Burzynski Patient Amelia S.’s Story

[Houston Press Readers: This is a re-post of an earlier story that really shows what we’re dealing with at the Clinic. The other story we recommend is Burzynski Patient MacKenzie L.’s story. Just last year, her family fought for him to get his “trials” back, and then horrible things happened to them.]

As Stanislaw Burzynski stands in front of the Texas Medical Board to answer for yet another litany of abominations, patients are no doubt gathering to protest in front of the courthouse so they can beg for their lives. Many of his supporters in the past have been then-current patients who were convinced that Burzynski is their only chance at life. Burzynski’s patients often have dismal prognoses and their prospects do not improve when they buy into his medical adventurism. In anticipation of such patients being used as human shields yet again, we are focusing on stories of people who have testified on Burzynski’s behalf, begged for their lives in courts and in the public, but who of course died anyway. These patients, so far, include Burzynski patient Elke B., Burzynski patient Douglas W.,Burzynski patient Janet C.Burzynski patient Sen. Ed G., and McKenzie L. These patients may not be testifying in the upcoming trial, but their stories are perhaps the most important and are far more eloquent and revealing.

Last week, we posted about the patient who had perhaps the most high profile campaign in the US in recent years. This one is perhaps the biggest in UK in recent years. The case of Amelia S. is a hard one to write about, because it tipped skeptics off to a pattern in the stories that patients at the clinic were telling, that their worsening symptoms were signs of improvement. As you will see, this is a story that Burzynski’s patients have been relating for decades. It’s a long post, but it’s important that you read to the bottom.

***

3-year old Amelia S. lived in Reading. In about September of 2011, Amelia started displaying neurological symptoms–wobbliness and a trembling left hand (often drawn into a fist). The family brought her in to the hospital after she started falling down. On Jan 30th, 2012, she was diagnosed with a brain tumor, and on the 1st of Feb it was determined to be a large tumor on the brainstem. Surgery revealed a grade 2 diffuse astrocytoma, which the family was given to understand meant that the core of the tumor was likely grade 3. Doctors were unable to remove much of the tumor, only the 4 biopsy samples.

Amelia’s medical team was honest. The benefit offered by radiation and chemotherapy, on average, could be measured in weeks. These are bad, bad tumors. The family brought Amelia home on the 20th of February, her mobility and speech impaired, opting to spare Amelia the unpleasantness of the chemotherapy and radiotherapy. When they saw Amelia improving (we’re not told what those improvements were–whether they were reduction in tumor size or reduced swelling as she recovered from surgery, for instance), however, family understandably felt obliged to look for other options.

They found Burzynski. Immediately, the enormous price tag of his antineoplaston treatments spurred the family on to raise funds. Amelia’s father began documenting their journey to Burzynski in a couple of places, at ameliasmiracle.com and on a Facebook page of the same name. As a whole, his story is the most moving and insightful account of parental heroism that I have read since I began this project, and I strongly recommend that you read it for yourself.

By the end of February 2012, the family had decided on Burzynski. We were introduced to Amelia on February 28th in a video posted by her father:

Attached to the video was a simple plea:

Our daughter, Amelia, was diagnosed at the beginning of February with a very rare type of inoperable brain tumour. She has only a few months to live. We have a ray of hope – treatment for her is available at the Burzynski clinic in Houston, Texas. This treatment in total will cost around £200,000. We need to raise this money to allow Amelia to have the chance to live a normal life.

From the beginning, the family sought media attention to raise money for the Burzynski Clinic, as we see in a Facebook post. the earliest example of Amelia’s story appearing in the press was in the local Wokingham Times on 8 March 2012. The public campaign was launched. And by 14 March, £45,000 had been raised by the community, enough to get Amelia in the door at the Clinic (recent accounts put that initial consult at $30,000). The Wokingham Times seems to have informally adopted the family and followed their progress closely for the rest of the year. These community fundraisers appear as human interest stories and reaffirm that people are basically kind and generous and trusting. In fact, my first exposure to Burzynski and realization that something was profoundly wrong came after I did a newspaper database search for all of the patients that I could find. Of those patients I could find an outcome for, every patient who appeared in the international press, usually begging for money, with a single exception was dead.

A week before Amelia hit the papers, on the 6th of March, Eric Merola, who made an uncritical hagiography to Burzynski unironically called, Burzynski: Cancer is a Serious Business, interviewed the family about their upcoming trip to Houston for his new movie, a sequel, which comes out soon. He planned to follow Amelia’s progress in the film. On the 17th, as they planned their trip to the US, the family put up a short video for Amelia’s donors:

So, she clearly she packed everyone’s hearts into her suitcase. Such a dear.

They left on the 23th of March for America, having raised a staggering £75,000 for Burzynski. In a Wokingham Times piece, her father stated some of the opposition that the family had met:

Mr Saunders added that he was amazed at the number of people who had suggested the American treatment would be fruitless.

He said: “I was warned about this before we decided to go with the Burzynski treatment – it is like there is a vendetta out against the man.

“It is so strange, and all I keep getting are contacts from patients who have been or are being cured by the treatment, or at the very least have had positive results.”

People for whom Burzynski’s treatments fail tend not get into contact with other patients. We are witnessing what is known as survivorship bias. You can talk to a dozen survivors and have a positive impression of a treatment but fail to take into account the 10,000 failures, which would put a treatment well below the efficacy of chance remission, misdiagnosis, and unrecognized responses to traditional therapies. This is why controlled trials are so important to determine efficacy, so we can sort out the background noise of chance from real effects. It is also an important reason that dependence on patient testimonials is a red flag for quackery.

Amelia has had a hole opened in her chest where a Hickman line has been inserted, where she will receive her ANP. These frequently have complications with infection and clogging.

By the 30th, Amelia has her backpack full of antineoplastons, as we see in a video. Her family will spend the customary 3 weeks or so in the US learning to administer the ANP themselves. They are infused at high doses almost continuously.

Amelia’s dad shares his first impression of the Clinic on the facebook page:

The clinic have been fantastic. I am still amazed that people give them such a bad press. They have literally bent over backwards to get this started for us. The receptionist Irena even has a photo of Amelia behind her desk, she is so lovely!

Well there is a reason, of course. It’s because they apparently tell patients that they can tell brain tumors are shrinking by looking at their urine:

Mr Saunders said: “Every day is a milestone and the clinic is being extremely thorough in its tests – Amelia has regular blood tests and these are all closely monitored to check for signs of all sorts of things.

“Interestingly, they can actually see the early signs of the tumour breaking down by how her body excretes it in her blood and urine. This might be the only time in my life I get excited by seeing this kind of information!

I’m not sure what this is supposed to mean, and before Amelia’s story I would not have even noticed this. I can see why a parent clinging to hope would sieze onto any augury of healing. Remember, this family has not had good news about Amelia since her diagnosis. Little steps, literally, mean the world to them. I contacted research oncologist David Gorski, who studies and treats breast cancer, about this claim, and he replied:

“Oncologists don’t monitor anything in the urine for tumor breakdown, at least not for that tumor. There is such a thing called tumor lysis syndrome, but that’s usually only seen in leukemias and lymphomas as a result of induction chemotherapy that kills a lot of cancer cells really fast, releasing potassium, and a number of other byproducts. However, as I said, you don’t generally see this in solid tumors (mainly because none of them respond nearly as dramatically to chemotherapy as hematological malignancies). It’s also a complication to be managed, because its most frequent result is renal failure. It’s possible that he’s referring to GFAP, which is a biomarker for glioma under study, but I don’t think it’s really been validated as a measurement of response to therapy.”

There are apparently no biomarkers for glioma that appear in urine. Amelia had chronically low potassium at this point in her treatment.

We don’t see a lot of what is going on at the clinic on facebook, where most of the story is told record, but we get a clue on Amelia’s other website:

10th April 2012

I realised I hadn’t updated the news section here for a few weeks, this is largely because we update our Facebook page daily and much of our time has been taken up going to and from the clinic. Every day has been a bit of a rollercoaster here. Amelia has been on antineoplaston treatment for a week and a half and at the end of last week we hit a bit of a wall with the treatment dosage. Amelia got pretty sick so we had to back down on the dose a little. Yesterday she started getting really bad headaches so we have now also put her on a low dose steroid as well. Other than this, she is doing well and responding well to treatment. We think there are some very slight improvements in her coordination of her left hand side. We are continuing the treatment, and the aim is now to increase the dosage more slowly to see how she responds. All in all we are doing well and looking forward to coming home soon!

So, she’s been up and down. The steroids are a recurring feature of treatment and can very quickly reduce inflammation in a way that leads to improvements of the type that the family is reporting. You see it a lot on this website. It’s hard not to think of John D., who experienced worsening symptoms while under treatment (and on steroids), which was met with joy on the part of the staff:

I want to mention that the IV nurse told mom today that she’s been there for 10 years & has seen this before & many times, the more severe symptoms that are seen as a result of the therapy is really a good sign that it’s working better. I know this nurse & she is very honest & helpful. She also runs the class they run every week for new patients.

On April 19th we hear that the family is preparing to return home, and on the Wokingham Times page where it is announced, we see that damned picture again, patients literally at death’s door, posing in front of the Burzynski Clinic. We get the update that they have arrived back in England on the 22nd. Amelia’s dad talks about the fundraising (truly amazing acts of generosity by the whole community) and how grateful he is for the immense support that the family has received. (Amelia gives her own thank you’s in an adorable little video a few days later.)  He speculates on the road ahead:

I have come home from Houston with a strange kind of feeling. Perhaps a little apprehension, a bit of fear, a dose of happiness and a shot of hope. We still feel that every day is a roller coaster. We may be sitting on a ticking time bomb, and it may still be that any day we might lose Amelia. Every day truly is so precious, and it is a joy to watch her and her little sister back together again, albeit in a different way, a more careful one, where we have to watch them all the time.

The next day, it sounds like Amelia is having the unquenchable thirst that comes with ANP:

Amelia has been OK today, she was a bit sick earlier but we think this was because she drank too much too quickly – she was fine shortly afterwards. We’ve been getting used to life again at home and putting everything in place we need to.

And we hear that she is due for her first post-treatment MRI:

As far as the MRI goes, I just want to make a point that we aren’t expecting a lot to have happened with this next scan. As part of the medical trial we are required to get a scan done every 4 – 5 weeks – and these things take time to show any change. It is very likely the tumour may be the same or have grown slightly. This is fine and we expect this, and clearly if it has shrunk then great – but we aren’t expecting it to have done.

Tumors on which chemotherapy is working should probably not be growing at all. It’s the definition of “working.”

On the 25th:

Today has been a busy day. Unfortunately Amelia was pretty sick this morning – those of you who have been following our journey will know that we are trying to increase Amelia’s dose of drugs and it sometimes has side effects, this seeming to be the most common. She was fine afterwards and has been eating for the rest of the day.

We had an appointment at the hospital at lunchtime and ended up spending most of the afternoon there so we could get everything sorted. The doctors here are being very cooperative – but I must emphasise that they are recommending different treatment (chemo) and we have consistently turned this down. We have not found a single person with a DIPG tumour that has had any effect with chemo – so continue to find it strange that this is offered. Our plan is to continue the antineoplaston treatment for as long as required. We realise this is being frowned upon by the doctors here – but ultimately we are trying the only thing we found that had credible results.

Credible results would have been publication and replication of his trials. Burzynski can’t seem to complete his trials, much less publish them (which is odd given that he has the test agent already developed and the tumors he is working have outcomes comparatively rapidly). If trial completion were a batting average, he’d be at .015 and his trial publication average would be .000.

By May 4, Amelia is a celebrity. They have raised £160,000 (!) and she is meeting and hanging out with celebrities. And the paper has clearly been reading Amelia’s dad’s updates. Also, her dad’s website announces:

Well we have now been back from Houston for a few weeks – and Amelia has continued to slowly improve with both her walking and speech getting better. The Burzynski clinic were brilliant – we were made to feel so welcome and Amelia really made an impression on everybody there!

We had an MRI scan on Monday that revealed her tumour has stopped growing. Considering she has had no treatment other than the antineoplaston therapy from the Burzynski clinic, we are really pleased (and impressed) that the treatment seems to be working so quickly. We are now continuing the treatment and increasing her dose such that we try to get her to the ‘target’ dose for her weight.

This tumor “stopped growing” news is taken as validation that the treatment is working, so much so, that the Wokingham Times irresponsibly reports that result.   According to her dad:

1. Amelia has been on treatment for less than 4 weeks.
2. She is not on full dose yet, and has some way to go to get there. This is a slow progress, perhaps taking another month or so to achieve this (or more).
3. She has a low grade tumour. Any response will be slow. In other kids where the treatment has worked it has taken many months to show response.
4. She is still on steroids.
5. Her previous scan showed a 13% growth in 7 weeks.

So, having now had several opinions of the scans, I can confirm that Amelia’s tumour has STOPPED GROWING. This is amazing news and we are over the moon that this is the case. For this tumour type, in this short time, with a tumour of the size of Amelia’s, this is an incredibly good result. This is an INCREDIBLY hard tumour to do anything with, one of the hardest to treat and normally very lethal. In most circumstances Amelia would no longer be here (in February there was no way we thought we’d get to May with her) so to have the thing stable is fantastic news.

A few important points. It’s a low grade (slow growing) tumor. This does not seem to have been a PET scan, which would give  a sense how of active the tumor was–to see if it had in fact “stopped.” And initial responses to chemotherapy (and ANP is chemotherapy by every definition) correlate poorly to outcomes, which is, of course, the final goal that everyone involved is keenly interested in. Of course, the Clinic doesn’t convey that information:

I also had a good chat with our doctor in Houston earlier. Again all sounding very positive, and we have again increased Amelia’s dose tonight […] The clinic sound very positive that Amelia’s tumour stopped growing so quickly. Let’s just hope we have more positive news on the next scan in June.

On 12 May, we get an update about Amelia’s progress:

Amelia was on top form today, she was pretty tired after the wedding but perked up and during doses, when we unplugged her from her backpack, she was really bubbly. Later in the afternoon she was doing some proper walking – unassisted. I think we have now realised that a lot of the walking problem now is just her confidence. She was walking almost normally, and certainly the same or better than she was before her operation. Fantastic.

So, they are at point zero, which considering where they have been is wonderful from the family’s perspective, but it doesn’t tell us that the ANP is working of if she has just recovered from surgery to her brain stem and is now on steroids. And this may be important, as dad mentions on the 20th:

She really has improved. We’ve both noticed significant improvements in her speech, mainly in the quality of her pronunciations and also the speed and which she speaks. Slow speech is a classic symptom of her tumour location, so any improvement is a good sign here. This might be the steroids causing this improvement so we have to be careful, but we have a lot of fingers crossed we’ll be taking her off the steroids within the next few weeks if we can get her second bag to target dose. We’ll see.

