Cancer quackery, Republican presidential candidates, and political influence

Yesterday, I wrote about how pediatric neurosurgeon turned presidential candidate Ben Carson is an excellent example demonstrating how the vast majority of physicians and surgeons, even highly accomplished ones admired as being at the top of their professions, are not scientists and how many of them are disturbingly prone to buying into pseudoscience. In Dr. Carson's case, that tendency to believe in pseudoscience derives from his fundamentalist religion that led him to reject evolution and accept arguments against evolution every bit as ignorant as the ones Kent Hovind or Ken Ham serves up on a regular basis as though they were scientifically valid. It also led him to pander to the antivaccine crowd during last week's Republican debate. At the time I speculated that a combination of his religion plus a trait all too common in physicians and surgeons, namely not knowing one's own limitations with respect to science, contributed greatly to Carson's having so thoroughly embarrassed himself with respect to science. Unfortunately, in today's world, the science didn't matter much, if at all, as Dr. Carson is doing much better in the polls. Even though he's never run anything larger than a small academic surgical department and the Johns Hopkins Craniofacial Center, Republican primary voters seem to think he's qualified to run the country.

I had wondered, though, whether as a pediatric neurosurgeon Dr. Carson had ever encountered patients of Stanislaw Burzynski. I realize it's been a long time since I've written about Stanislaw Burzynski, the Polish expat doctor who has no formal training in medical or surgical oncology but in the 1970s became convinced that substances he isolated from the blood and urine that he dubbed "antineoplastons" had potent anticancer activity and started using them on patients, producing stories of "miracle cures" that didn't stand up under scrutiny. The whole sordid story was documented a couple of years ago in a long article in Skeptical Inquirer, and I've written about him on and off over the last four years, be it about his legal thuggery directed at skeptics questioning his results, claims by patients understandably convinced he cured their deadly brain cancer (or other cancer) when a detailed analysis of what is known about their cases shows that he almost certainly did not, or the two "documentaries" about him by Eric Merola, Burzynski The Movie: Cancer Is A Serious Business and Burzynski: Cancer Is A Serious Business, Part 2, documentaries that might better be described as propaganda films, given that they don't even give even the slightest pretense of objectivity and are so emotionally manipulative in favor of Burzysnki.

A couple of days ago, I got my answer—maybe. In it, Dr. Carson doesn't come across as being as ignorant about science as he has been when he's discussed evolution, but the story, if true, actually casts some doubt about his judgment as a surgeon and clinical investigator.

I say "if true," because the story comes from a very dubious source. Specifically, it comes in the form of an article and 29 minute YouTube video by Eric Merola, the filmmaker responsible for the two Burzynski movies, not exactly what you would call anything resembling an objective source.

Let's look at the article first. One notes that Merola begins by repeating a claim that he's made on numerous occasions that David Axelrod had been impressed by the movie:

For instance, in late 2009, right before I released the first “Burzynski” documentary, a Burzynski supporter and former college buddy of David Axelrod (President Obama’s former Chief Of Staff) watched “Burzynski, the Movie” before its release and had this to say:

“This is very important, but it’s just too big. Maybe in 10 years we can face this – but not right now, it’s just too big.”

This was quite a sobering thing to hear.

First off, let me note that this story has morphed. When Eric Merola first told this story, it was a college buddy of David Axelrod who showed him this film while he was still President Obama's Chief of Staff, and it was David Axelrod whom Merola quoted as having said that:

David Axelrod was President Obama’s Chief of Staff at the time and after watching the film, he said that “it’s very important but it’s just too big.” He said “we can’t face this in this country not for at least ten years” and, he even alluded that the economy had just tanked. He even alluded that it could possibly send the country into a further recession because of what it would do to companies like Amgen which is 90% reliant on cancer therapies. It would, the stock market would, plummet if this thing was released. And this comes from the pharmaceutical world. It’s just the sad reality.

Since Merola first told that story at a Q&A session after a screening of his second movie, I and other skeptics have reached out to Mr. Axelrod on more than one occasion to attempt to verify this claim, but we've never received an answer. Now we know that Merola was full of fetid dingo's kidneys when he told that story back in 2013 (it's at about the 13:56 mark in the video, and in case Merola decides to delete the clip I downloaded a copy). Now we learn that it was Axelrod's buddy, not Axelrod himself, who said this about Burzynski's antineoplastons. From this version of the story, it sounds as though Axelrod never actually saw the movie.

