We at SBM don’t normally ask our 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. 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 disingenuousness of Burzynski’s response, unfortunately he’s still managing to find his way into legitimate scientific meetings.
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.
Skeptics for the Protection of Cancer Patients
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 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. 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. Finally, contrary to Burzynski’s claim, there are occasional long-term survivors, some of whom received little or no therapy, such as 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. That they are wrong is almost beside the point. What politician can say no to such an appeal? 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? At the very least, they will look into it and put pressure on the FDA. That’s 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.