The year 2013 finished with serious setbacks for Stanislaw Burzynski and his unproven cancer treatment that he dubbed “antineoplastons” (ANPs) way back in the early 1970s. As you might recall, in November, two things happened. First, the FDA released its initial reports on its inspection of the Burzynski Clinic and Burzynski Research Institute (BRI) carried out from January to March 2013. They were damning in the extreme, pointing out the shoddy operating methods of the institutional review board (IRB) used by the BRI to approve and oversee Burzynski’s “clinical trials” (and I use the term loosely) of ANPs. Violations included using expedited approvals to review single patient protocols, something so far outside the purview of what the expedited approval process was intended for, namely approving minor tweaks to human subjects research protocols without requiring a full meeting of the IRB, that the FDA called Burzynski out for it. Other violations included failure to report serious adverse events (SAEs) and adverse events (AEs) to the FDA and/or the IRB, failure to follow proper informed consent procedures, failure to determine that risks to subjects were minimized and that risks to subjects were reasonable in relation to anticipated benefits, if any, and a lot of other violations listed in my post on the subject.
Later in November, Liz Szabo of USA TODAY published a fantastic expose of Burzynski entitled Doctor accused of selling false hope to families, in which, in addition to many of the violations revealed by the FDA, it was further reported that the child whose death in the summer of 2012 triggered the FDA investigation was Josia Cotto, and that the child died of hypernatremia (elevated sodium levels in the blood) caused by ANP therapy. In response to the reports of shoddy record keeping, lack of ethics, and contributing to the death of a child, Burzynski was his characteristically cuddly self, referring to his critics as “hooligans” and “hired assassins,” while claiming that they “pretend they got sick and would like to extort money from us.” When last I wrote about Burzynski in November, his empire was struggling to strike back. Eric Merola, the film maker responsible for two pro-Burzynski propaganda movies Burzynski: Cancer Is A Serious Business and Burzynski: Cancer Is A Serious Business, Part 2, likened USA TODAY to everything from Nazi propaganda under Joseph Goebbels, to slave masters, and to the Westboro Baptist Church protesting at the funerals of gay soldiers killed in the line of duty. Meanwhile Burzynski himself tried to answer the FDA findings and failed miserably, nor did his poster presentation of singularly unimpressive results at the Society of Neuro-Oncology Meeting right before Thanksgiving help. The year ended with the Texas Medical Board using the FDA’s findings as part of the basis of charging Burzynski with false advertising, meaning that Burzynski will be spending a lot of time defending himself against the TMB in 2014.
Unfortunately, beginning in December, Burzynski and his allies decided to go back to the future, so to speak (or maybe just back to the 1990s) and resurrect the campaign that worked so well for them the last time Burzynski’s back was against the wall. Unfortunately, this strategy, rooted as it is in using cancer patients to lobby Congress to force the FDA to allow Burzynski to use antineoplastons, could work. Pro-Burzynski forces, in a nod to the past, have even hired the same lobbyist who, or so it is claimed by the pro-Burzynski forces, so brilliantly in the mid-1990s in persuading Rep. Joe Barton (R-TX), then the chair of the House Subcommittee on Oversight and Investigations, to “investigate” the FDA’s “harassment” of Burzynski.
If you want to understand Burzynski’s new strategy to keep using ANPs, you have but to go back and examine his previous strategy, which was to milk dying cancer patients for every bit of human sympathy they can evoke from lawmakers and the public. Everything old is new again, as Burzynski replays the same strategy with patients such as McKenzie Lowe, Liza Cozad, and Elisha Cohen.
Meanwhile those of us who stand up and say no, who try to point out that Burzynski can’t save these patients, that they are being used by him so that he can re-open his ANP clinical trials, are pummeled with arguments like the one by Randy Barnes that we should “respect the parents’ choice.” After pointing out that he is “not a fan” of the Burzynski Clinic, and “agrees with many of the criticisms leveled at Stanislaw Burzynski and his treatments,” he asserts that “Raphael Elisha’s parents are the only ones with the right and responsibility to make the best decisions they can in a horrible situation that no one who has not faced the loss of a child can possibly understand.” He then concludes:
If you choose not to sign the petition that is fine, but please, allow the Cohens the dignity they deserve by respecting their right to make the choices they deem fit for their child. Publicly fighting the Burzynski Clinic in Raphael Elisha’s name will only bring more pain to an already suffering family.
This is the argument we’re up against as well, an argument that is every bit as invalid as when it is used to defend, for example, the family of Sarah Hershberger for relying on quackery instead of chemotherapy to treat a deadly lymphoma. We can respect the parents’ decision, to the extent that they are the parents. We can try to understand the desperation that led them to it, even though they are aware of all the criticisms of Burzynski. Most parents can only imagine how they would react under similar circumstances. Even I couldn’t guarantee that I wouldn’t be tempted by the blandishments of Burzynski and his followers if I were in the same position as the Cohens. However, sympathy and respect do not equal agreement, nor do they require us to acquiesce and just “shut up” when the Cohen’s grief and desperation lead them to do something profoundly harmful to public health, to use the power of their story to persuade lawmakers to call off the FDA.
