Burzynski: in dire need of credibility

A guest post by Keir Liddle^

The Burzynski clinic has, of late, had something of a public relations problem. No longer are the majority of sites on the internet uncritically praising the maverick doctor and his miraculous “natural” cure for seemingly ever cancer that has ever mutated.

Thanks to a high profile Twitter campaign that was supportive of a family raising funds to send a person to the clinic and a couple of UK Skeptic red flags – “groundbreaking treatment” and “not available on the NHS”, there was a marked increase in scrutiny of the Burzynski Clinic and the poorly named Burzynski Research Institute (which has to date published no results of the numerous clinical trials Burzynski has “conducted”).

The explosion of interest in Burzynski can be traced back to the efforts of Marc Stephens who reacted to this criticism by attempting a nonsensical legal chill. The high point of which was probably the red arrow email which he sent to several prominent UK Skeptics claiming they were part of a conspiratorial skeptic society funded by big pharma. The low point was sending Rhys Morgan an “I know where you live email” complete with pictures and a map showing Rhys’s house.

What Marc Stephens didn’t realise was that UK Skeptics don’t take kindly
to libel threats, ever since the British Chiropractic Association attempted to sue Simon Singh, and a spectacular Streisand effect spread like wildfire across the internet.

Had this not happened the blogs might have been ignored by the mainstream media and the controversy would have remained hidden behind a sickening veneer of “human interest” stories about the latest family seeking the extortionate funds Burzynski requires to deal them his particular brand of false hope.

Marc Stephens has since parted company with the clinic and they now have a new PR consultant*. First spotted at the Burzynski clinic Christmas party, former investigative journalist Wayne Dolcefino appears to have taken the reins of the clinic’s PR. Dolcefinos company, Dolcefino Communications LLC offers media training, crisis communications, political consulting and
opposition research.

The Burzynski clinic is certainly in need of some crisis management regarding the current “negative” press arising from skeptical scrutiny and criticism. It is in crisis because people noticed in over 35 years of working with antineoplastons Burzynski has not published a single peer reviewed publication from any of his 60 odd trials for various cancers. It is in crisis because skeptics have cast Burzynski’s dubious legal history into the light of day and exposed the ethical warnings Burzynskis IRB have received from the FDA. The clinic is in crisis because of the damage done to patients like Lola Quinlan and the FDA’s lumbering bureaucracy has seemingly stepped in to stop Burzynski prescribing ANPs at least temporarily while the clinic is audited.

But who is Dolcefino? Well he is a former investigative journalist and for nearly 26 years he headed up the ABC-owned station’s 13 Undercover unit. Over the course of his career Dolfecino exposed corruption that led to Harris County Commissioner Jerry Eversole’s resignation and the indictment of Harris County Precinct 6 Constable Victor Trevino on four felony offenses.

One of Dolcefino’s investigations landed him in legal hot water after he implicated State Rep. Sylvester Turner in a $6.5 million insurance scam. Costing Turner the Houston Mayoral election. Though the supreme court later overturned this decision. A blog case study of the case can be found here. As you can see the case was brought by Turner because he believed that the Dolcefino report implicated him in an insurance fraud perpetuated by one of his acquaintances.

Dolcefino’s defence was twofold:

  1. That every statement in the report was on its face accurate. Because of the libel requires falsity, Turner could not prevail in the suit.
  2. That Turner, as a public official and public figure, must show actual malice and would not be able to do so. Essentially, he would have to prove Dolcefino and KTRK knew the publication was false or acted with reckless disregard to the truth.

In the original case the court ruled against the first defence but accepted the second. The court said it was possible to recover for “libel by implication,” essentially arranging true facts in a way that the overall impression were false. This decision was subsequently overturned by supreme court appeal.

Reportedly one of Dolcefino’s first clients was former Houston attorney Ben Hall who has hired Dolcefino to dig for dirt on his opponent in the upcoming Houston mayoral elections incumbent Annise Parker. But this news was later denied by Hall and by Dolcefino himself.

One wonders if he will be tasked with digging up any dirt on the skeptics who have criticised Burzynski? I wish him luck finding any dirt on me and look forward to Peter Bowditch being the victim of yet another case of mistaken identity. Or if his job will simply be to help the clinic weather yet another storm of criticism?

Whatever his specific role Wayne Dolcefino has a huge job ahead of him to turn around the clinic’s fortunes but one wonders why someone whose companies motto is “credibility when you need it most” has chosen to represent someone who completely lacks scientific or medical credibility.

* UPDATE (12/02/12 16:58)

There has been a lot of tweeting from the anonymous Burzynski shill about this argument questioning the evidence that Dolcefino has indeed taken on the role of clinic PR.

Well as the text below, from an email sent to some high profile former patients and critics of the clinic confirms he does indeed seem to have the job. Or at least claims to have taken it:

My name is Wayne Dolcefino . I am former investigative reporter at KTRK TV Houston and now have a media consulting company. Dr. Burzynskis office has retained my company to assist them in establishing, how should I say it, more mature conversations with people who have issues with the clinic.

If Dolcefino is not representing the clinic one wonders who is impersonating him or indeed why he may have taken it upon himself to declare a non-existent financial connection.

^ Keir usually posts at The 21st Floor, which has been offline following a complaint by the live blood analysis quack, Errol Denton. They came back online on 13th February and this post now also appears there.

73 responses to “Burzynski: in dire need of credibility

  1. Marc Stephens Is Insane

    He was also arrested in 2009 for criminal tresspass.

    I presume a big part of the crisis management will be to handle the backlash when word spreads that the FDA has effectively banned Count Stan from doling out his ANPs.

  2. All very interesting, but how do we know that Dolcefino is really Burzynski’s new PR guy? Please tell me you have more reliable information than just “spotted at the Burzynski Xmas party”?

