And another thing…

Burzynski and Patient Choice

Posted on | March 12, 2012 | 15 Comments

It’s difficult to know where to start a post like this, perhaps because I most often start my posts by noting something which has been asserted as fact, and then proceed to debunk it. This post is about Burzynski, a subject which is becoming increasingly hard to write about, because two issues – namely the validity of the treatment (incorporating Burzynski’s practices, honesty, publication, etc), and the patients being treated – have become so entangled that it is difficult to discuss one without treading on ground covered by the other. Last week, after being contacted by a tweeter who asked me some leading questions about Burzynski, I tweeted the following messages:

 

This sparked a series of messages (excerpts of this particular exchange can be seen here, many examples can be seen by simply searching for #Burzynski on Twitter) the general form of which have become par for the course for any people critically discussing Burzynski on Twitter. It isn’t long before I am being asked to comment on specific patient cases (in this case, Laura Hymas of HopeForLaura), and before that specific patient is drawn in to the conversation. Despite the fact that it was a supporter of Burzysnki who originally began to include Laura in the conversation, it quickly becomes a case of “skeptics attacking a patient”.

Though I suspect our reasons will differ wildly, there is one point on which myself and @BurzynskiSaves agree on here – it is all very sad indeed; a conversation which started about a treatment, and the need to publish data, has devolved into mudslinging with patients and supporters.

Stanislaw Burzynski & Antineoplastons

At the heart of all of these exchanges are the questions of validity, honesty, and integrity – does Burzynski’s treatment work as advertised, is he being honest about the protocols that he is using and the results he is getting, and is it correct for him to be operating as he does. At the risk of treading over old ground, I do not currently believe that Burzynski’s treatment works as advertised. However, this belief is not because I blindly believe whatever the FDA tells me, or because I want to help suppress a revolutionary cancer cure; it is because I have examined the evidence presented to me, and concluded that it does not support the assertions that he is making. Burzynski’s website tells us that he discovered antineoplastons in 1967, the same year he graduated. It also tells us that he founded his clinic and began treating patients in 1977. Burzynski’s resume notes that he made a presentation on April 9th, 1988, in Kurume, Japan, at the Kurume University School of Medicine. The title of this presentation was “Clinical Results of Antineoplaston Therapy”. In order for such a presentation to be made (assuming that the details about the presentation are accurate), there would have to be clinical results, and in order for there to be results, there would have to be clinical trials. One can postulate, then, that Burzynski began trying his antineoplaston therapy, in humans, at some date before the presentation. It has been approximately 45 years since he discovered antineoplastons, approximately 35 years since he began treating patients with them, and approximately 24 years since that first presentation in which he discussed the clinical results of his treatment. This is an extremely long time to be testing a treatment without publishing significant results, moving further through the trial process, or reaching a stage where the product can be marketed to the general public. The FDA estimates that it takes approximately 8.5 years for a new cancer drug to reach the market, from inception, through trialling, and to delivery. This 8.5 year timeline includes laboratory and animal testing. The FDA have recognised that some drugs are a priority, and have even made special processes available to try to shorten this timeframe further, to allow patients to benefit from lifesaving drugs. Even allowing for extra time in laboratory development, typical delays in the process, and other factors, 45 years is an extremely long time for anyone to be trialling a drug, especially one with such astonishing results.

There have also been some questions raised about the honesty of Burzynski, and this is of particular importance when it pertains to his treatment protocols. Patients go to Burzynski when they have no other treatment options available, or when those treatment options available have proved unsuccessful or too dangerous. They do so because what Burzynski advertises is a targeted gene therapy using his antineoplastons. I suspect that many are not expecting to be given chemotheraputic drugs as part of their treatment, and it is certainly not something that is featured prominently on his website, but Burzynski isn’t just treating with antineoplastons – he’s often prescribing multiple chemotheraputic drugs for off-label use, at highly inflated prices from his own pharmacy. One patient blog talks about Afinitor and Votrient, and mentions that the patient is taking a combination of five off-label chemo drugs, along with the antineoplastons. This is not the only mention of Afinitor, there are numerous comments (scroll to comments for those) and patient blogs which mention that they are taking this (and other) chemo drug in addition to the antineoplastons. This couple maintain that they were not told that some of the drugs were chemotheraputic drugs, and that taking those drugs has cause problems with eligibility for other trials (though I am uncertain of the veracity of this site). Though the Burzynski clinic website prominently features the antineoplastons as the cure for cancer, it seems that many (if not all) of the patients are being given traditional chemotherapy in addition to the antineoplastons.

