One for the good guys

[Taichiturtle]

Sorry guys. I haven't forgotten the thread - just a bit busy in the week. I will formulate something on this and post it up - just give me a bit of time.

[Taichiturtle]

So 'one of the good guys ' survived an attempt by 'the man' to shoot him down. He can now go on 'curing' cancer and saving lives at the expense of 'Big Pharma' and 'The Establishment'.

*trumpet fanfare*

On the other hand, as I previously stated, nobody really seems to know what he does to treat the patients. The clinic claims it uses antineoplastons in the treatment of the disease. These are said to have been found in the blood and urine of healthy patients, but not cancer patients.
Enough of this work has been published to work out what these antineoplastons are: they are simple by-products of metabolism of amino acids, such as tyrosine and phenylalanine: phenyl acetate and phenylacetylglutamine, namely. Latterly, the use of these has been superseded by use of phenylbutyrate, which is broken down in the body to form the above compounds. This is where it gets interesting, because there are well over 1000 reports in the literature of use of phenylbutyrate in cancer studies. It also has orphan drug status for treatment of urea cycle disorders, so it is FDA-approved (while we are on the subject, orphan drugs are a class of drugs where, generally, nobody makes any money - they are out there for the good of patients with rare diseases that are not profitable to work on.). This is where we see a loophole in action: if a drug is FDA-approved, you are allowed to use it in treatment as long as you are doing this as part of a clinical trial.
So what happens is that Burzynski's patients are enrolled in open-label clinical trials and prescribed these antineoplastons (phenylbutyrate). The patients tend to be those who have not responded to several rounds of chemo- so there is no standard of care for them and hence you do not need to administer other drugs as you do in normal cancer trials.
If you check clinicaltrials.gov, you will find that Burzynski has initiated lots of trials, but has never reported on any of them. He also has many publications in journals which cannot be accessed online where a lot of his case studies are reported. If you look for them through Pubmed you can read the abstract, where results are described, but not access the full paper to see the methods used in detail, or view any data generated in the trials. So you can read about these amazing results, but not see how they were generated.
So let's look at phenylbutyrate and what it is reported to do: it's biological activity is reported as being a mild histone deacetylase (HDAC) inhibitor. There are a few of these in clinical use. The main one is sodium valproate for bipolar disorder. However, it's ability to kill cancer cells in vitro is reported: if you apply massive doses of it to a test tube containing cancer cells, you will start to inhibit their growth. So the plus side is, it is safe. But that is hardly surprising, since it is broken down to generate by-products of amino acid metabolism. However, one thing you need to do is dose it as the sodium salt, since it is an acid in it's natural state. To obtain the blood levels high enough to kill cancer cells in patients you have to dose sufficient sodium phenylbutyrate to induce hypernatremia in the patient. Owing to it's safety, there are many studies with sodium phenylbutyrate in cancer, and all of them have this sort of result: hypernatremia is observed before any effect on the tumour is, and treatment is discontinued. This is corroborated with reports from Burzynski's patients of having seizures (he refers to them as tremors in his clinical trial reports), and most patients who discontinue treatment do so because of strokes caused by the hypernatremia. They are made to drink 5+ litres of water per day to counteract the effects of excessive sodium.

So, we have a drug which can be legally administered as part of a trial, which is safe, but for which no efficacy is reported in multiple studies. Essentially the Burzynski clinic is claiming that using this method produces results. The results are not supported in the wider literature.

Now let's assess the other point: that antineoplastons are 'natural' drugs, and that their use is being suppressed by pharma companies.

