Investigating Burzynski

By Keir Liddle

Skeptics have uncovered more documents and patient blogs that highlight the concerns many hold regarding the practices and ethics of The Burzynski Clinic, it’s staff and it’s proprietor Dr Stanislaw Burzynski. We have previously covered the problems with Burzynskis claims that his therapy is gene targeted, natural and non-toxic. We have previously found his claims to hold a PhD questionable in the extreme and we have analysed what little there is of his published research.

Tragically we also covered those who bought into Burzynskis treatment, literally and mentally, whom his treatment failed.

Supporters of Burzynski still appear blind to the concerns raised repeatedly by skeptics that the research conducted by the clinic and Burzynski research Institute is unethical, poorly designed and has never been published in a reputable journal of oncology. Critics of Burzynski have uncovered many documents that detail problems in Burzynskis research method, his ethical procedures and shocking documents that show his reported efficacy to the FDA is nowhere near the efficacy reported to his patients.

What is shocking about these documents is that they have by and large not been published recently. They span the whole of Doctor Burzynskis thirty plus year failed “crusade” to prove antineoplastons (ANP) work.  The latest document discovered dates from 2001 and it’s contents may have many critics scratching their heads wondering just what exactly Dr. B. has to do for the authorities to intervene.

The latest document is a letter to Burzynskis Institutional Review Board (IRB) - the body responsible for assuring that research conducted is safe, ethical and properly designed. Supporters of Burzynski have attempted to deflect criticism based around letters to the Burzynski IRB by misleading people into believing that they are a separate company and that IRB stands for “independent review board” but this is far from the case.

A 2009 warning letter by the FDA lists  IRB chairman , Carlton F. Hazlewood, Ph.D. as a clinical investigator in studies concerning ANP. Hazlewood is also listed as being on the board of directors of the Burzynski research institute.

Which is very far from being independent as supporters would have us believe.

The letter raises the following concerns following an inspection of the IRB:

  • Failure to keep a copy of the [redacted] study protocol and informed consent form.
  • Failure to recieve and/or require a final report from the principal investigatorfor the [redacted] study prior to removing the study from IRB list of active studies
  • Failure to assure that FDA approval was obtained by the principal investigator prior to the treatment of a patient under a special exemption

Another warning letter was sent in 2009 that seems to imply not much has changed since that letter, and others like it, were sent. Despite the Clinic and research institutes assurances to the contrary. The 2009 letter raises the following concerns:

  • The IRB approved research without determining that the following criteria were met: That risks to subjects were minimized and That risks to subjects were reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result
  • The IRB Failed to prepare, maintain, and follow written procedures for conducting its initial and continuing review of research
  • The IRB failed to ensure that informed consent would be sought from each prospective subject or the subject’s legally authorized representative
  • The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest
  • The IRB failed to conduct continuing reviews

These are not letters to be taken lightly. They show a complete failure by the IRB to ensure research is conducted ethically and reported properly. Most worrying is that the clinic seems uninterested in insuring informed consent is obtained from those they go on to “treat”.

Combined with testimony from patients (link Hxxp’d) it paints a worrying picture of a clinic and researcher playing at best “fast and loose” with research ethics and at worst someone who believes themselves to be above such concerns.

The blog describes how a patient raised concerns about the treatment regimen (non ANP) that the clinic was offering, one that cost thousands of dollars and appears to be a cocktail of expensive chemo drugs.  The patient was “having none of it” and they returned to the clinic next day to request an alternative protocol. They were

"Immediately ushered into the financial counselor’s office again.  She asked us if we were prepared to pay the treatment deposit, and if we had filled out all the financial aid forms.  We gleefully said that we hadn’t filled out the forms because we had decided not to take synthetic drugs as part of the treatment.  She just stared blankly at us for a few seconds."

They were then passed onto a doctor Sano who informed them that the MRI scan they had just had done showed “lesions” on the brain tumour and that due to this “change in circumstance” they would have to meet with Doctor Sano to discuss what to do next. She:

"wanted to know exactly where we stood financially and what we wanted to do about the medications, so she could tell the doctor exactly where we stood.  And we were totally honest with her.  We can’t afford the meds.  We just can’t do it.  She told us that it was now possible that Dr. Burzynski might want to put Adam in the clinical trial.  Now he had a "persistant" tumor, and there was something measurable.  If he was given permission by the FDA to receive the antineoplaston treatment, now there was material they could measure and watch it shrink.  This is essential to be considered for the trial."

They were shown the lesions on a zoomed in MRI. We have no reason to question whether this is the case but the manner in which they were moved from a cocktail of chemotherapy agents to an ANP “trial”. The timing is convenient to say the least, but such coincidences are possible and without further evidence one has to give the clinic the benefit of the doubt in this instance.

What is worrying about this is the amount of time the patient spent with Burzynski to confirm they would take part in the trial: ten minutes. Which seems a remarkably quick time in which to complete a proper and ethical informed consent process…

In fairness there isn’t much we can take from this single patient blog other than insinuation, which is not evidence of wrongdoing. Skeptics and critics will likely agree that this seems dodgy and supporters will see it as a slur. However skeptics have uncovered a lot more than simple slurs against Burzynski. We have uncovered documents that show his treatment is nowhere near as effective as he claims, we have exposed ANPs as neither natural or non-toxic, we have shown Burzynski does not have the expertise needed to conduct gene-targeted therapy and we have shown the majority of patients that attend the clinic either vanish or die.

This is not a debate that will be settled by insinuation and character assassination. It will only be settled by the clinic releasing it’s results, procedures and protocols to proper scientific scrutiny.

The ball is in Doctor Burzynskis court. Put up or shut up.

Phase 3 - the magic number for Burzynski?

By Keir Liddle

Supporters of Burzynski are keen to point out, time and again, that the Food and Drug Administration (FDA) have “approved” a phase three trial of Antineoplastons (ANP) that will show that ANP can effectively treat cancer. But is this phase three trial all that it appears to be?

The Burzynski clinic submitted the trial in December 2010 (but has yet to start recruiting) and many supporters of Doctor Burzynskis’ “natural” (it isn’t) and non-toxic (it isn’t) treatment look forward to it’s results validating their fervent support of the clinic.

The 0nly phase three trial of ANP that appears on clinicaltrials.gov (a registry of clinical trials in the US) can be found here. It states that the purpose of the trial is to:

"compare progression free survival (PFS), the time from randomization to progressive disease, in children with optic pathway glioma (OPG) age ≥ 6 months to

The observant among us will n0te that the cancer the Burzynski clinic intends to test ANP against is not Diffuse Brainstem Glioma (DBG) which may surprise some as it is high grade DBGs that many patients have found themselves seeking treatment for in Texas. Indeed the cancer that ANPs effectiveness is being trialled on is Optic Pathway Glioma (OPG), include chemotherapy, surgery and radiation, which is interesting for a number of reasons…

  • Optic Pathway Glioma is a cancer that accounts for 5 percent of all childhood brain tumors.
  • In two thirds of cases in patients with NF-1, an additional genetic condition, the tumours stop growing and disappears forever on their own without treatment. Spontaneous regression is common.
  • It can be life threatening, but the risk for death is extremely low.
  • Current treatments for OPG include chemotherapy, surgery and radiation and there is a cure rate of 90%

The other interesting thing about the trial, given some Burzynski supporters insistence that the therapy is not poisonous chemotherapy is that for this phase three trial Burzynski will be comparing ANP with Temozolomide which is… chemotherapy.

Temozolomide is used in the treatment of brainstem gliomas and common side effects include nausea and vomiting. It is being further developed for the treatment of brainstem glioma through scientific research. So how do supported of Dr Burzynski who are fiercely anti-chemotherapy defend that?

Some critics of Burzynski are beginning to suspect the phase three trial will never come to pass. The more cynical believe this suits Burzynski just fine allowing him to forever deflect criticism by pointing at his Phase 3 approval as a manyana, manyana promise to research ANP properly.

So far the much vaunted promise of the phase three trial is beginning to look a little empty…

ANP: Not gene targeted. Almost certainly not curative.

By Lightbluesquare, edited by Josephine Jones

This post concerns the implications that ‘antineoplastons’ are ‘gene targeted drugs’. Something which is not only untrue, but I believe is specifically designed to mislead potential patients into thinking they will receive state of the art, targeted drug treatments with little or no toxicity. In reality, they are likely to be receiving a very old, not at all ‘gene-targeted’ drug by the popularly accepted definition of the term. While this may or may not be of therapeutic benefit, it does carry considerable risk.

Firstly it is important to understand what a gene targeted drug actually is, so I will use an example. A type of leukaemia, called chronic myeloid leukaemia (CML) was until the late 1990s almost entirely incurable, with a dismal five year survival rate of around 10%. This particular type of leukaemia is caused by something called a fusion gene (or chromosomal translocation), where two bits of DNA that are normally supposed to be separate, actually fuse together causing the normal functions of these two genes to be disrupted. In the case of CML, the gene is called the Philadelphia chromosome where two genes called BCR and ABL (a protein called a tyrosine kinase) join together to cause BCR/ABL.  This turns the normally inactive ABL on and results in leukaemia.

BCR/ABL was discovered by Dr Janet Rowley in the 1970s, a truly inspiring woman and scientist and for many years, CML patients were still succumbing to their illness. However, in the late 1990s, a drug company research group from Novartis in combination with Dr Brian Druker, and groups from elsewhere in the US, Italy and the UK specifically designed a drug which would target ABL and turn it off again, stopping the disease in its tracks. This single drug transformed the five year survival rate for CML from less than 10% to over 95%. The phase III trial carried out in the year 2000 randomised patients onto conventional treatment containing a range of chemotherapy agents or Imatinib, and the results were so staggering in favour of Imatinib, the trial was finished early for ethical reasons and all patients in the trial were treated with Imatinib. In 2001, the drug was approved by the FDA for treatment of CML (shortly followed by other countries), and holds the record for the quickest ever approval of a drug by the FDA, less than five years from discovery to widespread approval for CML patients.

Imatinib is not only a potent example of a truly targeted drug (although it must be mentioned that it does have some residual effect on other tyrosine kinase proteins such as KIT, but this is a different and complex story) with few associated side effects, but a lesson to the entire medical and scientific community in how to identify the root cause of a disease as Dr Rowley did in 1973, collaborate extensively to develop a targeted drug, test the drug quickly and efficiently and get it helping cancer patients as soon as possible.

So, onto Burzynski. Others have written about his ‘antineoplastons’, notably David Gorski with an excellent critical appraisal, summed up perfectly by the observation that what Burzynski calls antineoplastons are nothing more than the byproducts of the body’s metabolism of the orphan drug sodium phenylbutyrate. I would like to expand a little more on what antineoplastons ‘might’ do theoretically, and why I feel that even if they do have any action against cancers, there are better alternatives now available.  Burzynski calls his drugs ‘antineoplastons’, but essentially, we know that a lot of the time, he gives ‘antineoplastons’ to patients by using a recognised drug called sodium phenylbutyrate. Sodium phenylbutyrate (PB) is converted to phenylacetate (PA) and phenylacetylglutamate (PAG) by the liver and kidneys (along with a few other chemicals summarised on the Burzynski website), so although these chemicals may have slightly different effects, we can presume that treatment with PB will result in ‘antineoplastons’ being in the bloodstream. It is a little similar to giving someone a cup of tea or giving them the tea bag and some hot water to make their own tea. Either way, they will end up with a cup of tea, albeit the strength of the tea might be slightly different.

Burzynski is not the only one using antineoplastons, or the pro-drug PB. PB is approved for some other conditions such as urea cycle disorder (again summarised perfectly by David Gorski) and has been trialled in other cancer types. So what do other scientists and doctors say about it?

In a 2001 study by Gilbert et al, 28 patients with a range of solid tumours were treated with PB. Notably the paper states ‘no patient had a partial or complete response’. The paper also details side effects, particularly at the higher PB doses used, including extreme fatigue and in one case, severe neurological toxicity. Supporters of the Burzynski Clinic (including the Burzynski Patient Group, recommended by the clinic to patients) believe that the treatment is non-toxic.  This is despite patient experiences of severe hypokalaemia (low potassium), hypernatraemia (high sodium), seizures, fatigue and kidney failure. All of these can be life threatening and in the case of the kidney failure, would appear to be the cause of death in one paediatric Burzynski patient. I suspect that Burzynski uses doses at the higher range of those stated in this paper, meaning that severe side effects may occur far more regularly than he seems to let on. Indeed, in 1998, the FDA noted that 65% of the 404 patients participating in a study were suffering from hypernatraemia, which they said may have contributed to the deaths of at least seven patients.

So, the big question is – does the treatment actually work? Unfortunately, Dr Burzynski has failed to publish any information on almost all of his clinical trials in order to answer this question. This is astounding in many ways, but mainly because if the treatment was as successful as he claims, publications would give him credibility, recognition (which it seems he badly craves and believes he is entitled to) and an increased customer base leading to, well… money (something which he also seems to enjoy). So, without any information of it in his hands – theoretically could it work?

Sadly the answer is as you might expect - not yes or no. PB is proposed to work as a histone deacetylase inhibitor (HDACi). Histone acetylation basically influences which genes are expressed in a cell and which are not expressed.  If a gene is expressed, protein can be made from it and then that protein can have any number of effects on the cell, such as making it divide, move to another part of the body or even die. Histone acetylation plays a role in controlling this and generally DNA which is very acetylated, expresses lots of genes, whereas DNA which is not highly acetylated expresses few. Therefore, disrupting histone acetylation with HDACi can alter the expression of some genes.

Sounds good so far, except there are a number of issues both with the drug and the way Burzynski sells it:

Burzynski claims that Antineoplastons ‘switch on’ tumour suppressor genes and ‘switch off’ oncogenes.

Histone deacetylase inhibitors will certainly ‘switch on’ certain genes and ‘switch off’ others (or more accurately, decrease the levels of some genes and increase the levels of others), but this spiel from Burzynski essentially claims that PB has conscious thought to switch on the good guys and turn off the bad ones. This is simply not possible. Genes in DNA are all a mixture of four DNA bases; A, T, G and C, regardless of whether they produce tumour suppressor genes or oncogenes. Although the roles of some of these genes are now apparent to us through years of research, it is ridiculous at best to suggest that a small molecule is capable of telling histones which genes to repress and which to activate. It frankly is just not that simple.

As for the drugs being ‘gene targeted’, this is quite simply untrue. The description of Imatinib above shows a truly gene targeted agent whereby activated ABL protein, characteristic of the root cause of the disease, is inhibited. Imatinib does have a few ‘off-target effects’ on a handful of other proteins, due to their structural similarity to ABL, and this has actually been used to therapeutic advantage in various other cancers such as a certain type of gastrointestinal tumour called GIST, which has an overexpression of a protein called KIT. Regardless, Imatinib can be considered to be gene targeted to just a handful of genes. PB however, will have effects on hundreds of genes via histone deacetylation, mostly not oncogenes or tumour suppressor genes, but ‘other’ genes, making the possibility of side effects quite large. Having an effect on ‘hundreds of genes’ is absolutely not a gene-targeted therapy, and it would appear that Burzynski is badly confused.

Of course, if he could publish his data regarding the mechanism of action of PB/antineoplastons in a reputable, reliable journal, maybe his claims would have more credence. The entire experiment could be achieved using now reasonably cheap ‘Gene expression microarrays’ at a cost of just a few thousand pounds – a drop in the ocean in research terms. Again, the fact that he hasn’t published this data, but continues to offer the treatment without any evidence of how it works, is astoundingly poor. At best, he doesn’t know what he is talking about, at worst, he is actively making all of this up.

Burzynski promotional literature has even gone so far to suggest that he is heralding in a new era of ‘gene targeted, personalised cancer therapy’. This is egotistical nonsense and frankly insulting to the scientists like Dr Brian Druker who truly are revolutionaries in the development of gene targeted therapies for cancer such as Imatinib. Burzynski has realised there is a party going on and attempted to gatecrash. Sadly it seems that he doesn’t even know where the party is, and has turned up a number of years late anyway. Its frankly a bit embarrassing from an outsider’s perspective.

If patients wish to try HDACi drugs, they should consider going on clinical trials using new, better HDACi drugs.

PB was discovered decades ago, and although it has been successful in treating a few disorders such as urea cycle diseases, there is little to suggest it is particularly useful in cancer. New generation HDACi drugs are in clinical trials across the US and other countries, which will likely have a higher efficacy (less drug needed for same effect), fewer side effects and may target histones in a different way. Regardless, there is a reason why PB has been largely forgotten about by mainstream medicine (and it’s not because Burzynski owns it, he doesn’t… it is owned by a mainstream pharmaceutical company he has no connection with). It is not as good as other available alternatives and is largely obsolete. Clinicaltrials.gov currently offers 145 open trials for HDACi drugs, almost all in a variety of cancers . In contrast, there is not a single trial listed for PB in any cancer. Uninformed critics may claim this is due to money and drugs companies not profiting from old drugs. This belief can be easily quashed by the observation that there are 28 open clinical trials for another HDACi drug; valproic acid, which has been around for in excess of 30 years (albeit in treatment for epilepsy – its HDACi properties were discovered comparatively recently), hence it is off-patent, exceptionally cheap and drug companies will likely only be able to make minimal profit from it. PB has not passed even phase II clinical trials for most applications, let alone phase III (a milestone which all drugs must normally pass, before being offered widely to the general public - another black mark on the dealings of Burzynski). However there are some phase I clinical trials (such as Gilbert et al, mentioned earlier), which appear not to have been followed up, indicating that the researchers were not pleased enough with the outcome to pursue the drug any further. In contrast newer HDACi Vorinostat is approved for treatment for a type of lymphoma (passed phase III)  and 95 open clinical trials are investigating its use in a range of other cancers.

There is very little evidence that HDACi are useful in cancer when used alone.

There is some preliminary evidence that HDACi in combination with other agents may be useful. For example, HDACi Vorinostat has been proposed to increase sensitivity of tumour cells to radiotherapy. Evidence suggesting that HDACi is useful alone in treatment of cancers, as various patient blogs and Twitter accounts have implied, is severely lacking.

Essentially, flogging a dead horse does not even begin to describe the way that Burzynski is using ‘antineoplastons’. I suspect he knows they don’t work very well either and is just attempting to engorge the Burzynski pension fund as much as possible. Potential Burzynski patients should know that yes, HDACi may have some effects in some tumours, but putting their trust in Burzynski who:

  • Is not an oncologist, but is arrogant enough to presume he can dabble in one of the most complicated medical disciplines with no formal training;
  • Is not a paediatrician, but experiments on children with a drug which has not even passed (or begun) phase III trials;
  • Seems to be happy for patients to believe his treatment is non-toxic when this is simply not the case;
  • Continues to sell antineoplastons as novel agents, when in fact PB is metabolised into the same chemicals;
  • Implies that antineoplastons are gene targeted, when this is clearly not the case at all;

…may be a big mistake.

I understand that a lot of these patients are in truly impossible situations where their cancer is terminal. I would urge them to speak to their oncologists regarding current trials, and even search the Clinicaltrials.gov website themselves, to find properly controlled clinical trials of new drugs, or new combinations of drugs that they may be eligible for. Most of the CML patients who opted in for the first phase III trial with Imatinib are probably still alive to this day, over ten years later. It would be unfair to claim that ‘Imatinib style successes’ happen frequently in clinical trials, as this is not the case, but improvement in outcome, whether it be months more than conventional treatment regimes, years or sometimes as in the case of Imatinib, a ‘cure’, do happen in clinical trials. Even a small chance of achieving a cure, or more time might be an improvement on Burzynski. His absolute reluctance to produce any kind of data and subject it to scrutiny from his peers indicates that Burzynski has no confidence in his outcomes either and this should set alarm bells ringing for any patients considering his treatment.

If patients are particularly interested in pursuing HDACi drug treatment, then I would suggest researching alternatives to Burzynski and be aware that very few bona fide, well respected centres will offer them on their own, due to absolutely no proof that they are ‘curative’ as single agents. The Burzynski treatment is out of date, will probably have worse side effects and as described by many others, the level of care received at the clinic seems simply inadequate for cancer patients trying an experimental treatment. After starting a new treatment in trials, patients should be closely monitored, not sent to nearby hotels and then rushed to other, mainstream hospitals if treatment complications arise - as recommended in Burzynski patient literature and as described in a recent patient blog.

Cancer treatment is complex, can be dangerous for the patient and should be studiously monitored by professionals. Burzynski appears to underestimate many of these critical factors and his patients may be suffering as a result.

Lost Hope

By Ed Cara

There’s something about the death of a child that hits us in a particular way. Maybe it’s the feeling of perversion at seeing death come so early, unnaturally, or our hidden parental instincts kicking in high gear. In the case of 5-year-old Billie Bainbridge‘s untimely death at the hands of an aggressive tumor lodged in her brain last weekend though, there’s another feeling that should pop up from under there, a feeling of anger towards one Dr. Stanislaw Burzynski.

Because Billie’s story isn’t just about the terminal cancer that took less than a year since its diagnosis to take her life, it’s about the antics of Burzynski, a now Texas-based doctor who for over 30 years has peddled his particular brand of cancer treatment, antineoplaston therapy, as an experimental but pioneering cure-all for all sorts of otherwise incurable tumors. Though his supporters allege a smear campaign by the government to suppress his wondercure from the public, Burzynski’s spent the last several decades enrolling countless cancer patients at the end of their rope in so-called clinical trials (since he can’t legally treat anyone with his unproven antineoplastons) that the patients themselves pay for with little to show for it. While he champions his antineoplastons (his coined term for a group of peptides originally derived from the body itself) as a non-toxic solution to all form of cancers, former patients’ testimonials and the ongoing investigation by the Texas medical board have noted the use of off-label chemotherapy drugs during his treatment sessions, a mish-mash of drugs being thrown together without any precaution and at extremely high markups that leave his “patients” with a hole in their pocket anywhere from $100,000 to $200,000.

It was the drive by Billie’s family in the UK to raise funds for a visit to the Burzynski clinic that brought to light many of the unscrupulous actions of Burzynski, but as it turns out, there’s been a myriad of similar fundraising campaigns throughout the years to send children, husbands, brothers and wives to the Texas clinic in pursuit of one final chance to stave off disease and death, many of which have similarly ended just as Billie’s journey did. Not that any of the blame for their wild goose chase should be placed on the shoulders of cancer sufferers and their families; there’s no telling to what extent any of us would go to for the opportunity to save those we love from the grips of an incurable condition, no matter how low the chances, but that doesn’t excuse the actions of a rogue doctor who sells those families fake promise and optimism to turn a buck and generate publicity for his product. Billie’s death and the heartbreaking details of it on her fundraising site are another somber reminder that we still have so far to go in dealing with the complicated and multifaceted disease of cancer. It’s also a reminder that hope can come at a price that no one should be tricked into paying.

With the advent of a lawsuit by a former patient and the aforementioned attempt by Texas to once and for all revoke Burzynski’s medical license, perhaps the uncritical praising of this “pioneer” will finally turn on its head, and Stanislaw’ll be seen for what he really is: A snake oil salesman with a PhD and painted on coat of legitimacy.

UPDATES/EDIT: The former patient of Burzynski’s, Lola Quinlan of Jupiter, Fl, passed away May 17th.

The court case against Burzynski by the Texas medical board was indefinitely delayed again in April. No word as to its next scheduled hearing yet.

Catch Ed and his writings at his twitter, TheImprovateer.

Burzynski: A media scandal

By Josephine Jones

An increasingly unwieldy list of well known serious legal and ethical issues has done nothing to stop the British media reporting on Dr Stanislaw Burzynski in an irresponsibly biased way. Such articles usually appear in the local press, though have also featured on ITV Daybreak, in the Daily Mirror and The Observer. They are always emotive, always full of hope and are presented from the point of view of families wishing to raise funds for ‘life saving‘ or ‘miracle‘ treatment. In doing so  – though of course they don’t see it this way, the media are effectively promoting the Burzynski Clinic.

When concerns are pointed out, heads are stuck deeper into the sand. Editors insist they are simply supporting a desperate family at a difficult time. They may even convince themselves that in mentioning that the treatment is ‘experimental’ or unproven, they are adequately reporting criticism of the clinic.

Critics are often accused of being heartless and sanctimonious. I don’t just refer to unnamed Twitter users, but also to people like the deputy editor and readers’ editor of The Observer, whose exaggerated reporting on critical bloggers left me feeling angry and personally insulted.

The latest newspaper to adopt this cowardly approach is the Reading Post, who have run a series of articles in support of a local family’s fundraising campaign. When I suggested to them that this kind of reporting is irresponsible, biased and misleads readers, I was told:

@_JosephineJones Our readers, and the family, are well aware of the surrounding issues. Faced with awful situation what else can you do?

The family may well be aware of the surrounding issues. I hope they are and that they have come to a properly informed decision. However, the vast majority of Reading Post readers will be totally unaware of the depth of the problem – or indeed the sheer number of problems. I can say this confidently as I know full well that the Reading Post have not reported them. They told me:

@_JosephineJones We have done more than one story. See:http://bit.ly/Jd0JSn especially comments from dad, below.

I assume that was the most balanced article they could find. It is entitled “Amelia’s appeal for a miracle cure”. It describes the treatment as ‘experimental’ and states that antineoplaston therapy aims to “target the cancer without destroying normal cells”. I believe this misleadingly implies that the treatment is new and pioneering and that side-effects are minimal or non-existent. If I didn’t already know such a complaint would be a complete waste of time, I may even consider writing to the PCC. Although later comments (including one from Amelia’s father) address at least some of my concerns, I think it unlikely that the vast majority of the Reading Post’s readership will have seen them.

In challenging the Reading Post on Twitter, I was – predictably – shouted down immediately by @BurzynskiSaves, an anonymous and prolific tweeter and keen follower of the #Burzynski hashtag. Although this person claims not to be employed by the clinic, s/he discusses conversations with current patients:

@_JosephineJones I will share this w you 4 what its worth. I’ve been on the phone w pts who’ve sobbed over ur actions. U know not what u do

@_JosephineJones not according to the cancer patients & their families. I swear if u heard their voices over this u would delete everything.

In fact I have sobbed over my actions myself. Patients and their families have my full sympathy and I’m in no position to criticise their decision to go to the clinic. To be accused of attacking patients gets on my nerves and to upset them breaks my heart. But I’m not the villain here.

Patients and families who decide to use the media to raise money for their cause are putting themselves in the public eye. Newspapers may wish to support such causes, but they also have a duty not to mislead their readership.

Kind-hearted members of the public wishing to support these desperate families ought to know where their money is going. Cancer patients watching well meant but biased media coverage could be persuaded to look into having treatment at the clinic themselves. This is how the media are promoting Burzynski.

I hope that such patients are not under any illusions about what their realistic chances of recovery actually are and that they are made fully aware of the side effects associated with the treatment. I suspect that this is not the case.

Jennifer Keane discusses patient choice and informed consent here, where she concludes that

Patients deserve information, not infomercials.

If you’ve not read the whole post already, I recommend that you do so. It strikes me that those standing up for the clinic (whether they be patients, their families, anonymous Twitter users or journalists) are either not willing or not able to objectively assess dry facts or to recognise what is reliable evidence and what is not. As convincing as they may be, patient testimonials are emphatically not reliable evidence.

Dr Burzynski has been using antineoplastons for over three decades and has still not published any real evidence the treatment is either effective or safe. He has not had a single paper published in a respectable peer reviewed journal. Patient testimonials are all that supporters of the clinic have got. And they continue to use them even after the patients have died.

But some testimonials are less welcome. Wayne and Lisa Merritt set up a blog to share their experience of the clinic and received threatening emails from the infamous pseudo-lawyer Marc Stephens as a result.

Others have gone to the press. Following the death of her husband, Edward,Michele Price spoke to the Houston Chronicle. She said that Dr Burzynski had given them false hope that the treatment was working. He insisted that MRI scans showed the medication was working, even after other doctors had broken the news that Edward’s condition was terminal. The fact that the couple first contacted the clinic after watching a glowing report on CBS television’s ’48 Hours’ is a clear example of how the media promote the clinic.

Others have gone to the courts. I mentioned this to @BurzynskiSaves as part of the Twitter exchange mentioned above. I was invited to

@_JosephineJones show me more than one patient suing Dr #Burzynski

In fact there have been several instances where patients or their bereaved families have taken Dr Burzynski and his companies to court.

The most obvious example is Lola Quinlan, whose case has been fairly well documented. She told a local news source

I’d like to see them shut down.  That’s my hope, that he can’t do this to anybody else

She said she was drawn to the clinic by a video advertisement on their website, and she was hoping the so-called ‘magic bullet’ touted by the clinic would improve her condition.

It was so perfect that I couldn’t even believe it because they weren’t going to do the chemo, they weren’t going to do the radiation, they weren’t going to take anything out

Lola Quinlan is not alone. There is another lady – Robin Reid, a stage IV breast cancer patient, named in court documents alongside Ms Quinlan. According to their First Amended Petition (a public document which may be viewed on the Harris County District Clerk website), Ms Reid was induced by Burzynski’s promises and assurances to undergo radical cancer treatment services in lieu of traditional treatment. She alleges that the treatments were not FDA approved (as Dr Burzynski and his clinic had claimed). She says that the treatments did not work (as they had promised). She did not receive all the treatments she had paid for, nor was she refunded. The phenylbutyrate treatment also caused a huge strain on her liver. An oncologist from outside the Burzynski Clinic later told her she should never have taken phenylbutyrate tablets because of the risk to the liver. Furthermore, representatives of the clinic failed to return numerous calls during a time when she was experiencing excruciating pain.

There are more. For example, Dr Burzynski made a $300,000 settlement with Stanley and Bernice Zabodyn – a couple whose daughter, Kay Wimberley, died of cancer following unsuccessful treatment at his clinic. They believe that the treatment increased her pain and hastened her death.

In addition to these, the current Texas Medical Board case also contains details of two further patients who were alleged to have been treated negligently (Patients A & B) . The case does not make pleasant reading and could even result in the revocation of Dr Burzynski’s licence to practise. Details include failing to discuss details and side effects of the cocktail of apparently randomly prescribed drugs, failing to encourage a patient to complete a course of radiotherapy, failing to discuss the lack of efficacy of treatment (as had been demonstrated by MRI scans) and failing to discuss alternative treatment.

To those accusing me of not caring about patients: I do this because I care. As I’m sure did Michele Price, who recounted the final months of her husbands life, frequently breaking down in tears. She told the Houston Chronicle

Maybe I’ll deter someone else from making a bad decision. And it was a bad decision.

These stories have not been reported by the British media. If their reason for regurgitating the dubious words of Dr Burzynski and his supporters is that they care about patients then where are the articles about Lola Quinlan? When will we read about Robin Reid? Why has there been no mention of Wayne Merritt, Edward Price or Kay Wimberley? What about Patients A and B?

Lazy and cowardly journalism do real harm. It’s time some heads were pulled out of the sand.

By Keir Liddle

One of the oft-repeated claims made by Burzynski supporters is that Antineoplasteon (ANP) therapy is “non-toxic" and not at all like those other chemotherapy agents with their nasty side effects. This seems based solely on a well-worn logical fallacy “ANPs are a therapy derived from “natural” sources so there is no way they could be harmful” and in reality the claim that ANP therapy is non-toxic fails to stand up to scrutiny.

Data, drawn from the clinic’s first annual report issued Jan. 23, 1998, details the first treatment results released by an outside agency on ANPs. They are not favourable on either efficacy or toxicity. The data shows that while marketing materials may describe antineoplastons as “non-toxic substances” this is at odds with the FDA analysis of Burzynski’s data, the data reported by investigators from Memorial Sloan-Kettering, Mayo and NIH (the institutions that conducted the NCI-sponsored trial of the substance) and the information contained in his own research protocols.

Burzynski favours a high dose regimen for ANP therapy (the refusal of independent investigators to give such high doses is one of the reasons he gives for the NCI-sponsored trial collapsing) but on a high dose regimen of ANP a patient is exposed daily to 2.6 times the total amount of sodium normally found in the body.

Side effects from sodium overdose alone are likely to include hypernatremia, edema, and, potentially, seizures. Even a low dose of antineoplastons pumps 41.4 grams of sodium into the same patient’s veins, by comparison, the daily sodium load of phenylacetate or phenylbuterate, two drugs closely related to antineoplastons, is around 8.8 grams. Yet even with a sodium content of about one-seventeenth of high-dose antineoplastons, phenylacetate and phenylbuterate are considered high-sodium drugs.

Patients being given high sodium drugs are generally carefully monitored, advised to go on a low-sodium diet and given diuretics. Burzynski has said his patients are encouraged to drink large amounts of fluid, but sometimes neglect to do so.

"When they stay in Houston, we watch them very carefully, and we monitor fluid in and out very carefully, and we try to convince then that this is important to do, but sometimes they don’t drink as much fluid as they should, and then they may get dehydrated, and they have an elevation of sodium."

FDA officials said that according to Burzynski’s data, 4% of his patients died while on protocol. According to FDA, hypernatremia,  or an excess of sodium in the blood, was present in 65% of patients participating and may have been a factor in the deaths of 1.7% of patients enrolled in the studies in 1997. Independent investigators involved in the NCI-sponsored trial also found ANP treatment to be associated with substantial toxicity finding severe toxicity in three (of nine) patients.

Dr Burzynski maintained, in a telephone interview with the cancer letter, that:

"We Don’t See Any Significant Toxicity"

Dr B. has also stated in interviews with various “natural cancer cure” sites that ANPs are completely non-toxic:

LE: Does the treatment affect normal cells?

Burzynski: No, this is why antineoplastons are a nontoxic treatment. They affect only abnormal cells.”

Though all medications come with side effects these can usually be offset against benefits derived from treatment in drugs that pass through the clinical trial process. Can this be said of ANP therapies?

According to the data drawn from the Burzynski clinic 1997 annual report the answer seems to be probably not.

Of 828 patients who received antineoplastons intravenously, there were 36 patients for whom Burzynski reported responses - 34 who were in FDA-approved studies and two among the group of patients who received antineoplaston by special exception because there was no conventional treatment available for them. The overall response rate, as reported by Burzynski, was just 4.3%. Eleven of the 36 patients who “responded” to treatment subsequently died and death was reported for 64 percent of all protocol patients and 61 percent of special exception patients. Forty-five percent of patients withdrew from the study at their own request and 36 percent withdrew because their tumors grew or their condition got worse while they were treated.

It is worth noting that there are questions over whether we can trust, even these unimpressive, numbers from Burzynski due to his lax research practices and I shall cover these in a future post.

But in terms of ANP it seems worth reminding supporters of Doctor B that, no matter what the substance, the difference between a cure and a poison is how large the dose is.

Burzynski and Patient Choice

By Jennifer Keane

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.

 Also appears on “And Another Thing…”