  3. There is no public confirmation that I know of but there have been private emails going round, indicating that Dolcefino has claimed to be representing the clinic.

  4. I spent a few hours finding out what I could on this chap. Appart from finding out far too many details about his personal life, he’s had an interesting legal past. Arrested for misdemeanour assault in 1995, then acquitted after the accuser didn’t show. Arrested for DWI (drink driving) on February 9, 1996 (charges don’t appear to have been filed). Named in a paternity lawsuit. Of course, the liable case that case that Kier has listed above (http://www.supreme.courts.state.tx.us/historical/2000/dec/99-0419tp.pdf – summary on page 33). In and out of court rooms for years. Just a side point, but he appears to have used the same legal team as Stan (Rob Swofford assisted by Dan Cogdel of “Collins, O’Neal & Swofford” in Huston for a good few years.

    He appears to have done a very good job to hiding his past, maybe he can do the same for big Stan?

  5. Dolcefino is well known in Houston due to his long career with KTRK in the shadow of Marvin Zindler. He’s considered a hero by some and reviled by others. His personal life IMO has very little to do with the fact that he seems to have been drawn by Stan’s money to the “dark side”. I find it hard to believe that he would champion this cause otherwise.

  6. That’s a fair comment. I would say though, if Mark Stephens taught people anything, it’s good to know in advance a little bit about these guys. His history probably has nothing to do with him working with Burzyński. He doesn’t appear to have any ideological links at all.

  7. Perhaps this could be added as an update to the above post?

    “There has been a lot of tweeting from the anonymous Burzynski shill about this argument questioning the evidence that Dolcefino has indeed taken on the role of clinic PR.

    Well as the text below, from an email sent to some high profile former patients and critics of the clinic confirms he does indeed seem to have the job. Or at least claims to have taken it:

    “”My name is Wayne Dolcefino . I am former investigative reporter at
    KTRK TV Houston and now have a media consulting company. Dr.
    Burzynskis office has retained my company to assist them in
    establishing, how should I say it, more mature conversations with
    people who have issues with the clinic.”

    If Dolcefino is not representing the clinic one wonders who is impersonating him or indeed why he may have taken it upon himself to declare a non-existant financial connection.”

  8. Marc Stephens Is Insane

    More “mature” conversations? Like the #BurzynskiSaves tweeter who calls people “c*nts”?

    I detect threats on the horizon. Make some popcorn, everybody. (Is popcorn popular in the UK? It seems like an American thing to me.) If not, get some packets of crisps then.

  9. Done. Have also corrected some annoying formatting caused by the way I copied and pasted the original text.

  10. Looks like @BurzynskiSaves is having a bit of a seizure over this. Either he’s angry that Stan didn’t tell him about Dolcefino, or he’s trying to play it down (both?). Pathetic and a bit laughable, if real lives weren’t wrapped up in this whole ugly mess.

    • Hard to know really. But it’s also interesting that after quite a lot of activity, @BurzynskiMovie seems to have gone very quiet. Perhaps he did get the memo that he’s been sacked and Dr B now has a new PR guy?

  11. Marc Stephens Is Insane

    Or he’s angry he didn’t get the job!

  12. Marc Stephens Is Insane

    Merola never acted officially as Count Stan’s PR guy. In fact they went to great lengths to claim that Merola had nothing to do with Burzynski; he was an independent “filmmaker” who took an interest in the great work that Stan was doing and was motivated to make the commercial.

    Of course it’s hardly ever mentioned that Eric Merola’s first cousin died as a Burzynski patient, two weeks after the doctor told her the tumour was shrinking. Her fundraising page is still up, over two years after her death, with no mention that she died.

    I’ve speculated before that maybe Merola offered to make the movie initially as barter for his cousin’s treatment. The cost of a movie like that is probably what she had to pay Burzynski.

    I have all the links supporting my statements if anyone is curious.

  13. Perhaps it is hard to put out a Pro-Burzynski movie, highly critical of the FDA, at the exact same time as FDA auditors are combing through records at the clinic…….

  14. Marc Stephens Is Insane

    Exactly. And since ANPs have been scrubbed out of existence, a good chunk of the movie is now probably irrelevant.

  15. Marc Stephens Is Insane

    And it’s well-known that Merola and brother “Peter Joseph” are the kooks behind the “Zeitgeist” series of conspiracy films. Merola uses an alias on those films, but it’s definitely him. I guess he wanted to keep his day job making Campbell’s Soup and Old Navy commercials separate from his crackpot conspiracy films.

  16. HarveySpooner@aol.com

    Burzynski? In dire need? You fucking people didn’t exist before the internet. For the most part you are all a bunched of failed naysaying jack-offs. I read your stuff you publish from time to time and wonder to myself if you ever read it back and listen to how incredibly fucking dumb you sound. Why anyone would want to have a conversation with you any of you assholes…..

    Interesting the other day I randomly queried the names of various proponents within the international sceptics groups and what not surprised to find that many have criminal records ranging from aggravated to sexual assault, many have declared bankruptcy……you get the picture….now fuck off….

    • Could you please specify what the international sceptics groups are to which you refer? Who specifically has a criminal record and could you provide details?

    • Actually Skepticism first appeared in it’s modern form around the time of the Scottish Enlightenment when David Hume proposed mitigated Skepticism. James Young Simpson debunked homeopathy around the same time.

      Other famous debunkers include Benjamin Franklin (who debunked animal magnetism) and Harry Houdini (who debunked psychics and mediums).

      The true modern definition of “skeptics with a K” scientific skepticism comes from Paul Kurtz and Carl Sagan.

      The CSI was founded in the late 70’s and the JREF the mid 90’s. long before the blogging explosion and widespread internet access and use.

