Respectful Insolence

Eric Merola alternates between offending me and making me laugh at his antics. Since it’s been a couple weeks since I’ve written anything about the Houston doctor who claims to be able to do so much better against many forms of cancer than conventional medicine, I have to express a bit of gratitude to Mr. Merola for giving me today’s topic for blogging. Mr. Merola, as you recall, produced two incredibly bad and deceptive movies lionizing that very same Houston cancer doctor as a brave maverick genius who’s been kept down by The Man (i.e., the Texas Medical Board, the FDA, the National Cancer Institute, and the like).

Yes, I’m talking about Stanislaw Burzynski, MD, the Polish Prince (or is it Count?) who has been administering peptides he claims to have isolated from urine and later learned to synthesize to cancer patients since at least 1976 but hasn’t bothered to actually demonstrate in a sufficiently rigorous fashion that they do what he claims they do or that they have significant anticancer activity in actual human beings. Instead, because various government entities quite understandably didn’t want him administering unproven chemotherapy to cancer patients (and, make no mistake, his peptide therapy, which he dubbed antineoplastons” are chemotherapy, the claims of his lackeys, toadies, and sycophants like Suzanne Somers not withstanding), in the mid-1990s he submitted a bunch of clinical trials to the FDA and—miracle of miracles!—despite a profound lack of preclinical evidence got them approved. Of course, he had help. Rep. Joe Barton (R-TX) had been torturing the FDA for doing its job and trying to shut the Burzynski Clinic down. As I described, he orchestrated brilliant political theater in which seriously ill cancer patients, honestly convinced that Burzynski was the only person who could save their lives, gave tearful testimony in front of Barton’s committee for the cameras. Meanwhile, the same patients marched and protested, providing more news fodder and putting more pressure on the FDA. So the FDA caved and approved 72 phase 2 clinical trials, even though they were, as Burzynski’s lawyer put it, an “artifice.”

However, even though Burzynski has dozens of clinical trials of antineoplastons against cancer registered at ClinicalTrials.gov but has not managed to publish even a single completed trial (yes, I know he’s published case reports and preliminary reports on two trials, he has not published a completed trial), there is another investigator who has been doing a randomized clinical trial. His name is Dr. Hidaeki Tsuda of the Kurume University Hospital in Japan. He’s an anesthesiologist, not a surgeon or oncologist; so I’m not sure why he’s doing clinical trials of a chemotherapy agent. Whatever the reason, he is, apparently. I discussed Dr. Tsuda’s trial, or at least what little we know about it from Eric Merola’s second movie, in my review of that movie. Aside from the suspicion that always comes to me when a scientist decides to “publish by press release” (or, in this case to publish by appearing in a crank’s movie, which is even worse), I have no way of judging the methodology and the results of the Dr. Tsuda’s trial. All I know is that it was a randomized clinical trial in which patients with liver metastases from colorectal cancer were randomized to receive intra-arterial 5-fluorouracil (5-FU)by hepatic artery pump or 5-FU plus antineoplastons. One thing I noted is that intra-arterial 5-FU is a rather outmoded treatment that isn’t used much anymore since the rise of combination regimens containing 5-FU plus other drugs, such as FOLFOX or FOLFIRI, but that’s about all I can say about the clinical trial besides mentioning that we can’t really tell whether the large increases in survival claimed in the movie by Dr. Tsuda are supported by his evidence.

Nor did I have any idea whether any progress had been made in getting the study published.

That’s why I have to thank Eric Merola for updating me. In my e-mail this morning was a prolonged whine about—you guessed it—Dr. Tsuda’s study. That led me to his movie Facebook page, where I found this notice, which was identical to the message in the e-mail:

The first ever independent randomized controlled clinical trial using Antineoplastons for the treatment of cancer at Kurume University in Japan—was rejected by Lancet Oncology this week. Even more interesting, the Japanese consulted with one of Britain’s top oncology peer-reviewers to ghostwrite the manuscript, to make sure it was in perfect format for the Lancet.

The Lancet‘s reason for the rejection? It had nothing to do with the science or the study’s design—but instead the Lancet simply said “we don’t have enough room in our journal for this randomized study on Antineoplastons”. In other words, the Lancet and the cancer establishment as a whole does not have any room for an oncology paper that involves cancer being cured by a paradigm-shifting invention, especially when the study is a randomized study which elevates “anecdote” to “proven”—since the randomized study is the industry’s holy grail of clinical testing. If the Lancet had accepted it—they would have ironically been Lanced.

