Respectful Insolence

I don’t normally ask you, my readers for much, if anything, other than to read and for the subset of you who like to be active in the comments to have at it and, if so inclined, to cover my back by swatting down the trolls, quacks, and antivaccinationists who occasionally show up to infest the comments, so that I don’t have to. However, given the story of Stanislaw Burzysnki, which I’ve been covering with frequent blog posts for over two years now, how could I not listen to the appeal of my friend and co-conspirator (note to Burzysnki fans: that “co-conspirator” bit was sarcasm) to take action in the wake of the USA TODAY story that ran two and a half weeks ago. Despite the hilarity of Burzynski’s response, unfortunately he’s still managing to slither his way into legitimate scientific meetings.

Friends,

As you know, the Skeptics for the Protection of Cancer Patients (SPCP) have launched a campaign to alert Congress to the horrendous research practices of the Burzynski Clinic that were uncovered by the FDA and to ask legislators to inquire into the circumstances that allowed Stanislaw Burzynski to peddle an unproven chemotherapy via his clinical trials. We are pleased to report that we are already hearing back from a number of congressional offices about this matter.

By sending them copies of the official observations from the FDA’s site inspections, we believe we are making the most powerful argument possible for an inquiry into how things were allowed to remain so bad for so long. At thehoustoncancerquack.com, we have letters for you to personalize that will introduce the Burzynski story to your representatives and will put the documents you send in context.

In order to run as efficient and evidence-based a campaign as possible, we have provided a feedback form so you can share your representatives’ responses. This is the most precious information that we can gather at this point in the campaign, because it will give us a sense of the audience we are crafting our message for.

The key committee regarding this matter in the House is the Committee on Oversight and Government Reform, and we certainly recommend that you look and see if your representative is on that committee. Anyone can approach the committee itself (or the Subcommittee on Energy, Health Care and Entitlements) for an investigation into the FDA’s continued approval of Burzynski’s catastrophically flawed trials. Send your documents here:

Committee on Oversight and Government Reform
2157 Rayburn House Office Building
Washington, DC 20515
Phone: (202) 225-5074 Fax: (202) 225-3974

In the Senate, your best bet is the Committee on Health, Education, Labor and Pensions. If your senator is on one of these committees, please take special action and write to them directly.

This is not the type of campaign where we can be half-in. One patient, responding to the recent USA Today article, posted that the last time Burzynski was on trial, she sent over a thousand letters to members of Congress. This is what we are up against, people who believe that Burzynski is the only one keeping them alive. They will fight for him; a few dozen survivors are probably the reason this has gone on so long. They will counter-organize. The skeptics’ advantage is in our numbers and the facts of the matter, and we need to make the best use of those advantages in this critical time.

Thank you,

Bob

Skeptics for the Protection of Cancer Patients
(skepticsprotect@gmail.com)

Lest you think this is not important, consider this. Even after the USA TODAY article, families of desperate cancer patients are still making appeals to raise money to take them to Houston to be treated by Stanislaw Burzynski. Right before the Thanksgiving holiday, there was an article on The Huffington Post entitled Child Cancer Patient Petitions For Brain Tumor Treatment Not Yet Approved By The FDA:

Last Thanksgiving, 12-year-old McKenzie Lowe was diagnosed with an inoperable brain tumor. Her family is petitioning New Hampshire’s governor to allow McKenzie to undergo Antineoplastons therapy, a treatment not approved by the FDA. The FDA has allowed 471 “compassionate use” exemptions to date, and McKenzie’s grandfather, Frank LaFountain, hopes she’ll be next in line.

“We’ve talked to survivors of this drug, who had the same condition McKenzie has,” he told HuffPost Live host Nancy Redd. “People say there aren’t any, but we know them. We’ve talked to them, and that’s what makes us so passionate about getting her this particular drug.”

And here’s the video:


Only a heartless bastard could fail to be moved by McKenzie’s story, which is, sadly, typical for pediatric patients with brain cancers. HuffPo pulled out all the stops to emphasize McKenzie’s cuteness and what a nice girl she is, while buying completely into the propaganda line that the Burzynski Clinic promotes.