      As for being a failure. Well I dunno I’m a PhD candidate at present heading for a research career. I’ve organised one of the largest and longest skeptical festivals on the planet and next year I am getting married. I count those all as things not exactly being in the “FAIL” column.

      One wonders why we blog these things when all we get in return is a torrent of abuse. Could it perhaps be because we can’t stand by and let people like Burzynski abuse and con the vulnerable? Apparently not. Apparently we are all just “mean” people. Well thanks for that.

    • I am pretty confident I existed before the internet. I existed before Al Gore’s political career.

    • I can tell you with complete confidence that I definitely existed before the internet. I have documentary evidence to prove this. KTHXBAI

  17. HarveySpooner@aol.com said:

    Why anyone would want to have a conversation with you any of you assholes…..

    Beats me too. Why did you then?

  18. Marc Stephens Is Insane

    What was his point? That Count Stan is doing fine? That’s why the FDA has stopped him doling out his flagship product and why he’s had to hire a new PR flack to put out fires? I guess the Titanic was doing fine too as it sank to the depths of the ocean.

    It would be nice if an adult could communicate without all the “f-bombs” and other offensive language. I’m not a prude but it shows his intellectual shortcomings when that’s the only way he can express himself.

  19. Marc Stephens Is Insane

    Keir,

    Are you receptive to pedantry? I’ve noticed you make the same error in English over and over again, and it’s a pet peeve of mine. Since you’re a writer I thought you might like to know about it, but some people don’t want to be corrected so if that’s the case I’ll shut up.

  20. Pingback: SKEPT!CAL blog » Wayne Dolcefino

  21. Pingback: Burzynski: An interview with Wayne Dolcefino | Josephine Jones

  22. Pingback: Burzynski blogs: My Master List | Josephine Jones

  23. This post is laughable since Burzynski has not claimed that antineoplastons can cure every type of cancer, and that is documented here:
    http://www.commonweal.org/pubs/choices/21.html
    Additionally, I find the comments re Lola Quinlan to be unsupported by the news report:
    http://www.jag-lawfirm.com/burzynski-suit-kprc-02012012.html
    Or:
    http://m.click2houston.com/news/Houston-cancer-doctor-draws-new-complaints-from-patients/-/16714936/8581480/-/hmrbjk/-/index.html

  24. I believe Keir has already linked you to information sent out by the Burzynski clinic to prospective patients:

    https://josephinejones.wordpress.com/2012/05/31/the-burzynski-clinic-misleads-prospective-patients/

    Much of this information discusses cancer in general, as though it were a single disease. Don’t get me wrong – I’m not suggesting that Burzynski thinks it is – but I believe to a layperson it gives the impression that antineoplastons are effective against cancer in general.

    But to be honest, I don’t really understand your point. I don’t see what this has to do with the post you are commenting on.

    And what are the comments about Lola Quinlan? Is it something in the linked Quackometer post? I really have no idea what on earth you’re on about.

    • Re Lola Quinlan, the post states:

      ” The clinic is in crisis because of the damage done to patients like Lola Quinlan …”

      From the link I provided, Lola got her money back, according to Richard (Rick) A. Jaffe, she was getting better, she had signed informed consent forms that pointed out that the in-house pharmacy is owned by Burzynski, she did NOT receive antineoplastons, etc., and so until someone provides additional information or the court case has documented evidence I am not aware of, I cannot support the idea that damage was done to her
      http://www.casewatch.org/civil/burzynski/quinlan/petition.shtml

      • There is documented evidence of the court case, as reported on the link you provided. And if you don’t want to take their word for it, you can go on to the Harris County District Clerk site yourself and read the original documents.

        Here’s a link:

        http://www.hcdistrictclerk.com/Edocs/Public/search.aspx

        Your comment suggests you know nothing about the case and haven’t even read the link you gave. I don’t know why you think she got her money back or that she was getting better or that she didn’t have antineoplastons. Of course, we know that the case was eventually dismissed but this was after Ms Quinlan’s death and we don’t know the reasons behind the dismissal.

    • I will quote directly from the article:

      “Burzynski said he was clinically impressed, especially with the results with prostate cancer … and brain cancers, specifically childhood gliomas, … After that, he said, in descending order, he is impressed with results with non-Hodgkin’s lymphomas (80% of tumors reduced by 50%) and pancreatic cancers (70% of tumors reduced by 50%). Breast cancer follows, with lung cancer and colon cancer further down the list. … These figures, he added, were for responses using his synthetic antineoplastons. He is in the process of completing a production plant for production of a natural antineoplaston derived directly from urine. With the natural product, he said that he expected better responses with mesotheliomas and lung, bladder, breast, and colon cancers.”

      “Burzynski replied that in the early years, he did not know which cancers would respond and which would not, so in his view–and in the view of colleagues with whom he discussed this issue–the decision was properly on the patient’s side. In later years, he said he has been more able to describe to patients whether or not he has had success with their kind of cancers, although some want to try the therapy even when the probability of success is not high (the same dilemma is well-known to conventional oncologists). He also responded that, in many cases, the effectiveness of the therapy can be determined within 6 weeks, which somewhat limits the financial burden to the patient.”

      • He was impressed with the results. Why has he not shared them?

      • As I have posted elsewhere, in my personal opinion Burzynski was waiting until he finished ALL clinical trials re A10 and AS2-1 before publishing the final results

      • What about the trials he abandoned? How many Phase II trials are necessary? I can’t find another treatment that remained in Phase II trials for as long or remained unpublished….

      • Or had as many Phase II trials open at one time…..30+? Seems a bit excessive, with no actual published results, don’t you think?