On the 21st:

Amelia has been a bit groggy, fairly lethargic and pretty reluctant to do a lot. […] Because of the lethargy, the doctor in the US has recommended increasing her steroid dose very slightly. We’ll see if this improves things – if it does then this is a good sign. It does all tie in with us increasing her dose, which is now at maximum on her larger bag. No wonder.

Also on the 21rd, just over a year ago, the fundraiser reaches its goal of £200,000, and the tally continues to climb. In the intervening time, however, we hear that Amelia has had some complications with the Hickman line, which has been replaced because of a tear:

She is doing well otherwise, and we’ll be resuming her treatment tonight. She is now walking by herself, her coordination and balance have all improved and her speech is much better. It looks like the treatment is definitely helping her.

In early June, dad is rattled by the deaths of patients Billie B. and Supatra A., who had the same tumor as Amelia, and for a few days he rails against skeptics. Apparently some have been contacting him and criticizing him. This is wrong, in my opinion. Cancer patients have enough on their plate.

On the 21st, we hear that the tumor remains stable:

Firstly we are waiting on a further interpretation from Dr Burzynski, but as we suspected from our own view of the scans this morning, Amelia’s tumour remains stable. In other words, there is no change since the last scan.

The family accepts this as a sign that they have stayed the brain tumor:

We are 100% sure that without antineoplastons, Amelia would either be in a hospice by now or dead. She has a grade 2 tumour, on scans it appears as a grade 3, and it is very large and in a very dangerous part of the brain. Even a few mm of growth would cause a significant impact on her quality of life at this size. We are all walking on a knife edge. Dr Burzynski’s treatment is undoubtedly keeping her alive. I actually want to wave this in the face of all the skeptics we came across along our journey.

It’s worth noting that the tumor hasn’t shrunk. Small victories–including just not dying–are huge when your child has one of these tumors.

Amelia has her 4th birthday on the 22nd of June, and it is celebrated in the papers.

Again, we see that the steroid dose is being increased on June 25th to control the symptoms of the disease:

We have been advised by the clinic to increase her steroid intake back to how it was last week to see if we see an improvement in her. We will then try in a couple of weeks time to reduce it again but at a slower rate, reducing it by 0.25mg instead of 0.5mg per day. The steroid intake is a tricky issue as they are essential and help reduce the symptoms of this awful disease (headaches, tiredness), however long term steroid use is not good and cause side effects such as weight gain, muscle problems.

We still haven’t seen anything that looks like clear evidence of improvement past diagnosis; it sounds like the symptoms return when the steroids are tapered. She seems to be doing pretty well on this dose of steroids, going to school. (Her last day of nursery school is 11 July.)

On July 15th we hear:

Well – we have had a pretty good weekend. I had a truly amazing conversation last night. Purely by chance I’ve been contacted by the mother of another little girl, who is almost the same age as Amelia, who is receiving the same treatment (for longer), with the same tumour (DIPG) and her tumour just shrunk. By 36%. We are so, so pleased. There is so much hope in our hearts now.

I’ll just briefly mention how frustrated we still are to read so much crap on the internet about Dr Burzynski. I feel like we are ‘insiders’, in a way, and know how the whole thing works now. These doubters clearly don’t. The lady I spoke to last night was told her daughter would die. When she went to Burzynski, her doctor shut her off. Refused to speak. Thank God she chose to follow her heart, and not that doctors advice. She might just have saved her daughters life. There is no doubt this works, and we want it in every hospital in the world. We’ll keep spreading the word until it is.

This child, sadly, is now dead.

By August the tumor has not shrunk, but Amelia has been coping very well. A few weeks earlier she had a wonderful day at the zoo. She’s still a little wobbly on her feet and in the pictures her family put on the Facebook page, you can tell that her face is not symmetrical, but by God she’s enjoying her life, which is an immense thing in itself. On the 6th however, she gets pale and sick; when her blood work is done, they find that her potassium and magnesium are way down, though they stabilize her.

On August 8, we hear:

One of the many things I have said throughout this year is that I hope that maybe, one day, I can learn that another child has had success with this treatment because of the inspiration they gained from Amelia. I know of one little girl, Chey, who is waiting to go to the clinic right now. But due to some complications with the FDA and the clinic, there are some delays – but we are all hoping she will get there very soon. We felt so welcomed by the Burzynski clinic and everything we saw there made us puzzled why so many people don’t believe in it.

We just found out exactly what happened. According to an SEC filing:

In a letter dated June 25, 2012, the [Burzynski] informed the FDA of a serious adverse event which may have been related to the administration of Antineoplastons.  On July 30, 2012, the FDA placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active Phase II or Phase III studies under IND 43,742.  The FDA imposed this partial clinical hold because, according to the FDA, insufficient information had been submitted by the Company to allow the FDA to determine whether the potential patient benefit justifies the potential risks of treatment use, and that the potential risks are not unreasonable in the context of the disease or condition to be treated.

According to the mother of patient Alynn H., her understanding was that a child had died (link is password protected). We have not heard anything else, only that the ANP trials, almost a year later, have not started up again and that the partial hold remains.

On August 13, Amelia’s dad posts a video about Amelia’s life since diagnosis. This write up an unusually long post for this blog, and I haven’t done justice to the support the family has received from their community or the sheer number of people who pitched in to help the family, and this video gives a sense of that:

On the fifteenth, we hear that the family is understandably anxious for the tumor to shrink:

Incidentally, we are well aware that a stable tumour is good. Mondays scan was one that we went into thinking ‘if it is stable then great’. I’ve had a few people come up to me and ask “is the tumour shrinking?”. Now I know people mean well – but it is a little like me walking up to somebody and saying “have you won the lottery yet?”. In other words, frustrating. I smile, say no, it will take time, and move the conversation on.

So far, the tumor’s behavior has been utterly unrelated to the dose of the antineoplaston chemotherapy. On Aug 25, we hear that Amelia is tired on treatment and that she has had a progression of symptoms:

We are still looking to increase her dose slightly as she has gained a little weight since Houston so she should be able to tolerate an increased dose (or at least we hope so). We will probably have to increase her steroids in line with this, but we have been considering this anyway as she seems to have become a lot more wobbly lately. We know from the MRI that the tumour hasn’t grown so an increase in her steroids should help this.

Now, I’m not sure how this was verified. The definition of a “stable” tumor can actually accommodate some growth, so, we can’t know exactly what is happening. And we hear from the family a few days later that they have come to a hard realization:

On the 27th, we hear:

Firstly, Amelia hasn’t quite been herself unfortunately. She has been very reluctant to walk, a lot more tired, slow and pretty lethargic. She was sick on Saturday night also. We are reasonably confident we have probably gone too far with the steroid reduction so we have actually increased these slightly again today. We decided we would rather have a happy and more alert Amelia than one who doesn’t want to do too much – so we made this decision today in coordination with the Burzynski clinic. We’ll see how she does. There is a small chance it is the tumour growing, but much more likely given the scans we have that this is due to swelling of the tumour caused by the treatment. Time will tell. […]

The symptoms we are seeing right now are a direct result of the tumour, hopefully due to it swelling, and the steroids will fix this. They are also what we would see if it has grown.

It really, really looks that her wellness is linked directly to how much steroid she is receiving. And here’s another example of something that is…desperately, desperately wrong at the Clinic. The patient is being told that the tumor is swelling because of the treatment. How is it that only at the Burzynski Clinic that getting worse is indistinguishable from getting better? Second point: this is a tumor on the brainstem. If a possible side effect were swelling of the thing pressing against the brainstem, you’d expect that to be on the informed consent form, right? The type of thing that would be among the “serious side effects,” right? It’s not, at least not in a version of the consent form used after Amelia had started ANP:

consent1 consent2 consent3consent2consent3

(Burzynski’s supporters who have been saying that the treatment has no long-term side effects would do well to look at that first paragraph. The paperwork that every patient signs says it can have exactly that.)

On September 5th, we see a candid moment on the facebook page. The parents are committed to seeing this therapy through, but the father has that lingering awareness that this nothing the tumor has not shrunk:

Whether we have returned to a feeling of optimism or not remains to be seen. I still feel uneasy about the fact that we are so far on without the tumour shrinking. It is frustrating, because we have worked SO hard with the treatment – our entire lives are ruled by it and it is almost a full time job sorting it all out – we just share it between us and make it happen. We just know to be patient, and we 100% know it can work.

At this time, Amelia was returning to school (she had already been going to nursery school on treatment). And the way it appeared in the press, and certainly how I and other skeptics read it, it was being promoted as, “See? This treatment is working enough to let this little girl go back,” a human interest story (The Mirror’s coverage was profoundly disgraceful–suggesting UK doctors “refused to treat” Amelia, whereas when you look above you see that in fact: “The doctors here are being very cooperative – but I must emphasise that they are recommending different treatment (chemo) and we have consistently turned this down”), and by god it was good to hear that Amelia was having a great time, but there’s a lot more going on than is contained in the articles. On the 5th we see how much support was needed to get Amelia in. This was not the return of a healed child that everyone took away from the coverage:

“There has been a LOT of organising around this, far more than getting a healthy child to school. We’ve arranged our nanny, we’ve had to work around the school timetable, we’ve had meetings with the school and the teachers and the hospital nurses and made everything happen. The school have been absolutely fantastic every step of the way – we literally cannot fault them.”

On the 8th, we see on the Facebook page:

“On Monday we have a physiotherapist coming to look at her to see if she can get her walking again. I tried a little walking with her today and she is really, really trying. You can see she struggles, like her brain doesn’t know how to do it but the conscious Amelia that we see and know does. It’s a bit like trying to write with the wrong hand – you know what to do but you can’t quite make your hand write as well as the other. She tries to walk, but can’t quite make it all fit.”

This is not a child improving.

September 10, on they were visited by Eric Merola for his utterly uncritical documentary about Burzynski. More on that in a moment.

On the morning of the 15th, Amelia woke up crying with a pain in her head. She went off treatment for a day or so and got better, not trembling, perhaps speaking a bit better. One wonders if she is not experiencing relief from the hypernatremia that can appear alongside such massive sodium doses and can have such side effects.

Amelia has a great couple of days in late September (and she really takes to her school!), and her dad talks about how the awful waiting game goes in between MRIs, which I have learned is how time is measured by cancer patients:

I’ve said this many times before, but the really frustrating thing for me is not having anything really tangible that tells you this is working, until we get the scan image in front of us. This means an 8 week wait between scans when you really have no idea what is going on, and if she gets worse like she did a few weeks back then I think you naturally assume the worst. Then she gets better, and you relax a little!

The October MRI shows no change. But later that month, the family is trying to come to grips with what life will mean in the likelihood that Amelia is not with them. It’s a beautiful post, and I hope you read it. It’s immensely sad and healthy and you can’t help but feel the full force of their grief and fear. This family is mentally preparing themselves for a horrible future, and this makes what happened next absolutely inexcusable by any measure.

By November 19th, Amelia’s right hand is immobilized, a clear progression, and the family gets the results of a recent scan:

What I don’t want to do is get ours, and everybody else’s hopes up about things. I could not bear thinking that this is working and then to be told it isn’t. (emphasis added)

What I will elude to is that the Burzynski clinic feel that there is a cyst forming inside Amelia’s tumour, very slowly. This does seem apparent on the scan images but we want to make sure this has grown over the longer timeframe. A cyst will form where there is cell breakdown, so clearly is a good thing from a ‘killing the tumour’ viewpoint, but possibly bad in that you then have fluid in a very difficult place to get to. We’ll address that little hurdle if we get to it being a problem in the first place.

This sounds exciting (it is), but we are really trying to be careful about getting too much so. Amelia has got worse, although she has had some improvement over the weeks before her MRI. This could be due to a number of factors and we know the tumour has not grown.

Another point with this is that the tumour isn’t shrinking, but if a cyst is forming then it might be some time before the tumour does shrink. We’ve always said that due to Amelia’s tumour being very slow growing, we have more time on our hands more than most kids who get this.

When this news was released on the family’s Facebook page, followed by rapturous confirmation the next day, it was brought to the attention of Orac at Respectful Insolence, who gave an honest medical opinion:

It pains me greatly to do this, because, no matter how I write this, it will be perceived as trying to take away the hope for Amelia’s survival that the Saunders family holds. Such is not my intent, by any stretch of the imagination. However, these “cysts” almost certainly represent areas of ischemia (low blood flow) leading to tissue death as the tumor outgrows its blood supply. This is a phenomenon commonly seen in advanced malignancy. I know this because tumor angiogenesis ia one of my areas of research interest. […]

Sadly, then, seeing “cysts” growing in Amelia’s tumor most likely says nothing one way or the other about whether or not it’s responding to Burzynski’s antineoplastons. That’s assuming that Burzynski’s interpretation of the scans is even correct, which I wouldn’t bet money on. Most likely, these “cysts” indicate that there is no therapeutic effect. I take no pleasure in saying this, but most likely this is true.

Amelia’s dad was understandably upset and actually responded to Orac on Nov 29th, but the day after Orac posted, the family updated their followers:

We know that some people doubt what we are doing. We understand that it is in human nature to question, and many people will not just take something on faith alone. But, ultimately, this is our choice. And that choice seems to be paying off.

Yesterday I sent a CD with the latest MRI scans on to our local oncologist and I’ll be waiting for their opinion. We’ll consider this, and then continue until the next scan and see if the cystic formation that we have been shown grows in some way. I don’t want anyone to think we just take things at face value and accept them – we consider what we see, what we are told, and get as many opinions as we can. We can see with our own eyes though that something has changed with the tumour and we hope this continues. Amelia’s tumour hasn’t enhanced or progressed, so we know it is unlikely to be anything other than cysts, but we will get that second opinion for sure.

Amelia had a magical week. She won a community award, the “Child of Courage” award, and was literally the star of a Nativity play with her friends. The reality of Amelia’s situation soon came upon the family, however. On 2 December:

The truth is, Amelia isn’t getting any better neurologically. We live with her every day and we see it. She is very slowly deteriorating and I think we would be putting our own heads in the sand if we didn’t accept this. On one hand we have the Burzynski clinic who believe the tumour is beginning to die. We are getting opinions here about this theory and we’ll very likely need another scan of a different type in early January to back this up. Everything is based on opinions – and nobody agrees, which makes it all very hard on us.

And the final assessment from the Great Ormond Street Hospital:

We had our meeting at Great Ormond Street yesterday and, sadly, they just don’t have anything for us. We kind of knew this before we went – but wondered if they might have a trial that we could take part in. Unfortunately they don’t.

They felt that Amelia is in the latter stages of the disease, and that what is called ‘progression’ has already started. This means her tumour is growing, the cancer is spreading and we don’t have a huge amount of time left. Again we had already guessed this was happening but it was good in a way to have another opinion of this.

Were it just a one-off bad interpretation of an MRI on the part of the Burzynski Clinic, we might have been able to write this off as a simple mistake. But it’s not. Not by a long shot.

