A tended to be within re-surgical treatment. The major adverse effects of antineoplastons were fullness of the stomach and phlebitis. However, no additional toxicity such as bone marrow suppression, liver dysfunction and renal dysfunction was found in the group A. Conclusion: Antineoplastons appears to be useful as an adjuvant therapy in addition to hepatic arterial infusion after hepatectomy in colorectal metastases to the liver.
    http://oncologypro.esmo.org/meeting-resources/meeting-abstracts/european-society-for-medical-oncology-esmo-2010/randomized-phase-ii-study-of-hepatic-ar-3558.aspx

    Just based on what they say, without seeing the actual data, I find it difficult to see how they can justify their conclusion that antineoplastons help – all you can really say is that they don’t make things much worse.

    There were more recurrences in the group treated with antineoplastons (group A) and no difference in disease-free survival (the gold-standard for success in a trial). I don’t understand enough about clinical jargon to know what this phrase means “The cancer-specific survival rate in the group A was higher than that in the group B.”, given that there was no difference in overall survival. I would be grateful if any clinicians can step in.

    This demonstrates neatly is why it’s so important to properly publish. Abstracts mean little – they have no hard figures, they show no graphs. They do not count as solid evidence. Publishing your data means that scientists and doctors can see for themselves exactly what you’ve found, and judge it accordingly.

    >>>Comment 2

    Both groups were getting chemo (that’s the HAI – hepatic artery infusion of 5-FU) group A was getting antineoplastons too.

    But the key thing is that (based on what this abstract tells us) there was no difference in overall disease-free survival (The length of time after treatment for a specific disease during which a patient survives with no sign of the disease), and in fact the rate of “single organ recurrence” was higher in the group with antineoplastons.

    However, “cancer-specific survival” was better in the antineoplaston group – defined by the NCI as “The percentage of people in a study or treatment group who have not died from a specific disease in a defined period of time. The time period usually begins at the time of diagnosis or at the start of treatment and ends at the time of death. Patients who died from causes other than the disease being studied are not counted in this measurement.” http://www.cancer.gov/dictionary?cdrid=44023. The abstract says nothing about the timepoint at which this difference in survival was mentioned. And it also points out that the patients receiving antineoplastons actually had MORE tumours growing back in their liver than the control group, which required surgery to remove.

    I’m really hoping a clinician can step in here and explain what they think these results mean, and if they are justification for the team’s conclusion – but of course that’s pretty hard to do without seeing the actual data and the variation within in. Which, just to reiterate, is why it’s so important that this data is actually published properly and opened for scrutiny.

    While Burzynski himself may not be making grand claims, the people pimping his clinic on his behalf (Oh, hello Eric Merola!) ARE holding it up as an amazing cure for cancer, without providing the evidence. As far as I can see, this abstract represents the only controlled trial of antineoplastons, and the results are not impressive, based on this abstract.

    Yes – the antineoplastons aren’t causing serious side effects (although in other reports there is evidence that deaths from ion imbalance can be attributed to the high levels of sodium in the antineoplaston formulation). But to my eyes anyway, they really don’t seem to be doing much to help.

  53. HFM says

    It appears that while both groups had similar disease-free survival times, the ANP group was more likely to have a localized recurrence (something that could be treated with another surgery). This is actually a good sign; it’s the ones you can’t cut out that are lethal. So these patients would be expected to live longer. They also probably got another round of chemo with their surgeries, so…meh. Without the data, it’s really hard to know whether this means anything – “more likely” could mean an extra patient or two, within the realm of random effects.

    I also find it interesting that there’s virtually no animal data in this set. A quick Google doesn’t turn up much either. Just cell cultures and people. I’d bet my shirt that it was tried in mouse and did absolutely nothing, to the point where even J. Department Copy Machine wouldn’t publish it.

  54. HFM says

    [I apologize if this double-posts; my internet connection may or may not have eaten the first attempt.]

    It appears that ANPs are basically Ammonul (a treatment for metabolic hyperammonemia). Which…there needs to be a LOLcat here to adequately capture the fail.

    For the non-biologists, let me break this down:

    * Hyperammonemia is what happens when the body is unable to get rid of excess nitrogen, usually due to inherited defects in the urea cycle.

    * Ammonul / ANPs bind to L-glutamine, a common amino acid in the blood, making it into a complex that can be excreted by the kidneys. This is an alternate way to get rid of nitrogen.

    * When you grow cells in a culture dish, particularly ones that grow quickly and don’t use glucose efficiently (virtually all cancer cells), you supplement the media with L-glutamine as an alternate energy source. It can go directly into various biosynthetic pathways (especially DNA building blocks, which fast-growing cells need). Without L-glutamine, your cancer cells die.

    * Which sounds like a good thing. Except. In a culture dish, the cells have no other way to get what they need, once the L-glutamine is bound and unavailable. In the body, there are massively redundant feedback loops to make sure the cells get what they need, no matter what.