      • In an attempt to address the quested posted by Lawrence, I accessed:
        http://www.clinicaltrials.gov
        Instead of taking the information they display at face value, where available I selected the National Cancer Institute at the National Institutes of Health (NCI) link in order to find out if their information differed, and found that some did:

        61 TOTAL
        1 – Not Yet Recruiting (Open)(Phase 3)
        1 – Closed
        2 – Terminated (Withdrawn due to slow enrollment)
        7 – Withdrawn (This study has been withdrawn prior to enrollment)
        10 – Recruiting (Open)
        11 – Open (1 Not Yet Recruiting / 10 Recruiting)
        40 – Active, not recruiting (Closed)

        I believe that it has been indicated that all Phase 2 trial have ended, which is why the FDA is supposedly at the clinic

      • In an attempt to address the question posed by Lawrence, as I posted elsewhere on this blog, it was pointed out to me that the Declaration of Helsinki, point 30. covers clinical trial results being published, but no timetable is mentioned, so it is open to interpretation as to WHEN to publish
        For comparison purposes I conducted the following research re ANP’s:

        Phenylacetylglutaminate (PG) and PHENYLACETATE (PN) are metabolites of PHENYLBUTYRATE (PB) and are constituents of antineoplaston AS2-1

        Sodium PHENYLBUTYRATE (PB)
        Year – Pubmed (110 entries)
        1958 – 1st entry
        1995 – 1st clinical trial
        2001 – Phase 1
        2009 – Phase 2
        2012 – Phase 3

        PHENYLACETATE (PN)
        Year – Pubmed (29,686 entries)
        1883 – 1st entry
        1994 – Phase 1
        1999 – Phase 2
        2013 – latest

        Antineoplaston(s)
        Year – Pubmed (88 entries)
        1976 – 1st entry
        1986 – Phase 1
        1999 – Phase 2
        2003 – Phase 2 preliminary
        2004 – Phase 2 preliminary
        2012 – latest

        So, by comparison, antineoplastons are new on the scene compared to Sodium PHENYLBUTYRATE (PB) and PHENYLACETATE (PN)

        2012 was the year that Sodium PHENYLBUTYRATE (PB) made it into a Phase 3 trial after being mentioned in a 1958 publication

        1999 was the latest year PHENYLACETATE (PN) was in the name of a Phase 2 trial, and it is still being researched

        It was 4 years between the Phase 2 and Phase 3 trial that Sodium PHENYLBUTYRATE (PB) was in

        So, if the FDA is at the clinic because Phase 2 trials just finished up, they still have 4 years for ANP’s to catch up with PHENYLBUTYRATE (PB) as far as being in a Phase 3 trial, and PHENYLBUTYRATE (PB) was not even the main focus of that trial

      • In an attempt to respond to the question posted by Lawrence, let us pretend there might be another blog out in the universe somewhere, which you would post on, and for the sake of this post, let us say that you might have posted comments on there:

        Post/2013 date
        11 – 1/21
        56 – 1/22
        70 – 1/23
        75 – 1/23
        87 – 1/23
        91 – 1/23

        and that I, the alleged “spammer,” might have posted my 1st post on that particular imaginary blog on 1/28 (#101), and that starting on 2/4 (Post #158), I started posting in chronological order, a history of Burzynski which specifically addressed the clinical trials in question, and perhaps on Post #180 (Part 2), there was an entry dated 2/29 – 3/25/1996 which was relevant to your question, on this “imaginary” blog that possibly could have a link that might look something like this ?
        http://scienceblogs.com/insolence/2013/01/21/quoth-joe-mercola-i-love-me-some-burzynski-antineoplastons

      • JJ, well thank you !

        I thought you would never ask !!

        Please see my blog that I posted before I saw your reply about my comments that suggest that I “know nothing about the case and haven’t even read the link” I gave

        Here’s a link:
        http://hypocriticaloath.scienceblog.com

        I do not know why you think she did not get her money back

        You do know that the court documents indicate WHY the case was dismissed, right ?

        By law, the Plaintiff was required to file with the court and defendant a report as to who their expert witness(es) would be, within 120 days of the case being filed

        Plaintiff’s attorney did not do this and the case was dismissed

      • Ms Quinlan died on on 17th May 2012 (as I recall, this was coincidentally the day that the 120 day deadline was up). The defendants attempted to get the case dismissed shortly after her death but Ms Quinlan’s representatives asked that this motion be denied (18/06.12). Then just over a month later (23/07/12), the case was actually dismissed (on plaintiff’s motion). We can only speculate on the reasons for this. I am aware of no recent news reports on this case. Could you point to a court document which confirms she got her money back? I haven’t seen one.

      • 1/18 – case filed
        2/1 – Richard (Rick) A. Jaffe

        “Jaffe said she reversed the charges on her credit card after changing her mind about the treatment, pointing out that only Dr. Burzynski has actually lost any money from her treatment”

        Article posted on Plaintiff’s attorney’s web-site, making it highly dubious that Jaffe’s statement is incorrect, and the requested jury trial had not started

        3/19 – Liability claims filed by Plaintiff
        5/17 – Ms. Quinlan passes
        6/1 – Defendant’s Motion to Severe other individual Plaintiff’s case from Quinlan’s case approved
        6/28 – Accelerated Appeal notice filed by Defendant re Court’s Denial of Defendant’s Motion to Dismiss – Expert(s) report not provided
        7/11 – Plaintiff’s Motion to Dismiss
        7/16 – Case Dismissed per Plaintiff’s Motion
        7/17 – Severed Case Expert(s) report due
        7/18 – Severed Case Dismissal Request per Defendant – Expert(s) report not provided
        7/23 – Severed Case Dismissed per Plaintiff’s Motion
        7/30 – Defendant’s Motion to Dismiss to be considered by Court (not necessary since Severed Case Dismissed)
        8/9 – Appeal’s Court Dismisses Defendant’s Appeal per Defendant, Case disposed (since case dismissed)
        Court of Appeals, 1st District
        No 01-12-00617-CV
        Motion to Dismiss Appeal
        http://statecasefiles.justia.com/documents/texas/first-court-of-appeals/01-12-00617-cv.pdf?ts=1344614867

  25. @Didums – ah, you can’t post in English. Color me impressed….