Discovering drugs outside of pharma companies looks similar to some of the ideas discussed above: you find approved or generic drugs, run small trials, get encouraged by the results, then apply for the money to run bigger phase 3 trials to generate the data needed. Contrary to popular belief, people do this all the time. People who get nowhere near the recognition they deserve for the work they do. Or you perform meta-analyses of other people's work to catch a larger data set. The money could come from public bodies or charities if there is no intellectual property to sell off, or from the private sector if there is. In the latter case, you obtain patents on your work and sell those to a company. They then front the cash (200 million bucks or so) for the trials and pay you royalties on the sales of the drugs.
Either method will get the drug out there to patients. Burzynski holds patents on some of the antineoplastons work. I have no idea whether they were granted. He does not have access to the hundreds of millions needed to put drugs on the market. Neither does he have the volumes of data required to apply for public money. So what is he trying to do? If he was 'one of the good guys' he would be publishing his work openly and collaborating, and everyone would be using his methods to treat patients, and he would not get richer. Loads of people do this. Conversely, he could sell his patents to a pharma company and become a billionaire. He is doing none of this.
Another alarming note in this is the report of one patient, who is on Burzynski’s website as a ‘successful’ case. His tumour was reported by the burzynski clinic as having reduced in size by ~%70 from looking at the MRI scan. When the patient handed the MRI to his surgeon back home, who had operated on him before he was sent to Burzynski, the surgeon said that the size reduction was due to the non-cancerous tissue healing after surgery – the ‘hole’ in the MRI was actually the hole left by the surgery.
There is one report from an independent group attempting to use antineoplastons in a clinical trial. They agreed before hand with Burzynski what doses should be used, and ran a trial whose design he agreed with. They reported that all of the patients developed hypernatremia before any effect on tumour growth was observed. They wrote up the study, published it and moved on. Burzynski then published an article claiming the studies did not work because the doses (the ones he agreed on) were not high enough to generate an effect. But they were the doses where toxicity was observed - the maximum dose possible.
So we have someone who uses a loophole to administer massive doses of a drug, which is reported to be ineffective. The drug has been given a flashy name and a makeover. And each patient is charged well over $100,000 for treatment. Burzynski has several outstanding lawsuits from patients. One patient alleges that he 'used her as an ATM'.

So he holds patents but does not attempt to commercialise them, has amazing results that other people cannot verify, and he charges patients obscene fees to receive his treatments. Here's an example from the UK press:

http://www.guardian.co.uk/theobserver/2 ... -by-cancer

tragic tragic tragic: A little girl gets a very rare, very aggressive cancer of the brain stem. It is essentially untreatable and average survival time from diagnosis is 7 months. The family contact the Burzynski clinic, he tells them that she can be enrolled in a trial, but the cost is around £200,000 Sterling. Cue lots of fundraising, famous people running benefit concerts etc. The little girl goes over to Texas, gets fitted with loads of tubes to deliver the drug directly into her chest. The result:

http://www.bbc.co.uk/news/uk-england-devon-18331017

Death about 7 months after diagnosis, her quality of life significantly affected and a £200,000 bill for a treatment that did not effect her survival time in any way. And somebody posted a blog article in relation to this case, questioning antineoplaston therapy, and received a bilious, ranting series of threats from someone claiming to be an attorney, but who actually turned out to be from Burzynski’s PR dept:

http://www.quackometer.net/blog/2011/11 ... amily.html

Again, when approached about this individual, Burzynski stated that he was not responsible for the actions of his employees. Same loophole he used with the Texas Medical Board.

And let’s not forget Amelia:

http://www.ameliasmiracle.com/index.html

She died a couple of weeks ago, 2 months after the Burzynski clinic told her family that her tumour was ‘dying from the inside’ – ie that it had outgrown it’s blood supply and the centre had started to necrotise, but that it was continuing to grow on the outsides. This is typical advanced tumour behaviour – not a sign that treatment is working. Tumours shrink and disappear when treated successfully. Reading the story on the website upset me so much that I started to cry – after all, I have a daughter not much older than Amelia. The local community came together, raised £250,000 and went to Houston for the treatment that was going to save her life. Result: no significant extension of life, and the kid was rigged up to a catheter when she could have been doing the things she wanted to do.
Think about it: your kid has been diagnosed with a cancer that has, effectively, 0% 5-year survival rate and no treatment options. You are hoping for a miracle. Then you come across the wesbite of someone offering you one. What do you do? You do everything in your power to make it happen. And this is what he feeds on: desperation.

[somatai]

plenty of people who go through the sanctioned channels die as well........the idea of authority in medicine is truly bullshit....i am not an advocate of the guy per say, but I am happy to see people allowed to explore and try to help and the idea that there is a group who knows what works and what doesn't is such a laugh...this type of authoritarian mind is more destructive than helpful in healing.

[Taichiturtle]

plenty of people who go through the sanctioned channels die as well.........

This was never really under discussion. The point i made was that the rate of deaths in Burzynski's treatment is no lower than the normal rate

the idea of authority in medicine is truly bullshit....

