Our regularly scheduled post will go live later this morning. In the meantime, this is a public service announcement...with GUITAR! (Oh, wait.)
As you recall, last week, the FDA inexplicably decided to lift the partial clinical hold on Stanislaw Burzynski's bogus clinical trials of antineoplastons, which he's used since the 1990s as a pretext to charge huge sums of money for "case management fees" to patients for a treatment whose efficacy he has never demonstrated. Yesterday, the Center for Inquiry laid in, and has sent a letter to legislators:
“We are frankly stunned to hear that the clinical hold against Dr. Burzynski has been lifted,” writes CFI in its letter. For decades, Dr. Burzynski and the Houston-based Burzynski Research Institute have been trafficking in unproven and scientifically baseless cancer treatments based on compounds known as antineoplastons, derived from human urine, which Burzynski claims — without evidence — can target and destroy cancer cells. He has taken advantage of desperate patients who are at their most vulnerable, and willing to pay any price.
After the death of a six-year-old patient in 2012, the FDA placed a hold on Burzynski’s trials with children, followed by a hold on trials with adults in 2013, prohibiting him from taking on new patients on whom he could experiment and from whom he could extract more money.
Over several decades, his clinic has proven it is unable to properly protect patient rights, adhere to basic ethical or scientific protocols, or even maintain correct patient records. It has also shown it is willing to exploit desperate cancer patients and their families, milking them out of enormous sums of money. But it has yet to show even a shred of evidence that its cancer treatments have any positive effect whatsoever.
“We struggle to see why the FDA continues to enable this deceptive, antiscientific, and unethical medical adventurism and profiteering, even for patients who are terminally ill,” writes CFI. “Given the behavior of Dr. Burzynski and the Burzynski Research Institute over the course of nearly three decades of failed research and trials, and in the face of a complete lack of scientific evidence demonstrating the efficacy of their expensive and dangerous antineoplaston treatment, we find the FDA’s decision perplexing and profoundly disturbing.”
The full text of the letter can be found here.
If only groups like the American Cancer Society would write similar letters. Cancer patients have been taken advantage of for nearly four decades, and Burzynski has made a mockery of the clinical trial process for nearly 20 years. It's gone on way too long.
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So why doesn't the American Cancer Society, and others like that write letters? That is a very good question Orac; one that we should all be demanding an answer to.
Then write a letter to them, Denis. :) Please please do!
I'd love to see CFI or Sfsbm start to build files with names and addresses of patient advocacy organizations. (and I'll find something in the next couple weeks to post, I promise). Its always better to arrange to meet with their executive directors if possible, but a phone call and a follow up letter would still make an impact.
I wrote to them today and left links to this blog post and to the CFI letter.
Hooray! Thanks, Denis!
This is convenient - I have missed a whole year of posts. I was reading this post recently:
Was there a part 2? I tried a search but with so many posts on the guy it's really hard to find the follow-on... It will take me a while to go through the backlog but I particularly wanted to read any Burzynski articles that I've missed.
The AMA, FDA and Health department work for drug companies have no cures and act like they know something about health. Liars and murders like their father, a godless bunch of morans. Vaccines kill babies and doctors are blaming parents..how evil can it get. http://www.laweekly.com/2013-11-07/news/shaken-baby-innocence-project-l…
Ms. Messer, that article has nothing to do with vaccines. It is about an alternate scenario for one child. You might actually try reading it, especially this paragraph:
So, since you did not read the article, and seem to be arguing with insults, could you please clarify and support your sentence: "Liars and murders like their father, a godless bunch of morans."
Also, Ms. Messer, who is the "father", and is it about the Moran family? Also which Moran family?
Chris...I think Ms. Messer meant "moron", no "moran".
In any case, her post does not make sense. There is no mention of any vaccines being implicated in the baby's death and there's the matter of the fractured skull, with a history of two falls; one fall while in his father's care on to a concrete surface and the second fall while in his grandmother's care, the following day.
Ms. Messer, I think you ought to sober up before you post rants on science blogs.
Perhaps, she did mention a "father." Though it points more to her confusion since this is an article on a cancer quack.
A check of the Google indicates that Ellen Messer focusses her drive-by drunkcommentry on antivax sites. She also has a RANDOM CAP-KEY problem.
Perhaps my cultural lens suffers from some aberration or something, but I thought this had been pretty well integrated.
We've got the Trifecta right here; Tenpenny, Carley and Messer:
Narad: "but I thought this had been pretty well integrated."
You know, he may have been protesting one of these many foundations named for Morans. I was amazed how many there are! It is a fairly common name, and only a moron would not know the difference.
some people just can't pronounce/spell/type moron it seems. There is also...
A term of derision often uttered by Bugs Bunny when referring to an interaction with a dopey adversary. It is a mispronunciation of the word "Moron"
What a maroon! A favorite expression of one of the RI Regulars.