It pained me to watch that video. It really did. But it also made me angry. Once again, Burzynski is offering false hope to families of cancer patients, and HuffPo deserves nothing but opprobrium for promoting this Change.org petition, which Eric Merola, producer of two propaganda “documentaries” for Burzynski is also promoting. As desperate as McKenzie’s situation is, Burzynski can’t help her. However, her family can help him, most likely unwittingly, by changing 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.

Do the Lowes know that Josia Cotto, a child with a similar tumor, died of massively elevated sodium levels from ANP therapy? Burzynski claims it was due to a blood sample contaminated by being drawn from an IV line with a solution with a lot of salt in it, but any physician would know that claim doesn’t pass the smell test, given that Cotto’s sodium level was 205 mEq/L (normal is between 135 and 145 mEq/L). Some IV lines do contain normal saline (NS), and if such IV lines contaminate a blood specimen they can indeed falsely elevate the measured sodium level. However, the concentration of sodium in NS is only 154 mEq/L of sodium (also expressed as 0.9%); so even a large-scale contamination can’t increase it much. Even if there were contamination from a line containing NS, it would be impossible to produce a sodium level of 205 mEq/L. The only way it would be feasible for contamination from an IV line to produce a sodium of 205 mEq/L would be if that line contained a much higher concentration of sodium. Physicians do sometimes infuse 3% sodium, the sodium concentration of which is 513 mEq/L, but 3% sodium is rarely used, particularly in children. Its only real use is the rapid correction of acute hyponatremia (low sodium), and it is rarely used in children. (Usually hyponatremia is corrected by restricting free water intake.) In any case, as reported by the long running British news magazine, BBC Panorama, the ICU over at nearby Texas Children’s Hospital all too frequently has to deal with desperately ill Burzynski patients that Burzynski can’t cope with. Meanwhile, families pay hundreds of thousands of dollars for Burzynski’s toxic, ineffective therapy.

In any case, the Change.org petition for McKenzie Lowe, as well-meaning as its sponsors are, is very misguided. The Friends of McKenzie Lowe are petitioning FDA Commissioner Margaret Hamburg to grant a compassionate use exemption for McKenzie so that Burzynski can treat her with ANPs. Recall that one of the very offenses that got Burzynski into hot water with the FDA was his investigational review board’s (IRB) history of playing fast and loose with single patient use protocols, in which patients were approved through the expedited approval process, which was never intended to be used for this purpose. Putting patients on compassionate single patient use requires full approval by the entire IRB. In essence, this petition is asking the FDA Commissioner to ignore those findings and let Burzynski do it again for McKenzie Lowe.

One also wonders whether the Lowes know other things about Burzynski. For instance, the FDA found that he had destroyed original patient records and, most importantly of all, misclassified partial and complete responses. Suffice to say, Burzynski’s explanations are underwhelming and unconvincing.

Finally, there is the oft-repeated claim that Burzynski is the only person who has ever cured the cancer that McKenzie has. These days, it is Burzynski’s favorite line, a line often parroted by his minions, particularly Eric Merola. Would that it were true! What Burzynski proponents can’t understand is that I would be very happy if there were a treatment that could actually cure children with diffuse intrinsic pontine glioma (DIPG). As I’ve discussed many times before, nearly all of Burzynski’s “cancer cure” testimonials, when examined more closely, are highly dubious with respect to whether it was actually ANPs that cured the tumor, with not a single one of them being particularly convincing when examined closely. Either there’s insufficient information (i.e., the timeline is vague), the possibility of misdiagnosis, or the mistaking of the natural reversal of pseudoprogression for an actual antitumor effect. Moreover, brainstem gliomas in children are a heterogeneous group of tumors. Moreover, many of these tumors aren’t biopsied, because of their location, and are usually diagnosed by their appearance on MRI. However, MRIs, as discussed in the case of Tori Moreno, can sometimes find masses that look for all the world like tumors but aren’t. Moreover, contrary to Burzynski’s claim, there are occasional long-term survivors, some of whom received little or no therapy, such Connor Frankenberg, a child from Germany, and two patients who underwent spontaneous remission. (Yes, I know that one of the children listed is a Burzynski patient, Tori Moreno. One notes that the DIPG Registry does not mention Burzynski or ANPs at all.)

