Stanislaw Burzynski and the cynical use of cancer patients as shields and weapons against the FDA, this time with rock stars

I don’t know if it’s a sign that I’ve arrived as being a bit more influential than just a blogger or just dumb luck when reporters start sending me things, but I’ll take it. It’s like blog fodder being served to me on the proverbial silver platter. Unfortunately, as a result of receiving a press release, FDA Denies Treatment to Two Terminally Ill Young Women, from two different sources, after yesterday’s hilarious (if I do say so myself) bit of fun with a certain woman who fancies herself a “Thinker” when everything she writes shows that she is anything but, I find myself tackling a much more serious topic that elicits in me a complicated mix of outrage and sadness because it involves corrupting the most noble impulses of the human spirit by yoking them to the service of a man who deserves none of it at the expense of dying cancer patients. Did I say “dying cancer patients”? Given that I did, you know of whom I speak. Yes, it’s Stanislaw Burzynski yet again. Truly, Count Stash is very much like what his heavy Polish accent reminds me of: A vampire who, no matter how many times you shoot or stab him (unless it’s with a wooden stake through the heart), always rises again. I had hoped that Liz Szabo’s excellent USA TODAY cover story about Burzynski in November might have been that stake, but unfortunately it appears not to have been.

As I’ve been documenting since before the Christmas holidays, patients with deadly brain tumors, both children and adult, have been putting themselves into the news in the service of trying to get the Food and Drug Administration (FDA) to lift its partial clinical hold on trials of Burzynski’s “wonder drug,” antineoplastons (ANPs). Those of you who’ve followed this story will recall that, as the result of a death of a child named Josia Cotto in June 2012 due to hypernatremia (too much sodium in the blood, a known complication of ANP therapy), the FDA put a partial clinical hold on Stanislaw Burzynski’s clinical trials. Later, in January 2013, the FDA showed up at the Burzynski Clinic for an inspection and expanded the partial clinical hold to include adults. Now, to review briefly, a partial clinical hold means that Burzynski can keep treating the subjects already enrolled in his ANP clinical trials but cannot enroll any new subjects to those trials. The trials are, in essence, closed to accrual. That’s why, beginning around Thanksgiving and continuing until now, there has been a concerted effort to try to reverse that situation. The Burzynski Clinic was very much built on the idea that he had a “natural” and “nontoxic” therapy (ANPs) that could cure incurable brain cancers. Without that concept, he was in trouble.

Burzynski’s cynically jumping on the bandwagon of “personalized medicine,” arrogant to the point of proclaiming himself a “pioneer” in the field of genomic medicine, by offering what he has referred to as “personalized gene-targeted cancer therapy” but what I refer to as “making it up as you go along.” Unfortunately for Stash, this involves nothing more than using a commercially available gene test and then using its results to pick a cocktail of very expensive targeted chemotherapy agents from big pharma, which doesn’t really sit too well with the “natural” crowd. Besides, the only difference between what Burzynski is doing and what, say, M. D. Anderson is doing is that Burzynski clearly doesn’t know what he is doing and M. D. Anderson does. Moreover, poor Burzynski doesn’t offer anything that any “brave maverick” oncologist couldn’t offer. There’s nothing unique in his “personalized, gene-targeted therapy.” Given the choice of going to M.D. Anderson, Memorial Sloan-Kettering, or any number of cancer centers doing cutting edge genomic research in cancer or Burzynski’s Houston office building, where are you going to go? It’s no wonder Burzynski is floundering without ANPs. ANPs distinguished him from the pack, let him claim to have something “natural” that no one else had (never mind that he chemically synthesized ANPs in his manufacturing facility). Also unfortunately for Stash, selling an existing drug as a “prodrug” for ANPs apparently wasn’t selling much better, either.

All of this is likely why a group known as the ANP Coalition was founded by a man, Ric Schiff, who is on the board of directors of the Burzynski Research Institute. It’s why groups like the Alliance for Natural Health USA (ANH-USA) have tried to smear Liz Szabo and use patient stories to try to tug on the heartstrings of its members to the point where they will write their legislators to put pressure on the FDA to lift some of the restrictions on ANP use by allowing compassionate use exemptions for ANPs for patients with horrible tumors, people like a young Jewish boy in Houston with a medulloblastoma (an aggressive tumor of the brain) named Raphael Elisha Cohen, a twelve year old girl named McKenzie Lowe, who has a diffuse intrinsic brainstem glioma (DIPG), and Liza Cozad, the wife of the drummer in rock star Sammy Hagar’s band, Liza Cozad, who also has a DIPG. It is Liza Cozad and McKenzie Lowe who were the subject of the press release from ANH-USA sent to me, which I will reproduce in full in case it goes down the memory hole:

McKenzie Lowe, age 12, and Liza Cozad Lauser, age 46, are both battling diffuse intrinsic pontine glioma (DIPG), a type of cancer that attacks the brain stem. There are currently no effective, FDA-approved treatments for this disease. The one option that has shown promise, antineoplastons therapy, is being denied them by the US Food and Drug Administration.