The fact is, Antineoplastons do not fit the Pharma mold, and therefore they are not allowed in. It’s just the way our system works. Science is secondary to profit in today’s market. Anyone who feels the need to come up with conspiracy theories to justify the ignorance toward Antineoplastons, just doesn’t have a basic understanding of how our system works. This is just business 101.

Profit has and will always trump scientific truth. The entire industry is clever enough to realize that if Antineoplastons were allowed onto the market, their patents would eventually run out and they would eventually become a generic drug. And that can’t be allowed to happen. If all companies within Pharma is allowed to make and sell Antineoplastons (as they do the antibiotic), who in their right mind would choose destructive and carcinogenic chemotherapy or radiation ever again? The industry knows this, and to protect the bottom line and Wall Street as a whole, Antineoplastons simply can’t be allowed in.

However, the Japanese randomized studies WILL be published, but likely not in a journal that serves the industry and the owners who dictate the journals’ content.

Stay tuned…

Eric, Eric, Eric, Eric, you are such a funny man. I really did laugh out loud when I read this. I can guess what almost certainly happened here, and—surprise! surprise!—it’s not exactly what Mr. Merola believes to have happened. Most of us who regularly submit papers to scientific journals have on occasion had this experience, namely the editorial rejection, which is something that sometimes happens when one submits manuscripts to high impact journals. I recognize the language. It’s nothing personal. It’s no conspiracy. Basically, such journals get way more submissions than they can ever publish. In fact, they get so many submissions that they can’t even send all of them out for review because they don’t have enough peer reviewers. So such journals exercise a form of triage. Manuscripts that they deem either uninteresting, not particularly good, or not quite fitting in with the normal subject get a quick rejection and aren’t even sent out for peer review. It happens all the time. It’s happened to me. As a scientist or clinical investigator, you just get up, brush yourself off, and submit the manuscript elsewhere. (Indeed, editorial rejection can be a favor; the authors get a quick answer and can thus submit the manuscript elsewhere rapidly.) Heck, there was one manuscript of mine a few years ago that took me four journals and two years to finally get into print. Did I whine about it? No! (Well, maybe just a little bit; I was getting to the point where I thought I’d give up on ever getting the data published.)

What does Mr. Merola do? He alleges a conspiracy by the “cancer establishment” to suppress a cure for cancer. The hyperbole he uses is vintage Merola, so over-the-top that it really is hard to suppress a laugh when reading it. So Dr. Tsuda consulted with a peer reviewer to ghostwrite the manuscript? So what? If the topic is not interesting or the data are crap, its being well-written and rigorously adherent to the journal’s format won’t save it. The sense of entitlement dripping from Mr. Merola’s little rant is quite simply, amazing.

Also amazing is his lack of understanding. He claims that antineoplastons “do not fit the pharma mold,” which is actually ridiculous. They are, after all, chemotherapy. Sure, Mr. Merola denies it. Burzynski apologists deny it. Even Burzynski himself denies it. None of that makes it any less true that antineoplastons are chemotherapy. They are a drug. They even have significant toxicity! So, in actuality antineoplastons very easily fall comfortably within the paradigm of cancer chemotherapy. Or at least they would, if there were any compelling clinical trial evidence that antineoplastons have significant anticancer activity. That’s the area where antineoplastons don’t fit comfortably in the “big pharma paradigm.” They are unproven and appear not to work. In a big pharma paradigm, they would fall into the category of a lead compound that didn’t show much promise and was therefore abandoned.

Another curious thing happened yesterday. There appeared this Tweet:

The Tweet linked to in the Tweet above was this one:

So basically, it appears that Mr. Merola likely transmitted suggestions for journals listed on Twitter to Dr. Burzynski and/or Dr. Tsuda, and the advice was taken. It’s almost as though this particular Burzynski apologist thought that Dr. Paul Morgan meant that Dr. Tsuda’s manuscript would definitely be accepted. Such naiveté is almost cute. Actually, it’s painful to behold such basic ignorance about how scientific publishing works.

