On Friday, PBS Ombudsman Michael Getler responded to CPT12’s recent airing of the first Burzynski movie as part of a fundraiser. PBS has always been quite responsive to its critics, and this is something that I have not seen in many large broadcasters in the past. He contacted a lot of the interested parties at the station, the FDA, and CPT12. I have no doubt that Getler took this subject seriously, and I appreciate this very much.

Furthermore, Burzynski is not Getler’s fight. To understand the complexities and history involved takes a lot of work, far more than we could possibly expect of Mr. Getler. The station is not his responsibility, nor is it PBS’s role to censor a member station. This was clear from his first post in the run-up to the airing of the documentary.

That said, however, I do disagree with some of his conclusions. (You could see that coming a mile away, couldn’t you?)

Getler starts off:

[Burzynski] is a long program — two and a half hours, with about 45 minutes of that devoted to pledge drive discussions and promotions of the film. It is about the decades-long struggle of a Polish-born physician and biochemist, Stanislaw Burzynski, who set up a clinic in Texas in 1976, to achieve acceptance for a cancer-cure therapy based on a treatment he developed based on what he calls “Antineoplastons.” [ANP]

I submit this is already wrong. There is little evidence that Burzynski is at all serious about developing antineoplastons for wider marketing. If that were true, surely he would have managed to have completed and published a single advanced trial in 35 years. If you look at the trials he’s been required to register at clinicaltrials.gov, you see over 60 trials, 1 completed, and none published. NONE. This is important because he is restricted to giving his ANP in clinical trials. But he apparently abandons his trials, almost all of them. This is not normal. He charges patients out the nose to participate in the clinical trials. This is not normal. This is not the behavior of someone who intends to market the product widely later and expects a return on an investment. It sure looks like someone taking the money while he can.

I put the word “documentary” in quotes above because while the actual film does indeed document very well Burzynski’s seemingly endless battle to win acceptance and approval for his treatment against the FDA, National Cancer Institute, patent challenges and big pharmaceutical companies — and includes very powerful filmed interviews with cancer survivors who say his treatment (in Texas, where it was allowed) saved them — it doesn’t have the kind of critical other-side that one is used to in other documentaries.

That last part is true. the movie is one-sided. Of course, why this is might be more apparent if Mr. Getler had realized that Merola’s cousin was a patient of Burzynski (she later died, of course) and that Merola raised funds for his cousin’s treatments on his website. Merola is not impartial. He has skin in the game. He has sunk an enormous amount into Burzynski.

Mr. Getler mentions that Shari Bernson, the person responsible for the programming and who appeared in fundraising spots, described the movie as “controversial.” To someone on the outside, it may appear to be controversial. To someone who understands the science and process of publication and who has found endless descriptions of how patients end up making really, really bad choices out of desperation at that clinic, however, there is no controversy. The fact remains that after 35+ years, the Clinic has never produced a single reproducible result that would constitute the barest minimum for serious consideration among experts. It just hasn’t. Should that ever happen (I’m not holding my breath), then, hell, yes, we’ll be on board cheering the advance of science. But he has to play by the rules.

And this is important too, playing by the rules that all real researchers abide to. Part of the FDA’s job is to ensure that Burzynski’s people are doing this. And on February 7th, they were doing just that; they were in the facility inspecting to make sure that Burzynski’s team was playing by the rules.

In a FOIA release this week, the FDA revealed a number of things that had been found out and reported to the clinic by the time the movie aired. By law, the Clinic had 15 days to respond, so if they responded, it was before CPT12’s love-in. (The observational notes can be found here: https://skepticalhumanities.files.wordpress.com/2013/03/burzynskiform483feb2013.pdf)

Two investigators observed:

“The IRB [Institutional Review Board] used an expedited review procedure for research which did not appear in an FDA list of categories eligible for expedited review, and which had not previously been approved by the IRB. Specifically, your IRB routinely provided expedited approvals for new subjects to enroll under Single Patient Protocols.” [2 adults and 3 pediatric patients are mentioned]

“The IRB approved the conduct of research, but did not determine that the risks to subjects were reasonable in relation to the anticipated benefits (if any) to subjects, and to the importance of the knowledge that might be expected to result. Specifically, your IRB gave Expedited Approval for several Single Patient Protocols (SPP) without all the information necessary to determine that the risk to subjects are minimized.” [4 examples follow]

“The IRB did not determine at the time of initial review that a study was in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’ Specifically, an IRB that reviews and approves research involving children is required to make a finding that the study is in compliance with 21 CFR Part 50 Subpart D, ‘Additional Safeguards for Children in Clinical Investigations.’ Your IRB approved research involving children without documentation of the IRBs finding that the clinical investigation satisfied the criteria under Subpart D.” [3 examples follow and there is a note that this is a repeat observation that had been found in an Oct 2010 Inspection.]