Eric Merola's mendacity about David Axelrod aside, in the course of the article and interview, Merola is now trying to convince readers that it's not just Obama's former Chief of Staff who's on Team Burzynski. Now he's trying to convince readers, no doubt to capitalize on the publicity due to the recent Presidential debate, that two Republican Presidential candidates, Ben Carson and Jeb Bush, are on Team Burzynski. Ben Carson is roped in because apparently one of the patients featured in Merola's first film, Kelsey Hill, saw Dr. Carson during the course of her treatment:

Then fast-forward to the summer of 2010. One of the patients I profiled in my first “Burzynski” movie, Kelsey Hill, was cured of stage IV adrenal cancer by using Burzynski’s Antineoplastons.

Since she was undergoing full body scans to find if there was any more metastasis beyond her kidney, liver, and lungs—an MRI found a small tumor in her brain, but it turned out not to be malignant. Once she got through her journey of being cured of her malignant tumors in her kidney, liver, and lungs, they decided to “watch and wait” on the tumor in her brain.

Finally, Kelsey’s parents decided to have the benign tumor in her brain removed. They chose America’s leading pediatric neurosurgeon Dr. Ben Carson of Johns Hopkins (who is now running for President of the United States, and is the subject of the feature film “Gifted Hands” starring Cuba Gooding Jr.).

During the first consultation, Dr. Ben Carson looked at Kelsey’s records and said, “Wow, she’s doing great for having been cured of cancer after undergoing the amount of chemotherapy and radiation she must have endured.”

Kelsey’s father Steven replied, “she wasn’t treated with any chemo or radiation, she was treated exclusively with Dr. Burzynski’s Antineoplastons.”

I've discussed Kelsey Hill's case in depth before as part of my review of the first Burzynski movie (transcript of the Kelsey Hill segment here), as did JLI in an in-depth post. You can read those two posts if you want the details, but basically the story of Kelsey Hill, as told in the first Burzynski movie revealed:

  • The parents’s information on how widespread the tumor was at the time of diagnosis was demonstrably unreliable, given the conflicting versions of the story related in the movie.
  • There was considerable uncertainty as to whether the primary tumor really was cancer.
  • The primary tumor was successfully removed by surgery.
  • There were liver and lung lesions of unknown malignancy that decreased in size as time passed.

Interestingly, there was no mention of a benign tumor in Kelsey Hill's brain in the movie, even though the movie was released after this was supposedly found. Be that as it may, I was surprised that a pediatric neurosurgeon had never heard of Stanislaw Burzynski, given how many patients were out there who sought out his services several years ago and given that he practiced at Johns Hopkins, which is close enough to DC where likely the periodic patient protests about the FDA and Burzynski's antineoplastons would have made it into the news. After all, I had heard of Burzynski before from a couple of my breast cancer patients several years ago, at least a couple of years before I started looking into his claims, "clinical trials," and practices in detail. In any case, the other thing that concerns me about this story is this:

Ben Carson had never heard of Dr. Burzynski before. Upon their second meeting with Dr. Carson, he said the same thing to them. This time Kelsey’s parents were armed with a DVD of my documentary, “Burzynski”—and corrected him a second time.

Dr. Ben Carson watched my documentary, and quickly discovered that Dr. Burzynski’s Antineoplastons (ANP) are the first medications in world history (at least within any controlled FDA-sanctioned study) to cure an inoperable brainstem glioma, and/or pontine glioma, also known as a “DIPG”.

Dr. Carson expressed that he himself has never seen a cure of this cancer type—DIPG, and he wanted to consider opening up clinical trials at Johns Hopkins using ANP for DIPG.

