Quoth Joe Mercola: I love me some Burzynski antineoplastons

As I contemplated how I wanted to start the blogging week, I thought that I should probably again plug Bob Blaskiewicz’s campaign to provide Dr. Stanislaw Burzynski, the Houston doctor who for the last 35 years has been treating patients diagnosed with advanced stage and terminal cancers with something he calls antineoplastons (ANPs), with a most excellent “gift” for his 70th birthday. This he does despite the astounding lack of compelling evidence that ANPs are actually effective against cancer, none of which stops him from charging patients exorbitant amounts of money, sometimes upwards of $100,000, for his “treatments,” which he claims to be part of being on a clinical trial. Never mind that, as I’ve pointed out time and time again, Burzynski has had dozens of phase II clinical trials since the 1990s and has published on precious few of them, and when he has claimed remissions others have not been able to replicate his results. In particular, a multicenter phase II trial carried out by investigators at the Mayo Clinic was a big failure, with a median survival of 5.2 months in patients with anaplastic oligoastrocytoma, anaplastic astrocytoma, or glioblastoma multiforme that had recurred after radiation therapy. Burzynski naturally has lots of excuses for why the trial failed and tried to blame the investigators, but his complaints are not convincing.

In any case, what Bob’s trying to do is, as I’ve pointed out before, to shame Dr. Burzynski into doing something good for cancer patients for a change. He’s doing this by challenging skeptics to raise money that will do cancer patients real good, namely to be given as a donation to the St. Jude’s Children’s Hospital. On Burzynski’s birthday (January 23), he’ll challenge Dr. Burzynski to match it. If Burzynski actually does match it (highly unlikely given that he has no shame), it will be the first good thing Burzynski has ever done for cancer patients. If he doesn’t, at least it will shine the light of publicity on what Burzynski has been getting away with doing for over 30 years. The link to donate is here. So what are you waiting for?

In the meantime, I can’t help but wonder about a recent post I saw at a particularly wretched hive of scum and quackery, Mercola.com, entitled Case Dismissed! Texas Ends 15-Year Fight Against Cancer Doctor Burzynski. It’s basically one big gloat over how the Texas Medical Board dropped its case against Burzynski in November, shortly before Thanksgiving. It’s two months late, but I suppose if you’re a quack it’s better late than never. It also ignores the way that Burzynski got off, basically on a technicality and by throwing the doctors who work for him under the bus. His slithering away from justice yet again is not in any way an indication that he has been vindicated. It is rather amusing in its timing, such that one can’t help but wonder whether Bob’s campaign is having an effect to the point where Stanislaw Burzynski and his own personal (but talentless) Leni Riefenstahl by the name of Eric Merola were feeling enough pressure that they felt that they had to respond (and to pimp his upcoming Burzynski sequel). If that’s the case, all I can say to Bob is: Good job!

About this sequel, entitled Burzynski: Cancer Is Serious Business, Chapter 2 | A Modern Story (and which I like to call Burzynski II: Antineoplaston Boogaloo or Burzynski II: The Color of Money), Mercola exults:

Dr. Burzynski received much-needed publicity two years ago with the release of Burzynski — The Movie, a documentary about Dr. Burzynski’s remarkable cancer discovery, and how he won the largest and possibly the most convoluted and intriguing legal battle against the Food and Drug Administration (FDA) in American history.

This year, a second film detailing his continued struggles, and victories, is scheduled to be released. As announced in the trailer (see above), Dr. Burzynski is now doing the unthinkable… He is “the first and only scientist in United States history to enter the federal drug approval process for a proprietary cancer therapy without any financial support from the American government, the pharmaceutical industry, or the cancer establishment.”

