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Saturday, July 12, 2014
PBS Ombudsman

Cancer Is 'Serious Business.' Is the 'Documentary'?

When PBS viewers talk about "March Madness," some of them are referring not to basketball but rather to pledge drives and special programming aired by local stations to attract new members and contributions. I've written about this several times over the years, focusing on the overall springtime phenomenon and on specific programs that seem to attract some criticism. Many of the programs used for pledge specials are not distributed by PBS but rather come from other sources. All of the PBS-member stations are independent and can broadcast what they choose.

A couple of points are worth making at the outset. Sometimes I get dozens, or scores, of emails from viewers upset about a specific pledge program. That is significant and may be reflective of a much larger body of feeling. On the other hand, PBS has a very large viewership and the fact that stations run and re-run these programs suggests that many other people like them and that they produce the necessary revenue.

At the same time, there have probably been a handful of pledge specials during my tenure here that do, in my opinion and that of some viewers, bump up against at least the spirit of what people expect to find on their local PBS outlet, and one or two cases that may actually cross the line, although PBS always disputes that.

Now, back to the pledge period at hand. At the bottom of this very long column is a sampling of new emails about pledge personalities and programs, most of whom have been the subject of previous complaints by some viewers and ombudsman columns. There are few surprises, but I feel it is important to post the views.

But what this column is really about is a controversial new film, described as a "documentary" by the producers and the station airing it, titled: "Burzynski the Movie — Cancer Is Serious Business". It is being used as the centerpiece of a spring pledge drive by CPT12, the Colorado public television station that has previously broadcast a number of provocative and controversial programs typically not seen elsewhere on mainstream or other public broadcasting stations. I have also written about this station before.

Long Program, Long Column

It 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."

The film, as described by CPT12, tells the story of "a pioneering medical doctor and PhD biochemist who won the largest — and possibly the most convoluted — legal battle against the Food and Drug Administration in American history. Burzynski's battles were centered on his belief in Antineoplastons, a gene-targeting cancer therapy he discovered in the 1970s. The ultimate approval of Antineoplastons would mark the first time in history a single scientist, not a pharmaceutical company, would hold the exclusive patent and distribution rights on a paradigm-shifting, life-saving medical breakthrough. Directed by Eric Merola, BURZYNKSI provides first-person testimonials of cancer patients who chose his treatment instead of surgery, chemotherapy or radiation — with full disclosure of original medical records to support their diagnosis and recovery."

There is almost nothing about this film that isn't controversial. Even the Wikipedia entry, which is pretty tough on the doctor and his treatment, is challenged by the film's website, which claims "the Wikipedia editors refuse to allow anything that show these medicines in a positive light to be allowed to be included in the Wiki post."

The film was first called to my attention by about a dozen critical letters that arrived in the ombudsman's mailbox days before the film even aired. Here's a typical one:

The country's most anti-science public television station — CPT in Denver — has achieved a new low in broadcast history with the airing of "Burzynski The Movie" on March 7th and 9th. This film is pure advertisement for a very expensive cancer treatment that has, in a widespread opinion in the scientific community, failed to show that "antineoplastons" have any effect on cancer, much less cure it. Is not commercial programming a violation of PBS's certification? If so, the repeated airing of this film by CPT warrants investigation. CPT is being complicit with Burzynski in marketing false hope to vulnerable families struggling with cancer. In its promo, CPT characterizes him as a "pioneering medical doctor" who has developed a "life-saving medical breakthrough" that has brought about the "recovery" for cancer patients in his care. For background on Burzynski and a critique of this film, I recommend this essay by oncologist David Gorski.

Linda Rosa, Loveland, CO

Oddly, once the film was actually broadcast only a couple of emails arrived.

In looking into this, I've questioned responsible officials at CPT-12, PBS and the FDA and have included their responses, as well as a longer and more detailed letter from Linda Rosa, who is a nurse, activist, and founder of a group called the Institute for Science in Medicine. All this contributes greatly to the length of this posting.

My Thoughts

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. In part, this is probably because FDA officials declined to be quoted on camera, as an ABC-TV news clip about the controversy made clear in the film.

What also diminished its impact, in my opinion, was the extensive, 45 minutes or so in total, on- air involvement of CPT officials interviewing producer Eric Merola and Azad Rastegar, a spokesperson with the Burzynski Clinic in Houston.

On the plus side, CPT Executive Producer Shari Bernson, who did the interviews with Merola, consistently brought up the controversial nature of the material, said that even some people at the station questioned whether it should be broadcast, and put across the station's iconic stance as a "truly independent place" where you can see something "different, give you information that you might otherwise not have." She said people have been "threatening us for years" but the idea was not to "upset you but to have you think." I actually thought she handled this well, and the station repeatedly ran medical disclaimers on screen to check with your doctor first.