“The IRB did not follow its written procedure for conducting its initial review of research. Specifically, the IRB is required to follow its written procedures for conducting initial and continuing review. Your IRB did not follow your written procedures for conducting initial and continuing review because these subjects received IRB approval via an expedited review procedure not described in your Standard Operating Procedures. If your IRB would have followed your own SOP for initial and continuing review, the following subjects would have received review and approval from the full board rather than an expedited review.” [2 adults and 3 pediatric patients are listed.]

“The IRB has no written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any unanticipated problems involving risks to human subjects or others. Specifically, your current SOP-2012 v2-draft doc does not describe the requirements on Investigators on how unanticipated problems are reported to the IRB, Institutional Official, and the FDA, such as time intervals and the mode of reporting, or otherwise address how the prompt reporting of such instances will be ensured.”

“The IRB has no written procedures [in the SOP-2012 v2-draft doc] for ensuring prompt reporting to the IRB, appropriate institutional officials, and the FDA of any instance of serious or continuing noncompliance with theses [sic] regulations or the requirements or determinations of the IRB.”

“A list of IRB members has not been prepared and maintained, identifying members by name, earned degrees, representative capacity, and any employment or other relationship between each member and the institution.”

You have to play by the rules. I’m not sure that this round of investigation is over yet, as the audience at the premier of the sequel was apparently told that the FDA was still on site. Researchers should not be playing fast and loose with the rules that protect children (a protected subject population, like prisoners and students–yeah, I’m IRB certified). There should be procedures in place to see that proper oversight and reporting of unexpected events is ensured. Hell, there was apparently no document even saying WHO was on the IRB!

This is not a report on a serious research institution. It’s more like the observations of the IRB of a clown school.

Back to Mr Getler’s letter:

On the other hand, Bernson’s sidekick on the in-studio, pledge-drive promotion who was interviewing the clinic spokesman, made me gag when she said, “I’m Rebecca Stevens and I’m proud to be a journalist who asks the hard questions.” There were no hard questions. [I believe the question that followed up this statement was, “What is peer-review?”–RJB] And where Bernson may have gone too far, depending on who you believe, was in her statement that: “Antineoplaston therapy has had significant success rates with terminal brain cancer patients and especially in children.”

No, she went too far no matter who you believe, and his next paragraph demonstrates this:

The National Cancer Institute, reporting last month on Antineoplastons, said, among other things: “No randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals” and that they are “not approved by the U.S. Food and Drug Administration for the prevention or treatment of any disease.”

Aaaand…how’s that controversial? In light of this, how could Sherri possibly be right?

My bottom line is that CPT12 obviously has a right to show this film.

Nobody questions that. What we wanted, and what was offered to the station, was the opportunity to have an independent oncologist in the studio at the time of the broadcast, you know, to stir up the kind of informed discussion the station says they want to have instead of settling for two True Believers talking to two CPT12 pitch people. When the station had that opportunity, they walked away from it. That’s indefensible. Especially when you consider that the people we are worried about, patients and their families, may NOT be as discerning as your average viewer, as CPT President Willard Rowland suggests in his response to the ombudsman:

“The program’s airing is grounded in the station’s mission, specifically those portions about respecting our viewers as inquisitive and discerning citizens, addressing social issues and public concerns not otherwise adequately covered in the community, and cultivating an environment of discovery and learning.”

Some of them haven’t had good news since their diagnosis. Then they hear that some lone genius with the cure for cancer is operating in Houston and they are on the next flight down. I’ve seen it dozens of times, and I have hundreds more patients on deck to write about. These are vulnerable, vulnerable people who deserve the best information from their public broadcasters.

I’m fairly disappointed by the tepid response, honestly. I have a hard time imagining that Mr. Getler, or Mr Willard Rowland for that matter, could possibly think that this program was anything but misleading if they spent a half hour at The OTHER Burzynski Patient Group, which chronicles, in patients’ own words, what goes on in that Clinic. All of the people told that getting worse is getting better (for decades being fed the same line!), the children having strokes (unrelated to their tumors) while on the medicine, the “terrifying” amounts of sodium that go into patients. The quasi-legalistic threats and phone calls to dissatisfied cancer patients. The untested chemo cocktails given to most of his patients. None of that was mentioned in the CPT12 fundraiser.

Of course, that’s not Mr. Getler’s fight.

RJB

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