It’s not just sympathetic families being used by Burzynski to further his cause, however. Right after the holidays, one of the most prominent pro-quackery advocacy groups in the world, the Alliance for Natural Health USA, launched a series of attacks and posts urging its supporters to write to their legislators to put pressure on the FDA to allow compassionate use exemptions for antineoplastons (ANPs). Also included is a smear campaign against Liz Szabo, Burzynski “skeptics,” and, of course, USA TODAY, all of whom are portrayed as being in the thrall of big pharma. I do note, with some mild amusement, that here was one article posted on the ANH-USA website claiming that the FDA violated patient privacy by providing Szabo with medical records of a patient without the parents’ permission. If you click on the link now, there’s nothing there. The article has apparently been taken down. there are, however, multiple links to it elsewhere, for example, here, here, here (our old friend Merola) and here. The article still shows up on the ANH sitemap, but there’s nothing there. Apparently, the ANH took it down, which is probably because it was full of misinformation and lies. I only wish I had saved a screenshot or web archive of the article. My mistake.
Bringing it all together: The ANP Coalition
It’s taken nine months since Burzynski supporters revealed in a video of the panel discussion after a screening of Eric Merola’s movie that various Burzynski patient groups were planning to form an organization to lobby Congress for fast track approval of ANPs. Indeed, Merola and his merry band of Burzynski sycophants were quite open about wanting fast track approval for ANPs so that Burzynski could then prescribe them off label for virtually any cancer and presumably could also sell them to any doctor who wanted to use them for whatever purpose. Of course, advertising a drug for off label uses is against the law, which is why the FDA takes such a dim view of it, but “word of mouth” and ANP-friendly groups like the ANH would make sure that word got around fast. Unfortunately for Stash, with the deficiencies of the procedures of the Burzynski Clinic and BRI with respect to running clinical trials having been laid bare in Liz Szabo’s article in USA TODAY, fast track approval for ANPs for glioblastoma is, at best, highly unlikely. So Burzynski’s allies have fallen back on lobbying Congress to lean on the FDA to allow single patient protocols, sometimes called “compassionate use” protocols, to allow Burzynski to treat patients with ANPs even though his clinical trials are shut down. To do this, they have formed a group called the ANP Coalition:
It is our fundamental belief that the discovery of Antineoplastons (ANP) can and will herald a new age of medical science and subsequent advancements in the treatment of previously incurable diseases. This benign yet effective drug contradicts the paradigm that cancer treatments have to be harmful to be effective, and redirects modern medicine back to its salient principal Primum non nocere, “first, do no harm”.
How does the ANP Coalition intend to accomplish our mission?
We will accomplish our mission by focusing on four main goals:
- To educate the public as to the importance and benefits of ANP.
- To advocate for patients who need access to ANP for medical conditions.
- To expedite regulatory approval for ANP thereby making it available to all.
- To further research and development of ANP.
Consistent with a lot of the rhetoric used by Eric Merola and the Burzynski Patient Group, the rhetoric on the ANP Coalition site is apocalyptic, painting the battle as nothing less than one of good versus evil:
This is not a time for all good men to act; it is a time when all good people must act. We live in an age of awareness, where technology has become the great equalizer. With technology comes communication, and through communication we can educate! Once armed with education, propaganda withers and dies!
This website is designed with the sole purpose of educating the public and exposing the truth. The battle starts here in cyber space, but the war is won in the real world, by real people who participate in real ways. It will be won by you!
We are no longer an organization of patients connected by a cure; we are the collective who will not allow evil to triumph.
I can provide a hint of why the rhetoric is so amped up. One has only to look at who owns the ANPcoalition.org. The domain is registered through Domains By Proxy, which makes one wonder why the ANP Coalition would want to hide who owns the domain. First of all, the pictures on the Contact page reveal several old friends, including Ric Schiff, whose wife Laura, not coincidentally, owns a related domain, theotheranpcoalition.org, and registered it under her real name and also appears on the Contact page. (A screenshot has been saved, of course.) Also there is Mary Jo Siegel and her husband Steve. These are the people behind ANP Coalition, just as they are heavily involved in the Burzynski Patient Group. In fact, in July 2013, Ric Schiff was elected to the board of directors of the BRI, which makes his involvement in this effort a massive conflict of interest.
Predictably, Elisha Cohen, Liza Cozad, and Mackenzie Lowe are featured as the stories used to drive petitions to lawmakers and the FDA to allow compassionate use of ANPs. In addition, there are two new patients, of whom I haven’t heard before, Laura Nowosad, a 7 year old girl from Canada with a DIPG whose story is sadly familiar to anyone who covers Burzynski:
Her parents, Janusz and Mira, are an amazing couple whose lives got shattered in an instant. Laura is their only child and their whole world. They couldn’t believe that this is happening to their little girl; they were hopeful that the doctors made a wrong diagnosis and went for a second opinion. Unfortunately, this diagnosis was confirmed. Words cannot explain the feelings of hopelessness, frustration, and terror they felt when they had to be faced with the truth.