Had Burzynski not used this line on the family who had given him by far the most publicity of any other in years, this recurring theme might have slipped by unnoticed. But it’s clear that this is not just a coincidence, it’s an M.O. predicated on false hope that strings parents and patients along. And it’s been going on for decades! And it leaves patients utterly crushed and confused. The few skeptics who have been working these stories in their spare time have found case after case of patients thinking that getting worse is getting better (a partial, growing list can be found in this post). Consider that the cases written up at this website represent 1/10th of the total cases we’ve been able to find and will be bringing to you, that we have only found a small fraction of cases, mostly from the most recent years, and that this guy has been operating for over 35 years! My god! Imagine what that means!

In light of this, when Eric Merola, in his new movie, says in a series of title cards:

Two months after this interview, Amelia’s tumor began to swell and fill with fluid.

There was confusion and disagreement among between their local radiologists and the radiologists in Houston, [sic] about why this was happening–

So her parents decided to discontinue antineoplaston therapy.

[Then he cuts to a picture of Amelia’s obituary and says,]

“Amelia passed away with her parents by her side on January 6, 2013.”

…it is fundamentally dishonest. There was no confusion. There was the right diagnosis and Burzynski’s diagnosis, a story that’s been spun for decades to desperate parents, and it’s a goddamned disgrace that Merola suggests that the parents’ evidence-based decision could have been related in any way to the outcome.

Instead of the usual plea for a donation to St. Jude Children’s Research Hospital, which researches children’s tumors and provides care for free, we’d like to ask you to make a donation to Naomi House, the children’s hospice center that cared for Amelia’s family in the last days and which seems to be the family’s preferred charity.

If you want to take action, protect the vulnerable, and put reliable information in front of patients who might be looking into this Clinic, the Skeptics for the Protection of Cancer Patients (facebook page here) have put up guidelines about how to boost good information into Burzynski’s search results.

Burzynski Patient Priscilla P.’s Story

Priscilla P. had driven a school bus in numerous cities around the country. In November 1998, she was diagnosed with ovarian cancer. She had radical surgery, a complete hysterectomy and removal of her gall bladder, appendix and lymph nodes. Following that, she endured a year and a half of chemotherapy.

On 8 June 2000, her story appeared in the Atlanta Journal Constitution, raising awareness of a fundraiser for Burzynski:

The chemo slows the cancer, but it’s still growing. But [Priscilla] is upbeat, determined and not about to give up. Her bright blue eyes are animated as she explains Dr. Stanislaw Burzynski’s experimental treatment program in Houston, where she has been accepted as a patient. The treatment is called antineoplaston therapy. Very basically, antineoplastons act as a biochemical microswitch, turning on tumor ­suppressing genes to stop tumor growth.

“My son read about it in People magazine,” she said. “Basically, you have an infusion or take a pill which only attacks cancer cells, without destroying healthy cells. It teaches the cancer cells to die. . . . He’s had over 3,000 patients with great results and very good results with soft sarcomas, which is what I’ve got.”

There’s only one snag to the scenario, and that, of course, is money.

Of course. he has no track record–no basis to claim ANY results with sarcomas because he has never published a respectable account of his treatment. And there is similarly no evidence that ANP is a “biochemical microswitch,” an unnecessarily sciency term if I’ve ever seen it. The article continues:

Since the clinical trial has not yet been approved by the FDA, insurance companies won’t pay for the treatments, which would total about $50,000 for a five-­month program. Like most people, [Priscilla] doesn’t have access to those kinds of funds, and the clinic requires up-­front payment of $20,000 before treatment can be started.

“I can’t understand why insurance won’t pay,” said [Priscilla]. “The cost is a bout the same as chemo, and it would only be for five months, where the chemo can go on indefinitely. . . . Less than five percent of patients are able to go for these kinds of clinical trials because of the money situation, but this is how cures are found. If they don’t have the people to do the trials, how can they hope to find a cure?”

I hate to have to disagree with a patient, but this is NOT how cures are found. Respectable researchers secure funding on the basis of the merit of their ideas, their track record, their ability to convince knowledgeable peers at research foundations to sponsor their research, or their ability to attract investors. Disreputable quacks hit up the dying for cash and bleed the desperate dry, never publishing anything convincing.

Part of Priscilla’s mission, it seems, was to spread the gospel of Burzynski, and she and her family repeated his talking points to the press, who dutifully reprinted it without critical comment, which is deeply irresponsible. I guess fact-checking is something that other newspapers do.

Education of the public is part of what they hope to accomplish as well, said [Priscilla’s daughter].

“I just want people to be aware that these kinds of treatments are available, but people can’t use them because they don’t have the money, and insurance won’t pay,” said [Priscilla’s daughter].

“The other thing is that people like my mom get accepted after everything else is exhausted. She’s had a year and a half of chemo, and she’s completely run down by it. What would have happened if she went (for the treatment) right after surgery? She may have been completely cured by now. If they could go immediately when diagnosed, rather than after chemo brings them to death’s door, how much more effective would that treatment be?”

In all probability, the fact that Burzynski’s patients usually have had prior treatment has lengthened the lives of his patients, as there is no evidence that his treatment does anything. It also gives Burzynski a bogus out for whenever a patient dies: It was the prior treatment that killed them.

On the 22 June an update appears. The fundraiser was successful and raised enough money for Burzynski that he’d let her start.

After the second month of treatment doctors will know whether or not it is effective. If it is not, [Priscilla’s daughter] plans to donate the rest of the money to another candidate for the treatment. The obstacle of money is almost overcome, but now there is a challenge of finding a place to stay during the treatment. [Priscilla’s daughter] is looking into several possibilities, including the Ronald McDonald House, but hopes a local resident with ties to Houston will help. Right now, [Priscilla] is being treated at Kennestone Hospital for blood clots in her lungs.

The Ronald McDonald House has denied Burzynski’s patients housing in the past because of who their doctor is. Think about what that says about the doctor.

An update appeared on November 23 in the AJC. She’s on treatment, and the family is still raising money for Burzynski:

To fund an experimental cancer treatment in Texas, she is selling cookbooks at Curves for Women, a Woodstock business on Main Street that features exercise and health routines for women. The $10 cookbook features low-­fat recipes for busy people and was written by Dawn Hall. The treatment costs  $9,200 a month and lasts five months. [Priscilla], 58, undergoes a 24­-hour­ a ­day infusion of anticancer medication and ingests several dozen pills daily.

Priscilla died of her ovarian cancer on 23 August 2001.

For reliable information about clinical trials, visit clinicaltrials.gov. Please contribute to St. Jude’s Children’s Hospital, which cares for sick children even if they can’t pay.

(Tip of the hat to the Research Ninja, whose hard work made the recent flurry of posts available. Many more to come.)

Burzynski Patient Alice C.’s Story

As Stanislaw Burzynski stands in front of the Texas Medical Board to answer for yet another litany of abominations, patients are no doubt planning to protest in front of the courthouse so they can beg for their lives. Many of his supporters in the past have been then-current patients who were convinced that Burzynski was their only chance at life. Burzynski’s patients often have dismal prognoses and their prospects do not improve when they buy into his medical adventurism. In anticipation of such patients being used as human shields yet again, we are focusing on stories of people who have testified on Burzynski’s behalf, begged for their lives in courts and in the public, but who of course died anyway. These patients, so far, include Burzynski patient Elke B., Burzynski patient Douglas W.,Burzynski patient Janet C.Burzynski patient Sen. Ed G., and McKenzie L. These patients may not be testifying in the upcoming trial, but their stories are perhaps the most important and are far more eloquent and revealing.

Alice C.’s story begins in August 1994, when after 2 years of a steadily growing lymph gland in her neck, she switched to a doctor who took the symptom to be something more serious than a mere infection. In December she received the diagnosis, non-Hodgkin’s lymphoma. She reports that the diagnosis was left unceremoniously on her answering machine, which might have been a massive privacy violation and she has every right and reason to be disgusted by that.

Alice’s story is shared in the book Women Confront Cancer: Twenty-one Leaders Making Medical History by Choosing Alternative and Complementary Therapies, in which she is described as a “real-estate broker, master gardener, and former flight attendant” (33).

In January of 1995, she began working with an oncologist who explained the prognosis, that it was not a curable cancer, but that it was treatable with chemotherapy. She reconstructed the conversation:

“I asked him, “Well, how soon do I need to start it?’

“He said, ‘Today.’

“I asked him, ‘Well, what kind of time are we talking about?’

“He said, ‘Ten years doing chemotherapy, five years if you don’t do the therapy.'” (34)

Alice insisted on an independent second opinion, a completely reasonable course of action. A bone biopsy showed the cancer in the marrow, meaning that the cancer was stage 4. The first mention of Burzynski in the account comes at this cancer center:”

“At the cancer center she asked one of the doctors what his opinion was of antineoplaston treatment, and he dismissed Dr. Burzynski as the ‘pee doctor.’ (His antineoplastons were originally derived from urine.)

Burzynski’s treatment was originally isolated from urine and the claim is that cancer patients lack these endogenous, cancer-fighting compounds. No other physician, researcher, or scientist has ever confirmed this, nor do they recognize antineoplaston as a risk factor for cancer. And the treatment has not gotten any mintier smelling since the early days, it seems. According to one recent patient, whose daughter was being treated with ANP:

BTW if you come over, expect our house to smell funny. Alynn’s medicine has a strong smell. I think it smells like a hamster cage.

The BBC’s flagship investigative journalism show Panorama, in their “Hope for Sale?” which looked into the Clinic. According to the BBC:

It looked like something out of Willy Wonka’s factory. A room full of pipes and noise; a production process that flowed through steel tubes, steaming boilers and glass tanks of bubbling liquid.

But there was one striking difference from a chocolate factory – the whole room smelled of urine.

And USA Today reports that the drugs have an unpleasant odor. Burzynski’s nickname, it seems, is not unearned.

Alice talked to other lymphoma patients and eventually decide to pursue alternative medicine. Part of her regimen was “a concoction of mistletoe and a few other ingredients” (35). And this is the interesting bit. A few months after deciding to not pursue traditional therapy, around February of 1995, she got the results of a scan. Her doctor told her:

“…that I was a case of spontaneous remission. This was either from the herbs that I was doing or from what doctors say about lymphoma, the waxing and waning process.” (35)

When there is no need to invoke the magic potion thrown together with no demonstrable medical skills, don’t. This type of cancer waxes and wanes. It would seem that whatever she happens to be doing as the cancer runs its natural unopposed course in her body will share credit for what the cancer would be doing anyway. This will include Burzynski’s treatment and all the other alt med remedies.

As is often the case, Alice’s doctors do not want to work with Burzynski. According to her story:

When she became [Burzynski’s] patient, she found that most other doctors were unwilling to work with her. ‘I didn’t get help from anywhere. I felt abandoned and alone.”

This, I’m certain, is misleading. Burzynski’s treatment requires a doctor to work with the patient in their home state while they are on treatment. Patients often have a hard time finding someone, especially finding a qualified oncologist, who will work with the Clinic. It’s not that they won’t work with the patient, you see, but with the Clinic. She has a hard time getting the port installed in her chest, where she will take in the ANP. When she does, she has numerous complications, including the port breaking and a piece of it traveling to her heart, where it needs to be removed. As far as I can tell, these are unnecessary complications of the treatment. These are the reasons why doctors don’t work with Burzynski.

Because of complications, including pain from necrotic tissue and swollen lymph nodes, she went off of ANP on 26 October 1996. A few weeks later, she learns that there was a 58% reduction in her cancer. (Of course, it’s still a waxing and waning cancer, so there is no need to give Burzynski any credit.)

It is during Alice’s treatment that Burzynski’s big fraud trial was underway. She appears in the Dallas Morning News at the height of the drama:

“The FDA is violating my constitutional rights to treatment,” said Alice [C], a 45­-year ­old Dallas woman suffering from non-­Hodgkins lymphoma. The agency, she said, “has made a list of who will live and who will die. I guess I’m not on the list.”

The article gives an example of a strategy that has worked for Burzynski in the past, letting his desperate patients stand as human shields between him and justice:

“Dozens of Dr. Burzynski’s tearful patients gathered Tuesday to accuse the U.S. Food and Drug Administration of murder for obtaining a court order that could close his practice beginning Wednesday.”

Alice had not ruled out chemotherapy, and she saw it as something to fall back on after she tried alternative medicine. We don’t know if she did rely on chemotherapy in the end. She died on 10 December 2004, however, right in line with her original prognosis if she took chemotherapy. But we simply don’t know. There is no reason to think that Burzynski’s treatment helped her, as the disease would flare up and go into remission on its own. Even if she never had conventional therapy, we can’t in principle know that she wasn’t a statistical outlier or if Burzynski’s treatment helped because both outcomes look exactly the same.

And that’s why testimonials are not evidence of efficacy.

Burzynski Patient Courtney H.’s Story

In October 1997. 6-year old Courtney H. started to have neurological symptoms, including headaches, trouble hearing, stumbling, and double vision. On 11 November 1997, Courtney was diagnosed with a tumor on her brain stem. According to a first-person narrative authored by her parents in February 1999, the prognosis was about 3 months. (This is of course, highly variable.) Courtney underwent 6 weeks of radiation therapy, some 33 treatments. The parents were clearly shocked by the weight gain caused by the steroids that her doctors put her on, likely to reduce swelling around the tumor.

After the radiation treatment, Courtney went to North Carolina to be put on a chemotherapy regimen at Duke. She had two more months of this treatment. Courtney, then, had two therapeutic regimens before she went to the Burzynski Clinic. This is important to consider when we see what came later. Both chemotherapy and radiation can kill cancer for months after they have been administered.

In April 1998, Courtney’s family took her to the Burzynski Clinic. According to the father:

With no time to waste, we packed up and drove to Texas. After 1 month on antineoplastons, the tumor had decreased by 30%. That was the best news I have ever had in my entire life. I felt as if a bulldozer had been lifted off my back.

The reasons that there are controlled trials is to determine whether or not it was the chemotherapy Courtney had just finished, the radiation that she had, the antineoplastons, or some combination of these that contributed to the reported decrease. It’s hard to tell what improvement, if any, she has experienced with respect to this reported decrease, as the father says:

However, Courtney was still suffering. The steroids had put her in a wheelchair because her feet were so swollen she couldn’t walk without crying.

Apparently, she is still on steroids at this point. (Steroids seem to be part of the routine at the Burzynski Clinic; she was on steroids before Burzynski as well.) Three months after the family started treatment, in the summer of 1998. the family was trying to taper her off of the steroids:

Courtney has done wonderfully on antineoplaston therapy. After 3 months of treatment, her tumor decreased by about 50%. When she was being tapered off the steroids, however, Courtney developed pneumonia, became dehydrated, and went into a coma. We were air­lifted by helicopter to Children’s Hospital. She was unresponsive for 3 days. She had a catheter inserted to collect urine, and IV in her arm, a tube in her nose to her stomach to remove excretions, and a tube down her throat so she could breathe. A spinal tap was performed. The doctors initially told me Courtney was bleeding in her brain. Later, we were relieved to find they were wrong. What they believed to be bleeding turned out to be calcium deposits. After she came out of the coma, she stayed in the hospital for another week. Then she came home, and we put her back on antineoplastons.