Of course, there is a way for Mr. Merola to demonstrate my educated guess about what really happened to be wrong. All he has to do is to answer a question and provide one bit of information. The question is, “Was Dr. Tsuda’s manuscript sent out for peer review?” If the answer is yes, then all we need to see to determine if Mr. Merola’s claim about the reason given for rejection of the manuscript is true is one simple thing. Show us the reviews from the peer reviewers. I bet that there aren’t any, but if there are I would be very confident that none of them said that there was “no room” for Dr. Tsuda’s manuscript in The Lancet Oncology.

It’s really that simple, Mr. Merola. Put up or shut up. In the meantime, it’s obvious what plan B is. (Hint: It won’t be to submit to the New England Journal of Medicine or the Journal of Clinical Oncology.) It will be to find a bottom-feeding open access vanity journal that will publish basically anything as long as the authors pay. I’m not talking PLoS ONE here, but the dark side of the open access movement has been these “pay to publish” journals whose scientific standards are lax. That’s where I see Dr. Tsuda’s study being published, and that’s where I see some of Dr. Burzynski’s studies ending up. The reason is easy. They won’t be able to make the cut to be published in respectable journals, traditional or open access.

Meanwhile, while I’m on the topic of Stanislaw Burzynski, it’s been pointed out to me that another website by Burzynski supporters has arisen. It’s called, unimaginatively, Burzynski Saves. Equally unimaginatively, it’s chock full of the same tropes that Burzynski apologists are fond of, seemingly straight out of the mouth of Stanislaw Burzynski:

Dr. Stanislaw Burzynski has dedicated his life to saving cancer patients. He has saved many patients who were given no hope of recovery who are now living happy, healthy, cancer-free lives. Because his treatment involves innovative “out of the box” methods, the cancer fighting establishment, (including the FDA and the Texas Medical Licensing Board) and self proclaimed “skeptic” groups have spent the last 40 years trying to crush him and stop him from treating patients. The film ‘Burzynski, Cancer is Serious Business’ documents this well and can be watched on the media page. The Burzynski Part II film was released in 2013 and exposes more of this same treatment. We cancer patients and families and supporters have had enough and are fighting back. People engaged in the life and death fight for their lives should have the right to choose their doctor and their treatment without interference from special interest groups and government bureaucrats.

Burzynski supporters really need a new schtick. This one’s getting really old. So is the schtick on the “Wall of Shame“:

There are organized groups of people who call themselves “skeptics”who have made it their mission to try and destroy Dr. Burzynski. They attack and ridicule him and his cancer patients in blogs and articles and on Social Media. They mock any medical treatments they consider “alternative”, chanting “where are the peer review articles?” (Peer review means that fellow MD’s read articles presented for publication and decide if they are worthy of publication). Dr. Burzynski has presented, and published many studies and articles which the large medical journals refuse to print. Skeptics conspire to sabotage his medical practice by writing bad reviews on his clinic website, the Burzysnki Patient website & others under the WOT rating system so this symbol appears every time someone navigates to the page:

This is just as silly as Mr. Mercola’s bloviation. The reason that medical journals have not published Dr. Burzynski’s work is because (1) he almost certainly isn’t trying very hard to be published and (2) his work just isn’t up to snuff. Amusingly, however, whoever’s behind the Burzynski Saves website honored me with a mention on the Hall of Shame. I wouldn’t have it any other way. But really, I can’t take all the credit. Bob Blaskiewicz will be envious!

On the other hand, the web design of the site is so horrendously ugly and its content is so bare bones that I can’t believe it took them months to put it together. they have, after all, been promising this website since the earliest screenings of the second Burzynski movie in April. Surely they could come up with something better than this. Apparently not.

Comments

  1. #1 elburto
    August 12, 2013

    The Lancet? Talk about aiming too high! That’s like trying to submit a child’s “What I did on my holidays” essay to the Booker Prize committee. Silly Eric.

    As for Count Scamula, I don’t think he ever had any intention of publishing. The excerpt from that book written by his former lawyer, that your “friend” posted, drove the last nail into that coffin. That indicated that he designed a “trial” for each type of cancer he was “treating” in order to get around FDA rules. If it is true then he’s more disgusting and mercenary than I ever thought possible.

  2. #2 Orac
    August 12, 2013

    This study, however, was Dr. Tsuda’s study, not one of Burzysnki’s. Same principle, but it might not be as bad as Stash’s phase 2 studies. Or it might. We don’t know.

  3. #3 Adam Jacobs
    UK
    August 12, 2013

    Interesting that they say they had someone ghostwrite the study. Pretty sure the Lancet (like all reputable journals) has an anti-ghostwriting policy. Perhaps that was the reason why it was rejected?

