Buryznski and The BBC, Cancer Quackery In Mexico and Do Doctors Die Differently From Patients?

14 Jan

I decided to write to the BBC again as I have not been the slighted bit satisfied by their previous responses. 

“The antineoplaston therapy aims to target the cancer without destroying normal cells.”
Whilst this may be the aim, of any chemotherapy, it is clearly untrue, as demonstrated in the literature, e.g. http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6
Antineoplaston therapy has numerous toxic side effects.
“The therapy involves antineoplastons – naturally occurring peptides in the body.” Missed out that they were derived from urine but now chemically synthesised and are the orphan drug sodium phenylbutyrate http://www.sciencebasedmedicine.org/index.php/stanislaw-burzynski-antineoplastons-and-the-orphan-drug-sodium-phenyl-butyrate/
“observed cancer patients typically had a deficiency of certain peptides in their blood.” no mention that no phase 3 trials conducted in 35 yrs, that current res shows no promise of efficacy & that correlation doesn’t imply cause or cure only offers a hypothesis of prior plausibility, which since proposed 35yrs ago still remains unfounded.
Please present evidence that these statements are factual and correct if you disagree. Thanks.

This video on cancer quackery in Mexico and at US borders is very relevant as to why we should maintain skepticism about Burzynski’s clinic.

Also of interest is this article “How Do You Want To Die?” based around an article describing a vast difference between how doctors die and how much, and what type of palliative care they receive compared to what patients receive. It discusses some of the difficult decisions around offering futile treatments and prolonging life but lessoning quality of life vs maintaining a shorter life with less invasive procedures, side effects and pain. Interesting stuff, would be nice to see some data on whether or not Doctors really do opt for less care. The article does highlight a problem with difficulties that families may face who are grieving, being given the responsibility to choose between complicated, confusing and not well described treatments and whether or not to go through them for the patient, during such crisis moments.

I E-mailed the FDA About My Concerns Regarding The Burzynski Clinic And Am Awaiting Their Reply

23 Dec

My e-mail to the FDA, it covers a lot of old ground. Hopefully, the FDA will answer at least one of the many questions I have asked.

“Due to recent press in the UK in our papers The Observer and The Evening Standard and on The BBC, The Burzynski Clinic has come to public attention. However, a number of researchers, scientists and members of the general public, upon researching the Clinic have found various concerns which were not mentioned in the press pieces.

It has come to our attention that the Burzynski clinic was issued this warning in 2009 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm192711.htm

I would like to know if this inspection was conducted and what the results of the investigation were. If not I am wondering why the clinic has not been investigated?

As the FDA highlights some very serious issues with the clinic’s IRB.

To summarize:-

  • Failing to report to the FDA that BRI had dosed human subjects without IRB approval.
  • Allowing a study to proceed, despite asking for further pre-clinical toxicology data.
  • Allowing a study to proceed without an investigator’s brochure having been submitted (the investigator’s brochure is the detailed summary of all data to date, and is mandatory for all investigational drugs).
  • Approving the use of a medical device without assessment of risk.
  • Failing to ensure that BRI obtained informed consent from patients or guardians.
  • Conflict of interest between BRI and the IRB – the IRB chairman was also an investigator.
  • Failing to carry out regular review of ongoing studies.
  • Multiple failures to maintain files and documents, including minutes of meetings.
  • Co-opting external people onto the IRB, against FDA rules.


I am also curious as to why Burzynski has 61 registered clinical trials on http://ClinicalTrials.gov/ct2/results?term=burzynski and averting that he was running 72 clinical trials simultaneously here his website in 2000 he listed 72 clinical trials were being conducted.

It seems odd that out of these 61 clinically trials only one is an RCT which has not yet begun, the rest are phase 1 trials of prior plausibility, and mostly phase 2 trials to test for dosing, safety and side effects.

I am also very concerned that 34 of the registered trials have ended up being declared ‘status unknown’. Since Burzynski charges people to take part in these clinical trials, it would seem that morally and ethically speaking Burzynski is required to publish the data, otherwise they have been mislead into believing that their participation and money has gone towards valuable scientific research.

In order to stop problems arising Burzynski should have strict criteria for the acceptance of participants into his clinical trials.

I am wonder what has happened to the results of these clinical trials? How can a clinical trial be marked as ‘unknown’?

It seems unlikely that 34 unexpected and uncontrollable adverse events could have caused Burzynski to be unable to complete the trials on the projected completion date and release the data. On top of this seven further studies are marked as withdrawn and two as terminated.

If Burzynski did less research simultaneously then perhaps he would have been able to complete the fewer projects he had started. Is there no maximum number of trials a single research group can conduct at any one time?

For what reasons were the seven withdrawn studies withdrawn? Are these valid reasons?

For what reasons were the two terminated studies terminated? Are these valid reasons?

Could the data still not be put to an appropriate use and should the FDA not enforce such matters?

It seems odd that so many studies with, essentially the same research question should be conducted by the same researcher.

It seems odd that Burzynski appears to be publishing these in the peer reviewed research as trials which demonstrate efficacy.