    I am a little confused by your list – since the status of the vast majority of those studies are “unknown” meaning no one has bothered to update them in 2+ years & seeing that some of the studies have, in fact, been open since 1999…..in comparison, I see numerous “completed” studies for the other two drugs, but only one in your list. I also see that most of the studies in the other two lists lasted 2 – 3 years, while the majority of the Burzynski studies have lasted much longer (10+ years in most cases).

    I have also noticed that in several of the “unknown” status studies, the last status was “recruiting” even multiple years after they were opened – for example:

    History of NCT00003453
    Brief title: Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
    Record State: RELEASED
    Updated View Type of info changed
    2005_06_23 Study Nothing (earliest version on record)
    2005_06_30 Study Changes Misc.
    2005_07_25 Study Changes Protocol
    2005_08_01 Study Changes Protocol
    2005_09_09 Study Changes Administrative, Misc.
    2005_12_08 Study Changes Protocol
    2006_03_30 Study Changes Protocol, Misc.
    2006_05_23 Study Changes Recruitment, Misc.
    2006_06_07 Study Changes Misc.
    2006_09_29 Study Changes Recruitment, Misc.
    2006_11_08 Study Changes Protocol, Recruitment, Misc.
    2007_01_11 Study Changes Misc.
    2007_01_16 Study Changes Protocol, Misc.
    2007_02_20 Study Changes Protocol, Recruitment, Misc.
    2007_06_04 Study Changes Protocol, Recruitment, Misc.
    2007_09_20 Study Changes Protocol, Recruitment, Misc.
    2007_10_17 Study Changes Protocol, Misc.
    2007_10_19 Study Changes Protocol, Misc.
    2007_10_29 Study Changes Protocol, Misc.
    2007_11_06 Study Changes Protocol, Misc.
    2007_11_16 Study Changes Recruitment, Misc.
    2007_12_26 Study Changes Protocol, Recruitment, Misc.
    2008_01_11 Study Changes Recruitment, Misc.
    2008_01_14 Study Changes Protocol, Misc.
    2008_04_09 Study Changes Recruitment, Misc.
    2008_05_26 Study Changes Protocol, Misc.
    2008_07_23 Study Changes Misc.
    2008_09_10 Study Changes Recruitment, Misc.
    2008_10_22 Study Changes Recruitment, Misc.
    2008_12_23 Study Changes Recruitment, Misc.
    2009_06_09 Study Changes Recruitment, Misc.

    Please note that the actual clinical trial entry was created:

    ClinicalTrials.gov Identifier:
    NCT00003453
    First received: November 1, 1999

    So, it took them 6 years to actual put something together & 4 years after that of changes / recruitment – then they stopped updating the record in 2009 – which was 4 years ago (again) at this point.

    I’m not seeing this same process in play with other drugs – where clinical trials are started, recruited and completed (and published) in much shorter periods of time. I am also not able to find a similar profile of “unknown” status clinical trials from elsewhere – especially where information has not been updated in as many as 4 – 6 years.

    I’m not sure how even this information can’t raise some red flags for you.

    • Lawrence – ah, you are correct, I

      “can’t post in English” 😉

      I am a little confused by your post, since you indicate that the

      “status of the vast majority of those studies are “unknown””

      Did you note that my above post indicated that

      “Instead of taking the information they display at face value, where available I selected the National Cancer Institute at the National Institutes of Health (NCI) link in order to find out if their information differed, and found that some did:”

      That “link” is near the bottom of the page; where applicable, under:

      > More Information

      Clinical trial summary from the National Cancer Institute’s PDQ® database

      and this individual one eventually lands you here:
      http://cancer.gov/clinicaltrials/search/view?cdrid=654477&version=healthprofessional
      (Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer)
      Phase II
      Status – Active
      Age – 6 months and over
      Protocol IDs – CDR0000066485
      BC-AD-2, NCT00003453

      We know that this is NOT one of the Protocols listed here:

      Form 10-Q (For the fiscal year ended February 29, 2012)

      The results of Protocols BT-06, BT-07, BT-08, BT-09, BT-10, BT-11, BT-12, BT-13, BT-15, BT-18, BT-20, BT-21, BT-22 and BT-23 are set forth below (as of May 1, 2012)
      http://www.sec.gov/Archives/edgar/data/724445/000110465912040430/a12-12972_110k.htm

      Which means it probably is NOT one of these:

      Form 10-Q (Received 10/15/12 • Period 08/31/12)

      Introduction

      “The Company believes Antineoplastons are useful in the treatment of human cancer and is currently conducting PHASE II CLINICAL TRIALS of Antineoplastons relating to the treatment of cancer”
      http://www.secinfo.com/d11MXs.p23hz.htm

      Which means it is probably NOT this “ONE:”

      Form 10-Q (For the quarterly period ended November 30, 2012) (1/14/2013)

      Introduction

      “The Company is currently conducting ONE FDA-approved CLINICAL TRIAL”
      http://www.faqs.org/sec-filings/130114/BURZYNSKI-RESEARCH-INSTITUTE-INC_10-Q

      Color me NOT impressed….