The DIPG Registry concludes that, although the vast majority of children with DIPGs do poorly:

The bottom line is: 1) we really don’t understand DIPGs, and 2) there are children who have been diagnosed with DIPGs-based on the incomplete knowledge that we currently have- who truly have had spontaneous regression of their tumors and 3) most of the children with reports of spontaneous regression have been very young.

The big problem is that, like many dubious cancer doctors, Burzynski appears not to keep good enough records to demonstrate that he can cure DIPG, and we already know he misclassified partial and complete responses. In brief, DIPG is a horrible disease, with only 10% surviving beyond two years, and there is no convincing evidence that Burzynski can do any better than conventional oncology, much less cure DIPG, as much as he repeats the claim that he can. Worse, he hasn’t published a single one of his completed phase II clinical trials, even though he’s had well over 15 years to complete them. With tumors this lethal, most such trials should be completed within five years.

All of this brings us back to Bob’s appeal.

The Lowes are petitioning various Senators and Representatives from New Hampshire and Massachusetts to lean on the FDA to grant the compassionate use exemption. This is what we are against, parents of children with cancer who truly believe that Burzynski is their family member’s only hope and will understandably do anything they can to put him back in business. What human being doesn’t have difficulty saying no to such an appeal, even when he knows the family’s desperation has led them down a dark path to viewing Burzynski as the only man who can save their loved one? That they are wrong is almost beside the point. What politician can say no to such an appeal? At the very least, they will look into it and put pressure on the FDA. 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.

Comments

  1. #1 jen
    December 3, 2013

    No you don’t ask for much- just encourage people to engage in hate campaigns and poll- crash- things like that.

  2. #2 T.
    December 3, 2013

    I would love to do it,but I am Italian, I doubt it counts :\

    I want to ask, has some skeptic looked at this?
    http://www.efi-online.de/PDF/UngeimpfteGesuender.pdf

    Sadly it is in German, but the anti-vaccine who linked it said, I quote:
    “We had a vast study in Germany, “KiGGS” (Study of health of children and youth, 3 year study, 17.641 participants), from which results could be extrapolated clearly. It’s German, but look at the graph at page 2 (Green is unvaccinated, red is vaccinated).

    http://www.efi-online.de/PDF/UngeimpfteGesuender.pdf

    “Kranke 10-17 Jahre in %” means “Percentage of sick people, 10-17 Years”. “Heuschnupfen” is hay fever.”

  3. #3 Johanna
    December 3, 2013

    Cute. Got a response of actual substance, Jen?

  4. #4 Orac
    December 3, 2013

    No you don’t ask for much- just encourage people to engage in hate campaigns and poll- crash- things like that.

    Uh, no. I never asked anyone to “poll crash.” In fact, I didn’t even provide a direct link to the Lowes’ Change.org petition. Moreover, I also pointed out how difficult and delicate it is to oppose requests for compassionate single patient use of antineoplastons. However, opposing such a request, given what we now know about Burzynski, is the right thing to do, and I trust my readers to be up to the task of doing so without attacking cancer patients.

  5. #5 Rebecca Fisher
    December 3, 2013

    jan – have you *any* idea what Burzynski actually does??

  6. #6 novalox
    December 3, 2013

    @jen

    Considering your support for people who try to get pro-science people fired from their jobs, your comment just smacks of hypocrisy.

  7. #7 Bob
    December 3, 2013

    If Jan irritated you, please go to thehoustoncancerquack.com and GET INVOLVED Let’s make sure this never happens again.

  8. #9 Lawrence
    December 3, 2013

    @Bob – my Representative sits on the Oversight Committee – I have drafted a letter (snail mail) and plan on following up with a meeting request with her staff to discuss this.

  9. #10 AnObservingParty
    December 3, 2013

    Jen

    No you don’t ask for much- just encourage people to engage in hate campaigns and poll- crash- things like that.