“Antineoplastons, which are peptides and amino acid derivates that activate tumor-suppressing genes, have shown tremendous potential in battling DIPG,” explained Gretchen DuBeau, executive and legal director of the Alliance for Natural Health USA (ANH-USA). “It is quite literally the only effective tool available to fight the disease, but in both these cases the FDA is preventing their use of the therapy. These young women have applied for Compassionate Use Exemptions, but neither has been granted permission to begin treatment,” DuBeau said.

The “Compassionate Use” or “Single Patient Protocol” exemption via the FDA’s expanded access rule allows for the case-by-case use of an experimental or unapproved drug outside of a clinical trial. To qualify, applicants must prove that they have a life-threatening condition; that no other treatment exists; and that the treatment offers no more risk than the disease. “Both candidates meet all these criteria,” DuBeau noted, “yet the exemptions are being withheld.”

The FDA’s denial has evoked a media uproar and a groundswell of support for the women. Senator Kelly Ayotte (R-NH) sent the agency a personal letter requesting that the FDA grant Ms. Lowe’s exemption. Two online petitions have garnered over 80,000 signatures asking the White House to intercede and pressure the agency to grant the exemptions.

“In addition,” DuBeau said, “ANH-USA forwarded over 26,000 letters to Congress from its members, asking that action be taken. And Sammy Hagar, former front man for Van Halen, is hosting a rock legends concert on February 12 to raise money and awareness for Ms. Lauser, who is the wife of his drummer, David Lauser.”

Lauser told reporters, “Why would you withhold something that would give her a chance?”

“Given the aggressive nature of this disease,” DuBeau explained, “the FDA’s failure to act swiftly to grant exemptions to these young women is seriously jeopardizing their ability to fight the cancer that has invaded their bodies. But since the FDA is not required to respond in any particular time frame,” DuBeau said, “there are no guarantees that an answer will come in time.”

The same misconceptions behind Burzynski’s ANPs that were in the last set of press releases by the ANH-USA are there again, the most important of which is the flawed central premise, that ANPs are the only things that could give Lowe and Cozad a chance at survival. Sadly, because, despite the roughly six dozen phase II clinical trials Burzynski registered, only one of them has been completed, and that trial’s final results remain unpublished. Indeed, there is no significant difference between the press release above and the press release issued January 6 about—you guessed it—Liza Cozad and McKenzie Lowe. The only difference is that press release was more detailed about Cozad’s and Lowe’s condition, and this one updates the efforts going into trying to pressure legislators to petition the FDA to do something that the FDA should never do: Compromise science and patient safety for political considerations.

I realize that these two people, one woman, one girl, are in a horrible situation. They have unrelenting, currently incurable disease. The problem is this. There is no evidence that Burzynski can do any more for them with his ANPs than conventional medicine can with science- and evidence-based palliative care, and there is plenty of evidence that ANPs are not benign drugs. Arguably, they are even more so than some commonly used varieties of chemotherapy. Burzynski likes to claim that no one has ever survived DIPG, but that claim is simply not true. Survival is rare, but certainly not unprecedented. So, absent the results of properly designed and conducted clinical trials, properly reported, there is simply no evidence to support Burzynski’s claims other than the odd case report and small case series from the larger phase II trials, none of which are particularly convincing. Indeed, even his latest attempt at scientific relevance, poster presentations at the Society of Neuro-Oncology meeting last December showed some pretty abysmal results.

Perhaps the most infuriating aspect of this effort by ANH-USA and the ANP Coalition is one that I almost have to laugh at. Do you remember how the ANH-USA tried to claim that USA TODAY was running a “smear campaign” against Burzynski, based on Liz Szabo’s expose? It was a ridiculously over-the-top lie, of course, but it comes across as even sillier given the article I saw in USA TODAY just last night, Sammy Hagar: Drug lobbyist (Really), which really should shatter any notion that there is some vast pharma-controlled conspiracy at USA TODAY to crush the upstart Burzynski because he’s too close to the cure for cancer:

In the “Not Something You See Every Day” category, former Van Halen frontman Sammy Hagar is leading a group of other hard rock musicians in a campaign to get the Food and Drug Administration to approve an experimental treatment for a friend’s brain cancer.