    L-glutamine blockers have been known since the 1950s (azaserine, there have been others). They are amazing in the culture dish, but that’s as far as they go, because they don’t work in real life.

    No wonder they don’t dare submit to real journals. This is a reprise of a treatment that went down in flames during the Eisenhower years, with less specificity and more intrusive dosing to boot. (6x/day central line injection is not fun even by cancer standards.) I’ve learned not to assume malice where stupidity would suffice…but in this case, I’m not even sure I can be that charitable.

    (Incidentally, this is why real scientists spend their time going after quacks. Most cancer patients don’t know all this stuff – they shouldn’t have to – but if they are online trying to educate themselves, there should be something besides happy horsecrap from people who want their money.)

  55. Jessica says

    Yes, convincing article, but I am not convinced. I am sure that research on vitamin C infusions and cancer also have not been included in many so called prestigious peer review journals either. Then why did vitamin C infusions SAVE MY LIFE? Chemo was not having even the slightest effect on my tumor, but it WAS killing my heart and killing me. Vitamin C infusions with the I.V. kept the chemo from killing me and I am here today 4 years later and cancer free. But, your stupid peer review journals would never publish such a thing I am sure. I had to hide the fact I was doing C infusions from my doctors because they were adverse to it. But, guess what? They obviously have not been taught about it’s benefits, are not allowed to embrace it and are brainwashed to think it was bad…..It was a true miracle for me. So, do I know that medicine today is somewhat of a sham? I sure do!

  56. Thompson says

    Jen,

    Get your facts straight. You need a peer review, do ya? You’re an idiot and instead of thoroughly investigating, you lazily side with what is generally considered the most reputable source(s). How’s that for a peer review?

    Those with half a brain know that we are being lied to by our government, the FDA and even the most prestigious medical journals print falsified information if it is in their best interest such as lining the pockets of the medical and pharmaceutical industries.

    How blind are you? It is your life and it is your choice to live as mentally handicapped as you wish, but you look really silly posting this with such conviction without having done any real research.

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  61. Florecilla Silvestre says

    Hiya there, greetings from Spain. I am having a little squabble with your average pathological chemtrailing antibigpharma/alienabduction/9-11truthing quack (yeah, we have them here too). Annointed with the truth as they are, they think that excuses them to spout their nonsense anywhere (he is doing it at a housing bubble forum!). Damn, are these people rude! We were discussing Mr Quackynski and his ANP and I explained his articles were published at low impact, low quality level and disproved at higher impact level (government reports, the Mayo Clinic Proceedings, etc.). Now he argues that his first “research” papers in Cancer Therapy and Pediatrics Drugs are FDA aproved so his claims must be true. I am sure the FDA supervision (if any) limits itself to some paperwork, random audits and can not be conceived as an endorsement of the published contents. But unnaquainted as I am with bioresearch and the USA, I am unable to confirm my suspicion. I am lost reviewing the bureacracy. So can anyone summarize what the *legal* situation is? Mr Quackynski is entering Phase III, isn’t he? now did he submit an NDA? Did his 2 infamous ANP papers qualify as Phase II clinical trials? Does the FDA review his publishing? Do they ask for the evidence he backs his papers with? Maybe, did the IRB fail? http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

    Thank you in advance

  62. says

    Imagine, when socialism is forced onto a people against their will…it’s Communism. And true Socialism is when Corporations and the Government merge.

    Do you suppose that a true published peer review would be akin to giving Stanislaw Burzynski a soap box to stump from?

    Ever heard the term blackballed?

    Why do you suppose the Texas Med., then the FDA would try so hard to shut him down over 4 decades. No less than 4 Congressional Gran Juries, of which one Senator called the FDAs efforts a witch hunt.

    I can hear your chants…….
    “crucify him, crucify him”

    the “obvious” craziness turns out to be a genuine cutting-edge discovery. As with the little child questioning the emperor’s clothing, sometimes the entire scientific community is misguided and incompetent. Sometimes only the lone voice of the maverick scientist is telling the truth.

    Below is a list of scientists who were reviled for their crackpottery, only to be later proven correct. Today’s science texts are dishonest to the extent that they hide these huge mistakes made by the scientific community. They rarely discuss the acts of intellectual suppression which were directed at the following researchers by their colleagues. And… after wide reading, I’ve never encountered any similar list.[1] This is very telling.