    As opposed to people like the Dachel-bot and her vultures, the Kid, Mercola and his cult, et al who actually do those things and try to get real scientists fired from their jobs, bully journalists and pro-science people, or scare people into listening to pseudoscience?

  10. #11 janet
    lost (and found) in thought
    December 3, 2013

    @ jen
    I don’t see any hate for anything but a “doctor” who sells false hope and poison. If the “doctor” could show SCIENTIFIC evidence that his treatment works, then we’d be all for it. But he can’t, and we grieve for his victims, especially the children who have no choice.

  11. #12 JGC
    December 3, 2013

    Jen, by what rational argument does writing to elected representatives to make them aware of the FDA audit’s findings of fact re: the Burzynski clinic, the lack of any clinical evidence demonstrating that antineoplastons are effective at treating advanced stage cancer (despite 60+ phase II trials initiated by the clinic over more than two decades but neither completed nor results released ), the fact that there is absolutely zero evidence that antineoplastons are effective treatments for anything, let alone advanced stage cancers, etc., constitute engaging in a hate campaign?

    Explain that one to me, if you can.

  12. #13 Shay
    December 3, 2013

    Based on her last few drive-bys, jen has two rules.

    1. Orac is always wrong.
    2. See rule #1.

  13. #14 Bob
    December 3, 2013

    T,

    People abroad can help by translating Burzynski’s wikipedia page into languages other than English. There are other instructions about how you can help at thehoustoncancerquack.com

  14. #15 jen
    December 3, 2013

    @Orac, you have at least 5 articles that even have “poll crash” in the title ie. “while I’m crashing polls”, “if you can’t beat ‘em join ‘em etc. etc. You are actually lying.

  15. #16 Orac
    December 3, 2013

    No, you are making a false accusation. You implied I was asking my readers to poll crash the Lowes’ petition.In the case of the Lowes’ petition, I quite simply did not do that, as is obvious to anyone with half a brain who read this post. If you were accusing me of encouraging “poll crashing” in general, then why bring it up here?

    As for those other “poll crashing” posts, odd that you only found five of them over nine years of blogging. That would suggest that I don’t do it very often, and indeed I don’t. That’s entirely consistent with my statement that I don’t ask my readers very often to do anything other than read and, if they feel like it, comment.

    Silly jen.

  16. #17 jen
    December 3, 2013

    I didn’t imply that. I was simply noting that contrary to your opening few sentences, you do encourage things like poll- crashing and hate campaigns. Period.

  17. #18 AnObservingParty
    December 3, 2013

    Wow @jen, with that latest being 2010 and linking to a request from PZ. Do you also call-out woo-meisters/antivaxxers/cranks/quacks/etc? Your accusations would actually be much more fitting with them, seeing as that’s really their only strategy. Falsely make themselves look bigger than they are.

  18. #19 AdamG
    December 3, 2013

    Orac:

    I don’t normally ask you, my readers for much

    jen:

    I was simply noting that contrary to your opening few sentences, you do encourage things like poll- crashing and hate campaigns

    Forget about that “normally,” jen?

  19. #20 Orac
    December 3, 2013

    Jen is very silly. I said I don’t often (as in “normally”) ask my readers to do anything. She finds old examples of my having asked for minor things from years ago, a total of five in my entire nearly nine-year blogging career, and tries to accuse me of lying. I would be offended at the false accusation of dishonesty if I weren’t laughing so hard at how she has actually provided very good evidence that it is true: I don’t normally ask my readers to do anything.

    But perhaps jen would like to come back to the actual topic of this post, now that that tangent has played out to the point of my wanting to use metaphors involving a deceased equine organism and bullwhips. Jen, what do you think of Stanislaw Burzynski?

  20. #21 Alain
    December 3, 2013

    Period.

    ooooooohhhhh….Jen want to have the last word?

    Silly Jen; if poll crashing (5 times….count’em…5) is all you can accuse Orac to do, I guess he’s doing a very fine job of irritating antivaxxers with its very respectful insolence :)

    Alain

  21. #22 kruuth
    December 3, 2013

    jen, please enlighten us about what is “hateful” about this. See, we tend to deal in these nasty things called facts.