      I’m not sure how even this information can’t raise some red flags for you

      Perhaps you might contact Clinical Trials . gov via the phone # they provide, or by e-mail, or contact the NCI, or Wayne Dolcefino, and find out who dropped the ball on updating the status of this Protocol 🙂

  26. @Didums – I picked that one at random. Let’s take a look at another one:

    Antineoplaston Therapy in Treating Patients With Glioblastoma Multiforme
    ClinicalTrials.gov Identifier:
    NCT00003456
    First received: November 1, 1999
    Last updated: July 23, 2008
    Last verified: July 2004

    2005_06_23 Study Nothing (earliest version on record)
    2005_06_30 Study Changes Misc.
    2005_07_25 Study Changes Protocol
    2005_08_01 Study Changes Protocol
    2005_12_08 Study Changes Protocol
    2007_01_11 Study Changes Recruitment, Misc.
    2007_02_09 Study Changes Protocol, Recruitment, Misc.
    2007_10_17 Study Changes Protocol, Recruitment status, Recruitment, Misc.
    2007_10_29 Study Changes Protocol, Misc.
    2007_11_06 Study Changes Protocol, Misc.
    2007_11_16 Study Changes Recruitment, Misc.
    2008_05_26 Study Changes Protocol, Misc.
    2008_07_23 Study Changes Misc.

    Interesting tidbit as well:

    Study Start Date: November 1998

    The rest of the information says that the study is “on-going” but not updated since 2008, not verified since 2004. We’re now talking about a study that has been going on for at least a decade – given that the average prognosis for this disease is 12- 14 months, how can a study be on-going for more than a decade, and not recruiting since 2007? Unless something miraculous has happened (and the public would probably want to know about it), these patients are all dead now.

    Again, if this doesn’t raise some red flags with you, I have no idea what would…..

  27. @Didums – you’re spamming of that particular blog, using formatting that was impossible to parse or even understand (given your tendency to link to the same page multiple times or even pages that were no longer relevant to what you thought they were), was quite annoying.

    Care to address, right here, right now, the two particular clinical studies that I’ve chosen at random, among the many “unknown” status studies listed?

    • Lawrence, your unsubstantiated excuses do not impress me

      Were you so busy huffing and puffing that you did not notice that I already replied about the 1st study in the post that you just replied to ?

      And now I have just replied about the 2nd

  28. @didums – your reliance on SEC filings does not impress me either, especially when it includes language like this:

    Notwithstanding the response results of the trials that have reached a Milestone, management believes it is likely that the FDA may require additional clinical trials based upon such protocols to be conducted by an institution not affiliated with the Company or Dr. Burzynski before advising that an NDA filing is warranted. In addition, the FDA has indicated it will not accept the efficacy data, but will accept toxicity data generated by the Phase II study according to Protocol CAN-1 because the trial was partially retrospective. At this time, the Company cannot predict if and/or when it will submit an NDA to the FDA, nor can the Company estimate the number or type of additional trials the FDA may require. Further, there can be no assurance that an NDA for Antineoplastons, as a treatment for cancer, will ever be approved by the FDA.

    No assurance can be given that any new IND for clinical tests on humans will be approved by the FDA for human clinical trials on cancer or other diseases, that the results of such human clinical trials will prove that Antineoplastons are safe or effective in the treatment of cancer or other diseases, or that the FDA would approve the sale of Antineoplastons in the United States.

    But this is the best of them all:

    FORWARD LOOKING STATEMENTS

    This report contains forward-looking statements, including statements regarding future financial performance and results and other statements that are not historical facts. Such statements are included in “Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report. When used in this report, words such as “may,” “will,” “should,” “could,” “anticipate,” “believe,” “expect,” “estimate,” “intend,” “plan,” “predict,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, there can be no assurance that actual results or developments anticipated by the Company will be realized or, even if realized, that they will have the expected effects on its business or operations. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors beyond the Company’s control including: the ability to develop safe and efficacious drugs, the failure to achieve positive clinical trials, the failure to successfully commercialize our products, competition and technological change and existing and future regulations affecting our business.

    SEC Filings are not peer-reviewed publications & should not be cited as such…..

    • Lawrence, nice SPAM ! 🙂

      Did you totally ignore the FACT that Protocol BT-07 is “Closed” according to the National Cancer Institute ?

      But this is the best of them all:

      1. SEC filings are legal documents
      http://www.law.cornell.edu/wex/securities_exchange_act_of_1934

      2. “The SEC’s power to compel the statutory disclosure requirements is backed by the SEC’s power to bring enforcement actions against companies that disseminate fraudulent or incomplete information in violation of the federal securities laws”

      • @Didums – and where exactly did I say that SEC files are not legal documents? What they aren’t are peer-reviewed scientific publications (and for obvious reasons, as has already been pointed out on numerous occasions, should not be treated as such).

        As to point #2 – I point back to the boilerplate language that you seem to want to ignore:

        FORWARD LOOKING STATEMENTS

        This report contains forward-looking statements, including statements regarding future financial performance and results and other statements that are not historical facts. Such statements are included in “Business,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this report. When used in this report, words such as “may,” “will,” “should,” “could,” “anticipate,” “believe,” “expect,” “estimate,” “intend,” “plan,” “predict,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, there can be no assurance that actual results or developments anticipated by the Company will be realized or, even if realized, that they will have the expected effects on its business or operations. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors beyond the Company’s control including: the ability to develop safe and efficacious drugs, the failure to achieve positive clinical trials, the failure to successfully commercialize our products, competition and technological change and existing and future regulations affecting our business.

      • If you put your trust in SEC filings as an accurate portrayal of a company’s position, you have probably never heard of Enron or Tyco International.

        SEC filings are legal documents, but they are carefully crafted to give the best possible spin. And if this is the best possible spin, then it’s not looking good.

        But hey, we’d know a lot more if Slippery Stan just published the results of the 60 trials. Wonder why he doesn’t do that?

      • “But hey, we’d know a lot more if Slippery Stan just published the results of the 60 trials. Wonder why he doesn’t do that?”

        Already asked and answered above:

        2/27 at 12:18 am

        As former President Ronald Reagan used to say:

        “Trust but verify”

        All anyone has to do is look at Burzynski’s Phase 2 preliminary reports and compare them with the SEC filings

      • Lawrence – and where exactly did I say that you said SEC files are not legal documents?

