Three weeks ago, USA TODAY published an expose of the Burzynski Clinic by Liz Szabo that was devastating in its scope and detail. Early on, Stanislaw Burzynski and his minions tried to do some damage control, with hilarious results given how inept and unconvincing his excuses were for all the violations of ethics and patient care and abuse of clinical trials detailed by Szabo. Later, Burzynski presented some abstracts at the Society of Neuro-Oncology meeting in San Francisco. Let’s just say that the case report and his reports of a phase 2 clinical trial were…similarly unimpressive. Overall, the initial Burzynski response was ineffective.
Unfortunately, when science fails, Burzynski can always play the sympathy card. And it works, too, unfortunately. Now, you’d think that after Liz Szabo’s expose about the Burzynski Clinic patients with cancer would be avoiding Burzynski like the plague, as well they should. You’d be wrong. I have little doubt that Szabo’s story has probably hurt Burzynski’s business, but he hasn’t survived and thrived for over 36 years because of a lack of skills in attracting patients and in publicizing himself. If anything, he’s shown an amazing perseverance, even when he was on trial for insurance fraud back in the 1990s. With the help of his attorney Richard Jaffe, he turned that trial into a circus, with patients demonstrating and U.S. Rep. Joe Barton (R-TX) running hearings looking into the FDA’s “persecution” of Burzynski, complete with panicked patients’s families who had been persuaded to believe that Burzynski was the only person who could save their loved ones.
Burzynski’s at it again, but in a different way.
The first example I mentioned was McKenzie Lowe, a 12-year-old girl with an inoperable brain tumor. No doubt given the idea by Burzynski, McKenzie’s family has been posting appeals to the FDA to allow McKenzie to be placed on antineoplastons as part of a compassionate use exemption. Once again, Burzynski was offering false hope to the families of cancer patients. As I said before, Burzynski can’t help McKenzie, but her family can help him by helping him change the narrative from a doctor without any training in internal medicine or oncology who is utterly unqualified to treat patients with advanced cancer who has cynically sidestepped the FDA and the Texas Medical Board for nearly 37 years while abusing the clinical trial process to keep giving a toxic, almost certainly ineffective chemotherapeutic agent to patients. And, make no mistake about it, antineoplastons (ANPs) are chemotherapy, no matter how much Burzynski tries to claim otherwise. It’s hard not to let sympathy for a child with a deadly cancer trumps reason and science if you’re a politician, and Burzynski knows that.w
Unfortunately, now there two more.
First up, there is a Jewish boy in Houston named Raphael Elisha Meir ben Devorah Cohen:
Then, the unthinkable happened. A series of symptoms in the couple’s young son, Raphael Elisha, led to the diagnosis of medulloblastoma, an aggressive form of cancer of the brain and spine. Initially, the now-6-year-old underwent surgery to remove as much of the brain tumor as possible, followed by radiation and chemotherapy.
For months after the surgery, because of a condition that developed as a result of the surgery, Rafael Elisha couldn’t speak, walk or eat. However, the tremendous faith and love of his family and the support of the family’s new friends and neighbors helped him fight through rehab. By the summer, he had been restored to his life as a fairly normal 6-year-old, and it looked as though the tumor was gone.
Then, in September 2012, on a routine MRI, his physicians saw evidence of the tumor’s return.
After this, the story is sadly familiar. Well-meaning people set up a fund to send Raphael Elisha to Houston for treatment by Stanislaw Burzynski. “How do I know this?” you might ask. After all, neither Burzynski nor antineoplastons are mentioned in this particular article. Nor are they mentioned in this Times of Israel article. They are, however mentioned in this article:
Perhaps we can all come to together to help Refael Elisha Meir ben Devorah.
Authorize the FDA to grant a compassionate use exemption to Refael Elisha Cohen for Antineoplaston therapy.
The Cohen family, of Houston, TX, is facing a battle none of us should have to go through – aggressive brain cancer in their 6-year old son Refael Elisha. Having recently received the devastating news from their doctors that “there is nothing more we can do for him,” the Cohens are turning to a last resort – Antineoplaston Therapy at the Burzyinski clinic. However, the FDA pulled their approval for this treatment in 2012 pending further clinical trials. We are told that the FDA is nearing approval to resume this treatment, but Refael Elisha does not have time to wait.
The FDA has the power to approve a “compassionate use exemption” so Refael Elisha can undergo this therapy to try and save his life.
We are asking the FDA to grant this exemption so we can continue to fight for his life.
As does this story.
And here’s the Whitehouse.gov petition:
The Cohen family, of Houston, TX, is facing a battle none of us should have to go through – aggressive brain cancer in their 6-year old son Refael Elisha. Having recently received the devastating news from their doctors that “there is nothing more we can do for him”, the Cohens are turning to a last resort – Antineoplaston Therapy at the Burzyinski clinic. However, the FDA pulled their approval for this treatment in 2012 pending further clinical trials. We are told that the FDA is nearing approval to resume this treatment, but Refael Elisha does not have time to wait.
This sort of thing infuriates me, because it really does appear as though the Cohen family is being lied to. According to this editorial, the Cohens are aware of Burzynski’s reputation. However, obviously either Burzynski, Eric Merola, or someone from the Burzynski Patient Group has been feeding them “success stories.” As I’ve explained time and time again, these “success stories” appear compelling on the surface, but if you look at them with a knowledge of how cancer progresses and how cancer treatments work it rapidly becomes apparent that they are not evidence that Burzynski’s antineoplastons can do any better against deadly cancers than conventional therapy. Think Hannah Bradley and Laura Hymas. Think Mary Jo Siegel. Think Tori Moreno. It seems as though Burzynski cured these patients, but he almost certainly did not.