    “When a true genius appears in this world, you may know him by this sign, that the dunces are all in confederacy against him.” – Jonathan Swift

    THE LIST: scroll down

    To add: Gilbert Ling, John C. Lilly

    Arrhenius (ion chemistry)
    Alfven, Hans (galaxy-scale plasma dynamics)
    Baird, John L. (television camera)
    Bakker, Robert (fast, warm-blooded dinosaurs)
    Bardeen & Brattain (transistor)
    Bretz J Harlen (ice age geology)
    Chandrasekhar, Subrahmanyan (black holes in 1930)
    Chladni, Ernst (meteorites in 1800)
    Crick & Watson (DNA)
    Doppler (optical Doppler effect)
    Folk, Robert L. (existence and importance of nanobacteria)
    Galvani (bioelectricity)
    Harvey, William (circulation of blood, 1628)
    Krebs (ATP energy, Krebs cycle)
    Galileo (supported the Copernican viewpoint)
    Gauss, Karl F. (nonEuclidean geometery)
    Binning/Roher/Gimzewski (scanning-tunneling microscope)
    Goddard, Robert (rocket-powered space ships)
    Goethe (Land color theory)
    Gold, Thomas (deep non-biological petroleum deposits)
    Gold, Thomas (deep mine bacteria)
    Lister, J (sterilizing)
    T Maiman (Laser)
    “Concepts which have proved useful for ordering things easily assume so great an authority over us, that we forget their terrestrial origin and accept them as unalterable facts. They then become labeled as ‘conceptual necessities,’ etc. The road of scientific progress is frequently blocked for long periods by such errors.” – Einstein
    Margulis, Lynn (endosymbiotic organelles)
    Mayer, Julius R. (The Law of Conservation of Energy)
    Marshall, B (ulcers caused by bacteria, helicobacter pylori)
    McClintlock, Barbara (mobile genetic elements, “jumping genes”, transposons)
    Newlands, J. (pre-Mendeleev periodic table)
    Nott, J. C. (mosquitos xmit Yellow Fever)
    Nottebohm, F. (neurogenesis: brains can grow neurons)
    Ohm, George S. (Ohm’s Law)
    Ovshinsky, Stanford R. (amorphous semiconductor devices)
    Pasteur, Louis (germ theory of disease)
    Prusiner, Stanley (existence of prions, 1982)
    Rous, Peyton (viruses cause cancer)
    Semmelweis, I. (surgeons wash hands, puerperal fever )
    Steen-McIntyre, Virginia (southwest US indians villiage , 300,000BC)
    Tesla, Nikola (Earth electrical resonance, “Schumann” resonance)
    Tesla, Nikola (brushless AC motor)
    J H van’t Hoff (molecules are 3D)
    Warren, Warren S (flaw in MRI theory)
    Wegener, Alfred (continental drift)
    Wright, Wilbur & Orville (flying machines)
    Zwicky, Fritz (existence of dark matter, 1933)
    Zweig, George (quark theory)

    ——————————————————————————–

    “Men show their character in nothing more clearly than by what they think laughable.” -J. W. Goethe

    ——————————————————————————–

    Some ridiculed ideas which had no single supporter:
    Ball lightning (lacking a theory, it was long dismissed as retinal afterimages)
    Catastrophism (ridicule of rapid Earth changes, asteroid mass extinctions)
    Child abuse (before 1950, doctors were mystified by “spontaneous” childhood bruising)
    Cooperation or altruism between animals (versus Evolution’s required competition)
    Instantaneous meteor noises (evidence rejected because sound should be delayed by distance)
    Mind-body connection (psychoneuroimmunology, doctors ridiculed any emotional basis for disease)
    Perceptrons (later vindicated as Neural Networks)
    Permanent magnet levitation (“Levitron” shouldn’t have worked)

    ——————————————————————————–

    “The mind likes a strange idea as little as the body likes a strange protein and resists it with similar energy. It would not perhaps be too fanciful to say that a new idea is the most quickly acting antigen known to science. If we watch ourselves honestly we shall often find that we have begun to argue against a new idea even before it has been completely stated.” – Wilfred Trotter, 1941

    ——————————————————————————–

    “The study of history is a powerful antidote to contemporary arrogance. It is humbling to discover how many of our glib assumptions, which seem to us novel and plausible, have been tested before, not once but many times and in innumerable guises; and discovered to be, at great human cost, wholly false.” -Paul Johnson

  63. Nigel says

    Thanks, Lowell. As we all know, the fact that some people prevailed despite public opinion to the contrary is logically proof that one person involved in a different discipline who has been criticized is clearly correct.

    I look forward to your, I’m guessing, 1000-times-longer post listing the names of crazies who were, amazingly enough, crazies (you know, just to give a little balance and perspective).

  64. says

    Jen, this is so poorly written. Your “facts” are more-less matters of personal opinion laced with political dictation. “crappy medical journal” “Sketch as hell paper” “I never read the papers…”” your male-esk mug shot I’m staring at makes you look sketch as hell. I went to his clinic with 3 months to live… I am now cancer free. Stick that in your research pipe and smoke it down. You may as well talk about lunar moduals landing on Pluto in the year 2084- you’ll showcase as much knowledge as you did on this subject. NOTHING.

  65. says

    I’ve been browsing online more than three hours today, yet I never found any interesting article like yours More damning revelations about Burzynski’s “research” | Blag Hag. It is pretty worth enough for me. Personally, if all webmasters and bloggers made good content as you did, the web will be a lot more useful than ever before.

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