        “What they aren’t are peer-reviewed scientific publications (and for obvious reasons, as has already been pointed out on numerous occasions, should not be treated as such)”

        Yeah, because we ALL know how reliable those well known peer-reviewed medical journals are; as I have addressed in my recent post:

        2/28 2:57 am

        “As to point #2 – I point back to the boilerplate language that you seem to want to ignore:”

        Way to “SPAM” that again, Lawrence ! 🙂

  29. @didymusjudasthomas – You wrote:

    As I have posted elsewhere, in my personal opinion Burzynski was waiting until he finished ALL clinical trials re A10 and AS2-1 before publishing the final results

    I don’t want to get bogged down in detail here, so will reiterate my reply to you when you posted elsewhere (here: https://josephinejones.wordpress.com/2013/02/13/burzynski-an-interview-with-wayne-dolcefino/#comment-4726)

    Burzynski has been using antineoplastons since the 1970s and since the late 90s, has had to use them within FDA approved clinical trials. That is an awful long time to carry on using an experimental therapy. It is also remarkable and shocking that patients have had to pay thousands, even hundreds of thousands of dollars for the privilege of participating in trials.

    It is not how medical research works. You don’t use something for thirty odd years before publishing data.

    • JJ – You wrote:

      “It may be remarkable and shocking to you that patients have had to pay thousands, even hundreds of thousands of dollars for the privilege of participating in trials”

      “It is not how medical research works”

      “You don’t use something for thirty odd years before publishing data”

      I don’t want to get bogged down in detail here, but

      1. It may be remarkable and shocking to you that patients have had to pay thousands, even hundreds of thousands of dollars for the privilege of participating in trials, but it is not to me since I have compared the costs to chemo and radiation and find that the costs are remarkably similar, and those patients can be proud that they have helped pave the way for this research to be developed further in Japan, and China – where Professor Ming-Cheng Liau (Ming C. Liau or M.C. Liau); who worked and published with Burzynski from 1986 – 1994, then went on to reference Burzynski’s work when he invented Cell Differentiation Agent-2 (CDA-2) purified from fresh human urine; which went through Phase 1 – 3 clinical trials and was approved July 2004 for treating cancer-affected patients in China and Taiwan, ROC

      He found out that methylation enzymes play a central role in the regulation of cell replication and differentiation, and by controlling these enzymes, cancer could be healed
      http://english.people.com.cn/200508/17/eng20050817_202981.html
      And he has U.S. patents:
      http://www.patentmaps.com/inventor/Ming-Cheng_Liau_1.html

      2. The FDA has approved the clinical trials

      3. The FDA has not stopped Burzynski for not complying with any U.S. laws or regulations you do not cite in support of your position

      4. The U.S. Government has not stopped him for not complying with any U.S. laws or regulations you do not cite in support of your position

      5. The State of Texas has not stopped him for not complying with any State laws or regulations you do not cite in support of your position

      6. The FDA has approved Phase 3 clinical trial

      7. Just because you say that “It is not how medical research works,” does not make it true, when you do not cite any U.S. law or regulation in support of your position

      • So the onus is on me to demonstrate that Burzynski is not a typical example of how medical research works? Either you know nothing about drug development or cancer research, or you are deliberately wasting my time.

        Also, I expect you are aware of at least the main legal and ethical issues; the various cases that have come up over the years, brought by the FDA, the TMB and by patients (if not, I suggest you look at the Legal and Ethical Issues section of my Burzynski Master List). The fact that nobody has been able to stop him so far suggests that the Burzynski Clinic have been adept at exploiting loopholes and slithering away from justice. It doesn’t mean there are have been no problems. I expect you know that the reason the TMB case was dropped was that Burzynski argued that he was not the patients’ treating physician, rather than that nothing unlawful had happened at his clinic.

        It’s unlikely that the FDA will approve antineoplastons trials in future. It’s also unlikely the phase III trial will ever happen.

        And here’s your first warning: posting links and repeating arguments that have already been dismissed elsewhere as being of no relevance is a way to get yourself blocked for spam.

      • JJ, seriously ?

        As I just posted 2/28 2:57 am, it is documented indisputable “fact” that certain U.S. entities engaged in changing a protocol without the approval of the party responsible for the drugs being used, and had been advised that the results would not be favorable based on their acts, that the trial had too few patients, and was closed, and then they published the results as if it had been a valid study

        Would you like to defend the “ethics” of that ?

        The U.S. Constitution does not have the word “ethics” in it

        That is because the USA is a Nation of laws, not man

        If we were a Nation of “ethics,” we would not claim another Nation has chemical and biological weapons of mass destruction, bomb them, and proclaim from the deck of a military vessel, “Mission Accomplished”

        I find that critics pull out the “loophole” and “slithering” excuse when things do not go their way, but then if it does go their way, it is all “Hunky Dory”

        The reason the TMB case was dropped was because the SOAH falsely claimed that both patients met Burzynski, when there was no record that he met either one, and that he was not even in the country when the 2nd patient was admitted, and there was no record in the medical records that he met either patient

        I should know, I posted about this case on my blog

        If the TMB thought something illegal was done, they had every opportunity to refile their complaint re the correct health care practitioners

        Just because YOU may believe that:

        “It’s unlikely that the FDA will approve antineoplastons trials in future. It’s also unlikely the phase III trial will ever happen”

        does not necessarily mean that is what is going to happen

        Who is repeating arguments ?

        I am simply stating “facts”

        1. Do you dispute the “fact” that Ming-Cheng Liau (M.C. Liau) worked and published with Burzynski from 1986 – 1994, when he is listed along with Burzynski on Burzynski’s web-site publications page ?