When I looked at his published results things seemed amiss:-

The most recent (S. R. Burzynski, T. J. Janicki, R. A. Weaver, & B. Burzynski, 2006) is a methodological nightmare. It’s unclear how many patients were originally signed up to the study, however the research states that 18 of the participants were evaluable. Eighteen is too low a number to establish anything either way, Burzynski either knows this and continues to choose studying small populations to deliberately make it difficult to judge the efficacy of his treatment, or he does not know this and is in that case an absolutely useless researcher. Of course, Burzynski, as we know, also doesn’t compare the effects of his treatment group with any other kind of control group. Not even a placebo group, which is odd because to decide wether or not Burzynski’s treatment is actually worthwhile at all it should be compared to the currently best available treatment for that type of cancer. Not just a placebo. Basically, even his last piece of research, as far as making clinical treatment decisions goes, is of absolutely no value or worth. Any judgement based on such preliminary data is premature and invalid.What’s worst is that out of his 18, probably best cases, Burzynski reports that only 39% of these eighteen survived two years, with 78% of participants dead within five years. S. R. Burzynski et al. (2006)describes a ‘complete response’ as disappearance of the tumor for four weeks (this is far from a lifelong clearance of cancer), he also defines ‘partial response’ as a 50% decrease in the tumor for 4 weeks. ‘Stable illness’ is described by Burzynski any change in the size of tumor which is less than 50%. Which obviously means if the tumors were slow growing they could easily have been portrayed as ‘stable’ by Burzynski. That being said he still only reports two cases of complete response and two cases of partial response, with seven cases classified as ‘progressive disease’, a 50% increase in cancer size and another seven classified as stable, that is up until 78% of all the patients had died, of course.This is hardly an impressive study.This time the experiment was conducted on 13 children, this time 54% were dead within five years, this seems odd since the abstract opens “Primitive neuroectodermal tumors (PNETs) are usually successfully treated with craniospinal radiation and chemotherapy”(S. R. Burzynski et al., 2005) and Burzynski et al, 2005 themselves admit “The serious side effects included single occurrences of fever, granulocytopenia, and anemia. The study is ongoing and accruing additional patients. The percentage of patients’ response is lower than for standard treatment”.An interesting point to note is that Burzynski claims his antineoplastons are not toxic, this study proves that they are toxic.In (S. R. Burzynski, R. A. Weaver, et al., 2004) Burzynski claims that his results are favourable compared to standard chemotherapy. This is incorrect, since Burzynski’s trial does not compare his treatment with standard chemotherapy.S. R. Burzynski, Lewy, et al. (2004) reports on a single patient, out of thousands of patients this is apparently Burzynski’s one success story. It is probably just a spontaneous remission and the long term survival of the patient is likely to have nothing to do with the Burzynski treatment. The reason that I’m coming to this conclusion is that the studies looked at so far suggest that the treatment is either useless or harmful.S. R. Burzynski et al. (2003) report a study, this time of ten ‘evaluable patients’. It is unclear in this study how many patients were recruited and what criteria excluded them from being ‘evaluable’. This time the survival of his treatment for 2 years was 33.3%. That means 67% of the patients were dead within two years, one was alive for more than five years since starting the treatment, another for more than four years. Burzynski also seems to say two were alive for five years since initial diagnosis, in order to try and take credit for this by lenghtening the overall survival time, rather than talking about how long they survived after starting his treatment. They also report on the toxicity of his antineoplaston treatment which included three cases of skin allergy, two of anaemia, fever and hypernatraemia and cases of agranulocytosis, hypoglycaemia, numbness, tiredness, myalgia and vomiting (S. R. Burzynski et al., 2003).Buckner et al. (1999)⁠ conducted a trial on antineoplaston therapy on nine patients, they report that no patient treated with antineoplaston demonstrated any tumor regression. This means that the treatment, in this study, simply and clearly did not work. They also report that severe neurotoxicity can occur. Vickers (2004)⁠ reports on this, stating further, that six patients demonstrated tumor progression, that the mean time to treatment failure was 29 days and that all nine patients died before the study was complete.

It also seems strange that Burzynski has not published anything in the peer reviewed research literature since 2006. Yet he advertises otherwise, using conference abstracts in dodgy journals to bump up his publication list in order to seem more convincing http://www.burzynskiclinic.com/publications.html

I would like to note that the pieces in the press have stated that Buryznski’s treatment is natural and does not harm normal cells, only cancer cells, and yet Burzynski’s published research suggests it does have toxic side effects, is it not illegal for Burzynski, press pieces or other advertisements promoting the clinic to make claims which go against the research and which Burzynski himself knows is misleading?

In the UK it is likely that the Cancer Act (1939) would not allow Burzynski to advertise his clinic, especially not in the way which it appears to currently be advertised.

I also wonder why the Burzynski Clinic is allowed to charge such high amounts for patients to take part in clinical trials. This seems an unethical practice.

I have noted that the Merritts state: -“Along with the long list of other meds that were supposed to work in conjunction with each other, the Burzynski Clinic gave my husband standard chemotherapy medications. We were never told that two of the medications were conventional chemo medications. We discovered from our local pharmacy that one medication the Burzynski Clinic had charged us over $2300.00 for could have been purchased from the pharmacy for around $170.00.”


at burzynskiscam.com

This does not seem an ethical or legal way for clinical trials to be conducted. Should the FDA not ensure that this practice is not immediately halted?

I am aware that the texas medical board is challenging Burzynski for a number of serious issues http://www.ministryoftruth.me.uk/wp-content/uploads/2011/11/tmbvsburzynski.pdf.

To summarise the charges are:-

“- failure to practice medicine in an acceptable professional manner consistent with public health and welfare;- failure to meet the standard of care;- negligence in performing medical services;- failure to use professional diligence;- failure to safeguard against potential complications;- failure to disclose reasonably foreseeable side effects of a procedure or treatment;- failure to disclose reasonable alternative treatments to a proposed procedure or treatment;- failure to obtain informed consent from the patient or other person authorized by law to consent to treatment on the patient’s behalf before performing tests, treatments, or procedures; and-prescription or administration of a drug in a manner that is not in compliance with Chapter 200 of this title (relating to Standards for Physicians Practicing Complementary and Alternative Medicine) or, that is either not approved by the Food and Drug Administration (FDA) for use in human beings or does not meet the standards for off-label use, unless an exemption has otherwise been obtained from the FDA.- unprofessional or dishonorable conduct that is likely to deceive or defraud the public or injure the public;- providing medically unnecessary services to a patient or submitting a billing statement to a patient or a third party payer that the licensee knew or should have known was improper. “Improper” means the billing statement is false, fraudulent, misrepresents services provided, or otherwise does not meet professional standards.”