In a letter sent at the end of January to FDA’s Center for Drug Evaluation and Research, Hagar and pals ask the agency to allow Liza Cozad-Lauser to have access to “an experimental treatment involving the use of antineoplastons.”

Cozad-Lauser is the wife of Hagar’s drummer, David Lauser, and the other signatories on the letter share the heavy metal connection: Van Halen drummer Michael Anthony; bassist Jack Blades of Night Ranger and guitarist Joe Satriani, who has played with a range of bands including Deep Purple.

I’m not a huge fan of Sammy Hagar’s music, although I did like some of the stuff he did with Van Halen and some of his solo work, but I do have to say: He sounds like a straight up guy trying to do what he thinks is the right thing. Unfortunately, unbeknownst to Hagar, his altruistic impulse has been partially placed in the service of a cause that will harm cancer patients, his friend’s wife included. Raising money for his friend’s wife is good. Raising money and “awareness” among his fans to petition Congress in favor of Burzynski is not. The problem is that, while raising money for his friend’s wife is a good thing, that good thing becomes very tainted if the purpose of the money raised from his concert tonight is to lobby Congress to pressure the FDA or even change the law. It’s very easy to understand wanting to help a bandmate’s wife, but unfortunately Hagar’s desire to do good has been yoked to a cause that will, if he succeeds, harm cancer patients who are drawn into Burzynski’s orbit. Worse, it’s clear that Hagar and his friends have been fed the party line by someone associated with Burzynski. Just look at this statement issued by Hagar and friends:

“We are aware there are differences of opinion within the medical community regarding the efficacy and potential of antineoplastons in treating patients afflicted with this illness,” they write. “We are not asking the FDA to take a side in this debate. We are writing to simply urge that Liza be allowed to receive the treatment she seeks while research on the potential of antineoplastons for potential widespread use continues.”

No, there really aren’t “differences of opinion within the medical community regarding the efficacy and potential of antineoplastons” against cancer, unless you define “difference of opinion” as Burzynski and his acolytes versus every other oncologist and oncology professional organization. Hagar has, sadly, fallen for the manufactroversy. ANPs have already been researched and judged almost universally by anyone who’s looked at them besides Burzynski and a Japanese researcher not to have significant potential against cancer. Worse, if the FDA were to allow a compassionate use exemption for Liza Cozad Lauser and McKenzie Lowe, then there would be no valid reason for it to refuse a compassionate use exemption for anyone that Burzynski could produce with a terminal cancer. He’d be back in business again, no pesky need to publish those clinical trials he’s already claimed to have done, no need to enroll more patients on clinical trials. That alone would be reason enough, but, as much as Burzynski drones will try to paint me as cold and heartless, I’m thinking of Liza Cozad and McKenzie Lowe. As hard as it is for their families to accept, they would be better off not going anywhere near the Burzynski Clinic. Burzynski will treat them, and they will spend a lot of time with portable infusion pumps, ports, IV medications, and the like. In the end, they will likely suffer a significant decrease in the quality of their remaining life, with no evidence that choosing ANPs will prolong it significantly.

What’s clear to me is that Burzynski is trying to do what worked for him the last time his back was against the wall, in the 1990s: (1) rally the base by appearing on quackery-friendly radio shows (now usually podcasts) claiming oppression and firing Godwins at his enemies (oh, look, he just did it a couple of days ago); (2) tug at the heart strings with cancer patient anecdotes like this entirely credulous one recently published, Dartmouth dad appeals to FDA to renew son’s tumor treatment (even Hannah Bradley and Pete Cohen recorded a video in support of the effort); (3) recruit celebrities like Sammy Hagar and Joe Satriani; and (4) try to pressure individual Congressional representatives. It’s even worked with Sen. Kelly Ayotte (R-NH), and, although I haven’t been able to locate the letter to the FDA from her, I’m told that it’s worked with Sen. Jeanne Shaheen (D-NH).

There’s little doubt at the moment that Burzynski is in trouble. I’ve heard rumors that, when put together with other sources to which I have access, paint a picture of a clinic in big trouble due to a large drop in patient volume. The Texas Medical Board is on his case again. The FDA, for now at least, shows no signs of loosening up its partial clinical hold on ANP clinical trials. As bad as his situation is, though, Burzynski could still potentially turn it around if he succeeds in his strategy, as I’ve outlined above. That’s why now is not the time to be complacent. Now is the time to turn up the heat. Write your Congressmen and Senators. Don’t let credulous articles like this one or the USA TODAY article pass without letters to the editor. Be ready for all the entertainment blogs and magazines that will likely report on Sammy Hagar’s concert as an uplifting human interest story and ignore or downplay the issues with ANPs. Now is not the time to let the pressure off.