    Mind you, it’s possible they don’t actually mean “ghostwrite”. It’s a term that a great many people misuse. Maybe the paper got rejected just because the study methods were hopelessly flawed.

  4. #4 herr doktor bimler
    August 12, 2013

    the Japanese consulted with one of Britain’s top oncology peer-reviewers to ghostwrite the manuscript

    Wait, what? A ghostwriter? Submitting a manuscript for publication under your name when it was actually written by someone else? Well well well. Grounds for rejection right there, for this and for future submissions.

    I am puzzled by this job description of “oncology peer-reviewer”. We are expected to believe in people who don’t actually conduct oncology research, but sit in offices reviewing manuscripts from the people who *do* conduct the research (or moonlighting to write material designed for this profession of peer-reviewers). Evidently there is a ranking system within the profession, grading one as not only an “oncology peer-reviewer”, but the top oncology peer-reviewer.

    Shenanigans, sez I.

  5. #5 herr doktor bimler
    August 12, 2013

    Curse the faster typing fingers of Adam Jacobs.

  6. #6 Orac
    August 12, 2013

    Whoa. The ghostwriter thing didn’t even register because I gave them too much of the benefit of the doubt and assumed that they put his name in the list of authors. But if they did that, he wouldn’t be a ghostwriter, would he? Good catch.

  7. #7 Anniemouse
    Stuck in peer review hell
    August 12, 2013

    Maybe they just sent the manuscript to a British scientist to get the English checked? I know a few Chinese/Japanese groups who do this and then you wouldn’t expect the UK scientists name on the paper, except maybe in the acknowledgments.

  8. #8 Josephine Jones
    August 12, 2013

    I think it’s very difficult to learn anything from Merola’s rant and would like to see this from a more reliable source than him before making too much of it. We are having to assume that both Merola and whoever gave him this information are being completely honest. We also have to assume that he hasn’t misunderstood anything, that he knows what he’s talking about. Given the rest of the content on the Burzynski Movie website, the reality may be quite different from what he has written.

  9. #9 Darwy
    Røde grøde med fløde
    August 12, 2013

    @Annie

    I’ve done some proofreading for a few of my Chinese friends – and that included making suggestions for grammar changes, clarity, etc.

    That’s basic editing. If they actually said ‘ghostwrited’ – that means something completely different from editing. It’s reason to reject it, and anything else submitted by them – permanently, IMO.

  10. #10 Chris Hickie
    August 12, 2013

    A scan of the rejection letter/email from Lancet might tell us more than one quackadoodle holding a pity party for another.

    My phd adviser did get one paper in the journal Science and one that did not during my stay there (alas, ’twas not my work that made it into Science), but other journals had been identified and a paper on the same research ready to submit to the lower-tier journal as a contingency. That and we always went to at least 1-2 research meetings yearly to present abstracts. And there were also papers we knew would never see the light of day in a top-tier journal because their content was not either broad enough in its audience or novel enough in its findings to merit such space. Those papers we sent to journals that were more specific to our research. I also noticed the same approach to submission of manuscripts by my postdoc adviser.

    There was no conspiracy by some cabal of foes.

  11. #11 Chris Hickie
    August 12, 2013

    pardon…my end italics was supposed to come right after the second mention of Science:

    A scan of the rejection letter/email from Lancet might tell us more than one quackadoodle holding a pity party for another.

    My phd adviser did get one paper in the journal Scienceand one that did not during my stay there (alas, ’twas not my work that made it into Science), but other journals had been identified and a paper on the same research ready to submit to the lower-tier journal as a contingency. That and we always went to at least 1-2 research meetings yearly to present abstracts. And there were also papers we knew would never see the light of day in a top-tier journal because their content was not either broad enough in its audience or novel enough in its findings to merit such space. Those papers we sent to journals that were more specific to our research. I also noticed the same approach to submission of manuscripts by my postdoc adviser.

    There was no conspiracy by some cabal of foes.

  12. #12 Bob Blaskiewicz
    August 12, 2013

    You are now my sworn enemy, Orac!

  13. #13 Salty Dog
    Vancouver, BC
    August 12, 2013

    I find the conspiracy angle so very interesting and can’t understand how it possibly persists. What does Mr. Merola think happens when those in on the “conspiracy” or their wives, husbands or children, get cancer? Do they just stay quiet and let them die, all in the name of profit? This conspiracy makes the mafia look like a leaky faucet, for not one of the millions involved has ever said a word.