Is it acceptable for the FDA to allow Burzynski to continue charging patients for clinical trials of which the results are never published whilst Burzynski is being charged for misleading patients, not disclosing his interest, deception and defrauding of the public and prescribing off label medications with no regard for safety, efficacy or drug interactions?

I also wonder if the FDA can comment on whether or not Burzynski’s clinical trials have adequate scientific protocol to investigate what they claim to investigate? I am aware the treatment is only available through clinical trials, however if these charges are true then the clinical trials have not been undertaken. No registered clinical trial that I can find looks at the safety, dosage and side effects or efficacy of the combination of drugs which Burzynski is apparently using. Does not this not render the claim that Burzynski is carrying out clinical trials null and void?

Should the FDA not also be regulating what goes on in these studies and investigating the nature of the TMBs charges. If they are true then does that not also mean that the FDA has been exploited and deceived and/or has been complacent in the malpractice conducted by Burzynski? Or is the FDA not responsible for regulating the clinical trials which it approves?

A cancer researcher, doctor and scientist has stated here http://www.sciencebasedmedicine.org/index.php/stanislaw-burzynski-antineoplastons-and-the-orphan-drug-sodium-phenyl-butyrate/ that antineoplaston therapy is actually the orphan drug sodium phenylbutyrate. Since the trials do not indicate they are measuring the effects of sodium phenyl butyrate, this appears it could be a major issue too and may be a deception in itself. Also, Burzynski seems not to take into account other research into this drug in his studies. It seems perhaps some of the studies Burzynski claims to be running probably have already taken place, as this drug has been in clinical trials since 1958, and that some conclusion about the use of the drug can already be drawn, even without the publication of Burzynski’s data. This should instruct whether or not Burzynski should be allowed to continue running clinical trials and if so which ones should be halted at least to stop further accrual of patients, or continued.

I am aware that in the past Burzynski has already successfully been charged with fraud and has also met other charges, and in the past was charged with improper animal housing and incorrect storage of human urine.

I believe a full inspection of Burzynski’s practice is required, in order to make sure that patient safety must be ensured, that the clinical trials Burzynski runs have a specific and strict entry criteria which is being met, that Burzynski has adequate staff and protocols in place to complete all of the clinical trials he is registering, that Burzynski is prescribing legally, that the scientific endpoints in Burzynski’s clinical trials are valuable, valid, logical and that the methodology is adequate to test these and that the data is being used, analysed and reported correctly, that excluded patients are excluded for valid reasons which could not have been predicted prior to patient enrolment and that all of the data from all of Burzynski’s clinical trials be published for scientific scrutiny and peer review.

The FDA should take action to enforce these requirements immediately.

Any information regarding these issues would be much appreciated”

Burzynski And The BBC: The BBC Fail To Answer Any Concerns Raised In My Complaint

20 Dec

Following on from my last post, I complained a second time stating:-

 “I do not understand what is holding the BBC back from rectifying this issue?

Whilst the skepticism is mentioned, it is not explained, why skepticism, what is the controversy surrounding the Burzynski clinic? This is uninformative and yet met by the advertising lines that the treatment is natural – it isn’t, and the line “The antineoplaston therapy aims to target the cancer without destroying normal cells.” which does go into details of the treatment. Whilst this is the aim it isn’t stated that the treatment has failed to be shown to do this. His own published studies show toxicity, side effects such as brain swelling and death. As this story does go into details of treatment, the argument you provided it doesn’t is false. It also does present a biased, un-researched view of the treatment. Since Burzynski is on trial for not informing patients he was giving them chemotherapy drugs and not disclosing he owned the pharmacy selling them, a link to their website doesn’t constitute ‘enough information’ for readers to make up their own minds.

What stopped the skepticism? The advertising which is likely illegal under the cancer act (1939)? It is clearly not evidence. This implicitly suggests they were swayed for good reason. Nor does the piece question why treatment is so costly, an unethical practice. Nor that Burzynski never releases the data of his clinical trials, which may falsely lead people to believe they are funding useful research. The other links don’t cover key concerns.”

Despite these statements of facts, clarifying some of the issues by quoting the piece itself, they respond with what seems to be denial, in essence claiming that they ‘never said that’, when I used a direct quote. It’s as if they have never even read the article. Or think they can somehow convince me those words aren’t contained in it. How foolish. At any rate the reply is unsatisfactory and answers none of my questions or concerns. They don’t even bother to justify why they think it’s an unbiased and acceptable article, despite the quite clear reasons why it would not be acceptable.

Here is their astonishing, dismissive and unacceptable reply

I maintain that the story we wrote is factually correct and has appropriate and balanced links attached.

Yeah. That’s it, in full. How strange

It looks like they still need to check their facts.

Balanced links aren’t good enough either, the article itself has to be balanced. Which it isn’t.

If they feel it is factually correct then they can provide the evidence which supports this. If they believe my complaint is unjustified then they need to explain why and justify their reasons for not making the article more balanced and accurate. As they have not done so, I will assume this is because they cannot do so. They are aware the article is not factually correct or balanced at this point in time but refuse to do anything about it. It is unclear why they refuse, but it seems it probably has to do with not wanting to be held accountable and lack in belief of their responsibility as providers of health information and misinformation. It seems like they have no concern whether or not their misleading uncritical article entices others into undergoing Burzynski treatment, at the risk of forgoing proven treatments or good quality palliative care. They don’t seem to be bothered that patients undergoing this treatment can suffer severe side effects and that evidence from the TMB suggests Burzynski prescribes irresponsibly, his trials take no regard of patient care and protection and he doesn’t inform patients correctly on what treatments they are actually receiving. This, to me, sounds like something that everyone should be bothered by.

