I happen to be out of town right now, attending the annual meeting of the American Society of Clinical Oncology in Chicago. It's been a more—shall we say?—eventful trip than anticipated, which is why at my not-so-super-secret other blog we have a guest post today and here I will (probably) be shorter than usual. I'm not really going to say much about what I mean by "more eventful than usual," because it's more personal than anything else. Suffice to say that it kept me from delivering the usual logorrhea. Well, the unexpected event plus spending the day visiting my sister and my nephews, one of whom is still less than five months old. As I said to a colleague at ASCO, "baby vs. meeting" = baby wins every time. At least I did get a chance to hang out with some of the Chicago Skeptics on Saturday night.
But enough blather about me. If there's one thing about attending a real scientific conference on cancer it's that it highlights to me the difference between real clinical trials and Stanislaw Burzynski. The reason is that I was curious what was going on since the FDA caved and cravenly decided to allow patients to receive antineoplastons after Burzynski relived the 1990s and successfully used cancer patients as weapons (with rock stars, even) to wield against the FDA. All of this has been part of an effort on the part of Burzynski and his supporters to overturn the FDA's decision to issue a partial clinical hold on all of Burzynski's clinical trials, which means that, although Burzynski can keep giving antineoplastons to patients already on trials, he can't enroll any new patients. This has lead to former patients who thought they were doing well and then recurred to find out that they could no longer receive antineoplastons. Never mind that the antineoplastons almost certainly weren't responsible for their good fortune, as I've described time and time again. The patients understandably thought they were.
So what's happening? It's as I predicted. The FDA thought it could defuse the situation of having angry cancer patients and their families who think the FDA is preventing them or their loved ones from accessing the only treatment that can possibly save them from raising a ruckus by stipulating that these patients could receive antineoplastons but only if it isn't Burzynski administering them. Given that there is a not inconsiderable amount of effort and paperwork to overcome the regulatory hurdles to administer antineoplastons under a single patient IND (a.k.a. compassionate use exemption). For one thing, such physicians have to submit their treatment plan to an institutional review board (IRB). Even so, patients are finding a way.
Take Liza Cozad-Lauser, for instance. She's the wife of Sammy Hagar's drummer David Lauser, and probably the most famous Burzynski patient at the moment. Recently, a reader posted a status update from David Lauser's Facebook page that reads:
It's been a while since I've posted as I have been learning how to administer Liza's ANP!
THAT'S RIGHT, Liza has the drug we've been working so hard to get...your support really made a difference in tipping the scales in her favor...thank you!
The VH Tribute band, "Hot For Teacher" has offered to perform at the Sweetwater in Mill Valley, CA and donate the proceeds to help Liza pay for medical costs!
They asked me if it was cool, and if I'd sit in and play a few tunes...I said of course, and that I and Liza would be there, along with Vic and Mona.
The date is set for Friday, June 20th, 2014.
Hopefully, the peeps that couldn't get tix for Liza's last concert can make it
One wonders if Burzynski is doing what he promised and waiving the cost of the antineoplastons, as the benefit page for Cozad-Lauser reads:
Join us for our second Benefit for Liza concert. Liza Cozad-Lauser is David Lauser's wife. David plays drums for Sammy Hagar's band The Wabos and he's trying to save his wife's life. In April, 2013 doctors diagnosed Liza with an inoperable, incurable, fatal brain tumor, but there was an experimental drug that had shown to be safe and effective on this type of tumor, but it wasn't approved by the FDA. We are happy to announce that following the efforts of our first concert, enough pressure was applied and the FDA has now approved the drug. Liza has just begun her treatment, this concert will help offset the costs associated with a disease of this nature. Come celebrate Liza with some of the best damn rock songs ever, expect special guests!
Why are the costs so high if Burzynski is doing what he said he would do and waiving the costs? It is also unclear who the physician is who has agreed to administer the ANPs, as the physician, not surprisingly, isn't identified. Perhaps an explanation can be found in the GoFundMe page for another Burzynski patient, Rachel Pearson-Thorup, a 20 month old baby who in January 2014 had a medulloblastoma surgically resected, which has already recurred. There's the usual Burzynski propaganda there, although Rachel's mother Salem gets it wrong when she says "several" phase III trials of ANPs have been approved. The fact is that only one phase III was ever approved and it was closed without ever accruing a single patient. Be that as it may, the Pearson-Thorups explain:
While Dr. Burzynski is not allowed to charge for the ANP's (but must charge for other clinic expenses- he has not recieved ANY grant money for research), any of our options for securing them for Rachel will be somewhat expensive- but no price is too high for our precious baby's life. We will be working on various types of fundraising, but we must first work to find the avenue through which Rachel can be treated. Her time is running short. We need your help & support to finish raising the funds needed to treat Rachel. Most of all, we need your prayers.
As I've said so many times before when I've seen stories like this, I completely understand how parents would believe that no price is too high to save their child's life. However, the way that this is phrased makes me wonder if there is some sort of financial prestidigitation going on here. Whatever the case, my heart goes out to the Pearson-Thorups. They've been understandably seduced by the false hope of the Burzynski Clinic, and now that they've fixated on antineoplastons as the only thing that can save their daughter they will do anything to make sure Rachel gets this treatment. What parent wouldn't? My only wonder is, again, who the doctor is who has agreed to administer the antineoplastons. The problem is that antineoplastons almost certainly can't save Rachel, but they can cause serious toxicity. I realize that my writing this simple truth will likely cause me to be labeled as insensitive and even evil by Rachel's supporters, but sometimes the truth, as painful as it is, is far kinder than a pleasant lie.