So, first, Dr. Carson didn't glean from the patient's medical records that there was uncertainty about whether Kelsey's primary tumor was actually malignant or not. That could be forgivable (somewhat) because Dr. Carson was a neurosurgeon, not a pediatric cancer surgeon who would understand the issues regarding the diagnosis of adrenal cancer and might not have had access to complete medical records and reports. (In fact, I'd be willing to bet that he probably did not.) If the story is true—and, again, I don't trust Merola's version of anything without verification—it does not speak well to Dr. Carson's judgment in evaluating testimonials. I also note that, although it is rare, there are cases in the literature of patients having survived long periods of time with DIPG, so much so that there is even a registry that keeps track of such survivors. Surely Dr. Carson should have known that, at least, even if he personally had never seen a survivor. Maybe he did; again, I don't trust anything Merola says about anything having to do with antineoplastons or Burzynski based on what I consider to be very good reasons.

In any case, apparently Dr. Carson, who was chief of pediatric neurosurgery at Johns Hopkins at the time, called Burzynski to talk about starting a clinical trial with antineoplastons versus DIPG at Johns Hopkins. Then something happened:

After this phone conversation, two weeks went by, and Dr. Ben Carson stopped returning any phone calls or emails related to this.

In Dr. Burzynski’s words, “It was a matter of time, someone obviously got to him.”

Queue the black helicopters, or maybe a visit from some nefariously shifty operative from the FDA.

Of course, what's far more likely is that Dr. Carson did some investigating into Burzynski's clinical trials, which Burzynski's own lawyer at the time, Richard Jaffe, described in a book as basically a means to an end, the end being to be able to give patients whatever antineoplaston therapy Burzynski wanted to. Indeed, Jaffe even described one of Burzynski's trials as a "joke." It wouldn't have taken much digging to have discovered the issues and Burzynski's history of having charged patients huge amounts of money to administer antineoplastons. It's quite possible that his own conversation with Burzynski raised some red flags, given Burzynski's own tendency towards massive self-aggrandizement. Who knows? Who knows if this story is even true? It is, after all, Eric Merola telling it. He even admits that he's telling the story now because Dr. Carson is running for President.

Next up is a story I hadn't heard before, namely that of the husband of a very politically connected woman named Elizabeth Fago-Smith, a Republican fund raiser who had been appointed to the board of directors of Scripps Florida by Jeb Bush when he was governor. Her life has been described as a "deranged soap opera of money, power and self-adoration."

Whatever her dubious past, one can't help but feel sympathy for her story. In 2014, her husband developed a brain tumor, as she describes in the video:

It's a sad tale, in which she describes her husband's first symptoms of lethargy and weakness that got progressively worse and led her to be concerned that he might have had a small stroke. She describes contacting all manner of well-connected medical friends and ultimately how her husband had an MRI that revealed an anaplastic astrocytoma. Subsequent conversations with doctors revealed how dismal the prognosis was. Using her connections, she got in touch with Stanislaw Burzynski, who was going to offer her husband his "oral antineoplaston." Of course, we know that this is nothing more than sodium phenylbutyrate (PB).

The next part of the story is what's disturbing. Fago-Smith relates using her political contacts to get in touch with the FDA. What doesn't jibe to me is that, according to her, her husband started the PB immediately, but then it was her job to get FDA approval for a single-patient IND. If true, this bespeaks just how unethical and lazy Burzynski is, because it really is the doctor's job to get the FDA to approve a single patient IND. You don't require a frazzled spouse of a patient to do your job.

Of course, it's likely that Burzynski knew just how politically connected Fago-Smith was, because she is certainly not shy about name dropping. Indeed, she describes contacting former House Majority Leader Dick Gephardt, who now runs a lobbying firm. He called the FDA himself and told her whom to talk to, greasing the wheels for her. The good thing was that the FDA was very resistant to approving her husband's being on Burzynski's protocol as a single patient IND. However, it's clear from the video that Fago-Smith used every bit of her political influence—she describes it as "getting in their face" and not being nice at all—to get the FDA to approve an emergency single patient IND. At first there were conditions: She had to get another doctor and her husband had to undergo at least radiation. She refused and threatened to sue and get them all fired. Indeed, she even described calling everyone she knew, including former President George W. Bush, Jeb Bush, Marco Rubio, Rick Scott, Senate Majority Leader Mitch McConnell, Vice President Joe Biden, and others. She even claims that they all made phone calls on her behalf to the FDA.