If they are not aware of the biases and inaccuracies then I believe they are not acting competently as journalists.

Further action does appear to be necessary.


Arguing With The BBC and The Observer about The Burzynski Clinic Of False Hope

20 Dec

The BBC are making weird statements that don’t make any defence about their Burzynski Clinic fundraising promotional article.

They don’t really give enough space in their complaints box for my to present the evidence so it’s kind of tricky.

I complained:- 

The Burzynski Treatment is harmful, by association uncritical articles in the media only serve to promote this harmful treatment. I am aware the editor has responded previously with ‘we feel readers can make up their own minds’ however the BBC article does not provide enough facts for readers to make up their own mind. Nor does Burzynski’s website, movie or other advertising, which would be illegal in UK.

This treatment is not provided on the NHS as it has no evidence of efficacy. In fact the treatment has been studied since 1958. Burzynski himself has run 61 clinical trials on the treatment, however he has failed to publish full peer reviewed papers since 2006. His past papers have failed to demonstrate efficacy but have demonstrated side effects.

Burzynski is under review by the texas medical board, which will likely revoke his licence as burzynski uses chemotherapy, off label, in large doses with no regard for drug interactions or side effects. He also charges a 1253% mark up on some of these drugs, not stating that they could be bought cheaper elsewhere.

The FDA issued a warning to Burzynski in 2009 due to his ethics committee having no regard for patient protection or wellbeing.

The treatment is illegal unless used in clinical trials, yet burzynski does not publish results of his clinical trials – paid for by patients, instead using them as a way to continue using his treatment. It is irresponsible and immoral for the BBC not to make this clear to readers.”

Unexpectedly, they failed to understand this complaint and continue to issue the type of illogical defensive reply I’d already told them not to bother with.

“Many thanks for your comments. Our report is about the family’s circumstances and is a much broader story than a feature simply about treatment they have elected for their daughter to receive. We are not suggesting the treatment works or promoting it. We simply include the fact that they are attending this clinic as a matter of record.  We make it clear that the treatment comes in the form of a clinical trial and note the family’s initial scepticism. As well as a link to the institute, we link to a cancer research website which lays out some of the objections which have been raised to the claims so I believe we do provide enough facts for readers to make up their minds about the treatment should they wish to explore that issue . I hope this is helpful. Your comments are much appreciated. With best wishes, Laura Ellis, Head of New Media BBC English Regions”

Apparently not mentioning legal action taken by the Texas Medical Board against Dr. Burzynski is fine, the fact the Buryznski may be stripped of the title ‘Dr’ in a few months holds no importance to people deciding whether or not to undergo his cancer treatment, according to the BBC. Clearly, a link to the TMB stating why they are taking him to court is a reasonable request?

The link the response mentions on antineoplaston therapy by the Cancer Research UK is not even the most recent update about Buryznski’s cancer research…which is actually this link - which highlights much more of the issues than the BBC article or any link it provides does.

I’m not sure how they could possibly fail to understand these complaints. Professor Steve Jones and BBC Trust Review Of Impartiality and Accuracy of the BBC’s coverage of science states that:-

“the Trust welcomes the fact that the Executive in its response is open to the suggestions for improvement that the report makes, has set out steps towards this and plans to monitor their efficacy. In particular, as set out below, the Trust is concerned that new editorial guidelines on “due impartiality” (introduced in 2010) are used appropriately and effectively in science coverage. Programme makers must make a distinction between well-established fact and opinion in science coverage and ensure the distinction is clear to the audience.”

Which the above BBC has quite clearly failed to do. As they state in that report they will do their utmost to meet those standards suggested it seems quite strange how reluctant they are to do so in this instance, sure it may be more about TV coverage, but it’s clear it can be applied to news journalism, online and in-print, too.

The MHRA also issue guidelines for journalists which state:-

“Yet the advertising legislation prevents these medicines being advertised to the public and the law applies to ‘any person’ – not just pharmaceutical companies. So what do journalists and patient organisations need to do to ensure they stay within the law when writing about medicines? Reporting information fairly and accurately while ensuring a balanced view is represented is paramount. Paying attention to these will help ensure the ban on advertising prescription medicines does not become an issue. The bottom line is – keep it factual and balanced to keep out of the advertising controls.”

So to me the BBC article fails to do this, since it states that the parents believe Burzynski’s treatment will work and it also states that Burzynski believes it will work and even goes into detail about how it works and what it’s aim is, despite there being no evidence that it works, let alone how. Despite contrary evidence the article includes a statement that the treatment doesn’t harm other cells. The BBC basically say it’s non-toxic, despite the fact Buryznki’s own published research (usually from unfinished clinical trials) states that it is (although his advertising says that it isn’t). The article also suggests that it is a ‘natural remedy’ which it isn’t, really. Sure, it used to be derived from urine, but it’s now chemically manufactured in Burzynski’s lab. On top of that it’s actually the orphan drug sodium phenylbutyrate. Which actually means ‘natural therapy’ types supporting this treatment, such as the alliance of natural health have been conned into literally becoming ‘Big Pharma Shills’. This treatment has been being studied since 1958, it turns out and Burzynski didn’t invent it, like he claims he did.