Finally, many have questioned Burzynski’s integrity, due to the prices of treatment at his clinic. Reported prices vary, but are generally in the tens of thousands per year of treatment. The FDA permits charging during clinical trials under very specific circumstances (related to investigational drugs), though it does not regulate what is charged. The FDA permits the charging so that drug manufacturers can recover the costs for making these drugs while trialling them. Although one patient blog mentions that the charge is not for the trial but for “case management” (suggesting that they are not being prescribed under this investigational drug regulation), it is possible that things have changed since this blog (and indeed, the law changed to allow for charges around the time of that blog). One can only speculate what it costs to produce antineoplastons, though Burzynski sells capsules containing antineoplastons for approximately $1 per capsule (0r $0.78, if you buy in bulk), though Burzynski seems to make most of his cash charging inflated rates for case management and off-label chemo drugs.

Data is important

It would be more than a little hypocritical of me to point out the fallacy of ad hominem attacks, and then base my own criticism of Burzynski solely on personal actions which are questionable. Whether or not Burzynski is himself ethical, honest, or even nice, if he has developed a miracle drug, he has as much right to trial it as anyone else (and even to be lauded for his discovery). Though I don’t like the stories which suggest dishonesty, they are just stories, and are as liable to bias as the patient anecdotes that “skeptics” dismiss as “not proof”. One thing which is more telling than any stories, and the point which should be focused on, is the lack of any real data to support Burzynski’s treatment. Though his website has many patient anecdotes and success stories, there are also plenty of examples where the treatment did not work, and as he seems to exclusively list success stories, they can not be counted on as reliable evidence. Most articles about antineoplastons published in scientific journals have been authored or co-authored by Burzynski himself. When people use these to point out that he has published data, they overlook the mediating factors – namely that the research hasn’t been replicated (to any significant degree) by completely external researchers, and that the journals in question are often considered poor quality. When it comes to drug development, data is king – this is simply the application of the scientific method. An assertion must have the data to support it, or else it should be considered false, and in this case, the data to support it is not reliable. It is true that there have been cases where data has been withheld from the FDA, and where drug companies have behaved unscrupulously – I absolutely won’t claim that “big pharma” is perfect – but these cases do not override the need to produce data which supports your assertion that your treatment works.

Patient Choice & Informed Consent

It has been said to me that patients don’t care about data, they care about people. They speak to people treated by Burzynski and they are given hope, and hope is the most important thing. It would be easy to keep discussing Burzynski in a very detached way, focusing only on the data (or lack thereof), but for many, this discussion is too shallow, because there are patients involved, and those patients have families and friends, and a whole host of people who would give anything for them to be better again. More than this, the patients have been drawn into the discussion, either willingly or unwillingly, and for them, attacks on Burzynski must often seem very personal, for a number of reasons.

One issue that is often raised is that of patient choice – the right of a patient to chose their treatment without criticism. Cancer treatment can be brutal, and even though treatments have improved, and the side effects are more manageable than before, there is an undeniable effect on the patient. Sometimes, patients decide that the side effects of the treatment outweigh the potential gain, and either decide to seek no more active treatment (e.g. pursuing palliative care only), or decide to seek an alternative, whether it be conventional treatment in another country/hospital, or an alternative therapy. Patient advocates, and Burzynski supporters, all maintain that patient choice is important, and I’m inclined to agree. I imagine that, if I were very ill, and the chances of a cure were not good, I would like the ability to choose whether to pursue further treatment. I wouldn’t like to deny this choice to anyone, but what I would like is for that choice to be based on the best information possible.

People say that patients don’t care about data, journals, and FDA squabbles, but even if that is true, patients do deserve the truth about their treatment, their prognosis, and everything associated with it. A patient has every right to choose alternative medicine over conventional treatment, but it is a poorly informed choice if it is based on informercials, advertising websites, and unproven claims. The fault, and the criticism, lies not with the patient, but with those who would prey on people when they are feeling vulnerable or desperate. Scientific papers are often dry and inaccessible (both because of the content, and because of the expensive paid access required to read them), and it is not as easy to relate to data points on a graph as it is to relate to a named patient, with an adorable picture and a heart-warming cure story. Quacks know this, and use it to manipulate people, helping only their own bank balance, and often leaving families devastated when the promised cure does not come about. I have been accused of attacking patients seeking Burzynski treatment, of wanting to deny their freedom of choice, or take away their last hope; this has never been the case. I don’t attack patients because I am aware of how difficult it is when a family member is sick, and when the treatment is difficult. I don’t attack patients, because I believe the blame should be laid squarely at the feet of those who manipulate and deceive patients.