Fago-Smith managed to line up a doctor named Joe Varon (who really should know better) to prepare the single patient IND, but then, according to her the Texas Medical Board, which had finally initiated another action against Burzynski, "threatened to arrest everybody" if they went through with this. So she called Florida Governor Rick Scott, who knew Texas Governor Rick Perry, who promised to "do everything he could" to pressure the Texas Medical Board. It worked. The FDA and Texas Medical Board caved, and her husband got antineoplaston infusions. She later asked Governor Perry to dismiss the charges of the TMB and/or to pardon Burzynski if he is convicted.

Sadly, Charles Robinson Smith III died of his brain tumor on March 23, 2015. Antineoplastons, as expected, did not save him. They probably didn't even prolong his life. At the end of the video, Merola asks in texts whether the three weeks it took to get the FDA to approve the single patient IND would have made a difference and if Smith might have been saved if treatment had started earlier, a classic gambit he likes to use to emotionally manipulate his audience.

As is the case with all Burzynski patients, I can't really blame Fago-Smith for using every tool and political contact at her disposal and calling in every favor she could in order to try to get antineoplastons for her husband. He was dying, and she believed that was the only way to save him. Where the fault lies is in Burzynski and his propagandists, like Eric Merola, who convince desperate people like Fago-Smith that the only way to save their loved one's life is to use antineoplastons. Once that idea takes hold, who wouldn't have done the same thing in Fago-Smith's place. If you really believe that Burzynski is the only way to save your husband, you will do what she did, even to the point of being angry that the FDA required Burzynski not to charge her for antineoplastons. On the other hand, it is depressing how easily politicians will assume that the FDA and a state medical board are out to "persecute" a "brave maverick doctor" like Burzynski, instead of what they are really trying to do in this case: Protect the public from an unscrupulous cancer quack.

So, as Burzynski's case before the Texas Medical Board proceeds to trial, hopefully next spring, consider this. I've wondered how Burzynski has survived nearly 40 years using a treatment that has no convincing evidence of significant efficacy in patients against any tumor. At least one of Burzynski's patients has very powerful political allies. It wouldn't surprise me in the least if Elizabeth Fago-Smith is not the only one using political contacts to pressure the Texas Medical Board and the FDA. It wouldn't surprise me in the least if there are a number of others who, through the years, have used their political power and influence to protect Burzynski.

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The point with Burzynski, and it cannot be restated often enough, is that he's opened 61 clinical trials for antineoplastons, but only ever completed one. The majority are 10 years old, marked as "unknown".

This creates two possibilities:
1. He has a very successful cancer drug, but he chooses not to reveal that by never reporting on his results. This allows him to have a boutique monopoly on an effective therapy at his private, "cash-only" clinic.

2. He's abusing the clinical trials system to sell a therapy that he knows doesn't work. His multi-modality "kitchen sink" approach hides the ineffectiveness of his patented drug.

I can't think of a scenario in which failing to complete clinical trials makes him anything but a monster, regardless of whether antineoplastons are an effective therapy for any cancer.

By c0nc0rdance (not verified) on 25 Sep 2015 #permalink

Thank you for your writeup Orac. It is tragic and scary that Burzynski has, for decades, used desperate patients and their families to persuade politicians to support him.

Most recently, both New Hampshire senators Shaheen (D) and Ayotte (R) intervened on behalf of the family of McKenzie Lowe, whose family managed to get the FDA to allow a single patient IND in an effort to treat a deadly brain tumor.

In 2000, there were fierce debates between the Republican presidential candidates but all 6 (Alan Keyes, Orrin Hatch, George W. Bush, John McCain, Gary Bauer, Steve Forbes) candidates helped lobby the FDA to get Burzynski’s treatment for a 5-year old named Tommy Navarro. Tommy’s father told the NY Post that Burzynski “had 74 FDA-approved clinical trials – and a 90 percent cure rate.” Alan Keyes, who had taken up Tommy’s cause, brought Tommy to a Republican debate and had the other 5 Presidential candidates sign a letter demanding that Secretary of Health and Human Services Donna Shalala allow Tommy to receive the treatment. George W. Bush initially refused to sign the letter and suggested more conventional treatment options, but eventually he too signed the letter.