The only ‘critical’ line in the BBC article basically says ‘there was some skepticism but they are confident now’.  On the whole I believe the article fairly clearly suggests that the treatment works, that the skepticism was abolished through some evidence or the skepticism was overcome by some logical and justified means – except a study of the evidence suggests that this is not the case. I like the argument that including a link to the clinics website provides information – a look at the advertising, suggests it may have been this that was persuasive to the parents choosing the treatment, rather than evidence. I’ll note again that this advertising would likely be illegal in the UK under the Cancer Act (1939), which prevents the exploitation of vulnerable and desperate patients.

Perhaps you could argue that the article only implicitly  and unintentionally is biased towards supporting the treatment. However, the problem remains that the article didn’t provide any counter evidence to it’s implicit suggestions. 

There’s no evidence Burzynski’s treatment works. It doesn’t seem to me like throwing in a few facts like that into the article would be very difficult, or irrelevant, especially when details of the treatment are mentioned in the article. There’s also evidence the treatment causes some very serious side effects, including brain swelling and death. It seems like this information might be an important factor in patients ‘making up their own minds’. So why is the BBC avoiding the seemingly, rather simple solution, which would certainly would stop the bother of people saying it’s biased and wondering whether or not it falls foul of the law?

Weird.

I’ve responded with a further complaint. We’ll see what they say to that. Hopefully I’ll put my further complaint and their reply here praising the BBC for taking some responsibility for their journalistic error and not mocking a completely useless, flimsy, laughable excuse-of-a-reply like this time. 

I also responded to The Observer, who released a really weird statement about the very high quantity of complaints they were getting about their similarly credulous article.

Subject: Recent Defensive Article About The Burzynski Clinic – Is It So Surprising That People Are Concerned About Those That Intend To Exploit Vulnerable, Desperate and Ill People With Terminally Sick Children?

E-mail:

“It is the stuff of nightmares. While her mother was undergoing chemotherapy for breast cancer, four-year-old Billie Bainbridge fell ill and was found to have an inoperable brain tumour. All the odds seemed stacked against her surviving beyond 18 months. Faced with such an appalling prognosis, the Bainbridges did what any family would do – find any way possible to prolong Billie’s life.”

All too understandable and true EXCEPT there is a very important ethical issue about parents and doctors being involved in prolonging low quality of life or providing high quality of life but not providing treatments which are deemed futile. There is no evidence to suggest that the Burzynski clinic’s activities can prolong life or enhance the quality of life. There is some question then about whether this treatment will be of benefit or a harm to Billie Bainbridge. Whilst it may momentarily please the parents to feel they ‘did all that they could’ they may also end up regretting making this choice because it meant losing time with their child and noticeably lowering her quality of life, they may also go the other way, when they lose their child, having been convinced of Burzynki’s propoganda they may feel that it is their fault and that they did not do everything that they could to protect their child. Either of these outcomes will of course will be devastating to them. The point is that it isn’t their fault. Burzynski’s treatment has no merit and cancer is indeed a cruel disease. It is however Burzynski’s false hope built on pseudoscience that prayed on that families vulnerabilities and fears and which took advantage of them, getting them into that position, leaving them doubting conventional treatment, making them feel like they had to do more and ultimately, when it doesn’t work, leaving them feeling as if they are to blame and responsible. This is surely not acceptable? To be clear I am arguing in favour of providing all the emotional support for the Bainbridge family and care for Billie that they need, though at times this may mean protecting them fro fraud’s. Perhaps it is too late now. Perhaps they made their choice and they are happy with or at least determined to stick with it. On these things I do not believe anyone wants to interfere. Although some would certainly like to fully understand the reasons why, what evidence they saw, what evidence they were missing and how they felt about a variety of different issues (that they may have known or not known about), it is clear that the person who should have asked these questions is their doctor, and that should have been done in a supportive, professional, caring and sensitive setting. It is clear now that the Bainbridge family are going through a very tough time. The complaints about the Burzynski clinic are not directed at the Bainbridge family nor are they intended to be insensitive to their plight. To suggest that this is the intention is in fact highly offensive to me.

Indeed it would appear that the original report was in violation of The Cancer Act (1939) and went against MHRA guidelines for uncritically promoting a clinic which has an unproven therapy, fails to protect patients in it’s clinical trials and throws up a whole bunch of patient protection issues.

“Dorothy Bishop, professor of developmental neuropsychology at Oxford, wrote to warn that Dr Burzynski’s methods are not recommended by cancer experts in either the UK or the US. “The reason the treatment is available in the US appears to be because ethical regulation is far laxer there than in the UK. Any person who wishes to sell an unproven treatment to patients can do so by describing it as a ‘clinical trial’.”
Cancer Research UK ran a blog offering sympathy to families in this cruel situation, but expressed concern that “people are lured by promises based on an unproven therapy. At the moment, there is very little solid scientific evidence to show that antineoplastons are effective at treating cancer, and virtually all the research in this area has been carried out by Burzynski and his team – a red flag to the scientific world.””

These paragraphs are most excellent. A win for all of those who complained.

“Undoubtedly, the Observer was wrong not to have included criticism of the treatment. A simple check with Cancer Research UK would have revealed the depth of concern about it and, no question, that concern should have been in the article,”

Indeed. Fully agreed. This is the main point of pretty much all of the complaints.

“but because it was absent doesn’t mean that the paper was promoting the treatment, as some have suggested”

Well it was, wasn’t it. It claimed the treatment might cure Bainbridge’s cancer, that NHS wasn’t providing it and that they needed £200,000 for it and all they help they could get to go to this pioneering maverick doctor. It was complicit in the ‘there’s a cancer conspiracy’ advertising that Burzynski uses to promote his treatment, implicitly at least, if not explicitly, though it’s support of The Burzynski Clinic was certainly explicit and there certainly wasn’t a single critical thing said about it in that article. Indeed, this was, no matter how unintended it may have been, a promotional piece for Burzynski and could easily lead others into forgoing conventional cancer therapy, or otherwise spending their lifesavings and last days undergoing Burzynski’s useless treatment.