In addition, Burzynski has been telling patients that the FDA is “nearing approval to resume” his clinical trials almost ever since the FDA imposed a partial clinical hold on Burzynski’s antineoplaston trials in the summer of 2012. That partial clinical hold meant that no further children could be enrolled on any of Burzynski’s clinical trials. Later, in early 2013, that partial clinical hold was extended to adults. Patients who were already receiving antineoplastons could continue to receive them, but no new patients could be enrolled in Burzynski’s clinical trials. Ever since then, Burzynski’s been dangling the hope that the FDA would lift the partial clinical hold. Now, apparently, he’s using those patients to try to get the attention of the White House. In Raphael Elisha’s case, the number of signatures is up to nearly 36,000.
Raphael Elisha is not alone, however. There’s an adult who is also going down the same road. This adult is actually a minor celebrity in that she is the wife of Sammy Hagar’s drummer. She is 46 and was diagnosed with an inoperable brainstem glioma. Her name is Liza Cozad, and to send her to the Burzynski Clinic there’s a Give Forward campaign that’s raised over $50,000 thus far. Of course, it doesn’t mention Burzynski, either, at least not in the main page. However, her Change.org petition does mention antineoplastons, although the drug is abbreviated ANP:
Six months ago, Liza was diagnosed with a deadly brainstem tumor – called a DIPG – it rarely strikes in adults (only about 20 in the U.S. each year) but is unfortunately common among brain tumors in children – and just as deadly – a year to a year and a half to live. No doctor can perform surgery to remove due to its location, chemo has consistently shown to be ineffective on Liza’s type of tumor, and even the radiologist tells her her best case scenario with radiation is it would return in 1-2 years, more aggressively, and they could no longer radiate. There is one drug that could save Liza’s life. The drug – ANP – has been approved for Phase III clinical trials by the FDA. This means it has been deemed safe (Phase I trials) and effective (Phase II trials). The FDA has continually denied Liza’s request for the treatment under a Single Patient Protocol (the FDA format under which she could be approved), saying they have questions for the manufacturer about the drug based on one patient out of hundreds’ response to sodium levels. They have cotinued with this for a year – each time the manufacturer answers all their questions, the FDA keeps coming back with more – all the time denying any new patients – including Liza – from receiving this drug the FDA has itself acknowledged to be safe and effective. This precious and caring young woman has been fighting her fight since April, but her health is declining. This drug has a documented 27% success rate on her exact kind of tumor – which is 27% better than her odds with all standard therapies – and with some children still cancer-free over 20 years later.
Recently Cozad and her husband posted a video appeal to YouTube:
There is, of course, no evidence that Burzynski has a 27% success rate in treating DIPG, but the video his heartbreaking. Cozad is seriously cross-eyed (to use a more colloquial term) and has obvious problems with her speech, indicating that the tumor is impinging on her optic nerves and affecting the nerves to her mouth and tongue. Her story is depressingly familiar to those of us who have familiarized ourselves with the Burzynski saga. After being given the diagnosis and told that radiation would only delay progression of the tumor, she went on the Internet and, as all too many patients with inoperable brain tumors do, found Stanislaw Burzynski. In her desperation, as all too many cancer patients have, Cozad latched on to the false hope that Burzynski offers. As so many of Burzynski’s patients have done, they talked to Burzynski’s “success stories,” who, being convinced themselves that Burzynski saved their lives when he almost certainly didn’t, convinced Cozad and her husband that Burzynski was the only one who could save her life.
This story has a twist, though, compared to past Burzynski stories. Clearly, they were told that Burzynski could help Cozad, were it not for that evil FDA putting a partial clinical hold on antineoplaston clinical trials. It’s truly painful to see Cozad trying so hard to tell the story. Her husband describes ANPs as a “clinically proven drug,” which it is not. Cozad states that the National Cancer Institute and FDA have “seen the studies” that prove the efficacy of ANPs against DIPG, citing the aforementioned 27% success rate. Again, there is no convincing evidence that Burzynski can do this. I cannot emphasize this enough. As I explained with the case of McKenzie Lowe, it is also not true that Dr. Burzynski is the only person who can cure DIPG and that no one ever survives it. True, survival is rare, but it is not unheard of.
The rest of the video is standard Burzynski Clinic boilerplate, obviously provided to the unfortunate couple by the Burzynski Clinic. The latest wrinkle is that apparently Cozad was told that she could go to Japan to receive antineoplastons, leading her and her husband to lament that they would have to sell their house and many of their possessions to pay $30,000 a month plus living expenses in Japan to receive “what they should be able to receive here.” They also claim that Burzynski can’t send ANPs abroad because, unlike other alternative treatments, this is a patented treatment. Now, there might be reasons why ANPs can’t be sent to Japan (although somehow that’s never stopped Hidaeki Tsuda from getting ahold of them to use in his alleged clinical trials), but just because ANPs are patented is not one of them.
I know I’ve said it all too many times, but 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 Cohen, and McKenzie Lowe, and their families do the rest. Given the success of the Lowe family in getting their Senators to write letters to the FDA, it’s obvious that Burzynski is using these families to put pressure on the FDA. Shockingly, he’s so cynical that he’s trying to get the FDA to allow him to do exactly one of the things that he got nailed for: Abuse the clinical trial process by having his institutional review board approve single patient protocols for compassionate use. One wonders if any of these patients have any idea how Burzynski overestimates response rates. Probably not.
I have to stop now. Reading these stories depresses the hell out of me.