Burzynski – it’s all over now, surely?

A strange situation exists in America that is exploited by several top Cancer Hospitals: Take MD Anderson and Virotherapy or The Preston Robert Tisch Cancer Centre at Duke and Dendritic cell therapy. Both these treatments have some clinical evidence behind them to show there is potential. But, truthfully, that’s about all. So, when all other treatments fail, a phase III clinical trial is set up to give these therapies a whirl. And in some cases they have met with great success. Importantly, the ‘trial’ is well documented, even when people die.

The same ‘methodology and logic’ has been exploited by controversial Doctor Stanislaw Burzynski. The FDA gave some credibility to antineoplastons (complex peptides and peptide mixtures that seemed to be missing in cancer patients) and after nearly 20 years of fighting between the FDA and/or The Texas Medical Board and Burzynski, a lull in the storm saw Burzynski reach for the phase III clinical trial gambit, and continue to treat cancer patients at his clinic. The background to all this can be found here.)

But. Following a Panorama Programme where Burzynski refused to provide results to date saying the FDA forbade it, and the FDA saying he could provide data, I wrote several times to the Burzynski Clinic for clarification. Like Panorama, I received no satisfactory response.

Worse was then uncovered – An analysis of work to date seems to show that with several dozen phase II clinical trials started, he never published a completed phase II trial, although there have been a couple of preliminary reports.

A step change occurred in 2012, with an apparent treatment-related death of a child and this led the FDA to issue a partial clinical hold on the Burzynski Clinic, preventing him enrolling any new children on his clinical trials, although he could keep treating existing patients and enroll new adult patients.

This ‘hold’ was later extended to new adults when the FDA arrived to investigate the clinic. The result of the investigations? More bad news for Burzynski when he received a warning letter from the FDA. That warning covered issues such deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that the clinic falls in line with regulations designed to protect human subjects during ‘research’ (for example, by maintaining adequate documentation covering the functions and operations of the IRB.

This, to some, may just seem like a lack of red tape provisions. But these are supposed to be randomized clinical trials of human beings and the Burzynski clinic needs to be as meticulous as any drugs company, perhaps more so given previous controversies. What seems to have been happening is that the Burzynski has been using what are ‘expedited reviews’. However, taking single patient protocols for an investigational drug that is not FDA-approved does not fall into any of the categories for which expedited review is appropriate, particularly when so many of the patients involved are children.

But the question still remains – Let’s see the results.

And not just the positive ones; what about side-effects like hypernatremia? Again the FDA have presented two new reports and these include statements such as ‘Failure to monitor the progress of an investigation’ and ‘an investigation was not conducted in accordance with the signed statement of investigator and investigational plan’ and ‘failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation’.

All I can conclude from this is that we are very unlikely to get proper clinical trial data at all.

But it gets worse. The FDA noted that
1. ‘You did not have a QA monitor properly monitor CRFs [case report forms] and subject records’
2. ‘The investigator destroyed critical subject case history records (target tumor measurement worksheets) or misplaced case history records (original subject CRFs) for all subjects’
3. ‘Your MRI tumor measurements initially recorded at baseline and on-treatment MRI studies for all study subjects were destroyed and are not available for FDA inspectional review’
4. ‘You failed to monitor as required by Section 16 of your Monitoring Plan. The investigator did not report adverse events (AEs) experienced by study subjects, including 18 cases of hypernatremia’, and (worse still)
5. ‘You failed to protect the rights, safety, and welfare of subjects under your care – Forty-eight (48) subjects experienced 102 investigational overdoses between January 1, 2005 and February 22, 2013, according to the Weekly List of Hospitalizations/SAE [REDACTED] Overdose [redacted]/Catheter Infection report. There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects’.

We last amended the write up in CANCERactive on Antineoplastons and The Burzynski Clinic after the Panorama report. At that time we asked ‘Where are the results?’ We shall shortly be revising it all again.

At CANCERactive we do not believe it correct to ignore ‘alternative’ cancer treatments. We try to explain what they are and what they are supposed to do, with research when it exists, but pointing out clearly if none exists. But the fact is the NCI has a review on its website about antineoplastons and the review seems positive. Wikipedia, even today, is surprisingly balanced. So, we will continue to tell patients what this is supposedly all about, but we will now answer our own question: Where are the results? And the answer is ‘Nowhere’.

People touched by cancer who contemplate spending large amounts of money to go to the Burzynski Clinic need to be absolutely clear on this latest information and factor it in to their decision making process.