This is the worry of all of those that have complained to the observer.

Those that have complained are patient advocates, fighting for patient protection against a practice which has been successfully charged for the defrauding of it’s patients. A clinician which will probably lose his medical license in April next year due to the illegal and harmful cocktails of drugs he provides, without informed consent and with no declaration of interest.

This is a story about the exploitation of the courage and generosity of thousands of people and The Observer has played a complicit role in this. The final words of the editor were too defensive. This (non) apology has ended up sounding self serving, self aggrandising, defensive, with a blatant disregard for the facts.

The paper has mentioned ‘there is controversy’ around Burzynski’s clinic but has absolutely failed to discuss what this controversy is. There are in fact a whole variety of legal and ethical issues that concern The Burzynski Clinic, and which are in the interest of the public, yet The Observer continues to gloss over these. It’s interesting to note that 100+ bloggers have covered the Burzynski story in far more detail, far more balance and far more sympathy than your newspaper has.

And here lies the final point”

“Luke Bainbridge told me: “From the start, Billie’s parents knew this treatment was experimental and has attracted scepticism but they were encouraged by the fact that the trials at the clinic are approved by the US Food and Drug Administration and that Billie would still be monitored by her specialists in the UK. Her parents know it is unproven, but there are other families in this country who were told by their hospital that their condition was terminal and nothing could be done for them, but were then treated at the clinic and survived. Knowing this, Billie’s parents felt they couldn’t sit back and do nothing if there was a small chance this treatment would save her life.”

This again is entirely understandable. Nobody suggests that Billie’s parent’s are wrong for choosing Burzynski’s treatment, his flash advertising, his emotionally manipulative film and testimonials, his long list of publications he cites to claim efficacy which all turn out to be either conference abstracts which are non peer reviewed , or poorly conducted peer reviewed trials which suggest the treatment has no efficacy once you actually dig them out and read them…if in a moment of desperation after seeing all this, who wouldn’t turn to Burzynski’s miracle treatment? And of course they say they choose it understanding full well the controversy surrounding the clinic…then fine, publish what that controversy is. If they understand the controversy so well what’s so upsetting about revealing it? Surely this will help others to make a more informed choice and not make the same mistake?

To be honest the Bainbridge family are the last people that need to comment on the Burzynski Clinic and it’s treatment. They have done their best. Why drag them into it? The person who has been targeted however is Burzynski. The sole responsibility lies with his advertising and promotional material, the way in which he conducts clinical trials, the in which the results are not reported, they way in which he charges extortionate amount for treatment, the treatment which he uses, the illegal way he uses chemotherapy off label and charges excessive amounts for it, the unethical way he charges patients to take part in clinical trials.
It’s no surprise people turn to someone claiming to have a miracle cure. It is a surprise to see anyone publicly and promote such practices as outlined above however.

So lets talk sensitivity, again.

My family have been affected by cancer. Indeed, it is people like these that I and others are sticking up for. With it affecting roughly one in four of all people, it is insensitive of the observer to call those who stood up against this treatment in order to increase patient awareness sanctimonious, aggressive and vitriolic. We do not want our friends, families and loved ones being taken advantage of. We do not want them seeing uncritical pieces in The Observer and believing there is a miracle wonder clinic out there, only to have their hopes dashed when they see the evidence. We do not want them to be robbed of their life savings or to spend their last months miserable, suffering unwarranted side effects (one of the things Burzynski is going to trial for), with their hopes dashed, money gone and quality of life severely reduced. Support of the Burzynski Clinic is also a slap in the face to all of those who undergo conventional cancer treatment – due to Burzynski’s completely made up ‘cancer conspiracy’ advertisements, film and book. It is upsetting to all of those that research cancer, that deliver cancer and palliative care.
If you want to talk about courage, generosity and kind hearts then why not talk about all of those standing up for patient protection, researching ethically and professionally what treatments do and do not work, publishing their results in peer reviewed papers, and staying with such patients in the last months and hours of the patients life, ensuring suffering is minimised and care is kept at a high quality level? What about those heroes?

Here is a quote from Kat Arney at Cancer Research UK:-

“To suggest that there is a conspiracy aimed at depriving cancer sufferers of effective treatments is not only absurd, it’s offensive to the global community of dedicated scientists, to the staff and supporters of cancer research organisations such as Cancer Research UK, and – most importantly – to cancer patients and their loved ones.
We have all lost friends and family to cancer. And our loss fuels our passion to beat this disease by finding out what really works, through scientific research”

http://scienceblog.cancerresearchuk.org/2011/07/06/there’s-no-conspiracy-sometimes-it-just-doesn’t-work/

It is understandable that the editor of the observer would be defensive for coming under attack. However, the attacks were justified and fair. We do expect journalists to do some research into the topic. It is harmful to patients when they do not.

Next time do not dismiss the concerns of your readings as being insensitive. It is that itself which was truly insensitive and sanctimonious.

Currently it appears that The Observer has learned nothing since the MMR debacle. 
Please try again, and this time at least try to understand why the public are so concerned about these uncritical reports and why they need more information about this controversy. Perhaps it would be better if you got someone who wasn’t related to the family, nor the father of a band member that has raised funds for this clinic to conduct a more professional investigation into this clinic and produce a more balanced article?

Thanks.

The Observer have issued no further reply, although others have complained about his response too, see here for a collection of complaints and here for the quackometer response, calling the editors reply a disgrace.

Also The Evening Standard have done a similar thing. Here’s a good article about someone complaining to them, getting a really crap response and explaining further why the article is irresponsible, immoral and unethical.