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.

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."

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." Links to recent FDA public documents are included below.

My bottom line is that CPT12 obviously has a right to show this film. The doctor has had years of previous publicity. And it is my sense that audiences can keep it in perspective. The documentary aspect of the film did indeed capture a fascinating battle between an individual and the powers that be that made you think, and at the same time made you wish that those powers were more forthcoming or that the producer had made a greater effort to get them to comment, especially because so many desperate people confront this killer disease and for the most part have terrible choices.

What follows is the more detailed critique by Rosa, responses by PBS as to their relationship with member stations and assessment of commercial aspects of the program, and responses from the station and from the FDA.

First, the More Detailed Charge by Rosa

Regarding CPT's airing of "Burzynski The Movie: Cancer is Serious Business," I would like to point out that this station may be in willful violation of FDA regulations by helping advertise an investigational therapy for cancer and benefiting from its promotion. The film presents several testimonials which the FDA considers to be advertising. Burzynski, in the film, states that his antineoplaston and other therapies help his patients. CPT12's Director Shari Bernson publicly stated — not as an opinion, mind you, but as a scientific fact — "Antineoplaston therapy has had significant success rates with terminal brain cancer patients and especially in children."

A CPT response [on their website] links to a recent formal FDA letter warning Burzynski to cease marketing antineoplastons. The station thereby admits that it is aware of the illegality of Burzynski making health claims for an investigational drug, yet it not only willfully aired the promotion anyway, but continues to make available the recorded fundraising event. In this way, CPT hopes to gain from these claims.

CPT has posted a disclaimer, but these are meaningless to forego enforcement by the FDA. The Burzynski film highlights several testimonials, which the FDA considers marketing, even if CPT12 does not. Certainly CPT is benefiting from this promotion of an investigational drug, so would this not be the same sort of activity that the FDA warns against in its 10/18/12 letter?

Upon reading the FDA Warning Letter, should not CPT12 have recognized and accepted an ethical responsibility to the public and heeded the dicta contained therein instead of possibly being complicit to a violation of its terms by the addressee . . . Its promotion of Burzynski is literally a life-or-death matter, and one that can drive some families into the poor house. Many believe that PBS will never act against its financial interests by de-certifying a local television station for unethical conduct. An acquaintance of mine has suggested that for PBS to do so a station would have to overtly air pornography on a Saturday morning.

PBS' Senior Vice President for Station Services Explains the Rules:

Unlike commercial broadcast networks, PBS is a membership organization whose stations are owned, operated and governed by local Boards. PBS members must be nonprofit organizations such as community organizations, colleges and universities, states and local school districts. PBS aggregates and distributes content to its members, but does not control program selection or scheduling . . . Our by-laws do not grant PBS oversight over station activities. Opinions and questions regarding any phase of a local operation should be directed to the local management and/or board which hold the full responsibility for its station's services. Autonomy of local stations is one of the most basic tenants of public television in America. This is demonstrated by the fact that each station holds complete responsibility for content decisions and all fiscal matters.

PBS has no authority to evaluate a local station's adherence to regulations from other agencies or organizations. The local governing authority which holds the FCC license has final responsibility for operational decisions.

PBS' Thomas Rosen, Senior Counsel for New Media & Regulatory Affairs, Adds:

This message is in response to the viewer inquiry and the importance of ensuring compliance with the PBS membership eligibility requirement that local stations maintain a noncommercial service on their broadcast distribution platforms. Based on the information available, we do not believe that Burzynski: The Movie is a program-length commercial advertisement. The producer appears to have self-funded the film and states that there is no direct affiliation with or editorial control granted to the subject of the program.

Given the independent nature of the funding for the production as well as the content of the program, we do not see this program as in tension with the requirement for stations to maintain a noncommercial service. The program contains pledge breaks, but these are a standard means of raising donations specifically for the broadcaster itself, not for the producer or the subject of the program. Federal Communications Commission regulations dating back to 1982 specifically permit public broadcasters to air announcements that promote "program related materials" for the benefit of the station and other non-profit organizations. The DVDs and books made available during the pledge breaks appear to qualify as program related materials in this case and there is nothing to indicate that the funds raised through these breaks were not used to further the station's noncommercial educational mission.

CPT President Willard Rowland Replies:

Thanks for advising us about the messages and your intent to address them. We're not surprised to hear that you've received the complaints. We have, too, and have posted them on our website.