The calcium deposits in the brain can appear following inflammation of brain tissue. The doctor’s suspicions of stroke, however, might not be unfounded. Children have had strokes while on antineoplastons; take the cases of Elizabeth K. and Haley S. (and the Clinic’s heartless response to Haley’s stroke), for instance.

In a brief Cincinnati Post article from 30 July 1999 we hear how much this treatment is costing Courtney’s family:

The controversial treatment, which was created by Dr. S.R. Burzynski, features the use of a substance called antineoplastons. The family struggles financially because their medical insurance won’t cover the $14,000 per month cost of the treatment, which is considered experimental.

Yes. Going to Burzynski bankrupts families, who turn to their community who often bankrolls the dubious patent medicine. Take for instance the junior-high student who raised over $3,600 for Burzynski, as reported in the Post on 4 March 1999. Or the $42,000 raised at a single fundraiser for Courtney, according to an article from June 24, 1999. Communities rally behind the sick. However, would they be so generous if they knew what it was funding?

Even in the laudatory report written by Courtney’s parents, it’s hard to see anything that looks like progress, as he reports that after she returned to treatment:

Unfortunately, that was not the end of Courtney’s problems. I noticed some discharge around her C­-line. It was infected and had to be removed. Courtney was given antibiotics.

Infection at the site of the port that is placed in the patient before administering the ANP is a fairly common complication (see the cases of Keith G.Erik M., Leo D., and James N.) and one that the Burzynski has had trouble reporting to the FDA in the past, at least according to a recent inspection, when the FDA told Burzynski:

“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 [trial number redacted] List of Hospitalizations/SAE (serious adverse events) [redacted]/ Overdose [redacted]/Catheter Infection report. Overdose incidents have been reported to you [….] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.” [emphasis added]

Sadly, more complications are lurking around the corner for Courtney:

After only a couple of more months of antineoplaston therapy, Courtney again began to have serious problems. She stopped eating, developed prolonged diarrhea, nausea, and vomiting. She stopped drinking, too. Therefore, her sodium levels became high. We found ourselves in and out of the emergency room. Finally, we decided that Courtney needed a feeding tube. The tube is connected to pumps that provide 100 cc of formula and 300 cc of water to Courtney every hour. From April 1998, when she began antineoplastons, to February of 1999, Courtney’s brain tumor has decreased by 75%.

It’s hard to imagine how this patient is benefiting from this supposed decrease. Even in the father’s story, things seem to be getting steadily worse. Indeed, when the parents’ account was written, Courtney is not attending school, attending ballet, running, or playing.

The father seems to think that the side effects are caused by the radiation. Of course, the high sodium levels are a well known side effect of antineoplastons–patients report having to take in huge amounts of water to keep their sodium levels in check–and the same type of complication may have killed Josiah Cotto, and it certainly led to an overdose in Luna P., whose regular doctor reacted like this when he heard how high her sodium level was (178):

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Indeed, hypernatremia is the top entry on the lengthy list of side effects that appear on the antineoplaston informed consent sheet that every patient receives:

consent1

consent2

consent3

By February of 1999, Courtney’s family has raised $100,000 for Burzynski, according to the family’s story.

In December 1999, according to the Post in March 2000, the family hears that the tumor is 90% gone, though if it is true, there is nothing to confirm that it was that antineoplastons and not all the prior treatment.

In May 2001, a magician decides to unicycle across the country to raise funds for Courtney. The snippet from the May 13th Cincinnati Enquirer is revealing:

“I really have two reasons. One, I want to raise money for Courtney. Two, I want to raise awareness of Dr. (Stanislaw) Burzynski and his Houston clinic.” “Courtney” is 10­-year­ old Courtney [H], suffering from an inoperable brain stem tumor and receiving Dr. Burzynski’s $7,200 a month treatment. It’s considered alternative, so insurance doesn’t help. Mr. Dalton’s brother Mark had the same treatment last year and his tumor was nearly gone when he had to go off the medication. He died in March 2000.

Imagine that. Tumor almost gone, patient dead shortly thereafter. This is not an aberration; it happens over and over and over. In another report, from 25 Jan 2001, we see this account of Mark’s tumor:

The treatment got rid of Mark’s tumor, but other complications arose. He died in March.

Bunk. But look at how Courtney’s parents describe what is happening:

However, many of the problems Courtney has experienced and is now experiencing are side effects of the radiation therapy she received.

It’s the same story, over and over. To the true believer, it’s never that the treatment didn’t work. It’s always something else.

Courtney died on 20 March 2002.

A side note. The account that this was based on comes from the Burzynski Patient Group. Her story has disappeared from that site:

memoryhole

This is one reason that this site exists, to make sure that nobody’s story disappears down a memory hole. All the stories are important, not just the ones that Burzynski’s supporters think make him look good. We have far more stories than the Burzynski Patient Group will ever have, well over a thousand at this point, and we’ll tell them all.

Burzynski Patient Chelsea S.’s Story

In May 2012, 3 months after she gave birth to her second set of twins, 35-year old dancer Chelsea S. lost vision and experienced numbness in one half of her body. She was diagnosed with a brain cancer almost never seen in adults, a pilomyxoid astrocytoma (PMA). It was near the brain stem and could not be removed, though she received a diagnosis after a biopsy. It appears that she also had radiation. In August, after the radiation, she was told that palliative care was her best option.

The family, understandably was upset and sought another option. As recounted in the Vancouver Sun in November 2012:

They weren’t ready to accept that Chelsea would die; within a matter of days, they had heard through friends of the Burzynski clinic; a quick search online brought them to his website. Steyns’ sister Emma filled out an online application, sent in a package of Steyns’ medical information, and two weeks later the sisters were on a flight to Texas.

They didn’t balk at controversy surrounding the doctor, or the cost: $35,000 up front and up to $30,000 a month for the targeted gene therapy treatment

According to a facebook page that was set up in Sept 2012,

Since her diagnosis, Chelsea’s case has been overseen by a team of doctors from both Lion’s Gate Hospital and the B.C. Cancer Clinic. She has just completed an aggressive round of radiation treatment but unfortunately it has not stopped the tumor growth and her doctors have said that they are unable to offer her any other conventional medical options. The Burzynski Clinic […] in Texas can offer her Personalized Gene Targeted Cancer Therapy which has shown huge success in the the treatment and remediation of Chelsea’s type of cancer, however because the treatment is still in its trial phases, it will come at a huge cost.

Usually, experimental therapies are provided at no cost to a patient. This may technically be true at the Burzynski Clinic, where they happily tell US senators that there will be no charge for the experimental agent, but then charge out the nose for all sorts of “support” services. How much in the case of Chelsea?

$35,000 up front and up to $30,000 a month for the targeted gene therapy treatment.

Now at this point it seems that it’s unclear which form of quackery Burzynski is pouring into her veins, whether it is the “antineoplaston” treatment, a fraction of human urine a lack of which is not recognized as a cause of cancer but which Burzynski “replaces” anyway, or the untested, potentially synergistically toxic chemo cocktail based on the genetic equivalent of palm reading that he calls “gene-targeted therapy.” Both are dangerous and unproven.

Burzynski is treated with well-earned contempt by physicians interviewed for the Vancouver Sun piece:

Dr. Chris Daugherty, an oncologist and international authority on medical ethics and end-of-life decision making at the MacLean Centre in Chicago, draws a line between patients pursuing treatments based on “real trials” and Burzynski, who he says is “off the bell-shaped curve 95 per cent of us practice on.”

Daugherty said it would be unfair to compare Burzynski, whose treatments have not been shown in any randomized study to be effective, with doctors conducting clinical trials at more traditional medical centres […].

Chelsea has her first appointment on Sept. 18th spends several weeks in Houston, suggesting that this is in fact that ANP treatment, Burzynski’s patent medicine. Of her first day, we hear on her blog:

Then we spent the rest of the day at the Burzynski Clinic where I met the Big Guy. See pic. They reviewed my files and images in a very formal way. We were interviewed by 2 separate doctors and then the 2 of them together with Dr. Burzynski. Then after they accepted me into phase 3 of the trial of the Antineoplastone program, they send you to financial department to drill you and see if you can actually afford it (thank goodness for the run). Next they take you for a physical – blood work and an exam. Now we wait for the FDA to approve my case which needs to happen before I can start (up to 3 days). We felt very excited leaving the clinic. A new pathway for me and some real hope to kick this tumour into remission!

Yep. They give you hope and then they shake you down for cash. It’s called the hard sell, and any number of patients have reported that. It’s curious that they think that they are in a trial, where it sounds like they are applying for a special exemption with the FDA. A few days later, we hear:

After receiving FDA approval, Chelsea has begun her customized treatment. She  had some wonderful days exploring neighboring towns with her sister […] last week before treatment started Thursday, and on Monday was joined by her brother […]. Despite a few challenges, she is doing well and continues to express her gratitude for everyone’s love and support here at home.

What are the few challenges? Perhaps the side effects of the ANP:

She has had difficulty tolerating the treatment, and is experiencing severe side-effects including dangerously low potassium levels, temporary blindness and severe pain.

It is chemotherapy by any reasonable definition. And isn’t temporary blindness her original symptom? Nonetheless, Chelsea’s sister is a nurse and is taking care of her, and we get a peak at what the family was being told at the Burzynski Clinic:

“Before we went to Texas I was just sad all the time,” [Chelsea’s sister] said. “Texas really gave us a boost because the nurses and doctors are saying they’ve seen patients come in totally debilitated, as bad as Chelsea, and walk out.”

Notice this is very different from actually seeing the patients get out of their wheelchairs. And since the nurses have a nasty habit of saying stupid things to patients at the clinic, like, “Your side effects are a sign the ANP is working,” one should take their words with a grain of salt substitute. They return from Texas on October 11. At any rate, Chelsea is very popular and her fundraisers, by November, have raised over $200,000 for Burzynski.

Another thing that sticks out from the Sun article, is how puffy Chelsea’s face is. This is likely a side effect of the steroids that Burzynski puts his patients on.

Just before Christmas, Chelsea’s facebook page reports, in between massively successful fundraisers for Burzynski:

Christmas has officially come early this year. Great news yesterday! Chelsea’s Tumor has shrunk 13% since the last MRI which was in October and this result has been confirmed by Doctors both here as well as in Texas.

On Feb 21 we get this update:

Update time: Chelsea had a scan on Feb 5th which again showed continued reduction of the tumor. This was not a surprise to her or her family as her movement and strength in both her legs and arms continued to improve also.

It’s been a rough month with colds which have been a challenge for Chels, but she has faced them all with a smile. Her best week included watching her “kids” dance at Snowmotion. Her next scheduled scan is in March.

We don’t hear about the March scan, only that she is on vacation with her family. The next update relevant to her treatment comes on May 24:

A very brief update on Chelsea: She is at home with [her husband] and the kids, and is continuing to receive cancer treatment. Some days are better than others as is to be expected, however she faces each one with positivism, spunk and resilience as only Miss Superwoman can.

Chelsea S. died on June 23rd.

For reliable information about clinical trials, visit to clinicaltrials.gov. Please contribute to St. Jude’s Children’s Hospital, which cares for sick children even if they can’t pay. Unlike Burzynski.

Burzynski Patient Derek W.’s story

As Stanislaw Burzynski heads to court again to answer charges made by the Texas Medical Board on behalf of a variety of patients, he is doubtlessly preparing by getting the testimony of current and former patients. In anticipation of this pony’s one trick, we are telling the stories of patients who have testified on Burzynski’s behalf over the course of his long, dubious career and see where they are now. Much of what follows is based on reporting from The Oregonian and on written testimony presented to Congress in 1996 in the same hearing in which Douglas W. testified.

Derek W. was just 7-years old but already knew what he wanted to be when he grew up: a preacher. His proud parents nicknamed him the “preacher in sneakers” and ensured he was active in their growing church congregation. Derek also enjoyed participating in his local cub scout troop.

On November 6, 1995, Derek’s parents received the devastating news that Derek had a deadly tumor in his upper brain stem. According to his dad, the news was bleak, so they scoured the country for a solution:

Without treatment he was given 3-6 weeks to live. With paliatory treatments, primarily radiation, he was given between 4 and 18 months. As any parent in our position would, we researched all known traditional and non-traditional cancer treatments.

The doctors’ recommendation of radiation was not likely to be curative. So the family decided to try Burzynski’s treatment antineoplastons because it “appeared to be based on firm scientific data.” Derek’s dad said Burzynski “felt that his success rate was as high as 20%,” but the trusting father acknowledged that the number “was not scientifically documented”.

Sadly, the data released by the Burzynski Clinic over the decades has been notoriously misleading. Indeed, the 20% survival number remains unsubstantiated even two decades later. And yet, other desperate families are still under the false impression that antineoplastons have been demonstrated to be safe and effective.

For example, the family of McKenzie L. thought she had a 27% chance of survival by being pumped full of Burzynski’s concoction. To a desperate parent, a 1-in-5 or better chance certainly sounds infinitely better than the 0% chance that brutally honest cancer doctors sometimes are required by ethics to provide.

The mother of Brendan B., who paid $10k to the Burzynski Clinic in 1991, describes the psychology in a 1996 New York Times article:

“I would have gone out and stood naked in traffic,” Mrs. [B] said. “I would have died in his place if that were possible. I would have done anything to make this child live.” Dr. Burzynski, she said, “offered us a thread to cling to.”

When she and her son Brendan were in Dr. Burzynski’s office, she said, “a very interesting thing happened.” She explained: “I got caught up in this whole thing with all these sick people, people coming and saying they were cured. I feel so stupid even talking about it because I am intelligent and educated and so is my husband.”

She believed in Dr. Burzynski, in spite of herself she said, because “this beautiful child is dying and here’s this person who may possibly have something.”

In addition to Burzynski’s treatment, Derek received radiation as recommended by his oncologists. His father is hopeful that the tumor’s lack of growth is a good sign:

We had an MRI that showed no new tumor growth since we began Dr. Burzynski’s medicine. We still feel [Derek’s] situation is shaky, and this does not mean the medicine is working for sure. It is our one and only hope. Without it, he for sure would die. With it, we still have a chance.

If only Derek’s parents had been able to speak to Mrs. B, who said, “It’s fine to say Dr. Burzynski offers hope, but you have to have hope in something that’s not ephemeral.”

And if only Derek’s parents had reviewed the results of a 1982 visit to the Burzynski Clinic by Canadian doctors. The doctors’ report contained a horrifying picture of what was happening in Houston, according to the 1996 NY Times article and a Usenet posting:

We were surprised that Dr. Burzynski would show us such questionable cases. We were left with the impression that either he knows very little about cancer and the response of different tumors to radiation and hormonal measures, or else he thinks that we are very stupid, and he has tried to hoodwink us.

As we look back over the cases were were shown, we are left with the impression that the only patients who are still alive either had slowly growing tumors, or had received effective treatment before being referred to Houston.

And the Canadians reportedly concluded:

After reviewing 20 case reports, selected by Dr. Burzynski as his best examples of clear cut responses to Antineoplastons we were unable to identify a single case in which therapeutic benefit could be attributed to Antineoplaston.

[…]

We believe that it is unethical to administer unproven agents such as Antineoplastons to patients without satisfying the requirements of the FDA and an ethics committee, that the minimum standards for human experimentation are being met. We also believe that it is immoral to charge patients for this unproven, experimental treatment.

What’s true in 1982 is still true today, since the American Cancer Society agrees that “there is no convincing evidence showing that antineoplastons actually work.” In fact, Burzynski has, according to FDA inspection records, a horrible time satisfying them that his evaluations of his trial outcomes are accurate. Indeed, the FDA recently found that his outcomes are inflated 2/3 of the time.

Derek died of his cancer on December 13, 1996, just over 11 months after his diagnosis. There is no available evidence that antineoplastons improved Derek’s survival.

Derek’s parents wanted to create a special memorial to their son. So when their church expanded to include three 40-foot crosses, they made sure one of them was dedicated in memory of him. The crosses were made of steel and shared their message at least 2 miles away.

Derek’s mom thought the memorial cross was a fitting way for her “preacher in sneakers” to continue to preach: “You want a chance to remember the person who died and to have their dreams live on. [The cross] is a testimony to our hope.”

 

Burzynski Patient Amelia S.’s Story

[This is a repost of an earlier story.]

As Stanislaw Burzynski stands in front of the Texas Medical Board to answer for yet another litany of abominations, patients are no doubt gathering to protest in front of the courthouse so they can beg for their lives. Many of his supporters in the past have been then-current patients who were convinced that Burzynski is their only chance at life. Burzynski’s patients often have dismal prognoses and their prospects do not improve when they buy into his medical adventurism. In anticipation of such patients being used as human shields yet again, we are focusing on stories of people who have testified on Burzynski’s behalf, begged for their lives in courts and in the public, but who of course died anyway. These patients, so far, include Burzynski patient Elke B., Burzynski patient Douglas W.,Burzynski patient Janet C.Burzynski patient Sen. Ed G., and McKenzie L. These patients may not be testifying in the upcoming trial, but their stories are perhaps the most important and are far more eloquent and revealing.

Last week, we posted about the patient who had perhaps the most high profile campaign in the US in recent years. This one is perhaps the biggest in UK in recent years. The case of Amelia S. is a hard one to write about, because it tipped skeptics off to a pattern in the stories that patients at the clinic were telling, that their worsening symptoms were signs of improvement. As you will see, this is a story that Burzynski’s patients have been relating for decades. It’s a long post, but it’s important that you read to the bottom.

***

3-year old Amelia S. lived in Reading. In about September of 2011, Amelia started displaying neurological symptoms–wobbliness and a trembling left hand (often drawn into a fist). The family brought her in to the hospital after she started falling down. On Jan 30th, 2012, she was diagnosed with a brain tumor, and on the 1st of Feb it was determined to be a large tumor on the brainstem. Surgery revealed a grade 2 diffuse astrocytoma, which the family was given to understand meant that the core of the tumor was likely grade 3. Doctors were unable to remove much of the tumor, only the 4 biopsy samples.

Amelia’s medical team was honest. The benefit offered by radiation and chemotherapy, on average, could be measured in weeks. These are bad, bad tumors. The family brought Amelia home on the 20th of February, her mobility and speech impaired, opting to spare Amelia the unpleasantness of the chemotherapy and radiotherapy. When they saw Amelia improving (we’re not told what those improvements were–whether they were reduction in tumor size or reduced swelling as she recovered from surgery, for instance), however, family understandably felt obliged to look for other options.

They found Burzynski. Immediately, the enormous price tag of his antineoplaston treatments spurred the family on to raise funds. Amelia’s father began documenting their journey to Burzynski in a couple of places, at ameliasmiracle.com and on a Facebook page of the same name. As a whole, his story is the most moving and insightful account of parental heroism that I have read since I began this project, and I strongly recommend that you read it for yourself.

By the end of February 2012, the family had decided on Burzynski. We were introduced to Amelia on February 28th in a video posted by her father:

Attached to the video was a simple plea:

Our daughter, Amelia, was diagnosed at the beginning of February with a very rare type of inoperable brain tumour. She has only a few months to live. We have a ray of hope – treatment for her is available at the Burzynski clinic in Houston, Texas. This treatment in total will cost around £200,000. We need to raise this money to allow Amelia to have the chance to live a normal life.

From the beginning, the family sought media attention to raise money for the Burzynski Clinic, as we see in a Facebook post. the earliest example of Amelia’s story appearing in the press was in the local Wokingham Times on 8 March 2012. The public campaign was launched. And by 14 March, £45,000 had been raised by the community, enough to get Amelia in the door at the Clinic (recent accounts put that initial consult at $30,000). The Wokingham Times seems to have informally adopted the family and followed their progress closely for the rest of the year. These community fundraisers appear as human interest stories and reaffirm that people are basically kind and generous and trusting. In fact, my first exposure to Burzynski and realization that something was profoundly wrong came after I did a newspaper database search for all of the patients that I could find. Of those patients I could find an outcome for, every patient who appeared in the international press, usually begging for money, with a single exception was dead.

A week before Amelia hit the papers, on the 6th of March, Eric Merola, who made an uncritical hagiography to Burzynski unironically called, Burzynski: Cancer is a Serious Business, interviewed the family about their upcoming trip to Houston for his new movie, a sequel, which comes out soon. He planned to follow Amelia’s progress in the film. On the 17th, as they planned their trip to the US, the family put up a short video for Amelia’s donors:

So, she clearly she packed everyone’s hearts into her suitcase. Such a dear.

They left on the 23th of March for America, having raised a staggering £75,000 for Burzynski. In a Wokingham Times piece, her father stated some of the opposition that the family had met:

Mr Saunders added that he was amazed at the number of people who had suggested the American treatment would be fruitless.

He said: “I was warned about this before we decided to go with the Burzynski treatment – it is like there is a vendetta out against the man.

“It is so strange, and all I keep getting are contacts from patients who have been or are being cured by the treatment, or at the very least have had positive results.”

People for whom Burzynski’s treatments fail tend not get into contact with other patients. We are witnessing what is known as survivorship bias. You can talk to a dozen survivors and have a positive impression of a treatment but fail to take into account the 10,000 failures, which would put a treatment well below the efficacy of chance remission, misdiagnosis, and unrecognized responses to traditional therapies. This is why controlled trials are so important to determine efficacy, so we can sort out the background noise of chance from real effects. It is also an important reason that dependence on patient testimonials is a red flag for quackery.

Amelia has had a hole opened in her chest where a Hickman line has been inserted, where she will receive her ANP. These frequently have complications with infection and clogging.

By the 30th, Amelia has her backpack full of antineoplastons, as we see in a video. Her family will spend the customary 3 weeks or so in the US learning to administer the ANP themselves. They are infused at high doses almost continuously.

Amelia’s dad shares his first impression of the Clinic on the facebook page:

The clinic have been fantastic. I am still amazed that people give them such a bad press. They have literally bent over backwards to get this started for us. The receptionist Irena even has a photo of Amelia behind her desk, she is so lovely!

Well there is a reason, of course. It’s because they apparently tell patients that they can tell brain tumors are shrinking by looking at their urine:

Mr Saunders said: “Every day is a milestone and the clinic is being extremely thorough in its tests – Amelia has regular blood tests and these are all closely monitored to check for signs of all sorts of things.

“Interestingly, they can actually see the early signs of the tumour breaking down by how her body excretes it in her blood and urine. This might be the only time in my life I get excited by seeing this kind of information!

I’m not sure what this is supposed to mean, and before Amelia’s story I would not have even noticed this. I can see why a parent clinging to hope would sieze onto any augury of healing. Remember, this family has not had good news about Amelia since her diagnosis. Little steps, literally, mean the world to them. I contacted research oncologist David Gorski, who studies and treats breast cancer, about this claim, and he replied:

“Oncologists don’t monitor anything in the urine for tumor breakdown, at least not for that tumor. There is such a thing called tumor lysis syndrome, but that’s usually only seen in leukemias and lymphomas as a result of induction chemotherapy that kills a lot of cancer cells really fast, releasing potassium, and a number of other byproducts. However, as I said, you don’t generally see this in solid tumors (mainly because none of them respond nearly as dramatically to chemotherapy as hematological malignancies). It’s also a complication to be managed, because its most frequent result is renal failure. It’s possible that he’s referring to GFAP, which is a biomarker for glioma under study, but I don’t think it’s really been validated as a measurement of response to therapy.”

There are apparently no biomarkers for glioma that appear in urine. Amelia had chronically low potassium at this point in her treatment.

We don’t see a lot of what is going on at the clinic on facebook, where most of the story is told record, but we get a clue on Amelia’s other website:

10th April 2012

I realised I hadn’t updated the news section here for a few weeks, this is largely because we update our Facebook page daily and much of our time has been taken up going to and from the clinic. Every day has been a bit of a rollercoaster here. Amelia has been on antineoplaston treatment for a week and a half and at the end of last week we hit a bit of a wall with the treatment dosage. Amelia got pretty sick so we had to back down on the dose a little. Yesterday she started getting really bad headaches so we have now also put her on a low dose steroid as well. Other than this, she is doing well and responding well to treatment. We think there are some very slight improvements in her coordination of her left hand side. We are continuing the treatment, and the aim is now to increase the dosage more slowly to see how she responds. All in all we are doing well and looking forward to coming home soon!

So, she’s been up and down. The steroids are a recurring feature of treatment and can very quickly reduce inflammation in a way that leads to improvements of the type that the family is reporting. You see it a lot on this website. It’s hard not to think of John D., who experienced worsening symptoms while under treatment (and on steroids), which was met with joy on the part of the staff:

I want to mention that the IV nurse told mom today that she’s been there for 10 years & has seen this before & many times, the more severe symptoms that are seen as a result of the therapy is really a good sign that it’s working better. I know this nurse & she is very honest & helpful. She also runs the class they run every week for new patients.

On April 19th we hear that the family is preparing to return home, and on the Wokingham Times page where it is announced, we see that damned picture again, patients literally at death’s door, posing in front of the Burzynski Clinic. We get the update that they have arrived back in England on the 22nd. Amelia’s dad talks about the fundraising (truly amazing acts of generosity by the whole community) and how grateful he is for the immense support that the family has received. (Amelia gives her own thank you’s in an adorable little video a few days later.)  He speculates on the road ahead:

I have come home from Houston with a strange kind of feeling. Perhaps a little apprehension, a bit of fear, a dose of happiness and a shot of hope. We still feel that every day is a roller coaster. We may be sitting on a ticking time bomb, and it may still be that any day we might lose Amelia. Every day truly is so precious, and it is a joy to watch her and her little sister back together again, albeit in a different way, a more careful one, where we have to watch them all the time.

The next day, it sounds like Amelia is having the unquenchable thirst that comes with ANP:

Amelia has been OK today, she was a bit sick earlier but we think this was because she drank too much too quickly – she was fine shortly afterwards. We’ve been getting used to life again at home and putting everything in place we need to.

And we hear that she is due for her first post-treatment MRI:

As far as the MRI goes, I just want to make a point that we aren’t expecting a lot to have happened with this next scan. As part of the medical trial we are required to get a scan done every 4 – 5 weeks – and these things take time to show any change. It is very likely the tumour may be the same or have grown slightly. This is fine and we expect this, and clearly if it has shrunk then great – but we aren’t expecting it to have done.

Tumors on which chemotherapy is working should probably not be growing at all. It’s the definition of “working.”

On the 25th:

Today has been a busy day. Unfortunately Amelia was pretty sick this morning – those of you who have been following our journey will know that we are trying to increase Amelia’s dose of drugs and it sometimes has side effects, this seeming to be the most common. She was fine afterwards and has been eating for the rest of the day.

We had an appointment at the hospital at lunchtime and ended up spending most of the afternoon there so we could get everything sorted. The doctors here are being very cooperative – but I must emphasise that they are recommending different treatment (chemo) and we have consistently turned this down. We have not found a single person with a DIPG tumour that has had any effect with chemo – so continue to find it strange that this is offered. Our plan is to continue the antineoplaston treatment for as long as required. We realise this is being frowned upon by the doctors here – but ultimately we are trying the only thing we found that had credible results.

Credible results would have been publication and replication of his trials. Burzynski can’t seem to complete his trials, much less publish them (which is odd given that he has the test agent already developed and the tumors he is working have outcomes comparatively rapidly). If trial completion were a batting average, he’d be at .015 and his trial publication average would be .000.

By May 4, Amelia is a celebrity. They have raised £160,000 (!) and she is meeting and hanging out with celebrities. And the paper has clearly been reading Amelia’s dad’s updates. Also, her dad’s website announces:

Well we have now been back from Houston for a few weeks – and Amelia has continued to slowly improve with both her walking and speech getting better. The Burzynski clinic were brilliant – we were made to feel so welcome and Amelia really made an impression on everybody there!

We had an MRI scan on Monday that revealed her tumour has stopped growing. Considering she has had no treatment other than the antineoplaston therapy from the Burzynski clinic, we are really pleased (and impressed) that the treatment seems to be working so quickly. We are now continuing the treatment and increasing her dose such that we try to get her to the ‘target’ dose for her weight.

This tumor “stopped growing” news is taken as validation that the treatment is working, so much so, that the Wokingham Times irresponsibly reports that result.   According to her dad:

1. Amelia has been on treatment for less than 4 weeks.
2. She is not on full dose yet, and has some way to go to get there. This is a slow progress, perhaps taking another month or so to achieve this (or more).
3. She has a low grade tumour. Any response will be slow. In other kids where the treatment has worked it has taken many months to show response.
4. She is still on steroids.
5. Her previous scan showed a 13% growth in 7 weeks.

So, having now had several opinions of the scans, I can confirm that Amelia’s tumour has STOPPED GROWING. This is amazing news and we are over the moon that this is the case. For this tumour type, in this short time, with a tumour of the size of Amelia’s, this is an incredibly good result. This is an INCREDIBLY hard tumour to do anything with, one of the hardest to treat and normally very lethal. In most circumstances Amelia would no longer be here (in February there was no way we thought we’d get to May with her) so to have the thing stable is fantastic news.