A Letter To Gov. Rick Perry Regarding The Burzynski Clinic

5 Dec

A quack website the Alliance Of Natural Health is sending letters to a whole bunch of people to stop them revoking Burzynski’s medical licence. I recommend everyone (US Citizens) send this ‘personalised’ version of their message that I made when I edited their form. I sent it anyway. They’ll love the support and encouragement for their good work.

Look at who it goes to! Gov. Rick Perry and all…

Recipients

  • Representative Lois W. Kolkhorst
  • Representative Vicki Truitt
  • Representative John Zerwas
  • Representative Carol Alvarado
  • Senator Bob Deuell
  • Representative Veronica Gonzales
  • Senator Jose Rodriguez
  • Senator Dan Patrick
  • Governor Rick Perry
  • Representative Sarah Davis
  • Representative Garnet F. Coleman
  • Representative Jodie Laubenberg
  • Senator Joan Huffman
  • Senator Jane Gray Nelson
  • Representative Charles Schwertner
  • Representative Elliott Naishtat
  • Representative Susan King
  • Senator Robert Nichols

Stanislaw Burzynski, MD, PhD (if he ever says where he got this Phd from), has been unsuccessfully treating deadly cancers with a useless, urine derived peptide which is far too large to be at all gene-targeted but is advertised as such anyway. This is usually added to conventional chemotherapy medications but at a 1253% increase in price, and passed off as his own treatment, with no mention that it’s conventional chemotherapy or that he owns the pharmacy that sells the treatment (no declaration of interest) or that it can be bought far cheaper elsewhere — a treatment not currently practiced anywhere in the world except for his Houston clinic.

From 1986 to 1996 the Texas Medical Board launched an unsuccessful campaign to revoke Dr. Burzynski’s license. Now the Texas Medical Board is making another attempt at shutting this practice down, a practice that has promised and failed to cure countless terminal cancer patients–and given those who could not be saved false hope, as well as shorter and lower quality of life, instead of letting patients enjoy time with their families, Burzynski gets them to apply to his ‘clinical trials’, flying them in from across the world, wasting the last weeks, months, or days of their lives undergoing a useless and unproven (practically disproven) treatment. They also have to spend their entire life savings to enrol in these clinical trials. A highly unethical procedure. Using the death of practically 100% of his patients as a pretext, the TMB is charging Dr. Burzynski with the off-label use of FDA-approved drugs.

This treatment is unacceptable. The citizens of Texas — not to mention the rest of the country (and the world) need to be protected from the fraud, extortion and illegal practices of this charlatan.

If the TMB has its way, it will set the “war on cancer” forward three hundred years in terms of important research and progress. Governor Rick Perry personally appointed the heads of the Texas Medical Board, and I urge both the Office of the Governor and the Senate and House committees who have oversight of the TMB to investigate the unfounded treatment Dr. Burzynski practices, and the absurd ‘clinical trials’ he claims to run. It is pleasing that Burzynski should go on trial, but if this can be moved forward please do so, it is painful to know that so many new patients could be conned whilst waiting for the trial that is scheduled to be held in a few months. Please urge the Texas Medical Board to end this pseudoscientific, harmful and dangerous practice now.

Once you review this case for yourselves, I am confident you will find that the TMB does have a legitimate case and Burzynski is abusing his position as a doctor and researcher, whilst exploiting FDA loopholes. In the past 30+ years there has been absolutely no evidence that Burzynski’s regimen has successfully treated a single patient with any type of cancer.

Think of the lives it could save to shut this quack down!

This doctor is practicing entirely outside of the law. He is a useless researcher. His treatments are highly toxic, regularly causing brain swelling and other side effects. He has a much lower success rate than conventional medicines. Please exercise your oversight and make sure his work is NOT allowed to continue any longer.

For Burzynski, Cancer Is Big Business

29 Nov

Cancer Is Big Business At The Burzynski Clinic

Who is Dr (for now) Burzynski and why should I care?

What do Radiohead, Peter Kay and Badly Drawn Boy all have in common?

The Billie Butterfly Fund.

Radiohead are auctioning a guitar, Peter Kay and Badly Drawn Boy are performing live shows and donating the proceedings to the Billie Butterfly Fund.

It’s a moving story, Billie is a four year old girl with an inoperable brain stem tumor. Chemotherapy only offers some respite but the family have found another way…

Or so they believe.

For just £200,000 Billie will be allowed to enrol on a ‘clinical trial’ of antineoplastons at The Burzysnki Clinic. This may cure Billie for good, they believe. In the observer

(“The worst year of my life: cancer has my family in its grip | From the Observer | The Observer,” Bainbridge, 2011) Luke Bainbridge (Billie’s uncle) writes “Is it impossible for her to survive? No, as it turns out. Sam and Terri very quickly found out about a pioneering treatment at the Burzynski Clinic in Texas for children with DIPG. The estimated cost is £200,000.”

However, not all is as it seems.

So why does this matter?

For a start, if Burzynski can cure cancer then he deserves a noble prize. He is also professionally and ethically obliged to publish his results, demonstrating that he can cure, for the greater good of humanity and society.

If Burzysnki cannot cure cancer then he is ethically obliged to release the results of his clinical trials, so that we can make a firm conclusion that antineoplastons are not effective against cancer. This would enable researchers and patients to focus their energy, time and money elsewhere. As you’ll see Burzynski’s treatment is not cheap, if it’s also useless then Burzynski is doing nothing more than praying on the desperate, ill and vulnerable in society and selling them false hope in return. If Burzynski’s treatment doesn’t work then there is no need for Burzynski to continue running ‘clinical trials’ to find out.

Before we delve into Burzynski’s research lets first look at the other public campaigns to raise money to get people this treatment and how they turned out.