  14. #14 Lawrence
    August 12, 2013

    So, rather than attempt to publish himself, Dr. B pushes a “surrogate” from Japan, who has been conducting this trial for how long exactly? As opposed to doing it himself, with the “decades” worth of data that he’s collected?

    Yet another means for Dr. B to resist publishing on his own, because now he can claim bias against his work in general (again).

    If this isn’t a general red flag for everyone, I don’t know what is.

  15. #15 c0nc0rdance
    August 12, 2013

    From the Lancet’s editorial page:
    “On submission to The Lancet, your report will first be read by one or more of the journal’s staff of physicians and scientists. Our acceptance rate overall is about 5% and it is an important feature of our selection process that many papers are turned away on the basis of in-house assessment alone. That decision will be communicated quickly”

    5% is the standard acceptance rate.

  16. #16 Shay
    August 12, 2013

    Salty Dog @13 — you don’t realize, do you, that all cancer doctors are childless, unmarried orphans.

    Except for Orac, who is merely a large box of blinking lights.

  17. #17 Eric Lund
    August 12, 2013

    His name is Dr. Hidaeki Tsuda of the Kurume University Hospital in Japan. He’s an anesthesiologist, not a surgeon or oncologist; so I’m not sure why he’s doing clinical trials of a chemotherapy agent.

    A quick search through Orac’s archives confirmed my recollection that when Burzynski was affiliated with a US university, way back when, he was in an anesthesiology department. Maybe a coincidence, maybe not.

    the Japanese consulted with one of Britain’s top oncology peer-reviewers to ghostwrite the manuscript

    There are several things about that statement which don’t add up. First, the bit about ghostwriting, as others above have mentioned. But even more telling is the claim that the ghostwriter is “one of Britain’s top oncology peer-reviewers”. How do they know? Peer reviewers are often not named (some journals I am familiar with give reviewers the option to self-identify after the fact). One of the issues I see with the peer review system is the perverse incentives involved: as there are generally no explicit rewards for doing it well, those who do it well are “rewarded” only with getting more requests, while those who do it badly are “punished” by getting fewer requests. The inference that a top academic researcher is a peer reviewer is reasonable, but only the editors are in a position to assess how well he does reviews, and they aren’t supposed to say.

  18. #18 Denice Walter
    August 12, 2013

    OT: but are alt med loons announcing their plans for future world domination/ enlightenment EVER truly OT @ RI?**

    Today MIke Adams announces his next moves upon the world stage via an audio clip:

    -there will be a “content focus shift” at Natural News- he’ll leave the activism and politics to others
    - he will stick with food science and natural cures
    - notes that there is a great increase in traffic
    - two new venues SCIENCE.naturalnews and BLOGS.naturalnews
    - the third venue will “rock the food industry”
    -Robert Scott Bell will partner with NN and GCN radio
    -Mike will have a show on GAIAM TV ( pay service)
    -Mike will publish a food science book, 2014
    - he’ll create an Open Market for natural foods/ products
    - Mike will provide answers that are currently being suppressed by you-know-who for you-know-what
    - you’ve been lied to and “dumbed down”
    -clean food leads to clear thinking
    -it is his mission to “awaken humanity” who are enslaved by bad food, fossil fuel energy, media lies
    -this spiritual awakening will occur after a time of tribulations and starvation
    - the new higher awareness will usher in a revolution of consciousness wherein people will learn their true purpose
    - there is life after death
    - references to the Matrix and the Jedi
    - missions cost money so visit the Store.naturalnews
    - hip hop commercial for Store.com

    ** Minions and lurkers should be aware that I endured 41 minutes of MIkey so you wouldn’t have to.. Oh, the things we do for love.
    but you’re WORTH it!. TOTALLY!

  19. #19 Darwy
    Røde grøde med fløde
    August 12, 2013

    Some journals do list their peer reviewers – for example, JAMA (Journal of American Medical Association).

    It’s one of the things I discovered about Gary Goldman’s padded CV (here: http://www.novaccine.com/gary_s_goldman.asp)

    He bills himself as “serves as a reviewer for the following peer-reviewed journals listed with the National Library of Medicine:

    Journal of the American Medical Association (JAMA)

    Since JAMA publicizes their reviewers, I went and took a look at which year(s) he served as a reviewer. It was a single year.