A few important points. It’s a low grade (slow growing) tumor. This does not seem to have been a PET scan, which would give  a sense how of active the tumor was–to see if it had in fact “stopped.” And initial responses to chemotherapy (and ANP is chemotherapy by every definition) correlate poorly to outcomes, which is, of course, the final goal that everyone involved is keenly interested in. Of course, the Clinic doesn’t convey that information:

I also had a good chat with our doctor in Houston earlier. Again all sounding very positive, and we have again increased Amelia’s dose tonight […] The clinic sound very positive that Amelia’s tumour stopped growing so quickly. Let’s just hope we have more positive news on the next scan in June.

On 12 May, we get an update about Amelia’s progress:

Amelia was on top form today, she was pretty tired after the wedding but perked up and during doses, when we unplugged her from her backpack, she was really bubbly. Later in the afternoon she was doing some proper walking – unassisted. I think we have now realised that a lot of the walking problem now is just her confidence. She was walking almost normally, and certainly the same or better than she was before her operation. Fantastic.

So, they are at point zero, which considering where they have been is wonderful from the family’s perspective, but it doesn’t tell us that the ANP is working of if she has just recovered from surgery to her brain stem and is now on steroids. And this may be important, as dad mentions on the 20th:

She really has improved. We’ve both noticed significant improvements in her speech, mainly in the quality of her pronunciations and also the speed and which she speaks. Slow speech is a classic symptom of her tumour location, so any improvement is a good sign here. This might be the steroids causing this improvement so we have to be careful, but we have a lot of fingers crossed we’ll be taking her off the steroids within the next few weeks if we can get her second bag to target dose. We’ll see.

On the 21st:

Amelia has been a bit groggy, fairly lethargic and pretty reluctant to do a lot. […] Because of the lethargy, the doctor in the US has recommended increasing her steroid dose very slightly. We’ll see if this improves things – if it does then this is a good sign. It does all tie in with us increasing her dose, which is now at maximum on her larger bag. No wonder.

Also on the 21rd, just over a year ago, the fundraiser reaches its goal of £200,000, and the tally continues to climb. In the intervening time, however, we hear that Amelia has had some complications with the Hickman line, which has been replaced because of a tear:

She is doing well otherwise, and we’ll be resuming her treatment tonight. She is now walking by herself, her coordination and balance have all improved and her speech is much better. It looks like the treatment is definitely helping her.

In early June, dad is rattled by the deaths of patients Billie B. and Supatra A., who had the same tumor as Amelia, and for a few days he rails against skeptics. Apparently some have been contacting him and criticizing him. This is wrong, in my opinion. Cancer patients have enough on their plate.

On the 21st, we hear that the tumor remains stable:

Firstly we are waiting on a further interpretation from Dr Burzynski, but as we suspected from our own view of the scans this morning, Amelia’s tumour remains stable. In other words, there is no change since the last scan.

The family accepts this as a sign that they have stayed the brain tumor:

We are 100% sure that without antineoplastons, Amelia would either be in a hospice by now or dead. She has a grade 2 tumour, on scans it appears as a grade 3, and it is very large and in a very dangerous part of the brain. Even a few mm of growth would cause a significant impact on her quality of life at this size. We are all walking on a knife edge. Dr Burzynski’s treatment is undoubtedly keeping her alive. I actually want to wave this in the face of all the skeptics we came across along our journey.

It’s worth noting that the tumor hasn’t shrunk. Small victories–including just not dying–are huge when your child has one of these tumors.

Amelia has her 4th birthday on the 22nd of June, and it is celebrated in the papers.

Again, we see that the steroid dose is being increased on June 25th to control the symptoms of the disease:

We have been advised by the clinic to increase her steroid intake back to how it was last week to see if we see an improvement in her. We will then try in a couple of weeks time to reduce it again but at a slower rate, reducing it by 0.25mg instead of 0.5mg per day. The steroid intake is a tricky issue as they are essential and help reduce the symptoms of this awful disease (headaches, tiredness), however long term steroid use is not good and cause side effects such as weight gain, muscle problems.

We still haven’t seen anything that looks like clear evidence of improvement past diagnosis; it sounds like the symptoms return when the steroids are tapered. She seems to be doing pretty well on this dose of steroids, going to school. (Her last day of nursery school is 11 July.)

On July 15th we hear:

Well – we have had a pretty good weekend. I had a truly amazing conversation last night. Purely by chance I’ve been contacted by the mother of another little girl, who is almost the same age as Amelia, who is receiving the same treatment (for longer), with the same tumour (DIPG) and her tumour just shrunk. By 36%. We are so, so pleased. There is so much hope in our hearts now.

I’ll just briefly mention how frustrated we still are to read so much crap on the internet about Dr Burzynski. I feel like we are ‘insiders’, in a way, and know how the whole thing works now. These doubters clearly don’t. The lady I spoke to last night was told her daughter would die. When she went to Burzynski, her doctor shut her off. Refused to speak. Thank God she chose to follow her heart, and not that doctors advice. She might just have saved her daughters life. There is no doubt this works, and we want it in every hospital in the world. We’ll keep spreading the word until it is.

This child, sadly, is now dead.

By August the tumor has not shrunk, but Amelia has been coping very well. A few weeks earlier she had a wonderful day at the zoo. She’s still a little wobbly on her feet and in the pictures her family put on the Facebook page, you can tell that her face is not symmetrical, but by God she’s enjoying her life, which is an immense thing in itself. On the 6th however, she gets pale and sick; when her blood work is done, they find that her potassium and magnesium are way down, though they stabilize her.

On August 8, we hear:

One of the many things I have said throughout this year is that I hope that maybe, one day, I can learn that another child has had success with this treatment because of the inspiration they gained from Amelia. I know of one little girl, Chey, who is waiting to go to the clinic right now. But due to some complications with the FDA and the clinic, there are some delays – but we are all hoping she will get there very soon. We felt so welcomed by the Burzynski clinic and everything we saw there made us puzzled why so many people don’t believe in it.

We just found out exactly what happened. According to an SEC filing:

In a letter dated June 25, 2012, the [Burzynski] informed the FDA of a serious adverse event which may have been related to the administration of Antineoplastons.  On July 30, 2012, the FDA placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active Phase II or Phase III studies under IND 43,742.  The FDA imposed this partial clinical hold because, according to the FDA, insufficient information had been submitted by the Company to allow the FDA to determine whether the potential patient benefit justifies the potential risks of treatment use, and that the potential risks are not unreasonable in the context of the disease or condition to be treated.

According to the mother of patient Alynn H., her understanding was that a child had died (link is password protected). We have not heard anything else, only that the ANP trials, almost a year later, have not started up again and that the partial hold remains.

On August 13, Amelia’s dad posts a video about Amelia’s life since diagnosis. This write up an unusually long post for this blog, and I haven’t done justice to the support the family has received from their community or the sheer number of people who pitched in to help the family, and this video gives a sense of that:

On the fifteenth, we hear that the family is understandably anxious for the tumor to shrink:

Incidentally, we are well aware that a stable tumour is good. Mondays scan was one that we went into thinking ‘if it is stable then great’. I’ve had a few people come up to me and ask “is the tumour shrinking?”. Now I know people mean well – but it is a little like me walking up to somebody and saying “have you won the lottery yet?”. In other words, frustrating. I smile, say no, it will take time, and move the conversation on.

So far, the tumor’s behavior has been utterly unrelated to the dose of the antineoplaston chemotherapy. On Aug 25, we hear that Amelia is tired on treatment and that she has had a progression of symptoms:

We are still looking to increase her dose slightly as she has gained a little weight since Houston so she should be able to tolerate an increased dose (or at least we hope so). We will probably have to increase her steroids in line with this, but we have been considering this anyway as she seems to have become a lot more wobbly lately. We know from the MRI that the tumour hasn’t grown so an increase in her steroids should help this.

Now, I’m not sure how this was verified. The definition of a “stable” tumor can actually accommodate some growth, so, we can’t know exactly what is happening. And we hear from the family a few days later that they have come to a hard realization:

On the 27th, we hear:

Firstly, Amelia hasn’t quite been herself unfortunately. She has been very reluctant to walk, a lot more tired, slow and pretty lethargic. She was sick on Saturday night also. We are reasonably confident we have probably gone too far with the steroid reduction so we have actually increased these slightly again today. We decided we would rather have a happy and more alert Amelia than one who doesn’t want to do too much – so we made this decision today in coordination with the Burzynski clinic. We’ll see how she does. There is a small chance it is the tumour growing, but much more likely given the scans we have that this is due to swelling of the tumour caused by the treatment. Time will tell. […]

The symptoms we are seeing right now are a direct result of the tumour, hopefully due to it swelling, and the steroids will fix this. They are also what we would see if it has grown.

It really, really looks that her wellness is linked directly to how much steroid she is receiving. And here’s another example of something that is…desperately, desperately wrong at the Clinic. The patient is being told that the tumor is swelling because of the treatment. How is it that only at the Burzynski Clinic that getting worse is indistinguishable from getting better? Second point: this is a tumor on the brainstem. If a possible side effect were swelling of the thing pressing against the brainstem, you’d expect that to be on the informed consent form, right? The type of thing that would be among the “serious side effects,” right? It’s not, at least not in a version of the consent form used after Amelia had started ANP:

consent1 consent2 consent3consent2consent3

(Burzynski’s supporters who have been saying that the treatment has no long-term side effects would do well to look at that first paragraph. The paperwork that every patient signs says it can have exactly that.)

On September 5th, we see a candid moment on the facebook page. The parents are committed to seeing this therapy through, but the father has that lingering awareness that this nothing the tumor has not shrunk:

Whether we have returned to a feeling of optimism or not remains to be seen. I still feel uneasy about the fact that we are so far on without the tumour shrinking. It is frustrating, because we have worked SO hard with the treatment – our entire lives are ruled by it and it is almost a full time job sorting it all out – we just share it between us and make it happen. We just know to be patient, and we 100% know it can work.

At this time, Amelia was returning to school (she had already been going to nursery school on treatment). And the way it appeared in the press, and certainly how I and other skeptics read it, it was being promoted as, “See? This treatment is working enough to let this little girl go back,” a human interest story (The Mirror’s coverage was profoundly disgraceful–suggesting UK doctors “refused to treat” Amelia, whereas when you look above you see that in fact: “The doctors here are being very cooperative – but I must emphasise that they are recommending different treatment (chemo) and we have consistently turned this down”), and by god it was good to hear that Amelia was having a great time, but there’s a lot more going on than is contained in the articles. On the 5th we see how much support was needed to get Amelia in. This was not the return of a healed child that everyone took away from the coverage:

“There has been a LOT of organising around this, far more than getting a healthy child to school. We’ve arranged our nanny, we’ve had to work around the school timetable, we’ve had meetings with the school and the teachers and the hospital nurses and made everything happen. The school have been absolutely fantastic every step of the way – we literally cannot fault them.”

On the 8th, we see on the Facebook page:

“On Monday we have a physiotherapist coming to look at her to see if she can get her walking again. I tried a little walking with her today and she is really, really trying. You can see she struggles, like her brain doesn’t know how to do it but the conscious Amelia that we see and know does. It’s a bit like trying to write with the wrong hand – you know what to do but you can’t quite make your hand write as well as the other. She tries to walk, but can’t quite make it all fit.”

This is not a child improving.

September 10, on they were visited by Eric Merola for his utterly uncritical documentary about Burzynski. More on that in a moment.

On the morning of the 15th, Amelia woke up crying with a pain in her head. She went off treatment for a day or so and got better, not trembling, perhaps speaking a bit better. One wonders if she is not experiencing relief from the hypernatremia that can appear alongside such massive sodium doses and can have such side effects.

Amelia has a great couple of days in late September (and she really takes to her school!), and her dad talks about how the awful waiting game goes in between MRIs, which I have learned is how time is measured by cancer patients:

I’ve said this many times before, but the really frustrating thing for me is not having anything really tangible that tells you this is working, until we get the scan image in front of us. This means an 8 week wait between scans when you really have no idea what is going on, and if she gets worse like she did a few weeks back then I think you naturally assume the worst. Then she gets better, and you relax a little!

The October MRI shows no change. But later that month, the family is trying to come to grips with what life will mean in the likelihood that Amelia is not with them. It’s a beautiful post, and I hope you read it. It’s immensely sad and healthy and you can’t help but feel the full force of their grief and fear. This family is mentally preparing themselves for a horrible future, and this makes what happened next absolutely inexcusable by any measure.

By November 19th, Amelia’s right hand is immobilized, a clear progression, and the family gets the results of a recent scan:

What I don’t want to do is get ours, and everybody else’s hopes up about things. I could not bear thinking that this is working and then to be told it isn’t. (emphasis added)

What I will elude to is that the Burzynski clinic feel that there is a cyst forming inside Amelia’s tumour, very slowly. This does seem apparent on the scan images but we want to make sure this has grown over the longer timeframe. A cyst will form where there is cell breakdown, so clearly is a good thing from a ‘killing the tumour’ viewpoint, but possibly bad in that you then have fluid in a very difficult place to get to. We’ll address that little hurdle if we get to it being a problem in the first place.

This sounds exciting (it is), but we are really trying to be careful about getting too much so. Amelia has got worse, although she has had some improvement over the weeks before her MRI. This could be due to a number of factors and we know the tumour has not grown.

Another point with this is that the tumour isn’t shrinking, but if a cyst is forming then it might be some time before the tumour does shrink. We’ve always said that due to Amelia’s tumour being very slow growing, we have more time on our hands more than most kids who get this.

When this news was released on the family’s Facebook page, followed by rapturous confirmation the next day, it was brought to the attention of Orac at Respectful Insolence, who gave an honest medical opinion:

It pains me greatly to do this, because, no matter how I write this, it will be perceived as trying to take away the hope for Amelia’s survival that the Saunders family holds. Such is not my intent, by any stretch of the imagination. However, these “cysts” almost certainly represent areas of ischemia (low blood flow) leading to tissue death as the tumor outgrows its blood supply. This is a phenomenon commonly seen in advanced malignancy. I know this because tumor angiogenesis ia one of my areas of research interest. […]

Sadly, then, seeing “cysts” growing in Amelia’s tumor most likely says nothing one way or the other about whether or not it’s responding to Burzynski’s antineoplastons. That’s assuming that Burzynski’s interpretation of the scans is even correct, which I wouldn’t bet money on. Most likely, these “cysts” indicate that there is no therapeutic effect. I take no pleasure in saying this, but most likely this is true.

Amelia’s dad was understandably upset and actually responded to Orac on Nov 29th, but the day after Orac posted, the family updated their followers:

We know that some people doubt what we are doing. We understand that it is in human nature to question, and many people will not just take something on faith alone. But, ultimately, this is our choice. And that choice seems to be paying off.