Continue reading

I Wasn’t Too Impressed By The BBC’s piece on ‘Wifi Refugees’ and EHS

13 Sep

Hey @bbchealth this article on EHS http://www.bbc.co.uk/news/world-us-canada-14887428 was under researched and failed to be at all informative.

WHO have already issued an official report on electromagnetic radiation. It’s very thorough. You’ll find their results on Electromagnetic Hyper-Sensitivity (EHS) on the second page http://www.who.int/peh-emf/about/WhatisEMF/en/index1.html. In the section on electromagnetic radiation’s effect on health in general they state

“In the area of biological effects and medical applications of non-ionizing radiation approximately 25,000 articles have been published over the past 30 years. Despite the feeling of some people that more research needs to be done, scientific knowledge in this area is now more extensive than for most chemicals. Based on a recent in-depth review of the scientific literature, the WHO report concluded that current evidence does not confirm the existence of any health consequences from exposure to low level electromagnetic fields.”

On EHS specifically the WHO report states

“There is little scientific evidence to support the idea of electromagnetic hypersensitivity. Recent Scandinavian studies found that individuals do not show consistent reactions under properly controlled conditions of electromagnetic field exposure. Nor is there any accepted biological mechanism to explain hypersensitivity. Research on this subject is difficult because many other subjective responses may be involved, apart from direct effects of fields themselves. More studies are continuing on the subject.”

If you need further understanding on why EHS may be due to nocebo effects (the evil twin of the placebo effect), incorrect attribution (there really is a problem but the wrong thing has been blamed as the cause) then there are some good articles around.

My problem with the BBC piece is that it seems to state “But EHS is not medically recognised in the US.” as if this is due to ignorant or dismissive scientists and health professionals that can’t be bothered to study the condition. Which has not been the case. It also claims that this is a ‘debated condition’ which gives the sense that their is controversy with the evidence, which seems to be false. It quotes a study by Dr. Marino claiming that “The study provides direct evidence that linking human symptoms with environmental factors, in this case EMF,”. Though to give it credit it does quote a skeptical physicist and the World Health Organization on the matter.

Interested, I continued reading the WHO report, which concludes

“To date, scientific evidence does not support a link between these symptoms and exposure to electromagnetic fields. At least some of these health problems may be caused by noise or other factors in the environment, or by anxiety related to the presence of new technologies.”

Continue reading

Lipstick On A Monster – Comment on This NHS U-turn was a fake by Jacqueline Davis and Nursing Times Poll Results

7 Jul

The BMA has twice voted for the bill to be scrapped, and a British Medical Journal poll this week showed 93% calling for its withdrawal. Today the heart tsar, Sir Roger Boyle, resigned, saying: “I feel in my bones the current changes are not correct and ministers were not prepared to change them substantially.” How much more proof is needed that nothing significant has changed? The BMJ christened the bill “Lansleys monster” when it first appeared. The politicians took it away, slapped on some lipstick and asked us to embrace it. A monster with lipstick is still a monster. It needs to be terminated with extreme prejudice.

via This NHS U-turn was a fake | Jacqueline Davis | Comment is free | The Guardian.

For people interested in the NHS Reforms (ie. anyone who has ever received or is interesting in receiving public healthcare) this pretty good gaurdian article by Jacqueline Davis reports a few interesting things, and is a good read.

In brief:

  • All the mechanisms for privatization of the NHS are still in place
  • Many trusts will be tempted to boost private income at the expense of public patients
  • The proposed reduction in bureaucracy and putting the power into the hands of GPs in reality means increased bureaucracy (various monitors, consortia, groups and organizations are no proposed) and GPs subordinate to commercial companies
  • A Poll by the BMJ has received a 93% vote that even despite changes (or perhaps because of) the health and social care bill should be scrapped.
  • “The secretary of state’s “duty to provide” comprehensive health care is now so obscure that teams of lawyers are working their way through the legalese in an attempt to understand it”

On top of that the Nursing Times this week released the results of their own poll questioning “Do changes to the health bill go far enough to safeguard the NHS?”

The results were 100% no, displaying that readers of the Nursing Times unanimously have absolutely no faith in the health and social care bill and the changes which the government has been making to it.

In conclusion, doctors don’t like it, nurses don’t like it, it would appear many patients don’t like, hell even most politicians don’t even like it but a couple of politicians love it and so do private companies.

I’m still not too keen.

Bury the bill — Delamothe et al. 342 — bmj.com

28 Jun

Only a handful of companies in the world exceed the £100bn turnover of the English NHS; none would have embarked on change in this harebrained fashion. This is the take home message for the next government that spots a once in a generation opportunity to reform the NHS.

via Bury the bill — Delamothe et al. 342 — bmj.com.

How Can Further Measles Outbreaks Be Prevented And The Decline In Vaccination Reversed? – Confirmed measles cases in US tops 150 + Outbreak in Wales.

22 Jun

“The leaders of the antivaccination movement say they speak out because they care about the children. When I see stories like these, from parents who are destroyed by the loss or serious illness of the children, I question those antivaccination advocates. And we know that when trying to sway opinion, just stating facts rarely works against antiscience claims like those of antivaxxers. I’m hoping that more parents see stories like the ones at Shot by Shot. We have the facts on our side, but we also need to touch these parents’ hearts before they’ll see the truth.”

Phil Plait

via Confirmed measles cases in US tops 150 | Bad Astronomy | Discover Magazine.

This Phil Plait article and the USA Today article it mentions are recommended reading to anyone concerned about public health right now and for the future.

I haven’t fully explored this issue yet but it seems to me that doctors, nurses, health professionals, the media and governing bodies are not doing enough to ensure that parents are given a complete and fully informed choice. Which may mean that parents are not giving valid reasons for not vaccinating their children. Continue reading

Follow

Get every new post delivered to your Inbox.