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Skeptic conspiracy – it’s no theory

When Professor David Colquhoun erroneously suggested in his 2012 blog that Chris Woollams was using the charity CANCERactive for ‘Private Gain’, it precipitated a chain of events that could be followed easily by anyone with a twitter account. Ironically, it has exposed the skeptic community. Some are shills, stooges, with interests in ‘action groups’ funded by big Pharma, while others are clearly using their anti-CAM websites as money making ventures, capturing personal data from innocent visitors – those coming through the attacks on Woollams, almost certainly with cancer. It’s a sorry, sad mess and only the genuine patient suffers. It begs the question ‘Dare any sensible person visit any of their websites’? To do so is to read a biased, sometimes absurd, inaccurate and even defamatory report at best, whilst potentially exposing your personal data and identity far more than you could ever imagine. The worst case scenario is that your data could even be sold on to third parties.

The claim by Colquhoun was clearly not an issue about science – Woollams took it as personal defamation. Some might call it a lie. Chris didn’t run the charity, he gives his many hours for free, the related ‘business’ he was claimed to be running was no such thing but a dormant company that had never even traded and used to park a trading company whilst a buyer was found. All this would have been scrutinised by Colquhoun’s expert lawyers. Worse for Colquhoun, the accountants for all the relevant companies provided evidence that Woollams took no funding from anywhere. Colquhoun’s lawyers told him to take his claims down – he then made a formal apology to Woollams, even at one point tweeting that the ‘research’ on which he had based his claims was flawed and he wanted to move on.

Most rational people would think that should be the end of the matter.

Selektive attacks?

But Colquhoun is a Skeptic, one of a gang of Skeptics totally focussed on rubbishing complementary therapies and their messengers. Colquhoun also has ‘form’. In the past he has called Patrick Holford, ‘Holfraud’ (more lawyer involvement) but more usually he likes to pick on little people; Dr Alan Lakin and his wife were another example of his ill considered claims. They just wrote to the Provost of UCL where Colquhoun is employed. Their complaint resulted in a formal joint statement with UCL saying that Colquhoun could carry on using the UCL website providing he stuck to being sceptical about science and didn’t attack individuals. Some while later, he was kicked off the UCL server. Attacks on individuals have never stopped.

It is a common theory that Skeptics are funded by Big Pharma. There is, of course, little evidence of payments to individuals. Only recently the attacks on What Doctors Don’t Tell You again focussed attention on Sense about Science, a Pharma-funded skeptic organization in the United Kingdom. At least 40 per cent of their funding in the years 2004-10 came from Big Pharma, according to detailed analysis by a consumer group, H:MC21. This amount increased when attacks were strengthened against homeopathy.

The orchestration of misleading and inaccurate disinformation

When Colquhoun was threatened with legal action by Woollams, the tweets flew. Twitter is a medium much used by Skeptics and trolls alike and it has been described as an ‘Echo chamber’ because it is often used by people who want to verbally pat each other on the back. It is not unusual for some people to send hundreds of tweets a day. The tweets are public.

Colquhoun was on record tweeting Simon Singh. Singh is a mathematician, writer, journalist and has been a leading light in Sense about Science. He had a squabble with some Chiropractors and ended up in the High Court where a judge correctly ruled the High Court was no place for a scientific argument and slung the combatants out. The Skeptics consider this a ‘win’ because he didn’t have to pay a hefty damages bill to the chiropractors. What they don’t want is a ‘loss’ and Colquhoun at this point must have looked rather a liability.

Singh then tweeted openly to the Skeptics and received responses from several, for example Josephine Jones and Lecanardnoir. An interesting tweet came from Alan Henness, a colleague of Singh’s and a ‘pal’ from Sense about Science, who tweeted ‘Poor Chris Woollams’, as plans for attack were drawn up. Henness, who has an IT background, runs the Nightingale Collaboration, an ‘organisation’ that attacks complementary therapists throughout Britain if he feels they make inaccurate claims. It is probably irrelevant to Henness that Florence Nightingale used complementary therapies, natural sunshine, herbs and homeopathy to treat patients. Instead, he and his cronies try to suppress complementary therapists with threats about reporting them to the Advertising Standards Authority and Trading Standards. Many supporters who meet in pubs are probably blissfully unaware of their new-found Pharmaceutical company connections.

Josephine Jones
is also a prodigious production line for complaints, but has already been politely told by the ASA to ‘limit’ her energies. ‘Josephine Jones’ is a figment of someone’s imagination – a nom de guerre. Jones is made out to be a ‘former scientist’. So ‘she’ could be a ‘he’ and could be Claire from Liverpool or Edward from California with a diploma in ‘computer sciences’ and IT like most of the key skeptics; ‘She’ could even be a Pharmaceutical company shill, we have no way of knowing. ‘Her’ writings have been inaccurate, misleading and even downright dangerous as we all saw in ‘her’ ridiculous critique of Woollams book and ‘her’ frightening ignorance over glucose. ‘She’ appears to have no serious credentials in medicine or the biological sciences.

With Lecanardnoir, and Guy Chapman it is simpler. They have definitely have none. Of course, that doesn’t stop them pontificating on the perils of homeopathy and other complementary therapies.