?

i am not an advocate of the guy per say

Could have fooled me

but I am happy to see people allowed to explore and try to help

This is what everyone is doing. In an open and transparent process. Incremental improvements abound from it.

and the idea that there is a group who knows what works and what doesn't is such a laugh

Where did this idea come from? again, this what journals and clinical trials are for.

...this type of authoritarian mind is more destructive than helpful in healing.

If you have methods that are more effective than conventional treatmetns, then document them in the literature, and they will be looked at by others. No authoritarian mind will argue with hard data. What part of it don't you understand? Projecting your authority issues onto medicine is even more destructive.

[somatai]

The amount of $ that goes into research boggles the mind....Considering how unhealthy most folks are and how expensive our medicine is you will have to forgive me for being unimpressed.

[bailewen]

So 'one of the good guys ' survived an attempt by 'the man' to shoot him down. He can now go on 'curing' cancer and saving lives at the expense of 'Big Pharma' and 'The Establishment'. . .

...snip...

http://www.guardian.co.uk/theobserver/2 ... -by-cancer

tragic tragic tragic: A little girl gets a very rare, very aggressive cancer of the brain stem. It is essentially untreatable and average survival time from diagnosis is 7 months. The family contact the Burzynski clinic, he tells them that she can be enrolled in a trial, but the cost is around £200,000 Sterling. Cue lots of fundraising, famous people running benefit concerts etc. The little girl goes over to Texas, gets fitted with loads of tubes to deliver the drug directly into her chest. The result:

http://www.bbc.co.uk/news/uk-england-devon-18331017

Death about 7 months after diagnosis, her quality of life significantly affected and a £200,000 bill for a treatment that did not effect her survival time in any way. And somebody posted a blog article in relation to this case, questioning antineoplaston therapy, and received a bilious, ranting series of threats from someone claiming to be an attorney, but who actually turned out to be from Burzynski’s PR dept:

http://www.quackometer.net/blog/2011/11 ... amily.html

Again, when approached about this individual, Burzynski stated that he was not responsible for the actions of his employees. Same loophole he used with the Texas Medical Board.

And let’s not forget Amelia:

http://www.ameliasmiracle.com/index.html

She died a couple of weeks ago, 2 months after the Burzynski clinic told her family that her tumour was ‘dying from the inside’ – ie that it had outgrown it’s blood supply and the centre had started to necrotise, but that it was continuing to grow on the outsides. This is typical advanced tumour behaviour – not a sign that treatment is working. Tumours shrink and disappear when treated successfully. Reading the story on the website upset me so much that I started to cry – after all, I have a daughter not much older than Amelia. The local community came together, raised £250,000 and went to Houston for the treatment that was going to save her life. Result: no significant extension of life, and the kid was rigged up to a catheter when she could have been doing the things she wanted to do.
Think about it: your kid has been diagnosed with a cancer that has, effectively, 0% 5-year survival rate and no treatment options. You are hoping for a miracle. Then you come across the wesbite of someone offering you one. What do you do? You do everything in your power to make it happen. And this is what he feeds on: desperation.

Funny you should mention this. I wasn't really tracking the thread but then yesterday afternoon I happened to catch this podcast:

http://ec.libsyn.com/p/8/1/9/81928758ad ... id=5306900

One of the news items (15 minutes in) was a discussion about the following campaign to shame the guy and raise money for actual science based Cancer treatments:

http://www.sciencebasedmedicine.org/ind ... -research/

The "good" Dr. was awarded "The Skeptics Guide To The Universe Jackass of the Year Award".

So yeah, I'm not clear how this guy getting off is a "win" either.

[Taichiturtle]

The amount of $ that goes into research boggles the mind....Considering how unhealthy most folks are and how expensive our medicine is you will have to forgive me for being unimpressed.

Duly noted. You are forgiven. The question is, what are you doing to address this? You seem very happy to criticise. Is it not possible that cancer is just f**king hard to treat? Or do you think that drinking p**s is the answer? And also is the unhealthiness of people due to modern medicine?

On the other hand, there are definite success stories: for example, if you have Her-2 positive breast cancer, you have really got a fighting chance of having a decent life. Some of the other oncogenes, for example VEGFR, also have some decent reatment regimens and are not necessarily death sentences any more.