Uh, not quite. Biotech startups go into the FDA drug approval process all the time without support from the American government. I suppose that you could say that they are par of the “pharmaceutical industry.” They are not, however, “big pharma,” which is what Mercola is clearly trying to imply. Mercola also parrots the Burzynski line that “personalized gene-targeted cancer therapy” is the wave of the future. Actually, that’s not a “line.” I do believe that personalized therapy is the wave of the future. The line of BS is that Burzynski is at the forefront of surfing that wave, as Mercola claims:

In recent years, the focus for cancer therapy has increasingly shifted toward individualized gene-targeted cancer treatment — such as that provided by Dr. Burzynski for the past 10 years. A description of how the patient’s individualized treatment plan is devised is given in the second video above, starting three minutes into the video. So, is it any wonder the industry wants to get rid of him in order to protect their own profits and access to research funds?

As an example, in January 2011, the Khalifa Foundation gave a $150 million grant to the University of Texas MD Anderson Cancer Center8 “to support genetic-analysis based research, diagnosis, and treatment of cancer.” In short, personalized cancer treatment is the future of oncology, and the US government has spared no expense in trying to make eliminate Dr. Burzynski from the race — including patent theft…

Because Burzynski’s rinky-dink operation is just like M. D. Anderson and Burzynski thinks himself on par with the most brilliant cancer researchers in the world who are pioneering personalized therapy, be it at M.D. Anderson, Memorial Sloan-Kettering Cancer Center, or any of the several NCI-designated comprehensive cancer centers working on developing personalized targeted therapy. No, Burzynski does not understand personalized therapy or genomics, which is why I’ve referred to his methods as “personalized gene-targeted cancer therapy for dummies,” and is full of the arrogance of ignorance to the point of laying down some major howlers about gene0-targeted therapy. Apparently, he thinks he invented the concept, which is truly risible. The odds that any useful new method to use genomics and protein expression profiles to guide personalized cancer therapy will come out of the Burzynski Clinic are about the same as the odds that a new scientific breakthrough in anything will be discovered by a homeopathy—slim and none.

In any case, as much as Mercola is kissing Burzynski’s posterior, the whole trailer is one big, fat load of conspiracy-mongering propaganda, not unlike the press release:

For most patients being treated by the Burzynski Clinic today—their advanced cancer itself runs secondary to the constant barrage of skepticism coming not only from their local oncologists—who simply do not understand Burzynski’s therapy—but also from their own friends and family who feel their loved ones are not making the correct treatment decisions—even though mainstream oncology has already left many of them for dead.

As this story unfolds, the audience will witness a real-time change of hearts and minds from many doctors and families.

Unlike the first documentary, we have interviewed board-certified oncologists, surgeons, and neurosurgeons for this film who witnessed their patients leave their care to return in great health, after opting for the Burzynski Clinic.

Since the mapping of the Cancer Genome, Burzynski has pioneered an expansion of his therapy that he calls, “Personalized Gene-Targeted Cancer Therapy”, where each patient’s Genomic Cancer Atlas is mapped, and a treatment regimen is personally tailored for each individual patient—vs. the conveyor belt, “one size fits all” approach that current oncology adheres to. This part of the film will likely be the first time most of the audience will become aware of this new direction.

Due to the slow-moving bureaucratic obstacles of Antineoplastons by the FDA, this new expanded “personalized gene-targeted” direction has allowed more patients who are denied access to Antineoplastons by the FDA to benefit from Burzynski’s practice in ways never before thought possible.

Note the framing. There are those nasty skeptics, oncologists, and promoters of science-based medicine who, out of concern for patients going to the Burzynski Clinic, try to warn patients that Burzynski doesn’t have the goods. Obviously, according to Merola, they’re too stupid, ignorant, or deluded to understand the genius that is The Great Stanislaw Burzynski! Especially those Houston oncologists and Houston ER docs, who are the ones on the front lines who actually have to try to pick up the human wreckage that Burzynski leaves behind with his treatments. Never mind that! Merola will show them! He’ll do it using what are, in essence, religious conversion stories, in which the metaphorical St. Paul is knocked off his horse by the sheer awesomeness that is Burzynski, recants his previous skepticism as the “miracle” of antineoplastons and Burzynski’s “personalized” therapy is revealed, and becomes a believer. Notice, however, no mention of—oh, you know—anything resembling actual scientific evidence.