With many of the skeptic gang, there may well be inaccuracy or exaggerated claims, and even defamation and the occasional lie.

Sometimes their comment is absolutely factually wrong, for example: http://www.homeopathyheals.me.uk/site/skeptic-watch/3198-guy-chapman-waxes-lyrical-about-hahnemanns-aphorisms-and-gets-it-wrong. The title says it all.

Lecanardnoir turned up to a debate in Dartington where he was on a panel of commentators about ‘Integrative’ approaches to medicine. (http://www.canceractive.com/cancer-active-page-link.aspx?n=3232&Title=Does%20Integrated%20Medicine%20make%20sense?) Who invited him when there are genuine experts all over Britain, goodness knows. According to another panellist, he had to be repeatedly corrected for his inaccuracies by Simon Mills, a Cambridge graduate and founder of the School of Complementary Medicine at Exeter University, Penninsular. But then, poor love, lecanardnoir is really Andy Lewis who works in computing. Not that this stops him from running a blog which features a ‘Quackometer’ no less, allowing him alone to decide who is a quack and who isn’t. The irony seems to be lost on him.

Guy Chapman is a self-confessed ‘computer nerd’ according to his LinkedIn site. He seems to write blogs 24/7. Why does he have so much time? He is an Affiliate Marketer by trade. What’s one of those? Well, Affiliate Marketers aim to capture personal data (for example, by using cookies), profile it, and then ‘groom’ people until they click on advertisements for products that might be relevant to them. The Affiliate Marketer then gets paid by click, and/or by commission from sales. It is business – and for some, very big business. So, apart from any personal convictions he may have, it’s Chapman’s ‘job’ to write blogs – they fuel his business with the replies they receive.

Chapman immediately wrote four blogs in three days on Woollams and CANCERactive. He became Colquhoun’s new best friend with the confused Colquhoun both apologising to Woollams while simultaneously providing links to Chapman’s verbose vitriol. Not that Chapman confines his defamatory comments to Woollams – you should see what he writes about Burzynski and Errol Denton (a blood analyst who accused him of racism). Four-letter words abound in uncontrolled rants.

But then this is also the case at RationalWiki, a website that seems to repeat many of the musings of Chapman almost verbatim. Chapman did originally ‘work’ for the real Wikipedia as an administrator but parted company with them in less than perfect circumstances. RationalWiki has been dubbed ‘Irrational Wacky’ and it is easy to see why. Just read their vitriol on the Daily Mail where every journalist merits a four letter expletive and you will instantly understand that this website is a spider’s web, there to trap innocent visitors erroneously thinking it might have sensible views on science.

Colquhoun took his rambling and inaccurate blog on CANCERactive down from the internet. It was replaced almost instantly by a similar load of garbage with the same title from Josephine Jones. The Skeptics try to build blogs which climb to positions right under the subjects they are attacking on Internet search engines so that, in this case, people with cancer will click on their website articles to read what they say by design or accident. This serves a double purpose – it aims to discredit the attacked (CANCERactive), whilst increasing the importance of the attacker’s website in the ‘eyes’ of the search engines. Thus the Skeptics use subjects like Burzynski, Denton, The Daily Mail and CANCERactive to power their own feeble websites up the Google rankings.

Next and unsurprisingly, after about a dozen positive 5-star reviews on Chris Woollams’ excellent book ‘Everything you need to know to help you beat cancer’, there were suddenly two negative reviews by – you’ve guessed it – alias Jones and Chapman.

Woollams was even attacked by another ‘secretive’ website – the Daily Quack. This usually attacks a small healer in Yorkshire or an acupuncturist in Manchester, people who can’t afford to defend themselves. But the writers had a pop at Chris Woollams, also claiming he lived on a sprawling estate in Buckinghamshire (he lives abroad and has done for 20 years) and that he was their new lead writer, which he is not. Of course, again, some innocent followers of Woollams – people with cancer – will click on this website thinking they really will find words of wisdom from him there.

One of the, now devalued, Colquhoun’s recurrent attacking themes against CANCERactive was that they ‘repeatedly’ broke the 1939 Cancer Act and that Trading Standards were useless in doing nothing. This theme was then taken up vociferously by Guy Chapman. Indeed, the sceptics organised a number of formal complaints to Trading Standards. The Trustees of CANCERactive then asked Trading Standards for a once-and-for-all definitive ruling and the matter was referred to the Government body, the MHRA.

The outcome? Both the MHRA and Trading Standards concluded that the 3600 page CANCERactive website was perfectly legal. Yet Chapman still has inaccurate blogs posted about CANCERactive breaking the law.

False identities aim to fool readers

A number of these skeptic websites are anonymous – Skeptics frequently use monikers. Why?