This is a documentary that was heavily researched, drew from extensive archival footage and relied on many interviews; it initially was licensed to the Documentary Channel and has only just now become available to us. As with much documentary work, including on PBS, it has a point of view, but it is not an infomercial and is well below the relationship between content and product promotion that is characteristic of so much premium-based PBS pledge programming.
Our airing implies no endorsement of the argument, techniques or therapies discussed; and medical disclaimers, already on website, will run around and during the pledge broadcast.

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. Those values reflect the general PBS mission to educate, inform and open up new worlds; they also imply controversy and uncomfortable clashes of strongly opposed opinion.

I should add that CPT12 has a strong record of advancing social and health debates well ahead of the curve. It pioneered discourse in areas of diet and holistic medicine that once were considered outré (and for which we were heavily criticized) and yet are now increasingly part of the good health canon. Many of the topics and investigations in such PBS series as Independent Lens and POV were first aired on CPT12 long before they were deemed acceptable topics for mainstream PBS air and before those series became part of the prime time NPS.

CPT Executive Producer Shari Bernson Adds This:

The production was fully funded by Merola Productions and personally by Producer/Director Eric Merola himself who spent years researching the story of Dr. Burzynski, an MD with a PhD in biochemistry who invented a proprietary gene-targeted alternative cancer therapy called Antineoplastons. Dr. Burzynski has worked in tandem under strict supervision of the FDA and their protocols, procedures and publication mandates and has operated within the full extent of the law in all clinical trials and treatments. This therapy has been through successful Phase I and fourteen Phase II FDA clinical trials which were just completed in July 2012 and has now has been approved for Phase III trials. Clinical trials are also going on in the UK and Japan. The fascination around this story is that at the same time antineoplaston therapy was going through clinical trials, the FDA tried to indict Dr. Burzynski five times and was successful the 5th time in indicting him for Interstate Commerce — he was treating people beyond Texas state lines who were coming to him from all over the world at their own free will. The case went to court and Dr. Burzynski won. All charges have been dropped and there are no outstanding charges against him.

Antineoplaston therapy has had significant success rates with terminal brain cancer patients and especially in children. For one example, you can see Skype interviews with Dustin Kunnari and his mom and dad at the CPT12 landing page. Dustin was treated by Dr. Burzynski as a toddler and is now a healthy, young man of 21 years. His mother's testimony at the 1996 Congressional Sub-Committee Hearings can be seen in the film. Dr. Burzynski states himself that antineoplaston therapy is not a one-size-fits-all treatment. Every case, and every individual's treatment is different.

The film contains archival footage from Congressional Sub-Committee Hearings, news media outlets, testimonies from patients and their families, MD's, PhD's, clips and documents from the National Cancer Institute and FDA as well as video clips of interviews with former heads of these very agencies. In the eyes of the station this documentary is just that — a documentary. It was licensed to the Documentary Channel and just became available. We are puzzled that people have referred to it as an infomercial or advertisement. This documentary spoke to me as fitting in as true mission for CPT12.

An FDA Spokesperson Responds, Sort Of . . .

We can't disclose where in the clinical trials process antineoplastons are. Federal law and FDA regulations prohibit the agency from commenting on or disclosing any information related to an Investigational New Drug (IND) application. However, here are links to publicly available documents associated with Dr. Burzynski.

Response to a petition to the White House

Untitled Letter and Promotional Material

2009 Warning Letter

Clinical Investigator Inspection Search


The Usual Suspects

During this current pledge drive, your primary PBS affiliate in Chicago — WTTW — has again devoted exceedingly large chunks of their programming time to promoters of pseudoscience and medical quackery such as Daniel Amen and Joel Fuhrman, among others. This seems odd, considering that PBS also airs quality programming devoted to genuine science such as Nova and Nature. I have to wonder if either WTTW or PBS has ever looked into the supposed medical and scientific qualifications of these hucksters or the truth of what they advocate.

It seems contradictory that a network that is devoted to educational and news programming would somehow allow people to broadcast glorified infomercials promoting one form of quackery or another merely because one of your affiliates feels the need to attract attention to their fundraising efforts regardless of the message conveyed. Such a strategy seems defeatist, especially considering what your stated purpose as a publicly-supposed educational network is.

If you think I'm alone in this sentiment, feel free to read this article by Dr. Robert Burton, which you may or may not be familiar with. I would also like to point out that I would gladly contribute to WTTW or PBS if either of you had changed your policies concerning your pledge-drive programming but as for now I cannot do so.