A final, thorny issue is that of fake patients. Even as people call for Burzynski to publish data, there are various patient blogs reporting successes and shrinking tumours, and a multitude of patient anecdotes and youtube videos featuring people who were given a very poor prognosis, and have lived far longer than expected. Whenever Burzynski is discussed, these patients are mentioned as proof, and I have more than once been asked to comment on specific patient cases, or asked if I am, in criticising Burzynski, calling these patients fakes, shills, or liars. The truth is, I can’t comment on these cases, because I just don’t know the circumstances. I am not privy to medical treatment details, personal information, or anything like it. I see the information that is made public by the patients and nothing more. I am glad to know that there are people beating the odds, living longer than expected, and even going into remission where before there was little hope for a cure, but I can’t say what causes these events any more than a Burzynski supporter can claim them as definite proof of efficacy. I would certainly prefer to believe that we do not live in a world where people pretend to have terminal illnesses to make money, sell a treatment, or otherwise deceive people, though I know there are those who have. Asking me to comment on patient cases is ultimately fruitless – I have no way to know if people are legitimate, or if they are telling the truth when they update their blogs – and, importantly, my quibble has never been with the patients. If there are people acting as paid marks for Burzynski, then they are doing something which my conscience would not allow me to do, but they are ultimately in the employ of Burzynski, and this is where the buck should stop.

This is not, and has never been, about me wanting to take away hope, or be malicious to patients. The onus is on Burzynski to publish data to support his claims, and I believe that patients are entitled to know what data there is (or is not). Patients deserve real information to help them make their treatment choices, they do not deserve to be manipulated or lied to. This has only ever been about one thing: information. Patients deserve information, not infomercials.

 

Comments

15 Responses to “Burzynski and Patient Choice”

  1. Josephine Jones
    March 12th, 2012 @ 13:09

    Thanks for such a well thought out and honest post. It can’t have been easy to write but it had to be said.

    Although the #Burzynski hashtag really gets to me at times, I try not to engage directly with patients or with supporters such as @BurzynskiSaves as they have made up their minds and aren’t likely to change them no matter how many times we point out the various issues. Many (but not all) supporters also appear more interested in mudslinging than discussion of the actual points raised. But then again, if nobody challenged them, would things be worse? Is it just a case of them trying to monopolise the hashtag so every time a critic of the clinic uses it, they have to immediately be accused of (eg) heartlessness to ‘cancel out’ their point?

    Although I’ve rarely engaged on Twitter, I was contacted (here http://josephinejones.wordpress.com/2011/12/16/dear-evening-standard-it-is-immoral-to-promote-the-burzynski-clinic/#comment-1161) by a friend of a patient. She seemed under the impression that critics are discrediting patients and accusing them of faking tumours and MRIs. Of course, I have never suggested any such thing and find the whole business very upsetting.

    My reply was as follows:

    “I find it very difficult discussing these issues with patients and their friends and families. I don’t want to make things any more stressful than they already are. But since you came to me, I feel it’s only right that I try to answer you as honestly as I can.

    To summarise, I echo what anarchic teapot has said – we aren’t accusing anyone of faking tumours. We are drawing attention to the various legal and ethical problems with the clinic.

    I find it distasteful that the clinic are using patients themselves (along with medical records) to promote the clinic (not only through newspaper articles and blogs but also, for example, on Facebook) while also charging them hundreds of thousands of pounds. For example, if I were seriously ill and in a clinic for any reason, I would be very uncomfortable with the clinic publishing my medical records and photographs in their promotional material. It’s unthinkable, really.

    It’s also not possible for critics to comment on the scans without upsetting patients. They have put them into the public domain but it seems morally wrong for them to be discussed in any detail. For that reason, it is rare that you will find critics of the clinic questioning the scans. By this, I don’t mean to imply that I don’t believe the tumours have shrunk. And I also don’t feel it’s any of my business to discuss individuals’ medical records without their consent.

    In any case (as I’ve said in a previous comment), testimonials from individuals don’t constitute reliable evidence. We need to see results from good, large scale trials. And we haven’t. Despite over thirty years of trials, we have still not seen the publication of meaningful data. As Rhys Morgan discusses here http://rhysmorgan.co/2012/01/burzynski-morally-reprehensible/ that is morally reprehensible.

    Concerns have been raised not only by outsiders criticising the clinic but also by former patients and their families, such as Wayne & Lisa Merritt (who feel they were scammed by the clinic and were sent legal threats as a result of writing about their experiences). One former patient, Lola Quinlan, is even seeking damages in court (http://www.courthousenews.com/2012/01/19/43165.htm).