It also looks as though Merola is going to amp up the conspiracy theory angle again even more than the first movie. I’m not sure how he will achieve this, given that the first installment in Burzynski The Movie was one-third anecdotes, two-thirds broadsides against the FDA and the Texas Medical Board chock full of conspiracy theories. In any case, I’d love to see what Burzynski and his propagandist have to say about his “personalized gene-targeted cancer therapy for dummies”-approach to personalized cancer therapy, because from what I can tell on his website and publicly available sources, not only does Burzynski completely misunderstand targeted therapy, thinking that working on more genes must be better (here’s a hint: chemotherapy works on a lot of genes), but he misapplies very basic knowledge of genomics by using a “one from column A, two from column B”-style mixing and matching of targeted agents devoid of any deep understanding of the consequences.

Let’s take a look at the trailer:

The clip starts off with what is very old news, a press conference by the director of the FDA through much of the 1990s David Kessler, being asked at a press conference whether the process of expedited review introduced then for anticancer therapies would speed up the approval of antineoplastons. Clearly, the two reporters asking questions are believers, as they keep badgering Kessler after he says that he doesn’t want to focus on any single anticancer agent. We’re then told ominously that less than one year after this press conference America’s federal and state agencies lost a “fourteen year campaign attempting to permanently revoke Burzynski’s medical license” and declares that “Burzynski’s victory” resulted in the government abandoning its attempt to “hijack” these medicines. Merola also accuses the government of colluding with one of Burzynski’s own scientists to file patents on Burzynski’s therapies, listed as patent numbers 6037376, 5635532, 5852056, 5654333, 5661179, 5635533, 5843994, 5710178 (which is the same as 5843994), 5877213 (listed as a continuation of 779744, which was abandoned), and 5881124. Several of these appear to be redundant, being continuations or combinations of other patents. Be that as it may, the researcher to which Merola refers is Dvorit Samid, who is currently Vice President of Medical Affairs at Synta Pharmaceutical and was Section Chief Differentiation Control, National Cancer Institute/National Institutes of Health Division of Cancer Treatment from 1990 to 1995. These patents have mainly to do with phenylacetic acid, which was one compound that Burzynski referred to as AS-2.1, and derivatives mostly as anticancer or differentiation compounds in in vitro systems. One of these patents (5881124) has nothing to do with antineoplastons and is in fact an imaging patent. Maybe it’s a typo that Merola will fix before he releases his movie.

Be that as it may, the claim that Dvorit Samid “stole” Burzynski’s antineoplaston patents strikes me as rather questionable (at best), given that, first, Samid was not “one of Burynski’s scientists” but a section chief at the NCI. Also, using Merola’s counting methods, Burzynski himself has four patents on antineoplastons, issued in the 1980s. These include 4,470,970, 4,558,057, 4,559,325, and 4,444,890 and since the 1990s has filed numerous patent applications for antineoplastons for everything from treating cancer using liposomal delivery systems, to treating hypercholesterolemia and Parkinson’s disease. What exactly happened between Burzynski and the NCI is difficult to discover, as it is documented objectively in few places but trumpeted around the web by Burzynski-friendly sources. Even a paper analyzing the incident from a sociological standpoint isn’t particularly revealing, given that it, too, slants towards Burzynski and was published in a highly dubious journal.