What a maroon! A favorite expression of one of the RI Regulars.
Oh. I was hoping we would be talking about Sebastian Moran, hunter and henchman.
Ms Messer, this article on shaken baby syndrome was very interesting, but I failed to see a mention about vaccines.
I don't understand the FDA, their last report was pretty damning - and now they lift the restrictions? That's pretty screwed up.
The following is the response I got to my letter to the American Cancer Society, asking why they don't write letters to the FDA deploring their recent blessing of Dr. Burzynski ....
Thank you for expressing your concern to the American Cancer Society. I have forwarded your message to the appropriate representatives for review and consideration, and you should be contacted if there is information to share about any American Cancer Society position or action with regard to the FDA's restoration of Dr. Burzynski's clinical trials on antineoplaston therapy.
To review the American Cancer Society’s current information about antineoplaston therapy, please feel free to use the link below to our website:
> Antineoplaston Therapy:
The Society often reaches out to organizations when we see something we think is not right, not fair, or not productive to the fight against cancer; however, we cannot do this in every case. That's why we rely on people like you, our supporters, to help us. Your words can mean more than you might think. As a volunteer organization, we know well the power of the public to change the course of cancer. For that reason, we encourage you to personally contact the FDA and others to express your opinion on this issue.
Thank you for reaching out to your American Cancer Society.
Online Cancer Information Specialist
If you have any questions, please contact us via http://www.cancer.org or call 1-800-ACS-2345. Information Specialists are available 24 hours a day, 7 days a week.
This document is making the rounds on Twitter: a new, 200-page list of Burynski Clinic offences from the TMB:
Everything from billing for unnecessary procedures, to performing procedures "without medical rationale," to being unethical and unprofessional for owning the pharmacy that sells drugs to his patients, to claiming that two of his staff were medical doctors when in fact they were not. He even referred to them as "doctor so-and-so" in written communications with patients' (real MD) doctors.
It's quite a read; I'm only a few pages in. I'm sure Orac will have lots to say about this new development in the eventual downfall of Stan once he's back from TAM. In fact I'm sure this is a hot topic among Burzynski critics at TAM right now.
Me too, and some of the typos already are painful (e.g., fn. 1). There are people who do that, guys.
How does Patient A suddenly have brain involvement in paragraph 23?
Kind of odd that Patient A started to be billed for, ah, lithium batteries a year before the infusion pump shows up on the tab. At $10.22 a crack. Figuring 2 AAs, that's an easy 300% markup. For batteries. Which apparently ran out between 2011 October 21 and 22.
Looks like an unproofed, non-final draft got leaked.
I semi-read about half of it, during which, by my count, four (4) people were alleged to be working at the Burzynski Clinic as doctors although they're not. (Treating patients, putting the initials "MD" after their names, the whole shebang.)
That's going to be a challenge to spin.
No, the first page is stamped "received." These goobers have f*cked up more than once before; one would hope they'd try to get it right this time.
And this is an amended complaint. Answer:
"23. Respondent admits some, denies others, and cannot respond to the final sentence fragment."
Hello, second amended complaint.
This instantly nukes items 1, 5, and 6 in the alleged violation, BTW.
Eight hundred bucks for 10 milligrams of Afinitor?
Paragraph 37: unintelligible.
^ OK, scratch that. I was misled by a faulty inference of parallelism with ¶ 38.
Allegations B.3, B.6, and B.7 make no sense, given that postsurgical chemotherapy was recommended in the first place.
Damn.....looks like Burzynski couldn't 't do anything that wasn't in violation of several associated statutes. The information on the IRB is particularly damning.
Allegation B.13 is a good one:
It remain unclear to me though, at page 29, exactly how the TMB avoids the same problem of an invented liability theory that screwed them the last time.
B.19 and B.21 look good. B.25(a) suggests that the A10 was billed about a month before antineoplastinoids were initiated (B.23).
Why was 500 mg of 4-PA $240 on 2011 February 10, $2160 a day later, and $1440 on February 18? [B.25(d), (e), (j)]
Assuming the $2160 was a seven-day supply, that's a price increase from $240 to $308.57. The next line item [B.25(l)], on February 22, was for $1080. On the 25th [B.25(o)], we're back to $1440. Ditto March 1.
Is the dosing completely haphazard?
"Is the dosing completely haphazard?"
Why not? If these were real clinical trials, it would be important to have a protocol and stick to it. But since they're not, any prescription that the patient can be induced to pay for is good enough.
Eh, I was just bitching that the axes on the complaint could have been transposed in a way that was both more rhetorically effective and less prone to errors due to boilerplate, but this gets messier by Patient G.
I've also got a bad feeling that the potential upshot of "unprofessional and dishonorable conduct" is little more than probation as far as the license itself goes.
THUS COMES, section 5 (and section 7, "withing 20 days"). Prognostication: It's going to drag on, and the end result will be business as usual.
Time to move the discussion over here: