The Secret of Burzynskis “success”?

By Keir Liddle

Dr Burzynskis Antineoplasteon (ANP) therapy has a tragically impressive list of failures but he appears to have a few success stories (even after you account for those who didn’t actually survive). But do these prove the effectiveness of ANPs as a treatment for cancer or is there perhaps something else that could explain the lucky few who his treatment appears to help?

The Burzynski clinic provides information for new patientsabout what treatment involves and what drugs patients will be taking alongside ANP treatment. This document explains how ANPs Atengenal (A10) and Astugenal (AS2-1) are to be delivered via an infusion pump. It details how ANP should be stored and shipped, they should be at a controlled temperature within the storage range (15-30 degrees Celsius or 59-86 degrees Fahrenheit) and tells the patients nurses will demonstrate the process the patients should use themselves for dressing changes, flushing, disconnecting, and reconnecting and medication administration via Hickman line.

Among other details the information provided to patients also details the other kinds of drugs they may also be prescribed alongside their course of ANP: anticonvulsants and steroids. Which are fairly standard types of drug to prescribe someone with a brain tumour, alongside treatment, as they aid recovery and assist with common side effects.

Anticonvulsants and steroids are routinely prescribed to combat the side effects of brain tumours including intercranial swelling fluid leaking into surrounding brain areas causing edema (pressure that disrupts the function of surrounding brain regions). These drugs are used to deal with side effects as diverse as grand mal seizures, language difficulties and other cognitive impairments.

However certain steroids used in cancer patients can have another surprising result, one that has implications when attempting to determine if Dr Burzynskis patients response on Magnetic Resonance Imaging (MRI) scans.

Dexamethasone, a steroid commonly used to combat the symptoms of tumour growth and brain swelling, is the steroid listed in Burzynskis patient information as being administered alongside ANP. Dexamethasone has become the steroid of choice in brain oedema due to its minimal salt retention and its relative potency when compared with other steroids.

A number of studies have revealed that prescription of dexamethasone has interesting implications when it comes to determining tumour progression or remission using MRI scans. As it can make it appear as if tumours are shrinking, or indeed vanishing, when they are not.

In a case reported in the Journal of Neurology, Neurosurgery and Psychiatry in 1997 a 56 year old man was treated for a left frontoparietal mass with oedema (brain tumour with swelling) with  2 mg dexamethasone three times daily. This treatment resulted in a resolution of his symptoms and after the patients brain was scanned and the oedema and the tumour had apparently disappeared (even with the use of contrast enhancement) the patient was sent home. The patient was scheduled for a biopsy three weeks later and was readmitted and rescanned. Having been removed from steroid treatment the tumour was again visible on the scan and massive brain swelling has occurred. The histology of the tumour showed it was a glioblastoma multiforme. He was admitted to intensive care and tragically he died within a few hours.

The doctors concluded that:

"You cannot be sure what the lesion is unless you have tissue for histology. It also shows that steroids can reduce the peritumorous oedema and apparent tumour size so that the tumour effectively disappears on the scans."

A similar case is reported in the Journal of Clinical Neuroscience where a 59-year-old man presented with a history of headache and confusion. A CT scan of the brain showed a tumour on the left parietal lobe adjacent to the posterior horn of the lateral ventricle. Again the patient received dexamethasone (16 mg/day), again the enhancing lesion seen on CT scan faded following dexamethasone therapy and again teh subsequent biopsy revealed the tumour to be a glioblastoma multiforme. The study authors note that:

"Various intrinsic cerebral lesions have been noted to disappear on CT imaging after the administration of corticosteriods,1 but it is less common for a glioma to do so.”

They further conclude that:

"This report reiterates the potential pitfall of presumptive diagnosis and highlights the importance of MRI guided biopsy in patients where a tumor fades on CT imaging after corticosteroid therapy. We also highlight the need to clarify the actions of corticosteroids on specific tumor types."

Again highlighting that one cannot rely on MRI scans as reliable proof of remission in cases of brain cancer other factors, such as the impact of steroid treatment, may make these scans less than fully reliable.

A paper published as recently as July of this year further highlights the diagnostic dilemma faced by physicians and oncologists in interpreting MRI results where the steroids that are prescribed may give rise to a situation where an MRI gives the false impression that a patients tumour is shrinking or has even vanished when it hasn’t.

Could Burzynskis much touted MRI scans showing dramatic improvement in tumour size, and indeed vanishing tumours, be simply down to the effects of Dexamethasone or could he have stumbled upon dexamethasone as an as of yet undiscovered effective treatment for brain stem cancers?

Research published in the Journal of Clinical Neuroscience throws cold water on the second interpretation as the authors undertook a search of the literature and found:

"only three other similar cases of rapidly vanishing glioblastomas after steroid treatment [4] and [5] (Table 1). All three cases were histologically proven glioblastoma multiforme and were given high doses of dexamethasone over a few weeks. Serial imaging performed within a few weeks of commencement of steroids showed a significant degree of resolution of the tumor

From the review, the daily dexamethasone dose ranged from 6 mg to 16 mg per day. The recurrence of the tumor typically was very aggressive and occurred within 1–4 weeks from the time of disappearance.

The glioblastomas that vanish rapidly are frequently multicentric with a predilection for the corpus callosum and are associated with rapid clinical deterioration and demise of the patient.”

The authors conclude that despite indications from MRI scans the prognosis of patients on high dose Dexamethasone remains poor and deterioration is often rapid.

It seems tragically plausible that Dr Burzynskis reported success and tumour reductions are nothing more miraculous than the clinically understood and scientifically reported side effects of steroid treatment. This might explain why so many family and patient blogs happily report successful treatment before going on to report rapid and unexpected deterioration.

Whether Dr Burzynski is aware of the effects and implications of prescribing high dose dexamethasone in determining tumour progression remains unknown. If he is unaware this implies nothing more than incompetence on his part but if he is aware it implies something much more sinister: that he is perhaps knowingly misleading his patients.

Whatever the truth of the matter it will remain unknown until the day Dr Burzynski decides to properly record and publish his results and submit them to the scrutiny of medical science.

Though given he has steadfastly avoided doing so for over 35 years I wouldn’t advise anyone hold their breath.

The Secret of Burzynskis “success”?

By Keir Liddle

Dr Burzynskis Antineoplasteon (ANP) therapy has a tragically impressive list of failures but he appears to have a few success stories (even after you account for those who didn’t actually survive). But do these prove the effectiveness of ANPs as a treatment for cancer or is there perhaps something else that could explain the lucky few who his treatment appears to help?

The Burzynski clinic provides information for new patientsabout what treatment involves and what drugs patients will be taking alongside ANP treatment. This document explains how ANPs Atengenal (A10) and Astugenal (AS2-1) are to be delivered via an infusion pump. It details how ANP should be stored and shipped, they should be at a controlled temperature within the storage range (15-30 degrees Celsius or 59-86 degrees Fahrenheit) and tells the patients nurses will demonstrate the process the patients should use themselves for dressing changes, flushing, disconnecting, and reconnecting and medication administration via Hickman line.

Among other details the information provided to patients also details the other kinds of drugs they may also be prescribed alongside their course of ANP: anticonvulsants and steroids. Which are fairly standard types of drug to prescribe someone with a brain tumour, alongside treatment, as they aid recovery and assist with common side effects.

Anticonvulsants and steroids are routinely prescribed to combat the side effects of brain tumours including intercranial swelling fluid leaking into surrounding brain areas causing edema (pressure that disrupts the function of surrounding brain regions). These drugs are used to deal with side effects as diverse as grand mal seizures, language difficulties and other cognitive impairments.

However certain steroids used in cancer patients can have another surprising result, one that has implications when attempting to determine if Dr Burzynskis patients response on Magnetic Resonance Imaging (MRI) scans.

Dexamethasone, a steroid commonly used to combat the symptoms of tumour growth and brain swelling, is the steroid listed in Burzynskis patient information as being administered alongside ANP. Dexamethasone has become the steroid of choice in brain oedema due to its minimal salt retention and its relative potency when compared with other steroids.

A number of studies have revealed that prescription of dexamethasone has interesting implications when it comes to determining tumour progression or remission using MRI scans. As it can make it appear as if tumours are shrinking, or indeed vanishing, when they are not.

In a case reported in the Journal of Neurology, Neurosurgery and Psychiatry in 1997 a 56 year old man was treated for a left frontoparietal mass with oedema (brain tumour with swelling) with  2 mg dexamethasone three times daily. This treatment resulted in a resolution of his symptoms and after the patients brain was scanned and the oedema and the tumour had apparently disappeared (even with the use of contrast enhancement) the patient was sent home. The patient was scheduled for a biopsy three weeks later and was readmitted and rescanned. Having been removed from steroid treatment the tumour was again visible on the scan and massive brain swelling has occurred. The histology of the tumour showed it was a glioblastoma multiforme. He was admitted to intensive care and tragically he died within a few hours.

The doctors concluded that:

"You cannot be sure what the lesion is unless you have tissue for histology. It also shows that steroids can reduce the peritumorous oedema and apparent tumour size so that the tumour effectively disappears on the scans."

A similar case is reported in the Journal of Clinical Neuroscience where a 59-year-old man presented with a history of headache and confusion. A CT scan of the brain showed a tumour on the left parietal lobe adjacent to the posterior horn of the lateral ventricle. Again the patient received dexamethasone (16 mg/day), again the enhancing lesion seen on CT scan faded following dexamethasone therapy and again teh subsequent biopsy revealed the tumour to be a glioblastoma multiforme. The study authors note that:

"Various intrinsic cerebral lesions have been noted to disappear on CT imaging after the administration of corticosteriods,1 but it is less common for a glioma to do so.”

They further conclude that:

"This report reiterates the potential pitfall of presumptive diagnosis and highlights the importance of MRI guided biopsy in patients where a tumor fades on CT imaging after corticosteroid therapy. We also highlight the need to clarify the actions of corticosteroids on specific tumor types."

Again highlighting that one cannot rely on MRI scans as reliable proof of remission in cases of brain cancer other factors, such as the impact of steroid treatment, may make these scans less than fully reliable.

A paper published as recently as July of this year further highlights the diagnostic dilemma faced by physicians and oncologists in interpreting MRI results where the steroids that are prescribed may give rise to a situation where an MRI gives the false impression that a patients tumour is shrinking or has even vanished when it hasn’t.

Could Burzynskis much touted MRI scans showing dramatic improvement in tumour size, and indeed vanishing tumours, be simply down to the effects of Dexamethasone or could he have stumbled upon dexamethasone as an as of yet undiscovered effective treatment for brain stem cancers?

Research published in the Journal of Clinical Neuroscience throws cold water on the second interpretation as the authors undertook a search of the literature and found:

"only three other similar cases of rapidly vanishing glioblastomas after steroid treatment [4] and [5] (Table 1). All three cases were histologically proven glioblastoma multiforme and were given high doses of dexamethasone over a few weeks. Serial imaging performed within a few weeks of commencement of steroids showed a significant degree of resolution of the tumor

From the review, the daily dexamethasone dose ranged from 6 mg to 16 mg per day. The recurrence of the tumor typically was very aggressive and occurred within 1–4 weeks from the time of disappearance.

The glioblastomas that vanish rapidly are frequently multicentric with a predilection for the corpus callosum and are associated with rapid clinical deterioration and demise of the patient.”

The authors conclude that despite indications from MRI scans the prognosis of patients on high dose Dexamethasone remains poor and deterioration is often rapid.

It seems tragically plausible that Dr Burzynskis reported success and tumour reductions are nothing more miraculous than the clinically understood and scientifically reported side effects of steroid treatment. This might explain why so many family and patient blogs happily report successful treatment before going on to report rapid and unexpected deterioration.

Whether Dr Burzynski is aware of the effects and implications of prescribing high dose dexamethasone in determining tumour progression remains unknown. If he is unaware this implies nothing more than incompetence on his part but if he is aware it implies something much more sinister: that he is perhaps knowingly misleading his patients.

Whatever the truth of the matter it will remain unknown until the day Dr Burzynski decides to properly record and publish his results and submit them to the scrutiny of medical science.

Though given he has steadfastly avoided doing so for over 35 years I wouldn’t advise anyone hold their breath.

Are pharmacists just shopkeepers?

By Edzard Ernst

We tend to trust pharmacists and are likely to assume that, if they sell this or that product, it must work. This attitude is, however, somewhat naïve and not necessarily correct. Alongside powerful drugs, most pharmacists also sell pure placebos masquerading as medicine – take, for instance, homeopathic preparations or Bach Flower remedies.

Most homeopathic remedies are so highly diluted that they contain not a single molecule of the ingredient printed on the label; in order to contain a single molecule of the declared substance, a “C30” pill [the dilution frequently sold by Boots] would need to have a diameter similar to the distance between the sun and the earth. This makes homeopathy very hard to swallow! About 200 clinical trials are available which tested whether homeopathic remedies have clinical effects beyond placebo. Collectively these data fail to provide good evidence in favour of homeopathy http://www.ncbi.nlm.nih.gov/pubmed/12492603.

Similarly, Bach Flower remedies have no basis in science. Like homeopathic preparations, they contain no active ingredients and, crucially, the clinical evidence is squarely negative http://www.ncbi.nlm.nih.gov/pubmed/20734279. In other words, they are pure and expensive placebos.

Why then are such remedies sold in virtually every pharmacy in the UK and abroad? Are pharmacists content to be shopkeepers, mainly out to make a profit, or are they healthcare professionals who adhere to certain ethical standards? Comments by a spokesman of the leading UK pharmacy chain, Boots, such as “we aim to offer the products we know our customers want”, seem to indicate that, regrettably, the former interests have won the upper hand [Bennett P.Are pharmacists shopkeepers out to make a profit? Pharm J 2010; 22]

But how can this be? Do pharmacists not have codes of ethics to which they are duty-bound? Yes, they do; in fact, even though they vary from country to country, these codes leave little room for manoeuvre instructing pharmacists in no uncertain terms to provide all the relevant information about the products they sell, to tell the truth as well as to act professionally and conscientiously. And such clear orders do not just apply to the sale of conventional drugs. When selling homeopathic or other alternative remedies, a pharmacist’s role is fundamentally the same.

Considering these facts, what choices do pharmacists have, if they elect to - or, if they are employed in chain pharmacies, have to - sell homeopathic or other disproven treatments? They could, of course, inform their customers honestly that these remedies are nothing more than placebos. This would probably deter all but a few from the purchase which hardly seems in the interest of the pharmacists or their employer. Alternatively, pharmacists might keep quiet about the evidence thinking “if the client wants it, she should have it”. This stance is prevalent today but, as it fails to provide the relevant information about the product in question, it clearly violates the pharmacists’ very own ethical code and standards. The only other option would be to stop selling disproven treatments altogether. It is not hard to imagine that this possibility might be unattractive; for some pharmacists, it would just mean earning less money, however, to the many UK pharmacists who are employed by large co-operations, such as Boots, it would mean taking a stand against co-operate policy and perhaps even losing their job in the course of doing so.

What is the solution to this conundrum? I do not pretend to know it, but I feel that pharmacists ought to find it sooner rather than later. As this profession is hoping to take on more responsibility in clinical care, their attitude towards selling disproven remedies should be clarified. Are they shopkeepers or healthcare professionals? Are corporate interests more important than professional ethics? These are not merely questions of professionalism, ethics and honesty but, more importantly, they are questions of patient welfare and public health.

Skeptic News: Alternative therapy kills

20120630-180351.jpgIn Perth, Australia, an alternative treatment offered for cancer has killed four patients.

Deputy State Coroner Evelyn Vicker investigated the deaths of Sandra McCarty, Pia Bosso, Sandra Kokalis, Deborah Gruber, and Carmelo Vinciullo. Four cancer patient whoall undertook an alternative cancer therapy at Kathi Preston Memorial Health Centre – which operated a “clinic” out of a Dr Boyd’s home in 2005.

The treatment, invented by Austrian doctor Hellfried Sartori involved an IV High pH Cancer Therapy, using a range of substances including caesium, the industrial solvent DMSO, and laetrile – all of which are potentially toxic.

Sartori hid his criminal record in order to practice in Australia after losing his medical license in several US states for previous involvement in AIDS and cancer cure scams.

Sartori told the inquest he believed that it was treatment the patients received under proper medical supervision that killed them.

Sartori has failed to save at least 24 patients in Australia alone and may faces charges.

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.

Skeptic News: Powered Baby Flesh Seized by South Korean Officials

By Lee Christie

A large number of capsules hidden in other medicine boxes has been seized by customs officials as they were being smuggled from China to South Korea. The pill contained powdered flesh from dead babies and foetuses. Over 17,000 capsules have reportedly been seized since August of last year.

The pills are, shockingly, considered by some alternative-medicine practitioners as a miracle “cure-all”. The bacteria in these capsules pose a significant health risk, and are far more likely to do harm than good. A customs official was quoted in The Korean Times stating:

"It was confirmed those capsules contain materials harmful to the human body, such as super bacteria. We need to take tougher measures to protect public health."

Deng Haihua, a Chinese ministry spokesman told China Daily:

"[China has] strict management of disposal of infant and foetal remains as well as placentas.”

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.

Chiropractic: a treatment for neck pain or a pain in the neck?

By Edzard Ernst

Chiropractic has not often been out of the news in recent months – bad news, that it! It started with the weird decision of the British Chiropractic Association to sue my friend and co-author (TRICK OR TREATMENT) Simon Singh. They not only lost the case but also money and reputation. What followed was dramatic: over 700 chiropractors were investigated by the General Chiropractic Council for making bogus claims.

As a result of all of this, most chiropractors do no longer advertise their services for non-spinal conditions, at least not openly. The more sensible amongst their ranks realise that neck and back-pain is their domain. The trouble is, however, that for neck pain in particular, the evidence is not that convincing either. Therefore a new trial was greeted with loud applause.

Within hours of the publication of this new US study1, the world of chiropractic celebrated it as a vindication of chiropractic spinal manipulation. Its aim was to “to determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term”. Because neck pain is such a common problem which is often difficult to treat, this study did indeed seem important.

The researchers recruited 272 patients suffering from nonspecific neck pain since 2 to 12 weeks, subsequently they treated them for 12 weeks with either SMT, medication, or HEA. The primary outcome was pain which was measured at 2, 4, 8, 12, 26, and 52 weeks. The results suggested that SMT had a significant advantage over medication after 8, 12, 26, and 52 weeks, and HEA was superior to medication at 26 weeks. No clinically important differences were found between SMT and HEA at any time. The authors concluded that, “for participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points”.

At first glance, this seems to be a rigorous piece of research. At closer scrutiny, however, the flaws of this study become fairly obvious. Here are the ones that strike me as particularly important. The medication group was treated in a different setting than the other two groups. The drugs administered were not clearly defined, and no information was provided about the dosage or the length of the drug therapy. Six patients of the medication group received no treatment at all. Thus any comparisons between patients receiving medication and the other two groups are problematic, to say the least.

Similar problems exist regarding the comparison between the SMT and the exercise group. There was no adequate control for non-specific effects. It is obvious that the therapeutic encounter and “tender loving care” (TLC) can be beneficial for patients who suffer from neck pain. The SMT group enjoyed an average of 15 hands-on sessions of TLC while the exercise group had just 2 sessions of instructions. For this reason alone, the comparison between these two groups tells us next to nothing about the specific effects of chiropractic SMT.

I therefore fear that this study merely shows that TLC and non-specific effects can strongly influence symptoms such as pain. If we consider the high costs of regular SMT versus the negligible expense of HEA, the latter would probably turn out to be preferable. If we finally factor in the potential for harm, the balance decidedly tilts towards HEA. Exercise is virtually risk-free, whereas SMT results in transient adverse effects in about 50% of all patients2; in addition, it is associated with several hundred severe complications including deaths3.

My conclusion is simple: Chiropractic, or more accurately, the uncritical promotion of this approach, can therefore be a pain in the neck.

Reference List

  (1)   Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH. Spinal manipulation, medication or home exercise with advice for acute and subacute neck pain. A randomised trial. Ann Intern Med 2012; 156:1-10.

(2)   Stevinson C, Ernst E. Risks associated with spinal manipulation. Am J Med 2002; 112:566-570.

(3)   Ernst E. Deaths after chiropractic: a review of published cases. Int J Clin Pract 2010; 64(8):1162-1165.

The problem with homeopathy for babies

By Matt Kaiser

I never thought I’d end up writing about homeopathy for babies, but some things just take you by surprise.

For those that are unaware, a homeopathic preparation starts by taking a substance, usually one that would cause an ailment, and dilute it down to such a degree that none of the original substance remains. The belief is that water retains a ‘memory’ of the agent, which can then be used to treat the ailment. The more diluted the preparation, the more effective the supposed remedy is. To give an idea of the level of dilution of most standard homeopathic preparations, the Merseyside Skeptics made ‘homeopathic vodka’ and tested it on a few willing volunteers.

The arguments against homeopathy have been made effectively elsewhere, so I won’t re-tread those well-articulated paths too heavily, but will sum it up briefly. To support homeopathy, proponents usually 'cherry-pick' flimsy, uncorroborated evidence to try and prove efficacy, suggest that a placebo effect is still a positive effect (and so what’s the problem?), or simply argue that everyone has an unhindered choice to decide what treatments they use. The primary problem for me (for it’s a problem among many) is that patients replace or delay conventional treatment in favour of alternative treatment, often at a serious detriment to their health. This is exacerbated by the decision to make homeopathic treatments available on the NHS - justified by the Government with the patient choice argument - and by major pharmacies that lends legitimacy to the practice in many people’s minds. The Science and Technology Committee, however, conclude unequivocally that it’s not valid.

So what’s this got to do with babies?

Well, we’re fairly sure that my little boy’s teething at the moment. This can be a pretty painful process and we would, of course, like to reduce his discomfort as much as possible. So it was with this in mind that my wife bought some teething granules, on the recommendation of some her friends who swore by this particular brand.

Now imagine my surprise when I whipped out the box, in anticipation of riding to my son’s rescue and alleviate his pain, only to discover that these were homeopathic teething granules. First, the surprise that these even exist; and second, the puzzlement that my wife, knowing my somewhat sceptical nature towards ‘alternative’ medicine, had actually bought them for our son. On the second point, she assured me that she didn’t realise they were homeopathic - this fact is revealed only on the back of the packet - and that she was going only on the testimonials of her friends (common ‘evidence’ homeopaths produce). So I’ll give her the benefit of the doubt on that score.

But the first point, that homeopathic pain relief exists for babies, has been troubling me since. The preparation is a 6C dilution of ‘Chamomilla’ (or chamomile). This means that it has been diluted 10-12, or to 0.000000000001 of the original substance. In the ‘homeopathic vodka’ preparation, this would have been reached by the 6th cup of water. So a pretty extreme dilution. Leaving aside the homeopathic tenet that the diluted agent should cause the symptoms of the ailment ('like with like' theory) and, as far as I know, chamomile doesn’t cause teething-like pain, there’s scant evidence I could find of this substance’s pain relief qualities (as advertised) nor of its often assumed general calming properties (also this). Nevertheless, at a 10-12 dilution, it seems extraordinary that there would be enough active molecules to have any effect, and we know that water cannot retain a ‘memory’ of a solute.

As soon I saw that this was a homeopathic treatment, I convinced my wife that we needed to buy a proper teething pain relief. We bought some teething gel, with some well-tested analgesic and antiseptic compounds in it to treat the gums directly, as well as some general pain relieving medicines. And this, to me, demonstrates the crux of the issue: if we’d persisted with the homeopathic treatment, then we would have delayed using the more reliable teething gel and could have caused our son a few nights of needlessly heightened pain.

My wife, bearing in mind the gushing anecdotes about the efficacy of this treatment, suggested we could use them alongside the proven analgesics, thereby nullifying my argument about delaying proper treatment. There’s no harm in it and if the homeopathic granules did work, then that’d be a bonus! After all, our first priority is to provide some respite for our child.

But this still made me uncomfortable for a number of reasons. First, as a subscriber to evidence-based decision-making, I was fundamentally uncomfortable with adding credence to this type of healthcare. I did not want to be part of the community that perpetuates this approach - the pain may have been alleviated independently of the homeopathic treatment but our friends could still have given us a ‘told-you-so’ nod.

In a wider context, I believe it to be utterly wrong that companies sell and profit from pseudoscientific approaches, given the concerns with these remedies outlined here and elsewhere. Any backing we gave it, either by buying more or telling our friends to give it a go, would fuel this industry and lend weight to its wide availability in pharmacies and through publicly funded health services. It would have cost us more money too, and this additional financial burden may force others to choose between effective and ineffective remedies - something that could be avoided by only making effective treatments available.

Lastly, all of the previous points relate to giving legitimacy to an unfounded treatment for teething pain, but homeopaths and their supporters often make erroneous generalisations about the efficacy of homeopathy. Proponents use their selected ‘evidence’ for homeopathic treatment of one condition to argue, ‘hey, homeopathy works!’, and so seamlessly advocate all manner of dilutions to treat every ailment going. This is as ludicrous as suggesting that just because one drug can successfully treat one type of viral infection, ‘hey, drugs work!’, and so we can use all manner of drugs for all types of infections, without showing individual therapies work.

This last point is particularly dangerous when it comes to treating extremely serious and potentially fatal diseases, such as malaria, HIV/AIDS and cancer. Any credibility people see in homeopathic treatment for one disorder may spill over to influence their decision in treating another disorder, with potentially dire consequences.

I may be getting ahead of myself, but I think I’ll get off this bandwagon while I can.

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This post is a re-working of a version originally posted at The Skeptical Dad.