Next up in the trailer is a mention of Burzynski’s infamous phase III clinical trial, A Randomized Study of Antineoplaston Therapy vs. Temozolomide in Subjects With Recurrent and / or Progressive Optic Pathway Glioma. What has always been puzzling to me, ever since I became interested in Burzynski and his antineoplastons, is why Food and Drug Administration (FDA) not only continues to let Burzynski set up phase II clinical trial after phase II clinical trial, nearly all of which never accrue enough patients to publish. Indeed, if you search ClinicalTrials.gov for “Burzynski” or “antineoplaston,” exclude all the trials with “unknown” status, you’ll find the aforementioned phase III trial, a whole lot of trials with “unknown” status, and a trial unrelated to antineoplastons for which a man named Joseph Burzynski appears to be an investigator at one of the sites. If you peruse the NCI website, you can find a very nice summary of the existing clinical trial data on antineoplastons. Of those sixty or so phase II studies, there are only a couple of them published, as is summarized nicely by the NCI:

Antineoplaston therapy has been studied as a complementary and alternative therapy for cancer. Case reports, phase I toxicity studies, and some phase II clinical studies examining the effectiveness of antineoplaston therapy have been published. For the most part, these publications have been authored by the developer of the therapy, Dr. Burzynski, in conjunction with his associates at the Burzynski Clinic. Although these studies often report remissions, other investigators have not been successful in duplicating these results.

A more detailed listing of the clinical evidence by the NCI is singularly unconvincing.

One notes that Burzynski’s phase III trial, although approved in December 2010, is not yet open to accrual, even though it was scheduled to begin accruing patients in December 2011. In any case, the reason that this is an issue is that Burzynski apologists have been pointing to this study as “evidence” that there must be something to antineoplastons, the rationale being that otherwise the FDA would not have given the trial the go-ahead. Given that there is no good clinical data published by Burzynski that I’ve been able to find to support a phase II clinical trial, this has puzzled me and other skeptics, at least one of whom suspects that, however he persuaded the FDA to approve this trial, it suits Dr. Burzynski just fine that it has not opened yet. It is a suspicion that I share. Think about it. This phase III trial is the biggest and most effective club that Burzynski apologists have to beat skeptics over the head with. If Burzynski actually started accruing to the trial, its results would, by law, have to be posted to ClinicalTrials.gov. An approved but not yet accruing trial is an infinitely better weapon than a trial that accrues and produces no results. It’s also interesting to note that this clinical trial includes chemotherapy. In fact, Burzynski uses a lot of chemotherapy.

As for the phase II trials, there are lots of trials listed as having “unknown” status (meaning that their status has not been verified in over two years) but still listed as being “open” as well. There are also several studies listed as “withdrawn.” It’s a total of 62 trials over the last 20 years or so, and not a single one of them, as far as I and others who have looked at them have ever been able to tell, has produced any useful evidence for the efficacy of antineoplaston therapy. Is it any wonder that many of us suspect that these “clinical trials” are shams designed to get around the orders of the Texas Medical Board back in the 1990s that prohibited Burzynski from using antineoplastons except within the context of being tested in clinical trials?

The rest of the trailer consists of nothing more than the usual Burzynski blather, anecdotes, this time bolstered with two conversion stories involving credulous oncologists who are now apparently Burzynski believers.

One wonders how much they would believe if they read some cases, the stories of several Burzynski patients. For example, there’s Wayne Merritt, who spent a lot of money at the Burzynski Clinic before figuring out that he was wasting his money. Mr. Merritt was threatened by a representative of the Burzynski Clinic, apparently because Burzynski didn’t like the Merritts’ Burzynski Scam site. Or maybe they should look at Denise D., a woman who was working as a temp without health insurance when she developed what sounds like inflammatory breast cancer. She went to the Burzynski Clinic, where she was charged large sums of money. When she managed to get some of the drugs she was being prescribed from the pharmaceutical companies through a compassionate use program, saving her thousands of dollars, the Burzynski Clinic turned around and started charging her a $1,500 per month “case management fee” just to submit refills of her submit refills for the Tarceva, Xeloda, Zolinza, and Zometa. These are all very expensive targeted drugs and chemotherapeutics.

When looking at the human cost of Burzynski’s activities, words fail me. Sadly, Wayne Merritt and Denise D. are not alone.