1. Some of the people have credible jobs and their employers might not like them using four letter words to rubbish people doing their best to help cancer patients for no personal reward.
2. Some of the Skeptics clearly lie about their subject. The legal word is defammation. If you use a moniker, hide your IP address with a proxy server etc, you are virtually untraceable if a lawyer comes looking for you. Hiding in rat holes somehow seems appropriate.
3 Some of the secret skeptics could well be paid directly or indirectly by Big Pharma. They could even currently work in a pharmaceutical company. How would any members of the public know?
4 A number of websites may be owned by just one person writing under several monikers. It was a tactic employed, for example, by Guy Chapman when at Wikipedia. If you have proxy accounts in false names, you can build a web of ‘people’ who seem to agree with you. This provides heightened credibility for your claims when in reality they may be devoid of evidence and complete trash.
5. You can also launch co-ordinated attacks. Chapman spent several weeks claiming Woollams was dishonest, while the message from Jones was that he used no research. Neither is true (Colquhoun took their posts down off his site after Woollams suggested he asked his lawyers for a view!)
6 No one knows which websites are linked. Affiliate marketers use a dashboard to see all their accounts in different names. It is possible that the fabricated Jones, Guy Chapman’s Blahg, Chapman Central (blahg.chapmancentral.co.uk), RationalWiki and more are all linked. An innocent cancer patient clicks on one website to read something about homeopathy and their data is collected by someone else.

This anonymity is supported by the use (abuse) of media contacts and of the word ‘experts’ and such-like. For example, ‘experts’ are appalled by the increasing use of complementary therapies in Britain. Actually real experts are not!

Collecting personal data for Private Gain

So, you visit a website mistakenly thinking Woollams is a contributor. The ‘secret’ owner captures your e mail address. They then put a ‘spider’ on this. A spider can profile you and provide basic information – age, male/female etc simply from the ‘secret’ information you gave when you signed up for an e mail account. BUT. Other spiders can use your e mail address to provide lists of all your contacts’ e mails over the years – all your friends and colleagues and their contacts. And they get profiled too. Some clever spiders cross-link all the social media websites and can thus provide data of your likes and far more about you. And this all goes into the Affiliate Marketer’s database and you are categorized by your age, interests, diseases, likes, whatever. All ready to then use the innocent ‘victim’ for personal gain.

How ironic that this all started because Woollams was accused of using a charity for personal gain.

Affiliate Marketers court controversy – if they write that Burzynski is a good man and raises money for the poor, no one will read their blogs. They need to write vitriolic attacks. Who cares whether it is true or defamatory. The newspaper, the Sunday Sport, showed the way with absurd headlines – so let’s hear it Guy … ‘Errol Denton ate my Hamster’. And that’s what the affiliate marketing skeptics are about.

Complementary Therapy is potentially big business

Complementary and Alternative medicine is a rich seam of leads for them. 80,000 practitioners in the UK alone; but of course blogs reach a worldwide audience, so the real figure is far higher. Also a staggering two thirds of patients now use a complementary therapy.

Even if a secret Skeptic is not an affiliate marketer, lists of profiled potential customers derived from their websites could be sold for approximately 8 pounds a thousand names. Some websites can accumulate a million names a year. It is not illegal to create and sell data lists.

Add it all up – it is huge business. So who is involved? Colquhoun, Singh, Jones, Jones, Henness, Chapman? Who knows? Maybe none apart from Chapman? Maybe the rest are just gullible innocents? Maybe they all genuinely think all CAM is quackery? But, really, in this secretive world of Pharma funding and false names and proxy websites, can you trust any of their websites not to collect and, even unwittingly, pass on your data?

Chapman is a top affiliate marketer. He gives speeches around the world. His website uses cookies which will become embedded into your computer to take data. He even sells spiders.

WARNING: VISIT A SKEPTIC SITE AT YOUR PERIL. THEY MAY CAPTURE YOUR DATA AND USE IT.

True scepticism and the emergence of non-drug therapies

What a sorry mess: Big pharma sponsoring ‘action groups’; lackeys and shills co-ordinating attacks on subjects like What Doctors Don’t Tell You and CANCERactive, while other skeptics simply fuel their own businesses capturing your personal details.

And, in all this, what happened to true scepticism? Where people with honest opinions could ask if Photodynamic Therapy (just going into Clinical Trials) was a genuine non-invasive alternative to drugs; or, similarly, Ablation (the use of energy from sources such as Ultrasound to heat up and kill cancers)? It has been used successfully with both prostate and breast cancers. Then there is the use of virotherapy and Dr Moira Brown’s successful clinical work with brain cancers. Or Dendritic Cell therapy and a few more coming fast.

It is easy to see why the skeptics are out in force. We could be witnessing the start of the last days of the Pharma Empire. The momentum of non-invasive alternative therapies (at significant savings both financially and in terms of patient stress) is almost too hard for them to stop.

Thank goodness.

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