  20. #20 Bronze Dog
    August 12, 2013

    I find the conspiracy angle so very interesting and can’t understand how it possibly persists. What does Mr. Merola think happens when those in on the “conspiracy” or their wives, husbands or children, get cancer?

    The other amusing angle is the idea that whistle blowers won’t reveal cures to win Nobel prizes, blackmail the conspiracy with evidence, or patent the treatment to get an edge over the other pharmaceutical companies. I’ve described this as a conspiracy that requires its members to be “selflessly greedy.”

  21. #21 elburto
    August 12, 2013

    @Denice-

    ** Minions and lurkers should be aware that I endured 41 minutes of MIkey so you wouldn’t have to..

    We should wash your feet with our tears of gratitude *weeps*

    @Orac – The first bit of my comment was about the Japanese study, and the rest (about Stan) was garbled because I was RI-ing when I should’ve been asleep! Four hours of sleep and zero caffeine = brainsludge.

    @Shay – oncologists are grown in vats in sterile, airless warehouses. They’re government drones you see.

  22. #22 Todd W.
    http://www.harpocratesspeaks.com
    August 12, 2013

    Wait. Wasn’t the use of ghostwriters by Merck for some Vioxx studies part of what got them in hot water? And a frequent harping point for alt-medders?

  23. #23 Eric Lund
    August 12, 2013

    Since JAMA publicizes their reviewers, I went and took a look at which year(s) he served as a reviewer. It was a single year.

    That is consistent with being asked to review one paper, and doing it so badly that he was never asked again. The authors of the paper in question would not have known* that he was a reviewer, at least while the paper was under review.

    Different journals handle it differently, of course. Some journals don’t publish reviewer names at all. Some do it annually, as JAMA does, or in the preface of a conference proceedings. At the journal I am most familiar with, the editor will add an acknowledgment along the lines of, “I. B. Editor thanks I. M. Scientist and another reviewer for their assistance in evaluating this paper.” In this case I. M. Scientist elected to self-identify and the other reviewer did not; both reviewers would be named if both elected to self-identify, and I. B. Editor would thank “two anonymous reviewers” if neither chose to self-identify.

    *In some cases, particularly in relatively small fields such as mine, it is possible to guess the identity of the reviewer from the reviewer comments. For instance, if the reviewer wants you to cite a paper by Fulano et al. which was published in a conference proceedings book so obscure that your library doesn’t have a copy, that is reason to suspect Dr. Fulano (or one of his co-authors) of being the reviewer in question. But it is quite common to guess wrong.

  24. #24 Rich Woods
    The green fields of forever
    August 12, 2013

    @Denice #18:

    -clean food leads to clear thinking

    And Mikey is the exemplar?

    Minions and lurkers should be aware that I endured 41 minutes of MIkey so you wouldn’t have to.

    I honestly don’t know how you manage to stay sane under such a daily load.

  25. #25 Denice Walter
    August 12, 2013

    @ elburto:

    I aims to please.

    @ Rich Wood:

    Yes, Mikey is the reason I make sure I eat GMOs, pasteurised milk products and standardly raised fish / chicken several times a week.

    And-
    I have no idea why I am able to wade through this drivel and emerge unscathed- I believ I inherited my ancestors’ high toleration for nonsense which stood them well in business for a few hundred years- of which I am aware- on two continents. It is a gift that my cousins and I share.

    -btw- Supposedly, the other web woo-er is also enjoying a huge uptake in popularity ( which crashed his prn site) because he appeared on a Christian radio show and on public TV.

    Is there no end to their power?

  26. #26 AdamG
    August 12, 2013

    Does anyone else find it odd that Merola never brings up specific results of the study in his whiny rant? One would think that if the study showed anything of interest he’d have included some of the findings as evidence that this is a ‘good paper.’

  27. #27 Chris Hickie
    August 12, 2013

    Does anyone else find it odd that Merola never brings up specific results of the study in his whiny rant? One would think that if the study showed anything of interest he’d have included some of the findings as evidence that this is a ‘good paper.’

    Pick either (or both):

    1. He doesn’t understand the findings of the paper.
    2. There were no findings of clinical interest in the paper.

  28. #28 herr doktor bimler
    August 12, 2013

    But if they did that, he wouldn’t be a ghostwriter, would he?