    I’m sorry if you find it distressing that people are being so negative about the clinic. I truly do wish Hannah and the other patients and their friends and families the very best. I hope that the treatment is successful.”

  2. Burzynski blogs: My Master List | Josephine Jones
    March 12th, 2012 @ 15:10

    [...] Burzynski and Patient Choice Buffy, And another thing…, 12/03/12 [...]

  3. The 21st Floor » Blog Archive » Burzynski and Patient Choice
    March 13th, 2012 @ 10:36

    [...]  Also appears on “And Another Thing…” VN:F [1.9.15_1155]please wait…Rating: 0.0/5 (0 votes cast)Share this:FacebookShareRedditStumbleUponEmailDiggWhy not discuss this article below or on the forum? Related Posts:The Cancer Industry“Don’t forget it was the chemo that cured you”Science and skepticism in Hobbitland – a round up [...]

  4. If the media care about Burzynski’s patients they must pull their heads out of the sand | Josephine Jones
    April 29th, 2012 @ 19:37

    [...] Keane discusses patient choice and informed consent here, where she concludes that Patients deserve information, not [...]

  5. The 21st Floor » Blog Archive » Burzynski: A media scandal
    May 10th, 2012 @ 11:32

    [...] Keane discusses patient choice and informed consent here, where she concludes that Patients deserve information, not [...]

  6. Guy Chapman
    June 17th, 2012 @ 21:39

    This is so true, and so hard to deal with in the context of Twitter where, like politics, everything is reduced to soundbytes and the ambiguity caused by excessive brevity is ruthlessly exploited to imply things which simply are not true.

    I know that most of us who are interested in the Burzynski story are desperately sorry for the patients involved. Informed choice is absolutely the core fo the matter, and cancer patients are particularly vulnerable to hucksters (hence the UK and Australia, for example, have Cancer Acts which specifically prevent the advertisement of unproven “miracle cures”).

    If Stanislaw Burzynski genuinely is a pioneering doctor with a revolutionary treatment then he needs to sack the used car salesmen with whom he has apparently surrounded himself and hire some scientists instead. There is no way the argument can ever be ended by one side shouting down the other, the only resolution will be in the court of science, through publication and replication.

  7. The Burzynski “Debate” – Guy Chapman's Blahg
    June 18th, 2012 @ 20:58

    [...] usual, Zenbuffy has a very measured take on things, and beautifully sums up the angst that many of us feel. We care about people with cancer. We care [...]

  8. Bad advice from CANCERactive | Josephine Jones
    July 11th, 2012 @ 21:24

    [...] Burzynski and Patient Choice Jennifer Keane, And another thing…, 03/12/12 [...]

  9. The 21st Floor » Blog Archive » CANCERactive Concerns
    July 12th, 2012 @ 00:02

    [...] Burzynski and Patient Choice Jennifer Keane, And another thing…, 03/12/12 [...]

  10. News Snippets – July 16th 2012 | Krank.ie
    July 16th, 2012 @ 19:09

    [...] Burzynski and Patient Choice by Jen Keane (zenbuffy.com) [...]

  11. Science-Based Medicine » Dr. Stanislaw Burzynski’s cancer “success” stories
    February 18th, 2013 @ 04:53

    [...] and Joe Mercola) to defend and promote him; attacking skeptics by characterizing them as “skeptics attacking recovering cancer patients on Twitter“: and, rather than publishing his results, he’s promoting his “results” in [...]

  12. Science-Based Medicine » Dr. Stanislaw Burzynski's cancer …
    February 18th, 2013 @ 08:20

    [...] Somers and Joe Mercola) to defend and promote him; attacking skeptics by characterizing them as “skeptics attacking recovering cancer patients on Twitter“: and, rather than publishing his results, he’s promoting his “results” in documentaries by [...]

  13. The Heresy Club
    July 31st, 2013 @ 03:19

    [...] science communication and the myths surrounding MMR vaccination, pseudo-science and alternative medicine. Earlier this year she discussed religious education on Irish radio alongside Michael Nugent and [...]

  14. 100 of Britain’s secular thinkers you should know about, who aren’t white men | The Heresy Club
    July 31st, 2013 @ 23:26

    [...] communication and the myths surrounding MMR vaccination, pseudo-science and alternative medicine. Earlier this year she discussed religious education on Irish radio alongside Michael Nugent and [...]

  15. “The Skeptics™” Colorado Public Television (CPT12) – PBS Facebook comment links | Didymus Judas Thomas' Hipocritical Oath Blog
    September 15th, 2013 @ 01:04