Finally, there is McKenzie Lowe, whose plight I've written about multiple times before. She was diagnosed with diffuse intrinsic pontine glioma (DIPG), an almost invariably fatal brain tumor. Apparently her family has managed to find a physician willing to administer antineoplastons as part of a single patient IND:
When Rochester physician Terry Bennett heard Lowe’s story, he knew firsthand what the preteen and her family were going through.
Bennett, in his late 70s, was also given a devastating diagnosis several years ago. Much like Lowe, he’s managed so far to beat the odds through unconventional means. That’s one of the reasons he stepped forward to oversee Lowe’s care.
“She’s only 12 — how could you not reach out,” Bennett said on Tuesday. “And right now, the clock is ticking for both of us.”
Unsurprisingly, Dr. Bennett is not an oncologist. There's also the unexpected twist in the story related above. He's suffering from cancer himself. But it goes beyond that. Bennett apparently has a history of battling the FDA to receive a drug for his own cancer. His cancer is a biliary ampullary adenocarcinoma, and it happened to express an oncogene known as HER2, the same oncogene that is not infrequently overexpressed in breast cancer. It's the same oncogene that is targeted by drugs like Herceptin (and, ironically, drugs targeting HER2 have made a fair amount of news out of ASCO). Certainly, it's not unreasonable to treat his tumor with a HER2-targeting agent like TDM-1 (trade name: Kadcyla), but it's not yet FDA-approved for cancers other than HER2-positive breast cancer. So when it's used off label, insurance companies won't pay for it. In any case, I find it ironic that a physician who battled the FDA because of how hospitals mark up the price of drugs like Kadcyla to cover infusion and uncompensated care, he's going to bat for a guy like Burzynski, whose ability to squeeze cash out of desperate cancer patients, even as a "clinical trial," is prodigious.
Still, one can understand why Dr. Bennett might be sympathetic to McKenzie's plight in a more personal way. Unfortunately, he's letting his own personal experience cloud his clinical judgment, given that antineoplastons almost certainly don't have appreciable anticancer activity, although they do have significant toxicity.
As I go back to the ASCO meeting this morning, I can't help but compare just how hard it is to develop a new cancer drug that is effective and without undue toxicity. The stories are here at ASCO every day of the meeting. Seeing Burzynski subvert the process, and seeing how that subversion taunts and tempts the families of desperate cancer patients with false hope and drains them of their money and energy leaves me as angry as it did when I first took a major interest in it three years ago.
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but must charge for other clinic expenses
It sounds like Burzynski and/or his henchmen are trying to pilot an aircraft carrier through that loophole. Are there no auditors on the case?
Give him an inch, he'll take Poland.
Oh Bob, I don't think that he'd really take Poland: the US has far many more people and money.
I'm trying to turn my dad's old saying "Philosophy is like Russia; full of swamps and frequently invaded by Germans" to suit this situation, but I'm not clever enough. Maybe Denice or Narad can.
(yes, Dad was an ETO vet *and* taught German philosophy, among other things).
Thanks for this update Orac.
I'm curious if anyone has any comments on this case study: Long-term Survival (>13 Years) in a Child With Recurrent Diffuse Pontine Gliosarcoma: A Case Report
Correction- here's the correct link: http://journals.lww.com/jpho-online/Abstract/publishahead/Long_term_Sur…
@Mike - besides making the "blind squirrel" reference, there isn't a whole lot there to actual evaluate.
@Mike - One mouse is no mouse.
He calls them "case management fees".
@Todd: Oh, of course. I've not encountered management fees in my limited experience with biomedical matters, but in other fields (most notoriously the financial industry), management fees are a standard method for generating profits…for the person or organization doing the managing. It's also an excellent method for ensuring that the client ends up with a small fortune…provided he started with a large fortune.
Here are the FDA rules on charging for clinical trials: http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol5/pdf/CFR-2011-title21…
One thing I don't get is why people think it's so tragic that Burzynski doesn't get any grant money. If you look at his lifestyle, it's pretty obvious he doesn't need any grant money.
Calli: Exactly- the Burzynski narrative makes no sense to anyone except his cult members.
I was listening to an NPR story about a scientist who was able to raise money and relatively quickly was able to show some promising results with unpatentable pregnancy hormones for treatment of MS. Compare and contrast that story with Burzynski's.
@Mike - and yes, if Burzynski's treatments held any water whatsoever, Pharma companies would be throwing money at him by the bushel to get the rights to the process......
Is there any reason to believe he ever submitted a grant proposal?
@LW: Burzynski was a professor at a legitimate medical school for a few years in the mid 1970s, so there is every reason to think he submitted grant proposals during those years. As I recall from a previous Orac post, Burzynski and the university in question had a less than amicable parting of ways. If you mean the last 35 years, then no, there is no reason I know of to think he submitted any proposals after going into private practice.
What's hot at ASCO this year? I hear that immunotherapy is trendy. Might Burzynski hijack this terminology -- like he did with "personalized gene therapy" -- and start marketing his antineoplastons as "natural substances" that "boost the immune system" to "help fight cancer"? Jerkface.