A study of antineoplastons fails to be published. Stanislaw Burzynski’s propagandist Eric Merola whines about it. News at 11.

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.