Yesterday I sent a CD with the latest MRI scans on to our local oncologist and I’ll be waiting for their opinion. We’ll consider this, and then continue until the next scan and see if the cystic formation that we have been shown grows in some way. I don’t want anyone to think we just take things at face value and accept them – we consider what we see, what we are told, and get as many opinions as we can. We can see with our own eyes though that something has changed with the tumour and we hope this continues. Amelia’s tumour hasn’t enhanced or progressed, so we know it is unlikely to be anything other than cysts, but we will get that second opinion for sure.

Amelia had a magical week. She won a community award, the “Child of Courage” award, and was literally the star of a Nativity play with her friends. The reality of Amelia’s situation soon came upon the family, however. On 2 December:

The truth is, Amelia isn’t getting any better neurologically. We live with her every day and we see it. She is very slowly deteriorating and I think we would be putting our own heads in the sand if we didn’t accept this. On one hand we have the Burzynski clinic who believe the tumour is beginning to die. We are getting opinions here about this theory and we’ll very likely need another scan of a different type in early January to back this up. Everything is based on opinions – and nobody agrees, which makes it all very hard on us.

And the final assessment from the Great Ormond Street Hospital:

We had our meeting at Great Ormond Street yesterday and, sadly, they just don’t have anything for us. We kind of knew this before we went – but wondered if they might have a trial that we could take part in. Unfortunately they don’t.

They felt that Amelia is in the latter stages of the disease, and that what is called ‘progression’ has already started. This means her tumour is growing, the cancer is spreading and we don’t have a huge amount of time left. Again we had already guessed this was happening but it was good in a way to have another opinion of this.

Were it just a one-off bad interpretation of an MRI on the part of the Burzynski Clinic, we might have been able to write this off as a simple mistake. But it’s not. Not by a long shot.

 

Had Burzynski not used this line on the family who had given him by far the most publicity of any other in years, this recurring theme might have slipped by unnoticed. But it’s clear that this is not just a coincidence, it’s an M.O. predicated on false hope that strings parents and patients along. And it’s been going on for decades! And it leaves patients utterly crushed and confused. The few skeptics who have been working these stories in their spare time have found case after case of patients thinking that getting worse is getting better (a partial, growing list can be found in this post). Consider that the cases written up at this website represent 1/10th of the total cases we’ve been able to find and will be bringing to you, that we have only found a small fraction of cases, mostly from the most recent years, and that this guy has been operating for over 35 years! My god! Imagine what that means!

In light of this, when Eric Merola, in his new movie, says in a series of title cards:

Two months after this interview, Amelia’s tumor began to swell and fill with fluid.

There was confusion and disagreement among between their local radiologists and the radiologists in Houston, [sic] about why this was happening–

So her parents decided to discontinue antineoplaston therapy.

[Then he cuts to a picture of Amelia’s obituary and says,]

“Amelia passed away with her parents by her side on January 6, 2013.”

…it is fundamentally dishonest. There was no confusion. There was the right diagnosis and Burzynski’s diagnosis, a story that’s been spun for decades to desperate parents, and it’s a goddamned disgrace that Merola suggests that the parents’ evidence-based decision could have been related in any way to the outcome.

Instead of the usual plea for a donation to St. Jude Children’s Research Hospital, which researches children’s tumors and provides care for free, we’d like to ask you to make a donation to Naomi House, the children’s hospice center that cared for Amelia’s family in the last days and which seems to be the family’s preferred charity.

If you want to take action, protect the vulnerable, and put reliable information in front of patients who might be looking into this Clinic, the Skeptics for the Protection of Cancer Patients (facebook page here) have put up guidelines about how to boost good information into Burzynski’s search results.

Burzynski Patients, Legal Threats, and a False DMCA Takedown Notice

Over the last few days, I (Bob) have been contacted by a handful of parents whose stories are on The OTHER Burzynski Patient Group. I have received two legal threats. First was an email from a father who ended his angry email: “I suggest you take down the personal blog that I wrote about my son […].” (The story, by the way, was by any measure the most horrifying illustration of alternative medicine’s predatory nature I have ever encountered.) I replied that I do not take stories down. Ever. He repeated the threat:

I expect it taken down – PERIOD – or you’ll be hearing from MY lawyer …

You have absolutely NO right to republish my blog …

Just try me – you can look up my current company [website] to see that I’ve been building another successful business and I’ll gladly use ALL the resources I have to fight this unlawful use of my personal story.

You have NO idea who you’re messing with!!

The second threat came and went while I slept. On the morning of March 3rd I received an email from my host, WordPress, which read in part:

We have received a DMCA notice (https://www.eff.org/issues/bloggers/legal/liability/IP#dmca) for material published on your WordPress.com site.

Normally this would mean that we’d have to disable access to the material. However, because we believe that this instance falls under fair use protections, we will not be removing it at this time. (emphasis added)

Section 107 of US copyright law identifies various purposes for which the reproduction of a particular work may be considered fair, such as criticism, comment, news reporting, teaching, scholarship, and research. You can learn more about that here:

http://www.copyright.gov/title17

http://www.copyright.gov/fls/fl102.html

While we believe that your use of the material is protected (we have fought for our users in similar cases in the past –http://en.blog.wordpress.com/2013/11/21/striking-back-against-censorship/), please keep in mind that the complainant may choose to continue to pursue this matter, perhaps directly with you. If you would prefer, you are still able to delete the content from your site yourself.

The question of whether or not I will take down posts is a non-starter. I have tried very hard to balance patient privacy and responsibly publishing information that I believe is in the public interest while also citing my sources. That so few patients have contacted me over the course of the last few years (and despite the fact that TOBPG appeared in a feature-length Burzynski-themed infomercial by Eric Merola) suggests that I have largely succeeded.

The night before the DMCA notice arrived, the following comment appeared in the comments of the “About TOBPG” page:

I just want to thank you so much for this site. My best pal is two years into a most likely fatal cancer diagnosis. As the traditional treatments have failed to cure her, we are searching far and wide for the next possible step, and Burzynski’s name came up. Seeing the facts laid out on your site (and others) made it so easy to understand that this is nothing more than quackery. Thanks for helping us avoid what could have been a horrible misstep.

The site and all the stories stay.

I have retained counsel, Ken White of Brown White & Osborne LLC, who writes at @Popehat and who represents me pro bono on First Amendment and free speech issues.

Burzynski Patient Sen. Ed G.’s Story

As Stanislaw Burzynski heads to court again to answer charges made by the Texas Medical Board on behalf of a variety of patients, he is doubtlessly preparing by getting the testimony of current and former patients. In anticipation of this pony’s one trick, we are telling the stories of patients who have testified on Burzynski’s behalf over the course of his long, dubious career and see where they are now. This one is notable because not only was the patient a State Senator, but he also reported that a probable sign of getting worse was a sign of getting better. Oh, and he testified on Burzynski’s behalf in front of Congress.

In the last week of the 1996 Georgia state senate race, incumbent from Macon Ed G. tried to speak on the phone, but couldn’t. Also, printed letters looked scrambled. While he initially dismissed it as stress related to his campaign, a friend who was a physician sent him to the doctor the next day. An MRI on Nov. 14th revealed not the small stroke they expected, but a brain tumor lodged in the front of his brain.

The decisions that he made in the days following the diagnosis reflect his approach to his treatment:

I went to three of the best neurosurgeons in Atlanta and they seemed to contradict themselves in what the best options for treatment were for me. The last doctor was one of the best neurosurgeons at Emory University in Atlanta. This doctor suggested chemotherapy and radiation and said this might control the growth of the tumor for a while but eventually it would come back and be a lot worse and at that time we would have to see what options were available. Obviously this was not a very good option in my opinion. I decided against chemotherapy and radiation because of the toxic side affects and the increase chance of other cancers they themselves caused. A person that takes chemo and radiation is 25 times more likely to have another form of cancer than the average person.

I talked it over with my wife and we decided to look at an alternative type of treatment. I looked and studied the options for several weeks and decided that Dr. Burzynski had the cure for brain tumors.

This, of course, is the Nirvana fallacy. Chemotherapy and radiation, while not perfect and while they carry real consequences, might actually have been the best course of action. And you reject the best advice of the best neurosurgeons at your own peril.

In mid-December, he went to the Burzynski Clinic, and he reports:

three weeks later 50% of the tumor was gone. After five months the cancerous part of the tumor was completely gone. I have to remain on the IV part of the treatment until the end of this year and then will take the antineoplastons for several years by capsule.

Of course, he was sold on the treatment entirely at this point. Adding to his commitment was a $14,000 start-up fee and $5,000 for the first treatment, according to the Macon Telegraph,  which broke the news of the state senator’s decision to undergo antineoplaston treatment on January 10th, 1997. This announcement seems not to have met any skepticism whatsoever, which is mildly surprising given that at the time Burzynski’s extensive legal troubles were at their height. The Senator’s state-run insurance was not going to cover the treatment, and so a number of public officials banded together to raise money for their unfortunate colleague’s doctor. Lt. Gov. Pierre Howard challenged people to raise funds for the treatment, and by the time the article ran, the church accepting the donations had received $35,000. The monthly treatment would cost an additional $9,000 a month, the church official interviewed reported: “He’s not sure how many months he’ll have to be in treatment. That will be decided as he goes along.”

The same representative reported that the Senator had had a brain scan the previous week:

“It showed that the tumor had not increased in size at all, so the treatment has stopped the growth,” Pardue said.  “He said to us it was moderately growing.”

So (besides it growing and not growing at the same time), even if the tumor had stopped growing, it would not mean that the treatment was having any effect, because of a feature of solid tumors known as Gompertzian growth or “day 2 of your introductory oncology class.” We also hear that the Senator is flying out to Texas every month for treatment. This is interesting because at this time it seems that the Clinic is obeying the rules that federal prosecutors were trying to enforce. The Senator will participate in the upcoming 40-day legislative session but he will be carrying a “fanny pack” that has his infusion pump.

Four days later, the Telegraph reports that the 44-year old Senator has returned from his most recent trip to Texas, and that his sons help him prepare his bags of ANP. He reports:

“I can’t sleep at night sometimes because of the medicine. Sometimes I have to take naps.”

What this public official can’t say in polite company is that the quality of sleep of patients on antineoplaston is heavily degraded because the high sodium load means that the patient has an unquenchable thirst, and he is constantly at the toilet. At the same time, he reports:

“My condition is improving, and the cancer is reducing.”

As the Macon Telegraph reported the next day, the Senator thanked his colleagues in the Senate for their support. Due to their efforts, $45,000 had been raised for the expected $100,000 treatment, projected to last for a year. The paper reported that that he told his colleagues “that his tumor, located in the right front area of his brain has already been reduced by 30 percent. He said he will return to Texas on Feb. 20 for another treatment and is hoping that doctors will find his tumor gone.”

We get an update from the Macon Telegraph on the 12th of March about the Senator’s progress:

“Ninety-two percent of the worse part of the tumor is gone,” he said. “I think God is going to heal this thing in his timing. […] Burzynski is predicting that the ‘worst part of the tumor’ will be gone in a month, [the Senator] said. The treatment will run another eight months[.]

It’s a strange qualification. 92% of the worst part? How does that relate to tumor size? Nonetheless, the Senator is now fully behind Burzynski, as you might expect. The same day, the paper would report, he presented a bill to the Senate that would allow patients to take “experimental treatment” without facing legal repercussions, though the article mentions that doctors could already prescribe experimental treatments to patients. The Senator says it will protect doctors, but the Medical Association of Georgia opposes it:

“This is misguided public policy,” said David Cook, director of governmental relations for the Medical Association of Georgia. “In the bill, a doctor could tap dance around your bed and that could be the cure for cancer.”

At least the tap dancing doctor could be entertaining and someone would be getting some exercise. ANP doesn’t show even those benefits. The bill passed the Senate 74-2. It passed in the House 146-19, the Telegraph reported on the 26th of March. It was rushed through by the urgency of the Senator’s situation.

By June 26th, Burzynski has already exacted all of the money raised by the Senator, and another fundraiser is in the works, this time to raise $100,000. One of the guests at the fundraiser is future Georgia Gov. Sonny Perdue. Half way through the article, the Senator reports something horrible:

[The Senator] said the treatments have shrunk the tumor to the point that brain scans now pick up a ‘2-inch circle of fluid or something. It’s not an additional mass,’ he said. ‘It’s actually eaten through the brain.

And there it is. Another patient reporting that a cyst in a tumor is a sign of improvement, not a sign that the tumor has outgrown its blood supply and that the ANP has not arrested its growth one jot. Patients have repeated this horrible, unconscionable, misleading prognosis for what is ischemic necrosis for decades.

Why? I bet it has something to do with the 100,000 that the future governor is raising.

At this time, it seems that the Senator will be on treatment for up to two years, and that he has another 8 months at least hooked up to the IV pump. He here confirms that he is experiencing the most noticeable side effect of treatment: “The only thing that I have is a tremendous amount of fluid going going through my body. It just wears you out.”

The fundraiser nets only $25,000 for the Senator. “It just means we’ll have to have another one,” he says in the July 8th edition of the Telegraph. In November, the poor guy is asking for another $25,000. The paper reports that:

“[…] recent tests show his brain tumor is completely gone, but he must continue is treatment for several more months ‘just to make sure.’ He now needs $25,000 to pay for the intravenous and oral medications.”

This seems difficult to believe, especially given what’s coming.

In September, the Senator is one of the delegation who travel to Washington to appear before Congress on behalf of the man who is bleeding him, his family, his church, and his colleagues dry. In his testimony in front of the Government Oversight and Reform Committee, the Senator says:

After learning of alternative treatments and the problems they were having with the FDA, this past January during the Georgia General Assembly I introduced and was successful in getting passed an Access to Medical Treatment Act. The citizens of Georgia believe that patients ought to have the access to the treatment of their choice when their lives are threatened. Because I am a State Senator my name has been in many stories nationwide associated with Dr. Burzynski. This has led many potential patients to call and ask me about the treatment and for help getting into a protocol.

The most disheartening thing about the whole ordeal with the FDA is that while the FDA is allowing the antineoplastons to go through clinical trials to test their efficacy, they are making patients take treatments they do not want to take before they can become a part of a clinical trial. One reason we choose Dr. Burzynski is that his medicine is nontoxic. For the FDA to make a patient take radiation before they can become part of a clinical trial for antineoplastons is unreal.

The FDA will not allow patients that don’t fit the protocols to take the antineoplastons without a fight. One gentleman from Texas had high blood pressure and because the medicine is a sodium based medicine taking the normal dose the way the protocol requires would have caused him more problems. This gentleman needed a special treatment unique to him. It took six weeks of fighting with the FDA and getting his Congressman involved before he could take the treatment.

When the FDA was created it was with good intent. The citizens of this country needed help with determining whether drugs were safe or not. But if I allowed my two boys to grow up without supervision they would become something different than they are now. They would be arrogant, belligerent, undisciplined and uncaring much like the FDA has become. I believe it is time that Congress steps in and brings some discipline to this department and restore some integrity.