  22. #23 jen
    December 3, 2013

    Regarding the poll crashing, I said at least 5, it could well be more. You should probably get back to some surgery or something…

  23. #24 Science Mom
    http://justthevax.blogspot.com/
    December 3, 2013

    WTF does this even have to do with “poll crashing”? What is wrong with you jen? Do you have something of import to say about Burzynski and his predation on desperate people? Or do you support that? I wouldn’t be surprised of the latter given your support of ghoulish “treatments” for autism.

  24. #25 Lawrence
    December 3, 2013

    @jen – perhaps you should return to AoA…seems like they need some help, you know, with Jake revealing the dark inner-workings of your leadership…..

  25. #26 JGC
    December 3, 2013

    Let’s assume that Orac has ased his eaders to respond to a poll (i.e., crash it) , let’s say, more than five times but less than 10 times over the past 9 years.

    What exactly do you feel would be wrong with making such a request- are you suggesting that the readers of his blog shouldn’t be encouraged to participate in such polls? If so, why?

  26. #27 Skeptical_Canadian
    December 3, 2013

    @Jen, denigrating ORAC is unproductive and frankly mildly offensive. How about some useful science-based insight as a response to JGC (#12) request? Facts. Got some?

  27. #28 Orac
    December 3, 2013

    Next I’ll be accused of hypocrisy because years ago I changed my mind about PZ’s poll crashing. I used to make fun of it and criticize it as pointless, but over time I saw that in some situations it could be useful as a means of making a point about the utter uselessness of Internet polls. Just you wait. The accusation’s coming next… :-)

  28. #29 Denice Walter
    December 3, 2013

    On the subject of ‘poll crashing’:

    results obtained through internet polls are notoriously unrealistic precisely because they are easy to crash- doing so illustrates succinctly why they shouldn’t be trusted or thought of as being scientific in any way.

    If there were an internet poll asking,” Do vaccines cause autism?” you can bet your net worth that within a few minutes anti-vaccine advocates would swoop down, shrieking banshee-style and inflating the numbers. Would this reflect the beliefs of average people or even average readers of a news site? No.

    AoA similarly bombards comment sectons to make it appear that more people are in their camp than reflects reality. ( see NPR polls). In reality, most people don’t fear vaccines and legions of medical professionals don’t comment or write about their beliefs.

  29. #30 Denice Walter
    December 3, 2013

    -btw- I didn’t see Orac’s comment when I wrote that.
    “great minds….etc.”

  30. #31 SpaceTrout
    Funkytown
    December 3, 2013

    NH Senator Kelly Ayotte has written a letter to the FDA in support of McKenzie Lowe:

    http://www.nashuatelegraph.com/news/1022469-469/ayotte-steps-in-to-help-ill-hudson.html#

    I wonder if she was presented the full story before she wrote this…

  31. #32 Alain
    December 3, 2013

    You should probably get back to some surgery or something…

    No, he shouldn’t listen to your suggestion. Beside, you don’t get to dictate how he spend his time.

    Alain

  32. #33 Sarah A
    December 3, 2013

    Either I’m being too literal-minded or I missed something in this post – where does Orac ask us to do anything poll-related? All I see is a request to write our representatives, including a link to a website with templates for doing so and the addresses to send them to. Some “hate campaign.”

    Anyways, if I’ve understood Orac’s other posts regarding Burzynski, lately he’s been using a licensed drug off-label to generate these antineoplastons. If there are really no evidence-based treatment options for this family and they’re bound and determined to try antineoplastons, couldn’t they get this medication from a competent physician in a hospital setting where they’re better set up to manage side effects? It might not be ideal, but it’d be a heck of a lot better than going to Burzynski, and at least they wouldn’t be out hundreds of thousands of dollars.

  33. #34 Eric Lund
    December 3, 2013

    AOP @10 nails it: Jen is engaged in some serious projection.