Also, 48 members of Congress cosponsored the “Thomas Navarro FDA Patient Rights Act”, which was designed to restrict FDA’s authority to deny expanded access petitions to experimental drugs.

Of course, Senator Tom Harkin (D) and Rep. Berkley Bedell (D) are responsible for the Office of Alternative Medicine (OAM), which became the NCCAM and now the NCCIH. It was funded at least in part in order to promote Burzynski’s treatment. Of the $2 million allocated to the OAM in 1992, $750k was allocated to study antineoplaston therapy. OAM money also went to study other cancer quackery: shark cartilage and Revici therapy.

Thanks for that bit of history. I have written about how both New Hampshire Senators, most persistently Kelly Ayotte, lobbied the FDA on the behalf of McKenzie Lowe. Then there was Rep. Joe Barton (R-Dallas), who routinely dragged then-FDA Director David Kessler in front of his committee four times over two years in the mid-1990s to explain why the FDA was “harassing” Burzynski.

Sadly, the phenomenon of powerful politicians intervening to protect Burzynski is not a new one, although this is the first time I've heard that Governor Rick Perry was successfully lobbied to interfere with the Texas Medical Board's most recent prosecution of Burzynski. Strangely enough, after his lukewarm defense of vaccines and his frequent attacks on evolution, Ben Carson actually doesn't come off all that badly here. He investigated Burzynski's clinical trials and appears to have concluded that he didn't want anything to do with them. Of course, Eric Merola, conspiracy-mongering loon that he is, thinks that "they" somehow "got to" Carson. :-)

If I were speaking for the FDA, my response to the parents would have been "We certainly want to do everything we can for your son, and just as soon as Burzynski provides us with final reports from those 74 clinical trials, so we can review them and confirm he's achieved a 90% success rate we'll expedite Tommys IND. "

Then sit back and watch the parents and all their high-powered friends badger Stan about releasing the reports/evidence.

I don't think that would work. Burzynski tells the families that the FDA is keeping him from saving their loved ones, and that's all they hear.

I've often speculated about why a well-educated person is unable to comprehend his or her limitations-
isn't it fundamental that areas of expertise HAVE limits?

I venture cautiously that they must believe in a sort of transfer- if I'm skilled in X, I must also be skilled in Y, Z, B .. something like general intelligence working for them.
HOWEVER doesn't everyone learn as a child that we have abilities that vary?
Part of adult executive functioning involves self-evaluation and self regulation- including self-censor.

I wonder if adulation and success work against that in some people? Nobel Disease? Emeritus-itis?

By Denice Walter (not verified) on 25 Sep 2015 #permalink

Orac@5: Exactly this. These people are already in deep, deep denial. Their only interest is in maintaining the lie, not getting at the truth.

"Of course, Eric Merola, conspiracy-mongering loon that he is, thinks that “they” somehow “got to” Carson." Damn it, Orac. He's not a conspiracy mongering loon. He's a one-trick conspiracy mongering pony person.

To Orac:

Two questions:

1) Regarding Burzynski, approximately how many people per year are afflicted with the conditions his apparently controversial work focuses on?

2) “Even though [Carson has] never run anything larger than a small academic surgical department and the Johns Hopkins Craniofacial Center, Republican primary voters seem to think he’s qualified to run the country.”

Barack Obama never ran anything prior to 2009. Assuming you voted for Obama, what did you think HIS qualifications to run the country were?

By See Noevo (not verified) on 25 Sep 2015 #permalink

I believe both President Obama and Dr. Carson are equally qualified to be President - they're both natural born citizens, resided in the US for at least 14 years, are 35 or over, and (at the time running) had not acted as President for 2 terms (or two years of someone else's term plus one term).

By Mephistopheles… (not verified) on 25 Sep 2015 #permalink

"I’ve often speculated about why a well-educated person is unable to comprehend his or her limitations-
isn’t it fundamental that areas of expertise HAVE limits?"

A question I found to be valuable when interviewing candidates for a technical position is, not what you know, but tell me how you would find answers to what you don't know. That requires an honest view of self knowledge, including limitations, and the process to acquire knowledge, which the best candidates have nailed. It often serves to separate the wheat from the chaff.