Bailewen: I think I know the article you speak of. the problem with things like this is that you obviously have to show due consideration to the family of the patient, who is already under alot of strain. Some people report receiving hate mail when they say they will go to see Burzynski, which is clearly counter-productive. You wonder whether his success in gaining patients is also related to the goodwill of carers and well-wishers who are keeping a respectful distance.

Either way, I definitely agree that current medications to treat cancer are just not good enough in the majority of cases. But we soldier on

[Michael]

The amount of $ that goes into research boggles the mind....Considering how unhealthy most folks are and how expensive our medicine is you will have to forgive me for being unimpressed.

And also is the unhealthiness of people due to modern medicine?

The dots that I (and perhaps somatai) are connecting, that perhaps you, Taichiturtle, are not at the moment seeing as being part of the problem, is that allopathic medicine, the dominant branch (among five or six licensed branches of medicine) in the USA that's received nearly all the funding in the past century, has become an authoritarian construct and dictatorial institution that can absolutely be judged based on the dismal results it has achieved in the past 60 years when one simply looks at the overall health of USA Americans in the North America and compares their per capita health care costs with those from other industrialized nations.

There was another thread recently where bailewen posted a TED talk about a medical statistician who revealed how Big Pharma removes negative study results to get their drugs passed. The amount of fraud going on in allopathic medicine and Big Pharma in the USA in a single Vioxx type incident is many, many orders of magnitude more harmful than all of the snake oil salesmen of the turn of the 20th century combined. When you add in the psychiatric fraud, well...

The stupidest people are those who believe their authority is the last word. Most doctors I've known fall into this trap, but it's no surprise because they're trained to believe they are the sole possessors of medical knowledge and have lots of monetary incentives to perpetuate that belief.

Your attitude here, Taichiturtle, is very similar to the doctors I'm referring to.

[Taichiturtle]

The dots that I (and perhaps somatai) are connecting, that perhaps you, Taichiturtle, are not at the moment seeing as being part of the problem, is that allopathic medicine, the dominant branch (among five or six licensed branches of medicine) in the USA that's received nearly all the funding in the past century, has become an authoritarian construct and dictatorial institution that can absolutely be judged based on the dismal results it has achieved in the past 60 years when one simply looks at the overall health of USA Americans in the North America and compares their per capita health care costs with those from other industrialized nations.

And as I stated to Somatai. This is not under discussion. It was a point that Somatai appeared to fall back on later in the thread. This can be discussed elsewhere.

There was another thread recently where bailewen posted a TED talk about a medical statistician who revealed how Big Pharma removes negative study results to get their drugs passed. The amount of fraud going on in allopathic medicine and Big Pharma in the USA in a single Vioxx type incident is many, many orders of magnitude more harmful than all of the snake oil salesmen of the turn of the 20th century combined. When you add in the psychiatric fraud, well....

Interesting. You should read that particular medical statistician's work before you try to use his statements in a debate. Are you familiar with his work? I am. In case you didn't realise, the cardiovascular safety data on Vioxx was always freely available and transparently published, and formed the basis of all of the resultant actions taken. The drug has now been withdrawn. Hence, you are using an example of how transparent peer review has led to the withdrawal of a potentially harmful medicine as evidence of fraud. This is a great example of the industry policing itself. The fraudulent activity of Merck officials here is hard to find. There may have been some foreknowledge, there may not. But the data was always out there.
You should also note that I am not from North America, and alot of the 'victims' of Vioxx were caused by the North American regulatory infrastructure. The problems were not as pronounced in the UK where I am from. Your vaunted medical statistician, mentioned above, made great reference to it in his work on this subject.

The stupidest people are those who believe their authority is the last word. Most doctors I've known fall into this trap, but it's no surprise because they're trained to believe they are the sole possessors of medical knowledge and have lots of monetary incentives to perpetuate that belief.

Your attitude here, Taichiturtle, is very similar to the doctors I'm referring to.

I have at no point expected anybody to rely on any perceived 'authority' of myself. I have restricted my arguments to interpretation of data when challenged as to what my opinions are. You, on the other hand, have resorted to quoting authority figures and making didactic truth statements to make points. (Actually, that phrase was also used alot by your medical statistician as well), so maybe you need to address this yourself.