Janusz and Mira are not giving up hope! They have taken Laura to The Burzynski Clinic in Houston, Texas. This clinic has seen significant improvement in patients facing similar diagnosis as Laura, using alternative therapies not available in Canada. However, the treatment is very expensive. The initial visit costs $25,000 and each month after is $30,000.
On the same page is yet another desperate family being used by Burzynski’s minions as well, that of Isaac DeHerrera, a five year old boy whose tale is presumably so new that there isn’t yet a fundraising website that I could find or a petition to let Burzynski treat Isaac with ANPs on a compassionate use protocol. I’m sure there will be more families added as soon as Burzynski and his minions can find them. Clearly Ric and Laura Schiff and Steve and Mary Jo Siegel believe that they can duplicate the success Burzynski patients had in the 1990s, which was the last time Burzynski was in a comparable amount of trouble, with demonstrations featuring patients chanting, “FDA go away! Let me live another day!” and the intense political pressure brought to bear by a compliant Senator or Representative, the way they persuaded Joe Barton to drag then-FDA director David Kessler in front of his committee four times over two years to explain why the FDA was “harassing” Burzynski. Only this time, they have the Internet, which was only in its infancy as an organizing tool back in 1995, which allows them to produce a “Meet the Miracles” section, which, presumably, will be full of glowing testimonials of Burzynski Patient Group patients. So far, there is only Jessica Ressel, who was featured in the first Burzynski movie and whose testimonial is not convincing, as I described in detail in my review. No doubt she believes Burzynski saved her, but it is almost certainly the case that he did not, which is the only reason I can forgive her regurgitating Burzynski Clinic talking points.
His experience with ANP extends more than 18 years back when he represented the Burzynski Patient Group in 1995 and 1996, organizing numerous patient demonstrations and a Congressional Hearing on February 29, 1996 before the U.S. House of Representatives Energy & Commerce Subcommittee on Oversight & Investigations. These efforts helped Burzynski patients obtain access to ANP through Phase II clinical studies.
This isn’t cheap. Unless Martinez is serving pro bono, his hourly rates are $250 to $400. I have no reason to doubt the claim that he worked on organizing the Congressional Hearing in 1996 at which Burzynski patients vented at the FDA, but I wonder. I’ve read both Richard Jaffe‘s Galileo’s Lawyer: Courtroom Battles in Alternative Health, Complementary Medicine and Experimental Treatments and Thomas D. Elias’ The Burzynski Breakthrough: The Most Promising Cancer Treatment and the Government’s Campaign to Squelch It. Both books describe the Congressional hearings in which Burzynski patients testified from a very pro-Burzynski standpoint. I don’t recall seeing Mr. Martinez’s name being mentioned even once, and a quick flip through the indices and relevant sections of these books did not change that assessment for me. If Martinez were so important to the 1996 hearings, one would think that Jaffe and/or Elias would mention him and at least briefly describe his role in their books. They didn’t, as far as I can tell.
So what does the ANP Coalition want to accomplish? Its list of demands is long and some are completely unrealistic. For example, on its page where it tells people how they can help, it asks people to write to Wikipedia to:
…demand removal of the “Burzynski Clinic” webpage, since it has been high jacked by a paid group who identify themselves as “The Skeptics”, and is no longer open for public contribution. The Wikipedia page on “Burzynski Clinic” is filled with untrue statements, statements taken entirely out of context, cherry-picked information, sources that do not qualify as sources under Wikipedia rules, fake sources—you name it.
Others, however, are not unachievable. Certainly organizing petitions and getting people to write to their lawmakers are achievable aims, and that’s what concerns me: How do we respond? In the absence of sound scientific information showing that ANPs almost certainly don’t work and are very toxic, Burzynski’s claims notwithstanding, legislators and politicians are going to go with the sympathetic story; i.e., the stories told by Burzynski supporters of children with deadly brain tumors who will die soon if they aren’t allowed to have ANP therapy. That’s why it infuriates me to see how Burzynski so cynically uses patients with deadly cancers in his battle with the FDA. Make no mistake, that is exactly what he is doing here. He dangles false hope in front of patients like Eliza Cozad, Raphael Elisha Meir ben Devorah Cohen, and McKenzie Lowe, and their families do the rest for him Even in the case that a legislator understands the lack of evidence, he might well go with a “What’s the harm?” attitude, not appreciating that the harm can be appreciable given how toxic ANPs are, not to mention the financial harm done to the family raising tens or hundreds of thousands of dollars for an ineffective treatment. That’s why information to show why, as much as we sympathize with the plight of these patients and their families, legislators should not overrule the FDA’s decision regarding antineoplastons. Indeed, the real investigation should be into why the FDA has allowed Burzynski to get away with what he’s gotten away with all these years.
I also appeal to you, our readers, for help and ideas. Visit Bob Blaskiewicz’s appeal and take action. In the meantime, let’s hear ideas for how to counter this latest initiative.