See @ #11, if you're quite done posting your little talking points, let me ask you why "running" something should be a prerequisite for the Presidency. Keep in mind that GWB "ran" a whole bunch of things before being installed into the White House, and proceeded to "run" up debts we're still stuck with, "ran" our international standing into the dirt, and nearly "ran" the country into ruin.

And as for your mealy-mouthed defense of Burzynski, your little "some say" weasel word trick isn't fooling anybody. His work is hardly "controversial" - it's just outright horse hockey. It's "controversial" in the same way as Cretinism - the "controversy" is manufactured by frauds and charlatans.

By Chan Kobun, th… (not verified) on 25 Sep 2015 #permalink

Regarding Burzynski, approximately how many people per year are afflicted with the conditions his apparently controversial work focuses on?

Add them up yourself, sloth.

@Mike #2:

George W. Bush initially refused to sign the letter and suggested more conventional treatment options, but eventually he too signed the letter.

For a fraction of a second there, I actually held Dubya in some small degree of respect.

I promise it won't happen again.

By Rich Woods (not verified) on 25 Sep 2015 #permalink

To Chan #14:

“See @ #11, if you’re quite done posting your little talking points, let me ask you why “running” something should be a prerequisite for the Presidency...”

You should be asking Orac this, not me.
............
But maybe you can answer my question to Orac:
How many people per year are afflicted with the conditions Burzynski’s work focuses on?

By See Noevo (not verified) on 25 Sep 2015 #permalink

To hear that rick "kill 'em all" perry defended burzinski by peddling political influence is not a shocker. To read (again) about what an utterly contemptible predator burzinski is, this too is not a shocker. I'm a bit shocked at how long he's been getting away with it, but given the state of American [failure of] politics, I'm really not surprised that [either completely stupid or morally bankrupt, take your pick] politicians have saved him so many times.

BTW, watch out for the commenter who calls himself "jdc." He's a real chicken-flavored nipple biscuit. True fact. I saw it on the internet, err, I mean "truth machine"

By alcaponejunior (not verified) on 25 Sep 2015 #permalink

I don't know what a 'chicken flavoured nipple biscuit' is but I might get a tattoo of it. It deserves remembrance.

By NumberWang (not verified) on 25 Sep 2015 #permalink

*Waves to Al*

NW, "chicken-flavoured nipple biscuit" is a term coined by the afore-mentioned JDC on a certain UK-ian forum not unconnected to Dr Ben Goldacre and used in a generally derisive and dismissive manner.

@14 and this, wrt sn: "mealy mouthed defense of Burzynski"

Given sn's rabid statements elsewhere about the importance of capitalism above all else, and his disdain for the ill, poor, and desperate, a reasonable conjecture is that he defends Burzynski because he runs a business, and if anyone is harmed by his "product" it is due to the foolishness of the customer, not a nefarious action by the good doctor.

Physicians thinking that their level of intelligence qualifies them to pronounce on anything is not new. The same goes for scientists, physicists in particular. The history of spiritualism is littered with the names of 19th Century British physicists. Sir Arthur Conan Doyle, without a doubt a brilliant man, also fell into its coils, but then Doyle was a physician.
Nathan Shockley (American, discovered the transistor, Nobelist) in the '70sclaimed that blacks were mentally inferior to whites, based on misunderstood IQ testing statistics. James Watson (Nobelist co-discoverer of DNA structure) fell into the same trap. Edward Teller was counted an expert on defense policy for his rôle in inventing nuclear weapons.
For the big names, it may have to do with the way that once famous, everyone (the media) wants their opinions on everything else besides their specialty. For examples, look at Albert Einstein, Benjamin Spock, and Jonas Salk.
So it's probably a simple matter - if people keep telling you you're brilliant and one of the elite, then you are at risk for believing it and then acting accordingly.

By Olld Rockin' Dave (not verified) on 27 Sep 2015 #permalink

demon dean in #22 is really picking up the pace.
About half a dozen falsehoods in just one sentence.

By See Noevo (not verified) on 27 Sep 2015 #permalink

Isn't it lovely how the head of his church comes to his town and See is just over-brimming with love for his fellow man as illustrated @23.

By Denice Walter (not verified) on 27 Sep 2015 #permalink

You've said all those things and.

Yeah for the phone while on a walk.

You've said all that and more sn