Chris Krolczyk, Chicago, IL

~ ~ ~

Just watched (while working on the computer) the hours long infomercial about Joel Fuhrman's three steps to health, without seeing any of those critical steps, just a promo for his expensive program, that apparently is just a vegan diet. Duh, vegan is healthy? Why is this on during a pledge, just so people can get his crap for a discount? I have donated in the past for good programming, but will not donate again, just to watch hours long commercials.

Salt Lake City, UT

~ ~ ~

Can you explain to me the rationale for airing programs featuring Dr. Daniel Amen on a public television station? His shows are commercial TV at its worst — windy sales pitches designed to convince viewers to buy books and services they don't need based on science that isn't valid. He's a poorly credentialed charlatan leaching credibility from his association with PBS. If excellence, professionalism, intellectual honesty and transparency are to be the cornerstones of public programming content, PBS has sorely missed the mark on this one. I feel this constitutes a breach of public trust.

Joan Fessler, Baltimore, MD

~ ~ ~

I believe that a public broadcaster should be more responsible about the factual content of its programs. Over the years, I have noticed a number of programs (particularly related to health) which promote ideas and products that are not supported by science and are often at odds with current scientific research. Gary Null and Brenda Watson come to mind. It is grossly irresponsible for a public broadcaster to present ideas which may mislead or even do physical harm to its viewers.

Ralph Keast, Vancouver

~ ~ ~

When PBS gives a platform to snake-oil salesman and greedy charlatan, "Dr." Wayne Dyer, you HAVE no editorial integrity.

Steve Beai, Pueblo, CO

~ ~ ~

When did PBS become the government?

My statement above is only one reason that your statement concerning Wayne Dyer's programming and the question of PBS' alleged-religious supported program is of egregiously serious concern to me. I am an absolute militant supporter of Free Speech, therefore, I must express my concern that your view goes, frightening, over the line and results from ignorance-gone-awry. The view you are designating as a religious view is one shared by persons of many religions and those of none. The Constitution protects one from the state in that the state cannot interfere PERIOD with one's beliefs (or lack of same). If PBS were to pull programs someone mistakenly thought was religious-inspired, it would have become egregiously anti-spiritual rather than neutral programming. Additionally, those who have problems are offended by an unintellectual idea which is NOT what the Constitution protects. Just because one is offended in no way illustrates that the state is acting unconstitutional.

Elisabeth Bunnell O'Reilly, Lexington, KY

~ ~ ~

We moved to the region about 7 years ago. I believe we are members and enjoy the programming very much. Indeed, our nation is most fortunate to have this gem. Having lived in several US locations I see that the fundraising drives on the Nine Network seem excessively long & frequent compared to other communities. It seems they are 3 weeks in length about 3 times a year. Too much. People tune out and find something else and risk not returning. Two weeks max, one week preferably. Once or twice a year only.

St. Louis, MO

~ ~ ~

I'm not a member of PBS but thought I would share my reaction to a program that wasted an hour of my time last night with the Ed Slott [pledge drive] program. I'm 75 yrs old and fairly knowledgeable about the various retirement products/strategies he discussed. The whole presentation came across as a duplication of past presentations/books he has made. He really skimmed over the tax impact of IRA Conversions and life insurance/fixed annuity funding and he never mentioned the importance of current age as a factor in decision making on any of the strategies. Appreciate PBS showing the program but more than a little disappointed in Ed — came across like an infomercial.

John Wallace, Englewood, CO

~ ~ ~

Last night, you ran on Channel 13 (9:30-11:30) an appallingly bad program on financial planning. The presenter was an old style insurance salesman whose ideas were just wrong and misleading. His presentation was very dramatic as he tried to intimidate and scare people into making very bad investment decisions. And then PBS tried to gain members and contributions by selling discs of his terrible financial planning ideas. This is the equivalent (or worse) of selling quack remedies and patent medicines except this fellow's truly irresponsible financial advice can do a lot more harm to innocent people. For shame! For shame!

John McGraw, Armonk, NY

~ ~ ~

I just posted this to Alabama Public's FB page: WOW . . . Without even turning to channel 26, I can tell by the little horrors you've scheduled that you must be fund-raising again. Why on earth do you program nothing but new-age schlock and mediocrities like Andrea Bocelli (the darling of the musically-illiterate and suburban housewives) when you want to get money? Why not show how great PBS can be by scheduling something like a rerun of some of the Ken Burns, some of the other great documentaries; Met Opera broadcast excerpts; rehash some of the classic "Masterpiece" offerings or vintage Dick Cavett interviews? I can virtually guarantee you my tv will NOT be tuned to your channels until all the crap programming is OVER.

Nancy Lea, Selma, AL


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