    Of course just because Merola is accusing the hapless Dr Tsuda of serious academic misconduct, does not mean we should believe him.

  29. #29 MedTek
    August 12, 2013

    The part that stands out for me is the apparent admission that everything is just anecdotal:

    “…especially when the study is a randomized study which elevates “anecdote” to “proven”…”

  30. #30 Young CC Prof
    August 12, 2013

    In some cases, particularly in relatively small fields such as mine, it is possible to guess the identity of the reviewer from the reviewer comments.

    In VERY small fields like mine, the number of qualified potential reviewers can sometimes be counted on the fingers of one hand, and the author probably knows all of them personally. Hence, anonymous review turns into something of a joke.

  31. #31 lsm
    August 12, 2013

    You gotta wonder about the “top peer reviewer” claim, given all the cutting edge, world renowned scientists that alt med toutsthat nobody in the scientific community has ever heard of.

    Also, Mr. Merola needs to spend 4 hours with a publishing scientist who will explain the entire clinical trial process, from hypothesis to publication, in minute detail. That’s how long it took someone to explain it to me–on the entire drive from Boise, Idaho to Washington state. It’s unbelievably complex, and one session like that would leave Merola a tad red faced at his presumption.

  32. #32 Xplodyncow
    August 12, 2013

    Biomedical communicators who contribute substantially to the writing or editing of a manuscript should be acknowledged with their permission and with disclosure of any pertinent professional or financial relationships.

    http://www.amwa.org/files/About%20Us/AMWA_PositionStatement_Contributions.pdf

    But, see, ghostwriting is bad only when Big Pharma does it. Of course.

  33. #34 Dangerous Bacon
    August 12, 2013

    If a researcher and colleagues aren’t very good at organizing data and putting together a coherent paper, is it unethical for them to obtain the services of someone with good paper-writing skills to do the job for them (and not list this person as a co-author)?

    I can’t imagine such a scenario occurring very often, since the ability to write a good paper should be part of every research professional’s job description. And it’s not all that difficult to put together a paper in the proper “format”. Just read some articles that have been published in the journal to get an idea of how they’re organized.

    In any event, the fact that Tsuda (et al?) bothered to get help and still got rejected by Lancet Oncology probably speaks to a lot more than just writing flaws.*

    *In Antivax-Land, they’d be busy checking the past of all possible peer reviewers to drum up damning conflicts of interest. Maybe that will be Merola’s next revelation.

  34. #35 Xplodyncow
    August 12, 2013

    If a researcher and colleagues aren’t very good at organizing data and putting together a coherent paper, is it unethical for them to obtain the services of someone with good paper-writing skills to do the job for them (and not list this person as a co-author)?

    Not at all. But this contribution must be acknowledged somewhere in the paper, along with any COIs, or it’s considered ghostwriting. (See pages 2-3-ish in International Committee of Medical Journal Editors.)

  35. #36 bad poet
    August 12, 2013

    Doesn’t everybody know Bobby Vinton is *the* Polish Prince? (Although I prefer (the late) Ed Blazonczyk and the Versatones for that gangnam polka style, being a Chicagoan.)

  36. #37 lsm
    August 12, 2013

    Sorry, brain freeze @ 31. I meant Merola should be explained the process from hypothesis through clinical trials through drug approval. Quite a deal.

  37. #38 Sadie Burke
    Literally tearing out my hair
    August 12, 2013

    @Xplodyncow: hear, hear! Thank you for posting the AMWA and ICMJE positions. I am a former AMWA member credited with “editorial assistance” on a number of papers. All pharma support was explicitly spelled out. I would really like to know the true story behind the peer-reviewer/ghostwriter.

    I love alt pharm’s continuous refrain of “Big Pharma’s poisoning you for money!” You know what? So are Burzynski and Tsuda. I’m currently on FOLFOX for colorectal cancer, and I would much rather have the side effects I’m experiencing from 5-fu and oxaliplatin over the unquenchable thirst and other things I’ve read on The Other Burzynski Patient Group.

  38. #39 SkepticalSlug
    At the eye-wash station
    August 13, 2013

    My body is slowly recovering from the grand mal cringe induced by the design of that page. Was the design serious and sincere, or was it given the charming, home-built design in a diabolical ruse to appeal to the “less sophisticated”?

    Do I sound like an uppity a-hole for even saying that?