Of course, a protocol is called a protocol for a reason, so that you can get reliable data by comparing like cases. A patient who has high blood pressure (and presumably a brain tumor) should probably not be on one of the sodium bombs that Burzynski’s Clinic administers.

On 20 August of the following year, the Senator decides to not run for another term in office, as reported in the Atlanta Journal Constitution:

State Sen. Ed [G], Republican from Macon, has changed his mind about running for re-election. [Senator G] was diagnosed with a brain tumor two years ago, and has withdrawn from the race for health reasons.

[Senator G] had no opposition in last month’s primary. The state Republican Party’s executive committee has nominated Susan Cable, a Macon community activist and former Bibb County school board member, to run in his place for the 27th District seat. The Democratic nominee in the race is Floyd Buford, a Macon attorney.

[Senator G] said he plans to serve out the rest of his term. However, he said the rigors of campaigning, combined with the medication he’s taking will prevent him from seeking re-election. “I probably wouldn’t be able to do it — not as well as I should,” he told the Macon Telegraph.

Since his diagnosis, [Senator G] has been traveling to Texas for alternative therapy that he said has resulted in significant improvement in his condition.

Yet he’s too sick to continue. What happened to the “disappeared tumor”?

The Senator died on Nov 8, 1999 according to the AP, “of brain cancer.” He was 46-years old. If the Senator was in a clinical trial, it remains unpublished to this day.

For reliable information about clinical trials, visit to clinicaltrials.gov. Please contribute to St. Jude’s Children’s Hospital, which cares for sick children even if they can’t pay. Unlike Burzynski.

Burzynski Patient Derek T.’s Story

Derek T. first appeared in the press in June 1993. At the time, he was suffering from a brain tumor and the community was rallying around him (and 2 other kids with cancer) to raise money for the Children’s Wish Foundation. Derek was 6 years old and had been taken to Sea World by the charity. According to his mother, who appeared in the Hamilton Spectator:

Derek’s mother […] was also overwhelmed.

“I just can’t believe how much the community is pulling for us,” she said. “People really didn’t know what to do, so they did this. It has helped the family and I think the trip to Sea World helped Derek’s health.”

Derek’s journey was chronicled by the Hamilton Spectator, so we have a pretty good record of his progress. At the time of the fundraiser for the Children’s Wish Foundation, according to an article that appeared in April of 1994, his tumor was shrinking thanks to radiation treatment. He went back to school in September but, then we hear in the issue from April 18:

But, around Christmas, his flu-­like symptoms turned out to be the tumor growing again and pressing on his brain.

‘It happened very fast,’ said his aunt.

Before long, he was confined to a wheelchair. As the condition overtook him, Derek could only shake his head and move his hands to communicate.

That’s when the [family] re-­mortgaged their home and decided to ignore the advice of caregivers at McMaster University Medical Centre.

They were on their way to Houston, to the Burzynski Clinic, where they have used an unproven experimental chemotherapy for nearly 40 years under the guise of clinical with no good evidence for efficacy. The Spectator is way out of its league and has basically no idea what the treatment entails as we see in April:

In Houston, he hopes to receive a new treatment involving injections of plasma­like antineoplaston cells through the chest catheter.

No, not even close. If only the Spectator had reviewed the 1982 report by Canadian physicians Blackstein and Bergsagel commissioned by the Ministry of Health in Ontario, which had some damning revelations:

We were left with the impression that either [Dr. Burzynski] knows very little about cancer and the response of different tumors to radiation and hormonal measures, or else he thinks that we are very stupid, and he has tried to hoodwink us. As we look back over the cases were were shown, we are left with the impression that the only patients who are still alive either had slowly growing tumors, or had received effective treatment before being referred to Houston.

The 1982 Canadian report concluded:

After reviewing 20 case reports, selected by Dr. Burzynski as his best examples of clear cut responses to Antineoplastons we were unable to identify a single case in which therapeutic benefit could be attributed to Antineoplaston.

And even more from the 1982 Canadian report:

We believe that it is unethical to administer unproven agents such as Antineoplastons to patients without satisfying the requirements of the FDA and an ethics committee, that the minimum standards for human experimentation are being met. We also believe that it is immoral to charge patients for this unproven, experimental treatment.

So, in April 1994, the family, facing the progressing disease ends up in Houston. Instantly, unnecessary life-threatening complications arise just trying to get Derek on treatment:

His parents […] and his five-­year­ old sister […] flew to Texas last Thursday, when Derek was admitted to hospital for insertion of a catheter in his chest through which the new drug will be pumped. ‘They had trouble inserting the catheter because they couldn’t find a vein, then when they got him stabilized … his heart went wild and started beating 200 times a minute,’ said his aunt […] in a telephone interview yesterday. ‘He has a very low blood count and when your blood count is down you don’t heal properly,’ she added. ‘We’ve been told the next 24 hours are going to be critical.’ The child has already received one blood transfusion and may need another, she said

The doctors objected to antineoplastons for a reason. At the same time, the family is feeling the pinch:

Money, she added, is becoming a major worry for the family. ‘This hospital stay isn’t something we’d planned on,’ she said. ‘OHIP doesn’t cover any of this because it’s an experimental treatment and you pay for your Kleenex and bedpans and everything.’

This is the case at Burzynski’s clinic, though it would probably not be elsewhere. Usually, patients receive medical care in exchange for being on a clinical trials, because the developers intend to make their money when the drug goes to market. R&D is an investment in real drug trials. At the Burzynski Clinic, patients pay dearly to receive experimental treatment.

When Derek was let out of the hospital, he moved into a motel, where they hoped treatment would begin:

‘They figured on Wednesday Derek was stable enough that they could start the treatments, so what’s going to happen is that they’ll set up all the medical equipment they need in the motel so they can do the treatments there rather than having to get Derek to the clinic every day,’ said [Derek’s aunt]. ‘I think someone will be coming over every day to spend a couple of hours to get this treatment into him. ‘We’re told they may be able to come home in two to three weeks, but it could be four to six weeks before they start to see any effect from the treatments,’ she added.

The kid’s too sick to go to the Clinic.

Two days later, we hear:

They have been told the treatments could last six months, or continue indefinitely at a cost of between $3,000 and $10,000 a month. Yesterday, Derek’s aunt […] said: ‘Yesterday was a good day for him, his spirits are up and he seems to be gaining strength. ‘What they’re going to do is continue the treatments for 10 to 14 days and then see about letting him come home. His parents seem to feel better now that the treatments have started. They seem to be a little more up now.’

All the while the community is rallying around Derek to raise money for Burzynski. A few days later, Derek’s uncle returns home and talks to the press:

‘I think our little guy’s getting better,’ [Derek’s uncle] said yesterday afternoon. ‘They’re saying that if he makes it through the next month his chances will improve fantastically.’ ‘I think the next two weeks are going to tell it all,’ he added.

The child is in a pretty horrible state, almost locked in, it seems:

‘Now he’s a lot more alert and staying awake a lot longer,’ he said. ‘They’ve worked out a little sign language to communicate with Derek ­­he looks up for yes and closes his eyes for no.

And in this interview we get a sense of the power of testimonials, which are nearly worthless as evidence of a treatment’s efficacy:

In the weeks before Derek’s parents […] decided to make one last attempt to save their son’s life, they contacted several former and current patients of the clinic to ease their natural suspicion. ‘We had a lot of suspicion before we went down,’ the uncle said. ‘We were asking ourselves should we go or should we just stay here and let Derek die in peace.’ That’s when they started talking to former patients, gathering uniform reports of miracle cures.

‘I sat there on the phone in tears talking to these people and then told John and Brenda they had to make a try,’ he said. ‘Everyone we talked to had a different story, but it was all one miracle after another.’

And that’s the hook. These patients stories are deceptive, and it’s not because the patients are lying (though they are almost certainly wrong in every case). USA Today reporter Liz Szabo documented some of the problems and practices at the Burzynski Clinic that explain the apparent “miracles” without crediting Burzynski.

On May 6, we hear that money has been pouring in for Burzynski on the back of this kid’s suffering. The uncle seems to be hearing that things are going well:

According to Derek’s uncle […], the child is improving every day. ‘He’s starting to move his arms and say things like ‘Mom’ and ‘No.” ‘They’re quite enthusiastic at the clinic about the progress he’s making. ‘Everything sounds really good so far.’

That may sound like a gain, but it also sounds… really, really slight. Almost imperceptible, and you know that the family is scanning and interpreting every grunt and motion as a reflection of what is going on with the tumor. Except the next week, on the 14th, we hear:

The Winona boy, 6, who is undergoing an experimental treatment for the brain ­stem cancer that threatens his life, was taken to hospital earlier this week for treatment of fatigue and because he wasn’t eating. Derek’s uncle […] said the hospital treatment was needed because the megadoses of the serum he’s receiving frequently left him too tired to eat properly. After two days, however, he was returned to the motel room where he’s staying with his parents. ‘He had a bit of a turn for the worse, but now he’s doing fine again.’

So, by the family’s account, this was a life-threatening side effect of the treatment.

But the fundraising for Burzynski has gone well. By May 25th, some $40,000 in donations have arrived for the treatment. The family is still in Houston. I wonder if he is too sick to move:

In a telephone interview yesterday, Derek’s mother said the child remains weak from the constant flow of drugs he is receiving, but she is learning to take great pleasure in small victories.

“I got really excited yesterday because I heard him laugh a little while he was watching cartoons,” she said. “That was the first time I’d heard him laugh in two months.”

When Derek was discharged from a Hamilton hospital two months ago, his parents were told there was little hope he would survive. That’s when they decided to make a last­-ditch stand against the disease.

“When he got out of the hospital in Hamilton, they said his time was limited, but now we’ve celebrated another birthday and that’s got to say something,” [his mom] said. “If you saw him in the hospital when he could barely move his arms, you’d know just how far he’s come.”

Honestly, I’d be interested in seeing what type of anti-inflammatory steroid dose the kid is on. As reported by USA Today, according to an FDA warning letter from April of 2013:

In a written response to FDA inspections sent to the agency in April, Burzynski had argued that patients with brain tumors often need anti-inflammatory drugs, called corticosteroids, to restore normal levels in the body. The FDA did not accept this explanation, however, noting that Burzynski had patients on steroid doses that were five to 64 times higher than the levels that doctors would expect patients to need. [emphasis added]

This does throw into question, as the FDA noted, the reliability of Burzynski’s results. And in reality, things are not going well, as we hear on the 28th of May:

A thousand miles from home, in a tiny motel room on the outskirts of Houston, Tex., [Derek’s parents] pray for a miracle.

On the bed in front of them lies their seven-year-old son Derek, his mouth hanging open, his pale body limp. A tumor the size of a golf ball is pressing on the stem of his brain, paralyzing most of his body and causing pain no child should suffer.

[…]

The youngster can’t move his limbs, he can’t talk, and it’s a struggle to even open his eyes. But he is alive.

[…]

“As a parent, you can’t just sit there and watch your son die,” [Derek’s mom] says. “You do everything in your power to save his life. You try anything and see anyone who might be able to help because that’s all you can do. You are so desperate.”

Yes. And that’s why the FDA and the TMB need to step up and stop playing ball with predatory alt med peddlers. In the same article, we see the family is having doubts:

At the moment, the [family is] not convinced Dr. Burzynski is Derek’s miracle maker.

[…]

It’s costing the [family] as much as $1,000 a day for doctors’ visits, equipment, emergency trips to the hospital, and to keep up the steady flow of Dr. Burzynski’s concoction for their son.

[…]

“Sometimes I wonder if maybe we should just hop on a plane and go home,” [Derek’s father] says. “But then the next day we’ll see an improvement and think, this is his only chance.”

And at this point, improvement is indistinguishable from just not getting worse. In some ways, this case is reminiscent of the course of Chase S.’s story. Chase was essentially lying in state for months in his parents’ living room, while the family insisted that he was improving.

The family has been in Houston much longer than the usual 3 weeks, and they are thinking about trying to get Derek home in early June, as we hear on the 4th:

While there’s no evidence yet to show the treatment is working with Derek, [his dad] said they are eager to come home. “We’ve been here quite a while now and we are comfortable administering the medication so we could do all that at home,” he said in an interview yesterday.

There were plans to do an MRI scan on Derek to determine if the brain tumor is shrinking but he’s been too weak the last 10 days to undergo the procedure.

He’s been battling fluid in the lungs and cold­-like symptoms; yesterday was his first day back on solid foods in a week.

The father says that Derek is better than when he came down, but how can that be? They plan to return to Canada with a 2-month supply of antineoplastons.

Once the family returns, the paper seems to give us a more frank assessment of Derek’s lack of progress:

“His eyes are much more alert and although he can’t talk, he’s able to communicate with us,” [Derek’s mom] said.

They don’t know for sure if the experimental treatment he received at the clinic ­­- called antineoplastons ­­- has shrunk the boy’s tumor; he has been too weak to undergo the scan that would determine its size.

But they believe the medication has at least stopped the tumor’s growth, based more on what they saw at the clinic than improvements in his physical condition.

“We really truly believe in that clinic,” Derek’s mother said. “We saw so many miracles down there, people coming in real bad shape and walking out of there. We are believers.”

She said seeing those people get better helped keep the two of them going during times when Derek was not doing so well.

“It made us strong and gave us hope,” she said.

“We have no regrets about going down. We’re glad we went and we hope everything works out,” [Derek’s dad] added.

If there is one regret, it’s that they didn’t discover the clinic earlier, when the tumor was smaller, [Derek’s mom] said.

The statement that they “saw so many miracles down there” is curious. It’s too bad they weren’t more explicit about the nature of those “miracles.” They even turn blame back on themselves for why they aren’t seeing improvement, that they did not get their sooner. It probably would have made no difference to anyone but Burzynski’s accounting staff if they had.

Another thing, there’s no evidence that Derek has received palliative care, which is surely indicated. And on June 21st the Spectator headline says it all:

“All we can do is hope, pray,’ says mom: No sign experimental drug is working for Derek”

On September 15th, Derek died. During the intervening time since the last update in the paper, Derek had been in the hospital a lot:

[His mom] explained Derek has been in and out of hospitals in Grimsby and Hamilton for the last five weeks suffering a variety of ailments that included a bleeding ulcer, pneumonia and urinary infections.

And in the end, the family rationalizes why the treatment did not help, as we see in the paper:

Derek’s father […] said they’d been told their son would need to get the anti­neoplaston treatment, delivered through a catheter inserted in his chest, for a solid six weeks in order to show any benefit.

Because of his recurring health problems, however, the longest stretch they managed was five weeks. “We got the treatment into him, but it was never as much as he needed,” [Derek’s dad] said.

This is the first time that we have heard this “six solid weeks” nonsense. As we know from any number of patient reports, nurses have claimed that it begins working immediately. It’s hard to say why in this case the family would be told this (if that is in fact accurate that they were), but it does give the Clinic an easy out when the boy arrived too sick to even make it to treatment.