        2. Do you dispute the “fact” that Burzynski is Referenced on Liau’s publications ?

        I refer you to my other blog:
        http://www.stanislawrajmundburzynski.wordpress.com

        Lawrence has posted the same thing twice more than I have here

  30. @Didums – I’ll guess we’ll see what comes of this audit….also, if the clinic has no problem publishing information for the SEC, why do they seem to have such problems publishing their trial conclusions in the past in peer-reviewed medical journals?

  31. @didums – sorry, spamming the same stupid links from a propaganda film for Dr. B isn’t evidence.

    How about anything from this past decade (or heck, even the current decade)?

    • Lawrence, I have to ask if you even read the above post considering as I was speculating why Burzynski has every righty to be skeptical of certain U.S .entities & businesses , which has nothing to do with how long ago it did or did not happen

      Did you read my above post re the Texas State Office of Administrative Hearings (SOAH) case with lasted from 2010 – 2012 where they tried to blame him just because he is the owner of the clinic ?

  32. @Didums – actually, his defense was that he wasn’t “responsible” because he wasn’t involved in the day-to-day care of the patients….though more than a few entries at “TOBPG” from former (now dead) patients seem to indicate that Dr. B was involved in their care…..basically, he threw his own doctors under the bus…a good defense in court, not so good for his employees.

    • Lawrence, no link(s) to support your post ?

      JJ can even provide links, like I do !

      Lawrence – actually, his defense was that:

      RESPONDENT’S ANSWER AND REQUEST TO STRIKE

      (Pg. 3 of 13 – II. FACTUAL ALLEGATIONS, Patient A)

      ·l.a. Denies that Patient A presented to Respondent as alleged

      la. Further denies that there was any doctor/patient relationship between
      Patient and Respondent

      (Pg. 4 of 13)

      At most, Respondent made treatment recommendations to Patient A’s duly licensed treating physicians employed by Respondent

      1.b. Denies that Respondent prescribed any medications to Patient A

      At most, Respondent recommended several drugs to the.patient’s treating physicians

      (Patient B)

      2.a. Denies that Patient B presented to Respondent or that Respondent`ever met the patient

      Admits that this patient presented to the clinic which Respondent owns and was treated by a licensed, board certified medical oncologist employed by Respondent

      Denies that there ever was a physician/patient relationship between Respondent and this patient

      2.b. Denies that Respondent prescribed any medications or made any treatment recommendations to this patient

      (Pg. 6 of 13 – REQUEST FOR SANCTIONS, Specific knowingly false statements in the Complaint, retreat A)

      -1. Respondent was not the physician of record of Patient A

      2. There·is no evidence in the medical records or anywhere else, … that Respondent had any direct contact with Patient A

      Hence the following statements are incorrect`and kncwn·to be incorrect by Petitioner

      a. 1..a “In approximately May of 2008 Patient A presented to Respondent with breast cancer that had metastasized to her brain,
      lung, and liver”

      In reality, the patient did not present to the Respondent for breast cancer or for anything else

      (Pg. 8 of 13 – Patient B)

      S. Respondent was not the physician of record of Patient B

      6. Respondent did not sign or make any medical notes or records for Patient B in which a course of treatment or drug was recommended, continued, changed or terminated

      8. There is no evidence in the medical records, or in any other record that Respondent was in any way involved in any specific treatment or prescription decisions involving Patient B

      9.I Respondent provided information to the Board that HE WAS OUT OF THE COUNTRY DURING THE ENTIRE TIME PATIENT B WAS AT THE CLINIC

      10. Patient B’s treating physician was a board certified medical oncologist employed by Respondent

      11. Petitioner is aware of all these facts, as it has had the medical records of Patient B since the beginning ofthe investigation

      (Pg. 9 of 13)

      13. Based on the foregoing, the following statements contained in the Complaint are incorrect and known to be incorrect by the Petitioner based on the medical records and other documents in its possession

      a. 2. a. “In approximately March of 2003, Patient B presented to Respondent with a diagnosis esthesioneuroblastoma”

      The patient never presented to Respondent and Respondent never met Patient B

      b. 2b “Respondent prescribed sodium phenylbutyrate….”

      Respondent prescribed nothing to Patient B

      Etc…

      TAG !! Your turn to back it up !!!
      https://cis.soah.state.tx.us/tokopenweb/tokweb24.ASP?WCI=openfolder&%25DB=63%DRAWERID=9%FOLDERID=2377%tonew=Yes

  33. @didums – you do realize that your link just confirmed exactly what I said, right? He successfully argued that he wasn’t responsible (even one iota) for patient care – despite the fact that we have written testimonials (in the form of what is linked to on TOBPG) that certainly seem to show that Dr. B is involved, has met patients, spoken to them about their treatment, etc.

    Again, let’s see what happens over the next few months – the scrubbing of ANPs from the clinic’s website is at least one indication that the something interesting is going on.

    • Lawrence, you do realize that you posted:

      ” ….though more than a few entries at “TOBPG” from former (now dead) patients seem to indicate that Dr. B was involved in their care…..”

      which is irrelevant since I did not see a sworn affidavit or deposition by either patient that backed up the Complaint

      and

      “basically, he threw his own doctors under the bus…a good defense in court, not so good for his employees”

      he did not throw anybody under the bus

      If the SOAH had an actual case they could have gone after the 2 doctors responsible for the patients

      The fact that they have NOT, speaks volumes as to what their real motive was for ignoring the Texas Medical Board recommendation and instead, proceeding with the case

  34. Pingback: Stanislaw Rajmund Burzynski, M.D., Ph.D and “Freedom of Speech” | Didymus Judas Thomas' Hipocritical Oath Blog

  35. Pingback: Critiquing “Bad Argument Special: Inexpertly sown doubt” | Didymus Judas Thomas' Hipocritical Oath Blog

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s