    If Burzynski and his backers don’t want people (like myself, and I’m sure others in the commentariat agree) to think of him as a con man, then perhaps he should refrain from acting like a con man. Such as: not encouraging families of kids with cancer to raise funds to cover the cost of sending those kids to Houston to be treated by the Burzynski Clinic with a protocol that not only doesn’t have FDA approval, but which has the FDA’s explicit disapproval. One of the red flags Burzynski should raise, independently of what the FDA thinks about him, is the amount of money he charges patients for these “experimental” (at best) treatments. Given how desperate these families are, I view that as predatory behavior, especially since (as other posters have pointed out) most clinical trials don’t charge patients for the experimental protocol.

  34. #35 Lawrence
    December 3, 2013

    @Eric – jen seems to have no issue with the Dachel-bot & her monkey-brigade swooping in on any article even remotely about autism & posting up the same series of stupid posts linking to debunked studies or junk science…..

  35. #36 Bob Blaskiewicz (@rjblaskiewicz)
    December 3, 2013

    Lawrence, when you hear back and have a conversation with your rep, please follow up with the feedback form at thehoustoncancerquack.com! Thanks very, very much!

  36. #37 herr doktor bimler
    December 3, 2013

    I want to ask, has some skeptic looked at this?
    http://www.efi-online.de/PDF/UngeimpfteGesuender.pdf
    Sadly it is in German, but the anti-vaccine who linked it said, I quote:
    “We had a vast study in Germany, “KiGGS” (Study of health of children and youth, 3 year study, 17.641 participants), from which results could be extrapolated clearly. It’s German, but look at the graph at page 2 (Green is unvaccinated, red is vaccinated).

    Our host has posted on the KiGGS a few times, most notable here:
    http://scienceblogs.com/insolence/2011/03/11/for-the-anti-vaccinationists-out-there-t/

  37. #38 Bob Blaskiewicz (@rjblaskiewicz)
    December 3, 2013

    Check to see if your representative is a member of the Congressional Childhood Cancer Caucus! Let’s get them on this! http://childhoodcancer-mccaul.house.gov/membership-list

  38. #39 Narad
    December 4, 2013

    Regarding the poll crashing, I said at least 5, it could well be more.

    Jen, do you really want to play “find what you are completely inaptly yet piteously whining about in the cesspool you normally swim in”?

  39. #40 Delurked Lurker
    On a mote of dust suspended in a sunbeam
    December 4, 2013

    Glass house troll is still glass house troll

  40. #41 Bob G
    Los Angeles
    December 5, 2013

    Bob B or anybody: I had a long talk with one of the local staffers for my congresswoman and explained the problem as best I could. Perhaps somebody can explain precisely what I should be asking for, and I will submit it in writing and it will be read by at least two of the staff to start with. My congressional rep is ranking Democrat on the health and technology subcommittee of a different House committee, one that has very little clout and is kept on a short leash by the Republicans. But I keep my fingers crossed that not all R’s are totally insane, and that cancer research and therapy is still of some importance to them. So what exactly should we ask for that does not involve just running a counter kangaroo court type of hearing?

    For example, if Issa’s committee tries to do some more mischief, what can a congressional rep who is not on that committee do? Whatever that is, we can ask directly.

    For example, the congress is famous for circulating “Dear Colleague” letters. Perhaps we could ask that such a letter supporting science based medicine be circulated. I would suggest going to Henry Waxman, for example, out here.

    For those of us who have a little access, no matter how small and trivial, it would also be a good idea to remind the congress that the NIH budget is being strangled and that it is doing a lot of damage. See Kevin Drum’s discussion of this at Mother Jones for the graph. That would be a useful second letter. Perhaps the NIH should be promoted as being at least as important as the defense budget, and treated accordingly.

  41. […] 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 […]

  42. […] what he claims to be able to do is too terrible to contemplate. This is why families like those of McKenzie Lowe, Raphael Elisha Meir ben Devorah Cohen, and Eliza Cozad, for example, go to such lengths to raise […]

  43. […] public. Everything old is new again, as Burzynski replays the same strategy with patients such as McKenzie Lowe, Liza Cozad, and Elisha […]