    If it is purposefully bad, I must say the motivational picture with the horse jumping into the surf and the caption “Sometimes, You Need To Become Your Own Hero” was a truly brilliant touch.

  39. #40 Chris,
    August 13, 2013

    Bob Blaskiewicz:

    You are now my sworn enemy, Orac!

    Get in line, no cuts allowed.

  40. #41 Adam Jacobs
    UK
    August 13, 2013

    @Dangerous Bacon (#34)

    It’s not unethical for authors to seek the help of professional medical writers when publishing a paper, provided that the role of the writer is disclosed (either as a co-author or in the acknowledgements section of the paper). If the writer’s role is not disclosed, then it’s ghostwriting, which is unethical.

    And actually, it does happen quite often, particularly in pharma-sponsored studies. Less often in academic-led research. It’s not just about whether the authors lack the skills to write a paper (although that’s sometimes an issue), it’s also about whether it’s an efficient use of their time. Clinical investigators are often more highly paid than medical writers, and also take longer to write papers, so it’s simply more efficient for the paper to be written by a professional writer.

    Next time you’re looking at a medical journal, just have a look at the acknowledgements sections of the papers. You might be surprised how often you find someone acknowledged for writing assistance.

  41. #42 Dangerous Bacon
    August 13, 2013

    Thanks for clearing up “ghostwriting” ethics.

    Maybe I could make some dough on the side cleaning up the writing I see in medical journals (though I really don’t need any, seeing as how my supplemental shill income from Big Pharma runs into the hundreds of thousands of dollars annually). ;)

  42. #43 janet
    where it's a beautiful day and I'm stuck in an office
    August 13, 2013

    @ Skeptical Slug
    You made me spit tea on my screen with the “grand mal cringe”. That so aptly describes portions of my day. I thank you, and I shall plagiarize you. :)

  43. #44 janet
    where it's a beautiful day and I'm stuck in an office
    August 13, 2013

    @ Dangerous Bacon
    I read papers and my fingers and toes curl at some of the, um, turgid prose and complete lack of clarity. The nuns (damn them) taught me better than that and I just can’t help myself–I NEED TO EDIT!!

  44. #45 Shay
    August 13, 2013

    Janet — ditto. I’m reviewing an IRB submission right now and I have a feeling the only reason I was asked to be a co-PI is because I have decent English skills.

  45. #46 T Herling
    August 13, 2013

    Merola’s use of the statement “Profit has and will always trump scientific truth” would be comically ironic if it weren’t for the said reality of all the desperate people who have paid Burzynski so much money.

  46. #47 LovleAnjel
    August 14, 2013

    No wonde Science refused to publish my paper on nematode behavior…it was a conspiracy by Big Fruitfly to keep nematode research from the public!

  47. #48 Paul Morgan
    United Kingdom
    August 14, 2013

    Merola’s claims are really quite laughable. I find it incredible that he seems to think that a journal I mentioned in a tweet in a response to a question about where Burzynski might publish his trial results would somehow automatically publish trial results of an antineoplaston study, no matter who conducted that trial.
    That Tsuda and his department of anaesthesia are involved in researching cancer therapies is rather bizarre, but there does seem to be a track record of doing so as a PubMed search for “Tsuda antineoplaston” yields 15 results. The last publication, however, dates back to 2005. Most are laboratory studies but there are a couple of case reports and small case series. Certainly nothing that comes close to showing any beneficial effect from antineoplaston therapy. The journals previously published in are not in the same league as “Lancet Oncology” which, it seems, only accepts around 5% of submitted articles for publication. Many submissions will not be of sufficient quality to even make it to the peer review process. It would therefore be useful to see a copy of the rejection letter (almost certainly an email) posted online. I strongly suspect that the paper was judged not good enough to even pass first sift, let alone get to peer review. Of course, this won’t stop Merola spouting more accusations of Big Pharma suppression but would at least show that a paper had been submitted in the first place. There are those of us who doubt that such a submission was made.
    Clinical trials in Japan are supposed to be registered much in the same way that they are in other countries. There are 3 registers in operation in Japan. All three are searchable in English. There are no registered trials of antineoplastons, and nor have there been in the nearly two years that I’ve been interested in Burzynski’s activities and the antineoplaston saga.

  48. [...] whines about it. News at 11. —————————————————————— http://scienceblogs.com/insolence/2013/08/12/antineoplaston-fails-publication/ ====================================== In regards to antineoplastons, Gorski [...]